Aytu BioScience
Corporate Overview | November 2015
Corporate Highlights
Expanding Portfolio of Revenue-Generating Urology Products
Current Specialty Products: ProstaScint® and Primsol®
Established Urology-Focused Sales Infrastructure
Proprietary MioxSYS™ Diagnostic for Male Infertility
Phase 3 Ready Clinical Asset Zertane™
Strong IP & Entrepreneurial Management
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Commercial-Focused Management Team with a
Strong History of Growing Commercial Organizations
Josh Disbrow – CEO
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Former VP of Commercial Operations at Arbor Pharmaceuticals where revenues grew from zero to over $127MM in <4 years
Previous COO of Ampio Pharmaceuticals/CEO of Luoxis, a specialty biotechnology company
Commercial roles at LipoScience, Cyberonics, and GlaxoSmithKline
Jarrett Disbrow – COO
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Founder and former President/CEO of Arbor Pharmaceuticals where revenues grew from zero to over $127MM in <4 years
Former CEO of Vyrix Pharmaceuticals, a specialty pharmaceutical company focused on male sexual dysfunction
Commercial roles at Accentia Pharmaceuticals, GlaxoSmithKline
Gregory Gould, CPA – CFO
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Former CFO of publicly traded life science companies: SeraCare Life Sciences, Atrix Laboratories, and Colorado MedTech
Significant transactional experience in M&A, product acquisition, divestiture, and licensing across pharma and diagnostics, including the
sale of Atrix Laboratories to QLT Pharma for over $800MM
Jonathan McGrael – VP of Sales
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Former Director of Sales at Arbor Pharmaceuticals; Significant history building Arbor with current Aytu management
Commercial leader who built commercial organization from 12 to over 400 employees in a five-year period
Progressive experience in sales, sales management, and marketing at TAP Pharmaceuticals (now Takeda)
Douglas Miller, PhD – VP of Technical Operations
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Co-founded Otologics LLC to commercialize an electronic implantable medical device that he developed while leading clinical research at
Washington University School of Medicine; 25 years in medical device, diagnostics, and therapeutics R&D and clinical affairs
Former Senior Research Engineer at Cochlear Ltd., the world’s leading cochlear implant manufacturer, where he directed all external
research for the North American division
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Complementary Urology Products and Pipeline
Currently Marketed, Revenue-Generating Products
• FDA-approved biologic for detection of prostate cancer lymph node metastasis:
• Newly diagnosed patients at higher risk for pelvic lymph node disease
• Patients with suspected recurrent disease
• Only FDA-approved trimethoprim oral solution; indicated for urinary tract infections
• Appropriate for patients with ‘sulfa’ allergies
• Significant prescribing by urologists despite no promotion
Late-Stage Pipeline Assets
• Developing clinical applications in male infertility for use in semen analysis
• Demonstrated clinical utility in two prospective clinical studies
• Easier to employ for diagnostic use compared to current methods
• Phase 3-ready, first-in-class treatment for premature ejaculation
• Currently no FDA-approved products
• Demonstrated significant increase in ejaculation time, achieving
normalization for many patients
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ProstaScint® (capromab pendetide)
FDA-Approved Prostate Biologic
• First-in-class, highly protected 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
• Uses an injection of low-level radioactive isotope
to determine if cancer has spread beyond the
prostate
• Generating revenues despite no sales promotion
since 2012; significant opportunity to regain Rxs
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Primsol® Solution (trimethoprim HCl oral solution)
Oral Solution for Urinary Tract Infections
• Second revenue-generating product in portfolio
• Only FDA-approved liquid formulation of
trimethoprim
• Standard of care antibiotic for treating
uncomplicated urinary tract infections
(UTIs)
U.S. Sales
Generating consistent Rxs
with no sales promotion and
minimal commercial support
• Well established therapy in current treatment
guidelines
• ~26% of prescriptions for UTIs without
commercial promotion
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Building a Leading Urology Commercial Infrastructure
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Hired initial U.S. sales force to re-launch commercial assets in U.S.
– Appointed Jonathan McGrael as Vice President of Sales
– Hired highly experienced, urology-focused account managers
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Sales Strategy
– Target and re-engage top historical prescribers for ProstaScint and Primsol
– Initiate ex-U.S. prescriber outreach and corporate partnerships
– Expect to see initial revenue growth by 2Q 2016
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Growth Strategy
– Acquire & integrate additional urology products by 3Q 2016
– Scale sales team and continue to build as revenues increase
– Build internal customer support functions
The Aytu management team has built and launched commercial teams
at specialty pharma companies
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MioxSYS™: Meeting a Significant Need in Male Infertility
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First-in-class, market-ready product
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Significant market opportunity in detection of oxidative stress in male infertility
CE Marked (2014); Health Canada approved (2014)
U.S. clinical and regulatory pathways are short and well defined
Clinical research underway with prominent academic centers in semen analysis
Technical development complete following two decades of R&D
– Completed product development for system and sensors
– Received ISO 13485 certification with CMDCAS
– First patents issued in 2012; 7 U.S. patents issued, multiple ex-U.S. patents
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Razor-razorblade commercial model
– Inexpensive analyzer / high-value, disposable sensors
– Early research revenues from pharma and academic collaborators
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Positive Clinical Data in Male Infertility
MiOXSYS™ Enables Real Time, Accurate Assessment of Oxidative Stress
in Either Semen and Seminal Plasma (P<0.001)
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High oxidative stress levels correlate strongly with low sperm motility
– As measured by MiOXSYS, in either semen (p=0.004) or seminal plasma (p=0.002)
– MiOXSYS achieved 100% sensitivity for predicting abnormal sperm motility in both
semen (specificity=89.5%) and seminal plasma (specificity=93.8%)
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MiOXSYS oxidative stress measurements are not time-sensitive
– Oxidative stress readings did not change significantly over a two hour period in either
semen or seminal plasma (p<0.05)
– Traditional methods of measuring seminal oxidative stress are time sensitive and time
consuming
Clinical Results Demonstrate MiOXSYS is a Faster, Easier to Employ Diagnostic
that Can Be Used Effectively for Screening Infertile Men For Oxidative Stress
Results presented at 2015 American Society for Reproductive Medicine annual meeting
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Zertane™ (Tramadol ODT)
Late-Stage Therapeutic Candidate
• First-in-class therapy for treating premature
ejaculation (PE)
• Improved oral formulation
• FDA IND accepted; Phase 3-ready asset
Orally Dissolving Tablet
Improved formulation of widely
known and safe drug (tramadol
HCL) that is proven to treat
premature ejaculation
• 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
• Significant opportunity in PE
• Most prevalent male sexual dysfunction
(~$1.3 billion U.S. market, 2015)
• Currently no FDA-approved products
• Market research suggests an oral,
as-needed formulation is in demand
Phase 3
Phase 2
Pivotal
Stage
Phase 1
Preclinical
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Investment Highlights
Expansion + Licensing
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Continue to acquire and/or
license near-commercial or
revenue-generating assets
Interested in acquiring latestage development (Phase 3
only) programs in urology
Two acquisitions already
completed; another asset
purchase in final negotiations
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Diagnostic Pipeline
Current Therapeutic Pipeline
Male infertility redox research
initiatives in place with world’s
leading center in male
infertility/oxidative stress
Potential for additional
infertility-based diagnostics
Strong IP Portfolio
Zertane
• Pivotal trial initiation
• First-in-class treatment for PE
• Uniquely designed oral tablet
formulation
• Prepared to commercialize in
US and international markets
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