Bristol Myers Squibb
Approvals in past 5 years: 3
Value of recent approvals: $15.49 billion
Percent of value from recent approvals: 9.33%
In the past five years, Bristol Myers Squibb has only pushed three new drugs across the FDA finish line. Each one came courtesy of Bristol's mammoth $74 billion Celgene merger, perhaps signaling why Bristol execs felt compelled to strike the buyout.
Bristol's entire arsenal of marketed drugs is worth $166.12 billion in net present value, EvaluatePharma and Evaluate Vantage analysts say. The company's three launches—Zeposia, Breyanzi and Abecma—account for about 9.3% of that value, or $15.49 billion.
Each of those meds took a different path to FDA approvals, but unfortunately for Celgene investors, Breyanzi's nod didn't come in time for a lucrative contingent value right tied to the buyout. Under the deal, the trio of former Celgene drugs each had to snag FDA approvals by particular deadlines. Zeposia and Abecma met theirs, but Breyanzi did not.
For investors to be eligible for the $6.4 billion payout, the CAR-T lymphoma drug Breyanzi would've had to score an FDA approval by New Year's Eve. Thanks to COVID-related inspection delays and other setbacks, the drug's green light didn't come until February.
While Breyanzi ultimately snagged its FDA nod, investors have sued BMS for what they say was "blatant misconduct" around the CVR payout scheme and the company's regulatory efforts on the medicine. After looking at other cases, Mizuho analyst Salim Syed wrote to clients in June that the company may settle with investors for $3 billion to $4 billion down the line.
Despite all of the controversy, Breyanzi is worth $5.6 billion, according to Evaluate's analysts.
When it comes to Breyanzi's CAR-T compatriot Abecma, BMS said on a recent earnings call that early demand for the multiple myeloma drug had outpaced production capacity. The company has increased the number of patient manufacturing slots it has on offer to help it catch up through August, Chris Boerner, Bristol Myers’ chief commercial officer, said on a call with analysts in July.
Analysts expect that drug to generate more than $1 billion at peak, but a challenger from Johnson & Johnson and Legend Biotech poses a potential future threat. Abecma is worth $3.8 billion right now, Evaluate says.
Meanwhile, Zeposia hit the scene following a March 2020 FDA nod in multiple sclerosis. Earlier this year, the S1P receptor won an approval in moderate-to-severe active ulcerative colitis, becoming the first treatment in its class to branch beyond multiple sclerosis. The Evaluate analysts say that the drug is worth about $6 billion.
While BMS has lagged some of its peers on the FDA approval front, the pharma giant's top line isn't suffering. The company picked up the megablockbuster Revlimid in the Celgene deal, and that medicine helped the company grow revenues by 63% in 2020. Meanwhile, sales stalwarts Eliquis and Opdivo are in the running to be the world's second and third best-selling drugs by 2026, according to a separate EvaluatePharma analysis.