Puneet Souda

Puneet Souda asked about the expected sequential increase in Signatera units for the current year, given strong Q4 2025 growth despite seasonality. He also sought insights on needle-moving data catalysts for the year and thoughts on NCCN guidelines. Additionally, he inquired about the marketing approach for the Fetal Focus product, its ability to gain market share, and its expected contribution to women's health growth.

Answer

Steve Chapman (CEO, Natera) highlighted data generation in broader indications like head and neck, gastroesophageal, and pancreatic cancer. Alexey Aleshin (General Manager of Oncology and Chief Medical Officer, Natera) mentioned significant excitement at ASCO GU and expected similar clinical readouts in breast, GI, and IO monitoring. Michael Brophy (CFO, Natera) suggested modeling sequential Signatera unit growth by averaging the trailing four quarters, which is approximately 20,000 units. Steve Chapman noted significant interest and increasing volume for Fetal Focus, attributing it to the product's flexibility and strong data, as evidenced by its SMFM plenary presentation.

Puneet Souda asked about the strong Signatera growth despite seasonality, how to project sequential unit increases given previous 8,000-10,000 increases, and the most needle-moving data catalysts and NCCN thoughts for the year. He also inquired about the marketing approach for the Fetal Focus product, its ability to gain market share, and its expected contribution to Women's Health growth.

Answer

Steve Chapman (CEO, Natera) highlighted data generation in broader indications like head and neck, gastroesophageal, and pancreatic cancer. Alexey Aleshin (General Manager of Oncology and Chief Medical Officer, Natera) noted excitement at ASCO GU and expected a similar drumbeat of clinical readouts in breast, GI, and IO monitoring. Michael Brophy (CFO, Natera) suggested modeling sequential Signatera unit growth by averaging the trailing four quarters, which is currently around 20,000 units. Steve Chapman (CEO, Natera) added that Fetal Focus is seeing significant interest and volume increase, with its flexibility in ordering and the SMFM plenary presentation indicating strong data, contributing to new customer acquisition in Women's Health.

Puneet Souda asked whether Natera's 2026 Signatera ASP increase assumptions are solely based on biomarker bills or also include additional indications. He also sought Natera's perspective on the Vega trial's prospects, given struggles in other de-escalation trials like Pegasus and Dynamic 3, and inquired about the positioning, salesforce training, and market share strategy for the Fetal Focus product in women's health, especially with competitor traction.

Answer

CFO Michael Brophy stated that while biomarker states and MolDX submissions are key drivers for Signatera ASPs, a modest headwind from ADLT reset is expected in 2026. He set a "conservative cast" of a $50 ASP increase for 2026, acknowledging potential for better outcomes. General Manager of Oncology and Chief Medical Officer Alex Aleshin highlighted Vega's serial testing, crossover options, and the benefit of insights from the non-randomized Galaxy patients, expressing confidence for the 2027 readout. CEO Steve Chapman explained Fetal Focus leverages Natera's existing carrier screening expertise and sales team, offering a unique solution for cases where the father is unavailable, positioning it strongly against competitors.

Puneet Souda inquired about the impact of ASCO on Signatera volumes, the current market penetration, the strategy and timeline for the PROCEED and FIND early cancer detection trials, and the monetization plan for the company's AI initiatives.

Answer

CEO Steve Chapman confirmed a post-ASCO lift in momentum and stated Signatera penetration remains in the low single digits. Regarding early cancer detection, Chapman and Alexey Aleshin, GM of Oncology, detailed a risk-mitigated strategy with a PROCEED trial readout in late fall 2025 and a FIND trial readout in 2027. Chapman outlined a dual path for AI monetization: large pharma partnerships and integrating AI tools into existing diagnostic platforms.

Puneet Souda asked about the lapping of Invitae comps in the women's health business and the confidence in ASP stability. He also inquired about the key drivers for continued Signatera growth into 2026.

Answer

Executive Mike Brophy confirmed that the Invitae acquisition is now fully lapped, with comps being clean going forward. He expressed confidence in ASP stability due to Natera's highly effective revenue cycle operations. CEO Steve Chapman identified two key Signatera growth drivers: acquiring new ordering physicians (currently at 45% of oncologists) and increasing test utilization within existing accounts by leveraging new clinical data. He stressed the market remains in the very low single-digits of penetration.

Puneet Souda of Leerink Partners asked about the expected cadence of revenue and gross margin growth throughout 2025, considering new product launches and ASP drivers, and also asked about NCCN guidelines and advanced adenoma data.

Answer

Executive Mike Brophy detailed the expected revenue cadence, with Women's Health returning to typical seasonality and Signatera/Prospera growth being more consistent. He confirmed the gross margin guidance implies a bullish outlook, driven by ASP improvements and scale. CEO Steve Chapman and an executive named Mark Massaro addressed the other questions, noting positive reception to NCCN updates and explaining the prospective, colonoscopy-matched sample collection method for the advanced adenoma study minimizes the risk of performance degradation.

Puneet Souda of Leerink Partners inquired about the drivers of Natera's ASP growth, particularly for Signatera, and the source of its volume increases. He also asked about the clinical impact of recent study publications and expectations for upcoming trial data.

Answer

Executive Mike Brophy detailed that Signatera's ASP growth from ~$800 to $1,050 is driven by better execution with Medicare Advantage payers, with future upside from state biomarker laws. CEO Steve Chapman added that investments in medical appeals have improved collections across the portfolio. Chapman also noted Signatera's volume growth is a mix from both academic and community settings, driven by new data like GALAXY. Chief Medical Officer Alexey Aleshin explained the Nature Medicine paper is significant for demonstrating overall survival (OS) benefit, impacting both physicians and pharma partners, and confirmed the IMvigor011 trial is on track for H1 2025.

Puneet Souda from Leerink Partners asked about the utilization of NASD's Train C, its anticipated full utilization in 2027, and the margin impact from this ramp, differentiating between commercial batches and early-stage pipeline work. He also inquired about the impact of small biotech capital raises on Agilent's business.

Answer

President and CEO Padraig McDonnell confirmed strong order backlog for NASD, with Train C and D capacity coming online. CFO Adam Elinoff noted that while Train C and D ramping in 2027 will have a negative margin impact, it will be offset by Ignite. Adam Elinoff clarified that a meaningful uptick from small/mid-cap biotech has not yet materialized, despite improving capital markets.

Puneet Souda asked for an update on the utilization of Train C on the oligos/NASD side, which is anticipated for full utilization in 2027, and its margin impact as it ramps up. He also inquired about the mix of commercial batches versus early-stage pipeline work. Additionally, he asked where the uptick from emerging and small biotechs is being observed across Agilent's business segments, such as LC-MS, cell analysis, or CDMO.

Answer

President and CEO Padraig McDonnell noted a strong order backlog and confidence in the FY2026 outlook, with Train C and D coming online at the right time as 2026 is booked out and 2027 is booking with larger commercial batches. CFO Adam S. Elinoff explained that while Train C and D ramping in 2027 will have a negative margin impact, it will be offset by other activities, mainly through Ignite, and that the specialty CDMO business is expected to return above corporate operating margin at steady state. Adam S. Elinoff clarified that a meaningful uptick in small/mid-cap biotech investments has not yet been observed, though capital markets are improving. Padraig McDonnell added that Agilent has relatively small exposure to small/medium biotech but is encouraged by improving funding and M&A, noting a lag between funding and spending, and that Agilent's tools (ProIQ LC-MS, Infinity III LC, cell analysis) are well-placed for recovery.

Puneet Souda from Leerink Partners asked about any acceleration in business momentum during July and August, and requested more detail on the performance in China and the expected government stimulus.

Answer

CEO Padraig McDonnell confirmed a pickup in quoting activity and the replacement cycle in recent months, with momentum being similarly strong in both Pharma and CAM markets. For China, he noted 4% growth in Q3, while Mike Zhang, President of the Applied Markets Group, added that the company is building a strong funnel in anticipation of stimulus funds, where they have a historically high win rate.

Puneet Souda from Leerink Partners asked about any acceleration in business momentum observed between July and August, comparing the pickup in the Pharma and CAM end markets. He also requested more detail on the expected stimulus in China.

Answer

President and CEO Padraig McDonnell confirmed a definite pickup in momentum reflected in the numbers, with increased quoting activity and a gradual acceleration in the instrument replacement cycle. He noted the momentum was similarly strong in both the Pharma and CAM markets. Regarding China, he mentioned stable growth and a new "quality productive forces" policy aimed at fostering innovation. Mike Zhang, President of the Applied Markets Group, added that the company is working closely with customers to build a strong funnel in anticipation of the stimulus, expressing confidence based on past high win rates.

Puneet Souda of Leerink Partners requested details on the InfinityLab LC replacement cycle's traction across different end markets. He also asked for quantification of the impacts from Lunar New Year timing and government stimulus on China's quarterly growth.

Answer

CEO Padraig McDonnell stated the InfinityLab LC launch is progressing 'extremely well' with strong customer adoption and higher service attach rates, noting it's a gradual replacement cycle. CFO Bob McMahon added that strong growth in small molecule QA/QC and PFAS testing serve as proof points. Regarding China, McMahon clarified the Lunar New Year impact was as expected, the consumables pull-forward was tariff-related, and the funnel for a new stimulus round looks promising for the second half of the year.

Puneet Souda asked for more detail on the China stimulus timing and inquired about the margin contribution from the 'Ignite' initiative and its key drivers.

Answer

CEO Padraig McDonnell explained the Q1 stimulus was a specific program where Agilent had a 50% win rate, and the next round is expected in the second half but not yet guided. Regarding 'Ignite,' he reiterated the 3-year goal of 70-100+ bps margin expansion. CFO Bob McMahon confirmed they are on track for the 50-70 bps target for the current fiscal year.

Puneet Souda asked for more detail on Agilent's global manufacturing footprint to assess the risk of retaliatory tariffs and inquired about the Infinity III launch, specifically if it caused an order pause and what the early order book indicates.

