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Hey there. That is Matthew Herper. It was a little bit chillier in San Francisco this morning, and you may really feel many JPM attendees dragging a bit from attempting to pack a month right into a day. It doesn’t assist that, a day after J&J, Eli Lilly, and GSK all introduced offers that gave some observers hope of a resurgence in M&A, Lilly, the mightiest drug firm within the land — or no less than the largest by market cap — introduced an earnings miss. However we’re all nonetheless right here, and we have now an unique podcast interview with Lilly CEO Dave Ricks on the backside of this text. Keep tuned.
A biotech legend’s recommendation
Joe Edelman, a billionaire hedge fund supervisor, sat down with STAT’s Adam Feuerstein at our in-person occasion on Monday night with a little bit of a tough lesson: “Nobody ever obtained actually wealthy shorting shares.”
Edelman cited the instance of Cassava Sciences, the Alzheimer’s firm whose former executives have been charged by the Securities and Change Fee with making deceptive statements. The corporate’s unhealthy information stored coming, however the valuation didn’t shrink, Edelman mentioned. A part of the issue is that timing a brief sale, the place traders guess a inventory will go down, is simply laborious.
When Edelman advised tales of his favourite trades, they have been longs: trades the place an vital new medication drove shares method up. Learn extra right here.
Vets of the primary Trump administration recreation out the second
Additionally at our occasion, held earlier than a packed viewers in a grand, transformed banking corridor, I used to be fortunate to take a seat down with Scott Gottlieb, who ran the Meals and Drug Administration within the final Trump administration, and Seema Verma, who ran the Facilities for Medicare and Medicaid Providers.
Gottlieb has publicly opposed the nomination of Robert F. Kennedy Jr. as President-elect Trump’s well being secretary as a result of he believes empowering Kennedy, who has been essential of vaccines, would endanger youngsters. He laid out a recipe for a way RFK Jr. may do hurt. However Gottlieb and Verma additionally laid out a collection of reforms that might play out within the incoming administration — together with some involving pharmacy profit managers and the Medicare Benefit program.
The pair additionally mentioned the overregulation of AI and endorsed the following heads of FDA and CMS to be humble and work with profession authorities officers. Learn extra in regards to the panel.
Contained in the Pfizer machine
Pfizer CEO Albert Bourla thinks you’re underestimating his firm. “Pfizer is identical firm that saved the world two years in the past as a result of we had operational excellence and scientific processes,” Bourla advised a bunch of journalists at a lunch Monday.
Bourla opined on what a Trump administration may imply — he acknowledges what others have described because the risk RFK Jr. would possibly pose to vaccine confidence and the FDA, however thinks the potential positives outweigh the negatives. He additionally talked up Pfizer’s experimental most cancers medicines, and mentioned that each political events are woke up to the risk China poses to the U.S. pharmaceutical business.
New particulars on what could have occurred with Oxbryta
Final yr, Pfizer recalled Oxbryta, a drug for sickle cell anemia, saying there was a excessive danger of extreme security occasions, together with deaths, in sufferers in scientific trials.
A few of these research have been in sub-Saharan Africa, and, at that very same lunch, Chris Boshoff, Pfizer’s new chief scientific officer, hypothesized that elevated vulnerability to malaria would possibly play a job in what went fallacious. He mentioned that the evaluation of the info, that are nonetheless not public, could be accomplished quickly, and even appeared to recommend Oxbryta may return to the market. Bourla squashed that hypothesis, urging warning.
Some JPM partying, with ambivalence
All the same old swank JPM events raged Monday evening, full with costly drinks and arguments about science and jockeying for place in analysis and business. However the tone of the generally boozy, spirited arguments — no less than as judged by this correspondent — wasn’t actually optimistic or pessimistic: It was impartial and muted.
Too a lot of an important selections for the business are taking place not in San Francisco, however in Washington, D.C., and no matter whether or not JPMers appeared to be placing a constructive or unfavorable spin on what’s taking part in on the market, they largely appeared to be simply reveling whereas they wait to search out out what’s going to occur subsequent.
Well being care developments again east
Talking of issues taking place in Washington: The incoming Trump administration appears to have lined up an appointee for an vital CMS function, the Federal Commerce Fee took difficulty as soon as once more with PBMs, and the HHS Workplace of Inspector Basic cited the accelerated approvals of Sarepta’s Exondys 51, the recalled preterm delivery drug Makena, and Biogen’s Aduhelm as problematic.
Eli Lilly misses for 2024
Eli Lilly expects gross sales within the fourth quarter of final yr to overlook forecasts, pushed by lower-than-expected gross sales of its diabetes and weight problems medication Mounjaro and Zepbound. The pharma large expects to have introduced in $13.5 billion in income, lower than the $13.9 billion that analysts polled by FactSet had forecast. Mounjaro and Zepbound are anticipated to have introduced in $3.5 billion and $1.9 billion, additionally lower than anticipated.
And talking of Eli Lilly…
Lilly CEO Dave Ricks spoke in regards to the firm’s earnings miss at a reside recording of STAT’s biotech podcast, “The Readout Loud,” simply a short while in the past. He didn’t sound shaken. “We’re in fairly early days right here, we’re simply lapping yr one on Zepbound, and plenty of issues are taking place that we haven’t seen at this scale or development fee earlier than so the forecasters are having a tough time,” he mentioned. He famous that many components, together with points with the stock held by pharmacy wholesalers, are affecting the corporate’s gross sales.
The GLP-1 enterprise, he mentioned, is annualizing at $25 billion a yr, rising at 60%. “We’ve by no means seen a drugs like this,” Ricks mentioned.
“I don’t know any firm our dimension on this sector, or many others, rising at that fee,” he mentioned. Nonetheless, he emphasised, “It’s our job to provide cheap steering within the Road after which attempt to hit that and we earnestly have been attempting to do this.”
Give the total dialog a pay attention right here.
Extra reads
Nvidia companions with Illumina and Mayo Clinic in well being push, Bloomberg
Federal watchdog raises some considerations in regards to the FDA’s accelerated approval program, STAT
FTC slams PBMs for reinforcing specialty drug costs on the expense of the U.S. well being care system, STAT
