#99801
Re: Farmas USA
Gracias, siempre se me olvida mirar el 10Q
NVAX
Se está hablando de:
#99802
Re: Farmas USA
Amarin (NASDAQ:AMRN): Q4 EPS of -$0.10 misses by $0.03.
Revenue of $38.7M (+45.3% Y/Y) beats by $3.62M.
AMRN
#99803
Re: Farmas USA
ACOR
Me he leído el 10K
Net revenue for Ampyra was $492.8 million for the year ended December 31, 2016 and $436.9 million for the year ended December 31, 2015. Income (loss) net per share 0,76
-> A los contables pregunto: esto es como el EPS pero en negativo, ¿no? Pues diría que no concuerda con los resultados trimestrales, pero la verdad es que no entiendo nada de contabilidad (página 73 http://seekingalpha.com/filing/3431871 ). Yya ponen los datos por ahí: EPS of $0.05 misses by $-0.06 | Revenue of $140.63M (+ 7.4% Y/Y) beats by $2.73M
net revenue reflected a 10.95% increase in our list sale price for Ampyra effective January 1, 2016. The net revenue increase comprised net volume increases of $21.1 million and price increases and discount and allowance adjustments of $34.8 million. Net revenue from sales of Ampyra increased for the year ended December 31, 2016 compared to the year ended December 31, 2015 due to our price increase and greater demand we believe due to, in part, the success of certain marketing programs such as our 60-day free trial program. As with a number of specialty pharmaceuticals, first quarter sales for Ampyra typically have been lower than the preceding fourth quarter sales due to inventory build in the fourth quarter, and the temporary effects of people changing insurance plans and entering the Medicare donut hole at the beginning of the year. We expect a similar trend in 2017. Effective January 1, 2017, we increased our list sale price to our customers by 9.5%.
At December 31, 2016, we had $158.5 million of cash and cash equivalents, compared to $353.3 million at December 31, 2015. There were no investments classified as short-term or long-term at December 31, 2016. We expect that our existing cash, cash flows from operations, and availability under the asset-based credit facility which closed on June 1, 2016, will be sufficient to fund our ongoing operations over the next 12 months from the financial statement reporting date.
As of December 31, 2016, we had an accumulated deficit of approximately $244.0 million. We had a net loss of $34.6 million for the year ended December 31, 2016. We had net income of $11.1 million for the year ended December 31, 2015, and $17.7 million for the year ended December 31, 2014. We may not achieve or sustain profitability because we expect to continue investing significant amounts to market our approved products, to continue product development and research and development activities, and, potentially, to acquire new products and product candidates.
As of December 31, 2016, we had approximately $158.5 million in cash and cash equivalents. We have several product candidates in various stages of development, and all will require significant further investment to develop, test and obtain regulatory approval prior to commercialization. We may need to seek additional equity or debt financing or strategic collaborations to complete our product development activities, and could require substantial funding to commercialize any products that we successfully develop.
Y luego está la cuestión de los cuatro juicios y la revisión ante la oficina de patentes, que son las que van a determinar el futuro de la compañía este mes. Si prospera una sola de ellas, la caída será importante.
Legal Proceedings in Part I, Item 3 of this report, there is currently a statutory stay which restricts the FDA from approving any remaining ANDAs, from the parties that have not settled with Acorda, until July 2017 at the earliest, unless a Federal district court issues a decision adverse to all of our asserted Orange Book-listed patents prior to that date. If the stay is either lifted or expires, as described, and the generic drug manufacturers otherwise meet the FDA’s requirements for the approval of ANDAs, the generic manufacturers may decide to begin selling a generic version of Ampyra even if our 61 lawsuits against these manufacturers are still pending and despite the fact that if we later win these lawsuits the generic manufacturers could be held liable for patent infringement damages. A bench trial against four generic companies was conducted in September 2016 (we have since reached a settlement agreement with one of those four companies) and we are currently awaiting the Court’s decision. Also, the validity of our patents can be challenged by third parties pursuant to procedures introduced by American Invents Act, specifically inter partes review and/or post grant review before the U.S. Patent and Trademark Office. For example, in February 2015, a hedge fund (acting with affiliated entities and individuals and proceeding under the name of the Coalition for Affordable Drugs) filed two separate inter partes review (IPR) petitions with the U.S. Patent and Trademark Office, challenging two of the five Ampyra Orange Book-listed patents. Although the U.S. Patent and Trademark Office Patent Trials and Appeals Board chose not to institute inter partes review of these patents, the hedge fund has filed motions for reconsideration requesting that the denial to institute these two IPRs be reversed. In addition, in September 2015 the same hedge fund filed four additional IPR petitions challenging four of the five listed Orange Book patents, including two of the same patents that were the subject of the February 2015 IPR petitions. We opposed the requests to institute these IPRs, but in March 2016 the PTAB decided to institute the IPR proceedings on all four patents. We filed our complete Patent Owner's Response in July 2016, and the hedge fund's response was filed in September 2016. The USPTO held an oral argument regarding the IPR petitions on January 19, 2017. A ruling on the IPR petitions is expected in March 2017
«Después de nada, o después de todo/ supe que todo no era más que nada.»
