Advanced Niyad™ supply chain development with
a focus on obtaining an Emergency Use Authorization in 2023
$0.6
million net revenue in Q2 2022; fifth consecutive quarter of
commercial (ex-DoD) sales volume growth for DSUVIA, with a 133%
increase compared to Q2 2021; on track for EU launch of DZUVEO in
the third quarter
Projected annual savings of $9 million beginning in June 2022 from realigned cost structure
$27.9 million in
cash and short-term investments as of June
30, 2022
$84.1 million
gain on extinguishment of debt due to termination of royalty
monetization
Webcast and Conference Call to be held today
at 4:30 p.m. EDT
HAYWARD,
Calif., Aug. 11,
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 second quarter
2022 financial results.
"Our commercial emphasis on procedural suites has resulted in a
successful quarter of growth for DSUVIA, while also reducing our
costs, allowing us to focus on our robust pipeline," stated
Vince Angotti, Chief Executive
Officer of AcelRx. "DSUVIA continues to demonstrate solid sales
growth in the procedural suite setting, with adoption beginning
across national accounts. Our European partner, Aguettant, also is
gearing up for the launch of DZUVEO. This said, we remain mindful
of our operating costs and plan to continue reducing our cash burn.
Importantly, we remain in discussions with potential partners with
the commercial resources to amplify the expected growth for
DSUVIA."
Mr. Angotti continued, "We're focused on a potential Emergency
Use Authorization for our lead nafamostat candidate, Niyad™, in
2023 as we are making solid progress across the supply chain.
Additionally, our pre-filled syringes remain on track for NDA
submissions this year. We believe each of these product candidates
will provide multiple value-creating catalysts in the
near-term."
Second Quarter and Recent
Highlights
•
|
In August, AcelRx
announced:
|
|
°
|
An abstract, entitled,
"Experience in Complex Outpatient Plastic Surgery Procedures
Using Sufentanil Sublingual
Tablets" was accepted for podium presentation at Plastic Surgery
The Meeting 2022, October 27-30 in Boston, MA.
|
|
°
|
An abstract, entitled,
"The Impact of Sublingual Sufentanil on Postoperative Pain Control in Patients
Undergoing Spine Surgery" (abstract # A4262) was accepted
for e-Abstract presentation
at the ANESTHESIOLOGY® 2022 annual meeting, being held October
21-25 in New Orleans, LA.
|
|
|
•
|
In June 2022, AcelRx
realigned its cost structure to reduce headcount by approximately
40%, generating expected annual savings of $9 million.
|
|
|
•
|
In May 2022, AcelRx
announced:
|
|
°
|
The publication of
clinical data from an investigator-initiated trial in patients
undergoing lengthy plastic surgery procedures performed under
general anesthesia, where use of a
single sufentanil sublingual tablet
30 mcg (SST; DSUVIA®)
in conjunction with intravenous
(IV) opioids was able to
dramatically reduce postoperative opioid requirements compared to an equivalent dose
of opioids administered
only via the IV route.
|
|
°
|
The U.S. Food and Drug
Administration (FDA) revised the DSUVIA Risk Evaluation and
Mitigation Strategies (REMS) program to eliminate the 6-month
healthcare setting audit requirement and reduce annual healthcare
setting audits to a total of up to 400 sites that have received a
shipment of DSUVIA in the past 6 months.
|
|
|
•
|
In May 2022, a key
opinion leader webinar highlighting the market for and benefits of
Niyad and LTX-608 with two internationally renowned acute kidney
injury experts, Stuart Goldstein, MD, from Cincinnati Children's
Hospital, and Lakhmir Chawla, MD, former Chief of the Division of
Intensive Care Medicine at the Washington D.C. Veterans Affairs
Medical Center. To listen to a replay of the event, click here or
visit the Investors/News & Events section of the company
website.
|
|
|
•
|
Advanced progress on
Niyad supply chain with contract manufacturing agreements in place
with a focus on obtaining an Emergency Use Authorization next
year.
