Vanda Pharmaceuticals Inc.

Thank 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 conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I'd now like to turn the call over to Kevin Morant, Vanda's Chief Financial Officer. Please go ahead.

Thank you, Jordan. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceutical's fourth quarter and full year 2025 performance. Our fourth quarter and full year 2025 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. In addition, we are providing live and archived versions of this conference call on our website. Joining me on today's call is Dr. Mahalis Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board, and Tim Williams, our General Counsel. Following my introductory remarks, Mahalis will update you on our ongoing activities. I will then comment on our financial results before we open the lines for your questions. Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, and uncertainties. These risks are described in the cautionary note regarding forward-looking statements, risk factors, and management's discussion and analysis of financial condition and results of operations sections of our most recent annual report on Form 10-K as updated by our subsequent quarterly reports on Form 10Q, current reports on Form 8K, and other filings with the SEC, which are available on the SEC's EDGAR system and on our website. We encourage all investors to read these reports and our other filings. The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information future events, or otherwise, except as required by law. With that said, I would now like to turn the call over to our CEO, Dr. Mahalis Polymeropoulos.

Mahalis Polymeropoulos Thank you very much, Kevin. Good afternoon, everyone, and thank you for joining Vanda Pharmaceuticals' fourth quarter and full year 2025 Financial Results Conference call. 2025 was a year of strong commercial execution and significant regulatory and clinical advancements for Vanda. I will briefly address some of the key highlights. Our lead product, FNAFT, drove impressive growth. Full year net product sales increased 24% to 117.3 million versus 2024, supported by a 28% rise in total prescriptions and a remarkable 149% surge in new-to-brand prescriptions. This reflects accelerating momentum, broader prescriber adoption, and the impact of our targeted commercial investments, including direct-to-consumer campaigns that boosted brand awareness. Our full commercial franchise, Fnapt, Hetlios, Hetlios LQ, and Ponvoy, generate total revenues of $216.1 million for the year, up 9% year-over-year, demonstrating solid performance across our market products. Clinical and regulatory milestone highlights. We achieved a major regulatory win with the FDA approval of Nereus, Tredyptan, in late 2025 for the prevention of vomiting induced by motion, the first new oral pharmacologic option in this space in over 40 years. opens a substantial market opportunity in motion sickness. Motion sickness is a common condition with prevalence estimates indicating that approximately 25 to 30% of US adults, roughly 65 to 78 million people, experience symptoms during travel or motion exposure. Tens of millions seek pharmacologic relief annually, yet current options are often limited by adverse events or inconsistent efficacy. Nereus addresses this unmet need as well-tolerated, targeted, neurocognitive receptor antagonist, and we're actively preparing for its commercial launch to bring this innovation to patients facing this common issue. Separately, we see strong adjunct potential for Nereus in the rapidly expanding GLP-1 agonist market. used for diabetes and obesity management have seen explosive growth, with market projections tens of billions annually, and vomiting remains a frequent side effect, impacting up to 50% of patients on agents like semaglutide. Nereus demonstrated positive clinical results in preventing vomiting induced by the GLP-1 analog semaglutide in our study. To capitalize on this, we plan to initiate a dedicated Phase III program in the first half of 2026, pursuing label expansion in this high-potential area where better tolerability could significantly improve patient adherence and outcomes. The Bisanti-Milch-Saperidin NDA for Bipolar I Disorder and Schizophrenia is under FDA review, with a PDUFA target action date of February 21, 2026. Approval would further strengthen our growing psychiatry franchise alongside FNAP in the global antipsychotic category. This category had the total addressable market estimated at approximately 20 billion in 2025. We submitted the IMSI-Dolimab BLA in the fourth quarter of 2025 for generalized pustular psoriasis, advancing us toward potential approval for this serious unmet need. Imcidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is being developed for GPP, a rare orphan indication. Regulatory and patent exclusivity for Imcidolimab is expected to extend into the late 2030s. Vanda holds an exclusive global license for the development and commercialization of Ipsidolimab from Anaftis Bio. CPP flares involve painful pustules over large skin areas accompanied by redness, itching, and systemic symptoms, and can be life-threatening if untreated. Late-stage clinical development programs include a Phase III study of Bisanti as a once-a-day adjunct treatment for major depression, which is ongoing and results expected by end of the year. Major depressive disorder is the most common psychiatric disorder in the United States, affecting more than 20 million American adults in any given year, according to estimates from the National Institute of Mental Health and large scale . It is characterized by persistent feelings of sadness, loss of interest, or pleasure, fatigue, changes in appetite or sleep, feelings of worthlessness, and impaired concentration or decision making, often leading to significant functional impairment in work, relationships, and daily life. MDD exhibits highly variable clinical expression and natural course ranging