Tycho Peterson

Tycho Peterson asked about the company's plans for MRD, including timelines for data, prioritized indications, and their competitive advantage. He also inquired about expanded coverage for Unity, specifically carrier screening, and any impact from competitor launches like the Fetal Focus assay.

Answer

Oguzhan Atay, Co-founder, CEO, and Board Chair, explained that BillionToOne is focusing on tumor-naive MRD, where their SMNGS QCT technology uniquely solves the noise problem that drives others to tumor-informed approaches, allowing for ultrasensitive levels. They plan a pan-cancer assay launch towards the end of 2026, coinciding with expected coverage for their response test. He stated that as of December 9, there has been no impact on their business from competitive launches, and they continue to grow as expected.

Tycho Peterson asked about BillionToOne's timelines for Minimal Residual Disease (MRD) data, prioritized indications, and the company's competitive advantage in this space. He also inquired about expanded coverage for UnityToOne, specifically on the carrier screening side, and any observed impact from recent competitive launches like the Fetal Focus assay.

Answer

Oguzhan Atay, Co-founder and CEO, explained that BillionToOne's SMNGS technology uniquely addresses the noise problem, enabling ultrasensitive tumor-naive MRD, which is a key differentiator from tumor-informed approaches. He anticipates a pan-cancer MRD assay launch towards the end of 2026, coinciding with expected coverage for the response test. Atay confirmed no observed impact on BillionToOne's business from competitive launches in the prenatal space, as reflected in Q3 performance and Q4 guidance.

Tycho Peterson inquired about the performance of BIOVECTRA, noting a discrepancy between guidance and actual results, and asked if the increased capital expenditure was primarily for CDMO. He also questioned the drivers behind the 75 basis points margin improvement guidance for FY2026 and if higher top-line growth could lead to better margin expansion.

Answer

President and CEO Padraig McDonnell expressed satisfaction with BIOVECTRA's strong year, driven by GLP business, and a robust book of business for 2026. CFO Adam Elinoff clarified that the incremental $100 million CapEx is allocated to NASD capacity and consumable expansion. Regarding margins, Mr. Elinoff explained the 75 basis points improvement is due to Ignite pricing optimization, operational efficiencies, tariff mitigations, and volume growth, which offsets inflationary impacts and funds strategic investments in digital, AI, and R&D.

Tycho Peterson asked about the dynamics of BioVectra's performance, noting it came in below guidance, and inquired if the $100 million increase in CapEx was solely for CDMO. He also sought details on the 75 basis points margin guidance for 2026 and if a higher top line could lead to better margin performance.

Answer

President and CEO Padraig McDonnell expressed satisfaction with BioVectra's strong performance, driven by the GLP business and successful integration. CFO Adam Elinoff clarified that the incremental CapEx is for NASD capacity and consumable expansion. Elinoff further explained that the 75 basis points margin improvement for 2026 is driven by Ignite pricing optimization, operational efficiencies, tariff mitigations, and volume growth, while also offsetting inflationary impacts and funding strategic investments in digital, AI, and R&D.

Tycho Peterson of Jefferies Financial Group asked for more detail on the easing of executive sign-offs in pharma, the performance of the PFAS business in the U.S., and the timing of the decision to increase commercial investment.

Answer

CEO Padraig McDonnell confirmed that reduced dependency on high-level approvals is a global trend in large pharma, improving the velocity of the instrument replacement cycle. He noted that while the PFAS business was down 20% in the Americas due to EPA-related uncertainty, it grew low-double-digits globally. The decision to increase commercial spending was described as a dynamic response to strong order momentum and new product success.

Tycho Peterson of Jefferies asked for more detail on the reduced dependency on executive-level approvals for purchases in the pharma market, questioned the performance of the PFAS business in the U.S., and inquired about the timing of the decision to increase commercial investments.

Answer

President and CEO Padraig McDonnell confirmed that the reduced need for high-level approvals is a global trend, particularly in small molecule pharma, which is improving the velocity of the replacement cycle. He stated that while global PFAS grew low-double digits, the Americas were down 20% due to uncertainty from U.S. EPA changes. McDonnell explained the commercial investment was a dynamic decision made to capitalize on strong market momentum and new product ramps like the Infinity Tree and Pro IQ LC MS.

Tycho Peterson of Jefferies asked about the full-year growth outlook for the NASD business, capacity utilization at its facilities, and whether onshoring trends were increasing pharma interest. He also inquired about the adoption rate of the new InfinityLab LC and the status of the GC replacement cycle.

Answer

Simon May, President of the Life Sciences & Diagnostics Markets Group, expressed growing confidence that NASD could reach double-digit growth for the year and noted that capacity utilization is becoming a positive driver. CEO Padraig McDonnell did not provide a specific adoption percentage for InfinityLab LC but reiterated its success. Mike Zhang, President of the Applied Markets Group, described the GC replacement cycle as a significant opportunity that will materialize over the coming quarters and years.

On behalf of Tycho Peterson, an analyst asked for data points to better understand the shape and pace of the instrument replacement cycle, looking out over the next few years.

Answer

CEO Padraig McDonnell stated that the Infinity III has kicked off a steady replacement cycle, driven by an aging installed base. CFO Bob McMahon added that they are in the 'early stages' of recovery, the average age of the installed base is older than normal, and order growth outpaced revenue growth in the quarter, suggesting a long runway for replacement.

Tycho Peterson asked for a performance breakdown of LC versus mass spectrometry within the pharma segment and questioned the risk of a spending pause from pharma customers. He also inquired about the NASD business, including cross-selling with BIOVECTRA.

Answer

CEO Padraig McDonnell stated that Agilent is not seeing a spending pause from pharma customers. CFO Robert McMahon specified that within pharma, LC/LCMS was up low single digits. On the CDMO business, McDonnell and LDG President Simon May confirmed strong engagement and cross-selling potential between NASD and BIOVECTRA. May projected high single-digit growth for NASD in FY25, supported by a strong order book, though some revenue benefits from current qualifications will materialize in FY26.

Tycho Peterson from Jefferies Financial Group Inc. asked about the BIOVECTRA acquisition, focusing on synergies with the NASD business, capacity implications, and the mix of clinical versus commercial revenue. He also inquired about the implied Q4 guidance for China and the outlook for a return to growth in 2025.

Answer

CEO Padraig McDonnell described BIOVECTRA as a strong strategic fit that enhances capabilities in gene editing and ADCs. Simon May, President of DGG, highlighted synergies in offering a complete gene editing solution and sterile fill-finish capabilities. On China, CFO Bob McMahon guided to a mid-single-digit decline for Q4 against easier comparisons and expects a gradual improvement throughout fiscal 2025, with stimulus benefits likely materializing then.

Tycho Peterson inquired about the BIOVECTRA acquisition, focusing on synergies with the NASD business, capacity implications, and the business mix. He also asked for the implied Q4 guidance for China and the outlook for its return to growth in 2025.

Answer

CEO Padraig McDonnell and DGG President Simon May detailed the BIOVECTRA deal, highlighting synergies in providing a complete gene editing solution, sterile fill-finish capabilities, and an entry into microbial fermentation for modalities like GLP-1s. CFO Bob McMahon addressed the China outlook, guiding to a mid-single-digit decline for Q4 against an easier comparison and expecting continued, steady improvement into FY25.

Tycho Peterson inquired about the drivers of Pharma strength in the Americas and China, the durability of the instrument replacement cycle, and the factors contributing to the double-digit Chemistry growth, which is tracking above historical trends.

