Viking Therapeutics, Inc. ($VKTX)

Great. Good morning, everyone. Thanks for joining us here at day 2 of the Leerink Partners Global Healthcare Conference. My name is Tom Smith. I'm one of the senior biotech analysts here at Leerink. And it's my pleasure to welcome our next company to the stage, Viking Therapeutics, joined by CEO, Brian Lian; CFO, Greg Zante; and Chief Commercial Officer, Neil Aubuchon. Gentlemen, thanks for joining us. Looking forward to the discussion.

Thank you.

Such a dynamic space, obesity. A lot of developments, obviously, and you guys had a great year of execution in '25, a number of data sets coming up here in '26 and then some important pivotal data coming in '27. Think there's probably a high awareness of what you guys are up to in the audience. But Brian, maybe if you want to just talk through some of that execution in '25 and what you're looking forward to here in the year ahead?

Yes. Yes. '25 was a big year for us. '26 is going to be a big year as well. But in '25, I think the big accomplishments there were to get our registration program underway for our dual agonist, VK2735, two Phase III trials underway, VANQUISH -1 and VANQUISH-2. We started those around midyear, and we've enrolled the VANQUISH-1 study in obesity in the fourth quarter. And then the VANQUISH-2 study, we expect to enroll very shortly here. So both of them enrolled a little more quickly than we expected. But really, really happy with the progress. And then the second thing that happened for us in '25 was the first Phase II data from our oral formulation, which showed a really nice profile overall. And at the end of the year, we had an end of Phase II meeting with the FDA, and we'll bring the oral program into Phase III now in the third quarter of this year. So by the end of the year, we'd have 4 Phase III trials ongoing. So a lot of execution for us in '26 and a big data set coming in the third quarter for our maintenance study, which is a transition study where people start with a weekly dose for some period of time and then transition to either a monthly dose or an oral dose. So all of that pretty exciting for data readouts in the third quarter.

Awesome. And then let's start with the subcu and VANQUISH-1 enrolled way ahead of schedule. VANQUISH-2, you said like well on your way. Maybe just describe, I guess, like what's driving the rapid enrollment there, some of the feedback that you're hearing from sites and investigators, like what is driving preference towards your subcu dual agonist?

Yes. Really high enthusiasm, I think, for weight loss therapies in general. And when we had that investigators meeting in the summer of '25. We were a little surprised by the attendance there. It was quite a bit better attended than you might expect for an investigator's meeting, and it was kind of interesting to see the number of investigators themselves who came, not just study coordinators or nurses from different sites, but the actual primary investigator came from many, many sites. So that struck us as kind of interesting. And then when we opened up enrollment, the enrollment was rapid. We kind of thought that might have been just a little burst as we started the study, but it held up, and we were able to enroll the study pretty quickly. And a larger size, too, we added more than we had actually targeted. So I don't know what the driver is, I guess, a very high awareness of GLP-1 therapies. I think some enthusiasm for the mechanism, a dual agonist versus a single agonist. But -- so hard to really put your finger on what drove it, but very nice to have the speed of enrollment.

Awesome. And you also recently completed a bioequivalent study for your auto-injector. You've talked about introducing the auto-injector into the VANQUISH program. Just remind us sort of blocking and tackling wise, like how do you expect to incorporate that? And what -- first, what you saw in the bioequivalence?

Yes. We had started the two studies with the vial and the syringe presentation and plan to introduce the auto-injector in the first half of this year. So we did the bioequivalent study and showed bioequivalence between the 2 dosage routes. And so we'll be introducing the auto-injector, and we've already introduced some. It's every -- they're on 4-week blocks. So the trial is 78 weeks long, and we want to have people go home with a 4 pack, so just backing up from 78 weeks at a multiple of 4. We've got 3 different windows where people will transition to the auto-injector, but that's already underway.

Okay. Cool. And just remind us the dosing that you're looking at in VANQUISH, and the titration schedule that you're using and how that compares to the Phase II experience?

Yes. So in the Phase II experience, we started everybody at 2.5 mg and they went to 5 mg, 7.5 mg, 10 mg and then 15 mg. So it's a bigger jump than from that 10 mg to the 15 mg than we're doing in the Phase III. In Phase III, everybody starts at a 1.25 mg dose for 2 weeks and then steps up at 2.5 milligram increments every 4 weeks. So 1.25 mg for 2 weeks, 2.5 mg for 4 weeks, 5 mg for 4 weeks. The first set dose is 7.5 mg. So when people reach 7.5 mg, that cohort will then stay at 7.5 mg. The next fixed dose is 12.5 mg, and then the highest fixed dose is 17.5 mg. So it takes about 26 weeks to get to that top 17.5 mg dose and then the guidance requires everybody stick at the final dose for 52 weeks. So that's the -- the 17.5 mg is the rate-limiting dose there.

