Initial Niyad development batch
successfully produced; preparations on track for an Emergency Use
Authorization submission
DSUVIA sales of $0.5M in the third quarter, a 217% increase over
prior year
$20.9 million in
cash and short-term investments as of September 30, 2022
Webcast and Conference Call to be held today
at 4:30 p.m. EDT
HAYWARD,
Calif., Nov. 14, 2022 /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 third quarter 2022
financial results.
"We have continued to reduce costs and advance the portfolio as
planned. We have progressed our lead nafamostat product candidate,
Niyad™ to prepare for a potential Emergency Use Authorization in
the first half of 2023 and initiated early commercial planning to
ensure we're prepared for a potential launch next year," stated
Vince Angotti, Chief Executive
Officer of AcelRx. "Additionally, we expect to submit our ephedrine
pre-filled syringe NDA by the end of this year, with the second
pre-filled syringe product submission planned for the first half of
next year to ensure we have multiple potential commercial products
available by the end of 2023."
Mr. Angotti continued, "Related to DSUVIA®, our commercial focus
in the third quarter remained on procedural suites, demonstrating
continued year-over-year growth despite the significant reduction
in the size of our commercial organization. We expect to finalize
an agreement for DSUVIA by the end of the year with a strategic
partner that can more fully maximize the DSUVIA opportunity with
additional resources. Our European partner, Aguettant, recently
launched DZUVEO® in Europe,
further extending the commercial footprint of our novel sufentanil
sublingual tablet."
Third Quarter and Recent Highlights
- The initial development batch of Niyad was successfully
produced earlier this month in preparation for the potential
Emergency Use Authorization in the first half of 2023.
- In October, the Company announced the European Launch of DZUVEO
by its partner, Aguettant across key European countries, with
commercialization in Spain, Portugal and Italy
expected to begin in the first half of 2023.
- In October, the Company announced the podium presentation of a
study of DSUVIA in a large cohort of patients undergoing plastic
surgery procedures entitled, "Experience in Complex Outpatient
Plastic Surgery Procedures Using Sufentanil Sublingual Tablets".
The study, conducted in 324 plastic surgery cases, was presented
on October 28th by Jeffrey DeWeese, M.D., FACS, at
Plastic Surgery The Meeting 2022, held October 27-30,
in Boston, MA. The study found many positive benefits of
using DSUVIA, including the ability to perform complex, extensive
cosmetic procedures without general anesthesia, allowing for a
rapid discharge time.
- In October, the Company announced two abstracts presented at
the ANESTHESIOLOGY® Annual Meeting 2022. The first
presentation was of an investigator-initiated trial demonstrating
the advantages of sufentanil sublingual tablet versus intravenous
opioids for postoperative spine surgery pain and the second was a
presentation by the Uniformed Services
University of the Health Sciences on DSUVIA for battlefield
pain management.
Financial Information
- The cash, cash equivalents and short-term investments balance
was $20.9 million as of September 30, 2022.
- Third quarter 2022 DSUVIA net sales were $0.5 million, a 217% increase over 2021;
year-to-date September 30, 2022
DSUVIA net sales were $1.5 million,
representing a 51% increase over the same period in 2021. Total
DSUVIA units sold in the third quarter of 2022 were 1,032 compared
to 371 units in 2021. Total net revenues in the third quarter 2022
of $0.5 million declined $1.4 million compared to the same period in 2021
due to the recognition of $1.7
million in revenues in the third quarter of 2021 attributed
to an upfront payment received related to our DZUVEO European
licensing agreement.
- Combined R&D and SG&A expenses for the third quarter of
2022 totaled $6.6 million compared to
$10.1 million for the third quarter
of 2021. Excluding non-cash depreciation and stock-based
compensation expense, these amounts were $5.7 million for the third quarter of 2022,
compared to $8.6 million for the
third quarter of 2021. The decrease in combined R&D and
SG&A expenses in the third quarter of 2022 was primarily due to
overall cost reductions principally focused on DSUVIA-related
commercial expenses.
- Net loss attributable to common shareholders for the third
quarter of 2022 was $6.9 million, or
$0.94 per basic and diluted share,
compared to a net loss of $8.4
million, or $1.40 per basic
and diluted share, for the third quarter of 2021.
