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ועידת המשקיעים 2007 של TheMarker ומגדל שוקי הון 3 בדצמבר, 2007. Forward Looking Statements.
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ועידת המשקיעים 2007 של TheMarker ומגדל שוקי הון3 בדצמבר, 2007
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.
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
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
Solid Revenue Growth (millions of dollars) 109.0 – 112.0 95.0 86.8 5.9 78.6 21.8 22.9 65.0 7.7 18.9 18.3 40.6 67.2 63.9 14.4 46.7 52.0 26.2 2003 2004 2005 2006 ‘07 Guidance 9 mos ‘07 US ROW Americas APAC/Japan EMEA
A Proven Razor/Razor BladeBusiness Model 9% 15% 21% 31% 4% 1% 43% 2% 2% 1% 87% 84% 77% 67% 56% 2003 2004 2005 2006 Q3 2007 PillCams Service Systems
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
The PillCam Platform * * Pending FDA clearance
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
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
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
SB: Huge U.S. Market Potential • 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 • Based on market survey, in which respondents stated they saw suspected Crohn’s patients 2 per week (2X50X10,000) • Based upon definition from ICCE Consensus 2006
OGIB Commercialization Suspected Crohn’s Commercialization Iron Deficiency Anemia Market Development Commercialization PillCam SB Target Indications 2007 2008 2009
Reimbursement Success Covered Lives(millions) 450 500 400 346 327 206 (1) Includes suspected Crohn’s disease and may include additional suspected small bowel pathologies.
PillCam SB Sales Growth(Thousands of PillCams) 165.1 9.0 136.8 32.5 134.5 8.4 34.5 28.3 91.0 26.0 123.6 51.5 100.1 100.0 17.7 65.0 33.8 2003 2004 2005 2006 9 mos ‘07 ROW US Americas EMEA APAC
Diagnosed Crohn’s Market Development Commercialization IBS+ Market Development Commercialization Celiac Market Development Future Growth Opportunities 2007 2008 2009
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
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
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
Market Development Commercialization Product & Procedure Dev. Market Development Commercialization Clinical Market Strategy Varices GERD 2007 2008 2009
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
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
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
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