Aytu Biopharma, Inc. · NASDAQ:AYTU
Aytu Biopharma — Aytu Bioscience — IPO Roadshow (September 2018)
34 slides from Aytu Biopharma's IPO roadshow presentation, Sep 28, 2018
Slide 1: Aytu BioScience Corporate Overview | October 2018
Aytu BioScience (NASDAQ: AYTU) Corporate Overview | October 2018
Slide 2: Forward-Looking Statement
Forward - Looking 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 conta
Slide 3: Statement about Free Writing Prospectus
Statement about Free Writing Prospectus This presentation highlights basic information about us and the offering. Because it is a summary that has been prepared sol ely for informational purposes, it does not contain all of the information that you should consider before investing in our compa ny. E
Slide 4: Overview
Overview • Commercial - stage, revenue - generating specialty pharmaceutical company – Portfolio of approved, revenue - generating products, leveraging focused commercial team; expertise in building specialty brands within well - established markets – Unique products address large, growing specialty
Slide 5: Novel Products Addressing Large Markets
Novel Products Addressing Large Markets 5 13 million U.S. men affected 1 6.8 million Rxs annually 2 $1.8 billion Rx category 2 Only FDA - Approved, Nasally - Administered Testosterone Replacement Therapy (TRT) 3 Up to 30% of U.S. adults affected 4 43 million Rxs annually 5 $1.8 billion Rx category 5
Slide 6: Natesto: The only FDA-approved, nasally-administered testosterone replacement therapy
Natesto®: The only FDA - approved, nasally - administered testosterone replacement therapy
Slide 7: Testosterone U.S. Market Opportunity
Branded Topicals ($U.S. - 2017) 1 Testosterone U.S. Market Opportunity 7 1. IQVIA December 2017 2 . AndroGel Prescribing Information. 3. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement.
Slide 8: Natesto: The only nasally delivered TRT
Natesto: The only nasally delivered TRT – Fast, clean application – Easy to use and transport • Natesto is the only topical TRT without a BLACK BOX warning 3 • All other TRTs carry a “BLACK BOX warning” due to the risk of transference 4 • Transference causes androgen/male - trait enhancing side effe
Slide 9: Unique pharmacokinetic profile leads to a distinct clinical profile for Natesto
Unique pharmacokinetic profile leads to a distinct clinical profile for Natesto • NATESTO causes statistically significant improvements in each of the 5 domains of erectile function; the majority of the effect was evident by Day 30 ( P < 0.0001) 3 • NATESTO caused substantial increase in positive af
Slide 10: Natesto Support Programs are Driving Revenue
83% 59% 62% 32% 31% 23% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% January-18 February-18 March-18 April-18 May-18 June-18 January-18 February-18 March-18 April-18 May-18 June-18 Natesto Support Programs are Driving Revenue 10 Before Support Programs After Support Programs 68% average monthly coupon use
Slide 11: Robust Growth in Paid Natesto Prescriptions
Robust Growth in Paid Natesto Prescriptions from First Half to Second Half FY 2018 11 Natesto Total Paid Prescriptions 2,574 3,780 1,000 1,500 2,000 2,500 3,000 3,500 4,000 1H 2018 2H 2018
Slide 12: Robust Company Revenue Growth
Robust Company Revenue Growth >100% revenue growth from March to September 2018* $607,000 $925,000 $1,300,000 NET REVENUE BY QUARTER 3/31/18 6/30/18 9/30/2018 12 * * Q4 FY18 Cash Use: $4.5M excluding ZolpiMist acquisition Projected financials; subject to auditor review Expected Q1 FY19 Net Cash Used
Slide 13: Catalysts to Accelerate Natesto Growth
Catalysts to Accelerate Natesto Growth 1. INCREASE FILL & REFILL RATES & HIGHER NET SELLING PRICE • Reimbursement Support Programs ; Underway in Q4 2018 – Patient support programs to facilitate improved product reimbursement and access via payors – Reimbursement support programs designed to : • Incr
Slide 14: Clinical Significance of the Natesto Spermatogenesis Study
The Clinical Significance of the Natesto Spermatogenesis Study is Substantial “Currently, there are no FDA - approved therapies to treat men with low testosterone who wish to preserve their fertility. About 20% of men with Low T deal with these decisions, and Natesto could be an alternative for simu
Slide 15: Natesto Could Shift a Clinical Paradigm in Hypogonadism Treatment
Current Tx Paradigm “As this study has shown in a randomized, double - blind, double - dummy, placebo - controlled manner, exogenous testosterone therapy with Androgel can clearly decrease sperm production and potentially impact fertility.” 1 Edward Kim, MD Urologist University of Tennessee Medical
Slide 16: Preliminary Published Data: Natesto Maintains Normal Semen Parameters
Preliminary Published Data: Natesto Maintains Normal Semen Parameters & Gonadotropins 16 Masterson T, Molina M, Ibrahim E, Ramasamy R. Natesto Effects on Reproductive Hormones and Semen Parameters: Results from an Ongoing Single - center, Investigator - initiated Phase IV Clinical Trial. European Ur
Slide 17: Natesto Spermatogenesis Study Strategic Implications
Natesto Spermatogenesis Study Strategic Implications Extend patent runway Secure market exclusivity (20% of patient pool) Gain leverage with payors FDA - approved label claims 17
Slide 18: Study Underway to Assess Natesto's Impact on Sperm Production
Study Underway to Assess Natesto’s Impact on Sperm Production & Endogenous Testosterone Study Summary – Interim Readout Expected November 2018 • “Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters” – This would be the first study ever to demonstra
Slide 19: Robust U.S. Market Opportunity
• $1.8 BN in annual total class revenues 4 • 13 Million men diagnosed in the U.S. 4 • Decrease in branded promotion in testosterone replacement therapy (TRT) category, yet substantial treatment needs remain 5 – Eli Lilly (NYSE: LLY) terminated Axiron® global licensing agreement (September 2017) 6 Si
Slide 20: ZolpiMist: The only FDA-approved, oral spray prescription sleep aid
ZolpiMist™: The only FDA - approved, oral spray prescription sleep aid
Slide 21: Launching ZolpiMist Oral Spray
Unique Patient Benefits & Innovative Delivery Launching ZolpiMist™ Oral Spray 21 In June 2018, acquired exclusive license for U.S. and Canadian markets Novel, rapid - acting formulation and oral spray delivery of most prescribed prescription sleep aid, zolpidem tartrate LTM gross revenue @ new blend
Slide 22: ZolpiMist: Sleep. Delivered. Fast.
