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Farmas USA

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Farmas USA
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#86073

Re: Farmas USA

Ya ves framus, parece una olla a presión.

NVAX

Paciencia.
Es difícil tenerla, pero trae muy buenos resultados.....

#86075

Re: Farmas USA

Yo he estado varias veces dentro (algunas sacándole pasta y otras palmando)Le dan mucha caña por los datos de diarrea en los estudios en los que no se tomaba loperamida de forma concomitante. Esto lo han solucionado en los últimos estudios como el Basket y un estudio adhoc en la que es la variable principal. Lógicamente quieren presentar parte de estos datos de seguridad como parte del dossier de registro del fármaco. Por cierto, me han comentado que la toma de loperamida de forma concomitante con neratinib soluciona el problema de la diarrea por completo.

No descartó volver a entrar en un futuro

Pbyi

#86076

Re: Farmas USA

NVAX
pues si viendo el grafico es evidente que cuando dió sobrecompra bajó de manera abrupta, ahora que da sobreventa esperemos lo contrario.


y como dice framus con el macd las señales fuerón de cine.

#86077

Re: Farmas USA

Upgrade de Guggenheim - $17 a $25

 

18 Marzo 2016 -

NVAX - BUY - Updating Model to Reflect More Bullish Outlook for Elderly RSV Opportunity; Raising PT to $25

- Novavax facing significant upcoming milestone with RSV vaccine. NVAX stock remains a favorite of ours because we believe the company is well positioned to develop an active vaccine for preventing infection by the respiratory syncytial virus (RSV). Data from the Phase 3 Resolve trial are expected, according to the company, in 3Q16. Based on the data from the Phase 2 trial released in 2015, we believe the probability that the Resolve trial is positive is relatively high. Our Novavax financial model, for example, contemplates a pTS of 75% for the indication.

- Elderly RSV Phase 3 readout key upcoming milestone. We believe the Resolve data could cement the degree to which Novavax could gain first-mover advantage for an RSV vaccine. Although many other companies are developing RSV vaccines, we believe most are at least five years from the market. If so, and if the Novavax vaccine is viewed as safe and effective, we believe that the company could establish a market presence that may be challenging to overcome. Most interesting may be the opportunity for the so-called pentavalent vaccine.

- A safe and effective RSV vaccine could address a significant, global unmet medical need. Infrequent in biotech is the opportunity for a 'smid' cap company to develop a drug product that could have a profound improvement on healthcare, in our opinion. Lacking any approved active RSV vaccine, we believe the Novavax experimental vaccine could have broad applicability as it relates to elderly subjects, pregnant women, and neonates. Novavax management has expressed the belief that an ex-U.S. commercialization partnership could be struck in 2016, and we view the RSV vaccine as a highly attractive asset.

- RSV vaccine could be the Trojan horse for seasonal flu vaccine market penetration. At a minimum, we believe the RSV vaccine, as part of a pentavalent vaccine that might prevent infection by the seasonal influenza virus and the RSV, could be an important new product offering. In a competitive seasonal flu commercial market, we see where investors might be skeptical as to Novavax's flu vaccine, but, as part of a combo vaccine that addresses two significant infectious diseases, particularly for elderly subjects, we believe a pentavalent vaccine could revolutionize the treatment of infectious disease from which significant health burdens are imposed.

- We are increasing our price target to $25 from $17. The change is driven primarily driven by additions to and improvements in our model for RSV in elderly subjects. We now assume Novavax delivers 45M doses at peak (75% of flu-vaccinated adults aged 60 or older) at $75 per dose, and an equivalent number of doses outside the United States at 50% of the price. We also added a pentavalent (quadrivalent flu + RSV) vaccine model that combines the prices of the flu and RSV vaccines to account for the potential for increased market share among older adults for these products.

- Updating Novavax Revenue Model. Our revised NVAX model reflects updated revenue estimates for the seasonal influenza and RSV vaccines, the latter for elderly subjects, pregnant women, and the pediatric population, while also contemplating the impact of a pentavalent vaccine (seasonal flu and RSV combination product). Our primary change is an assumption that Novavax directly markets all vaccine candidates itself in the United States, whereas we had previously assumed a larger degree of partnering of all RSV assets. We assume Novavax will partner ex-U.S. marketing efforts, which we assume yields a royalty of 20% of ex-U.S. sales. Discussion of individual vaccine candidates follows.

- RSV (elderly subjects) Major changes: - increased price and addressable market for RSV vaccine in older adults. We had previously assumed the program was completely partnered, with Novavax receiving a 20% royalty on net sales, but we now assume Novavax markets the vaccine itself within the United States and partners in ex-U.S. markets. Our prior model had assumed Novavax sold 22M peak doses (37% of adults age 60 or older) at $50 per dose, with equivalent results outside the United States. We now assume Novavax delivers 45M doses at peak (75% of flu-vaccinated adults aged 60 or older) at $75 per dose, and an equivalent number of doses outside the United States at 50% of the price. With respect to the RSV vaccine in elderly subjects, we assume a product launch in the United States for the 2018–2019 RSV season. We assume an initial market share of 15% of flu-vaccinated adults aged 60 and over (65% of that demographic group), growing to 75% of that group over five years. We assume a price of approximately $75 per vaccination. Outside the United States, we assume the product launches the following season in the European Union and the following season again in Asia, with similar market share assumptions applied to half the population-wide rate of vaccination, netting 50% of the U.S. price. These inputs result in ex-U.S. sales that are approximately 30% of the U.S. gross sales level, which our research indicates is conservatively consistent with other international flu vaccines. We lastly assume Novavax captures a 20% royalty of ex-U.S. vaccine sales, which is applied to net revenue.

