EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1 exhibit_99-1.htm


EXHIBIT 99.1
 
1
NASDAQ: KMDA JUNE 2015
KAMADA INVESTOR PRESENTATION
 
 

 
2
Investor Presentation | June 2015
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. 
This presentation contains forward-looking statements,
which express the current beliefs and expectations of
Kamada’s management. Such statements involve a
number of known and unknown risks and uncertainties
that could cause Kamada's future results, performance
or achievements to differ significantly from the results,
performance or achievements expressed or implied by
such forward-looking statements. Important factors that
could cause or contribute to such differences include
risks relating to Kamada's ability to successfully develop
and commercialize its pharmaceutical products, the
progress and results of any clinical trials, the
introduction of competing products, the impact of any
changes in regulation and legislation that could affect
the pharmaceutical industry, the difficulty of predicting
U.S. Food and Drug Administration, European
Medicines Agency and other regulatory authority
approvals, the regulatory environment and changes in
the health policies and structures of various countries,
environmental risks, changes in the worldwide
pharmaceutical industry and other factors that are
discussed in Kamada's prospectus related to this
offering.
This presentation includes certain non-GAAP financial
information, which is not intended to be considered in
isolation or as a substitute for, or superior to, the
financial information prepared and presented in
accordance with GAAP. The non-GAAP financial
measures may be calculated differently from, and
therefore may not be comparable to, similarly titled
measures used by other companies. A reconciliation of
these non-GAAP financial measures to the comparable
GAAP measures is included in an appendix to this
presentation. Management uses these non-GAAP
financial measures for financial and operational decision
-making and as a means to evaluate period-to-period
comparisons. Management believes that these non-
GAAP financial measures provide meaningful
supplemental information regarding Kamada’s
performance and liquidity.
Forward-looking statements speak only as of the date
they are made, and Kamada undertakes no obligation to
update any forward-looking statement to reflect the
impact of circumstances or events that arise after the
date the forward-looking statement was made.  You
should not place undue reliance on any forward-looking
statement and should consider the uncertainties and
risks noted above, as well as the risks and uncertainties
more fully discussed under the heading “Risk Factors” of
Kamada’s 201
4 Annual Report on Form 20-F filed with
the U.S. Securities and Exchange Commission on April
29, 2015.
 
 

 
3
Investor Presentation | June 2015
Kamada Overview
1. Rapidly Growing, Globally Positioned Biopharmaceutical
 Company Focused on Orphan Diseases and Plasma-
 Derived Protein Therapeutics
       ● Revenue and profitability with 10 marketed products
       ● $100M of revenues expected by 2017
2. Leader in the Development of Alpha-1 Antitrypsin (“AAT”)
 Products Globally and Specific Immunoglobulin
       ●     Developed and obtained FDA Approval for the first and only liquid,
               ready-to-use intravenous AAT product, Glassia® for AAT deficiency
 Selling Glassia® in selected emerging markets globally and through
 Baxalta (formerly Baxter) collaboration in the U.S.
 KamRAB for rabies prophylaxis (U.S. Phase III complete) to be
 launched in U.S. through collaboration with Kedrion
3. Attractive Pipeline for 5 Orphan Indications including
 AAT to treat type-1 diabetes (Phase II/III)
 AAT to treat Graft-vs-Host Disease (GVHD) (Phase I/II)
 Novel Inhaled AAT for AATD (EU Phase III completed)
 Pursuing approval in EU, MAA submission end 2015
 Ongoing Phase II in the U.S.; pathway to be discussed with FDA
4. Fully Integrated Manufacturing and Distribution
Notes: 1. As of March 31, 2015 2. Market data as of May 13, 2015
 Founded in 1990. Based in Weizmann Science Park,
 Israel
 Employees: ~300 (1)
 Listed on NASDAQ since 2013 & TASE since 2005
 (KMDA)
 Current market capitalization: ~$157MM (2)
 Cash, cash equivalents and ST investments: $50MM(1)
 Total Debt: $7.5MM(1) 
Key Statistics
 
 

