Viking Therapeutics Q1 2025 Earnings Report

Viking Therapeutics EPS Results

• Actual EPS: -$0.41
• Consensus EPS: -$0.31
• Beat/Miss: Missed by -$0.10
• One Year Ago EPS: -$0.26

Viking Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Viking Therapeutics Announcement Details

• Quarter: Q1 2025
• Date: 4/23/2025
• Time: After Market Closes
• Conference Call Date: Wednesday, April 23, 2025
• Conference Call Time: 4:30PM ET

Viking Therapeutics (NASDAQ:VKTX) is a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders. Headquartered in San Diego, California, the company’s pipeline leverages small-molecule approaches to target hormone signaling pathways implicated in conditions such as non‐alcoholic steatohepatitis (NASH), dyslipidemia, type 2 diabetes and muscle wasting disorders.

The company’s lead programs include VK2809, a thyroid hormone receptor‐beta agonist designed to reduce liver fat and improve lipid profiles in patients with NASH and dyslipidemia, and VK5211, a selective androgen receptor modulator (SARM) aimed at enhancing muscle mass and function in individuals with muscle wasting conditions. Viking conducts Phase 2 clinical trials for these candidates, evaluating safety, tolerability and efficacy across multiple patient populations.

Viking Therapeutics maintains operations across the United States, engaging with clinical research sites to enroll patients in its ongoing studies. The company also collaborates with academic institutions and regulatory agencies to advance trial designs and biomarker strategies that support its drug development objectives.

Under the leadership of President and Chief Executive Officer David A. Woodhouse, Viking has built a management team with extensive experience in endocrinology, metabolic disease and biopharmaceutical development. The company’s strategic focus remains on progressing its pipeline through clinical milestones and exploring opportunities to extend its proprietary technology platform into additional indications.

Viking Therapeutics Q1 2025 Earnings Call Transcript

Key Takeaways

• Phase III initiation on track: Viking plans to commence Phase III trials of its subcutaneous VK2735 obesity treatment later this quarter after positive Phase II results.
• Oral VK2735 Phase II enrollment complete: The 13-week oral tablet obesity study enrolled ~280 patients rapidly, reflecting strong clinician and patient interest.
• Manufacturing agreement secured: A long-term, large-scale API and fill-and-finish deal supports potential multibillion-dollar annual sales of VK2735 in both injectable and oral forms.
• Robust cash runway: $852 million in cash, equivalents, and short-term investments at quarter end provides funding for Phase III trials and other pipeline programs.
• Widening net loss: First-quarter net loss grew to $45.6 million versus $27.4 million a year ago, driven by higher R&D and G&A expenses.

Presentation

[Operator]

As a reminder, this conference call is being recorded today, April 23rd, 2025. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

[Stephanie Diaz, Manager of Investor Relations at Viking]

Hello and thank you 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, April 23rd, 2025, will contain forward-looking statements under the Safe Harbor Provisions of the U.S. Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines, 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.

[Stephanie Diaz, Manager of Investor Relations at Viking]

I'll now turn the call over to Brian Lian for his initial comments.

[Brian Lian, President and CEO at Viking]

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the first quarter ended March 31st, 2025, and provide an update on recent progress with our development programs and operations. In the first quarter of 2025, Viking continued to build upon the strong momentum achieved in 2024. In the past year, we announced positive data from four separate clinical programs, including our VK2735 subcutaneous program for obesity, our VK2735 oral tablet program for obesity, our VK2809 program for the treatment of MASH and fibrosis, and our VK0214 program for X-linked adrenoleukodystrophy. By any measure, 2024 was our most productive year to date, and this positive momentum has continued into 2025.

[Brian Lian, President and CEO at Viking]

During the first quarter, the company made great progress toward the initiation of Phase III trials for our subcutaneous VK2735 program, and we expect to commence these studies later this quarter. The company also announced the initiation of a Phase II trial evaluating the tablet formulation of VK2735 in subjects with obesity. Later in the first quarter, we announced the completion of enrollment in this trial. We believe this study's rapid enrollment reflects continued enthusiasm for our obesity program, and we look forward to announcing the results of the study later this year. Also, during the first quarter, Viking entered into a long-term, large-scale manufacturing agreement to support the future commercialization of VK2735 in obesity. The agreement provides for both API and fill-and-finish activities, which we believe will be sufficient to support a potential multi-billion dollar annual product opportunity.

