EXHIBIT 99.1
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KAMADA
INVESTOR PRESENTATION
INVESTOR PRESENTATION
January 2015
NASDAQ: KMDA
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-12.jpg)
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.
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.
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.
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.
The issuer has filed a registration statement (including a prospectus) with the US Securities and Exchange Commission (the “SEC”) for the offering to which this communication
relates. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more complete information
about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, a copy of the prospectus may be
obtained from the offices of Morgan Stanley & Co. LLC, Attention: Prospectus Department 180 Varick Street, 2nd Floor, New York, New York 10014; telephone 866-718-1649;
email: prospectus@morganstanley.com or from Jefferies LLC at 520 Madison Avenue, 12th Floor, New York, NY, 10022, Attention: Equity Syndicate Prospectus Department;
telephone (877) 547-6340; email: Prospectus_Department@Jefferies.com.
relates. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more complete information
about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, a copy of the prospectus may be
obtained from the offices of Morgan Stanley & Co. LLC, Attention: Prospectus Department 180 Varick Street, 2nd Floor, New York, New York 10014; telephone 866-718-1649;
email: prospectus@morganstanley.com or from Jefferies LLC at 520 Madison Avenue, 12th Floor, New York, NY, 10022, Attention: Equity Syndicate Prospectus Department;
telephone (877) 547-6340; email: Prospectus_Department@Jefferies.com.
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-135.jpg)
• Revenue and Profitability with 10 Marketed Products
• Developed and Obtained FDA Approval for the First and Only
Liquid, Ready-to-Use Intravenous AAT Product, Glassia® for AAT
Deficiency
Liquid, Ready-to-Use Intravenous AAT Product, Glassia® for AAT
Deficiency
• Selling Glassia® in Selected Emerging Markets Globally and
Through Baxter Collaboration in the U.S.
Through Baxter Collaboration in the U.S.
• Glassia to treat Graft-vs-Host Disease (GVHD) (Phase I/II)
• Novel Inhaled AAT Product for AATD (EU Phase III completed)
• Pursuing conditional approval in EU
Notes
1. As of December 31, 2014
2. Market data as of January 7, 2015
3. See Appendix for a reconciliation of Adjusted EBITDA to IFRS Net Profit (Loss)
1
2
3
4
Key Statistics
• Founded in 1990 and based in Weizmann Science Park, Israel
• Employees: ~300 (1)
• Listed on NASDAQ since 2013 & TASE since 2005 (KMDA)
• Current market capitalization: ~$162MM (2)
• Cash, cash equivalents and ST investments: $60MM(1)
• Total Debt: $8MM (1)
Historical Adjusted EBITDA (3)
$MM
Historical Revenue
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-14.jpg)
Integrated, Efficient, Scalable Platform Technology
Fully-Invested Manufacturing
Facility & Marketed Products
Facility & Marketed Products
• FDA approved since 2010
• cGMP compliant
• Multiple countries' certifications
(US, Brazil, Israel, Mexico, Russia)
(US, Brazil, Israel, Mexico, Russia)
• State-of-the-art clean room
environment
environment
• Located in Beit Kama, Israel
Proprietary, Innovative and
Patented Technology Platform
Patented Technology Platform
• Patent protected:
Chromatography-based
purification process
Chromatography-based
purification process
• Enables high purity extraction
• Ready-to-use, liquid and stable
specialty protein therapeutics
(AAT, Albumin, Transferrin and
many others)
specialty protein therapeutics
(AAT, Albumin, Transferrin and
many others)
• Enables production of almost any
human plasma-derived specific
immunoglobulins
human plasma-derived specific
immunoglobulins
Benefits
• Enables manufacturing of plasma-
derived protein therapeutics with
differentiated product profiles
derived protein therapeutics with
differentiated product profiles
• Efficient production process with
higher yield than manufacturing
methods employed by
competitors
higher yield than manufacturing
methods employed by
competitors
• High safety profile and proven
track record
track record
• Infrastructure in place to meet
future pipeline product demand
future pipeline product demand
• Expandable product platform to
additional territories and
indications
