Justin Bowers

Justin Bowers asked Anshul Thakral about the timeframe for AI's impact on accelerating discovery (near-term vs. longer duration) and identified which functions within clinical trial operations are most addressable by AI in the near term.

Answer

Anshul Thakral, Chief Executive Officer and Director, clarified that AI's impact on discovery has been ongoing for a period, not just recent months, building on prior data processing capabilities. He noted that AI is having early impact in task automation within pharmacovigilance (e.g., case processing), centralized monitoring (e.g., alerts), and data management (e.g., data cleaning, query reduction). He emphasized that AI is not currently impacting site-level activities, relationships, or physical data monitoring.

Justin Bowers asked for clarification on whether Fortrea's observation of AI accelerating discovery is a near-term phenomenon or a longer-duration trend. He also inquired about which specific functions within clinical trial operations are most addressable by AI in the near term.

Answer

CEO Anshul Thakral clarified that the acceleration of discovery through AI and data processing has been a longer-duration trend, based on client conversations, rather than just a recent development. For clinical trial operations, he identified task automation in pharmacovigilance (e.g., case processing), centralized monitoring (e.g., alerts, data review), and early impacts in data management (e.g., data cleaning, query reduction) as the most addressable functions for AI in the near term, noting no current impact at the site level.

Justin Bowers from Deutsche Bank inquired about the current demand environment across the pharma and biotech sectors and requested an update on the company's robust Phase I (Clinical Pharmacology) business, particularly regarding its reliance on third-party capacity.

Answer

CEO Anshul Thakral expressed cautious optimism, noting that RFP pipelines are trending upwards for both biotech and large pharma. CFO Jill McConnell added that the Clinical Pharmacology business continues to be an industry leader but is facing capacity constraints, necessitating the use of third-party support, which the company is actively working to manage and normalize.

Justin Bowers inquired about the performance of the clinical pharmacology segment, asking about RFP volume, the outlook for the year, any changes in win rates, and plans for price optimization.

Answer

CEO Tom Pike described the clinical pharmacology business as strong, noting that while Q1 bookings were slightly soft, the pipeline has since recovered. He highlighted the success of a strategic shift to focus more on large pharma clients. Pike also mentioned that the company is working to convert more pass-through work, which involves third-party services due to capacity constraints, into direct service revenue.

Justin Bowers inquired about the assumptions behind the 2025 guidance, specifically the implied backlog burn rate, the mix of business opportunities, and the expected ratios for cost of services and SG&A.

Answer

CEO Tom Pike stated the business mix remains around 50/50 between large pharma and biotech. CFO Jill McConnell confirmed that the implied burn rate is an appropriate way to model for now, given the slower-burning nature of the current project mix. McConnell also guided for an 80 basis point reduction in SG&A as a percentage of revenue in 2025, with another 100 basis points targeted for 2026.

Justin Bowers asked for a characterization of the current large pharma spending environment and the status of industry restructurings, and also questioned which component of the Q4 EBITDA bridge—revenue growth or cost savings—has more variability.

Answer

CEO Tom Pike categorized large pharma clients into three groups (growing, flat, and slow-growth), noting Fortrea's exposure is manageable. CFO Jill McConnell explained that Q4 EBITDA variability is influenced by factors like variable compensation and the timing of revenue from large clinical pharmacology projects, which can be affected by holiday schedules.

Justin Bowers asked about GMP revenue in 2025 and any expected seasonality for TriLink in 2026, excluding COVID revenue. He also sought clarification on 2025 GMP consumables revenue and an update on alternative revenue generation or space sharing initiatives in Flanders.

Answer

CEO Bernd Brust explained that business lumpiness is tied to order sizes and clinical trial success, not seasonality. He clarified that one Flanders site is fully occupied by CDMO, while the other is closed. CFO Rajesh Asarpota stated that combined GMP and CDMO business was in the mid-thirties for 2025, with GMP consumables (excluding CDMO) projected at $43 million for 2026.

Justin Bowers asked about GMP revenue in 2025 and any expected seasonality for TriLink in 2026, excluding COVID revenue. He also inquired about 2025 GMP consumables revenue and an update on alternative revenue generation activities in Flanders.

Answer

Bernd Brust (CEO) explained that business lumpiness is not seasonal but tied to clinical trial success and program progression (Phase 1 to 2 to 3), as large orders shift. Rajesh Asarpota (CFO) stated that the combined GMP and CDMO business was in the mid-thirties for 2025. Bernd Brust (CEO) clarified that one Flanders site is fully occupied by CDMO, while the other is closed, and they are not actively seeking incremental revenues from it.

Justin Bowers of Deutsche Bank asked about trends in the preclinical market, specifically in the order book or RFP volume over the last 6-12 months. He also inquired if Maravai is seeing increased opportunities for mRNA outside the U.S. following recent American policy announcements.