[Brian Lian, President and CEO at Viking]

During the quarter, the company also made progress with its newest program evaluating a series of internally developed agonists of the amylin receptor, which have demonstrated improvements in body weight and metabolic profile in in vivo models. I'll have additional comments on our operations and development activities following a review of our first quarter financial results. For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

[Greg Zante, CFO at Viking]

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later this month. I'll now go over our results for the first quarter. Research and development expenses were $41.4 million for the three months ended March 31st, 2025, compared to $24.1 million for the same period in 2024. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, stock-based compensation, and salaries and benefits, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $14.1 million for the three months ended March 31st, 2025, compared to $10 million for the same period in 2024.

[Greg Zante, CFO at Viking]

The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, and insurance, partially offset by decreased expenses related to salaries and benefits. For the three months ended March 31st, 2025, Viking reported a net loss of $45.6 million or $0.41 per share, compared to a net loss of $27.4 million or $0.26 per share in the corresponding period of 2024. The increase in net loss for the three months ended March 31st, 2025, 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 2024. Turning to the balance sheet, at March 31st, 2025, Viking held cash, cash equivalents, and short-term investments of $852 million compared to $903 million as of December 31st, 2024.

[Greg Zante, CFO at Viking]

This concludes my financial review, and I'll now turn the call back over to Brian.

[Brian Lian, President and CEO at Viking]

Thanks, Greg. I'll now provide an overview of our pipeline programs and outline next steps for each, 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 prior phase 1 trial for the subcutaneous formulation of VK2735 demonstrated promising safety, tolerability, and pharmacokinetics, and treated subjects demonstrated up to approximately 8% weight loss from baseline after 28 days, with no signs of plateau. Following the successful completion of Phase I studies, we initiated a Phase IIa study called the Venture Study. This study evaluated 13 weeks of dosing with VK2735 in subjects with obesity. As we reported last year, the Venture Study successfully achieved its primary and secondary endpoints. Subjects receiving VK2735 achieved statistically significant reductions in mean body weight from baseline, ranging up to 14.7%.

[Brian Lian, President and CEO at Viking]

The 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 results, as well as additional results from follow-up visits conducted at four and seven weeks after completion of dosing, were highlighted in a presentation at ObesityWeek 2024, the annual meeting of the Obesity Society. The follow-up data showed that subjects receiving VK2735 maintained the majority of their weight loss through the seven-week follow-up visit. This included the 2.5 mg weekly dose, the lowest dose evaluated, for which over 90% of the initial weight loss was maintained seven weeks after the last dose was administered.

[Brian Lian, President and CEO at Viking]

In a subset of participants, an evaluation of plasma levels of VK2735 at various time points following completion of the 13-week dosing period was conducted. We believe the pharmacokinetic results support the potential for once-monthly dosing in the maintenance setting, and the company is planning to further evaluate a monthly dosing regimen later this year. Following the successful conclusion of the Phase II Venture Study and after receiving feedback from a Type C meeting with the FDA last summer, we made the decision to advance VK2735 into Phase III development for obesity. To this end, we requested an End-of-Phase II meeting with the agency, which took place in the fourth quarter of last year. The feedback from this meeting was extremely helpful in informing our overall development plan and, in particular, our Phase III plan for the program.

[Brian Lian, President and CEO at Viking]

Since the End-of-Phase II meeting, our team has been working diligently to prepare for the initiation of the Phase III trials, and we remain on track to initiate these studies later this quarter. In parallel with the advancement of the subcutaneous formulation of VK2735, Viking is also evaluating an oral tablet formulation. The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved. We believe a key differentiating advantage of our obesity program is that we have both a tablet formulation and a subcutaneous formulation that utilize the same molecule. These formulations create the potential to transition patients from one formulation to another with the possibility of reducing the risk of unexpected safety or tolerability challenges.

[Brian Lian, President and CEO at Viking]

We believe this represents a potentially valuable option for those with obesity and their clinicians. Viking's Phase I study for the oral formulation was a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kg/m². The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days, with secondary and exploratory objectives evaluating the pharmacokinetics of oral VK2735, as well as changes in body weight and other metrics. As with the Venture Phase II study, the oral Phase I trial successfully achieved its objectives. The data from this study showed that cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 days.

