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•Price Consolidation Positions SanuWave Health (OTC: SNWV) For Catalyst-Based Rebound

noreply@blogger.com (VFC) — Thu, 16 May 2013 18:06:00 +0000

Shares of SanuWave Health (OTCBB: SNWV) swiftly achieved a near double in price earlier this year as investor anticipation grew in regards to the initiation of a new Phase III trial testing the company's dermaPACE shockwave therapy in the treatment of diabetic foot ulcers. A new trial design and an agreement with the FDA to utilize some previous Phase III data added to the enthusiasm and hinted that SNWV shares had the potential to approach price levels seen during the last Phase III trial. That trial, as previously discussed, ended without the endpoint being met, although the results were convincing enough that success could be easily achieved after the new trial designs were implemented.

Since the quick spike in price, however, SanuWave shares have retreated again after many of the short-term minded day, swing and momentum likely took some profits and moved on in search of another quick winner - although you can never blame anyone for taking some profit from the table - but the result of such action could potentially be another buying opportunity for investors who may have missed out on the last quick run. Given the encouraging prospects for the upcoming trial and the numerous catalysts that will be slated to unfold - in terms of interim and actual results - once the trial gains momentum, SanuWave shares could quickly rebound once the current phase of consolidation is complete.

On Monday of this week the company announced that it had concluded an "investigator meeting" with 75 representatives from 18 clinical trial sites. During the meeting, the 75 reps were provided training on the prospective use of the dermaPACE therapy during the trial, while also emphasizing the newly-implemented design protocol that is expected to maximize patient enrollment and follow-up. Unforeseen variables surrounding patient follow-up during the first Phase III go-round were assessed to have altered the end results, so company officials are taking out all the stops to ensure a smooth and more-regulated operation this time.

With the investigator meeting wrapped up and the clinical sites prepared to start enrolling patients, SnauWave remains on track to get this trial underway within the current quarter. The latest retreat in share price, as mentioned above, may provide a nice period of consolidation for those looking to play the future catalysts and milestones - and for those looking to accumulate a position with eyes towards the end game.

It's the potential of that end game that could attract the longer-term speculative investors. While SanuWave eventually plans to target a broad portion of the chronic wound market, its first US-based indication of diabetic foot ulcers provides the company a booming market into which to enter. Even gaining just a small foothold could return significant share price and market cap gains, given the alarming rate at which cases of diabetes are growing.

Over Twenty-three million people in the United States have been diagnosed with diabetes and it is speculated that millions more have it, but are yet-to-be diagnosed. It is also assessed that fifty seven million people in the US are pre-diabetic, according to statistics posted by the American Diabetes Association. Globally, the diagnosed numbers are much more severe and it's also estimated that a higher percentage of cases go undiagnosed. The burdens placed on the healthcare industry as a result of this growth is obvious.

Weekly Stock Watch, Week Of 13 May 2013: APHY, TROV, ANTB, KERX, AMRN, SNWV

noreply@blogger.com (VFC) — Mon, 13 May 2013 20:47:00 +0000

Many market analysts and economic pundits have predicted over the past few months that the record-setting highs - although nice while they lasted - would only be short-lived and a pullback or outright market correction was in store. Stocks proved overly resilient, though, and despite some questionable economic news at times to go along with gloomy predictions from many financial media outlets, new records have continuously been set, defying the negative forecasts and making winners out of many green portfolios and IRA accounts. The continuous uptrend may have made believers out of many, but some skepticism still prevails as we head into a new trading week, leaving the door open for investors to take advantage of the individual stocks and stories that may not be gaining much mainstream attention.

Here's a few to keep an eye on for the week of 13 May, 2013...

Assured Pharmacy Announces New Store Openings

Shares of Assured Pharmacy (OTCBB: APHY) have been steadily gaining investor attention over the past weeks, if trading volume is to be an indication, and recent announcement just days ago of multiple new store openings over the near term may not only explain the uptick in volume, but also provide assurances that the company's potential to significantly grow its revenue stream over the coming quarters is leaning more towards the likelihood of being a probability, rather than just a possibility.

A letter to shareholders last month set the stage for what's to come over the coming year, but last week's definitive announcement of major store openings within months confirms the previous promises and speculation. According to the news, two new stores - in Denver and Boston - are slated to open this summer in what Assured officials are labeling a "major expansion strategy."

As previously mentioned, the new openings will essentially mimic the operation of Assured's most successful store to date, its Kansas location, and open with the support of local physician groups. The Kansas store was also the first Assured location to move beyond treating only the indication of chronic pain, as target business is now geared towards the prescription and distribution of all "chronic controlled medications."

Such revisions in the business strategy have Assured officials believing that overall revenue can be doubled within the next two years. Already the company has realized revenue numbers of well over ten million dollars on an annual basis, indicating that the APHY share price may have significant room to grow over the coming quarters if the new revenue projections can be matched, especially in consideration to the currently-speculative market cap.

In addition to the imminent Boston and Denver grand openings, Assured has identified four other locations where new stores may be slated for operation.  As it now stands, a total of twelve locations can be opened without blowing the corporate structure, supporting company promises of gaining a national footprint over the near to mid term.

Although still a speculative stock selection, this could be a pivotal year in Assured's progression as plans for rapid expansion support an aggressive growth strategy. It also helps that industry trends favor Assured's business plan of providing strict regulation of controlled medications while also offering personalized pharmacy service, making this company a hot one to watch over the coming weeks and quarters.

As volume picks up, so, too, can the share price - especially if the new locations can replicate the success of the Kansas store.

TrovaGene Successes Highlighted By Analyst Coverage

Shares of TrovaGene Inc (NASDAQ: TROV) have roughly quadrupled in price at times over the past couple of quarters based on the rapid development of the company's pipeline of urine-based diagnostics that are designed to detect and identify various cancers and infectious disease types. The convincing price action was based on the anticipation of a series of pending product launches, including the launch in March of a diagnostic that could detect human papillomavirus (HPV) by means of a simple urine sample. While already a hugely successful story for the year, evidence indicates that TrovaGene may still only be in the early stages of growth and a price target issued last week by Highline Research Advisors could confirm that fact.

According to Highline, which initiated coverage through Empire Asset Management Company, a FINRA member, TROV shares could hit a high of $17 over the course of the next twelve months. The enthusiastic price target, naturally, was accompanied with a rating of 'Buy.' Recent developments have supported the speculative rise in the TrovaGene share price, but growing collaboration and additional product launches may indicate that the Highline price target - which is nearly triple the current levels - could easily meet fruition.

In maybe the biggest collaboration news to date, TROV announced last month a partnership with PerkinElmer Health Sciences Inc (NYSE: PKI) in which the two entities will design an assay to determine the risk for developing hepatocellular carcinoma.  A deal such as this one with a highly-established player in the sector comes as a huge sign of validation for TrovaGene and the news may have placed its technology on the map for a good few investors, judging by the volume and price action following the announcement. These collaborative efforts, which include another high-profile deal with the Texas MD Anderson Cancer Center, also lay the groundwork for significant royalty-based revenue later on down the road.

In addition to the partnership possibilities emphasized by the Highline rating, the price target also likely bears in mind the numerous catalysts that are expected to unfold during the coming months, which include at least one new commercial launch of a urine-based diagnostic during each quarter for the remainder of the year, according to a recent company presentation. Those product launches, in combination with expansion on the partnership front, build a solid foundation for the company moving forward and could justify the near-triple in price expected by Highline.

Still a developing story to keep an eye on for the upcoming week - and then for the remainder of the year.

AntriaBio Opportunity Widens As Shares Slip And Volume Picks Up

Although some early-year interest propelled AntriaBio, Inc. (OTCBB: ANTB) shares to well over double their current trading levels, investor interest on the surging broad markets may be allowing this story to slip below the radar again. AntriaBio, as outlined on previous occasions, is well-positioned to take advantage of shifting trends in the healthcare sector with AB101, a once-weekly injection of basal insulin that will look to replace the current standards of at least once-daily injections. The company has been relatively quiet of late, but volume has been on the rise and investor interest could grow as some key catalysts play out over the duration of the year.

According to a presentation posted to the AntriaBio website, ANTB is slated to build on the foundation set by preclinical studies and initiate human trials later this year. Data from those trials are expected by year-end, at which point AntriaBio could look to partner with a larger company to help fund further development - assuming successful results. Considering the multi-billion dollar industry into which AB101 may be positioning to enter, the interest of big pharma could come quick - should results look solid - as recently outlined by Another Seeking Alpha author.

A noticeable spike in volume through the month of April could be an indication that shares are consolidating ahead of the expected key trial catalysts. Those who keep an eye out for 'volume before price' plays may take note of the recent volume spike with enthusiasm, especially as this company's story looks to be sliding below the radar as the broad markets continuously set new record highs.

In an effort to control costs, human trials will be conducted in Russia first, where costs are significantly lower and where patient recruitment is known to be up to ten times higher than in the US and Europe. In the meantime, the AntriaBio team will will move forward with the FDA IND process in order to set the stage for US trials, too.  Positive data from Russian could expedite that process and - as mentioned above - potentially attract partnership interest.

Beyond AB101, AntriaBio is also establishing a secondary pipeline product, AB201, a long-acting Glucagon-like peptide-1. This product is quickly approaching the pre-clinical stages and will be tested as a once-monthly replacement for the current standard of care. While still early in development, a secondary pipeline product allows investors to consider AntriaBio as not a 'one trick pony.' Keryx Biopharmaceuticals (NASDAQ: KERX), for instance, has recently emphasized the necessity of a company to have a back-up plan, should its lead product fail. That back-up plan helps to alleviate future risk to investors, too.

For the time being, however, all attention is on AB101 and it should only be a matter of time before the expected catalysts start to hit the wires. In the meantime, a boost in volume may offer an indication that interest in the story is growing and shares are consolidating. The speculative sector often takes a hit when there is a widespread market rally as there has been thus far this year, but sometimes those 'under the radar' stories can bounce back fairly quickly once the rally sputters. The likes of AntriaBio could stand to benefit.

Worth watching.

Amarin's Volatility Growing In Line With Vascepa Prescriptions

It's been a see-saw battle for shares of Amarin Corporation (NASDAQ: AMRN) while this stock's trading range has consistently bounced from the sixes to the sevens and then back to the sixes again. The volatility is directly related to the continued long and short-sided battles that are played out in the headlines on a near-daily basis by numerous popular financial media outlets, although due respect also goes to the catalyst events (or lack thereof) that are keeping Amarin at or near the top of the list for the most-watched of the sector. The company released its latest earlnings report on Thursday of last week, an event that led to a six percent price spike on Friday.

An enthusiastic case was made on the solid growth in prescription numbers for Vascepa, but overall revenue still came in at modest enough numbers to keep skepticism alive - especially when considering that many expect Vascepa to quickly approach blockbuster status in quick time. That said, the expanded approvals for which the company has already applied would provide a significant boost to those expectations.

Moving into the new week, however, not much should be expected to change in terms of AMRN's trading action. In the absence of news - which includes the absence of certainty surrounding Vascepa's New Chemical Entity (NCE) status - the registered trading range of the recent past will be expected to continue into the future, too, at least for the short term. That said, a definitive decision on NCE by the FDA could reinvigorate the buyout and/or partnership rumours that surrounded this stock before the company decided to launch Vascepa on its own. Such an event could quickly push the share price back to the ten dollar mark quick, fast and in a hurry.

Any potential suitors may also be encouraged by the swift growth in prescription numbers that Vascepa has registered through the last quarter, while also considering the fact that the revenue numbers are somewhat skewed by discounting and other product-pushing bargains for consumers. While proven to be a solid trading candidate over recent months, the long case still exists. Vascepa is demonstrating growth while the stock action continues to look similar to that of Human Genome Sciences shares before that company was bought out by GlaxoSmithKline (NYSE: GSK) about a year ago.

Another factor contributing to Amarin's volatile trading patterns of late could be the wide circulation last week of a study in Italy indicating that fish oil doesn't work in reducing triglyceride levels as much as expected. The naysayers will make the case that Vascepa will ultimately fail, thanks to the results of that revealing study. To make that conclusion, however, could only be considered weak. Vascepa blew away trials in the much more regulated US with the ANCHOR and MARINE trials, and the Italian study is merely propaganda at this point, and nothing else. To make "news" out of anything going on in Italy aside from Silvio Berlusconi's bunga-bunga parties is merely a distraction. For all we know, this study could have been conducted at one of those parties.

The economy over there is on the brink, but a largely unregulated "study" is getting all the press? C'mon now. Let's keep it a bit more real.  Next we'll hear that Luca Brasi is actually sleeping with the fish oil, not the fishes. Weak.

As usual, AMRN will be a hot one to watch this week, especially after Friday's six percent rebound.

SanuWave Retraces, But Unfolding Catalysts Could Spark Rebound

Similar to the AntriaBio story mentioned above, it's easy for the market to ignore still-developing or speculative growth stories while the broad markets are rising fast and keeping investor portfolios well in the green, even without the under the radar winners that are often sought out in stable or declining markets. What SanuWave does have to offer, however, is a late-stage product-based therapy that could transform its target market over the short term. When considering the current market cap, though, investors may be disregarding the opportunity that SanuWave's 'shock therapy' has to offer.

In imminent time, SanuWave is set to reinvigorate the Phase III development of dermaPACE in the treatment of diabetic foot ulcers. A previous trial proved that SanuWave's 'shockwave therapy' works, although the primary endpoints of the trial were not met. A new trial design, however, and expectations of more regimented patient participation during this go-around may be the key to fulfilling the positive predictions of the past. Enthusiasm is high, with the FDA having assisted the company in developing the new trial design. The FDA also agreed to consider the previous Phase III data along with the new data that will be compiled during the upcoming trial.

With cases of diabetes growing at an alarming rate on a global scale, SanuWave may have done its technology justice in targeting the cases of diabetic foot ulcers first. Over Twenty-three million people in the United States have been diagnosed with diabetes and it is speculated that millions more have it, but are yet-to-be diagnosed. It is also assessed that fifty seven million people in the US are pre-diabetic, according to statistics posted by the American Diabetes Association. Globally, the diagnosed numbers are much more severe and it's also estimated that a higher percentage of cases go undiagnosed. In relation to SanuWave's initial application of dermaPACE, fifteen percent of diabetics will acquire "non-healing" ulcers in their lifetime, including the target indication of diabetic foot ulcers. According to the above-linked statistics, this market is quickly approaching two billion dollars annually, which solidly positions this company to take advantage of a swiftly-growing market.

The burdens placed on the healthcare industry as a result of the growth of diabetic growth is obvious and SanuWave, which traded multiple times higher during the last Phase III trial, could stand to gain and rebound as the new trial progresses and investors absorb market potential of the technology. A recent decline in share price could be attributed to a bout of profit taking after the swift spike in share price, but may also be related to the overall market rally, which often takes attention away from the more speculative plays such as SNWV.

As the upcoming trial progresses, look for attention on the company to become more intense, especially if actual or interim data hints at success. SanuWave has been relatively silent on the news front of late, although a new appointment to the medical team was announced earlier in the month in a move that strengthened the FDA approval team.

It's already been a successful - and pivotal - year for SanuWave, but the upcoming trial could hold the key to the near and mid term catalysts. Any hints at success could launch shares back to the levels seen during the previous trial.

Roundup: Attention is still on the broad market rally, but investors should still keep an eye on those speculative stories that may still pay off later on down the road. Earnings season is in full flux this week, too, but reports thus far have not had too much of an effect on the overall market action. That said, this will be a retailer-heavy week, which means any disappointments would confirm first quarter warnings that consumer spending is on the decline. Regardless of the overall market action, however, investors looking to take a flyer on the more speculative side are going to be looking for bargains with their early-year profits. While caution should always be exercised with the more speculative picks - as with all in the stock market - significant gains could be had while finding a few before the rest of the market catches on. Above we've mentioned just a few of tomorrow's potential winners.

As always, each investor should conduct his or her own DD and devise entry and exit strategies respective to each investor's tolerance for risk. Always expect volatility, potential lossses and sporadic fund-raising events in line with the speculative sector. With that in mind, investors utilizing a strategy that includes trading the 'trading shares' into price catalysts could find themselves on 'house money' by the time the full story plays out, even while also compiling a core base of shares with eyes towards the long term story playing out.

It's an exciting market all around these days. Enjoy it.

Happy Trading!!!

Disclosure: Long ANTB, APHY, AMRN.

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Assured Pharmacy (OTC: APHY): Aggressive Expansion Could Lead To Explosive Growth

noreply@blogger.com (VFC) — Sat, 04 May 2013 21:42:00 +0000

Through the course of its early development and growth stages, Assured Pharmacy (OTCBB: APHY) has admittedly faced challenges not uncommon to other niche start-ups in a tough economic climate, but with trends shifting in the company's favor and its newest store also its most profitable, this company could be on the verge of a breakout with significant expansion coming. Assured Pharmacy is a unique, personalized pharmacy that caters specifically to the prescription needs of its customers while also heavily scrutinizing the distribution and use of heavily-regulated prescription medications for both doctors and patients in order to ensure strict compliance with federal regulations. Assured has targeted the chronic pain market for its services, given the high rate of abuse and misuse in the sector, which has highlighted the need for specialized pharmacies.  Its customer base of both doctors utilizing its services and patients receiving their personalized care has grown and is currently in a backlog, according to statements made in a recent letter to shareholders.

As additional funds can support, Assured will be able to take on additional customers, which could quickly double the current patient base - again according to recent communications by the company.

Four stores are currently in operation in relatively modest markets, but - as mentioned above - the Kansas store is the most recent to open and has quickly become the largest and most profitable of the four. Based on the Kansas model, Assured looks to significantly expand its presence on a national scale through the coming months, with six locations expected to open in 2013. A grand opening in Colorado is imminent, according to the latest financial report, and more highly-populated areas are being targeted in order to quickly expand its presence and patient base.

Given the growth expected in the existing stores, should funding allow, and the targeted expansion into densely-populated regions this year, Assured could be at a pivot point in becoming a mainstream destination for patients of chronic pain looking for the personalized services being highlighted by shifting industry trends.

The company is also enhancing its already-stringent distribution methods to further cement its reputation for quality, efficient and safe pharmaceutical services as the new locations are opened. This is a key component of the company's future growth strategy, as its strict compliance with regulations has the potential to position the company as an industry leader, which could then attract the interest of a broader base of doctors and patients and fuel future growth while also attracting the preferences of those national and private insurance and regulatory agencies who tend to shy away from sub par services.

These prospects and strategies could be bearing fruit just at a the right time, as many of the already-established big players in the sector, such as Walgreen (NYSE: WAG), Rite Aid (NYSE: RAD), CVS (NYSE: CVS), and Wal-Mart (NYSE: WMT) (whose business strategies rely more on selling copies of US Weekly magazine and discount Halloween toys) often come under fire for unprofessional and imperfect regulatory compliance.  Through its initial operations, Assured has built itself a crisp and clean reputation thus far and the company is nicely positioned to capitalize, especially considering the amount of planned expansion over the coming quarters.

Along with the noted progress made on the business front, Assured has taken measurable steps forward on the investor relations front, too. Company shares were recently uplisted to the OTCQB from the pink sheets, a move which will inherently attract a new investor base as generally only the most speculative investors play on the pinks, while an uplisting the AMEX or NASDAQ has also been discussed, should APHY meet the respective listing requirements of those big boards. A move to one of those platforms would lend even more credibility to the company and would likely attract the investor base desired by the company, assuming the growth strategies implemented beforehand bear fruition and potential. The latest shareholder letter also noted the fact that Assured is planning a more aggressive investor relation campaign as the new locations are open, too, a factor that could potentially weigh heavily on trading over the next few quarters, if the 'road show' is successful.

What APHY needs first, though, is a steady influx of trading volume.  Although modestly on the rise over recent weeks, volume is still at levels that would label this company as one with 'under the radar potential.' The still-speculative level of the market cap, too, would validate that theory, but both factors are indicative that potential investors may be taking a 'wait and see' approach before dabbling into APHY. In the speculative world, however, finding the undiscovered companies before they become discovered could return huge gains to investors willing to jump in early and who may also be willing to absorb the significant risk that comes along with jumping into the speculative sector. As previously emphasized, a strategy that includes slow accumulation geared towards the long term - with the utilization of trading shares to play the catalysts along the way - could help to alleviate the risks (although you can never eliminate them) and allow investors to potentially come out on house money before the full story plays out.

Hints at profitability exist when looking through Assured's publicly available information, especially in terms of the Kansas store, and company officials are looking to duplicate that early success with the slew of new grand openings planned for the coming months. Industry trends are heading towards reliability and accountability, a factor that heavily increases the odds that Assured can make a dent in the market, and the rampant abuse and misuse of pain medications in today's society also heavily favors the shift towards this company's niche services. It's been proven during the early-going that Assured's stringent methods of compliance drastically reduce the threat of abuse.

This could quickly turn into a pivotal year for Assured Pharmacy - one that should keep investors satisfied with a steady flow of news. Should the company start receiving more mainstream attention as growth is realized and new locations are open, a more consistent volume and trading base could be formed, which may also include a speculative share price boost, too.

A nice one to keep an eye on over the coming months.

Disclosure: Long APHY.

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TrovaGene (NASDAQ: TROV) 'Ups The Ante' With PerkinElmer Collaboration

noreply@blogger.com (VFC) — Sat, 04 May 2013 21:42:00 +0000

The imminent expectation of multiple product launches during the course of the coming year and the further development of a pipeline full of urine-based diagnostics designed to detect various cancers and infectious diseases placed TrovaGene Inc (NASDAQ: TROV) on the map during the closing half of 2012, especially when shares nearly quadrupled in value in anticipation of the many milestone catalyst events that were due to unfold throughout 2013. The first of those catalysts came to fruition in late March when TrovaGene announced that it had commercially launched a urine-based human papillomavirus (HPV) diagnostic test, the first of numerous elements of its pipeline expected to hit market this year and a move into a very lucrative market, as six million new cases of HPV are diagnosed in the United States each year, according to the Centers for Disease Control and Prevention.

TrovaGene's technology utilizes transrenal DNA and RNA from simple urine samples to detect genetic abnormalities that may result from cell deaths and/or disease progression.  Any diagnostic test resulting from the advancement of this technology follows the current healthcare industry trends of emphasizing early detection through less-invasive (and less costly) means and launching its first test onto the market is a huge validation to the company and its future prospects. That said, the development and commercialization of such next-generation technology may not be enough alone to convince investors looking at the near term that the medical community is ready to fully embrace such a drastic shift in early-detection methods, but investors could quickly become convinced if much larger and more relevant parties from the industry come into play to support future development.

Just such an instance was reported earlier this year when TrovaGene announced a collaborative effort with the University of Texas MD Anderson Cancer Center to detect transrenal BRAF mutations in the urine of patients with advanced or metastatic cancers provided.  At the time this deal provided TROV a significant boost in validation, given the Anderson Center's stature in the arena of cancer care, and led to a bounce in the share price.  Another deal, however, announced last week in an SEC filing may hold even more collaborative relevance and may have made believers out of some of the remaining skeptics that may doubt TrovaGene's potential to take its technology mainstream.

In a Friday 8-k filing, TrovaGene revealed that it had entered into a collaborative agreement with PerkinElmer Health Sciences Inc (NYSE: PKI) in which the two entities will design an assay to determine the risk for developing hepatocellular carcinoma. The two companies will jointly validate the assay while also exploring the possibilities of combining PerkinElmer's technology for the automation of nucleic acid isolation with TrovaGene's TrNA technology. The deal, should the combined effort develop into any diagnostics, could return TrovaGene notable milestone payments and - later on down the road - royalties on future sales.  Investors were keen on the significance of this announcement, as TROV shares jumped by ten percent on nearly triple the average volume.

Monday's trading session also saw volume roll in at levels above the norm, although price levels remained relatively flat.

In addition to the noted developmental guidelines, the two entities also outlined the potential for future licensing agreements to be negotiated, too, pending further collaboration. Such forward-looking talk indicates that a long-term partnership may be materializing between the two companies, which could be considered a boon for a TrovaGene as it enters the late developmental and early commercial stages. It also lays the groundwork for future merger and acquisition speculation, as TrovaGene's growing portfolio of patents alone could be worth a significant bundle later on down the road if the technology is consistently proven to work is embraced by medical professionals.

With industry trends shifting, the market may be ready for this next-generation technology. As outlined above, the target market for the recently-launched HPV is very significant and medical professionals may be quickly-convinced that its urine-based diagnostic may eventually negate the much more intrusive methods of detection that are the current standards of care. The same can be said for the potential results of the PKI collaboration.

Hepatocellular carcinoma has been identified as the third leading cause of cancer deaths worldwide and treatment - including early detection - involves numerous MRIs, ultrasounds and/or CT-scans of the abdominal section, all more intrusive - and much more costly - options than what could potentially be provided by a urine-based diagnostic. With that in mind, the PKI collaborative effort has the potential to turn into a very lucrative endeavor for both companies involved.

Furthermore, incidences of hepatocellular carcinoma are especially prevalent in Asia and Africa, according to the above-linked information portal, and as outlined in a Seeking Alpha report last week, PerkinElmer already holds a significant presence in Asia through past merger and acquisition deals. This fact could significantly underlie the intentions of PKI to quickly bring any diagnostic developed in conjunction with TrovaGene's technology to market in an environment where demand is intense. Not only does the PKI agreement come with collaborative development, the sharing of technology and future milestones and royalty payments, but it also comes with a global reach already in tact.

That's not a small point to miss.

Over the coming quarters, investors will look to monitor the PKI collaboration, as this agreement could later on down the road prove as one of the most significant milestones undertaken by the company. It'll also be worth identifying the commercial progress of the HPV test, as only modest market penetration could justify significantly higher share prices for TROV, according to numbers posted in the most recent company presentation. The potential over the longer term, however, is even more significant as the early detection and identification of cancer is a multi-billion dollar business. Should the medical profession embrace the shifting industry trends with TrovaGene's urine-based methods of detection, then exponential gains are possible for shareholders as the company capitalizes on its position in the industry.

Those prospects and possibilities continue to make TrovaGene one of the more intriguing speculative picks out there right now, especially with quite a few more commercial launches slated for the coming quarters.

As per the latest financial report issued earlier this month, TROV had just over ten million dollars of cash on hand at the end of the reporting period. The company conducted an offering of stock and warrants in early 2012 which raised nine million dollars and a private placement during the fourth quarter, which raised more than four million dollars. While the PKI agreement indicates that milestone payments and future royalties are likely if the collaboration is a success, the details are still unknown and there are no indications that TrovaGene will bring in enough revenue over the short term to alleviate the need to raise money again at some point in the coming quarters.

With numerous milestones still expected throughout the course of the year, however, potential price catalysts still exist and investors with eyes on the short term stand to benefit, as do those who are looking to put some 'trading shares' to use while potentially holding on for the long term to see this story out. TrovaGene has gained increased attention over recent months from multiple popular financial media outlets, a good indication that the market is starting to take notice of the potential of the company's technology.

Although volume has spiked in conjunction with key news events over the past months, it's still not yet rolling in at a point that indicates a widespread belief of future success. Should the recent momentum carry over into the coming months, and should the commercialized diagnostics start gaining a share of their respective markets, then volume could flow in at an increased rate, which would likely lead to a price boost, too.

If nothing else, this company should provide investors with enough news this year to keep investors interested. By announcing the collaboration with as big a player as PerkinElmer, however, TrovaGene has 'upped the ante' just a little bit.

Still a story to keep an eye on.

Disclosure: No positions.

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Don't Let These Five Speculative Plays Slip Below The Radar: FPMI, APHY, ANTB, SSH, TTNP

noreply@blogger.com (VFC) — Mon, 29 Apr 2013 12:05:00 +0000

On numerous occasions during the record-breaking rally of 2013 we've pointed out the fact that the more speculative and 'under the radar' sectors of the investing world are often ignored and disregarded when everyone is making 'easy money' while the markets are setting record highs on a seemingly day-by-day basis. At some point, however, we also argued that profits would be taken and - since most investors and traders don't like to see their money sitting idle - would possibly be transferred into those more speculative companies and sectors that hold the potential to return catalyst-based gains over the coming months and quarters. The recent volatility experienced by stocks - with highs and lows of the day in the DOW, for instance, trading in a range of well over a hundred points - could be an indication that profits are being taken and the traders are taking over. It could be an opportune time to concentrate more on where the money is going next. That's where industry trends and pending catalysts come into play, as those companies that have been trading under the radar for a while could start to come to the forefront of their respective sectors.

With that in mind, we'll take a look at a few companies with catalysts pending that could offer investors an opportunity to capitalize in the near and long term futures...

FluoroPharma: Volume First, Exposure Next - Share Price And Results To Follow?

Trading volume for FluoroPharma Medical (OTCBB: FPMI) has continued on a relative uptick during the early portion of 2013 thus far, based chiefly on the encouraging initial results returned from ongoing Phase II trials involving the company's positron emission tomography (PET) technology that may already be proving superior to the current market standards. As volume has increased, however, the share price has not, which could be an indicator of accumulation ahead of expected catalysts.

With its PET technology, FluoroPharma has developed a pipeline of imaging agents designed for the efficient detection and assessment of various forms of coronary artery disease (CAD) and certain types of cancer. Shifting industry trends towards prevention and early detection - from the current standards of emphasizing treatment - favor FluoroPharma's entrance into this market, and even more so when considering that early detection of CAD utilizing PET technology is also a growing trend.  Both of FluoroPharma's front-line agents, CardioPET and BFPET, are currently engaged in Phase II trials as imaging agents for CAD and ischemic and infarcted tissue within the myocardium in chronic CAD patients, respectively. Encouragingly, both have also already returned evidence of superior performance to the current standards, a key factor in speculating as to why shares look to have been under accumulation during the latter portion of the first quarter this year.

Results from these trials are expected to start leaking out as soon as during the second half of 2013, another factor in considering as FluoroPharma as a potential short term catalyst play, while also entertaining its prospects as a long term accumulation play.

As volume increased when the already-realized trial updates became publicly available, increased exposure from the investing community has started to follow, too, and it looks like more of that exposure can be expected over the coming months. Zacks issued an assessment on the company earlier this year that was accompanied by a price target of roughly three times the current FPMI trading levels. Another sign that FluoroPharma is ready for an exposure spike came last week when it was announced that the company's President & CEO would present at the 10th Annual Small Cap Equity Conference in early May in New York City.

A volume boost has already set the stage for FluoroPharma as a potential 'volume before price play' and exposure is often the next step in the process. Assuming that FPMI does pan out into a 'volume before price' story, then it could also be expected that the share price will follow, especially if additional trial updates warrant the increased attention and market cap boost. Therefore, it's worth keeping an eye on this company and it's stock over the near term while the longer term catalysts play out.

Over the long term, continued positive results indicating that FluoroPharma's PET images provide a more clear and concise analysis of a patient's condition could place the company on the map in this category and return investors very significant rewards.  FluoroPharma's current market cap - while justified in terms of its speculative nature - may hardly be justified in terms of overall market potential. Already the PET imaging market is measured in the billions of dollars, while PET for use in detecting CAD - the current focus of the company's development - is turning into a billion dollar market in itself. Needless to say, with this company's market cap barely a fraction of its overall market potential, assuming continued positive results, then the potential for swift and significant price gains are possible, possibly in line with the Zacks recommendation.

As is always the case with developmental picks such as this one, investors will identify the potential for cash raising events to stall any rally that materializes around catalyst-based events or price spikes. Such considerations should always be noted and are a large reason why utilizing a strategy that includes 'trading shares' - which allow an investor to trade the volatility around catalyst events - while also building a long term position, for those who wish to see the full story play out. Such a strategy often allows an investor to come out ahead - or on house money - by the time the end-game is near.

In the case of FPMI, the company should have enough cash on hand to last through another trial update, but bear in mind that developmental companies can be expected to raise funds at any point they see fit, which often comes at the risk of dilution to shareholders - hence the strategy of putting 'trading shares' to work along the way.

With volume on the rise and exposure expected to also increase as the ongoing Phase II trials continue to unfold, it's worth keeping FluoroPharma on the radar.

Assured Pharmacy Shareholder Letter Outlines Potential

Although to a more modest degree than the above-mentioned FluoroPharma, Assured Pharmacy (OTCBB: APHY) has also experienced an uptick in its trading volume and - based on industry trends and expansion plans - holds significant potential to appreciate in value over the coming months and quarters. With the abuse and misuse of prescription medications rampant in today's society, Assured is quickly setting the standard in the growing genre of personalized pharmaceutical services, which - through more stringent regulation of medications and prescriptions - will help to alleviate the risks of abuse. Assured also works closely with doctors and gears its services towards the early identification of what works best for a particular patient, in a manner more personalized than current standards - and in a manner that alleviates the threat of another Lindsay Lohan riding the train of prescription drug abuse pain.

Thus far, the company has built a foundation of four 'boutique' pharmacies geared towards the treatment of patients suffering from chronic pain and a shareholder letter issued this week highlights the booming growth of its targeted industry and plans for expansion that could place Assured's services into the mainstream of shifting trends, while making its name known on a national level by year-end 2013.

While the early successes of Assured's existing locations provides a solid foundation from which to move forward, the company expects even more growth during the course of the year with an additional six locations slated for grand openings. A store in Colorodo is expected to open next month, according to the latest financial report. In order to ensure a business model that can replicate the success of the Kansas location, in particular, company officials are already networking with local physician groups in the new prospective locations to ensure an early patient base - and hopefully profitability - from the start. Additionally, the company is enhancing its already-stringent distribution methods to further cement its reputation for quality, efficient and safe pharmaceutical services as the new locations are opened.

