Jack Meehan

Jack Meehan asked about the core industrial segment, specifically how to reconcile signs of life in PMI with the Q1 flat growth guide, inquiring about any timing dynamics. He also asked about the drop-through to the margin line if incremental organic growth were to materialize in core industrial.

Answer

CFO Shawn Vadala explained that the Q1 flat guide for core industrial reflects a step-down from H2 2025, as this business has more sensitivity to the economy and a lag in seeing PMI improvements. He noted that about 60% of core industrial serves pharma, biopharma, food manufacturing, and chemical, with the chemical sector currently under pressure. He also assumed typical company caution in releasing funds at the start of the year. Regarding drop-through, Shawn Vadala stated it would be around the corporate average, with faster-growing automation and digitalization sectors being above average, while more cyclical parts of the portfolio would be below average.

Jack Meehan asked about the core industrial segment's flat Q1 guide despite positive PMI trends, inquiring about timing dynamics, and the drop-through to margin if incremental organic growth were to materialize in core industrial.

Answer

CFO Shawn Vadala explained the Q1 step-down for core industrial, noting its sensitivity to the economy, a lag for PMI trends, and pressure in the chemical sector. He assumed typical Q1 caution from companies. He stated that the drop-through to margin for core industrial would be around the corporate average, with automation/digitalization segments being above average and more cyclical parts below average.

Jack Meehan from Nephron Research asked if there were any pull-forward dynamics that may have benefited the second quarter results. He also requested further elaboration on the timing issues that impacted the service business.

Answer

CEO Patrick Kaltenbach stated there were no indications of any customer pull-forwards in Q2, attributing the strong results to the company's competitive product portfolio. He reiterated that the service business timing issue was primarily related to the quarterly transition of larger service projects and some spare parts orders, emphasizing it is not an underlying trend and that the outlook for the second half remains positive.

Jack Meehan of Nephron Research questioned whether there was any evidence of customers pulling forward orders in Q1 or April in anticipation of tariffs. He also requested more color on the performance of the Process Analytics business within the Laboratory segment.

Answer

CEO Patrick Kaltenbach stated that the company has not observed any meaningful customer pull-forward related to tariffs. He also confirmed strong growth in the Process Analytics business, highlighting a healthy recovery in demand for single-use sensors as biopharma customers have worked through previous inventory overstocking.

Jack Meehan of Nephron Research inquired about the outlook for the core Industrial business given recent positive macro indicators like the PMI, and asked for clarification on the drivers behind the increase in the 2025 EPS forecast.

Answer

CEO Patrick Kaltenbach cautioned against directly linking core Industrial performance to PMIs, pointing to persistent softness in China. CFO Shawn Vadala reiterated the low-single-digit growth forecast for core Industrial in 2025. Regarding the EPS guidance increase, Mr. Vadala explained it was driven by the Q4 beat, which was partially offset by negative foreign exchange, but benefited from lower interest expense and higher other income assumptions.

Jack Meehan questioned the conservatism in the Q4 revenue guidance, noting the implied sequential growth is below historical norms, and asked about expectations for a year-end budget flush.

Answer

CFO Shawn Vadala acknowledged the Q4 sequential growth forecast is more cautious than the historical 10% average, attributing it to general market softness, particularly in China. As a result, he stated the company is not counting on a significant year-end budget flush from customers, citing mixed signals of ongoing activity alongside continued project delays.

Jack Meehan from Nephron asked about the potential impact of competitors' $100 genome price point headlines on Illumina, particularly how the company plans to address such competitive pricing claims and if it affects Illumina's own pricing strategy, given its current list pricing and discounts.

Answer

CEO Jacob Thaysen stated that Illumina looks forward to AGBT, where competitors will present their best, but emphasized that Illumina's customers consider more than just one parameter, focusing on the full workflow. He asserted that Illumina has the portfolio, pipeline, and capability to compete on all parameters and is open to addressing market segments with different price points if there's significant elasticity, engaging in regular conversations with customers on this topic.

Jack Meehan followed up on the AGBT discussion, asking about the competitive landscape, specifically how Illumina plans to address investor concerns regarding competitors touting a $100 price point per genome, and what this could mean for Illumina's pricing strategy.

Answer

CEO Jacob Thaysen stated that AGBT will see competitors present their best, but Illumina's customers consider more than just one parameter, focusing on the full workflow. He expressed confidence in Illumina's portfolio and pipeline to compete on all parameters and noted the company is open to addressing market segments with different price points if significant elasticity exists.

Jack Meehan of Nephron Research inquired about the impact of geopolitical tariff dynamics on customer demand, asking if there was any evidence of purchasing behavior changes in the first quarter or since the tariffs were officially announced.

Answer

CEO Jacob Thaysen stated that Illumina did not see any material change in customer purchasing behavior related to tariffs in Q1 or in Q2 to date, outside of some minor pull-in within China due to concerns about local developments. CFO Ankur Dhingra added that while there was no past impact, the company's forward-looking guidance anticipates some demand impact for the remainder of the year.

Jack Meehan asked Thierry Bernard for comments regarding recent headlines about QIAGEN being a potential deal target.

Answer

Thierry Bernard (CEO, QIAGEN) acknowledged market consolidation and stated QIAGEN's focus on executing its 2024-2028 plan (7% CAGR, 31% EBIT margin, $2 billion from growth pillars). He reiterated that the company does not comment on rumors but remains open to discussions that could create shareholder value.

Jack Meehan inquired about QIAGEN's stance on recent headlines regarding its potential as a deal target and sought an update on the ongoing CEO succession search.

Answer

Thierry Bernard (CEO) addressed rumors of QIAGEN being a deal target by stating the market is consolidating and QIAGEN is focused on its 2024-2028 plan (7% CAGR, 31% EBIT margin, $2B from growth pillars), while remaining open to value-creating discussions. Regarding CEO succession, he confirmed an ongoing external and internal search, emphasizing the need to find the best candidate and assuring that current management remains fully dedicated.

Jack Meehan asked about the full-year operating margin forecast of approximately 30%, seeking details on the interplay between tariff impacts, foreign exchange, and operational factors.

Answer

CFO Roland Sackers confirmed the strong Q2 margin performance and stated that the full-year tariff headwind is expected to be around 90 basis points on the adjusted gross margin, though mitigation efforts are ongoing. He expressed confidence in the outlook, noting that while they aim for 30%, it might be a tick lower, but still represents significant year-over-year improvement and supports the strong $2.35 EPS target.

Jack Meehan asked about the drivers of the strong 14% growth in the PCR Technologies segment, noting it implied very high growth outside of QIAcuity. He also questioned if the prior $105 million target for QIAcuity was now a stretch due to the instrument environment.

Answer

CEO Thierry Bernard attributed the strong PCR performance to two factors: continued market share gains in digital PCR (QIAcuity) and a particularly strong quarter for OEM sales, which he noted can be variable. While acknowledging the challenging capital sales environment, he reaffirmed the long-term ambition for QIAcuity to exceed $200 million by 2028, emphasizing its market share gains and strong consumable growth.

