Kamada Ltd. · NASDAQ:KMDA
Kamada — Investor Presentation (April 2019)
35 slides from Kamada's investor presentation, April 2019
Slide 1: Kamada Investor Presentation
Insert Photo KAMADA INVESTOR TITLE (CPITAL LETTERS) PRESENTATION NASDAQ & TASE: KMDA April 2019
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT This presentation is not intended to provide investment or This presentation includes certain non-IFRS financial medical advice. It should be noted that some products under information, which is not intended to be considered in isolation development described herein have no
Slide 3: Kamada Company Overview
KAMADA COMPANY OVERVIEW COMMERCIAL Kamada is focused on plasma-derived FDA approved products: GLASSIA® for protein therapeutics 2 AATD; KEDRAB® for Post-exposure prevention of rabies infection for orphan indications, with a commercial 4 IgG products marketed world wide product portfolio and a late-s
Slide 4: High Value Product Portfolio and Pipeline
HIGH VALUE PRODUCT PORTFOLIO AND PIPELINE Product Indication Phase I Phase II Phase III Market FDA approved (2010) U.S. distribution through Glassia® (IV AAT) AAT Deficiency Launched (2010) / KamRab®/KedRab® Prophylaxis for FDA approved (2017) U.S. distribution through (IM Anti-Rabies) Rabies Launch
Slide 5: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM NAME ROLE Amir London CEO Chaime Orlev CFO Michal Ayalon, PhD VP Research and Development Yael Brenner VP Quality Eitan Kyiet VP Business Development Eran Nir VP Operations Orit Pinchuk VP Regulatory Affairs & PVG Ariella Raban VP Human Resources Michal Stein, MD VP Medic
Slide 6: Increasing Revenue Growth and Profitability
INCREASING REVENUE GROWTH AND PROFITABILITY FY 2015 FY 2016 % Change FY 2017 % Change FY 2018 % Change US $ M Audited Audited 2016/2015 Audited 2017/2016 Unaudited 2018/2017 Proprietary Products 43 56 30% 80 42% 91 14% Distribution Products 27 21 -22% 23 8% 24 2% Total Revenues 70 77 10% 103 33% 115
Slide 7: Alpha-1 Antitrypsin Deficiency (AATD)
Alpha-1 Antitrypsin Deficiency (AATD) Insert Photo
Slide 8: What Is Alpha-1 Antitrypsin
WHAT IS ALPHA-1 ANTITRYPSIN • Alpha-1 Antitrypsin (AAT) 52-kDa serum serine-protease inhibitor that is produced by hepatocytes and mononuclear phagocytes. It is the most predominant protease inhibitor in the plasma. Concentrations of 1-3 mg/ml that are upregulated several folds during inflammation.
Slide 9: AAT Deficiency
AAT DEFICIENCY Potentially Lethal and Often Undiagnosed AAT AAT Level Deficiency U.S. EU Genetic condition Affects more than Causes predisposition causing decreased 100,000 people in the to lung and liver levels of AAT in blood U.S. and lower diseases and tissues numbers in Europe AAT deficiency-ass
Slide 10: AAT Deficiency (AATD) Is a $1B Market
AAT DEFICIENCY (AATD) IS A $1B MARKET Significant expansion opportunity ● Most of AATD patients are undiagnosed & untreated ● Better disease awareness and availability of diagnostics contribute to increased demand ● Growing U.S. market – 6-8% annual growth1 ● Average annual reimbursement (U.S.) ~$80
Slide 11: Glassia: Liquid AAT for the Treatment of AAT Deficiency
GLASSIA®: Liquid AAT for the Treatment of AAT Insert Photo Deficiency
Slide 12: Glassia Is a Differentiated Product
GLASSIA® IS A DIFFERENTIATED PRODUCT • Glassia® was the first liquid, FDA-approved ready-to- use, plasma-derived AAT product: o No reconstitution required o Reduces treatment time o Reduces risk of contamination and infection • Kamada’s highly purified liquid product is manufactured through a propri
