Andrew Cooper

Andrew Cooper asked for specific observations indicating that the competitive balance has shifted in vascular closure, beyond the product's known quality, ahead of revenue showing that shift. He also inquired about the plasma segment's implied Q4 fiscal year 2026 numbers, which suggest a larger-than-typical seasonal step-down, asking if this is due to conservatism, stocking, or related to an earlier software renewal.

Answer

Chris Simon (President and CEO, Haemonetics) attributed the shifted balance to the bifurcation of the sales force, with 200 representatives focused solely on closure, improved tracking of win rates, closing of sales force vacancies, and new reps coming up the learning curve (60% of the field team in their current role for less than six months). He also highlighted effective key account work with IDNs, providing 'air cover' for sales, and achieving these gains without compromising gross margins or price points. For plasma's Q4, he confirmed that 'prudence' is the right word for the guidance, reiterating that Q3's strong performance was driven by share gains, not one-offs or order timing, and reflects only directly controllable factors.

Andrew Cooper asked for further explanation on the 'balance shifted' comment regarding competitive dynamics in the Interventional Technologies (IVT) vascular closure business, seeking to understand what specific observations inform this view ahead of actual revenue showing the shift. He also inquired about the plasma business, noting a larger-than-typical seasonal step-down implied for Q4 2026, asking if this reflects conservatism or other factors like stocking or share gains.

Answer

Chris Simon, President and CEO, attributed the shifted balance in IVT to the bifurcation of efforts, with 200 field representatives focused on closure, particularly MVP and MVP XL in electrophysiology. He highlighted improved win rates, closing field force vacancies, and new reps coming up the learning curve (60% of the team in their role less than six months). Simon also noted effective key account work with IDNs, providing 'air cover' for the sales team, leading to wins without compromising gross margins. For plasma, Simon confirmed that the implied Q4 step-down reflects 'prudence' in guidance, focusing on controllable factors like further share uptick and the final stages of price annualization, rather than order timing or one-offs.

Andrew Cooper noted that Vascade MVP/XL's 6% growth was against an easy comp and asked for more detail on the executional actions being taken. He also questioned how much of the one-time software revenue benefit impacted the bottom line and what 'inning' the company is in regarding plasma share gains.

Answer

CEO Christopher Simon acknowledged the 6% growth was below market and reiterated the comprehensive plan to improve execution, including new leadership and building a strategic accounts team. CFO James D'Arecca clarified the software deal's 210 basis point gross margin benefit dropped entirely to the bottom line and was contemplated in the full-year plan. Regarding plasma share gains, Simon described it as an FY26 and H1'27 story, stating they are 'midway through' with 'more ahead of us than behind us.'

Andrew Cooper of Raymond James asked for an update on the smaller bore VASCADE product, noting its performance may have worsened, and inquired about the pacing of improvements through fiscal 2026. He also questioned the higher-than-expected operating expenses in the quarter and the trajectory of OpEx going forward.

Answer

CEO Christopher Simon acknowledged the need to improve performance for the base VASCADE product, which is about 15% of closure revenue, and stated that a refocused sales force is expected to drive a modest return to growth in fiscal 2026. CFO James D'Arecca clarified there were no one-time items in Q4 OpEx, attributing it to the timing of expenses. CEO Simon added that while operating leverage will build through the year, the company will not reduce investments in R&D and sales to drive long-term growth.

Andrew Cooper asked for more color on the performance of the base VASCADE product, potential impacts from tariffs in Mexico, and a breakdown of the margin guidance improvement, including the impact from the Whole Blood divestiture.

Answer

CEO Christopher Simon acknowledged a step-up in competition for VASCADE and an internal focus on new product launches. Regarding tariffs, he highlighted no China exposure and a strong U.S. manufacturing presence. CFO James D'Arecca quantified the Whole Blood divestiture's positive impact as 30-40 basis points on operating margin, mitigating some Mexico risk.

Andrew Cooper inquired about the nature of planned clinical investments, particularly if they were a reaction to the complexity of the OpSens sale, and also requested an update on the international launch of VASCADE.

