Vanda Pharmaceuticals Inc. (VNDA) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call reveals mixed signals: a 9% revenue increase is positive, but a significant net loss and increased operating expenses are concerning. The Q&A section highlights optimism for FDA approvals, but uncertainties in commercialization and regulatory timelines persist. While there are positive developments, such as potential new drug approvals and ongoing clinical trials, the lack of clear guidance and increased expenses balance the sentiment to neutral.
Key Financial Performance
Fanapt net product sales $117.3 million for the full year 2025, a 24% increase compared to $94.3 million for the full year 2024. This increase was attributable to an increase in volume, supported by a 28% rise in total prescriptions and a 149% surge in new-to-brand prescriptions. The growth reflects accelerating momentum, broader prescriber adoption, and targeted commercial investments, including direct-to-consumer campaigns.
HETLIOZ net product sales $71.4 million for the full year 2025, a 7% decrease compared to $76.7 million in the full year 2024. The decrease was due to continued generic competition in the U.S., leading to a reduction in volume and price net of deductions. Despite this, HETLIOZ retained the majority of market share.
PONVORY net product sales $27.4 million for the full year 2025, a 2% decrease compared to $27.8 million for the full year 2024. The decrease was attributed to variable consideration subject to dispute, although underlying patient demand showed modest sequential growth over the last three quarters.
Total revenues $216.1 million for the full year 2025, a 9% increase compared to $198.8 million for the full year 2024. The increase was primarily driven by growth in Fanapt revenue due to the bipolar commercial launch, partially offset by decreased HETLIOZ revenue from generic competition.
Net loss $220.5 million for the full year 2025 compared to a net loss of $18.9 million for the full year 2024. The increase in net loss was primarily driven by a one-time noncash income tax charge of $113.7 million related to a valuation allowance against deferred tax assets, as well as higher SG&A and R&D expenses.
Operating expenses $367.3 million for the full year 2025 compared to $239.4 million for the full year 2024, an increase of $127.8 million. The increase was driven by higher SG&A expenses related to commercial launches of Fanapt in bipolar disorder and PONVORY in multiple sclerosis, as well as R&D expenses for clinical development programs and licensing agreements.
Cash, cash equivalents, and marketable securities $263.8 million as of December 31, 2025, a decrease of $110.8 million compared to December 31, 2024. The decrease was driven by the net loss, excluding the impact of the one-time noncash charge, as well as timing of cash received from customers and payments for operating expenses.
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Operating Highlights
Fanapt: Achieved a 24% increase in net product sales to $117.3 million in 2025, driven by a 28% rise in total prescriptions and a 149% surge in new-to-brand prescriptions. Expanded sales force and direct-to-consumer campaigns contributed to growth.
Nereus tradipitant: Received FDA approval in late 2025 for motion sickness prevention, marking the first new oral pharmacologic option in over 40 years. Plans for commercial launch and Phase III program for label expansion in GLP-1 agonist-induced vomiting.
Bysanti milsaperidone: NDA under FDA review for bipolar 1 disorder and schizophrenia with a PDUFA target date of February 21, 2026. Phase III study ongoing for major depressive disorder.
Imsidolimab: BLA submitted for generalized pustular psoriasis, with regulatory and patent exclusivity expected into the late 2030s.
VQW-765: Phase III study initiated for social anxiety disorder, with results expected by the end of 2026.
PONVORY: Ongoing clinical development for psoriasis and ulcerative colitis, with Phase III evaluation planned.
Motion sickness market: Nereus tradipitant addresses a market of 65-78 million U.S. adults, with tens of millions seeking pharmacologic relief annually.
GLP-1 agonist market: Potential adjunct use of Nereus in the growing diabetes and obesity management market, addressing vomiting side effects in up to 50% of patients.
Antipsychotic market: Bysanti and Fanapt target a $20 billion market in 2025, with Fanapt showing strong growth.
Long-acting injectable antipsychotics: Represents a $6-7 billion market in 2025, with ongoing Phase III study for Fanapt's long-acting injectable formulation.
Social anxiety disorder market: VQW-765 targets a condition affecting 30 million U.S. adults, with limited effective treatments available.
Psoriasis and ulcerative colitis market: PONVORY aims to expand into these markets, leveraging its pharmacological advantages.
Revenue growth: Total revenues increased by 9% to $216.1 million in 2025, driven by Fanapt's performance.
Sales force expansion: Fanapt sales force grew from 160 to 300 representatives in 2025, enhancing prescriber reach and frequency.
