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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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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 Adjacent Areas
Redox-modulated conditions • Urological
cancers • Infertility
diagnostics • Erectile
dysfunction
Sexual Health • Premature
ejaculation • Erectile
dysfunction • Female sexual
disorder
Urology Conditions • Prostate, BPH • Urinary tract
infection • Incontinence,
Bladder
• Urological diagnostics
Product Development & Commercial Strategy
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Corporate Structure
Therapeutics Development & Commercialization
• 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
• 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
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Diagnostics Development & Commercialization
Zertane™ (Tramadol ODT) Lead Therapeutic Candidate Orally Dissolving Tablet
• 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
Improved oral formulation of a widely known and safe drug (tramadol hydrochloride) that is proven to treat premature ejaculation
Preclinical
Phase 1
Phase 2
Phase 3 Pivotal Study
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• 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
• Market research suggests an oral, as-needed formulation is in demand
$10B Market by 2017
Global Urological Disorders
>$1.3B Market by 2015
Premature Ejaculation
Attractive Competitive Landscape
PE Market Opportunity
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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)
• 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
High Clinical Demand: PE Survey
Significant Medical Need
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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.
• Randomized, blinded, placebo-controlled, in a total of 102 PE patients showed a clear dose response for efficacy in terms of IELT
Phase 2 Studies
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
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IELT = prolonged time to ejaculation
Phase 3 Clinical Trials Indicate Improved Patient Control and Satisfaction
0.4
1.06
0
0.2
0.4
0.6
0.8
1
1.2
Satisfaction with intercourse (mean change)
Placebo 89 mg tramadol ODT
• Control over ejaculation
• Ejaculation-related distress
• Ejaculation-related interpersonal difficulty
(Source – European Urology 2012)
p < 0.001 Significant Improvement
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Demonstrated Improved IELT in Phase 3
0.6
1.91
0.6
2.59
0
0.5
1
1.5
2
2.5
3
Baseline IELT Treatment
IELT Change versus Baseline
Placebo 89 mg tramadol ODT
3.17
6
0
1
2
3
4
5
6
7
Treatment
Fold Increase in IELT versus Baseline
Placebo 89 mg tramadol ODT
Min
ute
s
NOTE: Only reflects patients with baseline IELT of <1 minute
(Source – European Urology 2012)
p < 0.01
p < 0.01
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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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• 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
Strong Intellectual Property Portfolio
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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
Zertane Opportunity Summary Significant Completed Milestones
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• 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
Infertility & Oxidative Stress
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“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.
• 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
RedoxSYS®: Developed & Market-Ready
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RedoxSYS Market Development Highlights
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
Commercial Development 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
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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
• 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
Academic Collaboration
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
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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Current Therapeutic Pipeline Expansion + Licensing
Zertane • Pivotal trial initiation • First-in-class treatment for PE • Uniquely designed oral tablet
formulation • Prepared to commercialize in
US and international markets
• Acquire and/or license near-commercial or revenue-generating 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
Investment Highlights
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