FDA approval of Eli Lilly’s Alzheimer’s drug cements our decision not to take profits

July 2, 2024

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Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street. Rally in markets: Stocks were higher across the board Tuesday afternoon, led by the Nasdaq Composite , which added 0.7% and was on pace for back-to-back record closes. The S & P 500 , which had been hovering near the flatline in earlier in the session, advanced around 0.4%. Shaking off earlier losses, the Dow Jones Industrial Average added about 100 points, or 0.25%. Big news for Lilly: The Food and Drug Administration on Tuesday approved Eli Lilly’s Alzheimer’s treatment donanemab. The drug will be sold under the brand name Kisunla and cost $32,000 for a 12-month course. Shares of Eli Lilly moved off session lows on the news. The stock was under more pressure earlier in the day due to President Joe Biden and Vermont Sen. Bernie Sanders criticizing the cost of the company’s fast-growing weight-loss drug Zepbound. Kisunla is not expected to be a significant driver of growth for Eli Lilly this year or into 2025, especially when considering the billions of dollars in projected sales for Zepbound and its sister drug Mounjaro, which shares an active ingredient, tirzepatide, and is used to treat type 2 diabetes. Still, we have viewed the FDA approval of Lilly’s Alzheimer’s drug as an important catalyst for the company to achieve a $1 trillion market value . Analysts see $477 million of sales for Kisunla in 2025 and roughly $1 billion in 2026, according to FactSet. And already, Lilly has next-generation treatments to succeed Kisunla in the works. Lilly had hoped for Kisunla to be approved by the end of March, but the timeline was pushed back after the FDA surprisingly called a meeting of an advisory panel to take a closer look at the safety and efficacy data. The 11-member panel eventually met in June and offered unanimous support for the drug . Tuesday’s approval represents a major breakthrough in Eli Lilly’s expensive, decadeslong pursuit of treatments for Alzheimer’s , a memory-robbing disease afflicting millions of Americans. Before Kisunla, Lilly had come up short on multiple other experimental drugs, most notably solanezumab, which failed a high-profile late-stage study in 2016 . The company officially ended development of that drug last year. Lilly’s Kisunla is the second treatment of its kind to receive full FDA approval, following in the footsteps of Biogen and Eiasi’s co-developed Leqembi in July 2023. The drugs seek to slow the disease progression in a similar way by reducing the buildup of so-called amyloid plaques on a patient’s brain. These abnormal clumps of the amyloid protein have long been an indicator of Alzheimer’s disease, though their exact role in the condition is not known. Both drugs are administered intravenously. Leqembi has encountered a slower-than-expected rollout as the U.S. health-care system worked to establish infrastructure to support this new class of treatment. Patients need to first see a doctor who can determine their eligibility for the anti-amyloid drug. Then, IV infusions need to be scheduled to deliver the drug every two weeks along with periodic MRI scans to monitor the side effects, which include brain swelling and bleeding. Leqembi is pricey, at more than $26,000 a year, so making sure insurance reimbursement is in place has been another important piece to the treatment puzzle. Biogen said in late April that uptake of Leqembi is accelerating, and executives offered encouraging commentary about hospital systems becoming better equipped to handle patients on the drug. Lillly’s entrance into the Alzheimer’s market may further accelerate that progress, according to Alisha Alaimo, the head of Biogen’s North America business. “In a space like this, where there has been such a heavy lift by the physician community, a competitor or another option is always really a good thing,” Alaimo said at a Goldman Sachs health-care conference June 12. “It’s a good thing for physicians. It’s a good thing for patients. But, more importantly, the market will develop faster with Lilly in play.” We had debated taking profits in Eli Lilly earlier Tuesday but ultimately decided against it because any elevated political risk from Washington in the short run does not change the long-term story for the pharmaceutical giant. We’ve been saying for years its growth prospects were the best among large-cap peers, anchored by Mounjaro and Zepbound, and now Kisunla can officially be considered part of the story. Corona on tap: Club holding Constellation Brands is set to report quarterly results before the bell on Wednesday. The post-earnings conference call is set for 10:30 a.m. ET. While there has been some concern about poor weather around Memorial Day impacting Constellation’s quarter, several analysts remain upbeat on the stock heading into the print. In a note to clients Friday, Goldman Sachs said investor expectations are low due to softer trends industrywide. But analysts said that based on feedback from their distributor and retailer contacts, the Corona and Modelo parent is primed for a beat on the top and bottom lines. Wall Street expects the company to earn $3.46 per share on revenues of $2.67 billion, according to estimates compiled by LSEG. We’ll also be looking for commentary on how the summer is shaping up for its key Mexican beer brands, and whether there are any green shoots in Constellation’s struggling wine-and-spirits business. Up next: The U.S. stock market closes early on Wednesday, at 1 p.m. ET, ahead of the Fourth of July. It is closed on Thursday in observance of the holiday. Before the break, though, we’ll get a look at private payroll growth in June via ADP’s employment survey on Wednesday morning along with weekly initial jobless claims. (See here for a full list of the stocks in Jim Cramer’s Charitable Trust.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will 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 about a 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.

Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street.

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