Jonathan Gardner

I've listened to hundreds of conference calls with pharma execs and never has there ever been a "we need to be able to build factories faster" regulatory ask in any of them.

Strange typo/tag/suffix at the end of the #LLY Q1 press release today.

#REGN Schleifer (cont'd): " So, I think that we don't get to set the policy. We hopefully get to influence a little bit, and we try and work through it." 8/

#REGN Schleifer (cont'd): "Obviously, experience does matter, and I really hope that we do not lose really good people at the FDA in the rank and file or even at the policy level. I think that would be deleterious." 7/

#REGN Schleifer (cont'd): "And I think that there are others who feel similarly as I do, that we can't lose the ability to do science. If we take a path where we just stop following science and we give up on tried and true methodologies, I think we could be in trouble." 6/

Risinger asked a similar question of #REGN c-suite team, and Len Schleifer at least gave a somewhat honest reply: "I told the President that I thought that RFK Jr, while he thinks outside the box, needed some assistance on the science front. I said that straight out and offered to provide that." 5/

I've been frankly flummoxed at how supine #pharma and #biotech has been through the first three months of this presidency, and CEO Rob Michael's "glittering generalities" response didn't suggest to me it would become more robust. 4/4

"... can you please comment on how your executive team and board are engaging differently today with Washington leadership to change the political agenda for the better?" 3/4

"... and also the Trump administration's agenda to take prices down more than the Biden administration took down drug prices. So considering what appears to be a lack of appreciation in Washington of the benefits that the biopharmaceutical industry brings to Americans ..." 2/4

Leerink's David Risinger asking #ABBV execs the broad Q that's on my mind re: #biotech #pharma: "The industry is facing 3 major US government risks actions that are harming biopharma innovation, including significant FDA disruption and questioning of proven medical science, tariff threats ..." 1/4

#MRK acknowledges $200 million in "costs related to tariffs
implemented to date," knocks a half-percentage point off gross margin guidance.

There is an absolutely mind-blowing number of abstracts from Chinese scientists of cancer drugs developed in China at #ASCO2025. Meanwhile, the USA is trying to impede trade with China at the same time as it handcuffs its great engine of biomedical innovation, the NIH.

This might be a bit of an exaggeration, but it really looks like the investment case for $HIMS is "the FDA will consider Ozempic to be in shortage forever."

One of the $LLY pipeline removals was volenrelaxin for heart failure (very bottom rectangle). Longtime #biotech watchers will remember that $NVS worked for years on a recombinant relaxin in heart failure before they decided to prioritize Entresto. Someday, a drugmaker will crack the relaxin puzzle.

The number of things he's said that are flat wrong, misleading, and uninformed is shocking. I've sat through a lot of confirmation hearings and I've never seen a performance like this. He is simply flat wrong on the amyloid hypothesis. There are two drugs now approved that block amyloid.

RFK: "Almost nothing is studied at NIH about the etiology of our chronic disease epidemic."

NIH:

Leaving aside any evidence on vaccine efficacy and safety, and any beliefs about abortion, this has been a disaster of a hearing for Robert F. Kennedy Jr. He's shown a stunning lack of knowledge about HHS and when pressed, had no answers about key programs under his authority.

Drug patents protect pharma profits. Track when they’ll expire. Patents protecting five of the first 10 drugs Medicare selected for price negotiations are set to expire by 2026 or earlier, although legal settlements may push back the launch of copycat versions.

It's unfortunate that there's no mechanism in the Inflation Reduction Act to account for nearing patent expirations. CMS will spend a lot of time and energy on Xtandi and Ibrance price constraints that take effect the year they go off-patent. #biotech #pharma

Insurers: "People don't stay on obesity drugs long enough to matter so we're not covering them."
Doctors: "People don't stay on obesity drugs because insurance doesn't cover them."

Wash and repeat.

$LLY

Novo’s next-gen obesity drug misses expectations in closely watched trial Novo shares lost nearly a quarter of their value after an experimental combination treatment called cagrisema fell short of the bar set by executives.

Weight-loss expectations for new obesity drugs are sky-high now: $NVO guided to 25% with cagrisema, and when it fell short it knocked down the company's market capitalizations by one-fifth. www.biopharmadive.com/news/novo-no...

Moreover, $BIOA is the first time in awhile I can recall that liver enzyme elevations derailed a drug other than a gene therapy. It feels like companies are getting more sophisticated in getting that AE risk out of the way before they go into human testing. #biotech #pharma

In the obesity space, the "lean mass preservation" segment seems to be where most of the not well-thought-out strategies seem to reside. $BIOA

We know obesity is, counterintuitively, a disease of poverty in the USA. I need to hear drug developers talk about this more. Getting Medicaid to cover Wegovy, Zepbound and their followers won't be an answer.

Obesity drug developers have talked a lot recently about the big share of the market that will be self-pay. What I don't hear them say is how that changes the willingness-to-pay dynamic of the market compared to the insured. $16K a year is not a price most people can absorb. #biotech #pharma

Lilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.

SURMOUNT-5 shows that Zepbound delivers superior weight loss to Wegovy, but we should watch the discontinuation rate. If the trial completion rate was 90% vs. < 50% real-world adherence, the findings may be less important than the topline suggests. $LLY $NOVO www.biopharmadive.com/news/lilly-z...

Outstanding work by my colleagues here.

Your next director of Medicare and Medicaid: "Believable or somewhat believable evidence supported 33% of the recommendations on The Dr Oz Show": www.bmj.com/content/349/...

Looks like I *do* have an account over here. Interested in everything having to do with biotech, pharma, antitrust, intellectual property law, and occasionally cycling, running and other Olympic sports.