Answer

President and CEO Udit Batra highlighted double-digit Pharma growth across regions, driven by the replacement cycle, new products like Alliance iS and Xevo TQ Absolute, GLP-1 testing, and biologics characterization. He noted China's growth from CDMOs supporting local biotech and India's generics market. CFO Amol Chaubal added that new product launches in Chemistry, especially bioseparations, are significantly contributing to growth by addressing unmet customer needs.

Tycho Peterson asked about the drivers of pharma strength in the Americas and China, the durability of the instrument replacement cycle, and the factors contributing to the double-digit chemistry growth.

Answer

CEO Udit Batra highlighted double-digit pharma growth across regions, driven by the instrument replacement cycle (Alliance iS up 30%, Xevo TQ Absolute up 30%), GLP-1 testing doubling, and strong performance in biologics characterization and bioseparations. In China, growth was fueled by CDMOs supporting local biotech, while India generics grew in high teens. CFO Amol Chaubal added that new chemistry product launches, solving critical unmet needs, quickly add significant revenue, with BD unlocking further growth opportunities in bioseparations.

Tycho Peterson of Jefferies Financial Group questioned the sustainability of the high single-digit LCMS growth, given the deceleration from Q1 and tougher upcoming comps. He also asked for the reasons behind the TA division's 20% decline in the Americas and sought details on the drivers and durability of the strong performance in China.

Answer

President and CEO Dr. Udit Batra stated they are not seeing a slowdown in the replacement cycle and that funnels remain strong, especially in downstream pharma. He attributed the TA division's weakness to macroeconomic conditions impacting materials science customers in the US. For China, he noted double-digit growth was broad-based across pharma (CDMOs), industrial (batteries), and A&G (localization), with only a modest stimulus impact. SVP & CFO Amol Chaubal added that the back-half guide conservatively assumes 5% instrument growth.

Tycho Peterson of Jefferies Financial Group questioned the sustainability of the high single-digit LC/MS growth given difficult upcoming comps, and asked about the performance of the new Xevo XR. He also sought an explanation for the 20% decline in the TA division in the Americas and inquired about the drivers of the strong performance in China.

Answer

President and CEO Dr. Udit Batra confirmed they are not seeing a slowdown in the replacement cycle, citing strong funnels in pharma and CDMOs. He attributed the TA division's weakness to macroeconomic pressures on materials science customers in the US. For China, he highlighted strength in battery testing (TA), localized products (A&G), and CDMOs (pharma). SVP & CFO Amol Chaubal added that guidance for the second half remains conservative, with instrument growth assumed at 5%, not reflecting the current strong momentum.

Tycho Peterson of Jefferies questioned the company's pricing strategy, its ability to realize price increases without pharma pushback, and the long-term sustainability of its strong growth in India.

Answer

CFO Amol Chaubal detailed a 200 basis point like-for-like price gain, plus an additional 50 basis points from tariff-related surcharges. CEO Udit Batra expressed confidence in the pricing, citing strong customer acceptance due to product innovation and collaboration on surcharges. Batra also affirmed the sustainability of India's growth, noting that Indian generics companies have global footprints and can adapt to macro shifts.

Tycho Peterson inquired about the impact of Q4 budget flush dynamics, the progress of the instrument replacement cycle, particularly the mix of Alliance iS, and the company's capital allocation priorities between M&A and share repurchases.

Answer

President and CEO Dr. Udit Batra described the Q4 budget flush as typical of a pre-pandemic year and highlighted strong instrument growth, with the Alliance iS system reaching 20% of HPLC sales. He noted the replacement cycle is beginning in earnest with large pharma. SVP and CFO Amol Chaubal added that the company is open to M&A, comfortable with leverage up to 2.5x, and focused on financially disciplined, accretive deals.

Tycho Peterson asked about the LC replacement cycle, specifically the mix between Alliance iS and Arc systems, the impact of new modules, and future growth drivers like patent expirations and oral GLP-1s. He also inquired about the 2025 outlook and capital allocation priorities.

Answer

President and CEO Dr. Udit Batra confirmed the LC replacement cycle is beginning, driven by large pharma QA/QC and strong demand in India. He highlighted that the new Alliance iS is a key factor in replacement discussions alongside the Arc HPLC. Batra noted a significant long-term opportunity from upcoming patent expirations. While declining to give specific 2025 guidance, he outlined key variables including stable recurring revenue, growth from generics and PFAS, and the pace of the replacement cycle and China stimulus. He described capital allocation as a balanced strategy prioritizing organic growth, followed by disciplined M&A and shareholder returns.

Tycho Peterson sought clarification on Avantor's lab market pricing strategy for next year, questioning if the company is committing to taking price given previous indications of trading price for share. He also asked for the rationale behind the $500 million share repurchase program, considering the early stage of the new CEO's tenure and the volatile market. Finally, he inquired whether the bioscience shipping timing issues are expected to resolve in Q4 and what is factored into the guidance.

Answer

R. Brent Jones, EVP and CFO, clarified that Avantor is realizing modest price increases against raw material inflation, with margin pressure stemming from the differential between price and COGS, while still aiming to accrete operating income and drive volume. Emmanuelle Ligner, President and CEO, stated the share repurchase demonstrates confidence in the company's long-term value and turnaround potential. He confirmed some improvement in Q4 for shipping issues but noted that some plant equipment investments require time.

Tycho Peterson sought clarification on Avantor's pricing strategy in the lab market, asking if the company is committing to taking price next year and how this aligns with previous messaging. He also questioned the rationale for the $500 million share repurchase program given the early stage of the turnaround, and whether Q3 bioprocessing shipping issues are expected to be recaptured in Q4 guidance.

Answer

EVP and CFO Brent Jones clarified that Avantor is taking price against raw material inflation, with margin pressure stemming from the differential between price and COGS. President and CEO Emmanuel Ligner stated the share repurchase reflects confidence in the company's long-term value and turnaround potential. He confirmed that the team is working to improve Q3 shipping issues, expecting some recapture in Q4, but noted that plant equipment investments take time.

Tycho Peterson asked for clarification on the free cash flow guidance cut, its connection to the $100 million in lab contract wins, and the mechanics of associated rebates. He also questioned the path to margin stabilization in the lab business and sought details on the timing and nature of the bioprocessing customer headwinds.

Answer

EVP & CFO R. Brent Jones confirmed the free cash flow reduction was driven by prepaid rebates on the new contracts and lower EBITDA. President & CEO Michael Stubblefield denied any channel stuffing, clarifying they are share gains with upfront payments. Stubblefield added that the customer headwinds materialized mid-quarter and outlined actions to improve performance, including enhancing delivery, increasing commercial intensity, and driving innovation.

Tycho Peterson asked for more color on the 'strong' Bioprocess order book, including demand trends and end-market mix. He also inquired about the size of the controlled environmental consumables business and the strategy to turn around its recent weakness.

Answer

CEO Michael Stubblefield described the Bioprocess order book momentum as broad-based across the portfolio and customer types, including large pharma, biotechs, and CDMOs. He explained that controlled environment consumables are part of the Bioprocessing platform and that the unexpected Q1 pullback was due to customer usage optimization. He added that the commercial team has increased its intensity and is seeing encouraging trends in recent order rates.

An analyst on behalf of Tycho Peterson sought clarification on academic and government performance, asked where lab share gains were occurring, and probed the level of conservatism in the mid-to-high single-digit bioprocess growth guidance.

Answer

CEO Michael Stubblefield clarified that higher education has been a bright spot driving share gains, while the government piece was weaker. He reiterated that the bioprocessing guidance is a prudent starting point for the year, with Q1 expected to be the low point followed by gradual improvement despite tougher comps later in the year.

Tycho Peterson requested more detail on the wide Q4 guidance range for both revenue and margins. He also asked for the outlook on the semiconductor and NuSil businesses within the Bioscience Production segment.