- Pentavalent vaccine Major changes: added contribution from a pentavalent (quadrivalent flu + RSV) vaccine model that combines the prices of the flu and RSV vaccines to account for the potential for increased market share among older adults for these products. We assume, as part of our base model, that Novavax will successfully develop a pentavalent vaccine product and assume a launch in 2019. Our model assumes vaccination of adults initially at 20% of the population, growing to 80% four years later. Subjects opting to receive the combination vaccine removes those recipients from the available pool of seasonal flu recipients. We assume the price for the combination vaccine is the sum of the flu and RSV vaccine doses, with the impact on the model primarily being to generate greater seasonal flu vaccine usage among the elderly population, given the bundling. Outside the United States, we assume the product launches the following season in the European Union and the following season again in Asia, with similar market share assumptions applied to half the population-wide rate of vaccination, netting 50% of the U.S. price. These inputs result in ex-U.S. sales that are approximately 33% of the U.S. gross sales level, which our research indicates is consistent with other international flu vaccines. We lastly assume Novavax captures a 20% royalty of ex-US vaccine sales, which is applied to net revenue.

- Seasonal Flu Major changes: reduced steady-state market share from 33% to 20% to reflect the addition of an explicitly modeled pentavalent vaccine, which itself reflects the market share benefit from Novavax’s competitive advantage. For seasonal flu, we assume vaccine launch for the 2018–2019 season, with an initial market share for the Novavax product of 4% of those vaccinated at a price of $15 per vaccination. Our model uses U.S., EU, and Asia demographic forecasts and assumes steady rates of flu vaccination within age cohorts (65% of those over 65, 70% of those under 5, and 47% of the population overall) that are consistent with those presently observed. We further forecast market share growing 4% per season to a peak of 20% of the vaccinated population in 2022 and 3% annual price increases. Outside the United States, we assume the product launches the following season in the European Union and the following season again in Asia, with similar market share assumptions applied to a lower overall percentage of the population being vaccinated and netting 75% of the U.S. price. These inputs result in ex-U.S. sales that are approximately 20% of the U.S. sales level, which our research indicates is consistent with other flu vaccines. We assume Novavax captures a 20% royalty of ex-U.S. vaccine sales, which is applied to net revenue.

- RSV (infants and pediatrics) Major changes: modest changes were made to the maternal and pediatric RSV models, most notably the addition of explicitly modeled ex-U.S. target populations. For RSV in infants, we assume a U.S. product launch in 2019, with an initial 10% market share (growing to 40% over 4 years) of our estimate for women receiving prenatal care. We assume a cost at launch of $383 per vaccination course, with sales outside the United States in the European Union and Asia beginning over the following two years. Similarly to other products, we assume Novavax captures a 20% royalty of ex-U.S. sales, which we forecast to occur at similar market share, though assuming a lower overall rate of prenatal care. For RSV in pediatrics, we assume a U.S. product launch in 2020, capturing an initial 10% (growing to 40% over four years) of children under prenatal care and carryover patients from prior years, plus a smaller percentage of children from the population of children not receiving prenatal care. Outside the United States, we assume the product launches the following season in the European Union and the following season again in Asia, with similar market share assumptions applied to half the population-wide rate of vaccination, netting 75% of the U.S. price and assuming Novavax captures a 20% royalty of ex-U.S. vaccine sales.

- Valuation . We are increasing our price target to $25 from $17, primarily driven by changes to our model for RSV in older adults. We had previously assumed the program was completely partnered, with Novavax receiving a 20% royalty on net sales, but now assume Novavax markets the vaccine itself within the United States, partnering ex-U.S. markets. Our prior model had assumed Novavax sold 22M peak doses (37% of adults age 60 or older) at $50 per dose, with equivalent results outside the United States. We now assume Novavax delivers 45M doses at peak (75% of flu-vaccinated adults aged 60 or older) at $75 per dose, and an equivalent number of doses outside the United States at 50% of the price. We also added a Pentavalent (quadrivalent flu + RSV) vaccine model that combines the prices of the flu and RSV vaccines to account for the potential for increased market share among older adults for these products. 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, the quadrivalent flu vaccine, and a pentavalent flu + RSV vaccine. While the company currently generates revenue 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 vaccine candidates itself within the U.S. market and partner overseas marketing, receiving a 20% royalty on net sales.

- 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.

 

#86078

Re: Farmas USA

Gracias Framus y Kiyo! Pues nada, todos con el lacito preparado para venderlas a 25$. Ojalá, pero creo que nos harán sufrir y desesperar aún un poco más. No pain, no glory!
NVAX

#86080

Re: Farmas USA

NVAX

Vaya.

"Buf, se me está haciendo más largo que un dia sin bolsa"