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RDUS insider BB biotech ha vuelto a comprar, 150.000 más a $35,3

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Otra colaboración más. Promete mucho y solo capitaliza 100M...

https://endpts.com/astrazeneca-commits-57-5m-to-seed-anticalin-rd-pact-with-pieris-a-biotech-on-a-roll/

ARRY Diario

Hombro-Cabeza-Hombro 

 

RDUS en SEMANAL

 

 

ARRY

 

Hola Framus....H-C-H pero invertido?

No acabo de verlo....

Cual sería la proyección?

Y tampoco entiendo nada de lo que pasó ayer....

Un saludo

invertido? donde tu ves invertido?

es un HCH normal, al uso, con finalizacion de la proyeccion en los 6,9x-7 ... que pare ahi ya es otro cantar, quien sabe.

este es grafico semanal, bueno, tecnicamente hablando tiene sentido testar la antigua bajista ...

suerte

 

Amarin (NASDAQ: AMRN): Q1 EPS of -$0.08 misses by $0.01.

Revenue of $34.64M (+35.6% Y/Y) misses by $1.89M.

 

 

Amarin Reports First Quarter 2017 Financial Results and Provides Update on Operations

 

 

Prescription Growth Up &#62 50%; Outcomes Study Beyond 80% Complete

Re-affirms Guidance on Full Year Net Product Revenues of between $155 and $165 Million

Management to Host Conference Call at 8:00 a.m. ET Today

BEDMINSTER, N.J. and DUBLIN, Ireland, May 03, 2017 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced financial results for the three months ended March 31, 2017, and provided an update on company operations.

Key Amarin achievements through March 31, 2017 include:

• U.S. revenue growth: Recognized $34.3 million in net product revenue from Vascepa^® (icosapent ethyl) sales in Q1 2017 compared to $25.3 million in Q1 2016, an increase of 36%.
• U.S. prescription growth: Increased normalized prescriptions for Vascepa by 52% and 58% compared to Q1 2016 based on data from Symphony Health Solutions and IMS Health, respectively.
• International development: China regulatory authorities approved the Vascepa clinical trial application (CTA) from Amarin's partner, Eddingpharm, paving the way for Eddingpharm to commence a clinical trial of Vascepa in China before the end of 2017.
• R&D progress: Our REDUCE-IT cardiovascular outcomes study, designed to provide data to support a significantly expanded market opportunity for Vascepa, is progressing as planned. Our statistical models indicate that in March 2017, the study reached the onset of approximately 80% of the target aggregate number of primary cardiovascular events. The onset of the target final primary cardiovascular event will likely be reached near the end of 2017 in this 8,175 patient study that commenced in 2011.
• Cash flow: Net cash outflow from operations during Q1 2017 was less than $1.5 million, excluding costs for R&D, interest and royalty. The company aims to be net cash flow positive on this basis for the full year with continued quarterly variability.
• Cash balance: As of March 31, 2017, Amarin had a cash balance of $96.1 million compared to $98.3 million at December 31, 2016.  The March 31^st cash balance includes approximately $13.7 million in net cash proceeds from the January 2017 redemption of debt and simultaneous issuance of $30.0 million face value of new debt long-term.

"Historically, Q1 has been our most challenging quarter for revenue growth due to seasonal factors.  We are pleased that both revenues and prescriptions for Vascepa grew significantly in Q1, as prescription growth exceeded our internal projections. We are on-track to achieve our full year 2017 product revenue guidance of $155 to $165 million," stated John F. Thero, president and chief executive officer. "Our expectations are that REDUCE-IT study results will be reported in mid-2018, and we are actively planning for expanded promotion based on anticipated positive results from this study. There is a large unmet medical need that we are seeking to address through demonstration of positive results in REDUCE-IT.  We believe the efficacy, safety, oral administration and affordable cost of Vascepa position the product for substantial growth, assuming that REDUCE-IT results are positive."

