REDWOOD CITY, Calif.,
Aug. 10, 2020 /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 2020
financial results.
"Despite the challenges with COVID in the second quarter, we
made meaningful progress towards generating long-term shareholder
value and expanding the DSUVIA launch through advancements with the
Department of Defense and our exclusive agreement with Zimmer
Biomet for dental surgeries," said Vince
Angotti, Chief Executive Officer of AcelRx. "We expect these
two revenue streams, both of which require minimal AcelRx
commercial investment, to be the main drivers of our near-term
revenue growth. Hospital and ambulatory surgery centers
remain the core focus of our commercial team, and we expect recent
hospital system wins to positively impact revenues in the mid to
long term. We continue to execute on our strategy while focusing on
prudent cash management."
Second Quarter and Recent Highlights
- DSUVIA achieved Milestone C approval from the Department of
Defense, a decision that approves DSUVIA for use in all U.S. Army
sets, kits and outfits (SKOs). AcelRx expects that initial stocking
orders beginning later this year for U.S. Army SKOs alone will
approximate $30 million over the next
three years, dependent on troop deployment schedules.
- The DoD issued a Notice of Intent, converting to a Request for
Proposal (RFP), for the purchase of up to 12,200 boxes or 122,000
DSUVIA units, expected to be ordered in the third quarter of 2020,
which is separate from expected purchases for SKOs.
- In July, AcelRx entered into a distribution agreement with
Zimmer Biomet to market DSUVIA® (sufentanil sublingual tablet), 30
mcg, within the dental and oral surgery markets in the United States exclusively through Zimmer
Biomet's Dental division, expanding U.S. availability of DSUVIA. It
is estimated that the applicable market in dental surgeries is over
7 million annual procedures.
- In July, AcelRx completed a $10
million common stock offering priced at the market with two
leading life science investors.
Financial Information
- As previously announced:
-
- Cash, cash equivalents and short-term investments balance of
$43.7 million as of June 30, 2020;
- Second quarter 2020 net revenues were $2.9 million, of which approximately $2.6 million relates to the recognition of
revenue related to the Company's Zalviso® agreement with Grünenthal
that was previously deferred;
- Combined R&D and SG&A expenses for the second quarter
of 2020 totaled $8.4 million compared
to $12.5 million for the second
quarter of 2019. Excluding stock-based compensation expense, these
amounts were $7.3 million for the
second quarter of 2020 compared to $11.2
million for the second quarter of 2019. R&D and SG&A
expenses for the first half of 2020 totaled $23.1 million compared to $23.8 million in the first half of 2019.
Excluding stock-based compensation expense, these figures were
$20.9 million for the first half of
2020 compared to $21.5 million for
the first half of 2019. The decrease in combined R&D and
SG&A expenses in the second quarter of 2020 was primarily due
to a reduction of $1.9 million in
DSUVIA-related commercialization expenses, a $1.7 million reduction in personnel costs, and a
net benefit of $0.5 million from the
receipt of a breakup fee from Tetraphase, net of expenses incurred
related to the transaction in the quarter. See the "Reconciliation
of Non-GAAP Financial Measures" table below for a reconciliation of
the non-GAAP operating expenses described above to their related
GAAP measures.
- For the second quarter of 2020, net loss was $6.6 million, or $0.08 per basic and diluted share, compared to
$12.4 million, or $0.16 per basic and diluted share, for the second
quarter of 2019. Net loss for the first half of 2020 was
$22.5 million, or $0.28 basic and diluted net loss per share,
compared to $26.1 million, or
$0.33 basic and diluted net loss per
share, for the prior year period.
Webcast and Conference Call Information
As previously
announced, AcelRx will host a live webcast Monday, August 10, 2020 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
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, approved by the FDA in November 2018, 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. The
European Commission approved DZUVEO for marketing in Europe in June
2018 and AcelRx is currently in discussions with potential
European marketing partners.
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 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.
AcelRx 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 one product candidate, Zalviso®
(sufentanil sublingual tablet system, SST system, 15 mcg), an
investigational product in the U.S., is being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings. DZUVEO and Zalviso are both approved products in
Europe.
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 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 near-term revenue drivers, the expected
impact of recent hospital system wins on revenue and the timing of
such impact, the timing and size of military orders and the ongoing
effects of the COVID-19 pandemic and its anticipated impacts on
AcelRx's business. 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.