 
4
Investor Presentation | June 2015
Integrated, Efficient, Scalable Platform Technology
Fully-Invested
Manufacturing Facility &
Marketed Products
 FDA approved since
 2010
 cGMP compliant
 Multiple countries'
 certifications (U.S.,
 Brazil, Israel, Mexico,
 Russia)
 State-of-the-art clean
 room environment
 Located in Beit Kama,
 Israel
Proprietary, Innovative
and Patented Technology
Platform
 Patent protected:
 Chromatography-based
 purification process
 Enables high purity
 extraction
 Ready-to-use, liquid and
 stable specialty protein
 therapeutics (AAT,
 Albumin, Transferrin and
 many others)
 Enables production of
 almost any human plasma
 -derived specific
 immunoglobulins
Benefits
 Enables manufacturing of
 plasma-derived protein
 therapeutics with differentiated
 product profiles
 Infrastructure in place to meet
 future pipeline product demand
 Expandable product platform to
 additional territories and
 indications
+
=
 
 

 
5
Respiratory
Glassia®
Immunoglo-
bulin
KamRAB™
KamRho (D) IM
KamRho (D) IV
Other
Products
Heparin Lock Flush
Kamacaine 0.5%
Human Transferrin
Respiratory
Bramitob
Foster  
Immunoglo-
bulins
IVIG 5%
Varitect
Hepatect CP
Megalotect
Zutectra
Critical
Care
Heparin sodium
Injection
Albumin
Other
Factor VIII  
Factor IX
 Proprietary
 Products
 Segment
 2014
 Revenue:
 $44MM
 Distribution
 Segment
 2014
 Revenue:
 $27MM
Alpha-1 Antitrypsin (human)
Anti-rabies immunoglobulin (human)
Rho(D) immunoglobulin (human)
Rho(D) immunoglobulin (human)
Heparin sodium
Bupivacaine HCl
Transferrin (Diagnostic grade)
Tobramycin
Beclomethasone+Formoterol
Gamma globulins (IgG) (human)
Varicella zoster immunoglobulin (human)
Hepatitis B immunoglobulin (human)
CMV immunoglobulin (human)
Hepatitis B Immunoglobulins S.C
Human serum Albumin
Coagulation Factor VIII (human)
Coagulation Factor IX (human)
Snake Antiserum
Anti-snake venom
Growing Proprietary Products Segment Through Glassia®
United States
Mexico
El Salvador
Brazil
Argentina
Slovenia
Croatia
Nigeria
Kenya
India
Thailand
South Korea
Russia
Turkey
Israel*
Chile
Sri Lanka
Diverse Portfolio of Predominantly Plasma-Derived Protein Therapeutics
Global Presence with Exposure to Emerging Markets
*Kamada distributes products directly in
Israel through its own salesforce
Countries where Kamada currently sells certain
of its Proprietary Products through strategic or
distributor partnerships
Countries where Kamada has received regulatory
approvals for certain of its Proprietary Products
Heparin sodium
 
 

 
6
Glassia® is a Differentiated Product
Key Product Advantages
AATD (IV) Product Sales
AATD (IV) Product Sales
W/O Milestone Revenues ( in MM$)
W/O Milestone Revenues ( in MM$)
 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 time
 Potentially reduced risk for adverse event and/or
 allergic reaction due to the absence of
 preservatives and stabilizing agent(s)
 Glassia® is sold in the U.S. by Baxalta (formerly
 Baxter), a leading plasma therapeutics company
  Significantly faster infusion rate was recently
 (2014) approved by the U.S. FDA
Glassia® is sold in 8 countries,
with majority of sales in the U.S.
 
 

 
7
Investor Presentation | June 2015
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, Australia and New Zealand
 Milestone and upfront revenues: $45MM ($34.5MM received)
 Agreement recently extended:
 Baxalta to distribute Glassia® produced by Kamada through 2017
 Minimum revenues of $191MM through 2017 ($121MM already recognized through 12/31/2014)
 Royalties from sales of Glassia® produced by Baxalta expected from 2018
 
 

 
8
Investor Presentation | June 2015
Significant Opportunity to
Expand the AATD Market
 Patients suffering from AAT Deficiency
 (“AATD”) remain under-identified and under-
 treated
 Only ~6% of cases treated in the U.S. and
 ~2% in EU
 Simple blood test for diagnosis expected to
 impact demand
 Greater AAT use in Europe and other
 geographies could further accelerate market
 growth
 Chronic therapy creates sustainable product
 opportunity
Sustainable Market with Strong
Growth Potential
AATD Prevalence: ~200,000
Yet Fewer than 5% of Potential Patients in
the U.S. and Europe are Treated
Source : Alpha 1 Foundation, MRB and Company estimates
 
 

