HAYWARD, Calif., May 17, 2021 /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 first quarter 2021
financial results.
"We continue to make solid progress on the commercialization of
DSUVIA despite the impact from the pandemic, which appears to be
easing as the month of April was our highest commercial ordering
month since the launch," said Vince
Angotti, Chief Executive Officer of AcelRx. "We remain
committed to building the body of evidence for DSUVIA and its
unique benefit to healthcare providers and their patients by
supporting real-world use studies in a number of different
settings. We look forward to expected data read-outs from
investigator-initiated studies with several prestigious
institutions."
First Quarter and Recent Highlights
- In the first quarter of 2021, AcelRx issued approximately
$36.4 million of stock through an
underwritten public offering and under its At-the-Market sales
agreement.
- In January 2021, AcelRx announced
an investigator-initiated study with University Hospitals Cleveland
Medical Center to evaluate the postoperative use of DSUVIA in a
prospective cohort of patients undergoing cardiac surgery with
cardiopulmonary bypass following a specialized enhanced recovery
protocol.
- In February 2021, AcelRx
announced an investigator-initiated study with Newport Plastic and
Reconstructive Surgery Center analyzing data from the historical
use of DSUVIA for various same-day plastic surgery procedures.
- In March 2021, AcelRx announced
the publication of a pooled analysis of Phase 3 data on the use of
DSUVIA for acute pain management in the postoperative and emergency
department settings in the Journal of Pain Research, which
reported high ratings for global assessment of the method of pain
control and a well-tolerated safety profile for all demographic
subgroups following the dosing of DSUVIA. See Cautionary Statements
section below.
- In March 2021, AcelRx announced
the appointment of Marina Bozilenko as an independent member of the
company's Board of Directors. Ms. Bozilenko has over 30 years of
investment banking and other healthcare industry experience,
including raising more than $30
billion in capital and executing numerous M&A
transactions.
- In April 2021, AcelRx announced
an investigator-initiated study at Montefiore Medical Center
evaluating the perioperative use of DSUVIA for same-day surgical
procedures in patients on buprenorphine therapy for opioid-use
disorder or for chronic pain management.
- In April 2021, the American
Dental Association provided a CDT Code (Code on Dental Procedures
and Nomenclature) establishing a pathway to reimbursement for
DSUVIA for dental and oral surgeons.
- In May 2021, AcelRx announced an
investigator-initiated study to be conducted at The CORE Institute
Specialty Hospital in Phoenix,
Arizona by the Musculoskeletal Orthopedic Research and
Education (MORE) Foundation evaluating the perioperative use of
DSUVIA for patients undergoing hip or knee replacement as a
same-day surgical procedure.
- In May 2021, AcelRx announced a
poster presentation at the 46th Annual American Society
of Regional Anesthesia (ASRA) Meeting reviewing the results of a
study on the intraoperative administration of DSUVIA (sufentanil
sublingual tablet; SST) 30 mcg for the management of acute pain in
an ambulatory surgery center.
- Through April 2021, AcelRx has
achieved 432 formulary approvals.
- A response to the FDA Warning Letter has been provided and
dialogue is ongoing to ensure a successful closeout. The Company
believes it has successfully addressed the points raised. Once
corrective actions are satisfactorily completed, AcelRx expects the
FDA to issue a Close-Out Letter.
Financial Information
- Cash, cash equivalents and short-term investments balance of
$67.3 million as of March 31, 2021;
- First quarter 2021 net revenues were $0.5 million;
- Combined R&D and SG&A expenses for the first quarter of
2021 totaled $8.6 million compared to
$14.7 million for the first quarter
of 2020. Excluding stock-based compensation expense, these amounts
were $7.5 million for the first
quarter of 2021 compared to $13.6
million for the first quarter of 2020. The decrease in
combined R&D and SG&A expenses in the first quarter 2021
was primarily due to reductions in personnel-related costs,
including travel expense, and DSUVIA-related commercialization
expenses. For the first quarter of 2021, net loss was $9.0 million, or $0.08 per basic and diluted share, compared to
$15.9 million, or $0.20 per basic and diluted share, for the first
quarter of 2020.
Webcast and Conference Call Information
As previously
announced, AcelRx will host a live webcast Monday, May 17, 2021 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these
financial results and provide other corporate updates. The webcast
is accessible by visiting the Investors page of AcelRx'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 AcelRx's website at
www.acelrx.com.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, known as DZUVEO® in Europe, 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 and AcelRx is currently in discussions
with potential European marketing partners.
This release is intended for investors only. For more
information, including important safety information and black box
warning for DSUVIA, 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.
