Supernus Pharmaceuticals, Inc.

Good afternoon and welcome to Supernost Pharmaceuticals' first quarter 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 conference over to Peter Bozzo, of Westwick Investor Relations Representative for Sopernis Pharmaceuticals.

You may begin. Thank you, Juergen. Good afternoon, everyone, and thank you for joining us today for Sopernis Pharmaceuticals' first 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 Sopernis' 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.supernus.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 Supernus' 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 who may be listening to the replay, this call is being held and recorded on May 5, 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 first quarter results. Since the beginning of 2021, we have made significant regulatory, operational, and commercial progress on a number of fronts. First, In April, we received FDA approval for CalBRI for the treatment of ADHD in pediatric patients 6 to 17 years of age. We are actively preparing for the launch of the product in the U.S., starting later in the second quarter, and are excited by the opportunity to provide this treatment as an important option for patients. Our commercial launch activities are ongoing and include engagement with both physicians and patient groups who have expressed great interest in this unique new alternative for the treatment of ADHD. We will be launching CalBRI with more than 175 sales representatives who have strong expertise in CNS. We are leveraging our heritage in the ADHD space, having created more ADHD products than any other company in the world over the past two decades. Superna's scientists created four different ADHD products using our technologies and expertise in the field. Our leadership in ADHD product development and commitment to the ADHD community is second to none. We are excited about the considerable level of attention Calvary has received since its approval from physicians, patient advocacy groups, and the media because of its unique profile as the first novel non-controlled substance to be approved in over a decade. We will conduct post-marketing commitment studies, including a new study of Calbee in preschool-aged children with ADHD four to five years of age. The completion of these studies is in response to a written request by the FDA and should therefore result in the FDA granting an additional six months of market exclusivity. Regarding the adult population, we are on track to submit a supplemental NDA to the FDA for CalBRI for the treatment of ADHD in adult patients in the third quarter of this year. The adult indication is important to help expand the use of CalBRI as adults represent approximately half of the total ADHD market in the U.S. Turning now to the NDA for the apomorphine infusion pump or SPN830. We recently met with the FDA to discuss the contents of the November 2020 refusal to file letter and the requirements for resubmission. Based on those discussions, we now plan to resubmit the SPN830 NDA in the second half of 2021. Since the last update we gave, we have made good progress on the additional device testing that the FDA has asked for and we are now focused on completing all the remaining activities to have a complete file for resubmission later this year. Regarding SBN 820, our first-in-class orally active mTORC1 activator, we have advanced it towards a Phase II clinical program in treatment-resistant depression following the successful completion of a multiple ascending dose study in healthy volunteers. In the MAD study, SPNA-20 exhibited a favorable safety and tolerability profile across a broad range of potentially therapeutic doses. We remain on track to initiate a randomized phase two clinical study in treatment-resistant depression by the end of 2021. Moving on to the commercial products, we saw familiar first quarter dynamics such as insurance pressure that impacted our brand's performance compared to the fourth quarter of 2020. For Apoken, net sales were also impacted by competitive headwinds for the brand that were initially seen in the fourth quarter of last year. While still early in the second quarter, we believe we are starting to see stabilization in the business and look forward to improving the trend for the remainder of the year. Compared to last year, net sales of Shoken DXR increased 5% in the first quarter of 2021 while net sales of Oxtelrexor grew by 14%. These products continue to report healthy net sales gains, despite the continued challenges from the pandemic, the typical first quarter market dynamics, and the fact that they have now been on the market for nearly eight years. First quarter 2021 prescriptions, as reported by IQVIA, and on an extended unit basis, were flat for Oxtelrexor as compared to the first quarter of 2020, While for CandyXR, first quarter extended unit prescriptions were down 13% as compared to the first quarter of 2020. 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.