Webcast and Conference Call Information
As previously
announced, AcelRx management will host a live webcast and
conference call at 4:30 p.m. Eastern Daylight
Time/1:30 p.m. Pacific Daylight Time
on November 14, 2022 to discuss the financial results and
provide an update on the Company's business. The webcast can be
accessed by visiting the "Investors" section of the Company's
website at www.acelrx.com and clicking on the webcast
link within the News & Events/Upcoming Events section. The
webcast will include a slide presentation and a replay will be
available on the AcelRx website for 90 days following the
event.
Investors who wish to participate in the conference call may do
so by dialing 1-866-361-2335 for domestic callers, 1-855-669-9657
for Canadian callers, or 1-412-902-4204 for international callers.
The conference ID is 10172773.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, branded 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/DZUVEO was designed to provide rapid
analgesia via a non-invasive route and to eliminate dosing errors
associated with intravenous (IV) administration. DSUVIA/DZUVEO 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. DZUVEO has been approved by the European
Medicines Agency and AcelRx's European commercialization
partner, Aguettant, markets the drug in Europe.
For more information, including important safety information and
black box warning for DSUVIA, please visit www.DSUVIA.com.
About Nafamostat
Nafamostat is a broad spectrum,
synthetic serine protease inhibitor with anticoagulant,
anti-inflammatory and potential anti-viral activities. Niyad™ is a
lyophilized formulation of nafamostat and is currently being
studied under an investigational device exemption, or IDE, as an
anticoagulant for the extracorporeal circuit, and has received
Breakthrough Device Designation Status from the FDA. LTX-608 is a
proprietary nafamostat formulation for direct IV infusion that will
be investigated and developed as a potential anti-viral for the
treatment of COVID, acute respiratory distress syndrome (ARDS),
disseminated intravascular coagulation (DIC) and acute
pancreatitis.
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 several
product candidates. The product candidates include: Zalviso®
(sufentanil sublingual tablet system, SST system, 15 mcg), an
investigational product in the U.S. being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings; two pre-filled, ready-to-use syringes of ephedrine and
phenylephrine licensed for the U.S. from Aguettant;
Niyad™, a regional anticoagulant for the extracorporeal circuit;
and LTX-608, for the potential treatment of COVID-19, disseminated
intravascular coagulation, acute respiratory distress syndrome and
acute pancreatitis. DZUVEO is an approved product
in Europe.
This release is intended for investors only. For additional
information about AcelRx, please visit www.acelrx.com.
Forward-looking statements
This press release contains
forward-looking statements based upon AcelRx's current
expectations. 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
"potential," "believe," "expect," "expects," "expected,"
"anticipate," "may," "will," "enable," "should," "seek,"
"approximately," "intends," "intended," "plans," "planned,"
"planning," "estimates," "benefits," 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, which are predictions, projections and
other statements about future events that are based on current
expectations and assumptions. 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: (i) risks relating to AcelRx's product
development activities and ongoing commercial business operations;
(ii) risks related to the ability of AcelRx and its business
partners to implement development plans, launch plans, forecasts
and other business expectations; (iii) risks related to unexpected
variations in market growth and demand for AcelRx's commercial and
developmental products and technologies; (iv) risks related to
AcelRx's liquidity and our ability to maintain capital resources;
(v) AcelRx's ability to retaining its listing on the Nasdaq
exchange; and (vi) risks relating to our ability to obtain
regulatory approvals for our developmental product candidates.
