REDWOOD CITY, Calif.,
May 8, 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 first quarter 2019
financial results.
"I am very pleased with the progress made in the first five
weeks of the DSUVIA™ launch. Shifting the paradigm in
healthcare facilities to a new, non-invasive treatment option for
acute pain will take time; however, from my time in the field, I
have seen first-hand the enthusiasm that healthcare professionals
have for DSUVIA," said Vince
Angotti, Chief Executive Officer of AcelRx. "In addition to
our planned hospital formulary approvals, we are excited that
AcelRx has already become an approved vendor for a large ambulatory
surgical center network with over 300 locations across the U.S.,
providing further evidence that DSUVIA's unique characteristics are
meaningful to healthcare providers," continued Angotti.
First Quarter and Recent Highlights
- Launched DSUVIA in the second-half of February 2019 using 15 hospital account managers,
with DSUVIA available for sale for five weeks in the first quarter
of 2019
- Successfully completed or scheduled 46 hospital formulary
reviews by mid-year, on track for 125 approvals by year-end
- In addition to hospital formularies, AcelRx became an approved
vendor for an ambulatory surgical center network with over 300
locations across the U.S., making DSUVIA available beyond the
hospital setting
- Pooled safety data from 804 patients was published in Pain
Management demonstrating sufentanil sublingual tablets are
well-tolerated in a wide variety of postoperative and emergency
room patients
Financial Information
- Cash, cash equivalents and short-term investments balance of
$90.2 million as of March 31, 2019;
- Combined R&D and SG&A expenses for the first quarter of
2019 totaled $11.4 million compared
to $7.5 million for the first quarter
of 2018. Excluding stock-based compensation expense, these amounts
were $10.3 million for the first
quarter of 2019 compared to $6.5
million for the first quarter 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 first quarter of 2019 was $15.5 million which included $2.3 million in debt service; and
- For the first quarter of 2019, net loss was $13.7 million, or $0.17 per basic and diluted share, compared to
$11.6 million, or $0.23 per basic and diluted share, for the first
quarter of 2018.
2019 Guidance
AcelRx remains on track to achieve 125
hospital formulary approvals by the end of 2019. The
acceleration of the second phase of hiring 25 additional hospital
account managers to the beginning of the third quarter from
the fourth quarter also remains as planned. Quarterly
combined R&D and SG&A expense for the remaining quarters of
2019 is expected to remain in the range of $15 million to $18
million, which includes approximately $2 million of non-cash stock-based compensation
per quarter.
2019 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 the safe harbor statements
below.
Webcast and Conference Call Information
As previously
announced, AcelRx will host a live webcast Wednesday, May 8, 2019 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 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
(888) 317-6003 for domestic callers or (412) 317-6061 for
international callers, passcode 5289662. 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
a certified medically supervised healthcare setting, such as
hospitals, surgical centers, and emergency departments, for the
management of acute pain in adult patients 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
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
currently marketed for intravenous (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 Medicines Agency (EMA) 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 this non-GAAP
financial measure provides useful supplementary information to, and
facilitates additional analysis by, investors and analysts. In
particular, the Company believes that this non-GAAP financial
measure, 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, this type of non-GAAP financial measure is
regularly used by investors and analysts to model and track the
Company's financial performance. AcelRx's management also regularly
uses this non-GAAP financial measure 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
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 commercial growth of, and market
demand for, DSUVIA in the United
States, and 2019 guidance regarding potential acceleration
of sales force growth, formulary approvals, quarterly operating
expenses and stock-based compensation expense. 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
|
|
March
31
|
|
2019
|
|
2018
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
Net product
sales
|
$
47
|
|
$
-
|
Collaboration
agreement
|
218
|
|
274
|
Contract and
other
|
-
|
|
69
|
Total
revenue
|
265
|
|
343
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
Cost of goods sold
(1)
|
1,230
|
|
1,114
|
Research and
development (1)
|
1,377
|
|
3,513
|
Selling, general and
administrative (1)
|
9,976
|
|
3,985
|
Total operating costs
and expenses
|
12,583
|
|
8,612
|
Loss from
operations
|
(12,318)
|
|
(8,269)
|
|
|
|
|
Other (expense)
income:
|
|
|
|
Interest
expense
|
(376)
|
|
(643)
|
Interest income and
other income (expense), net
|
627
|
|
136
|
Non-cash interest
expense on liability related to sale of future royalties
|
(1,607)
|
|
(2,816)
|
Total other
expense
|
(1,356)
|
|
(3,323)
|
Net loss
|
$
(13,674)
|
|
$
(11,592)
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.17)
|
|
$
(0.23)
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
78,789
|
|
50,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
Cost of goods sold
|
$
61
|
|
$
87
|
Research and development
|
224
|
|
432
|
Selling, general and administrative
|
822
|
|
561
|
Total
|
$
1,107
|
|
$
1,080
|
|
|
|
|
|
|
|
|
|
|
March 31,
2019
|
|
December 31,
2018
|
Selected Balance
Sheet Data
|
|
|
|
Cash, cash
equivalents and investments
|
$
90,150
|
|
$
105,715
|
Total
assets
|
113,444
|
|
120,533
|
Total
liabilities
|
121,335
|
|
116,280
|
Total stockholders'
(deficit) equity
|
(7,891)
|
|
4,253
|
|
|
|
|
Reconciliation
of Non-GAAP Financial Measures
|
|
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
Three Months
Ended
|
|
March
31
|
|
2019
|
|
2018
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
Research and
development
|
$
1,377
|
|
$
3,513
|
Selling, general and
administrative
|
9,976
|
|
3,985
|
Total operating
expenses
|
11,353
|
|
7,498
|
Less associated
stock-based
|
|
|
|
compensation
expense
|
1,046
|
|
993
|
Operating expenses
(non-GAAP)
|
$
10,307
|
|
$
6,505
|
|
|
|
|
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SOURCE AcelRx Pharmaceuticals, Inc.