Although the potential is there for Assured to eventually set the standard for personalized pharmaceutical care, investors should still understand the competition that exists from existing big players in the market, such as Walgreen (NYSE: WAG), Rite Aid (NYSE: RAD), CVS (NYSE: CVS), and even Wal-Mart (NYSE: WMT). The primary difference, however, is that these names emphasize convenience over service, whereas today's patient base is following the trends of the healthcare sector as a whole, which is emphasizing efficiency and safety. That's where Assured could be set to capitalize heavily. While patients are herded through isles of candies, cards, magazines and snacks (and even beer for the big game in many states), which encompass the majority of the floor space at the above-mentioned pharmacies, Assured can quickly gain market share with the help of those doctors and patients looking for quality.

Another key item that investors should note from the shareholder letter is mention of the difficulties that Assured has had in securing financing for its early endeavors. The past few years have not exactly provided the best environment for developmental or still-emerging companies to thrive, but Assured has managed to survive thus far and - as mentioned above - plans significant expansion through the course of the year and also claims an excessive backlog of patients, for which the company will need to raise cash in order to treat.

While additional means of funding should be expected as the expansion picks up steam, however, Assured has taken some measures that could help to alleviate the stresses behind attracting investments. The first major item to note is that the company now trades on the OTCQB, an uplisting from the pinks and a platform to which a new investor base could be attracted. Additionally, an uplisting the AMEX or NASDAQ is also on the "near-term" horizon, according to the shareholder letter, another eventuality that could attract yet more committed investor interest.

To achieve listing on those big boards, however, the company may need to meet higher share price and/or market cap levels, which puts a huge emphasis on the growth expected to be achieved with the upcoming expansion.

In the case of speculative investments, investors are forced to entertain the risks and rewards associated with such investments. As noted above, utilizing a 'trading' strategy with a handful of trading shares with which to play catalysts while potentially building a position for the long term, too, could help to alleviate the risks, but not eliminate them. Still considered a new start-up, there is no guarantee that patients and doctors will jump on the industry trends and choose efficiency and safety over convenience, while securing funds may continue to be a challenge. Although hints at profitability exist, the company is still returning losses. That said - and with the risks entertained - the best bargains in the speculative market are often found before the story becomes one of noted success; henceforth, the rewards are the greatest when a story is found before the majority of the investing community finds it.

As industry trends shift in its favor, Assured Pharmacy and its investors could be positioned to capitalize on upcoming catalysts and milestone events that could place the company on the national stage.

Like FluoroPharma, APHY could be an 'under the radar' play positioning as a nice speculative story for the year 2013.

Quiet AntriaBio Could Quickly Start Making Some Noise

AntriaBio, Inc. (OTCBB: ANTB) made some noise earlier this year when news circulated that the company's once-a-week basal insulin shot, AB101, could eventually replace the current standard of care - currently comprising of daily shots - in a market measured by the billions of dollars and currently dominated by Sanofi-Aventis' Lantus and Novo Nordisk's (NYSE: NVO) Levenir. AB101 was acquired by AntriaBio in bankruptcy court - after millions had already been put into its development - and news that human trials were imminent resulted in a price spike that returned more than a double in price. As the broad markets rallied, however, and interest on the speculative sectors remained low, ANTB shares have drifted back towards their fifty-two week lows and may have presented investors with another solid speculative opportunity, considering the trial catalysts still pending.

AB101 looks to capitalize on one of the fastest-growing trends in the healthcare sector, namely the boom in diabetic care. Other companies, such as SanuWave Health (OTCBB: SNWV) and Mannkind Corporation (NASDAQ: MNKD) have also enjoyed share price success this year based on their own unique approaches to the booming industry, but AntriBio's once-daily injection could turn into the holy grail for patients who have been subjected to daily injections for years, hence the interest on the upcoming human trials, which can return results as soon as later this year. Given that the above-mentioned once-daily (at least) industry standards, Lantus and Levenir, pull in over eight billion dollars annually (combined) the potential for swift appreciation of the ANTB share price is possible, assuming successful trials. Should AB101 reach the later stages of development, then those in at the very early stages could be returned very notable gains, but it's still early for many investors - even the more speculative ones - to look that far ahead.

Concentration now is on the most imminent milestone events, although due attention could be given to the long term story in the peripheral vision.

Of the imminent milestones, AB101 is expected to hit the clinical stage over the near-term, following a successful round of pre-clinical development, according to a recent presentation posted to the AntriaBio website. The company will initiate trials in Russia first, where the costs of conducting such trials are significantly lower and where patient recruitment is known to be up to ten times higher than in the US and Europe. In the meantime, however, AntriaBio will move forward with the FDA IND process while development in Russia continues.  With early human data available from the Russian trial available, it's possible that the data could help to expedite the initial IND process in the United States,too. At which point AntriaBio plans to follow the course set by many other developmental companies and look for regional and/or multi-national partners that could potentially help fund development, according to recent company presentations. Such a strategy could help to alleviate investor concerns of excessive rounds of dilutive financing deals that often accompany the pipeline progression of early-stage companies.

That said, the threat of such cash-raising events always exists in this sector, hence the benefits of entertaining the combined trading and accumulation strategy mentioned above.

As the clinical stage positions at the starting block, the catalysts to expect this year include the initiation of the Russian trials, interim and/or actual results and comments referring to the initiation of the IND process in the United States. Company and investor presentations could also include discussions of the pre-clinical data and the potential impact that AB101's once-daily advantages could have on the multi-billion dollar market which it targets. If clinical data starts to return success and as the speculative investing community digests AntriaBio's potential, then volume could pour in to levels that would justify share price increases that could approach the 52-week high levels seen earlier this year.

In building a pipeline of potential - so as not to be known as a 'one trick pony' - AntriaBio is also establishing a long-acting Glucagon-like peptide-1, known as AB201, which is approaching the pre-clinical stages. AB201 would also present a major upgrade as the current standard of care as a once-monthly replacement for what is already on the market.

Numerous industry veterans have been brought on board to helm the developmental stages of AntriaBio's pipeline, all of whom have an established history of bringing small biopharmaceutical start-ups through the point of commercialization. Additionally, multiple members of the management team have histories which involve bringing developmental start-ups to the point of mergers and acquisitions, a point not likely to go un-noticed by those speculative investors looking more towards the near-term catalyst potential. Given recent comments regarding using human data to land regional partners, M&A may be the course of action expected by investors moving forward.

AntriaBio's pipeline is still in the very early stages, but as mentioned at points above, those that find their way into a story early have the potential to reap the biggest rewards over the long run, and ANTB could offer ground-floor potential that could shape the future of basal insulin delivery. As always, the risks should be entertained, including the above-mentioned financing risks, while concerns of trial failures always dominate the sector.

With numerous catalysts pending over the course of the year and with a product that could change the face of a multi-billion dollar industry, it may be worth not letting this story slip too far below the radar, whether it be for purposes of a short term trade or a long term hold - or potentially both.

Sunshine's Dip Below Five Emphasizes Speculative Opportunity

As recently discussed, Sunshine Heart (NASDAQ: SSH) may be positioned to evolve into one of the better 'but the dips' plays of the year. A recent stock offering dropped shares from over the six dollar mark to below five, but the current stages of development of the company's C-Pulse Heart Assist system, designed to treat Class III and ambulatory Class IV heart failure - and market potential of the product - defy SSH's still-highly-speculative market cap. Even more so when considering that the European medical authorities have already granted the device a CE Mark approval, too, and the company could start receiving revenue from sales and/or reimbursement over the near-term.

The pricing of the offering was $5.25, above the levels where shares currently trade.

As a brief recap for those that may be taking their first look at the company, let's take a quick snapshot of the target market: According to statistics posted by the National Institutes of Health (NIH), heart failure is an all too common condition where the heart becomes unable to pump a sufficient supply of blood to meet the demands of the body. The condition is progressive, effecting over five million people in the United States alone, and leads to over a quarter million deaths per year. Over 1.5 million of these cases fall into the category of Class III heart failure - the ambulatory Class IV category adds even more to that total - where current treatments may temporarily relieve a patient's symptoms, but are not fully capable of controlling the effects or symptoms, or of even halting the progression of the condition.

Completed studies to date have indicated that implantation with the C-Pulse could provide superior results to the standards already on the market, leaving Sunshine with an ample opportunity to steal significant share of this multi-billion dollar industry, should C-Pulse advance to the commercialization points. In addition to potentially superior results in treating heart failure, C-Pulse also holds the advantage over competitors that its device is implanted outside of a patient's blood stream, unlike devices by firms such as Heartware International (NASDAQ: HTWR) and Thoratec (NASDAQ: THOR), for example. Devices implanted within the blood stream increase the risk of contamination, while the procedures behind their implantation - since they 'touch the blood' - are also considered much more highly-intrusive than that of the C-Pulse. Another key benefit to being implanted outside of the bloodstream is that it allows for more quality-of-life conveniences, such as the ability to disconnect the device when needed or necessary, during showering, for example.

Although this company has already received its share of attention, especially when shares touched highs near the twenty dollar mark last year, Sunshine may have again slipped below the radar as the broad markets sit at or near their record highs. While slipping even lower than the price of the recent offering, yet continuously returning milestone events that hint at eventual success, SSH is another one to keep on the speculative map. The recent offering dropped the share price down another notch, but all things considered, the company is sitting on a healthy cash pile and could quickly become a buyout/partnership story if the US trial resembles the encouraging results already realized.

D-Day For Titan

Titan Pharmaceuticals (OTCBB: TTNP) may represent one of the most successful speculative stories of all time. During the course of its pipeline development (including periods where it traded on the AMEX as TTP) the spikes and dips continuously returned double, triples - and even more at times - before the failure of one its lead pipeline candidates failed dropped shares to a penny a handful of years ago. A rejuvenated pipeline based on the prospects of Probuphine and the subcutaneous, controlled-release ProNeura technology, however, has revitalized the company and its share price, while returning investors huge rewards along the way. Shares currently sit at levels of a near-triple, too, in just over a few months time.

A new chapter in this company's development has emerged, though, which could prove to be the most significant milestone reached by the company ever. The FDA is slated to decide within days the fate of Titan's approval application for Probuphine in the treatment of opioid addiction. Multiple trials have proven the treatment effective and an FDA advisory committee recommended its approval in a recent vote. All indications point to approval.

Some speculate, however, that concerns over REMS for Probuphine may delay approval, while others speculate that the FDA may request additional data in regards to dosing before granting the green light for commercialization. Few believe that Probuphine will be denied approval. Those playing this imminent catalyst may take up a couple of strategies, the first being accumulating before the catalyst in order to bank the expected approval gains. Others believe that REMS may delay - not deny - the vote, in which case investors may expect a temporary pullback into which to buy for the next D-day that would then be presented by the FDA.

Regardless of the outcome of this month's decision, an eventual approval is likely. For the record, Titan is one of my personal bests over the years and am sitting this decision out, but will buy back in, should the decision be to delay approval and the share price drops a bit as a result.

While attention is paid to the broad market highs, however, don't forget about those companies with imminent catalyst getting read to unfold, such as those mentioned above, including Titan Pharmaceuticals.

Should Titan receive the nod, the company will be a demonstration of how years and years of patience, trials and tribulations could finally pay off for a company, its investors, and those that will benefit from a new product or treatment hitting market.

Happy Trading!!!

Disclosure: Long APHY, SNWV, ANTB.

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SanuWave (SNWV) Patents Boost Long Term Potential

noreply@blogger.com (VFC) — Mon, 29 Apr 2013 12:04:00 +0000

SanuWave Health (OTCBB: SNWV), with trial catalysts pending over the near term, has received its fair share of attention during the course of 2013 thus far, but the company's potential value over the long term may have received a significant boost earlier this month with the issuance of a patent covering the company's shockwave technology for use in blood purification. Although not yet in development for that indication, SanuWave projects that its shockwave technology could disrupt "the outer membrane of bacteria and viruses which," according to a company press release on the topic, would result in the death of such pathogens.  For SanuWave, this patent also represents the first for the company outside of those obtained for its initial methods-of-use - which include wound care and regenerative medicine - and provides another solid starting point from which the company can grow.

In today's day and age a solid baseline of intellectual property (IP) is invaluable for a company. Patent wars are seemingly popping up on a near-daily basis in numerous sectors and solid patent protection alone could be worth tens of millions of dollars - at least - to companies looking to protect their respective technologies in settlements.  Additionally, patents could also bring in new revenue streams for companies utilizing similar technologies, as was demonstrated by the signing of a licensing agreement between Synergy Pharmaceuticals (NASDAQ: SGYP) and Ironwood Pharmaceuticals (NASDAQ: IRWD) last year, as each company's respective drug used a similar mechanism of action. Amarin Corporation (NASDAQ: AMRN), too, is a company whose patents are day-by-day being tallied by at investors at home, given the continued uncertainty surrounding Vascepa's New Chemical Entity (NCE) status.

In terms of potential mergers and acquisitions, patents are factored into deals just as much as developmental pipelines and some deals are actually consummated on the basis of patents alone. Needless to say, patents may be more valuable now than at any time before - and maybe event to the point of becoming a detriment to progress and innovation. That said, a company has to have them to succeed.

So although the more short-term minded investors may disregard news items relating to the issuance of patents - since they are not often accompanied by trials (at the time) or immediate price catalysts - investors looking towards future value can start to factor in the impact that a patent issuance can have on a particular company's future value.

In determining the potential value of SanuWave putting its technology to use in newly-covered indications, let's take a look at the trends.  We've concentrated a lot of time and print these days into identifying growing trends in the healthcare sector and then identifying companies who could be primed to capitalize. For instance, SanuWave itself is already positioning itself to take advantage of the growing boom in the diabetic care market, given the pending diabetic foot ulcer trial, and other companies such as AntriaBio, Inc. (OTCBB: ANTB) and MannKind Corporation (NASDAQ: MNKD) are also looking to capitalize on the growth of that sector. Similarly, Titan Pharmaceuticals (OTCBB: TTNP) and Assured Pharmacy (PINK: APHY) are soundly-positioned in trends relating to the reduction of pharmaceutical abuses and investors who likewise jumped in early were handsomely rewarded.

The next trend into which SanuWave is preparing to enter, according to the issued patent, is the blood purification market.  Partly as a result of the already-discussed diabetes epidemic, this market is also moving forward at exponential speeds, leaving in its wake a global shortage of a safe blood supply with which to respond to natural disasters and routine medical procedures.

According to statistics discussed by entities already fully engaged in developing next-generation technology, the blood purification market in the US and Europe alone is can be measured in the tens of billions of dollars, while the market is also growing at exponential rates in other major economies around the globe. Such statistics offer companies looking to gain early footholds - and investors also looking to capitalize - the opportunity to stand ready, positioned and prepared when the growing trends become more mainstream. So although investors are always wise to play the volatility of the still-developmental sector and put some trading shares to use while also potentially building a core position for the long term, news of patent protection should not be taken lightly and could also be used as an insight into a company's strategy moving forward.

For SanuWave, all attention at the current time relates to the diabetic foot ulcer trial, but sometimes those just looking at the tree may miss the forest that could be building out there. Intentions to develop the shockwave technology in the treatment of various indications outside of those already discuss provides the company with numerous avenues for potential success - and a 'Plan B' that longer-term investors like to see before committing for the duration.

It shouldn't be assumed, however, that the only way SanuWave - or any company for that matter - can capitalize on patent protection relates to the initiation of new trials. It's likely that the company could look to develop its own clinical path to infiltrate the blood purification market later on down the road, but another option is to out-license the now-protected technology to another player in the sector who may be willing to fund development itself, in turn for an agreement that may include milestone payments and future royalties. This possibility was briefly discussed in this article's open in relation to Synergy and Ironwood and is not an uncommon scenario in the developmental sector.  It may be more realistic, however, to expect such an event after the technology demonstrates more late-stage success in other indications.

It's evident that the long term business plan may be expanding as the short term developments unfold, and while it's always worth looking long term, too, it's the short term catalysts for SNWV that have the potential to move the share price.  In that light, all attention is still on the dermaPACE diabetic foot ulcer trial that is expected to begin enrolling patients within the current quarter.  If successful, dermaPACE would be positioned to enter into a multi-billion dollar - and still growing - market, therefore investor anticipation of this trial has been heavy and led to a swift increase in the SNWV share price. Positive results, whether they be interim or actual, could lead to further gains and put this company on the map for its potential to enter the next-generation wound care and foot ulcer markets.

Confidence for success regarding the upcoming trial is growing, given previous clinical results and a new trial design. Some investors, however, remain skeptical over the results from the past trial because although it returned encouraging results, the endpoint was not met. This skepticism is likely a large part of the reason why the SNWV market cap remains at still-speculative levels, considering the overall market potential and cap levels achieved during the last trial. Only positive results can combat that skepticism at this point, hence the high amount of interest this company has been garnering and the volatility experienced over the past weeks - both of which indicate both short term and long term investors may be taking up positions ahead of the upcoming catalysts.

As always in the developmental sector, the inherent risks should be noted. Financing is always a concern during the developmental stages and even with SanuWave bringing in revenue in Europe, as discussed in a previous write-up, it cannot yet offset the losses still being realized by the costs of development. There's no guarantee that this company will not at some point need to raise additional cash to fund development, but SanuWave management has undertaken some responsible measures to help offset investor concerns, including basing the latest CEO agreement on goal-oriented milestones (see the above-linked report). International growth is expected during the current year, too, as approvals in Australia and New Zealand can help to augment European sales, although even the most enthusiastic of investors should expect overall losses to continue.  The trend, however, has been to see the losses shrink, according to most recent financial reports, while indications also have it that the gross profit numbers behind treatments are also growing, to levels as high as seventy one percent.

Risk still exists, but given recent developments, pending catalysts and an expanding base of IP, SanuWave still looks like a solid rebound story for 2013.

Happy Trading!!!

Disclosure: Long APHY, SNWV, ANTB.

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Assured Pharmacy: Industry Trends Lead Shift Towards Specialized Pain Management

noreply@blogger.com (VFC) — Wed, 24 Apr 2013 08:28:00 +0000

Discovering industry trends early and then establishing positions in companies who may benefit from those trends ahead of the general market could quickly turn into a successful trading strategy.  For a prime example of such, look no further than 3D Systems Corp (NYSE: DDD) and Organovo Holdings (PINK: ONVO). Shares of both companies traded along relatively under the radar until investors caught onto the fact that 3D printing was advancing quickly enough that the next generation of the technology was quickly becoming considered the 'now' generation. Shares of 3D tripled in quick time, as did the more speculative Organovo Holdings, whose technology could eventually be used to 'print' organs for transplant patients, and investors who caught the trend early were very handsomely rewarded.

Over the course of the past few weeks we've also discussed heavy trend shifts towards diabetes treatment, since that industry is growing at alarming rates. Companies such as SanuWave Health (OTCBB: SNWV), AntriaBio, Inc. (OTCBB: ANTB), and MannKind Corporation (NASDAQ: MNKD) have already seen their respective share prices rise over early-year levels as key upcoming catalysts and more cost-effective and less-intrusive technologies could quickly thrust each company to the forefront of the booming multi-billion dollar industry.
Another sector trend worth identifying now is shifts within the chronic pain market. Treatment of chronic pain conditions remains stable at $20 billion-plus in the US on an annual basis - $50 billion globally - and numerous companies whose share prices could stand to appreciate in value, pending developing catalysts, are lining to take advantage of the next generation of this robust sector. When assessing the trends inside this portion of the industry, it's important to bear in mind that for years this subsector has been run with the cowboy flair of the 'anything goes' lifestlye - hence some of Hollywood's greatest stars becoming living train wrecks and a significant amount of those treated for chronic pain becoming addicted to their medications.
To combat those facts, the new wave of health care treatment revolves around preventative medicine, while also emphasizing less-intrusive and more cost-effective processes and products.

The US may be a little behind the curve in this sense, as emphasis for decades has been on treatment - not curing - because there is no money in a cure like there is in treatment.

Some examples of companies jumping head-first into the new shift in strategy can be identified by BioDelivery Sciences (NASDAQ: BDSI) and Titan Pharmaceuticals (OTCBB: TTNP). BioDelivery, for example, has received multiple approvals for Onsolis, a treatment for chronic pain caused by cancer. Onsolis involves placing a strip of film to the inner lining of a patient's cheek, a method intended to control delivery and mitigate the risks of addiction. Titan, on the other hand, has developed the ProNeura technology, which is a subcutaneous 'stick' implanted in a patient's armpit and - like BioDelivery's strip - allows for controlled release and drastically reduces a patient's risk of addiction. In fact, the first indication for which ProNeura has been designed to treat is opioid addiction - a treatment known as Probuphine - often for patients who have already become addicted to other pain medications.

In identifying the benefits offered by these two companies and their respective technologies early, investors were rewarded with quick share price triples. In fact, Titan traded for a penny at one point as a result to failures of another product in its pipeline unrelated to Probuphine. Those that saw potential in Probuphine, which is also being developed for the treatment of chronic pain and not just addiction, and identified early shifts in the market were rewarded.

Although the above-mentioned companies address ongoing shifts in the sector, leading to more controlled and responsible use of drugs and treatments in the industry, they still don't key directly on the preventative side of the house - for that we can look directly to the controlled distribution points of today's most common drugs and treatments, the pharmacies.  Any consumer will find one location of any of the biggest market players - be it a Walgreen (NYSE: WAG), Rite Aid (NYSE: RAD) or CVS (NYSE: CVS) - on just about evey street corner or within every strip mall in America. Patients filling and refilling prescriptions at these locations has turned into an industry registered in the hundreds of billions of dollars. It's such a lucrative business that even the likes of Wal-Mart (NYSE: WMT) jumped in with a pharmacy of its own.

Although the industry is booming, the idea of treating patients may have been lost in the quest to pull in the big bucks. Like cattle, patients are herded through isle after isle of candies, cards, magazines and food items before lining up to receive a prescription in the back of the store. Pharmacies are not pharmacies any more - if they ever were - they are merely miniature versions of your favorite supermarket. In some states, one can even pick up a few beers and a bottle of wine for the big game while filling a prescription, hardly an experience centered on the patient. Let's face it, in the world of big business, money wins and personalization loses - that's just the nature of the beast.

With that in mind, there may be another industry shift underway that encompasses all of the items discussed above - the shift towards personalized and preventative patient care in the prescription market.

Assured Pharmacy (PINK: APHY) may be one such up-and-comer that is positioned to take advantage of these trends. As a personalized - or 'boutique' - pharmacy with multiple locations already in operation, Assured has jumped into the chronic pain market and is consistently setting the standard for personalized and professional patient care in the pain prescription market. In concentrating the first phase of its development in four smaller markets, Assured raked in fourteen million dollars in revenue last year and has eyes towards significant expansion over the coming years.  Since the precedent has already been set that the business model can work, much larger markets are now being targeted, with a location in Denver, CO slated to open next, according to the latest financial report. Encouragingly enough, and again according to the company's above-linked financials, it takes roughly $350,000 to open a new location - a relatively modest amount, given the financial girth of the industry.

It should also be noted that although the initial revenue streams look encouraging for future growth prospects, the latest report also indicates that the company is still registering losses, too. Expansion into much larger target markets should help alleviate the losses, as the customer base could potentially grow exponentially on a per-capita basis, especially if Assured can capitalize on the personalized services that are being sought after by the "me" generation. After all, in the absence of the daily threat of a global nuclear war breaking out, the population is in tune with the 'it's all about me' mantra more now than ever before. That fact paves the way for boutique pharmacies such as Assured to thrive.

Established pharmacies are still going to pose a major threat to Assured gaining market share, regardless of the benefits provided, but the road ahead looks manageable. Aside from just offering personalized services that cater to an individual patient's need, Assured can also benefit from its more stringent and tight monitoring of prescriptions and decreased potential for abuse that result from its business model, which could make the company a more desirable option for public and private health care professionals and/or relevant insurance companies. Additional benefits exist in terms of cost-efficiency since the personalized model better enables doctors and patients to identify early on the medication most applicable to his or her condition. The popular culture of 'try this and see what happens' may be going the way of the 8-track.

Although risks still exist in regards to the business model moving forward, the company's current market cap and lack of viable trading volume indicates that investors are not yet sold on Assured's potential to thrive, or even its ability to carve out a niche market within the tens of billions brought in by pharmacies for pain medications yearly. As discussed in the above paragraphs, the risks are still notable for the company, but as also discussed, identifying early trends and sticking with them can enable investors to reap rewards by already being 'in' before the broad investing base jumps on board. Very modest volume has already enabled shares to more than double since the year's open, but a fair amount of speculative interest could push shares higher still. It'll be worth monitoring those numbers.

Health care in general is likely to garner an increased amount of attention again this year as Obamacare hits full stride, and companies that succeed in preventative and personalized care stand to prosper. Titan and BioDelivery, for example, could lead the way through the transition period of these trends while the boutique pharmacies - like Assured - could gain a foothold now while sitting on the cutting edge of the next generation of pharmacy care.

As always, investors should always conduct his or her own DD and invest accordingly, while entertainging risks and losses as well as future growth potential. In the case of Assured Pharmacy and some of the other companies listed above, the prospects of capitalizing on shifting healthcare trends exists and could be worth a look for the more speculative portfolio.

Disclosure: Long APHY, SNWV, ANTB.

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Sunshine Heart (SSH): A 'Buy The Dips' Play That Could Pay Off Big

noreply@blogger.com (VFC) — Tue, 16 Apr 2013 19:13:00 +0000

Investors of the developmental healthcare sector are well aware that cash raising events and dilutive financings are an established part of the process in bringing a new drug or medical device through the trial stages and to market. While few investors look forward to these events with heavy anticipation, given the potential for a rally to be stalled or for a share price to drop to the level at which an offering was conducted, these events are wholly necessary, given the design of today's health care and financial systems. That said, those who exercise patience and utilize an investing strategy that includes trading into the spikes and dips with a position of 'trading shares' - while also potentially building a core position with eyes towards the long term - could survive the tides largely unaffected, while potentially coming out on 'house money' by the time the developmental stage plays out.

Such a strategy also includes not going 'all in' on a particular stock when initiating a position for the first time. Buying in with just a fraction of what one plans as a total investment amount allows for additional buys later on down the road should the targeted share price dip. As noted above, stock offerings and other means of cash-raising for companies often contribute to share price slides, since the new shares are generally 'offered' as a discount to recent levels.

Last week Sunshine Heart (NASDAQ: SSH) announced a public offering of common stock pursuant to a previously-filed shelf registration. The pricing of the offering was $5.25, whereas company shares had been trading along steadily at roughly six bucks before the announcement. In turn, SSH traded down late last week to price levels right in line with the offering. Investors, after already having seen this stock trade from roughly the three dollar mark to nearly twenty over the past year, are left to decide whether or not the post-offering slide offers a decent accumulation point or whether there can be more pain in store as the company's technology edges its way through trials and - should encouraging results continue - ultimately to market.

While numerous risks still apply moving forward, as is always the case through the developmental stages (more on those risks below), there is reason to believe that Sunshine's latest dip could again have provided a nice accumulation point for investors looking to the play the end-result and the potential price catalysts that could be provided along the way. Those catalysts all revolve the C-Pulse Heart Assist System, Sunshine's proprietary implantable medical device designed to treat Class III and ambulatory Class IV heart failure. Studies completed thus far have demonstrated that this device may not only halt the progression of heart failure, but also reverse the effects of the disease, too. Given the size of the target market and the distinct advantages that C-Pulse looks to have over the perceived competition, it's reasonable to believe that the SSH share price has ample room to appreciate in value, should the ongoing studies continue to produce positive results.

Let's take a quick snapshot of the market: According to statistics posted by the National Institutes of Health (NIH), heart failure is an all too common condition where the heart becomes unable to pump a sufficient supply of blood to meet the demands of the body. The condition is progressive, effecting over five million people in the United States alone, and leads to over a quarter million deaths per year. Over 1.5 million of these cases fall into the category of Class III heart failure - the ambulatory Class IV category adds even more to that total - where current treatments may temporarily relieve a patient's symptoms, but are not fully capable of controlling the effects or symptoms, or of even halting the progression of the condition.

Completed studies to date have indicated that implantation with the C-Pulse could provide superior results to the standards already on the market, leaving Sunshine with an ample opportunity to steal significant share of this multi-billion dollar industry, should C-Pulse advance to the commercialization points. In addition to potentially superior results in treating heart failure, C-Pulse also holds the advantage over competitors that its device is implanted outside of a patient's blood stream, unlike devices by firms such as Heartware International (NASDAQ: HTWR) and Thoratec (NASDAQ: THOR), for example. Devices implanted within the blood stream increase the risk of contamination, while the procedures behind their implantation - since they 'touch the blood' - are also considered much more highly-intrusive than that of the C-Pulse. Another key benefit to being implanted outside of the bloodstream is that it allows for more quality-of-life conveniences, such as the ability to disconnect the device when needed or necessary, during showering, for example.

Considering those points, the high amount of speculative interest in this company is highly justified and European regulators may have already taken notice.

Last year Sunshine Heart was granted a CE Mark approval in Europe for C-Pulse. The announcement of that milestone event, in part, led to the aforementioned run towards twenty last year and invigorated interest in the US trial that is now underway. Shares tapered back after the post-approval run, as investors and analysts largely consider FDA approvals as the 'holy grail' in the sector, with overseas approvals only garnering secondary attention. A post-approval trial is underway in Europe, however, and any move towards commercialization could help to alleviate the potential of large-scale offerings in the future. It should be noted, too, that last-week's offering was not of the 'over the top' type that would drive investors away in droves. Comparatively speaking to the norms of the sector, an offering of 2.5 million shares is relatively modest and responsible and supports the end-goal, which is the funding trials and ultimately receiving an FDA approval.

That said, investors are rarely enthusiastic when it comes to hearing news of stock offerings, but, as discussed in the lead-in, such events are the standard for the developmental sector. Sunshine has made no secret of its intentions to raise cash during the course of the current round of trials, so investors are not likely to be caught by surprise by last week's announcement. Moreover, those investors that may be building longer-term positions with the intent of seeing this story play out - as well as traders looking to take advantage of any dips - may appreciate the pullback in price that has materialized as a result of the offering. Sunshine has traded in a relatively stable range since its monumental run last year, and this offering may have just lowered the bottom end of the range a bit, but still provides a point where unfolding catalysts could return shares back to previously-traded levels, if news warrants.

Aside from the risks and share price reactions to these financing deals, some investors may also be concerned that the full results from the US trial are not expected for nearly another three years. That leaves a lot of time for an investor's money to sit idle while awaiting the key milestones. Even worse, investors could see their shares lose significant value, should Sunshine conduct additional offerings in the future. After all, even with a European approval in the books there are no indications that the company will be able to fund their trials without raising cash at times. Such concerns are justified and investors are correct to entertain all possibilities, hence the discussion during this article's open about not jumping 'all in' with initial investments and utilizing some 'trading shares' at opportune points in time while also potentially building a core position to play the longer-term catalysts. Until significant revenue is realized, this one will continue to trade on speculation and news catalysts, but that doesn't mean things will be boring in the meantime.

Other events and potential milestones exist that investors can monitor along the way. For one, it's likely that interim results could be discussed or released at certain progression points and one specific time period to keep an eye on is the mid-way point of the US trial. Previous financing agreements have hinted that there may already exist significant partnership or buyout interest in the C-Pulse system and current financing agreements keep the company financed through the mid-way point. With that in mind, it's worth speculating that C-Pulse could be shopped around at that time, assuming interim data looks solid.

Another possibility would be to see a bigger player in the sector - who may express more confidence in C-Pulse with solid interim results - jump on board as a partner and at least help fund the remainder of the trial. Such thoughts are purely speculation at this juncture, but are common to the sector and - just like the risk aspects - should also be entertained as possibilities.

As investors engage the possibilities of a device like C-Pulse on the market, there are some very optimistic estimates out there regarding Sunshine's future share price potential. Such speculations may seem unrealistic at the current point in time, but as trials progress attention is likely to come back on this company by a wider range of media outlets and analysts. For a while there last year it seemed as if everyone was covering Sunshine, small and large media alike, just based on the potential of C-Pulse alone. By the time attention comes back, however, those investors already holding shares may find themselves in a prime position to take advantage of the volatile moves that often develop in this sector as trial results and key milestones unfold.

While understanding the inherent risks of the sector - failure is always a possibility - and the overall potential of the C-Pulse in a multi-billion dollar market, Sunshine may be worth a look for a speculative investor with eyes towards the completion of the ongoing trials and an eventual date with the FDA. Interim events may also influence trading along the way, making a plan of 'buying the dips' and trading some trading shares a potential winning strategy. What will attract the longer term investors, however, is that a positive trial result, whether it still be years away or not, would likely send SSH shares higher by significant margins, given the still-rather-speculative market cap of the company - which at the current time either does not indicate investor confidence of trial success or is a reflection of the somewhat prolonged period of time until full trial results are expected.

In today's investing environment the 'buy and hold' crowd has been brushed aside by the traders, where the quick buck wins in favor of a patiently-unfolding story. In some instances, however, there is a case to be made for slowly accumulating a position of 'buy the dips' shares - while also playing the trading shares - in order to wait for the full story to evolve. Given the potential of C-Pulse in its target market and the solid results already demonstrated in multiple studies, a case can be made that Sunshine Heart is one of those 'buy the dips' plays, and right now we're in a dip.

Disclosure: Long SSH.

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Stock Watch Thursday, 11 April 2013: SSH, INO, TTNP, APHY

noreply@blogger.com (VFC) — Tue, 16 Apr 2013 19:12:00 +0000

Despite recent concerns that the record-setting market rally of 2013 was losing its steam, Wednesday saw another day of record highs as investors remained enthusiastic following encouraging comments from the Fed, while economic data overseas, specifically in China, represented a continued global recovery. The record-setting day in the US sparked international rallies on Thursday, although early indications were that US markets may experience tempered trading, given existing concerns that each move higher could just create that much more of a dropoff, should a pullback materialize. With earnings season underway, more and more attention will be paid to the 'hits' and 'misses' of the street, with ample consideration given to the fact that it's no secret company's have been under-guiding during the recovery period in order to look that much better if a stronger-than-expected report hits. Guidance moving forward, however, has been tempered, meaning weak earnings reports during the current quarter could end up pushing the markets lower, as many pundits expect will be the case.