Answer

CEO Padraig McDonnell and CFO Robert McMahon explained that Agilent is well-prepared for tariff scenarios, having diversified its supply chain and invested heavily in 'in China for China' manufacturing, which minimizes exposure of U.S. exports to China. Regarding the Infinity III, McDonnell stated there was minimal pre-launch pause in orders due to careful customer management. He added that the order book is strong, driven by the new system's productivity benefits.

Puneet Souda of Leerink Partners sought more insight into the instrumentation recovery, noting the book-to-bill ratio has been above one for two consecutive quarters, and asked what provides confidence for a continued rebound in 2025. He also asked about the impact of IRA drug pricing negotiations on large pharma R&D spending.

Answer

CEO Padraig McDonnell pointed to positive customer sentiment and strong activity in specific areas like PFAS testing as signs of a 'slow and steady' recovery. CFO Bob McMahon added that no budget flush is assumed in Q4 guidance. Regarding the IRA, McDonnell observed that while pharma customers are cautious, R&D programs in key modalities like GLP-1 are increasing, and the high spending levels of recent years are now normalizing.

Puneet Souda asked about the confidence in an instrumentation recovery, given two consecutive quarters of book-to-bill ratios above one. He also inquired about the impact of IRA drug pricing negotiations on large pharma R&D spending, based on customer conversations.

Answer

CEO Padraig McDonnell and CFO Bob McMahon responded. Mr. McDonnell described the instrumentation recovery as 'slow and steady,' supported by positive customer sentiment but noted no budget flush is assumed in Q4 guidance. Regarding the IRA, he conveyed that while pharma customers are cautious amid consolidation, the number of R&D programs, particularly in high-growth areas like GLP-1s, continues to increase.

Puneet Souda requested more detail on the book-to-bill ratio, specifically for instrumentation and China, and asked for clarification on the Q2 revenue guide's sequential step-down. He also asked which sub-segments within pharma were showing the most traction.

Answer

CFO Robert McMahon and CEO Michael McMullen clarified that the Q2 guide reflects normal seasonality plus a $15 million demand pull-forward from China into Q1. The book-to-bill was above one in China but below one for instruments, as expected. Regarding pharma, McMahon noted relative strength was in biopharma, especially with mid-to-large cap companies, and highlighted strong performance in ACG services and consumables, indicating lab activity.

Puneet Souda from Leerink Partners asked for the expected growth contribution from the Agilent CrossLab Group (ACG) in fiscal 2024, given its high percentage of service contracts. He also inquired about the growth outlook for LSAG and sought more detail on onshoring and environmental testing as growth drivers.

Answer

CFO Robert McMahon projected mid-single-digit growth for ACG in fiscal 2024, driven by double-digit growth in contract services, which is moderated by headwinds from new instrument placements. For the LSAG segment, he guided to a low-single-digit decline. While acknowledging the potential of onshoring and PFAS testing, McMahon stated the company is taking a prudent approach in its initial guidance. CEO Michael McMullen added that PFAS testing is expanding into new areas like the food market.

Puneet Souda inquired about Myriad Genetics' confidence in achieving a high single-digit long-term growth rate for 2027 and beyond, building on 2026 projections. He also asked for details on the Precise MRD launch strategy, including how Myriad plans to manage volume given market competitiveness and the reimbursement timeline, and sought clarification on the prenatal growth rate for Q1 and its expected recovery throughout the year.

Answer

Sam Raha, President and CEO, expressed confidence in achieving high single-digit to low double-digit sustained profitable growth by 2027-2028, driven by new product launches like Precise MRD, AI-enabled Prolaris, and FirstGene, alongside improved execution and prenatal business recovery. For MRD, Mr. Raha noted a selective alpha launch for breast cancer, focusing on user experience and operational efficiency before MolDx submission in early H2. Ben Wheeler, CFO, explained that prenatal Q1 growth would face an unfavorable year-over-year comparison, leading to a decline, but anticipated recovery from Q2 onwards, driven by a focused sales force and new product opportunities.

Puneet Souda asked about Myriad Genetics' confidence in achieving a high single-digit long-term growth rate for 2027 and beyond, building on 2026 projections. He also inquired about the MRD launch strategy, including how the company plans to manage volume given market competitiveness and reimbursement status, and sought clarification on prenatal growth rates for Q1 and expected recovery throughout the year.

Answer

Sam Raha, President and CEO, expressed confidence in 2026 growth drivers such as the expanded MyRisk Panel, improved execution, increased headcount, and anticipated prenatal business recovery. He projected high single-digit to low double-digit sustained profitable growth for 2027-2028, driven by new product launches like Precise MRD, AI-enabled Prolaris, and FirstGene. Regarding MRD, Mr. Raha detailed a selective alpha launch focusing on user experience and operational efficiency before MolDx submission (planned for early H2 for breast, later for renal/colorectal). Ben Wheeler, CFO, addressed prenatal, noting an expected Q1 decline due to unfavorable year-over-year comparisons and deductible resets, with recovery anticipated from Q2, but did not provide specific product-level guidance.

Puneet Souda from Leerink Partners asked for an update on the GeneSight submission to UnitedHealthcare, including the timeline for a potential resolution, and whether other payers are requesting reconsiderations. He also sought clarification on the PRECISE MRD launch timeline and remaining validation requirements.

Answer

COO Mark Verratti detailed that three publications will be submitted to UnitedHealthcare during its fall review cycle, with a potential policy update expected around November for a 2026 effective date. He noted no negative reconsiderations from other payers, highlighting new coverage wins instead. CEO Sam Raha clarified the MRD strategy involves an 'early access' launch in the first half of 2026 to get the test to key providers, which may occur before a full commercial launch post-MolDX approval.

Puneet Souda of Leerink Partners inquired about GeneSight payer dynamics, asking if other payers were following UnitedHealthcare's negative coverage decision and if provider prescribing habits were changing. He also asked CEO Sam Raha for his view on the current product portfolio and the potential for divestitures.

Answer

CFO Scott Leffler stated that no other payers have followed UnitedHealthcare's policy change for GeneSight, and in fact, Myriad has secured some small incremental coverage wins. COO Mark Verratti noted no meaningful change in provider prescribing behavior, though reduced marketing spend did impact Q1 volume. CEO Samraat Raha explained that a full portfolio review is underway to optimize for profitable growth, with oncology remaining the core focus, and that strategic decisions will be finalized in the coming months.

Puneet Souda asked about the company's exposure to potential Medicaid spending cuts and how it is prioritizing investments across its portfolio, considering potential tailwinds like ACOG guideline updates.

Answer

COO Samraat Raha stated that Medicaid exposure is low, as the revenue is concentrated in prenatal testing, which is not a historical target for cuts. He affirmed that investment priorities remain unchanged across oncology, women's health, and pharmacogenomics. He highlighted that Myriad is prepared for ACOG updates with its Foresight Universal Plus test and is focused on building out the full continuum of cancer care, from MyRisk to the upcoming MRD test, supplemented by strategic partnerships like PATHOMIQ.

Puneet Souda of Leerink Partners asked for confirmation of the GeneSight Medicare rate, questioned why other payers wouldn't also apply pressure, and inquired about the competitive landscape for hereditary cancer testing following a recent acquisition in the sector.

Answer

President and CEO Paul Diaz confirmed the GeneSight Medicare rate is $13.56 and reiterated that while the whole system faces pressure, Myriad has upside from low test adoption and significant 'no-pay' opportunity. Regarding competition, Diaz and Chief Commercial Officer Mark Verratti framed recent market dislocations, including the Ambry acquisition, as significant opportunities to gain share for their 'gold standard' MyRisk test.

Puneet Souda asked for insights into the strong oncology growth observed, specifically how Guardant anticipates the growth of Guardant360 versus Reveal volumes throughout the year, considering unbaked-in drivers like the camizestrant launch.

Answer

Helmy Eltoukhy, Co-CEO, projected another strong year for Guardant360 with at least 20% volume growth, and Reveal continuing as the fastest-growing product, accelerating with therapy monitoring. Mike Bell, CFO, added that Guardant360 Tissue also saw acceleration in H2 2025 following Smart upgrades and expects continued growth, potentially boosted by FDA approval.

Puneet Souda inquired about the expected oncology growth trajectory for Guardant360 versus Reveal throughout the year, considering unguided drivers like chemo-resistant launch.

Answer

Co-CEO Helmy Eltoukhy and CFO Mike Bell expressed bullishness for 2026, projecting at least 20% volume growth for Guardant360 and continued acceleration for Reveal as the fastest-growing product. Mike Bell added that Guardant360 Tissue is also expected to accelerate following SMART upgrades.

Puneet Souda from Leerink Partners asked about the key drivers behind Shield's impressive growth, the outlook for its Average Selling Price (ASP), and for an update on the data timeline for Shield V2.

Answer

Co-CEO AmirAli Talasaz attributed Shield's strong performance to high market pull and increased sales team productivity. CFO Michael Bell explained the Q2 ASP rose to over $900 due to ADLT status and strong Medicare Advantage reimbursement, but guided for a full-year ASP around $800 to account for a potential payer mix shift. Regarding Shield V2, Talasaz described it as a 'very active program' without providing a specific data release date.

Puneet Souda inquired about where the Shield test is gaining the most traction in the market and the plans for sales force expansion. He also asked about the product-market fit for Reveal, particularly in CRC surveillance and breast cancer, given its later entry.

Answer

Co-CEO AmirAli Talasaz noted Shield is seeing strong traction with PCPs due to the large unscreened population, with plans to have about 200 reps deployed by year-end. Co-CEO Helmy Eltoukhy explained that Reveal's key differentiators are its fast turnaround time for the adjuvant setting and its broad catchment ability for surveillance, making it highly competitive despite being a later entrant.

Puneet Souda asked about the drivers behind the strong 2025 Shield revenue guidance and how the company reconciles its optimism for Guardant Reveal with recent NCCN guidelines that recommended against its use in surveillance.

Answer

Co-CEO AmirAli Talasaz attributed the Shield guidance to a back-half loaded ramp from an expanded sales force, which grew to 100 reps by the end of 2024. Co-CEO Helmy Eltoukhy addressed the NCCN guidelines for Reveal, stating they view the update as a step forward and noted that guidelines often lag behind clinical practice, similar to the early adoption curve of Guardant360.

