Kamada Ltd. · NASDAQ:KMDA
Kamada — Investor Presentation (March 2013)
30 slides from Kamada's investor presentation, March 2013
Slide 1: Investor Presentation
Investor Presentation March 2013
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation is not intended to provide investment or medical advice. advice It should be noted that some products under development described herein have not been found safe or effective by any regulatory agency and are not approved for any use outside of clinical tri
Slide 3: Kamada Overview
Kamada Overview Leader in the Development of Alpha‐1 Antitrypsin (“AAT”) Key Statistics Products Globally • Founded in 1990 and based in Weizmann Science Park, Israel • Employees: ~300 (1) Developed D l d andd Obtained Ob i d FDA Approval A l for f the h First Fi and d • P bli l listed Publicly
Slide 4: Diversified Product Portfolio with Extended Global Reach
Diversified Product Portfolio with Extended Global Reach Diverse Portfolio of Predominantly Plasma‐Derived Protein Therapeutics Global Presence with Exposure to Emerging Markets Glassia® Alpha‐1 Antitrypsin (human) Respiratory p y KamRAB Anti‐rabies immunoglobulin (human) KamRho (D) IM Rho(D) immuno
Slide 5: Kamada Investment Highlights
Kamada Investment Highlights 1 Intersection of Attractive Orphan and Plasma‐Derived Protein Industries 2 Significant Opportunity to Expand the AATD Market 3 Glassia® Growth Supported by Differentiated Product Profile and Strategic Partnership 4 Valuable R&D Pipeline Focused on Orphan Indications 5 I
Slide 6: Attractive Plasma-Derived Protein Therapeutics Industry
1 Attractive Plasma‐Derived Protein Therapeutics Industry Positive Industry Dynamics Favorable Growth Forecasts The Global Market for Plasma‐Derived Protein Therapeutics Plasma‐derived protein therapeutics are drugs that are $ Bn f fractionatedd and d purified f d from f human h plasma l andd its
Slide 7: Significant Opportunity to Expand the AATD Market
2 Significant Opportunity to Expand the AATD Market Sustainable Market with Strong Growth Potential North America and Europe AATD Patient Counts (000s) Patients suffering from AAT Deficiency (“AATD”) remain 250 under‐identified and under‐treated – Only ~5% of cases treated in the US and ~2% in EU
Slide 8: Growth of Glassia Driven by Strategic Partnership and Differentiated Product Profile
3 Growth of Glassia® Driven by Strategic Partnership and Differentiated Product Profile Key Product Advantages AATD Product Sales and Milestone Revenues First and only liquid, ready‐to‐use, IV plasma‐derived AAT $MM Sold in 5 countries, with majority of sales in the US product 40 34 No reconstit
Slide 9: High Value Pipeline Focused on Orphan Indications
4 High Value Pipeline Focused on Orphan Indications Partnership Product Indication Phase 1 Phase 2 Phase 3 Agreement Ph II/III in Process in EU Alpha‐1 Antitrypsin 1 Inhaled AAT for AATD Completed Entering Ph II in the EU: Deficiency* US 2 B1‐AAT (IH) Bronchiectasis* Completed ‐ Completed 3 C1‐AAT (
Slide 10: Inhaled AAT for AATD is a Novel, Late-Stage Pipeline Product
4 Inhaled AAT for AATD is a Novel, Late‐Stage Pipeline Product AAT is inhaled by AAT deficient subjects who lack AAT and experience inflammation and occurrence of Sound scientific rationale emphysema Targets site of action Product is directed to the site of action – the lung Deposition pattern was f
Slide 11: Dedicated eFlow Device Developed Specifically by PARI Pharma for Kamada
4 Dedicated eFlow Device Developed Specifically by PARI Pharma for Kamada Kamada’ss Inhaled AAT eFlow Device Technology Highlights eFlow Device CE marked in EU Generates particle size of ~3 microns, well‐ suited for an appropriate lung deposition of AATD CF and COPD AATD, Enables direct a
Slide 12: Inhaled AAT Product Development on Track
4 Inhaled AAT Product Development on Track Phase IA Phase IB Phase II – Lung Deposition Single blind, placebo controlled Single blind, placebo controlled Three treatment groups 24 healthy h l h subjects b 15 healthy h l h subjects b – 2: Healthy l h volunteers l Trial Design Single admin
Slide 13: Inhaled AAT for AATD in Pivotal Phase II/III Trials in Europe and Entering Phase II in the US
4 Inhaled AAT for AATD in Pivotal Phase II/III Trials in Europe and Entering Phase II in the US Phase II / III EU Phase II US Description Randomized; Over 160 AATD subjects, majority Randomized; Sample size of over 36 subjects are treatment naïve Double blind, placebo controlled Double blind
Slide 14: Expected to Launch 2015 in the EU and 2016 in the US
4 Expected to Launch 2015 in the EU and 2016 in the US Indicative Development Timeline: Completion of US launch for Initiation of Phase Phase II Inhaled Inhaled AAT for II Inhaled AAT for US AAT for AATD AATD AATD clinical trial U clinical trial (if approved) Q4 2012 2013 2014 2015 2016 EU Phase II/
Slide 15: Additional High Value Orphan Indications for AAT IV & Inhaled
