Kamada Ltd. · NASDAQ:KMDA
Kamada — Investor Presentation (June 2015)
45 slides from Kamada's investor presentation, Jun 3, 2015
Slide 1: Kamada Investor Presentation
EXHIBIT 99.1 KAMADA INVESTOR PRESENTATION NASDAQ: KMDA JUNE 2015 1
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation is not intended to provide investment This presentation includes certain non-GAAP financial or medical advice. It should be noted that some information, which is not intended to be considered in products under development described herein have not isolatio
Slide 3: Kamada Overview
Kamada Overview 1. Rapidly Growing, Globally Positioned Biopharmaceutical Key Statistics Company Focused on Orphan Diseases and Plasma- ● Founded in 1990. Based in Weizmann Science Park, Derived Protein Therapeutics Israel ● Employees: ~300 (1) ● Revenue and profitability with 10 marketed products ●
Slide 4: Integrated, Efficient, Scalable Platform Technology
Integrated, Efficient, Scalable Platform Technology Proprietary, Innovative Fully-Invested and Patented Technology Manufacturing Facility & Benefits Platform Marketed Products ● Patent protected: ● FDA approved since ● Enables manufacturing of Chromatography-based 2010 plasma-derived protein purific
Slide 5: Growing Proprietary Products Segment Through Glassia
Diverse Portfolio of Predominantly Plasma-Derived Protein Therapeutics Global Presence with Exposure to Emerging Markets Respiratory Glassia® Alpha-1 Antitrypsin (human) Proprietary Products KamRAB™ Anti-rabies immunoglobulin (human) Segment Immunoglo- KamRho (D) IM Rho(D) immunoglobulin (human) bul
Slide 6: Glassia is a Differentiated Product
Glassia® is a Differentiated Product Key Product Advantages AATD (IV) Product Sales W/O Milestone Revenues ( in MM$) ● Glassia® is the first and only liquid, ready-to-use, IV plasma-derived AAT product ● No reconstitution required, reducing risk of contamination and infection and reducing treatment
Slide 7: Growth of Glassia Driven by Strategic Partnership with Baxalta
Growth of Glassia® Driven by Strategic Partnership with Baxalta (formerly Baxter) ● Commencement: Sales to Baxalta commenced in September 2010 ● Agreements: distribution, technology license and fraction IV supply ● Product: AAT IV (Glassia®), including future AAT IV ● Territories: U.S., Canada, Aust
Slide 8: Significant Opportunity to Expand the AATD Market
Significant Opportunity to Expand the AATD Market Sustainable Market with Strong AATD Prevalence: ~200,000 Growth Potential Yet Fewer than 5% of Potential Patients in the U.S. and Europe are Treated ● Patients suffering from AAT Deficiency (“AATD”) remain under-identified and under- treated ● Only ~
Slide 9: KamRAB: Human Rabies Immune Globulin
KamRAB: Human Rabies Immune Globulin Kamada’s human rabies immune globulin is a post-exposure prophylaxis (PEP) for rabies. U. S. Opportunity ● Strategic agreement with Kedrion S.p.A for the clinical development and marketing of KamRAB in the U.S. ● U.S. Phase II/III clinical trial completed, with d
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 Intravenous FDA Approved (2010) AAT Deficiency U.S.: AAT D1-AAT (IV) Type 1 Diabetes* Completed Ph II/III In Process U.S.: G1-AAT (IV) GVHD* Ph I/II In Process U.S.: L1-AAT (IV) Lung trans
Slide 11: Inhaled AAT to Treat AATD
Inhaled AAT to Treat AATD 11
Slide 12: Inhaled AAT for AATD: Completed Pivotal Phase II/III Trials in Europe and ongoing Phase II in the U.S.
