Episode 169 - January 16, 2026

You're listening to Biotech Hangout, a live and unedited weekly discussion of all the latest news in our industry with a group of biotech leaders and experts. I'm Chris Garibidean, and my co-host today are Mike Yee, Paul Matisse, and Sam Fizzelli. For more information about our hosts and guest speakers or to listen to the most recent episode, please go to biotechhangout.com. So we're going to go ahead and get started. So first, obviously, biggest week of the year, and probably the biggest signal for sentiment, coming out of the JP Morgan conference, which just ended yesterday, or today if you've got some follow-on meetings. So I'll just say it was my first JPM since 2019, and it felt really good. I mean, I think all positive signals were on. Mike Yee is going to talk about this a little further in terms of investor sentiment. The big news was that there wasn't as much M&A, but actually Adam Forstein and Daphne Zohar posted his article, did a really nice article I thought on why this is a good thing, why this could mean some positive momentum that there wasn't as much M&A announced this week. And I think there were some good reasons for that. But overall, I think, sort of a macro existential non-biotech geopolitical crisis, I think things should look good for 2026. But Paul, why don't you wait on this, what were your thoughts coming out of the week? Yeah, I mean, I think in general, on Monday, some of the chatter was, there's not much news, not much going on, XBI sold off a little bit on that, but it feels like a lot of investors are coming off a great year last year to say the least. And I think we've talked about on this podcast a lot of structural tailwinds of the sector, right? You know, drug pricing risk is knock on wood, like not that significant right now, a lot of successful commercial launches, a lot of great data readouts, investors getting rewarded on taking data risk, we saw some financings early in the year that were really significant and that didn't take the wind out of the sales. And so, especially with the red men news the week before, which realizing that's not a done deal, but that's a really, really big M&A ticket. My conversations were generally very positive, and I also think they're positive, but things like aren't overheated, right? Which I think is also good. Like you almost, if you're an investor or a company in this sector, like you want sentiment to be 7 out of 10, right? Like you don't want it to be 3 out of 10, you don't want it to be 10 out of 10 because 10 out of 10 is scary too, so I feel pretty good. Yeah, and I know Sam, you didn't attend, but just curious what your thoughts were from just reading the new flow or following X and any post, did you have any, take away? Yeah, so the way that, so everybody went in, as Paul said, looking for maybe some M&A. And of course, you look after the, you know, we didn't get that, and healthcare space did, we didn't. And you look at the share price action during the week and it tells you, I really quite liked the way that Paul put it 7 out of 10, which is, which is nice, tells you a little bit what the feeling was out of the conference. You know, on our drug chat, we have a pretty hefty drug chat with over 2,000 people. It just felt to me that people were taking it in their stride, is that the best phrase, that's the best phrase I can come up with now. There was an over-enthusiasm, there were some questions about the way that people were commenting on their week, et cetera. But I think the sentiment was, I've just asked the question, actually, and I didn't ask, was the sentiment, was your sentiment negative coming out of the meeting? And I think it was, it was in that, in that same zone of 6 to 7 out of 10, which sounds, which is great. And, you know, and also, we started the year with a super strong week where we got M&A and a whole host of secondaries. So we'd love to hear what Mike thought. Yeah, Mike, you talked to a lot of investors and just companies, and yeah, we'd love to hear your perspective from the kind of insider investor scoop, and did they have similar sentiment? Yes, we can. Perfect. To the coin, one is on specialists and hedge funds, and there's that we are quite familiar with. And then, of course, just a broader, a mutual fine, broader, generalist community, which is important. And I think that you guys said it well. A lot of things have passed drug pricing, stocks are acting a lot better. And I think that folks coming into 2026, specialists, definitely more optimistic about putting money to work. You know, you're seeing follow-ons, obviously there was also an IPO that happened that traded up well. I think that's notable. And there's definitely a buzz in the specialist community about privates and crossovers and all that sort of action, getting done all on the expectation, and I would say agree that a lot of this is coming down the pipe and is all going to go public this year. So that's all a good telltale sign, obviously that there is some anticipation, and ability to go out, and that's all from a lot of specialist money. So I think that's important, and that is a reflection of the optimism that I think that people generally see, not one of frothy, you know, bull market, climactic, you know, IPO is trading up 100 and 200 percent, those are probably bad signs, and obviously not IPOs that presumably are just going to tank. So that's the last one, that's the other side, and the other side of the corner thing is also important, which of course, just the broader market, broader portfolio funds, provide and manage that mutual funds, where they don't obviously traffic so much in small biotechs, but obviously the idea that people feel better about putting more money to work in large pharma and large biotech, and just broader biotech, and this obviously a bit of a reflection of the fears and concerns about the broader S&P 500, which is at an all-time eye, and obviously the whole AI trade, which is not so relevant to this podcast, but fears that growth and things are a little bit expensive, make farm and biotech inexpensive at 15, 14 or even really at 30 times, it's not expensive if cost doing Walmart trade at 40 times. So that's good, and that makes our group a little bit more focused on as money comes in, and that's good for both sides of the coin, and that's good for both sides. Hey Mike, do you feel like General's interest in the sector is still largely restricted to the, like, momentomy large caps, or do you get the sense that it's actually even broader than that? Exactly, why we are more optimistic about the whole pharma biotech group and actually pharma, to some extent, because it's more than just, I like Lily, or I like Abby, and that is that people definitely care more about Merck and Bristol, and Pfizer even that, and then that means that Gilead and Amjum, which by the way, have traded pretty well in the last six