Answer

EVP and CFO Brent Jones explained the Q4 revenue range reflects uncertainty around the seasonal ramp in the lab business, with the margin outlook expected to be consistent with Q3. President and CEO Michael Stubblefield described the NuSil platform as performing well with a strong long-term outlook, while confirming that the semiconductor business recovery had stalled in the U.S., impacting near-term results.

Tycho Peterson of Jefferies sought further insight into the central lab business's strength, specifically the acceleration observed in Q3 compared to Q2, and the expected durability of this positive trend.

Answer

Chairman and CEO Adam Schechter confirmed the central lab business's continued strength, reporting 10% growth (7% constant currency) and projecting mid-single-digit growth for the full year. He highlighted a strong book-to-bill and the presence of several large, multi-year studies, indicating sustained growth that is expected to offset softness in early development.

Tycho Peterson probed further into the strength of the central lab business, asking about the acceleration seen in Q3 and the durability of this trend.

Answer

Chairman and CEO Adam Schechter confirmed the central lab business remains strong, with 10% top-line growth (7% constant currency), which is a very healthy rate. He expects mid-single-digit growth for the full year, consistent with typical central laboratory performance. Strong book-to-bill and several large, multi-year studies contribute to its durability, offsetting softness in early development.

Tycho Peterson from Jefferies Financial Group inquired about new test launches, specifically asking about the market opportunity for Alzheimer's diagnostics and the adoption and strategy for Minimal Residual Disease (MRD) tests.

Answer

President, CEO, and Chairman Adam Schechter emphasized that the company's strategy is not about a single test but about offering a broad portfolio. He explained that specialty tests like MRD are critical because they pull through a significant volume of other routine tests for the same patient. In oncology, LabCorp aims to be a leader in therapy selection and MRD monitoring, while taking a more measured 'follower' approach in the long-term cancer screening market.

Tycho Peterson of Jefferies asked about a key diagnostic partnership, inquiring about the resources required ahead of its launch and the potential impact from regulatory and legal developments like the Braidwood case. He also sought more detail on the legislative strategy regarding PAMA and the SALSA Act.

Answer

CEO Adam Schechter deferred specific questions about litigation and launch timing to the partner company but affirmed that Labcorp will be prepared to launch when appropriate. Regarding PAMA, he explained that Labcorp's trade group is actively working with lawmakers from both parties to find a more logical legislative solution than the current framework, but his base case assumption remains that PAMA will be implemented in 2026.

Tycho Peterson of Jefferies Financial Group asked about the ROI on various OpEx investments beyond sales hires, the drivers behind the significant increase in CapEx, the current denial rates and future leverage, and an update on the traction of earlier product launches like cerebral palsy and IEI.

Answer

Kevin Feeley, CFO, detailed OpEx investments in commercial expansion, R&D, and customer experience as crucial for long-term market share, with Katherine Stueland, CEO and President, emphasizing strategic sales rep deployment and brand awareness. Kevin attributed CapEx growth primarily to sequencer additions for volume scale. He reported mid-to-high 50% collection rates, bolstered by high Medicaid payment rates. Katherine confirmed that new indications like cerebral palsy and IEI are contributing to growth, highlighting underutilization.

Tycho Peterson asked for more color on the ROI of GeneDx's OpEx investments, specifically flagging sales hires, the first brand campaign, international expansion, and product/technology investments, and their relative meaningfulness. He also inquired about the threefold increase in CapEx over the last year, asking if it relates to the Maryland facility or Fabric Genomics, and how to think about future CapEx. Additionally, Peterson sought an update on denial rates at quarter-end and the expected leverage in H1 2026, and an update on the tracking of earlier launches this year, such as cerebral palsy and IEI.

Answer

Kevin Feeley, CFO, explained that OpEx investments are crucial for expanding into new physician types beyond the current three, targeting 60,000 pediatricians. He noted that CapEx is primarily for additional sequencers to keep pace with scaling volumes, with the Maryland facility having ample room. Feeley stated that collection rates are in the mid-to-high 50s, with Medicaid payment rates around 80%, and expects the average collection rate to remain at or higher than current levels. Katherine Stueland, CEO and President, added that the brand campaign aims to raise awareness among general clinicians and parents, and new indications like cerebral palsy and IEI are contributing to growth due to vast underutilization of testing.

Tycho Peterson asked about potential adoption hurdles for the new AAP guidelines, such as pediatrician workload, the timeline for securing commercial payer coverage, and the outlook for state-level Medicaid expansion.

Answer

CEO Katherine Stueland addressed adoption concerns by highlighting plans to simplify the entire customer and reporting experience and empower parents via a portal. CFO Kevin Feeley noted the 18-24 month adoption timeline includes the period needed to educate payers. Both executives expressed confidence in continued state Medicaid expansion, with Katherine Stueland emphasizing the test's cost-saving value proposition.

Tycho Peterson from Jefferies Financial Group asked about potential adoption barriers in the pediatrician market, the timeline for getting commercial payers to adopt new guidelines, and the outlook for state-level legislation and potential Medicaid headwinds.

Answer

CEO Katherine Stueland addressed adoption barriers by highlighting plans to simplify the entire customer experience to reduce reliance on specialists. CFO Kevin Feeley noted the 18-24 month adoption timeline includes the lead time needed to present data to payers. Management expressed confidence in continued state-level Medicaid expansion, positioning GeneDx's value proposition as a cost-saver for the healthcare system.

Tycho Peterson sought details on the expected contribution from new clinical indications, the potential mix for ultraRapid testing, the rationale for gross margin guidance, the trajectory for denial rates, and what to watch for in the pharma business.

Answer

CFO Kevin Feeley stated that new indications are blended into the overall 30%+ volume guide and it's too early to predict the ultraRapid mix. He described the gross margin guidance as a prudent raise, pending reimbursement data on new launches. He expects denial rates (currently mid-40s) to continue improving quarterly. CEO Katherine Stueland advised watching for a 'steady drumbeat' of new pharma partnerships, though revenue impact remains nascent.

Tycho Peterson probed into the reagents business, asking if it declined in Q3, about the go-forward incremental margins (previously 60-70%), and the impact of pricing and inflation on its margin profile.

Answer

Senior Vice President of Investor Relations Steve Willoughby confirmed reagents were down very slightly year-over-year in Q3 due to lighter summer months, but reiterated no change in the power of incremental margins, with pricing holding firm and expected margin benefits as lab activity ramps. Peterson also asked if a pharma budget flush into year-end was baked into guidance and if it represented a call option for Q4. Senior Vice President and CFO Max Krakowiak noted a modest seasonal step-up for instruments in Q4, not fully back to historical budget flush levels, but acknowledged an uptick in instrumentation pipeline activity. Lastly, Peterson inquired about the 2026 tax rate baseline of 18%, its sustainability, and potential for further leverage. Krakowiak praised the tax team for resetting the baseline from 20% to 18%, stating that the company forecasts based on this baseline without factoring in one-time benefits.

Tycho Peterson of Jefferies asked for the full-year outlook for pharma instruments, considering potential R&D cuts and the long-term trend of phasing out animal testing. He also questioned why Revvity's consumables business grew while peers' declined, asking if it was due to price or market share gains.

Answer

CEO Prahlad Singh explained that the company's in vivo imaging is used in early research with small rodents, which can help reduce larger animal experiments, positioning it as a tailwind for the FDA's 3.0 agenda. He noted any R&D pressure would likely remain on the CapEx side. CFO Maxwell Krakowiak attributed the strong consumables performance to product differentiation and commercial execution rather than speculating on specific market share shifts.

