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Patent Cliff Looms Large for Bristol-Myers Squibb Stock (BMY)

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Bristol-Myers Squibb (BMY) stock is down 11% year-to-date as the company navigates several looming patent cliffs. After a $13 billion acquisition of MyoKardia for its obstructive hypertrophic myopathy (HCM) drug, Camzyos, in 2020, the pharmaceutical giant has had difficulty achieving a return on investment.

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Bristol-Myers Squibb (BMY) price history year-to-date
Bristol-Myers Squibb (BMY) price history year-to-date

Bristol once believed Camzyos, FDA-approved for obstructive HCM (oHCM), could generate $4 billion in peak annual sales, but this has taken a hit on many fronts. Last week, Bristol revealed that Camyzos failed a critical Phase 3 trial assessing the drug in patients with non-obstructive HCM (nHCM), negating one-third of the HCM market. The company’s struggles to “fill the shoes” of blockbusters like Eliquis and Revlimid concern its future prospects, meriting a bearish outlook on its stock.

Camzyos Trial Failure Compounds BMY’s Market Struggles

After a slower-than-expected launch, Camzyos generated $223 million in revenue in the fourth quarter of 2024. Although the drug is the first of its kind for this genetic heart disease, it also competes with traditional treatments such as beta blockers.

Main Street Data shows BMY's revenue by segment since 2020
Main Street Data shows BMY’s revenue by segment since 2020

Moreover, many HCM patients go undiagnosed, further limiting the total addressable market. After a failure in nHCM, the company may have to temper its expectations of Camzyos. Moreover, Bristol may soon face competition from Cytokinetics (CYTK), whose me-too cardiac myosin inhibitor, aficamten, awaits a September FDA approval decision in oHCM.

Aficamten could split the market for oHCM, especially should the drug generate a different outcome in nHCM. While the nHCM failure definitely limits Camzyos’ market, the drug is still anticipated to generate upwards of $2 billion in peak annual revenue.

BMY’s Patent Cliff Dilemma Sees 45% of Revenue at Risk

Prospects like Camzyos are crucial because BMY wants to see a return on investment after dishing out $13 billion and because BMY has several blockbuster drugs nearing a “patent cliff.” To review, after drugs are approved, their intellectual property is protected for a limited time before others can sell generic versions. After this exclusivity period, generics can flood the market, effectively decreasing the branded drug’s pricing power and market share. This is also why large pharmaceutical companies invest so much in research and development and are willing to spend billions on promising drugs.