Vertex Pharma Q2 Loss Narrows, Lowers Top-end Of 2013 Revenue Guidance

(RTTNews) - Biotechnology company Vertex Pharmaceuticals Inc. (VRTX) on Monday reported a loss for the second quarter that narrowed from last year as lower revenues were more than offset by a decline in costs and expenses. Looking ahead, Vertex lowered the top end of its fiscal 2013 revenue outlook range, but raised its forecast for full-year sales of its cystic fibrosis drug Kalydeco.

Separately, the company said that Kalydeco showed statistically significant improvements in lung function in people with non-G551D gating mutations in an ongoing phase III label-expansion study. Kalydeco, known generically as Ivacaftor, is already approved for the treatment of cystic fibrosis in patients age 6 years and older who have a G551D mutation in the CFTR gene.

Vertex's second-quarter net product revenues of $254.79 million include product revenues of about $155.8 million from hepatitis C drug Incivek or telaprevir, and about $99.0 million from sales of Kalydeco. This compares to total product revenues of $373.27 million in the year-ago period.

Incivek revenues were down 52 percent from last year, due to fewer HCV patients initiating treatment in the second quarter compared to the year-ago period. Net product revenues from Kalydeco more than doubled, primarily from the rapid uptake of Kalydeco in eligible patients in Europe following the conclusion of reimbursement discussions.

Royalty revenues from Incivo for the quarter surged 57 percent to $44.1 million, while total royalty revenues rose 13 percent to $49.1 million. Meanwhile, collaborative revenues declined 41 percent to $6.8 million.

Cambridge, Massachusetts-based Vertex's second-quarter net loss narrowed to $57.17 million or $0.26 per share from $64.93 million or $0.31 per share in the same period last year.

Excluding charges, adjusted net loss for the quarter was $6.22 million or $0.03 per share, compared to adjusted net income of $99.76 million or $0.46 per share a year ago.

On average, eighteen analysts polled by Thomson Reuters expected the company to report loss of $0.18 per share for the quarter. Analysts' estimates typically exclude special items.

Total revenues for the quarter declined 26 percent to $310.75 million from $418.31 million in the same period last year, but beat analysts' consensus estimate of $308.15 million.

Total costs and expenses decreased 14 percent to $367.68 million from $429.08 million in the year-ago quarter.

Looking ahead to fiscal 2013, Vertex now expects total revenues in a range of $1.10 billion to $1.20 billion, compared to its prior forecast of $1.10 to $1.25 billion. Analysts currently expect the company to report revenues of $1.20 billion for the year.

The company now projects full-year Kalydeco net revenues in a range of $345 million to $360 million, up from the prior range of $300 million to $340 million.

Separately, Vertex said that data from one of its ongoing late-stage studies of ivacaftor or Kalydeco monotherapy in patients with CF showed statistically significant improvements in lung function in people with non-G551D gating mutation.

The company plans to submit a supplemental New Drug Application or sNDA in the U.S. and a Marketing Authorization Application or 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.

Worldwide, about 2,000 people with CF aged six and older have at least one copy of the G551D mutation, while about 400 people with CF aged six and above have at least one non-G551D gating mutation.

Last week, the FDA placed a partial clinical hold on Vertex's ongoing phase II U.S. study of its hepatitis C virus candidate, VX-135.

VRTX closed Monday's trading at $79.66, down $1.05 or 1.30 percent on a volume of 1.59 million shares. However, in after-hours, the stock gained $2.34 or 2.94 percent to $82.00.