Divestment of DSUVIA® to Alora Pharmaceuticals
expected to close the week of April 3,
2023
AcelRx advancing its proprietary Niyad™
nafamastat program with FDA Breakthrough designation in line with a
strategic focus on late-stage assets
Near-term corporate milestones expected by the
end of Q2 2023 include Niyad Emergency Use Authorization submission
and the filing of a New Drug Application for Fedsyra™, the first of
two pre-filled syringe product candidates
$20.8
million in cash and short-term investments as of December
31, 2022
Webcast and conference call to be held today
at 4:30 p.m. EDT
HAYWARD,
Calif., March 30, 2023 /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 full year and fourth
quarter 2022 financial results and provided a corporate update.
"We are pleased to have signed an agreement to divest DSUVIA to
Alora Pharmaceuticals, a well-resourced commercial partner, to
expand the reach of this innovative product," stated Vince Angotti, Chief Executive Officer of
AcelRx. "Alora has extensive experience commercializing
products in hospitals, expertise in the manufacturing and sales of
controlled substances and a team of over 200 salespersons. In
addition, we believe the opportunity to receive a 75% royalty on
net sales to the Department of Defense, the single largest customer
of DSUVIA, will drive long-term value for our shareholders. With
this transaction, we have continued to reduce costs while
leveraging our clinical development and regulatory expertise to
achieve the near-term milestones related to our late-stage
development pipeline."
Mr. Angotti continued, "We believe that the accelerated
stability testing of Niyad, our lead nafamostat product candidate,
has produced data to support a planned Emergency Use Authorization
submission in the second quarter and to support initiation of the
single registrational trial in the second half of 2023. Our recent
market research continues to confirm the urgent medical need for an
alternative anticoagulant for use in continuous renal replacement
therapy, or CRRT. From this data, we believe the opportunity for
Niyad is approximately 60% of the CRRT market. In addition, we are
prepared to submit an NDA for Fedsyra, our ephedrine pre-filled
syringe (PFS) product candidate, by the end of next quarter. Both
the Niyad and Fedsyra regulatory submissions will bring us closer
to delivering important advancements for the healthcare system and
increased value for our shareholders."
2022 Fourth Quarter and Recent Corporate Highlights
- In March 2023, AcelRx announced
the divestment of its FDA-approved drug, DSUVIA to Alora
Pharmaceuticals (Alora). The agreement allows AcelRx to participate
in the long-term value expected to be created by Alora as they
expand the commercialization of DSUVIA. The agreement provides
AcelRx with a 15% royalty on commercial sales of DSUVIA, a 75%
royalty on sales of DSUVIA to the Department of Defense, DSUVIA's
single largest customer, and up to $116.5
million in sales-based milestones. Closing of the
transaction is expected the week of April
3rd, and AcelRx will provide, and be reimbursed for,
transition services during a period of up to 6 months post-closing.
In exchange for the 75% royalty on net sales to the DoD, AcelRx
will lead the relationship to ensure continued engagement and
expected expansion of sales to the DoD. Importantly, the divestment
enables AcelRx to focus its operations and capital on its late
stage, high-value asset programs, with specific prioritization of
its lead nafamostat program, Niyad, as an anticoagulant for the
extracorporeal circuit with peak sales potential of $200 million.
- Accelerated stability testing of Niyad at elevated temperatures
has produced data for our near-term EUA submission and initiation
of the single registrational clinical trial expected to start in
the second half of 2023.
- In December 2022, AcelRx
sponsored a quantitative market research study of current CRRT
practices among 150 U.S. physicians which demonstrated an urgent
need for alternative anticoagulants other than citrate and heparin.
Due to side effects of citrate and heparin, 29% of patients receive
no anticoagulant during CRRT, which is below the international
standard of care. When no anticoagulant is used, over 80% of the
physicians reported blood clotting the dialysis filter, which can
lead to the patient requiring transfusions and increased filter
changes. Despite physicians reporting significant side effects with
the use of citrate, it is used in 28% of CRRT patients. The Company
believes the market opportunity for Niyad includes patients that
are receiving no anticoagulant as well as those that are receiving
citrate, totaling 57% of CRRT patients. The Company plans to submit
the study data for publication in the second quarter of 2023.
- In December 2022, AcelRx entered
into an agreement with a life sciences-focused investment fund for
the sale of shares of its common stock, pre-funded warrants and
common warrants. Gross proceeds from the offering were
approximately $7.5 million.
- 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 commencing in the first half of
2023.
Recent Publications
- In March 2023, AcelRx announced
the publication of a report arising from a series of rhinology
procedures successfully performed using sufentanil sublingual
tablet 30 mcg (SST; DSUVIA) in Otolaryngology Case Reports.
