ועידת המשקיעים 2007 של TheMarker ומגדל שוקי הון 3 בדצמבר, 2007
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Transcript of ועידת המשקיעים 2007 של TheMarker ומגדל שוקי הון 3 בדצמבר, 2007
של 2007ועידת המשקיעים TheMarker
ומגדל שוקי הון
2007 בדצמבר, 3
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Forward Looking Statements
These slides accompany an oral presentation by Given Imaging Ltd., which contains forward-looking
statements. These statements involve risks and uncertainties that could cause actual results to differ
from those anticipated or indicated. Any forward-looking statements should be considered in light of such
risks and uncertainties, including, without limitation, those detailed in the Company’s annual report on Form
20-F filed with the SEC on May 16, 2007.
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Company Profile
• Founded 1998• 2006 revenues: $95 million• 9 mos ‘07 revenues: $78.6 million• Three marketed products:
– PillCam SB – FDA clearance 2001• PillCam SB 2 – FDA clearance May 2007
– PillCam ESO – FDA clearance 2004– PillCam COLON – CE Mark 2006; Pending FDA clearance
• Strong, debt-free balance sheet, over $100 million in cash• 2007 Guidance
– Revenues: $109 – $112 million– EPS (non-GAAP): $0.34 - $0.44
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Competitive Advantage• Multi-product portfolio
– Workstation compatible with SB, ESO and COLON capsules
– Next generation PillCam SB 2 and Rapid 5 already launched
• Significant installed base
• Unmatched clinical data and clinical images enabling physicians shorter reading time
• Track record of product development and software innovation
• Solid intellectual property estate
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Solid Revenue Growth (millions of dollars)
40.6
65.0
86.8
95.0
109.0 – 112.0
67.267.214.4
18.3
22.9
2003 2004 2005 2006 9 mos ‘07 ‘07 Guidance
US ROW
78.6
7.77.7
5.9
Americas EMEA APAC/Japan
26.226.246.746.7
63.963.9
52.0
52.0
21.8
18.9
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A Proven Razor/Razor BladeBusiness Model
56%56%
1%
43%
67%67%
2%
31%
77%77%
2%
21%
84%84%
1%
15%
87%87%
4%
9%
2003 2004 2005 2006 Q3 2007
PillCams Service Systems
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2007 – 2010 Corporate Goals
• Pursue 3 x 3 strategy– 3 products – PillCam SB, ESO and COLON– 3 geographic selling areas – US, EMEA, Asia/Pacific
• Deliver consistent organic growth of more than 20%• Expand our international footprint
– Direct sales– Distributors– Other alliances
• Remain at the forefront of innovation• Explore external growth opportunities
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The PillCam Platform
* Pending FDA clearance
*
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The Brain Behind The Capsule
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RAPID 5 Software
• US marketing clearance for RAPID 5 in May, 2007
• Supports PillCam SB 2, PillCam ESO 2 and PillCam COLON
• New features include:– QuickView – Pre-reads most interesting images in < 5
minutes
– Enhanced Images – Sharper, brighter images, viewing in blue mode
– Expanded Image Atlas – Reference library with hundreds of images
– New image shape - Increased angle of view
– Includes the Lewis Score – Objective scoring system for small bowel findings
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PillCam SB
“Capsule endoscopy provides a gold standard of accuracy in the detection and diagnosis of small
bowel tumors.” Dr. Jamie Barkin, Division of Gastroenterology, Mt. Sinai Medical Center, Miami
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PillCam SB
• A non-invasive tool to visualize the entire small intestine
• PillCam SB 2 – FDA clearance in May 2007
• > 8-hour battery life
• Transmits > 50,000 images
• More than 600,000 capsules sold since inception
• Marketed in 60 countries
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SB: Huge U.S. Market PotentialDisorder Opportunity
Prevalence Potential
Annual CE
Procedures
Potential
Cases/Week (2,000 Systems)
Bleeding n/a 50,000-100,000
1
IDA ? 1.25M (1) 12
Crohn’s –
Suspected5M+ 1.0M (2) 10
Crohn’s -
Diagnosed.4 – 2M ? ?
Celiac 3M 250,000 ?
IBS 15M ? 10+
NSAIDs 17M ? ?
