Oh, you're good. Wonderful. Thank you guys. It is wonderful to see you all here today. Thank you so much for taking the time. It is my privilege to have the Viking team here with me. I've got Gregory and Brian, the CEO and CFO of the company. This is a particularly interesting and exciting time in the world of cardiometabolic obesity and kind of all the places that you guys play. Undoubtedly there's lots of questions and lots of things that everyone wants to dive into. For those of you who don't know me, my name is Courtney Breen. I am the U.S. Biopharma Lead Analyst here at Bernstein. I think about a lot about all the large cap names, but also all the companies that are coming in to look to compete with many, many of those large cap names or partner with them over the years. We're going to spend a bit of time with the Viking team walking us through some presentation materials and then we'll dive into Q&A. Just a reminder, we do have the Pigeonhole app available, so if anyone has any question, please feel free to put those through on Pigeonhole and I'll be happy to integrate them into the Q&A at the end. With that I will hand over to you to walk through some of these presentation slides. Great. Thanks, Courtney. Thanks also to Bernstein for the opportunity to participate. We've got a great schedule and good to see you all today. I'll make some forward-looking statements. I'd refer anybody listening to this presentation reviewing these slides to the Securities and Exchange Commission's website for the most current information on Viking. Happy to walk through the story. We're developing novel therapeutics for metabolic and endocrine diseases. We have multiple clinical programs that have demonstrated what we believe to be best-in-class data. The metabolic disease programs are highlighted by our VK2735 molecule. It's a dual agonist of the GLP-1 and GIP receptors. It's currently in a phase III program we call the VANQUISH phase III program for obesity. There are two trials underway there. We have an oral formulation of the same compound that has recently completed a phase II study, successfully achieved primary and secondary endpoints in that study. Finally, we have an amylin agonist, a novel amylin agonist that we plan to move into the clinic late this year or early next year following the filing of the IND. We have additional programs that are focused on the thyroid beta receptor. VK2809 is a thyroid beta receptor agonist that completed phase 2b in NASH. We have a separate molecule, VK0214, that's completed a study in X-linked adrenoleukodystrophy. Both of those are in-house, available for licensing, but not something we'll focus on in the near term. This slide shows the pipeline where we stand today. The VK2735 subcutaneous formulation in phase III, the oral formulation just completed the phase IIa study, and the amylin agonist heading into the clinic later this year. A little bit of the background on the peptide hormone program. We initiated this program back in 2019 and we looked at all of the agonists, the mono GLP-1 agonist, the dual agonist where you add GIP activity on top, and the triple agonist with the glucagon agonism on top of the dual. We selected the dual agonist really because the triples didn't look any better to us and duals just seemed to be very attractive. We stuck with those. VK2735 was the lead that we selected based on the initial profile and it has completed now a phase I SAD MAD study that we reported in 1H23. phase II study reported last year and the phase III studies are underway with VANQUISH registration program with the oral formulation. We completed the AD and MAD work last year, and then a phase II study just recently read out in the third quarter. This just shows some of the early data. All of our compounds are very potent at the GLP-1 and GIP receptors. Robust weight loss has been observed in multiple species. This slide just shows the weight loss over 14 days, generally up to about 30% weight loss relative to vehicle. Pretty clean PK, 2 to 7 day half-life in primates. This shows a compound we call VK2735, and just an example of how tight the PK profiles are. Very consistent, well-behaved PK profiles. We had selected VK2735 as the compound to bring further into development, and we just reported some data in August from the oral tablet formulation. I'll walk through the tablet first and then the subcutaneous formulation after that. These are the phase I data from the oral tablets. This is a 28-day study, daily dosing for 28 days. In this study, we did see a dose-dependent reduction in body weight across all of the arms, leading up to around 8% from baseline. At the 100 mg dose, about 7% placebo-adjusted. Overall, I think an attractive dose response here in a 28-day study. When we look at the trajectories from this study, really nice, again dose response and a consistent progressive effect through the 28-day window. One thing that was interesting when we looked at the follow-up data from this study was this period following 28 days out to day 57. You can see it's most obvious here with the 100 mg, really a durable effect. This was 8.2% from baseline at 28 days, 8.3% from baseline at 57 days. A very nice maintenance effect reflects, we think, the long half-life, and I think it suggests that maintenance might be feasible at lower doses than the induction window. The takeaways from the phase I study: up to 8.2% reduction in body weight after 28 