Aytu Biopharma, Inc. · NASDAQ:AYTU
Aytu Biopharma — Aytu Bioscience — IPO Roadshow (October 2016)
28 slides from Aytu Biopharma's IPO roadshow presentation, Oct 11, 2016
Slide 1: Aytu BioScience Corporate Overview | October 2016
Aytu BioScience Corporate Overview | October 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: Offering Summary
Offering Summary 3 Aytu BioScience , Inc. Expected Offering Up to approximately $12,500,000 of common stock and warrants (100% Primary) Listing OTCQX : A YTU & AYTUW We intend to list our common stock and warrants on the NYSE MKT under the symbols “AYTU” and “AYTUW”, respectively, once we meet NYSE
Slide 4: Company Description
Company Description • Specialty Pharmaceutical Company, Focused on Urology – Hypogonadism, prostate cancer, male infertility, & urinary tract infections • Experienced, entrepreneurial management team with proven success in launching and growing specialty pharmaceutical companies – Founding managemen
Slide 5: AYTU History
AYTU History 5 Jan 2016 spinout from Ampio Pharma (AMPE) Acquired U.S. rights to Natesto® - launching into $2.4BN testosterone replacement therapy market $7.5 million registered offering completed in May 2016 FY 2016 Results : Net revenues of $2.6 million; 10x growth over FY 2015 $8.1M in cash 3 mar
Slide 6: Complementary Urology Products and Pipeline
Complementary Urology Products and Pipeline 6 Established, Revenue - Generating Products • FDA - approved imaging agent for prostate cancer detection and staging 2 : • Newly diagnosed patients at higher risk for pelvic lymph node disease • Patients with suspected recurrent disease • Only FDA - appro
Slide 7: Natesto: Launching the only FDA-approved, nasally-administered testosterone replacement therapy
Natesto®: Launching the only FDA - approved, nasally - administered testosterone replacement therapy
Slide 8: 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 1 • Current topical treatments ( AndroGel ®, Axiron ®) have BLACK BOX WARNING related to transference of TRT, causing androgen/male - trait enhancing side effe
Slide 9: Natesto (testosterone) nasal gel FDA-Approved Testosterone
Natesto (testosterone) nasal gel FDA - Approved Testosterone • Uniquely - delivered, strongly patented TRT with multiple advantages over competitors 1 - 3 • Only nasally - administered TRT • Unique, low - dose of testosterone • No BLACK BOX WARNING associated with transference of testosterone • Disc
Slide 10: 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 1 : – 70% of the per protocol patients in the B.I.D. ‘titration arm’ (n=141) ac
Slide 11: Natesto: TRT in Seconds
Natesto: TRT in Seconds • 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 complicate a man’
Slide 12: Natesto Offers Significant Clinical Advantages Over Androgel
Natesto Offers Significant Clinical Advantages Over Market - Leading Androgel® 1 - 2 12 70% of men in the Natesto pivotal trial said they would switch from their current TRT to treatment with Natesto. 3 1. Natesto Prescribing Information. 2. Androgel Prescribing Information. 3. Patient Market Resear
Slide 13: Natesto is well positioned to gain significant market share in the U.S. TRT market
Natesto is well positioned to gain significant market share in the U.S. TRT market 13 Growing TRT market No ‘low cost’ topical TRT options Dramatically reduced competitive promotion – No “P1” details Limited direct - to - consumer advertising Rising out - of - pocket costs for branded products
Slide 14: Projected 5% Market Penetration of the $2.4BN U.S. Testosterone Market
Projected 5% Market Penetration of the $2.4BN U.S. Testosterone Market = $120,000,000 in Annual Sales Total $2.4BN U.S. Market (1) 5% Market Share 14 5% Market Share: $120,000,000 in Annual Sales 1. Annual testosterone drug revenue in the U.S. in 2013 and 2018 (in billion U.S. dollars). Statista: Th
