Good afternoon, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Olds. We're the biotech analysts here, and it's my pleasure to introduce Brian Lian, CEO from Viking Therapeutics. Before we get started, I just need to read a quick disclaimer for important disclosures. Please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, maybe, Brian, I'll just hand it over to you to make some introductory comments for people that might not be familiar with your story. Sure, sure. Thanks, Mike. Thanks to Morgan Stanley also for the invitation. Appreciate the schedule and really, really a great list of investors to meet with. Yeah, I'm Brian Lian, CEO of Viking Therapeutics. We have a lot going on at the company. We have, today, two phase III trials ongoing in obesity. Those were initiated in the second quarter, seem to be enrolling well so far, and looking forward to completing the enrollment and then executing those studies through the next 78 weeks of treatment period following the completion of enrollment. We recently read out a phase IIa trial, a 13-week study with an oral formulation of the same compound that's in phase III. This was a 13-week daily dosing study, which showed up to 12% weight loss at 13 weeks, which we were really, really happy about. Good tolerability. The next step with the oral program would be to hopefully schedule an end-of-phase II meeting with the FDA by the end of the year and then decide what the next steps are with that program. We have an earlier program targeting the amylin receptor, also for obesity. We are hoping to file an IND toward the end of the year with that program and then move into a phase I single-ascending dose study followed by a multiple-ascending dose study that we would expect to read out probably in the 2026 timeframe. We have a maintenance study with the injectable formulation that's going to initiate late this month or in October that will evaluate the transition from a weekly regimen to a less frequent dosing regimen, a monthly regimen, to see what the maintenance effect is of these less frequent dosing regimens. There will also be some cohorts in this study that transition people to daily oral therapy to see what the maintenance effect is with the oral. There will be one cohort also that transitions to a weekly oral. A range of different maintenance strategies there because maintenance is, we think, a really important future area of development for obesity therapies. All right. Great. Thanks for that introduction. You obviously have a lot going on and executing across all your studies. You did mention your recent oral data for VK2735, and you highlighted some of the efficacy and safety. Maybe just dig a little bit more into the efficacy. You saw weight loss up to 12.2%. Yeah, 12.2, yeah. At the highest dose, maybe talk about some of the lower doses and how you think about those effects. Yeah. We dose from 30 to 120 milligrams daily there. We had another interesting experimental cohort in there where people were titrated up to 90 milligrams for four weeks and then brought back down to 30 for the remaining seven weeks. In the regular daily arms up to 120 milligrams, really nice dose response curve there, consistent. Each dose showed a successfully greater degree of weight loss from about 2.3% down to 12.2% with the good trajectories throughout the course of the study. With the transition dosing arm, I think that was a really interesting experiment. We saw at six weeks, we saw 8.1% weight loss. Then transitioning from 90 to 30 milligrams daily, we saw a continued weight loss down to whatever, 9.2% or something like that. It was another 1.2% weight loss. Whereas we expected with that arm, once you go from 90 to 30, you know flatlining would have been great for us, but they actually continued losing weight. We had hoped to avoid any rebound effect because normally when you have a sharp reduction, the rebound drive is a little stronger. In this case, we saw a gradual continuation of weight loss. All of those were, I think, very exciting. From the dose response across the normal cohorts to the maintenance dose, all I think really positive readouts. Can you put that weight loss at 13 weeks into the context of some of the oral competitors out there? Hard to do those sort of cross-trial comparisons because most of those studies were a little bit longer. I think we feel okay about the way the curves will progress over time. It's difficult to make those sorts of trials with different lengths and maybe some different enrollment criteria. It's really, really hard to make those cross-trial comparisons. Makes sense. In terms of tolerability and what you saw there relative to the phase I, it looked like maybe you saw a little bit more GI effects than you had in the past. Any thoughts on what drove that? Yeah. In the phase I study, we saw really a fantastic tolerability, really no meaningful adverse events until you got to the 100 mg dose, which was better than expected. In the phase II, we felt comfortable accelerating the titration cadence to be two-week blocks. The 15 and the 30 mg doses were fixed doses for 13 weeks, but every dose above the 30 mg started at 30 and then would titrate up every two weeks. I think the traditional cadence is more of a four-week. We went two weeks because the phase I looks so good. At the end of the study, we did see higher rates of GI adverse events than would have been predicted from the phase I. I think when we look at the histogram of those, they tend to happen early, highest in