REDWOOD CITY, Calif.,
Nov. 6, 2019 /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 third quarter 2019
financial results.
"Achieving 125 REMS-certified facilities two months ahead of our
year-end goal demonstrates healthcare providers' increasing
interest in DSUVIA," said Vince
Angotti, Chief Executive Officer of AcelRx. "We also expect
to achieve our year-end objective of 125 formulary approvals and
anticipate expanded use across a variety of healthcare settings as
the feedback on DSUVIA® from healthcare professionals
continues to be very positive," continued Angotti.
Third Quarter and Recent Highlights
- 130 healthcare facilities are now REMS-certified and able to
purchase DSUVIA and 105 formulary approvals have been achieved
through October 31, 2019;
approximately 60% of REMS certifications and formulary approvals
have occurred since the date of the Company's last earnings
call
- AcelRx was selected to present at one of the two plenary
sessions of the 2019 Military Health System Research Symposium; the
presentation was entitled "Pooled Safety Analysis of Patients Who
Were Exposed to < 300 mcg vs. ≥300 mcg of Sublingual Sufentanil
in a 24 Hour Period for Treatment of Acute Pain"
- Pooled dosing and efficacy data from use of the sufentanil
sublingual tablet (SST) 30 mcg among multiple demographic subgroups
(age, sex, race, and body mass index) was accepted for publication
in the Journal of PeriAnesthesia Nursing to aid nurses in
understanding the effectiveness and duration of action of SST 30
mcg in the management of moderate-to-severe acute pain across a
variety of patient demographics
Financial Information
- Cash, cash equivalents and short-term investments balance of
$80.4 million as of September 30, 2019;
- Combined R&D and SG&A expenses for the third quarter of
2019 totaled $12.0 million compared
to $8.8 million for the third quarter
of 2018. Excluding stock-based compensation expense, these amounts
were $10.7 million for the third
quarter of 2019 compared to $7.1
million for the third quarter of 2018. R&D and SG&A
expenses for the first nine months of 2019 totaled $35.8 million compared to $23.6 million in the first nine months of 2018.
Excluding stock-based compensation expense, these figures were
$32.3 million for the first nine
months of 2019 compared to $19.9
million for the first nine months of 2018. The increase in
R&D and SG&A expenses is primarily due to increased
personnel-related expenses for the commercial launch of DSUVIA. 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;
- Net cash outflow for the third quarter of 2019 was $11.1 million, which included $0.6 million in debt service;
- For the third quarter of 2019, net loss was $12.7 million, or $0.16 per basic and diluted share, compared to
$12.5 million, or $0.21 per basic and diluted share, for the third
quarter of 2018. Net loss for the first nine months of 2019 was
$38.8 million, or $0.49 per basic and diluted share, compared to
$34.6 million, or $0.64 per basic and diluted share, for the prior
year period.
Webcast and Conference Call Information
As previously
announced, AcelRx will host a live webcast Wednesday, November 6, 2019 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss these
financial results and provide other corporate updates. The webcast
is accessible by visiting the Investors page of the Company'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 the Company'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 the Company is currently in discussions with
potential European marketing partners.
For more information, 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 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), the Company uses
certain non-GAAP financial measures in this press release, in
particular, excluding stock-based compensation expense from its
operating expenses. The Company believes that these non-GAAP
financial measures provide useful supplementary information to, and
facilitate additional analysis by, investors and analysts. In
particular, the Company believes that these non-GAAP financial
measures, when considered together with the Company's financial
information prepared in accordance with GAAP, can enhance
investors' and analysts' ability to meaningfully compare the
Company'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 the
Company's financial performance. AcelRx's management also regularly
uses these non-GAAP financial measures internally to understand,
manage and evaluate the Company'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 condensed
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 anticipated formulary approvals and use of
DSUVIA. 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. 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 the Company'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 the Company's most recent annual, quarterly or current
report as filed or furnished with the SEC. The Company's SEC
reports are available at www.acelrx.com under the "Investors" tab.
Except to the extent required by law, the Company 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.
Selected Financial
Data
|
(in thousands, except
per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30
|
|
September
30
|
|
2019
|
2018
|
|
2019
|
2018
|
|
|
|
|
|
|
Net product
sales
|
$
116
|
$
-
|
|
$
218
|
$
-
|
Collaboration
agreement
|
492
|
177
|
|
$
1,596
|
$
802
|
Contract and
other
|
-
|
200
|
|
-
|
736
|
Total
revenue
|
608
|
377
|
|
1,814
|
1,538
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
Cost of goods
sold
|
2,148
|
875
|
|
5,188
|
2,738
|
Research and
development
|
1,058
|
3,642
|
|
3,598
|
10,433
|
General and
administrative
|
10,936
|
5,188
|
|
32,241
|
13,117
|
Total operating costs
and expenses
|
14,142
|
9,705
|
|
41,027
|
26,288
|
Loss from
operations
|
(13,534)
|
(9,328)
|
|
(39,213)
|
(24,750)
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
Interest
expense
|
(828)
|
(529)
|
|
(1,704)
|
(1,758)
|
Interest income and
other income (expense), net
|
645
|
312
|
|
1,728
|
643
|
Non-cash interest
income (expense) on liability related to sale of future
royalties
|
986
|
(2,913)
|
|
375
|
(8,724)
|
Total other income
(expense)
|
803
|
(3,130)
|
|
399
|
(9,839)
|
Provision for income
taxes
|
-
|
-
|
|
(3)
|
(2)
|
Net loss
|
$
(12,731)
|
$(12,458)
|
|
$(38,817)
|
$(34,591)
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.16)
|
$
(0.21)
|
|
$
(0.49)
|
$
(0.64)
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
79,461
|
60,004
|
|
79,053
|
54,292
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
68
|
$
119
|
|
$
197
|
$
280
|
Research and development
|
242
|
769
|
|
699
|
1,578
|
Selling, general and administrative
|
1,016
|
920
|
|
2,883
|
2,078
|
Total
|
$
1,326
|
$
1,808
|
|
$
3,779
|
$
3,936
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2019
|
December 31,
2018
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
80,400
|
$
105,715
|
|
|
|
Total
assets
|
104,978
|
120,533
|
|
|
|
Total
liabilities
|
133,252
|
116,280
|
|
|
|
Total stockholders'
(deficit) equity
|
(28,274)
|
4,253
|
|
|
|
Reconciliation
of Non-GAAP Financial Measures
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30
|
|
September
30
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
1,058
|
|
$ 3,642
|
|
$
3,598
|
|
$ 10,433
|
Selling, general and
administrative
|
10,936
|
|
5,188
|
|
32,241
|
|
13,117
|
Total operating
expenses
|
11,994
|
|
8,830
|
|
35,839
|
|
23,550
|
Less associated
stock-based compensation
expense
|
1,258
|
|
1,689
|
|
3,582
|
|
3,656
|
Operating expenses
(non-GAAP)
|
$ 10,736
|
|
$ 7,141
|
|
$ 32,257
|
|
$ 19,894
|
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SOURCE AcelRx Pharmaceuticals, Inc.