Viking Therapeutics, Inc. (NASDAQ:VKTX) Q4 2024 Earnings Call Transcript

Viking Therapeutics, Inc. (NASDAQ:VKTX) Q4 2024 Earnings Call Transcript February 7, 2024

Viking Therapeutics, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Welcome to the Viking Therapeutics Fourth Quarter and Full Year 2023 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 7, 2024. I would now like to turn the conference over to Viking’s Manager of Investor Relations, Stephanie Diaz. Please go ahead.

Stephanie Diaz: 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 7, 2024, 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, 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. I’ll now turn the call over to Brian Lian for his initial comments.

Brian Lian: Thanks, Stephanie, and good afternoon to everyone dialed in by phone or listening on the webcast. Today, we’ll review our financial results for the fourth quarter and full year ended December 31, 2023 and provide an update on recent progress with our clinical programs and operations. 2023 was an exciting year for Viking, highlighted by important data releases from two of our four clinical programs. With respect to our obesity program, during the year, we announced positive results from a first-in-human Phase 1 clinical trial of VK2735, a dual agonist of the GLP-1 and GIP receptors. In this study, subjects dosed with VK2735 demonstrated statistically significant weight loss with favorable safety and tolerability. Following these results, we initiated the Phase 2 trial called VENTURE to further evaluate VK2735 in patients with obesity.

We expect to report top line results from this study later this quarter. During the year, we also initiated a Phase 1 clinical trial, evaluating an oral formulation of VK2735. We expect to report results from this study later this quarter. Viking made good progress with other pipeline programs during the year as well. In May, we announced positive topline results from the Phase 2b VOYAGE study of our thyroid hormone receptor beta agonist, VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis and fibrosis. This trial met its primary endpoint with patients receiving VK2809 demonstrating statistically significant reductions in liver fat as well as other important measures compared with patients treated with placebo. We look forward to reporting the 52-week biopsy data from this study in the first half of 2024.

On the financial side, we completed 2023 with a strong balance sheet, thanks to our continued diligence in managing expenses, along with a successful public offering of common stock, which resulted in gross proceeds of approximately $288 million. These funds will be used to support the continued advancement of our pipeline programs through multiple clinical milestones. I’ll provide further details on our operations and development activities after we review our financial results for the fourth quarter and full year 2023. With that, I’ll turn the call over to Greg Zante, Viking’s Chief Financial Officer.

Greg Zante: 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 today. I’ll now go over our results for the fourth quarter and full year ended December 31, 2023, beginning with the results for the quarter. Research and development expenses for the three months ended December 31, 2023, were $20.5 million compared to $16.2 million for the same period in 2022. The increase was primarily due to increased expenses related to clinical studies, pre-clinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits and third-party consultants. General and administrative expenses for the three months ended December 31, 2023, were $8.8 million compared to $4.1 million for the same period in 2022.

The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation and third-party consultants, partially offset by decreased expenses related to salaries and benefits. For the three months ended December 31, 2023, Viking reported a net loss of $24.6 million, or $0.25 per share, compared to a net loss of $19.6 million, or $0.26 per share, in the corresponding period in 2022. The increase in net loss for the three months ended December 31, 2023, 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 2022. I’ll now go over the results for the 12 months ended December 31, 2023.

Our research and development expenses for the year ended December 31, 2023 were $63.8 million compared to $54.2 million for the same period in 2022. The increase was primarily due to increased expenses related to preclinical studies, stock-based compensation, manufacturing for our drug candidates, salaries and benefits and services provided by third-party consultants, partially offset by decreased expenses related to clinical studies. Our general and administrative expenses for the year ended December 31, 2023 were $37 million compared to $16.1 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, third-party consultants and salaries and benefits.

For the year ended December 31, 2023, Viking reported a net loss of $85.9 million or $0.91 per share compared to a net loss of $68.9 million or $0.90 per share in the corresponding period in 2022. The increase in net loss for the year ended December 31, 2023 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 2022. Turning to the balance sheet. At December 31, 2023, Viking held cash, cash equivalents and short-term investments of $362 million compared to $155 million as of December 31, 2022. This concludes my financial review and I’ll now turn the call back over to Brian.