additional territories and
indications
=
+
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-15.jpg)
Diverse Portfolio of Predominantly Plasma-Derived Protein Therapeutics
Global Presence with Exposure to Emerging Markets
Growing Proprietary Products Segment Through Glassia®
Respiratory
Glassia®
Immunoglobulin
KamRAB™
KamRho (D) IM
KamRho (D) IV
Other Products
Heparin Lock Flush
Kamacaine 0.5%
Human Transferrin
Respiratory
Bramitob
Foster
Immunoglobulins
IVIG 5%
Varitect
Hepatect CP
Megalotect
Zutectra
Critical Care
Heparin sodium injection
Albumin
Other
Factor VIII
Factor IX
Proprietary
Products
Segment
Products
Segment
2013 Revenue:
$51MM
$51MM
Distribution
Segment
Segment
2013 Revenue:
$20MM
$20MM
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
Heparin sodium
Human serum Albumin
Coagulation Factor VIII (human)
Coagulation Factor IX (human)
*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
strategic or distributor partnerships
United States
Mexico
El Salvador
Brazil
Argentina
Slovenia
Croatia
Nigeria
Kenya
India
Thailand
South Korea
Russia
Turkey
Israel*
Chile
Sri Lanka
Countries where Kamada has received regulatory approvals for certain of its Proprietary
Products
Products
Snake Antiserum
Anti-snake venom
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-16.jpg)
Glassia® Is A Differentiated Product
• Glassia® is the first and only liquid, ready-to-use, IV
plasma-derived AAT product
plasma-derived AAT product
• No reconstitution required, reducing risk of
contamination and infection and reducing treatment
time
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)
allergic reaction due to the absence of preservatives
and stabilizing agent(s)
• Glassia® is sold by Baxter, a leading plasma
therapeutics company in the U.S.
therapeutics company in the U.S.
• Significantly faster infusion rate was recently
approved by the U.S.-FDA
approved by the U.S.-FDA
Key Product Advantages
AATD (IV) Product Sales and Milestone Revenues
Sold in 7 countries, with majority of sales in the US
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-17.jpg)
Growth of Glassia® Driven by Strategic Partnership
• Sales to Baxter commenced in September 2010
• Agreements: distribution, technology license and fraction IV supply
• Product: AAT IV (Glassia®), including future AAT IV
• Territories: US, Canada, Australia and New Zealand
• Milestone and upfront revenues: $45MM ($34.5MM received)
• Agreement recently extended:
– Baxter to distribute Glassia® produced by Kamada through 2017
– Minimum revenues of $191MM through 2017 ($94MM already recognized through 12/31/2013)
• Royalties from sales of Glassia® produced by Baxter expected from 2018
Strategic Partnership with Baxter
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-18.jpg)
Significant Opportunity to Expand the AATD Market
• Patients suffering from AAT Deficiency (“AATD”)
remain under-identified and under-treated
remain under-identified and under-treated
– Only ~6% of cases treated in the US and ~2% in EU
• Simple blood test for diagnosis expected to impact
demand
demand
• Greater AAT use in Europe and other geographies
could further accelerate market growth
could further accelerate market growth
• Chronic therapy creates sustainable product
opportunity
opportunity
• Average annual cost of treatment estimated at ~$80-
$100K per patient
$100K per patient
Sustainable Market with Strong Growth Potential
North America and Europe AATD Patient Counts
Source MRB and Company estimates
Source Alpha 1 Foundation, MRB and Company estimates
Source MRB and Company estimates
(000s)
~
~
~
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-136.jpg)
KamRab
Investor Presentation | January 2015
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• Kamada’s human rabies immune globulin is a post-exposure prophylaxis (PEP) for rabies that is
marketed in 7 countries
marketed in 7 countries
• Strategic agreement with Kedrion S.p.A for the clinical development and marketing of KamRAB in
the U.S.
the U.S.
o U.S. Phase II/III clinical trial completed, with data by mid 2015
o Expect to file Biological License Application with the FDA in 2015
o U.S. launch expected by 2016
• In the U.S., there are ~40,000 post-exposure prophylaxis treatments administered each year,
representing an ~$100 million market opportunity
representing an ~$100 million market opportunity
o Currently only one significant provider of anti-rabies immunoglobulin in U.S.