months, are also a beneficiary, and again, that's part of because the whole sector has been so bad for the past few years, and everyone has never said about the rest of the market getting a little tipsy, so that makes our space better. Now, obviously fundamentals are good too, which is happening, right? Then that makes it better, and it's not just what we call renting, renting the space, or leasing the space, but rather wanting to own the group more this year, and I think you could all see it potentially by Redmond, the stock treated up when Abby was looking to buy Redmond, at least for an hour, the stock is actually up 6% in that hour, so it speaks to people who don't care about wanting to buy the group, if these pharma companies and biotech companies are putting money to work and making their stories better, it's a pattern closer to bad, that there is broader money going out, because it's certainly enough specialist by Abby, or Mark, to make the stock one that much. So that's all. So kind of just, I heard from folks who were there, did it feel like a lighter JPM, do you have the stats already, because when I listened to the very nice stats, actually, Red out loud, it was the, or whatever it's called, the podcast that they have, they started off by saying, actually, it was very easy for us to get here, it was not difficult to book a flight, it wasn't full, and it just felt like they were in, it's saying that it's not, it wasn't as busy, did you, did you get that feeling, anyone? You know, I haven't been since 2019, as I mentioned, but it seemed, one noticeable thing is, there wasn't as much street traffic, that's what I remember from old JPMs, is that the streets seemed as crowded as the hotel lobbies and all of that. I do know that the traffic was still very tough to get it Uber, to just go, you know, half a mile was really challenging. You still saw, you know, you know, many lobbies full, but, you know, I think it abated during the downturn, and I don't think we're totally fully back. I don't know the numbers, I'm sure somebody's capturing that. I wouldn't necessarily put stock in that the flights weren't necessarily full at a boss, and that is notable, but definitely there was a lot of activity there, it felt, it felt good, and it felt, you know, busy, but I don't know if anybody else wants to comment. Let me comment on how all of this, how I see it as it relates from the venture side. So first, everybody, you know, venture is a lagging indicator. So we very much follow the public markets, the valuations, the IPO window, all of that tells us that it is a safer market for VC, especially if we have portfolio companies that might be candidates to go public. And here's my take on it. First of all, the last quarter was really healthy follow-ons, you know, it was the best quarter for a long time, and the valuations came up. I think that's why companies were comfortable raising money, usually off of data readouts and stock, you know, movement, you know, stocks are moving on data, generally speaking, and so that bodes well to do follow-on offerings. And then the first week was, you know, a record, you know, week before JPMorgan, somebody did analysis going back at least 10 years, I think, and it was like the best first week of financing's prior to JPMorgan or at least one of the best. And the reason I think this is important is, you know, management generally doesn't look to sell quickly unless they have to. And so, you know, they'll take a big premium, they'll take a exit. And I think you're seeing a wave, and this is related to the idea that we didn't see as much M&A this week, is I think you've got more companies that are flush with cash. They don't need to be acquired. They can still execute and continue to grow value. We're seeing a larger group of companies with data that, you know, has a pathway forward toward a commercial product and to, you know, have the dream of becoming that, you know, you know, $10, $20, $30, $40 billion stock, a valued stock. You've got a number of companies that have entered that category who want to be the next, you know, vertex, if you will. And so, I think that's part of the theme that I see on why there may not be as much M&A. And I think this means that, you know, maybe the market is shifting a little bit to being, you know, you know, a biotech market versus a pharma market, you know, buyers market versus a, I'm sorry, sellers market versus a buyers market. And so, I think, you know, that really bodes well. And I think, you know, people are seeing those companies to stay independent that, you know, they do reap the rewards of that. And so, you know, I'm intrigued by that because what it means for VC is that, you know, there will be more opportunities for companies to feel like if they have a good data set or they have a really differentiated product, that if the IPO windows, that's what we're all waiting for, you know, can IPOs go out there? Can they hold their value? And, you know, does the window really open up in the first quarter or the second quarter? And so, that's what we're going to be looking at. But I think also VCs are deploying capital not to miss out on 2026 if the IPO window does open. They don't want to be on the sidelines if a lot of, you know, those bets go public and they have good aftermarket performance because their LPs, all of our LPs are, you know, waiting for money to come back. And so, if the, you know, M&A isn't the possibility than the IPO is the other way to exit. So, I'm feeling pretty optimistic for venture in 2026 that, you know, like we've all been saying, it's not exuberant, but it's kind of a healthy steady state that I think we've all been hoping for. You know, what's interesting there, Paul? You just pretty much, you know, what he said about the M&A companies are cash and they can just wait. Management don't have to sell. You literally describe red met there, right? Which is perhaps why it hasn't come to pass because they've got plenty of cash that just did the deal with the royalty farmer a few months ago. They have assets that look really interesting and meaning for probability of getting to market. So, what's the rush? Yeah, absolutely Sam. So, and that was Chris who made those comments, but I'm going to go to Paul next. So, Al Nilem, you know, interesting. They, they borrowed a little bit of the playbook from John Marginori. We all remember way back when he had that five-year plan and then he updated it again and kind of delivered on that pipeline. And now Yvonne Green Street had another kind of longer-term plan unveiled. You want to, you want to speak to that, Paul? Yeah, so Al Nilem had a really, really interesting T.A.P. Morgan going into this year, right? They launched in Vulture and TCR Abel Adosis. It's been one of these, you know, biotech launches that we've seen over the past few years with the mid cap, gradually into a large cap like Argenics and