Answer

CEO Bernd Brust described the preclinical pipeline as solid, noting that recent research growth was driven by GMP consumables for clinical trials. While much of the activity is still U.S.-based, he confirmed they are seeing 'great growth' in the funnels for GMP-manufactured consumables in non-U.S. markets.

Justin Bowers asked about the key variables or 'swing factors' that could influence the Q4 revenue outcome for the NAPs business and questioned if the pending acquisition of Officinae Bio is expected to contribute revenue in 2025.

Answer

Chief Financial Officer Kevin Herde explained that Officinae is primarily a technology acquisition that will add low single-digit millions in revenue and will not be dilutive. For Q4 variability, he cited the unpredictable nature of smaller discovery business orders, the absence of large 'drop-in' CleanCap POs, and potential timing shifts in GMP services revenue recognition.

Justin Bowers requested clarification on the 50 basis points tariff headwind related to margins and inquired about other moving parts contributing to organic margin expansion in 2026.

Answer

Jason Garland, CFO, confirmed the 50 basis points tariff headwind is due to surcharges and passing costs. He explained that gross margin expansion will be driven by volume leverage, pricing, and productivity, offsetting inflation, with a nominal mix impact. OpEx management involves a step-up in Q1 due to annual compensation increases and prioritized Fit for Growth investments, followed by flattish to slightly increasing OpEx through the year, enabling operating leverage. He highlighted 240 basis points of organic margin expansion in 2025.

Justin Bowers requested clarification on the 50 basis point tariff headwind for margins in 2026 and sought to understand other moving parts contributing to organic margin expansion.

Answer

President and CEO Olivier Loeillot (speaking on behalf of the CFO) confirmed the 50 basis point headwind from tariffs, which are passed through as costs. He explained that gross margin expansion would be driven by volume leverage, pricing, and productivity, offsetting inflation. OpEx management, including a Q1 step-up due to annual compensation increases and Fit for Growth investments, would enable operating leverage, building on 240 basis points of organic margin expansion in 2025.

Justin Bowers asked about the margin trajectory outlined in the five-year strategic plan for both gross and operating margins. He also requested clarification on the moving parts affecting margins in the current quarter and outlook, such as tariffs and FX, and asked about the pricing assumption.

Answer

CFO Jason Garland stated the company is still targeting a 30% EBITDA margin over the five-year plan, driven by productivity, volume leverage, and modest pricing. For Q2, he explained that margin was impacted by an unfavorable mix from high chromatography resin pass-through sales but was supported by volume. He expects sequential margin improvement in Q3 and Q4. He confirmed the pricing assumption is low single digits, which has been achieved year-to-date.

Justin Bowers asked for Repligen's perspective on recent announcements from large biopharma companies about onshoring and increasing CapEx, and whether this is leading to early discussions. He also requested clarification on the expected gross margin cadence for the remainder of the year.

Answer

Executive Olivier Loeillot viewed the onshoring trend as a positive long-term tailwind, confirming that early discussions are happening with these key customers. Executive Jason Garland explained that Q1 gross margin was a high point due to a favorable protein mix, and he expects margins to be around 52% for the rest of the year, with productivity and volume leverage offsetting mix shifts.

Justin Bowers of Deutsche Bank requested more detail on the hardware strength, including any platform wins, and asked about the growth drivers in APAC ex-China, specifically the mix between CDMO and pharma.

Answer

President and CEO Olivier Loeillot confirmed hardware strength was broad-based and driven by differentiated solutions with integrated PAT. He revealed that Repligen is now being 'platformed' at 3-4 large pharma companies for its CFF manufacturing solutions. Regarding APAC ex-China, he described the growth as balanced, citing Korea's mix of large CDMOs and biosimilar firms, and highlighted Japan and Singapore as other key growth regions.

Justin Bowers asked for perspective on whether 2025 will be a year of normalization for the industry, the key swing factors for growth, and the current activity levels in process development.

Answer

President and CEO Olivier Loeillot expressed that Repligen is in a much better spot than a year ago, citing strong momentum in CDMO, pharma, and consumables. He identified equipment uptake and emerging biotech softness as areas to watch. He noted that while process development activity could be constrained by funding, Repligen is not seeing an impact due to high customer engagement.

Justin Bowers requested further details on the special committee's review of the take-private proposal, including potential strategic alternatives and any timing goalposts. He also asked about the impact of Q1 weather across segments and any differences in operating days between Q1 2025 and Q1 2026.

Answer

Michael Malatesta, EVP and CFO, stated that the company was unable to comment further on the special committee's ongoing process beyond the initial statement. Regarding weather, he noted no material impact on the inpatient divisions but confirmed an impact on the outpatient division in early 2026, with some recovery expected.