[Brian Lian, President and CEO at Viking]

Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day 57, four weeks after the last dose was administered. Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond 28 days may provide further reductions in body weight. The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 mg. The majority of observed treatment-emergent adverse events were mild or moderate, with most reported as mild. Similarly, all observed gastrointestinal adverse events were reported as mild or moderate, with the majority reported as mild. The results from this study were presented at the ObesityWeek conference last November.

[Brian Lian, President and CEO at Viking]

Following the successful conclusion of the Phase I study, in January of this year, Viking announced the initiation of a Phase II trial called the Venture Oral Dosing Trial in subjects with obesity. The Venture Oral Trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. In March, we announced completion of enrollment for this trial and that the trial had successfully met its enrollment objective, enrolling approximately 280 adults who are obese or adults who are overweight with at least one weight-related comorbid condition. Enrolled subjects have been evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment.

[Brian Lian, President and CEO at Viking]

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. We believe the rapid enrollment of this trial speaks to the continued high level of interest and enthusiasm for new weight loss options among both clinicians and their patients. We expect to report data from this study in the second half of 2025. Beyond our incretin program, last year at the annual meeting of the American Diabetes Association, we announced a new program evaluating a series of novel agonists of the amylin receptor. We believe activation of the amylin receptor represents an important additional mechanism related to appetite and weight management. Progress with our amylin program is continuing, and we expect to file an IND for the program later this year. Moving to additional corporate milestones, in the first quarter, we announced that we had entered into an important supply agreement related to the VK2735 program.

[Brian Lian, President and CEO at Viking]

This agreement provides for large-scale API manufacturing as well as fill-and-finish capacity for both the injectable and oral formulations of VK2735. With this important partnership in place, Viking believes it will have access to a commercial supply of API, autoinjectors, vial and syringe kits, and oral tablets sufficient to support a potential multi-billion dollar annual product opportunity. With respect to the company's financial position, as Greg indicated in his comments, Viking continues to maintain a strong balance sheet with more than $850 million in cash as of the end of the first quarter. This provides us with the runway to complete our planned Phase III trials for the VK2735 obesity program, as well as to aggressively pursue the clinical development of our additional programs. In other corporate matters, like many others, we are awaiting clarity on how the potential introduction of tariffs might impact our current and future operations.

[Brian Lian, President and CEO at Viking]

At this point, we expect minimal near-term impact across our development programs. As to the longer-term impact on potential commercial activities, it's too early for us to assess what the tariff environment may be at some point in the future. We look forward to these important negotiations being completed as soon as practicable. In conclusion, we are excited to report that the tremendous progress Viking made in 2024 has carried over into the first quarter of 2025. Following the company's most productive year-to-date, Viking made great progress preparing for the initiation of Phase III trials for subcutaneous VK2735, which are on track to begin in the second quarter. In the first quarter, we also announced both the initiation and completion of enrollment in our Phase II Venture Oral Dosing Trial.

[Brian Lian, President and CEO at Viking]

We believe that this study's rapid enrollment reflects the continued enthusiasm for our program, and we look forward to reporting data from this study in the second half of the year. With respect to our new amylin agonist program, we continue to make progress toward an IND filing, which we expect to submit later this year. Also, during the first quarter, we are happy to sign a broad multi-year manufacturing agreement to support the future commercialization of VK2735. This comprehensive agreement provides large-scale annual supply of API, as well as fill-and-finish capacities for both the injectable and oral product forms. Finally, our strong balance sheet allows us to continue to advance each of these programs effectively and aggressively, including through Phase III trials for the VK2735 obesity program and other key inflection points. This concludes our prepared comments for today.

[Brian Lian, President and CEO at Viking]

Thanks very much for joining us, and we'll now open the call for questions. Operator.

[Operator]

We will now begin the question-and-answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. Due to our limited time today, as well as the large queue for the Q&A, we respectfully request that everyone limit themselves to a single primary question and one follow-up question only. At this time, we will pause momentarily to assemble our roster. The first question comes from Joon Lee with Truist Securities. Please go ahead.

