REDWOOD CITY, Calif.,
March 7, 2019 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a
specialty pharmaceutical company focused on innovative therapies
for use in medically supervised settings, today provided a business
update and reported its fourth quarter and full year 2018 financial
results.
"This past year was a tremendous success for the Company,
highlighted by the FDA approval of DSUVIA in the U.S., followed by
our staged launch last month," said Vince
Angotti, Chief Executive Officer of AcelRx. "Our
recent efforts with the wholesalers and GPOs have laid the
foundation for DSUVIA's use in certified medically supervised
healthcare settings. While the launch is only one month old, we are
pleased with the initial response by healthcare professionals to
DSUVIA as an effective and efficient new option for the management
of acute pain in these settings," continued Angotti.
Fourth Quarter and Recent Highlights
- Following the positive recommendation from the FDA advisory
committee in October 2018, the FDA
approved DSUVIA in November 2018 for
use in adults in certified medically supervised healthcare
settings, such as hospitals, surgical centers, and emergency
departments, for the management of acute pain severe enough to
require an opioid analgesic and for which alternative treatments
are inadequate.
- AcelRx now has 14 Orange Book listed patents with exclusivity
dates ranging from 2027 through 2031.
- The staged DSUVIA launch was initiated with fifteen hospital
account managers hired, trained and placed in the field beginning
in second half of January 2019.
- Commercial launch of DSUVIA with initial contracted wholesaler
orders received and shipped in the second half of February, as
planned.
- Contracts executed with GPO targets covering approximately 80%
of the hospital customers included in the DSUVIA initial launch
markets.
Financial Information
- Cash, cash equivalents and short-term investments balance of
$105.7 million as of December 31, 2018;
- Combined R&D and G&A expenses for the fourth quarter
2018 totaled $10.4 million compared
to $7.6 million for the prior year
period. Excluding stock-based compensation expense, these amounts
were $9.2 million for the fourth
quarter of 2018 compared to $6.6
million for the prior year period. The increase in R&D
and G&A expenses is primarily due to increased
personnel-related expenses in preparation for the commercial launch
of DSUVIA. R&D and G&A expenses for the year ended
December 31, 2018 totaled
$33.9 million compared to
$36.0 million in the year ended
December 31, 2017. Excluding
stock-based compensation expense, these amounts were $29.1 million for 2018 compared to $32.0 million for the prior year. The decrease in
R&D and G&A expenses is primarily due to lower
Zalviso-related expenses attributed to the Phase 3 clinical program
completed in 2017, partially offset by increased personnel-related
expenses in preparation for the commercial launch of DSUVIA. 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;
- Excluding $53.4 million in net
proceeds raised from the issuance of equity, the Company used
$11.3 million in cash, including
$2.3 million in debt service, during
the quarter ended December 31, 2018;
and
- For the fourth quarter of 2018, net loss was $12.6 million, or $0.18 per basic and diluted share, compared to
$9.9 million, or $0.20 per basic and diluted share, for the fourth
quarter of 2017. Net loss for the year ended December 31, 2018 was $47.1 million, or $0.81 basic and diluted net loss per share,
compared to $51.5 million, or
$1.10 basic and diluted net loss per
share, for the prior year.
2019 Guidance
Based on the initial month of experience
in the field with its commercial team, the Company is increasing
its expected number of formulary approval wins by the end of 2019
to 125, up from the previous guidance of 100. In addition,
the Company plans to accelerate the hiring of the next stage of 25
hospital account managers to the third quarter from the fourth
quarter to better cover the initial indications of interest in
DSUVIA by hospitals. Quarterly combined R&D and SG&A
expense in 2019 is expected to range from $15 million to $18
million, depending on the quarter, which includes
approximately $2 million of non-cash
stock-based compensation per quarter. Annual debt service is
expected to approximate $9 million.
Annual capital expenditures are expected to range from
$5-$7
million attributed mainly to the installation of a new
high-volume, automated packaging line at our contract
manufacturer.
2019 financial guidance is based on the Company's current
expectations and are forward-looking statements. Actual
results could differ materially depending on market conditions and
the factors set forth under "Safe Harbor Statement"
below.
Conference Call and Webcast Information
As previously
announced, AcelRx will conduct an investment-community conference
call Thursday, March 7, 2019 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 DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA™, known as DZUVEO™ outside the United States, approved by the FDA in
November 2018, is indicated for use
in adults in a certified medically supervised healthcare setting,
such as hospitals, surgical centers, and emergency departments, for
the management of acute pain in adult patients severe enough to
require an opioid analgesic, and for which alternative treatments
are inadequate. DSUVIA was designed to provide rapid analgesia via
a non-invasive route and to eliminate dosing errors associated with
IV administration. DSUVIA is a single-strength solid dosage form
administered sublingually via a single-dose applicator (SDA) by
healthcare professionals. Sufentanil is an opioid analgesic
currently marketed for intravenous (IV) and epidural anesthesia and
analgesia. The sufentanil pharmacokinetic profile
when delivered sublingually avoids the high peak plasma levels and
short duration of action observed with IV administration. The
European Medicines Agency (EMA) approved DZUVEO for marketing in
Europe in June 2018 and the Company is currently in
discussions with potential European marketing partners.
