Kamada Ltd. · NASDAQ:KMDA
Kamada — Investor Presentation (June 2014)
30 slides from Kamada's investor presentation, June 2014
Slide 1: Investor Presentation
Investor Presentation June 2014 NASDAQ: KMDA
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation is not intended to provide investment or medical 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 trials. Th
Slide 3: Kamada Overview and Key Statistics
Kamada Overview Key Statistics • Founded in 1990 and based in Weizmann Science Park, Israel • Employees: ~300 (1) 1. 1 Leader in the Development of Alpha-1 Antitrypsin (“AAT”) • Listed on NASDAQ since 2013 & TASE since 2005 (KMDA) Products Globally • Current market capitalization: ~$300MM (2) • Cash
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 Respiratory Glassia® Alpha-1 Antitrypsin (human) KamRAB™ Anti-rabies immunoglobulin (human) Proprietary KamRho (D) IM Rho(
Slide 5: Glassia Is A Differentiated Product
2 Glassia® Is A Differentiated Product Key Product Advantages AATD (IV) Product Sales and Milestone Revenues Glassia® is the first and only liquid, ready-to-use, IV Sold in 7 countries, with majority of sales in the US plasma-derived AAT product 40 35 34 No reconstitution required, reducing risk
Slide 6: Kamada Investment Highlights
Kamada Investment Highlights Rapidly Growing, Globally Positioned Biopharmaceutical Company - Focused on Orphan Diseases and Plasma Derived Protein Therapeutics Flagship Product Glassia® Approved for Alpha-1 Antitrypsin Deficiency - Has a Unique and Differentiated Product Profile and Represents an E
Slide 7: 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 fractionated and purified from human plasma and its 18 derivatives C
Slide 8: 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 9: Growth of Glassia Driven by Strategic Partnership
3 Growth of Glassia® Driven by Strategic Partnership Strategic Partnership with Baxter Sales to Baxter commenced in September 2010 Agreements: distribution, technology license and fraction IV supply Product: AAT IV (Glassia®), including future AAT IV Territories: US, Canada, Australia and Ne
Slide 10: High Value Pipeline Focused on Orphan Indications
4 High Value Pipeline Focused on Orphan Indications Product Indication Phase I Phase II Phase III Market Partners 1 Intravenous AAT AAT Deficiency FDA Approved (2010) US: Type 1 2 D1-AAT (IV) Diabetes* Completed Ph II/III In Process US: 3 G1-AAT (IV) GVHD Ph I/II In Process US: EU: Study Completed E
Slide 11: Inhaled AAT Is A Significant Opportunity
4 Inhaled AAT Is A Significant Opportunity Inhaled AAT Highlights Strategic Partnership with Chiesi First and only Inhaled AAT product for AATD Chiesi distribution agreement as of August 2012 – Device and drug combination enable optimal size Agreement: Chiesi responsible for S&M, patient ID, p
Slide 12: 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 subjects who are AAT Deficient and experience lung inflammation and occurrence of Sound scientific rationale emphysema Targets site of action Product is directed to the site of action – the diseased lung tissue Depositi
Slide 13: Dedicated eFlow Device Developed by PARI Pharma
4 Dedicated eFlow Device Developed by PARI Pharma for Kamada’s 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 Enables direct access to the diseased lung
Slide 14: Inhaled AAT Completed Pivotal Phase II/III Trials in Europe
4 Inhaled AAT for AATD Completed Pivotal Phase II/III Trials in Europe and Initiated Phase II in the US Phase II / III EU Phase II US Description Randomized; Over 160 AATD subjects, majority are Randomized; Sample size of ~ 36-40 subjects treatment naïve Double blind, placebo controlled, rando
Slide 15: Inhaled AAT for AATD: Preliminary Results Phase II/III