[Operator]

Hi, congrats on the quarter, and thanks for taking the questions. This is [Austin Ronald] on for June, just a couple from us. Is the Phase II Venture Oral readout going to include the four-week follow-up data, or will the top-line readout only include data with 13 weeks of dosing? As a follow-up, when do you plan on introducing the autoinjector into the Phase III and what are the plans and timing for a bridging study? Thank you.

[Brian Lian, President and CEO at Viking]

Yeah, thanks for the questions. For the top-line data from the oral study, we've historically reported the top-line data when they're available, and I would expect that's likely before the four-week follow-up data are available. Keep in mind, they'll be top-line data. With the introduction of the autoinjector, that will be as soon as we can introduce it. I would say that's most likely early next year, and we will be doing a bridging study with the vial and syringe comparing to the autoinjector in the interim.

[Brian Lian, President and CEO at Viking]

Thank you, Brian.

[Brian Lian, President and CEO at Viking]

Thanks.

[Operator]

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

[Mike Ulz, Executive Director and Biotechnology Equity Research Analyst at Morgan Stanley]

Good afternoon, and thanks for taking the question. Maybe just one on the Phase II Venture Oral data that you plan to share in the second half of this year. Just curious if there's a specific level of weight loss you're looking to achieve there, and how do you think about that level of weight loss at the lower doses versus the higher doses? Thanks.

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Mike. Hard to project. It's a larger study than the Phase I, but it's obviously dosing longer as well. I think if we can show 8% or so, which is what we showed at the high dose last time, if we can show that after 12 weeks, I think we'd have a competitive profile. Really hard to know prior to unblinding the data. With the lower doses, yeah, again, just really hard to prognosticate on what the efficacy might be. Hopefully, over time, as you see continued accumulation, you'll see those lower doses perform well. It's hard to tell.

[Mike Ulz, Executive Director and Biotechnology Equity Research Analyst at Morgan Stanley]

Great. Thank you.

[Brian Lian, President and CEO at Viking]

Thanks, Mike.

[Operator]

The next question comes from Ryan Deschner with Raymond James. Please go ahead.

[Ryan Deschner, Managing Director in Equity Research at Raymond James]

Hi, thanks for the question. Wondering how you're currently looking at the potential positioning of the DACRA candidate. If you were to evaluate its potential as a co-formulation with VK2735, how early in the clinical progression of this candidate would you do that? Thanks.

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Ryan. The first study there would be the typical SAD/MAD study like we did with the VK2735 program. We would like to evaluate a combination regimen as soon as we can, but that probably would not happen until next year sometime. We would like to understand the single agent profile first.

[Operator]

Thank you. We have the next question from Jay Olson with Oppenheimer. Please go ahead.

[Jay Olson, Managing Director and Senior Analyst at Oppenheimer]

Oh, hey. Congrats on the progress, and thanks for taking the questions. Are you planning to test oral VK2735 in other indications besides obesity, like type 2 diabetes? I had a follow-up question, if I could.

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Jay. The Phase III program will consist of one study in obese subjects and one study in obese diabetics. In that second study, those will be type 2 patients. We'll be looking at weight change and glycemic control, but that will give us a lot of really useful data, we think.

[Jay Olson, Managing Director and Senior Analyst at Oppenheimer]

Oh, okay. Great. Thank you for that. Can you share any comments on recent obesity deals, especially for novel targets and small molecules and assets coming out of China, and maybe comment on the overall level of strategic interest in the obesity space?

[Brian Lian, President and CEO at Viking]

Yeah, it's hard for us to comment on any BD-type discussions, but I'd say there continues to be high interest in the space, and I think we have a very attractive portfolio. Yeah, hard to give a lot of color on further discussions there.

[Jay Olson, Managing Director and Senior Analyst at Oppenheimer]

Okay. Fair enough. Thanks for taking the questions.

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Jay.

[Operator]

The next question comes from Hardik Parikh with J.P. Morgan. Please go ahead.

[Hardik Parikh, Equity Research Analyst at JPMorgan]

Hey, Brian. Thanks for the update today. I think in the past you've mentioned that you were sorting through some logistics before kind of initiating the Phase III for VK2735. I was just wondering if you could kind of provide us an update there. Are the remaining to-dos, are they more regulatory in nature, like with the FDA, or are they more internal operational items? The second part is, is there any chance that the initiation of the Phase III bleeds into 3Q? Thank you.

