PROTALIX BIOTHERAPEUTICS, INC. (PLX)

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Corporate Presentation I October 2023

https://www.marketscreener.com/quote/stock/PROTALIX-BIOTHERAPEUTICS--45401/news/Protalix-BioTherapeutics-PLX-Corporate-Presentation-October-2023-45126311/

Investment Highlights

A Strong Foundation To Further Expand Into The Rare Disease Space

Two Approved Drugs in LSDs

Elelyso® (alfataliglicerase in Brazil): FDA approved, commercially marketed drug for Gaucher disease.

Elfabrio® (pegunigalsidase alfa) has been approved for marketing by the European Commission for Fabry disease and by the FDA.

Clinically-Validated Platforms

Proprietary ProCellEx® platform for recombinant protein expression cGMP manufacturing facility successfully inspected and audited by multiple regulatory agencies, including the FDA & EMA.

Strong Partnerships

Chiesi Farmaceutici S.p.A.

Pfizer Inc.

Fundação Oswaldo Cruz (Fiocruz)

Clinical and Regulatory Expertise in Rare Genetic Space

Strong clinical and regulatory expertise for biologics and world-class network of Lysosomal Storage Disorder disease experts.

Development Pipeline

Uricase (PRX-115) for the treatment of severe gout.

Long Acting DNase I (PRX-119) for the treatment of NETs-related diseases, as well as other product candidates, in discovery and preclinical phases.

Revenue-Generating

Multiple revenue streams, including sales to Pfizer, Fiocruz (Brazil) and Chiesi.

Note: cGMP = Current Good Manufacturing Practice.; LSD: Lysosomal Storage Disorders

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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

(taliglucerase alfa)

Elfabrio®

Fabry Disease

Approved (US and EU)

(pegunigalsidase alfa)

Uricase (PRX-115)Severe GoutFinal results PhI (expected 2Q'24)

Long Acting (LA) DNase I

NETs-Related Diseases

(PRX-119)

Research programs

Rare

Disease

Note: Current pipeline candidates are recombinant proteins expressed via our proprietary ProCellEx® system

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Elelyso® for Gaucher Disease

First plant cell derived recombinant protein approved by the FDA

Gaucher Disease

Rare autosomal recessive disorder: affects 1 in 40,000 people
Glucocerebrosidase (GCD) enzyme deficiency resulting in accumulation of glucosylceramide, a lipid, in bone marrow, lungs, spleen, liver, and sometimes brain
Product

• Elelyso (alfataliglicerase in Brazil) is a proprietary, recombinant form of GCD for long-term treatment of patients with a confirmed diagnosis of type 1 Gaucher disease

Based on ProCellEx® platform
Symptoms and Treatment

Possible symptoms include enlarged liver and spleen, various bone disorders, easy bruising and bleeding and anemia
Left untreated, it can cause permanent body damage and decreased life expectancy
Standard of Care: Enzyme Replacement Therapy
Commercial Potential

Approved in 23 markets
Worldwide exclusive license agreement with Pfizer in 2009, amended in 2015 (excluding Brazil)
Sales ~$9.5M in Brazil (FY2022) via Fundação Oswaldo Cruz
Market Share in Brazil: ~25%
1. Approved in 23 markets including the US, Australia, Canada, Israel, Brazil, Russia and Turkey. In 2010, the European Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion but also concluded that the medicine cannot be granted marketing authorization in the EU because of the market exclusivity that had been granted to Vpriv® (Shire), which was authorized in August 2010, for the same condition. The orphan market exclusivity expired in August 2022.

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Elfabrio® for Fabry Disease

Second plant cell derived recombinant protein approved by the FDA

Fabry Disease

Rare X-linked disease: affecting about one in every 40,000 to 60,000 men worldwide
a-galactosidase-Aenzyme deficiency leads to accumulation of the fatty substance globotriaosylceramide (Gb3) in blood and blood vessel walls throughout the body
Product

• Elfabrio (pegunigalsidase alfa): Chemically Modified, Plant Cell Derived, PEGylated, Covalently Linked Homodimer

Approved for marketing by the European
Commission and by the FDA

Symptoms and Treatment

Progressive disease that can lead to renal failure, cardiomyopathy with potentially malignant cardiac arrhythmias, and strokes
Symptoms such as abdominal and neuropathic pain can appear in patients as young as two years old
Standard of Care: Enzyme Replacement Therapy (Replagal® or Fabrazyme®1,2)
Commercial Potential

Fabry: ~$2B (2022) expected to reach ~$3B (2030)
Poised to capture significant global market share (20-25%)
Will potentially be entitled to $150M-$200Mroyalties per year from Chiesi 3
Does not include Galafold®, a small molecule drug indicated for adult Fabry patients with an amenable GLA variant.
Replagal is not approved in the US.
Based on projected 20-25% share of projected market size increase to ~$2.9 billion by 2028.
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Committed Commercial Partner

Global Partnership with

Chiesi Farmaceutici S.p.A.

International research-focused pharmaceuticals and healthcare group with
~$3B in revenue

Operating in 30 countries with over 6,000 employees
Strong sales and marketing partner poised to maximize the market potential of pegunigalsidase alfa as the centerpiece of their new strategic U.S.-based Orphan Drug division
• Committed global partner with experienced sales team

Strategic focus on Rare Disease
Specific expertise in Fabry Disease
Ideally suited to bring Elfabrio® to
patients in Fabry Disease*

*Tiered royalties of 15-35%(ex-US);15-40% (US)

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Growing Focus on High Unmet Needs in Rare Disease Space

Focus on Rare Disease Space

Goal: Within 2 years, 4-6discovery to PhII programs in the pipeline

Rare Genetic

and Non-

Genetic

Rare Genetic

Lysosomal

Storage

Disorders

Our Strategy: Focus on rare diseases space

Both genetic and non-genetic opportunities
Prioritize opportunities with LCM potential
Diseases with high unmet needs
Surrogate endpoints/biomarkers
Systematic Approach to BD&L Screen

Significant in-licensing to build a sustainable portfolio
Open to modalities outside protein (exc. CGT)
Protalix has initiated a large BD&L process to bring in novel opportunities in the rare disease space
Protalix is also reviewing emerging innovative platforms
In-House Discovery Pipeline based on Protein Capabilities

Leveraging ProCellEx platform and PEGylation capabilities for highly innovative opportunities
Reinforce protein capabilities
CGT = Cell and Gene Therapies; LCM = Life cycle management

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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

Initial Success

Protalix Now

Vision

Next Steps

May 2012:

May 2023:

Protalix's 1st approved product

Protalix's 2nd approved product

Within 2 years, 4-6 discovery to PhII programs

Reinforce Protein Discovery

Capabilities

BD&L: Preclinical/Clinical Pipeline

Develop highly innovative rare disease treatments addressing real unmet needs

Building a significant pipeline with innovative rare disease clinical programs

Fully Integrated with End-to-Endcapabilities

Commercial infrastructure to support novel products

Leveraging novel technology platforms with broad potential in rare diseases

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