Jack Meehan asked about the industry supply and demand dynamics for Thermo Fisher Scientific's Pharma Services business within the Laboratory Products and Biopharma Services (LPBS) segment for 2026, and what is reflected in the guidance. He also questioned the competitive advantage of the channel business, its stability, and the impact of recent investments.

Answer

Marc Casper, Chairman, President, and CEO, stated that the Pharma Services business is executing well, particularly in sterile fill-finish where demand is heightened relative to capacity, partly addressed by the Sanofi site acquisition. He expects continued growth for this business. Regarding the channel business, he noted its consistent strong performance, excellent supplier partners, and methodical share gains across pharma, biotech, and industrial customers, with stable share in academic and government despite market pressures.

Jack Meehan asked about the industry supply and demand dynamics for the Pharma Services business within the Laboratory Products and Biopharma Services (LPBS) segment entering 2026, and what is reflected in the guidance. He also questioned the competitive performance of the channel business and whether its competitive advantage is stable or expanding.

Answer

Marc Casper, Chairman, President, and Chief Executive Officer, stated that the Pharma Services business is executing very well, particularly in sterile fill-finish where demand is heightened, leading to strategic acquisitions like the Sanofi site. He expects this business to be a significant long-term growth contributor. For the channel business, he noted consistent strong performance, an excellent portfolio, and broad-based strength across pharma/biotech and industrial customers, indicating stable competitive dynamics and continued methodical share gains.

Jack Meehan asked for an update on the 2026 outlook, specifically regarding the progression towards the 3-6% organic growth target, and how recent MFN agreements and market conditions align with this view. He also followed up on the clinical research business, seeking color on trends, new authorizations, pharma customer sentiment on trials, and the traction of the Accelerator Drug Development solution and OpenAI collaboration.

Answer

Chairman, President, and CEO Marc Casper reaffirmed confidence in the 3-6% midterm organic growth, noting MFN agreements were as expected. He explained that the current 2% organic growth (3% ex-COVID runoff) would improve with stabilization in academic/government and China, plus share gains. Senior Vice President and CFO Stephen Williamson added details on a 2026 FX tailwind and the impact of recent M&A. For clinical research, Mr. Casper highlighted strong execution, stepped-up revenue growth (low single-digit vs. Q2's slightly positive), and strong authorizations. He emphasized the significant business wins and customer resonance of the Accelerator Drug Development solution, especially with biotech, and the value of the OpenAI collaboration in improving trial cycle times and leveraging data.

Jack Meehan asked for Marc Casper's latest perspective on the company's 2026 outlook, particularly regarding the progression towards the 3% to 6% organic growth target, based on recent customer dialogues and market observations. He also followed up on the clinical research business, seeking additional color on trends, new authorizations, pharma customer sentiment regarding trials, and the traction of the Accelerator Drug Development program.

Answer

Marc Casper (Chairman, President and CEO) reaffirmed strong confidence in the midterm outlook of 3% to 6% organic growth with robust operating margin and income growth, noting that the current 2% organic growth effectively starts at 3% when accounting for the non-recurring 1% COVID runoff headwind. He anticipates academic/government stabilization and China stabilization to further boost growth. Stephen Williamson (SVP and CFO) added that 2026 could see a couple hundred million dollars in FX tailwind and detailed the financial implications of recent acquisitions, including the Solventum filtration business and Sanofi sterile fill-finish site. For clinical research, Mr. Casper reported strong execution, with Q3 revenue growth stepping up to low single digits and authorizations well ahead. He highlighted the Accelerator Drug Development program's strong adoption, especially in biotech, and the OpenAI collaboration's role in improving clinical trial cycle times and leveraging data.

Jack Meehan asked for an update on the biopharma manufacturing reshoring trend and whether it caused any customer purchasing pauses in Q2. He also questioned if the organic growth decline in Analytical Instruments was solely due to academic markets or if pressure was seen from pharma and biotech as well.

Answer

CEO Marc Casper confirmed heightened interest in U.S. manufacturing expansion, citing the Sanofi deal as an example, and stated it is a future tailwind with no evidence of purchasing pauses. He clarified the Analytical Instruments pressure was from academic/government and the tariff environment, not pharma, and highlighted that strong innovation like the new AstroZoom mass spectrometer is driving a 'phenomenal' order book and continued share gains.

Jack Meehan asked about the risks and opportunities related to potential pharmaceutical tariffs and what the company is hearing from customers. He followed up by asking about the Pharma Services business's stage in its post-COVID recovery and where customer demand is concentrated.

Answer

CEO Marc Casper noted that while pharma tariffs are not yet formalized, customers are planning, and Thermo Fisher is seeing high demand for its U.S. manufacturing capabilities, prompting a $2 billion investment. He confirmed the Pharma Services business has fully backfilled its COVID-related capacity with new contracts and is now ramping up production, with the strongest demand seen in drug product services like fill-finish.

Jack Meehan inquired about the phasing of services revenue in 2025, the specific guidance assumptions for the PPD clinical research business, current trends in new authorizations, and the company's confidence in returning to its long-term growth targets.

Answer

Stephen Williamson, SVP and CFO, clarified that Q1 phasing is affected by fewer selling days and a more pronounced pandemic revenue runoff. Marc Casper, Chairman, President and CEO, added that the clinical research business saw strong authorizations in H2 2024, which bodes well for late 2025 and 2026. Management expressed confidence in returning to long-term growth rates as the market continues to improve.

Jack Meehan asked about the intra-quarter performance, noting that core organic growth was flat versus the Street's 1% expectation, and questioned if September was weak. He also asked why the full-year guidance range was not narrowed.

Answer

Marc Casper, Chairman, President and CEO, responded that the quarter's growth was largely in line with the company's internal expectations and that there were no significant patterns, aside from minor softness in academic and government at the very end of the quarter. Stephen Williamson, CFO, added that the guidance range was kept for simplicity and advised focusing on the midpoint, noting the largest variable for Q4 is year-end customer spending.

Jack Meehan (Nephron Research) probed the life sciences guidance, specifically using Q4 2025 as a baseline for 2026, asking if year-end budget flushes influenced Q4 results and what sustainable trends could be built upon. He also sought further clarification from Matt McGrew, Executive Vice President and Chief Financial Officer, on the margin puts and takes for 2026, including the $250 million cost actions, biotechnology growth, and BBP, to understand the path to 100 basis points or more margin expansion.

Answer

Rainer Blair, President and CEO, noted Q4 life sciences performance was slightly above expectations, driven by SCIEX and Beckman Coulter Life Sciences, with a modest budget flush in Europe. He anticipates continued improvement in pharma, stable clinical/applied markets, and eventual moderation in academic/government. Matt McGrew, Executive Vice President and Chief Financial Officer, outlined the EPS guide ($8.35-$8.50) based on 3%-4% core growth, 35%-40% fall-through, and a $0.30 benefit from 2025 cost actions, suggesting upside potential if core growth exceeds this range.

