Protalix BioTherapeutics, Inc. (de) · AMEX:PLX
Protalix BioTherapeutics, Inc. (de) — Investor Presentation (May 2024)
19 slides from Protalix BioTherapeutics, Inc. (de)'s investor presentation, May 2024
Slide 1: Protalix Biotherapeutics Corporate Presentation
PROTALIX BIOTHERAPEUTICS CORPORATE PRESENTATION May 2024 1
Slide 2: Disclaimers
Disclaimers Third-Party Information This presentation also contains estimates and other data made by independent parties and Protalix relating to market size and growth and other data related to the industry in which Protalix operates. This data involves a number of assumptions and limitations, and
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Forward-looking statements are neither histor
Slide 4: Investment Highlights
Investment Highlights A strong foundation to further expand into the Rare Disease space Two Approved Drugs Clinical and Regulatory Expertise in Rare Elelyso® (alfataliglicerase in Brazil): FDA approved, commercially Genetic Space marketed drug for Gaucher disease. Strong clinical and regulatory expe
Slide 5: Product Pipeline
Product Pipeline Recombinant proteins designed to have potentially improved therapeutic profiles that target unmet medical needs and established pharmaceutical markets Discovery and Preclinical Phase I Phase II Phase III Marketing Application Elelyso® Gaucher Disease Approved in 23 markets (taligluc
Slide 6: Elelyso for Gaucher Disease
Elelyso® for Gaucher Disease First plant cell derived recombinant protein approved by the FDA Gaucher Disease Symptoms and Treatment • Rare autosomal recessive disorder: affects 1 in • Possible symptoms include enlarged liver and 40,000 people spleen, various bone disorders, easy bruising and • Gluc
Slide 7: Elfabrio for Fabry Disease
Elfabrio® for Fabry Disease Second plant cell derived recombinant protein approved by the FDA Fabry Disease Symptoms and Treatment • Progressive disease that can lead to renal failure, • Rare X-linked disease: affecting about one in every cardiomyopathy with potentially malignant cardiac 40,000 to 6
Slide 8: Fabry Disease Competitive Landscape
Fabry Disease Competitive Landscape ~$2B market (2023) expected to reach over $3.1B (2030), CAGR of 6.8% Product Name Fabrazyme® Replagal® Galafold® Elfabrio® Parent Company Mechanism ERT ERT Pharmacological chaperone ERT Approved for Adults and pediatric patients 2+ Adults (E.U. only) Accelerated a
Slide 9: Committed Commercial Partner Chiesi Farmaceutici S.p.A.
Committed Commercial Partner Global Partnership with Chiesi Farmaceutici S.p.A. • International research-focused • Committed global partner with biopharmaceutical group with sales in excess of $3B in 2023 (reflecting 10% experienced sales team growth year-on-year • Strategic focus on rare diseases •
Slide 10: Gout
Gout Most Common Accumulation of Excess Uric Systemic Disease Currently Available Therapies Inflammatory Arthritis Acid Gout affects Hyperuricemia leads to Gout flares can lead to First-line xanthine oxidase approximately 14 million deposition of monosodium substantial morbidity, severe inhibitors (
Slide 11: PRX-115 has Significant Potential in Uncontrolled Gout
PRX-115 has Significant Potential in Uncontrolled Gout An estimated approximately 5% of the gout population is considered to have chronic refractory disease Gout is generally considered severe when urate crystals occur with any of the following: Chronic Refractory • Frequent recurrent gout flares Go
Slide 12: PRX-115: Chemically Modified, Plant Cell Derived, PEGylated Homotetramer
PRX-115: Chemically Modified, Plant Cell Derived, PEGylated, Covalently Linked Homotetramer • PRX-115 is a PEGylated enzyme designed to potentially have lower immunogenicity and an improved safety profile • PRX-115 is a plant cell-based recombinant Candida Utilis Uricase with substitution of Cystein
Slide 13: PRX-115 Phase I Single Ascending Dose Study Preliminary Data Summary
PRX-115 Phase I Single Ascending Dose Study Preliminary Data Summary First in Human trial enrolled 56 subjects with elevated uric acid levels across 7 dose cohorts Safety Pharmacokinetics and Pharmacodynamics Favorable tolerability profile Rapid reduction of plasma uric acid concentrations to below
Slide 14: PRX-115 Overview
PRX-115 Overview Recombinant PEGylated Uricase Enzyme for Potential Treatment of Uncontrolled Gout Addressable Market Asset Overview Approximately 14 million U.S. gout • Recombinant PEGylated uricase enzyme produced via patients ProCellEx plant cell-based expression system • Favorable safety and tol
Slide 15: Growing Focus on High Unmet Needs in Rare Disease Space
Growing Focus on High Unmet Needs in Rare Disease Space Focus on Rare Disease Space Our Strategy: Focus on Rare Disease space Goal: Within 3 years, 4-5 discovery to PhII programs in the pipeline • Both genetic and non-genetic opportunities • Prioritize opportunities with LCM potential Rare Genetic •
Slide 16: Evolving Protalix: Addressing High Unmet Needs in the Rare Disease Space
Evolving Protalix: Addressing High Unmet Needs in the Rare Disease Space Leveraging track record of success into other rare diseases Strategy Striving for Continued Success in Rare Diseases (Genetic and Non-Genetic) Track Record of Success in Rare Genetic Space Vision Next Steps Protalix Now Initial
Slide 17: Well Capitalized to Advance Protalix to Next Phase
Well Capitalized to Advance Protalix to Next Phase CASH REVENUE $48.5M (Q1 2024) $3.7M in revenue (Q1 2024) Cash Streams NET BURN RATE Three revenue and cash streams from Projected: 0 to +$1.5 M/Q Pfizer, Fiocruz and Chiesi CASH RUNWAY(1) DEBT Sufficient cash to support the $20.4M in debt (Convertib
Slide 18: Experienced Leadership Team
Experienced Leadership Team DROR BASHAN SHOSHI TESSLER, PH.D. EYAL RUBIN YARON NAOS YAEL HAYON, PH.D. President & CEO VP, Clinical Development SVP & CFO SVP of Operations VP of R&D & Regulatory Affairs Mr. Bashan has served as our Dr. Tessler joined Protalix in Mr. Rubin has served as our SVP Mr. Na
Slide 19: Accomplished Board of Directors
Accomplished Board of Directors ELIOT FORSTER, PH.D. DROR BASHAN POL F. BOUDES, M.D. GWEN A. MELINCOFF Chairman President & CEO, Director Director Director AHARON SCHWARTZ, PH.D. AMOS BAR SHALEV SHMUEL “MULI” BEN ZVI, PH.D. Director Director Director Corporate Presentation I May 2024 19
Protalix BioTherapeutics — Investor Presentation (May 2024) on 6ix