Ep. 346 - 2026 Public Markets Preview

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<v Jeff Cranmer>Biotech's Bull is back and investors think it can stick on a special edition of the BioCentury This week podcast, we'll explore why this podcast coincides with BioCentury's publishing the four part 2026 public markets preview.

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<v Jeff Cranmer>Joining me to discuss this, are the author and my fellow.

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<v Jeff Cranmer>BioCentury's this week host Stephen Hansen and Editor in Chief Simone Fishburne, and Executive Editor Selina Koch, who edited the package.

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<v Jeff Cranmer>I'm Jeff Cranmer, Executive Editor here at BioCentury.

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<v Jeff Cranmer>Let's get to it.

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<v Jeff Cranmer>Stephen.

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<v Jeff Cranmer>We've had about four years in a row where we're like, yeah, we can make a comeback, but people think it can stick this time, break it down for us.

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<v Stephen Hansen>Yeah.

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<v Stephen Hansen>Thanks Jeff.

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<v Stephen Hansen>Yeah.

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<v Stephen Hansen>As you say, there's been,  I think in the story I counted, we've maybe said five false starts sort of over the past four years where.

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<v Stephen Hansen>People thought there was a chance the market was finally in a recovery, and then something always happened that, uh, you know, shot it down and, uh, sent everyone back to the doldrums.

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<v Stephen Hansen>And so, sort of in hindsight, looking back here, I mean, we can definitely say that biotech is now fully in recovery mode.

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<v Stephen Hansen>I think we can say,  tech Index has, you know, finally outperformed the broader markets Last year, you know, the XBI was even better than.

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<v Stephen Hansen>Not only was it better than tech and sort of the s and p, I mean it even beat the Magnificent seven, which are the, uh, you know, the seven tech stocks, AI stocks that, uh, were up 25% last year.

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<v Stephen Hansen>whereas if you look at XBI, it was about 36%, for the year and up 83% from its trough in April.

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<v Stephen Hansen>so I think it's clearly we can say that, that the recovery is underway.

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<v Stephen Hansen>now the main question that we were then looking at was, why won't this be another false start for the sector?

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<v Stephen Hansen>there were a couple key points, and I'll just mention'em here briefly and then we can maybe dig into them.

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<v Stephen Hansen>But one was about,  this enthusiasm for sort of a new cohort of.

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<v Stephen Hansen>commercial growth stories of, of new companies that are in early launch phase where there's a significant opportunity for them to see sort of rapid, revenue growth.

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<v Stephen Hansen>and so that is one thing that's very, uh, very enticing, from the investor's perspective.

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<v Stephen Hansen>continued M&A was another strong theme.

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<v Stephen Hansen>Uh, we saw a ton of deals this past year and there's every expectation that those are going to continue into 2026.

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<v Stephen Hansen>And then, just the capital, capital formation.

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<v Stephen Hansen>I mean, part of that being, you know, a rotation sort of from generalists more into biotech and that being able to then fuel more follow-ons, the potential for IPOs, the see year.

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<v Stephen Hansen>and then finally when we look at sort of what could potentially halt the momentum, there were, there were a number of things over the past several years that were kind of overhangs for the sector.

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<v Stephen Hansen>You know, whether they were sort of policy issues like MFN or tariffs or FDA.

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<v Stephen Hansen>And you know, from investor's perspective, a lot of those have, while they're still there, they may be not as strong of a sort of headwind for the sector as they once were thought to be, maybe even six months ago.

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<v Stephen Hansen>So you combine all those together and, As I sort of said in a lot of my interviews with these, uh, investors, what had been sort of cautious optimism six months ago has now really transitioned to, to just straight optimism.

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<v Stephen Hansen>People were just really excited actually about, heading into 2026.

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<v Selina Koch>Something I really enjoyed, um,  in your package that seemed to be a theme from, in your discussions with multiple investors, right?

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<v Selina Koch>Which is this analogy to the post 2008 crisis, so maybe 2012, 2013.

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<v Selina Koch>tell us a little bit about how they did that.

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<v Stephen Hansen>that was really interesting.

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<v Stephen Hansen>And I think, put it this way, it came up mostly in conversations with folks who  Who went through that crisis, right?

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<v Stephen Hansen>I mean, people that had been there and sort of saw it.

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<v Stephen Hansen>So the idea was, you know, as I'm sure everyone remember, 2008, 2009, there was the, uh, financial crisis, credit crunch, uh, whatever term you wanna use to name it.

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<v Stephen Hansen>And it was pretty bad, right?

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<v Stephen Hansen>For the markets in several years following that.

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<v Stephen Hansen>But three years post that crisis, right around 2012, sort of into 2013.

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<v Stephen Hansen>You had this emergence sort of at the same time a handful of companies.

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<v Stephen Hansen>So say about, I think there were about six where you had these sort of mid-cap biotechs  that were all launching sort of high growth, potentially blockbuster, new categories of products.

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<v Stephen Hansen>lemme just run through 'em quickly.

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<v Stephen Hansen>So Gilead had their HCV programs.

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<v Stephen Hansen>Vertex had Kalydeco, which was the first of, you know, what was to be, numerous, cystic fibrosis combinations.

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<v Stephen Hansen>Regeneron had Eylea, Biogen had Tecfidera, Amgen had denosumab.

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<v Stephen Hansen>And then Celgene was ramping up Revlimid and bringing on their next multiple myeloma product, uh, Pomalyst And all of these, essentially in that period sort of really got investors excited as they were seeing high growth of these new launches, sort of all at the same time.