Puneet Souda asked for the expected timing of data for Shield V2 and the company's current assumption for market penetration in CRC screening, given its significant head start.

Answer

Co-CEO AmirAli Talasaz stated that Guardant Health expects to have Shield V2 data in 2025 and could potentially upgrade the test that year if the data is positive. Regarding market share, he reiterated the Investor Day assumption of aiming for 60% of the blood-based CRC screening market, noting that the company now has at least a 2.5-year lead before any competitor is expected to gain FDA approval and Medicare reimbursement.

Puneet Souda asked if the long-term revenue plan (LRP) of 12-13% growth is still in consideration, how NeoGenomics plans to convert new customers to higher-value tests, and for insights into the competitive landscape for tissue CGP and liquid biopsy in the community setting.

Answer

Tony Zook (CEO, NeoGenomics) stated that the company is not discussing LRP, focusing on the 2026 guidance with confidence and anticipated accelerated growth into 2027. Jeff Sherman (CFO, NeoGenomics) and Abhishek Jain (EVP of Finance and Incoming CFO, NeoGenomics) noted that AUP growth would be driven by new tests in the latter half of 2026. Warren Stone (Chief Commercial Officer, NeoGenomics) explained the strategy to expand new products to existing customers, often leading with heme solutions and then expanding into solid tumor, noting no significant change in the competitive landscape and NeoGenomics' favorable position due to its broad portfolio and service.

Puneet Souda (SVB Leerink) asked for clarification on the status of the previously communicated long-range plan (LRP) and how NeoGenomics expects to convert new customers to higher-value tests, including the anticipated timeframe for impact. He also sought insights into the competitive landscape for tissue CGP and liquid biopsy in the community setting.

Answer

CEO Tony Zook stated that the company is not discussing the LRP, focusing instead on the current year's confident guidance and anticipated accelerated growth into 2027. CFO Jeff Sherman and EVP of Finance and Incoming CFO Abhishek Jain indicated that AUP would grow as higher-value tests are added. Chief Commercial Officer Warren Stone explained that the strategy involves expanding new products to existing customers, often leading with heme solutions for new oncology practices before expanding into solid tumor, with sales cycles being relatively quick. He reiterated that the competitive landscape in the community setting for solid tumor and liquid biopsy remains consistent, with NeoGenomics' broad portfolio and service focus driving success.

Puneet Souda asked about the anticipated impact of bringing MRD on board on average revenue per unit (AUP), competitive dynamics in the NGS market (specifically CGP growth), and the levers NeoGenomics has to reduce cost of goods sold (COGS) with new assays, including the overall cost per test.

Answer

CFO Jeff Sherman stated that while MolDX approval for RaDaR is a good first step, commercial approval will take time, and it will likely drive AUP starting in H2 2026 and into 2027. COO Warren Stone acknowledged a hotly contested NGS environment but noted that NeoGenomics' comprehensive portfolio, including the PanTracer family and NeoTypes, creates differentiation and has been well-received. Jeff Sherman outlined COGS reduction levers: LBx volume covering COGS, operating efficiency from larger panel test volumes, LIMS consolidation, lab automation, digitizing processes, digital pathology, and leveraging existing lab capacity. Warren Stone added that moving to larger flow panels and NovaSeqX in 2026 will further drive down costs. Jeff Sherman also mentioned that Pathline's higher cost per test will decrease with incremental volume.

Puneet Souda asked about the anticipated impact on average revenue per clinical test (AUP) as MRD assays are brought on board. He also inquired about the competitive landscape in the NGS business, specifically if NeoGenomics is observing any different dynamics given the continued growth of comprehensive genomic profiling (CGP) for other companies.

Answer

CFO Jeff Sherman explained that while Moldex approval for Radar was a good first step, commercial approval and coverage would take time, making it an AUP driver primarily in H2 2026 and into 2027. COO Warren Stone acknowledged the NGS competitive environment as hotly contested but noted that NeoGenomics' rounded-out portfolio, including the PanTracer family and cancer-specific NeoTypes, has been well-received and creates differentiation in the marketplace.

Puneet Souda of Leerink Partners asked about the size and strategy of the oncology sales force, the source of NGS sales (oncologist vs. pathologist), and how the company is competing in an increasingly crowded market. He also asked about OpEx cuts.

Answer

President & COO Warren Stone confirmed the sales force is at its target of ~135 people, with the majority of NGS growth driven by the oncology specialist team. CEO Tony Zook added that competitive 'stickiness' is built through a broad portfolio and operational excellence. CFO Jeff Sherman stated that while not providing future guidance, the company expects to achieve operating efficiencies in the second half of the year.

Puneet Souda of Leerink Partners inquired about the oncology sales force structure and its role in driving NGS growth amidst rising competition, and also asked about any planned operating expense reductions.

Answer

President & COO Warren Stone detailed the ~135-person sales force, noting the oncology specialist team drives the majority of NGS growth. CEO Tony Zook added that their broad portfolio creates competitive "stickiness." CFO Jeff Sherman indicated that while no specific cuts were announced, the company continues to focus on achieving operating efficiencies.

Puneet Souda of Leerink Partners noted that NGS growth appeared lower and asked about long-term expectations and whether core AUP was down beyond the Pathline dilution. He also inquired about cost-lowering initiatives given the near-term growth profile.

Answer

CFO Jeff Sherman explained the lower NGS growth was due to a difficult year-over-year comparison of over 50% growth in Q1 2024, and the company still expects over 25% NGS growth for the full year. Management detailed several cost-saving initiatives, including gaining operating leverage from volume growth, a long-term LIMS project, lab automation, optimizing the site footprint, and transitioning to more cost-effective sequencing platforms like the NovaSeq X and the new Ultima Genomics partnership.

Puneet Souda inquired about the Average Unit Price (AUP) assumptions within the 2025 guidance, the expected gross margin impact from the new PanTracer liquid biopsy, its commercial strategy, and the growth outlook for the Pharma business.

Answer

CEO Christopher Smith stated that the mix of volume and AUP growth in 2025 is expected to be similar to the previous year. CFO Jeff Sherman noted PanTracer will be accretive to gross margins. CCO Warren Stone explained the commercial strategy leverages concurrent tissue and liquid testing on a common platform. Management expects modest growth in the Pharma business for 2025 after a challenging 2024.

Puneet Souda asked if the current Average Unit Price (AUP) could serve as a baseline for 2025 and requested a breakdown of the clinical revenue payer mix.

Answer

An executive provided the Q3 payer mix as approximately 58% direct client bill, 15% commercial, and 13% government. He also stated it is reasonable to assume AUP will continue to grow over time, driven by the increasing NGS mix and Revenue Cycle Management initiatives, but deferred specific guidance on the pace of that growth.

Puneet Souda sought details on the FLEX APEX rebranding, the mix of FLEX V1 versus V2 in Q4, the expected adoption and pricing impact of FLEX APEX in 2026, and potential switching from 3 Prime/5 Prime GenX kits.

Answer

CEO Serge Saxonov confirmed FLEX APEX launched strongly in Q4, but it's too early to detail the mix of FLEX versions. He highlighted new, additive use cases, existing users not switching, and some migration from other products. The focus is on driving additional volume, with CFO Adam Taich noting over 30% reaction volume growth in Q4 as a potential anchor for 2026.

Puneet Souda asked for clarification on Flex Apex (rebranded Flex v2), the mix of Flex v1 vs. v2 in Q4 2025, the expected impact of Flex Apex adoption on pricing throughout 2026, and the potential pricing headwind from 3' and 5' GEM-X kits switching to Apex.

Answer

CEO Serge Saxonov confirmed Flex Apex launched in Q4 and saw strong initial performance, though it's too early to detail the mix. He noted Flex Apex opens new, additive use cases, while some users won't switch from other products. For those who do switch, some will run more samples for the same cost, others will pay less for the same number of samples, creating a headwind, but the focus is on driving additional volume, as evidenced by over 30% reaction volume growth in Q4.

An analyst on behalf of Puneet Souda asked for an update on the contribution from recent product launches like GEM-X and other platform upgrades, and for the current sales mix of GEM-X versus older kits.

Answer

CEO Serge Saxonov reported that the new GEM-X product line now constitutes a "large majority" of sales within the Chromium franchise. He emphasized that the company's business is now largely driven by the suite of products launched over the last year, with GEM-X Flex and on-chip multiplexing performing particularly well and driving higher reaction volumes.

Puneet Souda challenged the decision not to include the NIH indirect cost cuts in the 2025 guidance, highlighting the significant uncertainty this creates for customers at major research institutions, which could delay instrument purchases.

Answer

CEO Serge Saxonov responded that the situation is highly volatile, making it difficult to bake in firm assumptions. He emphasized that instrument exposure to this issue is somewhat bounded, as a smaller fraction of instruments go to academic core labs and are typically financed through direct funds. He reiterated that CFO Adam Taich's quantification of a potential $10-$15M impact was meant to provide transparency on the bounded risk.

Puneet Souda asked for details on the sales force size and open positions, questioning the timeline for normalization. He also probed the Xenium instrument placements versus expectations and whether the shortfall was due to sales force issues or a fundamental slowdown in the spatial market.

Answer

CEO Serge Saxonov attributed the disappointing Q3 Xenium placement number primarily to the combination of a challenged CapEx environment and the disruption from the commercial reorganization. He asserted that fundamental demand indicators like customer interest, funding signals, and healthy instrument utilization remain strong, suggesting the issue is not with fundamental market demand.

Puneet Souda from Leerink Partners followed up on the academic and government customer segment, asking for feedback on interactions in Q1 2026, especially given the NIH budget increase and political challenges affecting grant disbursements.

Answer

Frank Laukien, President and CEO, stated that while the absence of strong headwinds from the previous year feels better for U.S. ACA Gov, orders in Q4 2025 were still weak. He expressed cautious optimism for gradual improvement, potentially benefiting bookings in the second half of 2026, but noted that it might not translate into revenue until Q4 2026 or 2027.

