FORM 8-K
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Florida
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1-13165
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59-2417093
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(State or Other Jurisdiction
of Incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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o
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Exhibit Number
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Description
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99.1*
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Slides posted at www.cryolife.com on November 15, 2011
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99.2**
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Form of 2011 Grant Agreement to Executive Officers pursuant to the CryoLife, Inc. 2007 Executive Incentive Plan entered into with each Named Executive Officer
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*
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This exhibit is furnished, not filed.
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**
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This exhibit is filed, not furnished.
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CRYOLIFE, INC. | |||
Date: November 15, 2011
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By:
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/s/ D.A. Lee | |
Name: | D. Ashley Lee | ||
Title: | Executive Vice President, Chief | ||
Operating Officer and Chief | |||
Financial Officer |
Focused Business Model
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• Products and technology addressing complex cardiac and vascular surgery
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Diversified Product Portfolio
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• Leading market share positions addressing $1B + total opportunity in various cardiovascular product segments
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Specialized Sales Force
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• ~70 person sales team; deep relationships with cardiac and vascular surgeons; distributors in 70 + countries
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World Class Training Programs
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• 200+ physicians trained per year at in-house facility and off-site workshops
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Executing Strategic Acquisitions
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• Cardiovascular companies with innovative technology
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Robust Product Pipeline
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• U.S. approval for PerClot & BioFoam could expand total addressable market by $1.5B in 2015
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•
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Tissue Processing
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•
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Cardiac Allograft Tissue
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•
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Vascular Allograft Tissue
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•
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Medical Devices
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•
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Cardiogenesis
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•
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Investment in ValveXchange
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•
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Surgical Sealants & Hemostats
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•
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PerClot
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•
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BioGlue
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•
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BioFoam
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Acquisitive Growth
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• Acquire innovative products and technologies to accelerate top line
• Focus on cardiac and vascular surgery
• Target deals that have a clear path to shareholder value
• Integrate products into global sales force
• Leverage commercial and clinical infrastructure
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Organic Growth
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• Commercialize innovative new products in core markets
• Invest strong cash flow into R&D and clinical trials
• Build leadership positions in base business
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•
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Starch Medical – September, 2010
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–
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Worldwide distribution and manufacturing agreement for PerClot®, a novel second-generation hemostatic agent used in surgery
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•
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BioGlue Japan Launch – April, 2011
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–
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Provided entry into second largest worldwide market for surgical hemostats and sealants
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•
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Cardiogenesis – May, 2011
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–
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Accretive acquisition (excluding acquisition and integration costs), provided entry into Transmyocardial Revascularization (TMR) market with high margin medical device
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•
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ValveXchange – July, 2011
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–
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Lifetime heart valve replacement technology platform spun-off from Cleveland Clinic
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–
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19% initial equity ownership and right of first refusal to acquire Company
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BioGlue
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$464
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CardioGenesis
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$175
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BioFoam EU
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$30
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PerClot EU
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$328
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Allograft Cardiac Tissue
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$50
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Allograft Vascular Tissue
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$68
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BioGlue
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$698
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CardioGenesis
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$182
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BioFoam EU
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$34
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PerClot EU
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$468
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Allograft Cardiac Tissue
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$56
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Allograft Vascular Tissue
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$84
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•
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~70 (50 U.S.) person direct sales team poised to further penetrate cardiac and vascular surgeon market
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•
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Relationships with over 1,000 cardiac and vascular surgeons
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•
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Independent distributors covering 70+ countries
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•
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Leading annual cardiovascular surgeon training event (Ross Summit) draws significant attendance
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BioGlue
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•
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Dominant adhesive/sealant for cardiovascular
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surgery; over 650,000 procedures worldwide
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•
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Overcomes air and fluid leakage challenges with
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sutures and staples
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•
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4-5x tensile strength of fibrin sealants
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•
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U.S., European and Shonin (Japanese) approval
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BioFoam
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•
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Surgical adhesive biogel expands 4-5x and quickly solidifies into soft foam
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•
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Stored at room temperature
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•
