Farmas USA

NOVAVAX - WEDBUSH UPDATE - 4 Mayo 2016 - Eyes Towards Pivotal Data in 3Q as Novavax Reports 1Q16;

Reiterate OUTPERFORM - PT $14

The Wedbush view: Novavax is developing a first in class RSV vaccine for high risk individuals such as the elderly and newborns (via maternal immunization). It has pivotal trials underway for each population; we expect data from the elderly study to read out in 3Q16. In our view, the study has been de-risked by Phase II data and is set up for success.

Novavax reports 1Q16 results. Novavax reported a loss per share of $0.29, greater than our estimates and consensus due to increased spend. Novavax finished 1Q16 with $433.9M in cash, including a $325M convertible debt financing; in our view, sufficient to see it through BLA filing for its RSV vaccine in the elderly, at least. We also anticipate potential non-dilutive financing through an ex-US partnership for its vaccine after data.

Pivotal trial data expected in 3Q16. Novavax is testing its RSV vaccine adults 60 years of age and older. The primary endpoint is a decrease in moderate to severe RSV, defined by RSV positive with at least three lower respiratory tract symptoms including chough, sputum production, wheezing and dyspnea; in the Phase II study, those vaccinated lowered events by 64%. Moderate to severe RSV occurred in the Phase II at a rate of 1.8%; our analysis of this RSV season suggests percentage of RSV positive cases this season is more or less in line with last year; in addition, Novavax has powered the study to account for a lower rate. (Figure 2). We believe the previous data de-risk the Phase III study and believe there is a high probability of success for the study.

Eye on Commercialization. Although there is inherent risk in commercializing a first RSV vaccine, we believe previous experience with a flu vaccine sets a clear path forward. According to the CDC, in 2014-15, 67% of the elderly 65 years or older were vaccinated for flu, this number is up 1.7% from 2013-14. Novavax is targeting adults above 60; this population generally sees physicians regularly and is vaccinated in doctor's offices or clinics. See more on page 2.

Influenza/RSV combination studies set to start in 1H17 can be an inflection point for shares. 

We reiterate our OUTPERFORM rating and price target of $14, based on a sum-of-the-parts analysis for its RSV and flu programs, discounted by 25% and 15%, respectively.

Eye on commercialization. We believe Novavax can leverage these visits as a logical entry point for RSV vaccination; the burden of disease for these two viruses is similar. Novavax has begun an awareness campaign, including a website, www.discoverrsv.com. The company is working with the CDC on accruing data on the burden of RSV, which should culminate into an Advisory Committee on Immunization Practices (ACIP) working group this summer. Although a CDC recommendation comes after approval, we believe the groundwork on disease burden should lay the foundation for a recommendation after potential FDA approval and ahead of the 2018 RSV season.

Influenza/RSV combination studies set to start in 1H17 could be an inflection point for share. Early next year, Novavax plans to initiate a robust trial incorporating its flu and RSV vaccines separately and in combination, both with and without adjuvant. Data from this study should direct future efforts for a combination respiratory vaccine, which we believe could be game changing.

Risks to our price target include failure of RSV-F vaccine to demonstrate a clinical benefit in the ongoing Phase III study. There is also regulatory risk; even with positive data, its vaccines may not get approved. Commercially, there is potential Novavax will not be able to market its vaccine and that competitors will come to market to take share.

Nvax

Que bien suena lo de derisk. Es un detalle muy importante.

NOVAVAX - GUGGENHEIM UPDATE - 5 Mayo 2016 - Resolve Trial Reveal Just Around the Corner

REITERATE BUY - PT $25

NVAX remains a favorite stock idea of ours. We believe Novavax is on the verge of developing the first active RSV vaccine and, with it, a sizable, global, unmet medical need could be addressed. The company's technology may be particularly well suited to develop vaccines for other infectious diseases that could also create significant commercial opportunities for the company, therefore, we see potential for a broad and deep clinical pipeline to emerge. Although few stocks have not been out of favor recently in the biotech sector, positive RSV elderly trial data could compel the market to embrace NVAX shares, in our opinion.

