speaker
Lauren
Conference Call Operator/Moderator

Good afternoon and welcome to Sopernos Pharmaceuticals' first quarter 2025 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 Vazzo of ICR Westwick, Investor Relations Representative for Sopernos Pharmaceuticals. You may begin.

speaker
Peter Vazzo
Investor Relations Representative

Thank you, Lauren. Good afternoon, everyone. Thank you for joining us today for Sopranos Bar & Suitable's first quarter 2025 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 Sopranos Chief Executive Officer Jack Katar and Chief Financial Officer Tim Desch. This call is being made available via the investor relations section of the company's website at ir.sopranos.com. 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 notes in the risk factor section of the company's latest S&P file. Actual results may differ materially and may be subjective 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 May 6th, 2025. 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 of the SEC. Sopranos declined any obligation to update these four of the statements, except as required by applicable securities laws. Announce and call and reject.

speaker
Jack Katar
Chief Executive Officer

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our first quarter results reflect, once again, double-digit revenue growth from our core products, as well as solid growth in adjusted operating earnings. Total revenues, excluding for Kendi XR and Oxtel XR, increased by 26% in the first quarter compared to the same quarter last year. Driving this growth was the robust performance of both Calgary and GoCovered. These two products collectively accounted for 67 percent of total net sales, while Trupendi XR and Oxtel XR accounted for only 9 and 7 percent, respectively. In the first quarter, Calgary grew by 22 percent in prescriptions, as reported by IQVIA, and by 44 percent in net sales. The product ended the first quarter in a strong position with monthly prescriptions in March reaching an all-time high of 75,277, up 25% compared to same period last year. In addition, we continue to extend the prescriber base for Calgary with the number of prescribers in the first quarter reaching 34,416, which is up by 23% compared to first quarter last year. We are also excited about the new data from the open label study in adults with ADHD and mood disorders. The data from all 161 adult patients will be presented at the American Psychiatric Association annual meeting later this month. The data shows significant improvements in clinician and patient rated measures of ADHD, depression, and anxiety symptoms and the safety outcomes in the trial were consistent with the double-blind pivotal trial of CalV and adult ADHD. Regarding recovery for the first quarter of 2025, prescriptions increased by 12% and net sales increased by 16% compared to the same quarter last year. The Medicare Inflation Reduction Act with the reduced patient out-of-pocket costs drove increased restrictions for GoCoverie among Medicare patients in the first quarter compared to the same period last year. On average, GoCoverie's Medicare co-pay declined by 42% compared to the first quarter of 2024, and by March 2025, 84% of GoCoverie's Medicare prescriptions were costing patients less than $25.00. In addition, prior authorizations and medical exception approval rates remained high in the quarter. These new dynamics and the resulting growth in the first quarter suggest that any potential negative impact from increased mandatory Medicare manufacturer payments for the year could end up being offset by increased prescriptions and gross sales in Medicare. Early in the second quarter, we launched on NAPCO, Superna's next growth product, It is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson's disease. It was launched with a support team of experts, including the nurse education program and access support, and utilizes our existing Parkinson's disease sales force and infrastructure. Initial response from physicians has been encouraging based on patient enrollment forms submitted early in the launch. In only a few weeks into the launch, more than 75% of the sales territories have generated one or more patient enrollment form, with more than 100 prescribers submitting such forms. Switching now to our legacy products, for the first quarter of 2025, combined net sales of Turkendi XR and Oxtel XR were down 46%. For the remainder of 2025, we expect further erosion in both product sales and maintain our 2025 guidance of 65 to 75 million in combined net sales. Moving on to our CNS pipeline of novel product candidates, we plan to initiate a follow-on Phase IIb multicenter randomized double-blind placebo-controlled trial with SPNA-20 in approximately 200 adults with major depressive disorders. This study will examine the safety and palatability of SPN820 at a dose of 2,400 milligrams given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant as well as assess the rapid onset of improvement in depressive symptoms. As we mentioned on our last call, we completed a pharmacokinetic study of two oral formulations of SPN443 in healthy adults. Both formulations of SPM443 showed adequate bioavailability and were well tolerated. SPM443 is our new stimulant-like product candidate for ADHD and other CNS disorders. The company expects to disclose a lead indication for the product by the end of 2025. Regarding corporate development, it continues to be a top priority for us looking for strategic opportunities to further strengthen our future growth with revenue-generating products or late-stage pipeline product candidates. And finally, given the current environment for tariffs, it is difficult to predict what impact, if any, they could potentially have on our business. We don't expect tariffs on finished products, to impact Kelvy, Trochendix, or GoCoveri, or NAPCO, or Apican, as they are either manufactured in the U.S. or are under arrangements that shield us from impact of tariffs. On the other hand, Myoblods, Zidane, or Nuxellates, or finished products, are manufactured in Europe or Canada, and therefore could become subject to import tariffs. All our products or materials are imported from various countries outside the U.S. Therefore, any potential impact on tariffs will highly depend on numerous factors, including but not limited to current inventory levels of various raw materials, timing of any new orders that may be subject to the tariffs, the country of origin for the various materials, and the applicable percentage tariffs. With that, I will now turn the call over to Tim.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-

Investor presentation