October 30, 2024

The need-to-know this morning

Abbvie reported stronger-than-expected earnings.
More earnings reports: Intra-Cellular Therapies, BioMarin Pharma, Neurocrine Biosciences, United Therapeutics and Blueprint Medicines.

pharma

A rare stumble for Lilly as sales and earnings fall short

Eli Lilly's third-quarter sales and earnings were lower than expected, a rare stumble for the company that had consistently reported strong sales and beat earnings forecasts since demand for its blockbuster weight loss and diabetes drugs began booming.

Overall revenue was $11.4 billion, lower than the $12.2 billion expected from analysts polled by Visible Alpha. Adjusted earnings per share also came in lower than expected at $1.18.

Lilly said sales of its GLP-1 drugs were affected by drug wholesalers buying less product. The diabetes treatment Mounjaro brought in $3.1 billion and the obesity medication Zepbound brought in $1.3 billion, lower than analysts' predictions of $3.6 billion and $1.7 billion, respectively.

pharma

Sales of GSK's RSV vaccine fall dramatically

It's been clear that sales of GSK's once-booming RSV vaccine were going to fall year over year, following narrower U.S. recommendations for who should get the shot. But third quarter earnings released this morning showed that sales of Arexvy were even lower than analysts expected, falling more than 70%.

GSK's vaccine struggles -- sales of its shingles vaccine also missed -- pushed the company's shares down a few percent Wednesday, even as the company reported strong results for its HIV and oncology drugs.

While GSK projected confidence about the longer-term outlook for its RSV vaccine, CEO Emma Walmsley acknowledged on a call with reporters the challenge short-term. It's quite a turnaround from 2023, when Arexvy reached $1.5 billion in sales in its debut year and was viewed as a new supplier of steady revenues at the pharma giant.

biotech

Biogen reports mixed earnings, sales for third quarter

From my colleague Adam Feuerstein: Biogen reported third-quarter revenue Wednesday slightly ahead of Wall Street expectations, but results were mixed for Leqembi and Skyclarys, two newly launched medicines most important to Biogen's turnaround efforts.

Total revenue in the quarter was $2.5 billion, a small beat over the $2.4 billion consensus estimate, according to Visible Alpha. Sales of the Alzheimer's treatment Leqembi were $67 million, topping Wall Street's forecast, but Skyclarys, a treatment for Friedreich's ataxia, delivered sales of $102 million, falling short.

On an adjusted basis, Biogen earned $4.08 in the third quarter, better than the $3.79-per-share consensus estimate.

For the remainder of the year, Biogen boosted earnings guidance to a range of $16.10-16.60 per share from its previous forecast of $15.75-16.25 per share. Its revenue forecast remains unchanged.

alzheimer's

Roche's Brainshuttle drug shows early promise

An experimental Alzheimer's therapy from Roche successfully cleared amyloid from patients' brains in an early-stage trial, the company reported Wednesday, adding to evidence that the drug shows promise.

Roche has not yet assessed whether there has been any corresponding change in cognitive function, but the early findings on the treatment, an antibody called trontinemab, suggest it may be safer than some of the other amyloid-clearing treatments. In particular, there have been comparatively few cases brain swelling or bleeding, that has been seen with the other antibodies.

Unlike Roche's previous attempts to develop an Alzheimer's drug, trontinemab is used with the company's Brainshuttle technology, which is designed to ferry drugs across the blood-brain barrier so that more of the molecule can reach the targeted tissue.

alzheimer's

Lilly pushes for modified dosing of Alzheimer's drug

A change in the dosing regimen of Eli Lilly's Alzheimer's drug Kisunla resulted in a lower rate of brain swelling among patients in a trial, new data show. But it's unclear whether the new dosing schedule, if approved by regulators, will convince doctors that the treatment is safer for patients.

Doctors are still waiting for more detailed results, and some clinicians have been reluctant to use Kisunla as well as Leqembi, the competing treatment from Eisai and Biogen. They produce only modest benefits along with potentially severe risks of brain swelling and bleeding, but they are the only two drugs on the U.S. market aimed at slowing progression of Alzheimer's.

financing

Startup pivots to pain therapies with $115 million

Axonis Therapeutics, a biotech that has been quietly operating for the last five years, said this morning it's raised $115 million in a Series A round led by Cormorant Asset Management and venBio Partners.

The company was originally founded in 2019 to develop treatments for spinal cord injuries and paralysis. It's still pursuing that work, though it has moved it to the back burner and the company has found a different source of funding for it.

It's now using the new the funds to jump into an emerging area of drug development: non-addictive therapies for pain. It's pursuing a mechanism that several other companies, most notably Vertex Pharmaceuticals, have also been testing in recent years.

Read more from STAT's Allison DeAngelis.

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