Tycho Peterson inquired about the drivers behind the strength in analytical instruments, specifically asking if it was primarily due to mass spectrometry or cryo-electron microscopy. He also sought insights into the segment's momentum heading into year-end, potential budget flush impacts in 2026, and any early signs of pickup from onshoring.

Answer

Marc Casper (Chairman, President and CEO) attributed the strong performance in analytical instruments to excellent innovation and adoption in both mass spectrometry and cryo-electron microscopy. He noted that electron microscopy and chromatography/mass spectrometry were the primary growth drivers, despite ongoing headwinds in the chemical analysis business. Mr. Casper indicated good underlying health and momentum for Q4, but cautioned that comparisons would be tougher due to very strong high single-digit growth in the prior year's fourth quarter.

Tycho W. Peterson inquired about the drivers of strength in the analytical instruments segment, specifically asking if it was led by mass spectrometry or cryo-electron microscopy, and the momentum expected into year-end, including any early thoughts on a 2026 budget flush or onshoring impact. He also asked about the conditions in China diagnostics and the overall performance of specialty diagnostics excluding the China drag, along with assumptions for China for the remainder of 2025 and early 2026.

Answer

Chairman, President, and CEO Marc Casper attributed analytical instruments' strength to innovation and adoption in mass spectrometry and cryo-electron microscopy, with mid-single-digit growth driven by these areas, despite pressures in chemical analysis. He noted a stronger Q4 comparison due to high single-digit growth last year. For specialty diagnostics, Mr. Casper explained the business provides high-value testing, and while China's weak conditions (pricing/reimbursement) impacted growth, it's a modest proportion of the business, showing slight improvement from the prior quarter.

Tycho Peterson asked if the CRO business could return to high single-digit growth in the next year and inquired about the opportunity set for CDMO asset transfers following the Sanofi deal. He also sought an update on customer traction with the 'Accelerated Drug Development' solution.

Answer

CEO Marc Casper stated that while the clinical research business is expected to return to growth and build from there, he did not commit to an immediate return to high single-digit growth next year, though he affirmed that as the long-term potential. He confirmed the 'Accelerated Drug Development' solution is being 'incredibly' adopted by customers and praised the Sanofi deal as a cost-effective way to add sterile fill-finish capacity to meet strong U.S. demand.

Tycho Peterson asked for more detail on the Pharma Services business, including order growth, the extent of share gains, and the impact of bundling. He also sought confirmation that the company is not concerned about major pharma R&D cuts in response to tariffs.

Answer

CEO Marc Casper described the biotech clinical research business as 'quite robust,' driven by a compelling and differentiated 'accelerated drug development' offering that provides speed and cost-effectiveness. He expressed confidence in the outlook for clinical research. Regarding tariffs, he noted that while pharmaceutical customers are planning, their ultimate response is not yet clear, and Thermo Fisher is prepared to help them navigate any changes.

Tycho Peterson asked about the timing and rationale for launching the 'Accelerator Drug Development' program, its target customers, and the company's 2025 growth assumptions and risk assessment for China, including trade restrictions and volume-based procurement.

Answer

Marc Casper, Chairman, President and CEO, explained the Accelerator program was launched after three years of internal work to ensure confident delivery on its value proposition. He noted interest from both biotech and large pharma. For China, he expects an environment similar to 2024 with some stimulus benefit but no broad economic recovery, confirming that the impact from volume-based procurement is minimal and already factored into guidance.

Tycho Peterson asked for more detail on the drivers within the Laboratory Products and Biopharma Services segment, including channel share gains and the performance of PPD and Patheon. He also inquired about the pricing environment and plans for Patheon's capacity expansion.

Answer

CFO Stephen Williamson confirmed that strong underlying growth in Pharma Services and clinical research offset pandemic headwinds. CEO Marc Casper added that the research and healthcare channels are performing well and winning new customers. Regarding pricing, Williamson noted it was just over 1% for the company. Casper described the pricing environment as 'back to normal' and confirmed ongoing investments in sterile fill finish capacity set to come online in 2025-2026.

Tycho Peterson probed further on oncology initiatives, specifically asking about additional indications for Haystack MRD, potential NCCN guideline inclusion, and when the Guardant partnership for colorectal cancer screening might become more meaningful, including the possibility of multi-cancer options.

Answer

CEO Jim Davis confirmed that for Guardant, the partnership is currently limited to colorectal cancer, with expected growth next year. For Haystack MRD, initial focus is on colon cancer with anticipated favorable reimbursement, and over 25 ongoing studies are building evidence for additional indications like head and neck, breast, and lung, aiming for broader coverage. He noted strong uptake from academic sites valuing the test's precision, sensitivity, and specificity.

Tycho Peterson probed further on oncology initiatives, specifically Haystack MRD's additional indications, NCCN guideline inclusion, and the Guardant partnership's potential for multi-cancer options and increased meaningfulness.

Answer

CEO Jim Davis confirmed that Haystack MRD's initial focus is colon cancer, with ongoing research for head and neck, breast, and lung indications through over 25 studies. He expects broader coverage for multiple cancer indications as evidence builds and anticipates favorable reimbursement in the November fee schedule. For Guardant, the partnership is currently limited to colorectal cancer, with expected growth next year, and there are no immediate plans for multi-cancer options.

On behalf of Tycho Peterson of Jefferies, an analyst asked about the company's exposure to preventative screening and any potential impact from the Braidwood v. Becerra court case.

Answer

CEO Jim Davis addressed the topic broadly, noting a positive societal shift from sickness care towards prevention and wellness. He stated that this trend is beneficial for the lab industry as it encourages early and frequent testing to prevent disease progression, highlighting the growth in functional medicine as an example of this shift.

Tycho Peterson probed Danaher's biotechnology comments, asking for details on the fourth-quarter guide, what would constitute an equipment recovery, the current order book, funnel building, and the likelihood of an equipment pick-up next year. He also inquired about Beckman Coulter's growth expectations for next year outside of VBP and any early impact from Alzheimer's, as well as Cepheid's base business growth excluding respiratory.

Answer

Matt McGrew (EVP and CFO) clarified Q4 biotechnology numbers, expecting high single-digit growth in bioprocessing and mid-single-digit declines in Discovery Medical due to prior year comps and life science tool pressures. Rainer Blair (President and CEO) discussed equipment, noting increased activity and discussions with pharma customers about reshoring and investments, driven by a stabilizing policy environment. He mentioned brownfield investments are more immediate but orders haven't translated yet. For diagnostics, Matt McGrew stated Alzheimer's is a longer-term play, expecting Beckman to continue mid-single-digit+ growth outside China. Cepheid's non-respiratory base business is expected to continue high single-digit to low double-digit growth, with respiratory flat at $1.7 billion.

Tycho Peterson probed Danaher's biotechnology segment, asking for details on the fourth-quarter guide, the conditions necessary for an equipment recovery, the current state of the order book and funnel, and the likelihood of an equipment pick-up next year. He also inquired about the diagnostics segment, specifically Beckman Coulter's ex-VBP performance for next year, potential impact from Alzheimer's, and the outlook for Cepheid's non-respiratory base business.

Answer

Matt McGrew, Executive Vice President and CFO, outlined Q4 expectations for biotechnology: high single-digit growth in bioprocessing and mid-single-digit decline in Discovery & Medical due to prior year comps and softness. Rainer Blair, President and CEO, discussed equipment, noting increased manufacturing volumes and a general need for investment, but policy discussions (like Most Favored Nation and tariffs) have delayed decisions. He observed more confidence and activity around brownfield investments, but orders have not yet materialized, leading to conservative planning. For diagnostics, Mr. McGrew indicated Alzheimer's impact is too early for next year's guide. He expects Beckman Coulter ex-China to continue mid-single-digit growth, driven by the DxI 9000, and Cepheid's non-respiratory base business to maintain high single-digit to low double-digit growth, with respiratory revenue assumed flat at $1.7 billion.