Puneet Souda asked about the drivers behind the lower-than-expected Q4 2025 margins, the focus and expected impact of cost initiatives beyond the initial $120 million, and the OpEx margin cadence for 2026, especially the 'meaningful' Q1 impact. He also inquired about the academic and government customer feedback given the NIH budget increase.

Answer

President and CEO Frank Laukien explained that Q4's lower margin was due to idiosyncratic mix factors, delayed tariff offsets, and stronger currency headwinds. He stated that cost initiatives are now expected to yield closer to $140 million or higher annually, becoming fully effective by mid-year 2026. EVP and CFO Gerald Herman added that Q1 2026 is expected to be softer due to strong Q1 2025 comps and timing of European cost actions, with a significant ramp in OpEx margin starting in Q2. Frank Laukien noted that while the NIH budget increase is encouraging, U.S. academic/government orders were still weak in Q4 2025, and confidence may take a couple more quarters to build, potentially impacting bookings in the second half of 2026 for 2027 revenue.

Puneet Souda inquired about the revised 2025 guidance, questioning why the strong backlog isn't providing more support and seeking clarity on the expected Q4 and FY2026 recovery. He also asked about the timing of UHF magnet revenue and the potential impact from an acquisition of BD's microbiology assets on Bruker's MALDI Biotyper channel.

Answer

Chairman, CEO & President Frank Laukien explained that the backlog is being utilized but has come down slightly, and expressed confidence in the Q4 ramp. He noted it's too early for specific 2026 guidance but emphasized margin expansion is planned even with no growth. He confirmed one UHF magnet revenue recognition is expected in Q4 2025. Regarding the BD asset sale, he stated that while the future is uncertain, Bruker has a strong direct sales channel and a history of successful partnerships.

Puneet Souda of Leerink Partners inquired about potential Q1 revenue pull-forward due to tariff concerns, order cancellations in the U.S. or Europe, and the potential for offsets like AI chip demand or German stimulus to mitigate headwinds.

Answer

CEO Frank Laukien clarified that there was no significant revenue pull-forward, though a UK system installation occurred in Q1 instead of Q2 due to smooth execution. He confirmed there have been no order cancellations, only delays, particularly in China. Laukien noted that while AI-related demand is a strong offset, major stimulus programs in Europe are more likely to impact fiscal 2026.

Puneet Souda questioned Bruker's confidence in its 2025 guidance, particularly the 3-4% organic growth and 140 bps margin expansion, given NIH funding uncertainty. He asked about offsetting growth drivers and customer feedback on instrument installations and potential backlog cancellations.

Answer

CEO Frank Laukien stated the guidance is balanced, acknowledging NIH uncertainty (less than 5% of revenue) but highlighting offsetting strength from a biopharma recovery, China stimulus, microbiology, and semiconductor markets. He affirmed confidence in the 5-7% CER revenue growth and the commitment to margin expansion and 14-16% CER EPS growth. Laukien noted no backlog cancellations have occurred but confirmed Q1 organic growth might be flat, baking in a cushion for the uncertainty.

Puneet Souda asked about the drivers behind the 2024 guidance reduction, questioning whether it was due to order pushouts or cancellations, and inquired about the outlook for 2025 EPS given the current market weakness.

Answer

CEO Frank Laukien confirmed there were no material cancellations. He attributed the guidance change to delayed recoveries in biopharma, which is undergoing significant cost-cutting, and a substantial, over 20% year-over-year decline in China orders. While China stimulus orders are beginning to materialize, their P&L impact won't be felt until the second half of 2025. Consequently, Laukien stated it "makes complete sense to lower estimates for 2025" from the prior base.

Puneet Souda asked for clarification on the conservatism in the acquired BD assets' growth numbers, specifically how much cushion is baked in, given the markets differ from pharma QA/QC and the company is not baking in pricing/KPI discipline. He also asked if the Q1 guidance contemplated any contribution from extra selling days.

Answer

President and CEO Udit Batra clarified that pricing improvements, deal desk, and launch readiness are not baked into the numbers. SVP and CFO Amol Chaubal stated that the guidance primarily bakes in headwinds from China DRG and continued slowness in other China-related elements and the academic/government market, aiming for prudence. Amol confirmed that the Q1 guide reflects four extra working days.

Puneet Souda circled back to the conservatism in the acquired BD assets' growth numbers, which are lower than earlier expectations. He sought to understand the extent of the cushion and how risk-adjusted these numbers are, especially given that these markets differ from Waters' traditional pharma QA/QC focus.

Answer

President and CEO Udit Batra clarified that they are not baking in pricing improvements, deal desk benefits, or launch readiness into the numbers. SVP and CFO Amol Chaubal explained that they are primarily baking in the headwind from China DRG and some continued slowness from other China-related elements or the academic and government market. He emphasized prudence at the beginning of the year, noting potential upside if Waters' success in areas like China and U.S. A&G can be reapplied to these new parts, despite the differing market dynamics.

Puneet Souda asked about the fourth-quarter guidance, specifically if a budget flush is expected, any pull-forwards from Q3, and the expected contribution of instruments versus chemistry. He also followed up on the incremental upside of the subscription-based model for Empower compared to the prior perpetual license model.

Answer

CEO Udit Batra stated no pull-forwards occurred, with orders exceeding sales and a healthy backlog. He emphasized the prudent Q4 guidance (5-7% constant currency sales growth), which assumes a lower sequential ramp than historical patterns. CFO Amol Chaubal detailed Q4 breakdown: chemistry up 6% (due to Q2 pull-forward dynamics), service up 8% (extra day), and instruments up 5%. Udit Batra then elaborated on the Empower 'Superhighway' strategy, aiming for compatibility with all analytical instruments for biologics, offering value-added cloud-ready services (utilization data, data viewer, data intelligence), and driving transition to a subscription model with significant potential upside from large pharma customers.

Puneet Souda questioned the Q4 guidance, asking about expectations for a budget flush, any pull-forwards from Q2/Q3, and the anticipated contribution of instruments versus Chemistry. He also followed up on the incremental upside of Empower's new subscription-based model.

Answer

President and CEO Udit Batra stated that no pull-forwards occurred, with orders exceeding sales, and highlighted the prudent Q4 guidance. CFO Amol Chaubal detailed the Q4 breakdown: Chemistry up 6%, Service up 8% (due to an extra day), and Instruments up 5%. Udit Batra elaborated on Empower's 'Superhighway' strategy, aiming for compatibility with all analytical instruments, offering value-added cloud-ready services, and leveraging AI/ML for data intelligence, which incentivizes the shift to a subscription model with significant potential upside.

Puneet Souda of Leerink Partners inquired about the outlook for the academic and government (A&G) market, particularly for instrumentation. He also asked about the expected sequence of realizing the $290 million in revenue synergies from the BD acquisition after the deal closes.

Answer

President and CEO Dr. Udit Batra noted that the A&G segment's 3% decline was better than expected, but the company remains conservative for the second half, assuming no funding improvements. Regarding BD deal synergies, he detailed that commercial execution initiatives like instrument replacement, service attachment, and e-commerce would have an immediate 'day one' impact. SVP & CFO Amol Chaubal added that a straight-line assumption for synergy realization over five years is reasonable.

Puneet Souda of Leerink Partners asked for details on supply chain realignments made to mitigate tariffs and questioned how pharma customer confidence in the U.S. and Europe compares to India, seeking to understand Waters' outperformance versus peers.

Answer

CFO Amol Chaubal explained that of the $45M gross tariff impact, $15M is offset by surcharges and $14M by manufacturing actions, with most plans already landing. CEO Udit Batra attributed Waters' outperformance to its strong downstream position in regulated, high-volume applications, the ongoing instrument replacement cycle, and idiosyncratic drivers like GLP-1 and PFAS testing.

Puneet Souda questioned the wide range of the Q1 2025 guidance (4-7% constant currency), asking how risks like NIH cuts were factored in. He also requested more detail on the strong performance in Europe and the sustainability of growth in India.

Answer

SVP and CFO Amol Chaubal explained the wider Q1 range reflects prudence given macro uncertainties and two fewer business days. President and CEO Dr. Udit Batra added that the company is investing for growth in Q1. Regarding India, Batra highlighted its significant opportunity tied to generic drug manufacturing, expecting it to add 70-100 bps to growth. Chaubal noted Europe's 11% growth was broad-based.

Puneet Souda inquired about the drivers behind Waters' instrument recovery, particularly its QA/QC positioning, while some peers still see declines. He also asked about the sustainability of the 8% chemistry growth and the breadth of Waters' position in the growing GLP-1 market, including for new oral formulations.

Answer

President and CEO Dr. Udit Batra described recurring revenues as a 'Swiss clock' due to their stability, which he expects to continue, fueled by innovation and service attachment. He attributed the strong instrument performance to Waters' focus on volume-driven QA/QC applications, the start of the replacement cycle, and a revitalized, best-in-class product portfolio. On GLP-1s, Batra confirmed a 'pole position' with the two largest injectable manufacturers and stated the company is well-positioned for future oral versions and generic competition.

Puneet Souda with Leerink Partners requested a breakdown of NovaSeq X instrument placements between research and clinical customers in Q4 2025. He also sought context on the research side, specifically how much of the guidance incorporates competitive pressures beyond academic funding challenges for both mid-throughput and high-throughput instruments.

Answer

CEO Jacob Thaysen confirmed that over 60% of the more than 100 NovaSeq X placements in Q4 2025 were to clinical customers, a dynamic expected to continue into 2026. He noted the mid-throughput business remains muted due to macro trends and conservative spending. CFO Ankur Dhingra added that competitive impact was minimal in Q4, and the research outlook for 2026 is primarily based on the funding environment, with strong interest in new multi-omic launches.

Puneet Souda inquired about the split of instrument placements between research and clinical customers in Q4 2025. He also asked for context on the research segment's performance, considering academic pressures and competitive dynamics in both mid-throughput and high-throughput instruments.

