Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — IPO Roadshow (August 2020)
28 slides from Fortress Biotech's IPO roadshow presentation, Aug 24, 2020
Slide 1: Corporate Presentation August 2020
CORPORATE PRESENTATION August 2020 Fortress Biotech FREE WRITING PROSPECTUS Filed Pursuant to Rule 433 Registration No. 333 - 226089 August 24, 2020
Slide 2: Free writing prospectus legend
The issuer has filed a registration statement (including a prospectus) and a preliminary prospectus supplement with the SEC for the offering to which this communication relates . Before you invest, you should read the prospectus in that registration statement, the preliminary prospectus supplement,
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 . For such forward - looking statements, we claim the protection of the safe h
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: 2,693,806 Monthly Dividends: $0.1953125 Dividend Payment Dates: Monthly on the last calendar day of each month L
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 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 $21.4 2016 2017 2018 2019 1H 2020 $ in millions 331% GROWTH 51% GROWTH 49% GROWTH 50% GROWTH OVER 1H 2019 8
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
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 Relatively de - ris
Slide 11: 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 11
Slide 12: Top-tier Academic & Commercial Partners
Top - tier Academic & Commercial Partners 12
Slide 13: 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 14: Pipeline: Late-stage candidates and milestones
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 15: Pipeline: Early clinical candidates and milestones
Candidate* Indication Preclinical Phase 1 Phase 2 Phase 3 Next Milestone Partnership % / Royalty † MB - 102 AML, BPDCN, and hrMDS First patient expected to be treated in Mustang IND trial 3Q 2020 25% Mustang; 4.5% Royalty $500M - $700M CEVA - 101 Traumatic Brain Injury (pediatric and adult) Phase 2
Slide 16: Pipeline: Preclinical candidates and milestones
Candidate* Indication Preclinical Phase 1 Phase 2 Phase 3 Next Milestone Partnership % / Royalty † Potential Peak Sales Revenue^ ATVS - 001 Gene Therapy AMD, PNH, and aHUS Non - human primate long - term toxicology data and additional POC in Dry AMD 62% Aevitas; 4.5% Royalty >$1B AAV - ATP7A Gene Th
Slide 17: Potential Near-term Value-Creating Events for FBIO Shareholders
17 Potential Near - term Value - Creating Events for FBIO Shareholders 1 IV Tramadol, CAEL - 101, Cosibelimab, CK - 101, CUTX - 101, MB - 107 (newly diagnosed XSCID), MB - 207 (previously transplanted XSCID) an d ONCOlogues are product candidates in development at FBIO partner companies 2 Fortress t
Slide 18: MB-107 & MB-207 for XSCID
18 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; Ra
Slide 19: CUTX-101 for Menkes Disease
19 o FDA granted Rare Pediatric Disease, Orphan Drug and Fast Track designations o EMA granted Orphan Medicinal Product Designation 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 F
Slide 20: Cosibelimab Anti-PD-L1
20 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 21: CK-101 Third-Gen EGFR Inhibitor
21 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 22: IV Tramadol for Post-operative Pain
Est. Market Estimated Peak Sales of $790M** Status FDA accepted NDA submission for review Next Steps PDUFA action date of October 10, 2020 CVRs Worth 10 - 20% of gross profits*** 22 o Uniquely positioned to address need for new post - operative pain therapies amid opioid crisis o Potential to replac
Slide 23: CAEL-101 for AL Amyloidosis
23 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 24: ONCOlogues: Gene-Silencing at the DNA Level
24 o Delivery platform allows PNAs to enter cell membrane & nucleus, displacing mutant DNA strand, preventing mutant mRNA transcription o ONCOlogues work higher upstream than traditional antisense and small molecule approaches, targeting the root of genetic disease o KRAS G12D remains a complete unm
Slide 25: BAER-101 for CNS Disorders
25 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 26: Key Takeaways
26 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 27: Financial Snapshot
NASDAQ FBIO Shares outstanding as of 6/30/20: 86,113,331 Market Cap as of 8/17/20: ~$279.0 million Consolidated cash as of 6/30/20: $199.9 million 1 FBIO standalone cash as of 6/30/20: $86.3 million 2 Value of FBIO ownership of public partner companies as of 8/17/20: ~$109.1 million 3 1 C onsolidate
Slide 28: Investment Highlights
Investment Highlights 28 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