the first week for sure and second highest in that first uptick in titration. I think starting a little lower and spreading out the titration steps to be the traditional four-week block would probably do a lot to mitigate the adverse events. The highest GI adverse event was nausea. Very interestingly, we saw an elevated rate in the placebo arm as well. The delta between the treated and placebo was really pretty minimal until you get to the higher doses. The higher doses are not necessarily relevant to the future development path for the compound. We felt pretty good about the adverse event profile since that is a known addressable topic with an alternative titration rate. Could you just put that sort of safety GI tolerability data into the context of the other orals out there? It's competitive, I think. I think the delta to placebo, very competitive. Why the placebo was a little bit higher, hard to know. I think it's 48% nausea in the placebo arm, and we're not sure what drove that. I think there's probably some expectations phenomenon in there. Everybody knows the mechanism induces nausea. Everybody knows someone who's taken one of these therapies and has experienced a GI side effect. Maybe that played a role, but hard to know. That's why you always kind of want to look at treated versus placebo. Everybody does that with the efficacy arms. You got to remember you also have to do that with the AEs. When we look at the AE deltas, there really wasn't a meaningful delta until, again, you get up to the irrelevant dose level. Gotcha. You touched on this already, but just for this exploratory low-dose maintenance arm, you saw some sort of maintenance of weight. Maybe just talk about the importance of that and how that's informing your thinking going forward. Yeah. It was more than maintenance. It was actually a continued weight loss, which was a surprise to us. The reason that's important is it suggests that you might be able to start somebody, titrate somebody up to a high dose, and then bring them down to a maintenance dose after some limited period of exposure at the high dose. That really helps when you consider the manufacturing costs and things like that. A sustained 100 mg daily dose or 150 mg daily dose for years, that's an expensive proposition. If you can put somebody at these elevated doses for a limited period of time and then bring them down to a maintenance dose, a much lower dose, that completely changes the margin considerations. I think it makes a number of different regimens feasible, and I think highly attractive from a margin perspective. Could you talk about the presentation of detailed data from this study? Are there any additional analyses we should look for and maybe the timing on that? Right. We got the top-line data last month. It's a limited set of data tables. The remaining data tables will likely come in late September or early October. We would target probably a medical conference in the first half of next year for the presentation. Gotcha. Maybe talk about the strategy for the oral formulation. It sounds like maintenance is probably the focus, but are you considering treatment at all with the oral, or is that not an option? The best use would be in the maintenance setting. Right now, there isn't really a regulatory path for a maintenance therapy in weight loss. If you were to envision a phase III program for the oral formulation right now, it would likely look like every other phase III program. You titrate up to some range of fixed doses and then keep people there for 52 weeks, and then let clinicians target whatever dose they think is most appropriate. I think the oral, though, is a nice option for people who have lost some amount of weight with the weekly sub-Q to transition either to a lower weekly sub-Q or to a low-dose oral for the longer-term care for maintenance. This should allow that avenue for patients. That kind of increase in flexibility, we think, should improve persistence of treatment over a longer period of time. You mentioned earlier about starting the maintenance study relatively soon here, I guess. What are the next steps to getting that going at this point? Yeah, yeah. The maintenance concept for the oral, because we're so interested in it, we actually started working on that in the first study, that phase I study where we titrated people up to 80 and then cut the dose to 80 every other day just to see what happened when you reduce exposures. We saw basically 80 every other day looked similar to the 80 daily. It gave us confidence. We put that 90 to 30 transition in the phase II study. That also confirmed the sort of notion that you can make those sorts of cuts in exposure and still see efficacy. The next study that you mentioned would be a study that we hope to start later this month or in October where everybody titrates up on a weekly injection basis. Everybody titrates up to some high weekly dose and then transitions either to a range of monthly doses or to a range of oral doses. The goal would be to really understand what doses are feasible from a monthly perspective and then what low oral doses would also be effective for maintenance. We'll have a cohort in there as well that has a weekly oral as well, higher weekly dose. All of them should provide really useful information to understanding the maintenance approach. Can you just comment for oral specifically in the maintenance study, just what sort of doses you're considering? You know, how low do you think you can go? Yeah. We haven't said