INVESTOR PRESENTATION - Kamada ENG/kamada intro January 2013... · INVESTOR PRESENTATION ......
Transcript of INVESTOR PRESENTATION - Kamada ENG/kamada intro January 2013... · INVESTOR PRESENTATION ......
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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 Annual Report
and its other filings with the Israeli Securities Authority.
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Kamada Overview
A Leader in the Development of AAT Products Globally
Developed and Obtained Approval for the First and Only Liquid, Ready-to-Use IV AAT Product, Glassia®
Selling Glassia® in Select Emerging Markets Globally and Through Baxter Collaboration in the US
Developed Novel Inhaled AAT Product that is in Phase II/III trials in EU and Entering Phase II in the US
Fully Integrated Manufacturer and Distributor of Plasma-Derived Protein Therapeutics
Growing Revenue and Profitability
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Established and Revenue Generating Company
• Founded in 1990 • Based in Weizmann Science Park in Ness Ziona,
Israel • Employees: ~300 (1)
• Publicly listed on TASE (KMDA) since 2005 • Current market capitalization: $282.3MM (2)
• Cash, cash equivalents and short term investments: $33.5MM (3)
• Total Debt: $26.5MM (3)(4) • 2012E forecast revenues of $72MM and already
EBITDA positive (3)
Notes
1. As of December 31, 2012
2. Market data as of January 21, 2013, at a conversion ratio of USD 0.268170 to ILS 1.00
3. As of 9 months ending September 30, 2012
4. Includes $22.7MM in convertible debentures and $3.8MM in conversion option in convertible debentures; represents the face value of the convertible debentures outstanding
Key Highlights Historical Revenue
$MM
Historical EBITDA
$MM
14
34
59
51
0
20
40
60
80
2009 2010 2011 9mo 2012
(12)
(6)
14
(15)
(10)
(5)
0
5
10
2009 2010 2011 9mo 2012
(3)
(3)
L2Y Share Price Performance (2)
ILS
+29.7%
MM
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Growing Business Segments
Proprietary Products
Distribution
• Leverages the Company’s expertise and presence in the plasma-derived protein therapeutics market
– Distributes more than 10 complementary plasma-derived products in Israel - Respiratory, Immunoglobulins, Critical Care and Coagulation Factors
– 3rd party manufactured products
• Operates at the intersection of two attractive markets: plasma-derived protein therapeutics and orphan diseases
• Strong portfolio includes 10 products marketed in the US, Israel, Russia, Brazil, India and other countries in Latin America, Eastern Europe and Asia
• Lead product Glassia® is the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA
• Late-stage pipeline of Inhaled AAT for AATD is in pivotal Phase II/III clinical trials in Europe and entering Phase II clinical trials in the US
• State-of-the-art, cGMP compliant, FDA approved, large-scale production facility located in Beit Kama, Israel
• Strategic partnerships with Baxter, Chiesi, Pari and Kedrion
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Focusing on growing AAT in new indications 1
Well Defined Strategy
2 Expanding our presence in emerging markets
3 Pursuing further strategic relationships
4 Investing in additional pipeline products
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Diversified Product Portfolio with Extended Global Reach
Respiratory Glassia®
Immunoglobulin
KamRAB KamRho (D) IM KamRho (D) IV
Other Products
Heparin Lock Flush Kamacaine 0.5% Human Transferrin
Diverse Portfolio of Predominantly Plasma-Derived Protein Therapeutics
Respiratory Bramitob
Immunoglobulins
IVIG 5% Varitect Hepatect CP Megalotect
Critical Care Heparin sodium injection Albumin
Other Factor VIII Factor IX
Proprietary Products Segment
Distribution Segment
Alpha-1 Antitrypsin (human)
Anti-rabies immunoglobulin (human) Rho(D) immunoglobulin (human) Rho(D) immunoglobulin (human)
Heparin sodium Bupivacaine HCl Transferrin (Diagnostic grade)
Tobramycin
Gamma globulins (IgG) (human) Varicella zoster immunoglobulin (human) Hepatitis B immunoglobulin (human) CMV immunoglobulin (human)
Heparin sodium Human serum Albumin
Coagulation Factor VIII (human) Coagulation Factor IX (human)
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
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
