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Farmas USA

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#43210

Re: Farmas USA

MACK

#43211

Re: Farmas USA

Buf, Soros es bajista en el SP500. Para el verano hay que salir por patas!!!

#43213

Re: Farmas USA

LJPC

Pues ha tocado los 18,90 en pre. Abriendo la plataforme para meter corto...

Eso de que para verano fuera, ni de coña; para verano, todo cortos.

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#43214

Re: Farmas USA

ACTC

Acaban de sacar formulario diciendo que su contabilidad de los últimos 4 años es un puto desastre y que la van rehacer, pero que eso no afecta al valor de la acción. Debería ser un día de caída importante, aunque en el fondo es la limpieza que esperábamos y la antesala del mercado organizado.

http://www.sec.gov/Archives/edgar/data/1140098/000101968714000787/actc_8k.htm

Y el artículo bajista consiguiente:

http://www.telegram.com/article/20140310/NEWS/303109808/1237

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#43215

Re: Farmas USA

Novavax's CEO Discusses Q4 2013 Results - Earnings Call Transcript
Mar. 11, 2014 3:04 AM ET | About: NVAX
Novavax, Inc. (NVAX) Q4 2013 Earnings Conference Call March 10, 2014 4:30 PM ET

Operator

Good day, ladies and gentlemen, and welcome to the Novavax Fourth Quarter and Year-End Earnings Conference Call. (Operator Instructions) I'd now like to turn the call over to your host for today's conference, Mr. Buck Phillips, Chief Financial Officer. Sir, you may proceed.

Buck Phillips - Chief Financial Officer
Thank you. Good afternoon. This is Buck Phillips, Chief Financial Officer of Novavax. And I would like to thank everyone for joining today's call to discuss our fourth quarter 2013 financial results. Today's earnings release is currently available on our website at novavax.com and an audio archive of this conference call will be available on our website later this evening.

Joining me on today's call is Novavax's President and Chief Executive Officer, Stan Erck; and Novavax's Senior Vice President of Research and Development, Dr. Greg Glenn; as well as other members of our executive team.

Before we begin our prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical or commercial projections. Statements relating to future financial or business performance, conditions or strategies and other financial and business related matters including expectations regarding revenue, operating expenses, cash usage and clinical developments and anticipated milestones are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time.

I will now turn the call over to Stan Erck, President and CEO.

Stan Erck - President and Chief Executive Officer
Thanks, Buck, and good afternoon everyone. We'll be following our standard earnings call format today. I'll begin with a few remarks to review recent developments and business highlights and then I'll turn the call back over to Buck to go over the financials. We'll then open the line to take any questions you have.

So starting with 2013, Novavax made substantial progress. Our vaccine pipeline took major steps forward with multiple clinical vaccine programs demonstrating proof-of-concepts and high levels of immunogenicity. Notably, we reported data from two RSV F vaccine trials during the year, one in 330 women of childbearing age and the other in 220 elderly adults. To remind everyone, both of these trials demonstrated the safety of our vaccine candidates and both resulted in post-vaccination antibody levels which are several fold the level of antibody that would be predicted to be protective. The results represent a breakthrough and encourage us to move ahead with the RSV vaccine programs for the maternal immunization, pediatric and elderly indications in 2014.

During 2013, we were also able to demonstrate our pipeline's capabilities with regards to pandemic preparedness. In April, less than 10 days after Chinese health authorities announced an outbreak of H7N9, we were able to commence production of the recombinant vaccine and shortly thereafter initiate a clinical development program for it, the first in the world to do so. By July, the first doses of our H7N9 vaccine were injected in humans. Our vaccine proved capable producing levels of antibodies that predict production following vaccination. And we were proud to see these results available online in November and published in the December 26, 2013, edition of the New England Journal of Medicine. This is the first and to date the only published data showing the ability to produce protective antibody levels against H7N9 in a high percentage of the population.

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#43216

Re: Farmas USA

Novavax's CEO Discusses Q4 2013 Results - Earnings Call Transcript
Mar. 11, 2014 3:04 AM ET | About: NVAX
On the strategic front, Novavax further expanded its platform during 2013 with the completed acquisition of Isconova, now referred to as Novavax AB. This acquisition brought in a novel saponin-based vaccine adjuvant technology, Matrix-M, which has been a natural and highly complementary fit for our recombinant vaccine platform. While Novavax has initiated its H7N9 clinical trial using Matrix-M, I should remind everyone that the US-based biotech company, Genocea, reported the successful use of Matrix-M with their HSV-2 vaccine candidate in Phase ½ trial under US IND in 2013.

