Welcome to day 1 of the J.P. Morgan Healthcare Conference, the industry's most significant dealmaking event each year.
For the 43rd edition of the JPM conference, Johnson & Johnson stole the spotlight off the bat, announcing a $14.6 billion acquisition of Intra-Cellular Therapies and its FDA-approved drug Caplyta, which treats schizophrenia or depression associated with bipolar 1 or 2 disorder.
Fierce reporters and editors are on the ground in San Francisco and we're sure the news will keep flowing into the evening. Check back here regularly for all of the day 1 headlines. For news from the conference on (pre)clinical companies and assets, such as GSK's proposed $1.15 billion deal for for IDRx, check out Fierce Biotech's roundup here.
11:55 p.m. ET
With 20 new growth drivers in its pipeline, Merck is confident in its long-term plan to “grow through the LOE, not just beyond the LOE” of oncology megablockbuster Keytruda, CEO Rob Davis said during the company’s presentation (PDF) Monday.
The drugmaker is already making “significant progress” in navigating the Keytruda LOE period and has nearly tripled the number of assets in phase 3 development since 2021, while having invested some $40 billion in strategic business development over the same time period, according to the CEO.
“I am more confident than ever that we are well positioned to be a sustainable, growing company well into the next decade and beyond,” Davis said.
Over the last few quarters, sales of the company’s staple Gardasil vaccine franchise have been dipping in China, reflecting a slowdown that Davis attributes to China’s general “macroeconomic situation” and other contributing factors. Now, the shot can reach about 200 million males in the country thanks to a recent nod from local authorities. Still, the uptake is “going to take longer,” with most of the growth coming near 2026, Davis warned.
11:52 p.m. ET
Cambridge-based Sarepta Therapeutics is joining a plethora of companies teasing their 2024 results ahead of a formal earnings wrap-up.
In a Monday press release, Sarepta reported preliminary full-year 2024 product revenue of $1.79 billion, besting its previously established guidance. That sum doesn’t account for additional sales Sarepta made from collaboration, contract manufacturing or royalties, the company explained.
Sarepta’s flagship Duchenne muscular dystrophy drug Elevidys—which won FDA approval in June 2023—delivered preliminary fourth-quarter and full-year sales of $384.2 million and $820.8 million, respectively.
Buoyed by those results, Sarepta says it closed out 2024 with cash and investments worth approximately $1.5 billion. Looking to 2025, the company continues to expect to generate net product revenue between $2.9 billion and $3.1 billion.
“2024 marked the most significant year to date for Sarepta and for the patients we serve,” the company’s CEO, Doug Ingram, said in a statement, stressing that the precision genetic medicine firm is entering the new year “with exceptionally strong performance.”
11:48 p.m. ET
Riding the momentum of last year’s approval of its metabolic dysfunction-associated steatohepatitis (MASH) drug Rezdiffra, Madrigal Pharmaceuticals highlighted the drug’s performance thus far and the company’s 2025 ambitions
With a little more than $100 million in fourth-quarter Rezdiffra revenues, Madrigal says the drug generated between $177 million and $180 million last year. There were more than 11,800 patients on Rezdiffra as of 2024’s end, Madrigal said in a press release.
Looking ahead, Madrigal is turning its attention toward a European expansion in the second half of 2025, plus results from its MAESTRO-NASH OUTCOMES trial for Rezdiffra in compensated cirrhosis, Sibold added.
While Madrigal has yet to provide revenue guidance for 2025, analysts at Evercore ISI expect Rezdiffra to reach sales of $590 million this year, according to a Monday note to clients.
6:50 p.m. ET
After Regeneron revealed early in the day preliminary sales results for Eylea HD, which Evercore ISI analyst Cory Kasimov called “relatively dismal,” CEO Len Schleifer admitted that the company didn’t have “all the necessary tools to optimize” the eye disease treatment.