[Brian Lian, President and CEO at Viking]

Thanks, Hardik. Right now we plan to initiate the study in the second quarter, and there's no reason to think we can't do that. As far as what is happening in preparation for the study, primarily it's logistical, getting the supplies ready, getting the sites up and ready. A lot of different doses, there will be a titration scheme in the study, so having the proper number of doses labeled, manufactured, and prepared for administration, it's a big lift. It's a lot of people, a lot larger overall program than the Phase IIa study.

[Hardik Parikh, Equity Research Analyst at JPMorgan]

Okay. Thank you.

[Brian Lian, President and CEO at Viking]

Thanks, Hardik.

[Operator]

The next question comes from Mayank Mamthani with B. Riley Securities. Please go ahead.

[Mayank Mamtani, Senior Managing Director and Group Head of Healthcare Research at B. Riley Securities]

Yes, good afternoon. Thanks for taking our questions, and congrats on the progress, Brian, on multiple fronts. On the manufacturing side with CordenPharma, are you able to comment on what sort of COGS you're targeting in a steady state and maybe differences between peptide and oral and any metrics we should be looking at API per year or something like that? I have a quick follow-up.

[Brian Lian, President and CEO at Viking]

No, I think it's hard to talk about COGS. Those are pretty tightly—that's tightly held information. But I'd say we'll have margins that are consistent with other peptide products, nothing unusual about what the margins might be. The scale of the manufacturing agreement is large, and there are tiers to pricing as scale increases. We think that's very favorable to us, but unable to give a lot of granularity on the specific price points.

[Mayank Mamtani, Senior Managing Director and Group Head of Healthcare Research at B. Riley Securities]

Okay. Nothing between the peptide versus oral? On the oral study, quickly, Brian, remind us of the objective for this 30 mg maintenance that you have in follow-up to the 90 mg cohort you're doing, and maybe just help us understand how to think about that data versus, say, a regular 90 mg that you're doing versus the higher dose, 120 mg. We're just trying to understand why you're doing the 30 mg maintenance. Thanks for taking the question.

[Brian Lian, President and CEO at Viking]

Yeah, sure. With that step down, you titrate up to 90 mg, and then I think people stay there for four weeks or so, and then you come down to 30 mg for the five remaining weeks. That is really to understand if you can come down from a high dose to a lower dose and prevent weight gain. It is sort of just a quick and dirty test on low-dose maintenance. We think it should provide sufficient drug to prevent weight gain. We have always thought the oral would be well utilized in a low-dose maintenance setting. Once you have lost weight down to some target range, you can transition potentially to a monthly injection or to a daily low-dose oral. This is just one way to understand that possibility a little bit better. I mean, it would be even better if weight loss continues, which is a possibility.

[Brian Lian, President and CEO at Viking]

I think our goal here is to understand if at least we prevent weight regain.

[Mayank Mamtani, Senior Managing Director and Group Head of Healthcare Research at B. Riley Securities]

Got it. Thank you.

[Operator]

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

[Annabel Samimy, Managing Director and Senior Research Analyst at Stifel]

Hi. Thanks for taking my question. Appreciate it. Just as far as the Phase III for the injectable, do you have a better sense of how you might incorporate the question of durability? I think you mentioned you're going to look at a monthly later on in the year, but is it possible it's going to be incorporated into the Phase III trials? For the autoinjector, you also said you're going to be conducting a bridging study. Does autoinjector need to be incorporated into the Phase III study in any way?

[Brian Lian, President and CEO at Viking]

Thanks, Annabel. Yeah, the autoinjector, we'll introduce the autoinjector into the Phase III, which is why we're doing the comparative study from the vial and syringe to the autoinjector. That's the reason for that comparison study. As far as the monthly regimen, first step there is to do the initial study, which will involve a titration upward using the weekly regimen to some high dose level, and then transition people onto the monthly regimen. Whether or not we would introduce that into the Phase III program is TBD. Right now, the Phase III protocols do not incorporate that. If there were an extension study or something like that, maybe that's a possibility to incorporate the monthly.

