Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — IPO Roadshow (November 2019)
22 slides from Fortress Biotech's IPO roadshow presentation, Nov 12, 2019
Slide 1: Corporate Presentation November 2019
CORPORATE PRESENTATION November 2019 Fortress Biotech FREE WRITING PROSPECTUS Filed Pursuant to Rule 433 Registration No. 333 - 226089 November 12, 2019
Slide 2: Free writing 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: 1,039,292 Dividends: $2.34375 Dividend Payment Dates: Quarterly on March 31, June 30, September 30 and December
Slide 5: Fortress Biotech Programs
Commercial Late Clinical Early Clinical Preclinical Targadox Cosibelimab MB - 102 ATVS - 001 Gene Therapy Ximino MB - 107 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 Tramadol MB - 108 CEV
Slide 6: Generating Shareholder Value
Generating Shareholder Value Fortress Biotech Creating value in five ways 6
Slide 7: Dermatology Product Revenue Growth
Dermatology Product Revenue Growth 7 Expect to in - license 1 to 3 new products in 2019 Reaching >70% of market via top 5,000 prescribing dermatologists $3,600,000 $15,520,000 $23,376,000 2016* 2017 2018 *Sales commenced in Q4 2016
Slide 8: 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. 8
Slide 9: How We Do It: Development Team, Programs, Secret Sauce
9 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 asset
Slide 10: Management 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 10
Slide 11: Near-term Monetization Opportunities
o Upon FDA approval and other conditions 1 o $180 Million aggregate cash purchase; $166M net of fees (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 prof
Slide 12: Near-Term Value Creating Pipeline Assets
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 File NDA by year - end 2019 29% Avenue** 10 - 20% CVR Royalty on gross profits**** ~$790M MB - 107 Gene Therapy XSCID I
Slide 13: MB-107 XSCID Gene Therapy
13 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 granted by FDA in August 2019 o Published clin
Slide 14: CUTX-101 Menkes Disease
14 o FDA granted 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 Assets Menkes Disease E
Slide 15: CK-101 Third-Gen EGFR Inhibitor
15 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 16: Cosibelimab Anti-PD-L1
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: IV Tramadol Post-operative Pain
Est. Market Estimated Peak Sales of $790M** Status Announced Positive Topline Data from 2 nd Pivotal Phase 3 Trial Next Steps File NDA by year - end 2019 Royalty to FBIO CVRs worth 10 - 20% of gross profits** 17 o Uniquely positioned to address need for new post - operative pain therapies amid opioi
Slide 18: CAEL-101 AL Amyloidosis
18 o Granted Orphan Drug designation 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* Fortress Biotech Near -
Slide 19: Top-tier Academic & Commercial Partners
Top - tier Academic & Commercial Partners 19
Slide 20: 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, and CEVA - 101 are product candidates in development at FBIO partner companies 2 Based on internal forecasts Fortress to receive ~1/3 of CVR royalty IV Tramadol
Slide 21: Financial Snapshot
NASDAQ FBIO Shares outstanding as of 9/30/19: 70,335,534 Market Cap as of 10/31/19: ~$99.2 million Consolidated cash as of 9/30/19: $156.0 million 1 FBIO standalone cash as of 09/30/19: $55.9 million 2 Value of FBIO ownership of public partner companies as of 10/31/19: ~$77.7 million 3 1 C onsolidat
Slide 22: Investment Highlights
Investment Highlights 22 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