Justin Bowers inquired about expanding on the special committee's review of the take-private proposal, including potential strategic alternatives and timing goalposts. He also asked about the impact of Q1 2026 weather on segments and any differences in days compared to Q1 2025.

Answer

Michael Malatesta (EVP and CFO, Select Medical Holdings Corporation) stated they could not comment further on the special committee process beyond the initial statement. He noted no material weather impact on inpatient divisions (Critical Illness and Inpatient Rehab) but confirmed an impact on the Outpatient division, with some recovery expected later in the quarter.

Justin Bowers from Deutsche Bank asked about the expected performance of the outpatient rehab business for the remainder of the year and the mid-term outlook for its EBITDA margins. He also sought to understand the Q2 financial impact of the high-cost outlier threshold and the policy initiatives being pursued to influence CMS.

Answer

EVP & CFO Michael Malatesta stated that outpatient rehab is expected to continue improving, targeting a 10% EBITDA margin by late 2025 or early 2026, driven by scheduling initiatives. Co-Founder & Executive Chairman Robert Ortenzio added that he is bullish on the division due to system upgrades. Ortenzio also noted that the current CMS administration is more open to dialogue on policy reform and that the Q2 outlier impact was less significant than in Q1, as anticipated.

Justin Bowers inquired about the Inpatient Rehabilitation Facility (IRF) occupancy outlook for the remainder of the year, given new capacity, and asked for quantification of the miss in the Long-Term Acute Care (LTAC) segment attributed to regulatory factors.

Answer

Executive Robert Ortenzio projected that IRF occupancy would remain strong at around 85% or higher, even with new hospitals coming online. Executive Martin Jackson clarified that the regulatory impact on the LTAC segment was larger than anticipated, particularly the 100% increase in high-cost outlier costs year-over-year, and noted this impact was factored into the revised guidance.

Justin Bowers of Bowers & Co. sought to clarify Select Medical's post-spin-off growth outlook for 2025, the maturation timeline and start-up costs for its extensive development pipeline, and the company's new long-term growth algorithm.

Answer

Martin Jackson, an executive, confirmed market confusion regarding the Concentra spin-off and validated the growth metrics. He explained that new inpatient rehab facilities mature quickly, projecting significant double-digit EBITDA growth in 2026 and 2027. For the near-term, Jackson anticipates double-digit EBITDA growth for the inpatient rehab and outpatient segments, with low single-digit growth for the critical illness (LTAC) division.

Justin Bowers from Deutsche Bank asked about Select Medical's post-spin capital deployment strategy, questioning the preference between deleveraging and share buybacks and inquiring about the company's optimal leverage range. He also sought clarification on LTAC development plans and the final Medicare rate for inpatient rehabilitation facilities (IRF).

Answer

Executive Robert Ortenzio explained that maintaining a leverage ratio around 3x is a key priority to preserve flexibility. He reiterated the company's opportunistic approach to capital deployment, balancing a robust development pipeline with deleveraging and stock buybacks. Ortenzio added that LTAC growth will be judicious, favoring less capital-intensive hospital-within-a-hospital models. Executive Martin Jackson confirmed the IRF Medicare base rate is expected to be in the 3% range.

Justin Bowers from Deutsche Bank sought further education on New Approach Methodologies (NAMs), which constitute about 20% of DSA revenue. He asked how the client base utilizes these methods, specifically whether adoption is concentrated among a few high-end clients or diverse across a large number, potentially for validating existing in vivo methods. Mr. Bowers also inquired about the business impact if AI enabled clients to screen significantly more targets in early-stage drug discovery, asking if this would be accretive, dilutive, or neutral.

Answer

Chair, President, and CEO Jim Foster explained that NAMs are being adopted across a broad client base, with big pharma historically exploring in vitro technologies. He noted that NAMs are more pronounced in discovery, aiming to accelerate clients to lead compounds. Mr. Foster highlighted PathoQuest (non-animal, next-gen sequencing) as a beneficial NAM replacing animal-based work in biologics, and Retrogenix for off-target effects. He stated that while some NAMs are beneficial, others are still early, and in safety assessment, they are likely augmentative rather than replacements, except for specific areas. Regarding AI enabling more targets, Mr. Foster affirmed this would be highly beneficial for clients and accretive for Charles River, as screening more high-probability drugs faster would generate incremental work, higher hit rates, and ultimately benefit society and human health.

Justin Bowers sought further education on NAMs, asking about their current usage by the client base, whether adoption is concentrated among a few high-end clients or diverse, and if clients use these technologies to validate existing in vivo methods. He also asked how a scenario of starting with 20,000 targets instead of 10 (due to AI) would impact the business.

