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Viking Therapeutics, Inc. (VKTX)

Q4 2025 Earnings Call· Wed, Feb 11, 2026

$32.79

-0.61%

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Transcript

Operator

Operator

Welcome to the Viking Therapeutics Fourth Quarter and Full Year 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, February 11, 2026. I would now like to turn the call over to Viking's Manager of Investor Relations, Ms. Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz

Analyst

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 11, 2026, 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.

Brian Lian

Analyst

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the fourth quarter and full year ended December 31, 2025, and review recent progress with our development programs and operations. 2025 was another strong year for Viking, with the company achieving multiple important milestones with our expanding obesity pipeline. With the subcutaneous formulation of our lead molecule, VK2735, following the positive efficacy, safety and tolerability data generated from our Phase II VENTURE study, Viking initiated its Phase III VANQUISH clinical program in obesity. The Phase III VANQUISH program includes 2 studies. VANQUISH-1 is evaluating the treatment of adults with obesity, and VANQUISH-2 is evaluating the treatment of adults with obesity and type 2 diabetes. In the fourth quarter, we announced completion of enrollment ahead of schedule in VANQUISH-1. Enrollment in VANQUISH-2 is nearing completion. With respect to our oral VK2735 program, in the third quarter of last year, the company announced positive top line results from the Phase II VENTURE oral dosing study in patients with obesity. This trial successfully achieved its primary and secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. We recently completed an end of Phase II meeting with the FDA regarding next steps with the oral formulation and are excited to advance this program further into development. Other important milestones achieved during 2025 include the initiation of a maintenance dosing study with VK2735 to assess the effect of various maintenance regimens, including monthly subcutaneous dosing, daily oral dosing or weekly oral dosing. Earlier in the year, Viking also signed a comprehensive manufacturing and supply agreement with CordenPharma to support the potential commercialization of VK2735. Under the terms of the agreement, CordenPharma will provide large-scale supply of active pharmaceutical ingredients, as well as fill and finish capacities for both our subcutaneous and oral formulations. We believe this agreement provides supply potentially sufficient to support a multibillion-dollar revenue opportunity. Also during the year, the company continued to add key staff in clinical, supply chain and manufacturing roles, and we recently announced the appointment of Neil Aubuchon as the company's Chief Commercial Officer. In this role, Neil will oversee the development and execution of our commercial strategy. I will have additional comments on our operations and development activities following a review of our financial results for the fourth quarter and year ended December 31. With that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Gregory Zante

Analyst

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, 2025, beginning with the quarter. Research and development expenses were $153.5 million for the 3 months ended December 31, 2025, compared to $31 million for the same period in 2024. The increase was primarily due to expenses related to running 2 Phase III clinical trials, stock-based compensation and salaries and benefits, partially offset by decreased expenses related to manufacturing for our drug candidates and preclinical studies. General and administrative expenses were $11.3 million for the 3 months ended December 31, 2025, compared to $15.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation. For the 3 months ended December 31, 2025, Viking reported a net loss of $157.7 million or $1.38 per share compared to a net loss of $35.4 million or $0.32 per share in the corresponding period in 2024. The increase in net loss for the 3 months ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income compared to the same period in 2024. I'll now go over the results for the full year ended December 31, 2025. Research and development expenses were $345 million for the year ended December 31, 2025, compared to $101.6 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits, regulatory services and consultants, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $48.4 million for the year ended December 31, 2025, compared to $49.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation, insurance and salaries and benefits. For the year ended December 31, 2025, Viking reported a net loss of $358.5 million or $3.19 per share compared to a net loss of $110 million or $1.01 per share in the corresponding period in 2024. The increase in net loss for the year ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income compared to the year ended December 31, 2024. Turning to the balance sheet. At December 31, 2025, Viking held cash, cash equivalents and short-term investments of $706 million compared to $903 million as of December 31, 2024. This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian

