REDWOOD CITY, Calif.,
Aug. 2, 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 second
quarter 2018 financial results.
"The first half of the year has been productive on all fronts as
we have accomplished all the milestones we established for the
period. We're very focused on reaching our remaining
milestones for the year and, if DSUVIA is approved in November,
eager to start commercializing our first U.S. product in Q1 2019,"
said Vince Angotti, Chief Executive
Officer of AcelRx. "We continue to believe we have a unique
product for the management of moderate to severe acute pain that
can fulfill an unmet need within appropriate healthcare
settings. We look forward to continued dialogue with the FDA
during the coming months to achieve these objectives," continued
Angotti.
Recent Highlights
- The U.S. Food and Drug Administration (FDA) accepted the New
Drug Application (NDA) for DSUVIA in May.
- Received approval from the European Commission for
DZUVEO™ for the management of acute moderate-to-severe
pain in medically monitored settings.
- Completed an underwritten public offering of 7,272,727 shares
of common stock, at a price of $2.75
per share to the public with estimated net proceeds to the company
of $18.7 million.
Financial Information
- June 30, 2018 cash and short-term
investment balance of $50.1
million;
- R&D and G&A expenses for the quarter ended June 30, 2018 totaled $7.2
million compared to $9.1
million for the prior year period. Excluding stock-based
compensation expense, these figures were $6.2 million for the second quarter of 2018
compared to $8.1 million for the
prior year period. R&D and G&A expenses for the first half
of 2018 totaled $14.7 million
compared to $20.1 million in the
first half of 2017. Excluding stock-based compensation expense,
these figures were $12.8 million for
the first half of 2018 compared to $18.1
million for the prior year period. The decrease in R&D
and G&A expenses in both periods 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 use during the second quarter 2018 was $8.5 million excluding proceeds from ATM
facility, included $2.3 million of
debt service; and
- For the second quarter of 2018 net loss was $10.5 million, or $0.20 per basic and diluted share, compared to
$13.1 million, or $0.29 per basic and diluted share, for the second
quarter of 2017. Net loss for the first half of 2018 was
$22.1 million, or $0.43 basic and diluted net loss per share,
compared to $28.6 million, or
$0.63 basic and diluted net loss per
share, for the prior year period.
2018 Remaining Milestones
- Expected FDA advisory committee meeting for DSUVIA in late
Q3/early Q4 2018;
- Prescription Drug User Fee Act, PDUFA, date for DSUVIA on
November 3, 2018; and
- Anticipated resubmission of NDA for Zalviso in Q4 2018.
Conference Call and Webcast Information
As previously
announced, AcelRx will conduct an investment-community conference
call today, August 2, 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 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 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; 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 May 10, 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
|
|
Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Collaboration
agreement revenue
|
$
351
|
|
$
2,192
|
|
$
625
|
|
$
5,219
|
Contract and other
revenue
|
467
|
|
467
|
|
536
|
|
549
|
Total
revenue
|
818
|
|
2,659
|
|
1,161
|
|
5,768
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
749
|
|
3,543
|
|
1,863
|
|
7,668
|
Research and
development (1)
|
3,278
|
|
4,901
|
|
6,791
|
|
11,820
|
General and
administrative (1)
|
3,944
|
|
4,156
|
|
7,929
|
|
8,294
|
Total operating costs
and expenses
|
7,971
|
|
12,600
|
|
16,583
|
|
27,782
|
Loss from
operations
|
(7,153)
|
|
(9,941)
|
|
(15,422)
|
|
(22,014)
|
|
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
Interest
expense
|
(586)
|
|
(903)
|
|
(1,229)
|
|
(1,677)
|
Interest income and
other income (expense), net
|
195
|
|
396
|
|
331
|
|
250
|
Non-cash interest
expense on liability related to sale of future royalties
|
(2,995)
|
|
(2,609)
|
|
(5,811)
|
|
(5,167)
|
Total other
expense
|
(3,386)
|
|
(3,116)
|
|
(6,709)
|
|
(6,594)
|
Benefit (provision)
for income taxes
|
(2)
|
|
(2)
|
|
(2)
|
|
(2)
|
Net loss
|
$
(10,541)
|
|
$
(13,059)
|
|
$(22,133)
|
|
$(28,610)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.20)
|
|
$
(0.29)
|
|
$
(0.43)
|
|
$
(0.63)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
51,842
|
|
45,379
|
|
51,389
|
|
45,364
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
74
|
|
$
79
|
|
$
161
|
|
$
163
|
Research and development
|
377
|
|
448
|
|
809
|
|
985
|
General and administrative
|
597
|
|
551
|
|
1,158
|
|
1,074
|
Total
|
$
1,048
|
|
$
1,078
|
|
$
2,128
|
|
$
2,222
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2018
|
|
December 31,
2017
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
50,122
|
|
$
60,469
|
|
|
|
|
Total
assets
|
64,620
|
|
75,552
|
|
|
|
|
Total
liabilities
|
113,586
|
|
112,061
|
|
|
|
|
Total stockholders'
deficit
|
(48,966)
|
|
(36,509)
|
|
|
|
|
Reconciliation of
Non-GAAP Financial Measures
|
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$ 3,278
|
|
$ 4,901
|
|
$
6,791
|
|
$ 11,820
|
General and
administrative
|
3,944
|
|
4,156
|
|
7,929
|
|
8,294
|
Total operating
expenses
|
7,222
|
|
9,057
|
|
14,720
|
|
20,114
|
Less associated
stock-based compensation
expense
|
974
|
|
999
|
|
1,967
|
|
2,059
|
Operating expenses
(non-GAAP)
|
$ 6,248
|
|
$ 8,058
|
|
$ 12,753
|
|
$ 18,055
|
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SOURCE AcelRx Pharmaceuticals, Inc.