#99804
Re: Farmas USA
http://www.streetinsider.com/dr/news.php?id=12599729
Guggenheim initiates coverage on Horizon Pharma (NASDAQ: HZNP) with a Buy rating and a price target of $30.00
#99805
Re: Farmas USA
BLUE: Comentarios/opiniones a este chart?
https://charts.stocktwits.com/production/original_75760036.png?1488251183
ACHN:
Achillion Pharmaceuticals to Support a Natural History Study of C3 Glomerulopathy, a Rare Renal Disorder, Conducted by Experts at Imperial College London
- Three-year study commenced to include up to 400 patients
- Natural history studies track course of a disease over time; can inform and support development and approval of new treatments for patients
- C3 glomerulopathy currently has no cure or approved treatment; affects about 8,000 people across Europe and the United States
NEW HAVEN, Conn., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced that it has entered into an agreement with Imperial College London to conduct a natural history study of C3 glomerulopathy (C3G), a rare renal disorder which includes dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). C3G affects an estimated 8,000 people across Europe and the United States.
#99806
Re: Farmas USA
ACOR
no entiendo muy bien tu duda... El -0,76 es el resultado EPS anual, y ese -0,05 el trimestral de Q4 (llevaban acumulados hasta Q3 un EPS de -0,71). Sí, cuando los datos salen entre paréntesis son negativos.
#99807
Re: Farmas USA
CEMP Cempra Inc (NASDAQ: CEMP) shares are rising close to 6% today on back of the biotech firm’s reveal that Phase 3 data read-outs in the first study of two skin infection (ABSSSI) studies with its fusidic acid pill Taksta have met both primary as well as secondary efficacy endpoints.We are most impressed with the 100% efficacy in the 99 patients
Roth Capital analyst Michael Higgins upgrades to a Buy rating on shares of CEMP while boosting the price target to $8, which represents an 86% increase from current levels.
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No tego dudas que una vez que empapelen bien al retail y el precio tape el gap en 3.15 , en unos meses o en el 3Q/2017,se podria poner en 8, en especial despues que ellos recojan los 250M del Offerring ATM que han soltado hoy, se anuncie que Tarka se va a ver la FDA y Solithromycin tiene menos hepatoxicidad en nuevas dosis de utilizacion o que han modificado la molecula tambien. Osea que creo que si pero todavia hay mucho que trabajar.
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February 28, 2017
Cempra Provides Corporate Update and Reports Fourth Quartes and Full Year 2016 Financial Results
On November 4, 2016, the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra's solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP). Members of AMDAC voted unanimously (13-0) that there was substantial evidence of the efficacy of solithromycin for CABP. The committee also voted (12-1) that the risk of hepatotoxicity with solithromycin had not been adequately characterized and discussed a variety of potential approaches to further characterize the existing liver safety information on solithromycin.
Corporate Restructuring Action These actions have resulted in an approximately 67 percent reduction in our workforce, from 136 to 45 employees, and significant reductions in external spending related to commercial preparedness and non-essential activities
- As of December 31, 2016, Cempra had cash and equivalents of $231.6 million and 52.4 million shares outstanding.
http://investor.cempra.com/releasedetail.cfm?ReleaseID=1014807-
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Interesante la distribucion de los votos del AMDAC en cuanto a eficacia y hepatoxcidad
#99808
Re: Farmas USA
Yo tampoco. Intento pillar algo básicamente. Gracias. ¿Qué tengo que hacer para entenderla como tú? ¿Alguien me deja unos apuntes? :D
«Después de nada, o después de todo/ supe que todo no era más que nada.»