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Mar 31, 2020
AcelRx Q1 2020 Earnings Report
Reported first quarter 2020 financial results and expects strong order volume from the U.S. Military following Milestone C Approval for DSUVIA and provided updates on Tetraphase Transaction.
Key Takeaways
AcelRx Pharmaceuticals reported first quarter 2020 financial results, highlighting the Milestone C approval for DSUVIA and the ongoing Tetraphase transaction. The company anticipates strong order volume from the U.S. Army and is integrating its commercial team with Tetraphase under a co-promotion agreement.
DSUVIA achieved Milestone C approval from the Department of Defense, approving it for use in all U.S. Army sets, kits and outfits (SKOs).
AcelRx expects initial stocking orders for U.S. Army SKOs to approximate $30 million over the next three years.
As of April 30, 2020, 221 healthcare facilities are REMS-certified and able to purchase DSUVIA, with 223 formulary approvals achieved.
AcelRx announced an agreement with Brigham and Women's Hospital for an investigator-initiated study of DSUVIA in spine surgery.
AcelRx
AcelRx
Forward Guidance
AcelRx expects to see a strong volume of orders from the U.S. Army beginning later this year and into the future.
Positive Outlook
- Milestone C approval for DSUVIA validates its key role in modernizing acute pain treatment.
- Expect strong volume of orders from the U.S. Army beginning later this year and into the future.
- Approval opens doors to other branches of the military, additional areas of the Federal government, and to state governments and agencies.
- The next step with the Department of Defense will be DSUVIA’s inclusion on the Joint Deployment Formulary.
- Pleased with the swift integration of commercial team with Tetraphase under co-promotion agreement, which is believed to benefit both companies moving forward.
Challenges Ahead
- COVID-19 pandemic has restricted in-person meetings with pharmaceutical company personnel.
- Year-end 2020 REMS-certified facilities and formulary approvals goals will be re-evaluated once COVID-19 restrictions are lifted.
- AcelRx may not be able to close the acquisition of Tetraphase or achieve the expected benefits and cost synergies from the transactions.
- Potential sales volumes to the Department of Defense may not materialize.
- The impacts AcelRx is experiencing from the ongoing COVID-19 pandemic may be prolonged or exacerbated.