 
9
Investor Presentation | June 2015
KamRAB: Human Rabies Immune Globulin
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 data expected during 2015
●  Expect to file Biological License Application with the FDA in beginning of 2016
●  U.S. launch expected by 2016/17
●  In the U.S., there are ~40,000 post-exposure prophylaxis treatments
    administered each year, representing an ~$100 million market opportunity
●  Currently, only one significant provider of anti-rabies immunoglobulin exists
Out of U.S.: Product marketed by Kamada in 10 countries
●  The product has been marketed since 2003
●  WHO estimates ~10 million people worldwide require medical treatment
    against rabies each year after being bitten by an animal suspected of rabies
    infection
Kamada’s human rabies immune globulin is a post-exposure
prophylaxis (PEP) for rabies.
 
 

 
10
Investor Presentation | June 2015
High Value Pipeline Focused on Orphan Indications
Product
Indication
Phase I
Phase II
Phase III
Market
Partners
Intravenous
AAT
AAT Deficiency
 
     
U.S.:
D1-AAT (IV)
Type 1 Diabetes*
 
     
U.S.:
G1-AAT (IV)
GVHD*
 
 
 
U.S.:
L1-AAT (IV)
Lung transplant
 
 
 
U.S.:
Inhaled AAT
AAT Deficiency*
 
     
EU:
 
B1-AAT (IH)
Bronchiectasis*
 
   
 
 
C1-AAT (IH)
Cystic Fibrosis*
 
   
 
 
KamRAB (IM)
Prophylaxis for
Rabies
 
   
U.S.:
Phase III Completed
(LPO)
  Ph II/III In Process
FDA Approved (2010)
Completed
  Ph I/II In Process
 U.S.: IND
 Approved
U.S.: Ph II
In Process
EU: Completed
Completed
Completed
* Orphan drug designation
  Ph I/II in Initiation
 
 

 
11
Inhaled AAT to Treat AATD
 
 

 
12
Investor Presentation | June 2015
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
 are treatment naïve
 Double blind, placebo controlled, randomized
 Multi center international study: Western EU (UK,
 IR, SC, SW, NL, DK, GR) and Canada
 80% power to detect a difference between the two
 groups at 1 year
 Powered for 20% difference between the two
 groups
 Power is based on number of events collected
 during the study
 Randomized; Sample size of ~36-40 subjects
 Double blind, placebo controlled, randomized
Route &
Dosage
Form
 Inhalation of human AAT, 160mg total, twice
 daily ~10-15 minutes; eFlow® device
 Inhalation of human AAT; two dosage groups
 (80mg and 160mg daily); eFlow® device
Clinical
Endpoints
 Exacerbation events (Primary: time to first
 moderate/severe, Secondary (among others):
 rate, severity of first event; Lung Function)
 Primary: Concentration of AAT in ELF
 Secondary: safety and tolerability, Concentration
 AAT in serum, ELF inflammatory analytes
Duration
 50 wk treatment in DB period; daily treatment
 50 wk open label extension ; daily treatment
 Study completed
 12 weeks double blind +
 12 weeks open label extension
  Study initiated in 1Q2014
 
 

 
13
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-
   exacerbations (trend) and reduction in dyspnea score (statistically significant) for
   first exacerbation
4.Safe and tolerable drug
Submission of MAA is planned by end of 2015 on the basis of:
1.Orphan designated drug
2.Demonstrated efficacy in lung function
3.Unmet patient need - Clinical primacy in efficacy data for IH AAT and AATD in
   general
4.EMA confirmed review of post-hoc analysis and totality of the data irrespective of
   not meeting primary endpoint
5.Pre-existing cases of approved drugs of similar nature (ODD, post hoc analyses
   and existing patient un met need)
Investor Presentation | June 2015
 
 

 
14
Investor Presentation | June 2015
Inhaled AAT Phase II/III Trial Results:
Spirometry Measures (MMRM*)
*MMRM = Mixed Model Repeated Measure, SE in brackets
Lung
Function
Least Squares Means (SEM)
(Changes at Week 50 from
Baseline)
P-Value*
(Changes at
Week 50)
Least Squares Means
(SEM) (overall treatment
effect)
P-Value*
(Overall
Effect)
AAT
(N= 84)
Placebo
(N= 81)
AAT
(N= 84)
Placebo
(N= 81)
FEV1 (L)
 -12mL
-0.01183
(0.02196)
-62mL
-0.06216
(0.02036)
0.0956
+15mL
0.01503
(0.01338)
-27mL
-0.02718
(0.01322)
0.0268
FEV1 (% of
predicted)
-0.1323
(0.6649)
-1.6205
(0.6140)
0.1032
0.5404
(0.4451)
-0.6273
(0.4425)
0.0658
FEV1/SVC
(%)
0.6183
(0.5015)
-1.0723
(0.4455)
0.0132
0.6230
(0.3931)
-0.8715
(0.3804)
0.0074
 