Tycho Peterson questioned why the full Q2 EPS beat was not flowed through to the annual guidance and asked about the drivers for the expected Q4 step-up in Life Sciences. He also asked if volume-based procurement (VBP) in China is a worsening issue.

Answer

EVP & CFO Matt McGrew explained that while realized cost savings and H1 FX benefits were passed through, they are holding back on flowing through better-than-expected respiratory results and favorable H2 FX. President & CEO Rainer Blair added that the H2 Life Sciences improvement is based on better comps, firmer China demand, and new product traction. He also confirmed the China VBP impact was in line with expectations and the $150 million full-year headwind forecast remains unchanged.

Tycho Peterson asked about Danaher's ability to use pricing to offset tariffs, the timeline for new biopharma CapEx to become a tailwind, and the long-range outlook for 2026.

Answer

EVP and CFO Matt McGrew stated that the 2025 price assumption is flattish due to VBP, with any tariff-related surcharges being incremental. President and CEO Rainer Blair noted it is too early to predict the timing of CapEx benefits but affirmed that Danaher is well-positioned and that the company's long-term growth outlook remains intact, viewing current headwinds as transient.

Tycho Peterson inquired about instrument growth excluding China, the performance of specific instrument categories, and the leading indicators for that market. He also questioned the feasibility of the consensus 2025 growth forecast for Life Sciences given the Q4 run rate and the outlook for bioprocessing in China.

Answer

EVP and CFO Matt McGrew stated that instrument growth ex-China was in the low to mid-single digits. President and CEO Rainer Blair added that developed markets were stable but an inflection hadn't occurred, though he noted early signs of improvement in pharma and biotech in North America. Blair emphasized that China's stimulus has not yet translated into meaningful orders. Regarding 2025, both executives stressed the need to see how Q4 plays out, particularly concerning China's stimulus and bioprocessing order momentum, before providing a forecast.

Priya, on behalf of Tycho Peterson, asked about the company's pricing strategy and whether PacBio is able to implement price increases or surcharges to offset potential tariff impacts, noting a competitor had done so.

Answer

President and CEO Christian Henry stated that PacBio has not adjusted its pricing because it is not currently experiencing significant tariff impacts. He affirmed that if a substantial impact were to materialize, the company would evaluate its options, including price changes or surcharges, but sees no need to act at this time.

Tycho Peterson asked about the extent to which the uncertain NIH funding environment is factored into the 2025 guidance, the order backlog and production scaling for the new Vega system, and what levers PacBio could pull to accelerate its timeline to cash flow breakeven.

Answer

President and CEO Christian Henry confirmed that significant headwinds from the NIH funding situation, particularly in the first half of the year, are baked into the guidance. He noted that strong growth in Europe and the clinical sector provides a partial offset. Regarding Vega, he stated that production is scaling, moving from a pilot line in H1 to a full production line in H2 2025, with demand expected to be strong. He also affirmed that while the focus is on growth and gross margin, other levers exist to reduce cash burn if necessary.

Tycho Peterson asked for an update on the Latitude tumor-naive test launch, the size of the TOMER (treatment on molecular recurrence) opportunity, and whether the proposed MolDx LCD changes for transplant testing pose a risk to MRD reimbursement.

Answer

Solomon Moshkevich, President of Clinical Diagnostics, stated that Latitude is showing competitive performance and is being brought to customers. He defined the TOMER opportunity as the entire recurrence monitoring market. CEO Steve Chapman addressed the MolDx LCD, viewing it as a net positive for their organ health business and stating he does not see a risk of the test-capping concept spilling over to MRD, as reimbursement cadences are already established.

An analyst on behalf of Tycho Peterson asked for the outlook on ASPs for the remainder of the year, considering true-ups and denials, and requested an update on the company's tumor-naive MRD test offering.

Answer

Executive Mike Brophy stated the guidance assumes stable ASPs for women's and organ health, with modest improvement in Signatera from better Medicare Advantage execution. He clarified that future true-ups are not included in the forward guidance. CEO Steve Chapman confirmed the forthcoming launch of the tumor-naive MRD test in colorectal cancer is on track, noting its performance is strong, though not as high as the tumor-informed test, as expected.

On behalf of Tycho Peterson from Jefferies, an associate asked for the initial market reaction to the CALGB/SWOG 80702 study and inquired about Natera's competitive strategy to maintain its market leadership in MRD testing.

Answer

CEO Steve Chapman and General Manager of Oncology, Alex Aleshin, reported an overwhelmingly positive and actionable response to the 80702 study, with some oncologists already changing their practice. Chapman emphasized that Natera's competitive strategy relies on producing high-quality clinical data, providing excellent customer experience, continuous innovation through significant R&D investment, and leveraging their strong IP position, all while remaining cash flow positive.

Tycho Peterson of Jefferies asked for the financial contribution from the Invitae asset, the drivers of the strong guidance raise, future Signatera community penetration, and timelines for key clinical trial readouts in breast and kidney cancer.

Answer

Executive Mike Brophy stated the guidance raise reflects continued growth across the business, even after backing out true-ups, and confirmed the Invitae asset's full-year contribution is in the $40 million zone. CEO Steve Chapman reiterated that Signatera penetration is still in the low single digits, with significant room for growth in the community setting, and confirmed Natera is actively adding sales and medical team members. Chapman noted a solid roadmap of data readouts is expected across a broad span of indications, with over 100 trials underway.

Lauren, on behalf of Tycho Peterson from Jefferies, inquired about the potential for a more favorable outcome from the draft LCD, asking what discussion points CareDx will raise during the public comment period to mitigate the outlined headwinds.

Answer

John Hanna, President & CEO, responded that CareDx will focus its public comments on three key areas: allowing clinicians to determine testing frequency, presenting evidence supporting the multimodal HeartCare product, and addressing the new concept of bundled payments. He noted the full comment letter will be published after the comment period closes.

An analyst on behalf of Tycho Peterson at Jefferies inquired about the Epic Aura integration, including its rollout timeline, associated costs, and potential impact on testing volumes. They also asked about the expected near-term penetration rate for the new pediatric heart and simultaneous pancreas-kidney indications.

Answer

An executive, Keith Kennedy, detailed the Epic integration plan, with a full launch setup by the end of Q2, pilot programs starting July 1, and a broad rollout in Q4, noting an annual investment of about $5 million plus per-test fees. CEO John Hanna added that penetration for the new indications could be 'relatively high' due to significant clinical need, despite the smaller total procedure volumes.

An analyst on behalf of Tycho Peterson asked for more specific details on the magnitude of the recent increase in surveillance testing mix and inquired about capital allocation priorities, particularly the potential for share buybacks given the company's strong cash position.

Answer

CEO John Hanna stated that while the company has seen a modest directional shift towards surveillance, it has not provided specific mix details, and he anticipates a full recovery over 2-3 quarters. Regarding capital allocation, Hanna emphasized that the primary focus is on investing in the core business to drive profitable growth before considering share buybacks.

Tycho Peterson asked about the outlook for the QIAcuity digital PCR platform in the second half, including pharma uptake and competitive dynamics, and sought to clarify if the 2028 target for QDI had been lowered.

Answer

CEO Thierry Bernard confirmed no 2028 targets have been revised. He expressed confidence in achieving QIAcuity placement goals despite cautious capital spending, welcoming new competition as market validation. He reiterated QIAGEN's competitive advantages in automation and cost, and the company's ambition to become the market leader in digital PCR.

