Welcome to the Viking Therapeutics Fourth Quarter and Full Year 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a question-and-answer session. [Operator Instructions] As a reminder, this conference call is being recorded today, February 5, 2025. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, February 5, 2025, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995 including statements about Viking's expectations regarding its development activities, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the three months and full year ended December 31, 2024, and provide an update on recent progress with our development programs and operations. 2024 was an exceptionally busy year for Viking. During the year, the company reported successful results from four different studies across our pipeline. These include the announcement of positive data from our VK2735 subcutaneous program for obesity. The results of our VK2735 oral tablet program for obesity, the histology results from our VK2809 program for the treatment of NASH and fibrosis and the initial proof-of-concept data from our VK0214 program for X-ALD. With respect to VK2735, our lead program for obesity, in the first quarter of 2024, we announced positive results from the Phase 2 VENTURE trial evaluating subcutaneous administration in obese subjects. This trial demonstrated impressive reductions in body weight after 13 weeks of treatment. Later in the first quarter, we announced the initial results from a 28-day Phase 1 trial evaluating an oral tablet formulation of VK2735 which demonstrated excellent tolerability and encouraging reductions in body weight. In the second quarter of 2024, we announced histology results from the Phase 2b VOYAGE trial evaluating our novel thyroid hormone receptor beta agonist, VK2809 for the treatment of NASH and fibrosis. This study successfully achieved its primary secondary and exploratory end points showing reductions in liver fat at 12 weeks and improvements in NASH resolution rate and fibrosis after 52 weeks. And finally, in the fourth quarter of 2024, the company announced positive results from a 28-day Phase 1b clinical trial of our second novel thyroid hormone receptor beta agonist, VK0214, in patients with X-linked adrenoleukodystrophy or X-ALD. Results from this study showed VK0214 to be safe and well tolerated, and treated patients demonstrated significant reductions in plasma levels of very long chain fatty acids compared with placebo. During the year, the company also announced the addition of a new program to its pipeline focused on a series of internally developed agonists of the amylin receptor. In animal models, these compounds demonstrated improvements in body weight and metabolic profile. On the corporate side, during the first quarter of 2024, Viking closed a successful public offering of common stock, raising more than $630 million in gross proceeds, providing the resources to aggressively move forward with our pipeline programs. I'll have additional comments on our operations and development activities after we review our financial results for the fourth quarter and year ending December 31. For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-K filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the fourth quarter and full year ended December 31, 2024, beginning with the quarter. Research and development expenses were $31 million for the 3 months ended December 31, 2024, compared to $20.5 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, salaries and benefits and stock-based compensation, partially offset by decreased expenses related to clinical and preclinical studies. General and administrative expenses were $15.3 million for the three months ended December 31, 2024, compared to $8.8 million for the same period in 2023. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, salaries and benefits, insurance and professional fees. For the three months ended December 31, 2024, Viking reported a net loss of $35.4 million or $0.32 per share compared to a net loss of $24.6 million or $0.25 per share in the corresponding period of 2023. The increase in net loss for the three months ended December 31, 2024, and was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2023. We I'll now go over our results for the full year ended December 31, 2024. Our research and development expenses for the year ended December 31, 2024 were $101.6 million compared to $63.8 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, stock-based compensation and salaries and benefits, partially offset by a decrease in expenses related to clinical and preclinical studies. Our general and administrative expenses for the year ended December 31, 2024 were $49.3 million compared to $37 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, professional fees, insurance and services provided by third-party consultants, partially offset by decreased expenses related to legal and patent services. For the year ended December 31, 2024, Viking reported a net loss of $110 million or $1.01 per share compared to a net loss of $85.9 million or $0.91 per share in the corresponding period in 2023. The increase in net loss for the year ended December 31, 2024, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2023. Turning to the balance sheet. At December 31, 2024, Viking cash, cash equivalents and short-term investments of $903 million compared to $362 million as of December 31, 2023. This concludes my financial review, and I'll now turn the call back over to Brian.

