Acerus Reports First Quarter 2016 Results and Provides Business Update

• Total revenues of $10.4 million
• Adjusted EBITDA of $0.3 million
• Strong ESTRACE® sales growth of 15%
• In-licensed GYNOFLOR™ for Canada
• New U.S. partner announced for NATESTO™

TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX: ASP) today reported its financial results for the three month period ended March 31, 2016 and provided a business update. Unless otherwise noted, all amounts are in U.S. dollars.

“The last few months have been extremely productive for Acerus as we continue to deliver on our corporate objectives,” said Tom Rossi, President and Chief Executive Officer of Acerus. “We reported positive adjusted EBITDA, this result primarily driven by strong ESTRACE® sales as well as sound expense management. We are also very pleased to have secured Aytu BioScience as our new U.S. partner for NATESTO™, and to have acquired the Canadian rights to GYNOFLOR™.”

Financial Results for the Three Months Ended March 31, 2016

Revenues for first quarter 2016 totalled $10.4 million (compared to $3.2 million for first quarter 2015), of which $8.5 million represents licensing revenue related to the accelerated amortization of upfront fees received under the existing NATESTOTM licensing agreement. Current period ESTRACE® product revenues increased by 15 per cent over the prior year comparable period reaching $1.9 million (CDN$2.5 million).

Research and Development (“R&D”) expenses totalled $0.5 million for first quarter 2016 compared to $0.8 million for first quarter 2015. The lower expenses reflect product development and professional fee spending reductions in the current period and NATESTOTM manufacturing process costs incurred in first quarter 2015.

Selling, general and administrative expenses (“SG&A”) for first quarter 2016 were $1.0 million compared to $1.4 million for first quarter 2015. The variance is mainly due to decreases in salaries, benefits, share based compensation and an overall effort to minimize overhead costs.

Earnings before interest, tax, depreciation and amortization (“EBITDA”) for first quarter 2016 was a loss of $1.5 million compared to a profit of $0.9 million in first quarter 2015. A large driver of this change was a foreign exchange loss of $1.7 million incurred in the current period compared to a foreign exchange gain of $2.1 million in the same period in 2015, offset by an overall decrease in expenses incurred in the first quarter 2016. Adjusted EBITDA (see “Non-IFRS Financial Measures” below), was $0.3 million for first quarter 2016 compared to negative $0.2 million for first quarter 2015. Basic and diluted EPS for first quarter 2016 was $0.03 compared to $0.00 in first quarter 2015.

NATESTO™ Update

On April 25, 2016, Acerus announced the signing of an agreement providing Aytu BioScience, Inc. with the exclusive rights to market NATESTO™ in the United States, following the return of the product to Acerus from Endo in June of this year. The agreement provides Acerus with a non-refundable upfront fee of $8.0 million, of which $2.0 million was paid at signing, and the remaining $6.0 million payable in September 2016 and January 2017. Additionally, the company is eligible to receive payments of up to $37.5 million based on the achievement of certain sales milestones. Acerus will continue to oversee the manufacturing of NATESTO™ and receive a tiered supply price for the product. Over the next few months, Acerus will work closely with Aytu to ensure a quick and smooth transition of NATESTO™ from Endo.

In Canada, Acerus is ramping up to launch NATESTO™ in the third quarter of 2016. The company is also exploring multiple out-licensing opportunities for the product in countries outside North America.

ESTRACE® Continues to Outperform

In the first quarter of 2016, ESTRACE® outperformed the market by a significant margin and achieved 15 per cent sales growth over first quarter 2015. This year over year growth was primarily driven by volume gains of 11 per cent.

As of the date of this release, no generic version of the brand has yet launched in Canada.

GYNOFLOR™ In-licensing

On April 18, 2016, Acerus announced a license and supply agreement with Medinova AG, a Swiss pharmaceutical company, granting Acerus the exclusive rights to commercialize GYNOFLOR™ in Canada. GYNOFLOR™ is an ultra-low dose estrogen (estriol) and lactobacillus combination vaginal tablet used for the treatment of atrophic vaginitis due to estrogen deficiency during menopause, for the restoration of vaginal flora following the use of anti-infectives and for the treatment of certain vaginal infections. Currently, there are no approved products in Canada containing estriol, or the unique combination of estrogen and lactobacillus.

GYNOFLOR™ is approved in 39 countries across Europe, Asia-Pacific, the Middle East, Africa and South America. It was first approved in Germany in 1982 and it is estimated that up to 28 million women worldwide have been treated with the product to date. Acerus plans to consult with Health Canada over the coming months to discuss the regulatory filing.

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.

Q1 2016 Financial Statements

Q1 2016 Management Discussion & Analysis (MD&A)

Conference Call

Shareholders are reminded of the conference call to discuss the company’s first quarter 2016 results to be held on Wednesday, May 4, 2016 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 Wednesday, May 11, 2016 by dialing 905-694-9451 or 1-800-408-3053, using access code: 8416341#.

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 approved in Canada, and available in the United States for replacement therapy in adult males diagnosed with hypogonadism. GYNOFLOR™, a product licensed to Acerus in Canada by Medinova AG and approved in 39 countries worldwide, is an ultra-low dose vaginal estrogen therapy with the addition of lactobacillus, for the treatment of atrophic vaginitis, certain vaginal infections and/or to restore a healthy vaginal environment. TEFINA™, a ‘use as required’ nasal testosterone gel, is an Acerus drug development candidate aimed at addressing a 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 2015 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, 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 1, 2016 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/20160504005524/en/

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

Source: Acerus Pharmaceuticals Corporation

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• BILL posts stronger Q4 revenue, profit growth but sees slower fiscal 2027
• NexPoint Residential Trust (NXRT) Reiterated at Market Perform by Citizens Post Guidance Cut
• Coty (COTY) Misses Q4 EPS by 1c, offers outlook