Answer

James Foster, Chair, President, and Chief Executive Officer, explained that NAMs are seen across a broad client base, particularly in discovery, with big pharma historically exploring in vitro technologies. He noted that beneficial NAMs like PathoQuest (replacing animal-based biologics testing) and Retrogenix (off-target effects) are already in use, providing better answers faster. He views AI's ability to screen more targets (e.g., 20,000 instead of 10) as highly beneficial, potentially leading to more drugs advancing to preclinical tox, clinic, and approval, thus generating incremental work for Charles River and improving hit rates for clients.

Justin Bowers followed up on the faster study starts, asking if the trend continued into May, whether it was isolated to large pharma, and if there were any changes in large pharma booking patterns.

Answer

CEO James Foster clarified that the fast starts were seen across the client base, not just large pharma, but reiterated it was likely a one-quarter phenomenon. CFO Flavia Pease added that the Q1 activity provides positive visibility for the first half of the year, but they are not assuming the trend will continue into the second half.

Justin Bowers sought clarification on whether the sequential stability in DSA bookings referred to the book-to-bill ratio or nominal bookings. He also asked for the underlying drivers of the projected mid-to-high single-digit organic revenue decline for DSA in 2025.

Answer

EVP & CFO Flavia Pease confirmed the stability was in the net book-to-bill ratio. Chair, President & CEO James Foster explained the 2025 DSA revenue decline will be driven roughly equally by both lower volume and lower pricing, whereas the 2024 decline was principally volume-driven.

Justin Bowers from Deutsche Bank asked about the significant improvement in Safety Assessment bookings and cancellations, questioning if it was broad-based and if the current level represents a stable run rate. He also inquired about how far out customers are booking and if pharma restructuring is creating CRADL opportunities.

Answer

Chairman, President and CEO James Foster confirmed lower cancellation rates across the client base and noted that biotech demand feels more stable, though the recovery is slow. EVP and CFO Flavia Pease added that study start times vary widely, from within a month to nine months out. She also noted that while the CRADL model remains attractive, some biotechs are rightsizing their space, causing some softness.

Justin Bowers asked about new GLP-1 molecules in the pipeline, specifically whether they require different HVP components like NovaPure or FluroTec, or just different configurations of existing programs. He also questioned if the average selling price (ASP) for these new molecules would be similar to the broader portfolio.

Answer

CEO Eric Green confirmed a mix, with some new molecules using similar elastomeric HVP components, while others, particularly new combination molecules, may require barrier coatings like FluroTec or NovaPure. He noted that the pipeline is evolving, supporting various modalities (vial, prefilled syringes, cartridges). CFO Bob McMahon added that future pricing for these new molecules is expected to be at or higher than today's, given the positive mix.

Justin Bowers inquired about the types of HVP components (e.g., NovaPure, FluroTec) being specified for new GLP-1 molecules in the pipeline, including newer diabesity GLPs, and whether the average selling price (ASP) would be similar to the broader portfolio.

Answer

CEO Eric Green noted a mix of similar elastomeric HVP components and new combination molecules requiring barrier coatings like FluroTec and NovaPure. He emphasized that West supports all modalities (vial, prefilled syringes, cartridges) and sees exciting pipeline growth outside GLP-1s. CFO Bob McMahon added that future pricing for these new molecules is expected to be similar to or higher than today's, given the positive mix.

Justin Bowers from Deutsche Bank asked about the impact of recent Annex 1 updates on customer decision-making and conversion acceleration, and whether the $20 million opportunity for liquid handling in Dublin represents the peak or if there's room for growth beyond 2026.

Answer

CEO Eric Green clarified that the $20 million for Dublin's drug handling is an early-stage ramp-up, with peak volumes and revenues expected in 2027 and beyond as utilization increases. Regarding Annex 1, he noted increased customer engagement with EU regulators, driving accelerated project pace, and emphasized that only a small fraction of the estimated 6 billion component market opportunity has been converted to commercial production.

Justin Bowers asked about the impact of recent Annex 1 updates on customer decision-making and conversions, and if the $20 million opportunity for liquid handling in Dublin represents its peak potential.

Answer

CEO Eric Green clarified that the $20 million for Dublin's drug handling business is an early-stage ramp-up, with peak revenues and utilization expected to be significantly higher beyond 2026. For Annex 1, he noted increased engagement with EU regulators and customers, accelerating projects, and highlighted that only a small fraction of the 6 billion component market opportunity has been converted to commercial production.

Justin Bowers from Deutsche Bank asked for an update on customer destocking, particularly in the strong generics segment, and what market conditions are necessary for West to return to durable high-single-digit growth.

Answer

CEO Eric Green stated that while some destocking headwinds persist in generics, ordering patterns are broadly normalizing. He emphasized that returning to the long-term growth algorithm depends on the High-Value Products (HVP) components business, which is expected to see stronger growth in the second half of the year driven by GLP-1 demand, biologics, and Annex One conversions.