 

 
15
Investor Presentation | June 2015
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 expressed by its
preservation of lung function and the changes shown in symptoms.”
Prof. Jan Stolk, MD, Department of Pulmonology, Leiden University Medical Center, Principal Investigator of the Phase
2/3 clinical trial and acting Chairman of the Alpha 1 International Registry (AIR)
“These new analyses confirm the clinically-meaningful lung function improvement seen
with inhaled AAT patients in this study. These results are impressive and underscore the
initial findings from this study. In my opinion, inhaled AAT has shown to be an efficacious
treatment for this orphan disease.”
 acceptance of the inhaled route of administration of alpha-
 1 antitrypsin augmentation therapy, which could be a real
 breakthrough for AATD patients.”
Robert A. Sandhaus, Ph.D., M.D., FCCP, Founder and Director
of the Alpha1-Antitrypsin Deficiency Program at National Jewish Health
in Denver, Colorado, and the Clinical Director of the Alpha-1 Foundation
 
 

 
16
Investor Presentation | June 2015
Inhaled AAT Phase II/III Trial Results:
Spirometry Measures (MMRM)
FEV1 (L) - MMRM
Week
FEV1/SVC - MMRM
Week
Overall effect +15ml
Overall effect -27ml
P=0.0268
Overall effect +0.623
Overall effect -0.8715
P=0.0074
Treatment Group
AAT
Placebo
 
 

 
17
Investor Presentation | June 2015
Inhaled AAT Phase II/III Trial:
Nature of the First Exacerbation
 ITT
N (%)
 
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 exacerbation
(Potential change from Type I to Type II)
Type I+II è Type I exacerbation stands for 41% within total of type I+
II exacerbations for AAT group vs. 68% for placebo group.
 
 

 
18
Investor Presentation | June 2015
Inhaled AAT Phase II/III Trial:
Symptom Score MMRM
*Adjustment to age, oxygen, BMI, Country, Treatment Duration
 Symptom
Exac. Type
Days
MMRM
Least Square Means
P-Value*
AAT
N=73
Placebo
N=71
 Dyspnea
 
0-10
11.9464
12.2548
0.0243
0-14
11.5803
11.7832
0.0817
 Sputum
 Volume
0-10
1.2748
1.3837
0.0334
0-14
1.2367
1.3206
0.0595
 Sputum Color
0-10
2.1566
2.0137
0.0502
0-14
2.0240
1.8393
0.0032
Analysis of First (Types I+II+III) Exacerbation Severity for each major Symptom
(during 0-10 and 0-14 days of the exacerbation event)
During first exacerbation, AAT group significantly improves
dyspnea and sputum volume symptoms
 
 

 
19
Inhaled AAT Phase II/III Trial Results
Continuous Symptom Score: Dyspnea
Continuous Symptom Score: Well Being
Dyspnea 4 Week Moving Average Graphs
Week
AAT
Placebo
Well Being 4 Week Moving Average Graphs
Week
Improvement trend in favor of AAT group, No statistical significance
This study has enlightened our understanding about the course of exacerbation events, specifically with respect
to its composite symptoms, exacerbation severity and frequency with linkage to patients’ baseline disease.
Importantly, the improvements seen in well-being and dyspnea in the inhaled AAT treated patients suggest that
in addition to lung function improvements, these patients are seeing important improvement in their symptoms,
which are correlated to quality of life.”
Prof. R.A. Stockley, M.D., Professor of Medicine at Birmingham University and Medical Director of the Lung Resource Centre,
Queen Elizabeth Hospital, Birmingham, U.K. and a principal investigator of the European Phase 2/3 study.
Improvement trend in favor of AAT group - not statistical significant
 
 

 
20
Investor Presentation | June 2015
Inhaled AAT: Moving Forward
 Compilation of an MAA dossier
 EMA submission (centralized
 procedure) end of 2015
EMA: EU Front
 Approach U.S.-FDA with results in
 H2 2015to obtain guidance on the
 clinical/ regulatory pathway for
 licensing the IH AAT by Kamada in
 the U.S.
FDA: U.S. Front
Kamada is committed to the AATD patient community to bring the IH AAT into
the market place and provide an adequate, safe and efficacious answer to
current unmet medical need of these orphan patients.
 
