2/24/2026

speaker
Operator
Conference Operator

Good afternoon and welcome to Sopranos Pharmaceuticals for the quarter and full year 2025 financial results conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session. Instructions will follow at this time. As a reminder, this conference is being recorded. I would now like to hand the conference over to Peter Bozzo of ICR Healthcare, Investor Relations Representative for Sopranos Pharmaceuticals. You may now begin.

speaker
Peter Bozzo
Investor Relations Representative, ICR Healthcare

Thank you, Antoine. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceutical's fourth quarter and full year 2025 financial results conference call. Today, after the close of market, the company issued a press release announcing these results. On the call with me today are Sopernos' Chief Executive Officer, Jack Attar, and Chief Financial Officer, Tim Deck. These calls being made available via the investor relations section of the company's website at www.ir.sopernis.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 Sopernis' current perspective on existing trends and information. Any such forward-looking statements are not guaranteed of future performance They involve risks and uncertainties, including those noted in the risk factor section of the company's latest SEC filings. As a result, may differ materially from those projected in this forward-looking statement. For the benefit of those of you who may be listening to the replay, this call is being held to record it on February 24th, 2026. 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 of the SEC. Sucurnis declined any obligation to update these four elective statements except as required by applicable securities laws. Announce the call of the executive.

speaker
Jack Attar
Chief Executive Officer

Thank you, Peter. Sucurnis had a remarkable 2025 with significant progress made against our strategic objectives. The company achieved the record total revenues of $719 million delivered strong growth of 40% in revenues from our four growth products, successfully executed an integrated acquisition of Sage Therapeutics, obtained the FDA approval of Onapco, and launched Onapco in the Parkinson's market. Our financial performance in 2025 once again underscored our emphasis on growing our core business, despite the loss of exclusivity on both Trochendi XR and Oxtelra XR. With our four growth products, Calvary, Recovery, Zerzuve, and Onepo, we have built a solid foundation for a new phase of accelerated growth for Supernos. During the fourth quarter of 2025, revenues from these four growth products accounted for approximately 76% of total revenue. Starting with Onetco during the fourth quarter of 2025, Onetco generated net sales of $8.9 million up from $6.8 million in the third quarter of 2025 and finished its first year on the market with $17.3 million in total net sales. Demand for the product continues to be healthy despite the announced supply constraints with more than 540 prescribers submitting over 1,800 enrollment forms since the launch of the product and through the end of January 2026. We have been focused on resolving the supply constraints that we discussed on our third quarter 2025 earnings poll. Progress with the current supplier has been made allowing us to resume new patient initiation while continuing to service our existing Monaco patients with maintenance therapy. Our current outreach effort for verifying health benefits and coverage includes more than 700 patients whose forms are currently in the queue for processing. In the fourth quarter of 2025, prescriptions grew by 29.6% and the number of prescribers grew by 28% compared to the third quarter Switching now to Zerzuve, the brand had strong performance in 2025 with $32.8 million in collaboration revenues in the fourth quarter and $53 million for the five-month period since the closing of the Sage acquisition on July 31, 2025. Full fourth quarter 2025 U.S. sales of Zerzuve as reported by Biogen, increased approximately 187% compared to the same period in 2024, and approximately 19% compared to the third quarter of 2025. The number of prescribers in 2025 doubled compared to 2024, with more than 70% being repeat prescribers. Total prescriptions in 2025 increased by more than 150% compared to 2024. Regarding Calgary, the product had another year of robust performance with 21% growth in total annual prescriptions in 2025 compared to 2024 and as reported by IQMIL. Calgary exceeded $300 million in net sales for the year 2025 delivering 26% growth compared to 2024. In 2025, the brand delivered double-digit prescription growth of 29% and 18% in both the adult and pediatric patient populations, respectively. For the fourth quarter of 2025, total descriptions increased by 18% compared to the same period in 2024, while net sales increased by 9% as net sales were impacted by an annual gross to net deduction. This was due to an unexpected bill of $4 million received from one of the PDMs covering the full year of 2025 and which was fully reflected in the fourth quarter. For full year 2025, gross to net for Calgary ended up at approximately 49%. Our expectation for 2026 continues to be consistent with our previously disclosed target of 50 to 55%. Switching now to recovery for full year 2025, net sales reached 146 million, increasing by 12% compared to 2024. And total annual descriptions reach an all-time high of approximately 67,000. growing by 14% compared to 2024. The brand finished 2025 with strong prescription growth of 16% in the fourth quarter compared to the same period last year and with net sales of $38.6 million. Moving on to R&D, we initiated a follow-on Phase IIb randomized double-blind placebo-controlled trial with SPNA20. in approximately 200 adults with major depressive disorder. 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 to the current baseline antidepressant therapy. Our face-to-be randomized double-blind placebo-controlled study of SPN817 is ongoing with a targeted enrollment of approximately 258 adult patients with treatment-resistant vocal seizures. This trial utilizes three milligram and four milligram twice daily doses. And for our SPM443 program, we expect to initiate a phase one single ascending and multiple ascending dose study in adult healthy volunteers in the second half of this year. We have completed our evaluation of the early stage pipeline assets from the SAGE acquisition. As a result, we will retain certain assets for internal development and we will be seeking partnerships for the remaining assets. Finally, corporate development will continue to be a priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through 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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