Answer

CEO Christopher Simon stated the investments were part of the original plan, not reactive, designed to build out commercial and R&D capabilities for new technologies like OpSens and Plasma DMS. Regarding international VASCADE, he highlighted Japan as a 'hotspot' with strong uptake due to favorable reimbursement, while noting that Europe is a slower, country-by-country build-out with different market dynamics.

Andrew Cooper inquired about an update on Azenta's strategy to leverage bundling and cross-selling primarily within segments, rather than across, and how these customer conversations have progressed given the noisy market environment.

Answer

President and CEO John Marotta explained that bundling efforts are focused within segments due to significant opportunities. In Multiomics, the 'one-stop shop' for gene reading and writing is performing well, supported by e-commerce platform investments. For Consumables & Instruments (CNI), bundling instruments and consumables, along with high service attachment rates for Automated Stores, is strong. Similarly, the Biorepository business is successfully bundling more product solutions for existing customers. Mr. Marotta noted that pharma and biotech customers are consolidating suppliers and seek partners offering high quality, fair pricing, and a broad range of products and solutions, which Azenta is meeting.

Andrew Cooper asked about the specific offsets Azenta plans to implement to achieve its 300 basis point EBITDA margin expansion, given the $3 million-$5 million in extra costs impacting gross margin, and whether any initiatives from fiscal year 2027 might be pulled forward. In a follow-up, he inquired about the progress of Azenta's strategy to leverage bundling and cross-selling within segments, rather than across, and how these conversations are progressing in the current market environment.

Answer

EVP and CFO Lawrence Lin outlined several levers for margin optimization, including a better mix from increased second-half volumes (especially in North America), accelerated ABS and productivity initiatives (e.g., Kaizen events, biorepository automation), focused efforts by general managers, addressing fixed costs in the Sanger business, and accelerating indirect cost savings. He noted these initiatives are being intensified due to the quality issues. President and CEO John Marotta explained that bundling efforts are concentrated within segments, such as offering 'read and write genes' in Multiomics, combining instruments and consumables in CNI with high service attachment rates, and providing more product solutions for existing biorepository customers. He emphasized that this focused approach within segments is due to significant opportunities and aligns with customers' desire to consolidate suppliers for high-quality, broad product solutions.

Andrew Cooper questioned the mid-single-digit growth target for the SMS segment, asking for a breakdown of segment performance and the contribution of price versus volume. He also asked John Marotta to elaborate on the balance between decentralizing decision-making closer to customers and integrating previously siloed operations, in the context of the 300 basis points of margin expansion.

Answer

CEO John Marotta highlighted the durability of SRS contracts (7-25 years, 90% recurring revenue) and contractual price obligations. EVP and CFO Lawrence Lin detailed SMS segments, expecting a slower start for CapEx in stores/cryo but strong CNI performance and robust SRS growth driven by new leadership and price optimization. John Marotta explained the shift to a decentralized model with product line P&Ls and general managers, embedding R&D, product management, sales, and marketing within businesses, while streamlining systems for synergies.

Andrew Cooper of Raymond James & Associates, Inc. questioned the mid-single-digit growth projection for the Sample Management Solutions (SMS) segment, asking for a segment-by-segment framework and the contribution of price versus volume. He also inquired about balancing the decentralization of decision-making with the historical need for integration, in the context of the 300 basis points margin expansion.

Answer

CEO John Marotta and CFO Lawrence Lin detailed SMS expectations, including a slower start for stores/cryo, strong CNI, and robust SRS growth driven by new leadership and price optimization. They explained price optimization primarily in CNI and SRS through better deployment of contracted rates. John Marotta elaborated on the organizational shift to a decentralized model with product line P&Ls and regional go-to-market strategies, emphasizing decision-making closer to the customer and streamlined systems for synergies.

Andrew Cooper of Raymond James inquired about the drivers of the significant SMS margin expansion, asking to distinguish between mix and structural cost savings, and questioned the confidence level in the Q4 SMS outlook.

Answer

CFO Lawrence Lin explained the 760 bps SMS margin expansion was driven largely by favorable product mix, supplemented by gross margin improvements from better operational execution and cost management. CEO John Marotta added that the Azenta Business System (ABS) is beginning to yield productivity gains. Lin reaffirmed Q4 confidence based on seasonality, backlog visibility, and NGS momentum.

