AcelRx Pharmaceuticals(ACRX) - 2022 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - AcelRx reported full year 2022 DSUVIA sales of $1.8 million, a 76% increase over 2021 despite reduced commercial investment [14] - The company ended 2022 with $20.8 million in cash and investments, and a debt balance of $5.4 million [15] - Combined R&D and SG&A expenses for Q4 2022 totaled $7.3 million, up from $6.9 million in Q4 2021 [15] Business Line Data and Key Metrics Changes - The divestment of DSUVIA to Alora Pharmaceuticals is expected to enhance sales through a 15% royalty on net commercial sales and $116.5 million in sales-based milestones [3] - The focus has shifted to the lead program, Niyad, which has FDA breakthrough designation and is being developed as an anticoagulant for extracorporeal circuits [6][9] Market Data and Key Metrics Changes - Market research indicates that 60% of CRRT patients currently receive no anticoagulant or use citrate, highlighting a significant opportunity for Niyad [8][29] - Niyad is estimated to have a peak sales potential of $200 million, specifically in the inpatient and outpatient dialysis markets [9][12] Company Strategy and Development Direction - AcelRx aims to leverage its expertise in drug development to focus on high-value assets, particularly the Niyad program and prefilled syringes [13] - The company plans to submit an EUA for Niyad in Q2 2023 and initiate a registrational trial in the second half of 2023 [10][49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term value creation from the DSUVIA transaction and the potential for increased sales under Alora's management [14] - The company is focused on efficient cash management while advancing its late-stage pipeline, including Niyad and Fed Sera [13][16] Other Important Information - AcelRx has completed the production of the initial development batch of Niyad and is preparing for stability product testing [9] - The company has received an ICD-10 CMS procedural code for reimbursement related to Niyad [9] Q&A Session Summary Question: Can you discuss who drives military procurement for DSUVIA and current DoD orders? - The military procurement process is decentralized across different branches, with relationships fostered over time to ensure supply during potential escalations [20][21] Question: What are the steps remaining for submitting the EUA for Niyad? - The company is confident in the EUA submission process, with most of the package ready and focusing on CMC [23][24] Question: What are the expectations for commercial traction under the EUA for Niyad? - The target market for Niyad includes patients receiving no anticoagulant and those using citrate, representing a significant opportunity [28][29] Question: When is the registrational trial for Niyad expected to commence? - The registrational trial is expected to start in the second half of 2023, with endpoints already agreed upon with the FDA [49][48]