Vanda Pharmaceuticals Inc.

Good afternoon and welcome to the Quarter 1 2025 Vanda Pharmaceuticals Incorporated Earnings Conference Call. I am Franz and I'll be the operator assisting you today. 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 1 on your telephone keyboard. And if you would like to withdraw your question, press star 1 again. Thank you. I would now like to turn the call over to Kevin Moran, Vanda Chief Financial Officer. Please go ahead.

Thank you, Francis. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' first quarter 2025 performance. Our first quarter 2025 results were released this afternoon and are available on the SEC's Edgar system online. and on our website, www.vandafarma.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 Plain-Moropoulos, 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 10-Q, current reports on Form 8-K, 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, and good afternoon, everyone. Thank you for joining us to discuss BANDA's first quarter 2025 results. Vanda has entered a new growth phase with multiple commercialized products and a rich, innovative pipeline. FNAP commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April, as an increasing number of prescribers are adding FNAP to their therapeutic armamentarium. Our recent new drug application filings for Tredipitant and Bisanti are a testament to our productive research and development pipeline. The addition of Imsidolimab alongside Ponvori establishes an anti-inflammatory front size that we believe has significant growth potential. These accomplishments have been possible because of our talented employees who for the first time surpassed 400 in number, a 22-year high. Some of the key operational highlights starting with commercial activities. On FNAFT, FNAFT was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of FNAFT at this indication in the third quarter of 2024. In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions increased by approximately 14% and FNAP net product sales increased by 14%. Additionally, new patient starts as reflected by new-to-brand prescriptions increased by nearly three-fold in the same period of time. FNAP total prescriptions for the week of April 25 reached the milestone of 2,000, making FNAP one of the fastest-growing atypical antipsychotics. Dana has also announced an expansion of its psychiatrist sales force to approximately 300 representatives. On Hetlios, through the first quarter of 2025, Hetlios continues to retain the largest portion of market share despite generic competition for over two years. On Ponesimod, when they initiate the commercial launch of Polvorii for the treatment of relapsing forms of multiple sclerosis, in the third quarter of 2024. In April 2025, new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has reinforced the Ponvori sales leadership team and announced an expansion of its Ponvori sales force to approximately 40 representatives. I will turn to regulatory and clinical development highlights. Predefinite new drug application for motion sickness accepted for filing by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act target action date of December 30, 2025. FNAP marketing authorization applications for bipolar 1 disorder and schizophrenia were submitted to the European Medicine Agency in the fourth quarter of 2024. Behatlius marking the authorization application in Smith-McGinnis submitted to the EMA in Q4 of 2024. Bisanti, new drug application for bipolar one disorder in schizophrenia accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. MC-dolimel biologic license application for the treatment of generalized postular psoriasis is expected to be submitted to the FDA in 2025. Some clinical highlights on FNAPT. First, on schizophrenia, a Phase III program for the long-acting injectable formulation of FNAPT for the treatment of schizophrenia relapse prevention is ongoing. Hypertensive, that's a program we first discussed in the prior quarter. Panda has initiated a study for Phenapt long-acting injectable as a once a month injectable for uncontrolled hypertension and plans to begin enrolling patients soon. Bisanti, Melissa Peridot. The new drug application for Bisanti for the acute treatment of bipolar disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Exclusivity for Bisanti, including pending patent applications, could extend into the 2040s. Bisanti is a new chemical entity which was initially identified as an active metabolite of alloperidone. PANDER discovered that nulsaperidone, when administered orally, quickly interconverts to alloperidone. In clinical studies, Nilsaperidone and Avoperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose patterns. The results of these clinical studies will be presented in late May at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Scottsdale, Arizona. The Bisanti Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder is ongoing. Results are expected in 2026. Hetlios clinical programs in pediatric insomnia and delayed sleep phase disorders are ongoing. The VANDAS marketing application authorization for Hetlios and Hetlios-LQ for Smith-Mageni syndrome in Europe, with the European Medicines Agency. An investigational new drug application, 4.40, has been submitted and accepted by the FDA in the fourth quarter of 2024 for the treatment of psoriasis and ulcerative colitis. For the treatment of motion sickness, the NDA was accepted for filing by the FDA with the PDUFA target action date December 30, 2025. In the fourth quarter of 2024, Vanda initiated a clinical study to study drug dividend in the prevention of vomiting induced by a GLP-1 analogue, that's Wegovy semaglutide. Results are expected in the third quarter of 2025. Imcidolimab, in February 2025, Vanda announced it entered into an exclusive global license agreement with Anaptis for the development and commercialization of Imcidolimab. That's the IL-36R antagonist map. A BLA for generalized porcelain psoriasis is expected to be submitted to the FDA in 2025. And some highlights of the early stage programs, VQW765, the alpha-7-ecotinic acetylcholine receptor, partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate phase three program in 2025. The investigation of new drug application for VCA894A in the treatment of sarcoma tooth disease axonal type 2S and inherited peripheral neuropathy for which there is no available treatment was accepted by the FDA in 2024. Previously in 2023, VCA894A was granted orphan drug designation for the same indication. The phase one clinical study for VCA894A is expected to enroll the patient by mid-2025. With that, I'll turn now to Kevin to discuss our financial results.