Jack Meehan pressed on the life sciences guidance assumptions, specifically whether Q4's performance was an elevated base due to push-outs from earlier in the year, and what aspects could be built upon for 2026. He also asked CFO Matt McGrew for more detail on the margin puts and takes for 2026, including the $250 million cost actions, bioprocessing growth, and VBP impacts, to understand the drivers for the expected 100+ basis points of margin expansion.

Answer

CEO Rainer Blair indicated continued improvement in the pharma end market, with clinical and applied markets remaining stable. Academic and government demand was muted but expected to moderate over time, contributing to a gradual improvement in life science end markets through 2026. CFO Matt McGrew outlined the EPS guide, assuming low-end core growth (3%-4%) with 35%-40% fall-through, and a $0.30 benefit from 2025 cost actions, which is inclusive of the 100 basis points margin expansion. He noted that below-the-line items like FX were assumed to net to zero, with potential EPS upside if core growth exceeds the initial assumption.

Jack Meehan focused on the diagnostics business, noting Q3 sales were about $60 million higher than consensus, with $200 million upside from respiratory. He asked what might have fallen short compared to street expectations, given positive commentary on Beckman Coulter, China, and Leica. He also followed up on the biotechnology business, asking about the dialogue on reshoring, the billions discussed in U.S. manufacturing, and how this might play out over the next few years for both capital demand and recurring revenue.

Answer

Matt McGrew (EVP and CFO) clarified that the Q3 diagnostics beat was primarily due to respiratory revenue being pulled forward ($125 million), with customers purchasing earlier than expected, and nothing else fell short. Rainer Blair (President and CEO) reiterated that reshoring/regionalization will lead to continued capital equipment investment, starting with brownfield projects and then larger greenfield investments over several years, potentially creating an extended capital cycle. He noted that while discussions are active, this hasn't yet translated into stronger order patterns.

Jack Meehan focused on the diagnostics business, noting that Q3 sales were significantly higher than consensus, with a substantial upside from respiratory revenue. He asked if anything specific fell short of street expectations, given the positive performance in Beckman Coulter (ex-China) and Leica. He also followed up on the biotechnology business, inquiring about the ongoing dialogue regarding reshoring, how the billions of dollars in U.S. manufacturing investments might play out over the next few years, and the implications for both capital demand and recurring revenue.

Answer

Matt McGrew, Executive Vice President and CFO, clarified that the diagnostics upside was primarily due to approximately $125 million in respiratory revenue pull-forward, as customers purchased earlier than typical, with no other specific shortfalls to highlight. Rainer Blair, President and CEO, discussed reshoring, stating that while specific numbers are hard to quantify, it is expected to drive continued capital equipment investment. He anticipates an initial focus on brownfield investments to quickly establish capacity and demonstrate regional commitment, followed by larger, longer-term greenfield projects. This trend could lead to an extended capital cycle over several years, though it has not yet translated into a significant increase in orders.

Jack Meehan asked for details on the 2025 guidance for the Life Sciences segment, questioning the pacing of the expected recovery and the timing for a return to growth. He also inquired about how the new U.S. administration and academic funding environment influenced the forecast.

Answer

President and CEO Rainer Blair stated the company took a prudent approach, expecting life science tools to be up low-single digits while Pall and genomics would be down. EVP and CFO Matt McGrew detailed the pacing, projecting a mid-single-digit decline in Q1, becoming flattish in Q2 before ramping up, citing a tough Q1 comparison for Pall. Regarding the political environment, management acknowledged potential 'puts and takes' and incorporated the 'noise' around the segment into their cautious initial guidance.

Jack Meehan asked about the diagnostics business in China, seeking to confirm its revenue contribution and to understand the performance of Beckman Coulter in the region, which he estimated could be down significantly. He also asked if the regional dynamics were driven more by price impacts or by shifts in market share.

Answer

EVP and CFO Matt McGrew confirmed the total China diagnostics revenue percentage was in the right ballpark but corrected that the decline for Beckman was in the low double-digits, not as high as suggested. President and CEO Rainer Blair added that clinical diagnostics performed strongly globally with the exception of China, where the impact of volume-based procurement (VBP) was the primary headwind. He noted high single-digit recurring revenue growth in North America and Europe, attributing the China issue to VBP rather than share shifts.

Jack Meehan asked about the competitive dynamics in the LC business, specifically the Q4 growth number for LC and LCMS instruments within the Life Sciences and Diagnostics Markets Group (LDG), and how that business is performing in other end markets.

Answer

President and CEO Padraig McDonnell reported low double-digit growth in LC and mid-teens growth in LCMS for Q4, indicating an accelerating replacement cycle driven by Infinity III adoption and market share gains. He attributed this to innovation, execution, improving pharma sentiment, and global reshoring. President of the Life Sciences and Diagnostics Markets Group Simon May added that food saw mid-single-digit growth, environmental and forensics grew in the 20s, and Pro iQ market acceptance was strong, with significant potential remaining in the replacement cycle.

Jack Meehan asked for more details on the competitive dynamics within the LC business, specifically the double-digit growth in the second half for LC and LCMS instruments in the Life Sciences and Diagnostics Markets Group (LDG), and how this business is performing in other end markets beyond pharma.

Answer

President and CEO Padraig McDonnell reported low double-digit growth in LC and mid-teens growth in LCMS for Q4, indicating an accelerating replacement cycle and market share gains driven by innovation like Infinity III and ProIQ LCMS. Simon May, President of the Life Sciences and Diagnostics Markets Group, added that food saw mid-single-digit growth, A&G declined, and environmental and forensics grew in the 20s, with continued strong traction for Infinity III and ProIQ, suggesting the replacement cycle is still in its early to mid-innings.

Jack Meehan of Nephron Research asked about the influence of tariffs on customer buying behavior, including any inventory stocking, and inquired about Agilent's exposure to the China diagnostics market amid VBP policies.

Answer

CEO Padraig McDonnell and Angelica Riemann, President of the CrossLab Group, confirmed that a consumable pull-forward from Q2 had normalized and there was no evidence of further stocking. Regarding China, McDonnell and Simon May, President of Life Sciences & Diagnostics, stated that Agilent's exposure is 'very low' and the impact from VBP is minimal as their products serve more advanced, esoteric applications.

Jack Meehan of Nephron Research asked if trade tariff dynamics influenced customer buying behavior, specifically regarding the previously mentioned consumable pull-forward, and inquired about Agilent's exposure and the impact of VBP/DRG policies in the China diagnostics market.

Answer

President and CEO Padraig McDonnell stated there were no new pull-forwards or stocking behaviors observed in Q3, noting lab activity remains strong. Angelica Riemann, President of the CrossLab Group, confirmed the Q2 pull-forward had resolved and that Q3's mid-single-digit consumables growth showed no signs of further stocking. On China diagnostics, McDonnell and Simon May, President of the Life Sciences and Diagnostics Markets Group, explained that Agilent's exposure is very low and stable, with minimal impact from VBP as their offering serves more advanced, esoteric staining applications.

