Vanda Pharmaceuticals Inc.

Thank you for standing by. My name is Hermione and I will be your conference operator today. At this time, I would like to welcome everyone to Q1 2024 of Wanda Pharmaceuticals Incorporated 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 1 again. I would now like to turn the call over to Vanda's Chief Financial Officer, Kevin Moran. Please go ahead.

Thank you, Hermione. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceutical's first quarter 2024 performance. Our first 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. Mahalis Polymeropoulos.

Thank you very much, Kevin, and good afternoon, everyone. Thank you all for joining us to discuss VANDAS first quarter 2024 results. Let me start by providing details on the progress for our psychiatry portfolio of compounds. Phenapt was approved on April 2nd as a first-line therapy for the acute treatment of manic or mixed episodes associated with Bipolar I disorder in adults. which for this discussion I will refer to as bipolar I disorder. The results of the study supporting this approval were published in the Journal of Clinical Psychiatry earlier this year. This approval for bipolar I disorder significantly expands the addressable patient population for FNAP where patent exclusivity is expected to last at least through late 2027. For milsaperidone, the active metabolite of FNAP, a new drug application, NDA, is expected to be submitted to the Food and Drug Administration in early 2025. If approved for marketing for schizophrenia and bipolar I disorder, there are patent applications that could extend exclusivity into the 2040s. We're currently planning clinical programs to test the efficacy of FNAPT and milsaperidone in the treatment of depressive symptoms, which, if successful, would significantly further expand the addressable patient population. In addition, we're planning to initiate a registration study of the FNAPT long-acting injectable, or FNAPT-LAI formulation, by the end of 2024. FNAPT-LAI in earlier studies has demonstrated a profile compatible with a once-a-month administration, offering a significant tool to address compliance issues in this disease population. Phenaptic AI could reach the U.S. market after 2026, and there are pending patent applications that it issued could extend exclusivity into the 2040s. This is a key differentiation from some currently marketed branded antipsychotics for which physical chemical properties or dosing requirements prevent the development of long-acting injectables. FNAPT-LAI could potentially address a large patient population with chronic psychiatric conditions where compliance is a significant treatment challenge. We're also evaluating the use of FNAPT-LAI in the treatment of major depression for which there is currently no approved long-acting injectable treatment. In addition to FENAT, Milsa-Peridone has further differentiated physical chemical properties that beyond the oral formulation could permit the additional development of long-acting injectables with variable duration that could extend up to several months. It is worth underscoring that most currently approved drugs in this atypical and psychotic class have not been formulated as long-acting injectables, making FENAP and milsaperidone differentiated in this greater than a billion dollar estimated commercial opportunity. It is our vision to develop a multi-product psychiatry portfolio that will address multiple psychiatric indications and will expand the estimated addressable patient population to over 20 million people across these indications. Turning now to Hetlius. Hetlius, our circadian rhythm regulator approved in 2014 for non-24-hour sleep-wake disorder, is the first and only treatment approved for this disorder that disproportionately affects totally blind people. with its unique mechanism of action has revolutionized treatment for this disorder and has significantly impacted patients' lives. Hetlius LQ was approved in 2020 for the treatment of nighttime sleep disturbances in Smith-Magenius syndrome, again offering the first ever approved treatment for symptoms of this rare orphan disorder. The FDA application for hetlius in insomnia received a complete response letter from the FDA in March, 2024, and the final agency action of our application for the treatment of jet lag disorder is being challenged in the U.S. Court of Appeals for the DC circuit. A study of hetlios in delayed sleep phase disorder, an indication with no approved treatments, is ongoing in the U.S. and Germany. We're currently evaluating the initiation of the clinical program with Hetlios LQ in pediatric insomnia for children with or without neurodevelopmental comorbidities. Hetlios LQ is not subject to a generic challenge at this time. Although exact estimates of prevalence of insomnia in children are difficult to quantify, it is estimated that 20 to 40% of children experience significant sleep problems. There are currently no approved treatments for pediatric insomnia. If ultimately approved for marketing, the addressable patient population for Hethleos LQ would be significantly expanded and market exclusivity would be expected to last in the 2040s. The Hethleos capsule formulation commercial opportunity is subject to the launch of the three generic formulations. Vanda is currently challenging all three products on the grounds of unlawful FDA approval, patent infringement, and other statutory violations in U.S. federal courts. We believe that the exceptional mechanism of action of Hetlios can be leveraged to address the needs of millions of people that suffer with disorders where the circadian rhythm circuitry is