Snake Antiserum
Anti-snake venom
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*Represents orphan drug designation
High Value Pipeline Focused on Orphan Indications
Product Indication Phase 1 Phase 2 Phase 3 Partnership Agreement
Inhaled AAT for AATD (1)
Alpha-1 Antitrypsin Deficiency*
EU:
B1-AAT (IH) (1) Bronchiectasis* -
C1-AAT (IH) (1) Cystic Fibrosis (CF)* -
D1-AAT (IV) (1) Type-1 Diabetes* -
KamRAB (IM) Prophylaxis of Rabies US:
Completed
Completed
1
2
3
4
5
Completed
Completed
Clinical Trial, Strategic Agreement Completed
Ph II/III in Process in EU
Note
1. Phase I and II were completed in Israel
Entering Ph II in the US
Contemplating Ph II/III
IND Ph II Approved
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Attractive Plasma-Derived Protein Therapeutics Industry 1
Kamada Investment Highlights
2 Significant Opportunity to Expand the AAT Market
3 Glassia® Growth Supported by Differentiated Product Profile and Strategic Partnership
4 Valuable R&D Pipeline Focused on Orphan Indications
5 Integrated, Efficient, Scalable Platform Technology
6 Strong Financial Profile with Increasing Profitability
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6.16.5
7.07.6
8.28.8
9.6
10.4
11.4
12.4
13.5
14.7
16.1
0
6
12
18
'05 '06 '07 '08 '09 '10 '11 '12 '13 '14 '15 '16 '17
Plasma-derived protein therapeutics are drugs that are fractionated and purified from human plasma and its derivatives
– Treat a variety of diseases including chronic, orphan conditions and acute, life threatening diseases
Expected growth driven by:
– Increasing patient populations in the developed world
– Increasing patient diagnosis, penetration, and compliance in the developing world
– Increasing medical uses and indications of plasma-derived protein therapeutics
Heavy regulation by health authorities in each country
Complexity of biologic manufacturing requirements
Attractive Plasma-Derived Protein Therapeutics Industry
Positive Industry Dynamics
The Global Market for Plasma-Derived Protein Therapeutics $ Bn
2005 – 2011 Market CAGR: 7.9% 2012 – 2017 Market CAGR: 9.1%
Source Blood: The Worldwide Market for Blood Products, Blood Testing, Blood Equipment, and Synthetic Blood; Exhibit 31; February 1, 2011
Favorable Growth Forecasts
CAGR = 7.9%
CAGR = 9.1%
1
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Patients suffering from AAT Deficiency (“AATD”) remain under-identified and under-treated
– Only ~5% of cases treated in the US and ~2% in EU
– Many patients are frequently misdiagnosed
Simple blood test for diagnosis and increased disease awareness activities is expected to impact demand
AAT products have the potential to treat additional indications including newly-diagnosed type-1 diabetes, CF, bronchiectasis, COPD and other orphan indications
Greater AAT use in Europe and other geographies could further accelerate market growth
Chronic, life-extending therapy helps increase demand
Average annual cost of treatment estimated at ~$80-$100K per patient
Significant Opportunity to Expand the AAT Market
Sustainable Market with Strong Growth Potential North America and Europe AATD Patient Counts
Source MRB and Company estimates
2
Source Alpha 1 Foundation, MRB and Company estimates
200
20
70
50
100
150
200
250
Estimated Prevalence Currently Identified Currently Treated
(000s)
~
~ ~
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Product Attributes
Baxter commenced US sales 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 revenues: $45MM ($30MM received)
Royalties from sales of Glassia® produced by Baxter expected from 2015
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12
1
0
5
10
15
20
25
30
2009A 2010A 2011A
Growth of Glassia® Driven by Differentiated Product Profile and Strategic Partnership
Does not require reconstitution and mixing before injection
Reduced risk of contamination and infection due to the preparation for infusion
Simple and easy to use by the patient or nurse
Potential reduction of the nurse's time during home visits, in the clinic or in the hospital
Reduced risk for adverse and/or allergic reaction due to the absence of stabilizing agent(s)
Key Product Advantages AATD Product Sales and Milestone Revenues
$MM
3
Strategic Partnership with Baxter