Brian Lian: Thanks, Greg. As I mentioned in my opening comments, in 2023, Viking made significant progress with each of our 4 clinical programs, positioning the company for an exciting year ahead. I’ll now briefly review our 2023 accomplishments and preview key objectives for 2024. I’ll begin with an update on our VK2735 program for obesity. VK2735 is Viking’s newest clinical stage compound and is a dual agonist of the glucagon-like peptide-1, or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor. In the first quarter of 2023, we announced positive results from a Phase 1 single ascending dose and multiple ascending dose study of VK2735. This study was designed to evaluate the compound’s initial safety, tolerability and pharmacokinetic profile, as well as its potential impact on exploratory metabolic measures, including body weight and liver fat.

The single ascending dose portion of the study enrolled healthy men and women and demonstrated that, single subcutaneous doses of VK2735 were safe and well tolerated and displayed favorable pharmacokinetics. VK2735 demonstrated a half-life of approximately 170 hours to 250 hours and excellent therapeutic exposures. The multiple ascending dose portion of this study enrolled healthy men and women with a minimum body mass index of 30 kilograms per meter squared. These subjects received subcutaneous doses of VK2735 once weekly for 28 days. As in the single ascending dose date, the multiple ascending dose study demonstrated encouraging safety and tolerability and positive signs of clinical activity. All cohorts receiving VK2735 demonstrated reductions in mean body weight from baseline ranging up to 7.8%.

Cohorts receiving VK2735 also demonstrated reductions in body weight relative to placebo, ranging up to 6%. Statistically significant differences in body weight compared to placebo were also maintained or improved at the day 43 follow-up time point, 21 days after the last dose of VK2735 was administered. With respect to safety and tolerability, 98% of observed adverse events in the multiple ascending dose portion of the study were reported as mild or moderate and 99% of gastrointestinal-related adverse events were reported as mild or moderate. This study also demonstrated VK2735’s encouraging impact on liver fat and plasma lipids. Specifically, after 4 weekly subcutaneous doses of VK2735, subjects in the Phase 1 trial reported liver fat reductions of up to 47% from baseline.

Among subjects with non-alcoholic fatty liver disease, placebo-adjusted reductions in liver fat reached approximately 59%. These results indicate VK2735’s potential benefit in patients with various forms of fatty liver disease. With respect to plasma lipids, treatment with VK2735 produced encouraging reductions from baseline in total cholesterol of up to 21% and reductions in LDL cholesterol of up to 23%. Plasma levels of apolipoprotein B were also reduced by up to 21%. These data are particularly interesting in light of the fact that these healthy volunteers began the study with normal baseline plasma lipid levels. These study results were featured in an oral presentation last October at Obesity Week and served as the basis for our decision to continue to advance this program further in clinical development.

To this end, in the third quarter of last year, Viking initiated the Phase 2 VENTURE trial to evaluate VK2735 in patients with obesity. The VENTURE trial is a randomized, double-blind, placebo-controlled multicenter study that is evaluating the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 administered subcutaneously once-weekly for 13 weeks. This trial was designed to enroll approximately 125 adults with obesity or adults who are overweight with at least 1 weight-related comorbid condition. Due to higher-than-expected clinician and patient interest, this trial’s enrollment was increased to 176 patients and completed ahead of schedule. The VENTURE trial is evaluating weekly subcutaneous doses of VK2735 of up to 15 milligrams compared to the 10-milligram top dose evaluated in the prior Phase 1 multiple ascending dose study.

The primary endpoint of the study will assess the percent change in body weight from baseline to week 13 among patients treated with VK2735 as compared with placebo. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. We expect to report the top line results from this study in the first quarter of this year. In addition to the subcutaneous formulation of VK2735, in the first quarter of last year, Viking announced the initiation of a Phase 1 clinical study evaluating a novel tablet formulation of this molecule. This study is an extension of the Phase 1 single ascending dose and multiple ascending dose study discussed a moment ago. The oral portion of the study is a randomized, double-blind, placebo-controlled study in healthy volunteers who have a minimum body mass index of 30 kilograms per meter squared.