Although new highs are still being set, volatility has increased, an indication that skepticism remains as to whether or not the rally continued. It also provides an indication that the traders may be taking hold of the market as the 'buy and hold' game may have been milked for all it's worth during the early-goings of 2013. As mentioned earlier this week, profit-taking money could start pulling out of the broad market, should expectations of a downturn arise. If that is the case, that money - along with any sideline cash that investors have been hording in case of a dip - is likely to find its way into individual stocks and stories that may have been trading below the radar as the big players in the markets rallied.

We'll continue this week to follow a few of those that could attract some speculative money, given pending catalysts, recent developments and overall growth potential.

As the noted news items of the day develop and the earnings stories roll in, there are still plenty of individual stocks and stories to keep an eye on. Here are just a few of them for Thursday, 11 April 2013 ...

Sunshine Heart Announces Public Offering

Sunshine Heart (NASDAQ: SSH) announced on Wednesday that the company has initiated a public offering of common stock pursuant to a previously-filed shelf registration. According to Wednesday's press release, the funds will be used for the cliche 'general corporate purposes,' but more importantly will also be used to fund the ongoing clinical trials, development and commercialization of the C-Pulse Heart Assist System. C-Pulse, as previously described, is an implantable medical device designed to treat Class III and ambulatory Class IV heart failure. Studies completed thus far have demonstrated that this device, which is implanted outside of the bloodstream, may not only halt the progression of heart failure, but also reverse the effects of the disease. Sunshine has already received an approval in Europe for its flagship device and a post-approval trial is being conducted on that continent as another trial simultaneously gains traction in the United States. The latest stock offering will help fund the progression of those trials.

Investors are rarely enthusiastic when it comes to hearing news of a company announcing a stock offering, but such events are the standard for the developmental sector. Sunshine, as we have previously discussed, has also made no secret of its intentions to raise cash, so investors are not likely to be caught by surprise by Wednesday's announcement. Moreover, those investors that may be building a longer term position to see this story play out - as well as traders looking to take advantage of any dips - may appreciate any pullback in price that materializes from the offering. Sunshine has traded in a relative 'under the radar' range ever since a monumental price run last year pushed shares towards twenty when the likes of Reuters jumped on the story, and the stock is currently sitting at the lower end of its range.

Astute investors often utilize a strategy that includes flipping a handful of trading shares at opportune points that develop as a result of the volatile nature of this speculative sector, while also potentially building a core group of shares to see the story play out. The trading shares can offer investors the chance to come out on 'house money' before the end-game is met, while the core shares still allow for one to remain invested, should unexpected news or developments hit the wire in the meantime. The core also allows the potential to reap the rewards, should the goal of FDA approval and commercialization be met. In the case of Sunshine, investors accumulating now are looking further down the road and gauging the potential market for C-Pulse.

According to statistics posted by the National Institutes of Health (NIH), heart failure is an all too common condition where the heart becomes unable to pump sufficient blood to meet the demands of one's body. The condition is progressive, effecting over five million people in the United States alone, and leads to over a quarter million deaths per year. Over 1.5 million of these cases fall into the category of Class III heart failure - more in the ambulatory Class IV category - where current treatments may temporarily relieve a patient's symptoms, but are not fully capable of controlling the effects or symptoms. C-Pulse's potential to break into that market justifies a high amount of speculative interest in the company's stock, especially given the early results.

Some are concerned about the time left on the table to see the end-game play out. Full results from the US trial are not expected for nearly another three years. That leaves a lot of time for an investor's money to sit idle while awaiting the key milestones. With that in mind, there are other avenues that investors can entertain to remain interested in the meantime. For one, it's likely that at some point the company could entertain discussing interim results, which may be speculated to be compiled at the trial mid-point. Previous financing agreements have hinted that there already exists significant partnership or buyout interest in regards to C-Pulse and current funding agreements keep the company financed through the mid-way point. With that in mind, it's worth speculating that C-Pulse could be shopped around if interim mid-way data looks solid.

There are some very optimistic estimates out there regarding Sunshine's potential and as the US trial progresses, attention is likely to come back on this company by a wider range of media outlets and analysts. By that time those investors already in may find themselves in a prime position to play the volatile moves that develop in this sector leading into trial results and unfolding catalysts. Although Sunshine has slipped below the radar for a bit, it's still one to keep an eye on.

Inovio Receives Boost From Federal Grant Money

As discussed on previous occasions, Inovio Pharmaceuticals (NYSEAMEX: INO), since it is known for developing a potential universal flu vaccine, is one of those companies out there that can move quickly when news circulates the wires in regards to a new flu outbreak. It happened during the winter when an epidemic outbreak criss-crossed America and it's happening again as the bird flu hits China. Although other factors have contributed to the rebound, it's likely that the newest flew outbreak helped Inovio shares shrug off disappointing results from a collaborative trial earlier this month, more on that later. Aside from the attention brought to Inovio as a result of another flu outbreak, investors were encouraged by news this week that the company had received a $3.5 million grant from the National Institute of Allergy and Infectious Diseases (NIAID) to advance its SynCon platform technology and its preferred method of vaccine delivery, electroporation, specifically in the cause of allowing the warfighters to stave off the effects of potential biological warfare.

SynCon is Inovio's proprietary technological platform from which numerous synthetic vaccines have been developed intended to treat a number of infectious diseases and cancer types. Among those in development are a universal flu vaccine, which has already returned positive - although early - results, and a hep C vaccine, for which the company will initiate its own trials this year, given the failure of the above-mentioned collaborative effort. It should be noted that Inovio's relationship to the failed trial revolved around the use of its electroporation technology and has no bearing on the development of its own SynCon-based vaccine development. Digestion of that fact likely also assisted the stock's rebound from the post-news lows.

With SynCon and electroporation, too, Inovio has developed a nice one-two punch, given that it offers vaccine candidates and a potentially superior method of delivering them, too. Electroporation, as described on Inovio's website, uses controlled, millisecond electrical pulses to create temporary pores in the cell membrane and allow dramatic cellular uptake of a synthetic DNA vaccine previously injected into muscle or skin. This method of delivery allows Inovio to more accurately and effectively direct its vaccine technology into the intended cells, while minimizing the risk of damaging surrounding cells and tissue. Consider it like using the precision of a cruise missile to hit its target. Thus far in development, electroporation has "demonstrated best-in-class immune responses" in relation to vaccine delivery.

The early successes of both the SynCon platform and the electroporation technology were the primary factor in attracting the NIAID grant money. Although a relative insignificant amount in comparison to the costs associated with bringing one - let alone many - products to market, a multi-million dollar grant comes as a huge plus for a small and still-developmental company, and it should also be encouraging to investors that this is not the first federal money issued to Inovio. Pending the results of the current collaboration, the money flow could continue at points in the future, as well, although investors should not assume that additional cash-raising will be needed over the course of pipeline development.

Inovio has other funding help, too, aside from just the grant money. Of the nine programs in development, six of those programs are being funded by third parties, a huge easing of the monetary burden moving forward. Again, though, that's not to say the company will not have to raise cash at points in the future since the pipeline is still considered a 'Phase II' pipeline, for the most part. More lucrative partnerships could materialize as the Phase III stages are reached.

With its SynCon and electroporation technologies attracting the interest of federal grant money and other intersted parties, Inovio remains one to keep an eye on. Upcoming Phase II results could set the stage to play some Phase III catalysts, but recent trading history has also shown that the volatility with which Inovio trades makes it worth using the 'trading shares' strategy, while also potentially accumulating for the long term.

Assured Pharmacy Positioned To Capitalize On Industry Trends

Over the course of the past few weeks we've been hitting a lot on the topic of following shifting trends in the healthcare industry. The booming nature of the diabetes epidemic, for instance, brought us to company's such as SanuWave Health (OTCBB: SNWV), AntriaBio, Inc. (OTCBB: ANTB), and MannKind Corporation (NASDAQ: MNKD). Following the trends - or even better, attempting to identify them before they become trends - can turn into a lucrative business for investors looking for a place to ingest some speculative money.

Another booming sector worth keeping an eye on is the chronic pain market. It's tough to scroll through companies in the pharmaceutical or developmental health care sectors without coming across a company that is either marketing or developing some treatment or another for chronic pain. BioDelivery Sciences (NASDAQ: BDSI), for instance, has developed a film that is placed inside a patient's cheek and delivers a steady supply of pain killer while Titan Pharmaceuticals (OTCBB: TTNP) is developing its subcutaneous treatment for opioid addiction, Probuphine, for use in the chronic pain market, too. Using Titan as a transition point, that brings to light another trend in the industry worth monitoring - that of eliminating, as best as possible, the abuse and misuse of medications and prescriptions, which also falls in line with preventative medicine, since abuse just creates more long term problems and financial burdens on the industry. Titan's ProNeura technology delivers a steady supply of buprenorphine to patients with a 'stick' inserted under the skin in order to control intake of the drug, and therefore eliminate the potential for abuse.

Assured Pharmacy (OTCPK: APHY), on the other hand, is taking a unique approach to attacking multiple of the industry trends listed above. With a number of 'specialty' or 'boutique' pharmacies already opened in the United States which offer services for medical professionals and patients of the chronic pain sector, Assured monitors the prescription habits for physicians while also ensuring education, assistance and prescription services (including delivery) for chronic pain patients in need of the more personalized care that large pharmacies such as Walgreen (NYSE: WAG) or Rite Aid (NYSE: RAD), for example, cannot provide. This more personalized service allows Assured to tighten prescription controls and heavily eliminates the potential for misuse by patients. Another benefit that fits the cost-effective trend is that the personalization helps to enable a patient to identify early on the medication most applicable to his or her condition.

Assured has four locations operating in relatively modest markets and those locations brought in just over $14 million dollars last year, according to the most recent annual report, which was down from the year prior. With a foundation set, the company is next looking to move into major metropolitan areas where increased customer bases would help to boost revenue and potentially offset some of the losses that are still coming in. The current market cap of the company may be an indication that investors have not yet bought into the belief that Assured's personalized prescription services could yet compete with the much larger and more established players in the sector, but expansion could be key, as can the above-mentioned shifts in the industry that are streamlining towards the more personalized and preventative options available for patients with Assured Pharmacy.

Still gaining traction in the market, Assured has tough, but manageable road ahead of it. The chronic pain market is currently measured in the tens of billions of dollars in the United States alone and a move into the big cities could enable this company to better capitalize. Additionally, the tight monitoring of prescriptions and decreased potential for abuse may set the standard for such services, which could make Assured more desirable an option for public and private health care professionals and/or relevant insurance companies.

Another key point not to miss in terms of trends is the fact that we're currently operating in the "me" generation, where more than ever before people tend to put their own needs and desires ahead of those of society as a whole. There's another area where Assured can capitalize, as this company's personalized service will not have patients feeling as if they are being herded like cattle in front of the pharmacy window at CVS only to be treated as another number and brushed away - there's a lot to be said for that in today's society.

When following the trends, Assured could be worth a look

Conclusion: International markets traded modestly higher on Thursday and US markets were positioning to open on a similar note. Investors are comfortable that the Fed won't be involved with stalling any rallies over the short term, but again - earnings season is key as indications earlier in the year were that there could be a slowdown in consumer spending and other economic indicators. Everyone's favorite word of early 2013 - "sequestration" - also hasn't been heard from in a while, probably because the politicians told us how it would spell 'gloom and doom' if implemented, but budget discussions and governmental layoffs still hold the potential to impact markets. Early headlines on Thursday morning discussed possibilities of tens of thousands of Department of Defense workers being dismissed - not just furloughed, but dismissed. Similar cuts elsewhere could start to have an effect on the economy. As mentioned above, the threat of a stall in the record-breaking rally has many investors - including this one - looking at speculative alternatives that could produce both short and long term gains with the profits taken from the broad rally. In my opinion, these are the times when DD matters most and the trading game becomes the most fun. There's a lot to keep an eye on these days.

Happy Trading!!!

Disclosure: Long SNWV, APHY, ANTB.

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FluoroPharma Medical (OTCBB: FPMI): A Rally Waiting To Happen?

noreply@blogger.com (VFC) — Sun, 14 Apr 2013 07:08:00 +0000

FluoroPharma Medical (OTCBB: FPMI), as briefly described earlier last week, has recently seen a modest uptick in trading volume as some first look data from ongoing Phase II trials indicated that the company's positron emission tomography (PET) technology may already be proving superior to the current market standards. Aside from a brief push towards the dollar mark during the opening days of the new year, shares have traded relatively un-moved and under the radar, even as February and March brought in enough trading volume to indicate that investors may be starting to take notice that FluoroPharma - with a pipeline of imaging agents that are potentially superior to what's already out there now - may be positioned to capitalize on shifting trends in the healthcare industry.

With that in mind, it could be safe to assume that the modest - but still noticeable - jump in volume over the past couple of months could be an indication that accumulation is under way in anticipation of some milestone catalysts that are expected to unfold over the course of the year. By comparison, shares of SanuWave Health (OTCBB: SNWV) traded in similar fashion, too, before that company's stock proved to be a 'volume before price' play and shares doubled in just a short period of time.

While assuming the inherent risks of the sector, and also understanding the potential of FluoroPharma's PET technology to infiltrate a shifting market trend, there is reason to believe that FPMI could also be positioned to trade higher leading into the upcoming trial catalysts. Furthermore, should those catalysts - largely based around interim and actual Phase II results - look positive, then there is reason to believe that shares could approach the price target set by Zacks not too long ago - a target that is roughly three times the current levels. Initial indications support the Zacks target, as initial trial returns hint that FMPI's PET technology is superior to the current market standards.

With that technology, FluoroPharma has developed a pipeline positron emission tomography (PET) imaging agents for the efficient detection and assessment of various forms of coronary artery disease (CAD) and certain types of cancer. Both of its front-line products, CardioPET and BFPET, are currently engaged in Phase II trials as imaging agents for CAD and ischemic and infarcted tissue within the myocardium in chronic CAD patients, respectively.  Encouragingly, both have also already returned evidence of superior performance to the current standards, a key factor in speculating as to why shares look to have been under accumulation earlier in the year.

Results from these trials are expected to start leaking out as soon as during the second half of 2013, positioning FluoroPharma to become a potential short term catalyst play, as well as a longer term growth story in anticipation of eventual regulatory approvals.

Industry trends also position this company for success, assuming approvals. Ballooning costs in the global healthcare industry have led to a dramatic shift towards early detection and prevention, rather than just treatment. Treatment has been the 'money' place to be over the years because treating patients continuously brings in a whole lot more money than curing them would, but governments and insurance companies around the globe have finally had enough of it and the move towards prevention and early detection is well underway.

Along with these noted shifts comes the search for more streamlined and cost-effective methods of detection, and FluoroPharma's PET technology - offering more clear, concise and definitive images than the current standards - fits right into that trend, too. Another variable that has arisen from these shifts is that PET imaging agents, routinely used for the detection and identification of cancers, are more being used in the identification and assessment of CAD. PET for use in that purpose is expected to grow into a billion dollar industry within just a couple of years, another reason why timing has FluoroPharma positioned to capitalized.

The market may continue to grow. Heart disease, like diabetes, is growing at an alarming rate on a global scale and remains the number one killer in the United States.  Most of those with the disease either have - or will see their condition evolve into - CAD. Assuming the current trends continue, PED identification of such conditions could grow into a multi-billion dollar business. On the other hand, though, preventative medicine - which includes dieting and exercise - could catch up and slow the alarming growth rate of heart disease - but that would assume people are willing to get up off the couch and lay off the fast food for a while.

Although all developmental companies require financing at points during their developmental phases, the most recent quarterly and full year reports indicate that FluoroPharma has managed to keep their expenses under control and at respectable and sustainable levels. Responsible management of finances is a key factor when investors gauge a speculative investment moving forward and FluoroPharma has thus far proven responsible enough. Investors should always bear in mind that price fluctuations and dilutive financing are a name of the developmental game in this sector and the potential is always there for such an announcement to stall rallies, but those that emphasize a strategy of utilizing some trading shares while also potentially building a base of core shares for the long term can somewhat alleviate those risks by banking profits at opportune points in time before buying again on the dips and recycling the strategy.

For those looking to play the upcoming catalysts, the coming quarters will be key. Solid follow-on data will now be somewhat expected after the initial salvos of quality trial returns, and if those trends continue into latter-stage results, then investors may begin to come on board with growing conviction.  Given that trading volume has already been on the increase over the past couple of months, indications are that some may be positioning now to play the results expected during the second half of the year, which sets this stock up as a potential 'volume before price' play.

Another angle to consider is that profit-takers are starting to leave the broad markets after an early-year record-setting rally, which means money that was designated to the more stable, large cap stocks, could start flowing into the short term catalyst plays during the coming months. In times of broad pullbacks and volatility, big money often looks for individual stocks and stories that can pay short term dividends. Many of those such catalyst plays lie in the developmental healthcare sector, another reason to start taking a deeper look at the more speculative plays such as FluoroPharma. The key is to look to already have a position in a stock before a rally materializes, which is why some investors play the 'volume before price' game.

As always, the potential for great rewards comes with great risks, too, so investors must weigh the odds, conduct his or her own DD and invest accordingly.

Positive trial results this year, though, could put FluoroPharma on the map.

Happy Trading!!!

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SanuWave Health (OTCBB: SNWV): A Price Run With Legs

noreply@blogger.com (VFC) — Thu, 11 Apr 2013 06:27:00 +0000

Shares of SanuWave Health (OTCBB: SNWV) have about doubled in the time span of just a few days - after already having tripled since the beginning of the year - with volume growing methodically higher along the way. No significant news has been released along the way to fuel the rally, but with some trial catalysts pending that could thrust SanuWave's Pulsed Acoustic Cellular Expression (PACE) technology directly into the middle of a booming subsector of the healthcare industry, investors may have again become aware of the company's potential as a short term rebound play and a longer term growth play. The PACE technology, known as a 'shockwave therapy' has been employed into the dermaPACE and orthoPACE medical devices and have already received CE Mark Approval in Europe for the treatment of chronic wounds, where revenue is already rolling in. In America, a Phase III trial is expected to begin enrolling patients within the current quarter for dermaPACE in the treatment of diabetic foot ulcers and improved trial designs devised in conjunction with FDA guidance has many investors enthusiastically expecting more definitive results than those seen in a previous trial, where efficacy was demonstrated, but an endpoint was not met and market approval was not achieved.

With a new round of trial catalysts pending, and give the size size, scope and rapid growth of the diabetes and chronic wound markets, it could be argued that this latest rally was based on the SanuWave market cap catching up to its speculative potential. If that is in fact true, and if the the pending trial progresses in a more defined manner under its new design, then both interim and actual results have the potential to rally shares even further than what has already been realized since the beginning of 2013. By comparison, SanuWave shares approached the six dollar mark in early 2011 at the height of previous anticipation regarding the thermaPACE therapy, and it's reasonable to believe that another push towards FDA approval could fuel a similar share price run. Such action is expected and routine in the developmental sector, although heavy volatility should also be expected, given the fair amount of day, swing, momentum and catalyst traders that move in and out of stocks in search of quick returns.

As described above, the dermaPACE device is founded on the idea of 'shockwave therapy,' which encompasses the sending of 'shockwaves' through damaged cells. The shockwave action, in turn, stimulates the cells to heal themselves, in similar fashion to the process in which muscle tissue heals itself after workout sessions - the 'breakdown' in tissue that results from the shockwaves, as with weightlifting, stimulates cell recuperation and - often times - results in the cell tissue coming back stronger. That is the desired effect of the 'shockwave therapy' applied by SanuWave and although the last Phase III failed to result in an approval, success and efficacy have been demonstrated thus far in development - enough to warrant numerous approvals overseas.

It's always the case, however, that the US market is any company's primary target for approval, given the sheer strength, power and dollar signs of America's healthcare industry. Because of the 'fast food' culture and (lack of) exercise among the population, the diabetes sector is growing at an alarming rate, as well, and that is also becoming the trend globally. Over Twenty-three million people in the United States have been diagnosed with diabetes and it is speculated that millions more have it, but are yet-to-be diagnosed. It is also assessed that fifty seven million people in the US are pre-diabetic, according to statistics posted by the American Diabetes Association. Globally, the diagnosed numbers are much more severe and it's also estimated that a higher percentage of cases go undiagnosed. The burdens placed on the healthcare industry as a result of this growth is obvious.

In relation to SanuWave's initial application of dermaPACE in America, fifteen percent of diabetics will acquire "non-healing" ulcers in their lifetime, including the indication of diabetic foot ulcers. According to the above-linked statistics, this market is quickly approaching two billion dollars annually, which - as mentioned in the open - positions this company nicely to take advantage of a swiftly-growing market. Even when considering the already-registered and impressive price gains of early-2013, it could be argued that there still remains room for share price growth over the short to mid term, especially as trial catalysts continue to unfold and investors digest the market potential of dermaPACE.

As discussed above, SanuWave expects to enroll its first patient into the foot ulcer trial within the current quarter. The FDA has already given the green light to start the trial, a key milestone met earlier this year, and also had an influence in the trial design since an earlier trial proved successful, although a missed endpoint kept it from receiving an approval. In the earlier trial, overall success was eventually achieved, just not in the time frame expected by the company. This miscalculation, however, was more due to inconsistencies in patient follow-up than it was to the efficacy of the dermaPACE device, a variable that was factored into the new trial design.

The new trial design, as noted in a publicly-available analytic report, will more stringently monitor the desired guidelines and - as part of an agreement with the FDA - will build on the results from the earlier trial. That fact could greatly enhance the efficiency and speed of the new trial, which is currently expected to enroll its last patient in just under a year from now, and also potentially hasten the approval path through the FDA. If all current milestones are met, then it's highly likely that dermaPACE could see market in the United States by early 2015.

With the initiation of the new trial, SanuWave made some changes at the top to usher in the next era of the company's development. Industry veteran Joseph Chiarelli was appointed as the new CEO earlier this month and will look to reverse the trends of his predecessor, who burned cash at an unexpected and unsustainable rate. That especially became a problem for SanuWave when money and funding dried up for developing companies through the depths of the recession. To ensure a new era of goal-oriented responsibility, Mr. Chiarelli's contract is based nearly exclusively on incentives, a heavy sign of his confidence in the technology and on his ability to bring it through development and to market.

In conjunction with the signing of the new CEO, SanuWave also announced the securing of a bridge financing deal worth two million dollars, significantly higher than the intended cash raise.

As with all still-developmental companies, there is no guarantee that SanuWave will not, at some point in time, conduct a fund-raising event to further fuel the advancement of its technology. There are various means by which a company can raise cash, including the above-mentioned bridge financings or dilutive offerings, and these expectations add to the volatile nature of the speculative sector as investors and traders will play catalyst events to bank some profits before taking advantage of any potential price dips.

Helping to alleviate some investor concern in regards to future financing, SanuWave is already bringing in some fairly significant revenue from its overseas sales and distribution network. In the year 2012 the company banked over three quarters of a million dollars, although that was slightly down from the year prior due to the extensive economic recession in Europe. Additionally, gross profits reached seventy one percent and international growth is expected during the current year, especially in light of the Australia and New Zealand approvals. Losses were also notably lower, but it should be expected that losses could continue through trial development.

The wild card, which is standard for the sector, is the potential landing of a partner - one of the key incentives in the CEO contract - or a potential buyout of the company, which could become the case quickly if it looks like and FDA approval is in the bag or even after the Phase III trials are completed, assuming success.

Investors should expect some profit taking and volatility to dominate trading during share price spikes as we've seen with SanuWave, and Tuesday may have provided a demonstration of such, given the mid-day stall at around the $1.50 mark. By comparison, however, when the focus is on a particular company or a hot sector as a whole, then increasing investor interest and growing volume could enable speculative rallies to push through resistance and profit taking. For example, Keryx Biopharmaceuticals (NASDAQ: KERX) has on numerous occasions over the course of its developmental phase has rallied and sank behind unfolding catalyst events. In similar fashion to SanuWave after its failed trial, KERX hit rock bottom for a while before once again positioning as a nice rebound play as its 'Plan B' product of Zerenex started to look attractive to investors. Ultimately, shares rallied and held their gains when final Zerenex Phase III results came back positive and subsequent buyout talk fueled the run higher yet. Such a success story brings light to SanuWave's potential to come back from the brink, too.

Another case similar to that of SanuWave's is the history of Titan Pharmaceuticals (OTCBB: TTNP). Titan, on the heels of failed trials and investor uncertainty had dropped to a penny at one point before rebounding heavily on the late-stage results of its subcutaneous treatment of opioid addiction, Probuphine. A positive recommendation of approval by an FDA advisory committee last month has shares pushing the two dollar mark again. Again, the volatility and successes of these two companies over their history is a testament to the ups-and-downs of the developmental sector and provides a nice insight into the fact that companies that look to be down, as SanuWave did following the last trial, may not be out.

In terms of seeing how attention on a hot sector as a whole can influence trading for individual companies, take the examples of the 3D Systems Corp (NYSE: DDD) and Organovo Holdings (OTCPK: ONVO). Both are heavily involved in the present day and future of 3D printing technology, respectively, and both companies enjoyed dramatic share price rallies when investors caught on to the booming nature of the sector. Even when the hype settled, these companies still saw their share prices trading at significantly higher levels than when investors originally caught the trend. Given the huge growth rate of diabetes over recent years and the boom in revenue related to treatment of the disease, investors have been taking notice of this sub-sector's potential to become the next hot 'rally market.' As such, companies like Mannkind Corporation (NASDAQ: MNKD) and AntriaBio, Inc. (OTCBB: ANTB), for example, have benefited from increased investor attention and a spurt of speculative money as both have significant milestones pending over the course of the year. SanuWave, too, may be the most recent example of investor interest in the sector.

Some will likely remain skeptical until positive results - interim or actual - are returned from the upcoming trials, while others will be hesitant to take a position in a company whose share price has already rallied as significantly as SNWV's since the beginning of the year, but as outlined above, the potential for rebound or continued upwards movement remains, given the attention paid to the sector and the market potential of dermaPACE in the US, should approval be warranted this time around. Additionally, the overseas market continues to return revenue and new avenues for growth are opening, too, as demonstrated by the recent approvals in Australia and New Zealand. Over the longer term, investors may be able to trade into the opportunities created by any volatility resulting from news and catalysts - 'buy the dips,' for example while selling a few trading shares into significant spikes. That could allow investors to come out on 'house money' well before the longer term story plays out.

With a new trial design, new skipper at the helm and new found investor interest, a rebound year of excitement and milestones is shaping up for SanuWave.

Happy Trading!!!

Disclosure: Long SNWV, ANTB.

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Weekly Stock Watch, Week Of 8 April 2013: AA, WMT, PIR, BBBY, SNWV, SSH, HTWR, THOR, FPMI

noreply@blogger.com (VFC) — Wed, 10 Apr 2013 10:30:00 +0000

Stocks head into the new week on a slight down tick, having drifted lower for the duration of the week prior. Friday's March jobs numbers disappointed as well, although the unemployment rate dropped to its lowest level in years, and investors will turn their attention to another earnings season that kicks off on Tuesday, with Alcoa (NYSE: AA) the first major player to report, as usual. Given the lost momentum of the early-year rally last week, the upcoming earnings season will be pivotal in assessing whether or not the market can maintain at least some of its gains.

There were some early warning signs last quarter - most notably from Wal-Mart (NYSE: WMT) executives - that 2013 tax hikes and other factors may have cut into consumer spending enough to make a significant dent in expectations for this quarter's earnings, and any sign that such is true could spark a turn of momentum and send stocks south. This week's reports will be banking-heavy, but a couple of retailers - such as Pier 1 Imports (NYSE: PIR) and Bed, Bath and Beyond (NASDAQ: BBBY) - could provide an early look into consumer sentiment for the just-completed quarter. The banks, and Pier 1 to a lesser degree, will provide insight into the housing market.

Drastic market drops should not be expected, however, given the progress made with the global recovery over the past few quarters and the continued stimulus policies of the Fed, which are not likely to end anytime soon. On that note, it'll be a busy week for the Fed, too, as numerous speakers - including Chairman Ben Bernanke - are slated for comments during the coming days that should provide an indication of just how long the stimulus will last - after all, we know it can't last forever.

Budget talks are sure to steal some spotlight, too - more in regards to fiscal year 2014 than to the remainder of this year - but investors and citizens both have likely reached a point of saturation with Washington's monetary talk and are probably more likely to tune into an Astros- Marlins game than listen any more to bickering politicians.

It'll be a busy week ahead for sure, one that could make or break the early momentum for the quarter, but in the meantime there will be plenty of individual stocks and stories to keep an eye on, too...Here are just a few of them...

This Week's Focus: Medical Devices

As the broad market rally looks to have sputtered and with the upcoming earnings season not expected to blow away estimates by any means, investors will be looking to bank profits from the early year run and move onto other plays that have the potential to reap both short and long term dividends. That means that some money will move into the more speculative sector, where individual stocks and stories have the potential to create the volatility needed for traders to trade and for the longer term investors to find adequate entry points to accumulate for the long term.

Below we'll take focus to some medical device and imaging agent plays that are still in the developmental phases, but could attract the interest of those investors who have banked profits during the DOW's record run this year, but now may realize that the 'easy money' gig is up as market conditions have somewhat deteriorated. Each comes with its own inherent risks often associated with the sector, including the potential for cash-raising events to stall rallies and/or the prospects of a failed trial or road bump in development, but each is also advancing novel and potentially next-generation technologies in huge, billion dollar markets.

Everyone was making money when the broad market was soaring, but now it may be time to go looking for the individual stories that can pay benefits down the road, hence the focus this week on the developmental sector...

SanuWave Health Heads Into The New Week On An Upswing

Price followed volume for shares of SanuWave Health (OTCBB: SNWV) as they closed the day Friday up by thirty percent on volume of well over ten times the daily norm. With key milestones pending for the duration of the 2013 and with momentum building after last week's trading action, SanuWave could turn into one of the healthcare sector's better rebound stories for the year.

What is currently attracting investor interest - and what also likely contributed to the growing volume of the past month or so - is the imminent start of a Phase III trial testing SanuWave's 'shockwave therapy' device, dermaPACE, in treating the condition of diabetic foot ulcers. The FDA gave its green light to start the trial earlier in the year and the company expects to enroll its first patient within the current quarter. Although a previous trial of similar design failed to meet its endpoint, it did demonstrate overall efficacy for dermaPACE. An improved trial blueprint this time around - charted in conjunction with the FDA - has investors speculating that round two carries with it an improved chance for success, especially since the FDA has agreed to use data compiled in the earlier trial towards this trial's endpoint, too.

While the developmental healthcare sector is often filled volatile trading based on pending catalysts and realized milestones, SanuWave shares may also be benefiting from a new found awareness of its target market. As diabetes cases soar at an alarming rate worldwide, the diabetic foot ulcer market is quickly approaching two billion dollars-plus annually. Given the success already demonstrated by dermaPACE, and also given the fact that the device is already approved for use in Europe and other international markets (as is its sister device orthoPACE), there is reason to believe that the upcoming trial catalysts in the United States could lift the SNWV market cap to more reasonable - although still speculative - levels. In fact, one Seeking Alpha contributor made a strong case last week that shares could be in for a triple as the market opportunity and potential of the technology is realized.

In conjunction with the new trial start, SanuWave has also initiated a new corporate strategy with the hiring of a new CEO, industry veteran Joseph Chiarelli . Key to this appointment is that Mr. Chiarelli's contract is based nearly exclusively on incentives, a heavy sign of his confidence in the technology and also an indication that the free-spending ways of his predecessor are finished. It's times for results.

Some investors may still be hesitant to jump in after the previous trial failed to garner an FDA approval, while others may consider the probabilities that the company may look to raise cash at some point in the near future, but interest is growing in the SanuWave story, if the month-long spike in trading volume is an indication. It's a highly volatile sector and trading in SNWV may be no different along the way as the momentum traders look to jump on board, but even after last week's significant spike, there is reason to believe that this company may still be trading at a relative discount, when compared to overall results, international approvals, and US market potential.

A hot one to watch this week, and potentially for the remainder of the year.

Sunshine Heart's Slowing Volume Could Mean Opportunity

Sunshine Heart (NASDAQ: SSH) is another medical device company worth watching this week, but maybe for opposite reasons those of SanuWave. Sunshine shares have declined off their recent highs and are once again approaching the lower end of a relative trading range that has been in place for multiple quarters now, since a booming run sent shares towards the twenty dollar mark at a point last year. A dropoff in trading volume has accompanied the slow retreat in share price, an indication that Sunshine may be in a lull between catalysts and milestones, but as pivotal trial sites in both the United States and Europe start enrolling patients over the coming months, Sunshine could again be thrust into the spotlight as investors digest the potential of the C-Pulse Heart Assist device to heavily infiltrate the Class III and ambulatory Class IV heart failure market. While full trial results are years away, there are a few reasons why investors are paying attention now.

For starters, C-Pulse would have relatively no competition on the market, if approved, because the device is implanted outside of a patient's bloodstream. That's not a note to ignore, as other heart-implant devices on the market - by Heartware International (NASDAQ: HTWR) and Thoratec (NASDAQ: THOR), for example - are implanted directly into the bloodstream, increasing the risk for blood contamination while also being considered a much more intrusive implant than one that does not touch the bloodstream. Another key benefit in relation to C-Pulse being implanted outside of the bloodstream is that it allows for other quality-of-life conveniences, too, such as the ability to be disconnected when necessary - for showering, for example.
Given the strong international trend that has the healthcare industry shifting to more cost-effective and less intrusive treatments and devices, C-Pulse has a good chance of making an immediate impact in the treatment of heart failure, assuming positive results - which have thus far revealed that C-Pulse may not only halt the progression of heart failure, but reverse it, too - continue through the pending trials.