from single episodic events to recurrent or chronic forms with episodes varying in severity, duration, and response to triggers. Despite the availability of multiple evidence-based treatments, a substantial unmet medical need remains. Approximately 30% to 50% of patients achieve only partial response or remission with first-line therapies. Many experience treatment-resistant depression. Relapse rates are high even after initial improvement and side effects. or delayed onset of action limit tolerability and adherence for a significant percentage of individuals. This persistent gap underscores the need for novel, more effective, and better tolerated adjunctive or alternative treatments to address the full spectrum of MDD. The phase three study of the long-acting injectable, LAI, formulation of iloperidone, continues to enroll patients for schizophrenia relapse prevention, representing a key enhancement to FNAP's long-term utility in psychiatric care. The long-acting injectable LAI antipsychotics market represents a significant and growing opportunity within the broader antipsychotic and psychiatric treatment landscape, driven by the need for improved adherence in chronic conditions, like schizophrenia and bipolar I disorder, where non-adherence to oral meds contributes to high relapse rates, hospitalizations, and costs. Estimates for the global LAI and psychotic-specific market vary across reports, but consensus points to a 2025 size in the 6 to 7 billion range with strong growth projected. A Phase III study of VQW765 are alpha-7 Nicotinic acetylcholine receptor parcel agonist in adults with social anxiety disorder has been initiated with results expected by end of 2026. Social anxiety disorder, SAD, affects approximately 30 million American adults, according to the 2023 National Health and Wellness Survey, with onset typically in the mid-teens or earlier and slightly higher diagnosis rates in females than males. It manifests as excessive fear of embarrassment, humiliation, scrutiny, evaluation, or rejection in social or performance situations leading to avoidance or intense distress that significantly impairs daily routine, occupational functioning, social life, and overall quality of life. Though individuals are generally asymptomatic, absent such triggers. Standard treatments include cognitive behavioral therapy, but many patients struggle to initiate or tolerate exposure due to the severity of anxiety. Off-label options like benzodiazepines offer rapid calming effects but carry risks of abuse, misuse, addiction, and black box warnings for interactions and dependency. Beta blockers provide situation relief but limited broader efficacy. This highlights the need for novel, on-demand therapies, like VQW765, to address acute episodes more effectively. Our clinical development programs for Ponvori, ponesimod, in psoriasis and ulcerative colitis are ongoing, building on its established profile as a selective S1, P1 receptor modulator approved for relapsing multiple sclerosis. For psoriasis, Convoy has already demonstrated strong efficacy in earlier studies, including a Phase II randomized double-blind placebo-controlled trial showing significant PASI 75 responses. That is greater than 75% reduction in psoriasis area and severity index at week 16 across tested doses of 10, 20, and 40 milligrams with sustained improvements in symptoms of moderate to severe chronic plaque psoriasis in a favorable time course of response. Recent updates indicate advancement over Phase III evaluation, positioning Ponvori as a potential oral option in this large inflammatory dermatology market. For ulcerative colitis, the S1P mechanism has been robustly validated by the successful commercialization approvals of other modulators, Zeposia and Velcipid, which have shown efficacy in Phase III trials for moderate to severe alternative colitis, achieving clinical remission and mucosal healing superior to placebo. PONFORI may be particularly well suited for this indication due to its pharmacological advantages of rapid onset of action, faster lymphocyte sequestration compared to some class members, and rapid lymphocyte recovery upon discontinuation. This profile offers greater flexibility for managing infections, vaccinations, surgery, pregnancy planning, or therapy switches, key considerations in chronic IBD where treatment interruptions or adjustments are common. These expansions will significantly broaden Purvoris addressable patient population and leverage its differentiated pharmacokinetics to address unmet needs in autoimmune inflammatory diseases beyond multiple sclerosis. We look forward to progress in these programs and sharing updates as they advance. Looking forward, we expect 2026 total revenues of 230 to 260 million from our current marketing projects only, that is FNAP, HETLIOS, HETLIOS-LQ, and PORVOY, establishing a strong baseline. We anticipate continued growth from this portfolio with further contributions from the nearest launch and potential approvals of Bisanti and IMSE-Doliman, plus progress across our late-stage programs. We believe that our growing psychiatry franchise is well-positioned for expansion, anchored by FNAPT on the market for schizophrenia and bipolar I disorder, with Bisanti, milsaperidone, currently under FDA review for bipolar I schizophrenia, with a PDUFA of February 21, 2026, and in ongoing phase III clinical development as an adjunctive treatment for major depressive disorder. Long-acting injectable formulation of alloperidone, advanced in Phase III for schizophrenia relapse prevention, and VQW 765 in a Phase III study for social anxiety disorder, with results expected by the end of 2026. Collectively, strengthening our portfolio across key psychiatric indications. In summary, 2025 showcased our ability to drive revenue while building a diversified, high-potential pipeline. We remain committed to delivering innovative therapies and long-term value for patients and shareholders. With that, I'll turn it over to Kevin.