Analyst

Thanks, Greg. In 2025, Viking made significant progress 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 insulin atrophic polypeptide, or GIP receptor that has demonstrated promising efficacy, safety and tolerability across multiple clinical trials. Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity. During 2025, we continued to advance both of these formulations further into development. We also initiated a novel study designed to explore maintenance dosing with this compound. With respect to the subcutaneous VK2735 program, the company's prior Phase I and Phase II studies both demonstrated impressive weight loss and encouraging safety, tolerability and pharmacokinetics following weekly dosing in subjects with obesity. In the Phase I study, participants receiving VK2735 demonstrated up to approximately 8% weight loss from baseline after 4 weekly doses with no signs of plateau. The company's subsequent Phase II VENTURE study demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% after 13 weekly doses with no signs of plateau. 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, resolved quickly and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-1 receptor. These results were highlighted in a presentation at the 2025 ObesityWeek Conference in November. The final results were also published last month in Obesity, the peer-reviewed Journal of the Obesity Society. Following the VENTURE study, the company completed a Type C meeting with the FDA as well as an end of Phase II meeting to discuss next steps with the subcutaneous…

Operator

Operator

[Operator Instructions] Please note that we have a large number of participants in the queue. The company will do its best to answer as many questions as possible. Our first question will come from Steve Seedhouse with Cantor Fitzgerald.

Unknown Analyst

Analyst

This is [ Timur Vanica ] on for Steve. Congratulations on the oral program advancement to Phase III. So first, could you talk about whether you will also need to run a Phase III study in patients with diabetes? And then, did you receive any feedback from the FDA on improving nausea rates even in the placebo arm, perhaps to lower the nausea rates with extended titration regimen?

Brian Lian

Analyst

Thanks for the questions. We're probably not going to get into too many details with respect to the specifics of the communication from the FDA, but I think we feel pretty comfortable with the transition into Phase III. What was the first part of that question again?

Gregory Zante

Analyst

Phase III.

Brian Lian

Analyst

Oh, yes, yes. So we'll talk about all the design elements as we get closer to launch. But you might imagine that it would parallel the VANQUISH-1 and VANQUISH-2 overall design paradigm.

Operator

Operator

The next question will come from Joon Lee with Truist Securities.

Joon Lee

Analyst

A lot's changed in the obesity space since you embarked on the Phase III program, including the growing influence of [ row and HIS ]. Does this change your go-to-market strategy? And would you consider partnering with either [ Row or HIMS ] or someone like them to help sell 2735? And also, we appreciate that you don't need an outcomes trial in obesity, but since the competition has, they have outcomes data, would you need to generate outcomes data to be reimbursed by payers? Or would your focus be more on the cash paying patients? And by the way, does the $700 million in cash cover the expense for developing oral 2735?

Brian Lian

Analyst

Thanks, Joon. A lot to unpack there. I'll go through the first part and then let Neil comment on the commercial strategy. What was the -- yes. Yes. As far as partnering, there are a lot of different options available to us. And I think those companies are -- they provide a pretty good avenue to access the market, but probably not something that we're going to disclose at this point. But a lot of different options available to us. Neil, do you want to add to that? Our new Chief Commercial Officer is here.

Unknown Executive

Analyst

Yes. Thanks, Joon. Look, I think there's -- what I always say on this is that there are some disadvantages with being a small company, but there's also some advantages. And as you point out, things are changing very, very rapidly. And we're starting here really from a blank slate. And so that we can take a look at the market with a blank slate mentality and think about where it's heading not just today, but where it's going to be a couple of years from now and optimize our commercial strategy accordingly. So as Brian said, we wouldn't disclose what that strategy is at this moment. But suffice to say that we're looking at all options and all channel possibilities and deciding what's going to be the right approach for us. But the fact that we have flexibility is something that is an advantage for us for sure.

Brian Lian

Analyst

And you're right to say, Joon, that the space is really evolving on a weekly basis. And so what might look attractive today might be different when we're getting set to launch. I mean I think 2 years ago, people probably wouldn't have given a lot of credence to the compounding avenue or some of these other partnering opportunities, where now, they're very important players in the space. So rapid evolution here, and we'll be able to, I think, adapt quickly to whatever the market dictates at that time.

Gregory Zante

Analyst

And Joon, on the cash front, yes, the short answer is we do have sufficient cash to get through 3 major catalysts, including the upcoming maintenance trial, data from our Phase III subcu trials. And also, yes, the oral Phase III trials get into top line data, we are sufficiently funded to get there.

Operator

Operator

Your next question will come from Hardik Parikh with JPMorgan.

Hardik Parikh

Analyst

Congratulations on the update so far. I was just wondering on the Phase III, I understand you can't give much detail there. I was just wondering on the design of actual tablet itself. I remember in the Phase IIa program, you guys used tablets that were in 30-milligram increments. Would you consider anything different here for the design of the tablet itself for Phase III?