Increases in New and Recurring Prescriptions Drive Steady Commercial Growth

During the first quarter, Amarin again experienced substantial prescription growth and continued increase in Vascepa market share, particularly among detailed physicians. Overall, approximately 150,000 patients received prescriptions for Vascepa during the quarter, with new prescriptions growing to approximately 5% of the non-statin lipid modifying market and approaching 30% of the prescription omega-3 market. Strong Vascepa growth is driven by positive physician experience in conjunction with our focused message delivery, compelling efficacy and safety data, and improved managed care coverage.  

Estimated normalized total Vascepa prescriptions, based on data from Symphony Health Solutions and IMS Health, totaled approximately 305,000 and 335,000, respectively, for the three months ended March 31, 2017. These prescription levels represent growth of approximately 52% and 58%, respectively, from prior year levels.

During the first quarter of 2017, overall wholesaler inventory levels decreased from year-end 2016 levels calculated based on estimated days of Vascepa sales on hand. Consequently, we estimate that this decrease in wholesaler inventory levels adversely impacted net product revenue by approximately $2.8 million to $3.1 million for the first quarter of 2017. During the first quarter of 2016, wholesaler inventory levels adversely impacted net product revenue by approximately $1.2 million to $1.5 million. We believe that changes in channel inventory at these independent wholesalers and retail pharmacies are common and impacted by numerous factors, including holiday timing and recent order trends. We also deduce, based on information available to us, that channel inventory levels at the end of the first quarters of 2017 and 2016 are within ordinary ranges, and that such levels will continue to vary from quarter to quarter.

REDUCE-IT Cardiovascular Outcomes Study

The REDUCE-IT cardiovascular outcomes trial continues to progress on schedule. Amarin anticipates the onset of the final primary cardiovascular event to occur near the end of 2017, with report of top-line results and publications in 2018. The projected timing of available data from which we can report top-line results should be easier to estimate after the interim look which, as discussed below, is scheduled to complete in Q3 2017. We currently estimate that we will report results of REDUCE-IT in mid-2018, assuming the study goes to completion. These estimates reflect our assumptions of the necessary time needed to collect vital data from all patients in the study, compile the results, and subject the results to scrutiny of the independent review committees and the REDUCE-IT operational team.

The 8,175-patient outcomes study is evaluating whether treatment with Vascepa reduces cardiovascular events in patients who despite stabilized statin therapy, have elevated triglyceride levels and other cardiovascular risk factors. The results of this important trial, if successful, could lead to improved medical care for tens of millions of patients.  Amarin is positioned to be the first company to complete an outcomes study in the population of patients being studied in REDUCE-IT.

The primary endpoint of this global, double-blind study is the time to the first occurrence of a composite of major adverse cardiovascular events (MACE).  Results will be compared between the Vascepa and placebo groups.  The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

Preparations are underway for a second pre-specified interim efficacy and safety analysis of REDUCE-IT by the independent DMC, since we believe that approximately 80% of the primary cardiovascular events occurred in the mid-March timeframe. The ensuing analysis should be completed before the end of Q3 2017.  Consistent with the trial design, Amarin continues to believe that the REDUCE-IT study is most likely to continue to completion of 100% of the target events.  We surmise this because the efficacy requirements detailed to the DMC for early study stoppage after the 80% interim assessment are high. Unlike the data analysis at the end of the study, the interim analysis and review by the DMC also includes robustness thresholds for certain secondary endpoints. There are potential statistical advantages for the study to run to its full term.

Amarin will remain blinded to results of the REDUCE-IT study until after the study is stopped and the database is locked at either the 80% interim analysis or at the final analysis.

