Supernus Pharmaceuticals, Inc.

Good afternoon and welcome to Super News Pharmaceuticals 3rd Quarter 2021 Financial Results Conference Call. At this time, all participants are in the 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 Bozzo of Westwick Investor Relations Representative for Super News Pharmaceuticals. You may begin.

Thank you, Nika. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' third 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 Kattar, 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. 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 November 3, 2021. 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 declares 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 third quarter results and recent developments. During the third quarter, we continue to execute on our long-term growth strategy and the 2023 Trochendi XR transition, as highlighted by the announcement in October of the proposed acquisition of Adamus Pharmaceuticals. This acquisition represents a significant step in further building a strong and diverse Parkinson's disease portfolio and aligns with our focus of acquiring value-enhancing, clinically differentiated products to treat CNS diseases. The acquisition will increase our revenue base and cash flow and reduce our dependency on TrochanDxR. The transaction is also expected to be accretive in 2022. Regarding Calvary, the launch is progressing well in line with our forecast. As expected, prescription growth accelerated as we entered the back-to-school season. For the month of September, total prescriptions were 7,132, an increase of 37% compared to the month of August, and an increase of 118% compared to the monthly average during the three-month period prior to September. In addition, the latest weekly prescriptions data shows total prescriptions of 2,248, an increase of 51% compared to the weekly average over the prior 12-week period. We also saw a significant increase of 340% in Calvary's base of prescribers during the third quarter of 2021 compared to the second quarter of 2021, with more than 3,470 physicians prescribing the product. On the managed care front, we've made great progress by securing coverage with one of the key PBMs and advancing discussions with the others. Also in Medicaid, Calvary is now covered as Tier 2 or better for 48% of all Medicaid lives versus 7% in the second quarter. During the third quarter, we received acknowledgement by the FDA that they received our supplemental NDA for Calvary to treat adult ADHD patients and that they have assigned a PDUFA date of April 29, 2022. We continue to make progress on the apomorphine infusion pump, or SPNA-30, and expect to file the NDA in this month. For SPNA-20, the IND was filed in September 2021, and the Phase II clinical study for treatment-resistant depression remains on track for initiation by the end of 2021. We are also pleased by our progress on SPN817 with the Phase II program now targeted to start in the first half of 2022 for the treatment of focal seizures in adults. Recall that 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. In addition to the above, we have achieved significant milestones with our internal research program. The program focuses on generating our own new chemical entities that target various CNS conditions. Recently, two new chemical entities, SPN443 and SPN446, were nominated for further development after successfully completing initial preclinical screening and lead optimization activities. Additional novel molecules are also undergoing further optimization before being nominated for further development. Moving on to the commercial products, we continue to be pleased with the performance of Trucandy XR and Oxtelar XR 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 efforts on supporting the current prescriber base. For the first nine months of 2021, the two products combined delivered net product sales of $314 million, essentially flat compared to $317 million in the same period last year. On APICAN, the year-over-year decline in net product sales was due partially to a higher level of channel inventory in the same quarter last year, as well as the lingering effects of competitive dynamics that have prevailed for the last 12 months. Finally, in addition to the significant corporate development activities over the past last year and a half, 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 Tim. Thank you, Jack.