That makes sense. And yes, just looking forward to VANQUISH-1 readout, like help frame, I guess, expectations. What's the weight loss that you're looking for? And then we'll come back and talk about the safety tolerability.

Yes. We haven't really given much guidance on the weight loss. We saw about 15% in 13 weeks with the 15-milligram dose. We saw no plateau at any dose there. So I would hope that we would be competitive with the agents that are currently available. I think we should be, probably a little better than a GLP-1 monoagonist, but really hard to project compared with other polyagonists out there. We'll just have to see where the data fall out. But when we model, it looks, I'd say, competitive to say the least.

Right. And one of the things I felt was striking from the Phase II was the safety tolerability experience, the GI tolerability looks quite compelling, I think. How do you project that forward into this 70 long-term readout and incorporating you're looking at a higher dose here, but your titration schedule and I guess, path to getting there seems reasonable?

Yes. When you see these GI-related side effects, they tend to happen, I don't know, call it, the first 4 to 6 weeks or so. And then for most people, they go away. So the idea when you design these studies is try to minimize that initial experience, so people have a good experience when they first start the therapies. And so here, we dropped the starting dose down to 1.25 mg and just have them stick there for two doses, really just to ease into the mechanism. And hopefully, that would give some improvement in tolerability. Once you get past the first couple of up titrations, I don't think tolerability is really an issue. It just kind of wanes over time. So it's not like you see a bump once you get to later doses.

Understood. I guess, projecting forward a competitive profile relative to the other dual agonists and tirzepatide specifically. But just remind us attributes of the compound, where you think you may be differentiated and how you think some of that differentiation could manifest in the VANQUISH program?

Yes. One big difference with this compound versus the approved agents is the half-life is quite a bit longer. It's about 8, 9 days in that range. And like the Cmax is higher at the same doses versus, say, for example, tirzepatide, the Tmax is later. All of these things give it just a different biological profile. Notably, we think over time, you get an accumulation if you stay on that weekly cadence. So the plasma levels begin to accumulate because the half-life is so long. We don't know, but hopefully, that would translate to an improvement in overall efficacy. And we have seen that in obese monkeys, a nice improvement in efficacy in head-to-head studies with other agents. Where we think it might be really advantageous for us and for patients would be in a less frequent dosing regimen. So if you get to some target weight using the weekly dose, because the half-life is long enough, we think then transitioning people to a monthly dose might be well received by people who are looking for a little bit more convenient maintenance regimen. And that was the whole basis for the maintenance study that's going to read out. So because of the unique PK profile, we think it opens that door anyway, and that's what we're planning to assess yes.

Great. Maybe I could bring Neil in and just talk about with the profile that Brian has just laid out, I guess, how you think about competing in a subcu market where you have pretty entrenched competition? And I guess, specifically with the resources of a SMID cap biotech, yes, just walk us through sort of the initial commercial plans around the subcu?

Sure. Well, it's always great to start with a good product, right? So the CagriSema data that's come out recently shows that the dual agonist class seems to be kind of the best one out there, and we're going to be the next dual agonist to launch. Of course, we're going to have an oral -- we should be the first oral to launch in terms of the dual agonist class. So that's a great starting point. The thing that's really nice for us is there's some disadvantages being small, but there's also some advantages. So we don't need to get 30% market share. We need to get 5% to 10% share, and we're extremely successful. So I look at a few different things. So one is ex U.S. opportunity, I don't think is being considered. So that's something for us to think about. The other thing is that Lilly and Novo have to -- they're in all segments. So they have to balance across various stakeholders. We don't have to do that. So we can be more aggressive in different segments. We can go after cash market. Lilly has been quite aggressive going after direct to employers recently. I think there's some room for us there potentially as well. So I mean, if we come in with a top-tier efficacy, which I'd expect to do, and being nimble and only having to get 5% to 10% share for us to have success, there's lots of ways being nimble that we can do that.

