HAYWARD, Calif., Aug. 16, 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 second quarter 2021
financial results.
"We continued to gain solid sales momentum with DSUVIA® as
the recent real-world data became more widely disseminated to
healthcare providers, and elective surgery restrictions at
ambulatory surgery centers and hospitals eased during the second
quarter," said Vince Angotti, Chief
Executive Officer of AcelRx. "Our continued commitment to
supporting investigator-initiated trials to generate additional
DSUVIA real-world data should further add to healthcare provider
awareness of the advantages of DSUVIA. Finally, business
development remains a key priority and completing the DZUVEO®
agreement with an exceptional partner in Europe and expanding our portfolio in the U.S.
with two complementary innovative product candidates should drive
incremental value to AcelRx."
Second Quarter and Recent Highlights
- In July 2021, AcelRx entered into
agreements with Laboratoire Aguettant (Aguettant) providing
Aguettant with a license to commercialize DZUVEO in Europe, allowing AcelRx to receive up to
approximately $55 million in combined
up-front and sales-based milestone payments, and providing AcelRx
with two innovative pre-filled syringe product candidates for the
U.S. The expected market opportunity for these two product
candidates exceeds $100 million, and
AcelRx currently plans to file New Drug Applications for them
within 12 months.
- In June 2021, the U.S. Army
Medical Materiel Development Activity (USAMMDA) publicly
communicated their support of DSUVIA for battlefield pain
management. USAMMDA stated concerns with the standard intramuscular
morphine autoinjectors and emphasized that another commonly used
battlefield analgesic, oral transmucosal fentanyl citrate, is
licensed only for use in chronic pain syndromes found in cancer
patients and it is specifically labeled not to be used for acute
pain management.
- In June 2021, AcelRx announced it
had reached agreement with the U.S. Food and Drug Administration
(FDA) with regards to finalizing corrective actions the company had
taken or plans to take in response to the previously announced FDA
warning letter, dated February 11,
2021, regarding certain DSUVIA promotional materials.
- In June 2021, AcelRx announced
important findings from a podium presentation on DSUVIA during the
Best Papers of the Regional Societies session at the
California Society of Plastic Surgeons 71st Annual Meeting.
Following long-duration procedures, which often included multiple
cosmetic procedures combined (averaging approximately 3 hours), 89%
of the patients were opioid-free in the PACU, recovery time
averaged 1 hour and the only adverse event was 1 patient that had
nausea. See Additional Study Information section below.
- In May 2021, AcelRx announced an
investigator-initiated study to be conducted at Tampa General
Hospital to evaluate the use of DSUVIA for patients with sickle
cell disease presenting to the emergency department with painful
vaso-occlusive crisis.
- 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 for the
management of acute pain in an ambulatory surgery center. Among
other results, the study showed orthopedic surgery patients in the
DSUVIA group required 50% less opioids in the PACU (p=0.018), with
significantly more of them opioid-free (36% vs 8%; p=0.037)
compared to the control group. Furthermore, DSUVIA-treated patients
had improved overall benefit of analgesia scores (OBAS) compared to
the control group (p=0.006). See Additional Study Information
section below.
- In May 2021, the fully automated
packaging equipment was installed at our contract manufacturer in
the U.S. with final site acceptance testing in the process of being
finalized and first commercial batches on target for Q3 2022,
subject to regulatory approvals.
- 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 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.
- Through July 31, 2021, AcelRx has
achieved 516 formulary approvals, and is on track to exceed its
guidance of 615 approvals by year end 2021.
Financial Information
- Cash, cash equivalents and short-term investments balance of
$55.3 million as of June 30, 2021;
- Second quarter 2021 net revenues were $0.4 million and first half 2021 net revenues
were $1.0 million;
- Combined R&D and SG&A expenses for the second quarter
of 2021 totaled $9.4 million compared
to $8.4 million for the second
quarter of 2020. Excluding stock-based compensation expense, these
amounts were $8.3 million for the
second quarter of 2021 compared to $7.3
million for the second quarter of 2020. R&D and SG&A
expenses for the first half of 2021 totaled $18.0 million compared to $23.1 million in the first half of 2020.