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<v Stephen Hansen>and so that then led to a new sort of IPO window in 2013, 2014 for biotech.

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<v Stephen Hansen>More and more money was flowing in.

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<v Stephen Hansen>And that really was one of the genesises of a lot of these new specialist funds where they made a lot of money in that period, and then were able to build up and raise new funds.

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<v Stephen Hansen>so the parallel that we're seeing here is.

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<v Stephen Hansen>I mean, it's not exactly the same, but, you know, we obviously had the bear markets, with the inflation sort of crisis coming out of COVID.

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<v Stephen Hansen>And that then, you know, really triggered, this downturn in the markets.

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<v Stephen Hansen>But now coming out of that, we have, you know, what we counted are at least 23 companies sort of entering 2026 that either have.

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<v Stephen Hansen>high growth launches coming or are very near to entering, entering the commercial space there a lot

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<v Selina Koch>So I think that that's one of the most interesting things for me about analogies is where they break down, right?

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<v Selina Koch>I joined BioCentury's in 2014, and I remember then it was just after that period you were talking about these quarterly previews.

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<v Selina Koch>I weren't involved in them, but discussions always had like something implicit in them.

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<v Selina Koch>Like, what's the new single thing that can, you know, have sector wide impact?

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<v Selina Koch>What's the new HCV?

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<v Selina Koch>And, and now it seems like the question is, well, if the industry is so big and so complex, there's so much going on.

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<v Selina Koch>Maybe there isn't a single theme that can float all boats.

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<v Selina Koch>But now we have this, like we have dozens of companies doing that work.

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<v Simone Fishburn>Yeah, I think that I am often a little bit skeptical also of historical analogies, but I do think that this one holds, and I do think it's different than before.

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<v Simone Fishburn>Sorry, when I say before, I mean the last four times there was a recovery and what you're pointing to when you list off the names Gilead, Vertex, and so on, Regeneron.

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<v Simone Fishburn>Many people sort of who've entered the industry since then may not have realized that those were not necessarily established names at that point.

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<v Simone Fishburn>Right.

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<v Simone Fishburn>And so what I think we had then, and what I think we have again now is, I don't know if I want to call it a realignment or a reshaping of the industry.

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<v Simone Fishburn>We have a whole new class of companies that can be.

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<v Simone Fishburn>The next Vertex or, you know, we've talked about this before.

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<v Simone Fishburn>We've talked about them being big players in Dealmaking There's a word that came to me that's this another common theme, and it's this sort of rotation idea.

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<v Simone Fishburn>So on the one hand we've got rotation of generalists coming back into the sector, and that's because they've got these.

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<v Simone Fishburn>Commercial companies that, you know, you pointed this out in the story, they understand them better, right?

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<v Simone Fishburn>It is a lot easier for generalists to understand a company that's got sales and now they can start projecting rather than the sort of risk factor.

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<v Simone Fishburn>And the other thing that's rotating, of course, that you talk to in the story is money from M&A.

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<v Simone Fishburn>So the, the drumbeat of M&A has recycled capital.

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<v Simone Fishburn>Back into the system.

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<v Simone Fishburn>And, and you know, I, I do wanna ask you one thing, and we're gonna get to the optimism part in a minute, Stephen.

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<v Simone Fishburn>Okay.

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<v Simone Fishburn>and the downside that Selena's looking for, but,  I think it's important to talk about AI because one of the things that you said was that it's as if many of the.

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<v Simone Fishburn>Investors who've been in AI are now looking for something else and they're gonna come back into, maybe come back into biotech or might look at biotech and I wanted to sort of pressure test that to the degree that, is there evidence for that or is it just the idea that there's an AI bust or, how do you think AI really is impacting biotech's fortunes?

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<v Stephen Hansen>I think the idea, and again, I don't think there's a lot of concrete evidence for this, but it was essentially the notion that you had a lot of generalist investors who, the simplest thing for them in 2023, 2024.

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<v Stephen Hansen>Was just to put more money into Nvidia, right?

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<v Stephen Hansen>And so you could keep buying, keep buying, keep buying or meta or whatever, any of these AI related investments where there's massive CapEx going into it.

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<v Stephen Hansen>And so they were just plowing money into those companies.

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<v Stephen Hansen>And as we saw over the last couple of years, those shared prices kept rising, right?

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<v Stephen Hansen>So they were getting growth out of those, out of those investments.

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<v Stephen Hansen>But obviously, as we all know, the larger and larger those go, the harder it is to keep.

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<v Stephen Hansen>Justifying sort of seeing those, those share prices go up.

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<v Stephen Hansen>And so I think some of them were starting to reduce their exposure there because they were worried about the downside risk.

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<v Stephen Hansen>If something does happen, if that bubble does burst, they wanted to try and avoid that downside risk.

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<v Stephen Hansen>And so, you know, uh, in my conversations with some investors, they were saying, well, these people then step back and they say, where else could my money go where I would have the opportunity for high growth?

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<v Stephen Hansen>And where there might be, even, even from a value perspective where things are undervalued and biotech clearly, you know, over the last four years is one of the arguably most undervalued sectors in the economy.

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<v Stephen Hansen>Right?

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<v Stephen Hansen>you couple that four year sort of underperformance, undervaluation.

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<v Stephen Hansen>And then you have what we saw from June onwards where.

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<v Stephen Hansen>You saw very good sort of performance relative to these other sectors.

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<v Stephen Hansen>You see things like, the very public, M&A fight over Metsera between Pfizer and Novo Nordisk.

