AcelRx Pharma (ACRX) Reports In-Line Q4 EPS

AcelRx Pharma (NASDAQ: ACRX) reported Q4 EPS of ($0.20), in-line with the analyst estimate of ($0.20). Revenue for the quarter came in at $740 thousand versus the consensus estimate of $5.25 million.

Financial Information

• 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 MilestonesAcelRx 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.

For earnings history and earnings-related data on AcelRx Pharma (ACRX) click here.

You May Also Be Interested In

• Brunswick (BC) Reports In-Line Q1 EPS, provides guidance
• Caterpillar (CAT) tops earnings expectations but sales volume declines
• International Paper Company (IP) Misses Q1 EPS by 5c