Justin Bowers followed up on the HVP supply constraint, asking for confirmation of the product line and whether some demand might shift into 2026. He also inquired about the tariff impact, specifically whether it affects component sourcing or finished goods.

Answer

CEO Eric Green confirmed the constraint is within an HVP plant and acknowledged that some demand could potentially spill over into 2026. Regarding tariffs, management clarified the impact is on both sourced components and finished goods, and that estimates for these costs are embedded in the current guidance.

Justin Bowers of Deutsche Bank sought clarification on whether the 100-150 basis points of growth from Annex 1 was specific to 2025 and if the focus on improving device profitability was related to Proprietary Products or Contract Manufacturing. He also asked about recent price/incentive headwinds.

Answer

CEO Eric Green confirmed the 100-150 bps growth from Annex 1 is a 2025 impact as projects convert to revenue. He specified his comments on device profitability were focused on the Proprietary SmartDose platform. He also clarified that the majority of a specific $0.44 EPS headwind was related to a device incentive, with a smaller portion from the CGM business transition.

Justin Bowers asked for an assessment of the current stage ('inning') of the destocking cycle across different product components and whether the high decremental margins seen recently could lead to stronger-than-normal incremental margins during the recovery.

Answer

CEO Eric Green detailed the destocking status by segment: pharma is mostly normalized, biologics destocking is getting closer to the end, and some generics destocking will persist into early 2025. CFO Bernard Birkett stated that once demand and mix normalize, margins should return to 2023 levels and then grow according to their long-term construct of ~100 bps annually, implying a strong recovery potential driven by the HVP mix.

Justin Bowers asked for more details on the business environment, including RFP activity, win rates, and the funding environment. He also sought clarification on the impact of cancellations, asking if they were normal, what net bookings would have been without them, and if they were concentrated in any specific therapeutic area, customer segment, or vintage.

Answer

CEO August Troendle described the business environment as reasonably good, noting that RFP activity was up slightly. He attributed the miss in expectations to a higher cancellation rate, despite gross bookings being substantially better than the prior year. Regarding cancellations, Mr. Troendle indicated they were somewhat skewed towards the metabolic area but otherwise widespread and relatively normal, declining to quantify the impact on net bookings.

Justin Bowers asked for more details on the business environment, including quantification of RFP activity or win rates, and insights into the funding environment during the quarter. He also inquired about the potential net bookings if cancellations were at a normal level and asked for a characterization of the elevated cancellations by therapeutic area, customer, or vintage.

Answer

CEO August Troendle described the business environment as reasonably good, noting that RFPs were up quarter-over-quarter and year-over-year. He attributed the miss to a higher cancellation rate, stating that gross bookings were substantially better than the prior year. Troendle specified that cancellations were somewhat skewed towards the Metabolic area, which has seen significant growth, but were otherwise relatively normal and widespread, not providing a specific figure for net bookings under normal cancellation rates.

Justin Bowers of Deutsche Bank requested clarification on the hiring growth forecast, asked about the mix of the pre-backlog pipeline, the timing of the cancellation inflection, and the level of change order activity.

Answer

President Jesse Geiger clarified the full-year headcount growth target is around 5-6%. CEO August Troendle confirmed the pre-backlog pipeline shows a continued shift towards metabolic studies and could not pinpoint an exact intra-quarter timing for the cancellation improvement. Both executives stated there was nothing unusual about change order activity during the quarter.

Justin Bowers from Deutsche Bank followed up on the faster program progression in Q1, asking if it was driven by internal execution or external client pressure. He also sought clarity on whether in-flight cancellations were elevated and if pricing pressure was coming from mid-sized or larger CRO competitors.

Answer

CFO Kevin Brady noted that Q1's strong program progression was not due to any specific internal changes but reflected the steady execution of active trials. CEO August Troendle confirmed that funding issues have been a significant driver of in-flight backlog cancellations, in addition to drug performance. President Jesse Geiger added that pricing pressure is coming from both mid-sized and larger competitors, as well as clients' own funding constraints.

Justin Bowers from Deutsche Bank asked about trends in pre-backlog awards and associated cancellations compared to the main backlog. He also inquired if the demand environment's trajectory of improving quality and stabilizing pricing was still intact and if decision-making velocity had changed.

Answer

CEO August Troendle reported that the flow into pre-backlog awards remains 'okay' and that cancellations decreased in that category, which had been a major headwind in 2024. He noted the business environment improved through the first three quarters of 2024 but felt weaker in Q4, emphasizing that the main issue had been funding-related cancellations rather than decision delays.

Justin Bowers inquired about the proportion of the current backlog originating from the 2020-2021 award vintage. He also asked about the historical contribution of the pre-backlog pipeline to quarterly bookings, the outlook for employee growth, and the expected trend for reimbursable costs.