During Regeneron’s presentation at the J.P. Morgan Healthcare Conference, it offered little else about the disappointing performance of Eylea HD, which the company is counting on to regain patients lost to Roche’s Vabysmo.
Schleifer raced through a checklist of items that Regeneron hopes to achieve for Eylea HD, including gaining approval for a pre-filled syringe by the middle of 2025. The company also has an FDA target date of April 20 for a decision on Eylea HD’s dosing interval to be stretched to 24 weeks for patients with macular degeneration. Regeneron also hopes for a retinal vein occlusion nod and for an every-four-week dosing option to maximize dosing flexibility.
"There’s a lot we can do to strengthen that product profile,” Schleifer said. “It needs a few more arrows in its quiver.”
6:00 p.m. ET
BeiGene CEO John Oyler spent a big chunk of his presentation at the J.P. Morgan Healthcare Conference poking holes in rival AstraZeneca’s latest fixed-duration BTK data for Calquence.
Results from the phase 3 Amplify trial, unveiled in December, linked the Calquence-venetoclax doublet to a 35% reduction in the risk of progression or death versus traditional chemoimmunotherapy in first-line chronic lymphocytic leukemia. A triplet regimen containing Roche’s Gazyva yielded a 58% improvement on the same endpoint. Both the Calquence doublet and triplet regimens were given for a finite treatment period in the study.
BeiGene, which sells the BTK inhibitor Brukinsa, considers the Amplify data “underwhelming,” Oyler said.
Both the Calquence doublet and triplet regimens underperformed historical fixed-duration venetoclax-Gazyva data in terms of undetectable minimal residual disease (MRD), Oyler noted. Undetectable MRD provides evidence of a deep response to treatment and is seen as an early indication of treatment success.
The BeiGene CEO also pointed to a sudden increase in the number of cases of disease progression in the Calquence arms later in the Amplify study, suggesting that a longer follow-up is needed to truly understand the regimens’ efficacy.
“This level of progression begs the question, is this a fixed-duration therapy, or is it an intermittent treatment?” Oyler said.
Oyler pointed to BeiGene’s investigational combination of Brukinsa and its BCL-2 candidate sonrotoclax. Phase 1 data released in December at the American Society of Hematology annual meeting showed the pairing achieved 91% undetectable MRD by week 48 when sonrotoclax was dosed at 320 mg.
BeiGene is running the phase 3 Celestial TN CLL trial testing Brukinsa and sonrotoclax as a fixed-duration regimen in first-line CLL. Launched in late 2023, the study is near enrollment completion, according to Oyler.
4:54 p.m. ET
With four potential launches planned for 2025, Incyte is looking at a “year of defining catalysts,” the company said in its JPM presentation (PDF).
During the second half of 2025, the drugmaker is expecting a pediatric approval for its Opzelura cream, an FDA nod for Monjuvi in follicular lymphoma and a label expansion for Zynyz in squamous cell anal carcinoma, where its drug could become the new standard of care for advanced disease.
The company is also gearing up to roll out its recently approved third-line graft-versus-host disease treatment Niktimvo during 2025’s first quarter.
Elsewhere, heavy hitters in Incyte’s pipeline include dermatology oral treatment povorcitinib, which could contribute revenue before 2029 across three indications.
4:03 p.m. ET
After two straight years of slightly declining revenue from 2021 through 2023, Gilead is set to reverse the trend in 2024 and continue the positive momentum into the future as “investment is turning into commercial benefits,” CEO Dan O’Day said on Monday at the J.P. Morgan Healthcare Conference.
That confidence comes from the company’s expectation to launch seven new HIV products before powerhouse Biktarvy loses its market exclusivity, which is expected to happen in 2033. One of those is twice-a-year injection lenacapavir—Science magazine’s 2024 breakthrough of the year—which dominated the company’s presentation and is expected to gain approval as a PrEP option this year.
While revenue has been stagnant, Gilead has had no issue generating billions in cash each year, allowing the company to do "appropriate M&A and partnerships to bring on and continue to supplement” the company’s portfolio. As an example, O'Day cited the company's $4.3 billion deal to acquire CymaBay and its liver disease medicine Livdelzi.
