Vanda Pharmaceuticals Inc.

Hello and thank you for standing by. At this time, I would like to welcome you to the Q4 2024 Vander Pharmaceuticals, Inc. Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker 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 conference over to Mr. 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 Pharmaceuticals' fourth quarter and full year 2024 performance. Our fourth quarter and full year 2024 results were released this afternoon. 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 in 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 for joining us to discuss VANDIS fourth quarter and full year 2024 results. As we discussed in our press release earlier this afternoon, strong revenue growth for FNAPT is putting us on a significant growth trajectory for 2025 and beyond, supported also by the commercial performance of Hedlius and Ponvori. The Phenapt long-acting injectable program, the new drug application for Bisanti for bipolar disorder, and schizophrenia, along with its development for major depressive disorder, have the potential to drive future growth in our psychiatry portfolio for many years to come. Tradipitant's new drug application for motion sickness was filed with a potential approval this year while we're pursuing approval in gastroparesis and the development of tradipitant to improve tolerability of GLP-1 analog, Wegovy. Our anti-inflammatory portfolio anchored by Ponvori was strengthened with the addition of Imcidolimab from Anaptis, an IL-36 receptor inhibitor for the treatment of generalized postular psoriasis. We plan to file a BLA later this year while we're exploring registration in Europe and Japan, as well as the development of this novel drug for other inflammatory disorders with an unopposed action. of the IL-36 system. In 2024, we returned to revenue growth, driven by the commercial launches in bipolar disorder and multiple sclerosis, and advanced our development pipeline with a number of projects at or near marketing applications. All this was achieved by the hard work, ingenuity, and efficiency of our organization and its wonderful people. I will now turn to FNAPT. FNAPT was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of FNAPT in this indication in the third quarter of 2024. In the fourth quarter, as compared to the fourth quarter of 2023, new patient starts as reflected by new-to-brand prescriptions, or NBRX, increased by over 160%, and FNAPT net product sales increased by 18%. A dedicated specialty sales force of approximately 200 persons has been promoting FNAPT, supported by a speaker program to improve peer-to-peer awareness. Given the successful trajectory and consistent with other peers, we're currently in the process of further expanding our sales force to 300 representatives, which will allow for increase in both reach and frequency. In January of 2025, we began our direct-to-consumer advertising to increase general consumer awareness of an app. We expect product adoption to continue as more prescribers develop treatment experiences and identify candidate patients. Banda also initiated a Phase III program for the long-acting injectable, LAI, formulation of FNAPT in the fourth quarter of 2024. The long-acting injectable, once a month FNAPT, is evaluated in relapse prevention for schizophrenia, where the oral formulation has already been shown to be successful and is already included in the FNAPT prescribing information. While all products so far have been developed in double-blind placebo-controlled studies, and while Vanda and FDA have agreed on this design, an IRB, institutional review board, has objected to a placebo-controlled design for schizophrenia maintenance. We're evaluating with the FDA ways to proceed outside of a placebo-controlled study, which could include a bridging study with the oral formulation. This evaluation is not specific to Vanda, and the outcome of this design will likely be required of others. Vanda plans to initiate a study for the Phenapt long-acting injectable as a once-a-month injectable for the treatment of hypertension to address both treatment resistance and treatment compliance. In the course of our extensive clinical program with FNAPT for over 20 years, we have now identified an unexpected but robust benefit in treating hypertension with FNAPT. Specifically, in a large meta-analysis of placebo controlled studies, we have identified a rapid and sustainable effect in reducing systolic and diastolic blood pressure especially among people with baseline hypertension. The effect size is comparable to effective antihypertensives. While the exact mechanism is not known, we believe that this effect is likely due to the mixed alpha, serotonin, and dopamine receptor antagonism observed with FENAPT. We plan to initiate a study to evaluate this effect with the once-a-month injectable Phenaptil-AI in people with treatment-resistant hypertension. It has been reported that medication non-adherence in hypertension is a significant public health risk, and as such, if we're successful in our studies, Phenaptil-AI could become the first medication to address this large public health need. Additionally, Vanda submitted a marketing authorization application in Europe in the fourth quarter of 2024 for FNAPT, and that is the European Medicine Agency for Bipolar I Disorder and Schizophrenia. I will now turn to Bisanti, known as Milsaperidone. Vanda expects to submit a new drug application for Bisanti for the treatments of acute bipolar I disorder and schizophrenia to the US Food and Drug Administration in the first quarter of 2025. Exclusivity, including pending patent applications, could extend into the 2040s. Bisanti is an active metabolite of alloperidone and has been extensively studied. In the last year, we have met with the FDA and agreed upon the clinical and manufacturing requirements and were now prepared