[Annabel Samimy, Managing Director and Senior Research Analyst at Stifel]

Got it. As a follow-up, with dosing for the oral, if all of these doses are tolerable, will you likely keep the doses or start to pare them down as you move into Phase III?

[Brian Lian, President and CEO at Viking]

Yeah, I think we'll have to see what the data look like. I think it's premature to pick doses now when we haven't seen any of the Phase II data.

[Annabel Samimy, Managing Director and Senior Research Analyst at Stifel]

Okay. Thank you.

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Annabel.

[Operator]

Our next question comes from Roger Song with Jefferies. Please go ahead.

[Roger Song, Senior Equity Research Analyst at Jefferies]

Great. Thanks for taking our question and for the update. Regarding the Phase III, the subQ, can you comment on the potential design of the Phase III, how different and similar to other OPC trials have been conducted? Regarding the amylin, what is the potential target profile you try to get before the IND, given we already see some preclinical data, how much better you want to see for your amylin? Thank you.

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Roger. With the Phase III trials, we'll announce all the details as we initiate the studies. I would say they'll conform to guidance. That is a minimum of 4,500 people total across the two studies, one in obese subjects, one in obese diabetics, and 52 weeks of post-titration treatment. As far as the doses and titration schemes, things like that, we'll wait to start the studies before we provide any further color on those. With the amylin program, we've done a lot of work with a lot of different compounds, looking at various combinations and formulation work to understand the best amylin candidate to bring forward. That took quite a while, but I think we have a really interesting compound. We'll bring that into the clinic. It'll be a weekly long-acting amylin.

[Brian Lian, President and CEO at Viking]

We'll bring that into the clinic, hopefully, by the end of the year.

[Roger Song, Senior Equity Research Analyst at Jefferies]

Thank you.

[Brian Lian, President and CEO at Viking]

Thanks, Roger.

[Operator]

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

[Andy Hsieh, Research Analyst at William Blair]

Thanks for taking our questions, and congratulations on the progress. For the maintenance study that you're contemplating, I'm curious about the design frameworks you're considering. Looking across some of the obesity studies with the maintenance components, like a ATTAIN-MAINTAIN with tirzepatide and orforglipron, TRIUMPH-6 with retatrutide, none of them actually use the same compound transitioning from subQ to oral. We're just curious, what parameters would you like to explore, such as longer interval, lower doses? Do you need to reach some sort of plateauing before the transition?

[Brian Lian, President and CEO at Viking]

Yeah. Yeah, thanks, Andy. Plateau on exposures or body weight, are you referring to?

[Andy Hsieh, Research Analyst at William Blair]

Oh, body weight. Basically, some sort of plateau in body weight and then transition to the maintenance phase of that part of the study.

[Brian Lian, President and CEO at Viking]

Yeah. No, no. Great question. Yeah. No, I don't think we'd want to wait for the plateau because I don't know when that might happen. It might happen quite a bit later. We would like to be able to titrate up to some elevated dose and then explore a less frequent regimen at a variety of doses, and then also look at transition to an oral regimen as well. We'll get a lot of information from that study.

[Andy Hsieh, Research Analyst at William Blair]

Cool. That's helpful. Maybe a commercial question. I know this is maybe several years away, but with the success of LillyDirect and also the complexity associated with contracting for rebates and discounting, I'm curious if direct-to-consumer model for the obesity market is already substantial and sufficient for kind of a standalone Viking to take a look at without going through all the complexity of negotiation, price negotiation, and that kind of stuff.

[Brian Lian, President and CEO at Viking]

Yeah. Yeah, Andy, it's a really great question. I think in normal times, it probably would be more challenging. What we've seen with the introduction of these compound pharmacies and these other direct-to-consumer models that do not have any sales force, that is a viable channel. You're right. It's a little early for us to make a decision like that. The viability of that sort of model is proven now. It gives us optionality, and it just opens different avenues to market the product.

[Andy Hsieh, Research Analyst at William Blair]

Great. One more, if I can squeeze in. Basically, the learnings that you gain from advancing VK2735, including potentially longer half-life, low Tmax, oral formulation, how much of that can be applied to your amylin program?

