Vertex Provides Preliminary Financial Results For 2015 And Outlook For 2016

(RTTNews) - Vertex Pharmaceuticals Inc. (VRTX) said it expects to report total 2015 net product revenues of approximately $980 million, including fourth quarter 2015 net product revenues of approximately $180 million for KALYDECO (ivacaftor) and approximately $220 million for ORKAMBI (lumacaftor/ivacaftor). As of December 31, 2015 more than 4,500 people had begun treatment with ORKAMBI in the U.S.

Vertex also provided 2016 net product revenue guidance of $670 to $690 million for KALYDECO and guidance of $1.18 to $1.23 billion for non-GAAP operating expenses, excluding costs of revenues. The company expects to provide net product revenue guidance for ORKAMBI during 2016 after gaining additional information on the launch of ORKAMBI in the U.S.

The company outlined key 2016 business priorities to support the company's efforts to discover and develop medicines for people with cystic fibrosis (CF) and other serious diseases. Approximately 25,000 people worldwide are currently eligible for one of Vertex's two approved medicines for CF, and Vertex today provided an update on its plans to develop new medicines that have the potential to treat all people with CF.

Vertex recently began clinical development of two next-generation correctors known as VX-152 and VX-440. Both VX-152 and VX-440 are being evaluated alone and as part of a triple combination with VX-661 and ivacaftor in ongoing Phase 1 studies in healthy volunteers. These studies are evaluating escalating doses of VX-152 and VX-440 for up to 14 days in duration. Pending results of these studies, Vertex plans to initiate Phase 2 studies in people with CF to evaluate VX-440 or VX-152 in combination with VX-661/ivacaftor in the second half of 2016.