Answer

CEO August Troendle did not provide a specific breakout of the backlog by award year but acknowledged that projects from that period still represent a "chunk" of the backlog. He reiterated that virtually 100% of quarterly bookings come from the pre-existing pipeline. President Jesse Geiger stated that headcount growth was modest but is expected to accelerate in 2025. CFO Kevin Brady noted that while reimbursable costs are stabilizing, they will likely remain somewhat elevated compared to the historical 33-35% range.

Justin Bowers with Deutsche Bank asked for clarification on whether AI represents an opportunity or risk for IQVIA's business, specifically if it's accretive to long-term growth for R&DS and Commercial Solutions. He also inquired about the improving business environment in R&DS, asking if the company is on track for a 1.2 book-to-bill ratio throughout 2026 and if the pipeline supports this outlook.

Answer

Ari Bousbib, Chairman and CEO of IQVIA, reiterated that AI is a significant positive for the business, emphasizing IQVIA's unique proprietary healthcare data assets and deep industry expertise that cannot be replicated by general-purpose AI. He stated that AI augments client teams and optimizes existing workflows, driving productivity and enhancing services rather than replacing them. Regarding R&DS, Bousbib confirmed strong demand metrics, including double-digit growth in qualified pipelines and RFP flow. He noted the improved book-to-bill ratio during the year, despite some Q4 cancellations, and highlighted strong EVP funding and a rich large pharma pipeline, indicating a robust demand environment.

Justin Bowers of Deutsche Bank sought clarification on whether AI represents an opportunity or risk for IQVIA, its impact on segment growth rates (R&DS and Commercial Solutions), and confirmation that it is accretive to long-term growth. He also inquired about the improving R&DS business environment, specifically if the company is on track for a 1.2 book-to-bill ratio throughout 2026, supported by the current pipeline.

Answer

IQVIA CEO Ari Bousbib reiterated that AI is a positive and accretive force for the business, emphasizing IQVIA's unique proprietary healthcare data and deep industry expertise that cannot be replicated by general-purpose AI. He highlighted strong R&DS demand metrics, including double-digit growth in qualified pipelines and RFP flow, and noted improved book-to-bill ratios throughout the year, despite some idiosyncratic cancellations in Q4 2025. He affirmed that demand indicators and funding remain strong, particularly in EBP and large pharma.

Justin Bowers inquired whether the current positive business momentum, including increased funding and strengthening TASS and R&DS segments, is expected to continue into 2026.

Answer

Ari Bousbib, Chairman and Chief Executive Officer, stated that while 2026 guidance is not yet available, he is confident that revenue growth for 2026 will be at least equal to or better than the over 5% growth projected for 2025, highlighting strong performance relative to peers.

Justin Bowers inquired about the improving business environment, strengthening TASS and R&DS segments, and whether this momentum is expected to continue into 2026.

Answer

Chairman and CEO Ari Bousbib confirmed strong top-line revenue growth of over 5% for the current year, highlighting it as a robust performance given recent market conditions. He expressed confidence that 2026 revenue growth would be at least the same or better than the current year.

Justin Bowers inquired about the primary drivers for the strong performance in Real-World Evidence (RWE) during the quarter, the outlook for the order book for the remainder of the year, and the sustainability of this outperformance.

Answer

Chairman and CEO Ari Bousbib explained that the Technology & Analytics Solutions (TAS) segment's outperformance was led by strong double-digit growth in RWE. He attributed this to a return of both discretionary and mission-critical work that had been previously delayed, creating pent-up demand. Based on the current book of business, he expects this positive trend to continue.

Justin Bowers of Deutsche Bank asked about capital deployment plans, given the underspend relative to the annual target, and whether pricing pressure was expanding beyond FSP to full-service outsourcing.

Answer

CEO Ari Bousbib confirmed capital deployment is below the $2-3 billion target due to uncompleted large M&A deals and stated a strong intention to 'massively buy' shares in Q4. He affirmed that pricing pressure is tough 'across the board' in both commercial and R&DS, driven by large pharma rebids and aggressive pricing from smaller competitors.

Justin Bowers inquired about the current industry environment, asking for a bifurcation between pharma and biotech sectors and insights into the tenor of conversations given increasing regulatory and trade clarity.

Answer

CEO Barry Balfe noted positive indicators from biotech funding and pharma's reaction to regulatory news, suggesting a move towards consistency. He emphasized that consistent policy, regardless of its nature, is beneficial for the sector. While RFP flow and gross bookings show improvement, he cautioned that revenue and earnings follow with a lag, characterizing the environment as encouraging but still mixed.

Justin Bowers asked for a discussion on the current industry environment, differentiating between pharma and biotech sectors, and the tenor of client conversations in light of increasing regulatory and trade clarity.