[Brian Lian, President and CEO at Viking]

Yeah, it's a good question. We do think the amylin probably are amenable to oral formulation. I think that's really interesting. The half-lives, I mean, each compound is a little different. The amylin is obviously a different peptide than the dual agonist. I don't know that you can translate a whole lot since the molecules are different. We do think the PK profile is supportive of a weekly regimen. Other than that, I guess since it's a different molecule, it's hard to translate a lot.

[Andy Hsieh, Research Analyst at William Blair]

Got it. That's super helpful. Thank you so much, Brian.

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Andy.

[Operator]

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

[Biren Amin, Managing Director and Senior Research Analyst at Piper Sandler]

Yeah, thanks, guys, for taking my questions. For the oral VK2735 program, is the formulation locked down, or are you doing any more formulation optimization work?

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Biren. We're always doing additional experimentation with the formulations. I think right now, we're pretty set with this formulation. We may make a minor change to the formulation, but nothing that would be, I think, considered too significant.

[Biren Amin, Managing Director and Senior Research Analyst at Piper Sandler]

Got it. For the monthly subQ regimen that you're hoping to test in a trial later this year, can you maybe disclose how many patients, what type of treatment duration? Is it a three-month study? I assume that you would need to run a separate Phase III with that regimen later on?

[Brian Lian, President and CEO at Viking]

Yeah, we don't know what the subsequent study would be. It would either be a dedicated longer Phase II or a Phase III. Not clear yet. As far as the number of doses, we haven't disclosed that. The first study would be more of a PK study to look at exposures and what do the exposures look like when you transition someone from a weekly regimen to a monthly regimen. You're thinking not 50 or 60 per arm, a lot lower than that, more like a PK study. As far as the overall number in the study, we'll disclose that once we start the study. Duration, it's going to take a little while to get up to the top doses. There is a titration element there. You can't just start people at the monthly dosing load.

[Brian Lian, President and CEO at Viking]

I would say probably a little longer than three months.

[Biren Amin, Managing Director and Senior Research Analyst at Piper Sandler]

Perfect. Thank you.

[Brian Lian, President and CEO at Viking]

Thanks, Biren.

[Operator]

The next question comes from Thomas Smith with Leerink Partners. Please go ahead.

[Thomas Smith, Senior Research Analyst at Leerink Partners]

Hey, guys. Good afternoon. Thanks for taking the questions. Just with respect to the Phase II Venture oral study, congrats on the rapid enrollment. I was wondering if you could comment at all on the baseline characteristics of the patients you've enrolled there and how that compares to the Phase II Venture study for injectable VK2735.

[Brian Lian, President and CEO at Viking]

Great question, Tom. I have not looked at the demographic data there. What we've seen in the past is that the body weights are right around 100 kg. The BMIs are in the mid-30s. I have no reason to believe this trial would be different. I don't know. I just haven't looked at that information.

[Thomas Smith, Senior Research Analyst at Leerink Partners]

Understood. And then just a follow-up, if I could, on the manufacturing and supply front. Appreciate the scale of the CordenPharma deal. But could you comment on whether you think you need additional commercial capacity or redundancy and what the plan would be for that? Thanks.

[Brian Lian, President and CEO at Viking]

Yeah, yeah. No, great question. We do plan to have redundancy across all elements of the supply chain. That is partly in anticipation of demand, but also just as a safety mechanism to have a backup in case something unexpected were to happen. We do expect to put in place redundancies across the board.

[Thomas Smith, Senior Research Analyst at Leerink Partners]

Got it. That makes sense. Thanks for taking the questions.

[Brian Lian, President and CEO at Viking]

Okay. Thanks, Tom.

[Operator]

The next question is from George Farmer with Scotiabank. Please go ahead.

[George Farmer, Managing Director at Scotiabank]

Hi. Thanks for taking my questions. Brian, can you comment on your level of comfort with any food effect or liquid effect on absorption of 2735 and that you need to engage in any further exploration, or has that been part of future studies?

[Brian Lian, President and CEO at Viking]

Yeah, thanks, George. We have not done a food effect study. We will do a food effect study. It is a large molecule, so I would certainly expect there to be a food effect. We have not done the study at this point.