we'll disclose the dose ranges for both the sub-Q and the oral cohorts when we start the study. What we saw in this phase IIa study was that 30 looks to be more than effective for maintenance. Probably look at doses below 30 in the upcoming transition from sub-Q to oral. The weekly sort of higher dose, just the rationale behind testing that? Yeah, yeah. We know from the phase II sub-Q study that when you look at the PK curves for most of the month, especially in the 10 and the 15 mg cohorts in that prior study, most, if not all, of the month, the plasma levels of drug are sort of in that therapeutic range. Above the 2.5 mg dose, which 2.5 gave you 9% weight loss, the thinking is because you've got that exposure over 28 days, if you transition someone to a monthly dose, 15 mg above or below, right in that sort of ballpark, you'll keep them in the therapeutic range and hopefully prevent weight gain and hopefully not introduce new side effects with the less frequent cadence. Gotcha. Maybe, I don't know if Stijn, you can comment on this, but just the monthly sort of sub-Q doses, you know how many doses sort of range what you're thinking, and how are you narrating that? Yeah, yeah. Multiple doses, and we haven't disclosed them. I mean, we're going to 17.5 in the phase III study. That wouldn't be a bad guess to assume that's the base dose. You'd want to spread above and below that just to see what the different range is for both maintenance and tolerability. Gotcha. Maybe we can switch to sort of the sub-Q formulation. Maybe just talk about the prior 13-week data and put that into the context of other competitors as well. Yeah. The prior data, we reported those data. I think we presented that at Obesity Week last November, 13-week study. What we saw in that study was a very nice dose response. Went from 2.5 mg to 15 mg, and the weight loss was 9% to 14.7%, so from baseline. I think a good early signal there, beautiful spread in responses, no plateauing. Because the tolerability profile was, you know, we thought, very encouraging, we decided to increase the dose a little bit in the phase III study. The phase III studies go up to 17.5, to 7.5, 12.5, and 17.5. As far as the comparison, it's always hard, again, to do the cross-trial comparisons. I think we feel comfortable with the profile versus competition. Again, you're pulling data off of a graph in a published paper versus our actual, and that's always fraught with error. Yeah, no, it makes sense. You mentioned earlier also you're starting your phase III program. It's two different studies. Maybe just talk a little bit more about the trial design and how that's been sort of tracking versus your expectations. Yeah. Two studies. We call them Vanquish 1 and Vanquish 2. They're both the phase III. Vanquish 1 is in obese subjects, BMI of at least 30, 4,500 people. Vanquish 2 is obese with type 2 diabetes, and that's, I think, 1,100 people. Both will titrate up to a top dose of 17.5 milligrams and maintain people at a per week, maintain people at that 17.5 milligram dose for 52 weeks for a total treatment period of 78 weeks. We kicked it off in June, had an investigators' meeting in late June. It was really well attended, more well attended than we had expected. High amount of enthusiasm from the investigators. Have been able to get the sites up and running pretty smoothly, pretty flawlessly. Enrollment's going well. I think we're too early to give guidance on timing there, but so far, so good with the way the trial's been initiated. Gotcha. Can you talk about the titration schedule you're using and kind of what the steps are? We had, in the phase II study, used three-week steps, and it seemed to work well. We didn't feel like there were any tolerability issues. It seems like most of the products these days that are available have four packs. They come in the four-pack of a fixed dose. We decided to extend the titration windows to four weeks. Right now, it's four weeks in essentially 2.5 mg increments, and that's what gets you to the 78-week total treatment window. In terms of timing and sort of getting that study completely enrolled, any general thoughts on when you might be able to hit that? You mentioned sort of interest and things seem to be going well. Yeah. I think it's too early to give clear guidance on that. Most of the sites are operational now across both studies, and I think the rate of enrollment has been pretty solid. I think it's going to take a little while to really get an idea. Some of the sites came on a little later than others. We need to see what the steady state enrollment pace is. So far, it's been satisfactory for us. Surprisingly, despite there being a lot of obesity studies ongoing, there hasn't really been, I don't know, not really been competition, not noticeable competition for patients. It's been pretty impressive. Yeah. Gotcha. Maybe we can move to just manufacturing. Earlier this year, you signed an agreement with Corden Pharma, and that's been like a sort of a focus heading into the end of last year. Maybe just talk a little bit about that agreement and why it was so important for you guys. Yeah. It was important because you know we've heard a lot about product shortages as the current obesity products have launched. We wanted to make sure that we could take that concern off the table as early as possible. What was really, I think, attractive to us about Corden Pharma, we had a history with Corden in other programs. We knew the company as a CDMO. What set them a little bit