Aytu BioScience
Corporate Overview | April 2015
Safe Harbor Statement
This presentation 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. Such forward-looking
statements include, without limitation, statements regarding 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 collaborations. These forward-looking statements are subject to a number of risks, uncertainties and
assumptions, including without limitation to the risks described in “Risk Factors” in Part I, Item 1A of Rosewind
Corporation 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. These risks are not exhaustive. Other sections of Rosewind Corporation
Annual Report on Form 10-K and such other filed reports and documents include additional factors that could
adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly
changing environment. New risk factors emerge from time to time and it is not possible for our management to
predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor,
or combination of factors, may cause actual results to differ materially from those contained in any forward-looking
statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure
you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and
actual results could differ materially from those projected in the forward looking statements. We assume no
obligation to update or supplement forward-looking statements.
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Corporate Highlights
Expanding Pipeline of Novel Therapies
Pivotal Trial of Lead Candidate: Zertane™
Established Global Commercial Agreements
Proprietary Commercial Diagnostic: RedoxSYS®
Strong IP & Entrepreneurial Management
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Product Development & Commercial Strategy
Build a leading pipeline of therapeutic and diagnostic assets for redox-
modulated conditions, with an initial focus on the $10BN urology market
Core Urology Focus
Sexual Health
• Premature
ejaculation
• Erectile
dysfunction
• Female sexual
disorder
Redoxmodulated
conditions
• Urological
cancers
• Infertility
diagnostics
• Erectile
dysfunction
Adjacent Areas
Urology Conditions
• Prostate, BPH
• Urinary tract
infection
• Incontinence,
Bladder
• Urological
diagnostics
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Corporate Structure
Therapeutics Development
& Commercialization
•
•
Diagnostics Development &
Commercialization
Seeking late-stage or commercial
therapeutics, devices, and diagnostics
related to urological disorders (initially)
•
Lead Candidate:
•
•
•
First-in-class, near commercial-stage
treatment for premature ejaculation
Establishing commercial agreements
in global territories
•
Proprietary, commercial-stage redox
diagnostic research tool
Focused on research use to build pipeline
of clinical applications
Developing clinical applications in
infertility in line with Aytu’s urology focus
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Zertane™ (Tramadol ODT)
Lead Therapeutic Candidate
• First-in-class therapy nearing commercial-stage
for treating premature ejaculation (PE)
• Currently preparing to initiate pivotal U.S.
clinical study
• Approval pathway is significantly de-risked
• Success in two European Phase 3, two Phase
2, and two Phase 1 trials
• 505(b)(2) path reduces costs and time to
market
• Prepared for the global market
• Commercial agreements in place for
Canada, South Korea, and Latin America
• Management team built and launched
commercial teams at specialty pharma
companies
Orally Dissolving Tablet
Improved oral formulation of a
widely known and safe drug
(tramadol hydrochloride) that is
proven to treat premature
ejaculation
Phase 3
Phase 2
Pivotal
Study
Phase 1
Preclinical
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PE Market Opportunity
Attractive Competitive Landscape
• Widely observed male sexual
dysfunction with estimated prevalence
between 2% and 23%1,2
• Currently no FDA-approved in the US
• Traditional remedies have limited
effectiveness
• Expected to reach >$1.3B in sales in
2015
– An increase of >10% since 2010
Global Urological Disorders
$10B
Market by 2017
Premature Ejaculation
>$1.3B
Market by 2015
• Market research suggests an oral, asneeded formulation is in demand
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Significant Medical Need
High Clinical Demand: PE Survey
•
•
•
•
Urologists report having a product
indicated for PE would double the
number of patients seeking treatment
80% report that Zertane would
completely replace their current PE
treatment
~15% of patients surveyed are unable to
engage in sexual activity because of PE
Majority of PE patients report that there
is no effective treatment for their PE
–
75% felt they would increase sexual activity with
an effective therapy
Treatment
Shortfall
Relationship
Therapy/Counseling
Time consuming, costly,
ineffective, stressful
Topical (OTC)
Messy, may cause numbing, skin
irritation
Oral Therapeutics
(SSRIs)
Significant side effects, including
diminished libido, ED, nausea,
among others
Tricyclic
antidepressants
Fatigue, nausea, dizziness, dry
mouth, hypotension
PDE-5 Inhibitors
Ineffective, may cause
headache, flushing, nausea
(Source – Campbell Alliance)
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Compelling Body of Clinical Evidence
Zertane Successfully Evaluated in
Phase 1
Phase 2
Phase 3
Pivotal Study
2
2
2 (Europe)
Preparing to initiate in U.S.