Excluding stock-based compensation expense, these figures were
$15.8 million for the first half of
2021 compared to $20.9 million for
the first half of 2020. The decrease in combined R&D and
SG&A expenses in the first half 2021 was primarily due to
reductions in personnel-related costs, including travel expense,
and DSUVIA-related commercialization expenses.
- For the second quarter of 2021, net loss was $9.9 million, or $0.08 per basic and diluted share, compared to
$6.6 million, or $0.08 per basic and diluted share, for the second
quarter of 2020. Net loss for the first half of 2021 was
$18.8 million, or $0.16 basic and diluted net loss per share,
compared to $22.5 million, or
$0.28 basic and diluted net loss per
share, for the prior year period.
Webcast and Conference Call Information
As previously
announced, AcelRx will host a live webcast Monday, August 16, 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 has entered into a licensing
agreement with Laboratoire Aguettant to commercialize DZUVEO in
Europe.
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.
AcelRx has obtained the rights to file New Drug Applications (NDAs)
and, subject to U.S. Food and Drug Administration (FDA) approval,
commercialize in the U.S. two of Laboratoire Aguettant's
innovative, EU-approved, pre-filled syringe products – ready-to-use
ephedrine and phenylephrine. 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.
Additional Study Information
Podium
Presentation. The presentation was presented by Hisham Seify, MD, PhD, FACS and reported on data
collected from a total of 76 patients during both short and
long-duration general anesthesia plastic surgery cases as well as
"awake" cosmetic procedures. Procedures were performed utilizing a
single DSUVIA tablet in combination with general anesthesia.
Patients undergoing short (< 1 hour) procedures required no
opioids in the postanesthesia care unit (PACU) and had an average
recovery time of 33 minutes with no adverse events reported. Dr.
Seify also presented his protocol for using DSUVIA during "awake"
surgery cases and reported that to date they had seen no adverse
events or vital sign instability in these patients. The data
presented at the meeting are from an investigator-initiated trial
supported by AcelRx. Dr. Seify is a paid consultant for AcelRx.
Poster Presentation. The primary objective of this study
was to determine if DSUVIA given prior to emergence from anesthesia
was efficacious in reducing initial post anesthesia care unit
(PACU) pain scores compared to a control group which received no
intervention. Secondary outcomes included opioid use and percentage
of patients opioid free in PACU, and time until ready to discharge.
The study was a prospective, randomized, controlled trial conducted
at an ambulatory surgery center with patients aged 18-80 undergoing
orthopedic surgery under general anesthesia. A total of 50
patients were included in the final analysis. There were no
significant differences in baseline characteristics or duration of
surgery between the two groups. The pain score on arrival to PACU
was not significantly different between either group. However,
patients in the DSUVIA group required 50% less opioids in the PACU
(p=0.018), with significantly more of them opioid-free (36% vs 8%;
p=0.037). Furthermore, DSUVIA-treated patients had improved overall
benefit of analgesia scores (OBAS) compared to the control group
(p=0.006). OBAS is a validated 7-item tool that assesses pain
intensity, adverse effects and patients' satisfaction with
analgesia. Limitations of the study include that the DSUVIA was not
compared to an active comparator, in that it did not allow for
preemptive opioid analgesia in the control group. Also, as the data
collection ended at discharge, the authors were unable to assess
any additional analgesic benefit of DSUVIA beyond the immediate
postoperative period. One of the investigators of the study is a
paid consultant for AcelRx but was not compensated for this
study.