Jack Meehan of Nephron Research sought clarification on the $15 million consumables revenue pull-forward in China, asking about customer motivations and if the guidance assumes a recapture of delayed instrument revenue. He also asked for the implied full-year operating margin outlook.

Answer

CFO Bob McMahon explained that Chinese customers stocked up on in-country consumables to get ahead of potential tariffs, an effect that was offset by instrument shipment delays at customs. He confirmed the guidance assumes this timing impact reverses in Q3. McMahon stated that full-year operating margins are now expected to be closer to flat year-over-year due to absorbing tariff costs, though underlying performance remains strong and full mitigation is expected in FY2026.

Jack Meehan inquired about recent changes to Agilent's management layers and any associated cost savings. He also requested an update on the BIOVECTRA acquisition, its Q1 sales, and its full-year target.

Answer

CEO Padraig McDonnell explained the changes are part of the 'Ignite' transformation to become nimbler, with associated cost reductions baked into the guide. On BIOVECTRA, President of Life Sciences and Diagnostics Simon May noted that while Q1 revenue was slightly soft due to a focus on operational integration, they are holding to the previous full-year guidance.

Jack Meehan requested the fiscal 2025 growth guidance for each of the legacy business segments and asked for more detail on expectations for the LC and LCMS business, including any contribution from GLP-1 applications.

Answer

CFO Robert McMahon provided the legacy segment guidance for FY25: LSAG at low-single digits, ACG at mid-to-high single digits, and DGG at low-to-mid single digits. CEO Padraig McDonnell addressed the LC/LCMS outlook, noting improving orders and excitement for the new Infinity III but maintaining a conservative forecast on the replacement cycle. He highlighted that the GLP-1 business grew 30% in fiscal 2024 and will be further supported by the BIOVECTRA acquisition.

Jack Meehan from Nephron Research LLC requested a breakdown of instrument performance across key categories like LC, LC/MS, GC, and spectroscopy. He also asked for color on the Chemical and Advanced Materials (CAM) end market's 5% decline and what areas softened relative to expectations.

Answer

CEO Padraig McDonnell noted that while instrument funnels are stable, deal closure rates remain elevated. CFO Bob McMahon specified that within instruments, LC and LC/MS were down in the mid-teens, while spectroscopy performed better. Regarding the CAM market, McDonnell attributed the decline to overproduction in China impacting global investment, which led to a 14% drop in instruments, though this was partially offset by a 7% increase in combined services and consumables revenue.

Jack Meehan requested more detail on instrument performance across major categories like LC, LC/MS, and GC. He also asked about the drivers of the 5% decline in the Chemical and Advanced Materials (CAM) end market.

Answer

CEO Padraig McDonnell and CFO Bob McMahon provided color. Mr. McMahon specified that within the low-double-digit decline for LSAG instruments, LC and LC/MS were down mid-teens while spectroscopy performed better. For the CAM market, Mr. McDonnell explained the decline was primarily due to overproduction in China, which negatively impacted global market investments, although services and consumables in the segment grew a combined 7%.

Jack Meehan of Nephron Research asked for the new sales outlook for the NASD business for the year and how the company is bridging to its longer-term targets. He also sought clarification on whether the new $100 million cost savings program is incremental and where the savings will originate.

Answer

CEO Padraig McDonnell noted a shift in the NASD business to 75% clinical, with an 'air pocket' in Q3 due to IRA-related pharma strategy shifts, but highlighted 50% growth in clinical orders. CFO Bob McMahon revised the full-year NASD outlook to roughly $300 million from $350 million but affirmed the long-term view is unchanged. McMahon also confirmed the $100 million in annualized savings is incremental and primarily headcount-related.

Jack Meehan asked about the performance of the genomics business within DGG and when a turnaround might be expected. He also inquired about the stability and durability of the academic end market, particularly in the U.S.

Answer

CEO Michael McMullen and CFO Robert McMahon described the genomics business as a 'tale of two cities.' The NGS QC portfolio grew mid-single digits, while the genomics chemistry business was down due to tough comps, with improvement expected in H2. Regarding the academic market, McMullen noted its 2% growth was a bright spot, driven by stable global funding from both public and private sources, and expressed optimism for the rest of the year.

Jack Meehan of Nephron Research requested a breakdown of the LSAG segment's quarterly growth between instruments and consumables. He also followed up on the book-to-bill commentary, asking if the ratio being above one was simply a mathematical result of a difficult revenue comparison.

Answer

CFO Robert McMahon reported that within LSAG, consumables performed better than instruments, declining low-single digits versus a much steeper drop for instruments. He clarified that while orders were down year-over-year, they were down less than revenue, and viewed the steady progression of the book-to-bill ratio as a genuine sign of market stabilization, not just a mathematical artifact. CEO Michael McMullen reiterated this point, emphasizing the market is stabilizing, not worsening.

Jack Meehan inquired about the latest thoughts on revenue synergies from the BD transaction and the potential impact of the recent FDA update on biosimilars for analytical assessments, particularly for Waters' LCMS systems.

Answer

CEO Udit Batra expressed confidence in the BD transaction after customer visits and integration planning, highlighting opportunities with BD FACSDiscover S8/A8 and Kiestra platform. He also noted the significant upside from the FDA's draft guidance on biosimilars, which shifts towards analytical testing over clinical studies, aligning with Waters' bioseparations and bioanalytical portfolios. CFO Amol Chaubal affirmed confidence in both revenue and cost synergy assumptions, expecting EPS accretion in the first 12 months post-transaction, driven by improved service plan attachment, new customer segments, and pricing discipline.

Jack Meehan asked for an update on the BD transaction, specifically regarding confidence in revenue synergies, and sought clarification on the implications of the recent FDA update on biosimilars for analytical assessments using LC-MS for Waters.

Answer

President and CEO Udit Batra shared positive customer feedback on BD's FACSDiscover S8 and A8 and Kiestra platform, confirming integration planning progress. CFO Amol Chaubal emphasized confidence in achieving EPS accretion in the first 12 months post-transaction, citing immediate synergies like improved service plan attachment and pricing discipline. Udit Batra expressed excitement about the FDA guidance shift towards analytical testing for biosimilar approval, seeing it as a significant volume growth opportunity for Waters' bioseparations and bioanalytical portfolios.

Jack Meehan of Nephron Research LLC inquired about the drivers of high single-digit growth in the Waters instrument segment, focusing on the LC replacement cycle and competitive wins for the Alliance IS platform. He also asked about the BD acquisition, specifically the timeline and strategy for developing a mass spectrometry product for the microbiology market.

Answer

President and CEO Dr. Udit Batra confirmed that LC/MS growth was strong in pharma and industrial segments, driven by a robust replacement cycle in large pharma and CDMOs, and aided by 300% growth in Alliance IS sales. He highlighted the new TQ Absolute XR's success in penetrating DMPK labs. Regarding the BD deal, Dr. Batra stated that the microbiology mass spec opportunity is a 3-5 year project not included in the deal model. SVP & CFO Amol Chaubal added that the biologic sterility opportunity could have an even earlier impact.