Although it is not possible to predict or identify all such risks
and uncertainties, they may include, but are not limited to, those
described under the caption "Risk Factors" and elsewhere 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) and any
subsequent public filings. 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 new information, 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
|
|
Nine Months
Ended
|
|
September
30
|
|
September
30
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Statement of
Comprehensive Income (Loss) Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
507
|
|
$
160
|
|
$
1,519
|
|
$
1,003
|
Contract
and other collaboration
|
-
|
|
1,702
|
|
-
|
|
1,813
|
Total
revenue
|
507
|
|
1,862
|
|
1,519
|
|
2,816
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
569
|
|
439
|
|
2,229
|
|
2,519
|
Research and
development (1)
|
1,308
|
|
1,416
|
|
4,167
|
|
3,109
|
Selling, general and
administrative (1)
|
5,262
|
|
8,640
|
|
19,422
|
|
24,978
|
Impairment of property
and equipment
|
-
|
|
-
|
|
4,901
|
|
-
|
Total operating costs
and expenses
|
7,139
|
|
10,495
|
|
30,719
|
|
30,606
|
Loss from
operations
|
(6,632)
|
|
(8,633)
|
|
(29,200)
|
|
(27,790)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(247)
|
|
(538)
|
|
(964)
|
|
(1,824)
|
Interest income and
other income (expense), net
|
140
|
|
32
|
|
229
|
|
92
|
Non-cash interest
income on liability related to sale of future royalties
|
-
|
|
764
|
|
1,136
|
|
2,345
|
Gain on termination of
liability related to sale of future royalties
|
-
|
|
-
|
|
84,052
|
|
-
|
Total other income
(expense)
|
(107)
|
|
258
|
|
84,453
|
|
613
|
Provision for income
taxes
|
(11)
|
|
-
|
|
(14)
|
|
(5)
|
Net income
(loss)
|
$
(6,750)
|
|
$
(8,375)
|
|
$
55,239
|
|
$
(27,182)
|
Deemed dividend related
to Series A Redeemable Convertible Preferred Stock
|
(186)
|
|
-
|
|
(186)
|
|
-
|
Income allocated to
participating securities
|
-
|
|
-
|
|
(129)
|
|
-
|
Net income (loss)
attributable to Common Shareholders
|
$
(6,936)
|
|
$
(8,375)
|
|
$
54,924
|
|
$
(27,182)
|
|
|
|
|
|
|
|
|
Basic net income (loss)
per common share
|
$
(0.94)
|
|
$
(1.40)
|
|
$
7.48
|
|
$
(4.64)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income (loss) per common share
|
7,377
|
|
5,961
|
|
7,339
|
|
5,861
|
|
|
|
|
|
|
|
|
Diluted net income
(loss) per common share
|
$
(0.94)
|
|
$
(1.40)
|
|
$
7.46
|
|
$
(4.64)
|
|
|
|
|
|
|
|
|
Shares used in
computing diluted net income (loss) per common share
|
7,377
|
|
5,961
|
|
7,367
|
|
5,861
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash depreciation and stock-based
compensation expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
58
|
|
$
73
|
|
$
189
|
|
$
221
|
Research and development
|
225
|
|
389
|
|
725
|
|
770
|
Selling, general and administrative
|
629
|
|
1,048
|
|
2,013
|
|
3,287
|
Total
|
$
912
|
|
$
1,510
|
|
$
2,927
|
|
$
4,278
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022
|
|
December 31,
2021
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash equivalents,
restricted cash and investments
|
$
20,926
|
|
$
51,630
|
|
|
|
|
Total assets
|
48,310
|
|
77,893
|
|
|
|
|
Total
liabilities
|
20,769
|
|
113,786
|
|
|
|
|
Total stockholders'
equity (deficit)
|
27,226
|
|
(35,893)
|
|
|
|
|
Reconciliation of
Non-GAAP Financial Measures
|
(Operating
Expenses less impairment of property and equipment, depreciation
and stock-based compensation expense)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
September
30
|
|
September
30
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
1,308
|
|
$
1,416
|
|
$
4,167
|
|
$
3,109
|
Selling, general and
administrative
|
5,262
|
|
8,640
|
|
19,422
|
|
24,978
|
Impairment of property
and equipment
|
-
|
|
-
|
|
4,901
|
|
-
|
Total operating
expenses
|
6,570
|
|
10,056
|
|
28,490
|
|
28,087
|
Less impairment of
property and
|
|
|
|
|
|
|
|
equipment,
depreciation and
|
|
|
|
|
|
|
|
stock-based
compensation expense
|
854
|
|
1,437
|
|
7,639
|
|
4,057
|
Operating expenses
(non-GAAP)
|
$
5,716
|
|
$
8,619
|
|
$
20,851
|
|
$
24,030
|
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SOURCE AcelRx Pharmaceuticals, Inc.