Kamada Ltd. · NASDAQ:KMDA
Kamada — Investor Presentation (February 2015)
34 slides from Kamada's investor presentation, February 2015
Slide 1: Kamada Investor Presentation
KAMADA INVESTOR PRESENTATION February 2015 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
Kamada Overview 1. 1 Rapidly Growing, Globally Positioned Biopharmaceutical Company Key Statistics Focused on Orphan Diseases and Plasma-Derived Protein Therapeutics • Founded in 1990 and based in Weizmann Science Park, Israel • Revenue and Profitability with 10 Marketed Products • Employees: ~300 (
Slide 4: Integrated, Efficient, Scalable Platform Technology
Integrated, Efficient, Scalable Platform Technology Proprietary, Innovative and Fully-Invested Manufacturing Benefits Patented Technology Platform Facility & Marketed Products • Patent protected: • FDA approved since 2010 • Enables manufacturing of plasma- Chromatography-based derived protein therap
Slide 5: 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 6: Glassia Is A Differentiated Product
Glassia® Is A Differentiated Product Key Product Advantages AATD (IV) Product Sales W/O Milestone Revenues Sold in 7 countries, with majority of sales in the US • Glassia® is the first and only liquid, ready-to-use, IV plasma-derived AAT product 34 • No reconstitution required, reducing risk of cont
Slide 7: Growth of Glassia Driven by Strategic Partnership
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 New
Slide 8: Significant Opportunity to Expand the AATD Market
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”) 250 remain under-identified and under-treated – Only ~6% of cases treated in the US and ~2% in EU 20
Slide 9: KamRab
KamRab Human Rabies Immune Globulin • Kamada’s human rabies immune globulin is a post-exposure prophylaxis (PEP) for rabies that is marketed in 7 countries • Strategic agreement with Kedrion S.p.A for the clinical development and marketing of KamRAB in the U.S. o U.S. Phase II/III clinical trial com
Slide 10: High Value Pipeline Focused on Orphan Indications
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: Completed EU: 4 In
Slide 11: Inhaled AAT for AATD Completed Pivotal Phase II/III Trials in Europe
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, randomi
Slide 12: Inhaled AAT Phase II/III trial Results
Inhaled AAT Phase II/III trial Results Summary of the Results • Primary and secondary endpoints didn’t demonstrate statistical significant difference • First AAT deficiency treatment to show impact on lung function • Concordance of the data in lung function (statistically significant collected for s
Slide 13: Inhaled AAT Phase II/III trial Results (cont.)
Inhaled AAT Phase II/III trial Results (cont.) Parameter ITT Lung function: +0.34% AAT vs -1.17% PL FEV1 % of SVC P Value= 0. 033 Change from baseline till end of treatment Lung function: -0.509 AAT vs -1.37 PL FEV1 % predicted P Value= NS Change from baseline till end of treatment Lung function: -2
Slide 14: Inhaled AAT Phase II/III trial Results: Lung Function Graphs
Inhaled AAT Phase II/III trial Results: Lung Function Graphs Investor Presentation | February 2015
Slide 15: Expected to Launch 2016/17 in the EU
Expected to Launch 2016/17 in the EU Indicative Development Timeline: Meeting with Completion of FDA re Inhaled Phase II Inhaled US AAT for AATD in AAT for AATD the US clinical trial 2015 2016 2017 EU EU launch for Inhaled AAT for Inhaled AAT for AATD MAA filing AATD (if approved) 5 Investor Present
Slide 16: AAT (IV) is a Promising Potential Treatment For Newly Diagnosed Type-1 Diabetes
AAT (IV) is a Promising Potential Treatment For Newly Diagnosed Type‐1 Diabetes Patients Type-1 Diabetes Preservation of beta cells occurs when the immune system Studies have shown that correlates with reduced risk attacks and destroys beta cells AAT protects beta cell islets of long term complicati
Slide 17: Mechanistic Evidence - Alpha1-Antitrypsin, a Therapeutic Approach for Type-1 Diabetes
Mechanistic Evidence - Alpha1-Antitrypsin, a Therapeutic Approach for Type- 1 Diabetes AAT Anti Inflammatory Immunomodulatory Protease Inhibitor Tissue protective - Induces the production of anti- AAT promotes Tregs and Inhibits proteins that activate Protects from cell death, inflammatory mediators
Slide 18: Clinical Development for Newly Diagnosed Type-1 Diabetes
