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8/4/2022
advising your hand is raised. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vosso of ICR Westwick, investor relations representative for Sopernis Pharmaceuticals. You may begin.
Thank you, Jason. Good afternoon, everyone, and thank you for joining us today for Sopernis Pharmaceuticals' second 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. 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 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 August 4, 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 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 second quarter results. During the first half of 2022, we continued to execute on our long-term growth strategy, focusing on successfully transitioning from our legacy and mature products to our growth products. For the first half of this year, total revenues were $322.6 million, representing an 18% increase over the same period last year. And adjusted non-GAAP operating earnings were $65.7 million, a 5% increase over the first half of last year, reflecting continued significant investment in Calgary and its launch activities. Regarding Calgary, we received approval for adult ADHD in April 2022. We launched the product in late May, expanding the market opportunity for Calgary into the largest segment of the ADHD market. Calvary represents true innovation in the adult market as the first novel non-stimulant to be introduced in 20 years. As mentioned previously, according to IQVIA exponent 52-week data, the adult market represents approximately 68% of the total market's prescriptions. The adult segment has been growing at a faster rate than the pediatric market and tends to be less seasonal. Calvary's launch continues to progress well with increased momentum in prescription growth and shipments. During the second quarter of 2022, total IQVIA prescriptions for Calvary reached 62,938, representing an increase of 33% compared to the first quarter of 2022. Prescriptions in the most recent month of June reached 23,403, the highest monthly total since the launch of the product. Calgary continues to expand its base of prescribers with over 9,276 prescribers in the second quarter of 2022, up from 6,900 prescribers in the first quarter of 2022. The product is supported by a sales force of approximately 195 sales representatives, calling on pediatricians, child and adult psychiatrists. The company will be increasing its commercial spend in the third quarter of this year as Calgary builds more momentum behind the adult launch and our preparation for the upcoming back-to-school season. Regarding recovery, the product delivered another quarter of solid growth with net sales reaching $24.7 million in the second quarter of 2022 representing a 23% increase compared to the $20.1 million reported by Adamas in the second quarter in 2021. Also, total prescriptions reached 10,929 in the second quarter of 2022, growing by approximately 16% over the same period last year. Moving on to the pipeline, we continue to work closely with the FDA as it reviews the new drug application for SPN830, our infusion device for the continuous treatment of motor fluctuations in Parkinson's disease. The company is preparing for the commercial launch of SPN830 in the first quarter of 2023, assuming timely approval by the FDA. The PDUFA target action date for SPN830 is in early October of this year. For SPNA20, our first-in-class orally active mTORC1 activator, we continue to enroll patients in a Phase II multicenter randomized double-blind placebo control study in adults with treatment-resistant depression. The study will examine the efficacy and safety of SPNA20 over the course of five weeks of treatment in approximately 270 patients. The primary outcome measure is a change from baseline to end of treatment period on the Montgomery-Asperg Depression Rating Scale Total Score, a standard depression rating scale. We are on track 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 buprozine A, which is a potent acetylcholinesterase inhibitor with pharmacological activities in CNS conditions such as epilepsy. Oxfeller XR continues to perform well, delivering a strong quarter with net product sales of $30 million, a 20% increase compared to the same period last year. while net product sales of Turkendi XR were approximately $72 million down from $79 million last year. On APICN, the company continues to monitor the situation surrounding the approved generic cartridge and to date has not seen a meaningful impact on our business. 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.
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