Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to the Sopranos Pharmaceuticals fourth quarter and full year 2023 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 Vazzo of ICR Westwick, Investor Relations Representative for Sopranos Pharmaceuticals. You may begin.

Thank you, Rivka. Good afternoon, everyone, and thank you for joining us today for Sopranos Pharmaceuticals' fourth quarter and full year 2023 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 Sopranos' 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.sopranos.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 Sopranos' 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 of you who may be listening to the replay, this call is being held and recorded on September, February 27th, 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 FTC. So, please decline any obligation to update these forward-looking statements, except as required by applicable securities laws. I will now send a call over to Jack.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our performance in 2023 underscored our strong execution and emphasis on growing our revenue base despite the loss of exclusivity on Trependi XR. Excluding Trependi XR, Sopernos delivered strong growth of 26% in total revenues in 2023 compared to 2022. Specifically, our growth products, Calvary and GoCovery, delivered robust 57% growth in combined net sales compared to last year. In addition, combined full-year 2023 net sales for Calvary and GoCovery reached approximately $260 million, which significantly exceeded the $167 million decline in net sales of Tocandy Exhaust. As a result of our emphasis on growing the rest of our portfolio throughout 2023, Trocan DXR closed the year, representing only 13% of total revenues in the last quarter of 2023. Regarding Calgary, the year 2023 was the first full year with both pediatric and adult indications. For the full year, Calgary's prescriptions, as reported by IQVIA, reached 617,192 prescriptions, representing a growth rate of 91% compared to 2022. Net sales for 2023 recorded an even stronger growth rate of 129%, benefiting from the prescription growth and the steady improvement in gross to net throughout the year. Moreover, Calgary finished the year with a strong fourth quarter, reaching net sales of $46.4 million. That represents a 97% increase over the fourth quarter of 2022, and a 25% sequential quarter-to-quarter increase from the third quarter of 2023. In the fourth quarter, prescriptions grew by 47% compared to 2022, and we exceeded our goal of lowering the gross to net deductions to the 50 to 55% range. Actual gross to net for the fourth quarter 2023 was 49.5%, resulting in an average net price per prescription of $268 compared to 61% and $201 respectively in the same period last year. For the year 2024, we expect the gross to net for Calgary to be in the range of 50 to 55% with fluctuations that you would typically expect on a quarterly basis. In 2023, Calgary also expanded its base of prescribers, ending the fourth quarter with approximately 25,938 prescribers, up from 16,822 in the fourth quarter of 2022. We continue to be encouraged by the high level of satisfaction by Calvary's prescribers. Satisfaction with Calvary among the heavy prescribers is as high as their satisfaction with extended release stimulants and is significantly higher than their satisfaction with strep error. In 2024, we will be placing more emphasis on the adult segment that represents approximately 67% of the total ADHD market. we expect the ADHD market to have a nominal prescription growth rate in line with the 3% growth rate it had in 2023, when it reached an all-time high of 93.4 million annual prescriptions. Switching now to recovery for full year 2023, prescriptions increased by 10% compared to 2022, and net sales increased by 15%, reaching a record of 120 million. We continue to be pleased with the performance of the brand based on its unique position in the marketplace, treating both off-episodes and this can be easier. The 2023 fourth quarter net sales were $32 million, up 10% compared to last year, and flat compared to the third quarter as they were impacted by the timing of orders at year end. Switching to our legacy products, Oxtel XR net sales were $113 million for full year 2023, essentially stable compared to 2022. In September 2024, we expect the introduction of the first generic Oxtel XR. For Tukendi XR, full year net sales were $94 million down by 64% from the $261 million in 2022. In 2024, we don't expect an increase in the number of genetic players in the market, but expect further erosion in Trochendi XR sales. We anticipate combined net sales of Trochendi XR and Oxtella XR in 2024 to be in the range of $125 million to $135 million. Regarding SPN 830, the FDA has scheduled a pre-approval manufacturing facility inspection, which will take place in Europe this month, and the FDA's review of the NDA remains ongoing with a PDUFA date of April 5, 2024. Assuming FDA approval, the company plans to launch SPN 830 in the second half of 2024, capitalizing on its existing infrastructure including the sales force, nurse educators, hub, and patient services. Moving on to our CNS pipeline of novel product candidates, we made great progress in 2023, setting the stage for a rich calendar of clinical milestones and data releases over the next 12 to 18 months across several programs. First, the company initiated a phase four study with Calvary in ADHD patients with comorbid mood disorders such as depression and anxiety. This trial is expected to include approximately 500 patients with data expected in the first half of 2025. Second, the company also initiated a phase two open label study with SPNA 20 in approximately 40 subjects with major depressive disorders. This study has the potential of providing data on this first-in-class molecule by the end of this year. Third, our ongoing Phase IIb multicenter randomized double-blind placebo control study of SPNA20 in adults with treatment-resistant depression has now enrolled approximately 120 patients. We expect top-line data from this trial in the first half of 2025. The company expects to report interim results from approximately one-half of the targeted randomized patients from its Phase IIa study on SPN817 in treatment-resistant seizures in May 2024. This study is examining the safety, tolerability, and efficacy of SPN817 as adjunctive therapy in adult patients with treatment-resistant seizures. Top line results for the full study are expected in the second half of 2024. Fifth, the initiation of a Phase IIb placebo-controlled study with SPN817 in patients with treatment-resistant focal seizures in the second half of this year. And finally, initiation of a Phase I single-dose study of SPN443 in healthy adults following the submission of an IND. SPM 443 is our new stimulant-like product candidate for ADHD and other CNS disorders. Regarding corporate development, the company continues to be active 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.