AcelRx 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), AcelRx uses
certain non-GAAP financial measures in this press release, in
particular, excluding stock-based compensation expense from its
operating expenses. AcelRx believes that these non-GAAP financial
measures provide useful supplementary information to, and
facilitate additional analysis by, investors and analysts. In
particular, AcelRx believes that these non-GAAP financial measures,
when considered together with AcelRx's financial information
prepared in accordance with GAAP, can enhance investors' and
analysts' ability to meaningfully compare AcelRx'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 AcelRx's financial
performance. AcelRx's management also regularly uses these non-GAAP
financial measures internally to understand, manage and evaluate
AcelRx'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.
Cautionary Statements
Pooled Analysis. The
global satisfaction analysis included a total of 283 patients who
had completed the assessments as well as their healthcare
professionals who had dosed DSUVIA in the clinical trials. Adverse
events occurring in ≥ 2% of the patients were nausea (22.9%),
headache (5.0%), dizziness (4.0%) and vomiting (3.1%). Importantly,
the adverse events of decreased oxygen saturation and somnolence
were low, occurring in 1.5% and 1.2% of the patients, respectively.
Study limitations included a higher enrollment of younger compared
to older patients, and opioid-tolerant patients were excluded.
These Phase 3 studies were funded by AcelRx and the Clinical and
Rehabilitative Medicine Research Program (CRMRP) of the US Army
Medical Research and Materiel Command (USAMRMC). The lead author,
David Leiman, MD, University of Texas at Houston Department of
Surgery and HD Research, Houston
TX, is a paid consultant of AcelRx.
Forward-Looking Statements
This press release
contains forward-looking statements, including, but not limited to,
statements related to the ongoing effects of the COVID-19 pandemic
and its anticipated impacts on AcelRx's business, expectations for
loosening of COVID-related restrictions, the expected continuation
of investigator-initiated studies and the scope of the studies, the
expected analysis and publication of clinical data, the belief that
AcelRx has successfully addressed the points raised in the FDA
Warning Letter, and the expectation that the FDA will issue a
close-out letter once corrective actions are satisfactorily
completed by AcelRx. 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, including the
uncertainties inherent in the initiation, execution and completion
of investigator-initiated studies. 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
AcelRx'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 AcelRx's most recent annual, quarterly
or current report as filed or furnished with the SEC. AcelRx's SEC
reports are available at www.acelrx.com under the "Investors" tab.
Except to the extent required by law, AcelRx 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
|
|
|
March
31
|
|
|
2021
|
|
2020
|
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Product
sales
|
$
451
|
|
$
274
|
|
Contract
and other collaboration
|
60
|
|
112
|
|
Total
revenue
|
511
|
|
386
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
Cost of goods sold
(1)
|
1,040
|
|
1,511
|
|
Research and
development (1)
|
969
|
|
1,412
|
|
Selling, general and
administrative (1)
|
7,644
|
|
13,311
|
|
Total operating costs
and expenses
|
9,653
|
|
16,234
|
|
Loss from
operations
|
(9,142)
|
|
(15,848)
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
expense
|
(672)
|
|
(855)
|
|
Interest income and
other income (expense), net
|
76
|
|
(65)
|
|
Non-cash interest
income on liability related to sale of future royalties
|
782
|
|
843
|
|
Total other income
(expense)
|
186
|
|
(77)
|
|
Net loss
|
$
(8,956)
|
|
$
(15,925)
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.08)
|
|
$
(0.20)
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
113,257
|
|
80,057
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
22
|
|
$
46
|
|
Research and development
|
181
|
|
200
|
|
Selling, general and administrative
|
886
|
|
900
|
|
Total
|
$
1,089
|
|
$
1,146
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2021
|
|
December 31,
2020
|
|
Selected Balance
Sheet Data
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
67,345
|
|
$
42,886
|
|
Total
assets
|
87,347
|
|
66,295
|
|
Total
liabilities
|
114,659
|
|
122,045
|
|
Total stockholders'
deficit
|
(27,312)
|
|
(55,750)
|
|
Reconciliation
of Non-GAAP Financial Measures
|
|
|
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
March
31
|
|
2021
|
|
2020
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
Research and
development
|
$
969
|
|
$
1,412
|
Selling, general and
administrative
|
7,644
|
|
13,311
|
Total operating
expenses
|
8,613
|
|
14,723
|
Less associated
stock-based
|
|
|
|
compensation
expense
|
1,067
|
|
1,100
|
Operating expenses
(non-GAAP)
|
$ 7,546
|
|
$ 13,623
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-reports-first-quarter-2021-financial-results-301292151.html
SOURCE AcelRx Pharmaceuticals, Inc.