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<v Stephen Hansen>and the analogy I sort of gave there was, you know, if you're a portfolio manager sitting in one of these big mutual fund complexes.

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<v Stephen Hansen>And let's say you, you know, had a banker come to you and offer you to participate in the Metsera IPO back in January that was at a $1.9 billion valuation.

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<v Stephen Hansen>And let's say you passed, you then look and, you know, nine, 10 months later, Metsera's being acquired for $10 billion.

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<v Stephen Hansen>That's a five x in less than a year that you missed out on.

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<v Stephen Hansen>And you have to remember, I mean these are human beings and there is a psychological effect and you know, a lot of investors are saying this.

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<v Stephen Hansen>I mean, this does, this is how that sort of FOMO mentality can be created is when you miss out on an opportunity and see it, you know, turn like that.

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<v Stephen Hansen>And so I think that's part of it is you have all the concerns that were swirling around ai, are you they ever gonna make a return on investment?

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<v Stephen Hansen>These sorts of things.

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<v Stephen Hansen>Then you couple that with opportunity and that's where I think you start to see some of that rotation.

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<v Stephen Hansen>one more thing to add though, I mean, where we do I think have evidence of generalist participation is very much what we saw in the follow on market, in the last quarter.

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<v Stephen Hansen>Because if you look, even just at December 9th, that was the day where there were $3.3 billion in follow-ons raised.

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<v Stephen Hansen>All of those deals were upsize deals, like substantially upsize deals.

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<v Stephen Hansen>And as most of the bankers told me.

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<v Stephen Hansen>You can't upsize deals in that way without there being substantial generalist participation in those deals.

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<v Stephen Hansen>I'll give one more little anecdote here from my conversations that I don't think actually made it into the story, but I thought was quite useful.

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<v Stephen Hansen>so one Baker told me about how a year ago you would have these mutual funds, if, if you were gonna raise a follow on the mutual funds would come in and say, yes, we'll buy into the deal, but.

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<v Stephen Hansen>We just want the minimum, just give us whatever the minimum amount is to sort of maintain our exposure, but we're not really buying more.

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<v Stephen Hansen>What you then saw, like in September, in the fourth quarter, was you had these mutual funds coming in and let's say the company was going to raise 150 million in the follow on, they would be saying, we want to put 150 million into the deal.

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<v Stephen Hansen>So they were willing to buy the whole deal, and so they were having to upsize these deals to basically allow for allocation to other investors.

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<v Stephen Hansen>But also wanted in.

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<v Stephen Hansen>So there was definite evidence of them looking to increase their exposure, to the sector, say over the last six months of, last year.

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<v Simone Fishburn>I, I think another thing, Stephen, that you know, know, and probably most of our, many of our audience know another fundamental difference from.

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<v Simone Fishburn>Let's say a decade ago, or you know, the last crisis is the number of mutual funds and so on that actually have dedicated biotech experts in them.

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<v Simone Fishburn>you know, that didn't used to be the case.

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<v Simone Fishburn>And so they've got, or I should say maybe, I don't know if I should call 'em biotech experts or science experts or whatever, but they've got people who are really able to understand better.

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<v Simone Fishburn>And so, which I think is really important, like breaking down that very siloed nature of us.

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<v Simone Fishburn>let's tap into Selina.

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<v Selina Koch>Tap into me.

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<v Selina Koch>Perfect.

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<v Selina Koch>I just wanted to say, when I was looking for a subtle way in which, you know, the situation today differed a bit from that analogy from earlier.

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<v Selina Koch>I was not trying to be pessimistic actually.

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<v Selina Koch>Uh, what the point I was trying to make is that, um, you know, if you have so much of the enthusiasm kind of writing on a single theme like say HCV, that can be a more fragile situation than what we have today.

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<v Selina Koch>Like, so the sector fundamentals.

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<v Selina Koch>Being so broadly distributed across so many disease areas and so many companies all feeling strong, seems to me like, it sets up a situation that can potentially be more robust.

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<v Selina Koch>Um, so I was trying to be positive, um, but we can move to the pessimistic.

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<v Jeff Cranmer>Well, I knew that P word was gonna come up.

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<v Jeff Cranmer>we don't even have Steve Usdin on, uh, this podcast, but, let's take a quick break, so that our listeners can hear about our upcoming conference in Seoul, in March.

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<v Jeff Cranmer>It's our fifth East-West summit.

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<v Alanna Farro>BioCentury This Week is brought to you by The 5th East-West Biopharma Summit in South Korea.

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<v Alanna Farro>An arc of innovation is emerging across Asia, and Western biopharma leaders are taking note-from cross-border deals to newcos.

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<v Alanna Farro>In March, 2026, The 5th BioCentury-BayHelix East-West BioPharma Summit visits South Korea for the first time.

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<v Jeff Cranmer>Okay, we are back.

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<v Jeff Cranmer>You're to a special edition of the BioCentury This Week podcast focused on my colleague Stephen Hansen 2026 public markets preview.

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<v Jeff Cranmer>we have some other juicy, look ahead stories coming up, in the coming days.

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<v Jeff Cranmer>We'll.

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<v Jeff Cranmer>Publish our catalyst story.

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<v Jeff Cranmer>we used to do a buy-side view story, but now, Lauren Martz and Stephen and Selina's and some of our other colleagues are pouring through, upcoming readouts, upcoming launches.

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<v Jeff Cranmer>And we'll put this all in perspective for you.

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<v Jeff Cranmer>So look for that in the next few days.

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<v Jeff Cranmer>Okay.

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<v Jeff Cranmer>Selina pessimism.