[George Farmer, Managing Director at Scotiabank]

Okay. So you're comfortable with that understanding right now before going into any additional studies, do you think? Or is that just something that'll be elucidated on the outcome of Phase II?

[Brian Lian, President and CEO at Viking]

Yeah, we'll elucidate that after we're done with the Phase II. We have to see what the profile looks like in the Phase II study first.

[George Farmer, Managing Director at Scotiabank]

Okay. Do you expect any sort of competition for API starting materials with Lilly and Novo, certainly as Lilly starts scaling up manufacturing of tirzepatide, for you guys to have adequate supply of VK2735 going forward?

[Brian Lian, President and CEO at Viking]

Yeah. When we talk to suppliers about that, we have not had anyone raise any alarms on starting materials being in short supply. I do not know, but no one has mentioned that to us. It seems like the starting materials should be available as we scale up.

[George Farmer, Managing Director at Scotiabank]

Okay. Thanks.

[Brian Lian, President and CEO at Viking]

Thanks, George.

[Operator]

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

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Good afternoon. Thanks for taking the questions. Just like to see what do you anticipate when you start Phase III, how many current cases you already prepared, and what might be the ultimate number of sites as the study progresses. Another follow-up question here is that any status report in terms of the partnering of either VK0214 or VK2809? Thanks.

[Brian Lian, President and CEO at Viking]

Yeah, thanks, Yale. With the thyroid programs, both are available for licensing. We are always receptive to interests in those programs. There is some interest in the programs. We just do not give a lot of detail on anything that is ongoing. With the Phase III footprint, hard to give a lot of details on the number of sites. Obviously, big studies. Both of the studies are large. They will use a lot of the same sites. They will use a fair amount of independent sites for each study as well. We have not disclosed the number of patients or the number of sites or anything like that at this point.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay. Great. Thanks, and congrats on the progression.

[Brian Lian, President and CEO at Viking]

Thank you.

[Stephanie Diaz, Manager of Investor Relations at Viking]

The next question comes from Jeet Mukherjee with BTIG. Please go ahead.

[Jeet Mukherjee, VP and Biotechnology Analyst at BTIG]

Great. Thanks for taking the questions. Two from me. Just given the good maintenance of weight loss you saw in the Phase I oral study, are you meaningfully evaluating dosing regimens longer than once a day for that? The second question was just around thoughts of pace of enrollment in your Phase III trials given the rapid enrollment you saw in the Phase II oral study. Thank you.

[Brian Lian, President and CEO at Viking]

Yeah, yeah. Thanks, Jeet. With the pace of enrollment in Phase III, much larger studies. It is encouraging to see the speed of enrollment and the continued high level of interest among study participants and clinicians. Hopefully, that continues in Phase III. We will not know until we really get it up and running. With the oral kind of persistence of effect in the Phase I study, it is something that we would like to explore in the upcoming maintenance study. We will likely explore something less frequent than a daily dose in that study.

[Operator]

Thank you. At this time, we must end the call. The company apologizes for those questions that we were unable to answer here. I would now like to turn the conference back over to Stephanie Diaz for any closing remarks.

[Stephanie Diaz, Manager of Investor Relations at Viking]

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Thank you.

[Operator]

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

Participants

Analysts

• Ryan Deschner, Managing Director in Equity Research at Raymond James
• Mike Ulz, Executive Director and Biotechnology Equity Research Analyst at Morgan Stanley
• Biren Amin, Managing Director and Senior Research Analyst at Piper Sandler
• Thomas Smith, Senior Research Analyst at Leerink Partners
• Brian Lian, President and CEO at Viking
• Andy Hsieh, Research Analyst at William Blair
• Greg Zante, CFO at Viking
• Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company
• George Farmer, Managing Director at Scotiabank
• Hardik Parikh, Equity Research Analyst at JPMorgan
• Jeet Mukherjee, VP and Biotechnology Analyst at BTIG
• Mayank Mamtani, Senior Managing Director and Group Head of Healthcare Research at B. Riley Securities
• Roger Song, Senior Equity Research Analyst at Jefferies
• Stephanie Diaz, Manager of Investor Relations at Viking
• Annabel Samimy, Managing Director and Senior Research Analyst at Stifel
• Analyst at Truist Securities
• Jay Olson, Managing Director and Senior Analyst at Oppenheimer