First and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA for the treatment of AATD
Naturally occurring protein found in fraction IV
Approved by the FDA in July 2010 for chronic augmentation and maintenance therapy in adults with emphysema due to congenital AATD
Currently sold in five countries, with a majority of sales in the US
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Valuable R&D Pipeline Focused on Orphan Indications
Immuno-modulatory Tissue Protective
AAT is a protein derived from human plasma with known & newly discovered therapeutic roles
Anti Inflammatory Antimicrobial
Indication
Phase
Orphan Drug Designation
Inhaled AAT for AATD
B1 – AAT (IH) C1 – AAT (IH) D1 – AAT (IV) Potential Additional Indications (1)
AATD Bronchiectasis Cystic Fibrosis Type-1 Diabetes
COPD
Transplant rejection
Graft-versus-host-disease
Phase II/III in Europe
Entering Phase II in US
Phase II (Completed in
Israel)
Phase II (Completed in
Israel)
Phase II (Completed in
Israel)
a a a a
4
Note
1. Pre-clinical indications
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Inhaled AAT for AATD is a Novel, Late-Stage Pipeline Product …
AAT is inhaled by AAT deficient subjects who lack AAT and experience inflammation and occurrence of emphysema
Sound scientific rationale
Product is directed to the site of action – the lung Targets site of action
Deposition pattern was found appropriate to support lung disease in mid/periphery lung regions – as in AATD
Deposition pattern
In use since 1987. Inhaled AAT for AATD by Kamada is not an entirely brand new product. Glassia® has been on the market in the US since July 2010
AAT is not a new product
Inhaled formulation of AAT has been in clinical development since 2006 and demonstrated high safety record to date
Safety experience
Inhaled formulation of AAT has suggested capability to reduce lung inflammation, providing a treatment rationale
Efficacy indications
Non-invasive and more convenient than existing IV treatments; option for home treatment Improved patient experience
Strategic distribution agreement, covering EU, Turkey and ex-CIS, announced August 2012 Chiesi strategic partnership
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Dedicated eFlow Device Developed Specifically by PARI Pharma for Kamada’s Inhaled AAT
CE marked in EU
Generates particle size of ~3 microns, well-suited for an appropriate lung deposition of AAT
Exclusive, worldwide license to use the eFlow device for the clinical development, registration and commercialization of the inhaled formulations of AAT
Enables direct access to the diseased lung tissues
Device was used in the Phase II – Lung Deposition study, as well as Phase II/III Inhaled AAT for AATD clinical trials in Europe, as well as Phase II bronchiectasis and Phase II cystic fibrosis clinical trials
eFlow Device Technology Highlights eFlow Device
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Inhaled AAT Product Development on Track
Trial Design
Results
Conclusions
Phase IA Phase IB Phase II – Lung Deposition
Single blind, placebo controlled 24 healthy subjects Single administration
No significant changes in vital signs or spirometry / labs One, possibly related AE – sense
of dry mouth No deaths and no SAEs, no
withdrawals
High safety profile, comparable to placebo Single-dose administration of
inhaled formulation of AAT was safe and well tolerated
Single blind, placebo controlled 15 healthy subjects Repeated administration
There was no drug-related AEs Immunogenic markers in
Epithelial lining fluid which did not indicate any changes from baseline
High safety profile, comparable to placebo Repeat daily administration was
safe and well-tolerated
Three treatment groups – 2: Healthy volunteers – 7: COPD patients with
emphysema – 7: Cystic Fibrosis
AAT reaches lung periphery, even in severe COPD patients including upper and mid lung regions
The deposition pattern demonstrated in the study supports different respiratory indications, including AATD, cystic fibrosis and bronchiectasis
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Inhaled AAT for AATD in Pivotal Phase II/III Trials in Europe and Entering Phase II in the US
International study: Western EU (UK, IR, SC, SW, NL, DK), GR and Canada
Over 160 AATD subjects, naïve. (subset of AAT IV users incl.)
