Realigning cost structure from a focus on
commercialization to a focus on development to advance late-stage
pipeline; expected to result in annual savings of $9 million
Completed acquisition of Lowell Therapeutics
and nafamostat franchise, including Niyad™ with Breakthrough Device
Designation
Continued DSUVIA sales momentum with
fourth consecutive quarter of sales volume growth, including 64%
commercial (ex-DoD) growth in Q1 2022 compared to Q4 2021
$39.3 million of
cash and short-term investments at March 31,
2022
Webcast and Conference Call to be held today
at 8:30 am EDT
HAYWARD,
Calif., May 16, 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 first quarter 2022
financial results.
"DSUVIA continues to demonstrate solid sales growth and
potential even with our limited commercial resources," stated
Vince Angotti, Chief Executive
Officer of AcelRx. "We remain steadfast in our belief in DSUVIA's
value and its benefits to patients and healthcare providers with
its unique pharmacokinetic characteristics, which are supported by
favorable feedback received from physicians administering DSUVIA
and numerous published studies. We believe that the uptake of this
product will be maximized through a larger commercial
infrastructure and, as such, we are in active discussions with
potential partners that can execute a more robust commercial plan
to support DSUVIA sales expansion, while further reducing AcelRx's
operating costs."
Mr. Angotti continued, "Accordingly, we are aligning our cost
structure to concentrate on our recently expanded development
pipeline, which now includes our nafamostat portfolio and our
pre-filled syringes. We believe these product candidates will
provide multiple value-creating catalysts in the near-term, with
two planned NDA submissions for the pre-filled syringes in 2022 and
a potential emergency use authorization for Niyad in 2023. The
reorganization of our corporate structure will drive shareholder
value by extending our cash runway allowing us to continue
progressing these development programs, remain focused on
procedural suite sales and pursue further upside with a partner for
DSUVIA."
First Quarter and Recent Highlights
- In May 2022, AcelRx reorganized
to reduce headcount by approximately 40%, generating projected
initial annual savings of $9
million.
- AcelRx announced the closing of its acquisition of Lowell
Therapeutics, Inc. (Lowell) in January
2022 in a transaction for consideration of approximately
$32.5 million plus net cash acquired
and certain other adjustments, and which includes up to
approximately $26.0 million of
contingent consideration payable in cash or stock at AcelRx's
option, upon the achievement of certain regulatory and sales-based
milestones. Niyad™ (nafamostat) is the lead product, with a
targeted indication of anticoagulation of the extracorporeal
circuit, and which has received Breakthrough Device Designation
from the FDA, as well as an ICD-10 procedural code from CMS which
allows for reimbursement. Annual peak sales potential for Niyad is
expected to exceed $200 million.
- In May 2022, AcelRx hosted 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.
https://www.acelrx.com/events/event-details/key-opinion-leader-kol-webinar-discuss-niyadtm-lyophilized-form-nafamostat
- As of March 31, 2022, AcelRx has
achieved 855 DSUVIA formulary approvals. As of April 30, 2022, AcelRx has achieved 893 formulary
approvals for DSUVIA.
- In the first quarter of 2022, AcelRx announced three
publications, including: (1) a comparative data study between two
different dialysis circuit anticoagulants in pediatric patients
undergoing continuous renal replacement therapy (CRRT); (2) a study
evaluating the use of a sufentanil sublingual tablet (SST) 30 mcg
for management of pain of radiofrequency microneedling of the face
or abdomen; and (3) a study evaluating real-world data in patients
undergoing awake plastic surgery showing a rapid recovery time and
minimal side effects with the use of SST for pain management.
- In March 2022, AcelRx received a
close-out letter from the U.S. Food and Drug Administration (FDA)
confirming that it had concluded its evaluation of the Company's
corrective actions in response to the Warning Letter and that the
Company had addressed the issues raised by the FDA Warning Letter
dated February 11, 2021 regarding
certain DSUVIA promotional materials.
Financial Information
- The cash, cash equivalents and short-term investments balance
was $39.3 million as of March 31, 2022.