• WHO estimates ~10 million people worldwide require medical treatment against rabies each year
after being bitten by an animal suspected of rabies infection
after being bitten by an animal suspected of rabies infection
o Product sold in ROW for years
Human Rabies Immune Globulin
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-110.jpg)
High Value Pipeline Focused on Orphan Indications
Product | Indication | Phase I | Phase II | Phase III | Market | Partners | |
1 | Intravenous AAT | AAT Deficiency | US: | ||||
2 | D1-AAT (IV) | Type 1 Diabetes* | US: | ||||
3 | G1-AAT (IV) | GVHD* | US: | ||||
4 | Inhaled AAT | AAT Deficiency* | EU: | ||||
5 | B1-AAT (IH) | Bronchiectasis* | |||||
6 | C1-AAT (IH) | Cystic Fibrosis (CF)* | |||||
7 | KamRAB (IM) | Prophylaxis of Rabies |
Phase III Completed (LPO)
Ph II/III In Process
FDA Approved (2010)
Completed
Completed
Ph I/II In Process
US: IND
Approved
US: Ph II In
Process
Process
EU: Completed
Completed
Completed
* Orphan drug designation
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-137.jpg)
Inhaled AAT for AATD Completed Pivotal Phase II/III
Trials in Europe and Initiated Phase II in the US
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 &
Dosage Form
Dosage Form
• Inhalation of human AAT, 160mg total, twice daily
~10-15 minutes; eFlow® device
~10-15 minutes; eFlow® device
• Inhalation of human AAT; two dosage groups
(80mg and 160mg daily); eFlow® device
(80mg and 160mg daily); eFlow® device
Clinical
Endpoints
Endpoints
• Exacerbation events (Primary: time to first
moderate/severe, Secondary (among others): rate,
severity of first event; Lung Function)
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
AAT in serum, ELF inflammatory analytes
Duration
• 50 wk treatment in DB period; daily treatment
• 50 wk open label extension ; daily treatment
• DB part - Study completed
• 12 weeks double blind +
• 12 weeks open label extension
• Study initiated in 1Q2014
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-112.jpg)
• 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 (statistically significant collected for safety data) and
signals in reduction in exacerbation frequency and severity in favor of AAT suggests possible
therapeutic benefit of AAT
signals in reduction in exacerbation frequency and severity in favor of AAT suggests possible
therapeutic benefit of AAT
• Study supports understanding the mechanism of action of the disease and the treatment -
lung inflammation
lung inflammation
• The company is advancing its discussions with the European Medicines Agency with the intent
to submit for conditional approval on the basis of:
to submit for conditional approval on the basis of:
o Orphan drug and unmet need
o Statistically significant data for lung function
o Prior discussions with the regulator
o Precedents of similar cases for drugs of orphan diseases
Inhaled AAT Phase II/III trial Results
Summary of the Results
Summary of the Results
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-113.jpg)
Inhaled AAT Phase II/III trial Results (cont.)