Direct-to-consumer campaigns: Launched in 2025, boosting brand awareness and contributing to Fanapt's growth.
R&D investments: Focused on late-stage clinical programs and preparation for commercial launches.
Pipeline diversification: Expanded pipeline with multiple late-stage programs and regulatory submissions, including Nereus, Bysanti, and Imsidolimab.
Market positioning: Strengthened presence in psychiatry and autoimmune inflammatory diseases through targeted product development and launches.
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Risk or Challenges
Generic competition for HETLIOZ: HETLIOZ net product sales decreased by 7% in 2025 due to continued generic competition in the U.S., leading to a decline in volume and price. This competition is expected to persist, potentially causing further significant declines in future sales.
Deferred tax assets valuation allowance: A one-time noncash income tax charge of $113.7 million was recorded due to a valuation allowance against all deferred tax assets. This reflects uncertainties in future revenue projections and could impact financial stability.
Increased operating expenses: Operating expenses rose by $127.8 million in 2025, driven by higher SG&A expenses for commercial launches and R&D activities. This increase in spending could strain financial resources if revenue growth does not offset these costs.
Cash burn and financial sustainability: Cash, cash equivalents, and marketable securities decreased by $110.8 million in 2025. The company anticipates a higher cash burn in 2026, which could challenge financial sustainability if revenue growth or cost management does not improve.
Regulatory and commercial risks: The success of future revenue growth depends on regulatory approvals and commercial launches, including Nereus, Bysanti, and Imsidolimab. Delays or failures in these areas could adversely impact financial performance.
HETLIOZ inventory levels: Elevated inventory levels at specialty pharmacy customers may result in reduced or delayed orders, impacting revenue in the first quarter of 2026.
Market access for PONVORY: Challenges in improving market access for PONVORY could limit its growth potential, affecting overall revenue.
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Guidance & Outlook
Revenue Guidance for 2026: Vanda expects total revenues from currently commercialized products (Fanapt, HETLIOZ, and PONVORY) to be between $230 million and $260 million, implying a midpoint revenue growth of approximately 13% compared to 2025.
Fanapt Revenue Projections: Fanapt net product sales are expected to be between $150 million and $170 million in 2026, representing a midpoint revenue growth of approximately 36% compared to 2025. Growth assumptions range from mid- to high single-digit quarterly TRx growth at the low end to low double-digit to mid-teen quarterly TRx growth at the high end.
Other Product Sales Projections: Other net product sales (HETLIOZ and PONVORY) are projected to be between $80 million and $90 million in 2026. This includes a further decline in HETLIOZ sales due to generic competition and modest growth in PONVORY sales, contingent on improved market access.
Nereus Launch and Label Expansion: Nereus, approved for motion sickness, is expected to contribute to revenue growth. A Phase III program for label expansion to address vomiting induced by GLP-1 analogs is planned for the first half of 2026.
Bysanti and Imsidolimab Approvals: Potential approvals of Bysanti (for bipolar 1 disorder and schizophrenia) and Imsidolimab (for generalized pustular psoriasis) in 2026 could further contribute to revenue growth.
Pipeline Developments: Ongoing Phase III studies include Bysanti for major depressive disorder (results expected by end of 2026), long-acting injectable iloperidone for schizophrenia relapse prevention, and VQW-765 for social anxiety disorder (results expected by end of 2026).
PONVORY Expansion: Clinical development programs for PONVORY in psoriasis and ulcerative colitis are advancing, with Phase III evaluations planned. These expansions aim to broaden PONVORY's addressable patient population.
Cash Burn and Investments: Vanda anticipates a higher cash burn in 2026 compared to 2025 due to R&D investments, commercial inventory production, and conditional commercial investments. Milestone payments of $10 million to Eli Lilly and $5 million to Anaptys are expected in 2026.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you characterize any FDA communication on outstanding issues during the review cycle for Bysanti, and discuss the day 1 commercial strategy?
A:Bysanti is being reviewed as a new drug application (NDA), not a bioequivalent generic. The company remains optimistic for on-time approval. Commercialization, if approved, will begin in Q3 when supplies are ready, and more details on the launch strategy and interplay with Fanapt will be provided later.
Q:What is the expected commercial infrastructure size and scope for imsidolimab?
A:A small specialty sales force targeting dermatologists and advocacy organizations is expected, given the rarity of GPP. Awareness has improved since the 2021 approval of spesolimab.