Inhaled AAT for AATD: Completed Pivotal Phase II/III Trials in Europe and on going Phase II in the U.S. Phase II / III EU Phase II U.S. Description ● Randomized; Over 160 AATD subjects, majority ● Randomized; Sample size of ~36-40 subjects are treatment naïve ● Double blind, placebo controlled, rand
Slide 13: Inhaled AAT Phase II/III Trial: Summary of the Results
Inhaled AAT Phase II/III Trial: Summary of the Results Results demonstrate: 1.Primary and secondary endpoints didn’t demonstrate statistical significant difference. 2.Efficacy in lung function (statistically significant) 3.Change in the nature of exacerbations (reduction in number of Type 1- exacerb
Slide 14: Inhaled AAT Phase II/III Trial Results: Spirometry Measures (MMRM)
Inhaled AAT Phase II/III Trial Results: Spirometry Measures (MMRM*) Least Squares Means (SEM) Least Squares Means (Changes at Week 50 from (SEM) (overall treatment Lung Baseline) P-Value* effect) P-Value* (Changes at (Overall Function Week 50) Effect) AAT Placebo AAT Placebo (N= 84) (N= 81) (N= 84)
Slide 15: In the Words of the Key Opinion Leaders
In the Words of the Key Opinion Leaders “ “The study results demonstrated primarily that the overall treatment effect on lung functions, is of significant clinical value. This study is the first study ever that is indicative of inhaled AAT’s ability to potentially reduce lung inflammation as express
Slide 16: Inhaled AAT Phase II/III Trial Results: Spirometry Measures (MMRM)
Inhaled AAT Phase II/III Trial Results: Spirometry Measures (MMRM) FEV1 (L) - MMRM FEV1/SVC - MMRM Overall effect +15ml Overall effect +0.623 P=0.0268 P=0.0074 Overall effect -27ml Overall effect -0.8715 Week Week Treatment Group AAT Placebo Investor Presentation | June 2015 16
Slide 17: Inhaled AAT Phase II/III Trial: Nature of the First Exacerbation
Inhaled AAT Phase II/III Trial: Nature of the First Exacerbation N (%) ITT AAT Placebo Type/Category N=85 N=83 Type I 16 (18.8%) 26 (31.3%) 0.0614 Type II 23 (27.1%) 12 (14.5%) 0.0444 Type III 34 (40.0%) 33 (39.8%) 0.9746 None 12 (14.1%) 12 (14.5%) 0.9498 AAT may change the nature of the exacerbatio
Slide 18: Inhaled AAT Phase II/III Trial: Symptom Score MMRM
Inhaled AAT Phase II/III Trial: Symptom Score MMRM Analysis of First (Types I+II+III) Exacerbation Severity for each major Symptom (during 0-10 and 0-14 days of the exacerbation event) MMRM Least Square Means Symptom Exac. Type Days P-Value* AAT Placebo N=73 N=71 0-10 11.9464 12.2548 0.0243 Dyspnea
Slide 19: Inhaled AAT Phase II/III Trial Results
Inhaled AAT Phase II/III Trial Results Continuous Symptom Score: Dyspnea Continuous Symptom Score: Well Being Dyspnea 4 Week Moving Average Graphs Well Being 4 Week Moving Average Graphs Week Week AAT Placebo Improvement trend in favor of AAT group - not statistical significant “ “This study has enl
Slide 20: Inhaled AAT: Moving Forward
Inhaled AAT: Moving Forward EMA: EU Front FDA: U.S. Front ● Compilation of an MAA dossier ● Approach U.S.-FDA with results in H2 2015to obtain guidance on the ● EMA submission (centralized clinical/ regulatory pathway for procedure) end of 2015 licensing the IH AAT by Kamada in the U.S. Kamada is co
Slide 21: AAT to Treat Type 1 Diabetes
AAT to Treat Type 1 Diabetes 21
Slide 22: AAT (IV) is a Promising Potential Treatment for Newly Diagnosed Type-1 Diabetes Patients
AAT (IV) is a Promising Potential Treatment for Newly Diagnosed Type ‐1 Diabetes Patients Type-1 Diabetes Studies have shown Preservation of beta cells occurs when the immune That AAT protects correlates with reduced risk system attacks and destroys beta cell islets of long term complications beta c
Slide 23: 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- tolerance-inducing profil
Slide 24: 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 25: Clinical Development for Newly Diagnosed Type-1 Diabetes: New Exciting Prospects
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 26: Diabetes Extension Clinical Study: Interim Report #2