- First quarter 2022 net revenues were $0.4 million. DSUVIA units sold in the first
quarter of 2022 were 10,530, compared to 8,960 units in the fourth
quarter of 2021, reflecting unit sales growth of 18% from the prior
quarter. Excluding fluctuating DoD revenues, unit sales growth was
64% in the first quarter of 2022 from the fourth quarter of
2021.
- Combined R&D and SG&A expenses for the first quarter of
2022 totaled $8.7 million compared to
$8.6 million for the first quarter of
2021. Excluding non-cash depreciation and stock-based compensation
expense, these amounts were $7.7
million for the first quarter of 2022, compared to
$7.4 million for the first quarter of
2021. The increase in combined R&D and SG&A expenses in the
first quarter of 2022 was primarily due to increased DSUVIA
manufacturing-related costs, partially offset by reductions in
personnel-related expenses.
- Net loss for the first quarter of 2021 was $8.7 million, or $0.06 per basic and diluted share, compared to
$9.0 million, or $0.08 per basic and diluted share, for the first
quarter of 2021.
Webcast and Conference Call Information
As
previously announced, AcelRx will host a live webcast Monday, May 16th at 8:30
a.m. Eastern Time (5:30 a.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. 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 and Zalviso are both approved products 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 the expected effect and scope of cost savings
arising from our restructuring efforts, the potential extension of
our cash runway, the expected benefits arising from potential
partnerships with DSUVIA, the expected benefits arising from our
recent acquisition of Lowell, potential near-term
value-creating catalysts arising under our development
pipeline, the expected market opportunity for our new
product candidates in-licensed from Aguettant and/or acquired
through the Lowell acquisition, our plans to file NDAs and other
regulatory submissions for our new product candidates and the
timing of such filings. 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," "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; (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
|
|
|
March
31
|
|
|
2022
|
|
2021
|
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Product
sales
|
$
442
|
|
$
451
|
|
Contract
and other collaboration
|
-
|
|
60
|
|
Total
revenue
|
442
|
|
511
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
Cost of goods sold
(1)
|
784
|
|
1,040
|
|
Research and
development (1)
|
1,315
|
|
969
|
|
Selling, general and
administrative (1)
|
7,338
|
|
7,644
|
|
Total operating costs
and expenses
|
9,437
|
|
9,653
|
|
Loss from
operations
|
(8,995)
|
|
(9,142)
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
expense
|
(390)
|
|
(672)
|
|
Interest income and
other income (expense), net
|
38
|
|
76
|
|
Non-cash interest
income on liability related to sale of future royalties
|
673
|
|
782
|
|
Total other income
(expense)
|
321
|
|
186
|
|
Net loss
|
$
(8,674)
|
|
$
(8,956)
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.06)
|
|
$
(0.08)
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
145,624
|
|
113,257
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash depreciation and stock-based
compensation expense:
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
67
|
|
$
77
|
|
Research and development
|
260
|
|
180
|
|
Selling, general and administrative
|
721
|
|
1,049
|
|
Total
|
$
1,048
|
|
$
1,306
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2022
|
|
December 31,
2021
|
|
Selected Balance
Sheet Data
|
|
|
|
|
Cash, cash equivalents
and investments
|
$
39,349
|
|
$
51,630
|
|
Total assets
|
71,971
|
|
77,893
|
|
Total
liabilities
|
110,244
|
|
113,786
|
|
Total stockholders'
deficit
|
(38,273)
|
|
(35,893)
|
|
|
|
|
|
|
Reconciliation of
Non-GAAP Financial Measures
|
|
|
|
(Operating
Expenses less associated depreciation and stock-based compensation
expense)
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
March
31
|
|
|
2022
|
|
2021
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
Research and
development
|
$
1,315
|
|
$
969
|
|
Selling, general and
administrative
|
7,338
|
|
7,644
|
|
Total operating
expenses
|
8,653
|
|
8,613
|
|
Less depreciation
and stock-based
|
|
|
|
|
compensation
expense
|
981
|
|
1,229
|
|
Operating expenses
(non-GAAP)
|
$
7,672
|
|
$
7,384
|
|
|
|
|
|
|
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SOURCE AcelRx Pharmaceuticals, Inc.