Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to the Superness Pharmaceuticals Second Quarter 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 ICR Westwick, Investor Relations Representative for Superness Pharmaceuticals. You may begin now.

Thank you, Corinne. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' second quarter 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 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, 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 guaranteed 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 foreign-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on August 6, 2024. 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. Sopranos declined any obligation to update these foreign-looking statements, except as required by applicable security laws. I'll now turn the call over to Jack.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. In the second quarter of 2024, we delivered strong net sales growth from our key growth drivers, Calgary and Recovery, and continue to advance our product pipeline, including SPNA-17 for treatment-resistant seizures and SPNA-20 for depressions. Total revenues, excluding Potendi XR and Oxtel XR, increased 32% in the second quarter. Driving this growth was Calgary's strong performance with 26% growth in prescriptions, as reported by IQVIA, and 92% growth in net sales. Prescriptions reached an all-time quarterly high of 184,342, and net sales were $59 million. In the first six months of 2024, Calgary prescriptions grew by 28% compared to the same period last year, and net sales were 105 million, representing an 84% growth over the same period last year. Growth in net sales of Calgary in the second quarter of 2024 benefited from both prescription growth and gross to net improvements compared to the same period last year. gross-to-net deductions during the second quarter of this year were below our target range of 50% to 55%. We saw a more favorable product returns trend with initial launch batches experiencing lower return rates than assumed and continued lower copay deductions in the quarter. As a result, for the remainder of 2024, we expect the gross-to-net for Calgary to be in the 45% to 50% range with fluctuations that you would typically expect on a quarterly basis. During the second quarter, Calgary also expanded its base of prescribers, ending the quarter with approximately 28,326 prescribers, up from 27,138 in the first quarter of this year. Prescriptions from adult patients now account for approximately 32% of Calgary's total prescriptions. Switching now to recovery, net sales increased to $32 million in the second quarter of 2024, representing a healthy increase of 10% over the same period in 2023, and reflecting recovery from some of the negative factors the brand faced in the first quarter of 2024. As you recall, earlier this year, we saw a significant increase in sample distribution by physicians, to patients to help them through their out-of-pocket expenses in the first quarter. This negatively impacted our prescriptions in the first quarter, but reversed in the second quarter as patients started transitioning from their samples to refilling their prescriptions. Switching to our legacy products, Oxtelra XR net sales for the second quarter of 2024 were $30 million compared to $24 million in the second quarter of last year. And for Trochendi XR, second quarter net sales were $17 million, down by 12% from the same quarter last year. For the first six months of 2024, net sales of Trochendi XR were down 39%. We expect further erosion in Trochendi XR sales and the entry of Oxfeller XR generics later this year. Given the trends in the first half of 2024, we now anticipate combined net sales of Trapendix R and Oxtelix R in 2024 to be in the range of $135 million to $145 million. Regarding SBN 830, we resubmitted the NDA last week and expect to learn from the FDA in a few weeks whether this submission will be considered as a Class I requiring a two-month review, or class two requiring a six-month review. We remain committed to Parkinson's patients who need this potential new treatment option. Moving on to our CNS pipeline of novel product candidates, we have exciting catalysts coming up in the next six to 12 months. For 8-20, the company expects to provide data from its Phase IIb study in adults with treatment-resistant depression in the first half of 2025. Three-quarters of the targeted number of patients are now enrolled in the study. Also, enrollment in the Phase II open-label study in patients with major depressive disorder is ongoing, and top-line results from that study are expected by the end of this year. In May 2024, we announced data from the planned interim analysis of our exploratory open-label Phase IIa study of SPN817, for treatment-resistant seizures. The interim analysis was based on 41 enrolled subjects, of which 19 completed the maintenance period at that time. We continue to expect top-line results for the full study in the second half of this year. In addition, the Phase IIb randomized double-blind placebo-controlled study with SBN817 in patients with treatment-resistant focal seizures is expected to start by the end of 2024. Also, we plan to initiate a phase one single-dose study of SPM443 in healthy adults following submission of an IND. SPM443 is our newest stimulant-like product candidate for ADHD and other CNS disorders. 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.