Kamada Ltd. · NASDAQ:KMDA
Kamada — Investor Presentation (November 2015)
47 slides from Kamada's investor presentation, November 2015
Slide 1: Kamada Investor Presentation
KAMADA INVESTOR PRESENTATION NASDAQ&TASE: KMDA November 2015 |
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation is not intended to provide This presentation includes certain non-GAAP financial investment or medical advice. It should be noted that information, which is not intended to be considered in some products under development described herein isolation or as a
Slide 3: Kamada Overview
Kamada Overview 1. Rapidly Growing, Globally Positioned Key Statistics Biopharmaceutical Company Focused on Orphan ● Founded in 1990. Based in Weizmann Science Diseases and Plasma-Derived Protein Therapeutics Park, Israel ● Employees: ~300 (1) ● Revenue and profitability with 10 proprietary products
Slide 4: Integrated, Efficient, Scalable Platform Technology
Integrated, Efficient, Scalable Platform Technology Proprietary, Innovative Fully-Invested and Patented Manufacturing Facility & Benefits Technology Platform Marketed Products ● Patent protected: ● FDA approved since ● Enables manufacturing of Chromatography-based 2010 plasma-derived protein purific
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) Proprietary Products KamRAB™ Anti-rabies immunoglobulin (human) Segment I
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- 34 use, IV plasma-derived AAT product 29 ● No reconstitution required, reducing risk of 27 contamination and infection and reducing
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 all future AAT IV indications in the territorie
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 AAT Deficiency FDA Approved (2010) 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 Investor Presentation 11.2015 | 11
Slide 12: 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 did not demonstrate statistical significant difference. 2. Efficacy in lung function (statistically significant) 3. Change in the nature of exacerbations (reduction in number of Type 1- exa
Slide 13: Inhaled AAT Phase II/III Trial Results: Spirometry Measures (MMRM)
Inhaled AAT Phase II/III Trial Results: Spirometry Measures (MMRM*) Least Squares Means Least Squares Means (SEM) (Changes at Week 50 P-Value* (SEM) (overall treatment Lung from Baseline) effect) P-Value* (Changes (Overall Function at Week Effect) AAT Placebo 50) AAT Placebo (N= 84) (N= 81) (N= 84)
Slide 14: 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 expres
Slide 15: 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 H1 2016 to obtain guidance on the ● EMA submission (centralized clinical/ regulatory pathway for procedure) 1Q 2016 licensing the IH AAT by Kamada in the U.S. ● AATD is among
Slide 16: AAT to Treat Type 1 Diabetes
AAT to Treat Type 1 Diabetes Investor Presentation 11.2015 | 16
Slide 17: AAT Serves as An Exciting Potential Therapy for Multiple Indications
AAT Serves as An Exciting Potential Therapy for Multiple Indications AAT is a safe plasma-derived protein with known & newly discovered therapeutic roles Immune- Anti-Inflammatory Tissue Antimicrobial modulatory Protective Investor Presentation 11.2015 | 17
Slide 18: 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 19: 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 AAT promotes Tregs and Inhibits proteins that activate Protects from cell death, anti-inflammatory mediators m
Slide 20: 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 21: 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 T
Slide 22: Newly Diagnosed Type-1 Diabetes 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 23: AAT to Treat Graft versus Host Disease
AAT to Treat Graft versus Host Disease Investor Presentation 11.2015 | 23
Slide 24: 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 25: 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 Dose: 4 dose groups - 15 day regimen. Doses given on days: 1,3,5,7, 9, 11, 13 and 15 24 patients with steroid- resistant GVHD following Primary End Points: % of patients at each dosing allogeneic
Slide 26: 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. Continuou
Slide 27: 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 28: AAT to Treat Lung Transplant Rejection
AAT to Treat Lung Transplant Rejection Investor Presentation 11.2015 | 28
Slide 29: Lung Transplant Rejection - Attractive opportunity to deliver a differentiated therapy
Lung Transplant Rejection - Attractive opportunity to deliver a differentiated therapy • The lungs have the highest rate of rejection among transplanted solid organs. • Approximately 1/3 will experience acute rejection within the first year and 1/2 will develop chronic rejection within the first 5 y
Slide 30: Financials
Financials Investor Presentation 11.2015 | 30
Slide 31: Compelling Investment Driven by Multiple Pillars of Growth
Compelling Investment Driven by Multiple Pillars of Growth Additional New Unencumbered The Kamada Geographies Pipeline Products Pillars Inhaled AAT D1-AAT (IV): Existing Anchor Potential to sell Type-1 diabetes in Products for AATD in existing and new Phase I/II Europe & U.S. products into new (
Slide 32: 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 33: Sustained and Rapid Growth has Made Kamada EBITDA Positive Within 3 Years
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 14 34 59 73 71 71 Revenues Growth 14
Slide 34: 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 35: 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 1Q16 2H15 Completion of Phase II for Inhaled AAT for AATD 1H16 trial (U.S.) Strategic agreements 2016 Initiation of Phase II lun
Slide 36: Kamada Investment Highlights
Kamada Investment Highlights Investor Presentation 11.2015 | 36
Slide 37: 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 38: Thank You
THANK YOU www.kamada.com Investor Presentation 11.2015 | 38
Slide 39: Appendix
APPENDIX Investor Presentation 11.2015 | 39
Slide 40: 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 41: 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 Adjusted mean change from baseline Adjusted mean change from baseline Overall effect +15ml Overall effect +0.623 P=0.0268 P=0.0074 Overall effect -27ml Overall effect -0.8715 Week Week Treatment Group
Slide 42: 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 Sputum Classification Rules Dyspnea Sputum Type/Category * Volume ** Color** Type I All 3 symptoms at high
Slide 43: 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 P Value 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 exa
Slide 44: 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 45: 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 4 Week Average Score 4 Week Average Score Week Week AAT Placebo Improvement trend in favor of AAT group - not sta
Slide 46: 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 47: Inhaled AAT Is A Significant Opportunity
Inhaled AAT Is A Significant Opportunity Inhaled AAT Highlights Strategic Partnership with Chiesi • The most advanced Inhaled AAT product • Chiesi distribution agreement as of August 2012 developed to date. • Agreement: Chiesi responsible for S&M, patient – Device and drug combination enable optimal