Clinical Development for Newly Diagnosed Type‐1 Diabetes: New Exciting Prospects Phase I/II Open Label Study to evaluate the safety, tolerability and efficacy of AAT on beta cell preservation and glycemic control on newly diagnosed T1D pediatric patients. End-of-study slope analysis of C-peptide[max
Slide 19: Newly Diagnosed Type-1 Diabetes Currently ongoing Phase II/III Clinical Trial
Newly Diagnosed Type‐1 Diabetes Currently ongoing Phase II/III Clinical Trial Pivotal, Phase II/III, Study objective: To evaluate the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) in the Double-Blind, Randomized, treatment of New Onset Type 1 Diabetes. Placebo-Controlled, Multicenter study
Slide 20: Graft versus Host Disease (GVHD): The Major Issue in Stem Cell Transplantation
Graft versus Host Disease (GVHD): The Major Issue in Stem Cell Transplantation • Donor’s immune cells (the graft) recognize the recipient (the host) as “Non-self“. The transplanted immune cells attack the host's body cells. • Deadly side effects: ~20% of transplanted patients’ deaths are caused by
Slide 21: Proof-of-Concept Study with AAT (IV) for GVHD
Proof-of-Concept Study with AAT (IV) for Graft- Versus-Host Disease (GVHD) • Phase I/II study open label of 24 patients with steroid-resistant GVHD following allogeneic bone-marrow stem cell transplant • Dose: 4 dose groups - 15 day regimen. Doses given on days: 1,3,5,7, 9, 11, 13 and 15 • Primary E
Slide 22: First Cohort Results Show AAT May Protect the Bowel Mucosa in Gut GVHD
First Cohort Results Show That AAT May Potentially Exert a Protective Effect on the Bowel Mucosa in Gut GVHD Study results have indicated that AAT may potentially exert healing of the bowel mucosa in gut GVHD slowing/stopping the disease progression and re-modulation of the immune attack. Continuous
Slide 23: Phase I/II Clinical Study Interim Report
Phase I/II Clinical Study Interim Report: Loss of AAT in stool is an FACS Analysis pre expression of intestinal injury. and post AAT therapy Post 8 doses of AAT Before After Duodenits Suspect severe Moderate mucosal denudement upper and lower GvHD and edema noted throughout the duodenum. 2 Investor
Slide 24: Financials
FINANCIALS 2 Investor Presentation | February 2015
Slide 25: 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 D1-AAT (IV): Inhaled AAT for Potential to sell existing Type-1 diabetes in Phase Existing Anchor AATD in and new products into I/II (Unencumbered Products Europ
Slide 26: Strong Financial Profile with Revenue Growth and Expanding Profitability
Strong Financial Profile with Revenue Growth and Expanding Profitability • Stable, profit generating revenue stream from marketed products • Strategic partnership model results in efficient operating expenses o Baxter purchase obligations provides stable revenue through 2017 and royalties thereafter
Slide 27: Sustained and Rapid Growth has Made Kamada EBITDA Positive
Sustained and Rapid Growth has Made Kamada EBITDA Positive Within 3 Years of Growth $MM FY2009 FY2010 FY2011 FY2012 FY2013 FY2014 Proprietary 10 23 35 47 51 45 Products Growth 130% 54% 32% 9% (12%) Distribution 4 11 24 26 20 27 Growth 187% 110% 8% (23%) 35% Total Revenues 14 34 59 73 71 72 Growth 14
Slide 28: Consistent Track Record of Execution
Consistent Track Record of Execution US FDA approval for Glassia® 2010 Strategic agreement with Baxter & First Glassia® sale in the US Strategic agreement for Rabies in the US with Kedrion Anti-Snake Venom launch Strategic agreement with Chiesi for Inhaled AAT for AATD in EU Newly diagnosed type-1 d
Slide 29: Future Milestones and Value Creation
Future Milestones and Value Creation Milestone Date Phase III Rabies Ig trial (US) results 1H15 Phase II/III Inhaled AAT for AATD (EU) presentation at ATS 2Q15 Interim data from GVHD trial 2015 MAA submission for Inhaled AAT for AATD 2015 BLA submission for the Rabies lg in the US 2015 Completion of
Slide 30: 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 31: Thank You
THANK YOU www.kamada.com Investor Presentation | February 2015
Slide 32: Appendix
APPENDIX 2 Investor Presentation | February 2015
Slide 33: Conditional Approval Guidance & Precedence
Conditional Approval Guidance & Precedence EMEA Guidance EMEA/509951/2006 GUIDELINE ON THE SCIENTIFIC APPLICATION AND THE PRACTICAL ARRANGEMENTS NECESSARY TO IMPLEMENT COMMISSION REGULATION (EC) No 507/2006 ON THE CONDITIONAL MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS FOR HUMAN USE FALLING WITHI
Slide 34: Inhaled AAT Is A Significant Opportunity
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, par