Phase 3 Studies
• Randomized, blinded, placebo-controlled, in a total of 677 PE patients showed strong
efficacy at optimal dose of Zertane
• When taken as needed between 2 and 8 hours before a sexual event
• Success based on co-primary endpoints: IELT and PEP/POPE
Phase 2 Studies
• Randomized, blinded, placebo-controlled, in a total of 102 PE patients showed a clear
dose response for efficacy in terms of IELT
IELT = prolonged time to ejaculation
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Phase 3 Clinical Trials Indicate Improved
Patient Control and Satisfaction
Satisfaction with intercourse
(mean change)
1.2
p < 0.001
1
1.06
Significant Improvement
• Control over ejaculation
0.8
• Ejaculation-related distress
0.6
• Ejaculation-related
interpersonal difficulty
0.4
0.4
0.2
0
Placebo
89 mg tramadol ODT
(Source – European Urology 2012)
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Demonstrated Improved IELT in Phase 3
Fold Increase in IELT versus
Baseline
IELT Change versus Baseline
3
7
Minutes
2.5
2.59
2
p < 0.01
6
6
5
1.91
4
1.5
p < 0.01
3.17
3
1
2
0.5
0.6
0.6
1
0
0
Baseline IELT
Placebo
Treatment
89 mg tramadol ODT
Treatment
Placebo
89 mg tramadol ODT
NOTE: Only reflects patients with baseline IELT of <1 minute
(Source – European Urology 2012)
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Prepared for Global Commercialization
Upon potential FDA approval, Aytu expects
to commercialize Zertane in the U.S.
Partnerships in place for South Korea and Brazil
Exclusive Rights to
•
•
•
Canada
South Africa and certain other
countries in sub-Saharan Africa
Columbia and Latin America
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Strong Intellectual Property Portfolio
• Zertane has patent protection in the U.S. and several
other large markets worldwide
• Use of tramadol hydrochloride to treat PE through 2022
• Combination of Zertane and PDE-5 inhibitors through 2028
• International patents covering Zertane-ED to treat comorbid PE
and ED and patents pending in the US
• As of December 31, 2014:
•
•
•
•
One issued U.S patent
Six U.S. pending patent applications
72 issued international patents
13 pending international patent applications
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Zertane Opportunity Summary
Significant Completed Milestones
 Completed two positive European Phase 3 clinical studies
 Received FDA guidance with confirmatory meeting to be held
 Completed qualitative validation of POPE
• IND near completion; protocol finalized pending pre-IND meeting outcome
• 21 Phase 3 sites confirmed




Developed worldwide patent portfolio
Established Scientific Advisory Board
Conducted U.S. market and pricing studies demonstrating commercial potential
Secured international partnerships to support worldwide patient exposure
(S. Korea, Brazil, Canada/South Africa with others in discussions)
 Established 10-year supply agreement with Ethypharm
 Manufactured clinical trial supplies
 Developed CMC module
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Infertility & Oxidative Stress
•
Urological conditions, particularly infertility and
erectile dysfunction, are shown to be correlated
with high oxidative stress levels
•
Oxidative stress: imbalance between oxidants
and the body’s ability to neutralize these
oxidants – often impacting semen quality and
function
•
Measurement of oxidative stress in real time
enables rapid assessment and monitoring of
components of infertility including sperm DNA
damage, semen function, and semen quality to
provide a comprehensive picture of infertility
and provide guidance on interventions and
lifestyle changes to improve outcomes
“Oxidative stress (OS) is a result
of the imbalance between
reactive oxygen species (ROS)
and antioxidants in the body,
which can lead to sperm
damage, deformity and
eventually male infertility. This
involves peroxidative damage to
sperm membrane and DNA
fragmentation at both nuclear
and mitochondrial levels. OS has
been implicated as the major
etiological factor leading to
sperm DNA damage.”