apart was their experience with peptide manufacturing as well as fill and finish. Fill and finish across a range of fill and finish products. They have the vial and syringe capacity. They have autoinjector capacity, and they have tablet capacity. For us, what was nice is that we were able to fit everything under the same roof where we have Corden Pharma prepare the API and then formulate it for, you know, dispensing with a vial and syringe or an autoinjector or a tablet. It's hard to find a vendor that can do that at scale, really. That's what we really liked about them. The base API agreement covers a multi-ton annual supply of API that's expandable. For the autoinjectors, it's 100 million units per year. The autoinjector expandable, the vial and syringe, 100 million units per year, vial and syringe. The tablets, up to a billion tablets a year. All of those can also be expanded at our discretion. Could you translate that into what the potential sales could be that you're covered for? What does that look like? Yeah. It's a high number. Yeah. On the sub-Q side, in the, I don't know, double-digit billions, easily with the API supply. On the oral side, as well, well into the billions there as well. One thing that's also attractive about the Corden Pharma arrangement is that it allows us to feed in API into the Corden Pharma fill and finish lines as well. If we wanted to add additional API suppliers, that gives us flexibility. In the past, you've mentioned a post-BIF agreement to maybe build some redundancies in the supply chain. Maybe just talk about your latest thinking there. Yeah. That's a pretty active process. We would like to have redundancies across the board. Not that we have any concerns about Corden Pharma. I think we've got a great setup there, just to have additional capacity or redundancies in the case of something unexpected happening. I think we'll be able to put redundancy in place for all of those elements of the supply chain: API, fill and finish on the vials, fill and finish on the autoinjector, as well as tablets. Got it. Maybe you can touch a little bit on cost. You mentioned this earlier, but that's sort of been an area of concern in general with peptides. How do you manage that? Yeah. We wouldn't see the peptide being, you know, materially different in cost of goods from any other, you know, peptide right now for obesity. I think we're not concerned about the COGS line right now. Where I think people ask more about is on the oral formulation. If you use a high dose to oral, how does the COGS, where's the limitation there? Certainly, higher the dose, the lower the margin there because the API is the most expensive input. Where we've seen the cost structures move just over the past 18 months is a nice downward move, I think, in overall price points. That makes sense because we've never seen peptide production on this scale before. Before the obesity programs, no one was making multiple tons of API per year. You could expect there to be efficiencies in just process improvements in solvent recycling and things like that and purification methods. I don't know what those, that's my speculation as to what's driving price improvement. For sure, we've seen price improvement in peptide supply. Where that ends, I don't know. So far, it's very favorable. With every incremental improvement in price, it gives you greater flexibility, especially on the oral side, for margin improvement. Makes sense. Maybe just sort of the obesity strategy, obviously a very competitive market. You have a competitive sub-Q. You also have the oral for maintenance. I guess, how do you, is that something you can launch on your own? Do you need to partner? What are sort of the options there? Yeah. I think we've always said that we'd prefer to work with a larger party. I think that would make the most of the product. We're always receptive and open for discussion there. We also have to plan for success as a standalone. It's a pretty active exercise right now, the commercial plan for Viking Therapeutics. The way we would see the products being introduced is the weekly injection would be the centerpiece product. The monthly would be a nice option for people to pursue if they wanted to transition from the weekly to the monthly. The oral would be another option. I think long-term, this concept of persistence on therapy is going to be really important to payers because the longer someone stays on, the more likely they will achieve these longer-term health benefits, cardiovascular, renal, potentially CNS. It's very important to keep people on therapy for longer periods of time and to maintain that weight loss once they achieve it. I think the optionality we give people so they can hit a target weight, reduce their weekly dose if they want to just stay on the weekly, they can transition to monthly if they want to have a less frequent dosing regimen, they can transition to a low-dose oral, all of them using the same molecule. We think that's highly differentiated for our pipeline. Yes. You mentioned your amylin receptor agonist program. How does that sort of fit within that strategy? Yeah. When we started working on amylin, we originally kind of thought of it as being an add-on to the dual agonists just to see the nice bump. You see that when you add amylin to GLP-1. You see a 30% to 50% improvement in efficacy. We thought if you added it to a GLP-GIP, you might see the same thing and really push the efficacy into a higher range. That is kind of the main strategy there. More