BioCentury This Week

Ep. 331 - Metsera M&A Melee & Tidmarsh Ouster

• BioCentury • Season 6 • Episode 331

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Novo Nordisk’s unsolicited $8.5 billion bid for Metsera has thrown a wrench into Pfizer’s plans to return to the obesity race via its acquisition of the New York-based start-up. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the details of the competing bids and what’s at stake for the pair of suitors.
The analysts also assess the reasons behind the abrupt departure of Center for Drug Evaluation and Research Director George Tidmarsh from FDA and a surge in activity on the Hong Kong stock exchange. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.

View full story: https://www.biocentury.com/article/657475

#Biotech #PharmaDeals #ObesityDrugs #MergersAndAcquisitions #FDA #LifeSciences #GlobalBiotech #HongKongMarket

00:01 - Sponsor Message: Voyager Therapeutics
01:53 - Metsera M&A
15:23 - Tidmarsh Ouster
25:12 - Hong Kong IPOs

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[AI-generated transcript.]

Eric Pierce:

BioCentury This Week is brought to you by Voyager Therapeutics. Voyager Therapeutics is dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure– neurological diseases. Voyager addresses the challenge of delivering novel treatments to the brain through the company's innovative TRACER™ AAV capsid discovery platform, as well as Voyager's NeuroShuttle™, a non-viral delivery platform designed to transport multiple modalities of neurotherapeutics across the blood-brain barrier. The company's programs address diseases with substantial unmet needs, including Alzheimer's disease, Friedrich's ataxia, Parkinson's disease, ALS, and other diseases of the central nervous system.

Jeff Cranmer:

5 weeks after it appeared that Pfizer was getting back into the obesity game via its proposed acquisition of Metsera for more than $7 billion. Those ambitions could be curtailed by an unsolicited bid from Novo Nordisk, which is offering 8.5 billion to acquire. The obesity startup. We will discuss the latest M&A intrigue on this week's BioCentury this week podcast and intrigue at FDA as well, Tidmarsh is out. We'll also touch on the latest from the Hong Kong Stock Exchange. I'm Jeff Cranmer, executive editor. Here at BioCentury's and joining me today are my colleagues, editor-in-Chief, Simone Fishburne, Washington, editor Steve Usdin, and our man in the U.K. Stephen Hansen. Stephen, you've been following the obesity space for some time now. Metsera, Pfizer, Novo. What do you make of what's going on?

Stephen Hansen:

Yeah. Thanks Jeff. yeah, we've got, uh, we've got a little bit of drama now. you know, as you said, back September 22nd, Pfizer had announced that it was acquiring Metsera for about, call it 4.9 billion upfront. And then there was a 22 and a half dollars per share, CVR attached to that, which brought it to about 7.3 to 7.4 billion. five weeks later, as you say, Novo comes public with an unsolicited offer. And as, kind of turned out, They were one of the parties that had been, negotiating with Metsera for quite some time, uh, basically back since the start of the year. and had kind of been one of the final two bidders for Metsera. so they've come public now, upped the ante. And you know, we were talking about this on Friday. You know, there were kind of three directions that this could go. Either Pfizer could step up and increase their bid. They could let Novo win, you know, and walk away with it. Or Pfizer could go the litigator route and basically sue Metsera for breach of contract. And as we kind of learned out over the weekend and today, it looks like Pfizer's chosen door number three. so they filed the one suit on Friday, which was for breach of contract against Metsera, and then they filed a second suit today, which was a federal antitrust claim. Against Metsera, their shareholders, and Novo, basically claiming that Novo was, illegally looking to acquire the company to suppress competition, destroy a, you know, startup, these sorts of things. Metsera, I believe

Jeff Cranmer:

That was really remarkable, Stephen, the way that press release was written, wasn't it?

