HAYWARD, Calif., March 10, 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 fourth quarter and full
year 2021 financial results.
"We are executing on our strategy to expand and diversify our
product portfolio by acquiring commercial-ready, or late-stage
development-ready assets that address what we consider as unmet
market needs for medically supervised settings. In particular, we
are currently focused on the development and ultimate approval of
our newly secured pre-filled syringes and Niyad (nafamostat)
product candidates which could potentially provide multiple value
creating catalysts for our shareholders in the near-term," said
Vince Angotti, Chief Executive
Officer of AcelRx. Mr. Angotti continued, "In addition, we have
taken deliberate actions to adapt to the evolving healthcare
environment as many medical procedures resulting in
moderate-to-severe pain that were previously performed in surgical
centers or hospitals have now been shifted to procedural suites,
allowing us the opportunity to introduce DSUVIA into these
settings. We have thus shifted our commercial resources, beginning
in the third quarter, to focus on this new customer base, resulting
in solid growth in DSUVIA unit sales in the fourth quarter
2021."
FY 2021 and Recent Highlights
- AcelRx entered into a license agreement with Laboratoire
Aguettant (Aguettant) 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 both in 2022.
- A second license transaction with Aguettant was completed
establishing Aguettant as the commercial partner for DZUVEO in
Europe with an expected launch in
the third quarter of 2022. AcelRx is entitled to receive up to
approximately $55 million in combined
up-front and sales-based milestone payments.
- 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 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.
- Since January 2021, six articles
on DSUVIA were published reporting the benefits of administering
DSUVIA in place of IV opioids, including reducing perioperative
opioid use, rapid recovery times, efficacy and safety among a wide
range of demographics and the overall advantages of sublingual
delivery. Of note, one of these articles was a commentary published
in Military Medicine, identifying DSUVIA as the next
evolution in battlefield pain management. An additional study of
DSUVIA for painful cosmetic procedures has been accepted for
publication by the American Journal of Cosmetic Surgery and
another study on the use of DSUVIA during general anesthesia for
lengthy plastic surgery procedures has been submitted for
publication.
- As of December 31, 2021, AcelRx
has achieved 725 approvals compared to our initial target of 615.
As of February 28, 2022, AcelRx has
achieved 813 formulary approvals for DSUVIA.
- In February 2022, AcelRx was
notified that it had met all requirements set by the U.S. Food and
Drug Administration (FDA) with regards to the FDA Warning Letter
regarding certain DSUVIA promotional materials, dated February 11, 2021, and a Closeout Letter is
expected in Q1 2022.
Financial Information
- The cash, cash equivalents and short-term investments balance
was $51.6 million as of December 31, 2021.
- 8,960 units of DSUVIA were sold in the fourth quarter of 2021,
compared to 3,710 units in the third quarter of 2021; however, the
Company has recognized only $2
thousand in net revenues in the fourth quarter 2021 as a
result of a $0.3 million reserve for
potential returns related to a certain wholesale customer that
purchased product for the Department of Defense (DoD) in 2020. The
DoD has purchased exclusively from a secondary wholesale customer
instead of their primary wholesaler, and therefore the Company has
recorded a reserve in the event this product is not ultimately sold
to the DoD.
- Unit sales growth in the first two months of Q1 2022, compared
to the first two months of Q4 2021 is 63%.
- Combined R&D and SG&A expenses for the fourth quarter
of 2021 totaled $6.9 million compared
to $8.7 million for the fourth
quarter of 2020. Excluding non-cash depreciation and stock-based
compensation expense, these amounts were $5.6 million for the fourth quarter of 2021,
compared to $7.5 million for the
fourth quarter of 2020. R&D and SG&A expenses for the year
ended December 31, 2021 totaled
$35.0 million compared $40.3 million for the year ended December 31, 2020. Excluding non-cash
depreciation and stock-based compensation expense, these figures
were $29.7 million for the year ended
December 31, 2021, compared to
$35.4 million for the year ended
December 31, 2020. The decrease in
combined R&D and SG&A expenses in the fourth quarter and
year ended 2021 was primarily due to reductions in
personnel-related costs, including travel expense, partially offset
by increased Catalent manufacturing-related DSUVIA development
expenses.
- Net loss for the fourth quarter of 2021 was $7.9 million, or $0.06 per basic and diluted share, compared to
$8.9 million, or $0.10 per basic and diluted share, for the fourth
quarter of 2020. Net loss for the year ended December 31, 2021 was $35.1 million, or $0.29 per basic and diluted share, compared to
$40.4 million, or $0.47 per basic and diluted share, for the year
ended December 31, 2020.
2022 Guidance
The Company's 2022 year-end goals include the submission of two
NDAs for its pre-filled syringe product candidates, pending outcome
of FDA feedback that is expected in the second quarter, and the
manufacturing of initial lots of nafamostat. Quarterly combined
R&D and SG&A expense is expected to be approximately
$9-$10
million (and $8-$9 million excluding stock compensation and
depreciation). Annual debt service is expected to approximate
$10 million as the Company continues
to pay down amounts outstanding under its senior debt facility that
matures in June 2023. Annual capital
expenditures are expected to approximate $2
million attributed mainly to the final validation of the
automated packaging line at AcelRx's contract manufacturer.
2022 financial guidance is based on the Company's current
expectations and are forward-looking statements. Actual
results could differ materially depending on market conditions and
the factors set forth under Forward-Looking Statements below.
