Le Lézard
Classified in: Health, Business
Subjects: ERN, CCA, ERP

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.

Recent Highlights

Financial Information

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:

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.

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The company has two product candidates including DSUVIAtm (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, and Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings.

For additional information about AcelRx's clinical programs, please visit www.acelrx.com.

Non-GAAP Financial Measures
To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses.  The company believes that this non-GAAP financial measure provides useful supplementary information to, and facilitates additional analysis by, investors and analysts. In particular, the company believes that this non-GAAP financial measure, when considered together with the company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance. In addition, this type of non-GAAP financial measure is regularly used by investors and analysts to model and track the company's financial performance. AcelRx's management also regularly uses this non-GAAP financial measure internally to understand, manage and evaluate the company's business and to make operating decisions.  Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, DSUVIAtm (sufentanil sublingual tablet, 30 mcg), known as DZUVEO outside the United States, and Zalviso® (sufentanil sublingual tablet system), including the timing and review of the NDA resubmission for DSUVIA based on the outcome of the Type A FDA meeting; the timing and results of the MAA opinion on DSUVEO; the anticipated timing of any FDA advisory committee meeting or PDUFA date regarding DSUVIA following the DSUVIA NDA resubmission; the timing of the planned resubmission of the Zalviso NDA; anticipated quarterly net cash usage for 2018 prior to any ramp up in pre-launch commercialization expenditures in anticipation of an FDA approval of the DSUVIA NDA; and the company's ability to continue its cash management plan and maintain a solid liquidity position. These forward-looking statements are based on AcelRx's current expectations and inherently involve significant risks and uncertainties. AcelRx's actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, DZUVEO in Europe and Zalviso in the United States; the possibility that the FDA may dispute or interpret differently the results of the company's planned Human Factors study to validate the effectiveness of the changes in the Directions for Use, or the supplemental information included in the planned resubmission of the NDA for DSUVIA; EMA review of the DZUVEO MAA, and the possibility that EMA may dispute or interpret differently clinical results obtained from the ARX-04 Phase 2 and 3 studies; the possibility that the FDA may dispute or interpret differently the results of the Zalviso development program, including the results from the IAP312 clinical trial; the accuracy of AcelRx's estimates regarding expenses, capital requirements and the need for financing; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on November 9, 2017. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Selected Financial Data

(in thousands, except per share data)

(unaudited)










 Three Months Ended  


 Twelve Months Ended  


December 31


 December 31 


2017


2016


2017


2016

Statement of Comprehensive Loss Data
















Revenue:








Collaboration agreement revenue

$               699


$                   1,771


$    7,143


$    6,440

Contract and other revenue 

41


4,664


852


10,917

      Total revenue

740


6,435


7,995


17,357









Operating costs and expenses:








Cost of goods sold (1)

962


3,161


10,659


12,315

Research and development (1)

3,676


6,334


19,409


21,402

General and administrative (1)

3,909


4,078


16,609


15,597

Total operating costs and expenses

8,547


13,573


46,677


49,314

Loss from operations

(7,807)


(7,138)


(38,682)


(31,957)









Other (expense) income:








Interest expense

(720)


(701)


(3,316)


(2,770)

Interest income and other income (expense), net(2)

725


618


510


918

Non-cash interest expense on liability related to sale of future royalties

(2,786)


(2,461)


(10,721)


(9,382)

Total other expense

(2,781)


(2,544)


(13,527)


(11,234)

Benefit (provision) for income taxes

703


-


701


34

Net loss

$          (9,885)


$                  (9,682)


$(51,508)


$(43,157)









Basic and diluted net loss per common share

$            (0.20)


$                    (0.21)


$    (1.10)


$    (0.95)









Shares used in computing basic and diluted net loss per common share

50,391


45,334


46,884


45,313

































(1)   Includes the following non-cash, stock-based compensation expense:
















            Cost of goods sold

$                 80


$                        77


$       324


$       302

            Research and development

459


562


1,901


2,308

            General and administrative

514


432


2,069


1,869

                   Total 

$            1,053


$                   1,071


$    4,294


$    4,479









(2)  Interest income and other income (expense) includes $0.6 million and $0.5 million in non-cash income for the three months ended December 31, 2017 and 2016, respectively, and $0.3 million and $0.6 million in non-cash income for the twelve months ended December 31, 2017 and 2016, respectively, related to warrants issued in connection with a private placement equity financing, completed in June 2012. These warrants expired in November 2017. 










December 31, 2017


December 31, 2016





Selected Balance Sheet Data








Cash, cash equivalents and investments

$          60,469


$                 80,310





Total assets

75,552


99,993





Total liabilities

112,061


105,330





Total stockholders' deficit

(36,509)


(5,337)





 

Reconciliation of Non-GAAP Financial Measures

(Operating Expenses less associated stock-based compensation expense)



Three Months Ended
December 31,

Three Months Ended
September 30,

Twelve Months Ended
December 31,


2017

2016

2017

2017

2016

Operating expenses (GAAP):






      Research and development

$             3,676

$             6,334

$             3,913

$           19,409

$           21,402

      General and administrative

3,909

4,078

4,406

16,609

15,597

Total operating expenses

7,585

10,412

8,319

36,018

36,999

      Less associated stock-based compensation expense

973

994

938

3,970

4,177

Operating expenses (non-GAAP)

$             6,612

$             9,418

$             7,381

$           32,048

$           32,822

 

AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.)

 

SOURCE AcelRx Pharmaceuticals, Inc.


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