Brian Lian

Analyst

Yes. That's a good question, Hardik. Yes, and again, like you mentioned, we'll give all details at the appropriate time. But the tablet size and tablet count were a little high in that Phase II study. We learned a lot from that. So we'll be reducing both of those in the upcoming Phase III program, both the size and the count.

Operator

Operator

Your next question will come from Andy Hsieh with William Blair.

Tsan-Yu Hsieh

Analyst

So maybe 2 parter, if you don't mind. For the maintenance study, I'm curious about your view on successes. I mean, there's a lot of different scientific questions you're asking. But just in light of ortho with the [ attainment can ] actually gaining 5 pounds, I'm just curious about your view on what success looks like? Second part, it has to do with the Phase III trial. I know you kind of frame it as an oral Phase III trial, but is it possible to include, let's say, like a subcu arm that basically titrate patients until the maximum weight loss is obtained and then transition to the oral, basically uncovering a longer-term maintenance dosing strategy?

Brian Lian

Analyst

Yes. Thanks, Andy. Really good questions. What does success look like? Well, we look at 3, I guess, major buckets there. Everybody titrates up to this high weekly level. And then you have some people transitioning to monthly injections, some transitioning to every other week injections, some transitioning to oral daily and some transitioning to oral weekly. So after that transition to the maintenance period, I think the best case scenario would be you see a continued progression of weight loss. That would indicate that you could continue on after the initial weekly dose and continue to lose weight with a less frequent dosing regimen. I think the base case is that you would stay flat and prevent weight regain once you've into the maintenance portion of the study. And then obviously, the least desirable -- although it will depend on the data -- the least desirable would be a rebound following the transition. I think we're favorably positioned there because of the extended half-life. So I think we should have good coverage at the doses we're exploring to activate the receptors through the course of the month, but we won't know. I think an important question also is when you reduce the frequency and you are still at that elevated dose, do you reintroduce any sort of GI signal. And what we've seen from other agents being dosed less frequently is that seems to be less of a risk than maybe we thought earlier on. As far as the -- sorry, the transition for what the maintenance or the extension window might look like in the VANQUISH studies, yes, we're not sure. We'd like to see these data and then let that drive what the extension window might look like. I mean right now, the extension in the VANQUISH studies allows people who are on placebo to continue on and be guaranteed access to therapy. But if we see something really intriguing in the maintenance study, we may have some options to introduce a less frequent dosing regimen or other regimen into that maintenance window for the VANQUISH study. So I think you were asking more about the oral Phase IIIs, but we may have an opportunity to do something creative in the extension for the VANQUISH studies.

Operator

Operator

Your next question will come from William Wood with B. Riley Securities.

William Wood

Analyst

Congratulations on a very nice quarter and year for that matter. Just curious in terms of your Phase I maintenance, it looks like you've split your 15 mg once every month into a once every 2 weeks dosing. And so I'm just kind of curious on what the decision was behind that in terms of PK modeling and then also potentially just sort of GI, how that may actually lead to further insight on what you can do with maintenance?

Brian Lian

Analyst

Yes. Thanks, William. Yes, we originally planned to do the 15 mgs once monthly. Once we got the trial underway, we started receiving more and more of these comments from investigators and just from our own market research that people were going to less frequent regimens every 2 weeks, every 3 weeks. And we thought, well, since we've got the study up and running, we could split that 15 into [ 27.5 ] and get an answer at a lower every other week maintenance dose. And we didn't have an every other week regimen in there. So it seemed like an opportune time to make a slight adjustment there while retaining those higher dose -- higher strength of monthly doses.

William Wood

Analyst

And then also just maybe thinking about the end of Phase II outcome and sort of the Phase III trials coming up. When we say trials, should we expect 1? Or do you think we can probably get -- or do you think it will be more 2? And then in terms of size, do you think we can get a reduced size sort of based on what we are -- since it is the same molecule based on what we've seen in the VANQUISH trials?

Brian Lian

Analyst

Yes, great question. As I said earlier, probably it's going to look like the VANQUISH program. So I think you could do a single study and have diabetes patients in there as well, but it's likely cleaner to keep them separate and do 2 studies. And your point about same molecule, that's a really important point. And you might imagine that, yes, we would be able to leverage some of the data generated in the subcu program to reduce the overall size of the oral Phase III program, and that's very important to leverage some of those data.

