Vanda Pharmaceuticals Inc.

Good afternoon, ladies and gentlemen, and welcome to the Q4 2020 Vanda Pharmaceuticals, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star, then zero on your touch-tone telephone. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Kevin Moran, Vanda's Chief Financial Officer. Thank you. Please go ahead.

Thank you, Sadie. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceutical's fourth quarter and full year 2020 performance. Our fourth quarter and full year 2020 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 and CEO. Following my introductory remarks, Mahalis will update you on our ongoing activities. I will then comment on our financial results before opening 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 annual report on Form 10-K for the fiscal year ended December 31, 2019, 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. Additional factors may be set forth in those sections of our annual report on Form 10-K for the fiscal year ended December 31st, 2020, to be filed with the SEC in the first quarter of 2021. We encourage all investors to read these reports and our other SEC 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 Palimoropoulos.

Thank you, Kevin. Good afternoon, everyone, and thank you very much for joining us. We're pleased with our financial performance as we navigated the pandemic this last year, and continue to drive strong growth during the year in line with our original forecast in February of 2020. Full year revenue for both projects was $248.2 million, a 9% increase compared to 2019. Despite a slowdown in late spring, since then we have seen a significant increase in new heftier scripts as the business has recovered and adapted to the new ways of promotion. This demand fueled Hetlio's growth in the fourth quarter and led us with positive momentum into 2021. Hetlio's fourth quarter revenue was 44.2 million, a sequential growth of 11%. Our forecast for 2021 is Hetlio's revenue of 180 to 200 million, a projected year-over-year growth of 12 to 24%. FNAP revenue in Q4 saw a 5% increase compared to the fourth quarter of 2019. Early in the summer, we launched a direct-to-consumer campaign with national television advertisement. While it is early in the campaign, the lead indicators of website visits and searches saw significant increase as compared to before the initiation of the campaign. In parallel, awareness for our Phenapt brand is entering the national stage. We remain optimistic that awareness will lead to new starts that will hopefully translate to an increase in the number of patients on Phenapt during 2021. As we announced on December 1st of 2020, the FDA approved oral, capsule, and liquid formulations of Hetlios for the treatment of nighttime sleep disturbances in Smith-Magenius syndrome for adults and children, respectively. Hetlius is the first FDA-approved medication for patients with SMS. SMS is a neurodevelopmental disorder caused by a genetic mutation of chromosome 17, which is a microdeletion in 90% of the patients, and a point mutation in the RAI gene, which is included in the microdeletion region in 10% of the patients. SMS affects 1 in 15,000 to 25,000 births, with an estimated U.S. prevalence of approximately 15,000 patients. The most common and most disruptive clinical expression is a sleep disorder that impacts the function of patients and consequently their families. Daniel has been working over the years in collaboration with the patient advocacy organization, PRISMS, to develop headless for SMS, and bring it now to patients. We're continuing our collaboration following the approval and expand our efforts to increase awareness of the disorder and of HETLIOS to the broader SMS patient population. While we're just at the beginning of the commercial launch of the HETLIOS capsule formulation for adult patients with SMS, we're encouraged by the early response. Specifically, more than 100 patient families have now been engaged and are at different states of discussing the treatment option with their physicians, while more than 20 have already received prescriptions. At this time, however, it's difficult to estimate a growth trajectory for the adoption of HETLIOS by SMS patients as we deploy different strategies to reach and inform the community of approximately 15,000 SMS patients of the therapeutic option that Headless brings. I'll turn now to tradipitant. The phase three study in gastroparesis is ongoing with over 65% enrolled, on track to complete enrollment in the first half and report results later in 2021. As we have previously communicated, we believe that the current phase three study can be the last efficacy study required for NDA filing. The response to our television ads for the gastroparesis study has been overwhelming, with more than 3,000 patients that have shown interest since late December, a testament to the significant unmet need for this disorder. In collaboration with the FDA, Almost all the patients that have requested expanded access to tradipitin for gastroparesis have now been approved for a period of six months, and the first completer of the six-month period has now been approved for a total of 12 months. The estimated prevalence of gastroparesis in the U.S. is over 5 million patients, the majority of whom remain undiagnosed. The only FDA-approved treatment for gastroparesis is metoclopramide, approved in 1979, which, due to its potential of severe side effects, carries a black box warning and limitations of use of no more than three months. Based on IQVIA data, there are over 3 million prescriptions for oral metoclopramide annually, given the highly limited treatment options and the safety and tolerability profile of metoclopramide we believe that a new therapy could achieve significant market share and can represent a substantial revenue opportunity for Vanda. Other Phase III tradipitin programs in motion sickness remain on pause until conditions allow us to resume and complete the pivotal Phase III study for this disorder. The Odyssey study of tradipitin in severely ill COVID-19 pneumonia patients is ongoing and continue to recruit patients following the first interim analysis in the summer. A scheduled interim analysis is expected to be completed in the first half of 2021. If the original analysis results are confirmed, the effects of Tredypsin may be of significant clinical benefit for patients as well as for public health. by decreasing the amount of resources employed in the treatment of patients with COVID-19 pneumonia and improving outcomes. Clinical programs for hetlias in delayed sleep phase disorder, or DSPD, and insomnia in autism spectrum disorder are in the process of finalization and begin to recruit patients this year. Clinical development programs for FNAP, include bipolar disorder, Parkinson's disease psychosis, and the long-acting injectable formulation in schizophrenia. All of them are in various stages of preparation and execution. The full-week phase three study of bipolar I disorder includes sites in both the United States and Europe. We have received approval for the ex-US countries, including Russia and the Ukraine. With these approvals, we plan to begin randomized patients in the U.S. and Europe shortly. On FNAP for Parkinson's disease varicosis, we're planning two studies. A phase two open-label study of two cohorts followed by a larger randomized placebo-controlled phase three study. Both studies will evaluate the efficacy of FNAP in the treatment of psychosis in Parkinson's disease. 20 to 40% of people with Parkinson's disease are reported to experience varying degrees of psychosis. There are almost a million people in the U.S. with Parkinson's disease. With only one approved treatment for Parkinson's disease, psychosis, and the significant burden that exists, the condition has on the patients and the caregivers, this remains an important unmet medical need. The Phase II cohort of 24-patient open-label study has now received approval to proceed by the FDA and is expected to commence this quarter. Our Cystic Fibrosis Transmembrane Conductance Regulator, CFTR activator, VSJ-110, is in development for the treatment of allergic conjunctivitis. The results from this Phase II study are expected in the first half of the year and will help us guide further development of ESA 110 to treat a variety of ocular inflammatory conditions, including dry eye disorder. For our CFTR inhibitor, BPO27, we have initiated a study at the Leiden Cholera Lab at Harvard University. This study is evaluating the ability of BPO27 to block cholera mortality using live vibrio stains in mice. To conclude, 2020 was an exceptional year for Vanda, and we're optimistic about the positive momentum we bring into 2021. The approval of for nighttime sleep disturbances in SNS patients provides an opportunity to continue our innovative and successful approach to identifying and treating patients with orphan disorders. We look forward to the results of our extradiputant gastroparesis study and are expecting NDA filing for this disorder later in the year. I will now turn the call back to Kevin to discuss our financial results for the year. And after that, I will be happy to address any questions you may have. Kevin.