Zevra Therapeutics(ZVRA) - 2023 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q2 2023, net revenue was $8.5 million, driven by $5.8 million from AZSTARYS and $2.8 million from the French Early Access Program for arimoclomol [28] - The company reported a net loss of $5.1 million or $0.15 per share, primarily due to R&D expenses of $7.4 million and G&A expenses of $7 million [28][29] - As of June 30, 2023, cash, cash equivalents, and investments totaled $87.4 million, supporting operations into 2026 [12][30] Business Line Data and Key Metrics Changes - Year-to-date net sales of AZSTARYS surpassed $25 million, triggering a $5 million milestone payment [12][25] - The company earned royalties of $800,000 from AZSTARYS in Q2 2023, with expectations for continued growth in royalties over the coming years [26][27] Market Data and Key Metrics Changes - The AZSTARYS program is showing increasing weekly prescription counts, indicating growing demand in the ADHD treatment landscape [26] - The company is actively working on disease awareness initiatives for arimoclomol to enhance market access [18][19] Company Strategy and Development Direction - The company aims to resubmit the NDA for arimoclomol by the end of 2023, focusing on addressing FDA feedback from previous submissions [9][15] - Zevra is committed to developing therapies for rare diseases and enhancing in-house commercial capabilities [7][14] - The company is exploring opportunities to acquire new pipeline assets that complement its portfolio [60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the collaborative nature of recent FDA meetings and the potential for a successful NDA resubmission [14][42] - The company is focused on three top priorities: resubmitting the arimoclomol NDA, completing the Phase II trial for KP1077, and expanding the KP1077 program into narcolepsy [59] Other Important Information - The company welcomed Tom Anderson to its Board of Directors, enhancing its expertise in commercial and rare disease sectors [13] - The total shares of common stock outstanding as of June 30 were 33,928,005, with fully diluted shares at 49,315,197 [30] Q&A Session Summary Question: Potential second net sales milestone for AZSTARYS - The second milestone is expected to be larger than the $5 million milestone earned in Q2, but specific details could not be disclosed [34] Question: Expectations for interim Phase II IH readout - The interim data will inform the Phase III trial design, focusing on dosing strategies [35] Question: Clarification on arimoclomol data handling with the FDA - The company is proceeding with the FDA's preferred primary analysis, which aligns with their original strategy [40] Question: Changes in FDA meeting tone and ADCOM request - The recent FDA meeting was collaborative, and while options for dispute resolution remain, the company is hopeful for a positive outcome [42][44] Question: Focus of the last FDA interaction - The majority of the last interaction focused on confirmatory evidence that had not been previously reviewed by the FDA [48] Question: Clarification on AZSTARYS revenue figures - The revenue figures were clarified, indicating that the $800,000 in royalties was not flat and included costs associated with the milestone [50][52]