October 26, 2023

The need-to-know this morning

Merck reported third-quarter adjusted earnings of $2.13 per share, or 9% ahead of analyst consensus. Revenue in the quarter was $16 billion, led by sales of the cancer immunotherapy Keytruda, which grew 17% to $6.3 billion.
Bristol Myers Squibb reported third-quarter adjusted earnings of $2 per share, or 14% ahead of analyst consensus. Revenue in the quarter totaled $11 billion, down 2% year over year but in line with consensus. The company raised its earnings forecast for the rest of the year but reaffirmed revenue down "low single digits." It also offered a less-confident, long-range forecast for new product sales — lowering guidance to "more than" $10 billion in 2026 from $10-13 billion in 2025.
Bristol's earnings report will also be the last for CEO Giovanni Caforio, who is retiring in November. Farewell, Giovanni!

Research

The future of Alzheimer's treatment rests on tiny needles

Leqembi, the first Alzheimer's disease treatment to show definitive effects on the disease's progression, is not exactly convenient. Patients have to show up to infusion centers twice a month for a lengthy administration of the intravenous drug, a costly proposition that will likely limit the drug's commercial launch.

That's why Eisai, Leqembi's inventor, has crafted a version of the drug that can be injected under the skin through a small needle. And as Adam Feuerstein reports, subcutaneous Leqembi appears to work just as well as the original. In data presented at an Alzheimer's conference yesterday, self-injected Leqembi did slightly better than the intravenous version at lower the amyloid plaques in patients' brains, data Eisai will submit to the FDA in March.

Analysts and physicians have long said the future of anti-amyloid Alzheimer's therapy will rely on subcutaneous medicines, as the limited number of available infusion centers places a constraint on intravenous drugs. Eli Lilly, whose intravenous donanemab is expected to win FDA approval this year, is at work on a subcutaneous amyloid treatment of its own, called remternetug. If everything goes according to plan, under-the-skin therapies will likely be the standard of care in the years to come.

Read more.

GLP-1

Does Pfizer have a future in obesity?

We'll find out any day now when the company discloses all-important mid-stage data on an oral medicine it hopes can compete with the heirs to Wegovy and Mounjaro.

The drug, danuglipron, is a twice-daily pill that targets GLP-1, the biological target that has upended the drug industry and shifted billions of dollars of value on the stock market. Pfizer is running a Phase 2 study testing whether danuglipron can meaningfully reduce body weight for patients diagnosed with obesity, and Leerink Partners analyst David Risinger expects the company to disclose results as early as Oct. 31.

The stakes are uncommonly high for a drugmaker of Pfizer's size. The declining demand for Covid-19 vaccines and treatments led the company to slash its revenue outlook, and Pfizer's stock has fallen 40% since the start of the year. The company's once-promising future in GLP-1 took a hit in June, when Pfizer discontinued one of its potential weight-loss pills. That puts added pressure on danuglipron, which will need to stack up to a promising oral GLP-1 therapy from Eli Lilly if Pfizer hopes to have a future in the fast-growing field.

R&D

Biogen is turning back to tau

For years, scientists have known that toxic tangles of the protein tau play a role in the advance of Alzheimer's disease. But unlike the case of the better-known amyloid, drugmakers' best ideas have never materialized into an effective tau-targeting medicine.

Biogen believes that might change. As STAT's Adam Feuerstein reports, the company presented early data showing that a tau-directed therapy, injected into the spine, significantly reduced measurable levels of the protein and, in a small group of patients, showed improvements in cognition, memory, and function.

The drug, BIIB080, is an antisense oligonucleotide, much like Biogen's approved spinal muscular atrophy treatment Spinraza. Unlike the failed tau-targeting antibodies of the past, BIIB080 is designed to shut down the production of protein before it has a chance to twist into neuron-destroying tangles, theoretically slowing the progression of Alzheimer's in the process.

Read more.

Financials

Biotech's slump is starving suppliers

When times were good in biotech, the industry's many outsourcers were selling picks and shovels in a gold rush, cashing in on the boom by providing services to an ever-expanding number of startups trying to develop new drugs. But in 2023, with biotech deep into a contraction, those businesses are suffering.

The latest example is Thermo Fisher Scientific, maker of lab tools, which has lost about $15 billion in value this week after cutting its profit forecast for the second time this year. The issue, executives have said, is sharply declining demand from the drug industry.

Thermo is hardly alone. Last month, Lonza, a contract manufacturer, abruptly replaced its CEO without explanation, news that sent the company's share price down more than 10% and stirred speculation that it would struggle to make its revenue targets. Earlier this year, competitor Danaher, a company that slashed its outlook three times in 2023 alone, agreed to pay $5.7 billion for the reagents firm Abcam to bolster its flagging business.

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