Jack Meehan of Nephron Research LLC inquired about the drivers of the high single-digit growth in Waters' instrument segment, focusing on the LC replacement cycle and competitive dynamics. He also asked about the timeline and strategy for bringing a mass spectrometry product for microbiology to market following the pending BD acquisition.

Answer

President and CEO Dr. Udit Batra attributed the strong LC/MS growth to the ongoing pharma replacement cycle, particularly with large pharma and CDMO customers, and the success of new products like the Alliance iS and TQ Absolute XR. Regarding the BD deal, Dr. Batra clarified that the mass spec for microbiology opportunity is not included in the deal model, estimating a product could take 2-5 years to develop. SVP & CFO Amol Chaubal added that the biologic sterility opportunity with BD is also significant and could materialize sooner.

Jack Meehan of Nephron Research inquired about the dynamics of the instrument replacement cycle in pharma, any changes in customer behavior related to tariffs, and the updated full-year 2025 instrument forecast.

Answer

CEO Udit Batra confirmed strong, double-digit instrument growth in Q1, driven by a robust replacement cycle in large pharma, generics, and CDMOs, with no evidence of order pull-forwards due to tariffs. CFO Amol Chaubal added that the full-year guide was only adjusted to derisk the small U.S. Academic & Government segment, with the impact offset by tariff-related surcharges.

Jack Meehan asked for more details on the site consolidation in the early development business, including market factors driving the decision and the expected earnings impact.

Answer

Chairman and CEO Adam Schechter explained that while biopharma laboratory services (BLS) performed well, driven by central laboratories, early development showed weakness due to delayed study starts. The decision to divest or consolidate approximately $50 million in annual revenue from non-core early development areas is expected to result in a slight increase in operating income, as these areas were negatively impacting accretion.

Jack Meehan of Nephron Research sought more details on the site consolidation and divestiture plans within the early development business, including the market factors leading to this decision and the expected earnings impact from the $50 million annual revenue adjustment.

Answer

Chairman and CEO Adam Schechter explained that the actions, impacting approximately $50 million in annualized revenue from non-core areas, were a response to lower-than-anticipated revenue in early development due to delayed study starts, despite stable RFP numbers and win rates. He anticipates a slight increase in operating income as these areas were negatively impacting accretion.

Jack Meehan from Nephron Research asked for an update on the Invitae acquisition as it approaches its one-year anniversary, focusing on revenue performance, market dynamics, and the path to profitability.

Answer

President, CEO, and Chairman Adam Schechter expressed high confidence, stating the integration is proceeding 'extremely well' and that the business remains on track for 10% revenue growth and to be slightly accretive for the full year. EVP & CFO Julia Wang added that enterprise margins expanded 20 basis points despite a 30 basis point headwind from Invitae, indicating strong underlying performance and setting the stage for full-year margin growth.

Jack Meehan questioned the financial path for Invitae to become accretive for the year, asking for clarification on its Q1 EBIT impact. He also inquired about the current lab M&A environment and expected pace of deals.

Answer

CEO Adam Schechter and CFO Julia Wang reiterated that the Invitae integration is progressing well and is on track to be slightly accretive for the full year, with the financial contribution expected to turn positive in the second half. On M&A, Schechter described the pipeline as 'very strong,' noting that macroeconomic pressures on health systems are increasing inbound interest, and he expects to announce more deals in coming quarters.

Jack Meehan of Nephron Research asked for an update on Labcorp's M&A pipeline and capital allocation priorities, given strong cash flow and leverage just over 2x. He also asked for new CFO Julia Wang's initial impressions and her view on the Invitae integration.

Answer

CEO Adam Schechter confirmed a strong M&A pipeline, particularly in hospital and regional lab deals, and reiterated a balanced capital allocation strategy prioritizing dividends, strategic M&A, and share buybacks. CFO Julia Wang expressed excitement about the company's compelling growth profile and culture. Schechter added that the Invitae integration is proceeding very well and remains on track financially, expecting it to be slightly accretive for the full year 2025.

Jack Meehan requested the specific revenue contribution from Invitae in the quarter, asked about early competitive dynamics in the hereditary testing market post-acquisition, and inquired about the interest expense forecast for 2024 and 2025 following recent debt refinancing.

Answer

CFO Glenn Eisenberg confirmed that Invitae's revenue was in line with expectations, validating the analyst's estimate of around $45 million. CEO Adam Schechter noted that while it's early, the integration is going well and customer response is positive, with a goal to grow at the market rate of about 10%. Regarding interest expense, Glenn Eisenberg stated that due to successful refinancing, the absolute interest expense should be slightly better than the previously guided $210 million for 2024 and $240 million for 2025.

Jack Meehan requested more color on the level of pass-throughs, asking for metrics as a percentage of gross revenue for 2024 and 2025, and how the backlog might shift this in 2026, to understand where gross margins might bottom out.

Answer

CFO Nigel Clerkin stated that ICON reports revenue in aggregate and does not break out pass-throughs and direct fees quantitatively, offering only qualitative commentary. CEO Barry Balfe added that business mix, particularly significant shifts in pass-through-heavy therapeutic areas like cardiometabolic, impacts pass-through load. He noted that while these are good for gross bookings and future direct fees, they require careful consideration for margin outlook.

Jack Meehan asked for more color on the level of pass-throughs, specifically as a percentage of gross revenue in 2024 versus 2025, and how the backlog might shift this in 2026, seeking insight into a potential gross margin floor.

Answer

CFO Nigel Clerkin stated that ICON plc reports revenue in aggregate and does not break out pass-throughs and direct fees, offering only qualitative commentary on the increasing proportion of pass-throughs. He declined to provide 2026 margin guidance. CEO Barry Balfe added that significant shifts in pass-through-heavy therapeutic areas like cardiometabolic have increased RFP activity and awards, impacting the pass-through load.

Jack Meehan from Nephron Research LLC asked for commentary on market share dynamics within the CRO industry and any color on ICON's win rates.

Answer

CEO Steve Cutler stated that while it's difficult to be quantitative, he senses ICON is successfully moving its market share forward. He pointed to broad-based gross wins and strong growth in key areas like the biotech segment, FSP business, early phase, and labs as indicators that the company is gaining share across its service lines.

Jack Meehan of Nephron Research inquired about the potential direct impact of tariffs on ICON's business, particularly in labs, and what the company is hearing from clients about broader pharmaceutical tariffs.

Answer

CEO Dr. Steve Cutler stated he does not foresee a material impact on ICON's services business, though lab kits could be slightly affected. Regarding pharmaceutical tariffs, he noted that it is too early to speculate on the potential flow-down impact, mentioning recent reports of delayed implementation by the White House.

Jack Meehan asked about the company's visibility into its 2025 revenue forecast, specifically requesting a revenue coverage statistic, and what book-to-bill ratio is necessary to achieve the financial forecast.

Answer

An executive declined to provide a specific revenue coverage percentage, citing the market uncertainty and the early stage of the year. CEO Dr. Steve Cutler reiterated that the company is targeting a book-to-bill ratio of at least 1.2x on a trailing 12-month basis, acknowledging that there will likely be some quarterly volatility in achieving this target.