Placebo controlled
50 wk treatment; daily treatment 50 wk open label extension
Exacerbation events
Lung Function
CT scan
QoL
Multi center
Inhalation of human AAT, 2* 80 mg (twice daily) 10-15 minutes eFlow device
Double Blind
Randomized
Clinical endpoints
Route & Dosage Form
Duration
Sample size of approximately 36-40 subjects
Placebo controlled
12 weeks Regulatory Status
Inhalation of human AAT; two dosage groups (80mg and 160mg daily); eFlow device
Double Blind
Randomized
Clinical endpoints
Route & Dosage Form
Duration IND Approved
Primary endpoints: safety and tolerability Secondary endpoints: PK parameters in ELF and serum
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Phase II / III EU Phase II US
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… Expected to Launch 2015 in the EU and 2016 in the US
Indicative Development Timeline:
EU
U
S
Phase II/III Inhaled AAT for AATD clinical trial results
Completion of Phase II Inhaled AAT for AATD clinical trial
Inhaled AAT for AATD MAA filing
US launch for Inhaled AAT for AATD (if approved)
LPI Phase II/III Inhaled AAT for AATD clinical trial
Initiation of Phase II Inhaled AAT for AATD clinical trial
EU launch for Inhaled AAT for AATD (if approved)
2015 Q4 2012 Q1 2014 Mid-2014 2013 2016
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Additional High Value Orphan Indications
B1: Bronchiectasis C1: Cystic Fibrosis D1: Type-1 Diabetes
Trial Conclusions /
Next Steps
Inhaled formulation of AAT was safe and well tolerated in bronchiectasis patients when inhaled daily for 12 weeks
Efficacy results suggested a positive effect of AAT on inflammation of the lungs
– Efficacy results not statistically significant due to small number of patients and variability of patients’ disease severity
Currently evaluating regulatory path for next Phase II or Phase II/III clinical trials
Pending strategic partnership
Phase II trial demonstrated that inhaled formulation of AAT was safe and well tolerated when inhaled daily for 28 days
Suggested an anti-inflammatory effect through the usage of the inhaled formulation of AAT in cystic fibrosis patients
FDA approved IND Phase II trial in December 2012
Pending strategic partnership
Glassia® has a high safety and tolerability profile
Results may indicate that AAT exerts a protective effect on beta-cells, slowing disease progression and re-modulation of the autoimmune attack
– Long-term, placebo-controlled studies with larger cohorts are needed to confirm this effect
Currently evaluating regulatory path for next Phase II or Phase II/III clinical trials
Stage
Completed Phase II
Double-blind, placebo controlled trials completed
21 patients
Completed in Israel
Completed Phase II
Double-blind, placebo controlled study
21 patients (adults and children)
Completed in Israel
Completed Phase I/II
– Open Label, Proof of Concept, Study of the Safety, Tolerability and Efficacy of AAT (Glassia®)
– 24 newly diagnosed type-1 diabetes pediatric patients
– Completed in Israel
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End-of-study slope analysis of C-peptide[max] and C-peptide[AUC] revealed no significant changes from baseline
Clinical Development for Newly Diagnosed Type‐1 Diabetes: New Exciting Prospects
Specific diabetes antibody levels decreased in all groups from baseline to study completion, a decrease that may indicate an immune modulatory effect
HbA1C data indicated that almost all patients reached glycemic control
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)
4
AUC% for C-peptide decreased 23% from baseline vs. ~40-50% expected decrease after 12-15M from diagnosis (1)
Note
1. Greenbaum CJ, et al. Diabetes. 2012;61:2066-2073
7.5% HbA1c7.5% HbA1c