days, progressive effect across all doses suggests that you should see an extension of that efficacy with longer treatment. Majority of the weight loss in every arm was maintained four weeks after the final dose, and very good tolerability. In the phase I study, 99% of the adverse events were mild to moderate, very minimal GI adverse events with low rates of the common GI adverse events, nausea, vomiting, and so forth. We did include an exploratory cohort in this study that looked at transition from 80 mg daily to 80 mg every other day, and we think those data looked very promising. They weren't in this deck, but they're in our poster from Obesity Week. Suggests feasibility of a lower dose for maintenance, providing a good maintenance effect. The phase I data supported advancing into phase two. We designed this study, we call it the VENTURE Oral dosing study. Thirteen-week study, multiple dosing arms. Lowest dose was 15 mg flat for 13 weeks, second dose, 30 mg flat for 13 weeks, and then 60 mg, 90 mg, and 120 mg. Each of these titrated starting at 30 mg for two weeks, then to the next dose for two weeks, and the next dose in 30 mg increments. The 120 mg, for example, started at 30 mg for two weeks, went to 60 mg for two weeks, 90 mg for two weeks, and then 120 mg. At the bottom here is an exploratory cohort that we thought was really interesting. These subjects were titrated very rapidly to 90 mg, so 30 mg per week, 60 mg per week, and then 90 mg for four weeks, then transitioned back down to 30 mg daily for seven weeks. That was to further explore the potential for a low dose maintenance regimen. Here are the data that we reported in August. This shows the% change in body weight at 13 weeks. Just like what we had shown previously with the subcutaneous formulation, a really nice dose response here leading up to 12% from baseline. At the top 120 mg dose, progressive and dose dependent across all the treatment arms would suggest that an enhancement of the effect should occur with longer dosing. As we look now, as we head forward, we'll probably be focusing on these doses in the 20 mg to 75 mg range. That's why I circled this range here, 30, 15 to 90, really attractive and competitive weight loss here, 7% to 8.7% with the 60 mg dose. Here's the data from the maintenance cohort. This again was the cohort that rapidly titrated up to 90 mg and brought people back down to 30. In comparison, this line here is the cohort that titrated up to 90 and held at 90. There you see 11.1% weight loss from baseline. The green line shows the cohort that titrated very quickly up to 90 and then at week six transitioned to 30 mg daily. After six weeks, four weeks of which were at 90, you see 8% weight loss, transition people to 30 and hold them there for seven weeks. We saw another 1.1%. It clearly supports this transition phenomenon where you can go to a lower dose. Here, not only suggest maintenance, but actually a continued improvement in body weight. This shows the secondary endpoint, proportion of patients achieving at least a 5% weight loss. Again, nice dose dependency up to 97% at the 120 mg dose. Even at the low dose, you're about three times what the placebo rate was. Very positive on the secondary endpoint there. A little bit delay on the buttons here. Maybe the battery died. Okay, okay. Proportion of patient, another secondary endpoint, proportion with a 10% weight loss. Again, a nice dose response, 7.5%, not significant there, but moving up to around 80%, experiencing 10% weight loss at 13 weeks, with the trajectories suggesting that all of these bars should improve over time with longer term dosing. When we look at discontinuation rates in this study here, we can see proportion who discontinued treatment early, that's stopping taking the medication, and you do see 18% in placebo trending up a little bit higher in higher doses. Discontinuation of the study really pretty flat across here, maybe a little uptick at the highest dose here, but pretty flat overall. Treatment emergent adverse events also reasonably consistent across the treatment arms. Drug related, maybe a slight uptick when you get to the higher doses, but that would be expected from the GI adverse events, and then the drug related treatment emergent adverse events leading to discontinuation, really no signal related to placebo. The majority of the treatment emergent adverse events were mild to moderate here. When we look then at the doses that will likely be bringing forward, that 20 mg - 75 mg range, again really not a significant difference relative to placebo on discontinuations or overall treatment emergent adverse events or those types of things. When we look at GI tolerability, what everybody likes to look at with the GLP-1 mechanism, we do see as you go across doses, an uptick in overall nausea at the higher doses. These middle doses really didn't separate too much from placebo. Placebo had a pretty high rate of nausea, vomiting slightly higher in the treated arms, likely addressable with slower titration rate. The other adverse events really not much of a signal at all. Again, when we look at our likely future doses here, between that 20 mg and 75 mg range, compared to placebo, really not significant delta at all on any endpoint. We're very satisfied with the AE profile given this rapid titration compared to placebo as being highly competitive. This slide is really interesting because it shows the time course of adverse