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Dec 31, 2022
AcelRx Q4 2022 Earnings Report
Reported full year and fourth quarter 2022 financial results and provided a corporate update.
Key Takeaways
AcelRx Pharmaceuticals reported its Q4 2022 financial results, highlighting the divestment of DSUVIA to Alora Pharmaceuticals and progress in its Niyad™ nafamastat program. The company is focusing on late-stage assets and expects near-term corporate milestones by the end of Q2 2023, including an Emergency Use Authorization submission for Niyad and a New Drug Application for Fedsyra™.
AcelRx signed an agreement to divest DSUVIA to Alora Pharmaceuticals, expecting the transaction to close the week of April 3, 2023.
The company will receive a 15% royalty on commercial sales of DSUVIA and a 75% royalty on net sales to the Department of Defense.
AcelRx is advancing its Niyad™ nafamastat program with FDA Breakthrough designation, with accelerated stability testing supporting a planned Emergency Use Authorization submission in Q2 2023.
The company plans to submit an NDA for Fedsyra, its ephedrine pre-filled syringe (PFS) product candidate, by the end of next quarter.
AcelRx
AcelRx
Forward Guidance
AcelRx is focused on advancing its late-stage development pipeline, particularly the Niyad and Fedsyra programs. The company anticipates near-term milestones including regulatory submissions and clinical trial initiations.
Positive Outlook
- Planned Emergency Use Authorization submission for Niyad in Q2 2023.
- Initiation of the single registrational trial for Niyad expected in the second half of 2023.
- NDA submission for Fedsyra by the end of next quarter.
- Continued engagement and expansion of sales to the Department of Defense through the DSUVIA divestment agreement.
- Market research confirms the urgent medical need for an alternative anticoagulant for use in continuous renal replacement therapy (CRRT).
Challenges Ahead
- Risks relating to AcelRx's product development activities and ongoing commercial business operations
- Risks related to the ability of AcelRx and its business partners to implement development plans, launch plans, forecasts and other business expectations
- Risks related to unexpected variations in market growth and demand for AcelRx's commercial and developmental products and technologies
- Risks related to AcelRx's liquidity and our ability to maintain capital resources
- AcelRx's ability to retaining its listing on the Nasdaq exchange