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Integrated, Efficient, Scalable Platform Technology
Fully-Invested Manufacturing Facility
FDA approved since 2010
cGMP compliant
Multiple countries' certifications (US, Brazil, Israel, Mexico, Russia)
State-of-the-art clean room environment
Located in Beit Kama, Israel
Proprietary, Innovative and Patented Technology Platform
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
Efficient production process with higher yield than manufacturing methods employed by competitors
High safety profile and proven track record
Infrastructure in place to meet future pipeline product demand
= +
5
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Existing Anchor
Products
Compelling Investment Driven By Multiple Pillars of Growth
Profitable unit
Sales in 15 countries
Predictable, stable
business
Existing Anchor
Products
+
Glassia®
(AAT-IV) in US
+
Inhaled AAT for
AATD in
Europe & US
+
New Geographies
+
Additional
Unencumbered
Pipeline Products
Glassia®
(AAT-IV) in US
Estimated only ~5% of
cases treated in US
Annual therapy costs
~$80K – $100K per
patient
Partnered with Baxter
solely for IV products in
the US (agreement
also covers Canada,
Australia and New
Zealand)
Key geographies
retained
New Geographies
Potential to sell existing
and new products into
new geographies
Capital-efficient
strategy minimizes
outlay required by
Kamada
Additional
Unencumbered
Pipeline Products
D1-AAT (IV):
Type-1 diabetes in
Phase I/II
(Unencumbered
outside of US, Canada,
Australia and New
Zeland)
C1-AAT (IH):
Cystic fibrosis
completed Phase II
(Unencumbered)
B1-AAT (IH):
Bonchiectasis
completed Phase II
(Unencumbered)
Multiple other high
potential applications
for AAT including:
COPD, transplant
rejection, inflammatory
bowel disease, graft-
versus-host-disease,
ischemic heart disease
and multiple sclerosis
Inhaled AAT for
AATD in
Europe & US
Estimated only ~2% of
cases treated in
Europe
Estimated only ~5% of
cases treated in US
Orphan drug
designation in US and
EU
Partnered with Chiesi
for Inhaled AAT for
AATD in Europe only
Distribution (no
technology out-
licensed in Europe)
Unencumbered in US
The Kamada
Pillars
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Pipeline products expected to accelerate revenue growth 1
Strong Financial Profile with Revenue Growth and Expanding Profitability
2 Margin expected to improve due to better product mix
5 Low capital expenditure to support infrastructure to meet future demand
6 No Israeli income tax expected to be paid until 2017
3 Efficient operating expense due to strategic partnership model
4 Stable, profit generating revenue stream from marketed products
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$MM FY2009 FY2010 FY2011 9M/11 9M/12
Proprietary Products
10 23 35 22 31
Growth 130% 54% 39%
Distribution 4 11 24 16 21
Growth 187% 110% 25%
Total Revenues 14 34 59 38 51
Growth 146% 73% 33%
Gross Profit (3) 6 17 10 14
R&D (9) (9) (12) (8) (9)
S&M and G&A (5) (7) (7) (5) (5)
EBITDA (12) (6) 1 (0) 4
Note
1. Do not add due to rounding
(1)
(1)
(1)
Sustained and Rapid Growth has Made Kamada EBITDA Positive Within 3 Years of Growth
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Initial Public Offering on the Tel Aviv Stock Exchange (KMDA)
Strategic agreement with Pari
US FDA approval for Glassia®
Strategic agreement with Baxter
First sale in the US
Strategic agreement for Rabies in the US with Kedrion
Anti-Snake Venom launch
Strategic agreement with Chiesi
LPI the Phase 2/3 Inhaled AAT for AATD trial (EU)
Newly diagnosed type-1 diabetes Phase 2 trial completed
Initiated open label extension for Phase 2/3 Inhaled AAT for AATD trial (EU)
Increased sales, profitability and production capacity
August 2005
January 2013
Consistent Track Record of Execution