Andrew Cooper from Raymond James sought clarification on Multiomics pricing dynamics, the impact of China tariffs on Gene Synthesis, and the prerequisites for resuming M&A activity.

Answer

CEO John P. Marotta and CFO Lawrence Lin clarified that NGS pricing is stable, while price headwinds are concentrated in the legacy Sanger sequencing business, which is being offset by rapid growth in the new Plasmid-EZ product. Marotta stated the Gene Synthesis business is well-positioned in a high-margin niche. Regarding M&A, he stressed the need for the company to first demonstrate a consistent track record of operational and financial execution to build credibility before considering acquisitions.

Andrew Cooper questioned why the fiscal 2025 growth guidance of 3-5% wasn't more bullish, given some favorable year-over-year comparisons and strong Q4 performance in the core business. He also sought clarification on the 300 basis point margin expansion guidance, asking if it was based on the reported FY24 results or a recasted number excluding B Medical.

Answer

CEO John P. Marotta explained the prudent guidance reflects internal factors such as open sales territories, recent employee turnover, and potential distractions from the company's transformation. CFO Herman Cueto clarified that the 300 basis points of margin expansion is on an apples-to-apples basis against a recasted fiscal 2024 number (excluding B Medical), and that the company would provide the recasted financials before the next quarterly filing. He guided to an FY25 EBITDA margin above 11%.

Andrew Cooper asked for a breakdown of the moving parts impacting Revvity's margins for the year, especially in Q1, considering factors like tariffs, FX, and cost-saving programs, and also how software launch expectations are calibrated given the challenging market and the shift to SaaS-oriented products.

Answer

Max Grykowiak, SVP and CFO, explained that Q1 margins are typically lower than the full-year average, and for 2026, Q1 and Q2 will be lighter due to an extra operating week (a margin headwind) and cost actions being implemented throughout the first half. Prahlad Singh, President and CEO, noted that new software products are largely upsell opportunities into the existing Signals suite, often driven by customer demand, and while they expect traction, it typically takes a few quarters.

Andrew Cooper asked for a detailed breakdown of the moving parts impacting margins for the year, especially in Q1, distinguishing between normal seasonal drops, tariffs, FX, and cost-saving program costs. He also inquired how Revvity has calibrated expectations for its software product launches, given the challenging end market, and how the constrained capital environment impacts the go-to-market strategy for new SaaS-oriented products.

Answer

Max Krakowiak, SVP and CFO, explained that Q1 margins are typically several hundred basis points below the full-year average. For 2026, Q1 and Q2 are expected to be lighter than normal due to the impact of an extra week (a headwind) and cost actions not being fully completed until the end of Q2. Prahlad Singh, President and CEO, noted that the software business leverages an installed base, making new product launches primarily upsell opportunities within the Signals Suite. These launches are driven by customer demand and asks, rather than a push of new products, and typically take a few quarters to gain traction.

Andrew Cooper sought to understand what Revvity is hearing directly from customers regarding budget plans amid regulatory and political uncertainty. He also asked about underlying margin performance, questioning if, absent the planned step-up in investments, the expansion would be above the previously communicated trend of 50 bps for mid-single-digit growth.

Answer

CEO Prahlad Singh reiterated that the guidance is based on prudence due to market uncertainty, not specific customer feedback about pausing budgets. He emphasized the stability of the Diagnostics, Software, and Reagents businesses. CFO Max Krakowiak confirmed it was a 'fair summary' that underlying margin expansion is strong, noting that tailwinds from gross margin improvements are helping to offset some of the strategic investments planned for the year.

Andrew Cooper requested an update on the launch timing for the new TB automation product. He also asked if the large share repurchase authorization signals a shift in M&A strategy and inquired about the current M&A pipeline.

Answer

CEO Prahlad Singh stated that the TB product launch has been pushed to Q1 2025 from Q4 2024. Regarding capital allocation, he explained that while M&A remains a focus, target valuations are still high, and the company currently sees greater value in repurchasing its own stock.