Forward-Looking Statements
This press release
contains forward-looking statements, including, but not limited to,
statements related to the effects of the COVID-19 pandemic and its
anticipated impacts on AcelRx's business, the expected incremental
value driven by business development efforts to AcelRx, the
expected support for, and continuation of, investigator-initiated
studies, the scope and benefits of investigator-initiated studies,
the expected market opportunity for product candidates, plans to
file NDAs and the timing of such filings, the expectation that the
FDA will issue a close-out letter once corrective actions are
satisfactorily completed by AcelRx, the availability of commercial
batches from the fully automated packaging equipment and the timing
thereof, and being on track to exceed its guidance of 615
approvals by year end 2021. 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
|
|
Six Months
Ended
|
|
|
June
30
|
|
June
30
|
|
|
2021
|
2020
|
$ Δ
|
% Δ
|
|
2021
|
2020
|
$ Δ
|
% Δ
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales
|
$
392
|
$
303
|
$
89
|
29%
|
|
$
843
|
$
577
|
$
266
|
|
|
Contract
and other collaboration
|
51
|
2,621
|
(2,570)
|
-98%
|
|
111
|
2,733
|
(2,622)
|
-96%
|
|
Total
revenue
|
443
|
2,924
|
(2,481)
|
-85%
|
|
954
|
3,310
|
(2,356)
|
-71%
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
1,040
|
1,370
|
330
|
24%
|
|
2,080
|
2,881
|
801
|
28%
|
|
Research and
development
|
724
|
813
|
89
|
11%
|
|
1,693
|
2,225
|
532
|
24%
|
|
General and
administrative
|
8,694
|
7,575
|
(1,119)
|
-15%
|
|
16,338
|
20,886
|
4,548
|
22%
|
|
Total operating costs
and expenses
|
10,458
|
9,758
|
(700)
|
-7%
|
|
20,111
|
25,992
|
5,881
|
23%
|
|
Loss from
operations
|
(10,015)
|
(6,834)
|
(3,181)
|
-47%
|
|
(19,157)
|
(22,682)
|
3,525
|
16%
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
(614)
|
(872)
|
258
|
30%
|
|
(1,286)
|
(1,727)
|
441
|
26%
|
|
Interest income and
other income (expense),
net
|
(16)
|
270
|
(286)
|
-106%
|
|
60
|
205
|
(145)
|
-71%
|
|
Non-cash interest
income on liability related
to sale of future royalties
|
799
|
834
|
(35)
|
-4%
|
|
1,581
|
1,677
|
(96)
|
-6%
|
|
Total other income
(expense)
|
169
|
232
|
(63)
|
-27%
|
|
355
|
155
|
200
|
129%
|
|
Provision for income
taxes
|
(5)
|
(4)
|
(1)
|
25%
|
|
(5)
|
(4)
|
(1)
|
25%
|
|
Net loss
|
$
(9,851)
|
$(6,606)
|
$(3,245)
|
49%
|
|
$(18,807)
|
$(22,531)
|
$ 3,724
|
-17%
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.08)
|
$
(0.08)
|
|
|
|
$
(0.16)
|
$
(0.28)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net
loss per common share
|
119,120
|
80,662
|
|
|
|
116,204
|
80,360
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
21
|
$
27
|
|
|
|
$
43
|
$
73
|
|
|
|
Research and development
|
200
|
184
|
|
|
|
381
|
384
|
|
|
|
Selling, general and administrative
|
951
|
879
|
|
|
|
1,837
|
1,779
|
|
|
|
Total
|
$
1,172
|
$
1,090
|
|
|
|
$
2,261
|
$
2,236
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2021
|
|
December 31,
2020
|
|
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
55,325
|
|
$
42,886
|
|
|
|
|
|
|
Total
assets
|
79,586
|
|
66,295
|
|
|
|
|
|
|
Total
liabilities
|
115,575
|
|
122,045
|
|
|
|
|
|
|
Total stockholders'
deficit
|
(35,989)
|
|
(55,750)
|
|
|
|
|
|
|
Reconciliation
of Non-GAAP Financial Measures
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30
|
|
June
30
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
724
|
|
$
813
|
|
$
1,693
|
|
$
2,225
|
Selling, general and
administrative
|
8,694
|
|
7,575
|
|
16,338
|
|
20,886
|
Total operating
expenses
|
9,418
|
|
8,388
|
|
18,031
|
|
23,111
|
Less associated
stock-based
|
|
|
|
|
|
|
|
compensation
expense
|
1,151
|
|
1,063
|
|
2,218
|
|
2,163
|
Operating expenses
(non-GAAP)
|
$ 8,267
|
|
$ 7,325
|
|
$ 15,813
|
|
$ 20,948
|
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SOURCE AcelRx Pharmaceuticals, Inc.