Lilly Misses 2024 Guidance, Expects More In 2025
Eli Lilly pre-announced its full-year 2024 revenue, which missed analyst consensus and the company’s own guidance, and provided its 2025 revenue guidance on the morning of 14 January ahead of CEO David Ricks’ fireside chat at J.P. Morgan in the afternoon.
Lilly said its 2024 revenue came in at $45bn, which is $400m below the low end of $45.4bn-$46.6bn in revenue that the company predicted for the year when it reported third quarter revenue at the end of October. The shortfall was attributed to lower than expected revenue from the GLP-1/GIP agonist tirzepatide franchise – Mounjaro for type 2 diabetes and Zepbound for obesity – during the fourth quarter. The US incretin market grew 45% in Q4, but Lilly said its guidance anticipated even faster growth for the quarter versus the same period in 2023.
Last year’s $45bn in revenue represents 32% growth from the prior year and the company expects about the same or more in 2025, with revenue rising to $58bn-$61bn, about 32% growth at the midpoint. Ricks told the J.P. Morgan crowd that the lower-than-expected sales of Mounjaro and Zepbound in Q4 could be attributed to two main things – a lack of a big rise in filled prescriptions that are normally seen in December and stockpiles at distributors.
“The rest of the portfolio performed incredibly well as well, now annualizing at about $20bn and growing in the mid-teens,” he said. “And I think if you stripped away incretins and GLP-1s from the pharma sector, the balance of Lilly would probably be the biggest fast-growing company [or] fastest-growing big company in the sector. And we’re very proud of that, because long-term it’s important that we have balance and we work on important medicines in diseases other than obesity.”
Wells Fargo analyst Mohit Bansal said in a same-day note that Lilly’s 2025 guidance is slightly higher than consensus.
“Can we trust in this guidance now?” he wrote. “That is the key question since the company has now missed two quarters in a row. We still do not think there is a demand issue yet and think both access and demand should grow in 2025 with label and geographical expansion. Supply appears to be improving, as LLY expects sellable doses to be higher by 60% in 1H25 compared to 1H24.”
Kisqali On Path To $8bn+
Novartis’s CDK4/6 inhibitor Kisqali (ribociclib) is on track to become the company’s best-selling drug following expansion into a new indication in early breast cancer, CEO Vas Narasimhan said during a presentation at the Westin.
Kisqali was approved by the US Food and Drug Administration in September for adjuvant treatment of HR+/HER2- stage II and stage III early breast cancer in patients at high risk of recurrence, including those with node negative disease in combination with an aromatase inhibitor. The new indication puts Kisqali at an advantage to its CDK4/6 competitors − Lilly’s Verzenio (abemaciclib) and Pfizer’s Ibrance (palbociclib).
“Kisqali now, given the trajectory that we’re seeing in early breast cancer, we believe can be an $8bn+ medicine in the breast cancer setting,” Narasimhan said. Those revenue estimates have the potential to position Kisqali as the company’s best-selling drug ever.
“Diovan was at that $7bn-$8bn range,” he said, referencing Novartis’s blockbuster antihypertensive that went generic in 2012. The company’s current top-selling drug is the heart failure drug Entresto (sacubitril/valsartan), built off the back of Diovan, which generated $6.04bn in 2023. But Entresto is approaching the end of its exclusivity and is expected to face generic competition in mid-2025 in the US, if not earlier, given a new threat from MSN Laboratories, which has threatened to launch a generic imminently.
Kisqali, meanwhile, generated $2.08bn in 2023, but is on a fast growth trajectory.
“Getting Kisqali right is going to be probably the one thing we have to do and all signs are that we’re on the right track,” Narasimhan added.
“The hard work is still to come. We have the launches in Europe. We have the launches in other parts of the world, but I think all the early signs would suggest this is going to be a really great launch,” he said.
Cobenfy May Be A Quick Contributor To BMS Growth
BMS has been gearing up for the last few years to grow revenue through new products as its biggest sellers – Revlimid (lenalidomide), Eliquis (apixaban) and Opdivo (nivolumab) – face competition from generics and biosimilars in the latter half of this decade. The company’s growth product portfolio made up nearly 50% of its 2024 revenue and is expected to generate more than half of Bristol’s revenue during 2025, chief financial officer David Elkins told Scrip at the J.P. Morgan Healthcare Conference.
And Cobenfy (xanomeline and trospium chloride), approved in the US in September and launched in October for the treatment of schizophrenia, appears on track to be a significant contributor to the company’s growth this year, based on patient, physician and payer feedback to date, according to chief commercialization officer Adam Lenkowsky.