Another factor that may contribute to investor satisfaction moving forward is that the company was able to significantly reduce its cash burn rate, as demonstrated by the most recent quarterly and annual report. Both full year and quarterly operating expenses were notably lower than during the previous year and quarter, respectively, and the company ended the year with a bit more than double the amount of cash on hand than it closed the previous year. In regards to funding of the trials and potential commercialization in Europe moving forward, Sunshine announced in January a stock purchase agreement with Aspire Capital Fund, LLC, where Aspire has agreed to purchase up to $25 million worth of SSH common over a period of two years, at intervals of Sunshine's choosing. Such an agreement could carry Sunshine well past the mid-way trial point, where any positive interim data could thrust the company into direct acquisition discussions. Previous financing agreements have hinted that there already exists significant partnership or buyout interest in regards to C-Pulse, and given the annual multi-billion dollar market of Class III heart failure, there is reason to believe that positive results - interim or actual - could attract a fair amount of attention.

With volume trading light over the past few trading sessions, and a potential broad-market dip about to be realized, Sunshine Heart is one to keep on the radar as a 'play the dips' accumulation type play - with eyes towards the upcoming trial catalysts.

FluoroPharma Positions Ahead Of Key Trial Catalysts

FluoroPharma Medical (OTCBB: FPMI), like Sunshine Heart above, has also seen its trading volume taper off of late, but also has key trials underway and could potentially provide a significant upgrade to the market standards for which its technology targets. This company has developed a pipeline positron emission tomography (PET) imaging agents for the efficient detection and assessment of various forms of coronary artery disease (CAD) and certain types of cancer. Both of its front-line products, CardioPET and BFPET - being tested as imaging agents for CAD and ischemic and infarcted tissue within the myocardium in chronic CAD patients, respectively - have already returned evidence of superior performance to the current standards, which has attracted the attention of Zacks. As the company moves its product candidates into the mid to late stages of Phase II, the most recent quarterly and full year reports also indicate that the company has managed to keep expenses at respectable and sustainable levels, a key factor when investors gauge a speculative investment moving forward.

As it stands now, FluoroPharma's market cap may not yet take into account the size of the technology's target market nor the current trends in the sector that could favor the more clear and concise imaging provided by CardioPET and BFPET. Heart disease, like diabetes - as mentioned above when discussing SanuWave - is growing at an alarming rate on a global scale. Cardiovascular disease remains the number one killer in the United States, while most of those with the disease either have - or will see their condition evolve into - CAD. Industry shifts have seen an increase in PET imaging agents being used in the identification and assessment of CAD and FluoroPharma looks to capitalize on that shift. Assuming the current trends continue, this could quickly become a billion dollar market opportunity for FPMI.

Results from the ongoing Phase II trials are expected to start releasing results during the second half of 2013, positioning FluoroPharma to become a potential short term catalyst play, even as the long term story plays out. To date, trial data and imaging quality is based on Phase I and early Phase II results, but if the positive results continue for the duration of the Phase II studies, then investors may be prepared to take this opportunity more seriously and less speculatively and enable shares to potentially approach the price target set by Zacks, which is still roughly triple the current levels.

Trends in the sector also favor FluoroPharma. As mentioned above, ballooning costs in the global healthcare industry have led to a dramatic shift towards early detection of common ailments, rather than just treatment. Treatment has been where the money is for big pharma and investors of the sector - since treating patients and not necessarily curing them keeps the revenue coming in - but governments and insurance companies have finally had enough and preventative medicine is currently where it's at. That shift enables the likes of FluoroPharma's technology, which has thus far proven superior to that already on the market, to grasp a quick foothold, if results continue and the technology is ultimately approved.

A boost in trading volume during the middle of 2013's first quarter failed to move the share price much, but it could be an indication that some investors are starting to take notice. By comparison, shares of SanuWave Health saw a similar boost in volume not too long ago, before settling down, only to then see the share price follow the volume last week. As the broad market rally looks to have sputtered, investors and traders alike will now go looking for individual stocks and stories that could pay potential short and long term dividends. With trial catalysts set to unfold during the coming quarters and with the company positioning to pounce on industry trends, FluoroPharma may be one to keep on the radar. Shares in this sector tend to run leading into trial results, and then potentially thereafter, too, if positive.

Roundup: International stocks traded mixed to higher on Monday morning as the US markets shift heavily into earnings season. Indications are that the rally of 2013 may be fading quickly as politics and geopolitical events weigh on any potential upside, but as mentioned above, that does not entirely mean profits need to sit on the sidelines until a new wide-scale entry point is realized. Many lesser-known individual stocks and stories have hovered below the radar during the recent rally, and some of those plays could start attracting investor attention again. As described above, the developmental sector is one such area that trades independent of the markets and could benefit from post-rally profit taking, as some money is likely to flow into catalyst and milestone plays for the short term, while some stories may be intriguing enough to keep investors interested for the long term, too. With uncertainty surrounding the upcoming earnings season, since investors have caught onto the 'guide lower' game that was heavily played last quarter, we're likely to see an increase in overall volatility. Keep the trading fingers ready.

Happy Trading!!!

Disclosure: Long SNWV, SSH, FPMI

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SanuWave Health Offers Investors Promise And Potential

noreply@blogger.com (VFC) — Sat, 06 Apr 2013 09:21:00 +0000

SanuWave Health (SNWV.OB), a company advancing a technology that could change the scope of chronic wound treatment for years to come, is sitting in the midst of a booming sector with numerous key milestones expected to unfold over the short to mid term. According to current trading volume and market cap levels, however, the company's stock could still be trading well below the radar. That could all quickly change, however, with late-stage trials due to initiate in the United States over the short term as overseas marketing and distribution efforts continue to yield results.  In the text below we'll take a look at the target market for SanuWave's technology, the potential impact that the technology itself could have on the future chronic wound treatment - specifically for that of diabetic foot ulcers - while also examining the inherent risks of the sector that investors should always bear in mind.

The Technology

SanuWave has developed Pulsed Acoustic Cellular Expression (PACE), a technology that utilizes 'shockwaves' to incite the healing and regeneration of cells. While the foundations of this technology have been used for decades in treating kidney stones and some orthopedic conditions, SanuWave has applied its shockwave therapies to creating a pipeline of stimulative treatments revolving around the dermaPACE and orthoPACE devices. Both are already CE Mark approved in Europe and have returned a revenue stream from units sold and also from the recurring sales of 'device applicators'. The next target is America, where the company looks to receive an FDA approval after completing a supplemental Phase III trial testing the effectiveness of dermaPACE in the condition of diabetic foot ulcers. The trial is expected to begin enrolling patients within the current quarter, while efforts to mobilize sales on an international level continue, too, as evidenced by recent regulatory approvals in Australia and New Zealand.

The PACE technology encompasses sending 'shockwaves' through damaged cells, an action that stimulates them to heal themselves. This process can be compared to the process in which muscle tissue heals itself and recuperates after being beaten down during workout session with weights, often times coming back stronger.  Clinical results and commercial applications overseas have demonstrated the success of these shockwave therapies in treating numerous types of chronic wounds, while the technology also looks to capitalize on some key trends in the healthcare industry - namely the push to introduce to market more cost-effective and less-intrusive methods of treating common ailments.

With the demonstrated ability to fully heal diabetic foot ulcers, thereby eliminating the need for extended and recurring treatments while also avoiding the amputations that result from a significant number of foot ulcer cases, dermaPACE fits directly into this trend. At the same time, however, the target market is growing exponentially, given the alarming growth rate of diabetes world wide.

The Market

The sharp - and seemingly irreversible - rise in diabetic cases internationally is alarming to both regulators and budget offices who are estimating the impact and costs on the global health care system. One of the fastest-growing diseases in the world, diabetes is becoming such a huge burden that, in fact, some of the most recent statistics indicate that it is a dilemma that can only be measured in the hundreds of billions of dollars. Over Twenty-three million people in the United States alone have been diagnosed with diabetes and it is speculated that millions more have it and are yet-to-be diagnosed. It is also assessed that fifty seven million people in the US are pre-diabetic, according to statistics posted by the American Diabetes Association. Globally, the diagnosed numbers are much more severe and it's also estimated that a higher percentage of cases go undiagnosed. The burdens placed on the healthcare industry as a result of this growth is obvious.

Moving on, fifteen percent of diabetics will acquire "non-healing" ulcers in their lifetime, including the indication that we've already discussed and the one being targeted by dermaPACE in the upcoming trial - diabetic foot ulcers. According to the above-linked statistics, this market is quickly approaching two billion dollars annually, offering a very significant upside opportunity for SanuWave and its investors - since the company's current market cap is a mere blip on the radar screen in comparison.  Given the late-stage development of dermaPACE and the fact that the technology is already commercialized in Europe, SNWV's market cap could appreciate rather quickly, once investors start catching on to the potential while also gaining or regaining - confidence in the upcoming trial.

The Trial

As discussed above, SanuWave expects to enroll its first patient into the foot ulcer trial within the current quarter. The FDA has already given the green light to start the trial, a key milestone met earlier this year, and also had an influence in the trial design since an earlier trial proved successful, although a missed endpoint kept it from receiving an approval. In the earlier trial, overall success was eventually achieved, just not in the time frame expected by the company. This miscalculation, however, was more due to inconsistencies in patient follow-up than it was to the efficacy of the dermaPACE device, a variable that was factored into the current trial design.

The new trial design, as noted in a publicly-available analytic report, will more stringently monitor the desired guidelines and - as part of an agreement with the FDA - will build on the results from the earlier trial. That fact could greatly enhance the efficiency and speed of the new trial, which is currently expected to enroll its last patient in just under a year from now, and also potentially hasten the approval path through the FDA. If all current milestones are met, then it's highly likely that dermaPACE could see market in the United States by early 2015.

As milestones are met along the way, however, especially if some interim results are announced, too, then the SanuWave share price could appreciate rapidly as investors move in to play the catalysts while becoming more confident in the potential success of the trial. Such action is highly common in the developmental sector, as is the potential for volatile price swings to enter the picture as the milestones play out. Those price swings often times offer investors the opportunity to utilize some trading shares to bank some profits along the way, while still hanging on to and accumulating a position for the long term.

The New Leadership Era

With the initiation of the new trial, SanuWave made some changes at the top to usher in the next era of the company's development.  Industry veteran Joseph Chiarelli was appointed as the new CEO earlier this month and will look to reverse the trends of his predecessor, who burned cash at an unexpected and unsustainable rate. That especially became a problem for SanuWave when money and funding dried up for developing companies through the depths of the recession. To ensure a new era of goal-oriented responsibility, Mr. Chiarelli's contract is based nearly exclusively on incentives, a heavy sign of his confidence in the technology and on his ability to bring it through development and to market.

In conjunction with the signing of the new CEO, SanuWave also announced the securing of a bridge financing deal worth two million dollars, significantly higher than the intended cash raise.

The Cash

As with all still-developmental companies, there is no guarantee that SanuWave will not, at some point in time, conduct a fund-raising event to further fuel the advancement of its technology. There are various means by which a company can raise cash, including the above-mentioned bridge financings or dilutive offerings, and these expectations add to the volatile nature of the speculative sector as investors and traders will play catalyst events to bank some profits before taking advantage of any potential price dips.

Helping to alleviate some investor concern in regards to future financing, SanuWave is already banking significant revenue from its overseas sales and distribution network. In the year 2012 the company banked over three quarters of a million dollars, although that was slightly down from the year prior due to the extensive economic recession in Europe. Additionally, gross profits reached seventy one percent and international growth is expected during the current year, especially in light of the Australia and New Zealand approvals. Losses were also notably lower, but it should be expected that losses could continue through trial development.

The wild card, as always in this sector, would be the landing of a significant partner - one of the key incentives in the CEO contract - or a potential buyout of the company, if an approval is in the bag or Phase III returns overwhelming success.

The Conclusion

Positioned ahead of numerous key milestones following multiple quarters of progress and turnaround, SanuWave is positioned nicely as a potential comeback story. The company's current market cap is extremely modest, in terms of the market potential discussed above, and has hardly priced in even the remotest chances of trial success. There are still huge risks at play, given the nature of the sector and the spectre of a failed approval attempt in the minds of some investors, but the collaborative effort with the FDA to improve the trial design greatly enhances the chances for success this time around.

The structuring of the new CEO contract - and the fact that he would agree to such terms - is also a sign of extreme confidence on his part.

Speculative investors often target the next booming market and next generation products that could play a significant role in that market. SanuWave capitalizes on both of those ideals, given the swift spike in global cases of diabetes. It also capitalizes on the trend of having a less-intrusive and more final therapy on the market that could ultimately save billions in health care costs over time, especially given the high rate of amputations that eventually occur from diabetic foot ulcers.

Further on down the road, the expanded use of dermaPACE, if approved, into other chronic wound markets raises the bar even higher, in terms of market infiltration, revenue potential and share price appreciation. For now, investors will key in on the upcoming trial launch. A very noticeable spike in trading volume last month provides an indication that the company is starting to get noticed as these key dates draw nearer.

These developments are well worth watching.

Happy Trading!!!

Disclosure: Long SNWV.

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Mannkind, SanuWave and AntriaBio: Investing In The Next Generation Of Diabetes Treatment

noreply@blogger.com (VFC) — Thu, 14 Mar 2013 18:19:00 +0000

A large part of investing in the speculative sector involves staying one step ahead of the game - finding the next big thing - the latest fad, brightest technology or newest bull market - before the other guy does.

For instance, those who dabbled in the 3D printing market before the hype hit the market hard could have made huge gains by jumping into 3D Systems Corp (DDD) before it tripled from its lows and - taking the healthcare spin - Organovo Holdings (ONVO.PK), which also posted a triple at point leading up to the bubble. Although the bubble burst and those companies have now seen their share prices retreat rather significantly, the point was made that 3D printing is here to stay and the strength of the sector should be taken seriously. Those who figured that out before the market made bank.

In the healthcare and biotech sectors, staying one step ahead of the game may be a bit tougher, as an epidemic of any type could hit at any given time with little or no notice.
That said, finding next-generation drugs while they are still in development can pay off handsomely for those with the patience to wait the story out, while maybe trading a few shares here and there to make sure at least some profits are had along the way. Dendreon's (DNDN) Provenge can be viewed as just such a present-day, but next-generation product, as it targeted an existing disease, prostate cancer, and then effectively ushered in the next generation of the cancer immunotherapy treatment. The DNDN share price, as a result, jumped from roughly three bucks to well over forty at one point along the way.

Searching for the newest trends can help investors, who need to have a little time on their hands, find the next bullish market before those markets hit overdrive. The sub-sector of diabetes treatment is one such market that looks like it could be lining up for take off, given the trends we will discuss below, although it's arguable that this sector has been heating up for years now, as more and more humans survive on fast food, sugary drinks and exercise that only includes couches, office chairs and golf carts.

Below we'll take a look at a disease that is quickly becoming one of the greatest burdens on the global health care system and a few companies that could play a large role in the sector for years to come, but may still be trading relatively below the radar.

Diabetes Is A Growing Burden On The Global Health Care System

Investors of the healthcare sector should take note of the magnitude with which diabetes treatment is burdening the global healthcare industry.
One of the fastest-growing diseases in the world, diabetes is becoming such a huge burden that, in fact, some of the most recent statistics indicate that it is a dilemma that can only be measured in the hundreds of millions of dollars. Twenty-two million people in the United States alone have been diagnosed with diabetes and it is speculated that millions more have it and are yet-to-be diagnosed. The diagnosed global numbers are much more severe, yet also much more undiagnosed. The burdens placed on national and private health care systems are obvious, especially in a time when governments around the globe are streamlining costs and looking for more efficient and less-intrusive ways to treat common diseases and ailments.

While there are many established players already out there and still evolving their own respective treatments, there are a few lesser-known players developing technologies or treatments that could play a large role in future treatment.

Here are just a few of them to keep on the radar...

AntriaBio Positioning For Launch Of Human Trials

Earlier this month we introduced readers and investors to AntriaBio, Inc. (ANTB.OB), an emerging company that could be ready to make a splash in the healthcare sector of diabetic treatment.

Specifically, AntriaBio is prepared to advance to the clinical stage a once-weekly basal insulin shot, known as AB-101, that could replace the current standard-of-care treatment, which includes a once-daily shot. The improved quality of life of such an advancement, should it eventually make market, is undeniable and the targeted sector is valued in the billions of dollars annually.

Having pulled back from recent highs of over two dollars on relatively light volume, ANTB could be positioning and consolidating before multiple catalysts unfold during the remainder of the year. Those catalysts include the initiation of human trials in Russia, the expected release of some of that human data by the end of the year, and the search for potential partners, whether they be regional or international. According to a presentation posted on the company's website, the goal is to find already-established regional partners in targeted areas.

In addition to the above-mentioned catalyst events, FDA milestones could be forthcoming, as well, as the company plans to proceed with the IND process in the US while simultaneously conducting trials overseas. Emphasis has been put on the overseas trials first, however, due to significant costs benefits of conducting trials elsewhere, while patient recruitment is often easier, too. Once some human data is established, then it makes the FDA process at home a little bit easier.

When the planned trials are initiated and (if) positive data starts rolling in, ANTB's relatively modest market cap - in terms of speculative potential - could start inching higher. Catalyst traders could also jump on board in anticipation of milestone events and potentially add volatility - and trading opportunities - to the mix, too.

The time to build a trading and/or accumulation base, however, may be when the company is still hovering below the radar, as it may be right now, although some increased attention has been noted and there may be more to come as the above-mentioned developments unfold.

Beyond AB101, AntriaBio is also establishing a secondary pipeline product, which helps a company still establishing itself to keep from being considered a 'one trick pony.' As Keryx Biopharmaceuticals (KERX) demonstrated last year, and AEterna Zentaris (AEZS) just about last night, a company almost has to have a backup plan in the event 'Plan A' hits a snag or outright fails.

AntriaBio's secondary product is AB-201, a long-acting Glucagon-like peptide-1 that is approaching the pre-clinical stages and will be tested as a once-monthly replacement for the current standard of care. While the bulk of attention is destined to be paid to AB101 over the coming months, the potential of AB-201 should not be ignored, in regards to potential valuation over the mid to long haul. That said, this product candidate will likely gain more credence once it is established in the clinical stage.

MannKind's Inhaled Insulin Could Provide A Non-Needle Alternative

Of the companies discussed in this write-up, MannKind Corporation (MNKD) is undoubtedly the best known, but may have just as much a chance at upside as the others, if not more - even after another five percent price spike on Tuesday. That rise followed numerous days of notable upticks since the opening bell of the week prior.

Although MannKind is still considered a speculative play because the Phase III inhaled insulin product Afrezza has already been brought before the FDA and denied, the current trials have been designed in a manner that has the company and investors enthusiastic about its prospects for success. The problem with the trial from a couple of years ago, for example, was not related to the effectiveness of the treatment, rather it was the fact that the company utilized one inhaler for the trial, while intending to market Afrezza with the next-generation device. The FDA requested the additional trials to confirm efficacy with the next-generation device and that is what the company is now doing.

With trial results slated for release over the course of the coming quarters and an NDA filing also expected this year, MNKD has plenty on tap to keep investors interested. Financing is no longer a major concern thanks to a deal struck last fall, so these upcoming milestone events have the potential to allow the MNKD share price to appreciate in value unabated, aside from the expected routine volatility, profit taking and consolidation of the sector. It also helps the financing cause that company CEO and founder Alfred Mann has put his money where his mouth is and invested over a billion dollars of his own personal fortune into the development of Afrezza.

Another aspect that may be a driving force behind the company's fifty percent gain since the post-financing lows is the ongoing speculation of a buyout or partnership. Such discussions could add instant fuel to the fire, as we saw last week, and may become even more heated later in the year around the time results are expected to be released, especially if those results are positive. Big pharma is well aware of the growing need for new and innovative treatments for diabetes, noting the epidemic discussed in the open, and Afrezza could potentially be considered a billion dollar product in itself, if it ever garners approval, based on the size of the target market - that could be enough to attract a buyout offer or two.

Just recently, volume rolled in at roughly five times the trading norm as partnership rumors made their rounds, although the consummation of any deal is unlikely to come before results are slated for release.

That said, there are still quite a few hurdles that Mannkind has to negotiate before investors again become true believers. Not only does Afrezza have to prove it can make it through trials, it then has to prove it can make it through the FDA, and that's been tried twice before. They say the 'third time is a charm,' although a skeptical investing crowd out there feels like it has seen this story before. The recent trading action could be an indication that investors are starting to accumulate positions again, but it's also likely that investors buying in at these levels would be inclined to bank some profits into any major bump higher, which would invite volatility over the coming weeks and months - but that's nothing new to the sector.

Headlines have speculated that MNKD could become one of the better plays of 2013 and there is a good chance that could be the case if the trial results are positive enough to attract big pharma interest. Either way, a pre-results runup is likely, but expect some skepticism to prevail, given the drama surrounding Afrezza's development thus far.

SanuWave Health Preparing For Late Stage Trial In Highly Lucrative Market

In assessing the market size of diabetic treatment as a whole and the potential of an investment in the sector, it's important to emphasize that there are many other aspects to diabetes treatment than just insulin delivery that add zeroes to left side of the decimal point - there are numerous conditions that result from diabetes itself that exponentially expand the market.
That's where another still-developmental company called SanuWave Health (SNWV.OB) comes into play.

SanuWave has developed a technology that could greatly alter the standard-of-care for one such diabetic foot ulcers, a major complication of diabetes mellitus that - if left untreated - could lead to severe infection and even amputation. Through its Pulsed Acoustic Cellular Expression (PACE), SanuWave has developed a portfolio of shockwave therapies intended to treat a variety of chronic wounds and plans to initiate a Phase III trial in the foot ulcer indication in the near-term future.

The company's Shockwave therapy encompasses sending 'shockwaves' through damaged cells, an action that stimulates them to heal themselves - not unlike the process in which muscle tissue heals itself and recuperates after being beaten down during workout session with weights. The most advanced of these shockwave therapies is dermaPACE in the treatment of the aforementioned chronic foot ulcers. Beyond this indication, however, the company plans to expand further into the chronic wound market, adding significantly more long term potential to the story.

Patient recruitment for the upcoming foot ulcer trial is expected to commence within the current quarter and the trial itself was designed in conjunction with the FDA, since an earlier trial proved successful, but did not quite meet its targeted endpoint. Although the overall endpoint was eventually met, it was not achieved in as timely a fashion as expected, potentially due to inconsistencies resulting from patient availability for the desired treatment. With that in mind, discussions with FDA led to an agreement that some of the data from the previous trial could be used to support data from the upcoming trial, too, and that patients will be administered treatment in a more consistent and effective manner than previously. That fact may significantly help to streamline the results and hasten the expected duration of the trial while also conserving finances and resources along the way, always an important factor for still-developing companies.

With the advancement of the new trial, SanuWave made some changes on the business front, too. Joseph Chiarelli was announced last week as the new CEO. Mr. Chiarelli is a noted industry veteran with a pronounced history of developing emerging companies, such as SNWV, and will usher in the new era of dermaPACE and its sister therapies. The cash burn rate under the previous CEO was such that operations were hardly sustainable, especially when confronted with the depths of the recession that dried up funding for developmental companies, so investors will look for more responsible spending with the new administration in place.

The reinvigorated development at SanuWave and the potential of dermaPACE in the treatment of foot ulcers and other chronic wounds has slowly started to attract the interest of the investment community. Zack's covered the SNWV developments last week and a recent spurt in volume also indicates growing investor attention. That said, volume is still not rolling in at the pace that would indicate mass awareness, but that could change as the upcoming catalysts unfold.

Given the changes made to the trial design based on the lessons learned from before, chances are rather decent that this trial could return the desired results. That said, investors should always be aware of the potential risks of the sector. As most recently demonstrated by AEterna Zentaris, unwelcome news can hit at any time, which is important to keep in mind when devising entry and exit strategies. As we've discussed before, it's always wise, in my opinion, to utilize a handful of trading shares to augment a core position of long shares in order to bank at least some profits when the opportunities present themselves in the form of catalyst and/or milestone-based spikes. This allows investors to potentially come out ahead of the game, or on 'house money,' well before the story plays out in full.

That said, those with the inherent nature to accept risk and who also have the ability to sleep easy while understanding the volatile nature of the sector can do pretty good over the long run. All it really takes is one winner out of a couple hand-fulls of picks to come out ahead for good - if the sell orders are utilized at the opportune times. SanuWave's current market cap is a testament to the highly speculative and 'under the radar' nature of the stock right now, but also proves that the potential for significant upside exists.

Roundup: As noted in the open, the diabetes epidemic is growing at an alarming rate, especially when considering the health of humankind along with the fiscal implications on the global health care system. Whether the epidemic is due to poor diet, excessive consumption of fast food or the lack of exercise - or a combination of all three - the need for new and more effective treatments is not debatable. With that known, investors looking to take advantage of emerging treatments and therapies while they are still in the developmental phases could potentially reap significant rewards, aside from knowing that novel new technologies are hitting the market.

AntriaBio, as discussed above, could greatly enhance the currently delivery methods of basal insulin while SanuWave may eventually take its technology into the full spectrum of treating chronic wounds. MannKind is banking on its third try to finally receive the nod from the FDA.

All three companies come with risk, but also come with great potential - and best of all, all three have multiple catalysts pending over the coming quarters.

Happy Trading!!!

Disclosure: Long SNWV, MNKD, ANTB.

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Stock Watch Wednesday, 13 March 2013: BA, SPPI, SNWV, IMSC

noreply@blogger.com (VFC) — Thu, 14 Mar 2013 18:18:00 +0000

Although the DOW closed modestly higher on Tuesday, the trend was lower for much of the day and the other major indices finished in the red. Headlines swirling Tuesday evening and Wednesday morning hinted that the record-setting rally of 2013 may be losing some steam, but the question is whether that means a plateau was hit and we're in for a period of sideways trading or whether concerns of sequestration and a still-sluggish global economy will push the markets lower again. World stocks indicated on Wednesday that the latter may be modestly true, but as we've discussed before, US markets don't typically follow trends, they set them - barring unforeseen developments from overseas that could heavily impact global markets.

Should investors go looking for reasons to support the argument that the rally has lost steam, discussions of Europe's hardly-recovering economy and the potential impacts of sequestration could lead the charge. Europe's continued woes have been largely ignored during the early-year rally, but could quickly become a factor over the near term, while sequestration may become a non-factor if Washington finally rallies itself and comes to an agreement. There's little doubt that voters are tired of the inaction and recent polls indicate that no side of the fence is immune to criticism over the current stalemate - and that might be enough to nudge these guys in the right direction, if they feel that their own political fate or the fate of their party is on the line.

So far, Washington in 2013 has been about as productive as A-Rod's playoff bat. So far that fact hasn't effected the markets at all, but another 'missed deadline' for a budget deal combined with massive cuts could set us down a notch or two.

As the major stories play out there are still plenty of individual stocks and stories to keep an eye on. Here are just a few of them for Wednesday, 13 March 2013 ...

Newsmakers:

Boeing Scores Big Win With Battery Fix And New Contract

The Boeing Company (BA) was creating a bit of buzz during the early hours on Wednesday after the FAA gave the go-ahead on Tuesday for the company to start testing its redesigned battery in the 787 Dreamliner. As previously noted, multiple Dreamliners experienced fires and other safety-related issues that resulted in emergency landings and the battery was found to be the likely culprit. The FAA approval to test the 'fix' is a bright sign for investors, the company and new and existing customers that the 787 could soon be airborne again. Although shares were initially hit when news of the Dreamliner woes circulated earlier in the year, the broad market rally lifted BA, too, as investors shrugged off the bad press as just growing pains for a next-generation aircraft. In fact, Boeing's stock has set new 52-week highs recently, even in light of the 787 grounding.

Also supporting the recent share price run was news that the company was close to signing a deal with Europe's Ryanair for up to $15 billion worth of its 737 aircraft. This deal not only adds to the company's bottom line, but it also reminds investors who may have shied away from the Boeing stock after the 787 dilemma that Boeing remains a global juggernaut - and there are little signs that this will change anytime soon.

Given the good news regarding the battery fix, it could be assumed that there is room for more upside over the near term, but as discussed during yesterday's write-up, it's not always a good idea to chase a stock higher. Day after day evidence presents itself that we may be at or approaching the peak of the 2013 rally and a pullback period of consolidation could be in store if the Street feels that we've hit a plateau. At some points investors will pull some profit from the table, especially given the uncertainty still existing in the global market. That could hurt - even if only temporarily - many of the companies whose share prices have recently approached or set new 52-week highs along the way.

The Boeing story is still a decent one to track for those entertaining the long term or retirement portfolio, but now may not be the time to go 'all in.' Funny enough, with the good news hitting the wires, investors should consider that some may play the 'sell the news' game and create a bit of short term volatility. That volatility, or an overall market pullback, may provide investors the chance to jump in at lower prices than the near 52-week-high levels that shares are currently trading.

It's good news that the battery woes look to be coming to an end, although it should always have been expected that a fix was forthcoming, and BA will be a hot story to watch moving forward.

Healthcare, Biotech, Pharmaceutical:

Spectrum Share Price In Line For A Haircut With Revised Guidance

Shares of Spectrum Pharmaceuticals (SPPI) were hammered during after hours trading on Tuesday and it's a near certainty that Wednesday's open will follow suit, given revised guidance from the company indicating a very sharp drop-off in Fusilev sales for the coming months and quarters. Although Fusilev sales had demonstrated robust growth during the past year or so due to the short supply of the generic competition, many predicted that generic competition would eventually eat away at the product's new found market share once supply caught up with demand. Fusilev revenue had leveled-off during the most recently reported, but company officials at the time still predicted overall growth for 2013, but did not specify where that growth would come from.

As per comments released on Tuesday evening via press release, no longer do company officials believe that any growth will come from Fusilev. In fact, revised guidance states that investors should expect a rough fifty to sixty percent cut in revenue, noting recent conversations with customers and other relevant parties. This guidance is a far cry from what investors heard merely weeks ago and vindicates the very heavy short interest that SPPI shares have carried for the better part of the last eighteen months.

Some investors may have seen this one coming ,as SPPI's share price dropped quickly after the last earnings release, most likely due to the lack of product-specific guidance through the year. Shares did rebound, however, and closed the day Tuesday at well over twelve bucks before collapsing after hours. The drastically-lowered guidance is going to draw huge criticism from investors who may feel betrayed by management and it's also very likely that the sharks will start circling and numerous law firms will issue press releases in search of a class action case against the company.

Such activity is routine, although most as these cases are fruitless, given investors should be well aware of the inherent risks of the sector and assume that bad news could hit the wire at any given time. That's why, in my opinion, investors should protect against such events by utilizing those trading shares along the way in order to bank at least some profits and turn out on house money - or better - in case things go sour. There will also be quite a bit of elation on the part of the shorts for the remainder of the week, which is fine - everyone enjoys patting themselves on the back once in a while. This has been a long time coming for them as Fusilev defied the odds, quarter after quarter, until now.

The bad press, a still-very-high short interest and possible lawsuit-related headlines will make SPPI a rough one to stomach over the short term, but at the end of the day the company has multiple revenue-generating products and a deep developmental pipeline, making it worth a look as a potential long term growth play after the dust from this latest drama settles - and once the share price receives its cut, the risk involved in an investment of SSPI will also decrease substantially.

Will trade with high volatility for a bit, but for now this is a hot story to watch for Wednesday.

SanuWave Ready To Roll With Full Trial Approval

SanuWave Health (SNWV) released news early on Wednesday morning that goes a long way to validating the company's comeback story while also emphasizing the potential of its shockwave therapies to play a significant role in the future treatment of chronic wounds. According to the above-linked press release, SanuWave has received full approval from the FDA to move forward with a Phase III trial measuring the effectiveness of its dermaPACE technology in the treatment of diabetic foot ulcers. As described earlier this month, dermaPACE operates utizling the company's Pulsed Acoustic Cellular Expression (PACE) technology, which treats damaged cells by sending 'shockwaves' their way and spurring them to heal and recovery themselves. This process is not unlike the process in which muscle tissue heals itself and recuperates after being beaten down during workout session with weights. Earlier trial results testing this 'shockwave therapy' in the treatment of diabetic foot ulcers were successful - in the eventual outcome - but did not meet the desired endpoint.

That is where the significance of Wedensday's announcement comes in. SanuWave worked with the FDA to appropriately design a new trial, and as stated by CEO Mr. Joseph Chiarelli, the new study was designed based on the successful portions of the last trial, which greatly enhances the chances for endpoint success this time around. Other key points regarding the design are highlighted in the pre-market release, and underscore the potential for success. Also of note, the fact that the FDA has granted approval of the Company's Investigational Device Exemption (IDE) Supplement to use the dermaPACE device during the upcoming trial helps to support a potential expedited review as the results roll in.

The contracted trial sites are also already in place and the first patient is expected to be enrolled within the coming quarter. The diabetes market is growing exponentially, as we've discussed before, and that could be a key reason why SanuWave decided to target the foot ulcer indication first, before looking to infiltrate the chronic wound market as a whole.

A new CEO is in place and a new trial is set to get underway, that makes SNWV as one to keep on the radar over the coming quarters. With the recovery story in place, investors may start paying attention again and volume has already increased enough to notice that a 'volume before price' play could be materializing. That said, there is still a ways to go before the light at the end of the tunnel approaches. One trial not meeting its endpoint will keep some investors skeptical until they see new and encouraging results and the standard concerns of the sector, of course, still apply here.

As Spectrum demonstrated above, it's a volatile sector, but often times investors who are not afraid to trade while also riding out the story for the long term could do very well. Given the momentum that may be built by Wednesday's news release, this is a story to watch over the coming months.