 

 
21
AAT to Treat Type 1 Diabetes
 
 

 
22
Investor Presentation | June 2015
AAT (IV) is a Promising Potential Treatment
for Newly Diagnosed Type ‐1 Diabetes Patients
Type-1 Diabetes
occurs when the immune
system attacks and destroys
beta cells in the pancreas
Studies have shown
That AAT protects
beta cell islets
Preservation of beta cells
correlates with reduced risk
of long term complications
 More than 10 million suffer
 from T1D globally
 100,000 new patients
 diagnosed annually
 In the U.S. alone: 3 million
 patients, with 30,000 new
 patients diagnosed annually
 Delays the onset of autoimmune
 diabetes
 Reduces the incidence of
 diabetes
 Inhibits insulitis and beta-cell
 apoptosis
 Decreases beta-cell inflammation
 DCCT* indicated that patients
 with C-peptide on MMTT ≥0.2
 pmol/mL were less likely to
 complicate of retinopathy and
 hypoglycemia (Greenbaum et al
 2012)
 Higher / sustained levels of C-
 peptide correlate with reduced
 incidences of the microvascular
 complications (Steffes et al 2013)
*Diabetes Control and Complications Trial
FDA Guidance: “We acknowledge the evidence from the DCCT and other studies that have
demonstrated clinical benefits in patients who achieve better glucose control, in terms of
delaying the chronic complications of diabetes”**
**FDA Guidance, 2008
 
 

 
 
23
Investor Presentation | June 2015
AAT
Anti Inflammatory
Blocks pro-Inflammatory
mediators incl. IL-1
b, IL-6,
IL-8 and TNF
a
Immunomodulatory
AAT promotes Tregs and
modifies dendritic cell
maturation towards a
tolerance-inducing profile
Tissue protective -
Protects from cell death,
blocks apoptosis
Regulatory T cell
differentiation
AAT promotes Tregs
differentiation
Blocks ‘danger’ molecules
AAT binds to gp96 (involved in
authoimmune attack) and diminishes gp96-
induced islet injury
Increases insulin release
AAT increases cAMP levels
(required for insulin release).
cAMP also induces IL-10
release
Protease Inhibitor
Inhibits proteins that activate
inflammation: Elastase, trypsin
& PR3 and has tissue-
protective effects
Modifies dendritic cells:
AAT modifies dendritic cell
maturation towards a tolerance-
inducing profile
Protect islets from injury
AAT protects islet cells from
IL-1b/IFNg-induced injury and
reduces the levels of released
nitric oxide
Reference: Fleixo-Lima et al. Mechanistic Evidence in Support of Alpha1-Antitrypsin as a
Therapeutic Approach for Type 1 Diabetes. J Diabetes Sci Technol. 2014.
 
 

 
23
Investor Presentation | June 2015
AAT
Anti Inflammatory
Blocks pro-Inflammatory
mediators incl. IL-1
b, IL-6,
IL-8 and TNF
a
Immunomodulatory
AAT promotes Tregs and
modifies dendritic cell
maturation towards a
tolerance-inducing profile
Tissue protective -
Protects from cell death,
blocks apoptosis
Regulatory T cell
differentiation
AAT promotes Tregs
differentiation
AAT binds to gp96 (involved in
authoimmune attack) and diminishes
gp96-induced islet injury
Increases insulin release
AAT increases cAMP levels
(required for insulin release).
cAMP also induces IL-10
release
Protease Inhibitor
Inhibits proteins that activate
inflammation: Elastase, trypsin
& PR3 and has tissue-protective
effects
Modifies dendritic cells:
AAT modifies dendritic cell
maturation towards a tolerance-
inducing profile
Protect islets from injury
AAT protects islet cells from
IL-1b/IFNg-induced injury and
reduces the levels of released
nitric oxide
Reference: Fleixo-Lima et al. Mechanistic Evidence in Support of Alpha1-Antitrypsin as a
Therapeutic Approach for Type 1 Diabetes. J Diabetes Sci Technol. 2014.
 
