Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — IPO Roadshow (May 2020)
25 slides from Fortress Biotech's IPO roadshow presentation, May 19, 2020
Slide 1: Corporate Presentation May 2020 - Fortress Biotech
CORPORATE PRESENTATION May 2020 Fortress Biotech FREE WRITING PROSPECTUS Filed Pursuant to Rule 433 Registration No. 333 - 226089 May 18, 2020
Slide 2: Registration statement and prospectus notice
The issuer has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates . Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more complete informat
Slide 3: Forward Looking Statements
Forward Looking Statements This presentation may contain “forward - looking statements” within the meaning of Section 27 A of the Securities Act of 1933 and Section 21 E of the Securities Exchange Act of 1934 , as amended . As used below and throughout this presentation, the words “we”, “us” and “ou
Slide 4: Summary of Expected Offering Terms
Summary of Expected Offering Terms Security: 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock Current Nasdaq Symbol: FBIOP Number of Preferred Shares Currently Outstanding: 2,054,917 Quarterly Dividends: $2.34375 Dividend Payment Dates: Quarterly on March 31, June 30, September 30 and
Slide 5: The Opportunity
5 The Opportunity ONE TWO THREE FOUR Valuation Dislocation Near - term Key Catalysts that will Create Value Opportunities Robust Pipeline with 25+ Development - stage Biotech Product Candidates 1 Solid Track Record of Execution FIVE Near - term Revenue Growth 1 Includes employees and product candida
Slide 6: Fortress Biotech Programs
Commercial Late Clinical Early Clinical Preclinical Targadox ® Cosibelimab MB - 102 ATVS - 001 Gene Therapy Ximino ® MB - 107 / MB - 207 CK - 101 AAV - ATP7A Gene Therapy Exelderm ® CAEL - 101 MB - 101 Anti - GITR Ceracade ® CUTX - 101 MB - 106 Anti - CAIX Luxamend ® CEVA - 101 MB - 103 CK - 103 IV
Slide 7: Generating Cash Flow & Shareholder Value
Generating Cash Flow & Shareholder Value 7 Creating value in five ways Fortress Biotech
Slide 8: Dermatology Product Revenue Growth
Dermatology Product Revenue Growth 8 Expect to acquire 1 to 2 new products in 2020 Reaching >70% of market via top 5,000 prescribing dermatologists $3.6 $15.5 $23.4 $34.9 $11.9 2016 2017 2018 2019 Q1 2020 $ in millions 331% GROWTH 51% GROWTH 49% GROWTH 95% GROWTH OVER Q1 2019
Slide 9: Strategy: Identify, Develop, Monetize
Identify Monetize Develop Strategy To build a pipeline of both development - stage / commercial - stage assets and leverage the most efficient course to move products forward with our partners. 9
Slide 10: How We Do It: Secret Sauce
10 Development Team Programs Secret Sauce How We Do It o 10+ Business Development Professionals o 30+ Manufacturing Professionals 1 o 25+ MDs and PhDs 1 o Current portfolio includes: 5 revenue - generating dermatology products o 25+ development - stage biotech product candidates 1 o De - risked asse
Slide 11: Profiles
Lindsay Rosenwald, MD Chairman, President, and CEO Michael S. Weiss Co - Vice Chairman of the Board, Strategic Development Eric K. Rowinsky, MD Co - Vice Chairman of the Board Robyn Hunter Chief Financial Officer George C. Avgerinos, PhD Senior Vice President, Operations Management Profiles 11
Slide 12: Near-term Monetization Opportunities
o Upon FDA approval and other conditions 1 o $180 Million aggregate cash purchase; (est. $13.92/share) 1 ; FBIO 29% or eligible to receive ~$48M of the distribution net of fees o Potential additional payments pursuant to Contingent Value Rights; CVR payout of 10 - 20% of gross profits 2 o FBIO stand
Slide 13: Near-term value creating pipeline candidates
Candidate* Indication Phase 1 Phase 2 Phase 3 Next Milestone Partnership % / Royalty † Potential Peak Sales Revenue^ IV Tramadol Moderate to moderately severe post - operative pain PDUFA action date of October 10, 2020 29% Avenue** 10 - 20% CVR Royalty on gross profits**** ~$790M MB - 107 & MB - 207