Operator

Operator

The next question will come from Roger Song with Jefferies.

Jiale Song

Analyst

Great. Congrats for the update. I understand that you will give us more detail around the Phase III oral design. Just curious about the thinking around the duration. Given you -- this is oral [ map ], do you think about [indiscernible] can test this a little bit shorter than the VANQUISH right now, maybe making this [ order ] and the subcu can get to the Phase III result relatively close and get those 2 into the label and approval in the relatively similar time fashion? And another question is anything you need to finish or generate before you start the Phase III oral in 3Q?

Brian Lian

Analyst

Yes. Thanks, Roger. Really good questions. I think good point. The trial duration we expect in the oral program will likely be not as long as the VANQUISH study. So you could see a reduction in the length, possibly. You could see a reduction in the size, and you might see a reduction in the intensity of clinic visits. And all of those might speak to a cheaper and more efficient execution on the Phase III program orally -- oral Phase III program. And that might compress that window from the availability of all of the subcu Phase III data and the oral Phase III data. Likely still be separate filings, but I wouldn't anticipate that as being a dramatic delay between the 2, given the efficiencies of the oral program.

Jiale Song

Analyst

Got it. Anything -- any data you need to generate before you start the Phase III oral in 3Q?

Brian Lian

Analyst

No, nothing that's really gating there. No.

Operator

Operator

Your next question will come from Annabel Samimy with Stifel.

Annabel Samimy

Analyst

Just a question on the maintenance studies, I want to drill down a little bit more. Do you expect that we can get a good sense of oral tolerability from the maintenance study? Anything with the injectable to the oral arm that could give us an idea of GI effects? Or do you expect that given that these patients were already on the injectable GLP, GIP, they wouldn't really have those tolerability effects? So I guess, what are your expectations with the tolerability there?

Brian Lian

Analyst

Yes. Thanks, Annabel. I would expect the tolerability to be pretty good. You're coming off these higher subcu doses which give really high exposures to an oral dose that is a fairly low oral dose than the exposures are lower with the tablet anyway. So I would expect to see minimal GI side effects. But it's possible, but I guess it would be a surprise to see something significant there.

Operator

Operator

Your question will come from Biren Amin with Piper Sandler.

Biren Amin

Analyst

Maybe just to start on the oral Phase III program. Have you gained agreement with the FDA on patient numbers and duration for the oral Phase III trial? So maybe that's the first question. And second question, on the supply of oral 2735 for the Phase III, is that readily available? Or are you going to need to make supply? Is that the gating item for starting the trial in Q3?

Brian Lian

Analyst

Yes. Thanks, Biren. We have a constant chain of supply moving through at different stages. So we wouldn't anticipate there to be a real challenge on the supply side. I mean, obviously, all these things are difficult, but we don't think supply is really going to be an issue there. It takes a little while to make it, but it's -- we shouldn't have any shortages or anything like that. As far as the sizes of the studies, I mean, we, of course, outlined our anticipated clinical development plan to the FDA, and we feel comfortable with the responses that we're okay to proceed at the design level that we presented.

Biren Amin

Analyst

Perfect. And then maybe if I could just have a couple of follow-ups. Can you talk about the status of the auto-injector and when you plan to introduce that into the VANQUISH studies? So that's first. And then on the amylin, when can we expect the Phase I to start given IND filing later this quarter? And could we expect Phase I data later this year? And what does that look like?

Brian Lian

Analyst

Yes. Thanks. The auto-injector, we did complete the bioequivalent study since our last quarterly update. It was a great study, turned out very positive for us, and we anticipate introducing the auto-injector this quarter. So that went according to schedule. As far as the amylin agonist, later in the quarter, we'll file the IND. And if we're able to proceed, and I would expect that we should be able to -- probably, the first dosing would occur in the second quarter. A little early to say just yet, but that's probably the likely timing. And it would parallel the VK2735 clinical program where we start with the SAD study, a single ascending dose study and then proceed to a multiple ascending dose study. So I would say if any data are available, likely be later in '26 for the stat portion.

Operator

Operator

The next question will come from Mike Ulz with Morgan Stanley.