Andrew Cooper inquired about the drivers of the 30% EBITDA margin in Q3, distinguishing between timing and operational performance, any incremental spend pulled into 2025, and the OpEx jumping-off point for 2026. He also asked for more detail on the competitive fit and monetization potential of Decipher's molecular features reports.

Answer

CFO Rebecca Chambers attributed the Q3 EBITDA margin to revenue outperformance, prior-period collections, and minor V2 Afirma benefits, with minimal incremental spend pulled into 2025. She indicated that 2026 OpEx will be managed to achieve a 25% Adjusted EBITDA target. Chief Commercial Officer John Leite and Chief Medical and Scientific Officer Phil Febbo clarified that molecular features are not directly monetized but enhance Decipher's value by providing predictive insights, helping clinicians manage complex high-risk patient decisions, and reinforcing the test's utility.

Andrew Cooper from Raymond James asked for a breakdown of the Q3 EBITDA margin, distinguishing between timing of spend and operational performance, and whether the Q4 guide includes incremental, previously unexpected spend. He also inquired about the OpEx jumping-off point for next year and how the molecular features reports fit competitively, their monetization potential, and comparison to Afirma's Net Promoter Score.

Answer

CFO Rebecca Chambers attributed Q3 EBITDA "goodness" to revenue outperformance, prior-period collections, and some v2 Afirma benefits, noting no specifically material incremental spend was pulled into Q4. She suggested that the OpEx jumping-off point for next year can be estimated by backing into the 25% adjusted EBITDA target for 2026. Chief Commercial Officer John Leite stated that molecular features are not directly monetized but serve to continuously improve and differentiate Decipher, proving its value to HCPs. Chief Medical and Scientific Officer Phil Febbo added that these features underscore the value of biology, helping clinicians manage increasingly complex decisions for high-risk and metastatic prostate cancer patients by complementing the prognostic signature with predictive insights.

Andrew Cooper followed up on the electrophysiology situation, asking for context on how much of the impact was due to customers lapping an inventory build versus a genuine lowering of end market demand expectations. He sought to understand if the slower performance of these customers indicated a broader slowdown in the EP market or if demand was being met by other customers or players Integer doesn't work with.

Answer

Payman Khales, President and CEO-elect, explained that the situation is an element of both. Customers had initially ramped up product acquisition, and are now adjusting their demand based on real-time feedback regarding the actual rate of market adoption for those products.

Andrew Cooper asked if Integer could recapture some of the lost electrophysiology volume with other customers, the timing of such a recovery, and how Integer plans to manage margins and costs in 2026 given the expected flat profitability.

Answer

Payman Khales, President and CEO-elect, reiterated that the electrophysiology business is strong excluding the two specific products, with new product launches planned for H2 2026 and 2027 across growth markets. He expressed confidence in returning to growth in H2 2026 due to easier year-over-year comparisons and planned launches. Diron Smith, EVP and CFO, addressed 2026 margins, noting the profit range aligns with sales. He explained that while volume leverage will be challenging, Integer Production System efficiencies and disciplined cost management will drive continuous improvement.

Andrew Cooper asked if there has been any change in conversations with customers about passing through tariff-related costs. He also inquired about the variability of Integer's content dollar value across different competing pulse field ablation (PFA) catheters in the market.

Answer

COO Peyman Khales stated that customer conversations have not changed regarding tariff pass-throughs and that discussions focus on logistical optimizations to minimize impact, with about 70% of business being under contract. On PFA, Khales could not provide specific dollar content per customer but emphasized that Integer has broad exposure to leading players with a range of offerings, from complex components to finished devices. He reiterated that Integer's growth is driven by its content across the entire EP procedure, not just the ablation catheter itself.

Andrew Cooper of Raymond James asked about the potential for a guidance raise after a strong Q1 and inquired about the integration of recent acquisitions and the company's appetite for larger M&A.

Answer

CEO Joseph Dziedzic indicated it was too early in the year to raise guidance, citing tariff volatility. President and CEO-Elect Payman Khales stated the recent coating acquisitions were strategic, integration is proceeding well, and customer conversations have begun. On M&A appetite, CFO Diron Smith reiterated a commitment to the 2.5x-3.5x leverage target and a focus on tuck-in acquisitions rather than transformative deals, noting about $350-$400 million in annual capacity.

