Supernus Pharmaceuticals, Inc.

Good afternoon and welcome to the Sopernos Pharmaceuticals first quarter 2024 financial results conference call. At this time, all participants are in a 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. I would now like to turn the conference over to Peter Bozzo of ICR Westwick, investor relations representatives, Supernas Pharmaceuticals. You may now begin.

Thank you, Mark. Good afternoon, everyone, and thank you for joining us today for Supernas Pharmaceuticals' first quarter 2024 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. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Supervisor's 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 file. 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 8, 2024. 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. So far, it has declined any obligation to update these form-making 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 on today's call. Following a productive year in 2023 in which we successfully minimized the impact of the Trochendi XR loss of exclusivity and positioned the company to mitigate the potential impact from the first genetic on Xtellar XR, We have continued to execute on our long-term growth strategy and have delivered another quarter with double-digit growth in total revenues, excluding Trochendi XR and Oxtel XR. Driving this growth is Calvary's strong performance with 31% growth in prescriptions, as reported by IQVIA, and 75% growth in net sales. Prescriptions reach an all-time quarterly high of 176,503, and net sales were at $45 million. Growth in net sales in the first quarter of 2024 benefited from both prescription growth and gross-to-net improvement compared to the same period last year. Gross-to-net during the first quarter of this year was well within our target range of 50% to 55%. which is encouraging for the first quarter, considering the typical beginning of year pressure from high deductibles and insurance resets that are seen across the pharmaceutical industry. For the remainder of 2024, we expect gross net for Calgary to remain in the range of 50 to 55% with fluctuations that you would typically expect on a quarterly basis. During the first quarter, Calgary further expanded its base of prescribers, ending the quarter with approximately 27,138, up from 25,938 in the fourth quarter of 2023. Descriptions from adult patients now account for approximately 32% of Calgary's total descriptions. Switching now to our Parkinson's franchise, we saw increased pressure on our brands in the first quarter, with higher Medicare rebates, patient out-of-pocket costs, and the closing of the patient assistance funds to new and existing patients. These dynamics contributed to increased gross-to-net deductions for our brands, leading, for example, to lower growth of 2% on net sales of GoCoveri compared to the same period in 2023. During the quarter, we also saw a significant 42% increase in sample distribution by physicians to patients. This increase in sample usage allowed many patients to stay on recovery while waiting to hit their maximum out-of-pocket costs. We have already seen a bounce back in the recovery business in the second quarter as we believe patients started transitioning from their samples to refilling their prescriptions. Switching to our legacy products, Oxtel XR net sales for first quarter 2024 were 26.9 compared to 28.9 million in the first quarter of last year. We expect the introduction of the first genetic of Oxtel XR in September 2024. For Tricandi XR, first quarter net sales were 16 million, down by 54% from the same quarter last year. With expected further erosion in Trukendi XR and the entry of an Oxtelar XR genetic later this year, we continue to anticipate combined net sales of Trukendi XR and Oxtelar XR in 2024 to be in the range of 125 to 135 million. Regarding SBN 830, as we disclosed in April, the FDA issued a complete response letter in response to the company's NDA indicating that the review cycle for the application is complete but that the application is not ready for approval in its present form the company will announce the timing for its resubmission after meeting with the fda later this month we are committed to parkinson's patients who need this potential new treatment option and to bringing spna 30 to the marketplace Moving on to our emerging CNS pipeline of novel product candidates, we have exciting catalysts coming up in the next 12 months. Regarding SPNA20, the company expects to provide data from its Phase IIb study in adults with treatment-resistant depression in the first half of 2025. The Phase IIb study recently achieved more than 50% enrollment of the total 268 targeted number of patients. The Phase 2 Open Label Study is currently enrolling and targeting a total of about 50 patients with major depressive disorder. Regarding the Phase 2A study of SPN817 for treatment-resistant seizures, the company now expects to report interim data from approximately 40 patients, greater than the one-half of total randomized patients originally targeted. As such, we plan to hold a conference call on May 23rd to report these interim data. This study is examining the safety, tolerability, and efficacy of SPN817 as a junket therapy in adult patients with treatment-resistant seizures. Topline results for the full study are expected in the second half of 2024. In addition, we plan to initiate a phase one single-dose study of SPN443 in healthy adults following submission of an investigational new drug application. SPN443 is our new stimulant-like product candidate for ADHD and other CNS disorders. Finally, we remain 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.