alkermes plc (ALKS) Key Developments
Alkermes plc Presents at NASDAQ OMX 31st Investor Program, Dec-02-2014 10:45 AM
Nov 25 14
Alkermes plc Presents at NASDAQ OMX 31st Investor Program, Dec-02-2014 10:45 AM. Venue: The Waldorf Hilton, Aldwych, London, WC2B 4DD, United Kingdom.
Alkermes plc Announces Unaudited Consolidated Financial Results for the Second Quarter and Six Months Ended September 30, 2013; Revises Earnings Guidance for the Full Year of 2014
Oct 29 14
Alkermes plc announced unaudited consolidated financial results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported total revenues of $159.992 million against $139.802 million a year ago. Total revenues were driven primarily by growth from its portfolio of five key commercial products which grew 38% compared to last year and now represent approximately 73% of its total revenue compared to approximately 59% in the same period last year. Operating loss was $32.738 million against $3.878 million a year ago. Loss before income taxes was $36.433 million against $7.529 million a year ago. Net loss – GAAP was $39.956 million or $0.27 per diluted share against $7.762 million or $0.06 per diluted share a year ago. Non-GAAP earnings per share – diluted were $0.03 against $0.22 a year ago. Non-GAAP net income was $3.899 million against $31.765 million a year ago. Capital expenditure was $8.888 million against $5.573 million a year ago. Negative free cash flow was $4.989 million against positive free cash flow of $26.192 million a year ago.
For the nine months, the company reported total revenues of $443.628 million against $441.855 million a year ago. Operating loss was $71.456 million against operating income of $28.633 million a year ago. Loss before income taxes was $54.809 million against income before income taxes of $10.387 million a year ago. Net loss – GAAP was $60.575 million or $0.42 per basic and diluted share against net income of $2.569 million or $0.02 per basic and diluted share a year ago. Non-GAAP earnings per share – diluted were $0.25 against $0.92 a year ago. Non-GAAP net income was $37.772 million against $130.871 million a year ago. Capital expenditure was $20.326 million against $17.457 million a year ago. Free cash flow was $17.446 million against $113.414 million a year ago.
The company revises earnings guidance for the full year of 2014. For the period, the company expects net other income to range from $85 million to $90 million, up from the previous range of $25 million to $30 million, reflecting approximately $60 million that Alkermes will earn related to the Civitas transaction. The company now expects GAAP net loss to range from $50 million to $70 million, or a basic and diluted loss per share of approximately $0.34 to $0.48, based on weighted average basic and diluted share counts of approximately 145 million shares outstanding. This compares to previous expectations of a GAAP net loss in the range of $90 million to $110 million, or a basic and diluted loss per share of $0.62 to $0.76, based on weighted average basic and diluted share counts of approximately 145 million shares outstanding. The company continues to expect non-GAAP net income to range from $30 million to $50 million, and non-GAAP diluted EPS to range from $0.19 to $0.32, based on a weighted average diluted share count of approximately 155 million shares outstanding. The company continues to expect capital expenditures to be approximately $30 million. The company continues to expect free cash flow of up to $20 million.
Alkermes plc, Q3 2014 Earnings Call, Oct 29, 2014
Oct 23 14
Alkermes plc, Q3 2014 Earnings Call, Oct 29, 2014
Alkermes' New Drug Application for Aripiprazole Lauroxil for Treatment of Schizophrenia Accepted for Filing by U.S. FDA
Oct 22 14
Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, the company's investigational, novel, once-monthly injectable atypical antipsychotic for the treatment of schizophrenia. Under the Prescription Drug User Fee Act (PDUFA), the FDA's target action date for the aripiprazole lauroxil NDA is Aug. 22, 2015. The NDA filing included the positive results from the pivotal phase 3 study assessing the efficacy and safety of aripiprazole lauroxil, in which aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms, compared to placebo. In the randomized, multicenter, double-blind, placebo-controlled study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once monthly, met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. Aripiprazole lauroxil was generally well tolerated in the study, and the observed safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache.
Alkermes plc Presents at Credit Suisse Annual Healthcare Conference, Nov-11-2014 11:00 AM
Oct 20 14
Alkermes plc Presents at Credit Suisse Annual Healthcare Conference, Nov-11-2014 11:00 AM. Venue: The Biltmore, 2400 E Missouri Ave, Phoenix, AZ 85016, United States. Speakers: Richard F. Pops, Chairman of the Board and Chief Executive Officer.