Andrew Cooper requested more details on the contract research business, specifically the traction of the Accelerator bundled program. He asked how this program's applicability to customers changes within the context of onshoring discussions, and how customers view this 'wraparound 360 partnership' versus historically separate CRO and CDMO services.

Answer

Marc Casper (Chairman, President and CEO) explained that the Accelerator program leverages Thermo Fisher's extensive CRO and pharma services capabilities to streamline drug development and production. He noted strong adoption, particularly in biotech, due to the integrated insights and capabilities, which has built a significant book of authorizations. Large pharma also shows considerable interest in the clinical trials' physical capabilities, logistics, packaging, and distribution of experimental medicines, driving share gain by linking with clinical research to reduce time and cost. Stephen Williamson (SVP and CFO) addressed the financial question, clarifying that the $0.30 Q3 beat, less $0.05 dilution from acquisitions, resulted in a $0.20 midpoint raise for the full year. He emphasized the strong position to finish the year and the significant raise on the low end of the guidance as a strong statement.

Andrew Cooper asked for more color on the contract research side, specifically the traction of the Accelerator Drug Development solution and how onshoring changes its applicability and customer partnerships. He also asked a financial question about the Q3 operational beat, FX/tariff tailwinds, and what factors might offset this traction in Q4, given the $0.20 midpoint raise and acquisition dilution.

Answer

Chairman, President, and CEO Marc Casper explained that Accelerator leverages combined CRO and pharma services capabilities to streamline drug development and production, seeing strong adoption, especially in biotech, and significant authorizations. He noted strong interest from large pharma in clinical trials logistics, driving share gain momentum by reducing time and cost. Senior Vice President and CFO Stephen Williamson clarified a $0.30 operational beat in Q3, with $0.05 additional dilution from acquisitions. He stated the $0.20 midpoint raise, coupled with a stronger raise on the low end, positions the company well for Q4.

Andrew Cooper of Raymond James asked if the VBP environment in China alters the competitive landscape for its immunoassay business. He also requested an update on the company's respiratory market share, particularly in primary and acute care settings.

Answer

CEO Brian Blaser stated that VBP impacts their long-term opportunity in China rather than causing an immediate competitive shift, and the focus remains on profitable growth. CFO Joseph Busky reiterated that the company's full-year flu guidance and its underlying assumptions regarding market share and test mix remain unchanged from the beginning of the year.

Andrew Cooper asked about the company's U.S. immunoassay manufacturing capacity split between its Rochester and U.K. facilities, and for details on its China business, including competitive win rates and the penetration of integrated instruments.

Answer

CEO Brian Blaser clarified that while there is some immunoassay manufacturing capacity in Rochester, the bulk of it is located in the U.K. Regarding China, he explained that the business is primarily in stand-alone clinical chemistry instruments, offering a significant runway to expand their immunoassay presence. He noted that the quarter's growth rate was mainly impacted by the Triage business.

Andrew Cooper of Raymond James & Associates, Inc. sought clarification on the carry-over impact of 2025 cost savings into 2026, asked about the Savanna trial timeline and its readiness for the next flu season, and inquired about the Donor Screening revenue assumption.

Answer

Chief Financial Officer Joe Busky confirmed the $30-$50 million in new savings are an in-year 2025 impact and that direct procurement initiatives will provide further benefits in 2026. Chief Executive Officer Brian Blaser stated the Savanna trial timeline is on track for a market launch later in the year. Joe Busky added that U.S. Donor Screening revenue is guided to be $40-$50 million in 2025, down from about $115 million in 2024.

Andrew Cooper asked how the company plans to operationalize its long-stated goal of increasing international cross-selling for legacy Quidel products like Sofia and QuickVue.

Answer

CFO Joe Busky acknowledged that cross-selling is in its "early innings" and that the strategy involves shifting more of the distributor-heavy Sofia business to their direct commercial channel and creating effective incentives for the sales teams to execute this shift.

