Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to Sopernos Pharmaceuticals' first quarter 2022 financial results conference call. At this time, all participants are in the listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded, and I would now like to turn the conference over to Peter Vasso of Westwick, Investor Relations Representative for Sopernos Pharmaceuticals. Sir, you may begin.

Thank you, Chris. Good afternoon, everyone, and thank you for joining us today for the Sopernos Pharmaceuticals first quarter 2022 financial results conference call. Today, after the close of the market, the company issued a press release announcing these results. On the call with me today are Sopernos' Chief Executive Officer, Jack Katar, and Chief Financial Officer, Tim Deck. Today's call is being made available via the investor relations section of the company's website at ir.sopernos.com. Following remarks by management, we will open the call to questions. During the course of this call, management may make forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Sopernos' current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the risk factor section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those who may be listening to the replay, this call is being held and recorded on May 9, 2022. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Sopernis declines any obligation to update these forward-looking statements except as required by applicable securities laws. I will now turn the call over to Jack.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us as we discuss our 2022 first quarter results. Following a productive year in 2021 in which we worked towards minimizing the impact of the 2023 Trochendi XR transition, we have continued to execute on our long-term growth strategy and focus on our strategic priorities. To quickly recap our overall performance in the first quarter of this year, Total revenues were $152.5 million, representing a 16% increase over the first quarter of last year. And adjusted non-GAAP operating earnings were 28 million and 11% increase over the first quarter of last year. The first quarter of 2022 represents the first full quarter we report on all products combined from the acquisitions in 2020 and 2021. Note that net sales of Trochendi XR as a percentage of total revenues was 41% in the first quarter of 2022, significantly down from 72% in the first quarter of 2020, which was the last full quarter before both acquisitions. This is the result of great execution and corporate development and commercial operations, diversifying our revenue base to minimize the impact of the 2023 Trochendi XR transition on our overall performance. Regarding Calvary, the product is off to a great start this year with continued momentum and prescription growth and shipments. We are actively preparing for the launch in the adult market after recently receiving approval from the FDA for the treatment of adults. For decades, adult patients had only one non-stimulant treatment option available to them. We are proud to be bringing innovation to the marketplace with the first novel non-stimulant in 20 years. Adult patients now have a new, safe, and effective treatment option that helps them stay away from controlled substances that have high potential of abuse and dependency. Sopernos expects to launch Calvary for adult patients by the end of this month. This represents a significant expansion opportunity in the largest segment of ADHD market. According to the recent IQV exponent 52-week data, the adult market now represents approximately 68% of the total market's prescriptions. Our launch of Calvary in the pediatric and adolescent market has been progressing very well. While we launched Calvary a year ago during a pandemic facing unprecedented headwinds, Calvary is on track to become the most successful ADHD launch in the past decade. Based on IQVIA prescription data aligning all recent ADHD launches on a monthly basis, Calvary has been consistently outperforming most of the products since its launch in June last year. and is well positioned to take the top ranking spot among all the recent ADHD launches. During the first quarter of 2022, total IQVIA prescriptions for Calgary reached 47,324 prescriptions, representing an increase of 38% compared to the fourth quarter of 2021. Prescriptions in the most recent month of March reached an all-time high of 18,380 prescriptions. In addition, Calgary continues to expand its base of prescribers with over 6,900 prescribers in the first quarter of 2022, up from 5,600 prescribers in the fourth quarter of 2021. We now have approximately 195 sales representatives promoting Calgary to pediatricians, child psychiatrists, and adult psychiatrists. The company will continue to support the launch of Kelvy in the pediatric and adult segments with heavy investment, which will significantly increase our commercial spend in the second and third quarters of this year. Regarding GoCoveri, we are pleased with the performance of GoCoveri during its first full quarter under Superness, with net sales for the product reaching $22.6 million this representing a 28% increase compared to the $17.7 million reported by Adamas in the first quarter in 2021. Also, total prescriptions reached 10,736 in the first quarter of 2022, growing by approximately 23% over the same period last year. After the first full quarter post the closing of the Adamas acquisitions, The integration has been substantially complete. Our Parkinson's sales force is fully trained in the field promoting recovery, and we are tracking towards the upper end of our goal of $60 to $80 million in synergies in the first 12 months of owning the business. Prokendi XR and Oxtelar XR continue to be promoted by a much smaller neurology sales force that is focusing its efforts on supporting the current prescriber base. For the first quarter of 2022, net product sales of Acstellar XR were $28 million, essentially unchanged compared to the same period last year, while net product sales of Trochendi XR were $63 million, down from $72 million last year. On APICN, the year-over-year decline in net product sales was mainly due to unfavorable changes at the beginning of the year and some Medicare plans and continued competitive dynamics. The company has been closely monitoring the situation surrounding the recently approved generic cartridge and to date has not seen a meaningful impact on our business. Moving on to the pipeline, we continue to work closely with the FDA as it reviews the NDA for SPN830, the infusion device for the continuous treatment of motor fluctuations and Parkinson's disease. The company is preparing for the commercial launch of SPN830 in the first quarter of 2023, assuming timely approval by the FDA. The PDUFA target action date for SPNA-30 is in early October of this year. For SPNA-20, our first-in-class orally active mTORC1 activator, we continue to enroll patients in a Phase II multicenter randomized double-blind placebo-controlled design study of SPNA-20 in adults with treatment-resistant depression. The study will examine the efficacy and safety of SPNA-20 over the course of five weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale total score which is a standard depression rating scale. We are on track to initiate an opt-in label phase two clinical study with SPN817 in the second half of 2022 in patients with treatment-resistant seizures. SPN817 represents a novel mechanism of action for an anticonvulsant and utilizes a synthetic form of buprozine A, which is a potent acetylcholinesterase inhibitor with pharmacological activities and CNS conditions such as epilepsy. Finally, we will continue to be active in corporate development, looking for strategic opportunities to further strengthen our future growth and leadership position in CNS. With that, I will now turn the call over to Tim.