He cited the Cobenfy approval, “the first novel agent for schizophrenia in decades,” as well as the December approval of the subcutaneous version of Opdivo, Opdivo Qvantig, “which will allow us to extend our [immuno-oncology] franchise into the 2030s,” as signature moments for the firm.
Lenkowsky noted that 2025 “is another important year as we continue to focus on driving performance across the growth portfolio. We’re off to a strong start with Cobenfy and we’re focusing on converting our Opdivo business over from I.V. to subq.”
He pointed out that by the end of this decade, BMS expects to launch 10 new medicines and up to 30 new indications for its approved products. Cobenfy’s launch could set a high bar if initial market and payer response turns into strong sales in the year ahead.
“The feedback from physicians and from patients has been outstanding,” Lenkowsky said. “We are hearing from physicians and from patients that not only is the product delivering against the efficacy and safety profile that we saw in Phase III studies, but patients are deriving benefit around clarity of thinking, cognition. They’re reengaging with their families. And so, it’s been incredible to see and hear these stories that come in on a weekly basis from our field teams.”
Sales teams already have reached more than 70% of targeted physicians and reimbursement negotiations are tracking ahead of Bristol’s projections, he said.
“As we now come into 2025, we have now secured nearly all state Medicaid programs to cover Cobenfy,” Lenkowsky said. “And for Medicare, which is another big part of covering this product, we’re making great progress. We should have near 100% coverage by the end of the first quarter or early second quarter. So, this is going to be important for us as we see the ramp of this product really coming in the second half of the year. We are very pleased, but we’re still early in the launch and we know the work that we have ahead of us to do.”
GSK Swooped Over Christmas To Secure Cancer Drug Deal
GSK kicked off this year’s J.P. Morgan dealmaking flurry on 13 January with its $1bn upfront payment for oncology specialist IDRx. One day on, CEO Emma Walmsley revealed at the company’s conference presentation that chief commercial officer Luke Miels had worked on Christmas Day in order to secure the acquisition.
The buyout brings with it IDRX-42, a highly selective KIT tyrosine kinase inhibitor (TKI) designed to treat gastrointestinal stromal tumors, that can target mutations not addressed by current standard therapies, including the older TKIs imatinib and sunitinib.
Miels added that the acquisition overlapped well with GSK’s growing portfolio in gastrointestinal cancers, including its anti-PD-1 Jemperli (dostarlimab), which is currently in a pivotal Phase II study for locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer.
Commenting on the decision to move fast for the Cambridge, MA-based biotech, Miels said: “We looked at that in December and decided if we left it until JPM, it probably wouldn’t be there. So hence the effort over the Christmas break.”
GSK is aiming to secure no fewer than five product approvals in 2025, the most important being the antibody-drug conjugate Blenrep (belantamab mafodotin), with a US Food and Drug Administration decision about a return to market for relapsed/refractory multiple myeloma, after having been withdrawn in 2002, expected on 23 July.
Sarepta Is Surefire Bet, CEO Ingram Tells Investors
Sarepta Therapeutics represents “an extraordinary opportunity for those interested in investing in companies focused on financial performance and execution,” according to CEO Doug Ingram, who told attendees at J.P. Morgan that his firm was one of the very few in the sector to actually turn a profit.
“As you all know, there are 1,000s of biotechs, both private and public, that exist today [and] we are one of only about 14 that have ever been profitable and durably cash flow positive,” he said. Speaking after presenting another stellar sales performance for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec) and talking up a recently-inked small interfering RNA (siRNA) deal with Arrowhead Pharmaceuticals (which has yet to close), Ingram also claimed that “our largely de-risked portfolio is poised to deliver substantial revenue and cash flow through 2030.”
By the end of the decade, Sarepta’s goal is to have 10 therapies on the market and revenues exceeding $30bn, he said, with $16bn in operating income and cash flow in the region of $13bn. This aim “does not rely on big, risky new approvals [or] binary development readouts,” Ingram claimed, but “primarily comes from our existing therapies and continuing execution by us, so we feel very good about where we’re heading.”
Much of his enthusiasm is based on the company’s plans to diversify beyond DMD with its first gene therapy for limb-girdle muscular dystrophy (LGMD). Sarepta plans to report Phase III results for SRP-9003 in LGMD type 2E during the first half of 2025 and file a biologics license application with the FDA in mid-2025.
Ingram said that Sarepta had “six programs for six different diseases under this broad umbrella called LGMD [and] each of these is a deadly disease and entirely unserved.” He added that there was “a real opportunity to do good by these patients and the second thing to understand as an investor is there’s an enormous commercial opportunity ... together, these represent about 71% of the Elevidys opportunity [and] if we’re successful, these will be likely in the top three most successful gene therapy launches when they come.”