REDWOOD CITY, Calif.,
March 15, 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 fourth quarter and full
year 2020 financial results.
"Last year we achieved many important milestones and objectives
that set the foundation for the growth of DSUVIA® in 2021 and
beyond, despite the global pandemic," said Vince Angotti, Chief Executive Officer of
AcelRx. "Like many other companies in our space, COVID has had an
impact on the pace of approvals and adoption of DSUVIA as formulary
review meetings and elective surgeries have been postponed.
However, with vaccine rollouts and elective surgeries ramping up,
we expect formulary approvals in the second half of 2021 to be back
to the accelerating rate we saw before the pandemic. Importantly,
we expect data from ongoing and upcoming studies this year to
continue to demonstrate the unique characteristics of DSUVIA that
benefit the patient and institutions alike."
FY 2020 and Recent Highlights
- In March, AcelRx announced an agreement with Brigham and
Women's Hospital for an investigator-initiated study of DSUVIA 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. This study is
ongoing and is evaluating the perioperative use of DSUVIA in
patients undergoing spine surgery compared to their standard
intravenous (IV) opioid regimen.
- In April, DSUVIA achieved Milestone C approval from the
Department of Defense (DoD), a decision that approves DSUVIA for
use in all U.S. Army sets, kits and outfits (SKOs). Initial
stocking orders have begun for U.S. Army SKOs and are expected to
approximate $30 million over the next
three years, dependent on troop deployment schedules.
- In July, AcelRx entered into a distribution agreement with
Zimmer Biomet to market DSUVIA within the dental and oral surgery
markets in the United States
exclusively through Zimmer Biomet's Dental division. The formal
launch is planned in 2021 and will expand once Zimmer Biomet
receives necessary licenses. The estimated applicable market in
dental surgeries is 7.5 million annual procedures.
- In August, AcelRx announced the publication of a study
entitled, "Reduced Opioid Use and Reduced Time in the
Postanesthesia Care Unit Following Preoperative Administration of
Sublingual Sufentanil in an Ambulatory Surgery Setting," by
Christian Tvetenstrand, MD and
Michael Wolff, MD, in the Journal
of Clinical Anesthesia and Pain Management. Highlights of the
publication included a greater than 50% overall reduction in
opioids administered perioperatively and a 34% reduction in
postanesthesia care unit (PACU) time in the DSUVIA-treated patients
compared to historical controls. See Cautionary Statements section
below.
- In August, AcelRx announced an investigator-initiated study
with Cleveland Clinic evaluating the effects of DSUVIA on
post-operative recovery from orthopedic surgery. This double-blind
study is ongoing and compares DSUVIA to IV fentanyl for patients
undergoing knee arthroscopy.
- In September, AcelRx announced that the U.S. military's access
to DSUVIA was expanded with the addition of DSUVIA to the DoD Joint
Deployment Formulary.
- In September, the U.S. Army awarded AcelRx a contract for up to
$3.6 million over four years for the
purchase of DSUVIA to support a DoD study to aid the development of
clinical practice guidelines.
- In December, AcelRx announced the publication of clinical data
in an article in the Journal of Universal Surgery entitled,
"A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg
for the Perioperative Management of Surgical Pain," by lead author
Koth Cassavaugh, PharmD, Director of
Pharmacy, which reported that perioperative dosing of DSUVIA can
provide more rapid PACU recovery times compared to standard IV
opioid administration. In addition, patients in the control group
received 66% higher mean dosing of intraoperative IV opioids
compared to patients receiving DSUVIA and postoperative opioid use
for the DSUVIA group was less than half of the control IV opioid
group, with orthopedic surgery patients having the largest decrease
(69%). See Cautionary Statements section below.
- In January and February 2021,
AcelRx issued approximately $36.3
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.
- Through February 2021, AcelRx has
achieved 387 formulary approvals.
Financial Information
- As previously announced, the cash, cash equivalents and
short-term investments balance was $42.9
million as of December 31,
2020, and net revenues for the fourth quarter 2020 were
$0.7 million, and for the full year
2020 were $5.4 million.
- Combined R&D and SG&A expenses for the fourth quarter
of 2020 totaled $8.7 million, a
significant reduction compared to $13.8
million for the fourth quarter of 2019. Excluding
stock-based compensation expense, these amounts were $7.6 million for the fourth quarter of 2020
compared to $12.6 million for the
fourth quarter of 2019. R&D and SG&A expenses for the year
ended December 31, 2020 totaled
$40.3 million compared $49.7 million for the year ended December 31, 2019. Excluding stock-based
compensation expense, these figures were $36.0 million for the year ended December 31, 2020, compared to $44.9 million for the year ended December 31, 2019. The decrease in combined
R&D and SG&A expenses in the fourth quarter and year ended
2020 was primarily due to reductions in personnel-related costs,
including travel expense, and DSUVIA-related commercialization
expenses.
- Net loss for the fourth quarter of 2020 was $8.9 million, or $0.10 per basic and diluted share, compared to
$14.4 million, or $0.18 per basic and diluted share, for the fourth
quarter of 2019. Net loss for the year ended December 31, 2020 was $40.4 million, or $0.47 per basic and diluted share, compared to
$53.2 million, or $0.67 per basic and diluted share, for the year
ended December 31, 2019.
2021 Guidance
The Company's 2021 year-end goals include obtaining 615
cumulative formulary approvals as we expect COVID restrictions on
elective surgeries to be loosened in the second half of 2021.
