Exhibit 99.1
KAMADA
INVESTOR PRESENTATION
INVESTOR PRESENTATION
September 2014
NASDAQ: KMDA
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.
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.
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.
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 | Sep. 2014
2
Kamada Overview
• AAT deficiency (AATD) is a genetic emphysema, caused by lack
of protein
of protein
• Existing Therapy is replacement of the protein
• Completed Phase II/III trials in EU- pursuing conditional
approval
approval
• Ongoing Phase II in the US- pathway to be discusses with FDA
• Upside in Type 1 Diabetes
Notes
1. As of June 30, 2014
2. Market data as of Aug 31 2014
3. See Appendix for a reconciliation of Adjusted EBITDA to IFRS Net Profit (Loss)
1
2
3
4
5
6
7
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: ~$250MM (2)
• Cash, cash equivalents and ST investments: $68MM(1)
• Total Debt: $17.6MM (1)
Historical Adjusted EBITDA (3)
$MM
Historical Revenue
Investor Presentation | Sep. 2014
3
Diverse Portfolio of Predominantly Plasma-Derived Protein Therapeutics
Global Presence with Exposure to Emerging Markets
Growing Proprietary Products Segment Through Glassia® and Inhaled AAT Product
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
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 | Sep. 2014
4
Kamada Investment Highlights
Rapidly Growing, Globally Positioned Biopharmaceutical Company
- Focused on Orphan Diseases and Plasma Derived Protein Therapeutics
Significant Opportunity in Novel Inhaled AAT for Alpha-1 Antitrypsin Deficiency
and in Intravenous AAT for Type-1 Diabetes
and in Intravenous AAT for Type-1 Diabetes
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
- Has a Unique and Differentiated Product Profile and Represents an Exciting Growth Opportunity
Investor Presentation | Sep. 2014
5
Glassia® Is A Differentiated Product
P Glassia® is the first and only liquid, ready-to-use, IV
plasma-derived AAT product
plasma-derived AAT product
P No reconstitution required, reducing risk of
contamination and infection and reducing treatment
time
contamination and infection and reducing treatment
time
P 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)
P Glassia® is sold by Baxter, a leading plasma
therapeutics company in the US
therapeutics company in the US
P Significantly faster infusion rate was recently
approved by the US-FDA
approved by the US-FDA
Key Product Advantages
AATD (IV) Product Sales and Milestone Revenues
Sold in 7 countries, with majority of sales in the US
Investor Presentation | Sep. 2014
6
Significant Opportunity to Expand the AATD Market
• Patients suffering from AAT Deficiency (“AATD”) remain
under-identified and under-treated
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
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 | Sep. 2014
7
Growth of Glassia® Driven by Strategic Partnership
P Sales to Baxter commenced in September 2010
P Agreements: distribution, technology license and fraction IV supply
P Product: AAT IV (Glassia®), including future AAT IV
P Territories: US, Canada, Australia and New Zealand
P Milestone and upfront revenues: $45MM ($34.5MM received)
P Royalties from sales of Glassia® produced by Baxter expected from 2017
P Agreement recently extended:
– Baxter to distribute Glassia® produced by Kamada through 2016
– Minimum revenues of $165MM through 2016 ($94MM already recognized through 12/31/2013)
Strategic Partnership with Baxter
Investor Presentation | Sep. 2014
8
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 |
|
US:
|
|||
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 | Sep. 2014
9
Inhaled AAT Is A Significant Opportunity
ü Chiesi distribution agreement as of August 2012
ü Agreement: Chiesi responsible for S&M, patient ID,
and reimbursement
and reimbursement
ü Product: AAT for AATD Inhaled only
ü Territories: EU and Turkey
ü Milestone revenues: $60MM upfront, regulatory and
sales
sales
ü Distributor price
ü Minimum purchases from 2nd yr following receipt of
regulatory and reimbursement approvals, ~$120MM
for first 4 years, subject to actual price after
regulatory approval
regulatory and reimbursement approvals, ~$120MM
for first 4 years, subject to actual price after
regulatory approval
Strategic Partnership with Chiesi
P 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
P Positive data to date in AATD and strong safety profile
P Potential to expand AATD market, particularly in
Europe
Europe
P 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.
