AcelRx Pharmaceuticals(ACRX) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2023 with $13.4 million in cash and short-term investments, including$26 million from a financing round [16] - Revenues for Q3 were $0.1 million, primarily from royalties on DSUVIA sales, with a 75$3.4 million in Q3, down from $4.5 million the previous year, with expectations for an increase in Q4 due to the upcoming clinical study [17] Business Line Data and Key Metrics Changes - The lead product candidate, Niyad, is a novel anticoagulant for dialysis, with a peak annual sales potential of over$200 million in the US, based on modest market penetration estimates [6][11] - The transition of DSUVIA to Alora Pharmaceuticals is ongoing, with AcelRx supporting Alora during this process [13] - DSUVIA demand from the Department of Defense remained stable, although revenue recognition was affected by shipment timing [14] Market Data and Key Metrics Changes - The market opportunity for Niyad is significant, with estimates suggesting a 20% share of the in-hospital CRRT market and 6% of the outpatient dialysis market [6] - The company is engaging with key opinion leaders in nephrology to discuss the NEPHRO study protocol, reinforcing the urgent medical need for alternatives in anticoagulation during dialysis [7][8] Company Strategy and Development Direction - AcelRx is focusing on unmet medical needs in dialysis, transitioning from acute pain management to developing Niyad for use in continuous renal replacement therapy [4] - The company is preparing for a PMA submission for Niyad in the second half of 2024, with potential launch in the first half of 2025 [11] - AcelRx is also evaluating the timing for NDA submission for its pre-filled syringe candidate, Fedsyra [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the success of the Niyad study, citing the favorable safety profile of nafamostat, which has been used in other markets [11] - The company anticipates robust enrollment for the NEPHRO CRRT study, with top-line data expected by mid-2024 [10][21] - Management highlighted the importance of the upcoming KOL panel discussion to further engage with the nephrology community [8] Other Important Information - The company received an ICD-10 CMS procedural code to facilitate reimbursement for Niyad [11] - AcelRx continues to lead its relationship with the Department of Defense, which is a significant customer for DSUVIA [14] Q&A Session Summary Question: Timeline for NEPHRO CRRT study enrollment and potential holiday impact - Management indicated that holiday periods do not significantly affect enrollment due to the nature of ICU patients [21] Question: Attributes for site selection in the NEPHRO CRRT study - Sites selected are major academic centers with expertise in nephrology and critical care, many of whom are advisors for the study [23] Question: Components of the PMA for Niyad beyond the registrational study data - Additional components include preclinical toxicology studies and stability data, which are being generated concurrently with the clinical trials [26] Question: Market opportunity against heparin and citrate - Management noted that while heparin is standard care, there is potential to capture market share from both citrate and patients receiving no anticoagulation [30][34] Question: Opportunities in intermittent hemodialysis - Management acknowledged that intermittent hemodialysis presents a larger market opportunity, although patients are generally less sick and may tolerate heparin better [36] Question: Future development opportunities beyond pre-filled syringes - The company is exploring development opportunities with LTX-608 for indications such as acute pancreatitis and disseminated intravascular coagulation [40]