vertex pharmaceuticals inc (VRTX) Key Developments
Vertex Pharmaceuticals Incorporated Reports Unaudited Consolidated Financial Results for the Third Quarter and Nine Months Ended September 30, 2013; Provides Earnings Outlook for the Year 2013
Oct 29 13
Vertex Pharmaceuticals Incorporated reported unaudited consolidated financial results for the third quarter and nine months ended September 30, 2013. For the quarter, the company’s total revenues were $221.7 million against $336.0 million for the same period a year ago. Loss from operations was $134.06 million against $1.07 million for the same period a year ago. Loss before provision for income taxes was $129.41 million against $5.11 million for the same period a year ago. Net loss attributable to the company was $124.13 million or $0.54 per diluted share against $57.54 million or $0.27 per diluted share for the same period a year ago. On Non-GAAP basis, net loss attributable to the company was $74,384,000 or $0.32 per diluted share against net income of $28,197,000 or $0.13 per diluted share for the same period a year ago. Loss from operations was $76,485,000 against income of $31,733,000 a year ago. Loss before provision for (benefit from) income tax was $71,829,000 against income of $28,158,000 a year ago. The decrease in the company's third quarter 2013 non-GAAP net income (loss) compared to the third quarter of 2012, is primarily attributable to a decrease in total revenues, specifically decreased INCIVEK revenues due to fewer HCV patients initiating treatment.
For the nine months, the company reported total revenues of $860.8 million against $1,193.0 million for the same period a year ago. Loss from operations was $629.28 million against income from operations of $79.81 million for the same period a year ago. Loss before provision for income taxes was $635.86 million against income before provision for income taxes of $68.4 million for the same period a year ago. Net loss attributable to the company was $489.31 million or $2.20 per diluted share against $30.88 million or $0.15 per diluted share for the same period a year ago. On non-GAAP basis, the company’s loss from operations of $68,197,000, loss before provision for income taxes was $71,038,000 and net loss attributable to the company of $74,850,000 or $0.34 per diluted share against income from operations of $260,094,000, income before provision for income taxes was $248,902,000 and net income attributable to the company of $246,567,000 or $1.15 per diluted share for the same period a year ago.
The company now expects lower 2013 total net revenues in the range of $1.0 billion to $1.05 billion. The company now expects total 2013 non-gaap operating expenses of approximately $1.1 billion, which is within the range provided previously for total 2013 non-gaap operating expenses.
Vertex Pharmaceuticals Reduces Workforce Related to INCIVEK
Oct 29 13
Vertex Pharmaceuticals Incorporated announced that the company will focus its investment on future opportunities in cystic fibrosis and other high-potential research and development programs and is reducing its workforce related to the support of INCIVEK following the continued and rapid decline in the number of people being treated with INCIVEK as other new medicines for hepatitis C near approval. The company is eliminating 370 positions, primarily related to the support of INCIVEK, representing approximately a 15% reduction in the company's global workforce. Approximately 175 positions are being eliminated in Massachusetts. Following the changes, Vertex expects to have approximately 1,800 employees worldwide, including approximately 1,300 in Massachusetts. All employees affected by the restructuring are being offered outplacement services as well as a comprehensive severance package based on their length of employment with Vertex.
