Expert Financial Analysis and Reporting

I have decided to go the sidelines on Savient (current price of $2.31) and I am recommending a switch into Discovery Laboratories (current price of $3.05). The critical issue with Savient is when a significant inflection point for Krystexxa sales might occur. It appears that based on audit data that sales are growing quarter over […]

Key Investment Conclusions In this report, I have made projections for sales, earnings and cash flow for A.P. Pharma (APPA.OB) through 2016. The underlying assumptions and calculations are explained within this report. However, let’s start with the conclusions. My base investment case is that A.P. Pharma will gain approval for its first commercial product APF530 in […]

Investment Opinion and Overview Now is the moment of truth for Transcept (TSPT) as the launch of Intermezzo has begun. I recommended Transcept in a report published on January 24, 2012 and I continue to recommend the stock. I would suggest that investors who need a refresher or are not familiar with the Transcept story […]

Summary I think that it is a question of when and not if Levadex is approved. The complete response letter or CRL issued for Levadex appears to be resolvable fairly quickly and could result in approval in July to October of 2012 in my best case scenario. In the worst case, I estimate that approval […]

Investment Opinion, In Brief The PDUFA date for Levadex, MAP Pharmaceutical’s lead product, is looming on March 26, 2012. I believe that there is a very high probability for approval and only a small chance for a Complete Response Letter. A CRL, if issued, would likely relate to the Chemical, Manufacturing and Control (CMC) section […]

When I was in high school I played the trombone in the marching band. I could never stay in step, but my mother always encouraged me when she said that everyone was out of step except me. I feel the same way now as I am positive on the outlook for Dendreon (DNDN) at a […]

EpiPen is a self-administered injection of epinephrine used to avert anaphylactic shock following a severe allergic reaction, as with a bee sting. It is manufactured by Pfizer (PFE) and distributed by Mylan Laboratories (MYL). EpiPen is on track to exceed $300 million of US sales in 2012. Teva (TEVA) is first to file and is […]

Report Summary With a number of cash infusions from a public offering, an ATM drawdown and warrant exercises, Discovery Laboratories (DSCO) has built a strong cash position. There remain a number of possible scenarios for how much more cash will come into the company depending on the exercise of the Green Shoe associated with the […]

Investment Thesis and Valuation The transformation of a biotechnology company from development stage to commercial can be the catalyst for a sustained increase in stock price. Discovery Laboratories (DSCO) received regulatory approval for its first product, Afectair, on February 2, 2012 and I believe that there is a strong possibility for approval of a second […]

I was somewhat alarmed to see a press release entitled “Cadence Pharmaceuticals Announces Voluntary Recall of One Lot of OFIRMEV® (Acetaminophen) Injection”. Cadence (CADX) is one of the stocks that I am recommending and my experience is that quality control issues can be very messy and disruptive. I wanted to follow-up with management to try […]