Bristol Myers Squibb, Amgen and Pfizer approach steepest patent cliffs among large drugmakers

By Angus Liu Dec 29, 2021 9:56am

Biopharma companies are constantly combating patent expirations. But three large drugmakers in particular will be the most negatively impacted from expected exclusivity losses by 2030.

Among 19 large U.S. and European biopharma companies, Bristol Myers Squibb, Amgen and Pfizer will face two major issues. All three companies will have a large portion of their 2025 revenues exposed to generic or biosimilar competition, and they will also see those revenues erode quickly, an SVB Leerink team led by analyst Geoffrey Porges said in a Monday note to clients.

BMS, Amgen and Pfizer will likely see copycats eat away 47%, 29% and 28% of their respective anticipated 2025 total revenues by 2030, Porges said. By contrast, Vertex, Sanofi and Novo Nordisk are expected to have the smallest erosion of 4%, 1% and 2% in growth, respectively.

Altogether, 66% of BMS’ 2025 revenue will come from drugs facing patent cliffs between 2021 and 2030. Most notably, Pfizer-shared blood thinner Eliquis, PD-1 inhibitor Opdivo and Celgene-inherited blood cancer med Revlimid will take the lion’s share.

Eliquis and Revlimid—both small molecules—will lose more than 80% of their revenues between 2025 and 2030, according to Wall Street consensus cited by Porges. That means $3.9 billion in revenue loss for Revlimid and about $11.5 billion for Eliquis. As for Opdivo, which will fall off the U.S. patent cliff in 2028, its 56% erosion will mean $3.9 billion in revenue gone by the end of the decade.

BMS itself has outlined around $12 billion to $14 billion related to exclusivity losses between 2020 and 2025 led by Revlimid, the patent for which expires in 2022. To fill the gap, the company plans to have several new products that could collectively deliver over $25 billion non-risk-adjusted revenue in 2029. These include anemia drug Reblozyl, heart drug mavacamten, TYK2 inhibitor deucravacitinib for inflammatory diseases and LAG-3 immuno-oncology agent relatlimab, among others.

In Amgen’s case, nine products in the Big Biotech’s offerings face patent expirations between 2021 and 2030. Among them, TNF blocker Enbrel, bone med Prolia/Xgeva and inflammatory disease therapy Otezla make up 41% of the company’s estimated 2025 total revenue.

Otezla, which Celgene sold to Amgen in 2019 for $13.4 billion to win antitrust clearance for its BMS merger, could lose 81% of its revenue, or nearly $2.7 billion, between 2025 and 2030, sell-side consensus showed. Enbrel and Prolia/Xgeva also need to brace for more than 50% erosion during that period, with losses of $1.6 billion and $2.9 billion, respectively.

Several key products in Amgen’s marketed portfolio face tough competition, and the company’s pipeline lacks vitality, Mizuho analyst Salim Syed warned in a recent note. To turn the tide, Amgen needs to be actively making deals, Syed suggested.

Amgen made several small acquisitions in 2021. It bought Five Prime Therapeutics for $1.9 billion to get its hands on bemarituzumab, a potentially first-in-class, phase 3 anti-FGFR2b cancer drug. The California biotech also put down $900 million upfront for Teneobio, which has bispecific and multispecific antibody technologies. And the company shelled out $55 million upfront to take over Rodeo Therapeutics for the small biotech’s preclinical 15-PGDH modulators, which hold potential in inflammatory diseases.

Lastly, Pfizer’s business includes 11 drugs facing loss of exclusivity by 2030, per Porges’ calculation. Besides BMS-shared Eliquis, the other most significant product is breast cancer therapy Ibrance. Together, the two meds are expected to constitute 23% of Pfizer’s 2025 revenue by consensus estimates. Wall Street analysts expect both Eliquis and Ibrance will suffer 77% in revenue loss by 2030, or $6.1 billion and $4.8 billion, respectively.

In addition, Astellas-shared prostate cancer drug Xtandi, which will lose U.S. patent protection in 2027, will quickly cede 87% of revenue, or $1.5 billion, between 2025 and 2030. Blockbuster transthyretin amyloidosis therapy Vyndaqel/Vyndamax will lose $2.7 billion during that period, and another $1.8 billion in revenue damage will come from JAK inhibitor Xeljanz.

Luckily for Pfizer, it’s enjoying humongous top-line gains from selling COVID-19 products including the BioNTech-partnered vaccine Comirnaty and the newly FDA-authorized antiviral Paxlovid. Cash generated from the products—and the planned demerger of Pfizer’s consumer health joint venture with GlaxoSmithKline—can give the New York pharma more M&A firepower to beef up its offerings.

Pfizer has already moved on the dealmaking front. In an agreement valued at $6.7 billion, the company is buying Arena Pharmaceuticals for etrasimod, an S1P modulator in development for several inflammatory diseases.