4 Inhaled AAT for AATD: Preliminary Results Phase II/III Primary endpoint: time to first moderate/severe exacerbations – preliminary results didn’t show difference between placebo and AAT group Secondary : frequency (rate) of exacerbations and severity of first exacerbations, lung function Ini
Slide 16: 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: Meeting with Completion of US launch for FDA re Inhaled Phase II Inhaled Inhaled AAT for US AAT for AATD in AAT for AATD AATD the US clinical trial (if approved) 2014 2015 2016 EU Phase II/III Inhaled EU launch f
Slide 17: 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 Phase I/II Completed Phase II Completed Phase II – Open Label, Proof of Concept, Study Double-blind, placebo controlled Double-blind, placebo controlled of t
Slide 18: 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 19: Studies Have Shown That AAT Protects Beta Cell Islets
5 Studies Have Shown That AAT Protects Beta Cell Islets • Delays the onset of autoimmune diabetes Type 1 Diabetes Statistics • Reduces the incidence of diabetes • more than 10 million suffer from T1D globally • 100,000 new patients diagnosed annually • Inhibits insulitis and beta-cell apoptosis • In
Slide 20: Preservation of beta cells correlates with reduced long term complications
5 Preservation of beta cells correlates positively with reduced risk of long term complications • The Diabetes Control and Complications Trial (DCCT*) “We acknowledge the evidence and the U.K. Prospective Diabetes Study from the DCCT and other studies demonstrated that retention of beta-cells is tha
Slide 21: Clinical Development for Newly Diagnosed Type-1 Diabetes
5 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 dec
Slide 22: Integrated, Efficient, Scalable Platform Technology
6 Integrated, Efficient, Scalable Platform Technology Proprietary, Innovative and Fully-Invested Manufacturing Benefits Patented Technology Platform Facility Patent protected: FDA approved since 2010 Enables manufacturing of plasma- Chromatography-based derived protein therapeutics with purifi
Slide 23: Financials
Financials
Slide 24: Compelling Investment Driven By Multiple Pillars of Growth
6 Compelling Investment Driven By Multiple Pillars of Growth Additional The Kamada Unencumbered New Geographies Pipeline Products Pillars C1-AAT (IH): Inhaled AAT for Potential to sell existing Cystic fibrosis Existing Anchor AATD in and new products into completed Phase II Products Europe & US
Slide 25: Strong Financial Profile with Revenue Growth and Expanding Profitability
7 Strong Financial Profile with Revenue Growth and Expanding Profitability Pipeline products expected to accelerate revenue growth Better product mix expected to improve gross margin Strategic partnership model results in efficient operating expenses Stable, profit generating revenue stream
Slide 26: Kamada EBITDA Positive Within 3 Years of Growth
7 Sustained and Rapid Growth has Made Kamada EBITDA Positive Within 3 Years of Growth $MM FY2009 FY2010 FY2011 FY2012 FY2013 Proprietary 10 23 35 47 51 Products Growth 130% 54% 32% 9% Distribution 4 11 24 26 20 Growth 187% 110% 8% (23%) Total Revenues 14 34 59 73 71 Growth 146% 73% 22% (3%) Gross Pr
Slide 27: 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 V
Slide 28: Future Milestones and Value Creation
Future Milestones and Value Creation Milestone Date Phase II/III Inhaled AAT for AATD trial (EU) final results 3Q14 MAA submission for Inhaled AAT for AATD 2014 Initiation of Phase ll for inhaled AAT for CF trial in the US 2014 Completion of Phase III for the Rabies lg in the US 2014 Completion of P
Slide 29: Kamada Investment Highlights
Kamada Investment Highlights Rapidly Growing, Globally Positioned Biopharmaceutical Company - Focused on Orphan Diseases and Plasma Derived Protein Therapeutics Flagship Product Glassia® Approved for Alpha-1 Antitrypsin Deficiency Disorder - Has a Unique and Differentiated Product Profile and Repres
Slide 30: Thank you.
Thank you. www.kamada.com