Jack Meehan questioned if large pharma pressure was related to customers reassessing their high concentration of work with ICON post-PRA acquisition and asked for quantification of the margin drag from growing pass-throughs.

Answer

CEO Dr. Steve Cutler acknowledged that in one or two cases, customers did bring in another competitor to diversify after the PRA union, which was an expected outcome. Outgoing CFO Brendan Brennan clarified his earlier comment, stating the change in pass-throughs affects the timing of cash flow (fewer upfront payments) but not the absolute quantum in the revenue mix, so it does not create an additional drag on revenue growth or margins.

Jack Meehan inquired about the strong cash flow conversion and the increased guide to $1.8 billion, asking about any one-time factors beyond the CARES Act payment, to understand the appropriate baseline for 2026 cash flow.

Answer

CFO Sam Samad confirmed that the strong cash flow, with an increased guide to $1.8 billion, includes one-time benefits that are not expected to repeat in 2026. These include a $46 million CARES Act payment and an additional $100-$130 million from recent tax legislation related to accelerated bonus depreciation and R&D expensing. CEO Jim Davis added that the growing consumer channel, being a direct cash business with upfront payments and no bad debt, also contributes positively to cash flow timeliness and certainty.

Jack Meehan questioned the strong cash flow conversion and the increased $1.8 billion guide, asking about one-time benefits beyond the CARES Act payment and the appropriate baseline for 2026 cash flow.

Answer

CFO Sam Samad confirmed strong cash flow, noting the $46 million CARES Act payment as a one-time benefit not expected to repeat. He also identified $100-$130 million in one-time cash tax benefits in 2025 from recent tax legislation (accelerated bonus depreciation and R&D expensing) that won't have the same magnitude in 2026. CEO Jim Davis added that the growing consumer channel, being a direct cash business with upfront payment and no bad debt, positively impacts cash flow timeliness and certainty.

Jack Meehan from Nephron Research LLC requested a breakdown of the M&A revenue contribution from the LifeLabs acquisition versus other deals, and asked for an update on the integration progress and expected EPS accretion.

Answer

CFO Sam Samad specified that of the 10% revenue growth from M&A, approximately 8% was from LifeLabs. He confirmed the integration is progressing well and tracking to its financial goals. CEO James Davis added that the company is realizing significant procurement and operational synergies, expressing high satisfaction with the acquisition's performance and the management team in Canada.

Jack Meehan asked for the specific year-over-year impact from weather in the quarter and sought confirmation on the expected EPS cadence for the remainder of the year.

Answer

James Davis, Chairman, CEO and President, stated that the combined year-over-year impact from weather and the leap year was 160 basis points on volume. Sam Samad, CFO, confirmed that the EPS seasonality is expected to be consistent with traditional patterns, where Q2 is the highest, followed by a step down in Q3 and Q4, with Q1 typically being the lowest quarter of the year.

Jack Meehan of Nephron Research requested an update on the Haystack MRD test, specifically asking about expectations for new clinical data releases and the progress toward securing Medicare reimbursement.

Answer

CEO Jim Davis reiterated that the company is now moving customers to full commercial arrangements and will begin the process of billing Medicare, expecting to fight initial denials to establish coverage. Regarding clinical data, he advised to 'stay tuned,' noting that several trials funded prior to the acquisition are nearing completion and could yield publications this year.

Jack Meehan requested specific financial details for the quarter, asking for the amount of COVID-19 sales and the revenue contribution from the LifeLabs acquisition versus other M&A.

Answer

CFO Sam Samad stated that COVID-19 revenue is now insignificant but had a negative 50 basis point impact on year-over-year growth. He clarified that of the total 8.5% revenue growth, M&A contributed about 4%, with the LifeLabs acquisition accounting for approximately $70 million in revenue during its five weeks in the quarter.

Jack Meehan of Nephron Research LLC inquired about the expected timing for FDA approval of the Caris Assure liquid biopsy and the potential market expansion from performing multiple tests per patient in breast cancer.

Answer

SVP & CFO Luke Power stated that while there is no specific guidance on the FDA approval timeline for Caris Assure, the strategy is to pursue approval and then an ADLT code, similar to the tissue test's path. President David Spetzler noted that the increasing use of molecular data to guide and monitor treatment will naturally expand the market by increasing the number of tests per patient.

Jack Meehan asked for the latest thinking on the timing for FDA approval of the Caris Assure liquid biopsy test and its importance for reimbursement. He also inquired about the potential market opportunity from running multiple tests per patient in breast cancer.

Answer

Luke Power, SVP, CFO & Chief Accounting Officer, stated that the company is not providing guidance on the timing of FDA approval for Caris Assure but confirmed the strategy is to pursue approval followed by ADLT status to secure reimbursement. Dr. David Spetzler, President, commented that the increasing use of molecular information to guide and monitor therapy will naturally expand the market through more frequent testing per patient.

Jack Meehan of Nephron Research inquired about the expected timing for FDA approval of the Carus Assure liquid biopsy and the potential market expansion from performing multiple tests per patient in breast cancer.

Answer

SVP & CFO Luke Power stated that while the company is not guiding on a specific timeline, the strategy for Carus Assure is to pursue FDA approval followed by ADLT status to secure reimbursement. President David Spetzler agreed that the use of molecular testing to monitor therapy response will naturally increase test utilization per patient, expanding the overall market.

Jack Meehan inquired about the progress in clinical customer adoption, asking for an estimate of the clinical mix of consumables revenue and its growth rate. He also asked about the dynamics of Revio's revenue pull-through and the impact of the new Spark chemistry rollout.

Answer

President and CEO Christian Henry stated that clinical customers now represent roughly 15% of consumable revenue, a figure that is growing and expected to be a key driver. CFO Jim Gibson added this figure excludes translational research. Henry explained that Q2 Revio pull-through was more normalized after a Q1 boost from a large order in Japan. He noted the Spark chemistry, now over 90% adopted, improves throughput and any impact on pull-through will normalize quickly.

Jack Meehan of Nephron Research asked for expectations on Revio and Vega placements implied in the 2025 guidance and questioned if PacBio would consider monetizing its paused short-read sequencing assets.

Answer

Christian Henry, President and CEO, stated that while specific unit numbers will not be provided, the company expects Revio shipments to be down year-over-year, but Vega placements are expected to grow significantly. Regarding the short-read platform, Henry confirmed that PacBio is prioritizing its long-read technology and is evaluating all alternatives for the short-read assets, including potential monetization.

Jack Meehan asked for more detail on the new Vega system, specifically the revenue recognized from the seven units shipped in Q4 and the state of the order book and placement assumptions for 2025.

Answer

President and CEO Christian Henry and executive Todd Friedman confirmed the seven units were sold at around the list price of $160,000 each. Christian Henry added that while they haven't disclosed ending orders, they have developed hundreds of opportunities, with over 70% being new customers. He expects the company to be more manufacturing-limited than order-limited in the first half of 2025 as production scales, and noted that ASPs are expected to remain strong with minimal discounting.