Vertex Pharmaceuticals Incorporated Announces 12-Week Results from an Ongoing Phase 2b Study of VX-509
Oct 18 13
Vertex Pharmaceuticals Incorporated announced 12-week results from an ongoing Phase 2b study of VX-509, an investigational oral, selective Janus kinase 3 (JAK3) inhibitor, dosed once or twice daily in people with active rheumatoid arthritis (RA) taking methotrexate. The study met its primary endpoints of both the proportion of people who achieved at least a 20% improvement in signs and symptoms of RA, as measured by the ACR improvement criteria (ACR20), and the change from baseline in Disease Activity Score for 28 joints (DAS28). All doses of VX-509 showed statistically significant ACR20 and ACR50 responses versus placebo and statistically significant improvement from baseline in DAS28 versus placebo. The three high dose groups showed ACR20 responses of between 58% and 68%, compared to 18% for placebo, and statistically significant ACR70 responses versus placebo. In the study, the discontinuation rate due to adverse events was 6.6% for the pooled VX-509 treatment group and 8.5% for the placebo group. Overall, adverse event rates were 51.2% in the pooled VX-509 treatment groups compared to 38.0% for those who received placebo, and the majority of adverse events observed in the study were mild to moderate. The results were published online as part of a late-breaker abstract accepted for an oral presentation at the American College of Rheumatology (ACR) annual meeting. The study is ongoing, and Vertex expects 24-week data to be available in early 2014. Phase 2b Study: This double-blind, randomized, placebo-controlled 24-week Phase 2b study of VX-509 enrolled and dosed 358 people with RA who had active disease despite methotrexate treatment. Patients continued to receive stable doses of methotrexate during the study. Up to 20% of people in the study could have previously been treated with a single tumor necrosis factor (TNF) inhibitor. People in the study were randomized to receive placebo or one of four doses of VX-509 (100 mg once daily (QD), 150 mg once daily, 200 mg once daily or 100 mg given twice daily (BID)) for 24 weeks.
Vertex Pharmaceuticals Incorporated Announces Progress in Research and Development Programs for Cystic Fibrosis
Oct 17 13
Vertex Pharmaceuticals Incorporated provided a comprehensive update on recent progress in its research and development activities in cystic fibrosis (CF) aimed at helping more people with CF and enhancing the clinical benefit for these patients with the company's approved and investigational medicines. Vertex announced that the TRAFFIC and TRANSPORT Phase 3 studies of lumacaftor (VX-809) in combination with ivacaftor in people with two copies of the F508del mutation are fully enrolled. Data from these studies are expected in mid-2014, and Vertex plans to submit a New Drug Application (NDA) in the U.S. and a Marketing Authorization Application (MAA) in Europe in the second half of 2014 for the combination of lumacaftor and ivacaftor. Vertex also provided updates on multiple ongoing label-expansion studies for ivacaftor, ongoing and planned Phase 2 combination studies of lumacaftor and ivacaftor and VX-661 and ivacaftor, and research efforts aimed at beginning clinical development of a next-generation corrector. KALYDECO(TM) (ivacaftor) is currently approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. More than 2,000 people with CF ages 6 and older have at least one copy of the G551D mutation in North America, Europe and Australia. Vertex has multiple studies planned and underway to evaluate whether ivacaftor may help additional people with CF who have other mutations that may respond to ivacaftor treatment. More than 7,000 people with CF, including those with the G551D mutation, have CFTR mutations that may respond to ivacaftor treatment. The company is also conducting studies to evaluate a combination of ivacaftor and a corrector in people with two copies of the most common CFTR mutation, F508del. Vertex provided the following updates: KALYDECO (ivacaftor) Global Availability of KALYDECO: KALYDECO is currently available to eligible patients in England, Scotland, Northern Ireland, Wales, the Republic of Ireland, France, Germany, the Netherlands, Austria, Denmark, Sweden, Norway, Greece and the U.S. Vertex is in active discussions with relevant agencies in Australia and Canada regarding public reimbursement of KALYDECO in these countries. PERSIST Data Presented at NACFC and Submitted to U.S. FDA: Data from the open-label PERSIST study will be presented as a poster at NACFC. PERSIST is an ongoing rollover study of people with CF ages 6 and older with a G551D mutation who took part in the Phase 3 STRIVE and ENVISON studies of KALYDECO. The data from PERSIST showed that 144 weeks of continuous treatment with KALYDECO provided durable treatment effects in lung function (as measured by FEV1), weight and other measures. The safety profile was consistent with what was observed in the 48-week Phase 3 studies that supported the approval of KALYDECO. The PERSIST data have been submitted to the U.S. Food and Drug Administration (FDA) for review for potential inclusion in the KALYDECO label.
Vertex Pharmaceuticals Incorporated Presents at 2013 Credit Suisse Annual Healthcare Conference, Nov-12-2013 11:30 AM
Oct 8 13
Vertex Pharmaceuticals Incorporated Presents at 2013 Credit Suisse Annual Healthcare Conference, Nov-12-2013 11:30 AM. Venue: The Phoenician, Scottsdale, Arizona, United States. Speakers: Ian F. Smith, Chief Financial Officer and Executive Vice President.