Viking Therapeutics Q2 2025 Earnings Call Summary and Q&A Highlights: Advancing Obesity and Diabetes Programs

Earnings Call
Jul 24

[Management View]
Viking Therapeutics launched its pivotal Phase 3 Vanquish program for VK2735, targeting obesity and type 2 diabetes, and completed enrollment in its key Phase 2 oral VENTURE study. The VENTURE subcutaneous trial achieved up to 14.7% weight loss over 13 weeks in subjects with obesity, with most weight maintained post-treatment and favorable safety data reported. A new IND for the amyloid receptor agonist program is scheduled for late 2025, highlighting sustained R&D pipeline advancement. The company’s cash reserves position it to fund the full Phase 3 VK2735 program and additional pipeline activities.

[Outlook]
Viking expects to explore monthly maintenance dosing and a weekly oral dosing regimen for VK2735 in upcoming studies. The company plans to further evaluate a monthly dosing regimen later this year. An IND filing for the amyloid receptor agonist program is targeted for Q4 2025. R&D expenses are forecasted to grow by 25% to 33% for Q3 and Q4 2025, reflecting ongoing clinical activity.

[Financial Performance]
Research and Development Expenses: $60.2 million for Q2 2025, up from $23.8 million in Q2 2024.
General and Administrative Expenses: $14.4 million in Q2 2025, up from $10.3 million in Q2 2024.
Net Loss: $65.6 million, or $0.58 per share, for Q2 2025, versus $22.3 million or $0.20 per share in Q2 2024.
Cash Position: $808 million as of the end of Q2 2025, down from $903 million at December 31, 2024.

[Q&A Highlights]
Question 1: In the Phase 1 oral study, you reported strong dose dependence regarding satiety and decreased appetite. Would you expect additional increases in patient satiety or decreased appetite durations longer than 28 days in the Phase 2 oral study, particularly for the lower doses?
Answer: Evidence of satiety as weight loss progresses is expected, but it is inconsistent across studies. The Phase 1 study showed dose dependence, so we'll see what it does in Phase 2.

Question 2: In the Phase 2a readout, will this include data from all cohorts, specifically the maintenance dosing arm?
Answer: Yes, it will include all cohorts. The cohort that doses up to 90 and then comes back to 30 for the remaining four weeks will be particularly interesting.

Question 3: Do you have an oral dose in mind for the monthly dosing study to start in Q3? Will you have Phase 2 oral VENTURE data out before starting the monthly dosing study?
Answer: We don't have a dose yet as we don't have the Phase 2 oral data. It's not mandatory to have those data before initiating the maintenance study.

Question 4: Could you talk about your rationale for going up from 15 mg to 17.5 mg in the Phase 3 Vanquish trial and the titration scheme relative to your prior Phase 2 trial?
Answer: The 13-week study showed excellent tolerability and efficacy at 15 mg. We thought there was room to go higher without significant safety or tolerability differences. The titration scheme was extended to four-week blocks to improve tolerability.

Question 5: Is there a scenario in VENTURE oral that may compel you to study the oral formulation as a frontline therapy?
Answer: It's premature to say without seeing the data, but there is a scenario where it could be a frontline therapy.

Question 6: Have you started patient dosing in the Phase 3 Vanquish programs, and how long do you expect enrollment to complete?
Answer: Yes, we are dosing. It's premature to make timing projections, but there is a lot of interest and enthusiasm.

Question 7: Are you planning to randomize with design in the subcu monthly maintenance study?
Answer: No, people will be titrated up to a high dose and then transition to a range of monthly doses or daily oral doses.

Question 8: Could you provide details on the specific titration doses for the oral program and the possibility of advancing straight to Phase 3?
Answer: The steps for the Phase 2 oral program involve two-week blocks. Whether we can go to Phase 3 depends on the data.

Question 9: How many cohorts are you considering for the maintenance study, and what is the duration of treatment?
Answer: The study is complex and sizable, with multiple arms for monthly injection, daily oral, and weekly oral. The post-transition period will be around three months.

Question 10: Do you need to meet with the FDA again for the oral Phase 3 study, and what efficacy and tolerability hurdles are you considering?
Answer: We would likely schedule an end-of-Phase 2 meeting with the FDA. The Phase 1 data looked encouraging, but we need to see the Phase 2 data to make further decisions.

Question 11: Can you provide guidance on R&D expenses for the rest of the year?
Answer: R&D expenses will increase by 25% to a third in Q3 and Q4 compared to Q2, driven by clinical trial, manufacturing, and other topics.

Question 12: What are your expectations for the high dose versus the maintenance dose in the oral Phase 2 study?
Answer: The highest dose is 120 mg, with the maintenance cohort going up to 90 mg and then back to 30 mg. We expect mid to high single-digit weight loss percentages.

Question 13: Can you comment on the 78-week duration for the Phase 3 trials and the timing for posting the trials on clinicaltrials.gov?
Answer: The 78 weeks include a 52-week maintenance period plus the titration window. The trials will be posted shortly.

Question 14: How long would it take to manufacture oral clinical supplies if you decide to advance to Phase 3?
Answer: Manufacturing would not be a gating factor for initiating a Phase 3 study.

Question 15: How do you plan to use auto-injectors in the Vanquish programs, and will you need a bridging study?
Answer: We will transition to auto-injectors early next year and conduct a bioequivalence study in the interim.

Question 16: How do you see the impact of Lilly's orforglipron Phase 3 data on your oral product presentation?
Answer: The sector can accommodate multiple agents given the market opportunity, so we are not too worried about another oral agent.

Question 17: What does the amyloid agonist program need to show in the Phase 1 trial to warrant continued development in obesity?
Answer: We need to see an impact on body weight and learn about the tolerability profile. The space has matured beyond focusing solely on four-week data.

[Sentiment Analysis]
The tone of the management was optimistic and confident about the progress and future plans. Analysts' questions were focused on understanding the details and implications of the clinical trials, with a positive outlook on the company's advancements.

[Quarterly Comparison]
| Metric | Q2 2025 | Q2 2024 |
|---------------------------------|------------------|------------------|
| Research and Development Expenses | $60.2 million | $23.8 million |
| General and Administrative Expenses | $14.4 million | $10.3 million |
| Net Loss | $65.6 million | $22.3 million |
| Cash Position | $808 million | $903 million (Dec 31, 2024) |

[Risks and Concerns]
1. Increased R&D expenses may impact short-term financial performance.
2. The success of clinical trials is uncertain and may affect future development plans.
3. Competition from other pharmaceutical companies in the obesity and diabetes treatment market.

[Final Takeaway]
Viking Therapeutics is making significant progress in its obesity and diabetes programs, with promising results from its Phase 2 VENTURE study and the initiation of the Phase 3 Vanquish program. The company's strong cash position supports its ongoing clinical activities and future plans. While there are risks associated with increased R&D expenses and competition, the management's optimistic outlook and strategic focus on advancing its clinical pipeline position Viking Therapeutics for potential long-term success.

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