Tycho Peterson sought clarity on guidance assumptions, specifically regarding the U.S. academic and government end market, potential for recovery in instrument sales, and possible drivers of upside in the second half of the year.

Answer

CEO Thierry Bernard noted that while the company is cautious on academic spending, its high consumable revenue mix (90%) provides some insulation. He anticipates a normalization in capital sales in H2 2025 or early 2026. CFO Roland Sackers added that potential upside could come from strong menu expansion for both QIAstat, following recent FDA approvals, and QIAcuity, with 100 new panels planned for the year, which is expected to drive strong consumable pull-through.

Tycho Peterson inquired about the 2025 growth outlook for QuantiFERON, the impact of a recent German patent victory, and the sustainability of QIAcuity's traction in pharma, including when instrument sales might recover.

Answer

CEO Thierry Bernard confirmed the forecast for low double-digit growth for QuantiFERON in 2025, noting the patent win reinforces their strong IP position. For QIAcuity, he stated the goal is to become #1 in digital PCR, aided by the new 12-plex solution and clinical expansion. He acknowledged the soft capital spending environment but highlighted that over 200 QIAcuity systems were still placed in Q4.

Tycho Peterson of Jefferies Financial Group questioned the drivers behind the raised financial guidance, the reason for the accompanying increase in operating expenses, and whether the company's underlying end-market growth assumptions for its long-range plan had changed since last fall.

Answer

President and CEO Sam Raha attributed the guidance raise to better and quicker-than-expected execution in addressing the challenges identified in Q1, particularly with GeneSight and unaffected hereditary cancer testing. CFO Scott Leffler added that they expect further acceleration in hereditary cancer and prenatal volumes in the second half. Raha confirmed that there have been no material changes to their end-market growth assumptions.

Tycho Peterson of Jefferies asked about Myriad's liquidity position, specifically its standing relative to its ABL credit facility covenant and its day-to-day cash needs. He also questioned if the updated guidance assumes further pricing pressure and asked for an update on the company's long-range plan (LRP).

Answer

CFO Scott Leffler confirmed Myriad is still above its ABL covenant requirement and has sufficient liquidity for 2025, with modest working capital needs. He also stated the guidance does not assume any new pricing headwinds. CEO Samraat Raha addressed the LRP, expressing confidence in a high single-digit to low double-digit revenue growth profile over the next few years, which will be refined during the ongoing strategy review.

Tycho Peterson asked about the specific steps and timeline required for Prolaris to achieve Level 1b evidence in guidelines and what growth is assumed in the 2025 forecast. He also questioned the change in the long-range plan's language from '12%' to 'double-digit' revenue growth for 2026 and beyond.

Answer

CEO Paul Diaz stated that the PATHOMIQ partnership is crucial for accelerating the timeline to Simon Level 1 evidence for Prolaris by improving access to samples and KOLs. CCO Mark Verratti confirmed they expect revenue and volume growth from Prolaris in 2025. Regarding the long-range plan, Diaz attributed the language modification to the significant $45 million run-rate impact from the UnitedHealthcare decision on GeneSight, a key growth driver, but noted the ultimate goal remains 12% growth.

Tycho Peterson of Jefferies asked for an explanation of the updated guidance, which included a slightly lower gross margin, and challenged the idea that the Ambry acquisition would create a similar share gain opportunity as past market disruptions.

Answer

An executive, likely CFO Scott Leffler, explained the minor gross margin guidance change was due to product mix variability, not a change in underlying fundamentals, noting that EPS guidance increased. President and CEO Paul Diaz clarified that while each competitive situation is different, any major integration creates disruption and service questions, giving Myriad's sales force an opportunity to highlight their stability and quality.

Tycho Peterson questioned the timing and commitment of the new $100-120 million cost-cutting program, asking why it wasn't initiated sooner. He also pressed on the more cautious 2026 growth outlook compared to recent commentary and asked about the company's debt leverage ratio relative to its covenants.

Answer

Chairman, CEO & President Frank Laukien detailed that cost-saving plans were progressively expanded as headwinds mounted, with about $30M impacting FY2025. He affirmed full commitment to the program regardless of market recovery. He attributed the more muted 2026 outlook to new weakness in biopharma and industrial markets. EVP & CFO Gerald Herman stated that debt covenants were satisfied and the company is working towards its target leverage ratio.

Tycho Peterson from Jefferies asked for more color on the strengthening biopharma market and whether the guidance accounts for a potential slowdown. He also questioned the M&A contribution to growth, noting a new acquisition did not seem to alter the outlook.

Answer

CEO Frank Laukien confirmed that biopharma demand was healthy in Q4 and Q1, driven by a broad portfolio, and noted the guidance assumes a moderated recovery due to tariff risks. He provided a scorecard on recent M&A, stating that while Chemspeed and ELITech are performing well, the spatial biology and cellular analysis acquisitions face headwinds but remain on track for 2026 breakeven.

Tycho Peterson asked for a breakdown of the M&A growth contribution by deal, expectations for backlog reduction, assumptions on import/export rules, the outlook for the semiconductor business, and the reason for soft Q1 operating margin guidance.

Answer

CEO Frank Laukien noted NanoString is running slightly below its pre-acquisition rate, ELITech is highly predictable, and Chemspeed is exceeding expectations. He confirmed that existing semi-related export restrictions are baked in and do not affect key proteomics instruments. CFO Gerald Herman stated they are not assuming a significant change in the high backlog level. Frank Laukien explained that Q1 operating margin softness is a mathematical effect, as Q1 2024 did not yet include the dilutive impact of the NanoString acquisition.

Tycho Peterson sought clarification on what management means by "significant margin expansion" in 2025 and asked for more detail on the semiconductor business outlook, given some weak industry data points.

Answer

CEO Frank Laukien clarified that "significant margin expansion" in 2025 would be "north of" the 110 basis points modeled by the Street, driven by cost discipline and improvements in acquired businesses. On the semiconductor front, he stated that orders have seen double-digit growth and that the semi business will likely lead the company's growth in 2025. He noted that any slowdown from key customers like ASML has already been factored into their outlook.

Tycho Peterson of Jefferies inquired about the outlook for biopharma R&D spending amid market uncertainty and also asked about trends in the US academic and government markets.

Answer

CEO Patrick Kaltenbach clarified that Mettler-Toledo's biopharma exposure is primarily in bioproduction and QA/QC, not early-stage R&D, making manufacturing onshoring a net positive. CFO Shawn Vadala added that about two-thirds of the company's 40% life sciences revenue is in manufacturing and QA/QC. Regarding the US academic and government market, Vadala stated it represents only about 2% of global sales and is not a significant factor in the company's overall performance.

Tycho Peterson of Jefferies asked about the pharma end market, including any price pressure from customers and the status of replacement cycles. He also questioned if Mettler-Toledo's China manufacturing footprint creates a share gain opportunity and if there were any signs of government stimulus in China.

Answer

CEO Patrick Kaltenbach reported healthy engagement with pharma customers with no signs of negative pricing pressure. He and CFO Shawn Vadala agreed that their long-standing local manufacturing and development presence in China is a significant competitive advantage. Mr. Kaltenbach concluded that the company is not currently aware of any new, impactful stimulus programs in China.

Tycho Peterson of Jefferies asked about the secular trends driving accelerated growth plans in India, the potential ceiling for pricing in an inflationary environment, and whether Process Analytics strength was from greenfield projects or market share gains.