Answer

CEO Jacob Thaysen reported that over 100 NovaSeq X instruments were placed in Q4, with more than 60% going to clinical customers, a trend expected to continue into 2026. He noted the mid-throughput business remains muted due to macro trends. CFO Ankur Dhingra added that competitive impact was minimal in Q4, and the research outlook is primarily based on the funding environment, with strong interest in new multi-omic launches.

Puneet Souda of Leerink Partners asked whether Illumina saw any customer purchasing pull-forward ahead of tariffs and inquired about the pace of the NovaSeq X transition among large clinical customers.

Answer

CEO Jacob Thaysen stated that the company did not see a significant pull-forward of orders. Instead, he noted that the order backlog is growing as customers gain confidence in the NovaSeq X platform for production-scale work. He described the clinical transition as a deliberate, customer-by-customer process designed to avoid disrupting growth during validation, rather than a sudden "cliff event."

Puneet Souda sought elaboration on why Illumina expects the 'unreliable entity list' designation from China to be reversed and asked for clarification on the clinical volume transition to NovaSeq X, specifically the target for year-end 2025.

Answer

CEO Jacob Thaysen declined to comment on a potential reversal or its timeline, stating the company is in active dialogue with the relevant parties. CFO Ankur Dhingra clarified that 50% of clinical volume had transitioned by the end of Q4 2024, and the aggregate goal remains ~75% of total high-throughput volume on X by mid-2025, with the remainder of the transition driven mostly by clinical customers.

Puneet Souda inquired about the source of the decline in mid-throughput instruments, asking if it was driven by China or competition in the U.S. and Europe, and asked for key considerations for 2025 revenue, particularly the impact of the clinical transition to the lower-cost NovaSeq X.

Answer

CEO Jacob Thaysen noted that while competition is global, he is encouraged by stabilizing sequential revenue in China. He attributed mid-throughput pressure primarily to macro constraints causing smaller biotechs to outsource sequencing. Regarding 2025, he reiterated the goal of returning to positive growth but deferred specific guidance until after Q4.

Puneet Souda inquired about the significant organic growth acceleration needed in the fourth fiscal quarter, the underlying drivers, and potential for high single-digit growth in fiscal year 2027. He also asked for a deeper dive into Bio-Techne's consistent outperformance in China compared to peers, seeking insights into the driving trends, end markets, and customer dynamics.

Answer

President and CEO Kim Kelderman highlighted core business recuperation, 30% growth in cell therapy (excluding Fast Track customers), strong traction in organoids, accelerating proteomic analysis, positive growth in spatial reagents, robust instrument order bookings, continuous new product introductions, and positive trends in China and APAC. CFO Jim Hipple added that comp tailwinds and building momentum in the baseline business (1% underlying growth in Q1, 3% in Q2, slight step up in Q3) would contribute. Kim Kelderman attributed China's growth to overall market momentum, the 15th five-year funding plan prioritizing life science, successful exits by local biotech companies, and improving CDMO/CRO activity.

Puneet Souda asked about the significant step-up required for organic growth in fiscal Q4 and whether Bio-Techne anticipates reaching high single-digit growth in fiscal 2027. He also sought deeper insight into the drivers behind Bio-Techne's consistent outperformance in China compared to peers.

Answer

Kim Kelderman, President and CEO, highlighted accelerating underlying business trends, strong growth in cell therapy (excluding two large customers), traction in organoids, and accelerating proteomic analysis. Jim Hipple, CFO, explained that easier Q4 comps and a 3% sequential tailwind from lower headwinds and easier academic/biotech comparisons would contribute to momentum. Kim Kelderman attributed China's growth to the country's 15th five-year funding plan prioritizing life science, successful exits by local biotechs, and improving CDMO/CRO activity.

Puneet Souda of Leerink Partners asked for clarification on the fiscal 2026 low single-digit growth outlook, questioning if it applied to the full year and its expected cadence across segments. He also inquired about which specific instruments were driving strong performance in the large pharma segment and the outlook for the core antibodies and cytokines business.

Answer

CFO James Hippel clarified the low single-digit growth outlook is expected to persist only until market uncertainties (e.g., NIH funding, pharma tariffs) are resolved, not necessarily for the entire fiscal year. President & CEO Kim Kelderman attributed strong instrument sales in large pharma to the biologics product lines (Maurice) and the new high-throughput Simple Western system (LEO), which are increasingly used in QA/QC applications. He also noted that while LUNARFOR placements were delayed, the order book remains strong.

Puneet Souda of Leerink Partners inquired about the drivers for the Q4 guidance slowdown, asking if it was due to a pharma pull-forward or academic market weakness, and sought clarity on the fiscal 2026 outlook, particularly for China.

Answer

CFO Jim Hippel clarified the Q4 guide reflects conservatism around new tariff uncertainties impacting pharma, a slowdown in academia following February policy announcements, and the non-repeat of large partner orders from Q3. He confirmed large pharma grew double-digits in Q3. CEO Kim Kelderman added that unlike Q2, there was no material pull-forward in Q3, and that more clarity on fiscal 2026 would be provided in the next quarter as market uncertainties resolve.

Puneet Souda of Morgan Stanley inquired about the sustainability of the strong growth momentum in the Diagnostics and Spatial Biology segment and sought confidence in the observed improvement in the biotech and biopharma end markets.

Answer

CEO Kim Kelderman affirmed the sustainability of the Diagnostics and Spatial Biology segment's growth, highlighting the strong market penetration runway for the ExoDx prostate test, a robust R&D funnel for Asuragen kits, and the early-stage launch of the multiomic-capable COMET spatial biology platform. CFO Jim Hippel added that while Q1's exceptional cell and gene therapy growth might moderate, he is confident in continued overall growth, supported by an encouraging pickup in the run-rate research-use-only (RUO) business from smaller biotechs, which began in the back half of Q1 and continued into October.

Puneet Souda asked about the Q3 to Q2 pull-forward of GMP reagent orders, the key drivers of the Q3 recovery, and the potential impact of NIH funding concerns. He also inquired about Bio-Techne's M&A strategy in the current market.

Answer

CEO Kim Kelderman confirmed that large GMP protein orders from late-stage clinical customers were pulled into Q2, driving growth. CFO Jim Hippel added that broad-based strength in large pharma provides confidence for Q3, offsetting the pull-forward, and downplayed NIH funding risks, noting academic growth improved in January. Kelderman reiterated that M&A is a priority, focusing on discovery platforms and cell and gene therapy manufacturing tools.

Puneet Souda asked for the real underlying NGS growth rate, excluding the impact of the large customer in Q1 and for the full fiscal year 2026.

Answer

Adam Laponis, CFO, explained that neutralizing for the growth from the one large customer, the overall NGS growth in 2025 would be closer to 20%, and a similar dynamic applies to 2026.

Puneet Souda asked for insights into the SynBio and Biopharma segments, particularly regarding a significant AI-driven biopharma order. He sought clarification on the sustainability and momentum of this trend, and the expected contribution of AI-enabled discovery to fiscal year 2026 revenue.

Answer

Patrick Finn, President and COO of Twist Bioscience, highlighted the strategic importance and close ties between the biopharma business and SynBio offerings, noting the large AI-driven order as validation. He emphasized that Twist's throughput and scale are crucial enablers for AI discovery, expressing continued optimism for future opportunities in this space.

Puneet Souda asked for the U.S. academic growth rate, more detail on the composition of the over $100 million in orders from the last two quarters, and whether there was any demand pull-forward from European customers concerned about retaliatory tariffs.

Answer

CFO Adam Laponis confirmed strong U.S. academic growth across NGS and SynBio but did not disclose a specific rate. He noted the strong order book reflected growth across all product platforms (SynBio, NGS, Biopharma) and explicitly stated there was no meaningful pull-forward of orders related to tariff concerns.

Puneet Souda of Leerink Partners asked about the growth outlook for the NGS and diagnostics segments amid market headwinds and questioned the decision not to raise the top end of the NGS revenue guidance.

Answer

CEO Emily Leproust expressed confidence in Twist's ability to perform well in any market environment due to its differentiated products. She emphasized that the company's strategy is to leverage its technology to drive top-line growth, which naturally expands gross margins, while maintaining disciplined operating expenses. She framed market turbulence as an opportunity to gain share.

On behalf of Puneet Souda, an analyst asked for the company's pharma and biotech exposure amid funding pressures and the source of confidence in the 2025 guide. A second question probed how core the biopharma business is, considering its revenue contribution, the Zoma deal, and a recent leadership change.

Answer

CEO Dr. Emily Leproust stated that healthcare exposure is approximately 60% and expressed confidence in navigating funding pressures due to Twist's differentiated products. Regarding the biopharma division, she acknowledged past commercial struggles but highlighted recent order growth and its strategic value in offering a '1-2 punch' of both products and services to the same customer base, which supports the SynBio business.

Puneet Souda from Leerink Partners asked about the sustainability of Decipher's volume growth, specifically if it can exceed 20% in 2026 given current penetration. He also sought insight into Veracyte's MRD position, differentiation strategy, and market approach amidst a competitive landscape with published prospective data from rivals.

Answer

CEO Marc Stapley affirmed confidence in durable double-digit growth for Decipher and Afirma, citing significant remaining market opportunity and lack of headwinds. Chief Medical and Scientific Officer Phil Febbo expressed confidence in Veracyte's MRD test performance, clinical evidence, and commercial channel for muscle-invasive bladder cancer, highlighting ongoing prospective trials and the company's commitment to evidence investment. CFO Rebecca Chambers noted that early looks at 2026 revenue are above street estimates, even with a biopharma revenue headwind, indicating the company's strategy is working.

Puneet Souda inquired about the sustainability of Decipher's volume growth exceeding 20% into 2026, and Veracyte's competitive positioning, market strategy, and differentiation for its MRD test given the evolving landscape.

Answer

CEO Marc Stapley affirmed confidence in durable double-digit growth for Decipher and Afirma into 2026, citing significant remaining market opportunity and strong evidence. Chief Medical and Scientific Officer Phil Febbo expressed confidence in Veracyte's MRD test for muscle-invasive bladder cancer (MIBC) due to its performance, clinical evidence, and commercial channel. CFO Rebecca Chambers added that early 2026 revenue outlook is above street estimates, even with biopharma headwinds, indicating the company's strategy is working.