perturbed. Turning now to Ponvoy. With the December 2023 acquisition of Ponvori, this makes the third commercial states product for Vanda. Currently approved as a once-a-day oral treatment for people with multiple sclerosis, Ponvori has a differentiated profile from other drugs in the class with high specificity and rapid reversibility, making for a versatile use to address the needs of people with multiple sclerosis. The transition from Janssen, a Johnson & Johnson company, is progressing well, with the completion expected in the coming months. In preparation for the U.S. commercial launch, Vanda is planning a host of commercial activities, including the creation of a specialty sales force, a prescriber awareness program, and a comprehensive marketing program. In addition, Vanda is evaluating Confori in additional autoimmune disorders including psoriasis and ulcerative colitis. Prior to our acquisition, Gonvori was tested in patients with psoriasis and demonstrated significant effects in both induction and maintenance of response. If approved in this indication, Gonvori would be the first oral sphingosin 1-phosphate analog in treating psoriasis and would significantly expand the addressable patient population of Punvori with over 8 million people diagnosed with psoriasis in the U.S. alone. Additionally, this class of drugs has proven to be effective in treating ulcerative colitis where Punvori, with its differentiated profile, could have a competitive advantage and significantly expand the addressable patient population with an estimated prevalence in the U.S. of approximately 2 million individuals with ulcerative colitis. Our vision is to increase awareness for Ponvori as an option for patients with multiple sclerosis in need of a specific and versatile agent. In addition, we intend to explore the application of Ponvori in a host of autoimmune disorders in which its mechanism of action could be therapeutically desirable. Finally, an update on tradipitin. Tradipitin, our neurokinin-1 receptor antagonist, is currently being developed for the treatment of gastroparesis with a new drug application under review by the FDA and an expected target action date in September of 2024. Gastroparesis prevalence is estimated to be over 6 million individuals in the U.S., and there has been no approved treatment in over 40 years. In addition to the FDA review, a clinical study is ongoing with over 600 patients to examine the safety and the exposure-response relationship of tradipitin in patients with gastroparesis. Close to 40 people have also been approved for treatment in the expanded access program with some of them have now been treated for a duration in excess of two years. Approval in this indication, gastroparesis, if received, will address a serious and mathematical need and bring a new therapeutic option to these patients for the first time in over 40 years. Tredipitant is also now completing the clinical program studying its effects in motion sickness with an NDA filing expected by year end. Results from the second and final phase three clinical study are expected in the coming months. The efficacy of tradipitin in motion sickness has previously been demonstrated in two clinical studies where tradipitin was effective in preventing vomiting associated with motion in traveling in the coastal waters of the United States. An eventual approval for this indication if received will significantly expand the addressable patient population with approximately 30% of the U.S. population reported to suffer from motion sickness under ordinary travel conditions that include sea, air, and land. Our vision is to evaluate and commercialize tradipitant for a host of indications including gastroparesis, motion sickness, and other disorders where this mechanism of action is desirable. Vanda also has earlier clinical programs which seek to address some medical needs for common and rare disorders ranging from dry eye, performance anxiety, and onychomycosis to polycythemia vera and sarcoma retube disease. We have been able to accomplish all this with a small but efficient organization that is enthusiastic to continue developing and commercializing treatments for people who need them. We expect several significant milestones in the coming months, including the launch of FENAPT in bipolar I disorder, the launch of PONVORI in multiple sclerosis, the potential approval of TREDIPTIN in gastroparesis, the Phase III results of tradipitin-emotion sickness, the upcoming NDA filings of milsaperidone in psychiatric disorders and of tradipitin-emotion sickness, and the initiation of clinical programs in depression, psoriasis, ulcerative colitis, and pediatric insomnia. We are confident that our robust revenue, strong cash position, and efficient operations position as well for significant growth and value creation in the years to come. Before turning to Kevin to walk you through our business and financial performance for the quarter, I want to take a minute to cover some other recent developments at Vanda. Yesterday, we issued a press release announcing that we are in receipt of a revised unsolicited takeover proposal. The board and management team are dedicated to acting in the best interest of our shareholders, and we would consider any ideas that would drive long-term shareholder value. To that end, our board of directors, alongside our independent financial and legal advisors, is in the process of reviewing and evaluating this revised unsolicited proposal. We will not comment further on this unsolicited takeover proposal before the board has completed its review. With that, I'll turn now to Kevin to discuss our financial results. Kevin.