FORWARD LOOKING STATEMENT Statements made in this presentation that look forward in time or that express management's beliefs, expectations, hopes or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties, including those detailed in CryoLife s Form 10-K filing for the year ended December 31, 2008, and later SEC filings as well as on the last few slides of this presentation. The Company does not undertake to update its forward-looking statements. 2
CORPORATE OVERVIEW Leader in the emerging fields of tissue engineering and surgical adhesives and hemostats Product Offering Proprietary line of surgical adhesives, hemostats, and allografts for cardiac and vascular reconstructive surgery Product Pipeline Direct sales force targeting cardiac and vascular surgeons exclusively Wholly-owned European subsidiary Strategic Partners / Licensors Strategic partnerships 3
TECHNOLOGY PLATFORMS Cardiac Core Markets Vascular Surgical Adhesives & Hemostats Tissue Preservation Three Technologies SynerGraft 4
2008 REVENUE BREAKOUT BY PRODUCT Other 3% Hemostase MPH 1% Cardiac Preservation Services 19% CryoValve SG 5% BioGlue 46% Vascular Preservation Services 26% Broad product offering targeting high-volume surgical procedures for critical cardiac and vascular conditions Leading market position across core market segments Increasing contribution from new product introductions 5
SURGICAL ADHESIVES AND HEMOSTATS 6
BIOGLUE SURGICAL ADHESIVE Market Opportunity and Need CryoLife Solution: BioGlue $200MM U.S. market growing to $380MM in 2013 Sutures and staples lack inherent sealing capabilities Air and fluid leakage at wound site post-operative morbidity Not ideal during minimally invasive surgeries Dominant adhesive/sealant used in cardiovascular surgery 4-5x tensile strength of fibrin sealants PMA approved for use in large vessel surgery as adjunct to sutures / staples CE Mark and int l approvals in 60+ countries for soft tissue repair Used in >450,000 procedures WW 7
HEMOSTASE MPH Market Opportunity and Need CryoLife Solution: Hemostase MPH $600MM U.S. market growing to $980MM in 2013 Thrombin products contain human or animal component risk of disease transmission or immunologic response Other products applied with carrier technology Absorbable hemostat derived from plant starch Adjunctive hemostatic device for use in cardiac, vascular and general surgery Exclusive distribution in U.S. for cardiac & vascular surgery 1 Exclusive OUS distribution in markets for cardiac, vascular & general surgery 2 8 (1) Excludes DOD facilities (2) Except Japan and China
9 TISSUE PRESERVATION
CARDIAC ALLOGRAFT TISSUE Market Opportunity and Need CryoLife Solution: Cardiac Allografts $550MM U.S. valve market; $450MM tissue valve market Need for chronic anti-coagulant therapy with mechanical valves Not fit for women of childbearing age Porcine/bovine valves contain synthetic materials Risk of calcification in pediatric and active endocarditis patients No need for anti-coagulant therapy Ideal for pediatric use lower rate of calcification vs other tissue valves Broad product offering Valve allografts CryoValve SG Pulmonary Human Heart Valve Cardiac patch material > 65% market share leading player in human tissue valve market 10
VASCULAR ALLOGRAFT TISSUE Market Opportunity and Need CryoLife Solution: Vascular Allografts $130MM U.S. peripheral graft market growing to $150MM by 2015 168,000 BTK amputations annually due to PAD Poor performance of synthetic grafts in below-the-knee use Graft kinking and occlusion Vascular reconstruction complicated by infections Used when no autologous tissue available Limb salvage in PAD Aortoiliac replacements Dialysis access Broad product offering Saphenous veins Femoral veins and arteries Aorto-iliac grafts Over 40,000 vascular grafts implanted ~ 90% market share leading player in human vascular allograft market 11
12 SYNERGRAFT
SYNERGRAFT Proprietary decellularization process designed to reduce the antigens typically found in standard processed human and animal tissues Potential decreased risk of calcification and improved longevity of graft CryoValve SG used for congenital heart repair & pulmonary valve replacement CryoValve SG received 510(k) clearance February 2008 ProPatch approved for soft tissue repair 13
14 SALES & DISTRIBUTION
WORLDWIDE SALES AND DISTRIBUTION United States 51-person direct sales force targeting cardiac and vascular surgeons exclusively Relationships with over 1,000 cardiac and vascular surgeons Access to world class cardiac surgery and vascular surgery centers across U.S. Ability to broaden product offering specifically based on surgeon needs/demands Trained field support personnel supporting implanting hospitals and surgeons International Wholly-owned European subsidiary, CryoLife Europa 11 direct reps covering the U.K. & Germany Independent distributors covering >50 countries worldwide Increasing presence in South America and Asia International 15% U.S. 85% 2008 Rev.: $105.1MM 15
LICENSE & DISTRIBUTION RELATIONSHIPS & OPPORTUNITIES Medafor Hemostase MPH Proxy Biomedical BioGlue for use in hernia mesh-fixation BioGlue - Century Medical (Japan) BioForm Medical BioGlue for cosmetic & plastic surgery 16
17 PRODUCT PIPELINE
PRODUCT PIPELINE BioFoam CryoValve SG aortic heart valve SynerGraft xenograft heart valves & vascular grafts 18
