Lilly, Bristol Meyers Squibb, Johnson & Johnson
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Lilly raises 2024 guidance even with supply constraints
Here are the main results from Lilly’s earnings this morning:
- Raised adjusted earnings guidance for 2024 to a range of $13.50 to $14.00 per share, up from a prior forecast of $12.20 to $12.70 per share
- Q1 earnings were $2.58 share, beating expectations of $2.39 per share
- The obesity drug Zepbound brought in $517 million in Q1 sales, more than the $389 million that analysts expected.
- But sales of the sister diabetes drug Mounjaro missed — it posted $1.8 billion in sales, lower than the $2.1 billion that analysts forecasted.
Lilly, as well as its competitor Novo Nordisk, have been hampered by supply constraints. They’re both rapidly scaling up manufacturing capacity, and Lilly said it expects the most significant production increases this year to occur in the second half.
Read more from me on the earnings results and how Lilly is responding to the supply challenges. And check back in after the earnings call that starts at 10 a.m. ET.
Judge deals blow to drugmakers challenging IRA
A federal judge ruled yesterday against a challenge brought by Bristol Myers Squibb and J&J aimed at dismantling Medicare’s new drug price negotiation authority created by the Inflation Reduction Act.
The pharma giants argued that the negotiation program is an unconstitutional confiscation of their drugs by the government, a violation of their right to freedom of speech, and an unconstitutional condition to participate in the Medicaid and Medicare programs. But the judge, a Biden appointee, said the companies failed to show that they’re legally compelled to sell drugs to Medicare and Medicaid patients.
This is a setback for the pharma industry’s strategy of getting split decisions in lower courts across the country to eventually get the attention of the Supreme Court.
Read more from STAT’s Rachel Cohrs on the details of the ruling.
FDA starts regulating lab-developed tests
From Theranos’ infamous blood tests to misleading prenatal genetic tests, lab-developed tests have historically not faced FDA scrutiny — until now.
The agency released final rules yesterday that detail how it will start regulating these tests. The rules are looser than an earlier plan that the FDA had proposed last year — it’s giving labs four years to comply and it’s choosing not to regulate some tests. Still, the agency estimates that around 12,000 labs will have to start submitting tests.
The move comes after Congress failed to pass a law that would have allowed the FDA to regulate lab tests through a more flexible, less costly framework. Now that the FDA has taken matters into its own hands, it’s expected to face legal challenges going forward.
Read more from STAT’s Lizzy Lawrence on the likely legal battle that will ensue and how the industry and patients feel about the rules.
FDA wants to hear your thoughts on advisory committees
The agency also announced yesterday that it will hold a “listening session” on June 13 to hear what the public thinks about the role of advisory committees.
These committees are groups of medical and scientific experts that provide advice to the FDA on regulatory decisions. Their recommendations are non-binding, but observers closely follow how they vote as a sign of whether the agency might approve or reject a drug or device. The FDA, though, has made controversial decisions that run counter to how committees have voted, like granting accelerated approval to Biogen’s Alzheimer’s drug Aduhelm after an advisory committee voted against it.
FDA Commissioner Robert Califf has said he would like to get rid of the voting process. He previously told STAT that “the purpose is not to take a vote on the approval of a product. The purpose to me is to get the advice of experts of various types.” But the FDA’s oncology head Richard Pazdur thinks differently, saying that the votes are helpful.
Patients sour on the pharma industry
The pharmaceutical industry enjoyed a fairly good reputation during the Covid-19 pandemic, when companies rapidly developed treatments and vaccines to use against the virus. But that’s changing, as patients grow more concerned about drug prices and increasing shortages.
In an annual survey of more than 2,500 patient groups, 57% said the pharma industry has an “excellent” or “good” reputation, a decline from previous years. Groups expressed a desire for drugs to be priced more equitably and made more accessible to patients around the world, and to have greater involvement in R&D.
Read more from STAT’s Ed Silverman on detailed results of the survey and which companies ranked the highest and lowest in reputation.