events over the course of the study. You can see here, by far the majority of the nausea and other GI events happened in that first week of treatment. That's the initial exposure to the mechanism. Following that first week you see a substantial drop off. It ticks up a little bit here at week three and that's your first up titration. Following that first up titration it really drops to pretty much zero across the rest of the treatment window. The lesson here and from the prior tables is, you know, you want to start low and you want to go slow and you will probably see this pull in quite a bit and these probably remain pretty flat. This is all doses combined. We don't yet have the individual cohort data but overall this graph looks very similar to what the subcutaneous data showed. That was initial exposure gives you a little bit of nausea, following that, it never comes back really. The VENTURE phase II oral study takeaways: up to 12% reduction in body weight after 13 weeks of oral dosing. We see a progressive dose dependent effect across all of the treatment groups. The maintenance cohort, very exciting for us as they successfully demonstrated the proof of concept from high dose to low dose, maintaining body weight. Really promising tolerability profile with the vast majority of adverse events mild to moderate. In particular, the majority of the GI adverse events were mild to moderate and transient. We expect those to improve with the optimized titration that we would pursue in a subsequent study which would probably have four week treatment windows or titration windows. Next steps here with the oral would be to initiate a subcutaneous to oral maintenance study which we've talked about in the past and that will begin late this quarter or early next quarter. Now I'll quickly review the other formulation. This is a subcutaneous formulation, a weekly dose. This was data we reported last year from the phase II we call the VENTURE. The other one is VENTURE oral. This is VENTURE. They're pretty much the same study design. This went from 2.5 mg - 15 mg. A parallel cohort with three week titration blocks for the 5 mg, 10 mg, and 15 mg doses. This study achieved its primary endpoint. Significant reduction in body weight observed after 13 weeks. This is the dose response from 2.5 up to 15 mgs. A beautiful dose response, approximately 15% from baseline after 13 weekly doses and progressive with no sign of moderation through the treatment window. This is the trajectory for weight loss from the weekly injection study. Again, we see a nice dose response and a very rapid effect throughout the 13 weeks. All doses statistically significant starting at week one and remaining that way through the course of the study. This summarizes the GI tolerability in the subcutaneous study. Pretty modest GI effects, what you would expect to see. You see a dose-dependent uptick again in the higher doses here, 15 mg and 10 mg. Overall, same with a little bit of an uptick in vomiting as well. Overall, nothing that you wouldn't expect from this mechanism. The majority of these are mild to moderate. This shows the time course of adverse events for the two higher doses. This is the 10 mg cohort. This is the 15 mg cohort. I show these because it dramatically illustrates the effect of titration. The 10 mg cohort, blue here, is nausea. You can see, 15%, 16% rate of nausea in that first dose drops off a cliff and then comes back at your first titration step and then pretty much goes to zero after that. This cohort started at 2.5 mgs. This is the 15 mg cohort. Big difference with the 15 mg is these guys started at 5 mgs. You can see this massive change in nausea that's brought way down by just starting at a lower dose. Following that first week, you see a rapid drop in GI adverse events. You see a little bit of a tick up here, and this was when you went from 10 mgs to 15 mgs. It just further illustrates that mantra, start low and go slow. This group started twice as high and did twice as high a step here out late. You just want to be steady through the treatment window to minimize GI adverse events. I think these two cohorts really show that nicely. The study takeaways from the subcutaneous study: up to nearly 15% weight loss after 13 weeks of treatment, very encouraging tolerability. Over 90% of the drug-related treatment emergent adverse events were mild to moderate. GI-related adverse events generally occurred early and then resolved quickly. When we look at durability here, we saw that more than 90% of the efficacy that was observed at week 13 was retained at week 17. A very attractive durability signal. We think the PK profile from this study suggests that a monthly regimen would be feasible, particularly in the maintenance setting. The current status of the subcutaneous formulation is that we've got two studies ongoing. VANQUISH one is our study in obese patients. That's about 4,500 people. VANQUISH two is in patients with diabetes and obesity. That's a little over 1,100 people. Both studies include an extension to assess long-term safety and efficacy. We initiated these in the second quarter of this year. Something that's upcoming for the subcutaneous formulation is this monthly dosing study. This is designed to evaluate a monthly regimen in the setting of maintenance. You titrate people up to a high weekly dose and then transition them to a monthly regimen. The second element of that study is a low-dose oral