Aytu Biopharma, Inc. · NASDAQ:AYTU
Aytu Biopharma — Aytu Bioscience — IPO Roadshow (April 2016)
35 slides from Aytu Biopharma's IPO roadshow presentation, Apr 25, 2016
Slide 1: Aytu BioScience Corporate Overview | April 2016
Aytu BioScience Corporate Overview | April 2016
Slide 2: Safe Harbor Statement
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 i
Slide 3: Free Writing Prospectus
Free Writing Prospectus This presentation highlights basic information about the Company and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing. This offering may only be made by means of a prospectus. We have filed a registrat
Slide 4: Corporate Highlights
Corporate Highlights Expanding Portfolio of Revenue - Generating Urology Products Novel Specialty Products: Natesto ™, ProstaScint ®, and Primsol® Established Urology - Focused Commercial Infrastructure Active Business Development for Additional Urology Assets CE Marked MiOXSYS™ Diagnostic for Male
Slide 5: Commercially-Focused Management Team with a History of Growing Commercial Organizations
Commercially - Focused Management Team with a History of Growing Commercial Organizations • 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 •
Slide 6: Complementary Urology Products and Pipeline
Complementary Urology Products and Pipeline 6 Currently Marketed, Revenue - Generating Products • O nly FDA - approved imaging agent for prostate cancer detection and staging 1 : • Newly diagnosed patients at higher risk for pelvic lymph node disease • Patients with suspected recurrent disease • Onl
Slide 7: Urology Market Opportunity
Urology Market Opportunity Large yet concentrated specialty can be efficiently targeted • Approximately 10,000 active urologists (U.S.) and can be efficiently reached – 90% practice in metropolitan areas – 81% in group practices – Over 60% are in practices of 4 or more • Sub - specialization within
Slide 8: Natesto: Launching the only FDA-approved, nasally-administered testosterone
Natesto : Launching the only FDA - approved, nasally - administered testosterone
Slide 9: Testosterone Market Opportunity
• More than $2BN in annual product class revenues – U.S. Testosterone Replacement Therapy (TRT) market expected to grow to over $5BN by 2017 • C urrent topical treatments ( AndroGel ®, AndroDerm ®, Axiron ®) have BLACK BOX WARNING related to transference of TRT, causing androgen/male - trait enhanci
Slide 10: Natesto (testosterone) nasal gel FDA-Approved Testosterone
Natesto (testosterone) nasal gel FDA - Approved Testosterone • Uniquely - delivered, strongly patented TRT with multiple advantages over competitors • Only nasally - administered TRT • Unique, low - dose of testosterone • No BLACK BOX WARNING associated with transference of testosterone • Discreet p
Slide 11: Natesto: Proven Effective with No Risk of Transference
Natesto : Proven Effective 2 - 3 Times Daily with No Risk of Transference • In the pivotal clinical trial studying the safety and efficacy of Natesto , which was conducted at 39 U.S. outpatient sites it was shown at day 90: – 70 % of the per protocol patients in the B.I.D. ‘titration arm’ ( n=141) a
Slide 12: Natesto: For Active Men "On the Go"
Natesto : For Active Men “On the Go” • Natesto will be positioned for active men with hypogonadism between 45 – 64 years of age for whom convenience, discretion, and quick use of a TRT is important. – Natesto is easy, quick to apply, and doesn’t add to the busy morning (or evening) routine – or comp
Slide 13: 5% Market Penetration of the $2.4BN U.S. Testosterone Market
5% Market Penetration of the $2.4BN U.S. Testosterone Market = $120,000,000 in Annual Sales Total $2.4BN U.S. Market 5% Market Share 13 5% Market Share: $120,000,000 in Annual Sales Annual testosterone drug revenue in the U.S. in 2013 and 2018 (in billion U.S. dollars). Statista: The Statistics Port
Slide 14: ProstaScint: The only FDA-approved prostate cancer imaging agent
ProstaScint: The only FDA - approved, prostate cancer imaging agent
Slide 15: Prostate Cancer Market Opportunity
• 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 • No other FDA - approved prostate cancer imaging agents • Accurate staging is critical for patient
Slide 16: ProstaScint (capromab pendetide) FDA-Approved Prostate Biologic
ProstaScint® (capromab pendetide) FDA - Approved Prostate Biologic ACS Prostate Cancer • First - in - class, highly protected monoclonal antibody imaging agent • Only FDA - approved prostate - specific imaging agent • Binds glycoprotein expressed by prostate epithelium – Prostate Specific Membrane A
Slide 17: ProstaScint's Clinical Performance: Significantly Improved since FDA Approval
ProstaScint’s Clinical Performance: Significantly Improved since FDA Approval 17 • Fused SPECT - CT imaging improves accuracy, sensitivity, and positive predictive value (PPV) of ProstaScint. • Fused technology/imaging not employed at time of FDA clearance but routinely employed today >95% Accuracy,
Slide 18: Primsol: The only FDA-approved trimethoprim-only oral solution
Primsol: The only FDA - approved trimethoprim - only oral solution
Slide 19: Significant Opportunity in Urinary Tract Infections