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<v Selina Koch>As, as exciting as this time is, there are of course always things that could be bumps in the road.

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<v Selina Koch>A couple of 'em that potentials that come into my mind are, what happens if that AI bubble burst?

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<v Selina Koch>Does it fuel this trend we've been seeing towards biotech?

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<v Selina Koch>Or does it actually just hurt everybody?

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<v Selina Koch>And then of course there's the regulatory policy environment.

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<v Selina Koch>Stephen, you wanna talk?

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<v Selina Koch>Start with the first one.

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<v Stephen Hansen>Sure.

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<v Stephen Hansen>Yeah.

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<v Stephen Hansen>I mean, I would say that in my discussions with the investors and bankers, that was, to be honest, I think that was somewhat of still like an open debate.

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<v Stephen Hansen>there were some views that biotech would be viewed as somewhat of a haven that could maybe weather, you know, when he said.

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<v Stephen Hansen>Obviously those ai, investments in companies are so massive and make up such a large component of the broader markets like the S&P I think, like those Mag seven account, somebody can, uh, write into us and tell me if I'm wrong, but I think it might even be like a third of the market valuation of the s and p 500.

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<v Stephen Hansen>So they make up a massive amount of, of the sector.

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<v Stephen Hansen>So obviously if there is any major downturn or bursting of a bubble around ai.

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<v Stephen Hansen>There's no way to avoid that having a hit on the broader markets.

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<v Stephen Hansen>but there were some people that, you know, we're talking about biotech as being a place where you could still find, you know, uh,  could still be a bit of a haven.

00:16:45.136 --> 00:16:53.611
<v Stephen Hansen>And I think  a lot of that maybe is just, what has always historically kind of traditionally been the rationale for why biotech can be non-cyclical.

00:16:53.812 --> 00:16:54.113
<v Stephen Hansen>Right?

00:16:54.113 --> 00:16:56.381
<v Stephen Hansen>Because, People are always getting sick.

00:16:56.381 --> 00:16:57.850
<v Stephen Hansen>People always need treatments.

00:16:57.850 --> 00:17:05.391
<v Stephen Hansen>And so there's, there are, there are reasons for investing in the sector that don't follow, you know, the, the normal cycles of, typical broader economy.

00:17:05.857 --> 00:17:06.125
<v Simone Fishburn>Yeah.

00:17:06.125 --> 00:17:06.692
<v Simone Fishburn>Stephen.

00:17:06.791 --> 00:17:12.263
<v Simone Fishburn>and then the other part of that is the FDA,  I'll give you my take on this and tell me if, this is sort of what you are hearing.

00:17:12.263 --> 00:17:17.935
<v Simone Fishburn>And I think everybody knows that there's actually not less regulatory risk than there was, let's say.

00:17:18.537 --> 00:17:21.539
<v Simone Fishburn>Three months ago, or six months ago, or nine months ago.

00:17:21.940 --> 00:17:27.913
<v Simone Fishburn>I think,  there's a little bit of feeling that, look, we can't just sit on the sidelines forever.

00:17:27.945 --> 00:17:29.048
<v Simone Fishburn>The risk is there.

00:17:29.314 --> 00:17:36.188
<v Simone Fishburn>maybe we can ride it out, you know, maybe we just have to keep going and just cross that risk when we come to it, as it were.

00:17:36.188 --> 00:17:44.896
<v Simone Fishburn>There are a few people who feel that there are good things happening at FDA, I think we can all look to that, but there are people who will also look to the fact that the pace of approvals.

00:17:45.663 --> 00:17:54.006
<v Simone Fishburn>Was, you know, quite robust last year, although there's obviously a lot of feeling that this is the year where the chickens will come home to roost kind of thing.

00:17:54.306 --> 00:17:58.309
<v Simone Fishburn>But I, I don't know if your feeling is, I think you gonna, you can only sit on the sidelines for so long.

00:17:58.309 --> 00:18:02.847
<v Simone Fishburn>I mean, their job is to spend, investor's job is to invest money not to sit on the sidelines.

00:18:02.847 --> 00:18:07.019
<v Simone Fishburn>So how long can you sit that one out and wait, and I, I don't know whether there's any.

00:18:07.586 --> 00:18:16.528
<v Simone Fishburn>of Selina, you talked to the AI thing about a particular crash, but going back to your other point, I'm not sure that there's a single regulatory event that anymore can bring it down.

00:18:16.528 --> 00:18:23.469
<v Simone Fishburn>That did happen when RFK Junior was nominated, but I, I don't anymore if there is a single thing that will bring this down.

00:18:24.135 --> 00:18:27.972
<v Selina Koch>Yeah, and I think there's regulatory risk and policy risk across industries, right?

00:18:27.972 --> 00:18:28.272
<v Selina Koch>It's not just.

00:18:28.574 --> 00:18:33.345
<v Simone Fishburn>It seemed to be just going you know, taco or whatever.

00:18:33.345 --> 00:18:34.946
<v Simone Fishburn>We'll deal with it, you know?

00:18:35.480 --> 00:18:35.780
<v Stephen Hansen>Yeah.

00:18:35.913 --> 00:18:36.381
<v Simone Fishburn>Steven.

00:18:36.949 --> 00:18:40.751
<v Stephen Hansen>know, I think, so we said sort of at the top that there were all these sort of overhangs, you know.

00:18:41.053 --> 00:18:45.057
<v Stephen Hansen>Previously that had everyone worried and obviously FDA was one of those.