regimen. We'll bring people from a high weekly dose to a low-dose oral or to a monthly regimen. This will look at PK, tolerability, and weight maintenance. I'll wrap up with the balance sheet here. We ended the second quarter with over $800 million in cash. We think that provides the runway to finish the phase III trials. Very fortunate to have the runway that we have and to support the programs, to develop them aggressively. This brings us back to the first slide. The pipeline is focused on metabolic and endocrine diseases. VK2735 compound for obesity is the lead program. The subcutaneous formulation is in phase III, the oral formulation just completing a successful phase II. The earlier program is an amylin agonist that we hope to move into the clinic toward the end of the year or early next year. That's all I have. Thanks for your attention and I'll open up to questions. Thanks. Fantastic. Thank you so much for walking us through there. Obviously, the recent phase II data for the oral has been kind of a source of a lot of investor focus, a lot of investor questions, and maybe just to talk through the next steps. Off the back of that, I think you've highlighted that there is the oral maintenance study that you anticipate to get up and running in the back part of this year. The next question is kind of the oral weight loss study and the potential path to achieving that. What do you need to see? What do you need to explore? What do you need to validate on your oral asset before you are in a position to initiate that phase III? Yeah, we hope to have in the fourth quarter an end-of-phase II FDA meeting to review all of the data, the animal data, the human data, and then understand what additional work might be required prior to phase III. We're hoping to schedule that in the fourth quarter and then decide on the next steps from there. In the interim, we will be starting near term that study I just mentioned, where we transition people from a high weekly dose to a variety of oral maintenance. We have two cohorts that will be a low dose oral daily, and then one cohort that will be a weekly oral dose as well, just to explore the maintenance effects. That would be the nearest term with the oral. The end-of-phase II, I think, will be very valuable in mapping the path forward there. Fantastic. As you think about the endpoints that exist in these trials today and the labels that we see for some of the GLP-1s and GLP-1/GIPs that are out there, they tend to be based on weight loss rather than necessarily weight maintenance. As you think about the path for the oral coming to market, do you need to have in your mind individual studies that generate weight loss evidence for that oral, or is there a path that you can foresee purely in that maintenance setting? There isn't a maintenance approval path right now. Every cohort that you would look at in a phase III oral study would be designed for weight change from beginning to end, and it would be up to the commercializing party to position it in maintenance or an induction, which is one of the reasons we're exploring these maintenance to see where's that dose for the maintenance effect. It's true there's not a regulatory path for maintenance. Every drug that's approved today anyway is approved for weight loss. Fantastic. As I look at some of the phase IIIs that you've got up and running, the VANQUISH- 1 study, you've made the decision to have a BMI cutoff at 30. You contrast that with some of the other studies that we see out there, which tend to go down to 27 for patients that have comorbidities. You've decided to keep it a little higher. Can you talk about that particular decision, why that feels like the right decision for you? Is that a trade-off of expense of the trial, getting the right patients in, delivering the evidence versus where the product might be used in the market? Both studies allow. It's 30 and above or 27 and above with a comorbidity. They are kind of in that traditional bucket. Turns out that the vast majority are always above 30. We did drop it if you've got a weight related comorbidity. We dropped it to 27 standard. Yep, great. That's super, super helpful. One other thing that I think is really important as we look at development of drugs in this space is, and this was certainly a large part of the conversation at EASD last week on the ground with physicians, the idea of placebo-controlled trials and whether they still make sense. This really comes down to two parts of the puzzle. One, on the patient side, how are you going to ethically, in some instances, offer a placebo to a patient who needs weight loss? The second side of it is for the company itself. How do you entice enough patients to come into your trial so you can recruit appropriately but also maintain enough patients in your trial over your 60, 70, or 80 week long trial that they may be in for that phase III? As you look at your position in the market, entering a market that's rapidly maturing, how are you making those trade-offs at the moment? It obviously impacts cost of trials, it impacts speed of trials, it impacts a lot of different factors that I'm sure you're weighing up. Yeah, the retention of placebo. Right now, the registration path is, it requires placebo-controlled studies. Active comparators could be an important component in the future. The registration trials are placebo-controlled according to guidance. The question is, how do you keep those guys