Also in 2013, our capital position has improved considerably. We ended the year with more than $130 million in cash, due in large part to the successful secondary offering of $100 million that took place this past fall. Now looking ahead to 2013, we believe this year holds the potential for even greater strides forward as a leader in the common vaccine development. We've already made some important progress during these first few months.

Last month, we were happy to announce that our influenza contract with HHS BARDA along with its access to $97 million in funding was extended beyond the original termination date of February 2014. And also this morning, we're announcing the initiation of a Phase 1/2 clinical trial of our H7N9 avian influenza VLP vaccine candidate using the Matrix-M adjuvant technology. This trial will enroll 610 healthy subjects to evaluate safety and immunogenicity response to the vaccine and adjuvant. This trial will evaluate three different dose levels of the antigen and two dose levels of the Matrix-M adjuvant. We expect the topline safety data and safety and immunogenicity data will be reported in the fourth quarter. This trial will lead to a dose confirmation trial in healthy and elderly adults followed by a Phase 3 immunogenicity trial.

We also recently further strengthened our management team with the addition of John Trizzino as Senior Vice President, Commercial Operations. John has played key management roles with MedImmune, which manufactures and markets FluMist and the RSV monoclonal antibody Synagis. He worked at ID Biomedical, which was acquired by GSK for its flu vaccine, and at Henry Schein, the largest vaccine distributor in US. John will play a key role in developing of our commercialization strategy with both the RSV and the influenza markets. We view this as a major addition to the team.

Planning and preparing the market for a new production introduction is key to a successful launch. We have confidence in our platform and the data that we've been generating. We look forward to leveraging his work as we continue to move closer to approval with our vaccine candidates.

So other milestones we expect to reach during the year include topline data from the ongoing Phase 2 clinical trial of the RSV vaccine candidate in women of childbearing age. This is currently planned for the second quarter of 2014. As I stated earlier, during the second half, we look forward to topline data from the recently initiated Phase 1/2 trial of our H7N9 pandemic influenza vaccine candidate. In the fourth quarter, we expect to initiate a Phase 2 trial of our RSV vaccine for the first time in pregnant women. And in addition, we expect to initiate the final Phase 2 trial of our novel quadrivalent seasonal influenza vaccine candidate.

And we have not yet set a date, but expect to launch a Phase 1 trial of our combination vaccine this year. We believe that this vaccine will be the first pentavalent vaccine, which will contain both our RSV vaccine and our quadrivalent influenza vaccine. We're very excited by this program and look forward to reporting data from all of these trials throughout 2015.

And with that, I'll turn the call over to Buck to review our fourth quarter 2013 financial results.

Buck Phillips - Chief Financial Officer
Thanks, Stan. Before I continue, as was the case last quarter, I must note that the financials I'll be discussing here reflect consolidated results inclusive of our July 2013 acquisition of Isconova AB, now known as Novavax AB. My comments 1today will primarily focus on fourth quarter results. Results of the full year of 2013 are available in the press release we issued this afternoon.

For the fourth quarter of 2013, we reported a net loss of $14.1 million or $0.07 per share compared to a net loss of $8 million or $0.06 per share for the fourth quarter of 2012. For the full year of 2013, the net loss was $52 million or $0.31 per share compared to a net loss of $28.5 million or $0.22 per share for 2012.

Novavax had revenue in the fourth quarter of 2013 of $8.7 million as compared to $4.6 million for the same period in 2012. The increase in revenue is primarily due to the HHS BARDA amendment relating to H7N9 manufacturing and other activities as well as the PATH amendment to support the company's Phase 2 clinical trial in women of childbearing age.

Research and development expenses increased $16.3 million in the fourth quarter of '13 compared to $9.6 million for the same period in 2012, primarily as a result of the increased cost related to the company's RSV and H7N9 avian vaccine candidate clinical trials, along with higher employee related costs.

General and administrative expenses increased $4.1 million in the fourth quarter of 2013 compared to $2.5 million for the same period in 2012, resulting primarily from Novavax AB's expenses and higher professional fees.

As of December 31, 2013, the company had $133.1 million in cash, cash equivalents and investments compared to $50.3 million as of December 31, 2012. Finally, net cash used in operating activities for 2013 was $45.4 million compared to $18.2 million for 2012. The increase in cash usage from the prior year was primarily due to the higher research and development spending described before, including the company's RSV and pandemic H7N9 influenza clinical trials, as well as increased employee related costs as we grow the company.

This concludes my prepared remarks. Let me hand it back over to Stan.

Stan Erck - President and Chief Executive Officer
Thanks. That's all we have for prepared remarks today and we'll open it up to Q&A.

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