JPM23, Day 2: Bayer raises peak sales forecast for new drugs; Amgen CEO reflects on pricing law

After a busy first day, the J.P. Morgan Healthcare Conference is rolling on in San Francisco. Roche, GSK, Bayer and many others are set to share their updates today.

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

UPDATED: Tuesday, Jan. 10 at 8:17 p.m. ET

Over the years, AbbVie has created “a very strong foundation,” CEO Rick Gonzalez said Tuesday. That foundation should come in handy later this month when the event the company has been “long planning for” comes to fruition: Humira’s loss of exclusivity. The company is confident it is ready to absorb the impact from the loss of exclusivity and “quickly return to strong growth” in 2025. There will be “a certain level” of price erosion in the first half of the year, but a higher level during the second half after many biosimilars enter mid-year, Gonzalez said.

UPDATED: Tuesday, Jan. 10 at 4:45 p.m. ET

Bayer made waves at the JPM conference on Tuesday, rolling out lofty sales projections for its new and up-and-coming products. The German company now sees heart medication Kerendia and prostate cancer treatment Nubeqa maxing out at 3 billion euros ($3.2 billion) each per year. But the biggest growth driver, the company said, will be asundexian. Currently in phase 3 testing to prevent stroke, atrial fibrillation and heart attack, Bayer has pegged its peak sales potential at 5 billion euros ($5.4 billion). The first-in-class FXIa inhibitor is on track for a 2026 approval, pharma chief Stefan Oelrich said. One more compound in the portfolio with blockbuster potential, according to Bayer, is elinzanetant, a first-in-class, non-hormonal treatment for hot flashes in menopausal women. The growth drivers combined have a peak sales potential of more than 12 billion euros ($12.9 billion), Bayer said. In response to the news, the company’s shares rose by 6.5%.

UPDATED: Tuesday, Jan. 10 at 3:16 p.m. ET

Since the last in-person JPM conference in 2020, Sanofi has been on a journey to transform and modernize, CEO Paul Hudson said. Now, with two launches and 27 readouts expected in 2023, this is what a typical year should look like for the drugmaker, he said. The launches this year for Altuviiio in hemophilia A and Beyfortus in RSV will represent two first-in-class, best-in-class launches for the first time in Sanofi’s history, Hudson said. This is “the new cadence” for the company, and while it comes with risks, “this is why we’re here,” Hudson added. Meanwhile, when Sanofi laid out a 10 billion euro ambition for Dupixent back in 2019, some industry watchers had doubts. But Hudson is confident the company will cross that milestone this year.

UPDATED: Tuesday, Jan. 10 at 2:28 p.m. ET

Sage Therapeutics has its eyes on a market in major depressive disorder that could top 6 to 7 million patients for the upcoming therapy zuranolone. To address that large patient population, as well as a second indication in post-partum depression, CEO Barry Green said the company has “an omni channel approach” to reach prescribers. Digital, virtual and live interactions will all be a part of the launch. After completing a rolling FDA submission late last year, Green said the company and its partner Biogen expect to hear in the next few months whether the drug will be granted a standard review or priority review, which would advance the decision date by about four months. 

UPDATED: Tuesday, Jan. 10 at 1:49 p.m. ET

The biopharma world is changing, Amgen CEO Robert Bradway said this week. “With factors like the Inflation Reduction Act, you either get ahead of it or it runs you over.” Bradway said he believes Democrats’ IRA will have a “chilling effect” on biopharma. Still, the challenges currently facing the industry give Amgen a chance to pounce. “In terms of getting ahead of the challenges facing our industry, we think the combination of compressed sector valuations and the rising cost of capital for some of the smaller companies in our industry and the scarcity of funding will create opportunities for us on the strategic business development front,” Bradway said. 

GSK is expected to battle Pfizer in RSV vaccines for older adults. “Having more than one player is rarely a bad thing, especially when you're creating a new market,” GSK CEO Emma Walmsley said Tuesday at JPM. Based on GSK’s market research, physicians see a “distinct difference” between the two candidates in high-risk patients, who will drive initial uptake. The “biggest variable” right now, as chief commercial officer Luke Miels sees it, is whether a vaccine could offer protection longer than one year. GSK expects to have data on that question before its final payer discussions in June.

In the recent battle for rare disease expert Horizon Therapeutics, Johnson & Johnson largely stuck to the background, CEO Joaquin Duato explained. While the interest was there initially, “Horizon Therapeutics was not a company that was in the sweetest spot of our strategic criteria,” Duato said at an in-person presentation Monday. Because Horizon didn’t make the M&A bar for J&J, “we never entered into diligence, never put a bid for Horizon Therapeutics,” the CEO pointed out. Nevertheless, J&J’s BD appetite is heathy as ever, Duato said. Story

Across its business, Zai Lab is pinning its hopes on wide-scale profitability by the end of 2025. To get there, the company is plotting at least eight launches over the next three years. Leading the pack is Novocure's TTFields platform, which Zai Lab says it will file for approval in China after Novocure submits its U.S. application, slated for the second half of 2023.