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CE Mark for parenchymal organ sealing; EU launch April 2010
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•
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Commencing US clinical trials; projected U.S. approval 2015/16
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•
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Next generation hemostatic agent derived from plant starch; rapid blood absorption
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•
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$1.3 Billion worldwide market growing to ~$1.9 billion in 2015
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•
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Decreases disease transmission and immunologic response; no human or animal components
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•
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Ready-to-use at surgical site
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–
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No pre mixing or carrier use
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–
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Room temperature storage
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•
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Worldwide distribution & technology licensing agreement
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•
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CE Mark; international distribution began 4Q 2010; U.S. approval expected no later than 2014
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•
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Dominant player with >50% market share
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•
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Ideal for young women and children
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•
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Lower rate of calcification vs. animal tissues
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•
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No need for blood thinners vs. mechanical valves
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•
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No synthetic materials vs. porcine/bovine valves
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•
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Broad product offering for cardiac reconstruction
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–
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Preserved human valves
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–
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CryoValve SG Pulmonary Human Heart Valve
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–
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CryoPatch material for cardiac reconstruction
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•
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Vascular disease is a significant co-morbidity of diabetes
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•
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Broad product offering
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–
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Saphenous veins, femoral veins & arteries, aortoiliac grafts
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–
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Used in limb salvage due to vascular disease, aortoiliac replacements, dialysis access, cardiac bypass
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•
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Overcomes poor performance of synthetic grafts below-the-knee
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–
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Graft kinking and occlusion
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–
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Infection complications
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•
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Treatment for no-option patients with severe angina, incomplete revascularization and chronic ischemic heart disease
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•
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Proprietary intramyocardial catheters
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•
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Intraoperative procedure performed by cardiac surgeon
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•
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Epicardial nature of procedure allows for direct vision of surgical area
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•
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Produces transmural channels of 1mm in diameter
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•
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Medicare approved and reimbursable
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Increases Addressable Market Opportunity
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• Adds $175 million initially, and up to $700 million with biologics
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Expanded Portfolio Allows For Significant Growth
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• 2010 revenue of $11.3M with >80% gross margin
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Strong Anticipated ROI
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• Expected break even within first year (excluding transaction and integration related charges and costs)
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[Photo of Sologrip® III Mini-thoracotomy]
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[Photo of Surgery]
[Photo of PEARL™ 5.0 Robotic Delivery]
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[Photo of Solargen™ 2100s Laser Console]
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Sologrip® III Mini-thoracotomy
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PEARL™ 5.0 Robotic Delivery
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Solargen™ 2100s Laser Console
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•
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Innovative Revascularization approach utilizing autogenous stem cell biologics to increase angiogenesis
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•
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CE Mark Approval; Planning 30 patient European study to commence in 2012
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•
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U.S. clinical trials expected to commence in 2012
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[Photo of Laser fiber deployed]
Laser fiber deployed 1
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[Photo of Three needles with side holes deployed]
Three needles with side holes deployed 2
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[Photo of 1 cc stem cells injected]
1 cc stem cells injected 3
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[Photo of Stem cells injected into the laser border zone]
Stem cells injected into the laser border zone 4
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•
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Next-generation lifetime heart valve replacement technology
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–
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Features potential transapical leaflet replacement; potentially overcomes long-term leaflet wear, which currently requires invasive replacement surgery
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–
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Applicable to patients of all ages
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•
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$1.5+ billion worldwide heart valve market, including rapidly expanding TAVI market
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•
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19% initial equity ownership with right of first refusal for acquisition
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–
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$3.5 million investment; $2.0 million revolving credit facility
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2006
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$81.3
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2007
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$94.8
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2008
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$105.0
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2009
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$111.7
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2010
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$116.6
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2011E
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$121.0
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2012E
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$130.0
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2013E
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$140.0
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2007
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$17.5
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2008
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$22.8
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2009
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$35.1
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2010
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$40.8
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9/30/2011
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$26.0*
