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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the quarter ended June 30, 2013. Vertex reported total second quarter 2013 revenues of $311 million, including net product revenues of $99 million from KALYDECO
TM (ivacaftor) and $156 million from INCIVEK
® (telaprevir). The GAAP net loss attributable to Vertex was $(57.2) million, or $(0.26) per share, for the second quarter of 2013, including certain charges of $51.0 million, comprised primarily of stock-based compensation expense. Non-GAAP net loss attributable to Vertex for the second quarter of 2013 was $(6.2) million, or $(0.03) per diluted share. The company reported $1.43 billion in cash, cash equivalents and marketable securities as of June 30, 2013 and has no outstanding convertible debt following the completion of a call of its outstanding Convertible Senior Subordinated Notes due 2015.
“Entering the second half of 2013, we continue to progress key programs in cystic fibrosis, hepatitis C and rheumatoid arthritis and have strengthened our financial position to support continued investment in our business," said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex. "Our progress in the first half of the year was marked by the initiation of a Phase 3 program in CF for people with the most common form of the disease, continued progress in bringing KALYDECO to people with CF around the world and the initiation of all-oral studies for VX-135 in hepatitis C.”
Development Program UpdatesCystic Fibrosis
Vertex's strategy in cystic fibrosis (CF) is to provide benefit to as many CF patients as possible, and to maximize the benefit for these patients, with our approved and investigational medicines.
Data from Phase 3 Label-Expansion Study of Ivacaftor Monotherapy in Gating Mutations Show Statistically Significant Improvements in Lung Function
In a separate press release issued today, Vertex announced data from a Phase 3 label-expansion study in people with CF who have at least one non-G551D cystic fibrosis transmembrane conductance regulator ( CFTR) gating mutation that showed statistically significant improvements in lung function (percent predicted forced expiratory volume in one second; FEV 1). Additional details on these data were provided in the separate press release.
Based on these data, Vertex plans to submit a supplemental New Drug Application (sNDA) in the United States and a Marketing Authorization Application (MAA) variation in Europe in the second half of 2013 for the use of ivacaftor monotherapy in people with CF ages 6 and older who have at least one non-G551D CFTR gating mutation. Approximately 400 people with CF ages six and older have a non-G551D gating mutation worldwide.
Continued Progress in Additional Label-Expansion Studies for Ivacaftor Monotherapy
Two additional Phase 3 label-expansion studies are ongoing for ivacaftor monotherapy, including a study in people with CF ages 6 and older who have at least one copy of the R117H mutation and a study in children with CF ages 2 to 5 who have a gating mutation, including the G551D mutation. Data from the study in the R117H mutation are expected in the second half of 2013, and, pending study results, Vertex plans to submit an sNDA in early 2014 for the use of ivacaftor monotherapy in people with CF ages 6 and older who have the R117H mutation. The pharmacokinetic portion of the study in children ages 2 to 5 is complete and a dose has been selected for the 24-week dosing period, which is now underway. Data from this study are expected in mid-2014.
Study of People with CF Who Have Evidence of Residual CFTR Function
Enrollment is ongoing in a Phase 2 proof-of-concept study evaluating ivacaftor in people with CF who have clinical evidence of residual CFTR function. Data from this study are expected in the first half of 2014.
Vertex believes that ivacaftor monotherapy may provide clinical benefit in 10 to 15 percent of the estimated 70,000 CF patients worldwide, pending results from our clinical studies and regulatory approvals.