Explosive Trace Detection (ETD) / Global Defense:

Implant's Exposure In Global Security News Highlights Potential

The recent Implant Sciences (IMSC) share price pullback has made this company a stock to watch as its technology is positioned to enter the very lucrative and rapidly-growing ETD and global defense markets. As discussed earlier in the week, the pullback may have created another opportunity for investors to either enter into or accumulate a position in the stock in anticipation of future growth that could stem from the TSA approval of Quantum Sniffer B220 explosive trace detector for use in air cargo screening earlier this year. Recent news regarding the extension of a financing agreement with DMRJ Group lays a firmer foundation moving forward, too.

With the approval in place and the financing settled for now, the company and its investors will now be concentrating on the growth strategy. Noting the potential of the Quantum Sniffer technology, the latest edition of 'Government Security News (GSN)' features Implant Sciences as one of its cover stories. As mentioned in the associated press release, and true by all standards, "GSN is considered the authoritative publication in the government security marketplace." It's reach stretches from various levels of government and civilian enterprise embedded in the sector and the exposure given to Implant's TSA approval could augment the already-available public information.

It is still early in the post-approval phase, but Implant has made some key strides in ensuring it could be a big player in the future of explosive trace detection, air cargo screening and global defense for years to come. The GSN mention bumped volume slightly higher than the modest norm we've been accustomed to over the short term, but it's still not to the consistent point that would indicate mass awareness. A few notable orders resulting from the approval could easily change that.

With exposure growing and finances settled for the remainder of the year, IMSC is still one to keep on the radar.

Roundup: Global shares traded mostly in the red on Wednesday and early indications were that US markets would open modestly lower, too. Wednesday could be a key day in assessing whether investors are in for a period of sideways trading over the coming days and weeks, or whether the sluggish global economy and threats of sequestration are going to come into play and hamper the markets. Washington has already implemented many cutbacks and 'holds' on cash flows due to the uncertainty of this budget impasse, so the effects on the economy may already be felt, but won't be fully known until the numbers are tallied. Remember, a cutback in defense during the fourth calendar quarter hurt GDP numbers and many of the cutbacks agreed-to in DC in regards to sequestration also trim the defense budget - that's not to say that enough private growth can't offset that trend, but it is something to consider moving into the next fiscal quarter come April.

There's also the earnings warning from Wal-Mart (WMT) last month that investors may have forgotten about, but should still keep fresh on the back-burner. It's easy to become complacent when record highs are being set day after day, but it's best to entertain all angles of a story and invest (or sit on the sidelines) accordingly.

On a brighter note, Hostess found a buyer for its Twinkies and other brands, so everyone's favorite diabetes bombs will be back on shelves by the summer, according to the latest reports. Hopefully all of those who stockpiled these products when bankruptcy was announced either sold high or had a good Twinkie party or two. It was only a matter of time before we saw the Twinkie again.

Happy Trading!!!

Disclosure: Long IMSC, SNWV.

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Weekly Stock Watch, Week Of 11 March 2013: BBRY, AAPL, GOOG, MCD, MNKD, SNWV, AMRN

noreply@blogger.com (VFC) — Tue, 12 Mar 2013 11:31:00 +0000

Record high after record high is what we saw from the DOW last week and investors will look this week to see if the momentum can carry over after a strong jobs report on Friday dropped the US unemployment rate to 7.7%. 236,000 jobs were added in February, well above previous estimates, and many see this as a positive sign that the economy continues to gain strength and is well on the road to a full recovery. Since the markets generally look ahead by a couple of quarters, the record highs could be justified, but the question is whether or not they can be sustained over the short term without any volatility entering the picture.

That question holds extra weight right now as the true effects of sequestration, which are still set to come into play in April, are still unknown. A harsh round of budget cuts and pullbacks could knock down the merry market mood just a notch, as ancillary evidence still exists - jobs numbers aside - that the economy is not yet healthy enough to grow substantially - if at all - without the help of the Fed's stimulus measures that have been in place since the depths of the recession. Look to 2012's fourth calendar quarter as evidence of such, when a pullback in defense spending caused GDP to roll flat for the quarter, only after being revised higher.

Although Fed Chairman Ben Bernanke last week indicated that there were no immediate plans in place to lighten up on the stimulus measures that have been in place since the depths of the recession, Friday's enthusiastic jobs report has refueled talk from many analysts and pundits that it makes little sense to keep these measures in place while the economy looks to be gaining strength on its own accord, while February's jobs numbers speak for themselves. A reversal from the Fed that indicates stimulus might be lightened could temper the market's early-year rally.

This week will be a light earnings week, with only a few major holdovers left to report.  Attention will be strictly paid to the debate that will likely rage over how much of an impact the pending sequestration will have on the new record highs.

It's been a definitive year of rebound thus far, and many would agree that - in retrospect - the markets are flowing on a stronger foundation now than they were when the old record highs were set just before the crash, but we've likely not yet approached the light at the end of the tunnel. Caution against going 'all in' at this point may still be advised, as any economic news that again creates uncertainty could quickly have an impact on the upwards momentum, as evidenced by the election news in Italy a few weeks ago that led to a DOW drop of more than two hundred points.

Enjoy the ride while it lasts. As always, there will be plenty of individual stocks and stories to keep an eye on while the major news plays out. Here are just a few of them for the week of 11 March, 2013...

Technology:
March A Pivotal Month For BlackBerry With US Release On Tap

The next few weeks could prove pivotal for BlackBerry (BBRY) and its share price.  The first wave of sales numbers associated with the international release of the BlackBerry 10 platform could become more transparent over the coming weeks, while the much-anticipated US launch may also provide a potential trading catalyst. Multiple reports regarding early sales numbers from overseas have been encouraging, but the numbers have not yet been definitive enough to keep a couple of analysts turning negative and issuing downgrades over the past few weeks. The most recently-revised analyst price targets have identified BBRY shares as heading lower towards the ten dollar mark, citing slow shipments and large inventories left over from initial orders, but it could still be a bit premature - being still only weeks-old - to call this launch a failure.

In fact, the first wave of the Z10 launch - which left out the American market - may have been more intended to create hype leading into the US launch, much as some major movies are being released on international markets these days to create buzz before the US open. With the US launch pending, the level of media attention received by the new products could significantly increase during the coming weeks, especially since consumers have had ample time to test drive the new devices.  A notable boost in coverage and reviews could eventually lead to the frenzy that the company was trying to create with its overseas 'tease' launches, geared - of course - towards recapturing some of the lost market share stolen by Apple's (AAPL) iPhone and Google's (GOOG) Android over recent years.

The next installment of the BB10 platform will be forthcoming in May with the launch of the Q10, a throwback to the BlackBerry of past, that has a full 'QWERTY' keyboard - with real buttons - installed below a bigger and improved-resolution screen. It's likely that the Q10 could attract those customers looking to come back 'home' after playing around with the competition for a few years running, but BBRY still has its work cut out for it in pulling the lost customer base back in.

For one, it's hard to compete with the App stores available for the iPhone and Android. As described in a recent write-up by a popular business news outlet, most companies do not regard it as a profitable endeavor to create apps for any other platform than the big two listed above. That poses a problem in itself for those looking at BBRY stealing back market share as many consumers will take into account the loss of access to their favorite apps when considering which phone to purchase - Instagram, for instance. Through default, such apps not available on the BlackBerry are exclusive to the competitors, and that's no small point to miss.

BlackBerry, to combat that trend, may have to foot the bill itself to develop some of the more popular apps for the BB10 platform, as they have with Facebook, or come up with competing apps of their own. Neither scenario is out of the question, given the nature of the consumer who will jump to whatever's popular at the moment, and BlackBerry's cash on hand, which places its book value at significantly higher than the current market cap.  If the hype surrounding the Z10 and Q10 can return some decent sales numbers, then the big players in the app industry may be inclined to return to BBRY on their own anyway.

It's yet to be seen whether BB10 is the revival that BlackBerry has long hoped for, but the coming weeks could be telling. The growing short interest of the stock - which sits at more than 20% of the float - indicates that the market is currently betting against a comeback, but it makes for an intriguing short squeeze play, should the right news, sales and developments hit all at once.

BBRY is one of the hotter stories to watch right now, as the retreating sales price may create an opportunity for those wanting in before the US launch, which is slated to begin as soon as the end of this week. Still a speculative recovery story, but also one that looks a lot better right now trading closer to ten bucks than it did trading closer to twenty not too long ago.

Food / Beverage:

McDonald's (MCD) shares jumped by nearly another two percent on Friday and remains one to keep an eye on for the long term and/or retirement portfolio as the company's share price treks towards the one hundred dollar mark. MCD is currently trading on the strength of February sales numbers that came in better than expected, but it's also highly relevant that UBS initiated coverage of the company with a "Buy" rating and a price target of $100 earlier in the year.  That rating coincided with enthusiastic sales trends and is quickly turning into an accurate estimate by UBS.

As previously discussed, McDonald's perch on the fast food throne is based on the company's ability to remain one step ahead of the competitors when it comes to menu pricing and variety. Recent moves by the company to introduce new products while weeding out those that hurt margins more than help them, especially at a time when rising taxes and increased labor costs may be coming into play, is another demonstration of the company being quick to act.

In terms of the rising share price, however, there are some items to consider. While the company continues to demonstrate its dominance of the low-cost fast food sector, growth in the sector is still sluggish, even given the above-mentioned February sales report that beat expectations. The recent market rally to new record highs has helped to support a MCD move to a hundred, but if sequestration and other factors - such as rising taxes or gas prices - start to weight on the market as a whole, then MCD could slip a bit, too. With that in mind, it's not entirely out of the question that investors who accumulated heavily in the mid-eighty dollar range late last year would treat the current run as a trading opportunity and bank some profits as the opportunity presents itself.

Even in the long term and retirement portfolios made up mostly of stable, large-cap players, there's plenty of room to take profits at opportune points with the intention of jumping back in at lower prices, should they materialize.

As mentioned in the open, the market generally looks a couple of quarters ahead and that could be a major reason why the DOW is setting record highs and MCD is marching back towards a hundred bucks. With that in mind, it could be assumed that investors consider MCD a solid play moving forward in line with the overall recovery, even considering the currently sluggish growth in the sector.

If the green we've seen for the past couple of weeks continues into the new trading week, MCD could be a bet to see a hundred again. One to keep an eye on.

Healthcare, Biotech, Pharmaceutical:

MannKind Pushes Through Three With Numerous Milestones Pending

MannKind Corporation (MNKD), a still-speculative healthcare play that is more apt to trade on catalysts and milestone events than on broad market movement, took advantage of the green pouring from Wall Street last week and jumped over the three dollar mark again while setting a new 52-week high in the process. Volume rolled in at roughly five times the trading norm as partnership rumors made rounds while the potential impact of the company's inhaled insulin product, Afrezza, also grabbed headlines.

The push through three makes MNKD a winner for investors by returning more than a 50% gain since the post-financing lows of late last year. Given the potential for Afrezza to infiltrate the insulin delivery market, should it ultimately receive FDA approval, it's safe to assume that even higher could be reached as the latest round of trials evolve. Afrezza failed to receive approval a couple of years ago because the company used a different model of inhaler during the trials than what it intended to use during the commercial phase. With that detail sorted out for the current trial, investors are looking for a positive outcome this time, as is company founder and CEO Al Mann who has personally invested over a billion dollars into the product.

With trial results slated for release over the course of the coming quarters and an NDA filing also expected this year, MNKD has plenty on tap to keep investors interested. Financing is no longer a concern that will weigh down the stock this year as it did last year, so these upcoming milestone events have the potential to provide substantial price catalysts. Discussions of potential partnerships, as we saw last week, may only add fuel to the fire, but because many are still skeptical that Afrezza will reach open market, however, and also because similar high-profile products failed commercially in the past, any swift spikes are likely to be followed by some profit taking and consolidation, which could lead to volatility.

Not only does Afrezza have to prove it can make it through the FDA, but it also has to win over a skeptical crowd that feels it has seen this story before. Last week's move provides an indication that some believers may be jumping on board, while the pending milestones should keep it interesting for the coming months.

SanuWave Health Preparing New Trial

In keeping with the theme of diabetic treatment and the billions that the sub-sector rakes in annually, SanuWave Health (SNWV) is another 'Phase III company' in the developing a treatment for diabetic-related indications that will be worth keeping an eye on during the coming weeks as a new trial is slated for initiation. Through the development of its Pulsed Acoustic Cellular Expression (PACE) technology, SanuWave has developed multiple shockwave therapies for the treatment of chronic wounds.  The most advanced of these therapies, dermaPACE in the treatment of diabetic foot ulcers, was already brought through Phase III trials once, but - although demonstrating significant potential and success - the trial failed to meet its endpoint due to certain trial limitations that have been modified, in conjunction with the FDA, during preparations for the upcoming trial.

As described on the company's website, the new trial - slated to begin recruiting patients within the coming quarter - will more vigorously monitor patient progress and better ensure consistent treatment, a variable missed during the last trial. It's also been agreed-upon with the FDA that some data from the previous trial can be used to support the data from the upcoming trial, too, which could help to streamline results and expedite the expected time allotted for the current trial. As recently outlined by another Seeking Alpha contributor, the current trial design could also cut back on costs over the short term.

In terms of financing, SanuWave last week also announced the appointment of a new CEO in conjunction with a bridge financing deal that put two million dollars towards the coming trial. The new CEO, Joseph Chiarelli, is an industry veteran with a history of developing emerging companies while the two million dollars is more than the intended value of the cash raise, according to the above-linked PR. While that fact indicates interest in the reinvigorated trials, it should always be expected that cash-raising events could come at any point during the course of development for emerging companies. Given the recent churn of events, other investment information outlets - such as Zack's - have started covering these developments.

With new trials slated to begin over the coming quarter, this could be a potential turnaround story to watch. Volume has picked up a bit lately as time draws nearer to the expected launch and speculative investors looking for 'volume before price' may be attracted to such a move, while the current market cap also indicates that this company may either be forgotten about or not found yet. Standard risks of investing in the speculative health care sector apply and investors may still be wise to utilize a group of trading shares to play into any potential price spikes, while potentially holding a core group of shares for the long term, to see the story out.

NCE On Tap Again For Amarin

Is it ever a 'Weekly Stock Watch' in this sector without interest in Amarin Corporation (AMRN)? Once again AMRN will be a stock to watch because investors anticipate that the FDA's Orange Book will be updated within the week. This is a hot item to watch because it could (or not) reveal Vascepa's designation as a New Chemical Entity (NCE). As previously discussed, the holdup in the NCE status could have also held up any potential partnership or buyout deals that were being discussed before the company decided to launch on its own because a true valuation of the product's potential may not have been easy to ascertain, given the uncertainty regarding protection.

In regards to protection, however, Amarin announced another patent covering ANCHOR last week, and it's been argued by company officials during conference calls before that the patent protection renders NCE relatively irrelevant, anyway. Judging by the lack of any partnership deals materializing when they were most expected, others may not agree, but it's certainly a significant piece of the puzzle to continue to monitor.

AMRN quickly rebounded from the lows hit after the most recent earnings report and closed the week closer to nine dollars than eight - still right within the trading range established since the beginning of the year. NCE is still one of the hotter potential catalysts to watch and this could finally be the week where the FDA decision is revealed. A positive outcome could push shares higher towards ten again, as it could renew the recently-depressed buyout rumors, while another delay would likely be disregarded as a non-factor again, since most investors are now immune to this event.

On another note, the recent discussions surrounding Amarin has emphasized how much of a big player in the investing community Seeking Alpha has become in a just a few short years. Many popular financial media outlets are spending more and more time commenting on the opinions and analysis of SA authors, and less on their own analysis and coverage of particular stories. Score that a big win for the Seeking Alpha team and its contributors.

As usual, AMRN is a hot one to watch this week for the possible NCE revelations.

Roundup: International stocks carried the momentum of last-week's record setting pace early on Monday, but settled down later in the day and traded mixed during the afternoon hours. As discussed earlier in the month, US markets generally set the trading tone, not follow it - aside from instances where significant overseas news hits the wires - so investors on this side of the pond will be watching as to whether the momentum built on last week's jobs report can carry into Monday's open. Early indications point to a lower open, possibly an indication that worries over sequestration - that have been thrust aside for weeks - may start to have an impact. Rumblings from Washington, however, are starting to indicate that politicians on both sides of the fence are wondering how much political capital they want to spend in standing firm and continuing to do nothing - especially since the doomsday scenario come 1 March has not played out, as many predicted it would. That said, it could again come down to crunch time as March progresses and politicians negotiate yet another deal to delay yet another deadline. It's like 'Deja Vu' all over again, as the great Yankee once said. Plenty to keep on tap for the week.

Happy Trading!!!

Disclosure: Long AMRN, MCD, SNWV.

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Stock Watch: AntriaBio (ANTB) Volume Boost Indicates Growing Interest

noreply@blogger.com (VFC) — Sun, 10 Mar 2013 12:13:00 +0000

AntriaBio, Inc. (ANTB) remains a stock to watch this week, as outlined in this week's 'Weekly Stock Watch,' due to a notable increase in trading volume over the past couple of the weeks and the advancement to human trials of a once-weekly basal insulin shot that has the potential to eventually replace the current standards of care, which includes once-or-twice daily shots. Having fallen off the recent highs set at $2.50, investors may be taking advantage of the current pullback as volume has notiecably increased over the past week. On Monday, in fact, ANTB shares registered their second-highest trading day of the year and were not too far off from seeing the most shares traded in one day since the symbol began trading in mid-January. Investors taking note of potential 'volume precedes price' action may anticipate an eventual move higher based on the recent volume and interest paid to this stock.

Over the long term, AntriaBio has the potential to enter a multi-billion dollar industry with a next-generation product that could drastically increase the quality of life for diabetic patients needing daily basal insulin shots as a sustained treatment option. Aside from this week's 'Weekly Stock Watch' report linked above, below is our original write-up on AntriaBio.

ANTB trades in a highly volatile sector, so there are key points to consider, as outlined below, but this is an emerging story to monitor these days.

Stay tuned...

AntriaBio Potentially Positioned For Both Long And Short Term Gains

AntriaBio, Inc. (ANTB) is an emerging story in the developmental biopharmaceutical sector that may be worth keeping on the radar as volume has been picking up of late and the company's potential to alter the scope of the future insulin delivery market by creating a once-weekly injection of insulin to replace a once-or-twice daily version is starting to gain increased exposure from popular financial media outlets and from the investing community as a whole.  Relatively new to the trading scene, AntriaBio became public through a reverse merger earlier this year after having first purchased the assets of PR Pharmaceuticals from bankruptcy court. PR Pharma had already invested tens of millions of dollars into the preclinical development of the above-mentioned once-weekly basal insulin shot, now known as AB101, but was unable to see its development through to fruition as the depths of the economic crisis dried up funding for many developmental biopharmas.

Now controlling the AB101 assets, AntriaBio has positioned itself, pending successful trials, to eventually enter the multi-billion dollar market of basal insulin delivery that is now dominated by Sanofi-Aventis' Lantus and Novo Nordisk's (NVO) Levenir, each of which requires patients to receive at least one shot daily.  Those two products alone pull in over eight billion dollars annually, highlighting the potential of AB101 to to steal quick market share, should it reach the point of commercialization. Emphasizing that once-weekly advantage, it's understandable why AB101 would be attracting the increased attention that it is right now, as some investors may consider this a ground floor opportunity of a potential next-generation technology.

There will be some investors that are skeptical about buying into companies that have only recently become public via means of a reverse merger, but such methods are becoming more and more common, given the current economic climate where cost-cutting and efficiency is key. Reverse mergers, after all, provide a much cheaper path to becoming publicly traded than going through the expensive IPO process. Not all reverse mergers are created equally, however - neither are IPOs - but AntriaBio could be worth a look because of the potential of its newly-established pipeline, which could be set to meet major milestones throughout the year.

According to a presentation posted to the AntriaBio website, pre-clinical animal studies have already been completed for AB101 and the intention is to have the first wave of human data available by the end of the year. AntriaBio, according to the above-linked presentation, will initiate the human trials in Russia first, where the costs of conducting such trials are significantly lower and where patient recruitment is known to be up to ten times higher than in the US and Europe. The company does plan, however, to move forward with the FDA IND process while development in Russia continues, and having the early human data available from its Russian trials could help to expedite the initial IND process in the United States. Once the early data is established, AntriaBio will look to land regional and/or multi-national partners, according to recent company presentations. Once a partner is on board, investor concerns of dilutive financing deals that often accompany the pipeline progression of developmental companies will somewhat subside.

The related catalysts to watch for this year are discussions of the preclinical data, the initiation of the Russian trials and comments referring to the initiation of the IND process in the United States. Beyond that, it is also expected that some human data will be presented before the end of the year, too.

Beyond AB101, AntriaBio is also establishing a secondary pipeline product.  A long-acting Glucagon-like peptide-1, also known as AB201, is approaching the pre-clinical stages and will be tested as a once-monthly replacement for the current standard of care. While the bulk of attention is slated to be paid to AB101 moving forward, a secondary pipeline product always eases investor nerves who would otherwise feel a company could be viewed as a 'one trick pony.'

Another item of interest for investors is the management team team that has been put in place since AntriaBio's inception.  Numerous industry veterans have been brought on board who have an established history of bringing small biopharmaceutical start-ups through the point of commercialization and/or - maybe most notably for those looking for a shorter-term return - to the point of mergers and acquisitions. Although speculation about potential buyouts often accompany the development of high-profile products with potential through development, having a management team in place with an established record of consummating deals attracts even more interest to the discussion.

For an example of another company brought to life through a reverse merger which has also garnered its fair share of merger and acquisition talk, look no further than Organovo Holdings (ONVO).  Organovo, quickly becoming a recognized leader in the field of 3D 'bioprinting', saw its share price nearly triple in quick fashion after its reverse merger about a year ago. Since then, bouts of volatility have led to many more trading opportunities, offering opportunity and profits for both traders and investors who may be accumulating for the long term. As always, such action emphasizes the ideal that it is always wise to utilize a handful of trading shares to bank at least some profits when available, even while potentially using the dips to accumulate a group of core shares to see the story out over the long term.

With ANTB's trading volume picking up as it has over the last week, it could be worth noting that opportune points to buy, sell and accumulate could be forthcoming, as the old adage goes that volume precedes price movement.

Shares initially spiked by twenty five percent on Monday morning before pulling back and closing the day flat, offering investors and/or traders a potential opportune point to monitor the stock. AB101 could be a game-changer if it makes through the point of development and it's highly likely that the release of human data as early as later this year could bring the company and the product to a grander stage. At that point the share price may be positioned to experience gains in line with Organovo's recent moves higher, especially if the partnership or buyout talk picks up, too, but those taking a look now may be taking advantage of a ground floor opportunity before the story plays out and attracts the volume and attention that could drive the share price higher.

One to keep an eye on right now as the stock - being newly traded - and the technology is just now starting to get noticed. A potential 'buy or accumulate the dips' play.
Disclosure: Long ANTB.

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Stock Watch Wednesday, 6 March 2013: IMSC, BBRY, AEZS, KERX

noreply@blogger.com (VFC) — Sun, 10 Mar 2013 12:09:00 +0000

A new DOW record is in the books and world stocks were moving higher on Wednesday as a result. As mentioned earlier this week, we're at a serious pivot point now as to whether the markets can sustain these or whether a pullback will materialize based on the developments of other general conditions and geopolitical events.  A positive private jobs report on Wednesday AM was key in determining the strength of the new record over the short term, but investors will now look towards the effects of sequestration and how budget cuts can have an impact over the coming weeks.

Most of the expected cuts that were regarded as a doomsday scenario by many politicians leading into the March 1 deadline, however, are not due to be implemented until the April time frame, according to the most recent reports from Washington. That allows more time for our elected officials to come up with something solid in terms of a budget for the first time in years, but it also leaves us in a position where investors could feel complacent with the bullish momentum just before the real impact could be seen. Many government programs are slated to lose at least portions of their funding and - maybe even more important for the already sluggish recovery - federally paid workers could be in for a slate of pay cuts and furloughs.  Those cuts could offer the markets a look at the potential impacts of having an increasing portion of the population relying on government money, whether it be through government jobs or handouts.

For the time being, investors are satisfied enough with what Fed Chairman Ben Bernanke had to say last week to keep the markets elevated, but now is also not the time for complacency.  With the uncertainty regarding budget cuts and federal furloughs, investors should prepare for multiple eventualities, which includes positioning for a pullback, should one - no matter how modest it may be - materialize.

Over the short term, the job numbers are the key indicator to watch, but in the absence of a budget deal - and the politicians don't look to be in a rush to push one through - watch for signs of how sequestration could impact consumer spending, consumer sentiment and overall growth.

As always, there will be plenty of individual stocks and stories to keep an eye on while the major news plays out. Here are just a few of them for Wednesday, 6 March 2013...

Explosive Trace Detection (ETD) / Global Defense:

Implant Could Potentially Be Impacted By DC's Stalled Budget Talks

In discussing the potential effects of sequestration and Washington's stalled budget talks, it may be worthwhile to consider the potential Impacts that these issues could have on Implant Sciences (IMSC) and other companies that may be looking towards government money to fuel growth. In the case of Implant, investors had speculated that recent TSA approval of its Quantum Sniffer B220 explosive trace detector would result in the landing of some key deals potentially associated with Washington's anti-terrorism efforts in relation to air cargo and overall aircraft and airline security. While the potential remains for Implant to land deals in the private sector for air cargo providers, the company's potential to enter into the government sector could be stalled by the budget woes in Washington, and investors should take note of that fact.

As news trickles out from DC regarding spending cuts and furloughs, one item mentioned is that Washington is in a period now where money already obligated to existing contracts will not be effected, but any new contracts or requests for fiscal obligations will be just as stalled as an elected official's 'to do' list once they arrive for work post-election. That could impact the type of new money that would be necessary for Implant to secure the government contracts - that's another aspect to consider in the patience game.

Such a scenario could lead to a period where investors may grow anxious at a point when large government-related deals were anticipated, but those looking towards the long term may appreciate the recent price pullback as an opportune time to add or continue with accumulation. As previously discussed, the advantages of Implant's ETD technology over the competition are distinct, and that underlies the potential for the company to play a large role in the growing homeland defense market. For that to occur, though, homeland defense needs to be funded and as we all know, the Mets might win the 'outfield of the year' award before a budget gets passed in DC.

A slowdown in domestic growth does not mean that the company can't come through on the international market, as has been noted in the past. On Tuesday, too, Implant noted that an existing aviation security customer in Africa had purchased three QS-H150 handheld units as part of a follow-on order. Having demonstrated a significant amount of overseas growth over the past year, including a multi-million dollar order to India, this company is not overly-reliant on the US market right now - but a budget resolution could help, as it'll free up new money for contracts again.

Also take note of the credit extension with DMRJ that places the company on stable financial grounding, at least for the next year.

Technology:

BlackBerry Sinks As Market Soars

Global markets may be setting multi-year highs these days, but shares of BlackBerry (BBRY) have retreated off their recent highs and were down another near-two percent on Tuesday. Speculation is still rampant about just how successful the launch of the new BlackBerry 10 platform is going, but most are reserving judgement until the full US launch is underway. Many consumer reviews have been positive thus far and the instant overseas statistics are encouraging, although there is some concern that abundant inventories and pricing promotions - both of which could lead to revenue reductions - may eat into margins.

The recent decline in the BBRY share price should not be attributed fully to expectations of a weak launch. As the market has inched higher just about every day over the past couple of weeks - culminating in Tuesday's triple-digit rally to break the record high - many investors have been concentrating their cash towards the hot DOW players and other market movers to enjoy the bull ride. As they say, everyone makes money in the bull market, so many investors tend to concentrate cash into those more stable investments that are likely to ride the broad-market wave. BlackBerry, still being highly speculative until those de-facto sales numbers start rolling in, doesn't quite fit that bill as it's still a potential rebound and recovery story, not necessarily a 'trade in-line with the market' play.

That could change if the BB10 platform proves to be a hit, or at least proves capable at stealing back some market share from its competitors.

If the market stabilizes where it is or starts to pull back, then investors are likely to start taking some profits from the table and that's when money could start flowing back into the more speculative stocks. At that point, BBRY may be the target of some of that money and start to inch higher again. Conveniently enough, that may coincide with the release of valid sales data from around the globe and propel shares higher towards their recent highs, assuming those numbers are positive or in line with general expectations.

It hasn't helped shares lately either that a couple of analysts have issued downgrades over the past few weeks and predict that the BBRY share price will not settle until it hits prices of at or just below the ten dollar mark. The respective analyst reports cite slow sales and shipments, but some may judge them as premature, given that the full global launch is not quite in full throttle and hype is not yet at its peak.

The recent pullback makes BlackBerry a much more attractive speculative play now than what it was when shares were sitting near twenty bucks. The overall potential recovery will still depend on sales numbers later on down the road, but as investors start taking profits from this easy-money bull run, then some cash could start slipping back into the speculative plays that have the potential to go up when/if the market comes back down.

Healthcare, Biotech, Pharmaceutical:

AEterna Zentaris Could Rise Even In Market Pulls Back

AEterna Zentaris (AEZS) is another more speculative play that has slipped lower recently but could rise even if the market decides to pull back from its record highs, mainly due to catalysts that are still to unfold over the coming weeks and months. Another reason that AEZS could trade independently of the broad market action, if news and developments warrant, is for the same reasons discussed in the BlackBerry discussion above. As investors pull profits from the highs of this record-setting rally, then money could flow back into those investments more speculative in nature that have the potential to spike - even in a down market - based on unfolding catalysts.

As previously identified, one potential near-term catalyst for AEterna is the expected NDA filing for AEZS-130 as a diagnostic test for Adult Growth Hormone Deficiency. This product candidate is not quite expected to become a huge money maker, if only because of the relative size of the intended market, but AEterna maintains world-wide rights to and - if approved - could provide a future revenue stream to assist in funding other pipeline products.

Also watch for developments on the AEZS-108 front.  AEterna recently announced that the first patient had been treated in a Phase II trial testing AEZS-108 in the treatment of triple-negative breast cancer, but Phase II studies also continue for AEZS-108 the treatment of prostate and bladder cancers.  Interim results from these trials are expected at various points throughout 2013. AEZS-108 is also being prepared for a near-term launch of a Phase III trial in the indication of endometrial cancer, according to the latest information published to the company's website, after already having established a proven record of success in other early to mid-stage trials. Investors looking for a place to insert some speculative money following the broad-market run, may like what the see on the AEZS catalyst plate.

Another key milestone to watch relates to Perifisone, a product whose potential may not be valued into the AEZS share price any more due to its Phase III failure in treating colon cancer. AEterna, however, retained full rights to Perifisone when then-partner Keryx Biopharmacueticals (KERX) pulled out and a Phase III trial continues in the treatment of multiple myeloma. An independent monitoring committee is slated to analyze interim results from this trial within the current quarter and if the committee recommends that the trial continue, investors still skeptical after the colon cancer outcome may be reassured to take another chance on the product's future, which provides yet another near-term catalyst.

The immediate market rally looks as if it will continue for now, but look for investors to start taking advantage of potential catalyst plays as profits start coming off the table and cash enters the speculative market again. AEZS could benefit at that time.

Roundup: Judging by international market action and Wednesday's encouraging private jobs data, we're likely to see new record highs during the course of the day. As mentioned above, though, it's not the time to get complacent as the global recovery is hardly set in stone and there are still many speed bumps that can materialize along the way, especially in the absence of resolution in Washington. While enjoying the broad market run that has filled up those 401Ks again, now's the time to start looking for the individual stocks and stories that have the potential to move higher based on catalysts and development, even if a pullback occurs.

Happy Trading!!!

Disclosure: Long IMSC, AEZS.

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Weekly Stock Watch, Week Of 4 March: DIS, AMRN, AZN, TEV, GSK, IMSC, KERX, ANTB, NVO, FPMI, MCD,

noreply@blogger.com (VFC) — Wed, 06 Mar 2013 05:16:00 +0000

This week could be a pivotal one.  Record market highs are well within sight and investors will look for evidence that last week's bullish momentum can continue into the new trading week, even as the effects of sequestration set in. Comments before Congress last week by Fed Chairman Ben Bernanke helped to reverse Monday's notable pullback and spark an overall move higher through the remainder of the week. All the while our politicians in Washington failed - yet again - to reach a budget deal that would stave off a harsh round of budget cuts that will end up slashing tens of billions of dollars from the federal budget over the coming quarters.

With the weekend under the belt and a few days for investors to digest the news and potential impacts of sequestration, we'll know fairly soon what the market makes of it all.  Significant cuts in defense spending, as we've noted before, led to a retraction in GDP numbers for the fourth calendar quarter of 2012, although those numbers were recently revised higher to demonstrate stagnant growth.

The point was made, however, that the US economy is still hovering in a state that is heavily reliant on government spending - that's why at least some investors will consider the looming sequestration as dangerous for the short term, although many will also argue that drastic cuts are needed in federal spending for a healthy long term outlook. Many would expect that those cuts would come responsibly, though, and not at the behest of another fiscal deadline imposed by the bureaucrats in DC who time and again prove the futility of their attempts to get the job done.

The finger pointing is rampant in our great capital, but unfortunately no one has yet been brave enough to point a finger at his or her self to accept at least a portion of the blame for the continued inaction.  Both sides, instead, retreat to the media looking to create a new battleground, one outside of the offices where the battles should be fought and the compromises made.

In the absence of leadership and action - and that's where we are right now - volatility in the market is likely to prevail over stability, making it a trader's game moving forward as the short term bulls and bears fight it out. A continued push towards the record highs could unfold this week, but general conditions do not point to a scenario where they would be sustained - if they are even met - unless some sort of a lasting budget deal can be reached. That looks a little far-fetched right now.