Jack Meehan from Nephron Research asked about the rationale for reducing the Revio list price to $599,000 and its potential interplay with the Vega launch. He also inquired about the development timeline for the high-throughput short-read platform.

Answer

CEO Christian Henry explained the new Revio list price aligns more closely with current average selling prices (ASPs) and is intended to lower the barrier for customer inquiries, thereby driving more demand. He stated it is not expected to dramatically change realized ASPs. Regarding the high-throughput short-read system, Henry confirmed the program is progressing well but declined to provide a specific launch date, stating the current focus is on SPRQ and Vega.

Jack Meehan of Nephron Research inquired about the assumed mix of flu/COVID combo tests within the respiratory guidance. He also asked about the long-term strategic positioning of the company's other molecular platforms, Solana and Lyra, following the planned acquisition of Lex Diagnostics.

Answer

CFO Joseph Busky confirmed the assumption that over 50% of the flu testing mix will be the combo test remains unchanged. CEO Brian Blaser stated that while Solana and Lyra will still have a place in the portfolio, the company's future molecular growth will be primarily driven by the new Lex platform.

Jack Meehan questioned the drivers behind the respiratory sales mix, where lower COVID sales were offset by stronger flu combo test sales, and asked for an update on the Savanna clinical trial, including any early data and the status of FDA engagement.

Answer

CEO Brian Blaser noted the COVID/flu combo test has proven to be a very durable and stable revenue source. CFO Joe Busky added that the full-year COVID guidance of $110M-$140M remains appropriate. Regarding Savanna, Blaser stated they are in the final stages of pre-submission testing and have not experienced any negative impacts in their interactions with the FDA, though they are monitoring industry-wide commentary on potential delays.

Jack Meehan of Nephron Research inquired about the 2025 free cash flow conversion guidance of 25-30%, the outlook for the China region, and sought clarification on the components of the cardiac revenue decline.

Answer

Chief Financial Officer Joe Busky confirmed the long-term goal for free cash flow conversion remains at least 50% of adjusted EBITDA, to be achieved over the next couple of years. Chief Executive Officer Brian Blaser noted that while China remains an attractive market, competitive intensity has led to a tempered growth outlook. Joe Busky clarified that the cardiac revenue decline was entirely within the Triage business, with the BNP business remaining flat.

Jack Meehan asked for clarification on the Q4 respiratory revenue guidance, particularly regarding potential pull-forward of demand, and sought to quantify the sales risk in China from cardiac product reimbursement changes.

Answer

CFO Joe Busky explained the respiratory guidance is prudent to avoid repeating last year's Q4 miss, acknowledging revenue could shift into Q1 2025. Regarding China, he stated the cardiac reimbursement impact is estimated to be 1% or less of 2025 China revenue.

Jack Meehan from Nephron Research asked whether the strength in Process Chromatography was due to easy comparisons or a genuine recovery, sought details on the food safety business growth driver, and inquired about demand trends from U.S. federally funded research customers.

Answer

President & COO Jonathan DiVincenzo stated that the Process Chromatography business is returning to a 'normal state' with demand now directly correlated to customer needs, moving past the previous year's inventory destocking. He described the food safety business as a high-single-digit grower in an applied market. Executive VP & CFO Roop Lakkaraju added that demand from federally funded research customers was stable throughout Q2, an improvement from the 'paralysis' seen in Q1.

Jack Meehan from Nephron Research asked for clarification on the tariff impact assumptions, including the time frame and whether a revenue impact was assumed. He also inquired about the performance of the China Diagnostics business in Q1 and the key levers for maintaining the full-year free cash flow forecast despite a lower operating margin outlook.

Answer

An executive, likely CFO Roop Lakkaraju, explained that the 130 basis point operating margin impact from tariffs considers all tariffs currently in effect and nets out the impact of surcharges. He stated that China's overall business was down mid-to-high single digits in the quarter and the environment became tougher as the quarter progressed. Regarding free cash flow, confidence in the maintained forecast stems from specific working capital initiatives, including inventory and supplier management, and a focus on improving days sales outstanding (DSO).

Jack Meehan from Nephron Research requested a segment breakdown for the Q1 sales forecast and the reasons for the expected decline versus Q4. He also asked for clarification on the annualized impact of the China diabetes reimbursement change and the risk of it expanding to other diagnostic areas.

Answer

Roop Lakkaraju, EVP and CFO, explained the Q1 year-over-year decline is an all-in number driven by continued market softness, the full impact of the donor screening business exit, China reimbursement, and FX headwinds, with an expected sequential recovery through the year. He clarified the China impact is in the mid-teens million range annually and stated that, at this time, the company does not expect the reimbursement changes to spread to other diagnostic products.

Jack Meehan asked for clarification on the 2025 China diagnostics headwind, the magnitude of the Q3 process chrome decline, and a normalized tax rate to use for 2025.

Answer

EVP and CFO Roop Lakkaraju clarified that the China concern is related to broad macro dynamics, not VBP. He stated the year-over-year decline for process chrome was in the 'high 20s' percent range. For 2025, he suggested a ~22% tax rate is a reasonable placeholder, pending final planning.

Jack Meehan inquired about the company's capital allocation strategy, particularly regarding M&A, and asked about the durability of the Breast Health business's recovery into 2026.

Answer

Chairman, CEO & President Stephen MacMillan noted that Hologic has spent over $750 million on share buybacks year-to-date and is not currently gearing up for a large M&A transaction. He expressed confidence in the Breast Health business, citing the upcoming Envision gantry launch and the strong performance of the interventional business, which is becoming a more significant growth driver.

Jack Meehan asked for details on the market dynamics in China that led to the revenue guidance reduction and which business segments were most affected. He also sought commentary on the broader healthcare utilization environment, referencing the 1% organic growth in GYN Surgical.

Answer

CEO Stephen MacMillan explained that Hologic is de-risking its China forecast due to the challenging environment, with the impact largely on the diagnostics business. CFO Karleen Oberton clarified this de-risks the forecast to a ~$30 million annual run-rate. Regarding utilization, MacMillan and COO Essex Mitchell noted that while overall procedure volume is solid, highly elective procedures like GYN surgery are seeing slower, more 'middling' growth after a post-COVID boom.

Jack Meehan asked for clarification on the guidance, specifically if the potential $30 million disruption to HIV testing was fully included, and inquired about the expected margin cadence for the second quarter.

Answer

CFO Karleen Oberton confirmed that the potential $30 million revenue impact from HIV testing disruption is substantially factored into the full-year guidance. She also clarified that this revenue is part of the Molecular Diagnostics segment. For Q2 margins, she guided to slight sequential improvement in operating margin, with more significant expansion in the second half of the year due to revenue growth and expense seasonality.

Jack Meehan asked for a sales breakdown for the Biotheranostics and BV/CV/TV assays for fiscal 2024 and their expected growth in 2025. He also inquired about the sales contribution from the respiratory panel in 2024 and the assumptions for its performance in the upcoming year.