4 Additional High Value Orphan Indications for AAT IV & Inhaled D1: Type‐1 Diabetes B1: Bronchiectasis C1: Cystic Fibrosis Completed C l t d Phase Ph I/II Completed C l t d Phase Ph II Completed C l t d Phase Ph II – Open Label, Proof of Concept, Study Double‐blind, placebo controlled Doub
Slide 16: Cystic Fibrosis Study, Phase II
4 Cystic Fibrosis Study, Phase II CF disease is characterized by: Chronic Decrease in Increases Exac Progression of NE Accumulation Tissue Damage Inflammation Lung Function Events Disease CF treatment rationale is based on: 1 The administration of the AAT is to address the imbalance of elastase and
Slide 17: Clinical Development for Newly Diagnosed Type-1 Diabetes: New Exciting Prospects
4 Clinical Development for Newly Diagnosed Type‐1 Diabetes: New Exciting Prospects End‐of‐study slope analysis of C‐peptide[max] and C‐ HbA1C data indicated that almost all patients reached peptide[AUC] revealed no significant changes from baseline glycemic control 7.5% HbA1c AUC% for C‐peptide decr
Slide 18: Integrated, Efficient, Scalable Platform Technology
5 Integrated, Efficient, Scalable Platform Technology Proprietary, Innovative and Fully‐Invested Manufacturing Benefits Patented Technology Platform Facility Chromatography‐based FDA approved since 2010 Enables manufacturing of plasma‐ purification process derived protein therapeutics with dif
Slide 19: Financials
Financials @) AMADA _
Slide 20: Compelling Investment Driven By Multiple Pillars of Growth
Compelling Investment Driven By Multiple Pillars of Growth Additional The Kamada Unencumbered New Geographies Pipeline Products Pillars C1 C1-AAT AAT (IH): Inhaled AAT for Potential to sell existing Cystic fibrosis Existing Anchor AATD in and new products into completed Phase II Products Europe
Slide 21: Strong Financial Profile with Revenue Growth and Expanding Profitability
Strong Financial Profile with Revenue Growth and Expanding Profitability 1 Pipeline products expected to accelerate revenue growth 2 Better product mix expected to improve gross margin 3 Strategic partnership model results in efficient operating expenses 4 Stable, profit generating revenue stream fr
Slide 22: Sustained and Rapid Growth has Made Kamada EBITDA Positive Within 3 Years of Growth
Sustained and Rapid Growth has Made Kamada EBITDA Positive Within 3 Years of Growth $MM FY2009 FY2010 FY2011 FY2012 Q4/2012 p y Proprietary 10 23 35 47 6 16 Products Growth 130% 54% 32% 21% Distribution 4 11 24 26 6 Growth 187% 110% 8% ‐25% Total Revenues 14 34 59 73 22 Growth 146% 73% 22% 4% Gross
Slide 23: Consistent Track Record of Execution
Consistent Track Record of Execution Initial Public Offering on the Tel Aviv Stock Exchange (KMDA) August 2005 Strategic agreement with PARI US FDA approval for Glassia® Strategic agreement with Baxter First Glassia® sale in the US Strategic agreement for Rabies in the US with Kedrion Anti‐Snake Ven
Slide 24: Future Milestones and Value Creation
Future Milestones and Value Creation Milestone Date Completion of Phase III for the Rabies lg in the US 2013 Initiation of Phase II for Inhaled AAT for AATD in the US 2013 Initiation of Phase II or II/III for type‐1 diabetes 2013 Completion of Phase II/III Inhaled AAT for AATD trial (EU) 2013 Strate
Slide 25: Investment Highlights
Investment Highlights 1 Intersection of Attractive Orphan and Plasma‐Derived Protein Industries 2 Significant Opportunity to Expand the AATD Market 3 Glassia® Growth Supported by Differentiated Product Profile and Strategic Partnership 4 Valuable R&D Pipeline Focused on Orphan Indications 5 Integrat
Slide 26: Appendix
Appendix @) AMADA _
Slide 27: From Inflammation through Emphysema to Disease Progression in AATD
From Inflammation through Emphysema to Disease Progression in AATD AAT Chronic & severe lung Deficiency inflammation Lack of Excess Destruction of lung AAT Ne parenchyma Imbalance Worsening of emphysema Loss of lung function Measurable “Vicious cycle” of Further loss in disease lung function deterio
Slide 28: Manufacturing
Manufacturing FDA approved and cGMP compliant facility located in Beit Kama, Israel – Passed US FDA inspection in 2010 and Israeli Ministry of Health cGMP audit in July 2011 Russian 2011; R i Mi Ministry i t off Health H lth andd similar i il authorities th iti iin Brazil B il andd Mexico M i have
Slide 29: IP
IP Five patent families in multiple countries, including the US, Europe and other countries – Manufacturing process patents considered material to operation of business – Focus is on seeking / maintaining patent protection in the US, the EU and Israel Additional protection provided by ‘know how’
Slide 30: Reconciliation of Adjusted EBITDA to the IFRS Net Loss
Reconciliation of Adjusted EBITDA to the IFRS Net Loss Year Ended December 31, ($000s) 2010 2011 2012 Net Profit (Loss) (14,421) (3,715) 260 Income tax expense — — 523 Financial expense, net 2,528 2,727 2,779 Depreciation and amortization expense 2,640 3,040 3,044 Share‐based compensation charges 1,