• UTIs among most common diagnoses in U.S . • ~25% of women will have recurrent UTIs • #1 complication of catheterized patients • Unique product profile: • Pleasant tasting, liquid oral solution • Sulfamethoxazole - free • Ideal for UTI patients who have difficulty swallowing tablets, or are allergi
Slide 20: Primsol Solution (trimethoprim HCl oral solution)
Primsol ® Solution (trimethoprim HCl oral solution) Oral Solution for Urinary Tract Infections • Second revenue - generating product in portfolio • Opportunity for growth with re - positioning to urologists for urinary tract infections (UTIs) • Only FDA - approved liquid formulation of trimethoprim
Slide 21: Increased Revenue Opportunity with ProstaScint & Primsol
Increased Revenue Opportunity with Existing Commercial Portfolio, ProstaScint & Primsol 893 1,593 8,216 7,842 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 ProstaScint Primsol HISTORICAL PEAK SALES VS. 2015 UNITS 2015 Sales (Units) Peak Year Sales (Units) $14.6 $5.3 $19.9 $- $5 $10 $15 $20
Slide 22: Significant Net Revenue Growth over First Two Full Quarters of Product Promotion
Significant Net Revenue Growth over First Two Full Quarters of Product Promotion 22 $469,000 $669,000 $200,000 $300,000 $400,000 $500,000 $600,000 $700,000 $800,000 42% QUARTER - OVER - QUARTER TOTAL REVENUE GROWTH Quarter Ended 12/31/15 Quarter Ended 3/31/2016* * $8.67 MM in cash and cash equivalen
Slide 23: MiOXSYS: First-in-class male infertility diagnostic system
MiOXSYS: First - in - class male infertility diagnostic system
Slide 24: Male Infertility Market Opportunity
• Increasing rates of infertility globally, with male factor infertility causing 40 - 50% of the cases in US and EU – 4.5 million US men are infertile • Oxidative stress (OS) broadly implicated in idiopathic infertility – Current OS testing platforms are cost - prohibitive and impractical for routin
Slide 25: MiOXSYS: Rapid Testing for Male Infertility
MiOXSYS™: Rapid Testing for Male Infertility First - in - Class I n V itro Diagnostic Device • CE Marked ; Rapid IVD test available for in - office testing to screen for infertility • Measures oxidative stress, which is broadly implicated in idiopathic male infertility • Current testing requires hig
Slide 26: Aytu BioScience and Cleveland Clinic Collaborate on ORP Marker
Aytu BioScience and Cleveland Clinic C ollaborate To Establish Oxidation - Reduction Potential (ORP) Marker for Male Infertility “ORP values are not affected by the age of semen for up to 120 minutes, thereby making it easier to employ this new technology for diagnostic use” - Agarwal 2015 26 Clinic
Slide 27: Zertane: Phase-Ready treatment for premature ejaculation
Zertane: Phase 3 - Ready treatment for premature ejaculation
Slide 28: Late-Stage Therapeutic Candidate: Significant Opportunity in PE
Late - Stage Therapeutic Candidate Significant Opportunity in PE • First - in - class therapy for treating premature ejaculation (PE) • Potential to be the first FDA approved drug to treat premature ejaculation • Unique strength and dosage form of an established drug • Approval pathway is significan
Slide 29: Zertane Phase 3 Studies: Improvement in Validated PE Endpoints
0.55 1.05 0 0.2 0.4 0.6 0.8 1 1.2 Ejaculation - related distress* (mean improvement) Zertane Phase 3 Studies: Improvement in Validated PE Endpoints 3.17 6 0 1 2 3 4 5 6 7 Six - Fold Increase in Ejaculation Time (IELT) versus Baseline** * Significant improvement also seen: - Satisfaction with interco
Slide 30: Scaling our Commercial Team for Sustained Success in Urology
Scaling our Commercial Team for Sustained Success in Urology
Slide 31: Building a Leading Urology Commercial Infrastructure
• Hired initial U.S. sales force to launch commercial assets in U.S. – Appointed Jonathan McGrael as Vice President of Sales – Hired highly experienced, urology - focused account managers – T erritory build around Natesto targets and ProstaScint centers • Sales Strategy – Initially focused on launch
Slide 32: Capitalization as of March 31, 2016
Capitalization as of March 31, 2016 Common Shares 22,446,481 84.76% Options Issued 1 3,667,500 13.85% Warrants Outstanding 2 369,665 1.39% Fully Diluted Shares 26,483,646 100% 32 1 Weighted average exercise price $1.55 2 Weighted average exercise price $1.73 As of March 31, 2016, Aytu also has conve
Slide 33: Summary Financials
Summary Financials 6 Months Ended December 31, 2015 Revenue $ 957,000 Operating Expenses: Cost of Sales 281,000 Sales, general & administrative 3,592,000 Research & Development 2,261,000 Total Operating Expenses 6,134,000 Operating Income (Loss) (5,177,000) Interest & Other Expense, net 432,000 Net
Slide 34: Summary Financials
Summary Financials As of Pro Forma As December 31, 2015 Adjusted 1 Cash & Cash Equivalents $ 10,960,000 $ 11,160,000 Working Capital $ 9,961,000 $ 10,161,000 Total Assets $ 24,410,000 $ 24,610,000 Total Liabilities $ 9,151,000 $ 4,901,000 Total Shareholders’ Equity $ 15,259,000 $ 19,709,000 Long Ter
Slide 35: Anticipated Aytu Value Drivers
Anticipated Aytu Value Drivers x Initial Growth & Value Opportunity • Launch Natesto in the U.S. • B uild out of full commercial infrastructure • July 2016 launch planned • Continue to grow sales of ProstaScint & Primsol • Reclaim historical prescribing and grow ProstaScint • Ex - U.S. partnering &