Eli Lilly, Novo Nordisk boost weight loss drug supply

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Good afternoon! A highly popular group of weight loss and diabetes drugs is still hard to find in the U.S. The dominant manufacturers of those treatments, Eli Lilly and Novo Nordisk, are making progress toward changing that. 

But Wall Street appears to be more encouraged by one than the other.  

The drugmakers shared supply updates when they reported their financial results for the first quarter. Demand for their weight loss and diabetes medications has far outpaced supply over the last year, forcing the pair to invest heavily to scale up their manufacturing.

Investors cheered Eli Lilly after the company hiked its full-year revenue outlook by $2 billion, in part due to confidence about increased production of its weight loss drug Zepbound, diabetes treatment Mounjaro, and similar drugs for the rest of the year. The company refers to those treatments as incretin drugs, which mimic certain gut hormones to suppress a person’s appetite and regulate blood sugar. 

“Now that we’re four months into the year, we have greater visibility into that, into these nodes of capacity and feel more confident,” Eli Lilly Chief Financial Officer Anat Ashkenazi told investors during an earnings call on April 30.

She noted that Eli Lilly has several manufacturing sites either “ramping up or under construction,” including two locations in North Carolina, two in Indiana, one in Ireland and one in Germany. There’s also a seventh site the company recently acquired from Nexus Pharmaceuticals. 

Ashkenazi also highlighted the recent approval and upcoming launch of a new delivery device for Mounjaro called KwikPen in Europe and the U.K., which she said will “unlock new supply capacity” for certain international markets. That’s because Eli Lilly for years has used that device for insulin, so the company can tap into existing manufacturing resources to make more of other incretin drugs. 

KwikPen is a single four-dose pen that covers a month’s treatment. Patients using current autoinjectors for weight loss and diabetes drugs go through four different pens per month. When asked whether the company will launch the device in the U.S., Eli Lilly CEO David Ricks told investors, “We haven’t ruled it out in other jurisdictions.” 

Eli Lilly expects supply for Zepbound, Mounjaro and other incretin drugs to remain “quite tight” in the near- to mid-term as demand remains high, Ashkenazi said. But she noted that Eli Lilly expects its production of sellable doses of incretin drugs to be at least 1.5 times higher later this year compared with the second half of 2023 — a goal the company first outlined in February. 

On the day Eli Lilly reported earnings, shares of the company jumped more than 5% on the raised guidance and supply updates. 

“While [Lilly] continues to see demand for incretins as outstripping supply for the foreseeable future, the company is clearly making progress ramping capacity, and this should translate to accelerating volume growth throughout the year,” JPMorgan analyst Chris Schott said in a research note last week. 

Meanwhile, investors seemed to be less impressed with Novo Nordisk last week. Shares of the company fell more than 2% on May 2 after releasing first-quarter results. 

Novo Nordisk executives said on a media call that day that the company is gradually increasing production of lower strength or “starter” doses of its weight loss drug Wegovy in the U.S. after restricting its supply of them last May to cope with demand. 

About 27,000 new patients in the U.S. are now starting the weekly injection each week, CEO Lars Fruergaard Jorgensen said on a media call. That’s up from 5,000 each week in December. 

“This is really a very nice volume ramp, as we were planning for,” Jorgensen said. 

He added that the company will continue to boost the supply of Wegovy and its diabetes counterpart Ozempic throughout the rest of the year. The company’s primary focus is “ensuring continuity of care for patients who have already initiated treatment,” Jorgensen said. 

Still, Novo Nordisk missed Wall Street’s estimates for sales of its weight loss drug Wegovy, even as supply and prescriptions for the drug increased during the quarter. Wegovy revenue more than doubled to 9.38 billion Danish kroner (US$1.35 billion) during the period, falling under analysts’ expectations of 10.55 billion Danish kroner (US$1.52 billion), according to FactSet.

That’s because prices for Wegovy and Ozempic fell in the first quarter as volumes and competition increased, Karsten Munk Knudsen, the company’s CFO, told analysts on a call. 

He added that the trend would continue through the rest of the year. The U.S. list prices for Wegovy and Ozempic are still roughly $1,000 a month, but Novo has been offering rebates and discounts to insurers to expand coverage to more patients.

We’ll be continuing to watch how the supply landscape shifts throughout the rest of the year. Stay tuned for our coverage.

Feel free to send any tips, suggestions, story ideas and data to Annika at [email protected].

Apple clinched a nod of approval from the U.S. Food and Drug Administration for its heart-monitoring technology on May 3. 

The agency announced that the Apple Watch’s Atrial Fibrillation History feature can be used in clinical studies through its medical device development tools program. Apple’s feature is the first digital health technology that qualifies under the program, the FDA said. 

The FDA program identifies technologies that are reliable enough to use in a scientific research context. It’s a voluntary pathway, and the tools and solutions that qualify under the MDDT program are then used to help evaluate new medical devices. 

Apple’s Atrial Fibrillation History technology will serve as a biomarker test to assess the safety and effectiveness of cardiac ablation devices, which are used to treat irregular heartbeats. 

Atrial fibrillation, often called AFib, is a type of irregular heart rhythm that is caused when the organ’s upper chambers beat “chaotically,” according to the Mayo Clinic. AFib often causes a rapid, pounding heartbeat, and can lead to blood clots and increased risk of stroke or heart failure. 

The condition affects individuals differently, and sometimes people don’t experience any symptoms. Even so, patients with AFib usually require treatment like medication, therapy or surgeries to prevent outcomes like a stroke, the Mayo Clinic said. 

Apple’s AFib History feature allows users to track the amount of time their heart shows signs of AFib over an extended period, according to the company’s website. The feature is not intended for use by people under the age of 22, and users need to wear their Apple Watch for at least 12 hours per day and five days a week to receive estimates.

Users can also share their data with their doctors to help determine the right treatments and next steps for them. 

AFib History was initially approved by the FDA two years ago, and Apple has step-by-step instructions online for patients who are interested in getting set up.  

Feel free to send any tips, suggestions, story ideas and data to Ashley at [email protected].