VNDA (2022 - Q1)

Ladies and gentlemen, thank you for standing by. And welcome to the Quarter 1 2022 Vanda Pharmaceuticals Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would like to turn the call over to our speaker today, Kevin Moran, Vanda's Chief Financial Officer. Sir, you may begin. Kevin Mo

Thank you, .Good afternoon. And thank you for joining us to discuss Vanda Pharmaceuticals First Quarter 2022 performance. Our first-quarter 2022 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. Mihael Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board. Additionally, we have Timothy Williams, our General Counsel, and Gunther Beers next, our Senior Vice President of Business Development and R&D Committee Member. Following my introductory remarks, Mihael 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, change 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 31st, 2021, 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. Mihael Polymeropoulos.

Thank you very much Kevin. Good afternoon, everyone. Thank you for joining us today to discuss Vanda's first quarter 2022 results. We believe 2022 is going to be an exciting year for the company, as we strengthen our commercial efforts and advance our clinical pipeline. Turning first to commercial performance. On HETLIOZ, talent as we payer denial for sighted patients with Non-24 proceeds. However, we're progressing efforts with commercial payers, Medicare, and Medicaid, to support basins, and increase reimbursement approval rates. Since 2021, over 15 states have revised their Medicaid prior authorization criteria, eliminating the restriction of HETLIOZ coverage on the base of others for the treatment of Non-24. At the same time, we see increase in the adoption of coverage for patients with night-time sleep disturbances in Smith-Magenis syndrome or SMS. We will continue to move these efforts forward and our committee to working with all parties to improve coverage for our patients. On SMS for the indication of night-time sleep disturbances, we're seeing continued interest by patients and caregivers attributed to direct-to-consumer campaigns. As we increase awareness around this SMS and our ongoing work with advocacy organizations such as prisons. Other educational initiatives for SMS are underway. As previously noted, many basis with SMS remain undiagnosed and are currently treated for various new developmental disorders. Our genetics work has identified that among patients with Autism, there is an increase in prevalence of the RAI1 deemed leasers and loss of function mutations. This is thus that some patients diagnosed with Autism may also have Thomas. We're evaluating opportunities to engage with the Autism community in elevate awareness of SMS among this population as well. On patent exclusivity for HETLIOZ, the products is currently a covered by a number of patterns listed in the FDA has orange book with explanations through 2,035. In January 2022, Bennett settled it's HETLIOZ partner litigation against the understand Pharmaceuticals defendants. In March 2022, the under trial for the consolidated lawsuit against the remaining defendants was held. A decision is expected from the court by December 2022. The four patents that are remaining in pursuit have expiration dates between 2033 and 2035. We remain confident in HETLIOZ and look forward to the court's decision. On clinical pipeline front, we have a number of late-stage programs underway. First, I would like to offer an update on our most advanced program with Tradipitant. In February, Vanda reported results of the Phase 3 study of Tradipitant in Gastroparesis and initial exploratory analysis. We have now completed a pooled analysis of two studies of Tradipitant in Gastroparesis consisting of a total of 342 patients and examined relevant clinical endpoints. We believe the studies are adequate and well-controlled and the results support substantial evidence of efficacy of Tradipitant. I retaliate to the figures and tables presented and included in today's press release. These large Meta analysis shows Tradipitant to be superior to placebo in key clinical parameters, including improvement in nausea, the primary endpoint parameter, percent nausea free days, the Patient Global Impression scale chains, the Overall Benefit Score, and the Gastroparesis Cardinal Symptom Index Score, and also open-label study of safety for Tradipitant in Gastroparesis is ongoing. We've continued to receive requires from patients interested in gaining access to Tradipitant through the Expanded Access program. Multiple patients in the Expanded Access program have been taking Tradipitant now for more than a year with the longest having been on Tradipitant for over 18 months. Vanda has now scheduled a pre - NDA meeting with FDA to discuss the planned new drug application submission for Tradipitant in the short-term treatment of nausea in Gastroparesis, and is committed to delivering this much needed treatment for patients. In addition, the Phase 3 study in the prevention of motion sickness has resumed enrollment and is already over 15% enrolled. A prior Phase 2 study with Tradipitant in motion sickness observed a significantly lower instance of vomiting in patients treated with Tradipitant as compared to Placebo treated patients. We expect enrollment to be complete by the end of 2022. Enrollment is also ongoing in the clinical development programs of HETLIOZ for the treatment of delayed sleep phase disorder and for symptoms of Autism spectrum disorder Finally, our Phase III clinical study of Fanapt in acute manic episodes in basins with bipolar disorder is progressing and is now over 75% enrolled. We expect to complete enrollment by the end of 2022. To conclude, we expect 2022 to be a year with significant milestones, as we advance a number of clinical programs forwards new indications. On that note, I will turn now the call over to Kevin to discuss the first quarter, 2022 financials. Kevin.