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 the
risk that the military and hospital systems delay, or fail to
place, orders, that AcelRx may not experience the expected benefits
from the Zimmer Biomet commercial opportunity or that the impacts
AcelRx is experiencing from the ongoing COVID-19 pandemic may be
prolonged or exacerbated. Although it is not possible to
predict or identify all such risks and uncertainties, they may
include, but are not limited to, those described 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). 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 events or circumstances after
the date hereof, or to reflect the occurrence of unanticipated
events.
Media
Contacts
|
Investor
Contacts
|
Evoke
|
Raffi Asadorian, CFO
AcelRx
|
Theresa Dolge /
Jessica Ross
|
investors@acelrx.com
|
215-928-2748 /
215-928-2346
|
Brian Korb, Solebury
Trout
|
theresa.dolge@evokegroup.com /
|
646-378-2923
|
jessica.ross@evokegroup.com
|
Investors@acelrx.com
|
Selected Financial
Data
|
(in thousands, except
per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30
|
|
June
30
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
303
|
|
$
768
|
|
$
577
|
|
$
894
|
Contract
and other collaboration
|
2,621
|
|
173
|
|
2,733
|
|
312
|
Total
revenue
|
2,924
|
|
941
|
|
3,310
|
|
1,206
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
1,370
|
|
1,810
|
|
2,881
|
|
3,040
|
Research and
development (1)
|
813
|
|
1,163
|
|
2,225
|
|
2,540
|
Selling, general and
administrative (1)
|
7,575
|
|
11,329
|
|
20,886
|
|
21,305
|
Total operating costs
and expenses
|
9,758
|
|
14,302
|
|
25,992
|
|
26,885
|
Loss from
operations
|
(6,834)
|
|
(13,361)
|
|
(22,682)
|
|
(25,679)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(872)
|
|
(500)
|
|
(1,727)
|
|
(876)
|
Interest income and
other income (expense), net
|
270
|
|
456
|
|
205
|
|
1,083
|
Non-cash interest
income (expense) on liability related to sale of future
royalties
|
834
|
|
996
|
|
1,677
|
|
(611)
|
Total other income
(expense)
|
232
|
|
952
|
|
155
|
|
(404)
|
Provision for income
taxes
|
(4)
|
|
(3)
|
|
(4)
|
|
(3)
|
Net loss
|
$
(6,606)
|
|
$
(12,412)
|
|
$
(22,531)
|
|
$
(26,086)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.08)
|
|
$
(0.16)
|
|
$
(0.28)
|
|
$
(0.33)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
80,662
|
|
78,902
|
|
80,360
|
|
78,846
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
27
|
|
$
68
|
|
$
73
|
|
$
129
|
Research and development
|
184
|
|
233
|
|
384
|
|
457
|
Selling, general and administrative
|
879
|
|
1,045
|
|
1,779
|
|
1,867
|
Total
|
$
1,090
|
|
$
1,346
|
|
$
2,236
|
|
$
2,453
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2020
|
|
December 31,
2019
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
43,686
|
|
$
66,137
|
|
|
|
|
Total
assets
|
67,400
|
|
91,356
|
|
|
|
|
Total
liabilities
|
127,532
|
|
132,774
|
|
|
|
|
Total stockholders'
(deficit) equity
|
(60,132)
|
|
(41,418)
|
|
|
|
|
Reconciliation
of Non-GAAP Financial Measures
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30
|
|
June
30
|
|
2020
|
|
2019
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
813
|
|
$
1,163
|
|
$
2,225
|
|
$
2,540
|
Selling, general and
administrative
|
7,575
|
|
11,329
|
|
20,886
|
|
21,305
|
Total operating
expenses
|
8,388
|
|
12,492
|
|
23,111
|
|
23,845
|
Less associated
stock-based
|
|
|
|
|
|
|
|
compensation
expense
|
1,063
|
|
1,278
|
|
2,163
|
|
2,324
|
Operating expenses
(non-GAAP)
|
$ 7,325
|
|
$ 11,214
|
|
$ 20,948
|
|
$ 21,521
|
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SOURCE AcelRx Pharmaceuticals, Inc.