REDWOOD CITY, Calif.,
May 9, 2018 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a
specialty pharmaceutical company focused on innovative therapies
for use in medically supervised settings, today reported its first
quarter 2018 financial results.
"The first quarter of this year was extremely productive as we
successfully advanced DSUVIA down the path for FDA approval with
our recent NDA resubmission for DSUVIA. We also received a CHMP
positive opinion for DZUVEO™ in Europe," said Vince
Angotti, Chief Executive Officer of AcelRx. "We've achieved
each of the milestones outlined on our year-end earnings
call. Our goal is to end the year with another approved
product in Europe and our first
approved product in the U.S. with DSUVIA," continued Angotti.
Q1 and Recent Highlights
- Constructive Type A FDA meeting held in January
clarifying DSUVIA path to resubmission;
- Successfully completed the Human Factors study performed to
validate the effectiveness of the revised DSUVIA Directions For Use
(DFU);
- Completed preparation and resubmission of the DSUVIA NDA
addressing the comments received from the FDA in the October 2017 Complete Response Letter; and
- Received a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) for DZUVEO recommending approval in
the European Union and European Economic Area for the management of
moderate-to-severe acute pain in medically monitored settings.
Financial Information
- March 31, 2018 cash and
short-term investment balance of $51.2
million;
- R&D and G&A expenses for the quarter ended March 31, 2018 totaled $7.5 million compared to $11.1 million for the prior year period.
Excluding stock-based compensation expense, these figures were
$6.5 million for the first quarter of
2018 compared to $10.0 million for
the prior year period. This decrease is primarily due to lower
Zalviso-related expenses attributed to the Phase 3 clinical program
completed in 2017. 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;
- Net cash usage during the first quarter 2018 of $9.3 million included $2.3
million of debt service; and
- For the first quarter of 2018 net loss was $11.6 million, or $0.23 per basic and diluted share, compared to
$15.6 million, or $0.34 per basic and diluted share, for the first
quarter of 2017.
2018 Remaining Milestones
- Expected acceptance of DSUVIA NDA by FDA in Q2 2018;
- Potential European Commission approval of DZUVEO in Q3
2018;
- Expected FDA advisory committee meeting for DSUVIA in Q3
2018;
- Anticipated Prescription Drug User Fee Act, PDUFA, date for
DSUVIA in Q4 2018; and
- 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, May 9, 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 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 DSUVIA™
(sufentanil sublingual tablet, 30 mcg), known as DZUVEO™
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, DSUVIA™
(sufentanil sublingual tablet, 30 mcg), known as DZUVEO™
outside the United States, and
Zalviso® (sufentanil sublingual tablet system),
including the acceptance of the NDA resubmission for DSUVIA by the
FDA and related expected PDUFA date; the timing and results of the
European Commission (EC) final decision on the Marketing
Authorization Application (MAA) for DZUVEO, the anticipated
resubmission of the Zalviso NDA, and the Company's anticipated
conservation of cash in expectation of a potential commercial
launch of DSUVIA, if approved. 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 Human Factors study to validate the effectiveness of the
changes in the Directions for Use, or the supplemental information
included in the resubmission of the NDA for DSUVIA; EC review of
the CHMP positive opinion and approval recommendation for the
DZUVEO MAA, and the possibility that EC may dispute or interpret
differently clinical results obtained from the DZUVEO 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 Annual Report on Form
10-K filed with the SEC on March 9,
2018. 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,
except as required by law.
Selected Financial
Data
|
(in thousands, except
per share data)
|
(unaudited)
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
March
31,
|
|
|
2018
|
|
2017
|
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Collaboration
agreement revenue
|
$
274
|
|
$
3,027
|
|
Contract and other
revenue
|
69
|
|
82
|
|
Total
revenue
|
343
|
|
3,109
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
Cost of goods sold
(1)
|
1,114
|
|
4,125
|
|
Research and
development (1)
|
3,513
|
|
6,919
|
|
General and
administrative (1)
|
3,985
|
|
4,138
|
|
Total operating costs
and expenses
|
8,612
|
|
15,182
|
|
Loss from
operations
|
(8,269)
|
|
(12,073)
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
Interest
expense
|
(643)
|
|
(774)
|
|
Interest income and
other income (expense), net
|
136
|
|
(146)
|
|
Non-cash interest
expense on liability related to sale of future royalties
|
(2,816)
|
|
(2,558)
|
|
Total other
expense
|
(3,323)
|
|
(3,478)
|
|
Benefit (provision)
for income taxes
|
-
|
|
-
|
|
Net loss
|
$
(11,592)
|
|
$
(15,551)
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.23)
|
|
$
(0.34)
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
50,931
|
|
45,348
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
87
|
|
$
84
|
|
Research and development
|
432
|
|
537
|
|
General and administrative
|
561
|
|
523
|
|
Total
|
$
1,080
|
|
$
1,144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2018
|
|
December 31,
2017
|
|
Selected Balance
Sheet Data
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
51,176
|
|
$
60,469
|
|
Total
assets
|
65,813
|
|
75,552
|
|
Total
liabilities
|
112,693
|
|
112,061
|
|
Total stockholders'
deficit
|
(46,880)
|
|
(36,509)
|
|
Reconciliation
of Non-GAAP Financial Measures
|
|
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
Three Months
Ended
|
|
March
31,
|
|
2018
|
|
2017
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
Research and
development
|
$
3,513
|
|
$
6,919
|
General and
administrative
|
3,985
|
|
4,138
|
Total operating
expenses
|
7,498
|
|
11,057
|
Less associated
stock-based
|
|
|
|
compensation
expense
|
993
|
|
1,060
|
Operating expenses
(non-GAAP)
|
$
6,505
|
|
$
9,997
|
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SOURCE AcelRx Pharmaceuticals, Inc.