Interesting. And you brought up the cash pay market. Maybe you could talk a little bit about how you're thinking about pricing overall? Obviously, it's early. We don't have the Phase III data. But we have seen Novo cut their pricing. I think some investors are a bit concerned that it could be somewhat of a commoditized, or race to the bottom type of dynamic. Like how do you guys view pricing 12, 36 months from now?

Yes, I'm glad you raised that because what we've seen -- I think we have to differentiate between list price reductions and net price reduction. So you've seen a lot of list price reductions, which, as we know, isn't really what's important. It's at the net level. So you have basically a duopoly with the two companies. I used to work at Lilly for 17 years. I think both companies are rational actors. When you have a duopoly, if you lower your price, you're just effectively lowering your own margins, right? So, I think, the other thing that's I think, quite encouraging is the crackdown on the compounders. So the compounders were, I would argue, irrational actors in the marketplace. So I think that is going to start to go away. And when you're left with just Lilly and Novo, I think you're going to have quite a bit of price stability going forward. And I think other companies entering the market are also going to be quite rational. So I kind of think that the way companies look at this, big companies, they look at sort of a price volume trade-off, and I think we sort of hit an equilibrium. And at this point, I think it's going to stay relatively stable, and we feel pretty good about this pricing level.

Got it. And maybe just early, I know you joined the company here relatively recently, but how do you think about like resourcing behind the potential commercialization? Like what's the size of the sales force that one might need to compete against the large pharma duopoly as you call it?

Yes. So it's actually -- again, it's actually an opportunity, not a problem, I think, because I don't need to tell this audience that there's a lot of inefficiencies in the health care system. So we have a -- we can look at this market with a blank slate, look at how we can take costs out of the system, which I think there's ample room to do. The other thing is that some of these channel partners that are out there, I won't go through the list of names. They do direct-to-consumer marketing extremely well. In fact, they do it better than big pharma companies do. So I think the fact that we are smaller means that we can actually leverage the channel infrastructure that's been developed and be able to leverage their expertise in a very efficient way. So I don't anticipate us. One of the things we can't do is we can't out Lilly, Lilly, right? So that's not going to be successful. So we have to look at orthogonal commercial models that are capital light. And again, when you're looking to get the 5% to 10% share, I think there's different ways that we can do that. So I'm actually -- the more I look at it, the more optimistic that I am that there is a path for us.

And I want to get to the oral clinical program, but just sticking with commercial for a minute. Just talk about, I guess, the value of having both a subcu and oral options, same molecule, sort of continuum of care optionality maybe for prescribers. Like how do you think about that value proposition?

Well, a couple of things. I mean, I think Brian will probably talk about the trial, but the fact that we're able to do the trial and it's the same molecule, just a different formulations. So the fact we're able to leverage some efficiencies in the clinical trial means that it can accelerate the time line compared to what we had thought. So that's the first thing. So the lag time between the two is going to be shorter. The second thing is as this market matures, it's going to get more and more segmented. And this is true with all markets. And so, I think, patients are going to want to -- like I think the maintenance segment is going to continue to grow. And so the fact that patients could either go from an oral to an injectable, or an injectable to an oral, it's the same molecule. So the tolerability, in theory, at least, we have to see how this plays out, should be improved as a result of staying with the same molecule. So even in the case of Lilly, they are about to launch orforglipron, it's, of course, not the same molecule as tirzepatide. So as you switch between one and the other, you might have some tolerability challenges where we think we will be able to avoid that having the same molecule.

Yes. That makes sense. Brian, I want to talk about the oral program. And you generated, I thought, very nice weight loss in the Phase II VENTURE-Oral study. I think it's up to 12.2%. Maybe talk about, sort of, the highlights from that data set and then you just came out of an end of Phase II discussion like incorporating the learnings into your planned Phase III?