 

 
24
Investor Presentation | June 2015
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
 AUC% for C-peptide decreased 23% from baseline vs. ~40-50% expected decrease after 12-15M from diagnosis (1)
 Specific diabetes antibody levels decreased in all groups from baseline to study completion, a decrease that may indicate
 an Immune modulatory effect.
 At end-of-study, 38% of patients decreased insulin dose.
 All subjects completed the study. No Serious AEs occurred. AEs were mild and mostly infusion-related (fatigue,
 headache)
End-of-study slope analysis of C-peptide[max] and
C-peptide[AUC] revealed no significant changes
from baseline
HbA1C data indicated that almost all patients reached
glycemic control
1. Greenbaum et al 2012
 
 

 
25
Diabetes Extension Clinical Study:
Interim Report #2
HbA1c
 Treated patients had an avg HbA1C of 7.5%, vs 7.9% for
 the follow-up patients
 60% of treated patients had HbA1C levels lower or equal
 to 7.5% vs. 44% of follow-up patients
 Differences are not statistically significant - study was not
 powered for efficacy
External Insulin Consumption and Safety
 Median insulin intake- treated patients 0.6 IU/kg/d vs to
 1.00 IU/kg/d for follow-up patients (p = 0.025)
 No safety issues were reported during this interim review
 of trial data
HbA1c (%) by Visit and Study Arm
After avg 26 months
from diagnosis
19 subjects enrolled : the treatment arm
(n=10), follow-up arm (n=9)
Data is presented 26 months (avg) post
T1D diagnosis- following 6 additional
AAT infusions
C- Peptide
 Mean peak C-peptide level, was 0.40 pmol/ml in
 the treatment group
 60% of treated patients had a level ≥ 0.2
 pmol/ml.
 C- peptide not collected for follow-up patients
Investor Presentation | June 2015
 
 

 
26
Investor Presentation | June 2015
Newly Diagnosed Type‐1 Diabetes Currently
Ongoing Phase II/III Clinical Trial
Study objective: To evaluate the efficacy and safety
of human, Alpha-1 Antitrypsin (AAT) in  the treatment
of new onset Type 1 Diabetes
Design: Two doses, placebo controlled, randomized
with ~190 pediatric and young adult patients
Expected Duration: Two years
Endpoints: In accordance with FDA / EMA guidance
for clinical trials evaluating beta-cell preservation [c
peptide parameters, HbA1C, hypoglycemic events and
insulin daily dose]
Pivotal, Phase II/III, Double-
Blind, Randomized, Placebo-
Controlled, Multicenter Study
 
 

 
27
AAT to Treat Graft versus Host Disease
 
 

 
28
Investor Presentation | June 2015
Graft versus Host Disease (GVHD):
The Major Issue in Stem Cell Transplantation
 Deadly side effects:
      ● ~20% of transplanted patients’ deaths are caused by GvHD complications
      ● ~70% mortality in patients with grade III/IV GvHD
      ● ~50% of patients are non responsive to steroids
 Searching for an effective treatment
 ● Standard of care prophylaxis exhibits poor efficacy/severe AE’s
    (Glucocorticoids)
 ● No FDA approved specific drug for GvHD indication
 Estimated market size: ~ $700 million
 Donor’s immune cells (the graft) recognize the recipient (the host) as
 “Non-self“. The transplanted immune cells attack the host's body cells.
 
 

 
29
Investor Presentation | June 2015
Proof-of-Concept Study with AAT (IV)
for Graft-Versus-Host Disease (GVHD)
This proof-of-concept study may serve as a potential platform,
to expand the use of AAT beyond GVHD, to other transplantations, based
on a similar mechanism of action
Dose: 4 dose groups - 15 day regimen. Doses given
on days: 1,3,5,7, 9, 11, 13 and 15
Primary End Points: % of patients at each dosing
cohort who experience no toxicity and in whom GVHD
is stable or improved
Secondary End Points - AAT levels, cytokine levels,
infection rate, progression of GVHD, SAEs.
In cooperation with Baxalta conducted at the Fred
Hutchinson Cancer Research Center in Seattle,
Washington
Phase I/II study open label
of 24 patients with steroid-
resistant GVHD following
allogeneic bone-marrow stem
cell transplant
 .
 
