Supernus Pharmaceuticals, Inc.

Good afternoon and welcome to Sopranos Pharmaceuticals second quarter 2021 financial results conference call. At this time, all participants are on 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 Westwick, investor relations representative for Sopranos Pharmaceuticals. You may begin.

Thank you, Josh. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' second quarter 2021 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 Katar, and Jim Kelly, Chief Financial Officer. Today's call is being made available via the investor relations section of the company's website at ir.sopernos.com. Following remarks by management, we will open the call to questions. 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 4, 2021, at approximately 4.30 p.m. Eastern Time. 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. Sopernos declines any obligation to update these forward-looking statements, except as required by applicable securities laws. I will now turn the call over to Jack.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us as we discuss our 2021 second quarter results. During the second quarter, we continue to make significant regulatory, operational, and commercial progress, highlighted by the approval of Calgary and its launch at the end of May for the treatment of ADHD in pediatric patients. The early performance of Calvary is on track with our expectations. Healthcare providers are excited about Calvary as the first novel, non-scheduled medication option for ADHD in over a decade. Calvary's prescriber base is rapidly expanding each week, and healthcare providers expect to increase prescribing significantly as children get back to school this fall. We are encouraged by the early clinical feedback, which has been positive and in line with the results of our phase three clinical trials. Reports from the field indicate that patients are experiencing demonstrated improvement in ADHD symptoms as early as week one, with continued improvement over the subsequent weeks. Having a once daily rapid and extended release sprinklable capsule for full day exposure has been well received and the safety and tolerability profile is allowing patients to stay on therapy. Early trends in prescriptions reflect the heavy sampling programs with patients starting on a two to four weeks of samples. Over 25,000 starter kits have been distributed since the launch and in preparation for the back-to-school season. We look forward to the back-to-school season to be in full swing so that we can help as many pediatric patients as possible. Regarding managed care coverage, overall more than 60% of lives in the pediatric market have access to Calvary. After just three months on the market and compared to other three branded non-stimulants, Calvary is at an advantage or is at parity in more than 80% of the commercial health plans and in more than 90% of the Medicaid plans. Regarding the adult population, we recently submitted a supplemental NDA to the FDA for Calvary for adult patients with ADHD. We expect to hear from the FDA in the third quarter regarding acceptance of the submission and potential PDUFA date. Turning now to the pipeline, the NDA for the apomorphine infusion pump, or SPN830, is on track for resubmission in the second half of this year. And the SPN820 Phase II Clinical Study in Treatment-Resistant Depression is on track for initiation by the end of 2021. Moving on to the commercial products and starting with Trukendi XR and Oxtelor XR, we are pleased with the stability of the brands despite declines in prescriptions and the reduced promotional efforts by the company. Since the launch of Calvary, the products have been promoted by a much smaller neurology sales force that is focusing its promotional efforts on supporting the current prescriber base. For the first half of 2021, the two products combined delivered net sales of $203 million, slightly lower than the $206 million in the same period last year. We continue to see an increase in the average size of a prescription for each product, contributing to the increase in the average wholesaler acquisition cost price per prescription. On APICN, we are encouraged with the second quarter performance and have started to see some stability with the brand after the competitive dynamics that have prevailed for the past nine months. And finally, regarding corporate development, we continue to be active in 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 Jim.