Vanda Pharmaceuticals Inc.

Good day everyone and thank you for standing by. My name is RG and I will be your conference operator today. At this time, I would like to welcome everyone to the Q2 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 would now like to turn the call over to Vanda's Chief Financial Officer, Kevin Moran. Please go ahead.

Great. Thank you, R.G. Good morning, and thank you for joining us to discuss Vanda Pharmaceutical's second quarter 2025 performance. Our second quarter 2025 results were released this morning and are available on the SEC's EDGAR system 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 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 Palai-Moropoulos.

Thank you very much, Kevin. Good morning, everyone. This second quarter, we continued the expansion of the FNAP sales force also continued our broad awareness campaign. FNAP revenue increased by 27% compared to the same period in the prior year, driven by the launch of the bipolar one indication. FNAP is now promoted in the U.S. across all 50 states with a dedicated sales force of approximately 300 representatives. With the expansion of the sales force during the second quarter we observed a significant increase in activity with a total number of calls going by more than 40% as compared to the first quarter of 2025 and growing by over 400% compared to the second quarter of 2024. Since the bipolar launch, the end is measured by total prescriptions, TRX, new prescriptions, NRX, and new-to-brand prescriptions, and BRX, with new highs in the second quarter. The commercialization of FNAP is also supported by a broad speakers program operating across the country that educates prescribers on the profile of FNAP and how to use it. We're excited by the progress our organization has made as we continue to support the commercialization of FNAP aiming for further growth in the coming periods. Total revenue from our three commercial branded products, FNAPT, Hetlios, and Ponvori, reached $102.6 million in the first six months of 2025. Hetlios continues to be the market share leader despite the availability of infomeric products, a testament to the brand loyalty of our patient customers for the last 11 years. We'll continue to build out and train our dedicated Bonvori Salesforce team, addressing prescribers for multiple sclerosis. In the last quarter, we saw an increase in new prescriptions as we identify our consumer and prescriber awareness programs. Regulatory clinical updates, first on Bisanti, The NDA for Bisanti for the acute treatment of bipolar I 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 recently identified as an active metabolite of Iloperidone. Van discovered that Milsiperidone, that's the generic name of Bisanti, was administered orally, quickly interconverts to Iloperidone. In case that Milsiperidone and Iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple-dose studies. The results of these clinical studies were presented in late May at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Scottsdale, Arizona. The Bisanti Phase III clinical study for years as the daily adjunctive treatment for major depressive disorder is ongoing. The results of that study are expected in 2026. The new drug application for Tredyptan for the treatment of motion sickness will be accepted for filing by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, VEM initiated a clinical trial to study Tredyptan in the prevention of vomiting induced by GLP-1 analog, Wegovy, that is semi-glutide. These cells are expected soon in the third quarter of 2025. On FNAPT, first schizophrenia, a PCC program for the long-acting injectable LAI formulation of FNAPT in the treatment of schizophrenia in relapse prevention is ongoing. On hypertension, Vanda initiated now a study of the FNAF long-acting injectable as a once-a-month injectable for and without hypertension and plans to begin enrolling patients soon. Imcidolimab. A BLA for Imcidolimab in the treatment of the rare orphan disorder generalized postular psoriasis GDP is expected to be submitted to the FDA this year, in 2013. Punvori. Investigational new drug applications for Punvori in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024, and has initiated the psoriasis study and plans to initiate a study in ulcerative colitis by early 2026. On the early stage programs, VQW765, the alpha-7 nicotinic acetylcholine receptor is currently in clinical development for the treatment of acute performance anxiety in normal situations. VANDEC has initiated a phase three program and to begin enrolling patients. So the IMD application for VCA 894 a for the treatment of Cervical disease, axonal type to us and inherited peripheral neuropathy for which there is no available treatment was accessed by the FDA in 2014. VCA 894 a was granted an orthodontic designation for the same indication in 2023. The physical clinical study for BCA894A enrolled the patient with specific mutation, and this patient has already received several doses of BCA894A. Finally, as part of our public policy contributions to drug development, Vande responded to an HHS request for information. On May 14, 2025, the U.S. Department of Health and Human Services, HHS, issued a request for information entitled, Inserting Lawful Regulation and Enhancing Innovation to Make America Healthy Again. On July 14, 2025, Vande submitted a public response to this RFI. The Vandafarma response proposed that FDA repeal unlawful regulations that delay and overburden the drug approval process and that FDA repeal 1990s era guidance mandating lethal animal testing. Our full response with exhibits is available on the investors' page of our website, that is www.vandafarma.com. at the government website, regulations.com. With this, I'll turn it back to Kevin. Kevin?