For more information, please visit www.DSUVIA.com.
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 one approved product in the U.S., DSUVIA™
(sufentanil sublingual tablet, 30 mcg), known as DZUVEO™
in Europe, indicated for the
management of acute pain severe enough to require an opioid
analgesic for adult patients in certified medically supervised
healthcare settings, and one product candidate, 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. DZUVEO and Zalviso are both approved
products in Europe.
For additional information about AcelRx, 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 anticipated commercial growth of DSUVIA in
the United States, and 2019
guidance regarding potential acceleration of sales force growth,
formulary approvals, quarterly operating expenses and stock-based
compensation expense, annual debt service and annual capital
expenditures, . These and any other forward-looking
statements are made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward-looking
terminology such as "believes," "expects," "anticipates," "may,"
"will," "should," "seeks," "approximately," "intends," "plans,"
"estimates," or the negative of these words or other comparable
terminology. The discussion of financial trends, strategy, plans or
intentions may also include forward-looking statements. These
forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
projected, anticipated or implied by such statements. Although it
is not possible to predict or identify all such risks and
uncertainties, they may include, but are not limited to, those
described in the Company's annual, quarterly and current reports
(i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished
with the Securities and Exchange Commission (SEC). You are
cautioned not to place undue reliance on any such forward-looking
statements, which speak only as of the date such statements were
first made. To the degree financial information is included in this
press release, it is in summary form only and must be considered in
the context of the full details provided in the Company's most
recent annual, quarterly or current report as filed or furnished
with the SEC. The Company's SEC reports are available at
www.acelrx.com under the "Investors" tab. Except to the extent
required by law, the Company undertakes no obligation to publicly
release the result of any revisions to these forward-looking
statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of unanticipated
events.
Selected Financial
Data
|
(in thousands, except
per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve
Months Ended
|
|
December
31
|
|
December
31
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Collaboration
agreement revenue
|
$
511
|
|
$
699
|
|
$
1,313
|
|
$
7,143
|
Contract and other
revenue
|
102
|
|
41
|
|
838
|
|
852
|
Total
revenue
|
613
|
|
740
|
|
2,151
|
|
7,995
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
1,238
|
|
962
|
|
3,976
|
|
10,659
|
Research and
development (1)
|
2,704
|
|
3,676
|
|
13,137
|
|
19,409
|
General and
administrative (1)
|
7,648
|
|
3,909
|
|
20,765
|
|
16,609
|
Total operating costs
and expenses
|
11,590
|
|
8,547
|
|
37,878
|
|
46,677
|
Loss from
operations
|
(10,977)
|
|
(7,807)
|
|
(35,727)
|
|
(38,682)
|
|
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
Interest
expense
|
(459)
|
|
(720)
|
|
(2,217)
|
|
(3,316)
|
Interest income and
other income (expense), net
|
495
|
|
725
|
|
1,138
|
|
510
|
Non-cash interest
expense on liability related to sale of future royalties
|
(1,617)
|
|
(2,786)
|
|
(10,341)
|
|
(10,721)
|
Total other
expense
|
(1,581)
|
|
(2,781)
|
|
(11,420)
|
|
(13,527)
|
(Benefit) provision
for income taxes
|
-
|
|
(703)
|
|
2
|
|
(701)
|
Net loss
|
$
(12,558)
|
|
$
(9,885)
|
|
$
(47,149)
|
|
$
(51,508)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.18)
|
|
$
(0.20)
|
|
$
(0.81)
|
|
$
(1.10)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
70,623
|
|
50,391
|
|
58,409
|
|
46,884
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
78
|
|
$
80
|
|
$
358
|
|
$
324
|
Research and development
|
392
|
|
459
|
|
1,970
|
|
1,901
|
General and administrative
|
762
|
|
514
|
|
2,840
|
|
2,069
|
Total
|
$
1,232
|
|
$
1,053
|
|
$
5,168
|
|
$
4,294
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2018
|
|
December 31,
2017
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
105,715
|
|
$
60,469
|
|
|
|
|
Total
assets
|
120,533
|
|
75,552
|
|
|
|
|
Total
liabilities
|
116,280
|
|
112,061
|
|
|
|
|
Total stockholders'
equity (deficit)
|
4,253
|
|
(36,509)
|
|
|
|
|
Reconciliation
of Non-GAAP Financial Measures
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve
Months Ended
|
|
December
31
|
|
December
31
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$ 2,704
|
|
$ 3,676
|
|
$ 13,137
|
|
$ 19,409
|
General and
administrative
|
7,648
|
|
3,909
|
|
20,765
|
|
16,609
|
Total operating
expenses
|
10,352
|
|
7,585
|
|
33,902
|
|
36,018
|
Less associated
stock-based
|
|
|
|
|
|
|
|
compensation
expense
|
1,154
|
|
973
|
|
4,810
|
|
3,970
|
Operating expenses
(non-GAAP)
|
$ 9,198
|
|
$ 6,612
|
|
$ 29,092
|
|
$ 32,048
|
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SOURCE AcelRx Pharmaceuticals, Inc.