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Aytu BioScience Provides Natesto(R) Commercial Update for the Quarter Ending December 31, 2018, Reports 27% Prescription Growth and Expansion of Natesto(R) Direct Program

January 10, 2019
Natesto Total Prescriptions Increased 27% and Refill Prescriptions Increased 52% SequentiallyENGLEWOOD, CO / ACCESSWIRE / January 10, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on global

Natesto Total Prescriptions Increased 27% and Refill Prescriptions Increased 52% Sequentially

ENGLEWOOD, CO / ACCESSWIRE / January 10, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, is providing an update on recent Natesto® commercialization activities following the close of the company’s fiscal 2019 second quarter ending December 31, 2018. During the second quarter, Natesto total prescriptions grew 27% sequentially from the quarter ending September 30, 2018.

Josh Disbrow, Aytu BioScience’s Chief Executive Officer, commented “We are pleased with the recent growth of Natesto, Aytu’s FDA-approved nasally-administered testosterone replacement therapy. During the quarter we demonstrated significant growth in Natesto prescriptions and have begun to realize the benefits of our recently implemented Natesto Direct patient support program.”

Mr. Disbrow added, “Total Natesto prescriptions and refill prescriptions through Natesto Direct have increased significantly from quarter to quarter. Through Natesto Direct, prescriptions are growing, and patients are gaining improved access to Natesto. This improved access and reimbursement is evidenced, in part, by the large increase in patient refills since last quarter.”

A primary source of prescription growth in the quarter has been the expanding adoption of Natesto Direct, through which Natesto refill prescriptions increased 52% sequentially. Additionally, the number of physicians submitting patients to Natesto Direct increased 33% over the same period. Further, commercial payors have continued to cover Natesto prescriptions submitted through Natesto Direct with one large, notable pharmacy benefit manager fully covering approximately 65% of Natesto prescriptions – with these patients eligible to receive $0 co-payments.

The company anticipates providing additional updates as Natesto commercialization efforts continue and Natesto Direct expands. The company expects to report complete financial and operational results for Q2 fiscal 2019 in early February.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu recently acquired exclusive U.S. commercial rights to Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. 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 of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning 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 products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

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, 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: risks relating to gaining market acceptance of our products, including Tuzistra XR, obtaining reimbursement by third-party payors, 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, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ″Risk Factors″ in Part I, Item 1A of the Company’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.

Contact for Investors:

James Carbonara

Hayden IR

(646)-755-7412

SOURCE: Aytu BioScience, Inc.

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