GROWTH STRATEGY Leverage world class direct sales infrastructure and expertise in core markets Drive organic growth through 51-person sales force focused on cardiovascular surgery Strengthen existing relationships with tissue banks and procurement agencies Strategically pursue complementary product / company acquisitions Add more products to the bag targeting cardiac and vascular surgeons Leverage channel access to establish strategic partnerships for unique products Focused R&D efforts to expand product pipeline Development of products based on proprietary SynerGraft and Protein Hydrogel Technology platforms targeting cardiac and vascular surgery applications Selectively expand target market for products by leveraging core technology Pursue additional indications or product line extensions for core products and technologies Geographic expansion in key international territories 19
20 FINANCIAL HIGHLIGHTS
SELECTED FINANCIAL DATA ($ in millions) $40.0 Quarterly Revenue $30.0 $24.5 $25.6 $23.0 $27.2 $22.2 $26.8 $25.1 $25.5 $20.0 $10.0 $0.0 1Q 2Q 3Q 4Q 2007 2008 21
SELECTED FINANCIAL DATA ($ in millions, except per share data) $5.0 Quarterly Net Income $0.20 Quarterly EPS (Diluted) $4.0 $3.0 $2.8 $3.9 $3.6 $2.6$2.6 $0.16 $0.12 $0.10 $0.14 $0.12 $0.10 $0.09 $2.0 $1.0 $1.4 $1.3 $1.9 $0.08 $0.04 $0.04 $0.05 $0.07 $0.0 1Q 2Q 3Q 4Q* $0.00 1Q 2Q 3Q 4Q* 2007 2008 2007 2008 22 *GAAP 4Q 2008 Net Income was $22.7 million and EPS (diluted) was $0.81. Adjusted for 4Q 2008 reversal of deferred tax asset valuation of $20.1 million.
INVESTMENT HIGHLIGHTS Proprietary product offering targeting cardiac and vascular surgery Leading position in human tissue processing and surgical adhesives/sealants Highly leveragable sales & marketing and distribution infrastructure across U.S., Canada, and Europe Pipeline of innovative complementary high-value products Strong strategic partnerships enabling entry into non-core markets Attractive operating scale and profitability margins with solid balance sheet Proven and experienced management team 23
NYSE: CRY WWW.CRYOLIFE.COM
Risk and Uncertainties facing CryoLife and its business include the following: The Company is significantly dependent on revenues from BioGlue and there are a variety of risks affecting BioGlue, demand for CryoValve SG may not reach anticipated levels, CryoValve SG may not perform as well as expected or provide all the benefits anticipated, SynerGraft processed heart valves have a one year shelf life, competitive pressures and tissue availability may adversely affect the Company s ability to grow revenues, the SynerGraft post-clearance study requested by the FDA may not provide the expected positive results, our products and tissues we process and preserve have allegedly caused and may in the future cause injury to patients, the possibility that the FDA could impose additional restrictions on the Company's operations, issue a 483, or warning letter, or require a recall, or prevent the Company from processing and distributing tissues or manufacturing and distributing other products, the Company's growth strategies may not generate the anticipated benefits, our ability to borrow under our credit facility may be limited, the credit facility limits our ability to pursue significant acquisitions, the financial and credit liquidity crisis may adversely affect our ability to borrow money or raise capital, there are limitations on our use of net operating loss carryforwards, adverse regulatory action outside of the United States could affect our business, physicians have been and may be reluctant to implant or use our preserved tissues or products, the Company's efforts to develop and introduce new products outside the U.S. may be unsuccessful, FDA and other approvals for products in development may not be obtained, and if obtained, may be costly and require lengthy review periods, our existing insurance policies may not be sufficient to cover our actual claims liability, if the economic crises continues, demand for our products and services may decrease, we may be unable to obtain adequate insurance at a reasonable cost or at all, the patents and proprietary technologies that we use or license could be infringed or duplicated by third parties and we may not be successful in preventing infringement or use, our patents and patent applications could be held to be invalid or null, we are dependent on key personnel, products and services under development may not be commercially feasible, the Company may be unable to effectively leverage its existing sales force to sell Hemostase, that surgeons may not choose to utilize Hemostase, that Hemostase may not perform as expected or provide all expected benefits, that other distributors of the Hemostase product may impede our ability to sell to new or existing customers, that a third party could infringe patents used to make Hemostase, we are reliant on one supplier for significant components of BioGlue, pending or future litigation may not be settled on terms acceptable to the Company, the Company may not have sufficient resources to pay punitive damages (which are not covered by insurance) or other liabilities in excess of available insurance, the Company may be unable to obtain sufficient financing to fully pursue its strategic plan, adverse future changes in currency exchange rates may materially reduce the Company s revenues, cash flow, financial position and profitability and future healthcare policies, healthcare reimbursement methods, and healthcare reimbursement policies may affect the availability, amount, and timing of the Company s revenues. These risks and uncertainties include the risk factors detailed in CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended 25 December 31, 2008, and the Company's other SEC filings.