Englewood, CO – May 18, 2016 – Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today provided an update on the strategic steps it has taken to expand and optimize its commercial infrastructure in support of the planned July 2016 launch of the Company’s newest product Natesto® into the $2 billion U.S. testosterone replacement therapy (“TRT”) market, and to enhance the commercial efforts for Aytu’s currently marketed products ProstaScint® and Primsol®.
Among the key changes, Jonathan McGrael was appointed to the newly created role of Vice President of Commercial Operations. Mr. McGrael previously held the title of Vice President of Sales at Aytu, and the new title reflects the expansion of his role to include sales, marketing, sales training, payor relations, distribution, and sales operations. He will lead Aytu’s commercialization effort with the support of an expanded team of senior sales and marketing managers and a substantially expanded specialty sales force focused on growing Aytu’s products in the U.S.
Further expansion of the commercial infrastructure includes the recent hiring of a team of seasoned pharmaceutical sales managers—all of whom have extensive experience in the pharmaceutical industry and strong histories of top sales management performance—to build, train, and lead Aytu’s expanding U.S. specialty sales force. Aytu has also hired director-level marketing and specialty distribution managers to lead many aspects of brand management, brand strategy, payor reimbursement, and product distribution across the U.S., with a distinct focus on launching Natesto. With the expanded sales and marketing leadership team now in place, the company will initiate the hiring of a nationwide sales force designed to strategically align to the highest TRT targets across the country, prioritizing urology and TRT-prescribing specialists. The sales force will also align to ProstaScint customers and the leading prostate cancer centers – through a strategic focus on key ProstaScint accounts.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, Inc., stated, “We are moving aggressively toward a launch of Natesto in late July 2016, following the June 30, 2016, expiration of Acerus’ existing U.S. commercial agreement with Endo International. We intend to launch with a fully scaled sales force covering all major metropolitan areas, which represents more than 5,000 of the highest prescribing TRT targets. The current U.S. TRT market generates $2 billion in annual sales, with a focused group of approximately 1,200 of the top TRT-prescribing urologists accounting for more than 430,000 TRT prescriptions annually. We believe we are poised to capture substantial potential revenue, based on what we deem to be a clear opportunity to make a direct impact on high prescribers with a strategically focused and efficient sales effort. We intend this expansion of our professional commercial organization to also bolster U.S. commercial support for our other FDA-approved products ProstaScint and Primsol that are already gaining traction with 42% revenue growth over the last two quarters.”
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. The company currently markets two products: ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate cancer, and Primsol® (trimethoprim hydrochloride), the only FDA-approved trimethoprim-only oral solution for urinary tract infections. Aytu recently acquired exclusive U.S. rights to Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”), which the company plans to launch in July 2016. Additionally, Aytu is developing MiOXSYS™, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared product, and Aytu is conducting U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating urology products, leveraging its focused commercial team and expertise to build leading brands within well-established markets.
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Forward Looking Statement
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as “may,” “will,” “should,” “forecast,” “could,” “expect,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, our anticipated future cash position and future events under our current and potential future collaborations. We also refer you to the risks described in “Risk Factors” in Part I, Item 1A of Aytu BioScience, Inc.’s Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.