Puneet Souda of Leerink Partners questioned the growth trajectory and ASP stability for Afirma, given its market maturity. He also asked about the commercial strategy for the MRD test, including sales force structure, customer targeting, and MolDX timing.

Answer

CCO John Leite stated that Afirma's growth will be driven by share gains and enhanced clinical evidence, with no major changes in ordering patterns. He confirmed the MRD launch will leverage the existing Decipher sales channel. CFO Rebecca Chambers noted that the negative impact from a laboratory benefit manager on Afirma's ASP will lapse in November 2025, which should improve its 2026 financial profile. She also confirmed the MRD tech assessment was submitted to MolDX in March.

Puneet Souda asked for clarification on the 2025 guidance not being raised despite a Q1 beat, the growth outlook for Afirma, the financial impact of the Marseille facility, and the differentiation strategy for the Prosigna LDT launch in the U.S.

Answer

CFO Rebecca Chambers clarified that the guidance is for testing revenue only, which met expectations, while the beat was from non-guided product and biopharma revenue. She reiterated high single-digit growth expectations for Afirma. On Marseille, she confirmed the process is on track to conclude by year-end. CEO Marc Stapley and CCO John Leite explained the Prosigna launch is timed with new evidence and will follow the successful Decipher playbook of using clinical data and KOL collaboration to gain share.

Puneet Souda of Leerink Partners asked about the key factors driving Decipher's strong volume growth, particularly the impact of NCCN guidelines, and sought clarification on the future of the Prosigna test given the potential changes to the company's French operations.

Answer

CEO Marc Stapley attributed Decipher's success to its robust Level 1 clinical evidence, which underpins the NCCN guidelines, rather than the guidelines being the sole driver. He clarified that while the French SAS entity's funding is under review, Veracyte is committed to continuing the Prosigna test supply, contingent on finding a buyer for that part of the business, and the long-term IVD strategy remains intact.

Puneet Souda from Leerink Partners asked for the expected forward growth rate for Decipher given its tailwinds and questioned the stability of commercial payer relationships in light of pressures seen by peers in other diagnostic areas.

Answer

CEO Marc Stapley declined to give a specific 2025 growth rate for Decipher but reiterated bullishness based on NCCN guidelines, the metastatic indication ramp in H2 2025, and new payer contracts. He distinguished Veracyte's position by highlighting the extensive clinical evidence supporting Afirma and Decipher, stating they are adding, not losing, commercial payer contracts, with Decipher now over 200 million covered lives.

Puneet Souda sought to understand how the Q3 momentum translates into 2026 guidance, noting the street's expectation of approximately 13% organic growth. He also asked about the gene therapy headwinds for H2 2025, recent news on in vivo CRISPR products, and the expected trend for new modalities overall in 2026.

Answer

President and CEO Olivier Loeillot stated that 2026 guidance would be provided during the Q4 earnings call in late February. He reiterated Repligen's aim to outpace industry growth by 5% over the medium term, expecting to exceed that this year. Loeillot confirmed a 200 basis point headwind in 2026 from a specific gene therapy customer. He highlighted the strength of Repligen's diversified portfolio, with over 80% of products going into monoclonal antibodies, which helps offset headwinds. He noted a good year outside of the specific gene therapy project and mentioned successful diversification into cell therapy and antibody drug conjugates.

Puneet Souda asked about Repligen's perspective on the street's 13% organic growth expectation for 2026, given the company's sustained order momentum. He also inquired about the new modality trends, specifically the gene therapy headwinds in H2 2025, and expectations for 2026.

Answer

Olivier Loeillot, President and CEO, stated that 2026 guidance would be provided in February, but reiterated the goal to outpace industry growth by 5% over the medium term, acknowledging a 200 basis point headwind from a specific gene therapy customer next year. He noted new modalities performed as expected in Q3 (muted demand), but Repligen's diversified portfolio (80%+ mAbs) helps offset headwinds. He also highlighted diversification into cell therapy and antibody-drug conjugates.

Puneet Souda inquired about the drivers of the strong order book, specifically the mix between clinical and commercial demand, and whether customers were pulling orders forward ahead of potential tariffs. He also asked for more detail on the company's gene therapy exposure and the outlook for 2026.

Answer

CEO Olivier Loeillot stated there was very little evidence of order pull-forward, except for a couple of million dollars in China. He noted that the company's business is shifting to be more commercial but did not provide an exact split. Regarding gene therapy, Loeillot confirmed the guidance accounts for a headwind from a specific platform but expressed confidence in other new modalities like cell therapy and ADCs. He declined to comment on 2026 guidance.

Puneet Souda questioned the sustainability of Repligen's growth, asking about the changing mix between clinical and commercial revenue. He also inquired about the commercial strategy for the newly acquired 908 Devices portfolio and the associated integration and cost-saving efforts.

Answer

Executive Olivier Loeillot explained that the clinical/commercial revenue split remains 65/35, but this masks a significant increase in commercial revenue that offset prior-year headwinds, projecting a move toward 50/50 over the next 4-5 years. He added that the 908 Devices integration is on schedule, with a focus on R&D synergies, cross-selling, and manufacturing consolidation to improve the cost base.

Puneet Souda of Leerink Partners questioned the sustainability of Repligen's strong order trends, especially given the less smooth recovery seen at peer companies, and asked if January and February trends were comparable to Q4.

Answer

President and CEO Olivier Loeillot emphasized the sustainability of the order trends, noting that order intake increased sequentially every quarter in 2024, with Q4 up 18% versus Q1. He pointed out that the book-to-bill ratio has been above one for six to seven consecutive quarters and that all franchises, excluding Proteins, saw double-digit order growth in 2024. He declined to comment on the current quarter's performance but stated that 'things are doing well.'

Puneet Souda asked about the business overlap between CDMOs and new modalities, the revenue split between clinical phases, and the company's current M&A strategy.

Answer

President and CEO Olivier Loeillot explained that while an exact overlap isn't tracked, many new modality customers are CDMOs. He noted that about 65% of business is clinical phase and that the M&A strategy remains focused on acquiring unique, differentiating technologies, including larger targets, while still pursuing bolt-on acquisitions like Tantti that offer strong portfolio synergy.

Puneet Souda asked if the observed instrumentation recovery in Q3 was due to China tariffs or broader activity, seeking clarification on customer feedback.

Answer

President and CEO Prahlad Singh confirmed that the activity was a broader trend from pharma biotech customers, not specific to China tariff-related opportunities, indicating increasing discussions on the life sciences instrument side. Souda also inquired about the academic and government segment, specifically reagent growth into 2026 given grant funding dynamics. Senior Vice President of Investor Relations Steve Willoughby stated that the 2%-3% organic growth guidance for 2026 assumes a similar market environment, not a significant ramp-up in underlying market activity. Lastly, Souda asked about the extent of Revvity's manufacturing for China sales being localized within China. Prahlad Singh noted that all reproductive health and newborn screening manufacturing for China is local, and over half of ImmunoDiagnostics manufacturing for China is also local, with capacity to move more if needed.

Puneet Souda questioned the drivers and sustainability of the strong software business growth and asked why it wasn't providing a greater lift to gross margins. He also asked a high-level question about the company's portfolio resiliency.

Answer

CEO Prahlad Singh attributed the 30%+ software growth to strong SaaS bookings and key metrics like net retention, calling it sustainable. CFO Max Krakowiak explained that the margin benefit was offset by the volume drop of high-margin diagnostic assays in China. Singh reiterated confidence in the portfolio's resilience, citing strengths across multiple business lines.

Puneet Souda inquired about the strong growth in the software business, asking if there were any one-time items and what the growth expectations are for Q1 and the full year 2025. He also asked about the company's direct and indirect exposure to NIH funding and how potential headwinds are factored into the guidance.

Answer

CEO Prahlad Singh explained that software revenue can be lumpy due to multi-year contract renewals but follows a predictable pattern, with the net contract value being the key metric. CFO Max Krakowiak confirmed the 2025 software growth outlook is low double-digits. Regarding NIH, Prahlad Singh stated that direct exposure is minimal (~1%) and estimated indirect exposure is not more than 5%. He noted the impact is not material as they primarily sell reagents and small-ticket items, which are essential for ongoing experiments regardless of budget pressures.

Puneet Souda asked for details on the drivers of the strong reagents growth, which outpaced peers, and inquired about management's confidence in China's instrument market once stimulus funds are released.

Answer

CEO Prahlad Singh attributed the reagents outperformance to the broad-based strength and diversity of the portfolio, including ELISA, HTRF, and BioLegend products. He expressed high confidence that the China stimulus program will be a significant growth driver in 2025, citing the large number of funding proposals his team is actively working on.

Puneet Souda asked for more color on bioprocessing, specifically order growth or book-to-bill in the quarter (which was around one last quarter), and Danaher's confidence in monoclonal antibody growth offsetting weakness in the AAV segment and innovative modalities. He also inquired about China's localization policy, including a 20% pricing rebate for local manufacturers, asking how much of Danaher's production and sales in China are manufactured locally (reagents and instrumentation), and where they have defensiveness or need to expand manufacturing if this policy spreads.

Answer

Matt McGrew (EVP and CFO) stated that the book-to-bill for bioprocessing was similar to earlier in the year, around one. Rainer Blair (President and CEO) expressed strong confidence in monoclonal antibody growth (75% of their bioprocessing business) driven by commercial volumes, new applications, and biosimilars, which offsets volatility in some AAV business. He noted that nucleic acid therapies will take time to become standard of care. For China localization, Rainer Blair stated that the 20% rebate for local manufacturers is not new. He confirmed that by year-end, much of their diagnostics businesses (equipment/reagents) will be localized, positioning them advantageously rather than as a headwind. He did not provide specific percentages but indicated strong positioning across the portfolio.