Simone Fishburn:

yeah. let's just get into it a little bit, Stephen, because, there's so many threads here to separate out. First of all, Metsera sort of even engaged in this by defining the Novo bid as a quote unquote superior company proposal. And that was a sort of clause, let's say, in the agreement with Pfizer. Now, Pfizer is questioning that, that questioning whether this qualifies, I think

Stephen Hansen:

Right. They're

Simone Fishburn:

superior company pro, and that's the claim for the breach of

Stephen Hansen:

exactly. They're claiming that Novo Nordisk's bid, which is about a billion dollars more than Pfizer's bid, does not constitute a superior company proposal, largely on the grounds that there is a high amount of regulatory risk in getting that deal completed. They're contending that they already essentially have the early termination granted by the FTC for the antitrust, waiting period, and that they basically have a, clear route through to getting the deal done. And so they're basically saying it's not a superior bid despite the billion dollar difference in the financials involved here.

Simone Fishburn:

Okay, so hang, hang on one sec. I'm not. You know, as I said, I just play a lawyer on tv, I'm not arguing whether there's merit or not in their cases. I'm just saying that we do know that in this, dance beforehand where there were many parties, but you know, Novo was party number one or whatever they called. there was a perception by Metsera, or Metsera's board of regulatory risk, so it's not completely out of the blue..

Stephen Hansen:

That is. And so that's part, that's part of the, sort of the palace intrigue here, is the fact that in the runup privately, when they were having these negotiations, in the, uh, in the proxy statement that was, you know, subsequently published by Metsera, they essentially, you know, said that their board went with the Pfizer offer, because while it was inferior from a, you know, fiduciary, you know, financial perspective. It was believed to be the better offer overall because there was a clearer site to being able to get the deal done. now the, the other bit of intrigue in this is the structure of the proposal from Novo. So what they are proposing is, six and a half billion equity value upfront. So $56 and 50 cents per share. And that is gonna be structured in such a way that they would effectively be buying 50% of, the outstanding equity stake in Metsera, via the issuance of new preferred non-voting shares. And then that upfront payment would immediately be paid and then paid out to shareholders as a dividend. Prior to any regulatory review, any of that stuff. So effectively shareholders would be getting all of that upfront money straight away. that also basically means that Novo is effectively taking a massive termination, fee risk here, because effectively all that money is then out the door before there's any regulatory review. So, if they were to go with the Novo deal. Under this structure that they've proposed. it's a big financial risk for Novo.

Simone Fishburn:

Well, let's come back to that in a minute because I, I just wanna cover there's so much landscape to cover before we analyze, Who, who's got more risk, whatever. there's also a Big America first part of the Pfizer response, right? Steve, I don't know if you wanna weigh in. You've used the word perfidious Danes, and I wanna see if I can get you to use it on the podcast.

Steve Usdin:

Yes. So I haven't, yes, I have been saying that, Pfizer's gonna be claiming that the perfidious Danes are, trying to beat out an American company. Look, the fact that, um, Albert Bourla, stood, arm in arm with Donald Trump in the White House. and was the first company to announce the most favored nation, agreement, with the White House, you know, isn't lost on anybody in Washington. And I think that they are going to basically try, you know, to try to leverage that, to their advantage, with the administration, with the courts and, um, with the, with the court of public opinion. You're

Stephen Hansen:

right. I mean, and that was quite clear in their, in the statement that they put out, in response to the publication of Novo's, um, unsolicited proposal. and then that language sort of continued even in, in their press releases about the litigation being filed. I mean, you know, they reference. Novo Taking an anti-competitive action to protect its dominant market position and to kill a nascent American competitor, before it gained the support of Pfizer, one of America's leading

Simone Fishburn:

wait. wait. Pfizer's not na. So I hope they're not saying Pfizer's nascent.