P US pathway to be discussed with FDA beginning 2015
Inhaled AAT Highlights
Investor Presentation | Sep. 2014
10
Expected to Launch 2016 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 | Sep. 2014
11
Inhaled AAT for AATD Completed Pivotal Phase II/III Trials
in Europe and Initiated Phase II in the US
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
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 | Sep. 2014
12
• 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 and signals in reduction in exacerbation frequency and
severity in favor of AAT , and in particular, for the frequent exacerbators, suggests possible
therapeutic benefit of AAT
severity in favor of AAT , and in particular, for the frequent exacerbators, suggests possible
therapeutic benefit of AAT
• Study supports understanding the mechanism of action of the disease and the treatment - lung
inflammation
inflammation
• The company is advancing its discussions with the European Medicines Agency with the intent to
submit for conditional approval on the basis of:
submit for conditional approval on the basis of:
o Orphan drug & Unmet need
o Concordance of data for ITT and frequent exacerbators
o Prior discussions with the regulator
o Precedents of similar cases for drugs of orphan diseases
Inhaled AAT Phase 2-3 trial Results
Summary of the Results
Summary of the Results
Investor Presentation | Sep. 2014
13
Inhaled AAT Phase 2-3 trial Results
|
Parameter
|
ITT
|
Frequent exacerbators
|
|
Primary endpoint :
“Time to the first moderate or severe
exacerbation event” |
No differences observed
|
Clinical difference observed AAT vs PL
Hazard ratio = 0.877
( 95% CI 0.563, 1.364) . P Value= NS |
|
Secondary endpoint :
“Time to first event-based
exacerbation with a severity of mild, moderate or severe |
No differences observed
|
Clinical difference observed AAT vs PL
Hazard ratio = 1.064
( 95% CI 0.717, 1.578) . P Value= NS |
|
Secondary endpoint :
“Severity of the first exacerbation
event” |
Lower number of first severe (Type 1,
SB*) events vs PL (18.8% and 31.1%, respectively. P Value= NS). Lower number of first moderate (EB**)
events vs PL (56.5% and 63.9%, respectively. P Value= NS) |
Lower number of first severe (Type 1) events vs PL (19.4% and
35.2%, respectively. P Value= NS). Lower number of first severe /moderate events vs PL (44.8% and
51.9%, respectively. P Value= NS) 15.1% lower number of first moderate (EB**) events vs PL . P
Value= NS 4.7% lower number of first moderate/ severe (EB**) events vs PL.
P Value= NS |
|
Secondary endpoint :
“Rate of event-based
exacerbation episodes”*** |
No differences observed
|
Reduction of 10% in AAT group vs PL in mild/ moderate/ severe
(EB) events Reduction of 13% in the number of moderate (EB) events
Reduction of 12% in the number moderate/ severe (EB) events.
P Value, for all measurements= NS
|
* Symptom based definition
** Event based definition
***The number of mild, moderate or severe event-based exacerbations per patient during the treatment period.
Investor Presentation | Sep. 2014
14
Inhaled AAT Phase 2-3 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 2-3 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.“
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 | Sep. 2014
15
Inhaled AAT Phase 2-3 trial Results:
Lung Function Graphs
Lung Function Graphs
Investor Presentation | Sep. 2014
16
AAT (IV) is a Promising Potential Treatment
For Newly Diagnosed Type‐1 Diabetes Patients
For Newly Diagnosed Type‐1 Diabetes Patients
Investor Presentation | Sep. 2014
17
Type-1 Diabetes
occurs when the immune system
attacks and destroys beta cells
in the pancreas
occurs when the immune system
attacks and destroys beta cells
in the pancreas
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”**
demonstrated clinical benefits in patients who achieve better glucose
control, in terms of delaying the chronic complications of diabetes”**
**FDA Guidance,
2008
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 | Sep. 2014
18
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.
