“Specifically, Ricks referred to the IRA’s nine-year restriction on market exclusivity before government price-setting for small-molecule drugs as “terminating ideas before they have time to even grow roots.”
“I think that we’re going to miss the next Keytruda. And that’s why we’re raising the points that we are,” Ricks stressed.”
Bristol Myers Squibb will cut 6% of its workforce in a restructuring meant to save $1.5 billion in costs by the end of next year.
The layoffs will affect some 2,200 employees, the company said Thursday. It’s also trimming its pipeline of experimental medicines, consolidating its array of offices and laboratories and reducing “third party” spending…
Bristol Myers’ growth in the near term will be hampered by looming patent expirations for its two top-selling drugs: the blood thinner Eliquis, which it sells with Pfizer, and the cancer immunotherapy Opdivo. Its third highest-grossing product, the multiple myeloma treatment Revlimid, already faces limited generic competition.
Eliquis is also one of the first 10 drugs the U.S. government has targeted for price negotiations under the Inflation Reduction Act, or IRA…
“While the IRA has an impact in the middle of the decade, we feel very good about being able to more than compensate for that with a very young and attractive growth profile coming from our … portfolio and the pipeline,” said Boerner, on a conference call with analysts.
The restructuring announced Thursday is another step, designed to prioritize products that Bristol Myers sees as having the highest potential. The company said it plans to reinvest the targeted $1.5 billion in savings in those opportunities.
Two-thirds of the savings is expected to come out of Bristol Myers’ spending on research and development. The company has discontinued 12 programs, including a successor version of its immunotherapy Yervoy, and will continue to review its pipeline through the rest of the year, Samit Hirawat, Bristol Myers’ chief medical officer, said on Thursday’s call.”
1 Discontinued Drug: Yervoy (biologic)
12 Discontinued Research Programs: Yervoy, unnamed research programs
“As for its pipeline, the pharma group disclosed in Wednesday’s earnings presentation that it had discontinued the development of four early-stage assets including camonsertinib—which was being trialed in solid tumors—and belvarafenib, which was likewise being assessed for solid tumors in combination with Genentech’s Cotellic (cobimetinib). Roche also terminated two new molecular candidates—one for colorectal cancer and one for psychiatric disorders.”
4 Discontinued Drugs: camonsertinib (small molecule), belvarafenib (small molecule), unnamed colorectal cancer drug, unnamed psychiatric disorder drug
4 Discontinued Research Programs
“Pfizer is letting go an undisclosed number of employees and ending research operations at its site in Boulder, CO, the company confirmed to Endpoints News… At one point, it employed almost 300 people, according to Pfizer’s website… The site mainly focused on small molecules for oncology, according to Pfizer’s webpage for the location.”
1 Discontinued Research Program
“Pfizer briefed investors on the strategic priorities for its oncology business, which will be built on a portfolio focused more on antibody-drug conjugates and bispecific antibodies and far less on small molecules. Pfizer executives said the company’s change in business strategy is motivated in part by the disparity in how the Inflation Reduction Act’s drug price negotiation provisions treat biologics versus small molecule drugs… Company leaders said that the mix of small molecule drugs in its cancer portfolio will plummet from 94% last year to 35% in 2030.”
1 Discontinued Research Program
“The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.”
“We expect that additional US federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the US federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.”
“The drug pricing provisions of the IRA, which was signed into law in August 2022, began to be implemented in 2023 and implementation efforts will continue over the next several years. In August 2023, the Biden Administration unveiled the first round of medicines subject to the “Medicare Drug Price Negotiation Program,” which requires manufacturers of select drugs to engage in a process with the Federal government to set new Medicare prices which would go into effect in 2026. Among the medicines included in the first round is Eliquis. We continue to evaluate the impact of the IRA on our business, operations and financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain. In addition, changes to the Medicaid program or the federal 340B drug pricing program, including legal or legislative developments at the federal or state level with respect to the 340B program, could have a material impact on our business.”
“The IRA’s drug pricing controls and Medicare redesign may have an adverse impact on our sales (particularly for our products that are more substantially reliant on Medicare reimbursement), our business and our results of operations. However, the degree of impact from this legislation on our business depends on a number of implementation decisions. We will continue to assess as further information becomes available.”