|
|
|
•
|
As of July 31, 2022,
AcelRx has achieved 983 DSUVIA formulary approvals.
|
Financial Information
•
|
The cash, cash
equivalents and short-term investments balance was $27.9 million as
of June 30, 2022.
|
|
|
•
|
Second quarter 2022 net
revenues were $0.6 million. Commercial unit sales growth, excluding
fluctuating DoD revenues, increased 18% in the second quarter of
2022 from the first quarter of 2022 and 133% compared to the second
quarter of 2021. Total DSUVIA units sold in the second quarter of
2022, including the fluctuating DoD volumes, were 10,600 compared
to 10,530 units In the first quarter of 2022.
|
|
|
•
|
Combined R&D and
SG&A expenses for the second quarter of 2022 totaled $8.4
million compared to $9.4 million for the second quarter of 2021.
Excluding non-cash depreciation and stock-based compensation
expense, these amounts were $7.5 million for the second quarter of
2022, compared to $8.0 million for the second quarter of 2021. The
decrease in combined R&D and SG&A expenses in the second
quarter of 2022 was primarily due to reductions in facilities and
DSUVIA related selling expenses and stock-based compensation
expense.
|
|
|
•
|
In the quarter ended
June 30, 2022, the company entered into a Termination Agreement
with SWK Funding, LLC to terminate the royalty monetization related
to Zalviso in Europe which resulted in an $84.1 million gain
recognized on extinguishment of the liability.
|
Net income for the second quarter of 2021 was $70.7 million, or $0.48 per basic and diluted share, compared to a
net loss of $9.9 million, or
$0.08 per basic and diluted share,
for the second quarter of 2021.
Webcast and Conference Call
Information
As previously announced, AcelRx will host a live conference call
and webcast Thursday, August 11th at
4:30 p.m. Eastern Daylight Time
(1:30 p.m. Pacific Time) to discuss
these financial results and provide other corporate updates.
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 10168540. The webcast will be 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. 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. DZUVEO has been approved
by the European Medicines Agency and AcelRx's European
commercialization partner, Aguettant, will market the drug 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 Nafamostat
Nafamostat is a broad spectrum, synthetic serine protease
inhibitor with anticoagulant, anti-inflamatory 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,
including, but not limited to, statements related to maintaining
commercial sales performance of DSUVIA, our plans to focus DSUVIA
commercialization efforts on select markets and certain potential
national accounts, DSUVIA partnering discussions with potential
commercial entities, the potential European launch of DZUVEO by
Aguettant, our plans to pursue a potential Emergency Use
Authorization for Niyad and establish a supply chain to support
such efforts, our plans to reduce cash burn and potentially reduce
operating costs, our plans to potentially file NDAs for our
developmental pre-filled syringe products and the timing of such
filings, expected effect and scope of cost savings arising from our
restructuring efforts, and potential near-term
value-creating catalysts arising under our development
pipeline. 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
"believe," "expect," "expected," "anticipate," "may," "potential,"
"will," "should," "seek," "approximately," "intends," "plans,"
"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) the risk that the restructuring of the Company
could adversely affect our ability to successfully market DSUVIA in
existing and in new and untested markets; (ii) risks relating to
our ability to obtain regulatory approvals for the pre-filled
syringe product candidates in-licensed from Aguettant; (iii) risks
relating to our ability to successfully commercialize the
pre-filled syringe product candidates in-licensed from Aguettant
should we obtain such regulatory approvals; (iv) risks relating to
