Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to Sopranos Pharmaceuticals' third quarter 2022 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, and I would now like to turn the conference over to Peter Vazzo of ICR Westwick, Investor Relations Representative for Sopranos Pharmaceuticals. Sir, you may begin.

Thank you, Chris. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' third quarter 2022 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 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 factors 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 November 8, 2022. 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. Superntis 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 2022 third quarter results. During the first nine months of 2022, we continue to execute on our long-term growth strategy, focusing on successfully transitioning from our legacy and mature products to our growth products. Products acquired or launched since 2020 accounted for 42% of our total net product sales, slightly surpassing Trekendi XR's net product sales contribution in the third quarter. For the first nine months of this year, total revenues were $500 million, representing a 19% increase over the same period last year. Adjusted non-GAAP operating earnings of $91 million reflected continued significant investment in Calgary. During the third quarter, the company increased its commercial efforts, including a direct-to-consumer campaign to build more momentum behind the adult launch and to support the important back-to-school season. Calvary's launch continues to progress well with increased momentum in prescription growth and shipments due to the launch in the adult population and the back-to-school season. And during the third quarter of 2022, total IQVIA prescriptions for Calvary reached 94,328, representing an increase of 50% compared to the second quarter of 2022. Prescriptions in the most recent month of September reached 34,633, the highest monthly total since the launch. Based on weekly IQVIA prescription data by age, at the end of the third quarter, adult prescriptions represented approximately 23% of total Calvary's prescriptions. During the third quarter, which was the first full quarter after the launch in adults, Adult prescriptions grew by 77%, and pediatric prescriptions showed solid growth of 43%. Calvary continues to expand its base of prescribers with over 14,265 prescribers in the third quarter of 2022, up from 9,276 prescribers in the second quarter of 2022. We continue to receive positive feedback from prescribers regarding the performance of Calvary in patients. A recent survey among prescribers for adult patients showed a 90% overall satisfaction level with Calvary compared to only 51% for Stratera. Regarding recovery, the product delivered another quarter of solid growth with net sales reaching $27.9 million in the third quarter of 2022, a 16% increase compared to the third quarter of 2021. For the first nine months of 2022, GoCoverie net product sales were $75.2 million, an increase of 22% compared to net product sales reported by Adamus in the first nine months of 2021. AccelerXR continues to perform well with net product sales of $88 million for the first nine months of this year, representing a 7% increase compared to the same period last year. For the nine months of 2022, nut product sales of Trocandy XR were $204 million, down from $232 million in the same period last year. The company has significantly reduced its in-person sales efforts in the second half of the year, but continues to provide support to physicians and patients through various sales and marketing programs. Moving on to the pipeline, as we announced last month, the FDA issued a complete response letter for the SPN830 new drug application. The CRL didn't request additional efficacy and safety clinical studies, but rather required additional information and analysis related to the infusion device and drug product across several areas of the NDA, including labeling, product quality and manufacturing, device performance, and risk analysis. The FDA mentioned that approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions. We will continue to work closely with the FDA and our partners to address all questions and to provide clarity regarding the potential timing of a resubmission of the NDA. FDA has made an initial determination that the amendment to the company's application in response to the CRL will be subject to a Class II or six-month review timeline. For SPNA20, our first-in-class orally active mTORC1 activator, the Phase II multicenter randomized double-blind placebo control study in adults with treatment-resistant depression is ongoing. The study will examine the efficacy and safety of SPNA20 over a course of five weeks of treatment in approximately 270 patients. Primary outcome measure is a change from baseline to end of treatment period on the Montgomery Aspect Depression Rating Scale total score, a standard depression rating scale. We're on track also to initiate an open-label Phase II clinical study with SPN817 in the fourth quarter of this year in patients with treatment-resistant seizures. SPN817 represents a novel mechanism of action for an anticonvulsant and utilizes synthetic form of fuprazine A, which is a potent acetylcholinesterase inhibitor with pharmacological activities in CNS conditions such as epilepsy. And 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 the call over to Tim.