Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to Supernus Pharmaceutical's fourth quarter and full year 2024 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 IVR Healthcare. investor relations representative for Sopernos Pharmaceuticals. You may begin.

Thank you, Jacinda. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' fourth quarter and full year 2024 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 Attar, and Chief Financial Officer, Tim Dex. Today's call will be made available via the Investment Relations section of the company's website at 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 guarantees of future performance and involve risks and uncertainties. including those noted in the risk factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these formative statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on February 25th, 2025. Since then, the company may have made additional announcements related to the topics discussed. These reference the company's most recent press releases and current filings with the SEC. supports the client in the obligation to update these forward-looking statements, except as required by applicable securities laws. I'll now turn the call to Vidya.

Thank you, Vito. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our 2024 results reflect solid commercial execution across the company, including continued growth of our core products and strong growth in operating earnings. Our performance in 2024 underscored our emphasis on growing our core business despite the loss of exclusivity on both Trochendi XR and Obstetler XR. Total revenues excluding Trochendi XR and Obstetler XR increased by 25% for the full year 2024. Driving this growth was Calgary's robust performance with 25% growth in annual prescriptions as reported by Ikelia and 72% growth in annual net sales. In the fourth quarter of 2024, prescriptions reached another all-time quarterly high of 214,600 prescriptions. In 2024, Calgary's annual prescription growth outpaced that of the ADHD market that grew by 9%, reaching 103 million prescriptions. Calgary's back-to-school momentum carried through the fourth quarter with sequential prescription growth of 11% compared to the third quarter. This prescription growth enabled Calgary to have a strong fourth quarter with net sales reaching $74 million, representing a 60% increase over the fourth quarter of 2023. In 2025, Calgary is off to a good start with exciting news about the NFDA approval of its updated label. The new label further elaborates and differentiates Calgary's mechanism of action as a novel non-stimulum, reinforcing its multimodal pharmacodynamic profile and highlighting its unique partial agonist activity at the serotonin 5-HD2C receptor and inhibition of the epinephrine transport. Also, the label is now updated with new and important lactation data for breastfeeding women with ADHD. Such information is crucial for the important and growing adult female patient segment. In addition, earlier this month at the annual National Psychopharmacology Update Conference, Sopranos presented interim results from an open-label Phase IV trial with Calgary and adult patients with ADHD and mood disorders. Interim data for the first 95 patients who completed the trial show improvements in clinician and patient-rated measures of ADHD, depression, and anxiety symptoms. The data are encouraging and suggest that the effects of Calgary may extend to adults with complex ADHD. The safety outcomes in the trial were consistent with the double-blind pivotal trial of Calgary in adult ADHD. Full results from all the 161 adult patients who were enrolled in the trial are now available and are consistent with the interim results. That data will be presented at the American Psychiatric Association annual meeting in May of this year. Finally and importantly, the company received a two-plus-year patent term extension from the U.S. Patent and Trademark Office for one of the U.S. patents that covers Calgary. This extends the original expiration date of that patent to the year 2035. Regarding recovery, for fall year 2024, net sales increased by 9% compared to 2023, and by 15% in the fourth quarter of 2024, reaching $37 million. Earlier this month, the FDA approved on Apto, Sopernos' next growth product. It is the first and only subcutaneous apomorphine infusion device for the treatment of molar fluctuations in adults with advanced Parkinson's disease. We are targeting the launch of ONAPCO in the second quarter of 2025 with a support team of experts, including a nurse education program and access support. ONAPCO fits very well within our portfolio as it utilizes our existing Parkinson's disease sales force and infrastructure. Switching to our legacy products, the first generic for Oxtel XR entered the market in early September 2024, resulting in both a year-over-year and sequential quarter-to-quarter decline in net sales of Oxtel XR in the fourth quarter of 2024. For full year 2024, combined net sales of Trochendi XR and Oxtel XR were down 22%. In 2025, we expect further erosion in both product sales with combined net sales to be in the range of 65 million to 75 million. Moving on to our CNS pipeline of novel product candidates, in November 2024, we reported top line results from an open-label Phase IIa study with SPN817 in patients with treatment-resistant seizures. The study suggested a differentiated profile with strong efficacy in focal seizures at the 3 mg to 4 mg twice-daily doses. SPN817 was safe and had acceptable tolerability with two subjects discontinuing because of treatment-related adverse events out of the 26 subjects who entered the maintenance period. Stage B of the Phase IIa study is ongoing and includes the concomitant use of an anti-emetic to reduce cholinergic adverse events observed in the study. The company has initiated a Phase IIb randomized double-blind placebo-controlled study of 3 mg and 4 mg twice daily doses of SPN817, targeting enrollment of approximately 258 adult patients with treatment-resistant focal seizures. Also, the company completed a pharmacokinetics study of two oral formulations of SPM443 in healthy adults. Both formulations of SPM443 showed adequate bioavailability and were well tolerated. SPM443 is our new stimulant-like product candidate for ADHD and other CNS disorders. We recently disclosed that the Phase IIb study of SPNA20 in adults with treatment-resistant depression did not demonstrate a statistically significant improvement on the primary and secondary endpoints versus placebo. The safety profile of SPNA20 in this study was consistent with previous clinical trials showing few adverse events. We continue to analyze the data and will update you when we reach a decision regarding the future steps for the program. Finally, corporate development will continue to be a top priority looking for strategic opportunities to further strengthen our future growth through additional revenue-generating products for late-stage pipeline product candidates. With that, I will now turn the call over to Tim.