11/4/2025

speaker
Raven
Conference Operator

All right, good afternoon and welcome to the SuperNIST Pharmaceuticals Third Quarter 2025 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 will now turn the conference over to Peter Bozzo of ICR Healthcare investor relations representative for Sopranos Pharmaceuticals. You may now begin.

speaker
Peter Bozzo
Healthcare Investor Relations Representative, ICR

Thank you, Raven. Good afternoon, everyone, and thank you for joining us today for Sopranos Pharmaceuticals' third quarter 2025 financial results conference call. Today, after the close of the market, the company issued a press release announcing the results. On the call with me today are Sopranos' chief executive officer, Jack Attar, and financial officer, Tim Deck. These calls are being made available via the investor relations section of the company's website at www.ir.sopernus.com. During the course of this call, management may make certain forward-looking statements regarding the future event and the company's future performance. These forward-looking statements reflect Sopernus' current perspective on the 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. After 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 November 4th, 2025. 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. Superntus declined any obligation to update these four liquid statements except as required by applicable securities laws. I'll now turn the call over to Jack.

speaker
Jack Attar
Chief Executive Officer

Thank you, Peter. Superntus delivered strong operating results in the third quarter, reflecting continued momentum from Calgary and GoCoverry. collaboration revenues from Zerzuwe, and an encouraging start to the launch of Onabco. With these four growth products, we have built a solid foundation for a new phase of accelerated growth for the company. During the third quarter of 2025, these four growth products accounted for approximately 78% of total revenues. Starting with ONAPCO during the third quarter of 2025, ONAPCO generated net sales of $6.8 million, up from $1.6 million in the second quarter. From launch through September 30, 2025, more than 1,300 enrollment forms were submitted by over 450 prescribers. Initial feedback from prescribers has been positive regarding the product and its performance. In addition, prescribers appreciate the high level of service provided by Sopernos in its Circle of Care program. Due to stronger than expected demand for Onapco, supplier constraints are impacting the company's ability to fully meet this demand. As a result of this supply imbalance, the company is prioritizing care for patients currently on Onapco. This requires pausing delivery to patients who have not started Onapco. The company is working to build adequate inventory and resume new patient initiation as soon as possible, and will provide timely updates as progress is made in resolving the supply constraint. Switching now to Zerzuve, collaboration revenue from Zerzuve was $20.2 million in the third quarter of 2025, representing approximately two months of collaboration revenue since the closing of the Sage acquisition on July 31, 2025. Full third quarter 2025 U.S. sales of Zerzuve, as reported by our partner Biogen, increased approximately 150% compared to the same period in 2024 and approximately 19% compared to the second quarter of 2025. We anticipate that the integration of Sage will be substantially completed by the end of this year. We continue to expect potential synergies up to $200 million on an annual basis by mid-2026. Regarding Kelby, the brand had another robust performance in the third quarter of 2025 with 23% growth in prescriptions, as reported by IQVIA, and 31% growth in net sales compared to the same period last year. The total ADHD market continues to experience healthy growth with an increase of 12% in prescriptions in the third quarter of 2025 compared to third quarter 2024. Prescription growth for the same period in the adult segment was 16%, outpacing the 5% growth in the pediatric segment. Calvary had a strong back-to-school season with pediatric prescriptions growing by 19% in the third quarter compared to the same period last year, while at the same time posting robust third quarter prescription growth in adults of 32%. In addition, the number of prescribers in the third quarter grew by 18% compared to the same period last year. Switching to GoCoverie, the product continues its strong performance on the back of the momentum it had in the first half of this year. Net sales grew by 15% in the third quarter of 2025 compared to the same period last year behind growth in prescriptions and number of prescribers. Moving on to R&D, for our SPN443 program, we have selected ADHD as the lead indication. We expect to initiate a phase one single ascending, multiple ascending dose study in adult healthy volunteers in 2026. We are on track to initiate a follow on phase 2B multicenter randomized double blind placebo control trial with SPNA 20 in approximately 200 adults with major depressive disorder by the end of 2025. This study will examine the safety and tolerability of SPN820 and its efficacy at a dose of 2,400 milligrams given intermittently twice per week as an adjunctive treatment in the current baseline antidepressant therapy. Our phase 2b randomized double-blind placebo control study of SPN817 is ongoing with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes 3 mg and 4 mg twice daily doses. Finally, corporate development will continue to be a top priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through additional revenue-generating products or late-stage pipeline product candidates. With that, I will now turn the call over to Tim.

Disclaimer

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