REDWOOD CITY, Calif.,
Aug. 5, 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 second quarter 2019
financial results.
"We successfully executed our first full quarter of launch with
only 15 hospital account managers focused on gaining early approval
for use of DSUVIA, leading to 51 REMS-certified facilities to
date," said Vince Angotti, Chief
Executive Officer of AcelRx. "The widespread appreciation of
DSUVIA's unique pharmacokinetic profile and route of administration
is evident in the diversity of REMS-certified facilities such as
hospitals, ambulatory surgical centers, and procedural centers
including orthopedic, vascular, plastic surgery and wound
care. We have strong momentum heading into the second half of
the year, particularly now that we have our commercial organization
at full strength with 40 hospital account managers," continued
Angotti.
Second Quarter and Recent Highlights
- 51 REMS-certified healthcare facilities now approved to
purchase and use DSUVIA within their healthcare settings,
two-thirds of which occurred since June
15; 43 formulary approvals achieved since launch
- Completed the second phase of commercial team hiring effective
July 1, as planned, increasing the
number of hospital account managers from 15 to 40; the balance of
the commercial launch organization now also includes 7 market
access personnel and 7 medical science liaisons in place to educate
healthcare professionals on the benefits of DSUVIA for their
patients and their institutions
- Refinanced previously existing senior secured debt facility in
the amount of $25.0 million,
providing the Company with a lower cost of capital, lower debt
service, and $15.9 million in net
proceeds after the $8.9 million
repayment of its outstanding obligations
- Added as a member of the Russell 2000® and Russell 3000®
Indexes effective July 1, 2019
Financial Information
- Cash, cash equivalents and short-term investments balance of
$91.5 million as of June 30, 2019;
- Combined R&D and SG&A expenses for the second quarter
of 2019 totaled $12.5 million
compared to $7.2 million for the
second quarter of 2018. Excluding stock-based compensation expense,
these amounts were $11.2 million for
the second quarter of 2019 compared to $6.2
million for the second quarter of 2018. R&D and G&A
expenses for the first half of 2019 totaled $23.8 million compared to $14.7 million in the first half of 2018.
Excluding stock-based compensation expense, these figures were
$21.5 million for the first half of
2019 compared to $12.8 million for
the first half 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 second quarter of 2019 was
$14.6 million, not including the
$15.9 million in net proceeds from
the refinancing of our senior secured debt which included
$1.8 million in debt service;
- For the second quarter of 2019, net loss was $12.4 million, or $0.16 per basic and diluted share, compared to
$10.5 million, or $0.20 per basic and diluted share, for the second
quarter of 2018. Net loss for the first half of 2019 was
$26.1 million, or $0.33 basic and diluted net loss per share,
compared to $22.1 million, or
$0.43 basic and diluted net loss per
share, for the prior year period.
2019 Guidance
AcelRx added the number of
REMS-certified facilities as another metric in addition to
formulary approvals. These combined metrics provide a more
comprehensive measure of healthcare facilities, including
hospitals, ambulatory surgery centers, and other medically
supervised settings which are purchasing or are certified to
purchase DSUVIA. Our expectation is there will be 125
REMS-certified facilities by the end of 2019, which is in line with
the 125 formulary wins expected by the end of 2019. As we
gain more experience with the launch, we plan to provide updates on
both metrics measuring access to medically supervised settings.
Quarterly combined R&D and SG&A expense for the
remaining quarters of 2019 is expected to remain in the range of
$16 million to $18 million, which includes approximately
$2 million of non-cash stock-based
compensation per quarter. Quarterly debt service for the last
two quarters of the year is expected to approximate $0.6 million.
Quarterly non-cash interest income for the rest of 2019 is
expected to approximate $1.0 million
mainly attributed to the accounting for the reduction in the
expected liability related to the previously recorded sale of
Zalviso royalties and milestones.
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 Monday, August 5, 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
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 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 2019 guidance regarding the number of
REMS-certified facilities and formulary approvals, quarterly
operating expenses and stock-based compensation expense, and
quarterly non-cash interest income. 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
|
|
Six Months
Ended
|
|
June
30
|
|
June
30
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Net product
sales
|
$
55
|
|
$
-
|
|
$
102
|
|
$
-
|
Collaboration
agreement
|
886
|
|
351
|
|
1,104
|
|
625
|
Contract and
other
|
-
|
|
467
|
|
-
|
|
536
|
Total
revenue
|
941
|
|
818
|
|
1,206
|
|
1,161
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
1,810
|
|
749
|
|
3,040
|
|
1,863
|
Research and
development (1)
|
1,163
|
|
3,278
|
|
2,540
|
|
6,791
|
Selling, general and
administrative (1)
|
11,329
|
|
3,944
|
|
21,305
|
|
7,929
|
Total operating costs
and expenses
|
14,302
|
|
7,971
|
|
26,885
|
|
16,583
|
Loss from
operations
|
(13,361)
|
|
(7,153)
|
|
(25,679)
|
|
(15,422)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(500)
|
|
(586)
|
|
(876)
|
|
(1,229)
|
Interest income and
other income (expense), net
|
456
|
|
195
|
|
1,083
|
|
331
|
Non-cash interest
income (expense) on liability related to sale of future
royalties
|
996
|
|
(2,995)
|
|
(611)
|
|
(5,811)
|
Total other income
(expense)
|
952
|
|
(3,386)
|
|
(404)
|
|
(6,709)
|
Provision for income
taxes
|
(3)
|
|
(2)
|
|
(3)
|
|
(2)
|
Net loss
|
$
(12,412)
|
|
$
(10,541)
|
|
$(26,086)
|
|
$(22,133)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.16)
|
|
$
(0.20)
|
|
$
(0.33)
|
|
$
(0.43)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
78,902
|
|
51,842
|
|
78,846
|
|
51,389
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
68
|
|
$
74
|
|
$
129
|
|
$
161
|
Research and development
|
233
|
|
377
|
|
457
|
|
809
|
Selling, general and administrative
|
1,045
|
|
597
|
|
1,867
|
|
1,158
|
Total
|
$
1,346
|
|
$
1,048
|
|
$
2,453
|
|
$
2,128
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2019
|
|
December 31,
2018
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
91,546
|
|
$
105,715
|
|
|
|
|
Total
assets
|
115,112
|
|
120,533
|
|
|
|
|
Total
liabilities
|
133,531
|
|
116,280
|
|
|
|
|
Total stockholders'
(deficit) equity
|
(18,419)
|
|
4,253
|
|
|
|
|
Reconciliation of
Non-GAAP Financial Measures
|
(Operating
Expenses less associated stock-based compensation
expense)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30
|
|
June
30
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
1,163
|
|
$ 3,278
|
|
$
2,540
|
|
$
6,791
|
Selling, general and
administrative
|
11,329
|
|
3,944
|
|
21,305
|
|
7,929
|
Total operating
expenses
|
12,492
|
|
7,222
|
|
23,845
|
|
14,720
|
Less associated
stock-based
|
|
|
|
|
|
|
|
compensation
expense
|
1,278
|
|
974
|
|
2,324
|
|
1,967
|
Operating expenses
(non-GAAP)
|
$ 11,214
|
|
$ 6,248
|
|
$ 21,521
|
|
$ 12,753
|
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SOURCE AcelRx Pharmaceuticals, Inc.