Slide 15: Natesto New Prescriptions Have Grown Every Week Since Launch
Natesto New Prescriptions ( NRx ) have Grown Every Week Since Aytu’s July 25 th Launch 6 Consecutive Weeks of NRx Growth Since Launch 15 • Consistent weekly Rx growth since field promotion began • Growing co - pay coupon redemptions – increase of 50% (current 2 weeks over previous 2 weeks) • Assure
Slide 16: ProstaScint: FDA-approved, prostate cancer biologic imaging agent
ProstaScint: FDA - approved, prostate cancer biologic imaging agent
Slide 17: ProstaScint (capromab pendetide) FDA-Approved Prostate Biologic
ProstaScint® (capromab pendetide) FDA - Approved Prostate Biologic ACS Prostate Cancer • First - in - class, proprietary monoclonal antibody imaging agent 1 • Only FDA - approved prostate - specific imaging agent • Binds glycoprotein expressed by prostate epithelium – Prostate Specific Membrane Anti
Slide 18: ProstaScint's Clinical Performance: Significantly Improved since FDA Approval
ProstaScint’s Clinical Performance: Significantly Improved since FDA Approval 18 • 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 19: Primsol: The only FDA-approved trimethoprim-only oral solution
Primsol: The only FDA - approved trimethoprim - only oral solution
Slide 20: Primsol Solution for Urinary Tract Infections
Primsol® Solution (trimethoprim HCl oral solution) Oral Solution for Urinary Tract Infections • Second revenue - generating product in portfolio with established prescriber base • Pediatric co - promotion in place • Opportunity for growth with re - positioning to urologists for urinary tract infecti
Slide 21: Strong Year-over-Year and FY 2016 Quarterly Net Revenue Growth
Strong Year - over - Year and FY 2016 Quarterly Net Revenue Growth – prior to Natesto launching $262,000 $2,563,000 $0 $500,000 $1,000,000 $1,500,000 $2,000,000 $2,500,000 $3,000,000 $3,500,000 FY 2015 FY 2016 Robust Year - over - Year Net Sales Growth $469,000 $669,000 $937,000 $0 $200,000 $400,000
Slide 22: MiOXSYS: First-in-class male infertility diagnostic system
MiOXSYS: First - in - class male infertility diagnostic system
Slide 23: MiOXSYS: Rapid Testing for Male Infertility
MiOXSYS™: Rapid Testing for Male Infertility First - in - Class In Vitro Diagnostic Device • CE Marked ; Rapid IVD test available for in - office testing to screen for infertility 1 • Measures oxidative stress, which is broadly implicated in idiopathic male infertility • Current testing requires hig
Slide 24: 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 <4 years • Previous COO of Ampio Pharmaceuticals/CEO of Luoxis, a specialty biotechnology company •
Slide 25: Capitalization as of September 30, 2016
Capitalization as of September 30, 2016 Common Shares 5,110,591 62.64% Options Issued 1 762,217 9.34% Warrants Outstanding 2 2,286,545 28.02% Fully Diluted Shares 8,159,353 100% 25 1 Weighted average exercise price $3.52 2 Weighted average exercise price $6.11
Slide 26: Summary Financials
Summary Financials 12 Months Ended June 30, 2016 Revenue $ 2,563,000 Operating Expenses: Cost of Sales 957,000 Sales, General & Administrative 8,825,000 Research & Development Impairment of Intangible Assets Amortization of Intangible Assets 6,320,000 7,500,000 665,000 Total Operating Expenses 24,26
Slide 27: Summary Financials
Summary Financials As of Pro Forma As June 30, 2016 Adjusted 1 Cash & Cash Equivalents $ 8,054,000 $ 8,686,000 Working Capital $ 16,000 $ 1,157,000 Total Assets $ 14,223,000 $ 14,854,000 Total Liabilities $ 14,258,000 $ 13,748,000 Total Shareholders’ Equity $ 10,085,000 $ 14,457,000 27 1 Adjust for
Slide 28: Potential Aytu Value Drivers
Potential Aytu Value Drivers x Initial Growth & Value Opportunity • Successfully launch Natesto in the U.S. • Built out full commercial infrastructure • August 2016 launch successfully underway • Continue to grow sales of ProstaScint & Primsol • Reclaim historical prescribing and grow ProstaScint •