Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to Supernas Pharmaceuticals' third quarter 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 Fossil of ICR Westwick, Investor Relations Representative for Supernas Pharmaceuticals. You may begin.

Thank you, Stephen. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' third quarter 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 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, the management may make certain 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 Of you who may be listening to the replay, this call is being held and recorded on November 8, 2023. 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 2023 third quarter results. Sopernos continues to execute well during a transition year with the loss of exclusivity on its flagship brand, Trocandy XR. Our third quarter performance underscores our strong execution with combined net sales of $70 million for our growth products, Calvary and GoCovery. representing an increase of 52% in the third quarter of 2023 compared to the same period last year. This $70 million in net sales from Calgary and GoCoverry far exceeded the $49 million decline in Trocandy XR net sales in the third quarter compared to the same period last year. Similarly, for the first nine months of 2023, combined net sales of Calvary and GoCovery grew by 61%, reaching $182 million, far exceeding the $129 million decline in net sales of Trocandy XR during the same period. In addition, in excluding Trocandy XR, Total year-to-date 2023 revenues for Sopernos grew by 25% compared to the same period last year. Moving on to the ADHD market, this year's back-to-school season showed a decline of 3% in total U.S. ADHD prescriptions in the month of September 2023, when the new school year is mostly in full swing across the U.S., as compared to the month of June 2023 when the prior school year mainly ends. This contrasts with the 4 to 10% growth in the previous four years over the same time period. While the overall ADHD market had a soft back-to-school season, Calvary delivered robust prescription growth of 16.6% in September 2023 compared to June 2023. In addition, Calvary accelerated its quarterly sequential prescription growth in the third quarter, 2023, to 12% up from the 9% sequential growth in the second quarter of this year. During the third quarter of 2023, the average net price per prescription for Calvary was $227, an increase of 7% compared to the second quarter of 2023. This increase was primarily due to an improvement in gross to net, which was around 58.7%, the lowest since the launch of the product, and a key step towards our year-end target of 50% to 55%. As a result, Calgary net sales in the third quarter grew by 20% and 100% compared to the second quarter of this year and the third quarter of last year, respectively. Finally, during the third quarter, Calgary expanded its base of prescribers to approximately 24,189, up from 21,291 prescribers from the second quarter of 2023. Switching now to GoCoveri, net sales increased to 33 million in the third quarter of 2023, representing a healthy increase of 18% over the same period in 2022 and 14% over the second quarter of this year. We continue to be pleased with the performance of the brand, which is now at an annualized run rate of approximately $130 million in net sales. Regarding Oxtelar XR, third quarter net sales were $30 million, essentially stable compared to net sales in the same period last year. For Trukendi XR, net sales in the third quarter were $21 million, up slightly from $19 million in the second quarter and down from $70 million in the third quarter of last year. Given the performance of Trekendi XR in the first nine months of this year, we are revising our financial guidance and now expect approximately $90 million in net sales for full year 2023. Regarding SBN 830, earlier this month, the FDA accepted the resubmission of the NDA and assigned to it a PDUFA date of April 5, 2024. A few weeks ago, we held an R&D day and shared an overview of our emerging CNS pipeline of novel product candidates. We highlighted an exciting pipeline of new chemical entities, some of which are first-in-class mechanisms of action to treat multiple therapeutic areas in CNS. The company has a significant number of near-term milestones. the initiation of a phase four study with Calvary in ADHD patients with comorbid mood disorders such as depression and anxiety before year end 2023. Second, the initiation of a phase two open label study with SPNA 20 in approximately 40 subjects with major depressive disorder also before year end 2023. Third, getting top line data in the first half of 2024 from the Phase IIa study of SPN817 for treatment-resistant focal seizures. Fourth, the initiation of a Phase IIb placebo-controlled study with SPN817 in patients with treatment-resistant focal seizures also in the first half of 2024. And fifth, the potential launch in the second half of 2024 of SPN830 for the continuous treatment of motor fluctuations in Parkinson's disease if approved by the FDA. 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.