Acerus Provides Business Update and Announces Third Quarter 2015 Financial Results

TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX: ASP) today provided a business update and reported its results for the three month period ended September 30, 2015. Unless otherwise noted, all amounts shown in this press release are in U.S. dollars.

Business Update

ESTRACE® Continued Double-Digit Growth

ESTRACE® experienced continued double-digit sales growth in third quarter 2015 as a result of various marketing and sales initiatives. In September, Acerus participated in the SIGMA Canadian Menopause Society Conference held in Toronto, Ontario, introducing the company to healthcare practitioners from across the country as a key player in the Women’s Health space.

NATESTO™ U.S. Update

Endo has informed Acerus of their intention to conduct a portfolio optimization process to realign their U.S. branded resources. Following the recent FDA approval of BELBUCA™, Endo intends to expand their pain sales force and reallocate resources to support its launch. This process is expected to lead to the de-prioritizing of select brands including NATESTO™. The company and Endo are working closely together to determine next steps and the implications on their partnership. Acerus will now delay the start of patient dosing for its NATESTO™ twice-daily study until the implications of this portfolio optimization process are fully known.

According to IMS data, NATESTO™ U.S. prescriptions increased by 62% in Q3 versus Q2 2015, reflecting an increase in market demand.

TEFINA™ Shift in Development Focus

In August, Acerus met with the FDA to solicit feedback on the clinical study program for TEFINA™, a ‘use as required’ nasal testosterone gel in development for Female Orgasmic Disorder (FOD). Based on this dialogue, it is apparent that Acerus could face several regulatory challenges on the path to FOD approval in the U.S.

The recent FDA approval of flibanserin in Hypoactive Sexual Desire Disorder (HSDD) has prompted Acerus to evaluate the development of TEFINA™ in HSDD. HSDD is a medical condition marked by a lack of sexual thoughts and desire for sexual activity, which causes women distress or puts a strain on their relationships with their partners. It is estimated that one in 10 women may have experienced HSDD at some point in their lives, and as such, HSDD represents a tremendous medical need. Previous studies have shown that testosterone can be effective in treating HSDD.

“While we continue to believe that TEFINA™ may provide a benefit to women suffering from FOD, the recent FDA approval of flibanserin in HSDD marks a significant development which cannot be overlooked,” said Tom Rossi, President and Chief Executive Officer of Acerus. “The regulatory path to approval in HSDD is now established, and the increased patient and physician awareness surrounding the disorder is expected to drastically improve study recruitment and implementation. By shifting our focus to developing a treatment for HSDD, our hope is to be able to offer a convenient, non-invasive, ‘on-demand’ option to the many women experiencing this medical condition.”

Financial Results for the Three Months Ended September 30, 2015

Revenue for third quarter 2015 totaled $2.8 million versus $1.7 million for third quarter 2014 and $2.7 million for second quarter 2015. Revenue for third quarter 2015 was derived from sales of ESTRACE® in Canada, sales of NATESTOTM to Endo at a base rate plus a revenue top-up on sales of NATESTOTM to Endo based on prescriptions filled in the U.S. in Q3 2015, and from the amortization of a $25 million upfront fee received under the NATESTOTM licensing agreement with Endo. Third quarter 2015 ESTRACE® revenue increased by 11% on a Canadian dollar basis over Q3 2014. Year-to-date NATESTOTM product revenue totals $1.1 million.

Research and Development (“R&D”) expenses totaled $0.7 million for third quarter 2015 versus $1.0 million for third quarter 2014. Third quarter 2015 YTD R&D expenses of $2.2 million are $5.7 million lower than third quarter 2014 YTD as the 2014 R&D expense included a $2.5 million milestone payment to Mattern Pharma as well as expenses related to the TEFINATM Phase II study completed in Q2 2014.

Selling, general and administrative expenses for third quarter 2015 were $1.4 million versus $3.8 million for the prior year period. This decrease is primarily due to costs related to the acquisition of the Canadian rights to ESTRACE® incurred in third quarter 2014 and totaling $2.3 million.

Earnings before interest, tax, depreciation and amortization (“EBITDA”) for third quarter 2015 were $1.3 million versus a loss of $3.4 million in third quarter 2014. The biggest drivers to this change were the ESTRACE® business acquisition costs incurred in 2014 and the increase in ESTRACE® sales in 2015. Adjusted EBITDA (see “Non-IFRS Financial Measures” below), was negative $0.3 million for third quarter 2015 versus negative $0.9 million for third quarter 2014. Basic and diluted EPS for third quarter 2015 was $0.01 compared to ($0.02) in third quarter 2014.

On September 30, 2015, the company had a cash balance of $25.2 million.

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.

Q3 2015 Financial Statements

Q3 2015 Management Discussion & Analysis (MD&A)

Conference Call

Shareholders are reminded of the conference call to discuss the company’s third quarter results to be held on Friday, November 6, 2015 at 8:30 a.m. Eastern Time. To access the call live, please dial 416-340-2219 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 Thursday, November 12, 2015 by dialing 905-694-9451 or 1-800-408-3053, using access code: 2619492#.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience.

Acerus markets ESTRACE® in Canada, a product indicated for the symptomatic relief of menopausal symptoms. NATESTO™, a product utilizing an Acerus licensed nasal gel technology, is the first and only testosterone nasal gel available in the United States for replacement therapy in adult males diagnosed with hypogonadism. It is also currently filed for approval in Canada. The commercial rights to NATESTO™ in the United States and Mexico have been licensed by Acerus to an affiliate of Endo International plc. TEFINA™, a ‘use as required’ nasal testosterone gel, is an Acerus drug development candidate aimed at addressing significant unmet need for women with female sexual dysfunction.

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 Q3 2015 MD&A.

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 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 4, 2015 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20151105005761/en/

Acerus Pharmaceuticals Corporation
Tiana DiMichele, 416-679-0822
Director, Marketing & Communications
[email protected]

Source: Acerus Pharmaceuticals Corporation

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