For Hetlioz, full-year net product sales fell 7% to $71.4 million. Moran said the decline reflected lower volume and price net of deductions amid continued U.S. generic competition, while noting the brand “continued to retain the majority of market share despite generic competition now for over three years.” Ponvory net product sales were $27.4 million, down 2% versus 2024, with the company also noting that certain variable consideration tied to Ponvory sales remains subject to dispute.Total 2025 revenues a ...

Vanda Pharmaceuticals (NasdaqGM:VNDA) Q4 2025 Earnings call February 11, 2026 04:30 PM ET Company ParticipantsAndrew Tsai - Managing DirectorKevin Moran - CFOMihael Polymeropoulos - CEORaghuram Selvaraju - Managing DirectorConference Call ParticipantsMadison El-Saadi - Healthcare Research AnalystNone - AnalystOperatorThank you for standing by. My name is Jordan, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Q4 2025 Vanda Pharmaceuticals Inc. earnings conferenc ...

Vanda Pharmaceuticals FY Conference Summary Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on innovative therapies with a strong commercial portfolio anchored by four FDA-approved brands: Fanapt, Hetlioz, Ponvory, and Nereus [2][3] Core Products and Pipeline - **Fanapt**: An atypical antipsychotic approved for bipolar I disorder and schizophrenia. A long-acting injectable formulation is in phase three for schizophrenia, and a program for hypertension has been initiated [4][5] - **Hetlioz**: Approved for non-24-hour sleep-wake disorder and other sleep disturbances. It is at the regulatory stage for insomnia and jet lag disorder [6][7] - **Ponvory**: Approved for relapsing forms of multiple sclerosis, with ongoing phase three programs for psoriasis and ulcerative colitis [6][7] - **Nereus**: Recently approved for motion sickness, with potential applications in GLP-1 induced nausea and vomiting, and gastroparesis [6][7][10] Financial Performance - For Q3 2025, Vanda reported revenue of $56.3 million, with contributions from Fanapt ($31 million), Hetlioz ($18 million), and Ponvory ($7 million). The company expects total revenue for 2025 to be between $210 million and $230 million [21][22] Strategic Focus - The company aims to grow and diversify revenue by expanding existing products and introducing new ones, targeting six commercial products by the end of 2026 [3][4] - Upcoming regulatory catalysts include Bysanti's PDUFA date on February 21, 2026, and the initiation of phase three programs for GLP-1 induced vomiting [7][10] Market Opportunities - **Nereus**: The motion sickness market has approximately 30% of adults in the U.S. experiencing symptoms, translating to a potential patient population of around 12 million. The GLP-1 market, valued at over $50 billion, presents a significant opportunity for Nereus as an adjunct treatment [11][12][35] - **Bysanti**: Expected to extend the psychiatry portfolio, especially with a potential indication for major depressive disorder (MDD), which could open treatment options for an additional 20 million patients [15][31] Commercialization Strategy - Vanda has a robust sales force of around 300 reps, primarily targeting psychiatrists, but plans to expand efforts to include primary care physicians for Bysanti [26][28] - The company anticipates a transition strategy from Fanapt to Bysanti, leveraging existing resources to maintain revenue streams post-Fanapt's expected loss of exclusivity around 2027 [28][29] R&D Milestones - Nereus's approval for motion sickness was a significant milestone, with a commercial launch expected in the second half of 2026. The company is also pursuing additional indications for its products [7][10] - Imsidolimab, targeting generalized pustular psoriasis, is under priority review with a potential launch in summer 2026 [17][37] Conclusion - Vanda Pharmaceuticals is positioned for significant growth with a strong pipeline and strategic focus on expanding its product offerings. The upcoming regulatory milestones and market opportunities in motion sickness and the GLP-1 space are key drivers for future revenue growth [39]

Core Viewpoint - Vanda Pharmaceuticals has submitted a Biologics License Application (BLA) to the FDA for imsidolimab, a novel treatment for generalized pustular psoriasis (GPP), addressing a significant unmet medical need in this rare condition [1][3]. Group 1: Drug Development and Clinical Trials - The BLA submission is supported by positive results from the Phase 3 GEMINI-1 and GEMINI-2 studies, where a single intravenous dose of imsidolimab resulted in rapid disease clearance, with 53% of patients achieving clear or almost clear skin at Week 4 compared to 13% on placebo [2][4]. - In the GEMINI-2 study, patients receiving monthly subcutaneous maintenance doses of imsidolimab maintained clear or almost clear skin with no flares, while the placebo group had a 63% flare rate [5]. Group 2: Market Potential and Company Strategy - GPP is characterized by sudden flares and represents a significant unmet medical need, with prevalence estimates ranging from approximately 2 to 124 cases per million worldwide [2]. - Vanda has requested priority review for the BLA, which could lead to a six-month review cycle and potential FDA approval by mid-2026, leveraging its commercial infrastructure to address GPP [3][8]. Group 3: Company Background and Product Information - Vanda Pharmaceuticals focuses on developing innovative therapies for high unmet medical needs, with imsidolimab being a fully humanized IgG4 monoclonal antibody targeting IL-36 receptor signaling [8][10]. - The company holds an exclusive global license for imsidolimab from AnaptysBio, with regulatory and patent exclusivity expected to extend into the late 2030s [8].