InSMed, where really just crush numbers to the point that the stock arguably got ahead of itself, right? And I think the chart tells you that where for 3Q, you know, they destroyed the sales side number and yet the stock traded off. And then going into 4Q, there was a lot of concern share traded down due to weak script data. And we were left with an interesting T.A.P. Morgan situation where they missed the fourth quarter, but gave really strong guidance for 2026 and some interesting five-year goals for 2030. You know, all of this was kind of received in a way that I thought was like somewhat polarizing. You know, on the one hand, the 2026 guidance was strong enough in the backdrop of a weaker 4Q that you had some people wondering if, you know, hey, is this actually too high of a bar, right? And then on the 2030 side, you know, there was some satisfaction with the revenue guide that they gave a 25% keger, but some consternation around the margin guide they gave a 30% operating margin, which, you know, I think people look at as not really all that competitive with other large cap companies. I'll just give our view quickly if anyone wants to say anything else. I mean, we thought that, you know, maybe this 2026 guide is not as much of a reach as others think from meeting without an item. They talked about a lot of factors that impacted the 4Q that, you know, could turn into tailwinds going forward. They had inventory drawdowns, some price concessions that, you know, maybe we're not going to see as big of a one the next couple quarters. And then on the 2030 side, you know, I mean, I think it's a really tricky situation for a company like El Mylem as it relates to managing to a margin because they talked about a 30% operating margin, which again, you know, relative to the kind of market cap years revenue appears is not that compelling, but, you know, people have to remember that they pay in these peak years about a quarter of Amvutra to Sanafi. So when you think about a 30% operating margin, X royalty, it's really over 50%. And if you're a company with a real R&D engine, unless you're like a spec farma company, you're not going to optimize your underlying business to something that is that much greater than a 50% operating margin. So we still felt like the update here from a fundamental perspective is still overall positive for El Mylem as it relates to the TTR franchise and the fact that they're going to be spending 30% of revenues on R&D. So you have to believe with, you know, four INDs a year, they're going to get more meaningful drugs coming out of this company or not in the model. But, you know, just an interesting example, right, of a company that crush numbers to the point that, you know, it created what people on Wall Street refer to as, I don't love this term, but a whisper number, right? Like a sort of true bi-psych consensus that is always, you know, kind of ethereal and higher than the cell-psych consensus, you know, and then now I think people are struggling with how to value this company. Do we think about the margin? Do we think about revenues? You know, how much credit do we give to the platform, but still feels like the relatively wall position, even if the stock has taken a breather? Yeah, it is interesting to drive a operating margin that far advanced because, you know, they have, we'll have many opportunities to adjust for the right reasons presumably over time. But I think they're signaling that we're going to be a, you know, cash flow positive company with good R&D and so that those are the two things people are looking for right in any long-term biotech play. Let's go to the next topic we have is Moderna. Sam, I know you've talked a lot about Moderna. I want to go to Mike too on just the mRNA space in general, but Sam, what was the update from Moderna? Sure. So Chris, this is a name that if you look at the share price move action since a low of 23 in November, it seems almost doubled. We're now at $41 and pretty much three things have been driving this. One, of course, is perhaps a little bit, I mean, I'm speculating on some of this, right? The superflu that people are talking about, maybe some folks have got a bit more into the groove about thinking again is this to be need to be invested and perhaps a lot of this retail. I don't know exactly. Back in the vaccine names and of course the company's guidance has been pretty wide 1.62 billion, which has been cut all along the year except until we came to the first week or second week of Jan, which was the announcement just ahead of JP Morgan, which was several positive things in it. One, they updated the guidance with regards to cash, which is great. So they said they're going to come out of the year with about $8.1 billion versus a six and a half to seven. That was guided in November. So that's a pretty big jump. About 0.6 of that, about a half of that is coming from a drawdown on the loan facility that they have, which kind of also brought me some questions in my mind. I'd love to hear what Mike thinks of that later. Why are they drawing down? There's no obvious need with that cash balance in the bank. We've asked our credit folks, they don't say they didn't say that there's any necessity to draw down as part of deals usually. Anyway, so that's that happened. And of course they guided slightly above the middle of the range, but which was in line with consensus that Bloomberg gathers and they gave, you know, they stuck with their 10% growth in 2026. I mean, I don't know how much stock you put by that because at the end of the day, they had pretty big numbers at the beginning of the year last year and we ended up at a much lower number in terms of revenue. And of course, the latest thing is the Arbitus situation who had a patent evaluated in Europe and Arbitus says, this has got nothing to appeal that. This is nothing to do with the, has no impact on the US litigation that's going on. And why I mentioned this is that this is the key bear argument on the name at the minute, apart from Covid shots sales dropping and the company's cash burn being high and all that, which they're addressing. So the Arbitus deal court case, I think is coming up, the trials coming up in March and there are people who believe that this is going to be a major, major problem for the company. We're doing our own analysis, hopefully out next week with our patent attorney colleagues within Bloomberg. We'll have a view on that. But this was some, this was the one thing that particularly drove the stock up today. He's up about 5% today. So, and I suspect it's going to give it some momentum and and change the maybe people's view with the with the risk of this trial. Anyway, at 26 is important for them because they might, they might get the cancer vaccine data for the adjuvant melanoma phase three trial read out this year, although the company says it could, obviously, it's the event to revenge the