Resolve reveal still planned for 3Q16. On yesterday's 1Q16 results conference call, management reiterated their expectation that data from the nearly 12,000 elderly subject pivotal Resolve trial of the experimental RSV vaccine would be released in 3Q16. The company is guiding to a 2017 BLA filing, which, given the likely inability to address the 2017-2018 RSV season in the Northern hemisphere, makes sense to us to not rush the application. We believe the commercial U.S. elderly market potential is in the multi-billion dollar range and management has expressed the expectation that commercial rights in that market will likely be retained by the company.

Partnering discussions ongoing. Management commented that they were "impressed" with the level of interest in the RSV vaccine, alluding, we believe, to the fact that Novavax is ahead of other RSV vaccine developers. Given the unmet medical need, we do not find that comment apocryphal, and we would not be surprised if stiff competition for partnering the asset emerges. Although contingencies can be created, we would not be surprised if a deal is not struck before release of the top-line data. Retention of commercial rights in key markets such as the U.S. may be a key underpinning element of the company's attractiveness as an acquisition candidate.

Zika may be a real opportunity for Novavax. By contrast with development of vaccines for potential pandemic diseases such as H5N1, H7N9 and Ebola, for example, for which the recurring business opportunity is uncertain (even stockpiling would likely not be recurring on an annual basis), we believe it reasonable to view the Zika virus infection as, unfortunately, a serious emerging pathogenic threat and one that may not wax and wane as other infectious agents may. Although the company's "plate is full" with development of the RSV and seasonal influenza vaccines, we would not be surprised to see the company mount a considerable effort to address the situation.

1Q16 results. Novavax reported 1Q16 opex and EPS of $79.5M and ($0.29) vs. our and consensus expectations of $88.5M/($0.30) and $81.7M/($0.27). The lower-than-expected costs were a result of R&D timing as the company advanced its ongoing development programs, particularly the elderly Resolve and pregnant women Prepare RSV vaccine trials. Novavax reported cash of $434M ($1.60 per share), up from $231M at year-end, following the $277M in net proceeds from the 1Q16 convertible note offering. We adjusted our estimates for R&D and contract revenue timing as well as potential dilution from the convertible note and thus revise our 2016/17 revenue and EPS estimates

Valuation. Our $25 NVAX price target is based on DCF and SOP analyses of the potential commercialization of the company’s RSV vaccine for pregnant women, infants, and the elderly and the quadrivalent flu vaccine. While the company currently generates revenues from BARDA grants only, our expectation is that successful development programs would lead to commercialization of these assets in 2018. We assume Novavax elects to market the RSV vaccine to the pregnant woman population and partner the elderly and pediatric sales effort, receiving a 20% royalty on net sales. We also assume Novavax elects to market a quadrivalent flu vaccine, ultimately capturing 33% of the US flu vaccine market, owing largely to a competitive advantage among the elderly demographic with the possible pentavalent vaccine, with our model currently incorporating peak global sales of approximately $1.5 billion.

Risks. Risks to our rating and valuation include the regulatory process and approval of the vaccine candidates, given uncertainty surrounding the process length and trial outcomes, as well as the potential for commercialization to be less productive than we forecast, as competition increases or other sales impediments are encountered.

PFE ANAC

Pfizer sale de compras

Pfizer announces deal to acquire Anacor for $99.25/share in cash, or about $5.2B. $ANAC shares up 52% on deal announcement.

http://www.businesswire.com/news/home/20160516005711/en/Pfizer-Acquire-Anacor

leches, ANAC habia emitido notas convertibles hace poco. Les estaba siguiendo para ver el comportamiento del precio.

nunca se sabe por donde puede venirte un BO, nunca.

Si lo dices por comparar con NVAX, hay un par de diferencias: la primera es que ANAC ya tenía aprobada una fase 3 con muy buenos resultados (en julio 15) y las notas convertibles fueron después de esos resultados. Es decir pasta (deuda) para lanzar el producto, y no pasta para finalizar el desarrollo, y esto última se castiga mucho más. Fíjate que intereses tenía ANAC, solo un 2%! Mucha confianza había allí.

Pero sí, un BO bien llevado no se entera nadie hasta que te lo encuentras encima.

Ya se que es pequeñita pero no llevaba alguien por aqui NANOSPHERE?

Otro BO

http://www.prnewswire.com/news-releases/luminex-corporation-signs-definitive-agreement-to-acquire-nanosphere-inc-300268741.html

Asi es Mugi, soy consciente de las diferencias, lo comente en su momento, la diferencia del comportamiento del precio.

ANAC