- Bristol-Myers Squibb Co.'s cancer immunotherapy Opdivo continued its steady ascent through the ranks of biopharma blockbusters during the first three months of 2018, earning just over $1.5 billion in sales despite intensifying competition from Merck & Co. and other rivals in oncology.
- Fast year-over-year growth from Opdivo and Bristol-Myers' anticoagulant Eliquis, however, disguised an otherwise stagnant portfolio. Excepting those two drugs, revenue from all other products fell by 19% from last year.
- Sales growth notwithstanding, Opdivo faces rising challenges. Merck's rival Keytruda has edged ahead in lung cancer, leading analysts to cut peak sales forecasts in the years ahead.
In many respects, Bristol-Myers has an enviable position in the industry's hottest field. Opdivo (nivolumab) remains the leading immunotherapy by sales (although Merck has yet to report first quarter earnings). And Bristol-Myers' anti-CTLA4 agent Yervoy (ipilimumab) has given the company a natural starting point in the hunt for more effective combination treatments.
Yet analysts have concerns that Bristol-Myers will be increasingly boxed out in non-small cell lung cancer, one of the largest and most lucrative markets in oncology.
At last month's annual meeting of the American Association for Cancer Research, results from a Phase 3 study showed Merck's Keytruda (pembrolizumab) cut the risk of death by half when paired with chemotherapy in first-line treatment of non-small cell lung cancer patients. That combination is already approved in the U.S., meaning the results should quickly translate into uptake.
Keytruda's success overshadowed positive late-stage data from a Bristol-Myers' combination trial called Checkmate-227. Impressive in its own right, the CheckMate-227 results showed Opdivo plus Yervoy extended progression-free survival, but only (for now) in patients with high tumor mutation burden (TMB).
"We see an important opportunity to deliver a chemo-sparing option in a defined set of patients and are encouraged by the deep and durable responses seen in study 227," said Bristol-Myers CEO Giovanni Carforio on an April 26 earnings call.
"At the same time, I acknowledge the competitive dynamics coming out of AACR," he added, suggesting Bristol-Myers recognizes Merck's improving position in lung cancer.
In light of the results, analysts now see narrower commercial opportunity in lung cancer, with some even questioning whether Opdivo will be a growth franchise in the future.
"We think Nivo/ipi can still see adoption in TMB-high patients, given the appeal of a chemo-free approach. The uptake of nivo/ipi, if approved, will largely depend on the adoption of TMB testing across different clinical settings," noted Leerink analyst Geoffrey Porges, also writing in an April 20 note.
Outside of lung cancer, Bristol-Myers position is stronger — particularly after an approval in first-line renal cell carcinoma, an indication company executives believe represents a $1 billion opportunity.
About 60% of Opdivo sales come from outside of its lung cancer indication, Bristol-Myers said.
"[Bristol-Myers] is still a formidable player in [immuno-oncology], given Opdivo's dominant positions in several tumors," wrote Cowen analyst Steve Scala in an April 20 note to investors.
Analyst scrutiny of Opdivo, even as sales of the drug climb, reflects the lack of growth drivers for Bristol-Myers outside of Eliquis. Among the nine other business lines for which Bristol-Myers breaks out sales, only two saw growth in the first quarter.
Sales of Eliquis rose 37% to $1.5 billion during the first quarter, and the drug is set to soon surpass the generic standard of care warfarin in total anticoagulation prescription share.
Overall revenues, meanwhile, grew 5% to $5.2 billion on the period.
Eliquis' success in lockstep with Opdivo means Bristol-Myers isn't a one-trick pharma show. It does, however, mean the company's growth story comes down to whether it wins or loses in the cancer and blood-thinner markets.