in? It's a really huge challenge for anybody working in the space. If you've got a person enrolled in the study that's not losing any weight and doesn't feel any GI adverse events, they sometimes feel like maybe they're on placebo. Everybody faces the challenge. I think one thing that really helps with retention, probably the best thing to help with retention, is to guarantee access to active therapy upon completion of the primary endpoint date. As long as people are sure they're going to get active therapy and they're getting it for free and they're receiving active medical care, that really does make a difference in retention. It's always there and I think everybody needs to try to navigate that. It's always a challenge. Absolutely. Yeah. It was a much louder part of the conversation, I think, over the last week at this conference than it has been in the past. I want to talk a little bit about Viking as a company as well. We've been deep in kind of the drugs, the trial design, kind of where you're going as a company. As you think about the next three, five years, we're going to be going through some of these phase III clinical trials, beginning to get to kind of some of the data cards turning over at the end. What does success look like for you at Viking? You made a comment kind of on your last couple of slides. You've got around $800 million of cash sitting there to fund kind of the position that you're in right now. What degrees of freedom does that enable you and what other pathways will you be wanting to explore to ensure that you've got all the choices that you might need to have so that you can have viable commercial products that are really competitive, entering the market and Viking sitting in the best place that it can? Yeah, we're pretty lean. We've always run pretty lean. We have just over 50 employees today and that will probably grow over the next couple of years as the phase III trials mature as we prepare for commercialization, but we've always, I think, gotten a lot done with limited resources and all of our expenses are, most of them are to external execution-related vendors. I think what's really unique about the obesity market, which probably wasn't in existence before the obesity market started to expand so rapidly, is the direct-to-patient is a really effective means. When you look at the successes of these combinations, compounding pharmacies and the compounders, they don't have any sales infrastructure. Our estimate is over $10 billion in revenue right now is going to that channel. It's a very unique market the way obesity is maturing. It, I think, fits nicely with a company like Viking that has always been very lean on infrastructure and has had a pretty low expense burden for infrastructure. I think the market here is set up very nicely for a company like Viking to be really successful. We just don't have that underlying infrastructure expense that a larger entity might have. Super, super useful. As I think about some of the big choices you have to make ahead of you, one of those is something that you reiterated I think a couple of times in the session, which is that notion of go low, go slow, which we hear repeated as a mantra from so many physicians. I think the most extreme version of this that I hear from some physicians today is, oh, I don't even get any AEs in my patients at all these days because they go much lower and much slower than what the labels tell me for the products that are out there. This is a growing appreciation, I think in this market, that you can really tolerate these patients with time and you can manage their adverse events. It's a trade off on kind of being able to deliver efficacy, kind of weight loss demonstration or health outcome demonstration over an efficient length of trial. As you look forward and kind of making that deployment of cash against some of these future clinical trials, how are you thinking about that particular trade off? For the phase III trials, we did slow down the titration rate just to make sure there are four-week blocks and ease people into the dose escalation. For all of the studies for registration, you've got to be at 52 weeks from the post-titration dose to the endpoint. Ours is 78 weeks. I think if you titrate faster, you can compress that a little bit, but the tolerability profile will suffer as a result. In the real world, people titrate to tolerability, really. I think for us, that's just the way our titration works; it's going to get us through 78 weeks before we get to the endpoint. In the real world, we'd expect it to be used kind of custom, just like we see right now at the current weight loss agency. People dose up to whatever they can tolerate. What's interesting we've heard anecdotally from some investigators is we've heard about patients coming into their clinician and asking to be up-titrated because they're not feeling any more GI adverse events, and they feel like, oh, it's not working anymore because I'm not seeing. It's kind of a backwards way to think; they shouldn't think that way. It tells you that some people are really looking for that. We think we probably saw a little bit of that in the oral phase II study with the higher than expected rate of nausea in placebo. It's just that everybody knows somebody who's on a GLP-1, and they all, everybody talks about the GI profile. Absolutely. Certainly on that point, I think two things that came to mind in your comment there. In