Answer

CEO Patrick Kaltenbach clarified they have growth plans in several countries, including India. CFO Shawn Vadala confirmed India's high-single-digit growth in 2024. On pricing, Mr. Vadala stated there is no hard ceiling, as the company is well-positioned to adjust based on the environment. CEO Kaltenbach attributed Process Analytics strength to a strong new product portfolio resonating across pharma/biopharma and semiconductor industries, suggesting potential share gains.

Tycho Peterson asked about the drivers for the Q4 Product Inspection guidance, challenges in food manufacturing, and how to reconcile comments on onshoring with soft automation demand.

Answer

CEO Patrick Kaltenbach explained that Product Inspection is competing well with its new mid-range portfolio, though the broader food manufacturing market remains slow. He noted that onshoring is a long-term process whose material impact has not yet been fully realized, which explains the current softness in automation. CFO Shawn Vadala confirmed the pricing assumption remains 2% for Q4 and 2025.

Tycho Peterson of Jefferies Financial Group inquired about the expected trajectory of NovaSeq X placements and the path to achieving 50% of high-throughput revenue from the X series by year-end. He also asked about the drivers behind the strong Q2 operating margin performance.

Answer

CEO Jacob Thaysen noted that strong placements from Q4 and Q1 are still ramping up and expects an average of 50-60 placements per quarter going forward. CFO Ankur Dhingra attributed the significant operating margin improvement primarily to the successful execution of cost-saving initiatives, which have resulted in a structural reduction in operating expenses. He clarified that benefits from tariff mitigation are expected in future periods, not in Q2.

Tycho Peterson of Jefferies challenged the assumption that Illumina could successfully implement price increases to offset tariffs, given the highly competitive environment, which includes a competitor reportedly offering free sequencing.

Answer

CEO Jacob Thaysen acknowledged that no customer likes price increases but framed it as a necessary and prudent step to ensure Illumina's long-term stability and continued innovation, which customers value. He contrasted this sustainable approach with competitors offering free sequencing, which he deemed an unsustainable business model.

Tycho Peterson asked about several topics, including whether Q4 saw a pull-forward of instrument placements, the status of the clinical transition to NovaSeq X, progress on application-specific pricing discussions, and how Illumina handles irrational pricing from competitors.

Answer

CEO Jacob Thaysen explained that a fraction of customers (~20%) historically take longer to transition technologies. Regarding competition, he noted Illumina is now engaged in a pilot study for the UK Biobank proteomics project and emphasized that competitors must eventually be profitable. CFO Ankur Dhingra confirmed active and encouraging discussions with customers on application-specific pricing for emerging tests.

Tycho Peterson asked about the pricing headwind from the clinical NovaSeq X transition and whether multiyear customer contracts, potentially related to GRAIL, would break upon moving to the X platform.

Answer

CEO Jacob Thaysen explained that demand elasticity is working, as customers adopt larger panels or deeper sequencing, mitigating a revenue cliff. He clarified that multiyear 'open offer letter' contracts are not instrument-specific and continue with the NovaSeq X. CFO Ankur Dhingra added that over half the sequencing volume has already transitioned.

Tycho Peterson from Jefferies Financial Group asked about the necessary steps to market Shield as a multi-cancer detection (MCD) test and questioned the potential risk to the business if the entire USPSTF panel were to be replaced.

Answer

Co-CEO AmirAli Talasaz stated that the Shield MCD test is now clinically validated and operationally ready, with results already being delivered in the NCI Vanguard study. He indicated they are not waiting for a pivotal study readout before broadening access. Regarding the USPSTF, he acknowledged the situation but expressed confidence in the long-term opportunity for Shield, given its strong current traction and healthy gross margin.

Tycho Peterson inquired about the assumptions baked into the new guidance for Guardant360 ASP, Guardant360 Tissue ASP, and the adoption rate for Reveal. He also asked about the future roadmap for the multi-cancer early detection (MCED) test, particularly regarding payer engagement.

Answer

CFO Mike Bell stated the Guardant360 ASP is expected to remain in the $3,000-$3,100 range, with the Tissue ASP holding around $1,700-$1,800. Co-CEO Helmy Eltoukhy noted they expect Reveal's tests-per-patient to grow considerably. Co-CEO AmirAli Talasaz highlighted the MCED roadmap includes generating more data from existing patient samples to demonstrate the platform's capabilities to stakeholders.

Tycho Peterson asked for clarification on Shield's 2025 guidance, questioning the slightly lower implied ASP versus Q4, the financial impact of the Abu Dhabi deal, the potential risk to ADLT status, and the expected timing for ACS guideline inclusion.

Answer

Co-CEO AmirAli Talasaz explained the ASP guidance is conservative after only one full quarter of data and does not include any potential upside from ADLT status, which they are confident in securing. He confirmed the Abu Dhabi deal is not dilutive to ASP and that its volume contribution to the guide is minimal initially.

Tycho Peterson requested clarification on the potential upside from Guardant Reveal surveillance coverage next year, the expected ASP trajectory, the Guardant360 ASP for the quarter, and a reiteration of the full-year 20% clinical volume growth target.

Answer

Co-CEO Helmy Eltoukhy confirmed the company still expects approximately 20% clinical volume growth for the current year and anticipates an acceleration in 2025. He stated that while it's difficult to quantify the Reveal ASP uptick until the Medicare rate is set, achieving CRC surveillance reimbursement and reducing COGS will allow them to accelerate volume growth next year as the test becomes gross margin positive.

Tycho Peterson from Jefferies inquired about the drivers of the expected second-half revenue ramp, asking for details on the contribution from new products and the pharma pipeline for RNA ligase orders.

Answer

CFO Georgia Erbez confirmed that the anticipated revenue growth in the second half of the year is expected to be driven by new contracts within the ECO Synthesis platform. She noted that the timing of this ramp reflects the typical timelines required to negotiate these significant deals.

An analyst on behalf of Tycho Peterson asked for more detail on current trends observed within the biopharma customer segment and how those trends are factored into the outlook.

Answer

CEO Serge Saxonov noted that while the biotech segment is under pressure from capital markets, well-funded biotechs and larger pharma companies continue to invest. He emphasized that biopharma remains a key priority, and the company's restructured sales team and new product capabilities are positioning it for progress toward its long-term goal of having biopharma represent 50% or more of its business.

Tycho Peterson asked about the specific contributions from new products and the Chan Zuckerberg Initiative baked into guidance, the outlook for legal spending, and why strong NIH funding for spatial biology has not yet translated to revenue.

Answer

CEO Serge Saxonov stated that new products, particularly the transition to GEM-X, and large projects like CZI are key components of the 2025 plan and are contemplated in the guide. He noted that while underlying NIH funding trends for spatial are healthy, the optimism is tempered by the current macro uncertainty. CFO Adam Taich added that total operating expenses, including legal costs, are expected to be roughly flat year-over-year.

Tycho Peterson asked for clarification on instrument performance, questioning if Xenium and Visium missed expectations equally. He also probed the risk of permanent market share loss versus temporary order delays due to the sales transition and pushed for more conviction on the expected demand elasticity from recent aggressive pricing on Xenium and Chromium products.

Answer

CEO Serge Saxonov clarified that Xenium instruments were disproportionately affected by the macro environment, but relative to internal expectations, all products were similarly impacted. On pricing, Saxonov expressed strong conviction in demand elasticity, citing historical examples from geographic price actions and early customer adoption of new products like Flex, which have shown volume growth sufficient to drive top-line revenue growth over a few quarters.

Tycho Peterson inquired about the drivers behind the strength in the core lab business, any noticeable changes in hospital customer behavior, and the company's competitive view on mass spectrometry as an emerging technology.