Webcast and Conference Call Information
As previously
announced, AcelRx will host a live webcast Thursday, March 10th 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
http://ir.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
http://ir.acelrx.com/.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, to be marketed 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 of administration and to eliminate dosing errors associated
with intravenous (IV) administration of opioid analgesics. 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 it will be
commercialized by AcelRx's European partner, Aguettant.
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. Niyad has received
Breakthrough Device Designation Status from the FDA. LTX-608 is a
proprietary nafamostat formulation for direct IV infusion that we
plan to potentially develop as a COVID anti-viral treatment, as
well as for the treatment of disseminated intravascular coagulation
(DIC), acute respiratory distress syndrome (ARDS), 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
has several product candidates in its portfolio. These 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.
market 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.
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 non-cash depreciation and 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.
Forward-Looking Statements
This press release
contains forward-looking statements, including, but not limited to,
statements related to the expected benefits arising from our recent
acquisition of Lowell, expected areas of growth for DSUVIA, the
expected launch of DZUVEO in Europe by Aguettant and the expected license
consideration arising from such commercialization activities, 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 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
"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, 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
acquisition of Lowell disrupts the current plans and operations of
AcelRx and could adversely affect its business and the price
of AcelRx's common stock; (ii) risks relating to our ability
to successfully market DSUVIA in existing and in new and untested
markets; (iii) risks relating to the ability of Aguettant to
successfully launch and commercialize DZUVEO in the European
marketplace and our attendant ability to realize licensing revenues
that are contingent on such success; (iv) risks relating to our
ability to obtain regulatory approvals for the pre-filled syringe
product candidates in-licensed from Aguettant; (v) risks relating
to our ability to successfully commercialize the pre-filled syringe
product candidates in-licensed from Aguettant should we obtain
regulatory approvals; (vi) risks relating to our ability to obtain
regulatory approvals for the nafamostat product candidates acquired
from Lowell; (vii) risks relating to our ability to successfully
commercialize the nafamostat product candidates acquired from
Lowell should we obtain regulatory approvals; (viii) risks relating
to AcelRx's product development activities diverting AcelRx
management's attention from ongoing commercial business operations;
(ix) risks related to the ability of AcelRx to implement its plans,
forecasts and other business expectations; (x) risks related to
obtaining final validation and regulatory approval of our fully
automated packaging line; and (xi) 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
|
|
Twelve Months
Ended
|
|
December
31
|
|
December
31
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
2
|
|
$
657
|
|
$
1,005
|
|
$
2,521
|
Contract
and other collaboration
|
-
|
|
81
|
|
1,813
|
|
2,895
|
Total
revenue
|
2
|
|
738
|
|
2,818
|
|
5,416
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
1,234
|
|
1,300
|
|
3,753
|
|
6,032
|
Research and
development (1)
|
986
|
|
836
|
|
4,095
|
|
4,017
|
Selling, general and
administrative (1)
|
5,957
|
|
7,846
|
|
30,935
|
|
36,330
|
Total operating costs
and expenses
|
8,177
|
|
9,982
|
|
38,783
|
|
46,379
|
Loss from
operations
|
(8,175)
|
|
(9,244)
|
|
(35,965)
|
|
(40,963)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(467)
|
|
(754)
|
|
(2,291)
|
|
(3,305)
|
Interest income and
other income (expense), net
|
32
|
|
272
|
|
124
|
|
583
|
Non-cash interest
income on liability related to sale of future royalties
|
693
|
|
808
|
|
3,038
|
|
3,310
|
Total other income
(expense)
|
258
|
|
326
|
|
871
|
|
588
|
Provision for income
taxes
|
-
|
|
-
|
|
(5)
|
|
(4)
|
Net loss
|
$
(7,917)
|
|
$
(8,918)
|
|
$
(35,099)
|
|
$
(40,379)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.06)
|
|
$
(0.10)
|
|
$
(0.29)
|
|
$
(0.47)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
127,688
|
|
92,290
|
|
119,860
|
|
85,257
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash depreciation and stock-based
compensation expense:
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
$
73
|
|
$
104
|
|
$
294
|
|
$
514
|
|
Research and
development
|
302
|
|
192
|
|
1,072
|
|
764
|
|
Selling, general and
administrative
|
1,018
|
|
1,029
|
|
4,305
|
|
4,221
|
Total
|
$
1,393
|
|
$
1,325
|
|
$
5,671
|
|
$
5,499
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2021
|
|
December 31,
2020
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash equivalents
and investments
|
$
51,630
|
|
$
42,886
|
|
|
|
|
Total assets
|
77,893
|
|
66,295
|
|
|
|
|
Total
liabilities
|
113,786
|
|
122,045
|
|
|
|
|
Total stockholders'
deficit
|
(35,893)
|
|
(55,750)
|
|
|
|
|
Reconciliation of
Non-GAAP Financial Measures
|
(Operating
Expenses less associated depreciation and stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
December
31
|
|
December
31
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
986
|
|
$
836
|
|
$
4,095
|
|
$
4,017
|
Selling, general and
administrative
|
5,957
|
|
7,846
|
|
30,935
|
|
36,330
|
Total operating
expenses
|
6,943
|
|
8,682
|
|
35,030
|
|
40,347
|
Less depreciation
and stock-based
|
|
|
|
|
|
|
|
compensation
expense
|
1,320
|
|
1,221
|
|
5,377
|
|
4,985
|
Operating expenses
(non-GAAP)
|
$
5,623
|
|
$
7,461
|
|
$
29,653
|
|
$
35,362
|
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SOURCE AcelRx Pharmaceuticals, Inc.