Apricus Biosciences Provides Corporate Update, Fourth Quarter and Full Year 2016 Financial Results
March 13 2017 - 4:19PM
Sale of Ex-U.S.
Vitaros Assets and Rights to Ferring Pharmaceuticals Strengthens
Financial Position
Vitaros U.S. NDA
Re-Submission on Track for Third Quarter 2017
Conference Call /
Webcast Today, Monday, March 13, 2017 at 4:30 p.m. ET
SAN DIEGO, March 13, 2017 (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical
company advancing innovative medicines in urology and rheumatology,
today reported financial results for the fourth quarter and full
year of 2016 and provided a corporate update on its priorities for
2017.
"Last week, we announced the divestiture of our
ex-U.S. Vitaros interests to Ferring Pharmaceuticals. The closing
of this transaction will allow us to focus our attention on the
U.S. Vitaros NDA resubmission in the third quarter of this year,
and advancing the RayVa clinical development program," stated
Richard W. Pascoe, Chief Executive Officer. "We continue to believe
in the tremendous value that our pipeline potentially offers to
patients, healthcare providers and shareholders as we look ahead
and we are committed to working with Ferring to ensure a smooth
transition of the Vitaros product outside of the United States.
Importantly, this transaction creates a more streamlined, capital
efficient organization with the potential to deliver on multiple
regulatory, clinical and business development milestones over the
next twelve months."
Strategic Priorities
Apricus continues to focus on achieving the
following key strategic objectives:
Vitaros(TM)(alprostadil)
-
Continue implementation of the U.S.
regulatory approval strategy to address the safety issues raised by
the FDA in the original Vitaros NDA submission. Apricus
anticipates a meeting with the FDA's Office of Product Quality in
the second quarter of 2017 to confirm the necessary device
engineering and compliance requirements, following which the
Company intends to resubmit the Vitaros NDA. An FDA approval
decision is expected after a six month review period;
-
Support the Ferring knowledge transfer,
to ensure a smooth transition of certain ex-U.S. assets and rights
related to Vitaros in an effort to ensure that Vitaros continues to
grow as a global brand.
RayVa(TM)(alprostadil)
-
Explore Orphan Drug Designation in the
U.S. and EU;
-
Finalize clinical trial protocol and
clinical trial material formulation work needed to initiate a Phase
2b study; and
-
Explore global or regional partnerships
prior to initiating the Phase 2b study.
Corporate/Financial
-
Reduce operating expenses by
approximately 30% in 2017 as compared to 2016 operating
expenses;
-
Regain compliance with the minimum $2.5
million shareholder equity requirement as required for continued
listing on The NASDAQ Capital Market under NASDAQ Listing Rule
5550(b)(2) on or before May 30, 2017.
Fourth Quarter and Full Year
Financial Results
Total revenues for the quarter and year to date
periods ended December 31, 2016 were $0.4 million and $5.8
million, respectively, as compared to $2.6 million and $4.8 million
for the quarter and year to date periods ended December 31, 2015,
respectively. The decrease during the fourth quarter comparison was
primarily due to license fee revenue of $2.25 million recognized in
the fourth quarter of 2015 associated with the Company's former
partner, Ferring. The increase during the full year comparison was
primarily due to increased license fee revenue and royalty revenue
in the current year. Net loss for the quarter ended
December 31, 2016 was $0.3 million, or loss per share of
$0.04, compared to a net loss of $2.3 million, or $0.05 per share
for the fourth quarter of 2015. Net loss for the year ended
December 31, 2016 was $7.4 million, or loss per share of $1.14,
compared to a net loss of $19.0 million, or loss per share of $3.83
for the year ended December 31, 2015. The reduction in the net loss
during the current year periods as compared to the prior year
periods is a result of decreased research and development expenses
as well as decreased general and administrative expenses. Also
reducing the net loss for the quarter and year ended
December 31, 2016 was a non-cash change in the fair value of
the Company's warrant liabilities in the amount of $2.4 million and
$7.5 million, respectively.
As of March 8, 2017, the Company's cash
totaled $5.4 million, compared to $2.1 million as of
December 31, 2016.
Conference Call Details
Apricus will host a live conference call and
webcast today at 4:30 p.m. Eastern Time to discuss the Company's
financial results and provide a corporate update. To participate by
telephone, please dial (855) 780-7196 (Domestic) or (631) 485-4867
(International). The conference ID number is 85861485. The
live and archived audio webcast can be accessed through the
Investors Relations' section of the Company's website
at www.apricusbio.com. Please log in approximately five to ten
minutes before the event to ensure a timely connection. The
archived webcast will be available for 30 days following the live
call.
About Apricus Biosciences,
Inc.
Apricus Biosciences, Inc. (APRI) is a
biopharmaceutical company advancing innovative medicines in urology
and rheumatology. Apricus has two product candidates currently in
development. Vitaros is a product candidate in the United States
for the treatment of erectile dysfunction, which is in-licensed
from Warner Chilcott Company, Inc., now a subsidiary of Allergan
plc (Allergan). RayVa is our product candidate in Phase 2
development for the treatment of the circulatory disorder Raynaud's
phenomenon, secondary to scleroderma, for which we own worldwide
rights.
For further information on Apricus,
visit http://www.apricusbio.com.
Vitaros(TM) is
Apricus' trademark in the United States, which is pending
registration and subject to the agreement with Allergan.