 

 
30
Investor Presentation | June 2015
First Cohort Results Show that AAT May Potentially Exert a
Protective Effect on the Bowel Mucosa in Gut GVHD
Preliminary results are
encouraging,
and further
exploration of AAT therapy in
extended phase II and randomized
trials as therapy of steroid
refractory acute GVHD or as first
line therapy are warranted
29
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.
Stool AAT levels showed a decrease
in intestinal AAT loss
, as measured
by AAT clearance and endoscopic
evaluation suggesting healing of the
bowel mucosa
Continuous administration of
AAT as salvage therapy for
steroid resistant gut GVHD is
feasible approach
without
clinically toxicity
 
 

 
31
Investor Presentation | June 2015
Phase I/II Clinical Study Interim Report

Loss of AAT in stool is an
expression of intestinal injury.
Before
Duodenits Suspect severe
upper and lower GvHD
After 8 doses of AAT
Moderate mucosal denudement
and edema noted throughout the duodenum.
FACS Analysis pre
and post AAT therapy
 
 

 
32
Investor Presentation | June 2015
Financials
 
 

 
33
Investor Presentation | June 2015
Compelling Investment Driven
by Multiple Pillars of Growth
Existing
Anchor
Products
§ Profitable unit
§ Sales in 15
 countries
§ Predictable,
   stable business
 

 
    ($0.5B)*
Existing Anchor
Products
+
Glassia®
(AAT-IV) in U.S.
+
Inhaled AAT for
AATD in
Europe & U.S.
+
New Geographies
+
Additional
Unencumbered
Pipeline Products
Glassia®
(AAT-IV)
in U.S.&ROW
§ Estimated only ~5%
 of cases treated in
 U.S.
§ Annual therapy costs
 ~$80K - $100K per
 patient
§ Partnered with Baxter
 solely for IV products
 in the U.S.
 (agreement also
 covers Canada,
 Australia and New
 Zealand)
§ Key geographies
 retained
 
    (100K pts.,
    $0.75- 1B)*
New
Geographies
§ Potential to sell
 existing and new
 products into new
 geographies
§ Rabies Ig to U.S. and
 additional territories
§ Capital-efficient
 strategy minimizes
 outlay required by
 Kamada
 ($0.5B)*
Additional
Unencumbered
Pipeline Products
§ D1-AAT (IV):
 Type-1 diabetes in
 Phase I/II
 (Unencumbered
 outside of U.S.,
 Canada, Australia and
 New Zealand)
 
(100K pts.,$3.5-5B)*
§ G1-AAT (IV)
   GVHD phase I/II
   in process
   ($0.5-1B)*
§ C1-AAT (IH):
 
Cystic fibrosis
 completed Phase II
 (Unencumbered)
 
(100K pts.,$0.5-1B)*
§ B1-AAT (IH):
 
Bronchiectasis
 completed Phase II
 (Unencumbered)
 
(600K pts.,$2B)*
Inhaled AAT for
AATD in
Europe & U.S.
§ Estimated only ~2% of
 cases treated in
 Europe
§ Estimated only ~5% of
 cases treated in U.S.
§ Orphan drug
 designation in U.S. and
 EU
§ Partnered with Chiesi
 for Inhaled AAT for
 AATD in Europe only
§ Distribution (no
 technology out-
 licensed in Europe)
§ Unencumbered in U.S.
 
 
   (200K pts.,$1-2B)*
The Kamada
Pillars
* Estimated market potential
 
 

 
34
Investor Presentation | June 2015
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 thereafter
 Kedrion partnership for Rabies Ig expected to increase revenues and
 profitability from 2017 and on
 Better product mix expected to improve gross margin
 Pipeline products expected to accelerate revenue growth
 Profits from marketed products to fund part of clinical development
 programs
 Low capital expenditure to support infrastructure meeting
 future demand
 Preferred tax treatment under Israeli law
 
 

 
35
Investor Presentation | June 2015
Sustained and Rapid Growth has Made Kamada
EBITDA Positive Within 3 Years of Growth
$MM
FY2009
FY2010
FY2011
FY2012
FY2013
FY2014
Proprietary
Products
10
23
35
47
51
44
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
 
146%
73%
22%
(3%)
0%
Gross Profit
(3)
6
17
23
26
16
R&D
(9)
(9)
(12)
(12)
(13)
(16)
S&M and G&A
(5)
(7)
(7)
(7)
(10) (2)
(10)
 Net Profit
 (Loss)
(21)
(14)
(4)
0.3
0.4
(11)
 Adjusted
 EBITDA (1)
(12)
(6)
1
9
9
(5)
Note
1. See Appendix for a reconciliation of Adjusted EBITDA to IFRS Net Profit (Loss)
2. Includes one time IPO related expenses of $1.4 M
 
