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Acerus Reports Third Quarter 2017 Financial ResultsAcerus 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 (News - Alert)") 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® 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 Thaiand, 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®
GYNOFLOR™
Update on Litigation Initiated by Mr. Eugene Melnyk
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Q3 Financial Statements
Conference Call 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 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 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
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