Subjects in this portion of the study will receive once-daily oral doses of VK2735 for 28 days. The primary objective of the study is to evaluate the safety, tolerability and pharmacokinetics of VK2735 following 28 days of oral dosing. Exploratory endpoints include changes in body weight and other pharmacodynamic markers. We expect to report the results from this study in the first quarter of this year. I’ll now provide an update on our VK2809 program for the treatment of NASH and fibrosis. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue, as well as the beta isoform of the receptor. Last May, we announced positive top line results from the ongoing Phase 2b VOYAGE study of VK2809.

The VOYAGE study is a randomized, double-blind, placebo-controlled multicenter international trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. Enrollment included patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction as well as F2 and F3 fibrosis. As we reported in May, this study successfully achieved its primary endpoint with patients receiving VK2809 demonstrating statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo. The median relative change from baseline in liver fat ranged from 38% to 55% among patients receiving VK2809 Importantly, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat.

This level of efficacy is associated with a greater likelihood of histologic benefit in NASH. As in prior studies, VK2809 treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides and atherogenic proteins. We believe these results indicate that VK2809 has the potential to provide long-term cardiovascular benefits. The initial VOYAGE data also served to further establish VK2809’s promising safety and tolerability profile. 94% of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate, discontinuation due to adverse events low and balanced among placebo and treatment arms. In particular, VK2809 demonstrated excellent gastrointestinal tolerability. In the VOYAGE study, the rates of nausea, diarrhea, stool frequency and vomiting were similar among VK2809-treated patients compared to placebo.

In November, Viking presented new data from this study at the Annual Meeting of the American Association for the Study of Liver Diseases. These new data demonstrated robust liver fat reductions among patients with or without type 2 diabetes as well as those having F2 or F3 fibrosis. Among patients with type 2 diabetes at week 12, reductions from baseline in liver fat ranged from 36% to 54% which was comparable to the reductions reported among patients without type 2 diabetes. These data suggest that activation of the thyroid hormone beta receptor remains effective at reducing liver fat in the presence of an important metabolic comorbidity commonly observed in patients with NASH. Treatment with VK2809 also demonstrated potent reductions in liver fat among patients with F2 or F3 fibrosis.

Thus, neither the presence of type 2 diabetes nor the presence of F2 or F3 fibrosis meaningfully impacted VK2809’s efficacy in reducing liver fat. As steatosis and lipotoxicity are believed to be underlying drivers in NASH, these results suggest important long-term benefits across key subgroups. We recently completed the final biopsies in the VOYAGE study and look forward to reporting data on histologic changes assessed after 52 weeks of treatment in the first half of 2024. Moving to our Orphan disease program. Our second thyroid hormone receptor beta agonist, VK0214, is currently being evaluated in Phase 1b trial in patients with X-linked adrenoleukodystrophy or X-ALD. Like VK2809, VK0214 is also an orally available small molecule that is selective for the beta isoform of the thyroid hormone receptor.

X-ALD is a rare and debilitating metabolic disorder that is caused by genetic patients that disable the function of peroxisomal transporter of very long-chain fatty acids. As a result, patients are unable to efficiently metabolize very long chain fatty acids and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD. In a prior Phase 1 study, VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and the half-life consistent with anticipated once-daily dosing. Subject to received VK0214 experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B and lipoprotein A. VK0214 also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose-related signals observed for GI side effects, vital signs or cardiovascular measures.

The ongoing Phase 1b study of VK0214 is being conducted in patients with the adrenomyeloneuropathy or AMN form of X-ALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled multicenter study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of VK0214 administered orally once daily for 28 days. The study also includes an exploratory assessment of changes in plasma levels of very long chain fatty acids. We expect to report the top line results from this study in the first half of 2024. In conclusion, 2023 was an exciting and productive year for Viking, with the company achieving significant progress with each of our clinical programs.

During the year, we reported the results from the first Phase 1 trial of VK2735, which demonstrated early signals of efficacy as well as promising safety and tolerability. We also initiated the Phase 1 clinical evaluation of a novel oral formulation of VK2735, which we believe may expand the market opportunity for this compound. In the fall of 2023, we initiated and completed the upsized enrolment of the VENTURE Phase 2 trial to evaluate VK2735’s longer-term clinical benefit in patients with obesity. We look forward to reporting the results from the VENTURE Phase 2 study later this quarter, along with the Phase 1 data from the oral formulation study. We also look forward to reporting data from the VOYAGE Phase 2b study of our thyroid beta receptor agonist, VK2809 in biopsy-confirmed NASH and fibrosis.