 

 
36
Investor Presentation | June 2015
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
Strategic agreement with Chiesi for Inhaled AAT for AATD in
EU
Newly diagnosed type-1 diabetes Phase II trial completed
Initiation of Phase II/III for type-1 diabetes
Initiation of U.S. Phase II for Inhaled AAT for AATD
Initiation of U.S. Phase I/II study of Glassia in GVHD
Completion of EU Phase II/III Inhaled AAT for AATD trial
Completion of U.S. Phase III Rabies Ig
U.S. & EU Orphan Drug Designation for Glassia to treat
GVHD
Increased sales, profitability and production capacity
2010
2015
May
 
 

 
37
 Milestone Date
Investor Presentation | June 2015
Future Milestones and Value Creation
 Phase III Rabies Ig trial (U.S.) results
2H15
 Interim data from GVHD trial
2H15
 MAA submission for Inhaled AAT for AATD
2H15
 Completion of Phase II for Inhaled AAT for AATD
 trial (U.S.)
2H15
 Strategic agreements
2015
 Initiation of Phase II lung transplantation trial
2015
 BLA submission for the Rabies lg in the U.S.
2016
 Initiation of Phase lll for intrevenous AAT for GVHD
2016
 Interim report for Phase II/III for type-1 diabetes trial
2016
 Rabies product launch in the U.S. (if approved)
2016/7
 Inhaled AAT for AATD launch (EU) (if approved)
2016/7
 Reaching $100 million of annual revenues
2017
 Double the number of Glassia patients WW
2018
2H15
2018
 
 

 
38
Investor Presentation | June 2015
Kamada Investment Highlights
 
 

 
39
Investor Presentation | June 2015
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 Represents an Exciting
 Growth Opportunity
  Valuable R&D Pipeline Focused on Various Orphan
 Indications
  Validating Strategic Partnerships with Industry Leaders
 Baxalta, Chiesi, Kedrion and Pari Pharma
 
 

 
40
THANK YOU
Investor Presentation | June 2015
 
 

 
41
Investor Presentation | June 2015
APPENDIX
 
 

 
42
Investor Presentation | June 2015
Inhaled AAT Phase II/III trial:
Symptom Based Exacerbation Analysis

Major Three (3) Exacerbation Symptoms by Severity:
Dyspnea; Sputum Volume; Sputum Color
Exacerbation
Type/Category
Classification Rules
Possible Manifestations
Dyspnea*
Sputum
Volume
**
Sputum
Color**
Type I
All 3 symptoms at high score
+
+
+
Type II
Two of the 3 symptoms at high
score
+
+
 
+
 
+
 
+
+
Type III
One of the 3 symptoms at high
score
+
 
 
 
+
 
 
 
+
Scores (by severity):
*5, 10, 15, 20 for Dyspnea (high severity score ≥10)
** 1, 2, 3, 4 for Sputum volume and Sputum color (high severity score ≥2)
*Kamada’s Inhaled AAT Phase 2-3 EU and Canada Study results. Denver USA 2015
 
 

 
43
Investor Presentation | June 2015
Conditional Approval Guidance & Precedence
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 WITHIN THE SCOPE OF REGULATION (EC) No 726/2004
EMEA Guidance
Arzerra - GSK
 
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aaAMTmwslwq4
 
Cometriq - Exelixis
 
http://www.exelixis.com/investors-media/press-releases
 
Translarna PTC Therapeutics
 
http://ir.ptcbio.com/releasedetail.cfm?ReleaseID=888466
 
Deltyba - Otsuka
 
http://www.otsuka.co.jp/en/company/release/2013/1125_02.html
 
Sirturo - Johnson & Johnson
 
http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=831021
 
Precedence for Conditional Approval
 
 

 
 
44
Investor Presentation | June 2015
Inhaled AAT Is A Significant Opportunity
 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 revenues: $60MM upfront, regulatory and
 sales
 Distributor price
 Minimum purchases from 2nd yr following receipt of
 regulatory and reimbursement approvals, ~$120MM
 for first 4 years, subject to actual price after
 regulatory approval
Strategic Partnership with Chiesi
Inhaled AAT Highlights