usual argument. It might push out to 2027. Over to Mike. Over to Mike. Yeah. I just wanted to comment that on Moderna, you know, new barge at a couple, he did, you know, I think a couple interviews and he definitely was throwing shade on the FDA about mRNA. And so he's doing his kind of PR to, you know, revive, you know, why mRNA is so important and needs to go. But Mike, any comments on that? Hey, you can hear me okay. I got my ex working. Yeah, we got you on. Cool. Cool. So three things. One, I think coming into the year, obviously, Moderna was one of the worst performers and has been so, you know, the start of the year, you're, we definitely were seeing some unwind of a lot of short positions that definitely was part of an early move on a hugely crowded short stock. That also started to unwind as people thought about the cash expenses that Sam's a saluted to, they gave improved cost cutting or more cost cutting, I should say, in November at their analyst event. And then yet again, here in January, so because there is a significant fear that this company is just burning through all the cash, it's definitely been helpful that they've cut the burn down from about three to four billion a year down to about two, so that's been helpful. So there were two fundamental things going on. One, is that there is definitely some view that the cancer vaccine data is coming later this year from melanoma. Sam mentioned that, you know, we're at about a 50% probability that that's going to work. That would be a significant catalyst to stock, but what's something we also picked up is that they're talking about a randomized phase two renal cell, adjuvant renal cell study reading out this year, and they reiterated that that's also possible. So just, if you have been short this stock or, you know, have been put this one out, a favor, they are saying that this renal cell carcinoma study, if it reads out, actually could be filed to the FDA, if it's positive on a phase two, and they have statistical protocols and all that kind of thing with the agency on that. To talk about the other, second part, is the patent situation. So yes, I agree that there is significant concern because if the company is burning multiple billions of dollars a year, based on various calculations depends if you're a, are viewed as bull or not, then you could be putting 5% royalties on the COVID sales, or 10 or 15 plus percent royalty damages on all of the COVID sales in the US. Funny enough, for instance, a non-pandemic portion. So if you go back, there's a, in the contract, the initial first year contract, the government protects you from any damages on the pandemic portion. But excluding the pandemic portion, a 15 billion dollars of sales outside the, of the pandemic. So if you put anywhere between a 5% royalty or 15, 20% royalty, you're up to multiple billions of dollars of damages. So if you're running out of cash and then that could happen, that could be pretty bad. So just want to point that that is coming up, but the company pointed to, well, people, many people think there could be a settlement. So if there's a settlement with the trial starting in March, that could be a positive. And then yes, as of today, again, another example that they beat biotech on some patents. All right, I guess this was our beauties, but also it proves that they beat biotech on some patents in Europe. And no one's paying attention to that. And so actually Pfizer and biotech may actually owe them money. So a lot of negativity on my journey. I don't want to spend too much time on that, but some positive things flipping around for 2026. Great. Thanks. All right, we're going to go to the Abbey deal. And let's go to Mike if you want to talk about that. By the way, there were other China deals. I mean, the China is still a presence and a player. I think they're going to remain so to continue to do deals. But Abbey did a big one. So why don't you talk to that? And then we can go straight to Sam to comment as well. Yeah. So this has been a consistent theme all of last year, right? And so here we go. Again, actually, this is the second Chinese PD1 VegeF deal in a row. Obviously, Pfizer 3S bio connected with one of the largest with the largest upfront payment for a PD1 VegeF. And then here, Abbey did one as well, speaking to this whole idea that Pharma can go to China and look for all of these assets and bring in all of this stuff in. So Abbey, which definitely has firepower and capacity to go out and get more things is jumping into the race in terms of the PD1 VegeF competition. And what was interesting about that is one is another China deal following Pfizer. And two, it's kind of funny, is obviously Abbey, one of Abbey's most significant in successful transactions with Pharma Cyklix and Bob Duggan and that whole crew, which has been phenomenal for Abbey. And of course, all of that management team is at Summit and Summit. They're radically looking for a partner. It was speculation that those two could connect there. And of course, they did and Abbey went to China to do the deal. So Summit's still looking, but they didn't end up connecting on that despite the prior management relationship. So that was an interesting angle. If you don't mind Chris, that is quite interesting. I mean, I remember that deal. I'm old enough to remember the deal. But so just a couple of things to add here, what I've just been looking at our licensing data in the Bloomberg terminal. Biontech's deal was the sixth largest upfront based on the data that I've got in the past five years. Above it was, of course, the Daichi Merck, Galapagos Gilead, Novartis Boucher, Longman. I mean, is that not quite the same kind of ballpark in Zealand and Russia? And then, of course, the six one was Biontech. And 3S buy was the eighth largest. So clearly, there's plenty of excitement in here. But the Abbey, $650 million kind of pales into relatively significant compared to the 1.25 billion that 3S got. And 1.5 billion and the Biontech got perhaps because of the stage of development or whatever. And of course, the other interesting thing is listening to all the companies at the conference. And they're all falling over each other trying to suggest that there's a reason what the air drug is different, better, best in class, etc. But what we know for sure is that summit is going to be first in class to market. Assuming the trial works and gives you sufficient clinical benefit. So what I'd love to hear how Mike's modeling this is, how do you share the piece of the market that they get from the future by similar PD1s between these drugs as they come? I mean, we can obviously take it and say, "Well, summit's going to be first, so it's going to be the largest." But then they don't have a partner yet. The Pfizer comes along or Bristol Myers comes along. So it's going to be quite interesting and quite fun to model this. Hopefully some of us will get it right. Mike, any