- Total Q2 revenues of $1.4 million
- Product revenue increased by 18% vs Q1 2017
- 2 New Licensing agreements executed for Natesto® covering 18 countries
TORONTO–(BUSINESS WIRE)–Acerus Pharmaceuticals Corporation (TSX: ASP) today reported its
financial results for the three and six-month period ended June 30,
2017. Unless otherwise noted, all amounts are in U.S. dollars.
In addition to the licensing transaction with Hyundai Pharm Co., which
closed in Q4 2016, the company has entered into two new Natesto® commercial
partnerships with Therios Health Care (“Therios”) for Saudi Arabia, the
United Arab Emirates and Egypt, and with medac Gesellschaft fur
klinische Spezialpraparate mbH (“medac”) for Germany, United Kingdom,
France, Italy, Czech Republic, Slovakia, Spain, Sweden, Finland,
Denmark, Norway, Poland, Austria, Netherlands, and Belgium.
“During the last quarter, we continued to execute on our plan to expand
Natesto®’s global reach by signing commercial partnerships in
key markets”, said Tom Rossi, President and Chief Executive Officer of
Acerus. “We have experienced a 14% growth in revenues in Q2 vs Q1 of
2017 and, with the Canadian launch of Natesto® off to a
strong start, prescriptions in the U.S. achieving new weekly highs, as
well as the anticipated launch of GynoflorTM in 2018, we are
now well positioned to drive further revenue growth in the coming
Financial Results for the Three Months Ended June
Product revenue for Q2 2017 increased 18% to $1.2 million from $1.0
million in Q1 and was lower compared to $2.1 million for the same prior
year period due to third party generic competition for Estrace®.
Product revenues for the six months ended June 30, 2017 and 2016 were
$2.2 million and $4.1 million respectively with Estrace®
accounting for the bulk of the sales.
Research and development (“R&D”) expenses for the three and six months
ended June 30, 2017 were $0.4 million and $1.1 million, respectively,
compared to R&D expenses for the three and six months ended June 30,
2016 of $0.7 million and $0.9 million, respectively. R&D expenses were
higher due to the New Drug Submission (“NDS”) fees for Gynoflor™ in Q1
Selling, general and administrative expenses (“SG&A”) were $1.5 million
and $3.1 million for the three and six months ended June 30, 2017. This
compared to $1.5 million and $2.4 million for the three and six month
periods in 2016 respectively. The increase in expenses are due to (i)
higher salary, benefits and stock based compensation expenses due to
recent additions to the management team and (ii) sales and marketing
costs mostly associated with programs to drive sales of Natesto®
Earnings before interest, tax, depreciation and amortization (“EBITDA”)
were a loss of $1.6 million and a loss of $3.4 million for the three and
six month periods ended June 30, 2017. This compared to a loss of $1.1
million and a loss of $2.6 million for the three and six month periods
ended June 30, 2016 respectively. Adjusted EBITDA (see “Non-IFRS
Financial Measures” below), were a loss of $0.7 million and a loss of
$2.1 million for the three and six months ended June 30, 2017 compared
to $0.1 million and $0.4 million for the three and six-month periods
ending June 30, 2016, respectively.
On June 30, 2017, the Company had current assets of $7.3 million and
$4.1 million in current liabilities.
Basic and diluted earnings per share were a loss of $0.01 and a loss of
$0.02 for the three and six months periods ended June 30, 2017
Natesto® is a nasal gel formulation of testosterone developed
by Acerus Pharmaceutical Corporation and indicated as a replacement
therapy for men diagnosed with conditions associated with a deficiency
or absence of endogenous testosterone (hypogonadism). It is the first
and only nasally-administered testosterone product approved by the U.S.
FDA and Health Canada and available in a ‘no-touch’ dispenser with a
metered dose pump. A copy of the Natesto® Canadian product
monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO®/default.aspx.
For further information, specific to the U.S. product dosing and
administration, please visit: www.NATESTO®.com.
On April 5, 2017, the Company announced that Hyundai Pharm Co., Ltd
filed an application for the marketing approval of Natesto® with
the Ministry of Food and Drug Safety (MFDS) in South Korea. Hyundai
Pharm acquired an exclusive license to market NATESTO® in
South Korea from Acerus in December 2016.
In addition to the transaction with Hyundai Pharm Co., which closed in
Q4 2016, the company continued its global expansion for Natesto®
by concluding partnerships with, Therios Health Care (“Therios”) for
Saudi Arabia, the United Arab Emirates and Egypt, and with medac
Gesellschaft fur klinische Spezialpraparate mbH for Germany, United
Kingdom, France, Italy, Czech Republic, Slovakia, Spain, Sweden,
Finland, Denmark, Norway, Poland, Austria, Netherlands, and Belgium. The
Corporation is currently pursuing additional commercial partnerships for
Natesto® in other key markets.
On November 16, 2015, Health Canada granted a Notice of Compliance (NOC)
for a third party generic version of Estrace®. The generic is
now commercially available in Canada with public reimbursement across
major provinces as of July 2016. As of June 2017, Estrace® has
maintained 46% share of all prescriptions for oral estradiol across
Canada despite 12 months of generic competition.
