REDWOOD CITY, Calif.,
March 16, 2020 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a
specialty pharmaceutical company focused on the development and
commercialization of innovative therapies for use in medically
supervised settings, today reported its fourth quarter and full
year 2019 financial results.
"After only two quarters in 2019 with an expanded sales team,
exceeding last year's formulary and REMS objectives is a solid
indicator of the growing acceptance of DSUVIA® as a treatment
option for the management of acute pain. We fully expect
DSUVIA's success to continue and look forward to the Department of
Defense's Milestone C meeting, which we believe will provide even
more opportunities," continued Angotti. "I'm also excited
about the announcement earlier today related to our acquisition of
Tetraphase Pharmaceuticals, Inc., which will add a key, high growth
product to the portfolio, enhancing our offering to healthcare
institutions, while increasing the productivity of the commercial
teams."
Fourth Quarter and Recent Highlights
- Announced an agreement to acquire Tetraphase Pharmaceuticals in
a stock for stock transaction at an exchange ratio of 0.6303 shares
of AcelRx for each share of Tetraphase, valuing Tetraphase at
$14.4 million as of the close of
trading on March 13, 2020. Also
entered into a co-promotion agreement to immediately begin
realizing commercial combination benefits prior to closing of the
acquisition.
- The Company is on track to achieve its previously communicated
target of 465 REMS-certified facilities and formulary approvals by
the end of 2020. As of March 15,
2020, 218 healthcare facilities are now REMS-certified and
able to purchase DSUVIA and 223 formulary approvals have been
achieved.
- Confirmed timing for April 2020
DSUVIA Milestone C meeting with the Department of Defense, with
procurement recommendation expected post-meeting.
- Announced an agreement with Brigham and Women's Hospital for an
investigator-initiated study led by Richard
D. Urman MD, MBA, Associate Professor of Anesthesia and
co-director of the Center for Perioperative Research at Brigham and
Women's Hospital and Harvard Medical
School. The study plans to examine the perioperative use of
DSUVIA in the analgesic regimen for spine surgery.
Financial Information
- Cash, cash equivalents and short-term investments balance of
$66.1 million as of December 31, 2019;
- Fourth quarter 2019 net revenues were $0.5 million, and for the full year 2019 were
$2.3 million, as previously
announced;
- Combined R&D and SG&A expenses for the fourth quarter
of 2019 totaled $13.8 million
compared to $10.4 million for the
fourth quarter of 2018. Excluding stock-based compensation expense,
these amounts were $12.6 million for
the fourth quarter of 2019 compared to $9.2
million for the fourth quarter of 2018. R&D and SG&A
expenses for the year ended December 31,
2019 totaled $49.7 million
compared to $33.9 million for the
year ended December 31, 2018.
Excluding stock-based compensation expense, these figures were
$44.9 million for the year ended
December 31, 2019 compared to
$29.1 million for the year ended
December 31, 2018. The increase in
combined R&D and SG&A expenses is primarily due to
increased personnel-related expenses 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;
- Net cash outflow for the fourth quarter of 2019 was
$14.3 million, including $0.6 million in debt service, and for the
year-ended December 31, 2019 was
$39.6 million, and;
- For the fourth quarter of 2019, net loss was $14.4 million, or $0.18 per basic and diluted share, compared to
$12.6 million, or $0.18 per basic and diluted share, for the fourth
quarter of 2018. Net loss for the year ended December 31, 2019 was $53.2 million, or $0.67 per basic and diluted share, compared to
$47.1 million, or $0.81 per basic and diluted share, for the year
ended December 31, 2018.
2020 Guidance
As previously announced, the Company's
year-end goals include obtaining 465 REMS-certified facilities and
465 formulary approvals in 2020. Quarterly combined R&D
and SG&A expense in 2020 is expected to range from $10 million to $13
million, depending on the quarter, and includes
approximately $1 million of non-cash
stock-based compensation per quarter ($9
million to $12 million
excluding stock-based compensation expense). Annual debt
service is expected to approximate $6
million. Annual capital expenditures are expected to
range from $4-$5 million attributed mainly to the installation
of a new high-volume, automated packaging line at our contract
manufacturer. These amounts do not consider the impact from
the previously announced acquisition of Tetraphase Pharmaceuticals
but reflect the benefits of the co-promotion agreement.
2020 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 the "Forward-Looking Statements"
heading below.
Webcast and Conference Call Information
As previously
announced, AcelRx will host a live webcast Monday, March 16, 2020 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss these
financial results and provide other corporate updates. The webcast
is accessible by visiting the Investors page of the Company's
website at www.acelrx.com and clicking on the webcast link.