our ability to obtain regulatory approvals for the nafamostat
product candidates acquired from Lowell; (v) risks relating to our
ability to obtain an Emergency Use Authorization for
Niyad; (vi) risks relating to our ability to
successfully commercialize the nafamostat product candidates
acquired from Lowell should we obtain regulatory approvals and/or
authorizations; (vii) risks relating to AcelRx's product
development activities diverting AcelRx management's attention from
ongoing commercial business operations; (viii) risks related to the
ability of AcelRx to implement its development plans, forecasts and
other business expectations; and (ix) risks related to unexpected
variations in market growth and demand for AcelRx's commercial and
developmental products and technologies. 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
|
|
Six Months
Ended
|
|
June
30
|
|
June
30
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
570
|
|
$
392
|
|
$
1,012
|
|
$
843
|
Contract
and other collaboration
|
-
|
|
51
|
|
-
|
|
111
|
Total
revenue
|
570
|
|
443
|
|
1,012
|
|
954
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
876
|
|
1,040
|
|
1,660
|
|
2,080
|
Research and
development (1)
|
1,544
|
|
724
|
|
2,859
|
|
1,693
|
Selling, general and
administrative (1)
|
6,822
|
|
8,694
|
|
14,160
|
|
16,338
|
Impairment of property
and equipment
|
4,901
|
|
-
|
|
4,901
|
|
-
|
Total operating costs
and expenses
|
14,143
|
|
10,458
|
|
23,580
|
|
20,111
|
Loss from
operations
|
(13,573)
|
|
(10,015)
|
|
(22,568)
|
|
(19,157)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(327)
|
|
(614)
|
|
(717)
|
|
(1,286)
|
Interest income and
other income (expense), net
|
51
|
|
(16)
|
|
89
|
|
60
|
Non-cash interest
income on liability related to sale of future royalties
|
463
|
|
799
|
|
1,136
|
|
1,581
|
Gain on termination of
liability related to sale of future royalties
|
84,052
|
|
-
|
|
84,052
|
|
-
|
Total other income
(expense)
|
84,239
|
|
169
|
|
84,560
|
|
355
|
Provision for income
taxes
|
(3)
|
|
(5)
|
|
(3)
|
|
(5)
|
Net income
(loss)
|
$
70,663
|
|
$
(9,851)
|
|
$
61,989
|
|
$
(18,807)
|
|
|
|
|
|
|
|
|
Basic net income (loss)
per common share
|
$
0.48
|
|
$
(0.08)
|
|
$
0.42
|
|
$
(0.16)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income (loss) per common share
|
147,139
|
|
119,120
|
|
146,386
|
|
116,204
|
|
|
|
|
|
|
|
|
Diluted net income
(loss) per common share
|
$
0.48
|
|
$
(0.08)
|
|
$
0.42
|
|
$
(0.16)
|
|
|
|
|
|
|
|
|
Shares used in
computing diluted net income (loss) per common share
|
147,209
|
|
119,120
|
|
146,420
|
|
116,204
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash depreciation and stock-based
compensation expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
64
|
|
$
70
|
|
$
131
|
|
$
148
|
Research and development
|
239
|
|
200
|
|
500
|
|
381
|
Selling, general and administrative
|
663
|
|
1,191
|
|
1,384
|
|
2,239
|
Total
|
$
966
|
|
$
1,461
|
|
$
2,015
|
|
$
2,768
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022
|
|
December 31,
2021
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash equivalents,
restricted cash and investments
|
$
27,923
|
|
$
51,630
|
|
|
|
|
Total assets
|
56,133
|
|
77,893
|
|
|
|
|
Total
liabilities
|
22,990
|
|
113,786
|
|
|
|
|
Total stockholders'
equity (deficit)
|
33,143
|
|
(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
|
|
June
30
|
|
June
30
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
1,544
|
|
$
724
|
|
$
2,859
|
|
$
1,693
|
Selling, general and
administrative
|
6,822
|
|
8,694
|
|
14,160
|
|
16,338
|
Impairment of property
and equipment
|
4,901
|
|
-
|
|
4,901
|
|
-
|
Total operating
expenses
|
13,267
|
|
9,418
|
|
21,920
|
|
18,031
|
Less impairment of
property and
|
|
|
|
|
|
|
|
equipment,
depreciation and
|
|
|
|
|
|
|
|
stock-based
compensation expense
|
5,803
|
|
1,391
|
|
6,785
|
|
2,620
|
Operating expenses
(non-GAAP)
|
$
7,464
|
|
$
8,027
|
|
$
15,135
|
|
$
15,411
|
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SOURCE AcelRx Pharmaceuticals, Inc.