JPM23, Day 1: Pfizer CEO shares pandemic predictions; BMS touts new launches

For the first time in three years, biopharma executives, investors, reporters and others are converging on the Westin St. Francis in San Francisco for the J.P. Morgan Healthcare Conference. This year's event marks the first in-person version of this conference since the pandemic began in 2020.

We're tracking the latest news from Monday here. Be sure to check back throughout today and this week for the latest headlines. And for biotech news, click here.

UPDATED: Monday, Jan. 9 at 7:11 p.m. ET

Moderna and its mRNA technology have a “very large white canvas to paint on,” CEO Stéphane Bancel said. The company aims to come up with novel ways to deliver mRNA into various cell types, each being a new application that Moderna calls a modality. Moderna has created candidates in seven different modalities so far over the last decade that cover areas such as cancer and infectious disease. The idea is that if the company invests on all the technology necessary to safely make the first vaccine work safely, then the next assets with the same application are just “copy and paste.” As for the future of the COVID-19 market, Bancel thinks that the flu market is a “pretty good model” for where things will end up. That means that the product (Spikevax boosters) will be updated regularly and potentially vary by geographic market.

Seagen’s new CEO David Epstein, who has been on the job for “a grand total of 61 days,” as he put it Monday at the JPM Conference, said that the biotech market is ripe for the picking. “Seagen is in a sweet spot in terms of being an excellent licensing partner with a great development and commercial engine,” said Epstein, who looks to supplement the company’s pipeline with novel products. The new CEO, a Novartis oncology veteran, said he wants the company to go beyond its longtime focus on antibody-drug conjugates. “I now believe our organization can develop and can now launch any kind of cancer product. We won’t do things that are far afield from our core, so you’ll never see us doing something like cell therapy. But just about anything else a cancer doc would use to treat his or her patients is something that we can develop and commercialize.”

UPDATED: Monday, Jan. 9 at 6:44 p.m. ET

Even as signs of the COVID-19 pandemic have dwindled in daily life in the U.S., Pfizer expects the SARS-CoV-2 virus to stick around. Speaking at a JPM fireside chat, CEO Albert Bourla said the virus is “all over” and “keeps mutating." Infection “creates very short-lasting immunity,” the CEO said, noting that people can “get the same strain after 6 months.” With these infection dynamics considered, Bourla said Pfizer’s scientists expect COVID-19 to be around “for the years to come.” Going forward, the CEO expects social distancing will “disappear” and that U.S. COVID-19 vaccination rates will stabilize at lower levels than seen during the initial vaccine rollouts. These low vaccination rates will cause more severe disease during future waves of infection, which should drive demand for treatments, Bourla added. 

UPDATED: Monday, Jan. 9 at 4:51 p.m. ET

Novartis has been narrowing its focus to innovative medicines, and, more specifically, five therapeutic areas. But that doesn’t mean the Swiss pharma will leave respiratory and eye diseases altogether, CEO Vas Narasimhan said Monday. Novartis has “no intention” of cutting loose its respiratory and eye meds at the moment, Narasimhan said, refuting a recent Bloomberg report that the company is weighing options, including divestitures, for those products. While non-core assets may not get much attention in Novartis’ overall business, “if something were to be a significant breakthrough, we could build back up,” Narasimhan added. Story

UPDATED: Monday, Jan. 9 at 4:10 p.m. ET

Biogen’s new CEO, Christopher Viehbacher, has been tasked with restoring the Massachusetts-based company to sustainable growth. The new CEO won’t be making any “radical left turns,” but will aim to redefine the company and make it known as a drugmaker with a broader focus. Neurology is a game of high risks and rewards, and Viehbacher sees a need to balance that risk by widening the company’s focus. While M&A is an option that he won’t shy away from, Viehbacher doesn’t feel pressure to strike deals, he said during a fireside chat.

Gilead Sciences has set its focus on growing its oncology portfolio and maximizing its HIV franchise. The company’s long-lasting HIV treatment, Sunlenca, recently won FDA approval for heavily treated patients, but Gilead isn’t stopping there. The company is testing the drug in various studies as a treatment and prevention tool. Meanwhile, Gilead has a lot on its plate and has “a lot to digest,” leaving it not very hungry for M&A, Andrew Dickinson, Gilead’s chief financial officer, noted on Monday. That doesn’t mean the company won't strike any deals in 2023, but they likely won't stack up to the drugmaker's prior large deals, such as its 2020 purchase of Immunomedics for $21 billion.

UPDATED: Monday, Jan. 9 at 3:36 p.m. ET

Bristol Myers Squibb knows it's nearing some big patent expirations for cancer star Opdivo and Pfizer-partnered blood thinner Eliquis later this decade. But the New York pharma giant isn't fazed. The company has several launches underway that are on their way to delivering billions of dollars in sales by 2025, BMS' chief commercialization officer Chris Boerner, Ph.D., said on Monday. Plus, the company's prior acquisitions give it the “scientific, financial and executional skills” to carry out more business development transactions, Boerner said. Story

Drugmakers often save good news to release at JPM, but this year, Regeneron did the opposite. Sales of Eylea in the fourth quarter were $1.5 billion, Regeneron said on Monday. The figure fell considerably short of the analyst expectation of between $1.63 and $1.65 billion and sent shares tumbling by more than 8%. During Regeneron’s presentation at JPM, CEO Len Schleifer credited sales performance to a “short-term shift” to off-label Avastin. In support of Eylea's outlook, Schleifer pointed to the drug's 75% “branded category share" and the recent trial success of its 8 mg formulation, which gives it the potential to become the “next-generation standard of care.” Story

With Sarepta anticipating an accelerated approval for its gene therapy to treat Duchenne’s muscular dystrophy, the company on Monday said it expects to achieve profitability by 2024. The expectation is buoyed by the forthcoming Duchenne’s med, SRP-9001, which if approved, could generate $4 billion in U.S. sales, Sarepta said. However, the company’s estimates for SRP-9001 are at odds with others, namely Evaluate Vantage, which put its own 2028 sales expectations for the drug at $2.2 billion. 