ZolpiMist: Sleep. Delivered. Fast. • ZolpiMist initiates sleep quicker than Ambien 1 • In the ZolpiMist Clinical Study Report for FDA approval, significantly more patients achieved therapeutic blood levels in 15 minutes with ZolpiMist than Ambien 1 22 19% 63% 0% 10% 20% 30% 40% 50% 60% 70% 80% Ambie
Slide 23: Significant Market Opportunity
Significant Market Opportunity • Large Prescription Class – 43.6 million sleep aid TRxs annually 1 • Zolpidem tartrate: Most commonly prescribed molecule for insomnia in the U.S. – $1.8 BN in annual class WAC sales 1 – >30 million TRxs annually (all zolpidem formulations) 1 • Achieving only 1% marke
Slide 24: MiOXSYS: First-in-class, CE Marked male infertility diagnostic system
MiOXSYS®: First - in - class, CE Marked male infertility diagnostic system
Slide 25: MiOXSYS for Male Infertility
MiOXSYS for Male Infertility First - in - Class In Vitro Diagnostic Device • CE Marked, Health Canada Cleared, Australian TGA & Mexican COFEPRAS Approved; Rapid IVD test available for in - office testing to screen for male infertility • Measures oxidative stress in male infertility cases that would
Slide 26: Recent Guidelines Support Seminal Oxidative Stress Testing
Recent Guidelines Support Seminal Oxidative Stress Testing in Recurrent Pregnancy Loss 26 • November 2017 Guideline on Recurrent Pregnancy Loss from the European Society of Human Reproduction and Embryology (ESHRE): The main cause of DNA damage is Oxidative Stress and this seems to be exacerbated by
Slide 27: Global Commercialization Underway
Global Commercialization Underway 28 Growing S ales F ootprint – Currently S old in 29 C ountries EUROPE 63 Placements Unillabs TDL Zech Clinic Invicta Clinic MIDDLE EAST - NORTH AFRICA 30 Placements Amerikan IVF Hamad Medical Corp. ASIA 13 Placements IVF Namba Clinic Dokkyo University Singapore Gen
Slide 28: Commercial Distribution, Upcoming Milestones, Capitalization
Commercial Distribution Upcoming Milestones Capitalization
Slide 29: Commercial Distribution
Commercial Distribution • U.S. Commercial Infrastructure & Distribution – U.S. - based, internal sales force with national footprint – 35 - person specialty sales force in major MSAs – Contracted with and shipping to all major national and regional U.S. wholesalers – Retail channel partners can read
Slide 30: Commercially-Focused Management Team
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 <5 years • Previous COO of Ampio Pharmaceuticals/CEO of Luoxis, a specialty biotechnology company •
Slide 31: Capitalization
Capitalization 31 Capitalization as of September 25, 2018* Common Shares Outstanding (9/25/18) 1,801,411 Options (weighted average exercise price $325.97) 1,798 Warrants (weighted average exercise price $25.94) 1,882,661 Fully Diluted Shares 3,679,221 * 100% equity financed; zero outstanding debt
Slide 32: Upcoming Catalysts
Upcoming Catalysts 1. Natesto Spermatogenesis Study • Interim readout – November 2018 • Final data readout – Summer 2019 2. ZolpiMist launch 3. Strong quarterly Natesto prescription and factory sales growth • Rollout of Natesto Support Program & NatestoDirect 33
Slide 33: Aytu Investment Considerations
Aytu Investment Considerations • Rapidly growing, revenue generating, specialty pharmaceutical company • Growing Product Portfolio Addressing Hypogonadism, Insomnia, and Male Infertility – Natesto - First and Only Intranasal Testosterone Treatment – Hypogonadism – ZolpiMist - First and Only Oral Spr
Slide 34: Contact Information
Contact Information Josh Disbrow Chairman & Chief Executive Officer +1 (720) 437 - 6520 josh.disbrow@aytubio.com