Thanks, Greg. I'll now provide a summary of clinical highlights from 2024 and outline next steps with our pipeline programs starting with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor. The company's initial Phase 1 single and multiple ascending dose trial for VK2735, demonstrating the promising safety, tolerability and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection to four weeks. Subjects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau. Following these results, the company initiated a Phase 2 study called the VENTURE study to evaluate longer-term dosing with VK2735 in subjects with obesity. This trial was a randomized, double-blind, placebo-controlled multicenter study that evaluated the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 administered subcutaneously once weekly for 13 weeks. In the first quarter of 2024, the company announced positive results from the VENTURE trial, which successfully achieved its primary and secondary endpoints. The study demonstrated that patients receiving VK2735 achieved statistically significant reductions in mean body weight from baseline ranging up to 14.7%. The VENTURE study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment-emergent adverse events characterized as mild or moderate. Adverse events generally occurred early in the course of treatment and were primarily related to the expected GI effects resulting from activation of the GLP-1 receptor. These data were presented last November at ObesityWeek, the Annual Meeting of the Obesity Society. This presentation also provided updated results from follow-up visits that occurred four and seven weeks after the last dose of VK2735 was administered. These results showed that cohorts receiving VK2735 maintain the majority…

We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Ryan Deschner with Raymond James. Please go ahead.

Thanks very much for the question. I wanted to see if I could give some more detail from the discussion on the feedback at the end of Phase 2 meeting, particularly details on the potential number of size or maybe even potential comparator arms for the Phase 3 studies that you plan to initiate next quarter. Thank you.

Yeah. Thanks, Ryan. We'll provide more detail on the study design when we announced the initiation. But the size would certainly conform to guidance, which requires at least 4,500 people in the Phase 3 program. For these three studies, there will be one in obese subjects and one in will be subjects with type 2 diabetes, we would plan to use multiple doses and conform in that we would target a 52-week treatment window as well. But we'll provide further details on the doses and other items when the trials initiate.

Thank you very much, Brian.

Thanks, Ryan.

And the next question comes from Mike Ulz with Morgan Stanley. Please go ahead.

Good afternoon. And thanks for taking the question. Maybe just on the Phase 3 obesity study. It looks like you narrowed the timing for the start there to 2Q versus first half '25 previously. Just curious what the rationale for that and kind of the remaining steps to getting that study going? Thanks.

Yeah. Thanks, Mike. We're just -- it's primarily logistical making the formulation, making the drug product to enter into the study. So having better visibility on the time lines for production of the clinical material allows us to focus the time -- the window a little bit better. But everything is going according to plan, so nothing -- no issues, just big complicated exercise, and we're well into it, though.

Thank you.

Thanks, Mike.

The next question comes from Joon Lee with Truist Securities. Please go ahead.

This is Asim Rana on for Joon Lee. Congrats on the quarter and thanks for taking the questions. Are these studies going to be standard weight loss studies? Or are you looking to include anything differentiating? And then how long do you think it will take to recruit patients? And then I have a follow-up.

Yeah, sure. Well, the primary endpoint would be a change in body weight. Diabetes study will also include glycemic endpoints as you typically would in type 2 diabetes study. But primary endpoint would be a change in body weight. I forgot the second question.

Just how long it will take to recruit patients?

Yeah, we can't give guidance on that just yet. We need to start the study and understand time lines to site initiation as well as what the enrollment queue looks like. But -- so we'll be able to provide that later, but can't peronosticate right now.

Okay. Just 1 more. Are these studies starting concurrently? And have you secured API for both Phase 3 studies? Thank you.

Yeah, we do have the API for both studies, not the API to get through the Phase 3 program. And we do hope to start them as close as possible to concurrent as we can.

Thank you.

Thanks, Asim.

And the next question comes from Jay Olson with Oppenheimer. Please go ahead.

Hey, congrats on all the progress. And thanks so much for taking the question. I think, Brian, you had mentioned that you were planning to test monthly for the subcu formulation later this year. Can you just talk about your thoughts on the study design and whether or not that can be implemented into Phase 3 and eventually get into the label? And then I have one follow-up, if I could.