Slide 13: Growth of Glassia Driven by Strategic Partnership with Takeda/Shire
GROWTH OF GLASSIA DRIVEN BY STRATEGIC PARTNERSHIP WITH TAKEDA/SHIRE Glassia is sold in 5 countries Significant Revenues to Kamada through 2020, majority of sales in the U.S. followed by 20 Years of Royalties 68 • Cumulative minimum/maximum revenues of $120M/$150M to 66 Kamada expected for 2019-2020
Slide 14: Advanced Immune Globulin Platform Technology
Advanced Immune Globulin Platform Technology Insert Photo
Slide 15: KamRAB/KedRAB
KamRAB/KedRAB Human Rabies Immune Globulin U.S. Market • FDA Approval - August 2017 • Successful product launch: April 2018 in U.S. collaboration with Kedrion • $12M – Kamada’s FY2018 KedRAB sales to Kedrion • Approx. 40,000 post-exposure prophylaxis treatments administered each year, representing U
Slide 16: Immune-Globulins Portfolio
IMMUNE-GLOBULINS PORTFOLIO KamRAB KamRho D IV KamRho D IM Anti- Snake Venom Post-exposure Second-line therapy Prevention of Israeli MOH strategic prevention of rabies for pediatric Rh-D immunization partnership supplying infection (KedRab in and adult patients in Rh-negative all national treatment t
Slide 17: Distribution Product Segment
Distribution Product Segment Insert Photo
Slide 18: Distribution Products Segment
DISTRIBUTION PRODUCTS SEGMENT Exclusive distributor in Israel for leading biopharmaceutical companies • Marketing and distribution of specialty pharmaceutical products of leading international pharmaceutical companies in the Israeli market through a dedicated salesforce • Expanding product portfolio
Slide 19: Inhaled AAT for Alpha-1 Antitrypsin Deficiency (AATD)
Inhaled AAT for Alpha-1 Antitrypsin Insert Photo Deficiency (AATD)
Slide 20: Inhaled AAT Anticipated Benefits
INHALED AAT ANTICIPATED BENEFITS X3 ELF2 Most effective Improved levels 2-3 mode of treatment Quality Of fold for reaching Life (QOL) greater than primary site of Inhaled AAT targets a injury3 IV world wide market of over $1B Alpha-1 Foundation Inhaled AAT ~ 50% of the dosage Intravenous AAT ~ 2% of
Slide 21: Inhaled AAT Demonstrated Reduced FEV1 Deterioration Compared to AAT-IV
INHALED AAT DEMONSTRATED REDUCED FEV11 DETERIORATION COMPARED TO AAT-IV IV studies Inhaled Seesholm 1997 AATD reg 1998 Dirksen 1999 Wenecker 2001 Chapman 2005 KAMADA INH 0 -10 -20 -30 -40 -50 -60 -70 -80 13.4 ml/y diff 50 ml/y diff -90 AAT Placebo 21 1. FEV1 = Forced Expiratory Volume in The 1st Sec
Slide 22: Inhaled AAT Moving Forward
INHALED AAT MOVING FORWARD • Ongoing discussions with the FDA addressing concerns and questions regarding the safety and efficacy of Inhaled AAT for the treatment of AATD U.S. • Revised proposed Ph3 protocol and additional information provided during recent months to the FDA • Continued clinical dev
Slide 23: AAT Represents an Exciting Potential Therapy for Multiple Indications
AAT REPRESENTS AN EXCITING POTENTIAL THERAPY FOR MULTIPLE INDICATIONS Anti-Inflammatory AAT 01 GvHD is a safe plasma- Immune derived protein Modulatory Lung with known and 02 Transplant newly discovered therapeutic Tissue Protective roles 03 Type-1 Diabetes Antimicrobial Strong safety profile, encou
Slide 24: Graft Versus Host Disease (GvHD)
GRAFT VERSUS HOST DISEASE (GVHD): 01 A Major Complication of Hematopoietic Cell Transplantation DEADLY SEARCHING FOR AN EFFECTIVE SIDE EFFECTS TREATMENT of bone marrow 30-40% transplantations will No established prophylactic develop acute GvHD treatment of acute GvHD will not Existing prophylaxis ma
Slide 25: Collaboration with MAGIC to Evaluate AAT for Preemption of SR-GvHD