Vitaros® is a
registered trademark of Ferring B.V. in certain countries outside
of the United States. RayVa(TM) is
Apricus' trademark, which is registered in certain countries
throughout the world and pending registration in the United
States.
Forward Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act, as amended. Statements in this press release that are
not purely historical are forward-looking statements. Such
forward-looking statements include, among other things: Apricus'
ability to transition its ex-U.S. assets and rights related to
Vitaros to Ferring; the timing and significance of the meeting with
the FDA regarding device engineering and compliance; the timing of
regulatory submission and approval of Vitaros in the United States,
if any; Apricus' plans for life-cycle development programs for
Vitaros; Apricus' development and partnering plans for RayVa;
Apricus' plans to reduce operating expenses and achieve
profitability, including projected 2017 cost savings; and Apricus'
strategic objectives, including efforts to regain compliance with
NASDAQ listing standards. Actual results could differ from those
projected in any forward-looking statements due to a variety of
reasons that are outside the control of Apricus, including, but not
limited to: the risk that Apricus fails to provide the transition
services as required by the transition services agreement with
Ferring; the risk that the cost and other negative effects related
to the reduction of Apricus' workforce may be greater than
anticipated; the risk that Apricus may not realize the benefits
expected from its workforce reduction and other cost control
measures; competition in the erectile dysfunction market and other
markets in which Apricus operates; Apricus' ability to obtain FDA
and other requisite governmental approval for Vitaros; Apricus'
ability to further develop Vitaros, such as delivery device
improvements; Apricus' ability to carry out further clinical
studies for Vitaros, if required, as well as the timing and success
of the results of such studies; Apricus' ability to achieve U.S.
and EU Orphan Designation for RayVa; the failure to meet NASDAQ
continued listing requirements which could result in Apricus'
common stock being delisted from the exchange; Apricus' ability to
retain and attract key personnel; Apricus' ability to raise
additional funding that it may need to continue to pursue its
commercial and business development plans; Apricus' ability to
secure an ex-U.S. strategic partner for RayVa; and market
conditions. These forward-looking statements are made as of the
date of this press release, and Apricus assumes no obligation to
update the forward-looking statements, or to update the reasons why
actual results could differ from those projected in the
forward-looking statements. Readers are urged to read the risk
factors set forth in Apricus' most recent annual report on Form
10-K, subsequent quarterly reports filed on Form 10-Q, and other
filings made with the SEC. Copies of these reports are available
from the SEC's website at www.sec.gov or without charge
from Apricus.
(Financial Information to
Follow)
Selected Financial Information |
Consolidated Statements of Operations |
(In thousands, except per share amounts) |
|
|
|
Year Ended
December 31, |
|
|
2016 |
|
2015 |
Revenue |
|
|
|
|
License fee revenue |
|
$ |
4,000 |
|
|
$ |
3,600 |
|
Royalty revenue |
|
1,088 |
|
|
650 |
|
Product sales |
|
675 |
|
|
589 |
|
Total
revenue |
|
5,763 |
|
|
4,839 |
|
|
|
|
|
|
Cost of goods
sold |
|
511 |
|
|
922 |
|
Cost of Sandoz
rights |
|
3,380 |
|
|
- |
|
Gross
profit |
|
1,872 |
|
|
3,917 |
|
|
|
|
|
|
Research &
development expense |
|
6,831 |
|
|
14,649 |
|
General &
administrative expense |
|
8,434 |
|
|
10,516 |
|
Loss on disposal of
assets |
|
14 |
|
|
102 |
|
Total
operating expense |
|
15,279 |
|
|
25,267 |
|
|
|
|
|
|
Other income |
|
5,974 |
|
|
2,327 |
|
Net
loss |
|
$ |
(7,433 |
) |
|
$ |
(19,023 |
) |
|
|
|
|
|
Basic and diluted loss
per common share |
|
$ |
(1.14 |
) |
|
$ |
(3.83 |
) |
Weighted average
common shares outstanding used for basic and diluted loss per
share |
|
6,516,662 |
|
|
4,972,858 |
|
Consolidated Balance Sheets |
(In thousands) |
|
|
|
|
December 31,
2016 |
|
December 31,
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
2,087 |
|
|
$ |
3,887 |
|
Other
current assets |
|
1,547 |
|
|
2,330 |
|
Property
and equipment, net |
|
1,006 |
|
|
1,290 |
|
Other long
term assets |
|
60 |
|
|
274 |
|
|
Total
assets |
|
$ |
4,700 |
|
|
$ |
7,781 |
|
|
|
|
|
|
|
Current
liabilities |
|
$ |
4,644 |
|
|
$ |
6,146 |
|
Notes
payable |
|
6,650 |
|
|
9,401 |
|
Warrant
liabilities |
|
846 |
|
|
1,841 |
|
Deferred
revenue |
|
- |
|
|
137 |
|
Other long
term liabilities |
|
76 |
|
|
200 |
|
Stockholders' deficit |
|
(7,516 |
) |
|
(9,944 |
) |
|
Total
liabilities and stockholders' deficit |
|
$ |
4,700 |
|
|
$ |
7,781 |
|
CONTACT:
Matthew Beck
mbeck@troutgroup.com
The Trout Group
(646) 378-2933
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Apricus Biosciences, Inc. via Globenewswire
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