Vertex Pharmaceuticals Incorporated VRTX provided a look at preliminary financial results for 2015 and also gave its outlook for 2016.
The company, which holds a strong position in the cystic fibrosis (CF) market, said that it expects to report total 2015 net product revenues of about $980 million, including Kalydeco fourth quarter sales of approximately $180 million and Orkambi sales of approximately $220 million. The preliminary results indicate a sequential increase in both Orkambi and Kalydeco revenues.
For 2016, the company expects Kalydeco revenues of $670 to $690 million, up from approximately $630 million in 2015. Growth rate in patients on Kalydeco will be tempered by enrollment in the VX-661 program.
Vertex, however, did not provide any guidance regarding Orkambi sales – the company said the same will be provided as the Orkambi launch progresses. As of Dec 31, 2015 more than 4,500 people were on Orkambi in the U.S. Vertex is currently working on gaining country-by-country reimbursement in the EU where Orkambi was approved in Nov 2015.
The company estimates that about 20,500 people in the U.S. and Europe are eligible for treatment with Orkambi.
Vertex is currently evaluating Orkambi in a couple of phase III studies in children ages 6 – 11. While positive results from the first study would allow Vertex to seek FDA approval in the first half of 2016 and expand the patient population by 2,400 children, the second study is being conducted to gain EU approval where 3,400 children are estimated to be eligible for treatment.
Meanwhile, Vertex expects a response from the FDA regarding the approval of Kalydeco for the treatment of patients (2 years and above) with one of 23 residual function mutations by Feb 7. More than 1,500 people in the U.S. fall in this category.
Operating expenses are expected to shoot up from approximately $1.06 billion in 2015 to $1.18 to $1.23 billion in 2016. In addition to working on expanding Kalydeco and Orkambi’s labels, Vertex is developing VX-661 (four late-stage studies ongoing with results expected in 2017), VX-371 (in collaboration with Parion Sciences, phase IIa study ongoing with results due in mid-16) and its next-generation correctors – VX-152 and VX – 440. Vertex is also looking beyond CF at therapeutic areas like cancer (three candidates in early-stage testing), pain (couple of candidates in development), primary ciliary dyskinesia (VX-371), acute spinal cord injury (VX-210) and flu (JNJ-872) among others.
Vertex, a Zacks Rank #3 (Hold) stock, will be reporting full year 2015 results on Jan 27. Some better-ranked stocks in the healthcare sector include companies like Baxalta Incorporated BXLT, Gilead Sciences Inc. GILD and Anika Therapeutics Inc. ANIK. All three are Zacks Rank #1 (strong Buy) stocks.
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