Diabetes Extension Clinical Study: Interim Report #2 19 subjects enrolled : the treatment arm HbA1c (n=10), follow-up arm (n=9) ● Treated patients had an avg HbA1C of 7.5%, vs 7.9% for the follow-up patients Data is presented 26 months (avg) post ● 60% of treated patients had HbA1C levels lower or e
Slide 27: 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, Double- Study objective: To evaluate the efficacy and safety of human, Alpha-1 Antitrypsin (AAT) in the treatment Blind, Randomized, Placebo- of new onset Type 1 Diabetes Controlled, Multicenter Stud
Slide 28: AAT to Treat Graft versus Host Disease
AAT to Treat Graft versus Host Disease 27
Slide 29: 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 G
Slide 30: Proof-of-Concept Study with AAT (IV) for Graft-Versus-Host Disease (GVHD)
Proof-of-Concept Study with AAT (IV) for Graft-Versus-Host Disease (GVHD) Phase I/II study open label Dose: 4 dose groups - 15 day regimen. Doses given on days: 1,3,5,7, 9, 11, 13 and 15 of 24 patients with steroid- resistant GVHD following Primary End Points: % of patients at each dosing allogeneic
Slide 31: First Cohort Results Show that AAT May Potentially Exert a Protective Effect on 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. Continuou
Slide 32: Phase I/II Clinical Study Interim Report
Phase I/II Clinical Study Interim Report Before FACS Analysis pre Duodenits Suspect severe upper and lower GvHD and post AAT therapy After 8 doses of AAT Loss of AAT in stool is an Moderate mucosal denudement expression of intestinal injury. and edema noted throughout the duodenum. Investor Presenta
Slide 33: Financials
Financials Investor Presentation | June 2015 32
Slide 34: Compelling Investment Driven by Multiple Pillars of Growth
Compelling Investment Driven by Multiple Pillars of Growth Additional The Kamada New Unencumbered Pillars Geographies Pipeline Products Inhaled AAT for Existing Anchor § Potential to sell § D1-AAT (IV): Products AATD in existing and new Type-1 diabetes in products into new Phase I/II Europe & U.S. (
Slide 35: 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 ● Baxalta purchase obligations provides stable revenue through 2017 and royalties thereafte
Slide 36: 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 FY2013 FY2014 Proprietary 10 23 35 47 51 44 Products Growth 130% 54% 32% 9% (14%) Distribution 4 11 24 26 20 27 Growth 187% 110% 8% (23%) 35% Total Revenues 14 34 59 73 71 71 Growth 14
Slide 37: Consistent Track Record of Execution
Consistent Track Record of Execution U.S. FDA approval for Glassia® Strategic agreement with Baxalta & First Glassia® sale in the U.S. Strategic agreement for Rabies in the U.S. with Kedrion Anti-Snake Venom launch 2010 Strategic agreement with Chiesi for Inhaled AAT for AATD in EU Newly diagnosed t
Slide 38: Future Milestones and Value Creation
Future Milestones and Value Creation Milestone Date Phase III Rabies Ig trial (U.S.) results 2H15 Interim data from GVHD trial 2H15 MAA submission for Inhaled AAT for AATD 2H15 2H15 Completion of Phase II for Inhaled AAT for AATD 2H15 trial (U.S.) Strategic agreements 2015 Initiation of Phase II lun
Slide 39: Kamada Investment Highlights
Kamada Investment Highlights Investor Presentation | June 2015 38
Slide 40: 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 41: Thank You
THANK YOU Investor Presentation | June 2015 40
Slide 42: Appendix
APPENDIX Investor Presentation | June 2015 41
Slide 43: Inhaled AAT Phase II/III Trial: Symptom Based Exacerbation Analysis
Inhaled AAT Phase II/III trial: Symptom Based Exacerbation Analysis Major Three (3) Exacerbation Symptoms by Severity: Dyspnea; Sputum Volume; Sputum Color Possible Manifestations Exacerbation Classification Rules Sputum Sputum Type/Category Dyspnea* Volume ** Color** Type I All 3 symptoms at high s
Slide 44: 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 45: Inhaled AAT Is A Significant Opportunity
Inhaled AAT Is A Significant Opportunity Inhaled AAT Highlights Strategic Partnership with Chiesi • Chiesi distribution agreement as of August 2012 • Agreement: Chiesi responsible for S&M, patient ID, and reimbursement • Product: AAT for AATD Inhaled only • Territories: EU and Turkey • Milestone rev