further comments on that? I don't have a strong view either way on that. I mean, I think two points is one, how big is the market going to be? And two, I'm fairly confident in some way is going to have to partner up at some point there. So your guess is as good as Mike. Great. Sam, there were some AI news. I know Jensen Hwang of NVIDIA was there. A lot of people cracked capturing selfies and they had their own news this week about China, potentially restricting the competition there. But what was the AI news of the week? Yes, so obviously, and so one thing I have to say first, I'm not sure, what was he wearing? Was he wearing a glittery jacket or a toned down jacket? He's got his own Steve Jobsy type look. Yeah, sure. Now look, there's never a shortage of interesting comments from the company in general. But of course, the week again, alongside the Moderna news, started with NVIDIA Lily deal putting a billion dollars together into this structure to fund over five years AI for using Pharma. Everybody's at it. So you know, one of the things that kind of stood out as I was listening to these things, you know, sometimes things just get stuck in your head. Pharma said, AI was a significant contributor in our ability to take out five point six billion dollars of cost. Plus even more in manufacturing, if you can't. So and now we are ready to scale it up to levels across the entire organization. What does that mean? Did it help the company reduce head count by handing over some administrative stuff to AI? I doubt that would have made much of a difference to the 5.6 billion cost cuts. Did it help with automation? Hence maybe then the comments on manufacture. I wish the questioner, of course, Chris shot does his best in a 40 minute space to get the most out of the conference comments or identified duplication, etc. I don't know. And we know we've recently at BI done a very massive 600 CC suite survey on AI. And frankly, nobody's really talking about head count reductions. Maybe they're not hiring or reducing the hiring rate. Certainly increasing productivity within the teams. But very few are looking at it as a way of reducing head count, which I think a lot of AI companies actually do say that. And so what's going to be interesting is the or the comments that were made by Nvidia again, Revity, Salesforce, Viva on all how their AI systems are helping through the true agentic systems, helping pharma and drug development. And I think we're going to have to wait a while before we see an actual drug make it through serious clinical trials where AI was a significant contributor to its discovery. And maybe another three or four years. That's my prediction. Yeah, that's how yeah, that sounds right. And I think, you know, this is going to take a while to see who the real winners are based on the number of drugs that are truly driven off AI that emerges truly best in class or really differentiated. I thought it was notable. I can't remember if it was stat news or endpoints or somebody interviewed Eric Toket. And the most fascinating, you know, is a question that said is a pharma going to step into buy an AI company. And it was, I mean, for anybody who would understand and know that dynamic, it would be Eric. And he said he had a definitive no. He didn't see it happening in 2026. And he says they're trying to build stuff organically internally. They're doing collaborations and partnerships, but he did not see a AI M&A on the near term horizon. I thought that was notable. So let's go to the regulatory front. And, you know, for one thing, you know, McCary was there at the conference. And FDA was there to do some talks. I think at the JPMorgan conference itself. But he definitely knows PR. And he was doing little videos and obviously waited to this week to announce some things. So Paul, why don't you take one of the notable things and then Mike, you can take the other? Yeah, sure. And, you know, whether this FDA is flexible and libertarian or structure than any FDA we've seen a long time continues to be this push and pull that investors are grappling with, especially for some of the smaller companies that cover that are focused on gene therapy or rare diseases where we've seen now a number of times where a company thinks that they have alignment around something like a single arm, natural history control and trial or analysis or biomarker. And then, you know, they're saying the rug got pulled out from under them and we're kind of left to say, okay, when we analyze public companies, you know, analysts and investors, we don't see meeting minutes. We're not sitting in the meeting, right? So it's it ends up being, he says, she said, but I think at this point, right? We've seen a number of things now that it's suggesting that this FDA, when McCary is on TV and talking about extra adding things and flexibility, then at least so far that feels like it's more talk than than reality. And so there was another example of this, right, where Dr. McCary was talking about streamlining certain things on the CMC side for so gene therapy, which Chris, you probably would have a more intimate understanding of the implications of that than me. But, you know, optically sounds very good, but then you had a TARA announced a regulatory update for their T cell product for Epstein-Barb virus, right, where they received a CRL and, you know, they felt like they had alignment on their path. And, you know, of course, the stock trades down 50%. And so, you know, I, we've talked about this in this podcast. I cover Unic here, which has become like the poster travel symbol of kind of, you know, FDA flexibility, you know, company has alignment, they have breakthrough, now they don't. And I still feel like, you know, again, from a, from a sector perspective, like in most cases, right, if you're investing in a company that has, you know, a defined clinical trial path with clear precedent, you know, placebo control, clinical outcomes endpoint, like this probably doesn't matter for the most part, but, you know, for companies in that kind of flexibility space where, you know, data maybe are more up to interpretation. You know, this continues to, continues to be an overhead. And maybe just the last thing I'll say before I turn it over to Mike is just, you know, someone, another analyst at C-Full said to me, you know, I don't remember the last drug that got approved on time. And I'm sure that's like hyperbolic, but then he and I were talking about our coverage and all the drugs that have gotten to protect our coverage so far under review have been delayed in the past six months. So, I still feel like an FDA is a small, small overhang here as well, still trying to figure out, like, how do we sort of price this risk and uncertainty going forward? Yeah. Mike? Yeah. So, another interesting development is if you've been following one of Marty McCarrie's ideas for accelerating drug development