00:18:45.523 --> 00:18:54.700
<v Stephen Hansen>And now in my conversations, FDA kind of remains the only one that is sort of the major potential risk that hangs out there.

00:18:55.000 --> 00:19:04.108
<v Stephen Hansen>I mean, you rightly say, I mean obviously for specialist investor, their LPs aren't paying them two 20, you know, to, um, you know, or, or whatever their, their fund agreements are.

00:19:04.542 --> 00:19:05.576
<v Stephen Hansen>To sit on cash, right?

00:19:05.576 --> 00:19:06.979
<v Stephen Hansen>They have to have that money invested.

00:19:06.979 --> 00:19:10.648
<v Stephen Hansen>So this is just an additional risk that they have to take into account.

00:19:10.715 --> 00:19:19.825
<v Stephen Hansen>And it sort of fell into two camps as I kind of framed it in the story, and I think it kind of follows, similar to what you were saying, Simone, so the glass half full and the glass half empty sort of approach.

00:19:20.125 --> 00:19:28.032
<v Stephen Hansen>There were some people that were saying, well, we've had this change at FDA, obviously since RFK came in last year, and then Makary coming in in April.

00:19:28.432 --> 00:19:36.575
<v Stephen Hansen>Everything, despite all this turmoil and despite, you know, reports of low morale despite, the staffing reductions, things still be, seemed to be going.

00:19:36.607 --> 00:19:49.153
<v Stephen Hansen>I had a lot of people telling me that, the companies that they do invest in and meet with management were saying that, the vast majority were still having normal interactions with FDA, that there weren't disruptions there from what they were seeing on the ground.

00:19:49.153 --> 00:19:51.557
<v Stephen Hansen>And so therefore, part of the camp, you know.

00:19:51.722 --> 00:19:59.798
<v Stephen Hansen>of the investors were saying, I don't see any reason to think that, you know, maybe it's not gonna be as disruptive as, we thought it was gonna be.

00:20:00.365 --> 00:20:04.068
<v Stephen Hansen>Then the other half were, as you were saying, you know, will the chickens come home to roost?

00:20:04.068 --> 00:20:09.106
<v Stephen Hansen>And they were essentially, you know, of, of the mindset of there's been all this disruption, all these changes.

00:20:09.441 --> 00:20:24.423
<v Stephen Hansen>At some point, this is just gonna compound and compound and it's gonna take time, but there will be a time in which we start to see more and more disruption and where that regulatory risk is gonna become a bigger and bigger impact on our investment decision making.

00:20:24.890 --> 00:20:29.428
<v Stephen Hansen>the question I guess is how does that actually translate then into share prices?

00:20:29.428 --> 00:20:30.429
<v Stephen Hansen>You know, does that mean that

00:20:30.761 --> 00:20:36.801
<v Simone Fishburn>I was also gonna ask whether it translates into sort of the timing of the opportunity you're investing in.

00:20:36.969 --> 00:20:42.441
<v Simone Fishburn>So if it's something that's got a really near PDUFA date and you know, could be commercial this year.

00:20:42.874 --> 00:20:46.310
<v Simone Fishburn>Maybe, you know, you're like, okay, I'm gonna start seeing revenue soon.

00:20:46.678 --> 00:20:54.385
<v Simone Fishburn>And if it's something where, the delay could happen and then really like push back that, you know, catalyst

00:20:54.519 --> 00:20:57.689
<v Stephen Hansen>it, it, it, can start to mess with people's models a bit, right?

00:20:57.689 --> 00:21:07.432
<v Stephen Hansen>I mean, if, if all of a sudden, you know, your, your launch was meant to be, year from now and all of a sudden the launch is not two, you know, it's two years from now, obviously that changes, you know, sort of evaluation models.

00:21:07.766 --> 00:21:11.202
<v Stephen Hansen>So there's, there's lots of different inputs to this, I think, where it can impact it.

00:21:11.269 --> 00:21:14.506
<v Stephen Hansen>But as I said, I mean, if you're a specialist, you still have to be in the sector.

00:21:14.506 --> 00:21:15.507
<v Stephen Hansen>it just creates.

00:21:16.275 --> 00:21:17.909
<v Simone Fishburn>Get another job if this isn't good.

00:21:18.844 --> 00:21:25.784
<v Stephen Hansen>it's just, it's another, it's another potential bump in the road that's,  two years ago, I don't think anyone would've said existed.

00:21:25.784 --> 00:21:25.951
<v Stephen Hansen>Right?

00:21:25.951 --> 00:21:31.390
<v Stephen Hansen>I mean, FDA was viewed as a, you know, sort of a partner with the industry that would help get innovation out to patients.

00:21:31.923 --> 00:21:38.596
<v Stephen Hansen>And I think some of the concern now is that, I mean, very much it's the concern for vaccines, but even beyond vaccines.

00:21:39.364 --> 00:21:43.402
<v Stephen Hansen>There's concern about whether what companies heard, let's say, a year ago.

00:21:43.969 --> 00:21:52.443
<v Stephen Hansen>Um, you know, we've seen instances of this where what companies were told, and for the development plans a year ago, maybe that advice doesn't hold true now.

00:21:52.477 --> 00:21:54.578
<v Stephen Hansen>And so that can create some disruption and some

00:21:55.614 --> 00:21:56.147
<v Simone Fishburn>I think that.

00:21:56.515 --> 00:21:59.250
<v Simone Fishburn>That's another thing, and we sort of had that in our survey.

00:21:59.617 --> 00:22:11.363
<v Simone Fishburn>You watched this a little bit as well, which is, you know, there will be areas where there's just like vaccines, no investment and I don't know, Selina, if you've got thoughts on what it means for orphan diseases and rare diseases.