Stephen Hansen:

No, it's Pfizer's not nascent, but you know, the, the multi-billion dollar Metsera is nascent in this

Simone Fishburn:

So, so Stephen, here's how I've been thinking about it. And tell me, I may be way off, but tell me what you think. So for me, I feel like. You know, Novo has had a lot of trouble recently. It's now got a new CEO, who's coming in, let's say Guns are blazing. Like let's try whatever we can. If it doesn't pan out, I don't know that Novo walks away looking. Particularly bad they tried something.'cause it feels like Pfizer, if they got outbid on this and, and Nova won and in, in light of the fact also that this is, what did you call it? Jeff, there, I, I forget what number attempt you said for them to get back into the obesity race,

Stephen Hansen:

I think it's their third.

Simone Fishburn:

It the third attempt to do that. So, I don't know. It feels like Pfizer, could take some sort of ego bruising over this if they lost out.

Stephen Hansen:

Yeah. No, I, I think that's right. I mean, so from the Novo Nordisk perspective. I think in some ways, to me this reads as if it shows their maybe lack of confidence in the commercial potential of CagriSema. I mean, there's some issues around, so it's, it's got, has some formulation issues. You know, obviously it didn't show the efficacy that investors were wanting. I think there's some question around how much that can challenge, you know, is Zepbound in Lilly with CagriSema. The follow on to that is amycretin, but that's basically at the same position that the Metsera programs are at. I mean, it's just starting Phase III now. So, I think this is an attempt by them to sort of try and broaden out their more near term competitive, portfolio in obesity. but you're right, I don't think they have a lot to lose on it other than money at this point. how I see this happening. I mean, this is, I think this is Metsera is effectively trying to play, you know, they're trying to play them off each other. They're basically trying to get Pfizer to pay an extra billion dollars, up the ante. and Pfizer has basically said, no, we're not gonna up the ante. We're gonna sue you. And that's effectively what Metsera said in their response is it basically said. that Pfizer's trying to litigate their way into paying not the fair price for Metsera.

Simone Fishburn:

Pfizer's saying we'd rather pay the lawyers than you, is what I'm understanding from you.

Jeff Cranmer:

yeah. Pfizer's, Pfizer's basically trying to play the uh, Marcellus card and say there's something rotten in the state of Denmark. But, but Stephen, uh, you know, met,

Simone Fishburn:

to go there. You had to go there. Yeah.

Jeff Cranmer:

you know, warming up the Shakespeare is always, good, uh, especially when you have a high school student getting ready to start reading his first Shakespeare. but Stephen, I, I think you're underselling Metsera's press release because. Pfizer's press release was, uh, if you haven't read it, dear listener, I urge you to read it. It, it's really, quite different than other press releases that Pfizer's Crack team of communications people puts out. But Metsera's was pretty good too. You know, they said, uh. Pfizer is trying to litigate its way into buying Metsera for a lower price, and then they said, Pfizer's litigation arguments are nonsense. Steven, final word before we, move on to some other

Stephen Hansen:

I mean, the other thing that struck me about this when we were talking about the potential ways this could go is when we were talking about the what ifs of the, the litigation route is. The thing that just didn't make sense to me is You know, these are assets that Pfizer really needs, and one of the most attractive, aspects about them is the fact that they're heading into Phase III. They're trying to play catch up, and so they really need these assets to be developed as quickly and as optimally as possible. And I just question whether tying Metsera's team up in litigation is the best way to put these assets to, for, I mean, these are the assets that they want to buy, and are you then potentially handicapping or you know, inhibiting their ability to optimize that development path? kind of feels like you're. Maybe shooting yourself in the foot if your Pfizer here by taking the litigation route, rather than just spending an extra billion dollars to, you know, to equal up the bid. But

Jeff Cranmer:

Yeah. What's, what's a billion dollars here?

Stephen Hansen:

what's a billion dollars between? Between friends, right?

Simone Fishburn:

well they spent more than that on, a lot more than that on Seagen and various other things. So we could talk about that and we probably will do again,

Jeff Cranmer:

I, I say, you know, JPMs around the corner, let's just, set up that ice rink in, Union Square as like a steel cage match rla and, who's the new CEO of, of Novo?