is this whole commissioner priority review voucher, commissioner national priority review voucher. And, you know, whatever you think about it, the idea of approving drugs and as fast as two months sounds pretty amazing. And they have given CNPVs to, what, 15 plus drugs. There's been two different rounds of that. And what is interesting if you go read the method to get the drugs, of course, I meant need, addressing particular big areas of health is that there is an angle that you would work with the administration to also reduce drug prices. So, that's a whole interesting angle, of course, and perhaps it's a discussion with the FDA. So, with all the insights into CNPV, there were a number of these drugs that could be approved and as fast as two months, and of course, it's better than priority reviews, which are eight months. And so, while there's only been one or maybe two drugs that have been actually approved under this, there's a number of drugs that are on file under and using currently under review, the voucher. That would have included Sanofi's T-Zield, a Type 1 diabetes drug, and also Lilly's Orphaglip Run, which got the voucher as well and has been filed and is under review, and hopefully it's going to be a fast approval. And people are thinking that could be very soon in Q1, be ahead of Lilly's guidance of Q2. And obviously Oral, Wagovi pill just got approved. And actually, if you're walking around the conference, there were some taxis or cars that had a whole wrap on them that said the pill is here. That was actually the Oral Wagovi advertising for that. That was interesting. But going back to what the point is, is that it was a report out saying that the FDA is scrutinizing a lot of the drugs, and that there were at least two delays. One was the Sanofi T-Zield, because there are some safety things that they're looking at. And two, specifically, and I'm not exactly sure how they got this insight, was that Lilly's Orpho is looking for an April 10th approval. So that was a date that is farther out than what Wall Street was expecting. And so Lilly traded down as much as 5%, I think, into the day down 3%. So what is the point? The point is, oh, it's not all these drugs are not going to get approved in two months. Each one is going to be different. I stand by the idea that these are going to be approved faster than a priority review. And you should expect that the FDA is going to take a look at stuff, and you'd want them to take a look at stuff, rather than just blindly approving drugs in two months. So they should look at Orpho. It does not matter if it's Q2 or Q1, even though this doctorated down, it's all very fast. And that's kind of a positive, I guess, let's come out, one of Bosser's is come out of the administration, I would say. Anyone have any thoughts on C&B? Yeah, let me just add, so first, the corollary is the prior review voucher, the companies get that are transferable. I thought it was notable that Jazz was able to sell theirs to an undisclosed buyer for 200 million. So those prices were coming down, that is a higher priority. Just a shout out to my boss, Joe Edelman, did an interview, he rarely does interviews, but he did it on biotech TV, and one, he wasn't too concerned about the overall FDA policy that all worked itself out, but he was concerned about staffing and being able to hit timelines and all of that. And then he also just related the gene therapy guidance, he thought he was asked what's the most underhyped area, and he was more bullish that gene therapy is still valid and should come back after this kind of cold period, but anybody else want to comment on the regulatory FDA policy firm? Chris, did we lose you? I'm still here, Mike. Chris is, Mike, why don't you get going on the next topic that we wanted to chat about, which was all the obviously you did to a degree, but you didn't talk about Amazon yet? Perfect, perfect, that is a perfect segue. So I just wanted to say, obviously obesity remains top of mind. It is top of mind for most mutual fund investors. It is still obviously a huge situation for small cap and mid cap biotech investors and biotech. And I just wanted to point to three things. Obviously, we already know we don't need to run through that all-agovie pill is now approved. And I think the first script surrounding that number just came as over 3,000, which is good. I know those trading up a few percent on that. But there are three developments on the obesity front that I think are important for audience. One is lily is imminent, and it's going to be big. And so this is going to be the year of how big the first year of oral GLP1 drugs are. And then two is the people coming right behind them. And if you haven't been paying attention in the last couple of months alone, obviously the meds are a deal closed with a bidding war. I'm sure you guys talked about that. We met with Pfizer. And the, as expected, the Metsara data should be out. And it's going to be presented at ADA in June. We could be getting some disclosure on that beforehand. And they have a monthly injection and a monthly amulet. And why that's interesting, of course, is because both Pfizer and Amgen would probably be the next two companies that are getting approvals and obesity other than novel and lily. And Amgen is finishing their phase three with their monthly. So the race for the two next guys is the monthly drugs. Now, Amgen was supposed to come out with big data on their monthly drug for the two-year data. And they did come out with something except there were zero numbers around it. So they came out and then did the whole fireside presentation. They said the data was positive. It looks like it's at at least a monthly or a quarterly. But there was actually no numbers, no data, no charts. And Wall Street was left a little bit disappointed there. So I just wanted to say that there was some controversy around that. But perhaps you're being, you know, keeping it close to the vests' competition. And then the last part of it is it's still not over because every single company I spoke with and I met with Abby and Bristol. And obviously, Mark and others, and they're all still looking for more obesity assets. Abby has got one thing. They're looking for more Amgen. She's looking for more in Bristol. Don't be surprised if they do something. In fact, the risk speculation they were wanting the early bitters on in that Sarah. So more to come on that. But, you know, we're going to hear a lot about obesity this year. So Mike, where are you on the obesity 20, 30 sales? We've got, we had Albert Borla, a Pfizer, talk about $150 billion. I'm not sure of who's model that is. I think we are at about a hundred, 210. Where are you at? You're at 210? That's a hundred, I think we're like a 115, 120. We have that split. Obviously, majority, Lily, then Novo, then the others. And we have Orals at about 25% of that. You know, the good thing I think which