Yes. We completed that study in the summer, read the data out in the, I guess, third quarter of last year. We saw a really nice dose response from 15 milligrams to 120 milligrams up to 12%. And really, until we get to the higher doses, outstanding tolerability, I think when you look at the comparison of the placebo arm, we had, I think, 4 arms that were really indistinguishable from placebo. But when you got to the 90 mg and the 120 mg, you did see a little bit of an uptick in the standard GI adverse events, probably driven in part by the higher starting dose and the rapid titration. We thought based on the Phase I data, we could start high. It didn't look like you really even needed to titrate from the Phase I to it was so clean. So we were a little more aggressive than we might have been had we seen more GI tolerability signals in the Phase I. When we go to the Phase III, we'll drop that starting dose down and stretch the blocks out to 4 weeks. And I think that should be pretty effective. We went to the FDA in -- yes, in the fourth quarter with all of the data from the oral program, as well as some of the tox data from the subcu program, and asked if it would be okay to move into Phase III and the FDA was okay with that. So we've been planning to move into Phase III now, full steam ahead there, hopefully starting 2 studies in the third quarter. And that program will be different from the subcu because we expect to be able to leverage some of the data, the safety data, the size of the studies and humans from the subcu program for the oral program. So likely much, much smaller, 75% or more smaller than the subcu program. Shorter, we will probably reduce the trial size probably by a couple -- or trial duration probably by a couple of months. And another thing is the visit schedule will be reduced relative to the VANQUISH subcu studies where the first 30 to 40 weeks, people are coming in every week, and then this trial will be more of a monthly visit. So all of those combined to dramatically change the expense associated with the Phase III oral program. It will be a much, much cheaper overall program than the VANQUISH studies.

Yes. So a much more efficient program. And just -- I'm sorry, on the size of the -- so like 25% less patients?

No, no, more like 75% less patients. Yes. Now it relies on us being able to use the subcu safety database from the VANQUISH studies, but there's no reason to think that we can't do that and the FDA is also on board with that approach.

Yes. Okay.

Since it's the same molecule, going back to your question earlier, because of that having the same active agent, you can leverage some of the -- like we're able to leverage the tox data. We should be able to leverage the VANQUISH human safety data. So all of those are favorable since it's the same molecule.

Yes. And I guess what can you say about expected dosing levels in the Phase III? So in the subcu, you explored a higher dose, probably not a need to explore a higher dose in oral. But like how are you thinking about dose? And you alluded to the longer titration walk?

Yes. Yes. So we went up to 120 mg in the Phase II. So we'll come down maybe kind of in the middle of that range, 0 mg to 120 mg, I mean, in the Phase III multi-dose study. So 2 to 3 active doses. And you're right, start at a lower dose and titrate up into those final doses. But we'll have all the details when we initiate the studies.

Awesome. And you mentioned the maintenance study fully enrolled, and you're looking at both the subcu and the oral in the maintenance study. Maybe just remind us on the design because you have a number of different cohorts in there, and then what you're looking to learn, we're going to see data from that study in Q3?

Yes, very complicated study. So everybody starts with a weekly dose and you titrate people -- now this is an accelerated titration up to 17.5 mg on a weekly basis. And then it kind of splits in two. The subcu side has people transitioning from a weekly subcu injection to a monthly subcu injection. We also have a cohort that goes from a weekly to an every other week subcu. So we'll have a lot of data from maintenance at both every other week and monthly. And the doses range from 7.5 mg every 2 weeks to 17.5 mg a month, 20 mg per month and 22.5 mg per month. And then we have two controls. One of the controls is 17.5 mg parked through the whole 31-week window. Another one titrates people up to 17.5 mg and then drops into placebo for the maintenance period. So -- week 19 to week 31, you're on placebo. That's the subcu side. The oral side is people come up to 17.5 mg weekly with the injection. And then after 19 weeks, transition to 17.5 mg daily oral, 27.5 mg daily oral, or 110 mg weekly oral. So you have a nice range of doses and regimens there on the oral side to look at maintenance also. And that component of the study also has two controls. One is a daily oral placebo and one is a weekly oral placebo. So really complicated, but should have a lot of information when that study reads out.

Yes. And what would be, I guess, the next step -- the kind of goal of the study and the next steps?

Yes. Goal is to understand what's feasible with maintenance. If monthly works, what's the right -- what's the best dose? What about every other week? Is that better than monthly? I don't know. And then if it's oral, what's the right dose? Same questions. So we -- with the VANQUISH studies, we do have a 1-year extension after everybody reaches at week 78, they're able to enroll in an extension study. With the maintenance data, if we're interested in one or more arms, we may have an opportunity then to introduce that maintenance regimen into that 1-year extension for VANQUISH. So really nice opportunity. Just the timing worked out well for us that might be able to give us some nice maintenance data that potentially could make it into a label.

Yes. Very interesting. And maybe, Neil, could you comment on, I guess, what the market research suggests in terms of like optimal dosing frequency like just the less frequent, the better? Or is there kind of like a sweet spot?

