- Vertex Pharmaceuticals’ full-year 2016 revenues were $980 million for its cystic fibrosis product Orkambi (lumacaftor/ivaftor), the company said in a Jan. 25 earnings call. While below its originally anticipated annual revenues of $1.1 billion for the drug, the figure approaches the top end of subsequently revised fiscal projections.
- The Boston-based company expects combined sales of Orkambi and Kalydeco, its second CF product, to rise from $1.68 billion in 2016 to up to $2.01 billion this year.
- Aside from its CF business, Vertex said it is it is optimistic about VX-150, a pain treatment in the pipeline which recently showed positive phase 2 data for osteoarthritic pain. But the company said it requires further study of its effects on acute pain and neuropathic pain, likely late this year into early 2018.
Opening the earnings call, Vertex Chairman and CEO Jeff Leiden outlined three goals for his company in 2017: increasing the number of people eligible for and being treated with Orkambi; advancing multiple potential new medicines for CF; and reinvesting in its pipeline to find medicines for other serious specialty diseases.
Leiden cited "strong uptake" of Orkambi for younger patients in the U.S. – the drug was approved by the Food and Drug Administration for use in children ages six to 11 in September 2016. In 2017, most of the drug’s growth will come from Europe after reimbursement discussions are completed, he said.
But Orkambi’s launch in Europe "is slow going (reimbursement has been arduous) and success in our opinion is already factored into the current valuation," Maxim Group equity analysts wrote in a note to investors. "In our view, for Vertex to break out of its current valuation range, we would need to see signals (data) of success for the next-generation drug tezacaftor/ivacaftor in the heterozygous market, which is where we see risk as it relates to efficacy."
Asked by one analyst why Vertex doesn’t move ahead with VX-150 immediately, the company said it intends to create a rational development plan by understanding the molecule against all three types of pain.
Analyst Mark Schoenebaum of Evercore ISI noted that Vertex said while CF assets are their first priority, it is also looking at early stage M&A to expand its footprint. "The company mentioned recent collaborations with CRISPR and Moderna (focused on gene editing and mRNA therapies, respectively) as examples of partnerships that both bolster their CF pipeline and open the door to a more diversified focus," the analyst said in a note to investors.
Vertex beat Wall Street forecasts for fourth-quarter 2016, posting net income just shy of $33 million versus a loss in the like period a year earlier. Fourth-quarter revenue was nearly $460 million.