Agrawal A, Makker K, Sharma R. Clinical
relevance of oxidative stress in male
factor infertility: an update. Am J Reprod
Immunol 2008 Jan; 59(1):2-11.
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RedoxSYS®: Developed & Market-Ready
•
First-in-class, market-ready product
–
–
–
–
•
Significant market opportunity in detection of oxidative stress in male infertility
CE Marked (2014); Health Canada approved (2014)
U.S. clinical pathway is short and well defined
Clinical research underway with major US academic center in infertility
Technical development complete following two decades of R&D
– Completed product development with CE Mark
– Received ISO 13485 certification with CMDCAS
– First patents issued in 2012; 6 US patents issued, multiple ex-US patents
•
Razor-razorblade commercial model
– Inexpensive analyzer / high-value, disposable sensors
– Early research revenues from pharma and academic collaborators
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RedoxSYS Market Development Highlights
Commercial Development
 Partnered with UK-based market development
company
–
Rapid development of relationships with key institutions
 Engaged with diagnostics executives
–
Former Managing Director of Genzyme Diagnostics, Europe
(Germany)
–
Former Founder and CSO of Lab21 (UK)
 Engaged with KOLs in ORP research
–
Prominent infertility experts in both US and Australia
–
Strong interest in incorporating ORP into research
–
Numerous peer-reviewed publications planned
 Engaged confidentially with strategic partners
–
Multiple region-specific distributors engaged for research
market
–
Publicly-traded UK-based diagnostics company
2015 Milestones
 Build-out of European distribution
network for research use – research
launch to follow
 Build-out of Asian distribution network
for research use – research launch to
follow
 Initiate market development for clinical
diagnostic applications in infertility
 Engage with FDA for 510k de novo
clearance, with potential for CLIA
clearance in infertility
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Research Initiative in Male Infertility
Opportunity for RedoxSYS
• Oxidative Stress is implicated as a potential cause of male infertility
• Negatively associated with structural and functional integrity of sperm
• Directly interferes with capacitation and fertilization
Academic Collaboration
• Ongoing collaboration with a prominent US and Australian universities to detect
oxidative stress in semen samples
• Based on successful proof-of-concept studies
• Easily integrated into current clinical workflow
• Initiated March 2015 with initial results expected Q3 2015
Attractive ~$300M Market
• Largely paid out-of-pocket, without reimbursement risk
• RedoxSYS priced moderately compared to expensive infertility treatments (>$10K/cycle)
• Potential to guide treatment and lifestyle modifications
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Global Network of Research Sites
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Aytu Management
Josh Disbrow, Chief Executive Officer
• Previously COO of Ampio Pharmaceuticals/CEO of Luoxis
• Former Vice President of Commercial Operations at Arbor
Pharmaceuticals
• Commercial roles at LipoScience (NASDAQ: LPDX), Cyberonics
(NASDAQ: CYBX), GlaxoSmithKline (NYSE: GSK)
Jarrett Disbrow, Chief Operating Officer
• Founder and former President/CEO of Arbor Pharmaceuticals
• Previously CEO of Vyrix Pharmaceuticals
• Commercial roles at Accentia Pharmaceuticals, GlaxoSmithKline
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Investment Highlights
Current Therapeutic Pipeline
Zertane
• Pivotal trial initiation
• First-in-class treatment for PE
• Uniquely designed oral tablet
formulation
• Prepared to commercialize in
US and international markets
Expansion + Licensing
•
•
Acquire and/or license nearcommercial or revenuegenerating assets
Interested in acquiring late-stage
development (Phase 3 only)
programs in urology
Diagnostic Pipeline
•
•
•
•
Infertility redox research
initiatives
Research focus to drive
revenue via industry and
awareness via academic
collaborations
Potential for additional
infertility-based diagnostics
Strong IP Portfolio
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