The study was lead-authored by otolaryngologist Dr. Ashley Sikand and entitled "Evaluation of
Sufentanil Sublingual Tablet 30 mcg for Perioperative Pain
Management of In-Office Rhinology Procedures." The study
demonstrated that DSUVIA can help manage acute pain during
rhinology surgery in an office-based setting with a well-tolerated
side-effect profile.
- In December, AcelRx announced a study published in the
Journal of Clinical Medicine Special Issue "Advances in
Postoperative Pain Management and Postoperative Chronic Pain". The
study was lead-authored by orthopedic surgeon Dr. Andrea Angelini and entitled "Sublingual
Sufentanil Tablet System for Postoperative Analgesia After
Orthopedic Surgery: A Retrospective Study". The study was conducted
by investigators at the University of Padova in Italy and retrospectively analyzed a total of
71 patients with respect to quality of postoperative pain
management following total knee arthroplasty (TKA). Investigators
analyzed data from 50 patients who received sufentanil sublingual
tablets (SSTs) postoperatively versus a control group of 21
patients who were treated according to standard pain management
protocol with continuous femoral nerve block. Adverse events were
noted as being consistently lower in the group administered SSTs,
and this was most notably observed to be the case with nausea (10%
versus 30%), typically the most frequently reported adverse event
with postoperative opioid administration.
- In October, an abstract, entitled, "Experience in Complex
Outpatient Plastic Surgery Procedures Using Sufentanil Sublingual
Tablets" was presented by Jeffrey
DeWeese, M.D., FACS, at Plastic Surgery The Meeting
2022, held October 27-30, in
Boston, MA. The study, conducted
in 324 patients undergoing complex plastic surgery procedures,
demonstrated the ability to perform such procedures using DSUVIA
without general anesthesia, allowing for a rapid discharge
time.
- Also in October, the Company announced two abstracts were
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 managing 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.
Fourth Quarter 2022 Financial Information
- The cash, cash equivalents and short-term investments balance
was $20.8 million as of December 31, 2022.
- Fourth quarter 2022 DSUVIA net sales were $0.3 million. Full year DSUVIA net sales for 2022
were $1.8 million, representing a 76%
increase over the same period in 2021.
- Combined R&D and SG&A expenses for the fourth quarter
of 2022 totaled $7.3 million compared
to $6.9 million for the fourth
quarter of 2021. Excluding non-cash depreciation and stock-based
compensation expense, these amounts were $6.6 million for the fourth quarter of 2022,
compared to $5.6 million for the
fourth quarter of 2021. The increase in combined R&D and
SG&A expenses in the fourth quarter of 2022 was primarily due
to allocated financing transaction related costs attributed to the
accounting for the warrant issued in the December 2022 financing, partially offset by
other net decreases in R&D and SG&A expenses compared to
the fourth quarter of 2021.
- Net loss attributable to common shareholders for the fourth
quarter of 2022 was $7.5 million, or
$1.00 per basic and diluted share,
compared to a net loss of $7.9
million, or $1.24 per basic
and diluted share, for the fourth quarter of 2021.
Webcast Information 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 March 30, 2023 to discuss the financial results and
provide an update on the Company's business.
The webcast can be accessed here or 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
1-412-902-4204 (toll applies) for international callers. The
conference ID is 10175958.
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 Alora Pharmaceuticals, LLC
Alora
Pharmaceuticals, LLC is the parent company of six specialty
pharmaceutical and pharmaceutical manufacturing companies. Alora is
headquartered in Alpharetta, GA.
Alora is the parent company of the following organizations that
comprise the Alora family of companies, Avion Pharmaceuticals,
Acella Pharmaceuticals, Osmotica Pharmaceuticals, Sovereign
Pharmaceuticals, Trigen Laboratories and Vertical
Pharmaceuticals.
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 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.