Parameter | ITT | Frequent exacerbators |
Lung function: FEV1 % of SVC Change from baseline till end of treatment | +0.34% AAT vs -1.17% PL P Value= 0. 033 | +0.2251% AAT vs -1.68% PL P Value= 0. 0208 |
Lung function: FEV1 % predicted Change from baseline till end of treatment | -0.509 AAT vs -1.37 PL P Value= NS | -0.58 AAT vs. -1.21 PL P Value= NS |
Lung function: FEV1 (liters) Change from baseline till end of treatment | -25ml AAT vs -52ml PL P Value= NS | -18ml AAT vs -51ml PL P Value= NS |
DLCO [mMol/min/Kpa] | -0.168 % AAT vs -0.28% PL P Value= NS | -0.206% AAT vs -0.336% PL P Value= NS |
Dr Jan Stolk , Principal Investigator of the Inhaled AAT Phase II/III study,
Department of Pulmonology Leiden University Medical Center, Leiden, The Netherlands:
Department of Pulmonology Leiden University Medical Center, Leiden, The Netherlands:
“This study is the first study ever that suggests inhaled AAT’s ability to potentially reduce lung inflammation as expressed by
its preservation of lung function and the trends shown in the reduction in intensity of exacerbation events. I am encouraged
by these results and hope that the regulatory authorities will acknowledge the progress in clinical research demonstrated in
this trial.“
its preservation of lung function and the trends shown in the reduction in intensity of exacerbation events. I am encouraged
by these results and hope that the regulatory authorities will acknowledge the progress in clinical research demonstrated in
this trial.“
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-114.jpg)
Inhaled AAT Phase II/III trial Results:
Lung Function Graphs
Lung Function Graphs
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-115.jpg)
Expected to Launch 2016/17 in the EU
Indicative Development Timeline:
EMA raparteur
meeting (4Q14) re
Inhaled AAT for
AATD in the EU
meeting (4Q14) re
Inhaled AAT for
AATD in the EU
Completion of
Phase II Inhaled
AAT for AATD
clinical trial
Phase II Inhaled
AAT for AATD
clinical trial
Inhaled AAT for
AATD MAA filing
AATD MAA filing
Meeting with
FDA re Inhaled
AAT for AATD in
the US
FDA re Inhaled
AAT for AATD in
the US
EU launch for
Inhaled AAT for
AATD
(if approved)
Inhaled AAT for
AATD
(if approved)
2015
2014
2016
2017
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-116.jpg)
AAT (IV) is a Promising Potential Treatment
For Newly Diagnosed Type‐1 Diabetes Patients
For Newly Diagnosed Type‐1 Diabetes Patients
Investor Presentation | January 2015
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Studies have shown that
AAT protects beta cell islets
AAT protects beta cell islets
Preservation of beta cells
correlates with reduced risk
of long term complications
correlates with reduced risk
of long term complications
• More than 10 million suffer from T1D
globally
globally
• 100,000 new patients diagnosed annually
• In the US alone: 3 million patients,
with 30,000 new patients diagnosed
annually
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)
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)
correlate with reduced incidences of the
microvascular complications (Steffes et al
2013)
*Diabetes Control and Complications Trial
“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”**
have demonstrated clinical benefits in patients who achieve better
glucose control, in terms of delaying the chronic complications of
diabetes”**
**FDA Guidance,
2008
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-117.jpg)
AAT
Anti Inflammatory
Blocks pro-Inflammatory
mediators incl. IL-1b, IL-6,
IL-8 and TNFa
mediators incl. IL-1b, IL-6,
IL-8 and TNFa
Immunomodulatory
AAT promotes Tregs and
modifies dendritic cell
maturation towards a
tolerance-inducing profile
modifies dendritic cell
maturation towards a
tolerance-inducing profile
Tissue protective -
Protects from cell death,
blocks apoptosis
blocks apoptosis
Regulatory T cell
differentiation
differentiation
AAT promotes Tregs
differentiation
differentiation
Increases insulin release
AAT increases cAMP levels
(required for insulin release).
cAMP also induces IL-10
release
(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
inflammation: Elastase, trypsin
& PR3 and has tissue-
protective effects
Modifies dendritic cells:
AAT modifies dendritic cell
maturation towards a tolerance-
inducing profile
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
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.
Therapeutic Approach for Type 1 Diabetes. J Diabetes Sci Technol. 2014.