Well, no, I don't think there is a sweet spot. I think that as the market matures, it's going to get more and more segmented. So I think that some patients actually -- you asked them, they actually say they like it once a week. People are concerned in some cases about side effects. So you think oh, once a month is better, but actually, no, if you have the nausea, then for the entire month, then that could actually be worse. So there are a segment of the population that's needle flow that's going to want an oral, and that's going to be fine. So I don't think you can sort of say there's sort of one size that fits all. I think this market is going to have multiple winners in it. And the fact that we have the -- we're going to generate this maintenance data. The fact of the matter is it's kind of the Wild West out there right now. Patients are actually kind of just experimenting on their own. So the fact we're actually going to have some data to guide patients, I think it's going to be a positive and can allow us to potentially take some share there.

That makes sense. I want to ask you about -- a deal you signed actually about 1 year ago, which is a manufacturing supply agreement with Corden. And this is large-scale API, fill/finish. Just talk -- like how are you thinking about ability to supply like a commercial supply? Is Corden going to end up being sufficient for everything? Are you still out there looking for additional manufacturing capacity?

Yes. Good agreement. I think it's -- we're at the 1-year anniversary of that agreement. I think we might have announced it last year at your conference, right? Yes. So yes, I think a great agreement. So it covers a multi-ton annual API supply. And then one of the things that set Corden apart from some of the other manufacturing partners we talked to was their ability to provide fill and finish services. So we've got 100 million vial and syringe units, 100 million auto-injector units and then 1 billion tablets in the initial agreement. So it's really kind of 4 agreements bundled in one. All of those components are expandable at our option. So we have good flexibility there. If we run out of capacity, we'll be okay. That's -- but so that we don't run out of capacity, we're adding redundancy across the chain there. But I think right now, it's well into the double-digit billions what that agreement can support as far as a product launch.

Yes. Makes sense. I want to ask about your amylin program that you're putting into the clinic. We've seen some readouts very recently. Would love to, I guess, get your thoughts around the recent data and how you're thinking about the mechanism, how that fits into the broader portfolio of what you're doing?

Yes. A lot of data is continuing to emerge from the amylin class. It looks like most of the compounds have this right in that 8% to 10% weight loss range with the exception of this eloralintide compound, which is nearly double that. So it seems like generally, outside of that Alora compound, these would be targeted for people who maybe don't need to lose 100 pounds. But BMI maybe 32, 34 that need to lose a little bit less weight. Or for the population that maybe can't tolerate a GLP-1 and so they're looking for something else. So those sound niche, but those are massive niches. So those are really, really big opportunities given the overall size of the market. How does ours compare? Don't know. It looks -- we haven't had in humans yet. In obese monkeys, it looks more effective than our dual agonist, but those are monkeys. So hard to project into humans. We'll start the single ascending dose study as soon as the IND clears, we're going to file the IND this quarter and go into the SAD study and see what the dose tolerability looks like on the SAD dosing paradigm and then move into a MAD following the SAD study.

When we think of the attributes of the amylin relative to eloralintide to look more -- I guess, more similar to that versus what we just saw from the Roche-Zealand compound? Or how does this stack up?

It's hard to say because the changes between the compounds are a little bit different. I mean, without getting too far in the [indiscernible], the changes made with the petrelintide and that Guber compound are on this little cyclic component on the -- what I look at the left hand of the chain. And those are intended to improve solution stability, but it seems like they had an impact on potency. With the eloralintide, I guess we look maybe a little bit more like a hybrid between cagrilintide and eloralintide structurally, I guess. We're more balanced. I mean, eloralintide is more amylin focused. We're a little bit more even on the calcitonin and amylin 3 receptors, but still seem to retain very, very good potency. So overall, I mean, it's an interesting compound.

Yes. And how are you thinking of like first-in-human experience very similar to what you did with 2735? And I guess, is it possible like when we think about potential for clinical data, something we could see later this year or?

Yes. The first study is going to be a SAD study, single ascending dose study. So -- and those are a little bit pedestrian. You do one cohort at a time. So it's hard to gauge much on the efficacy side with those sorts of studies. But I think if we had something interesting, we'd report it. But the more meaningful data would be after the multiple ascending dose study. And hopefully, that would be something we'd have next year.

Awesome. All right. Well, unfortunately, we're up against time. But thank you, Viking team for joining us and sharing the insights and a lot to look forward to here in '26.

Thanks a lot, Tom.

Thank you.