to submit a new drug application in the coming weeks. Vanda initiated a Phase III clinical study for Bisanti as a once-a-day adjunctive treatment for major depressive disorder in the fourth quarter of 2024. Results are expected in 2026. I will now move on to Hetlius Tazimelkin. Vanda has initiated clinical programs in pediatric insomnia and delayed sleep phase disorder, and these programs are ongoing. Vanda's MAA for Hetlius and Hetlius LQ for Smith-Mageni syndrome is now pending with the European Medicines Agency. In addition, Vanda is continuing to pursue the approval of Hetlios in sleep-onset insomnia and the treatment of jet lag. Vanda has completed successfully multiple studies in these indications that have demonstrated substantial evidence of efficacy and a positive benefit-risk profile. Vanda has requested an FDA hearing on the insomnia indication, and an appeals court is expected to rule in the coming months on the jet lag application. Ponvori, Ponacimod. Vanda initiated the commercial launch of Ponvori for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. A new specialty sales force is now promoting Ponvori for this indication across the United States. We believe that Ponvori's profile, when appreciated, will drive the preferences of prescribers and patients. The sales force supported by a new speakers program for peer-to-peer awareness. Investigational new drug applications for Ponvori in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Ponvori has been previously shown to be effective in treating acute episodes of psoriasis, as well as preventing relapse. This study was conducted by Actelion before Vanda's acquisition of the product, and the results have been published. Vanda is now finalizing the development program that could lead to a new drug application filing in this indication. The new drug application for tradipitin for the treatment of motion sickness. was submitted to the FDA in the fourth quarter of 2024. This application is supported by three positive studies in prevention of motion-induced vomiting in actual sea travel conditions. We expect an FDA decision later this year. VANA has recently initiated a clinical trial to study traduptant in the prevention of vomiting induced by a GLP-1 analog, Wegovy, that is semaglutide, in the fourth quarter of 2024. A frequent and at times severe treatment emerging adverse event with GLP-1 analogs is nausea and vomiting, which requires slower titration and delayed onset of effect. We're evaluating whether tradipitin can prevent Wegovy induced nausea and vomiting, and if it does, it could become a very useful product during GLP-1 analog treatment initiation. Banda has now accepted the opportunity for a hearing with the FDA on the approvability of the NDA for tradipitin for the treatment of symptoms of gastroparesis. Banda has identified a number of faults in the FDA review. that led to a complete response letter, and we believe that if allowed to be reviewed by experts, they would also reach the conclusion that tradipitin can be a useful product in treating symptoms of gastroparesis. In the meantime, more than 50 patients are currently treated with tradipitin through the expanded access program, and many additional ones are being evaluated to initiate treatment. IMSI-Dolimab. In February 2025, Vanda announced it entered into an exclusive global license agreement with Anaptis Bio, Anaptis, for the development and commercialization of IMSI-Dolimab. That is an IL-36 receptor antagonist monoclonal antibody. Vanda expects to initiate and complete the technology transfer activities in 2025 and to immediately begin preparing the biologic license application, BLA, and MAA for generalized postural psoriasis, GPP, for the U.S. and European Union. Generalized postural psoriasis, or GPP, is a rare, severe skin disorder that is often caused by recessive mutations in the IL-36 RN gene, regulator of the IL-36 activity. The role of such mutations in heterozygous state, which are far more common, is not yet appreciated, but it may play a significant role in the pathogenesis and progression of other inflammatory skin conditions. We plan to file a BLA later this year while we're exploring registration in Europe and Japan, and as well as the development of this novel drug in other inflammatory disorders with an unopposed action of the IL-36 cytokine system. Finally, on early stage program highlights, VKW-765 and alpha-7 nicotinic a cephalocollin receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. We have previously reported results from a Phase II study with encouraging outcomes in a model of acute performance anxiety. We plan to meet with the FDA in the coming months at the end of Phase II meeting and plan to initiate Phase III program in social anxiety disorder in 2025. The IND application for VCA894A, an antisense oligonucleotide, in the treatment of Sarcot-Marie-Tooth disease, axonal type 2S, an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. The Phase I clinical study for VCA894A is expected to enroll this single patient by mid-2025. In December 2024, Vanda announced that the FDA has granted orphan drug designation for VGT1849A, a selective antisense oligonucleotide-based JAK2 inhibitor for the treatment of polycythemia vera, a form of a rare hematologic malignancy that is estimated to affect 1 in 2,000 Americans. I will just review the key regulatory milestones. Tredipitin NDA for motion sickness, submitted in Q4 2024. FNAPT MAA in Europe. for Bipolar I Disorder and Schizophrenia, submitted in Q4, 2024. Hetlios, MAA in Europe, for Smith-Mageni Syndrome, submitted in Q4, 2024. Bisanti, new drug application for Bipolar I Disorder and Schizophrenia, expected to be submitted in Q1, 2025. And Imcidolimab, BLA in generalized postular psoriasis, expect to be submitted in 2025. With that, I'll turn now to Kevin to discuss our financial results. Kevin.