Acceder

Farmas USA

136K respuestas
Farmas USA
85 suscriptores
Farmas USA
Página
10.954 / 17.032
#87625

Re: Farmas USA

dibujando rayuelas de fuego bajo un cielo gris
De donde nadie vuelve yo te vi regresar...
https://youtu.be/DRvIV2l8ido

atentos al after de nvax

#87626

Re: Farmas USA

pues ahi las tienes, 4,80.

yo mañana me lo tomo libre, de excursion con la mujer y la cria, para desconectar despues de la conference. Paso de estar viendo la sesion de mañana.
Aunque debo decir que estoy considerando seriamente hacer uso de una parte del lote que tengo reservado para Montoro si mañana el precio termina de despeñarse y se les va la mano dandonos por saco. Aunque no quisiera .

NVAX

#87629

Re: Farmas USA

NVAX
Pues con esos datos parece que mañana nos van a dar bien. Así que, disfruta de tu excursión.

#87630

Re: Farmas USA

Novavax Reports First Quarter 2016 Financial Results

http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArticle&ID=2165107

 

GAITHERSBURG, Md., May 04, 2016 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced its financial results for the first quarter ended March 31, 2016.

Novavax First Quarter Achievements:

  • Continued execution of Resolve™, a pivotal Phase 3 trial of our RSV F Vaccine in older adults (60 years of age and older). Resolve is a randomized, observer-blinded, placebo-controlled trial in 11,850 older adults at 60 sites in the United States. The primary efficacy objective is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. Enrollment was completed in the fourth quarter of 2015.
     
  • Ongoing execution of a Phase 2 rollover clinical trial of our RSV F Vaccine in 1,330 older adults. The trial is a randomized, observer-blinded, placebo-controlled rollover trial designed to enroll from the population of older adults who participated in the prior Phase 2 trial. The primary endpoints of the trial will evaluate safety and serum anti-F IgG antibody concentrations in response to immunization with our RSV F Vaccine. Enrollment was completed in the fourth quarter of 2015.
     
  • Expanded enrollment of Prepare™, a pivotal Phase 3 trial of our RSV F Vaccine in healthy pregnant women, to multiple international sites to take advantage of the RSV season in the southern hemisphere. Prepare is a randomized, observer-blinded, placebo-controlled trial. The primary objective is to determine the efficacy of maternal immunization with our RSV F Vaccine against symptomatic RSV lower respiratory tract infection with hypoxemia in infants through the first 90 days of life. Prepare is supported by a grant of up to $89 million from the Bill & Melinda Gates Foundation (BMGF).
     
  • Issued a total of $325 million Convertible Senior Notes, resulting in net proceeds of $276.5 million. The Notes’ initial conversion price of approximately $6.81 per common share represents a 22.5% premium to Novavax’ common stock on January 25, 2016, the day the Notes were issued.  In conjunction with the issuance of the Notes, the Company entered into capped call transactions with an initial cap price of$9.73 per share. The capped call will serve to reduce dilution from issuance of shares upon conversion at prices greater than the Notes’ conversion price of $6.81.
     
  • Appointed Bob Darius to Senior Vice President, Quality Operations and promoted Gregory M. Glenn, M.D., to President, Research & Development, Amy B. Fix to Senior Vice President, Regulatory Affairs, Louis F. Fries III, M.D., to Senior Vice President and Chief Medical Officer, and Iksung Cho to Vice President, Biostatistics.

2016 Anticipated Events:

  • Announce top-line data from Resolve, the Phase 3 pivotal RSV F Vaccine trial in older adults in the third quarter of 2016; and
     
  • Announce top-line data from the Phase 2 RSV F Vaccine rollover trial in older adults in the second half of 2016.

Summary

“During the first quarter, we continued to successfully execute on our two ongoing pivotal Phase 3 trials of our RSV F Vaccine. We also raised$325 million in a successful Convertible Senior Notes offering, which strengthens Novavax’ balance sheet ahead of data from the pivotal Phase 3 Resolve clinical trial,” said Stanley C. Erck, President and CEO. “We are pleased to see significant interest from a number of multinational, world-class vaccine companies seeking potential partnership and commercialization rights to our RSV F Vaccine franchise outside of North America. We remain well positioned to announce value creating data from the Resolve trial and the Phase 2 rollover trial in older adults in 2016.”

Financial Results for the Three Months Ended March 31, 2016

Novavax reported a net loss of $77.3 million, or $0.29 per share, for the first quarter of 2016, compared to a net loss of $24.4 million, or $0.10per share, for the first quarter of 2015.

Novavax revenue in the first quarter of 2016 decreased 57% to $4.2 million, compared to $9.9 million for the same period in 2015. Lower revenue under the HHS BARDA contract of $7.3 million is the primary driver of this decrease. The lower HHS BARDA revenue is the result of a lower level of activity in the three months ended March 31, 2016, as compared to the same period in 2015, along with a one-time revenue recognition of $3.1 million in the first quarter of 2015. This decrease in HHS BARDA revenue was partially offset by $1.6 million in revenue recorded under the BMGF grant relating to our ongoing Prepare clinical trial.

Research and development expenses increased 143% to $69.0 million in the first quarter of 2016, compared to $28.3 million for the same period in 2015. The increase in research and development expenses was primarily due to increased costs associated with the clinical trials and development activities of our RSV F Vaccine and higher employee-related costs, including non-cash stock-based compensation.

General and administrative expenses increased 80% to $10.5 million in the first quarter of 2016, compared to $5.8 million for the same period in 2015. The increase was primarily due to higher employee-related costs, including non-cash stock-based compensation expense, and professional fees for pre-commercialization activities, as compared to the same period in 2015.

Interest income (expense), net for the first quarter of 2016 includes $2.1 million of interest expense relating the Company’s Convertible Senior Notes offering.

As of March 31, 2016, the company had $433.9 million in cash and cash equivalents and marketable securities compared to $230.7 million as of December 31, 2015. Net cash used in operating activities for the first quarter of 2016 was $69.8 million, compared to $30.5 million for same period in 2015. The increase in cash usage was primarily due to increased costs relating to our RSV F Vaccine, higher employee-related costs and timing of vendor payments. As previously mentioned, Novavax completed a $325 million Convertible Senior Notes offering in the first quarter of 2016.

#87631

Re: Farmas USA

NVAX
Lo que no veo que haya dicho nada del tema de la gripe que si comento el 29/2. Solo que ha habido menos ingresos de los fondos BARDA.

#87632

Re: Farmas USA

Eso sera en la conferencia. 

No se si lo dije aqui o a quien, si no hay press release sobre el tema de la gripe es que no ha habido cambio sustancial sobre el tema, me temo. Vamos, pienso yo.

Porque si se reactiva el tema con BARDA en cualquier sentido, eso seria new a liberar de todas todas, insisto, creo yo.

De todos modos hasta que no salga la transcripcion yo me espero de conjeturar mas.

NVAX

Te puede interesar...
  1. Primeras dudas sobre la 'Trumponomics', ¿corrección o toma de beneficios?