you could appreciate and everyone could appreciate is that even though the price went down, which would be expected is that they did do the Medicare deal, which opens up a significant portion of the population and the cash pay portion that the price came way down as expected. But that offers a lot of people the ability to get these drugs for an affordable price. We could debate who can and can't afford, you know, $299 a month and $399 a month. But an interesting data point for you. And for everybody is that actually Europe and outside the United States, which all cash pay has been crushing sales numbers in last quarter, Lily throughout the number. And that's all cash pay. The European governments do not pay for the drugs in obesity and yet the sales are crushing it and it's all cash pay. So yes, there is demand for it at $300 a month. So where do we stand on that? A lot more to come. And a lot more interesting. I'm not that I look forward to other future podcasters. We're going to talk about if you haven't already or maybe you did last month the in the in a B stuff, the activity stuff. That's cool. And obviously some of the other agents that are coming. So that's that's pretty cool. Yeah, I'm the numbers in terms of cash pay in the UK. Reimbursed version by through through nice is is for people with a BMI of 40 plus at least a certain number of and maybe I can't remember is it three four comorbidities. I mean, I think we've worked out the number there is something in the region of 150 to 100,000 subject patients. And that's not even that's only been going on since June. So I don't know how many people have actually got a paid prescription. So I'm not surprised that most of it is cash. And then of course, we've got the interesting dynamic between Lily and Novo. Novo being only 10% of their business in the US being the cash channel, the DTC channel. And then and then about 30% for for Lily. That's let's see if that the launch of the oral changes that or does or whatever Lily does maybe change. Sorry, Novo does changes that. And so let's move on to some data. We haven't got a little time left and we've had so much technical. Yeah, yeah, I can hear Sam. Can you can you hear me Sam? I can hear you now. Yes, I can. Okay. Yeah. So let's go a little rapid fire. We've got five data readouts before we close. Paul, do you want to cover Lexi on Biomerin first? And then we'll go to Sam for Jan. Jay. Yeah. Sure. And Chris, I'll cover Biomerin first because I want to hear your perspective to give him your long history in this space. So Biomerin had some top line data for their DMD candidate, which is an X on 51 drug that is an oligonucleotide therapy that on efficacy really surprised to the upside. We haven't seen the full data, but they got up to 5% distrofen, 5% of wild type. This was unadjusted for muscle content. So to my knowledge, that's the highest number someone has gotten in this X on. And if you follow DMD closely, you know, each X on is really different because the baseline distrofen quantity is different. So there's a ceiling. I think how well you can do to somebody. Right? Maybe X on, you know, 44, 45, you'll be able to get a lot higher. So it's really interesting because there's really not a lot of price in the Biomerin. I take a little bit more of a not cautious view, but like, wait and see, view here because, and then Chris, this is where I want your history for our listeners. This drug comes from, I want to say it comes from Procensa because, you know, it didn't exist when Procensa was acquired, but, you know, it's out of that project, right? With Driza person, the original oligo from this portfolio, which, you know, did make some distrofen, but was super toxic. And I think the underlying issue here is that these oligos are not conjugated to either TFR1 or a peptide. So they stay around in circulation. They're immunogenic, there can be risk of thrombocytopenia or renal toxin. Again, we haven't seen anything, but for this molecule, like, there's actually no safety signal that's been reported, but I thought it was notable that really nothing was set on safety at all, and we just need to wait for a medical meeting, which to me remains kind of the most salient question for the competitiveness of this product. So Chris, anything you want to add from your history here? Well, yeah, I mean, one, I do think their chemistry is more toxic, and so I think I always look at what is any company in DMD not sharing, and that usually raises flags. The other thing is while, you know, I also argued for, you know, distrofen being a good surrogate marker, but there still is not a hard correlation between the distrofen production and outcomes. And so I think, you know, in this space, and we still need to see what happens to syreptus exoskeping and what the FDA ultimately addresses with that. So I still have a lens of skepticism until we see full data sets and really understand what's going on, but I think it's good for the field that there's another player and obviously an expansion of different exons that are being targeted, obviously with a vidity and dine and others, other players in the mix, I think it's overall good. But yeah, I want to see the full data set before I would render judgment. Access. You know, maybe very quickly, I'm lactose, since you're talking about gene therapy, they had more data for their PKP2 gene therapy. This is a rare cardiac disease. It's got, you know, kind of a cult falling among biotech investors because there's tens of thousands of patients with PKP2 deficiency. So it's actually one of the bigger gene therapy opportunities out there. You know, I think the challenge in this disease and you saw it from the lexio data and how the stock reacted is really finding the right endpoint, you know, lexio, rocket, and I, they're forging the path here. And so, you know, lexio showed a signal on NSVT, non-sustained ventricular tachycardia, PVCs, of these kind of electrical measures of how the heart behaves and, you know, they're trending in the right direction, but a lot of variability. All I would say is that, you know, this is kind of, you know, I think investors get impatient, right? They want the signal to be totally unequivocal in the first data set or the second data set who doesn't. But this reminds me a little bit of how the free just a taxi program played out for lexio where some of the early data were interesting, there was variability, you know, it's six months there's a signal, but people are debating how big that signal is. But the data got a lot better over time and then they were able to kind of forge a path with the FDA on a perspective phase three study that is natural history controlled. And so, you know, like still riskier, but, but, you know, I think, you know, the reaction maybe just kind of was, I think it overreaction, because again, when you're sort of first in education, you know, sometimes you have to