Club holding Eli Lilly is expecting to get approval for its Alzheimer’s treatment in the approaching weeks, but investors in search of 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. Briefly: Uptake of the drug, the primary of its kind to receive full U.S. regulatory approval, has been limited by bottlenecks within the healthcare system including access to dementia specialists who could make an Alzheimer’s diagnosis. Eli Lilly’s experimental treatment — which has similarities to Leqembi in the way in which it targets the disease and is run to patients — is more likely to face the identical obstacles if cleared by the Food and Drug Administration despite its long-term promise. The FDA’s decision on Lilly’s drug, often called donanemab, is anticipated by the top of March. The most recent update from Biogen underscores the challenges ahead for Lilly in making donanemab a industrial success. Within the meantime, Eli Lilly’s diabetes and obesity drugs, the guts of our investment thesis, should proceed to fuel the lion’s share of the corporate’s topline growth. About 2,000 patients are currently taking Leqembi, Biogen said Tuesday, up from 800 on the time of the corporate’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 top 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 supply reimbursement for the treatment. “We’re clearly seeing that there’s demand for the product,” Biogen CEO Chris Viehbacher said Tuesday. Nevertheless, the challenge is converting individuals who wish to be on Leqembi into recipients attributable to healthcare system bottlenecks. Along with the variety of dementia specialists, Viehbacher said scheduling a checkup MRI to observe the drug’s negative effects also has stood in the way in which 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. Because of 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 precise 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 primary quarter, which ends March 31. The choice could have implications for fellow Club holding GE Healthcare , which makes MRI machines utilized in monitoring negative effects. We expect the medical equipment maker to profit 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 thus far in 2024. Donanemab — and Lilly’s next-generation Alzheimer’s therapies, for that matter — should help fuel growth for the corporate within the years ahead. But within 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 a very powerful drivers of its financials and stock, which has been an enormous winner in recent times including thus far 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 turn into 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 line with estimates compiled by FactSet. Meanwhile, Mounjaro and Zepbound are expected to herald a combined $11.7 billion, FactSet data shows. Pharmaceutical firms, including Biogen and Eli Lilly, have spent billions of dollars through the years developing experimental Alzheimer’s treatments, but Leqembi is the primary drug designed to slow the progression of the disease to receive traditional FDA clearance. In that way, Biogen and Eisai are the primary firms to run into the bottlenecks within the healthcare system for Alzheimer’s treatment, though analysts consider Eli Lilly’s expected presence out there will help alleviate a number 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 idea 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 within the disease shouldn’t be fully understood. Unwanted 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, however 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 negative 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 might be whether it has any different screening and monitoring requirements compared with Leqembi, Morgan Stanley analysts also said within the note. (Jim Cramer’s Charitable Trust is long LLY and GEHC. See here for a full list of the stocks.) As a subscriber to the CNBC Investing Club with Jim Cramer, you’ll receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust’s portfolio. If Jim has talked a couple of stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.
Eli Lilly hits $1 trillion market value, first for health care company
An indication with the corporate logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.Scott...
