Apricus Biosciences Provides Corporate Update and Second Quarter 2017 Financial Results
August 02 2017 - 3:01PM
Vitaros Drug-Device Human Factor Studies
Successfully Completed
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical
company advancing innovative medicines in urology and rheumatology,
today reported financial results for the second quarter of 2017 and
provided a corporate update on its priorities for the remainder of
the year.
“In the second quarter of this year, we continued
to execute on our strategy by creating a stable, financially
healthier organization focused on resubmission of the Vitaros NDA,”
stated Richard W. Pascoe, Chief Executive Officer. “We have
improved our financial outlook through a combination of fundraising
and expense reduction, resulting in a balance sheet that is
expected to fund our current operating plan through the third
quarter of 2018. Importantly, we have completed the final
draft of the Vitaros NDA and we expect to re-submit the Vitaros NDA
this quarter with an anticipated FDA approval decision in the first
quarter of 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)
- Continued implementation of the U.S. regulatory approval
strategy to address issues raised by the FDA in the original
Vitaros NDA submission. Specifically, all safety, chemistry,
manufacturing and control (CMC) related issues raised in the
original Non-Approvable Letter will be addressed in the
re-submission. In addition, Apricus has confirmed the
necessary drug-device engineering and compliance requirements,
including human factor testing, and those studies are now complete;
and
- Continued to ensure a smooth transition of the Vitaros ex-US
rights and assets to Ferring International. Under the
agreement, Apricus has received approximately $12.45 million to
date, including an upfront payment of $11.5 million, approximately
$0.7 million for the delivery of certain product-related inventory
and $0.25 million related to transition services. Apricus is
eligible to receive an additional $0.25 million payment related to
transition services, subject to certain limitations, 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 on an underwritten public offering of common stock and
warrants for gross proceeds of approximately $7.0 million; and
- Regained compliance with all criteria for continued listing on
The NASDAQ Capital Market.
Second Quarter and Year-to-Date Financial
Results
Net loss for the quarter ended June 30, 2017
was $1.5 million, or loss per share of $0.13, compared to a net
loss of $3.3 million, or loss per share of $0.54, for the second
quarter of 2016. Net loss during the second quarter of 2017 was
primarily due to expenses related to the preparation of our
resubmission of the Vitaros NDA and other general and
administrative expenses.
Net income for the six months ended June 30,
2017 was $6.6 million, or income per share of $0.69, compared to a
net loss of $5.8 million, or loss per share of $1.00, for the
second quarter of 2016. Net income during the six months ended June
30, 2017 was primarily due to the $12.1 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 June 30, 2017, the
Company’s cash totaled $7.8 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 58725002. 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: Apricus’
ability to transition its ex-U.S. assets and rights related to
Vitaros to Ferring and receive the second transition services
payment from Ferring; the timing of regulatory submission and
approval of Vitaros in the United States, if any; Apricus’
development and partnering plans for RayVa; Apricus’ plans to
reduce operating expenses, including projected 2017 cost savings;
and Apricus’ 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: 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 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; 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; 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 |
Condensed Consolidated Statements of
Operations |
(In thousands, except per share
amounts) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating expense |
|
|
|
|
|
|
|
Research
and development |
$ |
(839 |
) |
|
$ |
(2,503 |
) |
|
$ |
(1,266 |
) |
|
$ |
(5,104 |
) |
General
and administrative |
(1,602 |
) |
|
(2,122 |
) |
|
(3,043 |
) |
|
(4,328 |
) |
Total
other income (expense) |
719 |
|
|
1,372 |
|
|
(832 |
) |
|
3,684 |
|
Loss from
continuing operations |
(1,722 |
) |
|
(3,253 |
) |
|
(5,141 |
) |
|
(5,748 |
) |
Income
(loss) from discontinued operations |
248 |
|
|
(85 |
) |
|
11,740 |
|
|
(95 |
) |
Net income (loss) |
$ |
(1,474 |
) |
|
$ |
(3,338 |
) |
|
$ |
6,599 |
|
|
$ |
(5,843 |
) |
|
|
|
|
|
|
|
|
Basic and diluted
earnings (loss) per share |
|
|
|
|
|
|
|
Continuing operations |
$ |
(0.15 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.98 |
) |
Discontinued operations |
$ |
0.02 |
|
|
$ |
(0.01 |
) |
|
$ |
1.23 |
|
|
$ |
(0.02 |
) |
Total
earnings (loss) per share |
$ |
(0.13 |
) |
|
$ |
(0.54 |
) |
|
$ |
0.69 |
|
|
$ |
(1.00 |
) |
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding for basic and diluted earnings
(loss) per share |
11,335 |
|
|
6,182 |
|
|
9,547 |
|
|
5,843 |
|
Condensed Consolidated Balance
Sheets |
(In thousands) |
|
|
June 30, 2017 |
|
December 31, 2016 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash |
$ |
7,821 |
|
|
$ |
2,087 |
|
Other current
assets |
322 |
|
|
177 |
|
Property and equipment,
net |
121 |
|
|
164 |
|
Other long term
assets |
45 |
|
|
60 |
|
Assets of discontinued
operations |
$ |
506 |
|
|
$ |
2,212 |
|
Total assets |
$ |
8,815 |
|
|
$ |
4,700 |
|
|
|
|
|
Liabilities and
stockholders’ equity (deficit) |
|
|
|
Current
liabilities |
$ |
1,513 |
|
|
$ |
2,536 |
|
Current liabilities of
discontinued operations |
331 |
|
|
2,108 |
|
Notes payable, net |
— |
|
|
6,650 |
|
Warrant
liabilities |
339 |
|
|
846 |
|
Other long term
liabilities |
60 |
|
|
76 |
|
Stockholders’ equity
(deficit) |
6,572 |
|
|
(7,516 |
) |
Total liabilities and stockholders’ equity
(deficit) |
$ |
8,815 |
|
|
$ |
4,700 |
|
CONTACT:
Matthew Beck
mbeck@troutgroup.com
The Trout Group
(646) 378-2933
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