Amid the political chaos, there will still be some key indicators to watch. Friday's job numbers could add to the bullish sentiment that grew last week, but those numbers may still be overshadowed by debates over sequestration. For weeks leading into the 1 March deadline we heard about the devastating impacts on society that governmental furloughs and budget cuts would have on society, but to this point no specific or all-encompassing plans were released to the public of what this all means, so investors will be watching with a heavy eye this week for details. One things for certain, these budget talks are as much of a mess right now as the Mets' outfield situation.

As always, there will be plenty of individual stocks and stories to keep an eye on while the major news plays out. Here are just a few of them for the week of 4 March, 2013...

Newsmakers:

Disney's Agenda Includes Shareholder Meeting And 'Oz' Remake

As Disney (DIS) hovers just below its recently-set 52-week high, a couple of key events mark the upcoming week. On Wednesday the company will host its annual shareholders meeting, which takes place on the heels of a robust earnings report that included encouraging guidance moving forward and positioned the company to prove immune to sequestration and the volatility that could dominate trading as the markets react to a barrage of news regarding cutbacks.  Issues of executive compensation are likely to come up at the meeting, too, but investors are also likely to hear additional details and plans relating to the high-profile acquisition of LucasFilm's 'Star Wars' franchise, from which a plethora of new movie ideas are being spawned. With a slew of new additions from Marvel Studios, too, Disney's movie business looks to continue moving strong while maintaining the enthusiasm around the company resulting from a flying-higher share price. Also this week on the movie front, Disney is planning to release a 'remake' of the timeless classic, 'The Wizard of Oz.' 'Oz the Great and Powerful' debuts on Friday and many view it as a gamble, but one that could pay off in a big way.

If the market fluctuates in a notable way with all the drama surrounding sequestration, opportunities and pullbacks may arise in stocks of all market types and categories. Investors looking for stable, long term holds for a retirement portfolio or other put-away plans, any dips in DIS could turn into a nice add. Still holding some of the most popular brands in TV, movies and theme parks, this behemoth looks to be entering another strong phase of growth.

Shareholders will be able to tune in to the annual meeting on Wednesday via webcast.

Earnings:

Amarin's Earnings Spark Share Price Dive

Amarin Corporation's (AMRN) issued its much-anticipated earnings report last week, followed by an earnings call that investors hoped would provide some insight or guidance into Vascepa sales expectations moving forward. The earnings portion of the Amarin report had little to do with Vascepa itself, as it was not yet commercialized during the last quarter, although one encouraging note was that the company had enough cash on hand to last "at least" the next twelve months, according to statements made by company officials during the call. That time period could allow sales to grow to the point where they could support continued operations on their own. In terms of guidance to that effect, however, the company did not offer any indications or numbers in relation to the ongoing Vascepa launch, with company CEO Joe Zakrzewski only noting that "we're pleased to-date with the progress that our sales representatives are making out in the field."

To the defense of the company and to temper the expectations of those investors who view the market as a scheme to bank a quick buck, the month or so that Vascepa has been on the market is not nearly enough to judge whether a launch has been successful or not - especially when, in the case of Amarin, full approval will not be considered until the FDA's decision on the Anchor indication. That said, it's also not too far-fetched for investors to expect at least some form of guidance in the form of sales and prescriptions. Many companies at least release prescription growth, because early-on that is the best indicator - not sales - to just how popular a drug is becoming, since revenue numbers can be skewed by early promotions, rebates and coupon offerings. The fact that Amarin released little of either will enable the bears to fuel their case a little bit more.

Moving forward, there may not be enough on the horizon to halt a continued downward trend in share price, barring an announcement regarding Vascepa's New Chemical Entity (NCE) status that could renew some buyout talk. Although shorts will downplay the prospects of a buyout and longs may be losing hope, the fact is that not too long ago Amarin was one of the more talked about potential buyout stories - with Teva Pharmaceuticals (TEV) and AstraZeneca (AZN) often being named in such talk - until continued NCE delays put a damper on the hype. In this volatile market, and especially in this volatile sector, such talk could be renewed in an instant and return quick results to patient investors.

We've used this example before, but Human Genome Sciences was another once-hot-runner that was beaten down when the buyout hype faded, but after setting lows and diminishing the hopes of long-time investors, GlaxoSmithKline (GSK) finally came through with the long-rumored buyout deal investors were waiting for. The deal, of course, was for a far lower valuation than investors had initially speculated, but it still came in for double the price where shares were trading, making a winner out of those who either bought into the drop or played the 'average down' game.

It's important to continue to entertain both sides of the story, and while the AMRN share price dips in the absence of encouraging sales numbers, the prospects for an eventual rebound are real. Catalysts to watch for start with NCE, next quarter's sales numbers - the company won't be able to hide at the point - and for an eventual Anchor approval. Although the potential still remains for a quick turnaround on the right news, as described above, AMRN may be more of a mid term play these days - one that could pay off with a little patience.  Until that time, Amarin's stock symbol will continue to be bombarded with headlines containing a pun on the words "fishy" or "fishier," just as New York sports writers take liberties with puns on David Wright's name on an all-too-common basis.

Explosive Trace Detection (ETD) / Global Defense:

Implant's Credit Extension Marks Potential Pivot Point

With the announcement last weak of Implant Sciences' (IMSC) deal to extend the terms of a debt agreement with its primary creditor - DMRJ Group - for a full year, investors and company officials can concentrate fully on the building of sales, revenue and - with a recent TSA approval in the bag - the path towards becoming a dominant player in the ETD and homeland defense markets. Implant had last year already extended this agreement through the current month.  In retrospect, this move looked to be a temporary fix in order to allow for the TSA approval to come to fruition, but the year-long extension allows ample time for the business to grow and the for the company to gain the means and resources to pay the portion of its debt that has not been converted into the convertible notes outlined in the press releases associated with the said credit agreements.

In noting the recent IMSC share price dip, short term credit concerns and uncertainty may have prevailed and curtailed enough investor interest to cause the drop. The relatively light volume, however, also indicates that many investors continue to hold to see this story - which is still in its early chapters - play out.

As noted last month when Implant released its most recent earnings report, an uptrend in revenue has already emphasized the potential of the company's Quantum Sniffer ETD technology to infiltrate numerous global defense-related markets, including the air cargo screening market for which the QS-B220 was recently approved.  The TSA approval, in its own right, lays the foundation for more significant and relevant deals to materialize over the coming months and quarters.

There will be concerns that sequestration could hamper the short term consummation of any government-related deals, but it's unlikely that Congress - or anyone else in Washington - would pull money from terrorism-related defenses when it's all said and done. It could take time to weed out some of the pork from budget allocations, though, which may delay the process somewhat. When considering the sequestration cutbacks, we should bear in mind that it looks like the Department of Defense will be hit the hardest - not homeland security - so the threat of an impact to Implant may be minimal, unless the guys or gals looking to finalize such deals on the government end find themselves furloughed along the way.

In the meantime, Implant has also demonstrated the ability to grow its business in other high-threat markets, which provides enough growth potential outside of the domestic circuit to keep investors interested.

Some are concerned that no major deals relating to the TSA approval have yet to be announced, but Implant routinely announces deals after they are finalized, shipped and the money banked, so that's a point to consider. Also consider that the high profile failures of companies receiving government bail out money through the recovery periods have led to a higher level of scrutiny of companies doing business with federal agencies, which includes concerns about the credit worthiness and viability of such companies. The newest agreement with DMRJ, however, takes any short term speculative nature out of the equation for Implant Sciences, and that fact alone can seal the deal.

As the only US company ready to hit the homeland defense market with a non-radioactive ETD device, and with a credit line now extended long enough to allow for significant growth, IMSC remains a company to watch in a hot - and still growing - sector. This most recent DMRJ deal emphasizes the cooperative working relationship that these two entities have forged over the years and allows for concentration to be paid on growing sales.

Worth watching.

Healthcare, Biotech, Pharmaceutical:

FluoroPharma (FPMI), a company developing a pipeline positron emission tomography (PET) imaging agents for the efficient detection and assessment of various forms of coronary artery disease (CAD) and certain types of cancer, is one to keep an eye on during the coming week and for the duration of 2013 as numerous potential catalysts are coming due. The first such catalyst was touched on last week when the company announced initial positive feedback from a recently-launched Phase II trial testing one of its most-advanced product candidates, CardioPET, as an imaging agent for CAD. The images released in association to the ongoing trial look to confirm the earlier successes of a Phase I trial and could be enough to garner increased investor interest as full results from the trial are expected for later this year. In a sign of increasing investor interest, two-day volume was at its highest point of the year following Thursday's announcement, although it is till not quite to the point that would indicate widespread investor interest.

FluoroPharma is developing another Phase II product candidate that could provide potential price catalysts as trials evolve. BFPET, like CardioPET, has already successfully returned positive Phase I results and initial images from the ongoing Phase II test - which is measuring its effectiveness as a blood flow imaging agent for the detection of ischemic and infarcted tissue within the myocardium in chronic CAD patients - have also proven positive.

These results have attracted the interest of Zacks, which issued a rating of 'outperform' on the company with a price target of more than double where shares currently trade. Given the fact that FPMI's imaging agents are entering a market that is valued at more than ten billion dollars, according to statements contained within a recent company presentation, the continued success of BFPET, CardioPET and other pre-clinical products may start to attract additional analyst coverage, if not attention from bigger players in the sector - a stark possibility since early indications state that FluoroPharma's technology provides superior results to the current diagnostic standards for the targeted indications.

While these early indications are encouraging, the products are still just in the early stages of Phase II testing, so there is a long ways to go before any of these pipeline products could reach market. Along the way with such companies, there are risks of trial failures and dilutive cash-raising events. Generally, when investors look at companies at this level of development they are doing so with the intent of potentially building a core position of shares that are slowly accumulated on the dips to hold through the long term, while simultaneously building a position of trading shares with which to play the potential price catalysts along the way.

In today's volatile market environment, however, more investors tend to play the short term trades rather than fully hold for the long term, so bear that in mind when assessing whether or not a stock that is still speculative in nature can sustain spikes attained after milestone news events are released. With last weeks initial results garnering a boost in trading volume and attracting a Zack's report, FPMI may be one for the watch list moving forward.

Buyout Talk Fuels Keryx Run

Keryx BioPharmaceuticals (KERX) on Friday offered investors a demonstration of just how quickly buyout rumors, no matter how obscure they may be, could fuel a share price run. KERX closed twelve percent higher - after having traded even higher throughout the day - on rumors that GlaxoSmithKline was entering the picture as a potential suitor for Kerxy and its recently-approved kidney failure drug, Zerenex. Given the renewed buyout speculation and the luster with which shares closed last week - volume rolled in at nearly double the daily norm - this will be a hot story to watch during the coming days. That said, and as demonstrated by Amarin over the course of months, it's not too often that buyouts occur immediately following the disseminating of a new rumor, so volatility to the up and downside should be more expected than a straight move higher.

As previously discussed, Zerenex is not expected to turn into a blockbuster, due to the overall size of the targeted market, but could provide a decent revenue stream for an acquiring company looking to fill product portfolios that have been depleted by the rash of drugs coming off patent over the past few years. Zerenex was approved for end-stage renal disease and may also hold a superior safety profile to the current standard of care on the market, which at this time is Sanofi's Renagel, the recognized leader in the field. Renagel, however, comes with some associated side effects that, comparatively speaking, have not been seen in Zerenex treatment.

These side effects include nausea, vomiting, and other intestinal maladies, which could be enough - when combined with other factors yet to be discussed - to spur Doctors and patients to give Zerenex a go. Another check in the "plus" box for Zerenex is that it is phosphate binder that is iron based, which therefore may enable patients to retain iron more efficiently than the competition currently on the market. This could play be key, as many patients on dialysis in end stage renal disease are anemic and are stuck on IV treatment - along with everything else - in order to maintain iron levels.

It's possible that Zerenex could alleviate the need for the IV and end up being considered 'one stop shopping'; a package deal that could provide enough of a pricing and logistical boost to make it the preferable treatment of choice. The same cannot be said, at least for the time being, for the competition, generic or not.

Given those advantages, it may be concluded that Zerenex is positioned to not only heavily compete with the competition currently on the market, but it might also have enough behind it to potentially become the market leader. That could be enough to attract the interest of a large player, such as GSK, and Friday's rumor and price run are a testament to that fact. Again, it's rare that rumors turn into deals right away, more often than not they are planted by one organization or another to create interest and frenzy, but this will be a key story to watch in the sector moving forward.

Volume Indicates Interest In AntriaBio

Trading volume has been on the uptick for AntriaBio, Inc. (ANTB) and this could be a story to watch entering the new week, as often time investors look for indications of a 'volume preceding' price scenario.  The boost in volume could be indicative that investors are taking notice of the potential of the company's once-weekly basal insulin injection, AB101, to eventually infiltrate the diabetic treatment market which - at least in terms of basal insulin delivery - is currently dominated by Sanofi-Aventis' Lantus and Novo Nordisk's (NVO) Levenir - each of which includes an at least once-daily injection, and both of which combine to bring in over eight billions dollars annually.

Numerous catalysts are planned for the duration of 2013 for investors to keep an eye on. According to a presentation posted to the AntriaBio website, pre-clinical animal studies have already been completed for AB101 and the intention is to have the first wave of human data available by the end of the year. AntriaBio plans to initiate the human trials in Russia first, where the costs of conducting such trials are significantly lower and where patient recruitment is known to be up to ten times higher than in the US and Europe.

The company does plan, however, to move forward with the FDA IND process while development in Russia continues, and having the early human data available from its Russian trials could help to expedite the initial IND process in the United States. Once the early data is established, AntriaBio will look to land regional and/or multi-national partners to advance the product towards the commercial stages.

While the potential of a once-weekly basal insulin injection is obvious, the standard concerns of investing in or trading developmental stage companies of the sector still exist. These concerns include, but are not limited to, the potential for dilutive financing to take place at various points through in the developmental process and the prospects that a pipeline product may fail altogether through the course of trials. With that said, it's often a wise move in this sector to build a cadre of both trading and long shares, should one want to take advantage of price and milestone catalysts along the way while also potentially holding a core group of shares for the long term to see a story through. This strategy can often put an investor on 'house money' well before it's all said and done.

In the case of AntriaBio, this story is relatively just beginning, so there's still a long way to go, but recent trading volume could be an indication that investors are starting to pay attention. Worth watching.

Food/Beverage:

McDonald's May Be Immune To Market Pullback

Like Disney, mentioned above under 'Newsmakers,' McDonald's (MCD) has found its share price on the move higher over the past weeks and is one to keep an eye on as a potential stable addition to the long term or retirement portfolio if a broad pullback should materialize. Given the company's low-cost food options, it's likely that MCD could withstand a large-scale pullback, too, since its restaurants are some of the cheaper options out there and people are always going to eat. Some causes for concern that have been addressed of late, however, revolve around a potential hike in the minimum wage that could eat into MCD's profits and margins as labor costs would undoubtedly increase. As previously discussed, such a move may not effect the bottom line too drastically as companies often reduce or streamline their work force to keep margins consistent, or just pass the labor increase onto consumers. The latter option has the potential to hurt business in the sense that customers could shy away from higher prices, but that's when the company would then streamline its product offerings and keep the money-makers in place.

A few moves announced last week could be a sign that the company is doing just that. In addition to dropping chicken fingers and a less-popular salad from the menu, McDonald's is considering dropping its Angus burger, too, and is experimenting with new offerings that could both attract business away from competitors and streamline margins and costs. While there is nothing significant to note about a business implementing a plan of profit-protecting and innovation to stay ahead of the game, it is important to emphasize that this has been a consistent strength demonstrated by McDonald's over the years that has enabled to maintain its position as the most recognizable global fast food brand.

With new 52-week highs well within reach after a recent analyst upgrade, MCD remains one to keep an eye on for the long term portfolio as the company again positions itself to remain a step or two ahead of its competitors.

Roundup: Most international markets traded in the red during the day Monday, but last week proved that US markets don't always follow suit with their international counterparts. Early signs are, however, that this time they will. European concerns have surfaced again during Monday's early hours, another indication that the bears may be ready to roll in. Aside from the events overseas, the primary focus this week will be the effects of sequestration and how they could potentially impact the market and the already-sluggish economic recovery. Few would disagree that Washington has long-needed to implement cuts, so over the long run sequestration is probably a good thing - especially if it forces federal agencies to exercise fiscal prudence in carrying out its day-to-day operations. The irresponsible nature in which these cuts are being implemented, however, could threaten the markets over the short term, and it doesn't help that the New York Times issued an early-hours report stating that sequestration could cost roughly 700,000 US jobs. The tone of the headlines may be evidence we're in for a manic Monday. As always, any market pullback just creates opportunities for those paying attention and looking to play the dips on some of those 'watch list' stocks. This could be a week where some of those opportunities materialize.

Happy Trading!!!

Disclosure: Long AMRN, ANTB, IMSC, FPMI, MCD, DIS.

Originally published at: http://vfcsstockhouse.com

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Weekly Stock Watch, Week Of 25 February, 2013: HD, LOW, BBY, DLTR, WMT, AMRN, SPPI, ANTB, NVO, ONVO

noreply@blogger.com (VFC) — Mon, 25 Feb 2013 15:55:00 +0000

Stocks gave us a wild ride last week as numerous factors converged to incite more extreme market volatility that we had seen since the conclusion of the fiscal cliff drama at the beginning of the year. The DOW jumped over a hundred points on Friday, following two notable down days, and closed the week above the 14,000 mark again, albeit barely. The volatile trading action is likely to continue into the new trading week as budget negotiations in Washington will likely dominate headlines and keep investors on edge. Unlike the fiscal cliff talks that resulted in a last-minute deal during the dawning hours of 2013, both sides look more inclined this time around to hold their ground, which means that the potential is high that the much-discussed sequestration measures will come into effect on Friday morning. Such an even would translate into swift federal spending cuts that have the potential to negatively impact the overall economy, let alone stall the recovery.

Another event with market-moving implications to keep an eye on this week is Fed Chairman Ben Bernake's date with Congress.  Much of last week's mid-week drop was attributed to statements from the Fed that stimulus measures long in place since the depths of the recession may be pulled back earlier than previously indicated and Congress on Tuesday and Wednesday will hear personally what Mr. Bernanke has to say in those regards. Friday's rebound provided some evidence last week that investors may have felt they overreacted by selling into the Fed comments last week, there's little doubt that Mr. Bernanke's comments this week will be heavily watched, especially in light of recent developments in Europe over the weekend.

Sooner or later those European concerns are likely to effect trading on this side of the pond again. With the enthusiasm of the January rally and the encouragement of this earnings season, investors easily brushed aside any concerns of a stalling global recovery, but analysts predicted last week that the European economy had at least another year of recession and turmoil on the table before reversing course and climbing into growth.

Warnings of slow growth were even apparent in the supposed powerhouse economies of Germany and England, but the light was dimmed even more when Moody's downgraded the UK's Triple-A credit rating. It's yet to be seen how much of an impact that move will have on the European or global markets, but it's an eye-opener heading into the new trading week.

Also this week, the Italian elections will be in the spotlight and it'll be a disappointing sign if Italy votes Berlusconi's 'Bunga Bunga' squad back into power, as it's time for the Italian economy to embrace the financial reforms that have been put into place since his ouster and not reverse course back into the all-too-recent past. That said, there's little doubt that the worst of the worst is in the rear view mirror for the Euro Zone (EZ) as a whole, but it's evident that the light at the end of the tunnel is still a ways off in the distance.

Bernanke's comments, US budget talks, looming sequestration and the EZ's continued strife could lead to a volatile week ahead. As is always the case, there will be plenty of individual stocks and stories to keep an eye on while the major news plays out. Here are just a few of them for the week of 25 February, 2013...

Earnings:

Retailer-heavy Week Could Mark Or Dispel Trends In Consumer Spending

There was enough gas left in the earnings season tank to help support Friday's price spike as a few high profile reports still rolled in, but most of the big players have already reported, so the remainder of the season will be dominated by the B-list, for the most part, and small cap or still-developing companies whose reports are hardly likely to move the markets as a whole.

With that being said, this week's reports will be retailer-heavy and the sector as a whole could prop up the markets, if the ancillary news discussed above allows. Of the major retailers, Home Depot (HD), Lowe's (LOW), Best Buy (BBY) and Dollar Tree (DLTR) can - through guidance for the current quarter - all help to mark or dispel a slowing trend in consumer spending noted by Wal-Mart (WMT) officials earlier in the month. Any indications that Wal-Mart was right - that consumers are slowing their pace of spending this quarter - and the markets could suffer, especially if investors don't like comments coming from the Fed and Europe. Any trading of the retailer stock will likely be solely forward-looking, given that consumer spending for the reported quarter has already been noted and documented by earlier reports. There shouldn't be any major surprises. Saks (SKS) is also one to keep an eye on in the sector, although earnings here represent more of a niche core of higher-end consumers and are not necessarily a sign of overall strength in the sector.

Amarin Report Centered On Vascepa Guidance

Amarin Corporation's (AMRN) earnings report and conference call is going to be one worth watching this week as it is one of the more popular stories in the biotech/healthcare sector and has garnered quite the fair share of headlines and speculation of late. Although the never-ending story of Vascepa's status as a New Chemical Entity (NCE) will continue to hog the spotlight, this week's earnings report, set for Thursday, 28 February, will have investors interested because of the possibilities of hearing an insight into how Vascepa's commercial launch is coming along and what - if any - guidance will be available moving forward. Bear in mind that the launch was undertaken in late January and will have no relevance to the earnings report itself, as it will cover the last quarter of 2012.

In anticipation of the Amarin report, speculative headlines popped up again over the weekend leading to the possibilities of a potential buyout of the company and the potential for the stock to eventually head higher even if a buyout does not materialize. These ideas have been covered heavily by numerous financial media outlets over the past year or so and will continue to be until the story plays out one way or another. The argument for Amarin as a buyout candidate, as previously discussed, revolves around previous predictions that Vascepa could eventually become a billion dollar blockbuster, once fully approved for both the MARINE and ANCHOR indications. Given the amount of major money-makers coming off patent these days in the world of big pharma, it's no secret that many of the larger biotech/pharmaceutical companies are looking to boost their respective pipelines, and Amarin - with a potential blockbuster in hand - could look like an attractive target.

NCE is also key because it would add significant overall value to any deal, although company officials have also noted in recent conference calls that the patent protection achieved for Vascepa should solidify the product's protection for years to come, regardless of NCE.

Although we've heard quite a bit from and about Amarin already in 2013, the upcoming call gives investors a chance to hear the latest updates regarding buyout talk, the status of the commercial launch and expectations of building momentum. The AMRN share price has been stuck in a range of between eight and nine bucks and is likely to remain there, barring a determination on NCE or growing strength regarding the launch. Any positive surprises in earnings guidance could send shares back to the double digits, as could a positive NCE outcome or renewed - and real - buyout talk. Nice earnings story to watch this week.

Spectrum Declines As Generic Competition Heats Up

Shares of Spectrum Pharmaceuticals (SPPI) traded lower last week after reporting earnings that, although record setting for the year, provided yet another round of evidence that Fusilev may be falling victim to an availability increase of its generic competition, leucovorin. It was widely recognized throughout 2012 that a supply shortage of the generic greatly contributed to the boost in Fusilev sales and the surge in SPPI share price that hit the high teens at one point before dropping back to the current levels.

As described by the company in the associated press release and earnings call, however, the quarter-over-quarter slowdown in Fusilev sales was attributed more to gross-to-net adjustments, primarily related to mandatory government rebates for some patients. In fact, notes the PR, sales themselves were up on a quarter-over-quarter basis. The company's story is certainly more favorable to the long argument, but investors should bear in mind that a continued boost in the generic supply chain could cause a continued slowdown in Fusilev sales.

The good news is that, moving forward, Spectrum expects revenue growth for Folotyn, a treatment for refractory peripheral T-cell lymphoma acquired in a deal last year for Allos Therapeutics, to potentially offset slowing Fusilev sales, should that scenario materialize. Folotyn brought in nearly fifteen million for the quarter and - adjusted to speculate on a year's worth of sales - returned stronger revenue numbers than were registered for Allos the year prior. Zevalin added another eight million for the quarter and the thirty million in revenue for the year helped the company achieve the record numbers reported in its press release.

Judging from the swift four percent price decline following Thursday's report, it's apparent that investors are harboring concerns that generic competition is going to eat away at Fusilev sales. Such concerns may be minimal if the company's notes about gross-to-net adjustments continue to be accurate, but no specific guidance was given moving forward, other than that revenue was going to continue to increase. Should Fusilev sales start to slow, an investment in SPPI at this point could be considered a vote of confidence that Zevalin revenue, which offered a significant year-over-year return, will continue on the upswing while Folotyn sales continue to grow, too.

Considering those aspects, it's not unreasonable to believe that the company's predictions of another overall growth in revenue for the year is possible, although the lack of specific guidance will leave some investors concerned that not even the management team is certain how the end game will play out. On the other hand, any surprises along the way that would spark a still-very-significant short interest to cover could lead to a quick rally.

Following last week's drop on another solid earnings report, Spectrum will be one to watch moving forward. If the market as a whole decides to drop again this week as the result of global geopolitical and economic events, as it did during the middle days of last week, then it's possible that SPPI could drop even lower than expected, potentially providing an entry point for those looking to play the future growth of the pipeline.

It's not too often that you see shares of a company reporting record revenue decline after the report, but the short interest indicates there are still some non-believers out there that doubt Fusilev's ability to thwart the generic competition. That's the key to watch for the short to mid term.

Healthcare, Biotech, Pharmaceutical:

AntriaBio Could Alter Diabetes Market

AntriaBio, Inc. (ANTB.OB) is an emerging story in the developmental biopharmaceutical sector that may be worth keeping an eye on this week as trading volume picked up quite a bit during the past few trading days when the company's potential in the diabetes market started gaining increased exposure from popular financial and healthcare news outlets.

After having purchased the assets of PR Pharmaceuticals in January of this year, AntriaBio has positioned itself, pending successful trials, to eventually enter the multi-billion dollar market of basal insulin delivery with its own once-a-week basal insulin shot, AB101. The current standards of care, measured by Sanofi-Aventis' Lantus and Novo Nordisk's (NVO) Levenir, each require patients to receive at least one shot daily and pull in over eight billion dollars annually, combined, according to publicly available information. Emphasizing the once-weekly advantage, it's understandable why AB101 is starting to attract the increased attention of investors who may be looking at buying into the ground floor of potential next-generation product.

AntriaBio itself has not been around for too long, becoming public only recently through a reverse merger after first having purchased the assets of PR Pharmaceuticals, as noted above. PR Pharma had already invested tens of millions of dollars into the preclinical development of AB101, but was unable to see its development through to fruition as the depths of the economic crisis dried up funding for many developmental biopharmas, PR included. As a result, PR Pharma followed suit with many other of those companies unable to find funding during the severe recession and declared bankruptcy in November of 2008 - but the AB101 technology lives on with AntriaBio.

Some investors are skeptical about buying into companies that have become public via means of a reverse merger, most notably because such transactions were in the past considered as a tool for companies to deliver themselves to investors without the transparency that accompanies a standard IPO, but also because such actions don't always bring in the large amount of immediate cash that an IPO does.  In today's economic climate, however, where cost effectiveness bears the highest of considerations, reverse mergers are considered much more commonplace because, quite simply, they provide a much cheaper path to becoming publicly traded than going through the expensive IPO process. That said, each investor needs to conduct his or her own due diligence on a case-by-case basis and invest accordingly, because not all reverse mergers - just like not all stocks - are created equal.

According to a presentation posted to the AntriaBio website, pre-clinical animal studies have already been completed and the company intends on having some human data available by the end of the year. Again, in a demonstrated effort to minimize costs through the early stages of development, ANTB will initiate trials in Russia first, where the costs of conducting such trials are significantly lower and where patient recruitment is known to be up to ten times higher than in the US and Europe, according to the above-linked presentation. The company does plan, however, to move forward with the IND process with the FDA in the US while continuing development in Russia. Should some human data already be available at that time, it could help to support and expedite the initial IND proceedings.

Another benefit to getting some human data under the belt early-on and in a cost-effective manner is that this strategy could also help to land an early partner. Also according to the most recent company presentation, AntriaBio will look to land regional and/or multi-national partners, once the initial trials have returned results. Once a partner is on board, investor concerns of dilutive financing deals that often accompany the pipeline progression of developmental companies somewhat subside.

AntriaBio is also utilizing its technology in producing the long-acting Glucagon-like peptide-1, also known as AB201, which would be intended for use as a once-monthly injection, again superior to other products already on the market. AB201 is in earlier stages of development than its pipeline counterpart and is currently being prepared for pre-clinical studies.

Yet another item that may be of interest for investors taking a look at this company is that the management team consisting of numerous industry veterans has a history of not only developing small biopharma start-ups, but also bringing them to the point of partnerships and/or sales. Merger, partnership and acquisition speculation often accompanies small companies in this sector and a management team with a history of consummating such deals often lends credence to the speculation.

As demonstrated by Organovo Holdings (ONVO.PK), another company brought public through means similar to that of AntriaBio, trading often starts off light for these companies, but has the potential to pick up steam as the technology and pipeline becomes known. Organovo, for instance, nearly tripled in quick fashion after its reverse merger about a year ago and has offered bouts of volatile trading opportunities since then, too, emphasizing the ideal that it is always wise to utilize a handful of trading shares to bank profits when available, even while potentially holding onto a core group of long shares to see the story out over the long term. With the trading volume picking up as it did last week, it could be worth keeping ANTB on the radar screen this week, and for weeks to come.

Roundup: Investors have had a lot to digest over the weekend, with the UK credit rating downgrade coupled with the increasing prospects that we're due for sequestration here in the US, which increases the emphasis on Mr. Bernanke's mid-week comments. Investors may become increasingly squeamish if the Fed intends to cut stimulus measures simultaneous with other disturbing news hitting the markets, and the continued lack of cooperation in Washington doesn't help matters much. Given the salvos of headlines hitting the wires from numerous fronts, it's highly likely that last week's volatility is going to continue into the new trading week. A round of solid numbers and guidance from the retailers reporting this week could be enough to stave off a broad market drop, especially if guidance contradicts the earlier Wal-Mart warnings for February, but we're still in trading territory where it looks like a pretty good idea to keep some cash on the sidelines and take advantage of any dips. It's also a good time to concentrate on the individual stocks and stories that make up our respective portfolios.

Happy Trading!!!

Disclosure: Long AMRN, ANTB.

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Implant Sciences (IMSC): Potential For Huge Growth Lies Ahead

noreply@blogger.com (VFC) — Tue, 22 Jan 2013 04:55:00 +0000

Implant Sciences (IMSC) may have just announced the most significant and potentially market-moving news in company history on Wednesday when it was revealed in a spontaneous conference call that the United States Transportation Security Administration (TSA) had approved Implant's Quantum Sniffer (QS)-B220 explosive trace detector for use in air cargo screening. This ruling could be considered the 'holy grail' of the validation process for Implant Sciences as it allows the QS technology to be listed in the next edition of the 'Air Cargo Screening Technology List' and opens up a new - and potentially very lucrative - avenue for revenue. It also offers a huge round of validation for the technology, as many government agencies - both in the US and around the globe - follow TSA validation guidelines in regards to their purchases. It's quite possible that now, with TSA approval in the bag, orders from these countries and agencies will start flowing in, providing a significant boost to the company's revenue stream and sparking a rally in the IMSC share price.

Already shares closed twenty three percent higher on Wednesday and - with volume well more than ten times the daily average - may be positioning to move even higher during the coming days and weeks. It was noted during Wednesday's call that the company expected to beat the revenue numbers of the latest guidance, which were in the range of seven million dollars, moving forward from this point. The TSA approval opens the path for government contracts to start rolling in, which often times come with bulk orders, and help the company meet the revised expectations. Of relevance the TSA has mandated that - as of 3 December - all cargo in-bound to the US on passenger aircraft will be screened for explosives. This is a market that Implant Sciences intends to exploit and given the benefits that the QS technology holds over the competitive standard currently on the market, there is reason to believe that market penetration could materialize quickly.

Contracts awarded to other firms in this arena have been valued in the tens of millions of dollars, and only one such contract for IMSC would likely lead to a swift move to a market cap to the north side of one hundred million for IMSC, with the possibility of a quick push even higher if a steady stream of orders starts flowing in from customers who may have been awaiting this milestone news before placing orders.

As noted by company officials during Wedensday's call, the QS-B220 can now be sold to "everyone, everywhere," with this approval, "and that wasn't the case before." With that being said, speculation alone may push the share price towards - or even higher than - the two dollar mark, as Implant could now be considered a major player in the homeland defense and air security markets. It is also safe to assume, judging from statements made on Wednesday in that call, that the company expects to shortly be able to bank ten million dollars-plus per quarter. Such a scenario, that comes along with increasing revenue on a quarter-over-quarter basis, will have investors looking back at the current share prices as a steal, even after Wednesday's jump.

Another item that investors will key on, and came up in Wednesday's call during the questions and answers session, is the nearly thirty million dollars in debt that Implant carries forward. The company came to an agreement with its primary secured lender, DMRJ Group LLC, late last year to extended much of that debt until the end of March of this year. The extension at the time provided the company a full two quarters of development and progress before Implant had to worry about any of it coming due - and maybe most importantly, allowed for time for the TSA to finalize its validation process.

Since the approval puts the company on much more solid footing today than it was when the deal was extended, it's hard to believe that DMRJ would not continue to work with Implant to structure the debt repayment in a manner that benefits both parties. Much like SiriusXM (SIRI), another still-growing company who a couple of years ago had loads of debt coming due, expect Implant to push a significant amount of its revenue growth towards debt repayment when the opportunities arise. Cash will also be pushed towards meeting product demand, research and development and even towards a listing on a major exchange, as it was noted in the call that a ticker on the Nasdaq is the ultimate goal.

