REDWOOD CITY, Calif.,
Jan. 13, 2020 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a
specialty pharmaceutical company focused on the development and
commercialization of innovative therapies for use in healthcare
institutions, today provided an update on its business and
DSUVIA® launch metrics.
"Exceeding our 2019 formulary approvals and number of
REMS-certified facilities targets after only two full quarters with
our 40-person sales team demonstrates DSUVIA's early acceptance by
healthcare facilities," said Vince
Angotti, Chief Executive Officer of AcelRx. "We begin 2020
with a solid foundation of REMS-certified healthcare facilities,
and will now increase our focus on DSUVIA's adoption and orders
from this installed base while continuing our expansion to an
expected 465 REMS-certified facilities and 465 formulary approvals
by the end of 2020. This increased focus on adoption is
expected to accelerate revenue growth in 2020," continued
Angotti.
Business Updates and Highlights
- 166 healthcare facilities are REMS-certified and able to
purchase DSUVIA and 148 formulary approvals have been achieved
through December 31, 2019, exceeding
year-end goals of 125 for each metric.
- Preliminary unaudited FY 2019 total revenues of $2.3 million.
- Cash, cash equivalents and short-term investments of
$66.1 million as of December 31, 2019.
- Year-end 2020 goals of 465 REMS-certified facilities and 465
formulary approvals.
- Department of Defense Milestone C meeting for DSUVIA is
expected in the second quarter of 2020; the Company expects the
military to begin procuring DSUVIA following successful completion
of this meeting.
- Commencement of investigator-initiated studies of DSUVIA in
post-operative pain management and Enhanced Recovery protocols at
prominent university hospitals is anticipated beginning in the
first half of 2020.
- The Company is hosting investor meetings in San Francisco this week during the JP Morgan
Healthcare Conference.
The information above related to the Company's expected
operating results for the year ended and as of December 31, 2019, including revenue and cash,
cash equivalents and short-term investments, is preliminary, has
not been audited and is subject to change upon completion of the
audit of the Company's financial statements as of and for the year
ended December 31, 2019.
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.
Forward-Looking Statements
This press
release contains forward-looking statements, including, but not
limited to, statements related to revenues, cash, cash equivalents
and short-term investments the Company expects to report for fiscal
year 2019, the number of REMS-certified facilities and formulary
approvals expected by the end of 2020, the timing of the Department
of Defense Milestone C meeting and procurement of DSUVIA by the
military, expected commencement of investigator-initiated studies
and anticipated acceleration of revenue growth. 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 challenges in achieving market
adoption of DSUVIA, REMS-certified facilities and formulary
approvals, or acceleration of revenue growth in a timely manner, or
at all. In addition, such risks and uncertainties 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.
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SOURCE AcelRx Pharmaceuticals, Inc.