Apricus Biosciences Provides Corporate Update and Third Quarter 2017 Financial Results
November 02 2017 - 4:01PM
Vitaros U.S. NDA Resubmission Review Remains on
TrackPDUFA Goal Date of February 17, 2018
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical
company advancing innovative medicines in urology and rheumatology,
today reported financial results for the third quarter of 2017 and
provided a corporate update on its priorities for the remainder of
the year.
“In the third quarter of this year, we continued
to execute on our key corporate objectives by filing the U.S.
Vitaros NDA resubmission with the FDA and improving our financial
outlook, resulting in a balance sheet that is expected to fund our
current operating plan through the end of 2018,” stated Richard W.
Pascoe, Chief Executive Officer. “Importantly, the FDA acknowledged
receipt of our resubmission and our PDUFA goal date is February 17,
2018. For the remainder of 2017, we will focus on working
with the FDA regarding the Vitaros NDA, maintaining a productive
dialogue with Allergan regarding the commercial potential for
Vitaros in the United States, securing a development partner for
RayVa, and continuing to diligently manage our corporate
resources.”
Recent Highlights
Apricus continues to execute on its corporate
strategy as highlighted below:
Vitaros™
(alprostadil)
- Resubmitted Vitaros NDA to the FDA, which Apricus believes
addressed all issues raised by the FDA’s complete response letter
to the original Vitaros NDA submission; specifically, all safety,
chemistry, manufacturing and control (CMC) related issues; and
- Completed the transition of the Vitaros ex-US rights and assets
to Ferring International. Apricus received the final $0.25
million payment related to transition services during the third
quarter of 2017.
RayVa™
(alprostadil)
- Continued a partnering process to secure a global or regional
RayVa partnership prior to initiating a Phase 2b clinical
study.
Corporate/Financial
- Closed a private placement of common stock and warrants for net
proceeds of approximately $3.1 million.
Third Quarter and Year-to-Date Financial
Results
Net loss for the quarter ended
September 30, 2017 was $3.8 million, or loss per share of
$0.29, compared to a net loss of $1.3 million, or loss per share of
$0.19, for the third quarter of 2016. Net loss during the third
quarter of 2017 was primarily due to the $1.5 million regulatory
milestone payment made to Allergan upon the FDA’s acknowledgment of
our Vitaros NDA resubmission, Vitaros commercial preparation
activities, as well as other general and administrative
expenses.
Net income for the nine months ended
September 30, 2017 was $2.8 million, or income per share of
$0.26, compared to a net loss of $7.1 million, or loss per share of
$1.17, for the third quarter of 2016. Net income during the nine
months ended September 30, 2017 was primarily due to the $12.3
million gain recorded for the sale of our ex-U.S. Vitaros rights
and assets to Ferring.
For all periods presented, financial statement
activity related to our ex-U.S. Vitaros business has been presented
as discontinued operations. As of September 30, 2017,
the Company’s cash totaled $8.5 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 8498419. 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™ 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
International Center S.A. in certain countries outside of the
United States. RayVa™ 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: the timing
of regulatory review and approval of the Vitaros NDA in the United
States, if any; Apricus’ partnering plans for RayVa; discussions
with Allergan regarding the commercial potential for Vitaros ; and
Apricus’ management of resources and strategic objectives. 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: Apricus’ ability to
obtain FDA and other requisite governmental approval for Vitaros;
the FDA could require additional clinical and pre-clinical data;
Apricus’ ability to have addressed any conditions for approvability
raised by the FDA in the 2008 complete response letter or the FDA
identifying other deficiencies in the resubmission; risks related
to the possibility of an advisory committee meeting related to
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; the failure to remain
in compliance with 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 a strategic partner for RayVa;
competition in the erectile dysfunction market and other markets in
which Apricus operates; 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)
CONTACT: Matthew
Beckmbeck@troutgroup.com The Trout Group(646) 378-2933
| |
| Selected Financial Information |
| Condensed Consolidated Statements of
Operations |
| (In thousands, except per share
amounts) |
| |
|
|
|
| |
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
| |
2017 |
|
2016 |
|
2017 |
|
2016 |
| Operating expense |
|
|
|
|
|
|
|
| Research
and development |
$ |
(1,960 |
) |
|
$ |
(170 |
) |
|
$ |
(3,226 |
) |
|
$ |
(5,274 |
) |
| General
and administrative |
(1,756 |
) |
|
(1,550 |
) |
|
(4,799 |
) |
|
(5,878 |
) |
| Total
other income (expense) |
(293 |
) |
|
124 |
|
|
(1,125 |
) |
|
3,808 |
|
| Loss from
continuing operations |
(4,009 |
) |
|
(1,596 |
) |
|
(9,150 |
) |
|
(7,344 |
) |
| Income
from discontinued operations |
177 |
|
|
305 |
|
|
11,917 |
|
|
210 |
|
| Net income (loss) |
$ |
(3,832 |
) |
|
$ |
(1,291 |
) |
|
$ |
2,767 |
|
|
$ |
(7,134 |
) |
| |
|
|
|
|
|
|
|
| Basic and diluted
earnings (loss) per share |
|
|
|
|
|
|
|
|
Continuing operations |
$ |
(0.30 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.85 |
) |
|
$ |
(1.20 |
) |
|
Discontinued operations |
$ |
0.01 |
|
|
$ |
0.05 |
|
|
$ |
1.11 |
|
|
$ |
0.03 |
|
| Total
earnings (loss) per share |
$ |
(0.29 |
) |
|
$ |
(0.19 |
) |
|
$ |
0.26 |
|
|
$ |
(1.17 |
) |
| |
|
|
|
|
|
|
|
| Weighted
average common shares outstanding for basic and diluted earnings
(loss) per share |
13,208 |
|
|
6,632 |
|
|
10,781 |
|
|
6,108 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| |
| Condensed Consolidated Balance
Sheets |
| (In thousands) |
| |
|
|
|
| |
September 30, 2017 |
|
December 31, 2016 |
| |
(Unaudited) |
|
|
|
Assets |
|
|
|
| Cash |
$ |
8,463 |
|
|
$ |
2,087 |
|
| Other current
assets |
216 |
|
|
177 |
|
| Property and equipment,
net |
100 |
|
|
164 |
|
| Other long term
assets |
35 |
|
|
60 |
|
| Assets of discontinued
operations |
$ |
9 |
|
|
$ |
2,212 |
|
|
Total assets |
$ |
8,823 |
|
|
$ |
4,700 |
|
| |
|
|
|
| Liabilities and
stockholders’ equity (deficit) |
|
|
|
| Current
liabilities |
$ |
1,713 |
|
|
$ |
2,536 |
|
| Current liabilities of
discontinued operations |
101 |
|
|
2,108 |
|
| Notes payable, net |
— |
|
|
6,650 |
|
| Warrant
liabilities |
636 |
|
|
846 |
|
| Other long term
liabilities |
54 |
|
|
76 |
|
| Stockholders’ equity
(deficit) |
6,319 |
|
|
(7,516 |
) |
|
Total liabilities and stockholders’ equity
(deficit) |
$ |
8,823 |
|
|
$ |
4,700 |
|
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