Vanda Pharmaceuticals Conference Call Summary Company Overview - Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on innovating to enhance people's happiness [2][3] - The company has three commercialized products: - **Fanapt**: Approved for bipolar disorder and schizophrenia in the U.S. - **Hetlioz**: Approved for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome in both adults and pediatric populations, with approvals in Europe as well [2][3] - **Ponvory**: Approved for multiple sclerosis, acquired from Johnson & Johnson at the end of 2023 [3] Financial Position - As of Q3 2025, Vanda has approximately $294 million in cash and no debt [3] - 2025 revenue guidance is set between $210 million and $230 million, with Q3 2025 revenue reported at $56.3 million [12][13] Product Pipeline and Regulatory Updates - **Fanapt**: - Pursuing FDA approval for **Basanti**, the active metabolite of Fanapt, with a PDUFA target action date of February 21, 2026 [3][10] - Phase three program for major depressive disorder (MDD) expected to yield results in 2026 [4][10] - Long-acting injectable formulation of Fanapt is in phase three trials [11] - **Hetlioz**: - Re-review of the jet lag supplemental new drug application (SNDA) with an FDA decision expected by January 7, 2026 [4][10] - Pursuing additional indications for Hetlioz, including jet lag and maintaining market share against generics [6][7] - **Ponvory**: - Commercial launch is progressing well, with increased patient demand noted [7][8] - Ongoing phase three programs for psoriasis and ulcerative colitis [12] - **Tradipitant**: - Upcoming PDUFA date for motion sickness on December 30, 2025 [9][12] - Phase two study for nausea in patients taking GLP-1 medications is underway, with results expected in Q4 2025 [9][46] - **Imsidolumab**: - Biologics License Application (BLA) for generalized pustular psoriasis (GPP) expected to be submitted by the end of the year [10] Strategic Focus - Vanda aims to grow revenue organically through existing products and through potential business development opportunities [5] - Focus on increasing access and affordability for patients while engaging directly with consumers [5] Market Dynamics and Competitive Landscape - The antipsychotic market is evolving with new entrants like Kobenphy, which presents both opportunities and challenges [25][26] - The treatment landscape remains promotionally sensitive, with a high switch rate among patients seeking effective medications [27][28] Upcoming Milestones and Expectations - The company is optimistic about the upcoming PDUFA dates and the potential for positive results in ongoing trials [20][32] - The MDD trial is seen as a significant opportunity, with a large addressable market [34][35] - The motion sickness and jet lag markets are expected to be driven by consumer demand, with potential insurance coverage as well [38][40] Conclusion - Vanda Pharmaceuticals is well-positioned with a strong financial foundation and a robust pipeline of products and regulatory submissions. The company is focused on maximizing the potential of its existing products while navigating the competitive landscape and addressing unmet medical needs in various therapeutic areas.

Financial Data and Key Metrics Changes - For the full year 2025, the company projects total revenues between $210 million and $250 million, with a midpoint of $230 million [23] - In the second quarter of 2025, the company reported revenue of $52.6 million, with net product sales from Fanapt at $29.3 million, Hetlioz at $16.2 million, and Ponvory at $7.1 million [23] - For the six months ended June 30, 2025, total revenue was approximately $103 million, with Fanapt being the lead revenue generator at approximately $53 million [23] - Operating expenses for the same period were approximately $182 million, resulting in a net loss of approximately $57 million [23] - The company ended the second quarter with approximately $325 million in cash and no debt [4][24] Business Line Data and Key Metrics Changes - Fanapt has seen significant prescription growth, reaching approximately 2,300 TRXs per week in mid-August 2025, compared to 1,300 to 1,400 TRXs per week around the same time last year [5] - New-to-brand prescriptions for Fanapt increased to about 240 NBRXs per week recently, up from about 40 NBRXs per week at the same time last year [5] - Hetlioz continues to face revenue erosion due to generic competition but maintains the majority of its patient population [6][7] - Ponvory, acquired from Johnson & Johnson, has shown higher patient demand in the second quarter of 2025 compared to the first quarter post-acquisition [9] Market Data and Key Metrics Changes - The company is focused on expanding its commercial footprint in the U.S. for Fanapt, increasing its sales representatives from approximately 150 to about 300 [4] - The company is pursuing FDA approval for Bysanti, with a PDUFA date set for February 21, 2026, and is also working on a clinical program for major depressive disorder [5][11] Company Strategy and Development Direction - The company aims to increase revenue both organically through existing products and through business development opportunities, as evidenced by the acquisition of Ponvory and in-licensing of imsidolumab [9][10] - The strategic focus includes advancing the pipeline with upcoming regulatory milestones that could increase the number of commercialized products from three to potentially six by the end of next year [10] - The company is committed to enhancing patient access and affordability for its medications while engaging directly with consumers [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming regulatory milestones and the potential for increased commercial presence [10] - The company remains focused on retaining market share for Hetlioz despite generic competition and is pursuing additional indications for the product [11] - Management highlighted the significant unmet medical need for gastroparesis and the potential market opportunity for tradipitant if approved [17] Other Important Information - The company has a robust pipeline with several products at various stages of development, including tradipitant for gastroparesis and motion sickness, with PDUFA dates approaching [12][16] - The company is also pursuing additional treatments for Ponvory in ulcerative colitis and psoriasis [12] Q&A Session Summary Question: What is the expected revenue for 2025? - The company projects total revenues between $210 million and $250 million for 2025, with a midpoint of $230 million [23] Question: How is the commercial launch of Ponvory progressing? - The company noted that patient demand for Ponvory in the second quarter was higher than in the first quarter post-acquisition, indicating positive momentum [9] Question: What are the plans for Hetlioz in light of generic competition? - Management stated that they are focused on retaining market share and pursuing additional indications for Hetlioz, particularly in the Smith-Magenis syndrome market [11]