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Clinical Research. Evolved. The world’s leading CRO, powered by Healthcare Intelligence Dr. Steve Cutler, CEO J.P. Morgan Healthcare Conference January 14, 2025
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Forward Looking Statement Statements included in this presentation which are not historical facts are forward-looking statements. Such forward-looking statements are made pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Forward-looking statements include statements regarding our financial guidance and outlook, and may be identified by the use of future tense or other forward looking words such as “believe”, “expect”, “anticipate”, “should”, “may”, “strategy”, or other variations or comparable terminology. The forward looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, our results could be materially adversely affected. The risks and uncertainties include, but are not limited to, dependence on the pharmaceutical industry and certain clients, the need to regularly win projects and then to execute them efficiently and correctly, the challenges presented by rapid growth, competition and the continuing consolidation of the industry, the dependence on certain key executives, changes in the regulatory environment and other factors identified in the Company’s SEC reports, including the Form 20-F filed on February 23, 2024 and any future filings with the SEC. The Company has no obligation under the PSLRA to update any forward looking statements and does not intend to do so. This presentation includes selected non-GAAP financial measures including, but not limited to, adjusted earnings per share. While non-GAAP financial measures are not superior to or a substitute for the comparable GAAP measures, we believe certain non-GAAP information is more useful to investors for historical comparison purposes. The full-year 2024 and 2025 guidance adjusted earnings per share measures are provided on a non-GAAP basis without a reconciliation to the most directly comparable GAAP measure because the company is unable to predict with a reasonable degree of certainty certain items contained in the GAAP measures without unreasonable efforts. For the same reasons, the company is unable to address the probable significance of the unavailable information. The information contained in this presentation is being provided for your convenience and information only. This information is accurate as of the date of its initial presentation. If you plan to use this information for any purpose, verification of its continued accuracy is your responsibility. ICON assumes no duty to update or revise the information contained in this presentation.
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2 Key considerations for ICON in 2025 ICON is well placed to capture increased opportunity• Encouraging RFP flow, strategic partnerships, demand for innovative solutions We will continue to manage the business appropriately based on the environment• Leveraging technology, automation and overall cost management initiatives We view 2025 as a transition period due to a combination of market and customer-specific factors
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Biotech funding improving; volatility continuing on a quarterly basisTotal biopharma funding increased c40% in 2024 3 Large market opportunity, supported by scientific innovation and need for efficient development ~$56 Bn2024 Estimate Continued investment & prioritization in late-stage developmentTotal R&D spend c18% total revenue at large pharma CRO Market Outlook - Phase I-IV Clinical Development Addressable Development Spend (Ph I-IV)Outsourced Penetrationc53% Sources: Industry Standard Research (2023); Wall Street Research; Management estimates; BioWorld c$105 Bn Near-term volatility expected, but core drivers of market growth remain in place Rise in novel, complex therapiesOncology & neuroscience remain largest areas of development Advanced technologies enabling increased innovation in development and in executionPhase I-III total clinical trial starts uptick in FY2024 CRO Market Estimate (Phase I-IV) Impacts to normalized market growth rates in 2025 expected from biopharma reprioritization/cost containment activity and slower biotech recovery
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Leading dedicated full- service biotech offering Global footprint & leadership in key segments World leader in full-service Phase II/III clinical research World leader in FSP Global #2 in Early Phase Global #2 in Late Phase/RWE 42,250global headcount50+countries100+locations *Management estimates. Headcount as at September 30 2024 Strategic partnerships with 17of top 20pharma 4
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5 Structured to deliver optimal performance in key segments Functional Centers of ExcellenceGlobal Business Support Services ICON Development & Commercialisation SolutionsComprehensive early development & laboratory solutions for all biopharma ICON PharmaPhase II-IV full-service and functional solutions for large pharma customers Operational structure designed to serve unique customer needs Phase II-IV full-service solutions for biotech customers
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6 ICON’s competitive strengths position us for continued leadership Customer-centric,innovativesolutions at scale Global reach & capabilities Singular focus in Clinical Phase I-IV ServicesDeep expertise in complex trials Integrated Technology, AI & Decentralized Solutions Site & patient-centric model Blended delivery modelsLargest functional & full-service Phase II/III offering 40,000+ employees in over 50 countries Contributed to 60% of FDA approved drugs in 2023 3.5 million hours of automation achieved in 2024
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Advancements in Robotic Process Automation Embracing digital disruption to drive innovation Identifying the right sites, the first timeCassandraPredicting trial post-marketing commitmentsICON Digital PlatformIntegrated capabilities for digitally enabled trials 1 million hours2022RPA Significant investments in human-enabled AI solutionsProprietary tools delivering value todayAI 2 million hours20233.5 million hours20242027Ambition for 8 million hours TokenisationICONex IntegratedDigital Innovation @ Enterprise-wideSolutions-focused Identifying key opinion leaders globally across therapeutic areas Linking patient data beyond trial setting to enhance evidence 7
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INDUSTRY CHALLENGES 8 Addressing industry challenges through proven solutions 30%Sites fail to enrolla single patient 41%Clinical trialsfailto meet planned enrolment 24%Increase in trials completed on time10%Faster site activation YoY Technology & trial management platform 33% Fewernon-recruiting sites Enhanced, automated processesCombining technology with service delivery and expertise to drive superior outcomes ICON RESULTS
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9 Delivering significant value at the portfolio level for customersPARTNERSHIPSTRUCTUREINTEGRATED DATA ANALYTICSCENTRALIZATION AND HUBBINGSITE ID AND ACTIVATIONMONITORING EFFICIENCYANCILLARY SERVICES Multi- to sole CRO modelFSP and FSO blendedRegional CRO hubsRole stratificationIntegrated tech stack Enterprise analytics from ICONMigrate to ICON Activation platformICON ownership of productivity Move from FTE to unit-based deliveryEnterprise strategy for design trial and executionOutcomes:>20% Reduction in monitoring costs20% Reduction in study start-up cycle times50% Increase in CRA productivity
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10 2025 Full-year financial guidance and outlook % increase(2025 Guidance vs. 2024 Guidance Midpoint)2025 Full-year Guidance2024 GuidanceMidpoint-2.8% to +4.5%$8,050m - $8,650m $8,280mRevenue -7.1% to +7.1%$13.00 - $15.00 $14.00Adjusted EPS* 2025 full-year guidance excludes future share repurchases and additional M&A* Excludes amortization, stock-based compensation, restructuring, FX and transaction & integration-related adjustments
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