Puneet Souda asked for more color on bioprocessing order growth and book-to-bill in the quarter, noting it was around one last quarter, and sought confidence on monoclonal antibody (MAB) growth offsetting weakness in the AAV segment and other innovative modalities. He also inquired about the localization policy in China, specifically the 20% pricing rebate for local manufacturers, asking about Danaher's current local production and sales in China (reagents and instrumentation), its defensiveness, and any need to expand manufacturing if the policy spreads.

Answer

Matt McGrew, Executive Vice President and CFO, stated that the book-to-bill ratio was similar to what has been seen all year, around one. Rainer Blair, President and CEO, expressed strong confidence in monoclonal antibody (MAB) growth, driven by increasing commercial volumes, new applications, and biosimilars, noting that MABs constitute 75% of the business and their growth helps offset volatility in the AAV segment. Regarding China's localization policy, Mr. Blair clarified that the 20% rebate is not new. He stated that Danaher is very well positioned for localization, with much of its diagnostic businesses (equipment and reagents) expected to be localized by year-end, viewing this as an advantageous position rather than a short-term headwind.

Puneet Souda requested an update on the company's financial exposure to tariffs and asked about the breadth of its exposure to the gene therapy market, particularly AAV-based therapies at Aldevron and Cytiva, in light of recent clinical setbacks for a customer.

Answer

EVP & CFO Matt McGrew estimated current tariff exposure at a 'couple hundred million' dollars and noted they successfully used levers to make the China tariff a net neutral event. President & CEO Rainer Blair described gene therapy as being in its 'early innings' and stated Danaher's total exposure is limited, as it is primarily a 'protein house.' He specified that the guidance already accounted for minimal H2 revenue from the Sarepta therapy via Aldevron.

Puneet Souda asked for clarity on the 2025 outlook for China, specifically seeking a proper jump-off point, the expected impact from value-based pricing (VBP), and the role of local bioprocess competition in the region.

Answer

EVP and CFO Matt McGrew reiterated the VBP impact is estimated at $150 million over three years but noted activity is ramping up, so the timing may shift. President and CEO Rainer Blair advised viewing China as 'bumping along the bottom' and not expecting a change in the short term without a material stimulus rollout. Regarding local competition, Blair stated it exists but is more on the margin, as companies targeting international markets still prefer multinational suppliers like Cytiva for regulatory assurance.

Puneet Souda from Leerink Partners sought clarification on the Sarepta revenue headwind, signs of broader caution in AAV gene therapy, the primary growth drivers for the MVE business, and the competitive landscape.

Answer

VP of IR Thomas Heinzen clarified the $2M Sarepta headwind is for H2 2025 only. Chief Scientific Officer Dr. Mark Sawicki attributed recent FDA caution to a new administration and sees no material market impact. Thomas Heinzen identified strong animal health sales and cryogenic system sales in APAC (ex-China) and EMEA as key MVE drivers. President & CEO Jerrell Shelton asserted that the competitive position is strengthening, not changing significantly.

Michael Almisry, on behalf of Puneet Souda, asked about the drivers behind the 500-basis point year-over-year expansion in service gross margins and whether similar growth could be expected for the rest of the year. He also requested color on clinical trial starts, comparing performance between small and large pharma clients.

Answer

CEO Jerrell Shelton confirmed the significant services gross margin increase, attributing it to leverage from core Cell & Gene Therapy services and expecting the trend to continue, albeit slightly moderated by new initiatives like IntegriCell. Chief Scientific Officer Dr. Mark Sawicki described trial additions as balanced between biotech and large pharma. Shelton added that Q1 saw a strong 32 trial additions, resulting in a net increase of 10.

Puneet Souda asked for details on the 2025 revenue guidance, specifically the service versus product growth assumptions, the potential impact from tariffs, and expectations for clinical trial growth.

Answer

CFO Robert Stefanovich indicated the 2025 guidance is driven by services growth, with a conservative view on products. Executive Jerrell Shelton and VP Thomas Heinzen stated tariff impacts would be passed on via surcharges with no expected margin impact, and that U.S. products are made domestically. Dr. Mark W. Sawicki expects 2025 clinical trial acquisition to be stronger than 2024, with minimal exposure to NIH issues.

Puneet Souda of Leerink Partners questioned the sequential and year-over-year performance of commercial revenue, asked for the rationale behind reiterating full-year guidance amid industry headwinds, and sought clarity on growth assumptions for the MVE business. He also requested an update on the new HV-3 shippers.

Answer

CSO Dr. Mark Sawicki explained that commercial revenue follows a 'stair step' pattern and was up 14% over the nine-month period, with a strong step-up expected in Q4. CEO Jerrell Shelton characterized this as normal for a start-up industry. CFO Robert Stefanovich stated the company is comfortable with its $225M-$235M guidance range and expects modest revenue changes for MVE. Dr. Sawicki added that the HV-3 shippers are in final qualification and will be available by year-end.

Puneet Souda of Leerink Partners asked for more detail on the drivers behind the 20%+ growth target for 2026, particularly the contribution from new federal funding programs. He also requested information on the expected revenue phasing for the AvCAD program, pricing power within grant-funded sales, and the gross margin ramp following the facility consolidation.

Answer

CEO Kevin Knopp outlined three growth catalysts for 2026: modernizing customer equipment with the existing portfolio, launching new products like Viper and the next-gen MX, and scaling the AvCAD program. CFO Joe Griffith added that the US state and local channel provides a steady baseline. On AvCAD, he reiterated it's a potential $10M+ annual opportunity over 5-7 years, likely ramping in 2026. He also confirmed the Danbury manufacturing consolidation is complete, providing ample capacity and setting the stage for future gross margin expansion.

Puneet Souda asked about the expected first-half versus second-half revenue split for the full-year guidance, the timing of revenue recognition for the Texas Department of Public Safety order, and the company's visibility into government contracts. He also followed up with questions on pricing levers for gross margin and the capacity utilization of the new Danbury facility.

Answer

Executive Joseph Griffith confirmed the Texas DPS order is a Q2 revenue event and that the company anticipates a back-half weighted ramp consistent with typical seasonality. He noted visibility comes from tracking large, multi-unit opportunities. Executive Kevin Knopp added that the company's transformation aligns with federal tailwinds in national security and law enforcement. Regarding margins, Knopp stated that pricing is holding for 2025 and that the Danbury facility move should yield immediate benefits with very little underutilization, as future product launches will fill out the space.

Puneet Souda from Leerink Partners inquired about the strategic process that led to the divestiture of the desktop bioprocessing portfolio to Repligen, asking if it was a competitive process. He also asked for clarification on any assumptions related to tariffs for Canada and Mexico and for details on MX908 installations and full-year expectations for handhelds.

Answer

CEO Kevin Knopp detailed that the company was approached by a potential acquirer, which led to a competitive bidding process that Repligen ultimately won. He emphasized the decision allows focus on the higher-growth handheld business. CFO Joe Griffith stated that while the company is monitoring potential tariff impacts, it is not a major concern for its primarily U.S.-based supply chain. He also highlighted strong combined handheld placements, including a significant MX908 order from Romania.

Puneet Souda asked if there are any structural or competitive issues in the handheld market contributing to the guidance miss, beyond government budget delays. He also inquired about the recovery trajectory for the desktop business into the first half of 2025 and questioned if the recent workforce reduction has appropriately rightsized the company to capitalize on a market recovery.

Answer

Executive Kevin Knopp denied any structural or competitive issues in the handheld market, attributing the weakness to the compressed government spending period and election-related uncertainty. He highlighted that core MX908 grew 20% when excluding the prior year's large AVCAD delivery. For desktops, he anticipates a sequential improvement in Q4 driven by partnerships but did not provide a specific outlook for H1 2025. Knopp affirmed that the 11% workforce reduction has rightsized the organization, enhancing agility while maintaining the capacity for future growth by leveraging direct sales and expanded channel partnerships.

Puneet Souda from Leerink Partners asked about the expected volume growth cadence for TissueCypher and sought details on the DecisionDx-SCC reconsideration request, including timelines and the contents of the submission.

Answer

CFO Frank Stokes stated that the guidance assumes continued strong growth for TissueCypher, which is not yet showing seasonality due to low penetration. Founder, CEO, & President Derek Maetzold detailed that the SCC reconsideration package included significant new clinical evidence published after the MACs' comment periods closed, and they expect a response from MolDx by early September.

Puneet Souda from Leerink Partners sought to reconcile the full-year growth outlook, asking for the implied growth for TissueCypher given the guidance for DecisionDx-Melanoma. He also asked about the TissueCypher sales force and commercial reimbursement progress.

Answer

CFO Frank Stokes confirmed that growth beyond melanoma is driven by TissueCypher and noted potential for ASP improvement in melanoma. CEO Derek Maetzold stated the company is assessing the impact of its recent expansion to 65 GI sales reps before committing to further hiring, acknowledging the current team size might be low for the target market.

Puneet Souda asked for an update on NCCN guidelines for melanoma, the impact of a peer's non-coverage decision on IDgenetix, the company's most defensible reimbursement areas, and the status of commercial payer efforts for melanoma.

Answer

CEO Derek Maetzold expects potential NCCN updates in December or early 2025. CFO Frank Stokes stated the peer's non-coverage decision has a minimal impact on IDgenetix and that the company continues to pursue commercial coverage for all its tests by generating strong clinical evidence. Stokes noted the challenge in pharmacogenomics reimbursement is that payers do not directly bear the cost of ineffective treatment.

Puneet Souda asked about the conversion strategy for legacy mammography gantries and the potential impact of recent changes to the USPSTF committee on testing guidelines.

Answer

CEO Stephen MacMillan described the gantry replacement as a steady, improving process, with the end-of-life program converting older units to the current product, while the new Envision system will target thought leaders later next year. Regarding the USPSTF, he expressed confidence that the fundamental importance of Hologic's tests insulates the business from short-term committee changes.

Puneet Souda asked a combined question about Hologic's supply chain mitigation strategies for tariffs and why the company doesn't anticipate more capital expenditure pressure from hospitals for its gantries, especially with a new launch approaching.