International Development of Vascepa

Our international initiatives are progressing positively. Our partner for China, Eddingpharm, submitted the clinical trial application (CTA) to the Chinese regulatory authorities in 2016. This CTA was recently approved, enables Eddingpharm to progress into the clinical testing phase, and potentially positions Vascepa to be the first prescription grade EPA product to receive drug approval in China. We believe the commercial opportunity in China is large based on the prevalence of hypertriglyceridemia, which is estimated to affect 11.9% of the adult Chinese population. Our partner in China is responsible for the conduct and cost of the clinical studies in China.  Amarin will provide the clinical trial material for this study. 

Financial Update

Net product revenue for the three months ended March 31, 2017 and 2016 was $34.3 million and $25.3 million, respectively. This increase in net product revenue was primarily attributable to increases both in new and recurring prescriptions of Vascepa driven by increased sales productivity and supported by expanded managed care coverage.  

In addition, Amarin recognized licensing revenue of $0.3 million and $0.2 million in the three months ended March 31, 2017 and 2016, respectively, related to agreements for the commercialization of Vascepa outside the United States. Based upon current estimates, Amarin anticipates approximately $1.2 million in licensing revenue to be recognized in aggregate during 2017 from existing agreements.    

Cost of goods sold for the three months ended March 31, 2017 and 2016 was $8.2 million and $6.9 million, respectively.  Gross margin on product sales improved to 76% in the quarter ended March 31, 2017 compared to 73% in the quarter ended March 31, 2016. The improvement in gross margin on product sales was primarily driven by lower active pharmaceutical ingredient cost.

Selling, general and administrative (SG&A) expenses in the three months ended March 31, 2017 and 2016 were $34.2 million and $28.0 million, respectively.  The increase in SG&A expenses primarily reflects a $1.7 million increase in co-promotion fees accrued under our contract with Kowa Pharmaceuticals America, Inc., increased promotional activities, and increased legal costs. The co-promotion fee is calculated based on gross margin on Vascepa product sales. The increase in co-promotion fees primarily reflects an increase during Q1 2017 compared to Q1 2016 in gross margin on product sales.

Research and development expenses in the three months ended March 31, 2017 and 2016 were $10.8 million and $13.7 million, respectively. This decrease in expense was primarily driven by the timing of REDUCE-IT expenses.  
                                                                              
Under GAAP, Amarin reported a net loss of $20.9 million in the first quarter of 2017, or basic and diluted loss per share of $0.08. This net loss included $3.4 million in non-cash stock-based compensation expense. Amarin reported a net loss of $29.8 million in the first quarter of 2016, or basic and diluted loss per share of $0.16. This net loss included $3.6 million in non-cash stock-based compensation expense, a $1.3 million non-cash loss on the change in fair value of derivatives.

Amarin reported cash and cash equivalents of $96.1 million at March 31, 2017. Excluding cash flow related to research and development and financing, net cash outflows in the quarter ended March 31, 2017 were approximately $1.4 million.  Cash outflows relating to research and development in Q1 2017 were approximately $10.4 million.  Cash flow from financing-type activities included approximately $13.7 million in net cash proceeds from the previously announced January 2017redemption of debt and simultaneous issuance of $30.0 million face value of new debt long-term. Cash paid for interest and royalties in Q1 2017 was approximately $4.1 million in aggregate.

As of March 31, 2017, the company had $29.5 million in net accounts receivable ($34.5 million in gross accounts receivable before allowances and reserves) and $23.9 million in inventory.

As of March 31, 2017, Amarin had approximately 270.7 million American Depository Shares (ADSs) and ordinary shares outstanding, 32.8 million common share equivalents of Series A Convertible Preferred Shares outstanding and approximately 23.5 million equivalent shares underlying stock options at a weighted-average exercise price of $3.25, as well as 9.8 million equivalent shares underlying restricted or deferred stock units.

Yo tengo intención de vender hoy RGLS y no quedarme a earnings. Las llevo con bastantes pluses y mi intención era tradearla, no quedarmela en el portfolio. Donde crees que puede llegar hoy? Ultimamente te veo acertado en las predicciones...