The webcast will be accompanied by a slide presentation. 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. A webcast
replay will be available on the AcelRx website for 90 days
following the call by visiting the Investor page of the Company's
website at www.acelrx.com.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated 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.
DSUVIA was designed to provide rapid analgesia via a non-invasive
route and to eliminate dosing errors associated with intravenous
(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
previously only marketed for 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 Commission 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), an
investigational product in the U.S., is 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 these non-GAAP
financial measures provide useful supplementary information to, and
facilitate additional analysis by, investors and analysts. In
particular, the Company believes that these non-GAAP financial
measures, 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, these types of non-GAAP financial measures
are regularly used by investors and analysts to model and track the
Company's financial performance. AcelRx's management also regularly
uses these non-GAAP financial measures 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 number of REMS-certified facilities and
formulary approvals expected by the end of 2020, the timing of the
Department of Defense Milestone C meeting and procurement of DSUVIA
by the military, opportunities that may result from the Milestone C
meeting, the continuing success of DSUVIA, expected commencement of
an investigator-initiated study, expected R&D and SG&A
expenses, debt service and capital expenditures, expected benefits
from the acquisition of Tetraphase and the co-promotion agreement,
and the acquisition being consummated. 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
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
377
|
|
$
390
|
|
$
1,830
|
|
$
825
|
Contract
and other collaboration
|
98
|
|
223
|
|
459
|
|
1,326
|
Total
revenue
|
475
|
|
613
|
|
2,289
|
|
2,151
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
1,618
|
|
1,238
|
|
6,806
|
|
3,976
|
Research and
development (1)
|
1,063
|
|
2,704
|
|
4,661
|
|
13,137
|
Selling, general and
administrative (1)
|
12,786
|
|
7,648
|
|
45,027
|
|
20,765
|
Total operating costs
and expenses
|
15,467
|
|
11,590
|
|
56,494
|
|
37,878
|
Loss from
operations
|
(14,992)
|
|
(10,977)
|
|
(54,205)
|
|
(35,727)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(831)
|
|
(459)
|
|
(2,535)
|
|
(2,217)
|
Interest income
and other income (expense), net
|
438
|
|
495
|
|
2,166
|
|
1,138
|
Non-cash
interest income (expense) on liability related to sale of future
royalties
|
962
|
|
(1,617)
|
|
1,337
|
|
(10,341)
|
Total other income
(expense)
|
569
|
|
(1,581)
|
|
968
|
|
(11,420)
|
Provision for income
taxes
|
-
|
|
-
|
|
(3)
|
|
(2)
|
Net loss
|
$
(14,423)
|
|
$
(12,558)
|
|
$
(53,240)
|
|
$
(47,149)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.18)
|
|
$
(0.18)
|
|
$
(0.67)
|
|
$
(0.81)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
79,573
|
|
70,623
|
|
79,184
|
|
58,409
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
63
|
|
$
78
|
|
$
260
|
|
$
358
|
Research and development
|
221
|
|
392
|
|
920
|
|
1,970
|
Selling, general and administrative
|
994
|
|
762
|
|
3,877
|
|
2,840
|
Total
|
$
1,278
|
|
$
1,232
|
|
$
5,057
|
|
$
5,168
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2019
|
|
December 31,
2018
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
66,137
|
|
$
105,715
|
|
|
|
|
Total
assets
|
91,356
|
|
120,533
|
|
|
|
|
Total
liabilities
|
132,774
|
|
116,280
|
|
|
|
|
Total stockholders'
(deficit) equity
|
(41,418)
|
|
4,253
|
|
|
|
|
Reconciliation
of Non-GAAP Financial Measures
|
|
|
|
|
|
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve
Months Ended
|
|
December 31,
2019
|
|
December 31,
2019
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
1,063
|
|
$
2,704
|
|
$
4,661
|
|
$
13,137
|
Selling, general and
administrative
|
12,786
|
|
7,648
|
|
45,027
|
|
20,765
|
Total operating
expenses
|
13,849
|
|
10,352
|
|
49,688
|
|
33,902
|
Less associated
stock-based compensation
expense
|
1,215
|
|
1,154
|
|
4,797
|
|
4,810
|
Operating expenses
(non-GAAP)
|
$
12,634
|
|
$
9,198
|
|
$
44,891
|
|
$
29,092
|
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SOURCE AcelRx Pharmaceuticals, Inc.