Protalix Biotherapeutics, Inc. (de) · AMEX:PLX
Protalix Biotherapeutics, Inc. (de) — Investor Presentation (December 2016)
17 slides from Protalix Biotherapeutics, Inc. (de)'s investor presentation, Dec 2, 2016
Slide 1: Company Presentation December 2016
Company Presentation December 2016 www.protalix.com 8 , 181 , 153 37 , 93 , 168 3 , 173 , 235 49 , 132 , 174 118, 206, 190 178, 213, 230
Slide 2: Note Regarding Forward-Looking Statements
www.protalix.com Note Regarding Forward - Looking Statements This presentation contains forward - looking statements . To the extent that statements in this presentation are not strictly historical, all such statements are forward - looking, and are made pursuant to the safe - harbour provisions of
Slide 3: Multiple Pathways for Growth
www.protalix.com Multiple Pathways for Growth • Well - funded biotechnology company positioned to capitalize on its product pipeline Funded through 2019, with pro - forma cash balance of $71.4 million (1) Potential for licensing/partnership opportunities to provide additional future funding • One ma
Slide 4: Protalix Leadership Team
www.protalix.com Protalix Leadership Team • Mr. Manor has served as President, Chief Executive Officer and Director since November 2014 • He also served in a number of senior executive positions at Teva from 1984 through 2012 . Most recently, he served as President of Teva Asia & Pacific where he le
Slide 5: Pro Forma Capitalization
www.protalix.com (1) Estimated based on expected transaction fees & expenses. Excludes accrued interest to be paid on retired 4.50% Convertib le Notes due 2018. ( 2 ) Based on a $0.5595 stock price at time of the exchange. Pro Forma Capitalization • Proceeds from private placement will be used to fu
Slide 6: Proprietary pipeline development capability is a key asset
www.protalix.com Protalix’s proprietary pipeline development capability is a key asset Source: Company information (1) Product marketed under the name of Uplyso in Brazil and certain other Latin American countries and Elelyso in the rest of the territories ProCellEx plant cell - based protein expres
Slide 7: Pipeline Overview
www.protalix.com Pipeline Overview Phase I Phase II Phase III Oral anti - TNF for Ulcerative Colitis OPRX - 106 AIR DNAse TM for Cystic Fibrosis PRX - 110 for Fabry Disease PRX - 102 ( 1 ) (1) Pending WHO publication (2) GlobalData ~$5.5 billion ~ $ 2.0 billion ~ $ 1.2 billion Estimated Current Mark
Slide 8: Key Opportunity: PRX-102 – A Bio-Better for Fabry Disease
www.protalix.com Key Opportunity: PRX - 102 – A Bio - Better for Fabry Disease • Rare genetic lysosomal storage disorder caused by deficiency in the enzyme α - galactosidase A. ~ 5 , 000 patients treated worldwide • Lipids accumulate in key organs (kidney, heart, CNS ) leading to a progressive and p
Slide 9: Fabry disease remains a high unmet need for which PRX-102 will be a bio-better
www.protalix.com Fabry disease remains a high unmet need for which we believe PRX - 102 will be a bio - better Peak Sales Potential of $ 1 Bn Annually • At current rate, market is projected to grow from $1.2 billion to $1.7 billion in the next 5 years (1) • Target – Worldwide Naïve & Switch patients
Slide 10: Results from Phase I/II Clinical Trial (PRX-102)
www.protalix.com 8 , 181 , 153 37 , 93 , 168 3 , 173 , 235 49, 132, 174 118, 206, 190 178, 213, 230 Plasma pegunigalsidase alfa concentration vs. time (PRX - 102 ) Results from Phase I/II Clinical Trial (1) Fabrazyme ® Prescribing Information (2) Measured as Annualized Rate of Estimated GFR Change (
Slide 11: Phase III Pivotal Trial Initiated (PRX-102)
www.protalix.com 8 , 181 , 153 37, 93, 168 3, 173, 235 49, 132, 174 118 , 206 , 190 178 , 213 , 230 • Randomized, double blind, active control study of PRX - 102 ( pegunigalsidase alfa ) compared to Fabrazyme ® in Fabry patients previously treated with Fabrazyme ® • Patients enrolment ongoing: 78 cl
Slide 12: Supportive Clinical Trial (PRX-102)
www.protalix.com 8 , 181 , 153 37, 93, 168 3, 173, 235 49 , 132 , 174 118 , 206 , 190 178 , 213 , 230 • Open label, single arm switch over study to assess the efficacy and safety of PRX - 102 ( pegunigalsidase alfa) in Fabry patients currently treated with Replagal ® • Number of patients to be enrol
Slide 13: Summary of Global Clinical Program to Support Filing
www.protalix.com 8, 181, 153 37, 93, 168 3 , 173 , 235 49 , 132 , 174 118 , 206 , 190 178, 213, 230 Head to Head vs. Fabrazyme ® in Switch Patients Switch - over from Replagal ® FDA 24 months Superiority Supportive – 12 months EMA Rest of World 12 months Comparability (potential for superiority ) Su
Slide 14: Key Opportunity: PRX-110 – Cystic Fibrosis
www.protalix.com Key Opportunity: PRX - 110 – Cystic Fibrosis (CF) • Rare genetic disease characterized by a highly viscous mucus most prominently leading to severe lung damage and loss of respiratory function • ~70,000 CF patients worldwide (1) – figure still growing, with patients needing care for
Slide 15: PRX-110: AIR DNase Clinical Development Plan for Cystic Fibrosis
www.protalix.com PRX - 110: AIR DNase TM Clinical Development Plan for Cystic Fibrosis • Chemically modified DNase enzyme resistant to inhibition by actin, thus designed to enhance the enzyme’s efficacy in CF patients’ sputa • Phase I: 18 healthy volunteers – Completed ─ AIR DNase TM found to be saf
Slide 16: Key Opportunity: OPRX-106 – Ulcerative Colitis
www.protalix.com Key Opportunity: OPRX - 106 – Ulcerative Colitis • Anti - tumor Necrosis Factor Alpha (anti - TNF α) for Inflammatory Diseases • Anti - TNF market >$ 30 billion with multiple blockbuster products (injections and IV infusions ) • Multiple indications: ─ Ulcerative Colitis (~$ 5.5 bil
Slide 17: OPRX-106 Phase II
www.protalix.com OPRX - 106 Phase II • First patient enrolled 30 November, 2016 • Potential to locally deliver higher doses with fewer side effects in an oral formulation • Study design: ─ 15 mild to moderate untreated ulcerative colitis patients ─ Oral once daily administration - 8 week treatment d
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