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Investments over past 2 years (prior to 9/30/2011)
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PerClot Technology Acquisition
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$6.75 million
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Cardiogenesis Acquisition
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$21.7 million
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Investment in ValveXchange
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$3.5 million
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Stock Buyback Program
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$7.3 million
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Business Development
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$5.1 million
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Total
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$44.35 million
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Current Products
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$1.1B
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Current Products
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$1.5B
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PerClot Worldwide
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$1.4B
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BioFoam US
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$77
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CardioGenesis (Phoenix)
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$518
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Any business development efforts and/or R&D investments are subject to delays, cost overages and regulatory difficulties, and efforts to fully integrate future acquisitions and new product offerings into our business, or efforts relating to R&D and clinical trials, may not be successful and can potentially disrupt our normal business activities. CryoLife’s projections regarding annual revenues may be materially impacted by CryoLife’s ability to obtain certain regulatory approvals on a timely basis, its ability to successfully market various products and services in multiple countries and jurisdictions, and changing economic conditions generally. CryoLife has also inherited certain risks and uncertainties related to its recent acquisition of Cardiogenesis' business. These risks and uncertainties include that CryoLife's ability to maintain revenues and achieve growth in revenues from Cardiogenesis’ revascularization technology in the future is dependent upon physician awareness of this technology as a safe, efficacious, and appropriate treatment for their patients, CryoLife may not be able to successfully market Cardiogenesis' revascularization technology if third party reimbursement for the procedures performed with this technology is not available for its health care provider customers, if suppliers or manufacturers with respect to Cardiogenesis products fail to comply with ongoing FDA or other foreign regulatory authority requirements, CryoLife's Cardiogenesis business may be negatively impacted, third-party distributors or CryoLife's own distributors may not effectively distribute Cardiogenesis products, CryoLife's international operations with respect to Cardiogenesis subject it to certain operating risks, which could adversely impact its net sales, results of operations and financial condition, Cardiogenesis has been named as a defendant in a patent infringement lawsuit and costly litigation may be necessary to protect or defend its intellectual property rights, and Cardiogenesis' internal controls over financial reporting may not have been effective prior to the merger, which could have a significant and adverse effect on CryoLife. These risks and uncertainties related to Cardiogenesis' business that CryoLife has inherited also include the risk factors detailed in Cardiogenesis' Securities and Exchange Commission filings, including its Form 10-K filing for the year ended December 31, 2010, and Cardiogenesis' other SEC filings. Our anticipated future performance, including revenue projections, is subject to the general risks associated with our business, including that we are significantly dependent on our revenues from BioGlue and are subject to a variety of risks affecting this product, including that a German Patent Court has nullified our main BioGlue patent in Germany, and if the ruling is upheld on appeal, we would be prevented from suing to prevent third parties from infringing the main BioGlue patent in Germany, the integration of Cardiogenesis’ business into our business may be slower than expected or unsuccessful, and our revenues and operating expenses may be materially adversely impacted as a result, we are subject to stringent domestic and foreign regulation which may impede the approval process of our tissues and products, hinder our development activities and manufacturing processes, and, in some cases, result in the recall or seizure of previously cleared or approved tissues and products, our liquidity and earnings may be impacted by our substantial investment in our distribution and license and manufacturing agreements with SMI, and we may not fully realize the benefit of our investment in future years unless we are able to obtain FDA approval for PerClot in the U.S., which will require an additional commitment of funds, the FDA rejected our initial IDE application for PerClot and we are working to address its concerns, but there is no guarantee that we can do so on a timely or cost efficient basis, if at all, uncertainties related to patents and protection of proprietary technology may adversely affect the value of our intellectual property, we are involved in significant litigation with Medafor and that litigation cost may have a material adverse impact on our profitability
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CRYOLIFE, INC.
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EXECUTIVE
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By: ___________________________
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___________________________
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Title: _________________________
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Adjusted Revenues*
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|||||||||||
Adjusted Revenue*
Target
(in thousands)
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$_____
Minimum
Level
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$______
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$______
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$______
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$______
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$______
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$_____
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$_____
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$______
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$______
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$______
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Bonus Payable
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$______
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$______
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$_______
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$_______
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$________
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$________
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$________
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$_______
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$_______
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$_______
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$_______
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Adjusted Net Income*
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|||||||||||
Adjusted Net Income* Target (in thousands)
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$______
Minimum
Level
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$______
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$______
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$______
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$______
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$______
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$_______
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$______
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$______
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$______
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$______
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Bonus Payable
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$______
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$________
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$_______
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$_______
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$_______
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$_______
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$_______
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$________
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$_______
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$______
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$_______
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Personal Performance
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||
Personal Performance Rating
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Does Not
Meet
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Meets or
Exceeds
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Bonus Payable
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$____
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$________
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