Bristol’s Caforio Says Opdivo Is Just The Beginning

The big pharma's new leader expects unprecedented growth from its immuno-oncology franchise and is making sure investments back that up.

This year has been nothing short of incredible for Bristol-Myers Squibb Co. Its PD-1 inhibitor Opdivo has had three early trial stops due to overwhelming efficacy, three regulatory filings and three far quicker-than-normal approvals. The big pharma's new CEO sees this as the start of a new phase and is backing that up with cash.

"Building on our success over the past few years, we are beginning an exciting new chapter, one characterized by the opportunity for growth for leading a transformation in the way cancer is treated and for strengthening and expanding our diversified portfolio of specialty medicines. And we are starting this next chapter from a position of strength," chief exec Giovanni Caforio said during Bristol’s second quarter earnings call on July 24 – his first official call at the helm of the company.

Bristol expects growth over the next five years to be driven by Opdivo (nivolumab) and the blood thinner Eliquis (apixaban).

"With Opdivo, we will leverage our leadership position in lung, melanoma and renal cancers," said Caforio. "With Eliquis, given the breadth of its label and the strength of its prescription trends, we are very encouraged and look to build on our moment. And regarding the rest of our marketed products, trends are good and we have the right resources in place to continue to compete and grow."

In the long term, Caforio intends to continue building its leading presence in immuno-oncology, which will take significant investment and strategic choices given the pressure from the rest of the pack (Also see "Bristol’s Oncology Strategy: Stay In The Lead On Immunotherapy" - Pink Sheet, 15 Jun, 2015.). In addition to multiple filings for Yervoy, Opdivo and Opdivo plus Yervoy under review at FDA, the company is gearing up for submission and launch of its SLAMF7 inhibitor elotuzumab for multiple myeloma (Also see "Emergence Of New Myeloma Drugs, And Combinations, Raises Red Flag On Costs" - Pink Sheet, 29 Jun, 2015.).

Outside of oncology, Bristol is focusing on fibrosis, heart failure, immunology and certain genetically defined diseases.

"Over the last several months, I have reviewed our growth opportunities and they are, for us, unprecedented. I have also focused on what we need to do to maximize them and I am fully committed to making the right strategic investments," the exec added.

Those strategic investments are set to begin in the second half of the year, and will include further investment in R&D – particularly in immuno-oncology, as well as commercial investments.

CFO Charlie Bancroft said the company is adding resources globally to fully support the launches of Opdivo and elotuzumab and is also behind Eliquis to support its continued strong growth. For Opdivo, he said Bristol is making additional investments across the board, not just in R&D.

"We are increasing investments to accelerate Opdivo development programs where possible and also to accelerate the development of new mechanisms and additional combination regimens,” he stated. “We are adding resources in our medical organization which include additional trials to generate data and also to increase field medical resources, which will be important for driving awareness of Opdivo both in the U.S. and around the world."

Opdivo had sales of $122 million during the quarter ended June 30, beating out analysts' consensus estimates of $105 million. Eliquis was Bristol’s top-selling single drug, with revenues of $437 million, up from $171 million, and beating estimates of $385 million.

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