Yeah. I think, Jay, the long-term goal would be to have something in the label, whether or not it would be in the initial NDA. Too early to tell right now. The study that we'd like to initiate will be a study where we rapidly titrate people to a high dose of VK2735 and then transition them from the weekly to the monthly cadence and really look for weight regain, how does -- we're not anticipating further weight loss, but how does maintenance work at this less frequent dosing interval.

Okay. Great. Thank you. And then further along the lines of maintenance dosing, I think you mentioned there was an option to transition from subcu to the oral formulation. Is that something that you were planning to do in a separate study?

Yeah. So ideally, this would be in the same study. So we would transition some to a low-dose oral. But we're working through the protocol currently. And the plan would be we do the first study as sort of a PK exploratory study and then followed up with a little bit longer-term study to look at longer-term maintenance effects.

Okay, great. Thanks, that’s super helpful. Appreciate taking the questions.

Thanks a lot, Jay.

And the next question comes from Annabel Samimy with Stifel. Please go ahead.

Hi, thanks for taking my questions. Just a couple for me. For the Phase 2 oral VENTURE trial, it looks like it's a pretty broad dose range still. And any reason why it's not more narrow? And at the highest dose, is that something that you'll realistically be pursuing? Or are you still just testing the maximum tolerability again?

Yeah. Thanks, Annabel. TBD on what the dose range would be in a subsequent study. We're just giving this one underway. But we really want to know when you treat for a longer period of time, do these lower doses continue to mature on body weight reduction. It looked like the lower doses did have that in the Phase 1 study, but it was so short and so small that it's really hard to tell. It does seem like as we get further accumulation with longer-term dosing, you should see this sort of maturing efficacy signal. But we haven't done the study yet, so we'll see how it out.

And at the highest dose, are you comfortable that you've tested maximum tolerability? Or are you just trying to push as broad a dose range as you can?

Yes. The Phase 1 study was very well tolerated at 100. We pushed a little bit higher here and we were okay to do that. So could we go even higher? I don't know. We only proposed 120. I think we could probably defend higher doses, but we balance that against the -- what we know about the accumulation rate as being slow and almost certainly, we're not at steady state at 28 days. So it's a balance where you pick that top dose. But 120 seems to be -- it will be an interesting dose to look at.

Okay. And then just as a follow-up, any updates on the manufacturing agreement and why it might be taking so long to finalize?

Yeah, spending a lot of time on manufacturing. We continue to work toward a comprehensive agreement or set of agreements. And the goal is really to enable the launch of a substantial commercial product and complicated discussions but making a lot of good progress, and we'll have more to say at the appropriate time.

Thank you.

Thanks, Annabel.

And the next question comes from Mayank Mamtani with B. Riley Securities. Please go ahead.

Yes, good afternoon. Thanks for taking my questions. And congrats on the operational progress. Just on the VENTURE oral Phase 2 study, I appreciate the rationale for choice of top dose selection there. Are you able to comment, Brian, on the 13-week weight loss expectation? And if you could also help us think about the cost of goods sold based on the manufacturing contracts you're working on to secure the API would be helpful. And then I have a follow-up.

Yeah. I'd say on both of those, a little too early to tell. We can't really predict where the weight loss might land after 13 weeks. When we look at the four-week graphs, you can see the trends continuing downward, but where do those go from here, it's really hard to predict. With COGS, it's -- I think it's premature to start discussing COGS as we're in a Phase 2 trial with the program. We certainly wouldn't want to target a product that isn't profitable though.

Okay. Got it. And then the concepts like weight regain or lean muscle mass preservation, any plans to study that as part of these Phase 2 studies, the oral and the once-monthly subcu? Or is that more TBD as those studies progress?

Well, the maintenance study that I think Jay asked about would be really to target weight regain. So that's where we dose people using the weekly regimen up to a high dose and then transition them to a monthly injection or a low-dose daily oral. And the primary objective is to understand how we regain manifests after you make that transition to either the monthly or the low-dose oral.

