Club holding Eli Lilly is expecting to get approval for its Alzheimer’s treatment in the coming weeks, but investors searching for immediate financial success should temper their expectations. On its fourth-quarter earnings call Tuesday, rival drugmaker Biogen shared data that showed its therapy for the memory-robbing disease, Leqembi, is off to a slower-than-expected start. In brief: Uptake of the drug, the first of its kind to receive full U.S. regulatory approval, has been limited by bottlenecks in the healthcare system including access to dementia specialists who can make an Alzheimer’s diagnosis. Eli Lilly’s experimental treatment — which is analogous to Leqembi in the way it targets the disease and is run to patients — is prone to face the same obstacles if cleared by the Food and Drug Administration despite its long-term promise. The FDA’s decision on Lilly’s drug, often known as donanemab, is anticipated by the end of March. The newest update from Biogen underscores the challenges ahead for Lilly in making donanemab a industrial success. In the meantime, Eli Lilly’s diabetes and obesity drugs, the heart of our investment thesis, should proceed to fuel the lion’s share of the company’s topline growth. About 2,000 patients are currently taking Leqembi, Biogen said Tuesday, up from 800 at the time of the company’s third-quarter report in November. Despite the progress, Biogen and its partner on the drug, Japan’s Eisai , are unlikely to achieve their previous goal of 10,000 patients on Leqembi by the end of March. The Food and Drug Administration granted full approval to Leqembi in July , a milestone decision that enabled the U.S. government’s medical health insurance plan for seniors, Medicare, to offer reimbursement for the treatment. “We’re clearly seeing that there may be demand for the product,” Biogen CEO Chris Viehbacher said Tuesday. Nonetheless, the challenge is converting individuals who need to be on Leqembi into recipients as a consequence of healthcare system bottlenecks. Along with the number of dementia specialists, Viehbacher said scheduling a checkup MRI to watch the drug’s unwanted side effects also has stood in the way of eligible people starting treatment. About 3,800 persons are in an Alzheimer’s Association registry for Leqembi recipients or people near starting treatment, Viehbacher said. That means between 260 and 265 people per week were being added to the registry, up about 56% compared with December, Viehbacher, said. The registry data cited by Biogen is “encouraging but we await conversion onto therapy,” Morgan Stanley analysts said in a note to clients. Resulting from the slower-than-expected launch, analysts lowered their Leqembi 2024 revenue estimates to $370 million from $470 million, while 2025 estimates were revised more modestly, to $1.1 billion from $1.2 billion. Still, Morgan Stanley reiterated its buy-equivalent rating on Biogen’s stock, citing optimism that Leqembi adoption will reach an inflection point this yr even when the exact timing is uncertain. Approval of Lilly’s Alzheimer’s therapy donanemab could come any day. Indianapolis-based pharmaceutical giant reiterated last week that it expects a call from the FDA in the first quarter, which ends March 31. The choice could have implications for fellow Club holding GE Healthcare , which makes MRI machines utilized in monitoring unwanted side effects. We expect the medical equipment maker to learn from the rollout of Alzheimer’s drugs in multiple ways, including increased demand for its MRI machines and Vizamyl, a tracing agent used to measure amyloid plaque and aid in patient diagnoses. LLY YTD mountain Eli Lilly’s stock performance up to now in 2024. Donanemab — and Lilly’s next-generation Alzheimer’s therapies, for that matter — should help fuel growth for the company in the years ahead. But in the short run, as Biogen and Eisai’s experience shows, investors should keep their donanemab sales expectations in check. Lilly’s diabetes and obesity treatments, led by Mounjaro and Zepbound, remain the most vital drivers of its financials and stock, which has been a giant winner lately including up to now in 2024. In some ways, the early success of the drugs, which share the lively ingredient tirzepatide, offers Lilly respiration room on the expected rollout of donanemab. Jim Cramer has long said tirzepatide could grow to be the best-selling drug of all time. Wall Street projects Eli Lilly will generate $41.07 billion in revenue in 2024, with donanemab contributing about 0.5%, or $185 million, of the companywide total, in response to estimates compiled by FactSet. Meanwhile, Mounjaro and Zepbound are expected to herald a combined $11.7 billion, FactSet data shows. Pharmaceutical corporations, including Biogen and Eli Lilly, have spent billions of dollars over the years developing experimental Alzheimer’s treatments, but Leqembi is the first drug designed to slow the progression of the disease to receive traditional FDA clearance. In that way, Biogen and Eisai are the first corporations to run into the bottlenecks in the healthcare system for Alzheimer’s treatment, though analysts consider Eli Lilly’s expected presence in the market will help alleviate some of the challenges, benefiting uptake of each Leqembi and donanemab. Each drugs are antibodies that seek to remove abnormal build-up of a protein called amyloid on the brain, rooted in the belief that doing so can slow the progression of Alzheimer’s. Clumps of amyloid — normally called plaques — have long been related to Alzheimer’s, though their exact role in the disease is just not fully understood. Negative effects of the anti-amyloid drugs include brain swelling and bleeding. In an 18-month late-stage study, donanemab slowed cognitive and functional decline by 35% in a single early Alzheimer’s patient group compared with people on a placebo. Leqembi slowed the progression of the disease by 27% in its 18-month trial, but the drug is usually seen as having a greater safety profile than Eli Lilly’s therapy. Leqembi is given through an IV every two weeks, while donanemab doses are received through an IV every 4 weeks. The unwanted side effects of Leqembi are monitored through regular MRI scans during treatment. In response to the FDA’s label, patients need a baseline MRI before receiving the drug then additional scans before their fifth, seventh, and 14th infusions. If the FDA does approve Lilly’s donanemab, a key focus will likely be whether it has any different screening and monitoring requirements compared with Leqembi, Morgan Stanley analysts also said in the note. (Jim Cramer’s Charitable Trust is long LLY and GEHC. 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