UPDATED: Tuesday, Jan. 10 at 11:05 a.m. ET

The FDA is tightening its policy around accelerated approvals but the basics of the regulatory pathway remain unchanged, FDA commissioner Robert Califf said. The big change, Califf said, is the recent passage of the Congress’s omnibus spending bill. Hitching a ride in the bill was language specifying that the FDA may require confirmatory trials—either before or within a certain period after—an accelerated approval. “I think it’s really important we need to be able to move quickly to either verify or disprove the concept of the treatment, [whether] its benefits outweigh its risks, as inherent in accelerated approval is a great degree of uncertainty,” Califf said. The message, as Califf put it, is that drug developers need to think about the evidence that the FDA may need—not just to get that initial accelerated approval but to get the definitive study done and to meet the needs of payers.

As the COVID emergency comes to an end, Novavax executives see opportunity. When the vaccine market eventually shifts to a "normal" commercial marketplace, Novavax thinks it could grow its market share in a big way, chief business officer John Trizzino said. In all, the vaccine maker sees a global revenue potential of up to $18 billion for its shot. Story

Biogen’s new CEO Chris Viehbacher is looking to take the neuroscience-focused company in new directions. Leqembi for Alzheimer’s disease and zuranolone for major depression disorder and postpartum depression should help the company tap into different markets, Veihbacher said during a fireside chat. At the same time, Biogen's bread and butter multiple sclerosis franchise is turning into a “melting iceberg” with a lack of growth opportunity. This is leading Viehbacher to push the company toward “the new Biogen," as he calls it. Story

UPDATED: Tuesday, Jan. 10 at 9:27 a.m. ET

Pfizer grew its revenues extremely quickly during the pandemic and doesn’t plan to stop now. The company is entering “the most important 18 months in the history of Pfizer,” CEO Albert Bourla said during his JPM fireside chat. Pfizer is planning 19 drug launches or label expansions over the next 18 months, and those new offerings should generate $20 billion in 2030 sales. In addition, Pfizer is seeking to find $25 billion in 2030 sales through external business development. Deals of various sizes are on the table, Bourla added. On the flip side, Pfizer will need to overcome $17 billion in patent expirations. Story 

UPDATED: Tuesday, Jan. 10 at 7:52 a.m. ET

It seems the elephant in the room every time Merck has an investor presentation is the company’s loss of patient protection for mega-blockbuster cancer drug Keytruda in 2028. Eighteen months into his tenure as CEO, the questions are becoming easier to answer for Rob Davis. Monday at the JPM Conference, Davis pointed to four recent moves—a $1.35 billion acquisition of hematology specialist Imago, a partnership with Kelun-Biotech to develop seven ADC oncology assets, a $290 million buy of a prostate cancer treatment developed by Orion and a collaboration with Moderna for a personalized cancer vaccine—that give Merck reason to believe new products are on their way. “Those four deals will bring assets, all starting phase 3 studies in 2023, all programs we didn’t have six, nine months ago,” Davis said. While some are waiting for Merck—with all its cash on hand—to execute a huge acquisition, Davis said it’s “science” that drives its business development strategy. “We tend to see more of our focus on smaller bolt-on acquisitions and increasingly, in more recent times, it’s been collaborations, licenses and partnerships,” Davis said. The upshot of Merck’s strategy? “We’re starting to talk less about 2028,” he said.

Fresh off an approval last month from the EU for its dengue vaccine Qdenga, Takeda is entering an uncertain arena. “When the public market will kick off and how it will happen, we have to see that,” CEO Christophe Weber said. Takeda is uncertain about Qdenga's sales potential as well, assigning a wide range of peak sales between $700 million and $1.5 billion. Weber said that Takeda is expanding its manufacturing capacity for Qdenga in anticipation of strong demand. The shot has received priority-review designation from the FDA. A key advantage of Qdenga is its ability to provide protection for 4.5 years—“not six months, like some recent vaccines,” Weber quipped. Another is that, unlike previous dengue vaccines, Qdenga can be used regardless of prior exposure to the virus. This is important because it is often difficult to determine prior exposure as first-time infections are typically mild and often mistaken for the flu. “We believe we have a very strong proposition here for all endemic countries. There are 4 billion people living in endemic countries in the world,” said Weber. Story