(1) Based on market survey, in which 80% of GI respondents stated they saw 2-3 IDA patients per week which were candidates for PillCam SB
(2) Based on market survey, in which respondents stated they saw suspected Crohn’s patients 2 per week (2X50X10,000)
(3) Based upon definition from ICCE Consensus 2006
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PillCam SB Target Indications
Commercialization
OGIB
2007 2008 2009
Commercialization
Suspected Crohn’s
CommercializationMarket Development
Iron Deficiency Anemia
(1) Includes suspected Crohn’s disease and may include additional suspected small bowel pathologies.
Reimbursement SuccessCovered Lives
(millions)Covered Lives
(millions)Region Covered Lives (mm)
U.S. 2007 Medicare Fees As of Nov. 07
Private 169
Medicare 40
Total U.S. 209
U.K. 58.0
Spain 42.0
Portugal 10.0
Sweden 8.8
Germany 8.4
Austria 8.0
Switzerland 7.5
Czech 7.0
Denmark 5.4
Italy 4.3
Total Europe 159.0
Israel 7.0
Australia, NZ 19.3
Japan 105
Grand Total ~ 500
450
0
200
400
600
Q4/03 Q4/04 Q4/05 Q4/06 Q2/07
No prior endoscopy Expanded indications(1) Bleeding Only
206
327346
400
500
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PillCam SB Sales Growth(Thousands of PillCams)
134.5
165.1
91.0
51.5
33.8
65.0
2003 2004 2005 2006
ROWUS
136.88.4
9 mos ‘07
Americas
32.5
EMEA APAC
28.3
9.0
100.017.7
26.0
34.5
123.6
100.1
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Future Growth Opportunities
2007 2008 2009
CommercializationMarket Development
IBS+
Market Development
Celiac
CommercializationMarket Development
Diagnosed Crohn’s
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The Japanese Opportunity
• Japanese FDA (PMDA) marketing clearance for PillCam SB received in April
• Global reimbursement for entire adult population effective October 1, 2007
• Promising market opportunity due to:– High level of genetic digestive problems
– High compliance rate
• Sales and marketing infrastructure in place; exclusive distribution partner Suzuken is now selling
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PillCam ESO
“Constitutes a new and exciting technique that will have a significant role in the non-invasive evaluation of patients
with esophageal diseases.” Dr. Blair Lewis, Clinical Professor, Medicine/Gastroenterology, Mount Sinai School of
Medicine
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PillCam ESOEsophageal Varices Indication
• Near-term: Surveillance of advanced liver disease patients for varices
– Population: 400,000 diagnosed
– 5 million at risk
– CPT code effective Jan ’07
– 30 million individuals with reimbursed access in US
• US sales expected to parallel reimbursement expansion
> 5 Million with Chronic Liver Disease
> 400,000 diagnosed cirrhotics
Esophageal Varices20% Mortality from bleeding
25,000 annual deaths
> 5 Million with Chronic Liver Disease
> 400,000 diagnosed cirrhotics
Esophageal Varices20% Mortality from bleeding
25,000 annual deaths
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Clinical Market Strategy
Varices
GERD
2007 2008 2009
Commercialization CommercializationMarket DevelopmentMarket Development
Commercialization Commercialization Market Development Market DevelopmentProduct & Procedure Dev.Product & Procedure Dev.
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PillCam COLON
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Colon Cancer Screening in the US
• Epidemiology
– Approximately 150,000 new cases annually
– 55,000 deaths a year
– 90% of deaths preventable by early screening
• Screening Guidelines
– Every adult >50 years
• Current Volumes and Compliance
– Approximately 5 million colonoscopies per year for screening
– Compliance <40%
– Colonoscopy capacity is reaching its limits
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PillCam COLON Can Help Meet the Unmet Need
• Administered by nurse/technician- Non-invasive- No sedation or anesthesia required
• Initial focus: Visualization, incomplete colonoscopies and non-compliance• Future products: PillCam COLON 2 to enable
full screening
• Market potential greater than PillCam SB and ESO combined
• Regulatory status:• CE Mark received, rolling launch
underway in Europe• US launch pending FDA marketing
clearance
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Near-term Opportunities
• Expanding the market for PillCam SB:
– Additional reimbursement as primary diagnostic tool or second to colonoscopy in the US
– Expanded reimbursement coverage in France
• PillCam SB penetration in Japan
• Expanded reimbursement for PillCam ESO
• US launch of PillCam COLON
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Summary
Given’s Strong Growth Builds on:• Large global market opportunities
• Multi-product portfolio
• Significant installed base
• Track record of innovation
• Solid intellectual property estate
• Financial strength