Stephen Hansen:

Mike Doustdar

Jeff Cranmer:

Steven, they can. They, they can just, you know, let's, get real. Let's let them just, duke it out in Union Square

Stephen Hansen:

in an ice rink? Do you to a figure skating match or what are you, what are you yeah. Well, yeah. That would actually be, that would actually be better. That would sort be like, uh, zoo, well, Zoolander, right? Or what, what's that guy?

Simone Fishburn:

I, I'd be a judge. I'd sit there putting up my, you know, 6.0. Anyway, let's move on.

Jeff Cranmer:

Alright. All right, well, we're gonna take a quick break Stephen, thanks for joining us. I know it's, your day off, but, uh, y you, you couldn't resist joining us. So, uh, have a lovely evening, sir, and I'll take a quick break and we will come back to, FDA, what can I say?

Alanna Farro:

BioCentury This Week is brought to you by The 5th East-West Biopharma Summit in South Korea. An arc of innovation is emerging across Asia, and Western biopharma leaders are taking note-from cross-border deals to newcos. In March, 2026, The 5th BioCentury-BayHelix East-West BioPharma Summit visits South Korea for the first time. Meet the biopharma leaders putting Korea innovation on the global map. Learn why Korea has become a clinical trial in manufacturing hub. Discover if Korea is the next hotspot for NewCo formation. Plus, meet biopharma innovators from India to Singapore, to China and Japan. Register now at BioCenturyEastWest.com.

Jeff Cranmer:

Attention to all our Boston peeps. The BioCentury's This week podcast will be on the road November 6th in the Boston Cambridge area for K-Blockbuster Night. Simone will be there and our colleague Josh Berlin will be there and you can join them at Venture Café Cambridge to watch a live recording of our podcast with special guests joining Simone and Josh to discuss Korea Biotech, register for free at venturecafecambridge.org or send Josh a note, our me a note on LinkedIn to learn more. And speaking of Korea, that's what the K-Blockbusters all about. BioCentury goes on the road again and will be in Seoul in March for our 5th East-West Summit. I am currently recruiting, presenting companies. And you can take advantage of early bird rates right now to register as a delegate or apply to present. Okay, Steve, you've had a busy weekend once again. tell us what's going on at FDA.

Steve Usdin:

Oh, I wish I knew. Okay. There's a lot of things going on at FDA. Here's a few of them. So George Tid the director of CDER, was put on administrative leave Sunday. They're conflicting reports about whether he's resigned, but one thing's completely clear, he's not gonna do a Prasad. He's not returning to FDA. He has burned his bridges. He said in media interviews that he was pushed out because he objected to the way FDA Commissioner Makary was trying to approve drugs under the commissioner's National Priority Voucher program, without due process and diligence that are typical in FDA reviews and, subject to political interference. But his ouster came as the HHS Inspector General was investigating allegations of ethics violations and Aurinia Pharmaceuticals filed a lawsuit against Tidmarsh. Personally, I think two things can be true. Tidmarsh could have expressed reservations about the approvals process. And the administration could be taking the concerns Aurinia raised very seriously and they are serious allegations that he use his official position to pursue a vendetta against Kevin Tang, Aurinia's Chairman, and that he initiated regulatory action against another company affiliated with Tang that makes API for desiccated thyroid products, and then tried to extort a bribe to make it go away. The truth of the allegations is gonna be decided by the courts. It's certain that Tidmarsh posted comments on LinkedIn and then deleted them. They were aimed at Aurinia when he deleted them. He wrote that they were his personal views and not FDA's or HHS'. I wrote a commentary in September when this happened, saying he should be fired, and that was before all these other allegations surfaced. Adding to the turmoil FDA staff report that Vinay Prasad, director of CBER and FDA's, Chief Medical and Scientific Officer. Has created a toxic work environment. Some of his top staff have asked for transfers to CDER, but Prasad has blocked them. FDA staff have told me that Prasad is rarely in Washington, that he calls on the cell phone and intimidates junior staff cutting out their supervisors. he claimed in a webcast recently that OCE Director, Richard Pazdur was responsible for a controversial. Complete response letter, that was issued to Replimune, but in fact, it was Prasad that signed, all the documentation. It was Prasad's call to issue, that complete response letter. And that's created a lot of, ill will around, FDA.

