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Farmas USA

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#53185

Re: Farmas USA

 Revisando el formulario 10-Q de este Q3 recientemente registrado en la SEC, veo dos cosillas, no vitales, pero las comento.

http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001144204-14-065719%2Etxt&FilePath=%5C2014%5C11%5C06%5C&CoName=NOVAVAX+INC&FormType=10-Q&RcvdDate=11%2F6%2F2014&pdf=

La primera es la Nota 11,

el acuerdo con Cadila Pharmaceuticals, renovado cada año en Marzo, vence en Marzo 2015. Si para entonces el importe resultante de los servicios aportados por Cadila son inferiores a 7,5 millones$, NVAX abonara una parte de los 2 primeros millones y el 50% de lo que supere los 2 millones $. Desde 2013 NVAX ha abonado 4,8 millones $, siendo 1,8 millones $ correspondientes a los 9 primeros meses de este 2014. Todo en concepto de servicios realizados por CPLB en nombre de Cadila Pharmaceuticals.

 

La segunda es la Nota 12, 

en 2007, NVAX entro en acuerdo con Wyeth Holding Corporation, una subsidiaria de Pfizer, para obtener los derechos de explotacion no exclusivos de una familia de patentes sobre la tecnologia VLP, que suposo en su momento un pago inicial y, posteriormente, pagos anuales. Las patentes expiraran en 2022. Este acuerdo solo podria ser cancelado por Wyeth alegando "razones/causas" ( entiendo que legitimas ) , y por parte de NVAX tras 90 dias de cese de todo actividad de explotacion. Desde el acuerdo alcanzado en 2007 hasta este Q3 2014 los pagos de NVAX han ascendido a 6,4 millones $. En estos momentos la compañía esta negociando los terminos económicos de dicho contrato con el fin de reducir el pago consecuencia de la fase 3 de la gripe H1N1 por parte de CPLB en la India que fue iniciado en julio 2014

NVAX

 

 

#53186

Re: Farmas USA

Menos da una piedra no? :P.

Bueno,seguimos ahi,rondando siempre los famosos 10 k,y mirando de reojo si llegaremos a los deseados 12 k para fin de año.

Mirando cifras:

Recognized $14.1 million in product revenue from Vascepa® (icosapent ethyl) sales in Q3 2014 compared to $12.6 million in Q2 2014 and $8.4 million in Q3 2013, an increase of 12% and 68%, respectively

Bueno,siguen creciendo los ingresos,no son escandalosos,pero bueno,que viendo el panorama,da moral ver que los ingresos siguen subiendo.

Reduced net cash outflows from operations to $19.9 million in Q3 2014

Bueno,en el otro trimestre fueron 13,8 y hablaban del objetivo de los 80 kilos,ahora van 58,7,la reduccion de gasto comparada con el año pasado es brutal,pero no comentaron nada del objetivo de los 80 kilos,vamos a estar ahi ahi con lo estimado.

Increased normalized prescriptions, based upon data from Symphony Health Solutions, by 20% in Q3 2014 compared to Q2 2014 and by 78% compared to Q3 2013

Mas de lo mismo,aumentamos recetas,pero queremos mucho mas.

Increased Vascepa tier-2 managed care lives covered to over 119 million

Esta parte no la entiendo,quiero pensar que en teoria ayudaria a vender mas pastillitas,pero no lo se :D

These increases were most significantly driven by increased prescriptions from the physicians who are the highest past prescribers of Vascepa with increasing contribution from a broader group of physicians. Timing of shipments to wholesalers, upon which revenues are recognized, and prescription levels can vary between periods. Such timing differences contributed to greater prescription growth than revenue growth in Q3 2014.

The increase in prescriptions during Q3 2014 reflects sales and marketing activities of both Amarin and its Vascepa co-promotion partner, Kowa Pharmaceuticals America, Inc. (Kowa). Growth was noted from physicians targeted by Amarin sales representatives only, Amarin and Kowa sales representatives jointly and Kowa sales representatives only.

Autobombo,paja,nah

During Q2, the prescription drug that most closely competes with Vascepa saw the launch of a generic and during Q3, a second generic version of such drug became available. Generic versions of this competitive drug are currently priced such that they are more expensive than Vascepa under most managed care plans. After such generic launch, formulary access to Vascepa, including tier-2 coverage, continues to improve overall with more than 119 million people in the United States currently insured by managed care plans that cover Vascepa on tier-2, 95% of which is already contracted for 2015.

Vamos,que tenemos mejor medicamento,mas barato que los genericos y entiendo que con cobertura en los seguros para mucha gente,otro motivo para ser optimista.