Q:Are there any promotional activities planned for Fanapt and Bysanti, particularly direct-to-consumer campaigns in 2026?
A:Currently, there is no Bysanti campaign planned. The direct-to-consumer campaign focuses on brand awareness for Vanda, Fanapt, and PONVORY. A dedicated campaign for Bysanti is expected post-launch, but no concrete plans exist yet.
Q:When will NEREUS be commercially available, and what is the regulatory outlook for tradipitant in gastroparesis?
A:Commercial materials for NEREUS are expected by late Q2 or early Q3. For tradipitant in gastroparesis, the company is preparing for an FDA hearing, which was previously delayed. The Phase III study for GLP-1 analogs is expected to produce results by late Q3 or Q4.
Q:Will the Phase III program for iloperidone LAI complete enrollment by year-end?
A:Enrollment is ongoing but slow due to delays in Europe. Recruitment is improving in the U.S., but there is no clear visibility on meeting year-end recruitment goals.
Q:What are the Fanapt GTN impacts given the increase in volume and the difference between that and sales increase year-over-year?
A:Script growth outpaced revenue growth due to a small reduction in net price, influenced by Medicare benefit redesign and increased commercial co-pay support. The gross-to-net differential is expected to stabilize, with Bysanti offering more favorable gross-to-net dynamics.
Q:What is the guidance for 2026 revenue growth and the impact of Bysanti's launch?
A:Revenue growth is expected to be volume-driven, with no price increases due to Medicare and Medicaid dynamics. Bysanti's launch in Q3 will not contribute to the 2026 revenue guidance.
Q:What is the expected pricing and sales growth for NEREUS in its first year?
A:Pricing for NEREUS is expected to be higher than motion sickness treatments like Dramamine and scopolamine patches, and within the $200-$600 range of NK1 class drugs. Sales growth guidance has not been provided, but the market potential is significant.
Q:What is the design and expected outcome of the GLP-1 Phase III study?
A:The design is similar to the Phase II study, using a 1 mg Wegovy dose in naive patients. The company expects similar efficacy, with no concerns about the higher challenge dose affecting results.
Q:Review of Unclear Management Responses
A:Management avoided providing concrete details on the Bysanti launch strategy, specific promotional plans for Bysanti, and pricing or sales growth guidance for NEREUS. They also lacked clarity on the timeline for completing enrollment in the iloperidone LAI Phase III program and the FDA's decision on the tradipitant hearing.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
BLA FDA
Full
HETLIOZ competition
HETLIOZ product
III study
LAI
LQ PONVORY
National
PONVORY product
PONVORY sclerosis
Phase III
TRx
adherence
adult
anxiety disorder
area
brand awareness
cash balance
charge
demand
development program
disorder PONVORY
efficacy
face
franchise
improvement
launch disorder
life
milestone
noncash income
onset
option
quarterization
rate
representative end
result end
severity
symptom
therapy
volume increase
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VNDA Transcript
Vanda Pharmaceuticals Inc. (VNDA) Q4 2025 Earnings Call Transcript
Unknown2-14
The earnings call reveals mixed signals: a 9% revenue increase is positive, but a significant net loss and increased operating expenses are concerning. The Q&A section highlights optimism for FDA approvals, but uncertainties in commercialization and regulatory timelines persist. While there are positive developments, such as potential new drug approvals and ongoing clinical trials, the lack of clear guidance and increased expenses balance the sentiment to neutral.
Vanda Pharmaceuticals Inc. (VNDA) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-15
Vanda Pharmaceuticals Inc. (VNDA) Q3 2025 Earnings Call Transcript
Unknown10-29
The earnings call reflects mixed signals: while Fanapt and PONVORY show growth, HETLIOZ faces revenue variability. The increased net loss and operating expenses raise concerns, but optimistic guidance and potential FDA approvals for new drugs provide a positive outlook. The Q&A session highlights optimism but lacks specific guidance, tempering expectations. Overall, the sentiment is neutral, with positive and negative elements balancing each other.
Vanda Pharmaceuticals Inc. (VNDA) Q2 2025 Earnings Call Transcript
Unknown7-31
The earnings report shows mixed results: strong growth in Fanapt sales but declines in PONVORY and HETLIOZ, coupled with a significant net loss increase due to higher expenses. The Q&A revealed uncertainties about PONVORY's revenue dispute and unclear management responses. Despite some positive guidance on Bysanti and potential future products, the overall sentiment is negative due to financial losses and market uncertainties, likely leading to a stock price decline in the next two weeks.
VNDA Report
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