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Momenta Pharma: A Pure Play on Bio-Generics

January 03, 2009 – Comments (0) | RELATED TICKERS: MNTA , NVS , TEVA

Momenta Pharma (MNTA) represents a pure play investment for the future of bio-generics, with two ANDAs filed at the FDA in partnership with the Sandoz division of Novartis (NVS) for multi-billion dollar biological agents Lovenox ($3.8B in sales for 2007) (blood thinner) – Sanofi-Aventis (SNY) and Copaxone ($1.7B in sales for 2007) (multiple sclerosis) – Teva Pharma (TEVA). However, it is important to note that the ANDAs for Lovenox and Copaxone can be approved through existing pathways at the FDA and do not require the passage of legislation to make it on the market.   [more]

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Five Top Rated Preventive Medicine Stocks

December 31, 2008 – Comments (0) | RELATED TICKERS: SQNM , EBS , APPY

Five Top Rated Preventive Medicine Stocks

[web link to index stats & Top 5 Rated Cos.]  [more]

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A New Index of Highly Defensive Stocks

December 31, 2008 – Comments (0) | RELATED TICKERS: WMT , MCD , DNA

A New Index of Highly Defensive Stocks

[web link to index stats and 36 companies]  [more]

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Anticipating Active '09 for AspenBio Pharma

December 31, 2008 – Comments (0) | RELATED TICKERS: APPY , SQNM , QGEN

Anticipating Active '09 for AspenBio Pharma

Now that AspenBio Pharma (APPY) has completed enrollment earlier this month in its FDA 510(k) clinical study for the world's first blood-based appendicitis screening test, AppyScore, investors will not have to wait much longer to get the results. Results in the 800 patient trial are expected in January, which will support APPY's 510(k) application for marketing clearance if the study objectives are met as in the previous, smaller clinical trial of AppyScore in 2007 with 98% sensitivity.

APPY expects to file its 510(k) with the FDA in January for the initial, 45-minute version of the test and hopes to gain marketing clearance by the end of 2Q09. However, assuming the clinical trial results support a 510(k) application, APPY will begin partnership discussions for an estimated $1 billion global market for the appendicitis screening test. Also, APPY is developing a faster, 15-minute version of the test which will follow the initial version and result in a second 510(k) filing at a later date.

APPY also has an animal health segment and signed a deal with Novartis (NVS) Animal Health earlier this year in April for exclusive licensing and commercialization of BoviPure LH and BoviPure FSH. The two animal health products are produced by recombinant DNA [rDNA] technology, which offers advantages such as increased potency, increased stability, no risk of disease transmission as with animal-based hormones, and lower manufacturing cost.

From a financial standpoint, APPY is well positioned with about $18M in cash, $26M in total assets, $6M in total liabilities, 31M shares outstanding, and 34.8M fully diluted shares. Insider and institutional ownership are significant at 23% and 40%, respectively, while the short interest declined to 841,286 as of mid-December. The Company has a very low burn rate of about $1.9M per quarter, which is much lower than most development-stage bio-pharma companies of its size.

The market cap currently stands at just $185M with APPY trading at around 6 bucks per share, with both metrics poised to move much higher if everything goes as planned in early 2009 with the trial results and AppyScore receives 510(k) marketing clearance by mid-2009. APPY should easily eclipse the all-time highs of around 15 bucks achieved in October 2007 based on initial annual revenue ranges [included in the accompanying table] of $126M-$296M for the appendicitis screening tests and the two animal health products.

At 15 bucks, APPY would trade at a market cap of less than $500M, which is still well below the $1.2B market cap for Sequenom (SQNM) and would also include more cash on the balance sheet from licensing deals and milestone payments. Also, the recent appointment of John Landon to the Board provides experience in the diagnostics industry and suggests APPY could become a takeover target as Mr. Landon served on the Board of Cholestech and Digene before they were sold to Inverness Medical (IMA) and Qiagen (QGEN), respectively.  [more]

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Four Healthy Stocks Trading Above Moving Averages

December 31, 2008 – Comments (0) | RELATED TICKERS: APPY , CYPB.DL , AMGN

Four Healthy Stocks Trading Above Moving Averages Amgen (AMGN), AspenBio Pharma (APPY), BioDelivery Sciences (BDSI), and Cypress Bioscience (CYPB) are four healthcare stocks that I follow which are poised to close out a rough 2008 for the overall market trading above their 50 and 200-day moving averages, in addition to having significant catalysts in 2009 which may lead to further gains. Below is a summary of the 2009 catalysts for these companies and click on the names or tickers below for a link to all of the articles on my blog for each stock:

Amgen filed a BLA for bone drug denosumab in the following two indications: the treatment + prevention of osteoporosis in post-menopausal women and the treatment + prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer, with the potential for over $3B in peak sales for the drug based on S&P analyst estimates. AMGN has also posted strong results this year while raising guidance on several occasions on better than expected results for their anemia drugs.

Now that APPY has completed enrollment earlier this month in its FDA 510(k) clinical study for the world's first blood-based appendicitis screening test, AppyScore, investors will not have to wait much longer to get the results. Results in the 800 patient trial are expected in January, which will support APPY's 510(k) application for marketing clearance if the study objectives are met as in the previous, smaller clinical trial of AppyScore in 2007 with 98% sensitivity.

The market cap currently stands at just $185M with APPY trading at around 6 bucks per share, with both metrics poised to move much higher if everything goes as planned in early 2009 with the trial results and AppyScore receives 510(k) marketing clearance by mid-2009. APPY should easily eclipse the all-time highs of around 15 bucks achieved in October 2007 based on initial annual revenue ranges [included in the accompanying table] of $126M-$296M for the appendicitis screening tests and the two animal health products.

In mid-December, BDSI submitted its Risk Evaluation and Mitigation Strategy for pain drug candidate Onsolis (BEMA fentanyl) based on the feedback it received from the FDA's complete response ruling on the NDA in August. Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent – although investors and traders will likely have to wait six months since the Company has guided expectations for a Class 2 review designation. BDSI expects to generate positive cash flow from operations next year with approval of Onsolis likely by mid-2009 and the $30M milestone payment upon FDA approval + market launch is a significant catalyst by itself given the Company's current market cap of around $48M.

CYPB and Forest Labs (FRX) announced positive Phase 3 results earlier this month for milnacipran in the treatment of fibromyalgia, which was statistically significant compared to placebo. CYPB has about 4 bucks in cash, zero debt, over 10 years of patient data for milnacipran outside the U.S., and a large database of milnacipran trial data confirming its benefit in the treatment of fibromyalgia. At current levels, the risk/reward ratio strongly favors the upside on milnacipran approval compared to the downside risk of more delays by the FDA – as an outright rejection appears highly unlikely given the statement by the agency at the time of the PDUFA date.   [more]

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