recently, we think amylin probably has a role as a single agent in people who might not, you know, people in a BMI 30 to 34, for example, who might not be the extreme overweight but just want to lose, you know, 10% of their body weight, something like that. There is a nice option there for amylin as a standalone. The other would be in people who can't tolerate a GLP-1 agonist. There will be a sizable group of people who would seek another option there. That is another place for the single agent. The first study we'll do with the amylin, we're going to file an IND hopefully late this year and then start the study late this year, early next year. First, it'll be a single agent SAD followed by a single agent MAD, but then in the background, continue to progress the combo. Yeah. You've been talking a lot about obesity. You have these two other programs, you know, in a NASH program and an X-ALD program. Maybe just your current thinking with those or where they are. Yeah. The NASH program with the VK2809, a THYROID beta agonist, really impressive phase IIb data, 52-week study, and biopsy-confirmed NASH, and showed nice NASH resolution rates, fibrosis improvement, both NASH resolution and fibrosis improvement, as well as fantastic improvements in lipids. The next step there after the phase IIb would be to transition into phase III. I think here's where the biopsy-confirmed phase III trials are probably not something we'd want to pursue alone. We'd seek a partner for that program prior to phase III. That could change if the FDA is amenable to FibroScan replacing the biopsy. That's a long way off, we think. If that were the case and that were confirmed, I'm sure that would be something we'd be interested in pursuing. In the absence of that, we think a partner would probably be the best place to go with the NASH program. The second program, X-ALD, same thing. I mean, we had a really interesting phase Ib study that showed a reduction in the key biomarker there, very long-chain fatty acids at 28 days. I think that would be probably best suited for a partner with experience in orphan diseases. You have a lot going on. Maybe just talk about your current cash position, what that covers in terms of your plan from your phase IIIs and maintenance studies, and then just sort of how far that gets you. Sure. Right now, we ended the second quarter with a little over $800 million in cash. The first two quarters of the year, we burned about $50 million per quarter. Right now, we think we've got the balance sheet that gets us through the sub-Q phase III and well into, if we were going to an oral phase III, well into an oral phase III, potentially through an oral phase III. It's too early to say yet without knowing what the parameters are around the oral phase III. I think minimally, we should be able to complete the ongoing phase III sub-Q program. Sounds good. Maybe in the last couple of minutes here, we can ask a couple of sort of macro questions that we've been seeing topical these days. There are three of them. I'll just start at the top, just with China's rise in biotech innovation. How are you thinking about your competitive position here? Will that influence your R&D or BD strategy? Yeah. A lot of activity. I think what maybe people forget is China's always been pretty active in biotech. Back in 2018, 2019, we didn't report this, but we spent a huge amount of effort on FXR agonists for NASH. The obeticholic acid was the kind of the, and then the tropifexor compound as well. We spent a ton of time on FXRs. What we found was that China was just loaded with FXR programs. It's not new that China is a source of a lot of programs that are also here in the West. Obesity is no different. I think the difference here is that there's so much more media exposure on the obesity front that China's getting a lot more visible than they were maybe historically. China with DPP4s, with SGLT2s, with FXRs has always been a source of a huge number of programs. Got it. You know, how are you currently leveraging artificial intelligence and thinking about AI's sort of future disruption potential in the industry? Yeah. I think it's early innings there. I don't know. We don't use it very intensively. I think, you know, for us, it's execution on known things, you know, designing phase III trial, executing phase III trial. I think there will probably be places for AI to play a role on the discovery side more than the advanced development side. I could be wrong there. I'm sure we use it a little bit on the discovery side of Viking Therapeutics, but most of our effort is in the execution of the registration studies. Makes sense. Maybe last question here. What's sort of been most impactful for you guys on the regulatory side? Would it be just, you know, FDA and the adjustments being made there, or MFN, or tariffs? I think the sort of, I don't know, turmoil might be a strong word, but just the transition and noise around FDA staffing has been a concern. You always want there to be a stability and reliability at the FDA. Fortunately for us, despite all of the headlines, work has been sort of business as usual with the FDA. Our communications have not been noticeably delayed. There hasn't been any disruption or, I don't know, any impact on our interaction. So far, so good there. I think others may have different experiences, but our experience has been pretty consistent. Okay. It looks like we're out of time, so why don't we end it there? Thanks so much, Brian. Appreciate your time. Thanks, Mike.