Lean muscle mass preservation is that more amylin focused?

No. We're -- we will do Dexas [ph] in the Phase 3 program, but no intention at this point to evaluate like our 5211 molecule for muscle preservation, but we will be doing Dexas -- I think everybody's doing Dexas in their Phase 3 programs on a subset of patients.

Got it. And lastly, on 2809 for NASH, obviously, you've been working through the post end of Phase 2 feedback and obviously, having strategic discussions. Is there any update to how maybe the counterparty feedback might be coming as obviously, there have been a slew of positive commercial and clinical updates in that space that could warrant a very positive return on investment? And maybe the complexity is not as bad as maybe it was thought a few years ago. Thanks again for my questions.

Yeah, sure. Well, hard to comment on discussions around partnering for really either of the assets. We had a very busy schedule at JPMorgan, and we're in the follow-up period now, but nothing further to say at this time on partnering. I think the overhang with the NASH program is the requirement for biopsies and that does complicate Phase 3 trials. But we'll see where some of the conversations lead.

Got it. Thank you.

Thanks, Mayank.

And the next question comes from Biren Amin with Piper Sandler. Please go ahead.

Yeah, hi, guys. Thanks for taking my question. Maybe let me just start with the monthly subcu dose study. Is the plan to evaluate the 10 and 15-milligram doses? And how are you thinking about timing of the start of the monthly subcu relative to the Phase 3 weekly subcu study?

Yeah, thanks. We're not going to disclose the doses until we get the study initiation. But we would intend to keep people on the weekly for probably four weeks before we transition them to the monthly. But all those details, we would disclose when we start the study.

Got it. And then maybe a follow-up question on the amylin program, what needs to be completed for IND submission this year?

Well, all of the IND-enabling work, particularly the tox work, but we hope to have that done to enable an IND filing this year.

Great. Thanks.

Thanks, Biren.

The next question comes from Hardik Parikh with JPMorgan. Please go ahead.

Hey, Brian. Thanks for all the updates toady. A couple of questions. First is on the subcu program. So I believe it was at our conference in January, where you announced that the first time that you would also be studying it in the type 2 diabetes plus obesity population. Was that originally part of your plan? Or was that more of a result of the FDA meetings you've had? And then the second one is on the oral program. You said data in the second half of the year. Is there any kind of thought process on whether that data would be headline data? Or could we see a full readout in the second half? Thank you.

Yeah. Thanks, Hardik. The data timing, generally, we report top line data when it's available. And then the final data are generally reported later. So when we have the key elements of the top line data set, which will probably be body weight change and safety profile, we would intend to release it. With the Phase 3 trial choices, the playbook there is -- it's not unique to us, it's generally a Phase 3 study in obese subjects. And then a separate Phase 3 study will be subjects with type 2 diabetes and the obesity studies, the larger of the two diabetes would be the smaller of the two. But that enables some discussion of glycemic control in the label.

Okay. And then just one more just follow-up on the amylin program. From the -- you're still deciding to which candidate you're going to kind of take forward. Is it possible that it could be one of those assets that you disclosed, I believe, back in ADA last year?

Yeah, it's possible. We have a number that looks really interesting, but that's possible, yeah.

Okay, thank you.

Thanks, Hardik.

The next question comes from Andy Hsieh with William Blair. Please go ahead.

Thanks for taking the questions. Just curious about your view on PK as data were presented at the ObesityWeek. So first, looking at the accumulation, I'm curious if there is like a multiple that you're looking for in the initial phase that would lend evidence to potentially longer dosing interval like you mentioned, the monthly dosing interval. And then also in terms of the plasma level, is there like a minimum that you're looking at the end of week four to give you confidence that the weight regain would be minimized?