UPDATED: Monday, Jan. 9 at 2:04 p.m. ET

Decades after its founding in 1997, BioMarin delivered its first profitable year in 2022, CEO Jean-Jacques Bienaimé said during the company’s presentation Monday. That performance came thanks to a base enzyme business that’s “profitable and still growing,” plus the launch of new achondroplasia drug Voxzogo, Bienaimé said. Overall, the company generated around $2.09 billion in unaudited 2022 sales, a 13% increase from 2021. BioMarin has no plans to stop there. The company wants to double sales by the middle of the decade and keep delivering profits on a “go-forward basis,” the CEO said. Up next for the company is the potential launch for hemophilia A gene therapy Roctavian, which should launch into a field with a large commercial opportunity, Bienaimé said.  

Right after the mid-December FDA approval for adagrasib, now known as Krazati, Mirati Therapeutics managed to get the drug out to patients, CEO David Meek said at the conference on Monday. So far, the early response to the therapy has been "very encouraging," Meek added. With an approval to treat previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC), Krazati is going head-to-head in the market with Amgen’s Lumakras, which won approval in 2021. Regulators in Europe are also considering the company's application, with a decision expected in the third quarter of this year. Asked whether Mirati will continue to go it alone in commercializing the therapy, Meek said the company is open to partnerships outside the U.S. 

UPDATED: Monday, Jan. 9 at 12:53 p.m. ET

“The next wave of innovation is right around the corner,” Vertex Pharmaceuticals CEO Reshma Kewalramani said in her JPM presentation, promising “multiple catalysts” in 2023. The company is working toward five launches in the next five years and has eight programs in mid- or late-stage development. Vertex considers its candidates for sickle cell disease, transfusion-dependent beta thalassemia, acute pain and cystic fibrosis as near-term commercial opportunities. The sickle cell disease and beta thalassemia drug, which is under a rolling review at the FDA, would be functional cures as one-time therapies. The company is also looking to tap into a multibillion-dollar market with its acute pain candidate.

UPDATED: Monday, Jan. 9 at 11:22 a.m. ET

Moderna and other COVID-19 vaccine makers have faced demand questions for many months, and on Monday the mRNA specialist provided new clues about the state of the COVID shot market. The company's Spikevax generated approximately $18.4 billion in revenue last year, short of the company’s original estimate of $22 billion at the start of the year. Still, the figure did exceed the shot's 2021 sales of $17.7 billion. Meanwhile, Moderna projects at least $5 billion in Spikevax sales this year and is spending heavily to support its mRNA pipeline. Story

Belgian drugmaker UCB also provided a financial update Monday morning. The company expects to land at the upper end of its guidance range of €5.3 billion to €5.4 billion in 2022 revenue despite economic headwinds. Cimzia, the company's treatment for Crohn's disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, reached its peak sales target of €2 billion much earlier than expected. The company will share full details about its 2022 performance on February 7.

On the dealmaking front, Royalty Pharma and Ionis got together for a blockbuster royalty agreement. Under the deal, Royalty will pay Ionis $500 million up front, plus up to $625 million in milestone payments, for certain rights to Biogen's spinal muscular atrophy drug Spinraza and Novartis' next-gen cardio drug pelacarsen. Ionis licensed out the therapies in 2016 and 2019, respectively. For Ionis, the cash influx will allow it to reach "commercial readiness" for its late-stage pipeline, the company said.

UPDATED: Monday, Jan. 9 at 10:30 a.m. ET

Even before the JPM conference started, Italy's Chiesi kicked off the dealmaking news Sunday with its $1.48 billion purchase of Amyrt. Sunday afternoon, Chiesi said it would pay up to $1.48 billion to buy Amyrt and its portfolio of approved and pipeline drugs. Amyrt, with several hundred employees and operations around the globe, sells Juxtapid for homozygous familial hypercholesterolemia, Myalept in congenital or acquired generalized lipodystrophy and Mycapssa, which is approved for certain patients with acromegaly. Chiesi also has its eyes on Amyrt’s rare skin disease drug Filsuvez, which last year won an approval in Europe to treat epidermolysis bullosa. The drug suffered an FDA rejection in early 2022. Story

Not to be left out, Ipsen bought up liver disease specialist Albireo for $952 million. In that $42-per-share deal, Ipsen gets the U.S.- and EU-approved Bylvay, which treats pruritis from progressive familial intrahepatic cholestasis (PFIC). The drug also has promise in biliary atresia, and Ipsen agreed to pay Albireo investors another $10 per share if it picks up an FDA approval in that use. Albireo’s competition in the iBAT drug class is Mirum Pharmaceuticals, which won approval for Livmarli to treat Alagille syndrome in 2021 and is wrapping up a phase 3 study in PFIC. Story

Elsewhere, bluebird bio wasn't going to let Monday pass without touting the latest on its gene therapy launches. The company's CEO Andrew Obenshain presents at JPM on Thursday, but the gene therapy specialist took a chance Monday to share launch updates for its gene therapies Zynteglo and Skysona. While those marketing efforts are underway, bluebird is also gearing up to submit sickle cell disease candidate lovo-cel to the FDA. All of this will cost bluebird $270 million to $300 million this year, and the company expects its current cash runway to extend into early 2024. Story