Thursday, May 16, 2013

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

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.
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 above - positions this company nicely to take advantage of the rapidly-growing numbers.

SanuWave also recently received a patent covering the use of its shockwave therapy for purposes of blood purification.  Although treatment of this indication is still in the very early stages of development, the patent enhances the future prospects of the company and also adds inherent value to the technology.

An investment here is not without risk - such is the case for any still-speculative investment - but the risk/reward profile continues to look more in favor of the potential rewards with each downtick in the share price.  Shares traded significantly higher during the last Phase III and any hints at success this time could quickly rebound shares to those levels.  The technology was already granted approval in Europe and acceptance is likely to grow if the shockwave therapy - which encompasses sending pulsed 'shockwaves' into damaged tissue to spark the regeneration of cells - continues to perform as advertised. 

SNWV is already a proven winner of the early portion of 2013 thus far, but the latest share price dip has positioned the company to potentially repeat its early successes.  Volume has tapered off a bit, too, an indication that the traders may be out for the time being, but with trial catalysts still pending, volume could come back in a hurry on the right news and spark another rally.

Still a story to watch.

Disclosure:  Long SNWV.

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Monday, May 13, 2013

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

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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Saturday, May 4, 2013

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

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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