Simone Fishburn:

Steve, I just wanna make a couple of points here. first of all, I think it's very clear that this huge amount of instability at FDA is really just not good generally, I think that you've pointed out that Tidmarsh made some, Statements or claims that actually have merit, um, regarding questions about the commissioner's, voucher program at the same time, there's really a lot of questionable activity allegedly, right? If you, believe that all the things that have come out in the Wall Street Journal and so on, uh, are correct. and to me it really, to be honest, seems like there's just very little due diligence going on behind these appointments. so I think that that ongoing instability is not great for the agency and, and therefore for drug developers. I do wanna make one more point though, because I think this gets lost in a lot of these really big headlines, which are very alarming. And I was speaking to A CEO over the weekend. There are a lot of really good people at FDA still working really hard, and these are the levels below. And a lot of companies are actually having engagements with the career people at FDA who have to navigate through all of this. And so there's sort of a sense that. They're kind of maybe getting lost in the narrative somewhere. Those people who are staying at FDA, doing their best and just trying to get drug development moving along. And for many companies it is moving along. And then for others, we know, we've seen the uniQure data, information today, which you might elaborate on. There's a lot of uncertainty and a lot of other companies, for example, in cell and gene therapies and their investors just don't know. How to think about the stability, the predictability of the things that FDA is saying. What do you think Steve?

Steve Usdin:

So, yeah, of course the fact that there's a great deal of instability, that there's turmoil at FDA doesn't mean that everything is going, down the toilet. It doesn't mean that nothing is working as it should. There are things that are advancing, and in fact, there are positive things that, FDA is doing from a policy standpoint. You know, when I was thinking about this podcast last week, I thought we would be. talking about remarks that Tidmarsh made at a patient meeting last Tuesday. all that seems moot now, but it really isn't. So at that meeting, he said that CDER was undertaking a review of endpoints used to support accelerated approval of cancer drugs, that overall survival should be the basis for confirmatory trials, and that companies should resist pressure from clinicians and patients to allow crossover from standard of care to investigational therapies and confirmatory trials. There was a furious response from cancer patient advocates and clinicians to that, to those statements. obviously with Tidmarsh, out the door, those issues are probably at least pushed into the future, if not, out the door. But Tidmarsh also outlined steps that FDA's taking to speed first in human trials to reduce delays in improving and advancing clinical trials. and other things that are really, top priorities of, of industry. So yeah, it's kind of a, a mixed bag. you mentioned about, um, due diligence, in recruiting Tidmarsh for the job. And it's interesting because at that same meeting, he told a story, John Crowley, who was moderating the, fireside chat. he asked Tidmarsh, he said, you know, basically, how was it that you, that you got the job? And what Tidmarsh said was that he got to know Jay Bhattacharya, who's the NIH director, back when they were both at, um, Stanford. And they were both engaged in a tremendous amount of controversy involving, COVID policies. after the, election. what Tidmarsh said is that, he had, dinner with, Jay Bhattacharya with Makary that Jay Bhattacharya was staying, at Makary's house, that they're, close friends and, that he basically offered to help. Makary, help him out at FDA, that McCarry started calling him on the phone and asking him for advice. And then after one of those calls Tidmarsh's wife turned to him and said, really, you know, Makary needs help, you should offer to help him, Tidmarsh said, oh yeah, okay. he called up, uh, Makary and said, you know, is there any way I could help? And Makary said, yeah, actually, I need somebody to run CDER. six weeks later, he was at a job. He was the, director of CDER. none of that really sounds like there was a tremendous amount of diligence as, as you mentioned.

Jeff Cranmer:

he, said that on stage.

Steve Usdin:

Yeah, yeah. He described all of this on stage.

