2024 Guidance
Full year 2024 guidance is as follows:
Organic revenue growth* of approximately 4% year-over-year.
Adjusted EBIT margin* in the range of 15.6% to 15.9%, reflecting an expansion of 50 to 80 basis points versus 2023 Adjusted EBIT margin* of 15.1%.
Adjusted effective tax rate (ETR)* in the range of 23% to 25%.
Adjusted EPS* in the range of $4.20 to $4.35, representing 7% to 11% growth versus Adjusted EPS* of $3.93 for 2023.
Free cash flow* of approximately $1.8 billion.
Eli Lilly (LLY) stock pulled back from bullish gains Tuesday despite strong sales of its new weight-loss drug, Zepbound, and promising results in liver disease treatment.
Zepbound was on the market for just weeks in the December quarter. But sales climbed rapidly to $175.8 million. That was more than double the $75 million estimate from analysts polled by FactSet. Another forecast suggested Zepbound could come in with $125 million.
Importantly, Lilly also announced positive results from a study of tirzepatide, the chemical backbone behind Zepbound and diabetes drug Mounjaro, in a liver disease called metabolic dysfunction-associated steatohepatitis, or MASH. After a year, 74% of patients who received tirzepatide showed no signs of MASH and their liver fibrosis didn't worsen. Just 13% of placebo recipients hit the same marks.
The news suggests GLP-1 drugs, like tirzepatide, could play a part in treating MASH, formerly known as nonalcoholic steatohepatitis, or NASH. But these drugs won't be a "silver bullet" or provide a functional cure for the disease, Leerink Partners analyst Thomas Smith said in a report.
"The size of the potential market and nature of the disease provide ample opportunity for multiple winners among companies developing (MASH) therapeutics," he said.
Eli Lilly stock slouched a fraction to 705.03. Earlier, shares rose as much as 4.8% to 740. Shares ended the regular session on Monday extended, up 12% from a 629.97 buy point, following a January breakout from a flat base, according to MarketSmith.com. The profit-taking zone runs from 755.96 to 787.46.
Meanwhile, shares of companies working on MASH treatments collapsed. 89bio (ETNB) stock crashed 17% to 8.13, Akero Therapeutics (AKRO) stock tumbled 12.3% to 17.76, and Madrigal Pharmaceuticals (MDGL) closed at 201.44, down 11.3%.
David Song, an investment partner at Tema ETFs, said Lilly is "doing exactly what they should be."
The company is investing in bolstering its obesity drug supply with a new $2.5 billion plant in Germany. It's also building out its research and development, evidenced by the MASH news Tuesday.
"Zepbound is off to a strong start as well after hitting pharmacy shelves on the fifth of December," Song said in an email to Investor's Business Daily. "In short, this was a straightforward quarter. What will be important during the year is further data readouts, like the positive MASH Phase 2 readout today and how the neurology story builds."
Notably, Mounjaro also put up a bullish performance in the fourth quarter. Revenue from the tirzepatide-based diabetes treatment grew nearly eightfold year over year, hitting $2.21 billion. That also handily beat Eli Lilly stock analysts' forecast for $1.73 billion in sales.
Third Bridge analyst Lee Brown says Lilly's direct-to-consumer website, LillyDirect, should help bolster sales of both "given available rebates for patients without insurance coverage for the drugs."
"Importantly, LillyDirect may encourage pharmacy benefit managers to expand coverage, particularly for Zepbound going into 2025 as managed care organizations consider how to market and price plans," he said in a report.
Overall, Lilly came up with adjusted profit of $2.49 per share and $9.35 billion in fourth-quarter sales. Earnings popped 19% and were well above the forecast for $2.30 a share. Sales advanced 28% to beat the Street's projection for $8.95 billion.
Third Bridge's Brown noted cancer drug Verzenio showed some strength. Sales jetted 42% higher to $1.15 billion. However, that missed expectations for $1.17 billion, according to FactSet. Diabetes drug Jardiance also put up a strong performance. Jardiance sales climbed 30% to $798.1 million and beat projections for $771.8 million.
Eli Lilly also provided promising guidance for the year. The company expects $40.4 billion to $41.6 billion in sales, easily above Wall Street's estimate for $39.27 billion. Lilly expects to earn an adjusted $12.20 to $12.70 per share. The midpoint of that outlook, $12.45, is slightly ahead of Eli Lilly stock analysts' forecasts for $12.39.
https://www.investors.com/news/technology/eli-lilly-stock-eli-lilly-earnings-q4-2023/
Kyverna Therapeutics, a Phase 2-ready biotech developing cell therapies for autoimmune diseases, raised the proposed deal size for its upcoming IPO on Tuesday.
The Emeryville, CA-based company now plans to raise $297 million by offering 14.5 million shares at a price range of $20 to $21. The company had previously filed to offer 11.1 million shares at a range of $17 to $19. At the midpoint of the revised range, Kyverna Therapeutics will raise 49% more in proceeds than previously anticipated.
Kyverna Therapeutics is focused on developing cell therapies for patients suffering from autoimmune diseases. Its lead program is KYV-101, an autologous CD19 CAR T-cell therapy made from an underlying chimeric antigen receptor licensed from the National Institutes of Health that previously completed a Phase 1 trial in oncology. Kyverna is developing KYV-101 across two broad areas of autoimmune disease: rheumatology and neurology. Its initial rheumatology development focus is on lupus nephritis (LN) and systemic sclerosis (SSc). The company plans to conduct two trials of KYV-101 in patients with LN, and has also received IND clearance for a Phase 1/2 study in SSc. In neurology, Kyverna is focused on myasthenia gravis (MG) and multiple sclerosis (MS), and it has received IND clearance for Phase 2 studies in both diseases.
Kyverna Therapeutics was founded in 2018 and plans to list on the Nasdaq under the symbol KYTX. J.P. Morgan, Morgan Stanley, Leerink Partners, and Wells Fargo Securities are the joint bookrunners on the deal. It is expected to price during the week of February 5, 2024.
FDA IND clearance is an important development milestone in advancing enobosarm in combination with GLP-1 drugs for potentially higher quality weight loss than has been shown with GLP-1 drug alone
Randomized Phase 2b clinical trial aims to show enobosarm preserves muscle and physical function while augmenting fat loss in sarcopenic obese or overweight elderly patients on GLP-1 drug for weight loss
Phase 2b clinical trial is expected to initiate by April 2024
Phase 2b clinical trial final topline results are anticipated by year-end