Quarterly combined R&D and SG&A expense is expected to be
approximately $9-$10 million (and $8.0-$8.5 million
excluding stock compensation and depreciation). Annual debt service
is expected to approximate $10
million as we continue to pay down amounts outstanding under
our senior debt facility. Annual capital expenditures are expected
to range from $4-$5 million attributed mainly to the final
installation of our new high-volume, automated packaging line at
our contract manufacturer. We expect initial packaging batches to
be produced at the end of this year, with commercial batches
beginning after regulatory approvals are received in Q3 2022. With
a path now clear to final installation of the automated packaging
line, we also plan to close on an agreement to out-license DZUVEO
for Europe later this year.
2021 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 Forward-Looking Statements below.
Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast
Monday, March 15, 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
http://ir.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
http://ir.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 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. 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.
Cautionary Statements
Tvetenstrand and Wolff Study. The study compared a
prospective group of patients with preoperative dosing of a single
sublingual DSUVIA tablet to a historical control group receiving
standard intravenous (IV) opioid administration for same-day
general surgery procedures. A total of 127 patients were evaluated
in the study. Study limitations include that it was an open-label
study, the retrospective nature of the control group, and the focus
on only general surgery patients. AcelRx did not provide funding
for the conduct of the Tvetenstrand and Wolff Study but did fund
medical writing support. Dr. Tvetenstrand is a paid
consultant of AcelRx.
Cassavaugh Study. The evaluation focused on 140 patients
who were dosed with DSUVIA compared to 158 patients who had been
dosed with traditional IV opioids during the same time period
undergoing the same surgical procedures. Study limitations included
that it was a single-center, retrospective study of DSUVIA dosing
in a surgical patient population and both inpatient and outpatient
surgery data was combined. The study did not control for whether
patients were opiate naïve or opiate tolerant in the treatment
groups, however, there is no reason for these patients to be
present at a substantially higher frequency in either group. AcelRx
did not provide funding for the conduct of the evaluation but did
fund medical writing support. Dr. Cassavaugh 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 expected
growth of DSUVIA, 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 timing and
size of military orders, opportunities that may result from the
Milestone C meeting, the timing of the expected formal launch by
Zimmer Biomet under the distribution agreement, the market for
DSUVIA in dental and oral surgeries, the number of formulary
approvals expected by the end of 2021, expected R&D and
SG&A expenses, debt service and capital expenditures, the
production and timing of initial packaging and commercial batches,
the timing of expected regulatory approvals, and the plan to close
an agreement to out-license DZUVEO.
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
risk that the military and hospital systems delay, or fail to
place, orders, that AcelRx may not experience the expected benefits
from the Zimmer Biomet commercial opportunity and 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
|
|
Twelve
Months Ended
|
|
December
31
|
|
December
31
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
657
|
|
$
377
|
|
$
2,521
|
|
$
1,830
|
Contract
and other collaboration
|
81
|
|
98
|
|
2,895
|
|
459
|
Total
revenue
|
738
|
|
475
|
|
5,416
|
|
2,289
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
1,300
|
|
1,618
|
|
6,032
|
|
6,806
|
Research and
development (1)
|
836
|
|
1,063
|
|
4,017
|
|
4,661
|
Selling, general and
administrative (1)
|
7,846
|
|
12,786
|
|
36,330
|
|
45,027
|
Total operating costs
and expenses
|
9,982
|
|
15,467
|
|
46,379
|
|
56,494
|
Loss from
operations
|
(9,244)
|
|
(14,992)
|
|
(40,963)
|
|
(54,205)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(754)
|
|
(831)
|
|
(3,305)
|
|
(2,535)
|
Interest income and
other income (expense), net
|
272
|
|
438
|
|
583
|
|
2,166
|
Non-cash interest
income (expense) on liability
related to sale of future royalties
|
808
|
|
962
|
|
3,310
|
|
1,337
|
Total other income
(expense)
|
326
|
|
569
|
|
588
|
|
968
|
Provision for income
taxes
|
-
|
|
-
|
|
(4)
|
|
(3)
|
Net loss
|
$
(8,918)
|
|
$
(14,423)
|
|
$
(40,379)
|
|
$
(53,240)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.10)
|
|
$
(0.18)
|
|
$
(0.47)
|
|
$
(0.67)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per
common share
|
92,290
|
|
79,573
|
|
85,257
|
|
79,184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
25
|
|
$
63
|
|
$
123
|
|
$
260
|
Research and development
|
192
|
|
221
|
|
764
|
|
920
|
Selling, general and administrative
|
867
|
|
994
|
|
3,537
|
|
3,877
|
Total
|
$
1,084
|
|
$
1,278
|
|
$
4,424
|
|
$
5,057
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2020
|
|
December 31,
2019
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
42,886
|
|
$
66,137
|
|
|
|
|
Total
assets
|
66,295
|
|
91,356
|
|
|
|
|
Total
liabilities
|
122,045
|
|
132,774
|
|
|
|
|
Total stockholders'
(deficit) equity
|
(55,750)
|
|
(41,418)
|
|
|
|
|
Reconciliation
of Non-GAAP Financial Measures
|
|
|
|
|
|
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve
Months Ended
|
|
December
31
|
|
December
31
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
836
|
|
$
1,063
|
|
$
4,017
|
|
$
4,661
|
Selling, general and
administrative
|
7,846
|
|
12,786
|
|
36,330
|
|
45,027
|
Total operating
expenses
|
8,682
|
|
13,849
|
|
40,347
|
|
49,688
|
Less associated
stock-based
|
|
|
|
|
|
|
|
compensation
expense
|
1,059
|
|
1,215
|
|
4,301
|
|
4,797
|
Operating expenses
(non-GAAP)
|
$
7,623
|
|
$
12,634
|
|
$
36,046
|
|
$
44,891
|
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SOURCE AcelRx Pharmaceuticals, Inc.