With a cooperative lender in place and a TSA approval on the books, Implant can concentrate its resources on expanding its presence in a market that is growing by the billions of dollars. The competitive benefits of the Quantum Sniffer technology could attract quick global attention from those players who may have been sitting on the sidelines awaiting TSA approval.

Possibly the most significant advantage is that the ionization process used to detect explosives - and/or narcotics - contains no radioactive particles. That not only eliminates any safety concerns for personnel using or being inspected by Sniffer technology, but it also eliminates the added layers of licensing and regulatory concerns that would be included in any implementation plans.

Just as significant a benefit is the quick "clear down" process for the QS. "Clear down" is the amount of time needed for a system to 'reset' itself after use before it is available for another round of inspection and detection. Implant's Sniffers can complete this process within seconds, while the standard for the competition is minutes. That's huge, when considering the need for speed and efficiency in meeting today's high demand for bulk cargo inspections, let alone the demands implemented the TSA's air cargo mandate.
Implant can also be considered a 'patriotic play,' as it is the only American company to have passed the rugged TSA validation process in this arena. In a time when American companies and the US government are looking for internal options, Implant stands to make a competitive play in the homeland defense and air security markets.

Additional advantages, as outlined on Implant's website, are very high ratings for accuracy - especially when compared to x-ray - and extremely low 'false positive' rates. In noting these distinct advantages, there's reason to believe that Implant is positioned to make a jump to the big leagues and mainstream of global defense, and compete head-to-head with the likes of the UK's Smith's Detection (SMGZY.PK).
Such a jump may be swift, as this company has been laying a foundation for some time. Some key additions to the management team have been added over the past year or so and not only added an extra layer of credibility to the still-growing company, but provided an 'in' with relevant entities in the homeland defense arena and ensured that the right personnel were in place to complete the mission of growth, once/if full TSA validation became a reality.

Dr. Bill McGann, for example, a pioneer of trace detection technology was appointed just months ago as the Chief Operating Officer and was added as a member of the company's Board. Dr. McGann co-founded Ion Track Instruments, the first ETD provider to receive TSA certification, and subsequently sold that company to General Electric (GE) for nearly $200 million before becoming the Chief Technology Officer for GE Security.

Implant also added Dr. Darryl Jones as the VP of Sales and Marketing. Dr. Jones was another addition also heavily-embedded in the homeland security market and is also a veteran of GE Security. He also has a tour under his belt of leading sales and marketing for Safran's Morpho Detection.

The pieces had already been falling into place in terms of revenue growth lately, as numerous orders have been announced over the past months with increasing lot sizes, and there's reason to believe that the pace of new orders will pick up even more rapidly now, with TSA approval in the bag.

It may also be worth entertaining the possibilities of a buyout. The TSA approval is a noted milestone and other big players in the sector may see it more beneficial to throw an offer to Implant while it trades on the relative cheap, rather than face stiff competition on the open market.

Implant Sciences has just entered the mainstream and judging by the huge bump in volume and share price, the company's stock could be positioning for a move to the upside over the coming weeks and quarters. Some periods of pullback and consolidation may take place, as IMSC is likely to trade in similar fashion to a developing drug company who just received FDA approval. The difference being, a drug company usually has some time to wait before it can launch its product post-approval.
Implant is ready to go now.

As the company is positioned to start realizing significant growth, shares could trade with significant volatility until investors can gauge more accurately how quickly orders will flow in and boost the revenue stream. There will also likely be quite a bit of consolidation moving forward over the short term, which should open up numerous trading and accumulation opportunities for both short and long term investors.
With a potentially ground-breaking product approved to enter a multi-billion dollar market, Implant Sciences is a hot one to consider moving forward.

Disclosure: Long IMSC, GE.

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Stock Watch Wednesday, 16 January: FB, GOOG, BA, JAL, ANA, GS, JPM, WFC, IRWD, FRX , ONVO, SSYS, DDD, AAPL

noreply@blogger.com (VFC) — Fri, 18 Jan 2013 20:53:00 +0000

Markets traded modestly higher for the Day on Tuesday as retail sales numbers came in better than expected for the month of December, easing worries created late last year of a slowdown in consumer spending. While the numbers beat the street, per say, they weren't strong enough to spark a widespread rally as investors are still waiting on the earnings reports of the big banks to better gauge the overall health of the recovery. Additionally, reports also started to swirl late Tuesday that any delay in a debt ceiling agreement in Washington could lead to a US credit rating downgrade, a move that would likely lead to a market decline.  Should an agreement not be reached, it would be a given that the US rating would be downgraded, but the Fitch warning also indicates that Washington's strategy of slowly running the budget tap just enough to keep the government running, without devising a de-facto solution, is finally starting to wear thin on all accounts.

Earnings picks up in earnest on Wednesday as hit the heart of the trading week and there could be plenty of catalysts still to come from the banks, US economic data and from Chinese data later in the week. Here are a few stocks and stories to keep an eye on for Wednesday, 16 January, 2013...

Newsmakers:

Market Says Facebook News Not Worth The Hype

In what may be considered a scenario where investors played the 'sell the news' game, Facebook (FB) shares retreated by nearly three percent on well more than double the normal trading average after the company announced at its much-anticipated media event that it would implement a 'Graph Search' to lead the way into the next stages of growth. As FB shares rolled through the thirty dollar mark with ease leading into this event, investors speculated on the possibilities of a Facebook phone entering the market. Initial indications following the announcement, however, are that investors are either outright unimpressed with the Graph Search announcement or are prepared to take a 'wait-and-see' approach to its impact on future earnings. A three percent drop does not indicate overall disappointment in the new search strategy, especially not after FB shares have risen swiftly from the twenty dollar mark without much of a pullback period on profit-taking, so investors may digest the news over the coming trading days, assess what it all means, and then trade accordingly.

Although the Graph Search does not go head-to-head with Google's (GOOG) search engine strategy, it does give Facebook a foothold in the market and will likely chip away at GOOG's market share in search, especially since users will not have to leave the Facebook site to find answers or recommendations from those most relevant to them - friends and family. Underlining that strategy is maybe the most important implication from this whole deal - that users will remain on the Facebook site longer to potentially click on ads; which means they won't be on Google, and that's good for business. It's likely investors recognize those aspects and why Tuesday's drop was barely negligible in the grand scheme of things, and more an indication of the simple 'sell the news' investing strategy.

The Graph Search is not the earth-shattering news that investors expected and was probably not worth such a hyped-up press event, but it should pay off well for Facebook over the long term - as long as users remain interested and loyal to the core business - which is social networking.

Boeing Dips On Continued Dreamliner Woes

Shares of The Boeing Company (BA), which had recovered slightly from a dip created by mechanical worries of the 787 Dreamliner earlier in the month, are dropping again during the pre-market hours on Wednesday as it was announced that two of Japan's main airlines, Japan Airlines (JAL) and All Nippon Airways (ANA), had grounded their respective Dreamliner fleets after an emergency landing earlier in the day sparked growing concerns of the safety of the aircraft. The slew of troubles has grown into a trend that has the headlines rolling and investors nervous about the future of the next-generation aircraft that was expected to fuel the next growth phase of the company. As argued previously, however, investigations are likely to narrow down any 'weak link' in the parts process fairly quickly - as it looks like there are issues specifically related to the aircraft battery - and a remedy is likely to be introduced just as quickly, barring any major structural flaws, which doesn't look to be the case. Assuming the faulty parts are fixed in quick time, any dips created by the much-hyped Dreamliner news should be looked back upon as solid accumulation points. Additionally, any fixes in the operational fleet will also be made to those aircraft still in production, alleviating future problems. Still a story to watch, as Boeing is going to be in prime focus until these problems are solved.

Earnings:

The Heart Of The Earnings Week Begins

Wednesday marks the start of the 'heart' of the earnings week as Goldman Sachs (GS) and JP Morgan (JPM) are both slated to report. As mentioned above, the retail sales numbers for December looked encouraging, but not encouraging enough to move the markets one way or another. The big banks may be able to incite some movement, based on the strength of their respective reports.  Although Wells Fargo and Company (WFC) impressed last week in terms of profits, investors were not so impressed with a slowdown in mortgages dished out. Those investors will be looking for insight into that trend as other big banks report for the duration of the week, beginning on Wednesday. Indicators are that the economic recovery is still healthy, making any dip in the banking sector a potential buy.

Ironwood Pharmaceuticals (IRWD) and Forest Laboratories (FRX) reported earnings in-line with expectations on Tuesday following the launch of Ironwood's Linzess for the treatment of chronic constipation during the fourth quarter of last year. Forest, as expected, took a hit related to the recent expiration of key patents and pushed money towards the launches of new products looking replace some of its now-off-patent pipeline, while Ironwood reported twenty million dollars of Linzess sales in an abbreviated first quarter on the market. The two will split revenue for the product, but neither is likely - even with an IRWD analyst upgrade on Tuesday - to see its trading patterns effected until/if sales pick up significantly over the coming months and indicate a hot launch. Linzess is expected to launch in Europe early this year under the name 'Constella.'

Healthcare, Biotech, Pharmaceutical:

Organovo's Price Run Regains Momentum On Tuesday

Organovo Holdings (ONVO.PK) regained its upward momentum on Tuesday with a seven percent spike after having retreated somewhat over the past week when the day, momentum and swing traders banked profits and moved on. Organovo's spike has not just resulted solely from the advancement of its own technology, which could help shape the future of 'bioprinting' in relation to medical research, discovery and treatment, but the move was also traded in-line with the trading of the 3D-printing sector as a whole.  2012 has proven to be a pivotal year for the technology and ONVO's move follows those of other leading companies in the sector, such as 3D Systems Corp (DDD) and Stratasys (SSYS), who were consistently setting new 52-week highs as the year progressed. ONVO's arrival to the sector-wide trend hit the market with just as much strength, as the stock has returned nearly a double in just a couple of months, and could be considered a major player now with the support of some high-profile collaborative efforts based on the advancement of the company's NovoGen MMX Bioprinter, which  uses live human cell samples to generate 3D "bioprints" of human tissue. Once the tissue is generated, these 3D prints can be used as disease model that enable therapeutic drug discovery and development and later on down the road could potentially be used to generate - or 'print' - organs for patients awaiting transplants. Tuesday indicated that ONVO's run may not be done, so it remains a hot story to watch - and the technology could be one to keep an eye on for years to come.

Roundup: Global markets were down on Wednesday and futures indicated that the same could be in store for US markets, at least at the onset. Apple (AAPL) continues to drag down the tech sector while a slowdown in European care sales added to renewed worries concerning the health of any economic recovery across the pond. It also didn't help that the World Bank revised its economic forecasts to the downside while Japan's markets dropped more pronounced than most others. Rather than following the trend, however, the US markets tend to set the tone, so any encouraging earnings notes that fuel the already-encouraging economic data releases in America could quickly turn the markets green. On the other hand, any bickering in Washington that hints at a deadlock over the debt ceiling would fuel a downturn, as noted by the Fitch credit warning, but any significant downturn these days should be viewed as a solid 'play the dips' opportunity. As all the big news plays out, there are still plenty of individual stories to keep us interested.

Happy Trading!!!

Disclosure: No positions.

Originally published at: http://vfcsstockhouse.com

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Weekly Stock Watch, Week of 14 January: AA, WFC, BAC, C, GS, JPM, MS, CS, XLF, RIMM, AAPL, TROV, DNDN, AET, MDVN, SNY, JNJ, ONVO, PFE, UTHR, INO, DDD, AMRN, FB, FCEL, TTNP

noreply@blogger.com (VFC) — Wed, 16 Jan 2013 17:18:00 +0000

At the conclusion of each week, VFC's Stock House examines some news items, stocks and stories that made headlines during the previous trading week, but may also make headlines or influence trends during the upcoming week as well.

The trading year of 2013 kicks off in a big way this week.  Although the markets rallied for the first couple of weeks of the year, the noted price and mood fluctuations were based mainly on political factors, rather than on factors inherent to the markets themselves. For example, a resolution to the fiscal cliff mess sparked more certainty than we'd seen for quite some time, while pessimism over the pending expiration of the US debt ceiling set in quickly and stalled the early-year run. Renewed headlines of Europe's economic woes and expectations of another lackluster earnings season also didn't help keep the rally going, but with a slew of economic data due this week and with earnings entering the 'full swing' phase after a couple of 'teaser' reports last week by Alcoa (AA) and Wells Fargo and Company (WFC). One way or another, things ought to get pretty exciting this week.

To gauge the health of the recovery, investors can digest this week retail sales numbers, housing starts data and consumer sentiment, in addition to some manufacturing data. Earnings are likely to steal the overall spotlight, but any improvements - or not - in these data over the previous month or quarter can move the markets, too, especially if the data supports any trend set by the earnings reports.

One item that can be put to rest is the silly talk surrounding this trillion-dollar coin that was so talked about over the last couple of weeks. The amount of attention paid that coin served as a steady sideshow to real news, and was a testament to the lack of any relevant discussion going on in the meantime. That will all change this week.

Plenty of action this week expected, but there's still always room for a few individual stocks and stories to keep an eye on...here are just a few of them...

Earnings:

Big Bank Reports Will Dominate

Alcoa kicked off the season last week on a high note, as previously discussed, and Wells Fargo followed with a worthy follow-up. Wells reported record profits, although some were concerned that the bank wrote fewer mortgages than it did during the previous quarter. Shares traded relatively flat following the report, closing down by less than a percentage point on Friday, but provided a solid introduction to a banking-heavy week with giants such as Bank of America (BAC), Citigroup (C), Goldman Sachs (GS) and JP Morgan (JPM) all slated to report. Those looking for early-year trends to assess the health of the banking industry at the offset of 2013 will find themselves with ample data and earnings to pore through this week, and any encouraging trend in the sector could spark a broad-based rally, especially if other reports from the likes of General Electric (GE), Intel (INTC) and eBay (EBAY) make positive waves themselves and validate a healthy rebound based on growing consumer demand. Bear in mind that profits is not enough to spark general excitement, as evidenced by the Wells report and the subsequent lull in share price movement; it's evidence of a healthy overall economy that investors are watching for, so it may be worth looking deeper than the headlines.

Banking:

Cutbacks And A Downgrade Thrust Earnings Into Spotlight

A couple of items from last week could temper the mood surrounding the banking industry leading into the new trading week. Morgan Stanley (MS) announced last week that it expected to initiate another round of cost-cutting measures, which would include the laying off 1600 personnel from its securities unit. The move is a sign of the times that large businesses, banks and corporations may not be finished with the restructuring that has been underway since the economic collapse of 2008-09. That said, investors should not panic looking ahead as many other big players in the industry, including Citigroup, Bank of America and Credit Suisse Group (CS) all undertook similar measures.    Also last week - and potentially playing a factor this week - Credit Suisse downgraded Bank of America from 'Outperform' to 'Neutral' and sparked a five percent price dive for BAC. These situations always make me laugh, as if there is no conflict of interest when one big bank covers another and sends shares either spiking or diving. The timing of the downgrade comes curious, too, just before earnings, making the BAC report one to watch.

Investors playing the longer term potential of the sector may enjoy short term dips that materialize from any negative news developments, such as the BAC downgrade, and more of the story will be told with the flurry of banking reports this week. Again, for those looking to play the overall sector, the Financial Sector SPDR ETF (XLF), or other electronically-traded funds, offer investors that opportunity.

Newsmakers:

Anticipation Of BlackBerry 10 Drives RIMM Shares Higher

Shares of Research In Motion (RIMM) were on the fly this past Friday - jumping by nearly fourteen percent - and should be another hot one to watch this week, too, as investors anticipate the pending launch of the BlackBerry 10 platform later this month.  RIMM shares have been highly volatile of late leading into the launch period and have more than doubled off their 52-week lows as investors speculate on a turnaround. Because it can - and has - been argued that consumers may have reached the point of saturation with Apple's (AAPL) iPhone, the avenue may be clear for RIM to start gaining back some of the market share lost with the rise of the iPhone, Galaxy and other recent innovators of the sector. Some popular financial media outlets have also covered the RIMM story as a potential bullish mover, which could help fuel a continued move higher after last week's run. It's been a period of consolidation for this stock after its quick double a few months ago and the company could turn into one of 2013's solid turnaround stories - assuming a successful BlackBerry 10 launch, of course.

TrovaGene Jumps Through Eight Bucks

We've followed the TrovaGene Inc (TROV) story as shares returned more than a triple since the summer months and another milestone was met last week as a significant boost in volume pushed TROV through the eight dollar mark while also setting a new 52-week high. Volume on Friday registered at more than five times the daily average and the price jump made the stock well more than a quadruple off its 2-week lows.   Fuelling this company's price run has been the pending commercialization of some of the company's numerous diagnostic tests that can detect various cancer indications through a simple urine sample. The first such test is slated to hit the market later this month and will be able to detect KRAS mutations through urine samples, with others expected to follow in achieving this significant milestone.  Aside from the pipeline developments alone, TrovaGene also received attention from some high-profile collaborative efforts and was also highlighted in a recent analyst report when Aegis Capital jumped on board and initiated coverage of the company with a rating of 'Buy.' Continuing a swift move higher, TROV will again be a stock to watch this week. Only twice in 2012 did trading volume hit as high as it did on Friday, a potential sign that more serious investors are moving in. Bear in mind that quick-movers such as this one - which have returned huge gains over a short period of time - are also to be watched for pullback periods of consolidation. TROV has already seen a couple of these on the way up, but pending developments - thus far - have been able to fuel a higher run.  It also helps that TrovaGene is capitalizing on the growing healthcare trend of exploiting less-invasive and less-expensive means of identifying and treating various cancers and disease types. Another hot one to watch this week.

Dendreon Spikes Twenty Percent

Dendreon (DNDN) was another of Friday's hot movers, with shares spiking by over a dollar on a twenty percent rise. Having already been identified as a potential rebound play for 2013 due to a reversal in trend for Provenge sales, partly the result of expanded insurance coverage by players such as Aetna (AET), Dendreon then received a boost last week from a Bernstein analyst who upgraded the DNDN stock to 'Outperform' while also upping the price target to $10 from $7. According to reports, the upgrade was based on feedback from urologists, but the company itself may also be benefiting from the implementation of numerous rounds of cost-cutting measures that have helped to sure-up the bottom line as the sales and management team worked to reverse what was - for at least a quarter - slowing Provenge sales. Provenge could continue to grow support from doctors and insurers if data continues to prove its worth in combination with other drugs and therapies, such as Medivation's (MDVN) Xtandi, Sanofi's (SNY) Jevtana, and Johnson & Johnson's (JNJ) Zytiga, for example, which are for the time being solely looked at as competition. Given Friday's boost on huge volume - five times above the daily norm - DNDN will be a hot one to watch again. Analsyts jumping on board the DNDN turnaround train validates what many longs have predicted for some time.

Healthcare, Biotech, Pharmaceutical:

Organovo Holdings Pushes The Four Dollar Mark

Organovo Holdings (ONVO) is another one that we've followed as its shares have returned a quick double in just a couple of months time. Fueling this price run may have been the increasing amount of attention paid to the 3D printing sector, but Organovo has also landed some high-profile partnerships for its own version of the technology that has added a large amount of validation to the company's future. Organovo has applied the 3D printing concept to the field of healthcare and biotechnology by developing the NovoGen MMX Bioprinter, which uses live human cell samples to generate 3D "bioprints" of human tissue that can then be used as disease models and enhance therapeutic drug discovery and development.  The potential of this technology over the short to mid term is significant, as mentioned above, in the realm of therapeutic research and development, but looking further on down the road Organovo could potentially put this technology to use in generating organs for patients awaiting transplants, as previously discussed. That specific potential was highlighted by The Economist magazine a couple of years ago while other high-profile coverage from CNBC validated ONVO's potential more recently. In regards to partnerships, Organovo already has standing deals with Pfizer (PFE) and United Therapeutics (UTHR) and just recently agreed to a deal with Autodesk Inc (ADSK) to develop 3D bioprinting software.

After pushing to just below the four dollar mark on huge volume last week, shares looked to have again consolidated in the low threes. Given the potential of the 3D printing sector to usher in the next generation of printing technologies - and specifically the potential Organovo to play a huge role in the bioprinting arena - ONVO remains a hot one to watch. As previously described when 3D Systems Corp (DDD) was moving big, ONVO is an example of how speculative investors can benefit from holding onto a smaller, lesser-known company when the sector itself is starting to run - potential aside.

Volume Spike Draws Eyes To Inovio

Inovio Pharmaceuticals (INO) shares have been in the spotlight during the early-goings of 2013 and are positioned to remain there as America's flu season continues to make headlines. This year's flu outbreak has already hit well more than the majority of all fifty states and is expected to get worse as the season progresses. As discussed earlier in the year, this development is likely to draw attention to companies with flu vaccines in development and Inovio has already gained early acclaim for its clinical-stage universal flu vaccine technology. When such flu outbreaks occur - remember the swine flu - it's not unusual to see the share prices of these developmental flu vaccine companies run, based not only on the potential that the vaccine holds in itself, but because the government also steps in with grant money to hasten the development of a potential vaccine. Investing in a company based on the potential for a short term trade to materialize on such developments is highly speculative, but the percentage gains that can be had with such moves are often significant.  Another benefit, though, is that attention can be drawn to pipelines that may otherwise be flying below the radar. Inovio may be benefiting from both scenarios right now.     Already this year INO has traded for prices roughly twenty five percent higher then where they began the year as volume moved in heavy last week to support the move. This trading action will again have the stock as a hot one to watch moving into the new trading week.

Inovio's pipeline, including the universal flu vaccine, is based on its proprietary SynCon technology. SynCon is a platform from which the company has developed numerous synthetic vaccines intended to treat numerous infectious diseases and cancer types and Inovio has already successfully attracted a few collaborative efforts, as six of these programs in development are funded by third parties. Three are in the Phase II stages of development.  Inovio may benefit this year from its evolution from a 'Phase II' play to a pure late-stage developmental play, as the three pipeline programs in Phase II will reach the latter stages of that milestone mark as the year progresses.  Investors often take note that Phase II pipelines are still considered years away from market, but some of the most impressive investment gains in the biotech/small pharma sector are had when successful Phase II and/or Phase III trials are announced. Even considering the recent run, INO is still trading at relatively speculative levels and could attract the interest of those looking to play future catalysts or simply hold for the future as this deep pipeline develops.

Still one to keep an eye on.

Briefly:

Amarin Corporation (AMRN): Hardly a week will go by without AMRN making the list of hot stocks to watch, especially with the launch of Vascepa pending for the very near term, as confirmed by a company presentation at last week's JP Morgan Healthcare conference in San Franciso. Although some of the AMRN trading action may have indicated that the shorts have started to cover during the opening days of 2013, the stock still carries a heavy short interest - which indicates that there is still an ample supply of non-believers, but it could also lead to a more protracted spike, should any positive news develop.  As has been the case for months, investors are still waiting for news on Vascepa's New Chemical Entity (NCE) status. A decision from the FDA in that regards will likely provide a catalyst - either up or down, depending on the outcome - for the AMRN and may also be the precursor needed to finalize any potential buyout or partnership offers that may have been previously entertained.

Of note on the news front last week, the company announced the issuance of another MARINE-related patent, which led to a modest three percent share price gain. Still one to watch with the Vascepa launch pending, as a hot start on the market will be crucial for those looking to hold off the short interest.

Facebook (FB): With a push to over thirty bucks achieved last week, Facebook is once again in the good graces of investors. Late-year expirations of share lock-ups did little to spark the rounds of selling seen in such scenarios earlier in the year, as indications are that investors are holding on to those shares in anticipation of future earnings. Facebook's last report noted some positive trends in mobile growth for the company and investors will be keeping a keen eye for a continuation of that trend with this quarter's report. The move to thirty again serves as a nice milestone to open the new year, but the pending quarterly report will provide the near-term catalyst, one way or another. It's also worth considering that although those holding the locked-up shares did not sell at lower levels last year, that's not to say that they won't at higher prices this year.

FuelCell Energy (FCEL): FCEL shares jumped another three percent on Friday on high volume, continuing a run that has returned more than a thirty percent gain in just the opening weeks of the new year. No news was released in conjunction with last week's move, but investors have been encouraged by recent developments on the business front - notably the deal with Dominion Resources (D) to develop the largest fuel cell power project in North America - and by a modest insider buy last week. The recent move higher on large volume, the significant short interest and the company's positioning for the future will keep this stock as one to watch for the week.

Titan Pharmaceuticals (TTNP): After hovering for the better part of a year at levels nearly a third of the current share price, Titan started making noise late last year when the company landed a partner for Probuphine, a subcutaneous treatment for opioid addiction that is also being investigated for use in treating chronic pain. In December it was noted that a push towards two bucks may materialize as we awaiting an approval decision for Probuphine, especially with partnership news in the rear view mirror, and that move has taken shape during the opening week of 2013 as Titan closed Friday at $1.73. Apple Tree Partners, with whom Titan partnered, has a history in the sector of developing and then selling developmental companies such as TTNP, adding to the speculation that 2013 could turn into a pivotal year validation for the small company. The quick gains returned to TTNP investors over the past couple of months are minimal when compared to the run from a penny to over two dollars of a couple of years ago, but a clean triple is nothing to complain about. Titan's push higher last week and the pending FDA decision still has this one as a story to watch.

Roundup: Some less-than-appealing economic news from Europe did little to keep investors at bay on Monday as world markets pushed higher, positioning US markets to follow suit, barring any negative developments before the market open. Investors may also enjoy the encouraging forecasts regarding the US economy over the next couple of years that were making headlines during the morning hours, but it won't be long before earnings numbers and new data start trumping all else on the market wires. It should be an exciting week ahead for investors and traders alike - and we can all be thankful that talk of the trillion dollar coin has finally been put to rest. That plan had as much chance of coming to fruition as RG III's knee has at ever lasting a full season again.

Happy Trading!!!

At the conclusion of each week, VFC's Stock House examines some news items, stocks and stories that made headlines during the previous trading week, but may also make headlines or influence trends during the upcoming week as well.

The trading year of 2013 kicks off in a big way this week.  Although the markets rallied for the first couple of weeks of the year, the noted price and mood fluctuations were based mainly on political factors, rather than on factors inherent to the markets themselves. For example, a resolution to the fiscal cliff mess sparked more certainty than we'd seen for quite some time, while pessimism over the pending expiration of the US debt ceiling set in quickly and stalled the early-year run. Renewed headlines of Europe's economic woes and expectations of another lackluster earnings season also didn't help keep the rally going, but with a slew of economic data due this week and with earnings entering the 'full swing' phase after a couple of 'teaser' reports last week by Alcoa (AA) and Wells Fargo and Company (WFC). One way or another, things ought to get pretty exciting this week.

To gauge the health of the recovery, investors can digest this week retail sales numbers, housing starts data and consumer sentiment, in addition to some manufacturing data. Earnings are likely to steal the overall spotlight, but any improvements - or not - in these data over the previous month or quarter can move the markets, too, especially if the data supports any trend set by the earnings reports.

One item that can be put to rest is the silly talk surrounding this trillion-dollar coin that was so talked about over the last couple of weeks. The amount of attention paid that coin served as a steady sideshow to real news, and was a testament to the lack of any relevant discussion going on in the meantime. That will all change this week.

Plenty of action this week expected, but there's still always room for a few individual stocks and stories to keep an eye on...here are just a few of them...

Earnings:

Big Bank Reports Will Dominate

Alcoa kicked off the season last week on a high note, as previously discussed, and Wells Fargo followed with a worthy follow-up. Wells reported record profits, although some were concerned that the bank wrote fewer mortgages than it did during the previous quarter. Shares traded relatively flat following the report, closing down by less than a percentage point on Friday, but provided a solid introduction to a banking-heavy week with giants such as Bank of America (BAC), Citigroup (C), Goldman Sachs (GS) and JP Morgan (JPM) all slated to report. Those looking for early-year trends to assess the health of the banking industry at the offset of 2013 will find themselves with ample data and earnings to pore through this week, and any encouraging trend in the sector could spark a broad-based rally, especially if other reports from the likes of General Electric (GE), Intel (INTC) and eBay (EBAY) make positive waves themselves and validate a healthy rebound based on growing consumer demand. Bear in mind that profits is not enough to spark general excitement, as evidenced by the Wells report and the subsequent lull in share price movement; it's evidence of a healthy overall economy that investors are watching for, so it may be worth looking deeper than the headlines.

Banking:

Cutbacks And A Downgrade Thrust Earnings Into Spotlight

A couple of items from last week could temper the mood surrounding the banking industry leading into the new trading week. Morgan Stanley (MS) announced last week that it expected to initiate another round of cost-cutting measures, which would include the laying off 1600 personnel from its securities unit. The move is a sign of the times that large businesses, banks and corporations may not be finished with the restructuring that has been underway since the economic collapse of 2008-09. That said, investors should not panic looking ahead as many other big players in the industry, including Citigroup, Bank of America and Credit Suisse Group (CS) all undertook similar measures.    Also last week - and potentially playing a factor this week - Credit Suisse downgraded Bank of America from 'Outperform' to 'Neutral' and sparked a five percent price dive for BAC. These situations always make me laugh, as if there is no conflict of interest when one big bank covers another and sends shares either spiking or diving. The timing of the downgrade comes curious, too, just before earnings, making the BAC report one to watch.

Investors playing the longer term potential of the sector may enjoy short term dips that materialize from any negative news developments, such as the BAC downgrade, and more of the story will be told with the flurry of banking reports this week. Again, for those looking to play the overall sector, the Financial Sector SPDR ETF (XLF), or other electronically-traded funds, offer investors that opportunity.

Newsmakers:

Anticipation Of BlackBerry 10 Drives RIMM Shares Higher

Shares of Research In Motion (RIMM) were on the fly this past Friday - jumping by nearly fourteen percent - and should be another hot one to watch this week, too, as investors anticipate the pending launch of the BlackBerry 10 platform later this month.  RIMM shares have been highly volatile of late leading into the launch period and have more than doubled off their 52-week lows as investors speculate on a turnaround. Because it can - and has - been argued that consumers may have reached the point of saturation with Apple's (AAPL) iPhone, the avenue may be clear for RIM to start gaining back some of the market share lost with the rise of the iPhone, Galaxy and other recent innovators of the sector. Some popular financial media outlets have also covered the RIMM story as a potential bullish mover, which could help fuel a continued move higher after last week's run. It's been a period of consolidation for this stock after its quick double a few months ago and the company could turn into one of 2013's solid turnaround stories - assuming a successful BlackBerry 10 launch, of course.

TrovaGene Jumps Through Eight Bucks

We've followed the TrovaGene Inc (TROV) story as shares returned more than a triple since the summer months and another milestone was met last week as a significant boost in volume pushed TROV through the eight dollar mark while also setting a new 52-week high. Volume on Friday registered at more than five times the daily average and the price jump made the stock well more than a quadruple off its 2-week lows.   Fuelling this company's price run has been the pending commercialization of some of the company's numerous diagnostic tests that can detect various cancer indications through a simple urine sample. The first such test is slated to hit the market later this month and will be able to detect KRAS mutations through urine samples, with others expected to follow in achieving this significant milestone.  Aside from the pipeline developments alone, TrovaGene also received attention from some high-profile collaborative efforts and was also highlighted in a recent analyst report when Aegis Capital jumped on board and initiated coverage of the company with a rating of 'Buy.' Continuing a swift move higher, TROV will again be a stock to watch this week. Only twice in 2012 did trading volume hit as high as it did on Friday, a potential sign that more serious investors are moving in. Bear in mind that quick-movers such as this one - which have returned huge gains over a short period of time - are also to be watched for pullback periods of consolidation. TROV has already seen a couple of these on the way up, but pending developments - thus far - have been able to fuel a higher run.  It also helps that TrovaGene is capitalizing on the growing healthcare trend of exploiting less-invasive and less-expensive means of identifying and treating various cancers and disease types. Another hot one to watch this week.

Dendreon Spikes Twenty Percent

Dendreon (DNDN) was another of Friday's hot movers, with shares spiking by over a dollar on a twenty percent rise. Having already been identified as a potential rebound play for 2013 due to a reversal in trend for Provenge sales, partly the result of expanded insurance coverage by players such as Aetna (AET), Dendreon then received a boost last week from a Bernstein analyst who upgraded the DNDN stock to 'Outperform' while also upping the price target to $10 from $7. According to reports, the upgrade was based on feedback from urologists, but the company itself may also be benefiting from the implementation of numerous rounds of cost-cutting measures that have helped to sure-up the bottom line as the sales and management team worked to reverse what was - for at least a quarter - slowing Provenge sales. Provenge could continue to grow support from doctors and insurers if data continues to prove its worth in combination with other drugs and therapies, such as Medivation's (MDVN) Xtandi, Sanofi's (SNY) Jevtana, and Johnson & Johnson's (JNJ) Zytiga, for example, which are for the time being solely looked at as competition. Given Friday's boost on huge volume - five times above the daily norm - DNDN will be a hot one to watch again. Analsyts jumping on board the DNDN turnaround train validates what many longs have predicted for some time.

Healthcare, Biotech, Pharmaceutical:

Organovo Holdings Pushes The Four Dollar Mark

Organovo Holdings (ONVO) is another one that we've followed as its shares have returned a quick double in just a couple of months time. Fueling this price run may have been the increasing amount of attention paid to the 3D printing sector, but Organovo has also landed some high-profile partnerships for its own version of the technology that has added a large amount of validation to the company's future. Organovo has applied the 3D printing concept to the field of healthcare and biotechnology by developing the NovoGen MMX Bioprinter, which uses live human cell samples to generate 3D "bioprints" of human tissue that can then be used as disease models and enhance therapeutic drug discovery and development.  The potential of this technology over the short to mid term is significant, as mentioned above, in the realm of therapeutic research and development, but looking further on down the road Organovo could potentially put this technology to use in generating organs for patients awaiting transplants, as previously discussed. That specific potential was highlighted by The Economist magazine a couple of years ago while other high-profile coverage from CNBC validated ONVO's potential more recently. In regards to partnerships, Organovo already has standing deals with Pfizer (PFE) and United Therapeutics (UTHR) and just recently agreed to a deal with Autodesk Inc (ADSK) to develop 3D bioprinting software.