Answer

CEO Stephen MacMillan responded that Hologic is evaluating options but feels well-positioned with its U.S.-centric manufacturing for diagnostics and mammography. He stated they are not planning to move their established Costa Rica operations. Regarding capital spending, he expressed confidence that hospitals will budget for the new gantry because it offers a meaningful product improvement and is not a massive purchase price for them.

Puneet Souda inquired about changes to sales incentives in the Breast Health division and the resilience of hospital capital spending on mammography systems if budget pressures were to increase.

Answer

CEO Stephen MacMillan expressed confidence that mammography equipment remains a high-priority capital expenditure for hospitals, even in challenging budget environments, due to its critical role in women's health. He noted that the sales force is now re-engaging its focus on driving gantry sales, a shift from the period during the chip shortage when product delivery was constrained.

Puneet Souda asked for a breakdown of the revised full-year guidance by business segment, the company's confidence in the guide given macro headwinds, Q2 expectations, whether Simoa ONE could cannibalize HD-X sales, and the revenue outlook for Lucent Diagnostics given the competitive landscape.

Answer

CFO Vandana Sriram explained the guidance assumes instruments will be flat to 2024, consumables will remain sticky, and the Accelerator business will see the largest year-over-year drop. She expects H1 to represent 45-48% of full-year revenue. CEO Masoud Toloue asserted that Simoa ONE will not cannibalize the HD-X, as it's a workhorse in neurology and the new platform will initially focus on immunology/oncology. Regarding LucentAD, he expressed high confidence in its superior multi-marker algorithm and noted that revenue contribution is gated by therapy adoption, but the company is investing heavily to build out its commercial infrastructure.

Puneet Souda challenged the 2025 guidance, noting it was well below Street expectations, and asked how the company could be confident in a second and third-quarter recovery given market uncertainty. He also questioned why Quanterix continues to value Akoya the same as it did in early January, despite a significant deterioration in the macro environment and sector valuations since the deal was announced.

Answer

President and CEO Masoud Toloue defended the guidance by highlighting Quanterix's double-digit growth in 2024 and stating that the current academic market pressure, which he views as transient, is fully baked into the 2025 forecast. Regarding the Akoya valuation, he emphasized that the decision is based on long-term value creation, not short-term market swings. He reiterated the deal's core benefits: an expanded addressable market, $40 million in derisked cost synergies, and an accelerated path to scale and profitability, with positive free cash flow expected in 2026.

Puneet Souda of Leerink Partners asked about the competitive positioning of the multi-marker assay, the 2025 OpEx outlook given FDA and commercialization efforts, and trends observed between academic and biopharma customers.

Answer

President and CEO Masoud Toloue emphasized that LucentAD Complete is unique as a five-marker algorithmic test, which significantly reduces the intermediate zone compared to competitors' single-marker assays. Executive Vandana Sriram stated that the current OpEx run rate is representative and that while 2025 will see further investment, the company has flexibility to scale spending based on market development. She also confirmed that instrument softness was seen across both academic and pharma customer segments.

Puneet Souda of Leerink Partners asked how recent clinical updates for competing molecules like rocatinlimab and amlitelimab inform AbCellera's view on the opportunity for its OX40L asset, ABCL575. He also inquired if AbCellera's Canadian base and IP domicile are factors in partnership discussions, given potential pharma tariffs.

Answer

President and CEO Dr. Carl L. Hansen stated that recent data, including Sanofi's positive subset results in asthma and other early data in alopecia and HS, reinforce the thesis that the OX40 ligand class will be large and applicable across many indications. He viewed these as positive tailwinds for ABCL575. CFO Andrew Booth addressed the IP question, stating that AbCellera's IP is held in Canada, which remains a good jurisdiction, and that spinning off assets is not a current topic of discussion.

Puneet Souda of Leerink Partners asked for an update on the GMP facility and potential impacts from the BIOSECURE Act, and also requested that management outline its near- and medium-term priorities heading into 2025.

Answer

CFO Andrew Booth updated that the GMP facility will see its first molecules in late 2025. President and CEO Dr. Carl Hansen added that controlling their own manufacturing provides a strategic advantage given geopolitical headwinds like the BIOSECURE Act. Dr. Hansen outlined the company's priorities as: 1) making smart capital allocation decisions to find a 'big winner' in their pipeline, 2) backing it up with a differentiated portfolio, and 3) maintaining operational efficiency.

Speaking on behalf of Puneet Souda, Michael Almisry asked about the drivers behind the strong number of new program starts in Q1 and whether the strength was balanced across partner types. He also inquired about the new exploration platform, seeking confirmation it is for existing partners and asking how its promotional costs align with the lowered operating expense guidance.

Answer

Matthew Foehr, President and CEO, attributed the program growth to continued innovation, new technologies like OmniAb, and momentum carrying over from late 2024, while noting that starts can be lumpy. He confirmed the exploration platform is a 'partner access program' for their 95 partners and stated its launch costs were already factored into the company's financial plans and updated guidance.

Puneet Souda from Leerink Partners sought clarification on the 2025 revenue guidance, particularly the cash versus non-cash components, the impact of NIH funding concerns on academic partners, and whether strong Q4 program additions continued into Q1.

Answer

CFO Kurt Gustafson explained the $20M-$25M revenue guidance is a GAAP figure, with the year-over-year decline driven by lower non-cash service revenue recognition; he noted that actual cash receipts are expected to increase in 2025. CEO Matthew Foehr stated that NIH funding concerns have not impacted academic partnerships, citing a recent new deal. Gustafson cautioned that program addition reporting can be lumpy and not to extrapolate from a single strong quarter.

Michael Almisry, on behalf of Puneet Souda, inquired about the drivers behind the significant increase in active programs, asking to distinguish between a macro biopharma recovery and company-specific gains, and also asked if the new OmniHub platform would be an additional revenue stream.

Answer

President and CEO Matt Foehr attributed the strong program growth to the company's new technologies, particularly the OmniAb platform for single-domain antibodies, and the overall validation of their platform. He clarified that OmniHub is an integrated tool designed to enhance partner collaboration and accelerate discovery workflows, rather than being a separate, billable line item.

Asked about the initial traction and volume mix of Cologuard Plus since its launch and how it's factored into the Q2 and full-year guidance.

Answer

Cologuard Plus is currently available for Medicare Part B patients, which is about 15% of their volume. The Q2 guidance reflects this, and the volume will grow as they secure contracts with Medicare Advantage and commercial payers. They are already testing a large volume of Cologuard Plus tests and will provide updates as they sign on more payers.

Puneet Souda of Leerink Partners questioned why the 2025 pricing lift from Cologuard Plus is only guided to 2 points and what factors could increase it. He also asked about the expected price for the Cancerguard test.

Answer

CFO Aaron Bloomer explained the 2-point lift assumes a Q2 launch impacting only the Medicare fee-for-service population (15% of volume), with the benefit weighted to the second half of the year. CEO Kevin Conroy added that there is potential upside as they renegotiate commercial contracts, but the current assumption is that this will occur more in 2026. The Cancerguard pricing question was deferred.

Asked why the price lift from Cologuard Plus is not expected to be more than 2 points and what levers could drive it higher. Also asked for a pricing assumption for Cancerguard.

Answer

Aaron Bloomer explained the 2-point lift assumes a Q2 launch only for the Medicare fee-for-service population (15% of volume), with most of the impact in the second half of the year. Kevin Conroy added that there is potential upside if commercial contracts are updated faster than assumed. The Cancerguard pricing question was deferred.

Puneet Souda questioned why the Cologuard Plus pricing lift is only expected to be 2 points in 2025 and asked about the pricing assumption for the upcoming Cancerguard test.

Answer

CFO Aaron Bloomer explained that the 2-point lift assumption is conservative, as it only includes a Q2 launch for the Medicare fee-for-service population (about 15% of volume) and accounts for the lag time between order and revenue recognition. He noted there is potential upside as commercial payer contracts are renegotiated. The question on Cancerguard pricing was deferred.

Puneet Souda from Leerink Partners asked if there was an 'air pocket' from switching to the Exact Nexus platform and if they have seen any impact from a competitor's blood-based test launched in August.

Answer

CEO Kevin Conroy confirmed there was a negative impact from moving Oncotype DX onto the Exact Nexus platform, as they anticipate not being paid for some processed tests, which contributed to the revised Q4 outlook. He also stated that based on research and anecdotal evidence, the company has seen no impact on its business from the competitive blood-based test launch.

Puneet Souda from Leerink Partners asked if there was an 'air pocket' or disruption from transitioning Oncotype DX to the Exact Nexus platform and whether a competitor's blood-based test launched in August had any market impact.

Answer

CEO Kevin Conroy confirmed there was a negative impact from moving Oncotype DX onto the Exact Nexus platform, as transitional challenges meant the company does not expect to be paid for some tests performed. He stated this was a component of the Q4 outlook. Regarding competition, he said the company has stayed close to the situation and has seen no impact on its business from the competitor's blood-based test, based on both anecdotal evidence and research.

Puneet Souda asked if the FDA would likely approve a blood-based assay with performance lower than a recently approved competitor test. He also inquired about the expected adoption rate of Cologuard Plus by primary care physicians upon its launch.

Answer

CEO Kevin Conroy stated that any test meeting its pre-established study endpoints, particularly the 74% Medicare minimum for sensitivity, is likely to gain FDA approval. Regarding Cologuard Plus adoption, he highlighted that its lower false positive rate (7% vs. 10% for original Cologuard) is a key driver. He noted that this improvement means tens of thousands fewer unnecessary colonoscopies at a population level, a significant benefit that he expects will drive physician adoption.

Puneet Souda asked about the current sentiment among large biopharma versus emerging biotech customers and how Thermo Fisher is positioned for a potential shift in drug discovery towards China, given the increase in IND filings from Chinese assets.

Answer

Marc Casper, Chairman, President and CEO, reported a "real change in confidence" among large pharma customers and a "reasonably confident" funding outlook for emerging biotech. Regarding innovation from China, he noted that while more licensing originates there, extensive development work still occurs in Western labs post-licensing, ensuring Thermo Fisher is well-positioned globally to support these programs.