Answer

CEO Brian Blaser attributed the strong 7% growth in the Labs business to broad-based geographic performance and a strong value proposition in lower-volume settings, with no significant new competitive headwinds. Regarding mass spectrometry, he viewed Roche's new product as focused on a specialty segment that does not compete with QuidelOrtho's mainstream core laboratory offerings at this time.

Speaking for Tycho Peterson of Jefferies, an analyst asked if macro uncertainties like tariffs and funding headwinds could impact clinical oncology volumes or ASPs. He also questioned if the vacating of the LDT final rule provides any incremental upside to margin expansion targets.

Answer

CEO Anthony Zook stated that he does not expect macro factors to impact clinical volumes, as cancer patients will continue to require care. CFO Jeff Sherman explained that the company does not expect a material change to its guidance from the LDT rule update, as they had already been basing new products on a design control framework and the expected costs in the near term were not material.

An analyst on behalf of Tycho Peterson from Jefferies inquired about the process chromatography business, asking why the strong Q1 performance wouldn't continue beyond the high single-digit guide. He also asked about the consumables versus instruments outlook within biopharma, clarification on the China reimbursement headwind, and any customer feedback on the pending acquisition of [Stella] Technology.

Answer

An executive, likely COO John DiVincenzo, explained that the Q1 strength in process chromatography was driven by the timing of customer orders, not a pull-forward, and the full-year high single-digit growth forecast remains intact as destocking normalizes. He clarified that market softness is concentrated in instrumentation, while consumables demand has held up well. The China reimbursement headwind of $15 million for the year played out as expected in Q1. Regarding the [Stella] acquisition, the executive noted significant excitement from internal teams and positive early feedback from the market, highlighting strong brand awareness and the platform's user-friendly workflow.

Tycho Peterson from Jefferies asked if the 1-2% ddPCR growth guidance for 2025 assumes another decline in instrument sales. He also inquired about the expected contribution from new products, the company's capital allocation strategy regarding M&A size, and the underlying pricing assumption for the year.

Answer

CFO Roop Lakkaraju stated the ddPCR guidance assumes instrument sales remain soft but not necessarily down, with consumables continuing to be strong. He noted new product contributions in 2025 are not significant but will build into 2026. CEO Norman Schwartz confirmed a pivot towards revenue-generating M&A, like Stilla, and that mid-sized or larger deals are on the radar. Lakkaraju concluded that the net pricing assumption for 2025 is around 1%, or about 1.5% excluding the China impact.

Tycho Peterson pressed for a timeline on the delayed QX Continuum launch, asked about pricing trends in digital PCR, questioned why Bio-Rad's bioprocess destocking commentary differs from peers, and requested the financial impact of a partner exiting the donor screening business.

Answer

EVP and CFO Roop Lakkaraju and CEO Norman Schwartz declined to provide a new timeline for the Continuum launch, citing a focus on product quality. Roop acknowledged the ddPCR market is competitive and the company is being 'appropriately reactive' on price. Management explained their bioprocess situation is unique due to their specific focus on the polishing stage and the resulting heavy stocking by key customers. Roop quantified the donor screening partner exit as a 'low double digits' million-dollar impact.

Inquired about the margin outlook, asking if higher sales and marketing spending is planned and if deeper G&A cuts are possible. Also asked for an update on whether the blood-based colon cancer assay is 'locked down'.

Answer

Aaron Bloomer stated the 2025 guidance implies 220 basis points of margin expansion, driven by fixed cost leverage, productivity, Cologuard Plus pricing, and G&A optimization. R&D spending will be similar to 2024 as a percentage of sales, while sales and marketing will see investment for the MRD launch but gain leverage over time. The question about the blood assay was deferred.

Tycho Peterson of Jefferies questioned the 2025 EBITDA margin outlook, asking about the balance between sales and marketing spend for new launches versus the potential for deeper G&A cuts. He also inquired if the blood-based colon cancer assay was finalized.

Answer

CFO Aaron Bloomer defended the guidance, which implies 220 basis points of margin expansion, driven by fixed cost leverage, Cologuard Plus pricing, and ongoing G&A optimization. He noted that while R&D as a percent of sales would be similar to 2024, there would be investment in Sales & Marketing to support the MRD launch. CEO Kevin Conroy deferred the blood test question.

Tycho Peterson questioned the 2025 EBITDA guidance being below consensus, asking about the balance between sales and marketing investments and G&A cuts. He also inquired about the development status of the blood-based colon cancer assay.

Answer

CFO Aaron Bloomer defended the guidance, highlighting that it implies 220 basis points of margin expansion and 30% EBITDA growth. He outlined key drivers including fixed cost leverage, Cologuard Plus pricing, and continued G&A optimization. He noted 2025 will be a year of investment in sales and marketing to support the Oncodetect (MRD) launch. CEO Kevin Conroy deferred the question on the blood assay.

Asked for quantification of the individual impacts on the guidance miss, how long the issues will linger, why Q4 guidance is down sequentially, and for any outlook on 2025.

Answer

The company declined to quantify each individual impact but stated the single biggest reason for the sequential Q4 revenue decline is the hurricanes. They reiterated four key growth drivers for 2025: rescreens, care gap programs, the Cologuard Plus launch with a price increase, and improved commercial execution, with new products like MRD also contributing.

Tycho Peterson from Jefferies asked for quantification of the guidance impacts, how long care gap and rep productivity issues might linger, why Q4 guidance is down sequentially, and for any commentary on 2025.

Answer

CFO Aaron Bloomer stated that the single biggest reason for the sequential Q4 revenue decline is the impact from hurricanes. He noted that while care gaps remain a strong growth driver, some program revenue was pulled forward into Q3. For 2025, both he and CEO Kevin Conroy expressed excitement for growth acceleration driven by four factors: rescreens, care gap programs, the Cologuard Plus launch with its expected price increase, and improved commercial execution.

Tycho Peterson from Jefferies requested a quantification of the guidance headwinds, asked how long the care gap and rep productivity issues might persist, questioned the sequential revenue decline in Q4, and inquired about the 2025 outlook.

Answer

CFO Aaron Bloomer stated the company would not quantify each individual headwind but confirmed the single biggest reason for the Q3-to-Q4 sequential decline is the impact from hurricanes. He noted some care gap program revenue was pulled into Q3 from Q4. For 2025, both Bloomer and CEO Kevin Conroy expressed confidence in growth acceleration, citing four key drivers: rescreens, care gap programs, the Cologuard Plus launch with a price increase, and improved commercial execution.

Tycho Peterson asked for details on the Cologuard Plus launch, including the transition timeline, commercial deployment strategy for varying insurance coverages, and pricing feedback. He also questioned the required sales force size for MRD, the timing of the blood test data release, and the potential performance drawbacks of using a PCR-based assay versus sequencing.

Answer

CEO Kevin Conroy explained the Cologuard Plus commercial transition would likely take 12-24 months to align with payer contract conversions, starting with setting a new Medicare rate. He emphasized the test's value proposition, including a lower false positive rate and cost savings for the healthcare system. He stated the blood test data would be released at an appropriate scientific conference and highlighted the scientific difficulty and cost advantages of their proprietary PCR technology. He did not directly address the MRD rep question in the initial response.

Tycho Peterson questioned the potential impact of the USPSTF and the Braidwood case on Hologic's screening portfolio and asked about the long-term growth outlook for Panther system utilization.

Answer

CEO Stephen MacMillan stated that the company does not expect a significant impact from potential policy changes related to screening, expressing confidence in the clinical value of its products. Regarding Panther, he sees a significant, multi-year opportunity to increase utilization on the existing installed base, driven primarily by expanding the menu through the Panther Fusion sidecar, which enables a new range of PCR assays.