Vanda Pharmaceuticals' Q3 2025 Earnings Call: Contradictions Emerge on PONVORY Growth and Tradipitant Approval Timelines

Date of Call: October 29, 2025

Financials Results

• Revenue: $56.3M (Q3 2025), up 18% YOY and up 7% sequentially vs $52.6M; first 9 months $158.9M, up 9% YOY

Guidance:

• Total revenues from Fanapt, HETLIOZ, and PONVORY expected to be $210M–$230M for 2025 (prior guidance $210M–$250M)
• Year-end 2025 cash expected to be $260M–$290M (prior guidance $280M–$320M)
• Near-term regulatory timelines: tradipitant PDUFA Dec 30, 2025; Bysanti PDUFA Feb 21, 2026; imsidolimab BLA expected submitted Q4 2025 (anticipated 6-month priority review)

Business Commentary:

* Revenue Growth and Product Performance: - Vanda Pharmaceuticals reported total net product sales of $56.3 million for Q3 2025, up 18% year-over-year, with Fanapt sales increasing by 31% and prescriptions growing by 35%. - The growth was driven by the successful commercial launch of Fanapt's bipolar disorder indication and increased promotional activities.

• Commercial Infrastructure Expansion:
• Vanda expanded its sales force for Fanapt from approximately 150 representatives in Q3 2024 to 300 in Q3 2025, leading to a 20% increase in face-to-face calls.

• This expansion aimed to enhance prescriber reach and support ongoing commercial launches.

• Operational Costs and R&D Investments:

• Operating expenses increased by $93.7 million to $269.7 million for the first 9 months of 2025, primarily due to higher SG&A and R&D expenses.

• This increase was attributed to investments in commercial products, sales force expansion, and the exclusive global license agreement for imsidolimab.

• Regulatory Milestones and FDA Collaborations:

• Vanda achieved regulatory milestones with tradipitant and Bysanti NDAs under FDA review, and an anticipated BLA submission for imsidolimab in Q4.
• The company's collaborative framework with the FDA, aimed at resolving disputes, contributed to these developments.

Sentiment Analysis:

Overall Tone: Positive

• Management highlighted "strong commercial execution" and key commercial metrics: total net product sales $56.3M, up 18% YOY; Fanapt sales +31% YOY and TRx +35% YOY. They cited a "collaborative framework" with the FDA and multiple near-term PDUFA/filing milestones, while acknowledging investments that reduced cash guidance.

Q&A:

• Question from Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division): Could you comment on hypothetical scenarios with the FDA and timing for tradipitant approval—could approval occur in H1 2026 if interactions proceed positively?
  Response: Management expects an FDA decision for tradipitant by Dec 30, 2025 and is optimistic about approval if the FDA clears the partial clinical‑hold reconsideration (FDA to re‑review the hold by end‑November).

• Question from Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division): Regarding PONVORY performance, what kind of quarterly growth should we expect over the next 2–3 quarters given current sales & marketing investments?
  Response: Underlying patient demand has increased for two consecutive quarters and the ~50‑rep specialty sales force was recently completed; management expects continued revenue growth into Q4 and into 2026 but provided no specific near‑term growth rate.

• Question from Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division): Will imsidolimab receive priority review once submitted and any updated timing for the MDD Phase III study?
  Response: Imsidolimab BLA is expected to be submitted in Q4 2025 and management anticipates a 6‑month priority review; the MDD (Bysanti adjunct) Phase III results are expected by the end of 2026, timing to be refined as enrollment progresses.

• Question from Olivia Brayer (Cantor Fitzgerald & Co., Research Division): Can you explain this quarter's guidance change—what pushed the revision and what are you seeing into October that informed the update?
  Response: Guidance narrowed to the lower revenue range because Fanapt growth is strong but HETLIOZ revenue can be volatile due to specialty pharmacy stocking patterns; Fanapt scripts have grown sequentially (Q1→Q2→Q3) and are expected to continue into Q4.

• Question from Olivia Brayer (Cantor Fitzgerald & Co., Research Division): Any details on FDA engagement for Bysanti (additional information requests, label discussions) and how will you commercially convince patients to switch from Fanapt to Bysanti?
  Response: Interactions with the FDA on Bysanti have been positive with no efficacy issues raised; label negotiations typically occur a few months before PDUFA. Commercially, management will leverage active promotion in a promotionally sensitive/high‑switch class, plus starter/titration packs, co‑pay programs, once‑daily dosing and expanded indications to drive switching.