kind of generate some data before you can really know what to focus on. Yeah, I also think, you know, gene therapy, if it's going to come back, people are watching valuations closely and I think, you know, companies like lexio, like solid, like others with gene therapy, you know, hovering around a half a billion, I think it'll be interesting to see where valuations go with as these gene therapy companies mature. I rapid fire, Sam, do you want to hit J&J myeloma, and then we'll go back to Paul. Yeah, yeah, quick one. J&J can be the goal post on myeloma. We've going from majestic three, we just had these have been interesting, which is the, the bi-specific BCMA CD-3 diesel-engager. And, and we, everyone's going to keep comparing to Carstead 4, which is our, which is legend and Johnson and Johnson's themselves, CAR-T therapy, CAR-VICT. And, and you've, you only have to just look at the share price chart for, for legend to see what the, the streets and the markets thinking about this evolution, not just from the bi-specific spot also from competing CAR-T's over. Great, Paul, we got two more news items for you to cover. And we went, we started a couple minutes late, so we're going to go a couple minutes over, but Paul, you got a couple other news items. Yeah, what's the one you want me to start with, Chris? Why don't you go to Vertex and then you can go to Lily? Yeah, Vertex and Ciona, their emerging competitor, had some interesting updates on both of their programs for cystic fibrosis. All of this says that this is evolving into like a really, really interesting year for both companies. I mean, Vertex is obviously really diversified their pipeline and their drug portfolio over the past five years. Since really the last time, there was a competitive overhang with Avv, and CFN, I don't even want to say that Ciona is an overhang because, you know, Vertex is a huge market cap, and Ciona doesn't have any patient data yet, but, you know, Ciona has a really, really interesting drug that targets NBD-1, which I would call a different mechanism of CFTR stabilization. I think Vertex is kind of making this sort of, taking this reservation with the term mechanism, right? Because all these drugs are correctors, but it's a different binding site on the protein that is not directly bound by the vertex drugs as we understand it. And so Ciona has some data at the middle of this year. Vertex has data for their next NCFTR modulators later this year, and they're not saying anything about those compounds for competitive reasons. You know, Mike and I attended the Vertex event. It was the first time I really saw them getting multiple questions from different analysts about this in a public forum. You know, I met the Ciona team, we cover that stock, and so just kind of heating up as being an interesting year in CF potentially. I think the other news I wanted to just briefly touch upon was, you know, the Lily commentary on their TB3 study and how people are trying to figure out how to interpret that commentary you saw by H&CLOF. You know, for context, this is to me as a neuroperson. I mean, this is the catalyst. I am by far the most interested out. It's interested in over the next 12-18 months. It's a readout that I am, this is not a stock on Lily, but I am super bullish on this readout, and I think it can be paradigm shifting for neurodegenerative disease. This is a study where they're essentially trying to prevent the onset of Alzheimer's disease and patients at risk. You know, we know amyloid beta has gone through a very, very long history, but if you look at the evolution of a beta treatment, you know, first studies in moderate to severe Alzheimer's don't work. Some of the studies in early MCI show a small benefit, but in a subset of early MCI and the biogenin lily trials and the patients who have the earliest disease, you see it considerably bigger effect size. Our view is that in these prevention trials, you should see an outside effect size. And also, you know, again, a lot of the infrastructure has to be built, but I think who wouldn't want their plaques taken out if it's going to lower their risk of Alzheimer's substantially as long as these drugs are safe, which I think in an earlier population they likely will be. You know, Lily was more affirming that the data are expected in 2027, which is not new, but people have been looking to 2026 as the time for a potential interim. I think the question is like, you know, does this 2027 reaffirmation suggest an interim has already happened or not? I wouldn't interpret this as an all negative to the POS. The study, I mean, Lily remains very confident. And I also think an interim analysis here is just going to be subject to the number of events. The biggest concern you with these prevention studies is no one really knows how to power them, right? Like no one knows what to expect for the control arm and the rate of progression, but the Lily study is an adventure of an study, which should be a good hedge against powering. So, Biden is laterally exposed here with LeCanemab, right, which has been a really significant disappointment. But we think if we get prevention data and it's great and the safety is clean, I think it can really change the narrative on this class. Sam, do you have any comments on that? Just as Paul is excited by this, so am I. I used to work on amyloid and I think this is going to be quite a, we all hope, a shift, the sort of shift that we haven't seen yet with any of them in the in the later stages of the disease. And I just hope it doesn't fail because it takes the wind out of the sales of all the other ideas that people are trying here. So I think it's crossed. Yeah, and I know by a gen, I didn't see the presentation, though this is what I heard people talking about that they are definitely leaning into other areas, therapeutic areas, so they're trying to make sure they have hedges against the Alzheimer's space. But I want to say thanks to everyone. Well, overall, I think we all came out with a positive feeling that 2026 is going to be good year, coming out of JPM. So if you weren't there, I think there's a lot of signs you can read from all the final reports that are coming out today and probably next week. So thanks to everyone who attended this JPM hangout event earlier this week at JPM. It was a great time. I was there. I didn't see as many co-hosts that I was hoping to see. I saw Brad. I saw Ted Cameron. I was there for about an hour and a half, but I think I missed a lot of the large group there. But it was a great, great to meet so many of you in the room. Special thanks to our Gold Badge sponsors CFGO Incubate Coalition and Cineos Health Communications and our Blue Badge sponsors FTI Consulting, Catalytic Agency and Ms. Pro. The event wouldn't have been possible without them. We're already looking forward to next year. And I I hope we see all of our audience there in turn out next year.