Aytu Corporate Presentation Q2 2015

Aytu BioScience
Corporate Overview | Q2 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 Urology Products
Lead Candidate Zertane™ is Phase 3 Ready
Commercial-stage with Acquisition of ProstaScint®
Proprietary Diagnostic for Male Infertility
Established Global Commercial Agreements
Strong IP & Entrepreneurial Management
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Product Development & Commercial Strategy
Build a specialty healthcare company with an initial focus on the $10B urology
by establishing a leading pipeline of novel therapeutic and diagnostic assets
Core Urology Focus
•
•
•
Adjacent Areas
• Erectile dysfunction
Premature Ejaculation
• Hypogonadism
Male Infertility
• Prostate, BPH
Urological Cancers
• Incontinence, bladder
4
Complementary Urology Products and Pipeline
Therapeutics
Commercialization
Marketed Product:
• FDA-approved biologic for
detection of prostate cancer
lymph node metastasis in:
• Newly diagnosed
patients at higher risk
for pelvic lymph node
disease
• Patients with suspected
recurrent disease
Therapeutics
Development
Lead Therapeutic Candidate:
•
•
First-in-class, near
commercial-stage treatment
for premature ejaculation
Global commercial
agreements in place
Diagnostics
Development
Lead Diagnostic Candidate:
• Proprietary, commercial-stage
redox diagnostic research tool
• Developing clinical applications
in male infertility for use in
semen analysis
• Clinical development program
in place with major US
academic center
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ProstaScint® (capromab pendetide)
FDA-Approved Prostate Biologic
• First-in-class monoclonal antibody imaging agent
• Binds glycoprotein expressed by prostate
epithelium – Prostate Specific Membrane
Antigen (PSMA)
ACS Prostate Cancer
EARLY DETECTION,
DIAGNOSIS, AND STAGING
TOPICS
• Enables accurate staging and guides appropriate
treatment, with emphasis on:
• Higher risk, newly diagnosed – to identify
organ confined disease
• Treatment failures post-curative intent – to
identify candidates for localized therapy
FDA
Approved/
Marketed
Phase 3
• Uses an injection of low-level radioactive material
to determine if cancer has spread beyond the
prostate
Phase 2
Phase 1
Preclinical
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Prostate Cancer Market Opportunity
Significant Market Need
•
•
•
Most common cancer in American men,
other than skin cancer
Second leading cause of cancer death
in American men
– ~1 in 38 men will die of prostate cancer
– ~27,540 prostate cancer deaths in 2015
Accurate staging is critical for patient
management
– 10% of new cases are considered high risk
– 20-40% of patients will recur following
curative intent treatment
Prostate Cancer Prevalence (U.S.)
2.9 MM
Annual New Prostate Cases (U.S.)
220,800
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Zertane™ (Tramadol ODT)
Late-Stage 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
• Most widely observed male sexual
dysfunction
• Currently no FDA-approved products
• Majority of PE patients report lack of
effective treatment for their PE
• Traditional remedies have limited
effectiveness and unwanted side effects
• Market research suggests an oral,
as-needed formulation is in demand
(Source – Campbell Alliance)
Global PE Prevalence
23-30%
U.S. Market in 2015
>$1.3B
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Zertane Phase 3: Improvement in validated co-primary endpoints
following full development program
Six-Fold Increase in Ejaculation
Time (IELT) versus Baseline**
Ejaculation-related distress*
(mean change)
1.2
7
1
6
p < 0.01
1.05
6
5
0.8
4
0.6
0.4
3
0.55
3.17
2
0.2
1
0
0
Placebo
89 mg tramadol ODT
Placebo
89 mg tramadol ODT
* Significant improvement also seen in satisfaction with intercourse, control over ejaculation, and
ejaculation-related interpersonal difficulty
** Reflects patients with baseline IELT of <1 minute (0.60 minutes median)
(Source – European Urology 2012)
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Zertane normalized IELT in many patients
25%
% of Patients Normalized
p < 0.01
20%
20%
18%
15%
16%
10%
11%
8%
5%
6%
6%
4%
0%
> 5 minutes
> 6 minutes
Placebo
> 7 minutes
> 8 minutes
89 mg tramadol ODT
NOTE: Reflects patients with baseline IELT of <1 minute (0.60 minutes median)
(Source – European Urology 2012)
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Prepared for Zertane Pivotal Study Initiation
• Concise, well-defined FDA pathway
– FDA meeting Q4 2014 confirmed:
• Co-primary endpoints (IELT, POPE/PRO)
• Inclusion/exclusion criteria including PE definition
– FDA protocol and patient reported outcome questionnaire
reviewed in detail Q1/2 2015
• 21 experienced study sites qualified and selected
• Selected CRO, defined budget
• Study drug manufactured and available
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RedoxSYS®: Meeting a Significant Need in
Male Infertility
•
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 semen analysis
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; 7 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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Male Infertility Market Opportunity
Attractive Competitive Landscape
•
•
•
Attractive, growing market
– largely paid out-of-pocket
– >$10K for IVF treatment, with many
couples repeating cycles
Oxidative stress broadly implicated
– Antioxidants commonly recommended
without FDA-approved test to assess efficacy
– Current testing platforms are costprohibitive and impractical for routine use
Potential to replace current oxidative stress
testing platform
– Active collaboration for RedoxSYS with
world’s most widely published research
group in male infertility
Global GAGR (2013-2020)
6.6%
Global Market in 2020
>$300 MM
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Strong Intellectual Property Across Portfolio
Zertane™
– 1 issued; 4 pending US patents
– 77 issued; 5 pending patents
internationally
– Use of tramadol hydrochloride to
treat PE through 2022
– Combination of Zertane and PDE-5
inhibitors through 2028
– Multiple life cycle management
opportunities
• Alternate dosage forms
• Enhanced PK profile
RedoxSYS®
– 6 issued; 11 pending US patents
– 5 issued; 45 pending patents
internationally
– Multiple apparatus/composition
patent families
– Multiple use patents across infertility,
acute illness, chronic illness, and use in
various fields of human and animal
research
– Significant trade secrets throughout
complex manufacturing processes
ProstaScint®
– Proprietary monoclonal antibody with
significant trade secrets throughout
complex manufacturing processes
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Aytu Management
Josh Disbrow, Chief Executive Officer
• Previously COO of Ampio Pharmaceuticals/CEO of Luoxis
• Former VP 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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Upcoming Milestones
Product
Event
Q2’15
Q3’15
Q4’15
Q1’16
Complete Acquisition
Commercial Launch
IND Acceptance
Initiate 1st Phase 3
male infertility initial
study results
Initiate FDA infertility
clinical studies
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Investment Highlights
Current Therapeutic Pipeline
Zertane
•
•
•
•
Pivotal trial initiation
First-in-class treatment
for PE
Efficient 505(b)2 FDA
pathway
Commercial partnerships
in place in major
international markets
Expansion + Licensing
•
•
•
Expand ProstaScint
utilization
Seek to acquire additional
revenue-generating assets
with a focus on urology
Consider acquiring late-stage
development (Phase 3 only)
programs in urology
Diagnostic Pipeline
•
•
•
Prospective infertility
research studies
underway
Research focus to drive
revenue via industry and
awareness via academic
collaborations
Strong IP Portfolio
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