Thank you, Mihael. I'll begin by summarizing our first quarter 2022 financial results. Total revenues for the first quarter of 2022 were $60.2 million, a 4% decrease compared to $62.7 million for the first quarter of 2021. HETLIOZ net product sales for $37 million for the first quarter of 2022 compared to $39.3 million in the first quarter of 2021. Consistent with prior years and expectations, the first quarter of 2022 HETLIOZ revenue was impacted by the annual Medicare manufacturer contribution and the annual payer disruption linked to new plan years, plan changes, and reauthorizations, which we've seen in prior years. Additionally, the first quarter of 2022 reflects the continued insignificant increase of reimbursement challenges from payers to fill HETLIOZ prescriptions for patients with Non-24. Turning to finance, Fanapt, net product sales in the first quarter of 2022 were $23.2 million essentially flat as compared to $23.3 million in the first quarter of 2021. Fanapt, net product sales in the first quarter of 2022 decreased by 3% as compared to $24 million in the fourth quarter of 2021. Fanapt prescriptions in the first quarter of 2022 as reported by IQVIAX ponent decreased by approximately 2% compared to the fourth quarter of 2021. This decrease is consistent with the performance of Fanapt. We've seen in the first quarter of prior years. For the first quarter of 2022, Vanda recorded a net loss of $6.4 million compared to net income of $8.7 million for the first quarter of 2021. The net loss for the first quarter of 2022 included an income tax benefit of $1.1 million as compared to an income tax provision of $1.8 million for the same period in 2021. Operating expenses in the first quarter of 2022 was $67.9 million compared to $52.3 million in the first quarter of 2021. The $15.5 million increase was primarily driven by higher expenses, associated with the support of the HETLIOZ franchise, legal support related to ongoing litigation, awareness, DTC campaigns, and other corporate expenses, as well as higher R&D expenses related to the late-stage Fanapt development program. Operating expenses in the first quarter of 2022 were $8.5 million higher as compared to $59.4 million in the fourth quarter of 2021. This increase was primarily attributable to higher expenses associated with support of the HETLIOZ franchise, legal support related to ongoing litigation, and other corporate expenses. Vanda's cash, cash equivalents, and marketable securities referred to as cash as of March 31, 2022 were $435.2 million representing an increase of $57 million compared to March 31, 2021, and an increase of $2.4 million compared to December 31, 2021. Vanda expects to achieve the following financial decades in 2022, net product sales from both HETLIOZ and Fanapt of between $240 million and $280 million, HETLIOZ net product sales of between 1$50 million and $180 million, Fanapt's net product sales of between $90 million and $100 million, year-end 2022, cash of greater than $440 million. With that, I will now turn the call back to Mihales.

Thank you very much Kevin. At this point we will be happy to answer any questions you may have.

Thank you very much. And thank you for joining us. We'll talk to you in the near future. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you, everyone for participating. You may now disconnect.