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-118.jpg)
Clinical Development for Newly Diagnosed Type‐1
Diabetes: New Exciting Prospects
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.
beta cell preservation and glycemic control on newly diagnosed T1D pediatric patients.
• Specific diabetes antibody levels decreased in all groups from baseline to study completion, a decrease that may
indicate an Immune modulatory effect.
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)
headache)
End-of-study slope analysis of C-peptide[max] and C-
peptide[AUC] revealed no significant changes from baseline
peptide[AUC] revealed no significant changes from baseline
HbA1C data indicated that almost all patients reached
glycemic control
glycemic control
Investor Presentation | January 2015
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1. Greenbaum et al 2012
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-119.jpg)
Newly Diagnosed Type‐1 Diabetes Currently ongoing
Phase II/III Clinical Trial
Phase II/III Clinical Trial
Study objective: To evaluate the Efficacy and Safety
of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in
the treatment of New Onset Type 1 Diabetes.
of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in
the treatment of New Onset Type 1 Diabetes.
Design: Two doses, placebo controlled, randomized
with ~190 pediatric and young adult patients.
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].
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.
-Blind, Randomized,
Placebo-Controlled,
Multicenter study.
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-120.jpg)
• Donor’s immune cells (the graft) recognize the recipient (the host) as “Non-self“.
The transplanted immune cells attack the host's body cells.
The transplanted immune cells attack the host's body cells.
• Deadly side effects:
Ø ~20% of transplanted patients’ deaths are caused by GvHD complications
Ø ~70% mortality in patients with grade III/IV GvHD
Ø ~50% of patients are non responsive to steroids
• Searching for an effective treatment
Ø Standard of care prophylaxis exhibits poor efficacy/severe AE’s (Glucocorticoids)
Ø No FDA approved specific drug for GvHD indication
• Estimated market size: ~ $700 million
Graft versus Host Disease (GVHD): The Major
Issue in Hematopoietic Stem Cell Transplantation
Issue in Hematopoietic Stem Cell Transplantation
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-121.jpg)
• Phase I/II study open label of 24 patients with steroid-resistant GVHD following allogeneic
bone-marrow stem cell transplant
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 End Points: % of patients at each dosing cohort who experience no toxicity and in
whom GVHD is stable or improved
whom GVHD is stable or improved
• Secondary End Points - AAT levels, cytokine levels, infection rate, progression of GVHD, SAEs.
• In cooperation with Baxter, conducted at the Fred Hutchinson Cancer Research Center in
Seattle, Washington
Seattle, Washington
Proof-of-Concept Study with AAT (IV) for Graft-Versus
-Host Disease (GVHD)
-Host Disease (GVHD)
This proof-of-concept study may serve as a potential platform,
to expand the use of GLASSIA beyond GVHD, to other transplantations,
based on a similar mechanism of action
to expand the use of GLASSIA beyond GVHD, to other transplantations,
based on a similar mechanism of action
Investor Presentation | January 2015
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![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-122.jpg)
Investor Presentation | January 2015
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Loss of AAT in stool is an
expression of intestinal injury.
FACS Analysis pre
and post AAT therapy
Post 8
doses of
AAT
Before
Duodenits Suspect severe
upper and lower GvHD
After
Moderate mucosal denudement
and edema noted throughout the duodenum.