COLLABORATION WITH MAGIC1 TO EVALUATE 01 AAT FOR PREEMPTION OF SR-GVHD Proof-of-Concept Study: Innovative • Utilization of novel blood biomarker algorithms approach may identify patients at high risk for SR-GvHD and • Open label single arm multicenter non-relapse mortality (NRM) study conducted in 5
Slide 26: Advancing the Lung Transplantation Opportunity
ADVANCING THE LUNG TRANSPLATATION 02 OPPORTUNITY Adults Lung Transplants Lungs have the highest rate of rejection among 100 Recipients Survival Rate1 transplanted solid organs ~33% will experience acute rejection within the first year 80 ~50% will develop chronic rejection within the first 5 years B
Slide 27: Ongoing Phase 2 Study with AAT IV for Prevention of Lung Transplant Rejection
ON-GOING PHASE 2 STUDY WITH AAT IV 02 For Prevention of Lung Transplant Rejection Phase 2: Study objective • To assess the safety of AAT IV and the effect on rate and severity of acute and chronic lung rejection as • Prospective, open label, well as pulmonary infections, in subjects undergoing stand
Slide 28: AAT (IV) as Potential Treatment for Newly Diagnosed Type-1 Diabetes Patients
AAT (IV) AS POTENTIAL TREATMENT FOR NEWLY 03 DIAGNOSED TYPE‐1 DIABETES (T1D) PATIENTS MARKET OPPORTUNITY AAT IMPACT EXPECTED BENEFITS Type-1 Diabetes Studies have shown Preservation of beta cells Occurs when the immune system that AAT may protect correlates with reduced risk attacks and destroys bet
Slide 29: T1D - Phase 2 Study
03 T1D - PHASE 2 STUDY Study • To evaluate efficacy and safety of AAT) in Phase 2 Completed: objective treatment of newly diagnosed Type 1 Diabetes patients Double-Blind, Design • Two doses, placebo controlled, randomized Randomized, Placebo- with 70 pediatric and young adult patients. Controlled, M
Slide 30: Key Value Creating 2019 Milestones
KEY VALUE CREATING 2019 MILESTONES Inhaled AAT for AATD - Continued FDA discussion 1H/2019 targeting IND approval Inhaled AAT for AATD phase 3 pivotal study – First patient 2H/2019 in (pending IND/CTA approval) Organ preservation program – Define regulatory and 1H/2019 commercial path End of Lung tr
Slide 31: Investment Highlights
INVESTMENT HIGHLIGHTS • Leader in plasma-derived protein therapeutics, focused on Alpha-1 Antitrypsin (AAT) and specific hyper-immune IgGs COMMERCIAL • 2 FDA approved products STAGE • Glassia® for AAT Deficiency (AATD); first FDA-approved liquid, ready-to-use IV AAT. Commercialized in the U.S. BIOPH
Slide 32: Thank You
THANK YOU www.kamada.com Kamada Investor Presentation / April 2019
Slide 33: Appendix A
APPENDIX A Appendix A: Reconciliation of Non-IFRS Measures Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation Adjusted EBITDA is defined as net income (loss), plus from, or as a substitute for, our IFRS results. We expect to income tax expens
Slide 34: Inhaled AAT - In the Words of the Key Opinion Leaders
INHALED AAT – IN THE WORDS OF THE KEY OPINION LEADERS EU Phase 2/3: “The study analysis suggests exciting results that US Phase 2: may lead to wider acceptance of the inhaled route of administration of alpha- 1 antitrypsin “The study results augmentation therapy, which could be a real “The results o
Slide 35: AAT IV - New Indications in the Words of the Key Opinion Leaders
AAT IV – NEW INDICATIONS IN THE WORDS OF THE KEY OPINION LEADERS GvHD Phase 2: GvHD Phase 2: “…we are very excited to initiate the first preemptive treatment “We are delighted to collaborate with Kamada on this study utilizing the MAGIC biomarkers. AAT has shown encouraging groundbreaking, first-in-