Answer

CEO Barry Balfe noted positive reactions to biotech funding in Q3 2025 and pharma news, suggesting a move towards consistency. He observed significant double-digit increases in RFP flow and gross bookings, but cautioned that revenue and earnings follow with a lag. He characterized the environment as encouraging but still mixed, with signs of increasing deal flow in large pharma.

Justin Bowers of Deutsche Bank requested insight into the new opportunities in ICON's pipeline, asking about the mix by therapeutic area and customer type, and what is needed for these opportunities to convert into bookings.

Answer

CEO Steve Cutler identified oncology as the primary driver of backlog and new wins. He also highlighted a significant uptick in the cardiovascular and metabolism therapeutic area, largely driven by obesity and NASH-related studies. In terms of trial phase, he noted that both early-phase and Phase III work are moving forward nicely.

Justin Bowers from Deutsche Bank asked about the current stage of large pharma reprioritization and what levers ICON can pull to increase its revenue burn rate.

Answer

CEO Dr. Steve Cutler stated that large pharma is currently focused on cost reduction but will eventually shift to R&D spending and M&A, positioning ICON well. COO Barry Balfe explained that the burn rate can be increased by accelerating trial execution through standardized best practices. CFO Nigel Clerkin confirmed the burn rate is a factor in the guidance range.

Justin Bowers inquired about the current demand environment for both large pharma and biotech customers, and whether the observed strength in Phase I clinical trials should be seen as a leading indicator for future Phase II and III work.

Answer

CEO Dr. Steve Cutler responded that the overall demand environment is solid, with stable opportunity flow from large pharma and low single-digit growth in biotech. While ICON's early-phase business is seeing a positive trend, he cautioned that there isn't a strong historical correlation for Phase I strength to directly pull through into later-phase studies for the same projects, describing the connection as 'fairly loose'.

Justin Bowers asked a two-part question on large pharma, seeking clarity on the persistence of development model changes and whether the two challenging customers would be a headwind in 2025 while the rest of the top 20 cohort grows.

Answer

CEO Dr. Steve Cutler confirmed it was a reasonable characterization that the two specific customers would be a headwind, but noted that growth outside of these accounts is strong, around 6%, and driven by higher-margin full-service work. He described development model preferences as cyclical and stated ICON is well-positioned with its hybrid model to capture work regardless of whether customers favor functional or full-service approaches.

Justin Bowers of Deutsche Bank asked for an explanation for the softer workers' compensation volume in Q1 2025 and whether the updated guidance assumes a specific same-store visit growth range. He also questioned if the stable employer services performance was driven by market trends or internal initiatives.

Answer

CEO Keith Newton attributed the Q1 softness to normal quarterly variability rather than a specific underlying issue. President & CFO Matthew DiCanio added that the back-half guidance assumes performance closer to the year-to-date average of Q1 and Q2, not just the strong Q2 results. On employer services, Newton described the performance as a mix of both internal initiatives, like sales restructuring, and a stable, albeit not rapidly growing, labor market.

Justin Bowers asked about the typical seasonality of workers' compensation fee schedule updates and inquired about any weather impacts in Q1, as well as the strategy for gaining market share with large Fortune 500 accounts.

Answer

Executive William Newton explained that 80-90% of workers' comp rate updates occur in Q1, with a majority effective January 1, and the remainder staggered in July and October. He noted that while weather has an impact, it's difficult to quantify year-over-year, so it wasn't called out. Regarding large accounts, Newton described a value proposition centered on deep integration with employers and their TPA partners, leveraging technology to speed up communication and return-to-work, which validation studies have shown can save clients 25-30% on healthcare costs.

Justin Bowers from Deutsche Bank asked for a summary of Concentra's long-term growth algorithm, clarification on whether the 2025 guidance includes development activity beyond what was announced, and the extent of the company's exposure to government payers.

Answer

Executive William Newton reiterated the company's long-term target of mid-to-high single-digit revenue growth, driven by low single-digit visit growth, approximately 3% rate increases, and ongoing de novo and M&A activities. He confirmed the 2025 guidance only includes the one center already opened and five with signed leases, with no further M&A assumed. Newton also stated that government payer exposure from Medicare and Medicaid is negligible, at less than 1% of the business.

Justin Bowers of Deutsche Bank asked for commentary on the business's seasonality and the factors driving the implied sequential decline for Q4 in the guidance. He also sought clarification on the timing for new center openings and the release of 2025 guidance.

Answer

Executive William Newton confirmed Q4 is historically the slowest quarter due to holidays and weather. Executive Matthew DiCanio added that the implied Q4 performance is expected to show stronger year-over-year growth than the first three quarters. DiCanio clarified that two new centers will open in Q4, with ten new on-site clinics ramping up through Q4 and into 2025. He also indicated that 2025 guidance would likely be issued before the Q4 earnings release.