Yeah. Good questions. The way we looked at -- starting with the second question, it seems as though when we look at that 2.5 mg dose over 13 weeks that leads to 9% weight loss, which is pretty good. So it feels like if you can maintain plasma levels in the neighborhood of that 2.5 mg dose after four weeks, four weeks from the prior dose, you're probably in a range that will prevent any significant weight gain. And so that's just kind of a high level the way we're looking at. And yeah, there's more numbers behind that, but that's kind of the way we consider it. With the accumulation, interesting when you look at the accumulation graphs, even the 5-milligram cohort after 13 weeks is still accumulating. And I think that speaks to the highly differentiated half-life we have that allows the accumulation to happen even though you've been fixed that 5-milligram dose for 10 weeks in that study, they're still an accumulation ongoing. So where does it go at higher doses, we're not quite sure, but I think it suggests that the 13-week data probably understate the long-term efficacy of what's possible.

And just a quick follow-up, Brian. I'm curious with the accumulation graph that you showed, would you be able to provide the follow-up period? So for example, like a 16-week follow-up with the accumulation PK? Or is that simply not measured in the VENTURE study?

Yeah. Well, that is actually the graph below it in the poster. When you look at the plasma level decay, that's over the following 7 weeks that would be 19 weeks total in that -- I mean, the final time point in that second graph would represent 19 weeks from day one of the study. If that makes sense.

Right, thanks right. Okay, that make sense. Okay, great. Thanks so much, Brian.

Thanks, Andy.

The next question comes from Yale Jen with Laidlaw & Company. Please go ahead.

Great. Thanks for taking the questions. And congrats on the progress. Just a few quick ones. The first is that for the Phase 3 study in terms of type 2 diabetes patients, would you also potentially seek a label on the diabetes alone or simply just a part of the obesity? Then I have a follow-up.

Yeah. Thanks, Yale. It's a great question. Really, we wouldn't be submitting a type 2 diabetes package for approval for treatment of type 2 diabetes. It's for inclusion in an obesity label in people with obesity and type 2 diabetes.

And a follow-up question here is that in terms of material preparing. Is auto injector part of that? And if so, what's the situation there?

Yeah. We do plan to introduce an auto-injector in the Phase 3 program. So we would anticipate the product to launch as an auto-injector.

And do you need to do a bridging study on that? Or that's not necessary if you don't start with auto injector for the Phase 3?

Yeah, we probably would do a bridging study just to make sure that we have bioequivalence with the auto-injector. So I think that would be the intention there.

Okay. Thanks a lot. And again congrats on all the progress.

Thanks a lot, Yale.

[Operator Instructions] Our next question comes from Justin Zelin with BTIG. Please go ahead.

Thanks for taking the question. And congrats on the updates here. Brian, I wanted to ask about the upcoming late stage oral, small molecule obesity readout in the field. And just your latest thoughts on the benefits associated with and the scalability of peptide API as compared to small molecules.

Yeah. So hard to predict the data upcoming. It's always -- I always do a bad job at that. But we'll wait for it just like everybody else. As far as scalability of peptides versus small molecules, I think there is some misperception out there that the small molecules are universally easier to make than peptides. That's -- I mean, I'm a small molecule chemists totally false, but I know that's the perception. Peptide chemistry is pretty simple. It's pretty low tech. It's scalability that is the challenge. The chemistry is not. And we're, I think, comfortable that we'll be able to produce scale that supports a multibillion-dollar franchise.

Thanks, Brian. Congrats again.

Thanks, Justin.

The next question comes from Fiona Jia [ph] with Jefferies. Please go ahead.

Hi, team. Thanks for taking our questions. And congrats on the quarter. So my question is on the amylin program. Can you just comment on the characterization of the compound that you selected? Because I seem to remember from ADA, most of the compound seem to follow a balanced profile. But I think there are like one or two that are more amylin biased. Can you comment on the like any characterization of the DC that you might select?

Yeah. All of them are -- well, we do have a range, but the ones that are of greatest interest are much more balanced more toward that one to one when you look at the -- I think we look at calcitonin to amylin three, pretty much one-to-one maybe up to 3 or 5 to 1, but as close as possible to one to one. I'm not sure that answers the question, but --

Yes, very helpful. Thank you.

This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Thank you very much for joining us today. We look forward to updating you again in the coming months. Have a good afternoon.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.