Vertex Pharma Expects 2015 Kalydeco Revenues Of $560 Mln To $580 Mln In 2015

(RTTNews) - Vertex Pharmaceuticals, Inc (VRTX) outlined Sunday its 2015 business priorities to support the development, approval and launch of new medicines for the treatment of people with cystic fibrosis. The company also provided revenue guidance for Kalydeco (ivacaftor) for the full-year 2015.

The company provided the updates ahead of the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco on Monday.

"We enter 2015 with a strong cash position of approximately $1.4 billion, which, when combined with continued revenue growth, will allow us to invest in key internal and external opportunities in CF and other diseases to bolster our pipeline and position the company to advance other transformative medicines in the coming years," Chairman, President and CEO Jeffrey Leiden said in a statement.

The Boston, Massachusetts-based company noted that it will be focused on the approval and launch of the combination of lumacaftor and ivacaftor, as well as the geographic and label expansion for Kalydeco in 2015.

Vertex continues to project total 2014 Kalydeco net revenues of about $460 million and fourth-quarter Kalydeco net revenues of about $120 million.

Looking ahead, Vertex expects total 2015 Kalydeco net revenues between $560 million and $580 million.

"We expect 2015 to be a year of rapid and significant growth in revenues based on treating many more people with CF following the potential approval and launch of the combination of lumacaftor and ivacaftor and further label and geographic expansion for KALYDECO. As our revenues increase, we are committed to managing our operating expense to support high future operating margins and earnings growth," CFO Ian Smith stated.

However, the company anticipates higher combined adjusted R&D and SG&A expenses of $1.05 billion to $1.1 billion in 2015 compared to 2014, due primarily to launch preparation activities for lumacaftor in combination with ivacaftor and the planned pivotal Phase 3 development program for VX-661 in combination with ivacaftor.

Vertex said its New Drug Application (NDA) for the use of ivacaftor in children ages 2 to 5 who have the G551D or one of the eight additional gating mutations was accepted for filing by the Food and Drug Administration (FDA), and a target review date of March 17, 2015 was set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision.

Vertex also announced that the FDA acceptance for its NDA for the combination of lumacaftor and ivacaftor in people with CF ages 12 and older who have two copies of the F508del mutation. The FDA granted Vertex's request for Priority Review, with a target review (PDUFA) date of July 5, 2015 for the FDA's approval decision.

Vertex also plans to initiate a study of lumacaftor in combination with ivacaftor in children ages 6 to 11 who have two copies of the F508del mutation in the first half of 2015.

Further, Vertex is currently conducting a 12-week Phase 2 study of VX-661 in combination with ivacaftor in people with CF who have two copies of the F508del mutation. Vertex completed enrollment in the study in October 2014.

The data from the 12-week Phase 2 study are expected in the first quarter of 2015. Vertex also plans to initiate a Phase 3 pivotal program of VX-661 in combination with ivacaftor in February.

Additionally, Vertex has multiple next-generation correctors in the lead-optimization stage of research and expects to begin clinical development of a next-generation corrector in 2015.

Vertex also expects multiple compounds in oncology and neurological diseases to be in clinical development in 2015.

VRTX closed Friday's regular trading session at $122.21, down $1.54 on a volume of 1.07 million shares.