After pushing to just below the four dollar mark on huge volume last week, shares looked to have again consolidated in the low threes. Given the potential of the 3D printing sector to usher in the next generation of printing technologies - and specifically the potential Organovo to play a huge role in the bioprinting arena - ONVO remains a hot one to watch. As previously described when 3D Systems Corp (DDD) was moving big, ONVO is an example of how speculative investors can benefit from holding onto a smaller, lesser-known company when the sector itself is starting to run - potential aside.

Volume Spike Draws Eyes To Inovio

Inovio Pharmaceuticals (INO) shares have been in the spotlight during the early-goings of 2013 and are positioned to remain there as America's flu season continues to make headlines. This year's flu outbreak has already hit well more than the majority of all fifty states and is expected to get worse as the season progresses. As discussed earlier in the year, this development is likely to draw attention to companies with flu vaccines in development and Inovio has already gained early acclaim for its clinical-stage universal flu vaccine technology. When such flu outbreaks occur - remember the swine flu - it's not unusual to see the share prices of these developmental flu vaccine companies run, based not only on the potential that the vaccine holds in itself, but because the government also steps in with grant money to hasten the development of a potential vaccine. Investing in a company based on the potential for a short term trade to materialize on such developments is highly speculative, but the percentage gains that can be had with such moves are often significant.  Another benefit, though, is that attention can be drawn to pipelines that may otherwise be flying below the radar. Inovio may be benefiting from both scenarios right now.     Already this year INO has traded for prices roughly twenty five percent higher then where they began the year as volume moved in heavy last week to support the move. This trading action will again have the stock as a hot one to watch moving into the new trading week.

Inovio's pipeline, including the universal flu vaccine, is based on its proprietary SynCon technology. SynCon is a platform from which the company has developed numerous synthetic vaccines intended to treat numerous infectious diseases and cancer types and Inovio has already successfully attracted a few collaborative efforts, as six of these programs in development are funded by third parties. Three are in the Phase II stages of development.  Inovio may benefit this year from its evolution from a 'Phase II' play to a pure late-stage developmental play, as the three pipeline programs in Phase II will reach the latter stages of that milestone mark as the year progresses.  Investors often take note that Phase II pipelines are still considered years away from market, but some of the most impressive investment gains in the biotech/small pharma sector are had when successful Phase II and/or Phase III trials are announced. Even considering the recent run, INO is still trading at relatively speculative levels and could attract the interest of those looking to play future catalysts or simply hold for the future as this deep pipeline develops.

Still one to keep an eye on.

Briefly:

Amarin Corporation (AMRN): Hardly a week will go by without AMRN making the list of hot stocks to watch, especially with the launch of Vascepa pending for the very near term, as confirmed by a company presentation at last week's JP Morgan Healthcare conference in San Franciso. Although some of the AMRN trading action may have indicated that the shorts have started to cover during the opening days of 2013, the stock still carries a heavy short interest - which indicates that there is still an ample supply of non-believers, but it could also lead to a more protracted spike, should any positive news develop.  As has been the case for months, investors are still waiting for news on Vascepa's New Chemical Entity (NCE) status. A decision from the FDA in that regards will likely provide a catalyst - either up or down, depending on the outcome - for the AMRN and may also be the precursor needed to finalize any potential buyout or partnership offers that may have been previously entertained.

Of note on the news front last week, the company announced the issuance of another MARINE-related patent, which led to a modest three percent share price gain. Still one to watch with the Vascepa launch pending, as a hot start on the market will be crucial for those looking to hold off the short interest.

Facebook (FB): With a push to over thirty bucks achieved last week, Facebook is once again in the good graces of investors. Late-year expirations of share lock-ups did little to spark the rounds of selling seen in such scenarios earlier in the year, as indications are that investors are holding on to those shares in anticipation of future earnings. Facebook's last report noted some positive trends in mobile growth for the company and investors will be keeping a keen eye for a continuation of that trend with this quarter's report. The move to thirty again serves as a nice milestone to open the new year, but the pending quarterly report will provide the near-term catalyst, one way or another. It's also worth considering that although those holding the locked-up shares did not sell at lower levels last year, that's not to say that they won't at higher prices this year.

FuelCell Energy (FCEL): FCEL shares jumped another three percent on Friday on high volume, continuing a run that has returned more than a thirty percent gain in just the opening weeks of the new year. No news was released in conjunction with last week's move, but investors have been encouraged by recent developments on the business front - notably the deal with Dominion Resources (D) to develop the largest fuel cell power project in North America - and by a modest insider buy last week. The recent move higher on large volume, the significant short interest and the company's positioning for the future will keep this stock as one to watch for the week.

Titan Pharmaceuticals (TTNP): After hovering for the better part of a year at levels nearly a third of the current share price, Titan started making noise late last year when the company landed a partner for Probuphine, a subcutaneous treatment for opioid addiction that is also being investigated for use in treating chronic pain. In December it was noted that a push towards two bucks may materialize as we awaiting an approval decision for Probuphine, especially with partnership news in the rear view mirror, and that move has taken shape during the opening week of 2013 as Titan closed Friday at $1.73. Apple Tree Partners, with whom Titan partnered, has a history in the sector of developing and then selling developmental companies such as TTNP, adding to the speculation that 2013 could turn into a pivotal year validation for the small company. The quick gains returned to TTNP investors over the past couple of months are minimal when compared to the run from a penny to over two dollars of a couple of years ago, but a clean triple is nothing to complain about. Titan's push higher last week and the pending FDA decision still has this one as a story to watch.

Roundup: Some less-than-appealing economic news from Europe did little to keep investors at bay on Monday as world markets pushed higher, positioning US markets to follow suit, barring any negative developments before the market open. Investors may also enjoy the encouraging forecasts regarding the US economy over the next couple of years that were making headlines during the morning hours, but it won't be long before earnings numbers and new data start trumping all else on the market wires. It should be an exciting week ahead for investors and traders alike - and we can all be thankful that talk of the trillion dollar coin has finally been put to rest. That plan had as much chance of coming to fruition as RG III's knee has at ever lasting a full season again.

Happy Trading!!!

Disclosure: Long FCEL, INO, AMRN, GE.

Originally published at: http://vfcsstockhouse.com

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Stock Watch Wednesday, 9 January: AA, BA, FCEL, D, INO, DNDN, PBTH, TEVA, MRIC

noreply@blogger.com (VFC) — Tue, 15 Jan 2013 05:57:00 +0000

Alcoa (AA) kicked off the earnings season on a positive note on Tuesday and global stock markets rallied on Wednesday as a result. The upbeat Alcoa report helped to offset reports earlier on Tuesday that the Euro Zone (EZ) unemployment rate is still inching higher, bringing to light again previous worries that Europe is still far behind the United States along the road to recovery. That report from Europe led to a drop in oil prices, but did little to quell the overall upbeat mood in the markets. On Tuesday, before the Alcoa report was out, US markets closed down, but some of that could be attributed to continued profit taking after the post-fiscal cliff rally last week. While few expect this earnings season to provide anything more than the occasional modestly-surprising report, Wednesday could turn into a nice up day thanks to Alcoa. Overall enthusiasm may be tempered, however, especially with the debt ceiling negotiations still set to kick off over the near term while also considering the fact that one positive earnings report does not yet indicate a trend.

With that said, there's always a few stocks and stories to keep an eye on as the major news of the day dominates the headlines ... here are a few for Wednesday, 9 January, 2013...

Earnings:

Alcoa Kicks Off The Earnings Season On A High Note

As mentioned in the open, Alcoa on Tuesday released an encouraging earnings report that sent global markets higher and reversed what had been a couple of down days. It wasn't just the numbers from the reported quarter that set the tone, although revenue slightly beat the street and earnings were generally in-line with analyst estimates of six cents per share, rather it was the outlook for 2013 that had investors giddy. Representatives of Alcoa, which is the largest aluminum provider in the United States, predicted that demand for the metal would grow by seven percent this year - slightly above last year's rate - providing validation that the global recovery is picking up steam. One positive report will not set a trend for the season, though, so investors will likely temper expectations moving forward and take an "I'll see it when I believe it" approach towards the remainder of the quarter, but the Alcoa news certainly helped to offset reports from Europe that unemployment was still on the rise in the EZ. A nice start to the season as indications are that the global recovery will continue into 2013 and also a sign that AA could continue to benefit throughout the year.

Newsmakers:

Boeing Drops On Dreamliner Woes

Shares of The Boeing Company (BA) dropped by over two percent on Tuesday as reports of more problems with the Dreamliner became widespread news throughout the day. With Boeing having so much invested in the Dreamliner and with over 800 orders left unfilled, any bad press will make investors nervous and lead to declines such as what we saw on Tuesday. That said, a two percent drop doesn't indicate all-out fear on the part of investors and the truth is that all aircraft - not just Dreamliners - experience incidents such as these presented by the media from time to time - even new aircraft - it's just that the Dreamliner is very high-profile right now and since the media loves to play with high-profile stories, every incident is making the news. BA shares should only be modestly and temporarily effected by such reports, unless a major structural flaw is found or something else of similar scope materializes, otherwise investors may look at these dips as ample accumulation points.  More relevant to investors may be the share price drops of suppliers of the defective parts that led to these incidents, such as the battery maker whose battery caused the reported fire, which in this case was Japan's GS Yuasa Corp. Yuasa dropped for a second straight day on Tuesday.

Industry, Clean Energy:

FuelCell Energy Off To A Strong Start

Shares of FuelCell Energy (FCEL) jumped by five percent on Tuesday and have risen by over fifteen percent already on the year. No significant news was released in conjunction with the five percent, high-volumed spike, although a company insider was noted to have made a modest share purchase.  The quick start this year could be a precursor for what's to come as the company announced numerous solid developments last year that have it positioned for success and growth in 2013. The most significant of the most recent developments may have been the news FuelCell - in collaboration with Dominion Resources (D) - would develop the largest fuel cell power project in North America. This deal, according to Bloomberg reporting, increased the company's backlog of orders to over $125 million and provided a testament to FCEL's ability to supply power independent of the national or regional grids - a big deal in the aftermath of Hurricane Sandy. Also in 2012 FuelCell secured a deal with South Korea's POSCO Energy, a deal that brought with it $30 million of up-front financing and laid the groundwork for future - and potentially more lucrative - collaborative efforts.

With a quick start to the year underway, FCEL will be a hot story to watch moving forward. Add in a fairly significant amount of short interest and things could get exciting quick, should those shorts look to cover as developments continue to unfold on a positive note. What has held this company back thus far is the slow trek towards profitability, but as investors become convinced that profitability is on the horizon, volume may start to trickle in at a higher rate and the share price could follow. Until profitability is met, however, the threat of a stock offering does exist - one such deal was struck last year around the time of the Posco announcement - but the company has also demonstrated its ability to raise funds through partnerships and other collaborative efforts.

Healthcare, Biotech, Pharmaceutical:

Inovio To Initiate New Clinical Trial

Inovio Pharmaceuticals (INO) is another company that has gotten off to a hot start in 2013 and remains one to keep an eye on as numerous interim and actual trial catalysts could unfold this year. One such catalyst materialized during the early hours on Wednesday morning as the company announced its intention to bring to the clinical stages its hepatitis C (HCV) DNA therapeutic vaccine, which is based on the company's proprietary SynCon synthetic vaccine platform. With the SynCon technology, Inovio has produced numerous synthetic vaccines intended to treat or prevent various infectious diseases and cancer types.  Three of these pipeline vaccines are moving through the Phase II stage of development and six of the company's programs are being funded by third parties. The addition of a hepatitis C vaccine to the clinical stages of development adds to the already deep potential of Inovio's pipeline to infiltrate numerous very lucrative markets with its synthetic vaccines. Volume has been relatively enormous for INO this week so far and this announcement could keep the ball rolling. Shares have jumped by roughly twenty five percent so far this year with attention being brought to the company's pipeline and technology, so the threat of a pullback exists, but there are enough developments unfolding and pending to keep attention on the company, even when focus on the sector cedes as numerous healthcare and biotech conferences wrap up later this week.  Inovio may also be receiving a boost from the flu outbreak that is gripping America this winter. As mentioned earlier in the week, companies developing flu vaccines - especially the universal types - typically garner more media attention than normal and INO's universal flu vaccine technology has already demonstrated early success. Definitely one to keep an eye on these days.

Dendreon Drops Six Percent

As mentioned on Tuesday, Dendreon (DNDN) released interim fourth quarter results that indicated a reversal in the downward trend of Provenge sales. One quarter will not mark a true reversal of trend, but it starts the year on a positive note for the company and lays the foundation for the 2013 rebound predicted by numerous financial media sites. With the news on the street, DNDN shares have dropped rapidly from the six dollar mark and closed Tuesday down another six percent on volume nearly double the daily average, but within the norm for the first trading week of the new year. The current drop may provide investors looking to play DNDN as a rebound story to accumulate shares with an eye towards the mid term, especially if the drop continues as attention rolls off the sector later this month. Expanded coverage by insurance companies and cost-cutting measures implemented last year by the company should help boost the Provenge sales numbers and firm up the bottom line. Given the volatility displayed thus far in 2013, DNDN remains one to keep an eye on as both a trade and potential accumulation play.

Prolor Secures New Patent

Shares of Prolor Biotech (initiated a Phase II pediatric trial in Europe early last year. The pediatric trial came as a huge sign of validation to the early results of the product, given that European regulators need to be essentially overwhelmed by trial data in adults before approving a trial in children. Data from these trials could start rolling in this year and given the multi-billion dollar growth hormone deficiency market, the Prolor share price could appreciate very significantly if these trials prove successful.

Although relatively quiet on the news front of late, Prolor announced earlier this week that it had received a notice of allowance from the US Patent and Trademark Office covering a patent application relating to the manufacturing methods of its CTP technology. This news may not look significant in itself to investors, but a company stands on stronger proprietary footing as its patent portfolio expands and these are developments worth monitoring. Should a company NOT receive allowance for a requested patent, then that gets interesting, being as it is a rare event.

With the market potential of hGH-CTP, Prolor is still one to keep an eye on. Should trial data start flowing in looking positive, then PBTH would be in a position to move higher fairly quickly. In the meantime, shares have remained stable in a range around the five dollar mark over the past few months, a level where those looking to play the pending trial catalysts feel comfortable adding.   It's also worth noting that Teva's (TEVA) Dr. Phillip Frost is already heavily invested in PBTH and that connection is intriguing because, which is already linked to other buyout rumors, could also be considered as a potential buyer of Prolor.

Briefly:

MRI Interventions (MRIC) is slated to present on Wednesday at the Biotech Showcase in San Francisco. This presentation could receive its fair share of investor interest, given that 2013 is projected to become a year of significant growth after the boosting of the sales force late last year and the already-impressive gains noted over the previous quarters. MRI, which also moved into the European market last year, has developed the ClearPoint and ClearTrace MRI-enhancing systems that provide real-time imagery during complicated procedures on the brain and heart, respectively. The company not only registers sales on a sold unit, but also receives regular revenue from the "disposable items" related to individual procedures. It is revenue from those items that has fueled the recent growth. One to keep an eye on, as MRIC has also proven to return decent trades from its current trading levels.

Roundup: International markets enjoyed a nice up day on Wednesday and the stage was set for US markets to do the same. Profit taking following the early-year run looks to be complete, freeing stocks to trade in line with earnings. As mentioned, the Alcoa report has investors in an up-beat mood, but that mood could shift quickly if the expected sub-par numbers start rolling in when the season picks up full steam. There could be some distractions in store for Wednesday as well, with early headlines throwing the debt ceiling negotiations (or lack thereof) into the spotlight and others keying in on the Dreamliner fuel leaks and low-priced iPhones. Could be an interesting day.

Happy Trading!!!

Disclosure: Long FCEL, INO.

Contact VFC's Stock House: vfc@vfcsstockhouse.com

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Weekly Stock Watch, Week Of 7 January: GOOG, AA, WFC, MSFT, YHOO, JPM, AMRN, TEV, AZN, PFE, DNDN, MDVN, SNY, JNJ, MNKD, MRIC, BSX, TROV, INO, CVM, ONVO, SIRI, LMCA

noreply@blogger.com (VFC) — Tue, 08 Jan 2013 17:41:00 +0000

A week of solid gains held up well into Friday's close last week as a last minute deal averted the implementation of the 'fiscal cliff' that could have put the US economy into another recession, according to many analysts. With those fears behind us, investors took advantage of recently-depressed stock prices to position for the new trading year. The good mood may not last long, however, as numerous headlines from over the weekend tell a cautionary tale regarding the earnings season that kicks off this week, not to mention the fact that political negotiations regarding the debt ceiling are also likely to start gaining steam during the coming days. Even President Barack Obama has warned that the US cannot afford any more of the heated battles that surrounded the cliff talks, but to expect anything less may be wishful thinking as the crew in Washington is having difficulties just agreeing on an aid package for the battered northeastern states following the devastation of Hurricane Sandy. On the other hand, most in the Congress and Senate have shown that a deal can get done when their respective backs are against the wall, so it's highly likely that a deal will get done on this one, too, as anything else could leave the US credit rating at risk.

We're likely to start experiencing some volatility regarding those talks over the near term as the media plays the headlines game on a daily basis. As always, taking emotion out of the equation and sticking to pre-conceived entry and exit strategy could help return traders and investors hefty rewards as the peaks and valleys are played. Adding to the volatility is earnings season. No one expects blockbuster numbers for the just-completed fourth quarter, but as we saw last quarter's reporting season when Google (GOOG) missed, one surprise report can send the markets south in a hurry - while a few better-than-expected reports could accomplish the reverse. In these uncertain times, it's best to be prepared for either eventuality. Of note, Alcoa (AA) and Wells Fargo and Company (WFC), among others, are slated to report this week, but neither is likely to set the tone for the season one way or the other.

Jobs and unemployment numbers for last month were in-line with expectations, so that should be considered a non-factor for the coming week, especially with so much other news priming to heat up.
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With all that going on, here's a few stocks and stories to keep an eye on this week...

Newsmakers:

Google Begins Year With A Regulatory Win

The US Federal Trade Commission (FTC) last week awarded Google a notable win in an ongoing investigation into the company's search practices, which were said to favor Google's own properties, products and services. The FTC, according to reports circulating last week, decided that Google's practices were not intended to hinder honest competition, rather they were intended to increase consumer ease and experience. With that in mind, Google agreed to a couple of compromises that will give advertisers and competitors more control over their information, rather than being forced to undertake a dramatic overhaul of its practices, as was previously suspected could be the outcome. GOOG shares jumped by two percent on the news as investor confidence was given a boost by the fact that Internet search giant escaped relatively unscathed from the investigation. Some concerns still exist, however, that European regulators may not be so kind in their assessment of the situation. Those concerns may hamper the ability of the company's to enjoy any sustained rally, but GOOG is more likely to trade based on its next earnings report, set for January 22nd, than anything else. Although search competitors such as Microsoft (MSFT) and Yahoo! (YHOO) may gain slightly from Google's new stipulations, this outcome will not threaten Google's status as the dominant player in search.

JP Morgan Healthcare Conference In Full Swing

The world of biotech and healthcare investing steals the show this week as the 31^st Annual JP Morgan (JPM) Healthcare Conference achieves full throttle on Monday.  Many of the sector's high-flyers, relative unknowns and predominant players will be featured in various presentations all through the week geared towards the investing community.  There's sure to be more than a fair share of updates, data and numbers set forth for investors large and small to digest and set the tone for the new year.

Of note, Amarin Corporation (AMRN) will be presenting at 11:30AM Monday morning. Amarin investors will be keying in on any comments from the CEO regarding a potential buyout or partnership as well as any additional insight into the status of discussions with the FDA over Vascepa's New Chemical Entity (NCE) status. An update offered early last month when the company announced its intention to go-it-alone with the Vascepa launch indicated that all strategic options were still on the table, with or without a finalized NCE decision. It could also be surmised, however, that any deal would not be finalized until the NCE resolution was known, leading Amarin to choose the path that it did for the time being.

Without any renewed buyout talk and/or a positive NCE decision over the near term, AMRN is likely to hang out at or near its current levels, but this one has been known to fly quickly when the right speculation hits.  Investors long and short are likely to keep their fingers close to the trigger this week, especially on Monday when the company is scheduled to present. Already Teva Pharmaceuticals (TEV) and AstraZeneca (AZN) have been linked to Amarin buyout talk and Pfizer (PFE) has also been recently added to the discussion. Still a hot story to watch and one to take a look at on any pullbacks. A solid start to the Vascepa launch could spark a rebound, if news doesn't warrant such action beforehand, although any indications that Vascepa will not turn into the ultimate blockbuster that many predict it will become would hurt. All eyes on Amarin to open the week.

Other hot players presenting on Monday are Celgene (CELG) and Onyx Pharmaceuticals (ONXX). Celgene is coming off a very solid 2012 and investors will be looking for signs that the run can continue through 2013 while Onyx will look to convince investors that Krypolis can still build on the momentum of its recent commercial launch and that the four percent gain on Friday - which followed a stellar 52-week period of significant gains - is for real moving forward.

Dendreon (DNDN) is another one to keep a hot eye on Monday the conference. As previously noted, many believe that this could be a turnaround year for Dendreon and it's prostate cancer immunotherapy treatment, Provenge. Early signs of such are encouraging as DNDN has already jumped about fifteen percent this year on high volume and closed the week at the six dollar mark. Although competition by Medivation's (MDVN) Xtandi and Johnson & Johnson's (JNJ) Zytiga may thwart some of Dendreon's rebound momentum, evidence exists that positive results could be had when Provenge is used in combination with such drugs, providing a basis for positive co-existence between the brands. Investors will also be looking for additional confirmation that the cost-cutting measures put into effect last year are working.

Other companies followed by VFC's Stock House presenting later in the week worth watching are:

Spectrum Pharmaceuticals (SPPI): Spectrum is still the target of short sellers who are increasingly convinced that a boost in the generic manufacturing of leucovorin will eat away at FUSILEV revenue. Investors will look for evidence to the contrary as well as developments surrounding Zevalin and other developmental pipeline candidates.

Keryx Biopharmaceuticals (KERX):  Keryx has gained about thirty percent since lat-summer and returned a rough double since the Perifisone collapse of last spring. Investors are also awaiting results from a Zerenex trial that could lead to an eventual approval of the product. Although some are skeptical that this product could succeed in a market already saturated with generics, a strong case can also be made that Zerenex could become a market leader, should it make it that far.

Mannkind Corp. (MNKD): Representatives of Mannkind will present later in the week, too, and investors will be seeking an update on the Afrezza trials. Afrezza is being developed as an inhaled insulin alternative to needle-delivered insulin and was last denied an FDA approval two years ago when the FDA demanded new trials be conducted utilizing the company's next-generation inhaler. Founder Al Mann recently injected new cash into the company but a partner is still being sought. MNKD has gained about twenty five percent since Thanksgiving, although recent history has shown that this stock's volatile peaks and valleys are best to play as trades, even if still holding onto a core group of long-term shares for the future.   Should be a relatively hot one to watch this year.

Healthcare, Biotech, Pharmaceutical:

MRI Interventions Looks To Set The Tone For 2013

Although not attending the JP Morgan event this week, MRI Interventions will be presenting at the 2013 Biotech Showcase on the 9th, an event also held in San Fransisco. With this presentation MRIC will look to set the tone for 2013, following the demonstrated swift developmental progress and revenue growth of 2012. MRIC is positioned to take full advantage of the current trends in healthcare, which have medical professionals looking for less-intrusive and more accurate (which together means less-costly) methods of conducting complicated procedures.

In combining those qualities, MRIC has developed the ClearPoint and ClearTrace MRI-enhancing systems that provide real-time imagery during complicated procedures on the brain and heart, respectively. With the assistance of partners such as Boston Scientific Corporation (BSX) and Brainlab, MRIC has successfully infiltrated the market for Brain surgery and a recent boost in the sales force, as announced during the last quarter of 2012, positions the company to infiltrate that market even further this year. Already MRI is registering notable growth.

Accordingly to the latest-filed quarterly report, revenue generated by the "disposable items" associated with the use of ClearPoint roughly tripled, when compared to the same quarter of the previous year, a key indication that the technology is catching on, or at least is being used more often.
As the ClearPoint equipment and procedures are used more often, revenue from those "disposables" will continue to grow, since those items need to be replaced before the machine can be used again. That's a key point to note when considering an investment in this stock - not only is revenue based on the number of systems sold, but the company is also essentially banking revenue each time it's used.

MRI last year moved into the European market, too, with some collaboration by Brainlab and was also named the "2012 Global Company of the Year" in November for "Image-Guided Neural Interventions" by Frost & Sullivan, a global business research and consulting firm.

Shares have steadied over the past couple of months following a summer full of volatility that returned a triple to investors, but a modest volume boost during the opening week of the new year could be an indication that positions are consolidating ahead of what could be a milestone year for MRIC. While MRIC is one to consider for long term accumulation on any dips as the ClearPoint and ClearTrace technology develops, recent history has also proven that shares picked up at or near the current levels have proven to turn into decent trades when the stock approaches two bucks.

TrovaGene Jumps Another Ten Percent

TrovaGene Inc (TROV) shares closed Friday on another high note when double-the-average volume resulted in a ten percent gain for the stock. Although TROV has been steadily climbing since last summer and has already returned a clean triple in price based on the progress and pending commercialization of its pipeline of diagnostics that have proven to be able to detect some cancer types with simple urine samples, last week's run is likely related to the announcement on Thursday that TROV will work in conjunction with the University of Texas MD Anderson Cancer Center to detect transrenal BRAF mutations in the urine of patients with advanced or metastatic cancers. As noted here last week, this announcement is significant because it could drastically broaden the scope of the cancers detected by TROV's diagnostics, but it's also a huge sign of validation from the medical community as the MD Anderson Cancer Center is a big player and highly respected in the field of cancer research and treatment.

2012 was a year of milestone development for TrovaGene as the scientific team was strengthened, new partnerships were signed and the pipeline moved towards commercialization, but 2013 could prove an even more fruitful year for the company after commercialization hits and the collaboration with MD Anderson progresses.

As noted last week, pullbacks and consolidation are not unusual when stocks in this sector move so quickly, but TROV has numerous main acts and side stories going for it right now that new interest could continue to flow in. Although volume has beaten the daily averages of late, there's still not enough to indicate overwhelming widespread interest just yet.

Inovio Primed For A Boost

Inovio Pharmaceuticals (INO) has already been discussed discussed as a hot, but still speculative stock to watch for 2013 based on its growing trading volume and a deep pipeline of synthetic vaccines derived from the company's proprietary SynCon platform.  Through SynCon Inovio has produced numerous synthetic vaccines intended to treat or prevent various infectious diseases and cancer types.  Maybe most notably - at least for the time being - the company has developed a universal flu vaccine that is currently being tested in clinical trials. This flu vaccine may have the company positioned to receive a significant amount of attention over the near term due to factors external of the market.

For those following the news these days, a widespread flu outbreak has hit forty one states and the number of those affected is growing rapidly. This year's outbreak has already surpassed last year's numbers and - as can always be expected in these instances - the CDC, government leaders and the general public are calling for a vaccine. Every few years (remember H1N1) or so an outbreak becomes large and widespread enough that any company developing a universal flu vaccine - or even one that treats the individual strand in question - gets thrust to into the spotlight, not only because a potential marketable solution could turn into a very lucrative proposition for a given company, but also because government money often starts flowing in the form of grants to help find a cure.  This grant money can be hugely beneficial to still-developmental companies and it's quite possible that Inovio may be primed to receive a boost in investor and/or financial media interest, given the early successes of its universal flu technology and the speculation that often follows these outbreaks.

A few years ago Cel-Sci Corp (CVM), for example, a company known for developing an immunotherapeutic treatment for head and neck cancer, about quadrupled in price due - in part - to speculation surrounding its LEAPS application as a potential treatment for the swine flu.

If Inovio does in fact become a recipient of increased media and/or investor attention, the recent volume boost discussed during the closing days of 2012 could be justified and shares may be in a position to move higher now. Increased scrutiny of the SynCon technology could also lead investors to look more closely at the rest of the SynCon-based pipeline, which includes nine programs in development, three of which are currently in Phase II and six of which are already being funded by third parties, according to documents contained on the Inovio website. While companies still in the Phase II stages of development are considered highly speculative options, investing in such plays early on could prove very lucrative for both long term investors and short term traders as some of the most impressive gains these stocks can achieve often develop in lieu of a transition from Phase II to Phase III and in conjunction with positive trial results. As often discussed here, it's a good idea, in my opinion, to play the trading opportunities with each significant catalyst along the way while still holding onto a group of core shares for the long term play, if one so chooses to hang around for the long haul. This strategy could have an investor on house money - or even better - in the green long before the entire story is played out and help alleviate the risk of remaining 'all-in' through dilutive financing events that may take place along the way, as is common for still-developing companies.

With or without increased attention from the ongoing flu outbreak, INO is one to keep an eye on this year. As proven recently with Organovo Holdings (ONVO), volume often precedes price and INO has already seen a volume boost. There are also several interim and actual trial results that could play out during the cost of 2013 that, if positive, provide significant catalysts for the stock.

Also of note, Inovio is slated to present at the Biotech Showcase 2013 investor conference in San Fransisco this week. This event could also attract new interest to the company.

Inovio Expands Collaborative Effort To Develop Malaria Vaccine

Just in time for Inovio's presentation at the Biotech Showcase, a new collaborative effort was announced early Monday morning that will combine existing technology of the PATH Malaria Vaccine Initiative (MVI) with Inovio's proprietary electroporation vaccine-delivery technology. Electroporation, as previously discussed, uses small, targeted electrical pulses to inject therapeutic treatments directly into damaged or infected cells. This method allows for more precise delivery of a therapy - which increases effectiveness - without damaging surrounding tissue, as does other current standards of care. This collaborative effort between PATH MVI and Inovio expands on a previous agreement singed in 2010 and follows early successes of the initial deal.

The expansion of the agreements not only provides huge potential in treating malaria, but it also provides another validation of the electroporation technology, which has already been put to test with other developmental therapies and procedures. A Phase I/IIa clinical trial based on Monday's news is roughly a year away, according to information contained in the press release, and provides another potential price and development catalyst later on down the road.

Given the death and devastation caused annually by malaria, PATH MVI is on a mission to develop the means and methods to eradicate the disease. It's collaborative efforts with Inovio provides significant validation to the electroporation delivery methods and also helps to validate INO as a speculative play with growing potential in the sector.

Technology, Products and Services:

SiriusXM Bursts Through Three

Shares of Sirius XM Radio Inc. (SIRI) had been trucking towards the three dollar mark for the better part of the last half of last year and finally hit that point in December before closing the year at just below that mark. They didn't stay there for long as heavy volume flowed in at the new year and enabled SIRI set a new 52-week of $3.15 on Friday and, given the encouraging subscriber and revenue growth trends of 2012, there's reason to believe that shares could still continue to rise. Also influencing the price and volume action, however, is the green light that Liberty Media (LMCA) received from the FCC to gain effective control of SIRI by boosting its stake in the company to over fifty percent. Liberty gave itself sixty days to accomplish that task and it's probable that the increased volume could last until it's a done deal. It's also arguable the share price will continue to inch higher, given the amount of positive press surrounding SIRI right now and the optimistic outlook for the future.

The only serious concerns expressed by investors these days, aside from routine pullbacks and consolidation that can occur following nice price spikes, is what Liberty will do with SiriusXM once it has control. Former CEO Mel Karmazin has already departed for reasons most likely due to personality conflicts with Liberty's John Malone, who helped SIRI stave off bankruptcy in 2009 when shares traded for a nickel, and it's questionable as to how much autonomy the replacement CEO will have once Malone has control.  James Meyer, a Sirius insider, is currently holding down the fort as a "search committee" seeks a permanent replacement. Some investors are also worried about dilution that could occur following Liberty's takeover as the company looks to reward its own shareholders through the acquisition, but those concerns could be unfounded.

The future value of the SiriusXM and its stock undoubtedly lies in the hands of Malone and once control is complete, investors will be listening closely to his vision for the company's future. At some point subscriber growth will slow in the US, so other avenues of growth may have to be entertained, whether it's expanding or combining existing technologies or platforms or even taking the business international - which - of course - would mean more satellites and an up-front cash investment. With the unique content and quality provided by SiriusXM, it's likely there would be demand for the services internationally, even without having to add too much local content for international subscribers.

With the Liberty takeover in full swing and the SIRI share price bursting through three on high volume, this is a hot story to watch this week. The only immediate negative that could materialize, aside from a surprising earnings disappointment, would be if some investors play the 'sell the news' game since it's now a done deal that Liberty will achieve takeover.

Roundup: International markets opened the new week on a down note, fueling worries that the early-year rally in the US could come to a swift end. In the absence of immediate financial and/or political drama to play up in Washington, Europe's financial woes are making headlines again and keeping investors jittery, although banks rallied on some easing of the rules on European banks by international banking regulators. With the negative tone making the rounds early on this week, and with an uncertain earnings season ahead of us, it's likely that the good-spirited rally of early 2013 may quickly fade. At least this week we have the JP Morgan conference and the health care sector to concentrate on while the bigger picture plays out in the headlines. Regardless of it all, there's always a few individual stocks and stories playing out in the background that make trading and investing fun and interesting - that's what we try to look for.

Happy Trading!!!

Disclosure: ONVO, INO, AMRN, YUM.

Contact VFC's Stock House: vfc@vfcsstockhouse.

Originally published at: http://vfcsstockhouse.com

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