my old life back in industry, I do think there is this idea, it's almost a bimodal distribution of patients, patients that want to treat a disease as hard and fast as they possibly can and the other patients that want to forget that they have the disease and want to make sure that that drug is kind of unrecognizable in the course of their lifestyle. I do think there are different shapes to the way that this shows up. Perhaps just as we get into our last five minutes or so of this conversation, I do want to open up to the market evolution because as we think about the GLP-1 space, and you made the comments about the direct-to-patient platforms, which I think is a really important one, what are the fundamental parameters of the GLP-1 market or the obesity market that are critical to framing the opportunity that you think you have? How do you see the market evolving and do you see Viking and your assets as they come to market, joining a growing market or disrupting a growing market? Yeah, it's a good question. We think the number one fundamental that both patients and clinicians want is efficacy. Everybody wants the most effective weight loss drug. You have to expect that and really be able to compete on that. That's why I think our study with the doses we selected and the profile we've seen with the drugs so far should be highly competitive on efficacy. I think second, tolerability becomes more important. Following efficacy and then learning how to properly titrate somebody is an important element of that and how we see us entering the market. I think the VK2735 molecule will be very competitive based on the profile we've seen thus far. As we look to the future, we expect efficacy to always be the most attractive characteristic for most people. When we think of our amylin program, we think an opportunity to combine the amylin with the dual agonist would, we think, possibly provide a weight loss effect that's above and beyond anything we've seen thus far in the pipeline. That's where we seek sort of the next step. Just like we've seen with the GLP-1 and then GLP, amylin, GLP, GIP, GLP, GIP, glucagon, adding different mechanisms on top of that GLP-1 backbone will likely continue to incrementally improve efficacy. I think if the amylin program matures in the way we hope it does, it should allow us to be really, really competitive. Fantastic. One other thing I want to ask, you mentioned as you were talking about the phase III clinical program that you've been a very lean organization over time and the roles and capabilities will need to evolve that you lean into. As you look at different ways of doing that, doing that fully in house versus partnering versus collaborating, how do you think about those decisions and ensuring that you're taking on the right risk within your own entity versus sharing risk with other players that might want a piece of the opportunity as well. We have to be receptive to ideas, and we've always felt that the programs could be most effectively developed with the help of a larger party. We're certainly open to collaborating with larger companies, but we also have to be able to map out the future if that doesn't materialize. That's what we've been focused on a lot. Whether you build in house or contract, contracting is a little bit more expensive, but it gives more variable cost, so it's easier to terminate than an in house salesforce. We're actually looking at all of those options right now. What's the best path? Our feeling is that if you build carefully and thoughtfully, in house is probably a better model than the rent to salesforce. Any of these more external models, when it comes to commercialization, when you're in development, it's much, much more effective to outsource things. That's the model we've pursued thus far. Absolutely. In our last couple of minutes, if you were thinking about Viking in five to 10 years in the future, what does success look like, and what are the challenges where you pinpoint and say these are the biggest decisions I've had to make that's enabled the success? I think where we would see the company is hopefully having more than one product on the market and, you know, an international footprint, a lot of work to do there. I think with the sort of direct-to-patient model that can be utilized in the U.S., it can be utilized in Europe, it can be utilized, you know, globally. I think that's, you know, it allows us to remain lean, building appropriately where we need to, but it would allow us to remain lean and also competitive. I think at the end of the day, it's the products. The products need to be the most effective or compelling to patients, because again, when you look at the compounders, these products sell themselves. People are going to compounders and health spas and asking for products that they're not, you know, doctors aren't getting detailed in those places. It's just a unique opportunity that I think is suited really nicely for a company like Viking. Absolutely. Absolutely. I think we're sitting here on the precipice of lots of exciting decisions ahead for Viking and lots of exciting data cards to continue turning over as well. Thank you so much for taking the time with us today. It's been a pleasure to have this conversation with you, and I hope everyone who's listened in has had the chance to understand the story a little bit more and see the catalysts that are on the horizon for Viking. Thanks, Courtney. Thanks.