Supernus Pharmaceuticals, Inc.

Good afternoon and welcome to Super News Pharmaceuticals' fourth quarter and full year 2020 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 conference over to Peter Vazil of Westwick, Investor Relations Representative for Supernus Pharmaceuticals. You may begin.

Thank you, Alex. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' fourth quarter and full year 2020 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 Jim Kelly, Chief Financial Officer. Today's call is being made available via the investor relations section of the company's website at ir.sopernis.com. Following remarks from 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 It involved 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 four 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 25, 2021, at 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 2020 fourth quarter and full year results. Despite its numerous unprecedented challenges and uncertainties, the year 2020 ended up being a monumental year for Sopernos with significant accomplishments. The company surpassed the half a billion dollar sales level behind the continued growth of Chukendi XR and Oxtel XR and the recently acquired CNS products. We reported for the year 2020 record revenues of $520 million and record operating earnings of $174 million. More importantly, during the year we achieved significant strategic objectives that should position us well into the future. By executing two key strategic transactions, we diversified our revenue and profits base, strengthened our pipeline, and enhanced our long-term growth with two key programs, SPNA20 and SPNA30, and also expanded our commercial capabilities in CNS. The company is well-positioned to launch SPNA12, if approved by the FDA, as the next novel ADHD treatment for pediatric patients. As we indicated in our press releases earlier this month, we resubmitted the SPNA-12 NDA in pediatric patients and subsequently received from the FDA a new PDUFA action date in early April 2021. We are now preparing for a potential launch in the second quarter of this year with more than 175 sales representatives leveraging our internal expertise in ADHD and CNS. Finally, in December 2020, we announced positive results from a Phase III study for SPNA12 in adults with ADHD. We plan to submit a supplemental NDA to the FDA for SPNA12 for the treatment of ADHD in adult patients in the second half of 2021, assuming approval for pediatric patients. The adult indication is important to help expand the use of SPNA12 in the adult segment which represents approximately half of the total ADHD market in the U.S. Turning now to the Apomorphine Infusion Pump NDA, or SPN-830, we are scheduled to meet with the FDA in March 2021 in a Type A meeting to discuss the contents of the refusal to file letter we received in November 2020. In the letter, the FDA requested certain documents and reports to be submitted in support of the application. We believe additional testing of the device will be necessary to support the SPNA30 NDA resubmission. We plan to resubmit the NDA after completing our discussions with the FDA and all the required activities for filing. Regarding SPNA20, our first-in-class orally active mTORC1 activator, Development activities are ongoing, including a multiple ascending dose study in healthy volunteers. The program remains on track to enter Phase II clinical testing in treatment-resistant depression by the end of 2021. Moving on to the commercial products, we are pleased with the overall performance of our products in 2020, despite the adverse impact of the pandemic on Salesforce access to physicians, patient visits, and new patient initiations. Trucandy XR delivered in 2020 healthy growth of 8% in net sales over 2019, reaching an all-time high of $320 million in sales. Similarly, Oxteller XR had a great year, reaching $99 million in net sales, representing a 12% growth compared to last year. On a prescription basis, as reported by IMS and as compared to 2019, Oxtelar XR showed growth of 3.3% in 2020, while growing by 8.2% in extended units, as represented by the number of tablets. For Trukendi XR, while IMS prescriptions declined by 11.7% in 2020, the extended units declined by 5.1% compared to 2019. This trend in extended units for both products is due to the fact that the average size of a monthly prescription for Trocandy XR and Oxtelar XR has been trending upwards since the start of the pandemic, and such larger size of monthly prescription was sustained through the fourth quarter. For Apokene, net sales recorded by Sopernos in 2020 for a partial year since the acquisition were $74 million, with $31 million in the fourth quarter. Overall, the product fared well in 2020 However, the resurgence of COVID in the fourth quarter and resulting increased closure of physician offices, together with some increased competition in the segment, pressured the brand performance compared to the third quarter. For Zedago in the year 2020, IMS prescriptions declined by 1% versus last year, while extended units grew by 3.8%. Finally, Myobloc continues to be the most affected by the pandemic where physician visits are instrumental for patient initiation and therapy maintenance. 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.