• Question from Unknown Analyst: If tradipitant (Dec 30) and HETLIOZ jet lag (Jan 7) are approved, what will your marketing strategy be and what will the launch curve look like?
  Response: Management plans consumer‑centric launches with DTC support, concierge distribution services and pre‑built brand awareness; if approved on the stated PDUFAs, they expect to be in market in H1 2026.

• Question from Unknown Analyst: Can you describe the GLP‑1 vomiting (Wegovy) study design and what positive efficacy looks like? For Bysanti Phase III MDD, what efficacy separation are you targeting?
  Response: The GLP‑1 study randomized patients receiving tradipitant (1 mg) vs placebo prior to Wegovy and uses vomiting episode counts (and nausea measures) as primary/secondary endpoints; top‑line results expected Q4 2025. The Bysanti MDD Phase III is powered to meet a conventional positive primary endpoint on standard depression scales; no specific effect size disclosed, with results expected in 2026.

Contradiction Point 1

PONVORY Revenue Growth Expectations

It involves expectations for PONVORY's revenue growth, which is a key financial metric for the company and investors.

What quarterly net sales growth should we expect for PONVORY over the next 2-3 quarters? - Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: We've seen increases in underlying patient demand for PONVORY over the past two quarters. With recent investments in a commercial sales force and speaker programs, we hope to see continued growth potential as we exit this year and into next year. - Kevin Moran(CFO)

What are your expectations for PONVORY revenues for its on-label indication, and do you expect significant revenue growth acceleration in H2 2025? - Raghuram Selvaraju (H.C. Wainwright)

2025Q2: The PONVORY launch is progressing with steady growth expected, rather than a rapid acceleration. The commercial launch activities are proceeding well, with the second quarter showing a record number of new patient prescriptions since the product's initiation. Growth is anticipated to be steady. - Kevin Moran(CFO)

Contradiction Point 2

FDA Interactions and Timeline for Tradipitant's Approval

It involves the company's interactions with the FDA and the timeline for tradipitant's approval, which are crucial for market expectations and strategic planning.

Can you comment on FDA interactions regarding tradipitant and the potential approval timeline? - Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: We're very pleased with the new collaborative framework with the FDA. We're encouraged by the rereview of tradipitant's partial clinical hold by end of November. So far, no issues have been raised with tradipitant's efficacy. Once cleared, we're optimistic for an approval by the end of this year. - Mihael Polymeropoulos(CEO)

What progress is expected for tradipitant by year-end, and when could it potentially launch in the U.S.? - Raghuram Selvaraju (H.C. Wainwright)

2025Q2: Tradipitant's FDA hearing request has not been granted, though success is expected if a hearing occurs. The review of tradipitant for motion sickness is ongoing, with safety data under review. Market launch could be as early as January 1, 2026, if approved by December 30. - Mihael Polymeropoulos(CEO)

Contradiction Point 3

Tradipitant Timing and Approval

It directly impacts expectations regarding the regulatory timeline and market availability of a key product, potentially influencing company revenue and investor expectations.

Can you comment on FDA interactions and approval timeline for tradipitant? - Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: We're optimistic for an approval by the end of this year. - Mihael Polymeropoulos(CEO)

What is the latest strategy for Tradipitant in gastroparesis, and when will next steps be announced? - Andrew Tsai (Jefferies)

2025Q1: The review cycle continues. We've requested an opportunity hearing, but the process is complex. - Mihael Polymeropoulos(CEO)

Contradiction Point 4

PONVORY Sales Growth

It involves changes in financial forecasts, specifically regarding PONVORY sales growth, which are critical indicators for investors.

What net sales growth should we expect for PONVORY over the next 2-3 quarters? - Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: We've seen increases in underlying patient demand for PONVORY over the past two quarters. - Kevin Moran(CFO)

What are your expectations for PONVORY sales in Q2? - Unidentified Analyst

2025Q1: This reflects strong growth in PONVORY sales. - Kevin Moran(CFO)

Contradiction Point 5

Traspipitant Approval Timeline

It involves the expected timeline for the approval of tradipitant, which is crucial for investors anticipating revenue growth.

Can you comment on hypothetical scenarios involving FDA interactions for tradipitant and potential approval timelines? - Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: We're very pleased with the new collaborative framework with the FDA. We're encouraged by the rereview of tradipitant's partial clinical hold by end of November. So far, no issues have been raised with tradipitant's efficacy. Once cleared, we're optimistic for an approval by the end of this year. - Mihael Polymeropoulos(CEO)

What caused the delay in filing the BLA for imsidolimab? Has a pre-BLA meeting been conducted? - Raghuram Selvaraju (H.C. Wainwright)

2024Q4: We believe we now have all the pieces in place to achieve this BLA submission before year-end 2024. - Mihael Polymeropoulos(CEO)