00:22:11.363 --> 00:22:13.699
<v Simone Fishburn>'cause FDA has sort of been back and forth on that.

00:22:13.765 --> 00:22:16.601
<v Selina Koch>That's exactly what I was gonna bring up as the area to watch.

00:22:16.601 --> 00:22:20.705
<v Selina Koch>I mean, in principles, there's some interesting good ideas floating around FDA right now, right?

00:22:20.705 --> 00:22:31.048
<v Selina Koch>They, release that framework on rare diseases, um, kind of codifying some things that have already, you know, been mostly accepted, such as like you can have a, a single trial.

00:22:31.316 --> 00:22:32.217
<v Selina Koch>instead of two.

00:22:32.217 --> 00:22:35.420
<v Selina Koch>And, but then there's also like the plausible mechanism pathway.

00:22:35.886 --> 00:22:36.688
<v Selina Koch>How will that be?

00:22:36.821 --> 00:22:38.190
<v Selina Koch>Will it be instantiated?

00:22:38.190 --> 00:22:39.657
<v Selina Koch>How will it be instantiated?

00:22:39.657 --> 00:22:42.227
<v Selina Koch>How many will it extend beyond N of one or not?

00:22:42.259 --> 00:22:44.895
<v Selina Koch>There's no principle, there's no reason why it couldn't.

00:22:45.230 --> 00:22:47.766
<v Selina Koch>So these are indicators of positive changes.

00:22:47.766 --> 00:22:54.306
<v Selina Koch>On the other hand, when it comes to regulatory decisions, some of those reversals just make you wonder.

00:22:54.538 --> 00:22:56.607
<v Selina Koch>If we can actually get from, from here to there.

00:22:56.607 --> 00:22:56.875
<v Selina Koch>Right.

00:22:56.875 --> 00:23:05.049
<v Selina Koch>There's the example of course of, of uniQure and it's a Huntington's therapy where it was told it could use a natural history comparator.

00:23:05.217 --> 00:23:05.549
<v Selina Koch>Right.

00:23:05.584 --> 00:23:09.186
<v Selina Koch>Devastating, very severe disease, no treatments for it.

00:23:09.253 --> 00:23:11.490
<v Selina Koch>Rare, and then later was told it couldn't.

00:23:11.490 --> 00:23:13.357
<v Selina Koch>So it's still uncertain for now.

00:23:14.291 --> 00:23:16.894
<v Stephen Hansen>Yeah, and that was, and that was you know, some of the investors that were.

00:23:17.395 --> 00:23:18.329
<v Stephen Hansen>More pessimistic.

00:23:18.730 --> 00:23:29.207
<v Stephen Hansen>They pointed to those sorts of examples and sort of the incongruity of kind of the messaging out of, out of FDA as being, as being a worry, you know, for what, what might unfold sort of in the year or two.

00:23:29.807 --> 00:23:31.643
<v Jeff Cranmer>Let's jump over to IPOs.

00:23:32.042 --> 00:23:35.913
<v Jeff Cranmer>we've had one Nasdaq IPO get out so far.

00:23:35.913 --> 00:23:38.650
<v Jeff Cranmer>That's Aktis Oncology.

00:23:39.049 --> 00:23:39.584
<v Jeff Cranmer>let's see.

00:23:39.584 --> 00:23:42.988
<v Jeff Cranmer>They, uh, were looking to get out at 16 18.

00:23:42.988 --> 00:23:46.391
<v Jeff Cranmer>They priced at the top end of that range.

00:23:46.691 --> 00:23:48.960
<v Jeff Cranmer>they got a nice pop in the first day.

00:23:49.461 --> 00:23:50.862
<v Jeff Cranmer>they're up about $4.

00:23:51.195 --> 00:23:52.463
<v Jeff Cranmer>What, what were you hearing about?

00:23:52.564 --> 00:23:55.333
<v Jeff Cranmer>obviously this set the stage nicely.

00:23:55.433 --> 00:24:00.204
<v Jeff Cranmer>are you hearing that more IPOs are on the way, Stephen, or are we gonna have to wait a bit for the window to open?

00:24:01.705 --> 00:24:08.880
<v Stephen Hansen>So I think there's every expectation that there's gonna be a broader window for IPOs this year, probably.

00:24:09.346 --> 00:24:17.189
<v Stephen Hansen>Starting sometime in the first half, I don't think nobody thought there was gonna be a flood, sort of pre JPM or even immediately after JPM.

00:24:17.588 --> 00:24:23.728
<v Stephen Hansen>obviously great setup for this was the fact that there were all these follow-ons in the fourth quarter and all of them did very well.

00:24:23.862 --> 00:24:35.039
<v Stephen Hansen>You know, there was good post-market performance and a lot of them, and that's almost always the setup that you need for IPOs, is you need follow along to work and then people can start thinking about, you know, what's considered to be a more risky asset class.

00:24:35.440 --> 00:24:42.580
<v Stephen Hansen>the two things that primarily came up in, in discussions about IPOs was that you kind of needed the first wave that was gonna come out.

00:24:42.646 --> 00:24:43.848
<v Stephen Hansen>You needed them to work.

00:24:44.082 --> 00:24:50.454
<v Stephen Hansen>And I think, you know, as you sort of described, they're at least so far for Aktis Oncology that seems to have worked and seems to be doing well.

00:24:50.521 --> 00:24:52.691
<v Stephen Hansen>You know, they're holding their, holding their prices, as you said.