The initial data from this study successfully achieved the primary endpoint and affirmed VK2809’s best-in-class effect on liver fat along with its favorable tolerability and safety profile. We expect to report the 52-week biopsy data from this study in the first half of 2024. The Phase 1b study of VK0214 for the treatment of adrenomyeloneuropathy also continues, and we look forward to announcing the results from this trial later in the first half. Finally, we completed 2023 with a strong balance sheet and a cash position that will support our objectives for 2024 and beyond. All of us at Viking are optimistic about the year ahead and would like to extend our thanks to our shareholders, partners, investigators and importantly, the patients participating in our clinical trials for their continued support.

This concludes our prepared comments for today. Thanks very much for joining us, and we’ll now open the call for questions. Operator?

See also 15 Highest Quality Tea Brands in 2024 and 15 Highest Quality Bed Sheets of 2024.

Q&A Session

Operator: [Operator Instructions]. And our first question comes from Joon Lee of Truist. Please go ahead.

Joon Lee: Thanks for the update. Thanks for taking our questions. Regarding the subcutaneous VK2735, you reminded us that in Phase I, you saw 6% placebo-adjusted weight loss in just 4 weeks. So with longer dosing of up to 13 weeks using up to 50% higher dose, what’s a reasonable expectation of rate loss in the upcoming VENTURE trial?

Brian Lian: Yes. Hi, Joon, thanks for the questions. So we’re really using around an 8% hurdle for the VENTURE study. I think if we showed that, that would be sufficient for us to move forward. I think it could be competitive at 13 weeks.

Joon Lee: And just a quick follow-up. What other safety and efficacy measures are you tracking that we should be looking out for in the VENTURE trial?

Brian Lian: I’m sorry, what other safety and what?

Joon Lee: Efficacy measures.

Brian Lian: Efficacy. Yes. We’re looking at, obviously, plasma lipids. We’re looking at plasma glucose, insulin, a standard battery of lab assessments and clinical chemistry. Cardiovascular safety as well. But it’s pretty same, nothing unusual or exotic in the safety analysis.

Joon Lee: Great. And then one last quick one. For the oral VK2735, are you able to disclose whether you’ve dosed higher than 20 milligrams in respect? Thank you.

Brian Lian: No, we’re not going to get into the details of the cohorts. We’ll disclose all of those details when we disclose the data.

Joon Lee: Looking forward to the data. Thank you.

Brian Lian: Thanks a lot. Joon.

Operator: The next question comes from Steven Seedhouse of Raymond James. Please go ahead. Steven your line is open. Are you muted on your end?

Steven Seedhouse: Sorry about that, guys. Can you hear me now?

Brian Lian: Yes, we can. Yes.

Steven Seedhouse: Sorry, my apologies. I appreciate you taking the question. I wanted to first ask about VENTURE. For the higher dose arms, particularly the 15-milligram cohort, if you were just following the tirzepatide titration schema like 2.5 milligrams titrated, in this case, every three weeks, you still wouldn’t get to the high dose. So I’m curious if you can just clarify like what are the dose increments and sort of schema for the titration in that study?

Brian Lian: Yes. We use a three-week blocks. The lowest dose is 2.5 mgs for 13 weeks. The second dose is — for three weeks and then 5 mgs for 10 weeks. The 10-milligram dose is 2.5 or three weeks, five for three weeks. And then 10 for seven weeks. And then the 15-milligram dose starts at five — so it’s 5 milligrams for 3 weeks, 7.5 milligrams for three weeks. 10 milligrams for three weeks and then 15 milligrams for four weeks.

Steven Seedhouse: Perfect. Appreciate that detail. And then just want to ask also is there’s a four-week follow-up period in the study off drug, and I’m curious if that’s — are we waiting for that four-week off-drug follow-up to conclude before analyzing the top line data? Or would the release just include the 13 weeks on drug?