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-138.jpg)
First Cohort Results Show That AAT May Potentially
Exert a Protective Effect on the Bowel Mucosa in Gut
GVHD
Exert a Protective Effect on the Bowel Mucosa in Gut
GVHD
Investor Presentation | January 2015
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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
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
Stool AAT levels showed a decrease in intestinal
AAT loss, as measured by
AAT loss, as measured by
AAT clearance and endoscopic evaluation
suggesting healing of the bowel mucosa
suggesting healing of the bowel mucosa
AAT administration during HCT
suppresses serum levels of pro-
inflammatory cytokines, interferes
with GVHD manifestation
suppresses serum levels of pro-
inflammatory cytokines, interferes
with GVHD manifestation
Continuous administration of AAT as
salvage therapy for steroid resistant
gut GVHD is feasible approach without
clinically toxicity
salvage therapy for steroid resistant
gut GVHD is feasible approach without
clinically toxicity
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-124.jpg)
FINANCIALS
24
Investor Presentation | January 2015
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-125.jpg)
Existing Anchor
Products
Products
§ Profitable unit
§ Sales in 15 countries
§ Predictable, stable
business
business
($0.5B)*
Existing Anchor
Products
Products
+
Glassia®
(AAT-IV) in US
(AAT-IV) in US
+
Inhaled AAT for AATD in
Europe & US
Europe & US
+
New Geographies
+
Additional
Unencumbered Pipeline
Products
Unencumbered Pipeline
Products
Glassia®
(AAT-IV)
(AAT-IV)
in US&ROW
§ Estimated only ~5% of
cases treated in US
cases treated in US
§ Annual therapy costs
~$80K - $100K per
patient
~$80K - $100K per
patient
§ Partnered with Baxter
solely for IV products in
the US (agreement also
covers Canada, Australia
and New Zealand)
solely for IV products in
the US (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
existing and new
products into new
geographies
§ Rabies Ig to US and
additional territories
additional territories
§ Capital-efficient
strategy minimizes
outlay required by
Kamada
strategy minimizes
outlay required by
Kamada
($0.5B)*
Additional
Unencumbered
Pipeline Products
Unencumbered
Pipeline Products
§ D1-AAT (IV):
Type-1 diabetes in Phase
I/II (Unencumbered
outside of US, Canada,
Australia and New
Zealand)
(100K pts.,$3.5-5B)*
Type-1 diabetes in Phase
I/II (Unencumbered
outside of US, Canada,
Australia and New
Zealand)
(100K pts.,$3.5-5B)*
§ G1-AAT (IV)
GVHD phase I/II in
process
($0.5-1B)*
process
($0.5-1B)*
§ C1-AAT (IH):
Cystic fibrosis completed
Phase II (Unencumbered)
(100K pts.,$0.5-1B)*
Cystic fibrosis completed
Phase II (Unencumbered)
(100K pts.,$0.5-1B)*
§ B1-AAT (IH):
Bronchiectasis
completed Phase II
(Unencumbered)
(600K pts.,$2B)*
Bronchiectasis
completed Phase II
(Unencumbered)
(600K pts.,$2B)*
Inhaled AAT for
AATD in
Europe & US
AATD in
Europe & US
§ Estimated only ~2% of
cases treated in Europe
cases treated in Europe
§ Estimated only ~5% of
cases treated in US
cases treated in US
§ Orphan drug designation
in US and EU
in US and EU
§ Partnered with Chiesi for
Inhaled AAT for AATD in
Europe only
Inhaled AAT for AATD in
Europe only
§ Distribution (no
technology out-licensed
in Europe)
technology out-licensed
in Europe)
§ Unencumbered in US
(200K pts.,$1-2B)*
The Kamada
Pillars
Pillars
* Estimated market potential
Investor Presentation | January 2015
25
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-126.jpg)
• Stable, profit generating revenue stream from marketed products
• Strategic partnership model results in efficient operating expenses
o Baxter purchase obligations provides stable revenue through 2017 and royalties thereafter
o Kedrion partnership for Rabies Ig expected to increase revenues and profitability from 2016 and on
• Better product mix expected to improve gross margin
• Pipeline products expected to accelerate revenue growth
o 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
Strong Financial Profile with Revenue Growth and
Expanding Profitability
Expanding Profitability
Investor Presentation | January 2015
26
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-139.jpg)
$MM | FY2009 | FY2010 | FY2011 | FY2012 | FY2013 |