As previously announced, in September 2014, we were notified that the Office of New Drugs (OND) within the U.S. Food and Drug Administration (FDA) denied Amarin's appeal of the FDA's rescission of the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement. Based on the FDA's repeated position in its appeal denials and its internal consultation with FDA officials at higher levels, we informed the FDA that we do not intend to appeal the SPA rescission further. Following this notification, our regulatory focus has shifted to advancing the ongoing REDUCE-IT outcomes study in pursuit of a broader indication for Vascepa and to seeking action on the ANCHOR sNDA.

Nos dejamos de peleas con la FDA,nos centramos en el reduce-it y confiamos en quedar de amiguitos todos,a ver si no dan mas por el culo...

Amarin reported cash and cash equivalents of $135.4 million at September 30, 2014, representing a net decrease of $15.1 million from reported cash and cash equivalents of $150.5 million as of June 30, 2014 and a net decrease of $56.1 million from reported cash and cash equivalents of $191.5 million as of December 31, 2013. Net cash outflows in the nine months ended September 30, 2014 included approximately $33.3 million in sales and marketing related expenses and approximately $20.5 million of costs incurred through our contracted clinical research organization and for clinical trial materials in support of the REDUCE-IT cardiovascular outcomes study.

The improvement in net cash outflow from operations to $58.7 million in the nine months ended September 30, 2014 compared to $157.2 million in the same period in 2013 reflects our focus on cash preservation and efficient spend targeting to maximize Vascepa revenues and minimize cash burn. It is anticipated that the company will experience fluctuations in quarterly net cash outflows. Amarin continues to estimate that, during 2014, net cash outflows will be less than $80 million.

Ahi estan los famosos 80 kilos again! :D

Cost of goods sold for the three months ended September 30, 2014 and 2013 was $5.4 million and $3.7 million, respectively. Cost of goods sold for the nine months ended September 30, 2014 and 2013 was $14.6 million and $7.8 million, respectively. Gross margin improved to 62% and 61% in the three and nine months ended September 30, 2014 compared to 56% and 52% in the three and nine months ended September 30, 2013. The improvement in gross margins in 2014 was primarily driven by lower unit cost active pharmaceutical ingredient, or API, purchases.

Bien,seguimos mejorando el margen bruto,siguen siendo buenas noticias.

Resumiendo:

Reduce-it:En el anterior report hablaron que tenian sobre 7000 pacientes,ahora nos comunican 7100,la cosa no va muy rapida que digamos,en el primero de 2014 hablaban de 6800...a este paso nos ponemos en 2015 mediados para no ser muy optimistas...la travesia sera larga.

Finanzas:Siguen con los 80 kilos de marras,siguen subiendo ventas,tienen un buen producto y barato...la cosa no esta tan mal como podria parecer

FDA:Dejan la guerra con ella,nos quita el incentivo de algun calenton previo a la decision,pero tambien nos da estabilidad y nos centramos en lo que preocupa.

Conclusion:Todo sigue igual,esto va para largo pero si se diera el caso y saliera todo bien,se va a ganar entre algo,mucho y muchisimo dinero,en funcion del precio al que se entre.

#53188

Re: Farmas USA

AMRN

Amarin Corp plc (NASDAQ: AMRN) reported Q3 EPS of ($0.17), $0.04 worse than the analyst estimate of ($0.13).
Recognized $14.1 million in product revenue from Vascepa® (icosapent ethyl) sales in Q3 2014 compared to $12.6 million in Q2 2014 and $8.4 million in Q3 2013, an increase of 12% and 68%, respectively

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

#53189

Re: Farmas USA

ZGNX

Zogenix (NASDAQ: ZGNX) reported Q3 EPS of ($0.09), $0.07 better than the analyst estimate of ($0.16). Revenue for the quarter came in at $8.8 million versus the consensus estimate of $8.3 million.
2014 Financial Guidance
The Company reiterates its 2014 financial guidance with the following update:
Expecting combined research and development and selling, general and administrative expenses of $25 million to $27 million for the fourth quarter, resulting in 2014 spending at the low end of the full-year range previously provided.

Transcripción de la rueda de prensa:
http://seekingalpha.com/article/2653975-zogenixs-zgnx-ceo-roger-hawley-on-q3-2014-results-earnings-call-transcript?page=1

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

#53190

Re: Farmas USA

OXGN

MLV & Co initiated OXiGENE (OXGN) coverage with Buy rating and price target $6.5

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

#53191

Re: Farmas USA

ZGNX

Sacan también S-3. 11.995.202 acciones a 1,295

http://boardvote.com/symbol/ZGNX/communique/807489

Por lo que dicen equivale a las acciones del acuerdo con Brabant

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

#53192

Re: Farmas USA

en pre a tus precios ¿pillaste?