Slide 14: MB-107 & MB-207 XSCID
14 o Lentiviral vector gene therapy o ~1 in 225k newborns per year (U.S.) o ~400 patients living with XSCID post - transplant in the US and ~650 patients living with XSCID post - transplant in high and mid - income ex - U.S. countries o RMAT Designation for MB - 107 granted by FDA in August 2019 o P
Slide 15: CUTX-101 Menkes Disease
15 o FDA granted Rare Pediatric Disease, Orphan Drug and Fast Track designations o Would be the first FDA approved therapy in this indication o Eligible for Rare Pediatric Disease Priority Review Voucher (valuation range ~$75M to $110M) CUTX - 101 Fortress Biotech Near - Term Value Creating Pipeline
Slide 16: Cosibelimab
16 o Fully human IgG1 monoclonal antibody o Potential therapy for lung cancer, endometrial cancer, colorectal cancer and cutaneous squamous cell carcinoma o Potentially differentiated vs marketed PD - (L)1s o Interim P1 data showed efficacy in multiple tumor types w/ well tolerated safety profile o
Slide 17: CK-101
17 o Irreversible inhibitor against selective mutations of EGFR o Potential to be effective in NSCLC patients with susceptible mutations as a monotherapy or in combination with anti - tumor immune potentiating therapies o Interim P1 data presented at 2018 World Conference on Lung Cancer o Potential
Slide 18: IV Tramadol
Est. Market Estimated Peak Sales of $790M** Status FDA accepted NDA submission for review Next Steps PDUFA action date of October 10, 2020 Royalty to FBIO CVRs worth 10 - 20% of gross profits*** 18 o Uniquely positioned to address need for new post - operative pain therapies amid opioid crisis o Pot
Slide 19: CAEL-101 AL Amyloidosis
19 o Granted Orphan Drug designations in the U.S. and EU o No FDA, EMEA, or PMDA approved therapies in this indication o ~30k - 45k patients in U.S. and EU o ~4.5k newly - diagnosed patients (U.S.) per year o Potentially understated market size given AL Amyloidosis often misdiagnosed CAEL - 101* For
Slide 20: BAER-101
20 o High affinity, selective modulator of GABA α receptor system o Selective positive allosteric modulator (PAM) for GABAα2/3, minimizing adverse events that are typically seen with benzodiazepines, which are non - selective agonists o Established safety profile o Epilepsy is among the most prevale
Slide 21: Top-tier Academic & Commercial Partners
Top - tier Academic & Commercial Partners 21
Slide 22: Potential Near-term Value-Creating Events for FBIO Shareholders
Potential Near - term Value - Creating Events for FBIO Shareholders 1 IV Tramadol, CAEL - 101, Cosibelimab, CK - 101, CUTX - 101, MB - 107 (newly diagnosed XSCID) and MB - 207 (previously transplanted XSCID) are product candidates in development at FBIO partner companies 2 Fortress to receive ~1/3 o
Slide 23: Key Takeaways
23 Key Takeaways ONE TWO THREE FOUR Valuation Dislocation Near - term Key Catalysts that will Create Value Opportunities Robust Pipeline with 25+ Development - stage Biotech Product Candidates 1 Solid Track Record of Execution FIVE Near - term Revenue Growth 1 Includes employees and product candidat
Slide 24: Fortress Biotech Financial Snapshot
NASDAQ FBIO Shares outstanding as of 3/31/20: 78,572,169 Market Cap as of 4/29/20: ~$157.8 million Consolidated cash as of 3/31/20: $152.5 million 1 FBIO standalone cash as of 3/31/20: $67.6 million 2 Value of FBIO ownership of public partner companies as of 4/29/20: ~$95.2 million 3 1 C onsolidated
Slide 25: Investment Highlights
Investment Highlights 25 o World class management team with extensive experience in all facets of biotech with multiple successful exits ; o Implementing revenue generating model focusing on low risk and low cost portfolio acquisition using strategic partners for funding ; o Deep existing portfolio