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Investors Business Daily
Investors Business Daily
Technology
ALLISON GATLIN

A Patent Cliff Is Coming For Bristol Myers — Can Billions In New Products Fill The Gap?

It's a new day at Bristol Myers Squibb, according to a company executive. But BMY stock remains under pressure ahead of a patent cliff threatening $200 billion in pharma sales by 2030.

Over the course of 2022, the Food and Drug Administration approved nine new medicines from Bristol Myers, Chief Commercialization Officer Chris Boerner told Investor's Business Daily. That tally included three first-in-class treatments for psoriasis, cardiomyopathy and melanoma. Bristol Myers also expanded its pipeline of drugs in early stages of testing.

This year, the company now is focusing on six new medicines in late-stage testing, including treatments for cancer, heart disease and lung conditions. A strong balance sheet also gives Bristol the flexibility to go after business development deals.

"With the strength of our base business, we have confidence through the middle of the decade," Boerner said.

Still, 2023 could be a "show-me" story for Bristol Myers.

BMY Stock: Big Patent Expirations Looming

The company is facing several patent expirations in the middle of the decade for two of its biggest moneymakers, cancer treatment Opdivo and blood thinner Eliquis. Bristol partners with Pfizer on Eliquis. Already, the patent for Revlimid, a cancer drug obtained in Bristol's 2019 acquisition of Celgene, has expired.

The Revlimid patent expiration gives BMY stock investors a forward look into what's coming next for the company's current bread-and-butter drugs. During the fourth quarter, Revlimid sales slipped 32% year over year to $2.26 billion. That continued a slide that began last year when Teva Pharmaceutical launched the first Revlimid generic.

Aside from Revlimid, Eliquis brought in $2.69 billion in sales and Opdivo accounted for about $2.22 billion. Further, Boerner counts Eliquis and Opdivo among Bristol's current "growth brands." All together, Bristol's three winningest drugs generated almost 63% of December-quarter sales.

But by 2030, the company expects Eliquis, Opdivo and other current drugs to make up the smallest portion of sales, according to a presentation at the J.P. Morgan Healthcare Conference in early January. The biggest chunk will come from the nascent new product portfolio.

Investors in BMY stock are now watching the early stages of that shift, Boerner says.

"We continue to see execution in the pipeline," he said. "We have six late-stage assets we believe have well in excess of $10 billion in sales potential."

Portfolio Renewal Underway

What Bristol calls the "portfolio renewal" began with nine product launches in 2022. Boerner counts Camzyos, Sotyktu and Opdualag among them, with all three first-in-class medicines. Camzyos treats a heart condition, Sotyktu is a plaque psoriasis treatment and Opdualag is a cancer medicine.

Specifically, Camzyos treats symptomatic obstructive hypertrophic cardiomyopathy, a condition in which the heart muscle becomes abnormally thick. Cytokinetics is also working on an experimental drug that could rival Camzyos, called aficamten. Aficamten is in Phase 3 testing.

But Boerner isn't concerned about competition for Camzyos.

"We're seeing very good (effectiveness)," he said. "So, the bar is high for any competition."

BMY stock investors also are watching Bristol's efforts to expand Camzyos into obstructive and nonobstructive hypertrophic cardiomyopathies.

Innovation In Cancer Treatment

Opdualag also is an important innovation in cancer treatment. It adds a second immuno-oncology mechanism to Opdivo. Boerner says this is a more convenient way to administer the two drugs. One blocks PD-1 and the other blocks LAG3. Also, tumor cells can use these proteins to undermine the immune system.

"We do believe given the success in melanoma, this has the potential to extend the (immuno-oncology) franchise into the next decade," he said.

Opdualag brought in $104 million in sales during the fourth quarter, while Camzyos and Sotyktu sales were a respective $16 million and $7 million.

Bristol Myers noted in its J.P. Morgan presentation that the nine products launched in 2022 are already annualizing a $2 billion run rate. Further, the company projects $10 billion to $13 billion in sales by 2025. By 2030, that could grow to $25 billion.

Late-Stage Pipeline Key For BMY Stock

Longer term, Bristol Myers is working on six late-stage drugs. Among those, the company notes a blood thinner, two multiple myeloma treatments, a lung cancer drug and two medicines for other lung conditions. All are experimental drugs with Phase 3 studies planned, underway or complete.

The latest among them is repotrectinib, a drug Bristol Myers acquired with biotech Turning Point Therapeutics last year. Bristol Myers expects repotrectinib to gain FDA approval in the second half of 2023 and become a new standard of care for patients with a specific form of lung cancer.

Multiple myeloma studies are already underway for experimental drugs called iberdomide and mezigdomide. Bristol Myers also has started a final-phase study of cendakimab in patients with an allergic condition that happens in the esophagus.

These drugs carry a potential of $10 billion in peak sales, Boerner said.

He also notes Bristol Myers has "significant financial flexibility" to focus on business development, including acquisitions. This will be important in the second half of the decade when Opdivo goes off patent.

Shares Remain Under Pressure

Despite the launches galore in 2022, BMY stock has steadily slipped since early December.

Boerner says Bristol Myers remains in a strong position in the new year.

"I think investors will see the productivity of our early pipeline coming through in 2023," he said, adding that "2022 was a strong year from an execution perspective. We will execute well in 2023."

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

This story has been updated to reflect the correct spelling of Opdualag.

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