Vanda Pharmaceuticals Inc.

Hello and thank you for standing by. At this time, I would like to welcome you to the Q3 2024 Vander 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 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again. I would now like to turn the conference over to Kevin Moran, Vanda's Chief Financial Officer. Please go ahead, sir.

Thank you, Jericho. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceutical's third quarter 2024 performance. Our third quarter 2024 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 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. Mahalas Palimoropoulos.

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss VANDIS third quarter 2024 results. During the last quarter, we have been focused on building and strengthening our commercial organization to support the new launches of FNAPT in bipolar I disorder and Punvori in multiple sclerosis. In Q3, we completed the first phase of our Salesforce build out to support the FNAPT launch with approximately 150 representatives marketing the product to psychiatry prescribers around the country. This launch has been supported by the FNAPT speakers program, creating awareness of the product among prescribers. The early indicators of commercial progress are encouraging and include more than 90% increase compared to Q3 of 2023 in new patient starts as captured by the IQVIA and BRX metric. This large increase is followed by observed increases in the NRX and TRX IQ metrics of new and total weekly prescriptions. We're observing a steady and continuous growth on adoption of the product with only a few months of operation of our enhanced national sales force. We have now initiated the second phase of sales force expansion that will bring the sales force to approximately 200 representatives by year end. We're excited with the commercial prospects of FNAPT, and we believe that significant growth can be accomplished in the near future. FNAPT is the flagship product of our psychiatry portfolio, which now also includes milsaperidone, an active metabolite of FNAPT, and FNAPT-LAI, long-acting injectable. A new drug application is planned for early 2025 for the indications of schizophrenia and bipolar I disorder for milsaperidone after a successful pre-NDA meeting with the FDA earlier this year. Additionally, we plan to initiate a Phase III program for milsaperidin in major depressive disorder this quarter. Success in this program is expected to significantly expand the potential of the franchise with the inclusion of the much more prevalent indication of depression. In addition, the pivotal long-term relapse prevention study with the once-monthly LAI FNAP is planned to start this quarter. We recently met with the FDA to discuss the potential NDA package for Fnapt-LAI, and we're in agreement that a successful completion of this upcoming study may be sufficient to support a new drug application for this product. I will now switch to Ponvori and our commercial efforts in multiple sclerosis, as well as our developing plans for indication expansion. Ponvori, a sphingosine 1-phosphate analog approved for the treatment of multiple sclerosis, was acquired last year from Janssen. In this last quarter, we built and launched our commercial sales team along with the Ponvori speakers program. The transition from Janssen was substantially completed in the third quarter after the transition of the marketing authorization was completed late in the second quarter. Our sales force, has received enthusiastic reception by many multiple sclerosis experts, some of whom were already familiar, while others are new to the product. Polivori is one of four products in this class and is differentiated by its receptor specificity and the quick onset and offset of action. In two recent publications, Clinician and Patient Preferences for sphingosine 1-phosphate analogs were examined in a discrete choice experiment design. Polvorio rose to the first choice position, both in the 200 U.S. neurologist study and the 400 multiple sclerosis patient study. The prescribers preferred ponesimod over siponimod, fingolimod, and ozanimod, primarily because of the fewer drug-drug interactions, while the multiple sclerosis patients chose ponesimod because of the shorter immune system recovery time in addition to the fewer drug-drug interactions. We look forward to increasing awareness of Ponvori among prescribers and patients over the coming quarters. Beyond multiple sclerosis, Ponvori has a potential utility in the treatment of other autoimmune disorders. In plaque psoriasis, Ponvori has shown significant efficacy in achieving PASI-75, the measurement of improvement of psoriasis score by week 16 in a large 326-patient study that included two doses of Ponvori and placebo. Both doses of Ponvori achieved the primary endpoint and showed highly significant results of p-value of less than 0.0001 for both doses tested. We expect to file an IND application for psoriasis with the FDA shortly. Successful completion of the program could result in a once-daily oral treatment for patients with psoriasis that may offer a convenient and effective option beyond the available injectable drugs. Separately, we have recently submitted an IND application to initiate a Ponvori program in ulcerative colitis. Again, here we believe that the successful completion of this program may bring a useful and differentiated option to patients with ulcerative colitis. On tradipitin, our neurokinin one receptor antagonist, we recently reported that the FDA denied approval for the treatment of symptoms of gastroparesis. We're disappointed with this decision as we believe that our application, the most expensive ever to be submitted to the FDA for this indication has already demonstrated substantial evidence of efficacy to warrant approval. The FDA's reasoning was mostly conclusory and not supported by the facts presented. This negative decision is especially disappointing for many patients with gastroparesis and especially for those that experience significant improvements in their condition where other treatments have failed for years. Dozens of patients are currently participating in the expanded access program, and many more have either applied or expressed interest to access tradipitant. We're committed to continue to pursue approval for this condition and support patients requesting expanded access. We believe that the best path forward would be for the FDA to convene the Scientific Advisory Committee to independently evaluate the evidence and offer their advice. In addition, we plan to initiate a clinical trial to study the effect of tradipitin in preventing vomiting in people treated with GLP-1 analogs, like semaglutide. Millions of patients are treated with GLP-1 analogs for diabetes and weight reduction, and a large portion of them experience nausea and vomiting, especially during the titration phase. We believe that tradipitin, because of its mechanism of action, has the potential to improve tolerability of these agents and permit more rapid titration, thereby improving the efficacy and safety profile of these useful agents. We have already shown in three adequate and well-controlled studies that tradipitin can be used to prevent vomiting induced by motion sickness. Traditionally, it has been shown to be effective at both doses tested during actual sea travel of the coastal waters of the United States. We plan to submit a new drug application for this indication by end of this year. While we highlight these programs, we continue our work to expand the indications for our approved products. Recently, we met with the FDA and agreed on a clinical program that could support the approval of hetlios in pediatric insomnia. Pediatric insomnia is a large unmet medical need with very few options and a very large burden to patients and their families. We believe that hetlios could have a significant public health impact in treating this very common pediatric condition. A clinical study in pediatric insomnia is underway. In our press release today, we briefly mentioned two other programs. The first with the CFTR activator VSJ110, which has shown encouraging results in dry eye disorder in an ongoing study. The second is a groundbreaking program in sarcoma tooth disease using antisensory nucleotide VCA894A, where this custom-developed drug is expected to be evaluated in a patient with this ultra-rare mutation later this year. In summary, we're excited with our FNAT loans and the revenue growth opportunities through all three of our commercial programs and look forward to providing updates on this as well as our promising pipeline in the future. With that, I'll turn now to Kevin to discuss our financial results. Kevin.