Slide 1: Kamada Investor Presentation
Exhibit 99.1 KAMADA INVESTOR PRESENTATION September 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
Kamada Overview Key Statistics 1 • Founded in 1990 and based in Weizmann Science Park, Israel • Employees: ~300 (1) • AAT deficiency (AATD) is a genetic emphysema, caused by • Listed on NASDAQ since 2013 & TASE since 2005 (KMDA) lack • Current market capitalization: ~$250MM (2) • Cash, cash equivale
Slide 4: Diverse Portfolio of Predominantly Plasma-Derived Protein Therapeutics
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(D) immunoglobulin (human) Products KamRho (D) IV Rho(D) i
Slide 5: 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 6: Glassia Is A Differentiated Product
Glassia® Is A Differentiated Product Key Product Advantages AATD (IV) Product Sales and Milestone Revenues Sold in 7 countries, with majority of sales in the US P Glassia® is the first and only liquid, ready-to-use, IV plasma-derived AAT product P No reconstitution required, reducing risk of contami
Slide 7: 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”) remain under-identified and under-treated – Only ~6% of cases treated in the US and ~2% in EU ~ • Si
Slide 8: Growth of Glassia Driven by Strategic Partnership
Growth of Glassia® Driven by Strategic Partnership Strategic Partnership with Baxter P Sales to Baxter commenced in September 2010 P Agreements: distribution, technology license and fraction IV supply P Product: AAT IV (Glassia®), including future AAT IV P Territories: US, Canada, Australia and New
Slide 9: 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: 2 D1-AAT (IV) Type 1 Diabetes* Completed Ph II/III In Process US: 3 G1-AAT (IV) GVHD Ph I/II In Process US: EU: Completed 4 Inhaled
Slide 10: Inhaled AAT Is A Significant Opportunity
Inhaled AAT Is A Significant Opportunity Inhaled AAT Highlights Strategic Partnership with Chiesi P First and only Inhaled AAT product for AATD ü Chiesi distribution agreement as of August 2012 – Device and drug combination enable optimal size ü Agreement: Chiesi responsible for S&M, patient ID, par
Slide 11: Expected to Launch 2016 in the EU
Expected to Launch 2016 in the EU Indicative Development Timeline: Meeting with Completion of FDA re Inhaled Phase II Inhaled AAT for AATD AAT for AATD in clinical trial the US 2014 2015 2016 2017 EMA raparteur EU launch for meeting (4Q14) re Inhaled AAT for Inhaled AAT for Inhaled AAT for AATD MAA
Slide 12: 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; Sample size of ~ 36-40 subjects • Double blind, placebo controlled, randomized Route & • Inhalation of human AAT, 160mg total, twice daily • I
Slide 13: Inhaled AAT Phase 2-3 trial Results
Inhaled AAT Phase 2-3 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 and signals in reduction in exacerbation freq
Slide 14: Inhaled AAT Phase 2-3 trial Results
Inhaled AAT Phase 2-3 trial Results Parameter ITT Frequent exacerbators Primary endpoint : No differences observed Clinical difference observed AAT vs PL “Time to the first moderate or severe Hazard ratio = 0.877 exacerbation event” ( 95% CI 0.563, 1.364) . P Value= NS Secondary endpoint : No differ
Slide 15: Inhaled AAT Phase 2-3 trial Results (cont.)
Inhaled AAT Phase 2-3 trial Results (cont.) Parameter ITT Frequent exacerbators Lung function: +0.34% AAT vs -1.17% PL +0.2251% AAT vs -1.68% PL FEV1 % of SVC P Value= 0. 033 P Value= 0. 0208 Change from baseline till end of treatment Lung function: -0.509 AAT vs -1.37 PL -0.58 AAT vs. -1.21 PL FEV1
Slide 16: Inhaled AAT Phase 2-3 trial Results: Lung Function Graphs
Inhaled AAT Phase 2-3 trial Results: Lung Function Graphs 16 Investor Presentation | Sep. 2014
Slide 17: 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 18: AAT
AAT Anti Inflammatory Immunomodulatory Protease Inhibitor Tissue protective - AAT promotes Tregs and Inhibits proteins that activate Protects from cell death, modifies dendritic cell inflammation: Elastase, trypsin blocks apoptosis maturation towards a & PR3 and has tissue-protective tolerance-induc
Slide 19: 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 (Glassia®) on beta cell preservation and glycemic control on newly diagnosed T1D pediatric patients. End-of-study slope analysis of C-
Slide 20: Currently ongoing Phase II/III Clinical Trial
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) [Glassia®] in Double the -Blind, Randomized, treatment of New Onset Type 1 Diabetes. Placebo-Controlled, Design: Two doses, placebo controlled
Slide 21: Graft versus Host Disease (GvHD): The Major Issue in Hematopoietic Stem Cell Transplantation
Graft versus Host Disease (GvHD): The Pro Major Issue in Hematopoietic 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: Ø ~20% of transplanted patients die
Slide 22: 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
Slide 23: 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 24: Financials
FINANCIALS 24 Investor Presentation | Sep. 2014
Slide 25: The Kamada Pillars
Additional The Kamada Unencumbered New Geographies Pipeline Products Pillars § D1-AAT (IV): Inhaled AAT for § Potential to sell existing Type-1 diabetes in Phase AATD in and new products into I/II (Unencumbered Europe & US Existing Anchor new geographies outside of US, Canada, Australia and New Prod
Slide 26: Strong Financial Profile with Revenue Growth and Expanding Profitability
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 fr
Slide 27: Proprietary Products
$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 Profit (3) 6 17 23 26 R&D (9) (9) (12) (12) (13) S&M and G&A (5) (7) (7) (7) (2)(10) NET
Slide 28: Consistent Track Record of Execution
Consistent Track Record of Execution Initial Public Offering on the Tel Aviv Stock Exchange (KMDA) August Strategic agreement with PARI Pharma GmbH 2005 US FDA approval for Glassia® Strategic agreement with Baxter & First Glassia® sale in the US Strategic agreement for Rabies in the US with Kedrion
Slide 29: Future Milestones and Value Creation
Future Milestones and Value Creation Milestone Date Phase III Rabies Ig trial (US) results 4Q14 EMA discussion on conditional approval 4Q14 MAA submission for Inhaled AAT for AATD 2015 BLA submission for the Rabies lg in the US 2015 Completion of Phase II for Inhaled AAT for AATD trial (US) 2015 Exp
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 31 Investor Presentation | Sep. 2014