2:35 p.m. ET
As part of a fireside chat Monday, Pfizer CEO Albert Bourla said the company is getting ready for a “LOE wave” that’s creeping toward the company in coming years, referring to losses of exclusivity on big-selling medicines.
The wave of patent losses stands to threaten some $17 billion to $18 billion in annual sales, Bourla said.
Pfizer moved to get out in front of the threat by striking a series of acquisitions in recent years. Products acquired in Pfizer’s string of M&A deals—such as its $43 billion purchase of Seagen—will contribute $20 billion in annual sales by 2030, more than offsetting expected losses of exclusivity, Bourla said.
Beyond acquired meds, Pfizer has confidence in its own recent launches and pipeline meds such as CDK4 inhibitor atirmociclib, which is in late-stage testing in second-line HR-positive, HER2-negative metastatic breast cancer, Bourla said.
2:05 p.m. ET
Speaking shortly after Johnson & Johnson revealed its $14.6 billion acquisition of Intra-Cellular Therapies, CEO Joaquin Duato tamped down any idea that the company was on the verge of going on an M&A binge.
“For us, larger deals are more outliers,” Duato said during his J.P. Morgan Healthcare Conference presentation. “The majority of the value that we create is through smaller deals and partnerships where we can use our scale.”
As for the acquisition of Intra-Cellular’s soon-to-be blockbuster Caplyta, Duato said the company believes it could become the new standard of care for schizophrenia, bipolar and major depressive disorder.
1:22 p.m. ET
While companies strive to accentuate the positive during the J.P. Morgan Healthcare Conference, the situation at Moderna requires the mRNA specialist to confront reality. Early Monday, the company shared word that it's dramatically slashing its 2025 sales guidance and "accelerating and expanding” its cost-savings drive. Moderna plans to slash $1 billion in costs this year and $500 million next year. Moderna's stock was trading down about 20% after the announcement.
12:47 p.m. ET
Vertex is starting off its year strong with a “multibillion-dollar opportunity” awaiting a potential FDA approval by Jan. 30, CEO Reshma Kewalramani, M.D., said during the company’s Monday presentation (PDF). Suzetrigine, a non-opioid candidate for acute pain, could “fundamentally reshape treatment” by offering a different mechanism of action than traditional opioid treatments, which carry the risks of addiction and abuse, according to the company.
As for Vertex’s FDA-approved sickle cell disease gene therapy Casgevy, the company says it’s focused on reaching more eligible patients after a “foundational 2024” for the drug. Casgevy and the company’s cystic fibrosis treatments, including standard-of-care Kaftrio and Trikafta, should help the drugmaker deliver 2025 revenues between $10.8 billion and $10.9 billion, according to the presentation.
In 2023, Vertex set a goal to launch five new drugs in five years. After making good on ambition that by 2028, the company believes it will be in a position to deliver sustainable growth. Besides suzetrigine, upcoming launches could include a “potential-best-in-class approach” to treat IgA nephropathy (IGAN) in povetacicept, which is currently in phase 3 trials.
12:42 p.m. ET
Coming off a protracted rough patch in 2023, generic and innovative medicines hybrid Teva Pharmaceutical Industries has busied itself in recent years executing on CEO Richard Francis’ “Pivot to Growth” strategy, which has subsequently helped the company achieve 7 straight quarters of revenue growth.
In that time, two of the drugmaker's branded medicine stalwarts—Austedo for tardive dyskinesia and Huntington’s disease and migraine prevention med Ajovy—have been joined by the long-acting schizophrenia injectable Uzedy. Together, that trio of growth drivers has nearly doubled sales—from roughly $1.3 billion in 2022 to an expected haul of $2.2 billion last year, Francis said during his company’s presentation (PDF) at the 2025 J.P. Morgan Healthcare Conference on Monday.
