Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to Superna's Pharmaceuticals Second Quarter 2023 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 that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vossel of ICR Westwick, Investor Relations Representative for Superna's Pharmaceuticals. You may begin.

Thank you, Stephen. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceutical's second quarter 2023 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 Katar, 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 guarantees of future performance and involve risks and uncertainties, including those noted in the risk factor section of the company's latest SEC filings. 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 August 8th, 2023. 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. Sopernis declines any obligation to update these four looking statements, except as required by applicable securities laws. I will now hand the call over to Jack.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us as we discuss our 2023 second quarter results. Sopernos continues to execute well during a transition year with the loss of exclusivity on its flagship brand, Trukendi XR. In the second quarter of this year, our growth products continue to deliver robust growth with Calvary and GoCoveri achieving combined net sales of $60 million. This represents 67% growth compared to the same period last year and by far exceeds the $52 million decline in Trocandy XR net sales in the second quarter compared to 2022. Similarly, for the first half of 2023, Sopernos generated $112 million in net sales from Calvary and GoCovery, which significantly exceeded the $80 million lost from Trocandy XR in the same period. Finally, excluding Trochendi XR, total revenues for Sopernos grew by 25% in the first half of 2023 compared to the same period last year. Moving on to more specifics about Calvary's strong performance in the second quarter despite the beginning of the weak summer season in the ADHD market. Per IQVIA prescription data, the ADHD market was essentially flat in the second quarter compared to the first quarter of this year, while Calvary's prescriptions grew by 9%, reaching an all-time high of 146,344 in quarterly prescriptions. In addition, Calvary's net sales grew by 20% in the second quarter compared to the first quarter of 2023, showing the resiliency of the brand and its continued growth potential despite the seasonality in the ADHD market. Moreover, the 146,344 quarterly prescriptions represent a 133% increase compared to the second quarter last year. As we approach mid-August, several metrics have now started signaling the return of the back to school season. For instance, pharmacy orders from wholesalers that are typically a good leading indicator for product demand have significantly increased in the first week of August compared to June and July, setting a new high since the launch of the product. Consequently, the factory shipments are starting to ramp up to satisfy demand from the pharmacies. Moreover, Calgary continues to capitalize on several dynamics, including a 12% increase in average total daily dose in the second quarter of 2023 compared to the second quarter of 2022. leading to one-third of Calvary's prescriptions now being more than 300 mg per day compared to 24% a year ago. Together with an improvement in the gross to net, this resulted in an average net price per prescription of $212, an increase of 20% compared to 2Q 2022, and 10% increase compared to the first quarter 2023. In addition, during the second quarter, Calvary expanded its base of prescribers to approximately 21,291, up from 19,917 prescribers from the first quarter of 2023. We expect Calvary's growth to continue with our increased capacity and broader reach behind the Salesforce expansion as well as the back-to-school season. Finally, we are very excited about a recent research article that was published last month in CNS Drugs by the authors, Doctors Maxwell Price and Richard Price. The peer-reviewed research article with the headline, Extended Release of Aloxazine Compared with Atomoxetine for Attention Deficit Hyperactivity Disorder, describes an independent retrospective chart review of 50 patients with ADHD in a routine clinical practice by the two physicians. Patients, adult and pediatric, received up to four weeks of atomoxetine per the required insurance prior authorization. They were then washed out for five days and then switched over to four weeks of Calvary treatment. Approximately half of the patients were also maintained on a stable dose of psychostimulants that they were on prior to receiving atomoxetine or Calvary with a suboptimal response. The ADHD rating scale 5 and adult investigator symptom rating scale were administered during the study. At baseline, at the end of the four-week atomoxetine trial or earlier if discontinued for AEs, and at the end of the subsequent four-week Calvary trial. Briefly, the results are as reported in the article are as follows. First, Calvary showed highly statistically significant improvements with a p-value of less than 0.00001 on the two ADHD scales compared to atomoxetine. Second, 96% of patients preferred Calvary over atomoxetine. Third, 85% of patients receiving stimulants chose to taper off the adjunctive stimulant once they are stable on Calvary. Fourth, 86% reported positive response by the second week of taking Calvary. And finally, 4% discontinued Calvary versus 36% discontinued atomoxetine due to AEs. In summary, and I quote the author's conclusion as published in the article, pediatric and adult ADHD patients who have experienced less than optimal response to atamoxetine demonstrate rapid improvement in inattention and in hyperactivity impulsivity with a greater tolerability on extended release of aloxazine. Please note that Supernost did not provide any support or funding for this research. We remain confident in the potential for Calvary, given its unique and differentiated clinical profile of a non-stimulant that works, works fast, works in both subscales of ADHD, and has shown great tolerability. Switching now to GoCoveri, net product sales increased to $29 million in the second quarter of 2023. This represents a healthy increase of 17% over the same period in 2022. We continue to be pleased with the performance of the brand, which is now at an annualized run rate of approximately $115 to $120 million in net product sales. Regarding Oxtelrex R, net product sales were $24 million compared to $30 million in the same period last year. The decline was primarily due to destocking by wholesalers impacting gross sales and higher rebates that are all hit in the same quarter. For Trekendi XR, net product sales in the second quarter were $19 million, down sequentially from $35 million in the first quarter of 2023 and down from $72 million in the second quarter of last year. There are now three generics in the market on Trekendi XR, and we expect further decline in quarterly sales on the brand. Given the performance of Trekendi XR in the first half of the year, we have revised guidance slightly with the midpoint of the range now at approximately $75 million for full year 2023. Regarding the pipeline, we will be hosting an R&D day in New York City on October 18, 2023, where we will share with you an overview of our product pipeline with an emphasis on SPN817 and the open-label Phase II clinical study in adult patients with treatment-resistant seizures, SPN820, our first in-class orally active mTORC1 activator, which is in a Phase IIb study in adults with treatment-resistant depression, as well as new clinical candidates from the company's discovery program. In addition, key thought leaders will share their perspectives on the current treatment paradigms, unmet medical needs, and the company's clinical development programs. Our team, in collaboration with our partners, continues to work hard towards the planned resubmission of the NDA for SPN830, our apomorphine infusion device, in the fourth quarter of this year. Finally, we continue to be 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 over the call to Tim.