Protalix BioTherapeutics, Inc. (de) · AMEX:PLX
Protalix BioTherapeutics, Inc. (de) — Investor Presentation (September 2020)
19 slides from Protalix BioTherapeutics, Inc. (de)'s investor presentation, September 2020
Slide 1: Protalix BioTherapeutics Corporate Presentation September 2020
Protalix BioTherapeutics, Inc. C O R P O R AT E P R E S E N TAT I O N | S E P T E M B E R 2 0 2 0
Slide 2: Note Regarding Forward-Looking Statements
Note Regarding Forward-Looking Statements This presentation (the “Presentation”) contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements, including, among others, st
Slide 3: Investment Highlights
Investment Highlights Plant cell expressed recombinant proteins with improved therapeutic profiles Revenue Generating FDA approved, commercially marketed drug for Gaucher disease. FDA accepted BLA in August 2020 and granted Priority Review for lead asset pegunigalsidase alfa (PRX-102) for the treatm
Slide 4: ProCellEx Platform
ProCellEx® Platform First and only company to gain FDA approval of a protein produced through plant cell based expression DEVELOPMENT OF TRANSGENIC CELL LINES FOR PRODUCTION OF TARGET PROTEIN Agrobacterium mediated cell transformation using the natural capability of the agrobacteria to transfer DNA
Slide 5: Advantages of Proprietary Plant Based Platform (ProCellEx)
Advantages of Proprietary Plant Based Platform (ProCellEx®) Experienced internal interdisciplinary capabilities to Ability to express certain proteins that are improve biologic dynamics (e.g., glycosylation, half-life, difficult to express in other systems immunogenicity) of a protein Biologic Can H
Slide 6: Elelyso for Gaucher Disease
Elelyso® for Gaucher Disease First plant cell derived recombinant protein Elelyso provides a consistent (and growing) revenue stream approved by the for Protalix while validating the ProCellEx platform technology and demonstrating the company’s manufacturing and production expertise Validation of th
Slide 7: Product Pipeline
Product Pipeline Recombinant proteins with improved therapeutic profiles that target unmet medical needs and established pharmaceutical markets DISCOVERY AND PRECLINICAL PHASE I PHASE II PHASE III pegunigalsidase alfa (PRX-102) Fabry Disease tulinercept (OPRX-106) Inflammatory Bowel Disease (UC) ali
Slide 8: Pegunigalsidase alfa (PRX-102) for Fabry Disease
Pegunigalsidase alfa (PRX-102) for Fabry Disease Fabry disease is primarily treated with Rare genetic disease ~$2B+ growing market enzyme replacement therapy occurs in one of every (expected CAGR ~10%) (ERT), to replace the missing 40,000 people. alpha Galactosidase-A enzyme with a recombinant form
Slide 9: Fabry Disease – Treatment Opportunities
Fabry Disease – Treatment Opportunities Affected organ targeting Reduction of Dosing frequency globotriaosylceramide (Gb3) burden in kidney biopsies Improved clinical Improved QOL measures Immunogenicity ©2020 Protalix BioTherapeutics, Inc. 9
Slide 10: Fabry Disease Competitive Landscape
Fabry Fabry Disease Disease Competitive Competitive Landscape Landscape Product Name Fabrazyme® Replagal® Galafold® Parent Company Sanofi Shire Amicus Mechanism ERT ERT Pharmacological chaperone Indication Fabrazyme is indicated for use in patients Replagal is indicated for long-term enzyme GALAFOLD
Slide 11: Pegunigalsidase alfa (PRX-102) for Fabry Disease
Pegunigalsidase alfa (PRX-102) for Fabry Disease pegunigalsidase • Chemically modified plant recombinant alpha-Galactosidase-A designed to provide active and stable alfa (PRX-102) enzyme throughout infusion interval for a potentially improved clinical benefit. • Demonstrated significant improvement
Slide 12: Pegunigalsidase alfa (PRX-102) Clinical Program
Pegunigalsidase alfa (PRX-102) Clinical Program Design Number of Patients Next Data Read-Out 1mg / kg 2 weeks Randomized Double Blind Head-to-Head vs. 78 Interim Results – 12 mos. follow up Fabrazyme® 100% Enrolled Expected H1 2021 24 mos. (Basis for EMA Submission) 1mg / kg 2 weeks Open Label Switc
Slide 13: Committed Commercial Partner
Committed Commercial Partner Global Partnership with Chiesi Farmaceutici S.p.A. Up to $1+ billion in potential milestone payments Chiesi’s 6,000 employees and $2B in revenue (2019) provides PLX with the strong Sales & Marketing partner to maximize Unigal’s market potential (pending approval) as the
Slide 14: Protalix Upcoming Expected Milestones
Protalix Upcoming Expected Milestones Q2 2020 Q1 2020 Q3 2020 Q1 2021 H1 2021 Top-Line results of SarcoMed USA BLA Acceptance for Anticipated FDA Anticipated launch of BRIDGE Agreement to develop pegunigalsidase alfa approval of pegunigalsidase alfa alidornase alfa for the and Priority Review peguni
Slide 15: Tulinercept (OPRX-106) for Inflammatory Bowel Disease (IBD)
Tulinercept (OPRX-106) for Inflammatory Bowel Disease (IBD) Tulinercept is a cutting edge development candidate for IBD expressed via ProCellEx® for oral delivery of recombinant proteins whereby the plant cell wall increases resistance and delays to degradation as compared to proteins produced via m
Slide 16: Tulinercept (OPRX-106) for IBD
Tulinercept (OPRX-106) for IBD CLINICAL RESULTS FROM PHASE IIA POSITIONING & UPSIDE • 89% of patients experienced improvements in Mayo Score; 72% • Anti-TNF alfa mechanism – known and established first line treatment improved rectal bleeding; 72% improvement in fecal calprotectin and for steroid ref
Slide 17: Alidornase alfa (PRX-110): Actin Inhibition Resistant DNase
Alidornase alfa (PRX-110): Actin Inhibition Resistant DNase OVERVIEW POSITIONING • Alidornase alfa is a plant cell expressed recombinant human DNase I • Biologically active and safe in humans, alidornase alfa is being chemically modified to resist inhibition by actin, thus enhancing developed for ot
Slide 18: Well Capitalized with Strong Institutional Shareholder Support
Well Capitalized with Strong Institutional Shareholder Support Recent ~$44M financing (March 2020) Cash = $40M (2Q’20) $8.7M in revenue (H1 20) Cash Runway to 2Q’22 Burn rate of $6M/Q, declining as patients shift over to extension study UBS O’Connor $58M in debt (Convertible Notes) due N
Slide 19: Experienced Leadership Team
Experienced Leadership Team Mr. Bashan has served as our President and Chief Executive Officer since June 2019. He has over 20 years DROR BASHAN of experience in the pharmaceutical industry with roles ranging from business development, marketing, sales President & CEO and finance, providing him with
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