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.
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
peptide[AUC] revealed no significant changes from baseline
HbA1C data indicated that almost all patients reached
glycemic control
glycemic control
Investor Presentation | Sep. 2014
19
1. Greenbaum et al 2012
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 | Sep. 2014
20
• 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 die of GvHD complications
Ø ~70% mortality in patients with grade iii-iv GvHD
Ø ~60% 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: ~ $0.5 billion
Graft versus Host Disease (GvHD): The Pro Major
Issue in Hematopoietic Stem Cell Transplantation
Issue in Hematopoietic Stem Cell Transplantation
Investor Presentation | Sep. 2014
21
• Phase I/II study open label of 24 patients with steroid-resistant GVHD following allogeneic bone-
marrow stem cell transplant
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
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
Washington
• Interim Report by the end of 2014
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 | Sep. 2014
22
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 | Sep. 2014
23
FINANCIALS
Investor Presentation | Sep. 2014
24
Existing Anchor
Products
Products
§ Profitable unit
§ Sales in 15 countries
§ Predictable, stable
business
($0.5B)*
business
($0.5B)*
Existing Anchor 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)*
(100K pts.,$0.75-1B)*
New Geographies
§ Potential to sell existing
and new products into
new geographies
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)*
(200K pts.,$1-2B)*
The Kamada
Pillars
Pillars
* Estimated market potential
Investor Presentation | Sep. 2014
25
• Pipeline products expected to accelerate revenue growth
• Better product mix expected to improve gross margin
• Strategic partnership model results in efficient operating expenses
• Stable, profit generating revenue stream from marketed products
• 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 | Sep. 2014
26
|
$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 | Sep. 2014
27
Consistent Track Record of Execution
|
Initial Public Offering on the Tel Aviv Stock Exchange (KMDA)
|
|
|
Strategic agreement with PARI Pharma GmbH
|
|
|
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
|
|
|
Newly diagnosed type-1 diabetes Phase II trial completed
|
|
|
Initiation of Phase II/III for type-1 diabetes
|
|
|
Initiation of Phase II for Inhaled AAT for AATD in the US
|
|
|
Completion of Phase II/III Inhaled AAT for AATD trial (EU)
|
|
|
Completion of Phase III Rabies Ig (US)
|
|
|
Increased sales, profitability and production capacity
|
|
August 2005
August 2014
Investor Presentation | Sep. 2014
28
Future Milestones and Value Creation
|
Phase III Rabies Ig trial (US) results
|
4Q14
|
|
EMA discussion on conditional approval
|
4Q14
|
|
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
|
|
Expansion to additional territories of Phase II/III for type-1
diabetes |
2015
|
|
Initiation of Phase ll for intrevenous AAT for GVHD
|
2015
|
|
Strategic agreements
|
2015
|
|
Rabies product launch in the US (if approved)
|
2016
|
|
Inhaled AAT for AATD launch (EU) (if approved)
|
2016
|
|
Interim report for Phase II/III for type-1 diabetes trial
|
2016
|
|
AAT IV for newly diagnosed type-1 diabetes launch (if approved)
|
2017/18
|
Milestone Date
Investor Presentation | Sep. 2014
29
Kamada Investment Highlights
Rapidly Growing, Globally Positioned Biopharmaceutical Company
- Focused on Orphan Diseases and Plasma Derived Protein Therapeutics
Significant Opportunity in Novel Inhaled AAT for Alpha-1 Antitrypsin Deficiency
and in Intravenous AAT for Type-1 Diabetes
and in Intravenous AAT for Type-1 Diabetes
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 | Sep. 2014
30
www.kamada.com
THANK YOU
Investor Presentation | Sep. 2014
31