00:24:53.290 --> 00:24:53.959
<v Stephen Hansen>That's good.

00:24:53.959 --> 00:24:56.928
<v Stephen Hansen>But we kind of need a couple more to do that.

00:24:57.394 --> 00:25:03.201
<v Stephen Hansen>But the primary thing that people have pointed to was, one of the investors said the term was quality discipline.

00:25:03.902 --> 00:25:08.038
<v Stephen Hansen>And so this is the idea that you really want the highest quality companies to come out.

00:25:08.038 --> 00:25:09.673
<v Stephen Hansen>You want the ones that are gonna perform best.

00:25:09.673 --> 00:25:13.044
<v Stephen Hansen>Because, you know, when I was asking people,  what are some of the risks?

00:25:13.111 --> 00:25:17.582
<v Stephen Hansen>You know, what are some of the things that could kill the momentum, you know, for this market next year?

00:25:17.915 --> 00:25:23.421
<v Stephen Hansen>in 2026, 1 of the common things that came up was, a slew of bad IPOs that.

00:25:23.622 --> 00:25:28.692
<v Stephen Hansen>Tank in the aftermarket and don't do well like that, that could be a momentum killer for the sector.

00:25:29.059 --> 00:25:45.143
<v Stephen Hansen>And so there was this real focus on, and frankly, especially from the investors, talking about bankers, saying bankers need to be very disciplined in the companies that they're willing to take forward for IPOs, or those VCs that are investing in those companies need to be very, disciplined in, in selecting high quality companies.

00:25:45.911 --> 00:25:50.147
<v Stephen Hansen>that can do well in this market and, and, you know, help to push it forward.

00:25:50.648 --> 00:25:58.990
<v Stephen Hansen>Um, now the good thing is because we've had this extended bear market, there have been a lot more private companies that have stayed private for a lot longer.

00:25:59.089 --> 00:26:04.461
<v Stephen Hansen>And so a lot of the people pointed to the fact that private companies have had more time to season and mature.

00:26:04.828 --> 00:26:08.500
<v Stephen Hansen>And so you've got a lot more clinical stage, late stage private companies.

00:26:08.700 --> 00:26:17.474
<v Stephen Hansen>That Should do well that should they look like high quality IPO candidates with good management teams, good VCs, all those sorts of criteria.

00:26:18.175 --> 00:26:30.055
<v Stephen Hansen>So the hope is that those will be the ones that will come out first, and then if they do well, things should start to open up more sort of towards the back end of the first half of the year, sort of around the May, June sort of, sort of timeframe.

00:26:30.588 --> 00:26:46.136
<v Stephen Hansen>but I think it's, right now it's a bit of a waiting game just to see, As you said, Aktis seems to have gone well, but we kind of need to see number two, number three, number four, see how they do before I think we go, we will get a real sense of, of what we might expect for the rest of the year.

00:26:47.372 --> 00:26:47.872
<v Jeff Cranmer>How about M&A

00:26:48.606 --> 00:26:54.412
<v Stephen Hansen>Yeah, I mean, M&A is, is, um, I don't think anyone has any expectation that that is gonna go away.

00:26:54.778 --> 00:26:58.583
<v Stephen Hansen>This year, I mean, for all the reasons, that M&A, it was big last year.

00:26:59.017 --> 00:27:03.922
<v Stephen Hansen>Lots of holes that pharmas need to fill in their pipelines, in their,  loss of exclusivity.

00:27:04.623 --> 00:27:06.625
<v Stephen Hansen>That hasn't changed, that story's the same.

00:27:06.625 --> 00:27:08.526
<v Stephen Hansen>And so there's an expectation that that's gonna continue.

00:27:08.526 --> 00:27:13.064
<v Stephen Hansen>And just, you know, like we mentioned earlier when we were talking about all these new growth stories.

00:27:13.330 --> 00:27:14.965
<v Stephen Hansen>Not all of those are gonna stay independent.

00:27:15.066 --> 00:27:15.266
<v Stephen Hansen>Right.

00:27:15.266 --> 00:27:23.474
<v Stephen Hansen>I'm sure that there are several of those that are gonna get taken out this year because there are near term, you know, launch opportunities with, high, peak sales opportunities for some of those products.

00:27:23.474 --> 00:27:25.276
<v Stephen Hansen>And so my expectation

00:27:25.309 --> 00:27:28.413
<v Simone Fishburn>Well that swings both ways Stephen, because on the one hand, they won't all stay independent.

00:27:28.413 --> 00:27:29.346
<v Simone Fishburn>They may get bought up.

00:27:29.346 --> 00:27:33.351
<v Simone Fishburn>On the other hand, they're also entering the M&A space right, themselves.

00:27:33.484 --> 00:27:34.586
<v Simone Fishburn>And so they're

00:27:34.919 --> 00:27:35.953
<v Selina Koch>as buyers, you mean

00:27:35.953 --> 00:27:36.988
<v Simone Fishburn>as buyers, yeah.

00:27:37.021 --> 00:27:37.321
<v Stephen Hansen>Yep.

00:27:37.655 --> 00:27:37.922
<v Stephen Hansen>Yep.

00:27:38.288 --> 00:27:42.160
<v Stephen Hansen>And so, I think those two kind of work, work together in some ways.

00:27:42.160 --> 00:27:46.597
<v Stephen Hansen>And so, um, you know, I mean even just like during JP Morgan that started JP Morgan, right?

00:27:46.597 --> 00:27:48.633
<v Stephen Hansen>I mean they haven't happened yet, but had these rumors.