Two years into the corporate overhaul, Francis said Teva is on track to deliver on his strategy’s 2027 targets, which hinge on the launch of new innovative drugs like the company’s long-acting injectable version of the atypical antipsychotic olanzapine, plus continued growth of Teva’s biosimilar portfolio.
On the topic of where the tactic will go in the coming years, the CEO emphasized that Teva wants to “keep the momentum we’ve got.”
12:26 p.m. ET
“Pushes and pulls” has been a key question for Bristol Myers Squibb over the last few years as several of its key medicines are nearing generic competition and as the drugmaker works to fill in the gaps with promising new therapies.
The subject was top of mind again Monday at the J.P. Morgan Healthcare Conference as CEO Chris Boerner said that the company’s “legacy portfolio” will see loss of exclusivity exposure “ratchet up” in 2025, especially for Revlimid. BMS expects the multiple myeloma drug, which generated worldwide sales of $4.4 billion in the first nine months of 2024, will pull in between $2 billion and $2.5 billion in 2025.
But Boerner also spoke to a generic “stacking effect” for BMS in 2025 as Pomalyst and Sprycel also face upcoming generic threats. As the legacy portfolio's generic exposure grows, BMS is working to capitalize on its newer assets, the CEO explained.
“We saw nice growth with our young portfolio growth assets last year—again on track to deliver double-digit growth in 2024—[and] that business will continue to grow,” Boerner said Monday at JPM. “This next wave of catalysts and delivering on those catalysts starting this year, and for the next 24 months, is a big area of focus for us.”
BMS is entering 2025 as a company with a younger and more diversified portfolio than before, the CEO said. The company sees the potential to launch 10 new drugs and secure 30 label expansions over the next five years.
10:17 a.m. ET
Alnylam is looking to generate more than $2 billion in sales in 2025. The company is forecasting full-year combined product revenue of between $2.05 billion to $2.25 billion, with $1.6 billon to $1.7 billion expected to come from the company's transthyretin (TTR) amyloidosis meds Onpattro and Amvuttra. The remaining $450 to $525 million is expected to come from rare disease medicines Givlaari and Oxlumo, the company said in a corporate update ahead of its Monday JPM presentation.
Last year, Amvuttra proved to be Alnylam’s biggest earner by far, generating $970 million in sales. The drug is currently approved in ATTR-polyneuropathy but is on track to pick up another indication in ATTR-cardiomyopathy, where Alnylam has standard-of-care hopes. All told, 2025 should mark an “important inflection point” for the company's TTR franchise, CEO Yvonne Greenstreet noted in the press release.
10:00 a.m. ET
Before Regeneron’s JPM presentation Monday afternoon, the company shared preliminary fourth-quarter 2024 results indicating that Eylea HD generated $305 million in the U.S. during the period, while the original Eylea pulled down $1.19 billion in Q4 sales. In a note to clients, Evercore ISI analyst Cory Kasimov called the Eylea HD figure “relatively dismal” as it represented a 22% decline from the third quarter of 2024. The number is “likely to raise questions” about the drug’s long-term competitiveness against Roche’s Vabysmo, Kasimov added. The analyst expects questions to persist around the company’s lucrative Eylea franchise, which pulled down roughly $6 billion in 2024.
9:15 a.m. ET
Johnson & Johnson has entered an agreement to purchase Intra-Cellular Therapies for $14.6 billion. The deal allows J&J to seize the spotlight of the J.P. Morgan industry confab and brings an FDA-approved drug, Caplyta, which has been forecast to generate between $665 million and $685 million in 2024 sales.
Perhaps a deal of that size should not come as a surprise, as analysts with EY and PwC predicted the industry will return to larger deals in 2025 after a somewhat muted 2024. A shifting interest rate landscape and clarity around the regulatory environment in the U.S. should provide more comfort for the industry's dealmakers, according to the analysts.
While we're on the subject on M&A, be sure to check out Fierce Pharma's recap of the industry's top deals of 2024, which went live earlier this morning.