Jeff Cranmer:

Wow. Okay. FDA, well, Simone said, Really glad to hear, that there's still some people working hard in the trenches to keep, drug developers in the U.S. and elsewhere in the world on track. But, it's a little disheartening, frankly, to hear what you just said there, Steve. uniQure came up at, sort of the beginning of this, what's going on there?

Steve Usdin:

We don't know exactly what's going on there, but this is an example of the kind of turmoil that's happening at FDA and in particular at CBER under, Vinay Prasad So uniQure was aligned with FDA on a submission for a gene therapy for a Huntington's disease. and um, actually they were even talking, as recently as last month about their plans for commercialization of this product. And it comes out today, now, and we find out that actually, FDA has completely reversed its position that it had before. They're not, on board with uniQure's submission. and that apparently the, the main problem was that they'd used, a natural history study as their, external control for the trial. And CBER is no longer willing to accept that as the control for the trial. This is really problematic. It's really problematic, especially for Huntington's patients. Look, this is a uniformly fatal disease. it affects I think, about 6,000 Americans a year, and this was the first thing that's come along that actually could help patients with Huntington's live longer. It was the first hope that they had. and apparently FDA is pulling the rug out from under them if they actually require a placebo controlled trial. First, what, Huntington's patient would agree to be in that trial? and second. It's probably gonna take three years to complete it. it's not clear whether it actually could be done at, all. but the ethical and the commercial implications of that are really, very troubling. And it also sends a message to other companies that are developing trials for rare progressive diseases that are based on natural history studies. that's been kind of an assumption, and FDA's explicitly agreed in many cases that they would, allow that. and now apparently they're r eversing position on it. It's not clear if it's just for Huntington's or is that gonna be read through, to other conditions, but it's a major uncertainty.

Jeff Cranmer:

it's remarkable and I, I haven't looked at. stocks for similar rare disease companies who are late stage. But I can tell you uniQure is down 42% today. They're now, under $2 billion in market cap. This is a, substantial company that's been on the forefront of developing drugs for rare diseases. they know what they're doing and, what a setback. It's just remarkable. Alright. It's enough enough doom and gloom for today. Let's, uh. Let's turn to a part of the world where things are happening. Hong Kong, the Hong Kong Stock Exchange, has been receiving most new listings quite warmly, five offerings have at least doubled in value during the first trading day. And last week, four more Biopharmas entered the Hong Kong queue, for either an IPO or a dual listing, BrightGene, NovaBridge, Alebund and let's see, uh, Lupeng, and then turning stateside, MapLight Therapeutics met its goal to go public. It, priced its IPO early last week raising nearly $300 million, in a public offering and concurrent private placement with Goldman Sachs, The company, uh, briefly traded above $20, gave back its gains. to finish a little bit below its $17 public offering price. you can check out all the latest on public financings in our weekly finance report. crafted by our, sometime podcast contributor Paul Bonanos, along with the newest BioCentury's Lindsay Martin, well, I, I think that's, uh, where we'll leave things this week. Steve is going to continue monitoring what's happening at FDA. And Stephen, will stay on top of the Metsera deal and we'll keep bringing it to you at BioCentury.com. If you like what you're hearing, like us, subscribe to us, ask us a question. we appreciate you listening to us. that's it for this week's BioCentury's This Week podcast. We are grateful to Kendall Square Orchestra for providing the music for our podcasts. And don't forget if you're in Boston, on Thursday night. Josh Berlin and Editor in Chief Simone. we'll be bringing the BioCentury's this week podcast to you at the Venture Café Cambridge, it. Is free to register. You can go to venturecafecambridge.org or you can send me a, uh, message on LinkedIn or at jeff@BioCentury.com or, hit Josh up. We will catch you, next week. Thanks for tuning in.

Eric Pierce:

BioCentury would like to thank Voyager Therapeutics for supporting the BioCentury This Week podcast. To learn more about Voyager's programs advancing transformative medicines for neurological diseases, visit voyagertherapeutics.com.

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