Answer

Chief Financial Officer Karleen Oberton stated that the BV/CV/TV assay generates several hundred million dollars in revenue and will continue strong double-digit growth, while Biotheranostics is near the $100 million-plus level with similar solid double-digit growth expected. She noted the respiratory panel contributed several tens of millions in 2024, but the company does not expect a similar transition from COVID revenue in 2025, creating a headwind.

Jack Meehan of Nephron Research LLC inquired about the latest trends in trial cancellations, asking if the moderation seen previously has continued into the second quarter.

Answer

CEO & Chairman Ari Bousbib confirmed that cancellation trends have normalized. He stated that Q2 cancellations were within the normal historical range, consistent with Q1. He added that for the first half of the year, there were no mega-cancellations or unusual activity, with the average rate returning to levels seen before the disruptions of the prior year.

Jack Meehan asked for clarification on the Q4 gross margin decline, questioning if it was due to trapped costs, and also inquired about the potential impact of the new political administration and any exposure to NIH funding.

Answer

Ronald Bruehlman, CFO, confirmed the gross margin was impacted by stranded costs from delayed trials and a business mix shift toward the high-growth but lower-margin real-world business. Ari Bousbib, CEO, addressed the policy question, stating there is 'zero' exposure to NIH funding and that he views the new administration as a net positive for the life sciences sector.

Jack Meehan of Nephron Research followed up on a previous question, asking for an update on the status of finalizing the colon cancer blood test and the associated leg of the BLUE-C study.

Answer

CEO Kevin Conroy confirmed the CRC blood test data unlock is on track for mid-2025. He reiterated that the company is not seeing a volume impact from competition and outlined the long path for any blood test to gain significant traction, including Medicare coverage, FDA approval, and USPSTF guidelines, which he estimates won't be fully in place until late 2027 or 2028 at the earliest.

Jack Meehan followed up on a previous question, asking for an update on the status of locking down the assay for the blood-based colon cancer test within the BLUE-C study.

Answer

CEO Kevin Conroy confirmed that the blood-based CRC test data readout is on track for mid-2025. He reiterated that for any blood test to have a significant market impact, it needs Medicare coverage, FDA approval, and USPSTF guideline inclusion, which he projects for late 2027 or 2028 at the earliest. He also stated that the company is not currently seeing a competitive impact on Cologuard volumes.

Asked about care gap programs, including whether the Medicare Star situation has increased payer engagement and about Cologuard's use versus FIT. Also asked for clarification on whether care gap sales are expected to be sequentially lower in Q4.

Answer

Management explained that care gap programs are a major growth driver, with their compliance rate improving to 22-24%, significantly better than FIT's ~10%. They clarified that Q4 care gap revenue is expected to be roughly similar to Q3, maybe slightly up. They sized the total addressable market for these programs as a multi-billion dollar opportunity for the company.

Jack Meehan from Nephron Research asked if the Medicare Star Rating changes have increased engagement from large payers on care gap programs and for clarification on whether care gap sales are expected to be lower sequentially in Q4.

Answer

CEO Kevin Conroy described care gap programs as a major growth driver, with patient compliance rates improving from 18% last year to 22% this year. CFO Aaron Bloomer clarified that Q4 care gap revenue would be roughly similar to Q3, possibly slightly up. He sized the addressable opportunity at 4-5 million completed FIT tests annually, making it a multi-billion dollar opportunity for Cologuard given its superior compliance.

Jack Meehan from Nephron Research asked about care gap programs, including whether the Medicare Star situation increased payer engagement and Cologuard's use relative to FIT. He also sought clarity on whether care gap sales would be sequentially lower in Q4.

Answer

CEO Kevin Conroy explained that care gap programs are a major growth avenue, with compliance rates improving from 18% last year to 22% this year, and 24% in Q3. He noted this is far superior to the typical 10% compliance for FIT tests. CFO Aaron Bloomer clarified that Q4 care gap revenue is expected to be roughly similar to Q3, perhaps up slightly, and sized the total addressable opportunity for these programs at a multi-billion dollar level over time.

Jack Meehan asked about Exact Sciences' marketing and competitive strategy now that a competitor's blood test (Shield) has received FDA approval for primary screening. He specifically inquired about the plan to counter-detail this new test and how the company expects this dynamic to play out with primary care physicians (PCPs).

Answer

CEO Kevin Conroy expressed confidence in their competitive position, citing deep relationships with over 300,000 providers, the best-in-class commercial team, and the Exact Nexus platform. He stated that competition makes the company better and sharper. He emphasized that the performance data difference between Cologuard Plus and blood tests is 'night and day,' and their team will leverage this data as a trusted source of information for providers, ultimately believing the competition will drive overall market growth.

Representing Tycho Peterson, Jack Meehan asked for a timeline update on RaDaR 1.1 and the next-generation version, and questioned how NeoGenomics plans to compete in the increasingly crowded MRD market, including retaining original RaDaR 1.0 users.

Answer

CEO Christopher Smith confirmed RaDaR 1.1 CLIA validation is on track for late Q1/early Q2, with a jury trial scheduled for October 2025. CIO Andrew Lukowiak added that the next-gen strategy focuses on higher sensitivity for adjuvant settings, while RaDaR 1.1 will be used in parallel for cost-effective surveillance. They believe sensitivity remains a key differentiator and are confident in their market position.

Jack Meehan asked for the reason behind the sequential step-up in interest expense guidance and for commentary on the low single-digit decline in the education market during the quarter.

Answer

An Unknown Executive attributed the interest expense guidance to accounting for amortized fees and FX on debt, with the full-year figure representing an average as the company deleverages. CEO Michael Stubblefield explained the education market decline was due to muted K-12 seasonality and weaker government spending, while noting that the higher education piece remains a bright spot.

Jack Meehan asked for a breakdown of the low-double-digit growth in newborn screening, particularly the trends in prenatal screening in China. He also requested an update on the performance and pipeline of the revenue mix.

Answer

CFO Maxwell Krakowiak stated that the strong newborn screening growth was global. He noted that prenatal screening also performed well, aided by some instrument placements and increased screening volumes, including in China. He added that the business has returned to positive growth for the year and has a robust pipeline.

Asked for details on the GLP-1 opportunity and its expected sales concentration. Also inquired about the performance of the Bettera business and whether it might be considered for divestiture as part of the strategic review.

Answer

The company sees a significant opportunity in the GLP-1 category, expecting it to be a major growth contributor starting in FY24 and inflecting in FY25, but did not provide a specific sales concentration. Regarding Bettera, while commercial progress is being made, all strategic options, including divestiture, are on the table as part of the strategic review, and it is premature to comment on specific outcomes.

Asked for more detail on the GLP-1 opportunity, the performance of the Patara business, and whether Patara could be a candidate for divestiture under the new strategic review.

Answer

The company described the GLP-1 opportunity as significant, expecting it to ramp up through FY24 and into FY25, but declined to quantify its contribution. Regarding Patara, they noted ongoing commercial progress, but confirmed that the strategic review will evaluate all businesses and it's too early to comment on specific divestiture plans, though all options are on the table.