The firm notes that Alexza ended the quarter with $26.4MM in cash, which can fund operations into the second quarter of 2013. The firm has modeled a $5MM milestone from Grupo Ferrer in 4Q12 for approval of Adasuve, an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults, in Europe. JMP continue to view feedback from the agencies as positive regarding the safety and efficacy of Adasuve and anticipates approval in both the U.S. and Europe in December. The $12 price target is derived through an NPV valuation of projected Adasuve sales in the U.S. and the EU through 2022, discounted at 20%.
JMP analysts believe that Adasuve regulatory updates are encouraging. Alexza provided updates on the progress with Adasuve ahead of its December 21st, 2012, PDUFA date and anticipated December decision from the CHMP on the submitted Marketing Authorization Application. Management provided insight into differences between the company's experience with the FDA and EMA site inspection processes, indicating that the FDA was more document focused in comparison with the EMA, which appears to have focused more on observations of employees and processes in action. Additionally, there was little, if any, overlap in the issues cited between the FDA and EMA inspections, increasing the confidence that there is unlikely to be a core fundamental issue that will prevent eventual approval. JMP analysts points out that they continue to expect a 2013 launch of Adasuve with partners both in the EU and U.S.
On July 24th, the firm also reiterated coverage on VIVUS (VVUS) with an "Outperform" rating and a price target of $31.00.
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health for U.S., Europe and other world markets.
On June 14, the firm initiated coverage on Apricus Biosciences (APRI) with an "outperform" rating and a price target of $6.
Apricus is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, high-demand therapeutic classes. The company has four approved products and has developed a strong pipeline of multiple late-stage product candidates.
On June 13th, the firm initiated coverage on shares of AP Pharma (OTC:APPA), and set an "Outperform" rating and a $3 price target on the stock.
A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks.