AcelRx Pharmaceuticals Reports Fourth Quarter 2017 Financial Results
REDWOOD CITY, Calif., March 8, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings today reported fourth quarter 2017 financial results.
"As disclosed earlier today, we had a constructive meeting with the FDA regarding DSUVIA at the end of January 2018. In summary, based on the meeting outcome and official meeting minutes, we plan to resubmit our DSUVIA NDA in the second quarter of this year. The AcelRx team, including our consultants and our partners at the Department of Defense, did an exceptional job collaborating to reach consensus on a path forward to resubmission," said Vince Angotti, Chief Executive Officer of AcelRx. "We also continued to demonstrate financial discipline through control of our spending, and ended the year with over $60 million in cash and investments, which provides sufficient liquidity heading into an expected PDUFA date later in the year," continued Angotti.
- The Type A FDA meeting on January 26, 2018 focused on addressing the two primary points in the October 2017 Complete Response Letter (CRL) regarding the DSUVIA New Drug Application (NDA). Official meeting minutes from FDA indicate proposals discussed in the Type A meeting were reasonable, which provides a path to resubmit the DSUVIA NDA in the second quarter of 2018.
- Completed preparation of Zalviso® NDA resubmission inclusive of positive IAP 312 study results on device functionality and tablet dispensing errors. However, AcelRx intends to hold resubmission until the second half of 2018 to focus on DSUVIA.
- December 31, 2017 cash and short-term investment balance of $60.5 million.
- Revenues of $8.0 million for the full year 2017, consisting of $7.1 million from the Grunenthal collaboration agreement, and $0.9 million for work performed under the Department of Defense (DoD) contract for DSUVIA. In contrast, revenues from those two agreements for the full year 2016 were $6.4 million and $10.9 million, respectively. The year-over-year decrease in DoD contract revenue reflects our completion in 2016 of the Phase 3 clinical program for DSUVIA, which was reimbursed under the contract.
- R&D and G&A expenses for the year ended December 31, 2017 totaled $36.0 million, and excluding stock-based compensation was $32.0 million, compared to $37.0 million, and excluding stock-based compensation, $32.8 million, for the year ended December 31, 2016. This decrease is due to lower DSUVIA-related expenses resulting from the completion of the Phase 3 clinical program in 2016, offset by an increase in Zalviso-related expenses attributed to the Phase 3 clinical program completed in 2017, and a small increase in pre-commercialization expenses in anticipation of potential FDA approval of DSUVIA. For the quarter ended December 31, 2017, R&D and G&A expenses totaled $7.6 million, and excluding stock-based compensation was $6.6 million, declining $2.8 million compared to the fourth quarter of 2016. The decrease was mainly due to lower DSUVIA-related expenses, which included the filing fee for the DSUVIA NDA during the fourth quarter of 2016. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures.
- For full year 2017, net loss was $51.5 million, or $1.10 basic and diluted net loss per share, compared to $43.2 million, or $0.95 basic and diluted net loss per share, for full year 2016. Net loss for the fourth quarter of 2017 was $9.9 million, or $0.20 basic and diluted net loss per share, compared to $9.7 million, or $0.21 basic and diluted net loss per share, for the fourth quarter of 2016.
- Net cash usage during the fourth quarter 2017 of $7.5 million included $4.0 million of debt service, inclusive of the payment of a $1.7 million deferred fee.
2018 Guidance and Expected Upcoming Milestones
AcelRx expects quarterly net cash usage in 2018 to remain in the $10-11 million range before initiating pre-launch commercialization investments, which are planned to ramp after obtaining FDA approval of DSUVIA. This upcoming year has many key milestones for AcelRx, including:
- Anticipated resubmission of NDA for DSUVIA in Q2 2018.
- Expected opinion on the Marketing Authorization Application (MAA) for DZUVEO from the Committee for Medicinal Products for Human Use (CHMP) in H1 2018.
- Expected FDA advisory committee meeting for DSUVIA in Q3 2018.
- Anticipated PDUFA date for DSUVIA in Q4 2018.
- Anticipated resubmission of NDA for Zalviso in H2 2018.
Conference Call and Webcast Information
As previously announced, AcelRx will conduct an investment-community conference call today, March 8, 2018 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to a webcast of the conference call live via the Internet may do so by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be archived on the AcelRx website for 90 days following the call.