Brian Lian: Well, yes, it’s a good question. It’s a six-week follow-up period. I might have earlier said four weeks mistakenly, but you have a six-week follow-up window. And I believe we’ll be through that when we report the top line data.

Steven Seedhouse: Okay. And I might as well be the first to ask, but what is the sequencing of the subcu and the oral data, which comes first? Or would they be announced together? Thanks.

Brian Lian: Yes. Thanks, Steve. No, not going to be announced together, and they’ll both be this quarter. I think that’s about all the granularity we’re going to give. The quarter is not very long.

Steven Seedhouse: Thanks a lot.

Brian Lian: Thanks Steve.

Operator: The next question comes from Jay Olson of Oppenheimer. Please go ahead.

Jay Olson: Congrats on the progress. And thanks for update. Can you just talk about for the oral Phase 1 data since you have the option to add cohorts, how many cohorts of data should we expect?

Brian Lian: Hi Jay, yes, thanks for the question. I mentioned to Joon, we’re not going to get into the details of numbers of cohorts until we actually release the data. The trial was recently designed to enrol four cohorts, but we maintain flexibility to add cohorts. But we’ll have all the details on that when we release the data.

Jay Olson: Okay. Great, thank you. And then I guess since Novo is planning to acquire Catalent, can you just talk about your manufacturing plans and any impact you might expect if that acquisition goes through?

Brian Lian: Yes. Thanks. Good question. It shouldn’t impact us at all, at least — definitely not in the near term, and I don’t believe as far as future plans as well. I think we’re all set to supply all of the clinical studies that would be required to receive approval.

Jay Olson: Okay. Great. And can you just talk big picture about the current landscape for oral weight loss drugs and where you think oral drugs will fit in the grand scheme of the obesity landscape?

Brian Lian: Yes. That’s a big question, Jay. But we’re 20 years into the GLP-1 era, and there’s 1 approved oral agent. That’s a very, very difficult challenge that the industry faces. So we’re working on a program we’re excited about, but it’s very, very difficult. I think orals have multiple different commercial positions, 1 would be as a lead in to a subcu therapeutic for someone who doesn’t want to maybe start with an injection. Second one would be in the maintenance setting. And we think that’s a really important setting because if you come off a large amount of weight loss and you don’t want to continue to take the subcu, transitioning to an oral would be a potentially really attractive option. And in that sense, you maybe wouldn’t require the same level of efficacy as a subcu to maintain a certain target body weight.

We think the other potential opportunity would be in the temporary use. You have an event coming up in 6 months or whatever, and you want to lose some weight ahead of that. So you wouldn’t necessarily need the magnitude of weight loss that could be provided by a subcu dosage form and oral would be suitable there. So a lot of different opportunities. We see the subcu as the meat of the market, but we see the oral opportunity is a really important incremental opportunity.

Jay Olson: Great. Thank you so much for taking our questions.

Brian Lian: Thanks Jay.

Operator: The next question comes from Naz Rahman of Maxim Group. Please go ahead.

Naz Rahman: Hi, everyone. Congrats on the progress and just a couple of questions for me. So obviously, you have a very, very busy first half of the Phase 2b VOYAGE and the VENTURE results. If both studies were to succeed and you see, which you want to see, could you provide some color or context around how much it would cost or what do we take to advance these programs into the next clinical trial?

Brian Lian: Yes. They’re obviously very large and expensive studies, more than — easily more than $100 million for study. Probably not going to give detailed guidance on the precise expenses of those studies. But suffice to say, I think everybody is aware, these are very extensive Phase 3 programs.

Naz Rahman: Got you. And now on your injectable. Could you talk a little bit about the current, I guess, delivery mechanism? Is it just patients use a vial in syringe? Do you have like an auto-injector or plans for like an auto-injector device for your injectable? Is any of that in the works?

Brian Lian: Yes, it is. The Phase II VENTURE study is using a vial in syringe but we will be using a different device in future studies.

Naz Rahman: Is that something we might get an update on this year? Or was that something we might get an update on more or like ’25?

Brian Lian: We’ll probably provide an update on that when we start the next study and the timing of that is TBD.

Naz Rahman: Got it. Thank you. Thanks for taking my questions.

Brian Lian: Thanks Naz.