Farmas USA

135K respuestas
Farmas USA
86 suscriptores
Farmas USA
10.560 / 16.994

Re: Farmas USA

Disculparme, crei que no salia jeje.


Re: Farmas USA

De momento te quita mucha paja, a bote pronto solo con entrar comprado 1 vela alcista y cerrar con la 1 vela bajista, los beneficios habrian sido espectaculares.


Re: Farmas USA

cortesia de Kiyo, gracias de nuevo!



Company Information : Book Value/sh $1.44  - Cash/sh $1.96 E - Enterprise Value (M) $1015.90 LT - Current Cash (M) $552.5

Novavax Prepares for Success with an Eye on Commercialization; Reiterate OUTPERFORM

  • With Phase III data for its RSV vaccine in the elderly coming in 3Q16, Novavax is preparing for success. We caught up with management to conduct a deeper dive into its plans for commercialization of its RSV vaccine in the elderly, assuming positive data this summer. With a recent convertible debt offering of $325M, it is moving forward with educational efforts and has hired key members of its commercial team (VP of Policy, Marketing and Medical Affairs) to position its vaccine for successful commercialization in 2018. With the recent market pullback, we recommend shares of Novavax ahead of pivotal data.
  • Flu vaccine as a template for RSV vaccine commercialization. Although there is inherent risk in commercializing the first RSV vaccine, we believe the 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 (Figure 1), 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. 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
  • Groundwork for a CDC recommendation underway. In our view, a key part of potential commercial success of an RSV vaccine will be an Advisory Committee on Immunization Practices (ACIP) recommendation. Although a recommendation is only given to approved products, Novavax, with the CDC respiratory disease team, will establish a working group before the end of the summer to investigate the epidemiology of RSV and available literature. The goal is to begin a dialogue and to educate the ACIP on the need for RSV vaccination. Novavax is aiming for a recommendation ahead of a potential launch before the 2018 RSV flu season.
  • Tweaking our estimates for a growing population. See page 2.
  • RSV rates and Phase III success. See page 3.
  • 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. Key risks to the attainment of our price target include failure of Novavax’s RSV vaccine in pivotal trials.


Tweaking our estimates for a growing population

Our initial RSV estimates for adults 65 years of age and older assumed a population of 39.5M; according to more current census data, this population is ~48M, growing to ~60M in 2025 (Figure 3). In addition, we remind investors that Novavax is testing its vaccine in adults 60 and older, providing upside to these population estimates. Our discussions with management set a benchmark for pricing of an RSV vaccine for this population, considering it is the first of its kind. The bottom of the range is for the Sanofi flu vaccine specifically for the elderly, at $38 a dose, to Prevenar for pneumonia, at $170 a dose. We remain in the bottom half of the range, at $70 a dose; there is upside to our estimates if the price is higher. Our peak sales estimate assumes 60% penetration, based on flu vaccination rates in the US.

Changing these numbers in our model and adjusting our estimates to account for seasonality in RSV sales increases our peak sale estimate for Novavax’s RSV vaccine to $1.6B from $860M. Net-net, our price target has not changed due to our incorporation of the recent convert into our model; we include these 47M shares in our valuation.

We have increased SG&A spending to better estimate costs of a 250-300 sales and marketing team including medical affairs. The force on the ground will be spread out throughout the U.S; however, depending on region and trends for flu vaccinations, there will be a focus on physicians’ offices, clinics or centers. Novavax expects to bring on medical affairs as a first step; it will likely wait for 1H18 approval to fill out its salesforce.


Thinking of Phase III success - looking at RSV rates

We anticipate topline data for the Phase III RSV F study in 3Q16. As a reminder, Phase II data from a 1600 person study demonstrated a clinical benefit of the RSV vaccine (Figure 4) with a 44% reduction in all symptomatic RSV. An ad hoc analysis demonstrated greater efficacy of 64% compared to placebo for RSV with at least three lower respiratory symptoms (from a list of coughing, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, or observed tachypnea (≥20 breaths per minute; Figure 5). This ad hoc analysis led to the primary endpoint of the ongoing pivotal study. Although we believe there is some clinical risk in changing the endpoint to this smaller population, we believe this endpoint is more meaningful from a clinical perspective and should resonate more with payors. Partially to account for smaller numbers, the study was upsized from initial estimates of 8000-10000 individuals to 11,850, increasing the power of the study; it is powered to see a significant difference between arms assuming a 1.8% rate of moderate to severe RSV, in line with the Phase II study.





Re: Farmas USA

pero que candidato beneficia a las farmas? porque si le hubiera ido mejor a Bernie, porque eso iba a suponer que es mejor para las armas? o si le va mal a Tump? cualquiera es "malo" para las farmas.

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