TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX: ASP) today reported its financial results for the three and nine-month period ended September 30, 2017. Unless otherwise noted, all amounts are in U.S. dollars.
The company continued to execute on its plan to expand global reach of Natesto® by signing a commercial partnership agreement with Eu Hwa Pte LTD for South East Asia on October 17, 2017.
“Due to strong Natesto® prescription growth in U.S. and our other international partners progressing towards market approval, we would expect to see acceleration of our Natesto® revenues going forward”, said Luc Mainville, Interim Chief Executive Officer of Acerus. “With 36% growth in product revenues in Q3 vs Q2 of 2017, increasing Natesto® prescriptions, and the anticipated launch of Gynoflor™ in 2018 if approved, we would expect to deliver product revenue growth in the coming quarters.”
Financial Results for the Three Months Ended September 30, 2017
Product revenue for Q3 2017 grew to $1.6 million versus $1.4 million for Q3 2016 mainly due to increased sales of Natesto®. Product revenues for the nine months ended September 30, 2017 and 2016 were $3.8 million and $5.5 million, respectively. While Estrace® accounted for the majority of the sales in the reported periods, Natesto® revenues is expected to contribute an increasing portion of the total revenues going forward.
Research and development ("R&D") expenses for the three and nine months ended September 30, 2017 were $0.4 million and $1.5 million, respectively, compared to R&D expenses for the three and nine months ended September 30, 2016 of $0.3 million and $1.2 million, respectively. R&D expenses were higher due to the New Drug Submission (“NDS”) fees for Gynoflor™ in Q1 2017.
Selling, general and administrative expenses (“SG&A”) were $1.8 million and $4.9 million for the three and nine months ended September 30, 2017. This compared to $1.4 million and $3.9 million for the three and nine-month periods in 2016, respectively. The increase in expenses are due to (i) cash and non-cash expenses related to recent additions to the management team and (ii) sales and marketing costs mostly associated with programs to drive sales of Natesto® in Canada.
Earnings before interest, tax, depreciation and amortization (“EBITDA”) were a loss of $2.0 million and a loss of $5.4 million for the three and nine-month periods ended September 30, 2017. This compared to a loss of $0.2 million and a loss of $2.9 million for the three and nine-month periods ended September 30, 2016 respectively. Adjusted EBITDA (see “Non-IFRS Financial Measures” below), were a loss of $0.6 million and a loss of $2.7 million for the three and nine months ended September 30, 2017 compared to $0.5 million and $0.1 million for the three and nine-month periods ending September 30, 2016, respectively.
On September 30, 2017, the Company had current assets of $7.3 million and $4.5 million in current liabilities.
Basic and diluted earnings per share were a loss of $0.01 and a loss of $0.03 for the three and nine-month periods ended September 30, 2017
NATESTO®
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 for Saudi Arabia, the United Arab Emirates and Egypt, 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, and Eu Hwa Pte LTD. for Thailand, Malaysia/Brunei, Singapore, Vietnam, Philippines, Hong Kong/Macau and one other small South East Asian country. The Corporation is currently pursuing additional commercial partnerships for Natesto® in other key markets.
ESTRACE®
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 September 30, 2017, Estrace® has
maintained 48% share of all prescriptions for oral estradiol across
Canada despite over 12 months of generic competition.
GYNOFLOR™
On February 28, 2017, the Corporation filed a NDS
with Health Canada to obtain marketing approval for Gynoflor™ in Canada.
If approved, Gynoflor™ 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,
the Company’s responding materials have been submitted, and a hearing
date for the appeal to the Divisional Court has been set for February
26, 2018.
Links
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.
2017
Q3 Financial Statements
2017
Q3 Management Discussion & Analysis (MD&A)
Conference Call
Shareholders are reminded of the conference
call to discuss the Company’s third quarter 2017 results to be held on
Tuesday, November 7, 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 Tuesday, November 14, 2017 by dialing 905-694-9451 or 1-800-408-3053, using access code:7324148#.
About Acerus
Acerus Pharmaceuticals Corporation is a
Canadian-based specialty pharmaceutical company focused on the
development, manufacture, marketing and distribution of innovative,
branded products that improve the patient experience, with a primary
focus in the field of men’s and women’s health. The Company
commercializes its products via its own salesforce in Canada, and
through a global network of licensed distributors in the US and other
territories.
Acerus currently has two marketed products: ESTRACE®, a product for the symptomatic relief of menopausal symptoms is commercialized in Canada; and NATESTO®, the first and only testosterone nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism, is commercialized in Canada and the United States. In addition, NATESTO® has been licensed for distribution in 29 countries worldwide. Marketing approvals in those other jurisdictions would be expected over the course of the coming years. Acerus’ pipeline includes two new innovative products: GYNOFLOR™, an ultra-low dose vaginal estrogen combined with a probiotic, for which a NDS has been filed in Canada for the treatment of atrophic vaginitis, restoration of vaginal flora and treatment of certain vaginal infections; and TEFINA™, a clinical stage product aimed at addressing a significant unmet need for women with female sexual dysfunction. Finally, the Company owns or has a license to numerous patents relating to proprietary delivery systems as well as novel formulations of products currently in the early stage of development.
Acerus’ shares trade on TSX under the symbol ASP. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.
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.