On February 28, 2017, the Corporation filed a New Drug Submission
(“NDS”) with Health Canada to obtain marketing approval for GynoflorTM
in Canada. If approved, GynoflorTM will be the first
combination product on the Canadian market to contain both an estrogen
(estriol) and a probiotic (lactobacillus) which may be used for the
treatment of symptoms of vaginal atrophy, for the restoration of vaginal
flora following the use of anti-infectives and for the treatment of mild
vaginal infections. Gynoflor™ is approved in 41 countries across Europe,
Asia-Pacific, the Middle East, Africa and South America, and it is
estimated that up to 32.7 million women worldwide have been treated with
the product to date.
Update on Litigation Initiated by Mr. Eugene Melnyk
On December 21, 2016, the Honourable Mr. Justice Wilton-Siegel of
the Ontario Superior Court of Justice heard a motion brought by
Mr. Eugene Melnyk for leave to commence a derivative action in the name
of the Company against certain of the Company’s directors and officers.
The motion was dismissed by Mr. Justice Wilton-Siegel with written
reasons to follow. On February 22, 2017, Justice Wilton-Siegel issued
his written reasons dismissing Mr. Melnyk’s claim with costs. On April
6, 2017, Mr. Eugene Melnyk served a Notice of Appeal to the Divisional
Court of the Ontario Superior Court of Justice in order to appeal the
decision of Justice Wilton-Siegel. Mr. Melnyk has perfected the appeal
and the Company’s responding materials are due by the end of August. A
hearing date for the appeal to the Divisional Court has not yet been set.
The above information is in summary form and readers are encouraged to
consult the documents noted below for further details at the links
indicated or on SEDAR at www.sedar.com.
Shareholders are reminded of the conference call to discuss the
Company’s second quarter 2017 results to be held on Friday, August 11,
2017 at 8:30 a.m. Eastern Time. To access the call live, please dial
416-340-2216 or 1-866-225-2055. Listeners are encouraged to dial in 10
minutes before the call begins to avoid delays.
A replay of the conference call will be available until 11:59 p.m.
Eastern Time on Friday, August 18, 2017 by dialing 905-694-9451 or
1-800-408-3053, using access code: 8897095#.
Acerus Pharmaceuticals Corporation is a fully- integrated, Canadian
specialty pharmaceutical company engaged in the development,
manufacture, marketing and distribution of innovative, branded products
in Men’s and Women’s Health. Acerus’ shares trade on TSX under the
symbol ASP. For more information, visit www.aceruspharma.com
and follow us on Twitter
Non-IFRS Financial Measures
The non-IFRS measures included in this press release are not recognized
measures under IFRS and do not have a standardized meaning prescribed by
IFRS and may not be comparable to similar measures presented by other
issuers. When used, these measures are defined in such terms as to allow
the reconciliation to the closest IFRS measure. These measures are
provided as additional information to complement those IFRS measures by
providing further understanding of our results of operations from our
perspective. Accordingly, they should not be considered in isolation nor
as a substitute for analysis of our financial information reported under
IFRS. Despite the importance of these measures to management in goal
setting and performance measurement, we stress that these are non-IFRS
measures that may have limits in their usefulness to investors.
We use non-IFRS measures, such as EBITDA and Adjusted EBITDA to provide
investors with a supplemental measure of our operating performance and
thus highlight trends in our core business that may not otherwise be
apparent when relying solely on IFRS financial measures. We also believe
that securities analysts, investors and other interested parties
frequently use non-IFRS measures in the valuation of issuers. We also
use non-IFRS measures in order to facilitate operating performance
comparisons from period to period, prepare annual operating budgets, and
to assess our ability to meet our future debt service, capital
expenditure and working capital requirements.
The definition and reconciliation of EBITDA and Adjusted EBITDA used and
presented by the Company to the most directly comparable IFRS measures
refer to the section “Non-IFRS Financial Measures” in our 2016 Annual
MD&A available on SEDAR at www.sedar.com.
Notice Regarding Forward-Looking Statements
Information in this press release that is not current or historical
factual information may constitute forward looking information within
the meaning of securities laws. Implicit in this information are
assumptions regarding our future operational results. These assumptions,
although considered reasonable by the company at the time of
preparation, may prove to be incorrect. Readers are cautioned that
actual performance of the company is subject to a number of risks and
uncertainties, including with respect to the ability of Acerus to obtain
regulatory approval for GYNOFLOR™, and could differ materially from what
is currently expected as set out above. For more exhaustive information
on these risks and uncertainties you should refer to our annual
information form dated March 7, 2017 which is available at www.sedar.com.
Forward-looking information contained in this press release is based on
our current estimates, expectations and projections, which we believe
are reasonable as of the current date. You should not place undue
importance on forward-looking information and should not rely upon this
information as of any other date. While we may elect to, we are under no
obligation and do not undertake to update this information at any
particular time, whether as a result of new information, future events
or otherwise, except as required by applicable securities law.
Acerus Pharmaceuticals Corporation
Tricia Symmes, 289-327-1499