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Completion of Phase 3 for the Rabies lg in the US 2013
Initiation of Phase 2 for Inhaled AAT for AATD in the US 2013
Initiation of Phase 2 or 2/3 for type-1 diabetes 2013
Completion of Phase 2/3 Inhaled AAT for AATD trial (EU) 2013
Strategic agreements 2013/4
Completion of Phase 2 for Inhaled AAT for AATD trial (US) 2014
MAA submission for Inhaled AAT for AATD 2014
Rabies product launch in the US (if approved) 2014/5
Inhaled AAT for AATD launch (EU) (if approved) 2015
Inhaled AAT for AATD launch (US) (if approved) 2016
AAT IV for newly diagnosed type-1 diabetes launch (if approved) 2017
Additional geographic expansion 2013 & beyond
Milestone Date
Future Milestones and Value Creation
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Attractive Plasma-Derived Protein Therapeutics Industry 1
Investment Highlights
2 Significant Opportunity to Expand the AAT Market
3 Glassia® Growth Supported by Differentiated Product Profile and Strategic Partnership
4 Valuable R&D Pipeline Focused on Orphan Indications
5 Integrated, Efficient, Scalable Platform Technology
6 Strong Financial Profile with Increasing Profitability
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Chronic & severe lung inflammation
AAT Deficiency
Lack of AAT
Excess Ne
Imbalance
Destruction of lung parenchyma
Worsening of emphysema
Loss of lung function
Increase in severity & frequency of exacerbation
Progression of disease Disease deterioration
“Vicious cycle” of disease deterioration
Further loss in lung function
Reduced quality of life, increased disability and mortality
Measurable
From Inflammation through Emphysema to Disease Progression in AATD
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Manufacturing
FDA approved and cGMP compliant facility located in Beit Kama, Israel
– Passed US FDA inspection in 2010 and Israeli Ministry of Health cGMP audit in July 2011; Russian Ministry of Health and similar authorities in Brazil and Mexico have also approved / conducted successful quality-assurance audits
State-of-the-art clean room environment
Facility organized on production-series process so that the facility produces one product only at any one time
– Plant operates three shifts per day, six days per week, depending on production plans
– Facility also devoted to producing materials for R&D purposes
Sufficient existing capacity to supply Glassia® and product pipeline through foreseeable future
Raw materials (mainly plasma/fraction IV) obtained from multiple suppliers regulated by US FDA and EU EMA
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IP
Five patent families in multiple countries, including the US, Europe and other
countries
– Manufacturing process patents considered material to operation of business
– Focus is on seeking / maintaining patent protection in the US, the EU and Israel
Additional protection provided by ‘know how’ and trade secrets
Orphan Drug Designation received:
– Inhaled AAT for AATD: US and EU
– Inhaled AAT for Cystic Fibrosis: US and EU
– Inhaled AAT for Bronchiectasis: US
– AAT IV for Newly Diagnosed Type-I Diabetes: US
33
Reconciliation of EBITDA to the IFRS Net Loss
Year Ended December 31,
Nine Months Ended September 30,
($000s) 2010 2011 2011 2012
Net Loss (14,421) (3,715) (4,170) (2,804)
Income tax expense — — — 600
Financial expense, net 2,528 2,727 2,051 2,090
Depreciation and amortization expense 2,640 3,040 2,274 2,283
Share-based compensation charges 1,620 878 648 974
Expense (Income) in respect of translation differences and derivatives instruments, net
1,052 (937) (635) 15
Expense (Income) in respect of revaluation of warrants fair value
640 (540) (530) 554
EBITDA (5,942) 1,453 (362) 3,712