Justin Bowers of Deutsche Bank asked if the similar Q2 growth outlook implies a divergence between segments, with Protein Sciences at low-single-digits and Diagnostics at mid-teens. He also sought confirmation on large pharma spending stability and trends within Protein Sciences' sub-businesses.

Answer

CFO Jim Hippel indicated that while the company doesn't guide by segment, the outlook suggests a gradual improvement in Protein Sciences as biotech momentum builds. He noted that Diagnostics and Spatial Biology growth could moderate from Q1's high level due to lumpiness in its OEM business. Hippel confirmed that large pharma spending has been stable sequentially since dropping off early in the calendar year, with no significant change expected until new budgets are released in 2025.

Sought clarity on GLP-1 revenue projections, including whether the sub-$100M for FY24 is incremental, the nature of the $500M+ run-rate, and if contracts have take-or-pay protections. Also asked about the gene therapy pipeline ex-Sarepta and the nature of the production ramp for the top customer.

Answer

The sub-$100M GLP-1 revenue for FY24 contributes to growth and is a second-half story. The $500M+ is a long-term outlook where capacity, not demand, is the constraint. The gene therapy pipeline ex-Sarepta is healthy with new late-stage programs. For the top customer, the company is on a productivity ramp with existing physical capacity, and progress is ahead of schedule.

Asked for a framework and timeline for returning to historical Biologics margins and the 3x target leverage level. Also sought clarification on the definition of 'normalized margins' and the composition of the COVID-19 revenue forecast.

Answer

The path to lower leverage involves growing EBITDA through improved utilization and reducing working capital. There is nothing preventing a return to historical, pre-pandemic margin levels in Biologics; it is a matter of execution over time. The COVID-19 revenue outlook does not include other respiratory program revenue.

Asked for a timeline to return to historical Biologics margins and target leverage, a clarification on what 'normalized margins' means, and whether the COVID revenue forecast includes other respiratory vaccines.

Answer

The company expects to make progress on margins through FY24 and enter FY25 with 'normalized margins,' which will in turn help the leverage ratio. 'Normalized margins' refers to pre-pandemic levels, and there is nothing preventing a return to them. The COVID revenue forecast does not include other respiratory vaccine programs.

Justin Bowers from Deutsche Bank asked about the outlook for the hospice segment, specifically regarding the stabilization of discharge rates, and requested a detailed financial bridge from Q4 2022 to Q1 2023.

Answer

EVP, CFO & Acting COO Scott Ginn confirmed that hospice discharge rates have stabilized and become more predictable, though still at a higher level than historically. He noted a more directed approach to referral sources to manage patient churn. For the Q4 to Q1 bridge, he detailed approximately $9 million in negative impacts from seasonality (fewer days, payroll tax reset, incentive plan reset), plus an additional $1.5-$2 million headwind from no longer adding back COVID costs, and the absence of a prior year's $7 million rate increase benefit.

Justin Bowers asked if labor constraints were specific to home health or also affected hospice, inquired about net hiring trends, and sought clarification on whether lower hospice ADC would lead to sequentially lower revenue.

Answer

President and CEO Chris Gerard confirmed that lower hospice ADC directly impacts revenue, though the October 1 rate increase provides a partial offset. He noted labor challenges are widespread across healthcare, not isolated to one segment, but reported that Amedisys is now seeing net clinical hiring increases in Q4. CFO Scott Ginn added that labor constraints were responsible for about 70% of the home health guidance reduction and 25% of the hospice reduction.

Justin Bowers of Deutsche Bank questioned the utilization dynamics in both home health and hospice, the reasons for the updated revenue guidance, and the status of the ZPIC audit accrual.

Answer

President and CEO Chris Gerard attributed the lower revenue outlook to softness in both segments: Hospice ADC was impacted by high Q1 discharge rates, and Home Health saw a shift from fee-for-service to lower-revenue Medicare Advantage. EVP and CFO Scott Ginn explained the ZPIC accrual adjustment was based on recent ALJ findings from a 2017 audit of a 2015 acquisition. He noted that strong cost control allows the company to reiterate its full-year EBITDA and EPS guidance despite top-line pressure.

Justin Bowers from Deutsche Bank asked how the Contessa acquisition has influenced discussions with Medicare Advantage plans and the company's ability to offer innovative, bundled products. He also inquired about the M&A environment and valuation multiples for smaller operators.

Answer

CEO Chris Gerard responded that Contessa's capabilities have directly led to new opportunities, including a risk-based palliative care model with a Medicare Advantage plan, with another significant deal expected soon. Regarding M&A, he noted that while the challenging environment is pressuring smaller operators, a significant fallout has not yet materialized, but he anticipates future roll-up opportunities for larger players like Amedisys.