Supernus Pharmaceuticals, Inc.

Good afternoon and welcome to Super News Pharmaceuticals Preliminary Fourth Quarter and Full Year 2021 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 call over to Peter Vozzo of Westwick Pharmaceuticals. investor relations representative for Supernus Pharmaceuticals. You may begin.

Thank you, May. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' preliminary fourth quarter and full year 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 Supernus' 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.sopernis.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 Sopernis' 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 February 28, 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. Sopernos declines any obligation to update these forward-looking statements, except as required by applicable securities 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 as we discuss our preliminary 2021 fourth quarter and full year results. I would like to first make a few comments about the year 2021 as a whole, and then get into more details about specific corporate accomplishments. 2021 was another outstanding year for Sopernos, during which we continued to execute on our long-term growth strategy and to work towards minimizing the impact of the 2023 Trocandy XR transition. During 2021, we launched Calvary, the first novel non-stimulant ADHD treatment to be launched in over a decade. We also closed on the acquisition of Adamas, adding GoCoveri as another key growth asset. And we resubmitted the NDA for SPN830, the apomorphine infusion device, which represents our third future growth driver. In addition, we closed the year with record revenues for Sopernos of approximately $580 million, up 11% compared to 2020. Finally, we advanced to Phase II, the clinical development of SPN820, our novel product candidate for treatment-resistant depression, and nominated SPN443 and SPN446, two internally discovered novel CNS drug candidates for development in CNS indications. Moving on to specific corporate accomplishments and starting with the Adamus acquisition, we made significant progress with the integration of the business with our Parkinson's sales force that is now fully trained in the field promoting GoCoveri. GoCoveri recorded a total of 3,330 prescriptions in the month of January the product's first full month under Superness in 2022, representing a 30% increase compared to the month of January in 2021. The Adamas transaction contributed approximately $10 million in revenues in the fourth quarter, and we are on track regarding our goal of $60 to $80 million in synergies over the first 12 months of owning the business. As mentioned earlier, we resubmitted the NDA for SPN830 infusion device for the continuous treatment of motor fluctuations in Parkinson's disease in the fourth quarter. And since then, we have received FDA acceptance of the submission with a PDUFA date in early October 2022. The company is preparing for the potential commercial launch of SPN830 in the first quarter of 2023, assuming timely approval by the FDA. Regarding Calgary, the launch is progressing well, continuing its growth trajectory with total IQVIA prescriptions in the fourth quarter reaching 34,328, an increase of 122% compared to total prescriptions of 15,453 in the third quarter of 2021. In January 2022, the most recent month available, total prescriptions reached 14,177. Moreover, in the first quarter of 2022, total prescriptions are showing a quarter to date during the first seven weeks, sequential growth rate of 42% versus the corresponding same seven-week period in the fourth quarter of 2021. In addition, Calvary continues to expand its base of prescribers with over 5,600 prescribers in the fourth quarter of 2021, up from 3,470 prescribers in the third quarter of 2021. And finally, preparations for the potential launch in the adult market are well underway, assuming timely approval by the FDA of the supplemental NDA for the adult indication. Sopranos will continue its heavy investment in Calgary's launch activities in 2022 as it enters the adult segment of the ADHD market, which represents about 50% to 60% of the total market. On the managed care side, we have made good progress in managed care coverage with continued improvement in gross-to-net deductions. For SPNA20, our first-in-class orally active mTORC1 activator, we initiated a Phase II multicenter randomized double-blind placebo-controlled parallel design study in adults with treatment-resistant depression. The Phase II study will examine the efficacy and safety of SPNA20 over a course of five weeks of treatment in approximately 400 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale Total Score which is a standard depression rating scale. We continue to expect to start a Phase II program with SPN817 in the second half of 2022 for the treatment of focal seizures in adults. If you recall, SPN817 represents a novel mechanism of action for an anticonvulsant and utilizes synthetic form fuprazine A, which is a potent acetylcholinesterase inhibitor with pharmacological activities and CNS conditions such as epilepsy. Moving on to the commercial products, Oxtelar XR finished another year with strong performance, reaching net sales of $111 million, up 12% compared to 2020. Also, Trocandy XR continues to hold up well despite the increased competition in the migraine prevention market, finishing the year with approximately $305 million in net sales. For full year 2021, the two products combined delivered net product sales of $416 million, essentially flat compared to $418 million in 2020. Apokin closed out the year with sales close to $100 million, given the competitive headwinds it faced during the year. Recently, the company became aware of an approval of a generic to the Apokin injection cartridge. The timing of availability of such a product is still largely unknown, and the generic cartridge will still need to be paired with the Apocon pen to administer the apomorphine injection. Finally, we will 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.