Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to Sopernos Pharmaceuticals' first quarter 2026 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 is being recorded. I would now like to turn the conference over to Peter Vazzo of ICR Healthcare, Investor Relations Representative for Sopernis Pharmaceuticals. You may begin.

Thank you. Good afternoon, everyone, and thank you for joining us today for Sopernis Pharmaceuticals' first quarter 2026 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 Sopernis' Chief Executive Officer, Jack Picar, and Chief Financial Officer, Tim Dannen. Today's call is 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 and involve risks and uncertainty. including those noted in the risk factor section of the company's latest SEC filing. 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 May 5th, 2026. Since then, the company may have made additional announcements relating to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Sopernos declined any obligation to update these forward-looking statements, except as required by applicable securities laws. I'll now turn the call over to Jack.

Thank you, Peter, and thanks everyone for taking the time to join us on today's call. Sopernos first quarter results reflect a strong start to the year, including a 56% year-over-year increase in combined revenues of our growth products. and an 11% year-over-year increase in adjusted operating earnings. Starting with Onetco, during the first quarter, Onetco generated net sales of $8.4 million, reflecting a partial benefit from the resumption of new patient initiations in February 2026. We are pleased with the rebound in the business since we resumed patient initiations with some of the metrics in March reaching or even exceeding levels achieved before the supply constraints for instance prescriptions in march reach 463 exceeding the level reach in october 2025 before the supply constraints also the number of prescribers in a single month with shipments to patients increased in march to the highest level since the launch of the product Overall, more than 645 prescribers have submitted approximately 2,200 enrollment forms since the launch of the product through the end of April 26. We are also pleased with the progress with the second supplier on Onepco. We expect regulatory submission to the FDA in the third quarter of this year with potential approval before mid-year 2027. Switching now to Zerzude, Sopernos reported $27.6 million in collaboration revenues in the first quarter. Full first quarter 2026 U.S. sales of Zerzuve, as reported by Viagin, increased approximately 100% compared to the same period in 2025. In the first quarter of 2026, Zerzuve saw strong growth of 82% and 73% in rhythm prescriptions and number of prescribers, respectively, compared to the same period last year. Since launch, 85% of the prescriptions have come from repeat prescribers, and more than 29,000 patients have been treated with Zerzuvae. Regarding Kelby, in the first quarter, and as reported by Icubia, prescriptions grew by 19% compared to the same period last year. outpacing the 10% growth in the total ADHD market. Net sales of 78 million represented a strong 20% increase over the first quarter last year. Despite typical first quarter headwinds, Kelby's growth continues to be solid and is coming from both patient populations, with adult prescription growth of 27% and pediatric prescription growth of 15%. In addition, the total quarterly number of prescribers for Calgary reached a high of approximately 43,000, with adult prescribers for the first time surpassing the number of pediatric prescribers. Switching now to recovery for the first quarter of 2026, net sales reached $35.2 million, increasing by 15% compared to the same quarter in 2025. total number of prescriptions grew by 7% in the first quarter of 2026 compared to the same period last year. Moving on to R&D, the follow-on Phase IIb randomized double-blind placebo-controlled trial with SPN820 in approximately 200 adults with major depressive disorder is ongoing. 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 Phase IIb randomized double-blind placebo-controlled study of SPN817 is also ongoing with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes three milligram and four milligram twice daily doses. And for SBN443, our novel stimulant ADHD product candidate, we expect to initiate a phase one single ascending and multiple ascending dose study in adult healthy volunteers in the second half of 2026. 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 revenue generating products or late stage pipeline product candidates. With that, I will now turn the call over to Tim.