00:27:48.633 --> 00:27:52.170
<v Stephen Hansen>There was the rumor about Revolution Medicines and whether they were gonna get taken out.

00:27:52.202 --> 00:27:55.073
<v Stephen Hansen>And I think the number that was floating around there was up to 32 billion.

00:27:55.272 --> 00:27:59.044
<v Stephen Hansen>There was Abivax rumors about a takeout at 17 and a half billion.

00:27:59.376 --> 00:28:06.017
<v Stephen Hansen>Both of those companies are on our list of near term launch, companies that could be high, you know, high growth companies going forward.

00:28:06.017 --> 00:28:08.185
<v Stephen Hansen>So,  like everything, this will be fits and starts.

00:28:08.185 --> 00:28:10.622
<v Stephen Hansen>I don't think it's gonna be the cadence that we saw.

00:28:10.654 --> 00:28:15.492
<v Stephen Hansen>I mean, I'm sure there will be at some point where we get the Monday M&A sort of thing happening, but

00:28:15.794 --> 00:28:19.698
<v Jeff Cranmer>And we had, uh, Cytokinetics is on the list as well, I believe, and.

00:28:20.365 --> 00:28:20.531
<v Stephen Hansen>They are.

00:28:20.531 --> 00:28:29.807
<v Jeff Cranmer>They had a great week in December where they got,  EMA’s, CHMP, recommended the drug and then China and FDA approved it.

00:28:30.141 --> 00:28:32.576
<v Jeff Cranmer>And they were in this bucket last year.

00:28:32.576 --> 00:28:36.647
<v Jeff Cranmer>I believe they, there were rumors that they were going to be acquired by Novartis.

00:28:36.780 --> 00:28:41.419
<v Jeff Cranmer>Who are some of the other companies, on that short list or is not actually a short list.

00:28:41.720 --> 00:28:43.188
<v Selina Koch>It, fortunately, it's a long list.

00:28:43.253 --> 00:28:43.654
<v Selina Koch>Yeah.

00:28:43.788 --> 00:28:44.122
<v Stephen Hansen>Yeah.

00:28:44.321 --> 00:28:46.324
<v Selina Koch>Well, you know, I watched the neuroscience space.

00:28:46.324 --> 00:28:58.569
<v Selina Koch>I think an interesting little company there that's breaking out could be Praxis Precision medicines, which had great data, a couple of indications, last year and we'll we'll see, you know, how that continues into this year.

00:28:58.903 --> 00:29:04.476
<v Selina Koch>There's also, you know, a few companies on here who have been around a long time like Ionis.

00:29:04.776 --> 00:29:09.146
<v Selina Koch>don't necessarily expect Ionis to get taken out in terms of that discussion, but you know, as a partner.

00:29:09.980 --> 00:29:12.317
<v Selina Koch>For a long time and had success.

00:29:12.450 --> 00:29:16.688
<v Selina Koch>Spinraza came from, from Myas, but now it's, doing some independent launches.

00:29:16.688 --> 00:29:21.659
<v Selina Koch>And, you know, I don't wanna steal the thunder from our Catalyst package, which we'll no doubt talk about next week.

00:29:21.792 --> 00:29:36.240
<v Selina Koch>but one of the big themes this year is gonna be the LP little A data, which Ionis has one of those and it's partnered with, Novartis, and that could be really important for, we've seen some momentum growing in cardiovascular and that that could help move it along.

00:29:37.407 --> 00:29:38.942
<v Jeff Cranmer>And Arrowhead is on the list.

00:29:38.942 --> 00:29:41.613
<v Jeff Cranmer>Simone, I know they, uh, caught your eye recently.

00:29:42.180 --> 00:29:43.381
<v Simone Fishburn>Yeah, Arrowhead did.

00:29:43.381 --> 00:29:59.130
<v Simone Fishburn>And you know, just to round this off, uh, I've mentioned conversation I had that we are gonna be publishing with the CEO of Novartis Basson, and he He talks a little bit about their LP little a program and what he expects in terms of, you know, the ramp up of sales there.

00:29:59.230 --> 00:30:01.865
<v Simone Fishburn>So I think that's an important space to watch.

00:30:01.865 --> 00:30:02.166
<v Simone Fishburn>Yeah.

00:30:03.233 --> 00:30:13.344
<v Jeff Cranmer>Alright, well, uh, Stephen’s package is out, right now on BioCentury.com BioCenturypodcast.com check it out.

00:30:13.443 --> 00:30:17.214
<v Jeff Cranmer>The Lauren Martz led Catalyst package is coming soon.

00:30:17.214 --> 00:30:22.787
<v Jeff Cranmer>So lots of good copy to, to dig into as you recover from uh, JPM.

00:30:22.787 --> 00:30:27.692
<v Jeff Cranmer>I know I'm still, recovering from, uh, a very busy week last week.

00:30:27.858 --> 00:30:31.628
<v Jeff Cranmer>Selina's, Simone, Stephen, uh, thanks for joining me today.

00:30:31.930 --> 00:30:34.699
<v Jeff Cranmer>And if you like what you're hearing,  follow us.

00:30:35.032 --> 00:30:36.134
<v Jeff Cranmer>Leave us a comment.

00:30:36.401 --> 00:30:41.005
<v Jeff Cranmer>this has been the BioCentury this week podcast.

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<v Jeff Cranmer>we'll catch you Monday with the next edition, of the pod.

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<v Jeff Cranmer>Special thanks to Kendall Square Orchestra for providing the music for podcasts.