Proprietary Products | 10 | 23 | 35 | 47 | 51 |
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 PROFIT (LOSS) Adjusted EBITDA (1) | (21) (12) | (14) (6) | (4) 1 | 0.3 9 | 0.4 9 |
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
Investor Presentation | January 2015
27
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-128.jpg)
Consistent Track Record of Execution
US FDA approval for Glassia® | |
Strategic agreement with Baxter & First Glassia® sale in the US | |
Strategic agreement for Rabies in the US 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 US Phase II for Inhaled AAT for AATD | |
Initiation of US Phase I/II study of Glassia in GVHD | |
Completion of EU Phase II/III Inhaled AAT for AATD trial | |
Completion of US Phase III Rabies Ig | |
US Orphan Drug Designation for Glassia to treat GVHD | |
Increased sales, profitability and production capacity |
2010
December 2014
Investor Presentation | January 2015
28
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-129.jpg)
Future Milestones and Value Creation
Phase III Rabies Ig trial (US) results | 1H15 |
Phase II/III Inhaled AAT for AATD (EU) presentation at ATS | 2Q15 |
Interim data from GVHD trial | 2015 |
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 |
Strategic agreements | 2015 |
Initiation of Phase lll for intrevenous AAT for GVHD | 2016 |
Rabies product launch in the US (if approved) | 2016 |
Inhaled AAT for AATD launch (EU) (if approved) | 2016/7 |
Interim report for Phase II/III for type-1 diabetes trial | 2016 |
AAT IV for newly diagnosed type-1 diabetes launch in ROW (if approved) | 2017/18 |
Milestone Date
Investor Presentation | January 2015
29
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-130.jpg)
Kamada Investment Highlights
Rapidly Growing, Globally Positioned Biopharmaceutical Company
- Focused on Orphan Diseases and Plasma Derived Protein Therapeutics
Significant Opportunity for Intravenous AAT for Type-1 Diabetes and Graft vs Host Disease and
for Novel Inhaled AAT for Alpha-1 Antitrypsin Deficiency
for Novel Inhaled AAT for Alpha-1 Antitrypsin Deficiency
Valuable R&D Pipeline Focused on Various Orphan Indications
Integrated, Efficient and Scalable Best-in-class Patented Platform Technology and Know-How
Strong Financial Profile with Increasing Profitability
Validating Strategic Partnerships with Industry Leaders Baxter, Chiesi, Kedrion and Pari Pharma
Flagship Product Glassia® Approved for Alpha-1 Antitrypsin Deficiency Disorder
- Has a Unique and Differentiated Product Profile and Represents an Exciting Growth Opportunity
Investor Presentation | January 2015
30
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-131.jpg)
www.kamada.com
THANK YOU
Investor Presentation | January 2015
31
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-132.jpg)
APPENDIX
Investor Presentation | January 2015
32
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-133.jpg)
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
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
Investor Presentation | January 2015
33
![](https://capedge.com/proxy/6-K/0001178913-15-000083/exhibit_99-134.jpg)
Inhaled AAT Is A Significant Opportunity
• Chiesi distribution agreement as of August 2012
• Agreement: Chiesi responsible for S&M, patient ID,
and reimbursement
and reimbursement
• Product: AAT for AATD Inhaled only
• Territories: EU and Turkey
• Milestone revenues: $60MM upfront, regulatory
and sales
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
of regulatory and reimbursement approvals,
~$120MM for first 4 years, subject to actual price
after regulatory approval
Strategic Partnership with Chiesi
• First and only Inhaled AAT product for AATD
– Device and drug combination enable optimal size
particles delivered directly to diseased tissue
particles delivered directly to diseased tissue
• Positive data to date in AATD and strong safety
profile
profile
• Potential to expand AATD market, particularly in
Europe
Europe
• Potential Inhaled AATD launch in Europe not before
2016 , pursuing conditional approval based on
phase 4 commitment.
2016 , pursuing conditional approval based on
phase 4 commitment.
• US pathway to be discussed with FDA beginning
2015
2015
Inhaled AAT Highlights
Investor Presentation | January 2015
34