AcelRx's lead nafamostat program is Niyad™, a regional
anticoagulant for the extracorporeal circuit, and it is also
developing LTX-608, for the potential treatment of COVID-19,
disseminated intravascular coagulation, acute respiratory distress
syndrome and acute pancreatitis. AcelRx plans to submit an
Emergency Use Authorization (EUA) to the U.S. Food and Drug
Administration (FDA) for Niyad, which has Breakthrough device
designation status, during the second quarter of 2023. AcelRx also
is developing two pre-filled, ready-to-use syringes (PFS-01 and
PFS-02) of ephedrine and phenylephrine, respectively, licensed for
the U.S. from Aguettant. AcelRx plans to file an NDA on
PFS-01 also by the end of the second quarter of 2023. 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
|
|
Twelve Months
Ended
|
|
December
31
|
|
December
31
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Statement of
Comprehensive Income (Loss) Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
252
|
|
$
2
|
|
$
1,771
|
|
$
1,005
|
Contract
and other collaboration
|
-
|
|
-
|
|
-
|
|
1,813
|
Total
revenue
|
252
|
|
2
|
|
1,771
|
|
2,818
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
362
|
|
1,234
|
|
2,591
|
|
3,753
|
Research and
development (1)
|
1,026
|
|
986
|
|
5,193
|
|
4,095
|
Selling, general and
administrative (1)
|
6,250
|
|
5,957
|
|
25,672
|
|
30,935
|
Impairment of property
and equipment
|
47
|
|
-
|
|
4,948
|
|
-
|
Total operating costs
and expenses
|
7,685
|
|
8,177
|
|
38,404
|
|
38,783
|
Loss from
operations
|
(7,433)
|
|
(8,175)
|
|
(36,633)
|
|
(35,965)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(189)
|
|
(467)
|
|
(1,153)
|
|
(2,291)
|
Interest income and
other income (expense), net
|
137
|
|
32
|
|
366
|
|
124
|
Non-cash interest
income on liability related to sale of future royalties
|
-
|
|
693
|
|
1,136
|
|
3,038
|
Gain on termination of
liability related to sale of future royalties
|
-
|
|
-
|
|
84,052
|
|
-
|
Total other income
(expense)
|
(52)
|
|
258
|
|
84,401
|
|
871
|
Provision (benefit) for
income taxes
|
(1)
|
|
-
|
|
13
|
|
5
|
Net income
(loss)
|
$
(7,484)
|
|
$
(7,917)
|
|
$
47,755
|
|
$
(35,099)
|
Deemed dividend related
to Series A Redeemable Convertible Preferred Stock
|
-
|
|
-
|
|
(186)
|
|
-
|
Income allocated to
participating securities
|
-
|
|
-
|
|
(5,240)
|
|
-
|
Net income (loss)
attributable to Common Shareholders, basic
|
$
(7,484)
|
|
$
(7,917)
|
|
$
42,329
|
|
$
(35,099)
|
|
|
|
|
|
|
|
|
Basic net income (loss)
per common share
|
$
(1.00)
|
|
$
(1.24)
|
|
$
5.73
|
|
$
(5.86)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income (loss) per common share
|
7,466
|
|
6,384
|
|
7,385
|
|
5,993
|
|
|
|
|
|
|
|
|
Net income (loss)
attributable to Common Shareholders, diluted
|
$
(7,484)
|
|
$
(7,917)
|
|
$
42,342
|
|
$
(35,099)
|
|
|
|
|
|
|
|
|
Diluted net income
(loss) per common share
|
$
(1.00)
|
|
$
(1.24)
|
|
$
5.72
|
|
$
(5.86)
|
|
|
|
|
|
|
|
|
Shares used in
computing diluted net income (loss) per common share
|
7,466
|
|
6,384
|
|
7,407
|
|
5,993
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash depreciation and stock-based
compensation expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
50
|
|
$
73
|
|
$
239
|
|
$
294
|
Research and development
|
190
|
|
302
|
|
915
|
|
1,072
|
Selling, general and administrative
|
535
|
|
1,018
|
|
2,547
|
|
4,305
|
Total
|
$
775
|
|
$
1,393
|
|
$
3,701
|
|
$
5,671
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2022
|
|
December 31,
2021
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash equivalents,
restricted cash and investments
|
$
20,770
|
|
$
51,630
|
|
|
|
|
Total assets
|
47,487
|
|
77,893
|
|
|
|
|
Total
liabilities
|
25,673
|
|
113,786
|
|
|
|
|
Total stockholders'
equity (deficit)
|
21,814
|
|
(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
|
|
Twelve Months
Ended
|
|
December 31,
2022
|
|
December 31,
2022
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$ 1,026
|
|
$
986
|
|
$
5,193
|
|
$
4,095
|
Selling, general and
administrative
|
6,250
|
|
5,957
|
|
25,672
|
|
30,935
|
Impairment of property
and equipment
|
47
|
|
-
|
|
4,948
|
|
-
|
Total operating
expenses
|
7,323
|
|
6,943
|
|
35,813
|
|
35,030
|
Less impairment of
property and
|
|
|
|
|
|
|
|
equipment,
depreciation and
|
|
|
|
|
|
|
|
stock-based
compensation expense
|
772
|
|
1,320
|
|
8,410
|
|
5,377
|
Operating expenses
(non-GAAP)
|
$ 6,551
|
|
$ 5,623
|
|
$ 27,403
|
|
$ 29,653
|
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SOURCE AcelRx Pharmaceuticals, Inc.