Rohit Bhasin

Analyst

This is Rohit on for Mike. Can you just talk about any read-throughs to oral VK2735 from the strong early uptake of Novo's oral Wegovy? And then secondly, in regards to R&D spend, should we consider the quarterly spend the new norm moving forward?

Brian Lian

Analyst

Yes. Thanks, Rohit. Good question. I think we've seen now with the oral peptide uptake, it's the fastest drug launch in history. So I think that bodes well for anybody developing an oral peptide. And for that compound, in particular, it sort of puts to bed -- we hope puts to bed this nonsense around how bad 30 minutes is to consume anything. And it's just kind of a joke that that's a big deal.

Gregory Zante

Analyst

And on the quarterly cash usage, I think -- you can think about it will range a bit as we move forward here between likely $60 million and $90 million per quarter. So that's about all I could say about that. So a range in that window there.

Operator

Operator

The next question will come from Thomas Smith with Leerink Partners.

Thomas Smith

Analyst

Congrats on the progress. Now that you have the maintenance study fully enrolled, are there any notable differences you'd highlight here specifically on the baseline characteristics relative to the VENTURE subcu or the oral studies? And then maybe a follow-up on the amylin program. Is this going to be a similar design and execution out of Australia as what you did with the 2735 Phase I experience? And could you help frame expectations for what you'd be looking for out of the MAD portion of that study with respect to weight loss?

Brian Lian

Analyst

Yes. Thanks, Tom. No, I think we'd be targeting a U.S.-based for the amylin study, U.S.-based clinical sites. And hard to say it's SAD. The first part will be a SAD study. So always difficult to really interpret any efficacy data from a single dose. But in primates, it looks pretty potent, more potent than the VK2735 compounded under both single and multiple dose scenarios. So it looks pretty good, but haven't been in humans yet. On the demographics for the maintenance study, the main baseline is people had to be -- BMI greater than 30. They're pretty small cohorts. So I don't know -- I would anticipate -- and I don't have access to that, I don't know the answer right now, but I expect there to be more women than men. I expect it to be mostly white. And they're all normal glycemic, so no diabetics. But I wouldn't expect it to be dramatically different than the VENTURE Phase II demographics, but I don't have the demographics in front of me.

Operator

Operator

The next question will come from Yale Jen with Laidlaw & Company.

Yale Jen

Analyst

Congrats on the quarters and the year. Two questions here. First one is that in terms of the maintenance study, although we are still seeking for -- looking for the data, do you -- depends on that, do you anticipate you will have -- you still need a larger scale so the maintenance study to be sort of finalized the alternate path forward as well as when you -- at the same time, you're conducting the Phase II study -- Phase III study for the oral?

Brian Lian

Analyst

Yes. Thanks, Yale. Unknown yet. As I mentioned earlier, it might be possible to introduce some maintenance arms into the extension in the VANQUISH studies, but we don't know yet. I would anticipate, though, a larger subsequent study, whether that's part of an extension or a stand-alone, that would likely be required to really understand longer-term maintenance and what the ideal dose is.

Yale Jen

Analyst

Okay. And maybe just a quick one on the auto injectors. I don't know whether that will be [ a year pain ] in terms of supply issue. And how do you see that going forward that -- once you transition everything into the -- all the subcu to the auto injectors?

Brian Lian

Analyst

Yes. We don't anticipate any supply issues there with the auto-injectors. The supplier is capable of producing a very high capacity. So no anticipated issues at this point with auto-injector supply.

Operator

Operator

As we are nearing the conclusion of today's call, our final question will come from Ryan Deschner with Raymond James.

Ryan Deschner

Analyst

Was there any notable differences in the end of Phase II meeting minutes for oral VK2735 versus the meeting you had for the injectable version? And would any patients in the maintenance study be transitioned to auto-injector?

Brian Lian

Analyst

On the second part, no, it's a good question, but no, these are going to be a vial and syringe, and the study is well underway now. So no, we're not going to introduce the auto-injector in the maintenance study. As far as the oral end of Phase II and the subcu into Phase II, we're not getting into the details of the discussions. But I'd say the feedback was consistent with what we heard from the end of Phase II for the subcu formulation. Different INDs, but many of the same people participated. So I think that we're comfortable going forward and pretty consistent feedback between the two meetings.

Operator

Operator

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

Stephanie Diaz

Analyst

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

Operator

Operator

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