Full Press Release Details
Aytu BioScience Provides Third Fiscal
Quarter 2016 Business Update
Live Conference Call and Webcast TODAY
Englewood, CO - May 11, 2016 - Aytu BioScience,
Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of
urology, provided today an overview of its business and growth strategy, as well as its financial results for the quarter ended
March 31, 2016. The Company will host a live conference call and webcast today at 4:30 p.m. ET.
Corporate Highlights:
Financial Highlights:
Josh Disbrow, Chief Executive Officer of Aytu BioScience, Inc.,
stated, "Within our first year in existence, Aytu has become a fully integrated, commercial-stage specialty pharmaceutical
company with a portfolio of FDA-approved urology products that are starting to generate early and encouraging revenue growth. We've
stayed true to our business model, which favors bringing in commercial or near commercial-ready urology-focused products rather
than costly and time-consuming R&D, and having reached a critical mass', we are poised to launch the company into
the next phase of our growth. Over the short term, we are carefully managing our continued commercial expansion to support our
newest and potentially largest product, Natesto, while ProstaScint and Primsol remain important value drivers as they grow into
expected substantial, sustainable lines of business. In parallel, MiOXSYS continues to generate initial sales outside the U.S.
and we now have a pathway forward with the FDA for potential clearance, representing additional upside to our current commercial
portfolio. With our recent financing, we are well capitalized to drive value creation over the coming quarters, primarily by anticipated
revenue growth along our multiple lines of business."
Acquiring U.S. commercial rights to Natesto (testosterone) Nasal
Gel from Acerus Pharmaceuticals positions Aytu to make a substantial impact within the $2 billion testosterone replacement therapy
market for men with hypogonadism (low testosterone, or "Low T"). Natesto's unique product profile confers significant
competitive advantages, both in terms of increased convenience for users and the fact that Natesto is the only topical testosterone
product on the market without a black box safety warning for the risk of testosterone transference. Aytu is currently scaling its
urology-centric sales force in preparation for a planned July 2016 product launch, and we will dedicate substantial commercial
resources to assertively convert prescriptions from current topical testosterone products and gain prescriptions from newly diagnosed
In March, Aytu established a study collaboration for its prostate-specific
diagnostic imaging agent ProstaScint for use with Hybridyne Imaging Technologies' high-resolution ProxiScan gamma
camera, which is small enough for trans-rectal prostate cancer diagnosis after the patient is injected with ProstaScint. A clinical
study is preparing to commence in Canada, where ProstaScint is also approved, and the Company expects to provide an update once
the study is underway. In addition, Aytu owns the global rights to ProstaScint and is in discussions with additional potential
partners outside the U.S.
In terms of commercialization, Aytu continues to re-engage historical
ProstaScint users, leveraging newer, published data related to ProstaScint's clinical performance, as well as work to expand
the use of ProstaScint to include high-risk, newly diagnosed patients. All of these factors contributed to the revenue growth compared
to the quarter ended December 31, 2015. Aytu continues to anticipate booking more than $1.5 million in revenue for this product
During the quarter, Aytu began marketing Primsol, the only FDA-approved
liquid oral formulation of trimethoprim, a gold standard antibiotic for treating uncomplicated urinary tract infections, or UTIs,
to urologists in the U.S. Initial revenue has started to grow and Aytu remains enthusiastic about the growth potential for this
product given its differentiated product profile and well characterized efficacy as a guideline-supported therapy for UTI.
To further augment the revenue opportunity for Primsol, in late
March, the Company secured a co-promotion agreement with Allegis Pharmaceuticals, a U.S.-based specialty pharmaceutical company
focused on pediatrics, to serve as Aytu's exclusive partner for marketing Primsol to pediatricians across the U.S. as a treatment
for acute otitis media, or middle ear infection, for which Primsol is an approved antibiotic therapy. This agreement enables Aytu
to additionally monetize Primsol in the form of a consistent and favorable royalty revenue stream through the life of this long-term
agreement, while allowing the Company to maintain its core urology focus.
In late March 2016, Aytu received approval from Health Canada
for MiOXSYS, the company's in vitro diagnostic device for male infertility, which in addition to receiving CE Marking
in Europe earlier this calendar year, represents the second major market approval for this product. Aytu continues to recognize
initial sales of MiOXSYS, mostly stemming from Europe and the Middle East, where the Company has partnered with influential thought
leaders in academia, urology and andrology to conduct studies showcasing the clinical utility of MiOXSYS. Aytu expects to establish
a distribution network to begin growing sales in territories where MiOXSYS is approved, as clinicians integrate MiOXSYS into their
routine assessments of male infertility status. The Company also expects to initiate the FDA process for MiOXSYS and is currently
finalizing a clinical study protocol in conjunction with the FDA to begin formalized studies under the FDA 510k de novo
Aytu recently completed an underwritten follow on equity offering
of its common stock and warrants for total gross proceeds of $7.5 million, net of expense $6.7 million. In addition to working
capital, the proceeds allow Aytu to grow its current sales force to support a successful launch of Natesto, as well as further
expand the Company's commercial infrastructure in real time as sales for ProstaScint and Primsol continue to ramp. Aytu also
expects proceeds to fund the remaining clinical development costs for MiOXSYS and enable anticipated FDA clearance for this product,
further expanding our commercial portfolio.
The Company reported revenue of $669,000 in the third fiscal
quarter 2016 (ended March 31, 2016), compared to $469,000 in the second fiscal quarter 2016 (ended December 31, 2015), representing
a 42% sequential increase. The Company ended its third fiscal quarter 2016 with $8.7 million in cash and cash equivalents, which
does not include the additional $6.7 million in net proceeds from the recently completed equity financing. This strong cash position
should enable the Company to continue scaling its sales infrastructure strategically and in direct proportion with growing sales
through fiscal 2017. In addition, proceeds from the recent financing are expected to cover the remaining development costs for
MiOXSYS along a potential FDA clearance pathway. Aytu also retired the remaining $1.05 million in debt principal from its September
2015 convertible debt offering, further strengthening its balance sheet.
Mr. Disbrow concluded, "Over the past 12 months, Aytu
has continued to execute successfully on our commercial strategy. We've shown consistent focus in bringing in high quality,
complementary assets to build our commercial pipeline, as well as secure partnerships and collaborations to add further value to
our products. Having laid this critical groundwork, we believe that we're now entering the next phase of our strategic growth
Conference Call Information:
Interested participants and investors may access the conference
call by dialing either:
The webcast will be accessible
live and archived on Aytu's website, www.aytubio.com, for 90 days.
A replay of the call will be available for seven days. Access
the replay by calling 1-877-344-7529 (U.S.) or 1-412-317-0088 (international) and using the replay access code 10085910.
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.
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine McCargo: jmccargo@tiberend.com; (646) 604-5150
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