Andrew Cooper of Raymond James sought clarity on the expected gross margin movement from Q2 through Q4, factoring in labor headwinds, facility start-up costs, and tariffs. He also asked about the synergy potential of the TPI acquisition and inquired about any potential supply chain drag on Stryker due to the AJR production issues.

Answer

SVP, Treasurer & CFO Ronald Lataille projected Q3 gross margin to be in the 'low-28s' due to increased labor penalties at the AJR facility, down from Q2's 28.8%. Chairman & CEO R. Jeffrey Bailly explained that TPI's internal supply role will evolve over time as new programs are developed, as switching existing qualified suppliers is a longer process. Regarding Stryker, Bailly described a strong relationship, noting that while UFP's supply is short, Stryker has other supply points to prevent disruptions and that UFP's goal is to rebuild their inventory in Q4.

Andrew Cooper of Raymond James inquired about the expected magnitude of gross margin changes in Q3 and Q4, the synergy potential of the TPI acquisition, and the impact of supply chain issues on the relationship with Stryker.

Answer

CFO Ronald Lataille forecasted that Q3 gross margin would dip into the 'low-28s' from Q2's 28.8% due to labor inefficiencies, with a rebound expected in Q4. CEO R. Jeffrey Bailly explained that TPI synergies would be realized over the long term as new products are developed to use its internal supply. He also characterized the relationship with Stryker as very strong, stating they appreciate UFP's transparency and have alternative suppliers to manage through the temporary disruption.

Andrew Cooper of Raymond James asked about the financial impact of price reductions from transferring safe patient handling business, where AJR's operational inefficiencies appear on the P&L, and how the company's long-term manufacturing footprint strategy has evolved with recent tariff discussions.

Answer

CEO Jeff Bailly stated that while customer prices will decrease by 15-20% on transferred business, UFP's own efficiencies should lead to higher margin percentages, and market growth may offset the revenue impact. Executive Ronald Lataille clarified that the temporary AJR inefficiencies are in direct labor costs within COGS and should normalize after Q2. Bailly affirmed UFP's commitment to its Dominican Republic expansion, as the cost savings outweigh tariff risks, and mentioned potential future expansion into the Asia Pacific region to serve local markets.

Andrew Cooper from Raymond James questioned the financial impact of price reductions from transferring production to the Dominican Republic, the source of inefficiencies at the AJR acquisition, and how the company's long-term manufacturing footprint strategy is evolving.

Answer

CEO Jeff Bailly explained that while customers receive a 15-20% price reduction on transferred products, UFP's internal efficiencies are expected to increase its margin percentage, with rapid market growth potentially offsetting the revenue impact. CFO Ronald Lataille identified the AJR inefficiencies as higher direct labor costs due to turnover and training, which he expects to normalize after Q2. Bailly affirmed UFP's commitment to its Dominican Republic expansion and noted they may expand in Asia Pacific to better serve that market in the future.

Andrew Cooper from Raymond James Financial questioned the implied second-half slowdown in the Anatomic Pathology (AP) guidance after a strong quarter. He also asked how recent managed care contract wins have impacted the business in terms of pricing versus volume, and how that performance compares to initial expectations.

Answer

Chief Commercial Officer Brandon Perthuis attributed the cautious AP outlook to potential back-half seasonality, though he noted a strong pipeline could offset this. CFO Paul Kim added that the company is investing heavily in sales and marketing and does not anticipate significant softness. Regarding managed care, Brandon Perthuis emphasized that in-network status is critical for the go-to-market strategy, while Paul Kim added that it also drives better reimbursement realization and efficiency, benefiting gross margins.

Andrew Cooper requested a breakdown of the Precision Diagnostics momentum between KNOVA and Beacon, asked about performance outside reproductive health, and questioned the trajectory for sales and marketing expenses and gross margins.

Answer

CCO Brandon Perthuis clarified that Beacon expanded carrier screening and pediatric rare disease tests were the primary growth drivers, while KNOVA is not yet a significant contributor. CFO Paul Kim explained that sales and marketing expenses will ramp from Q2 to Q4 within a $10M-$11M quarterly range as new hires join. He also stated that non-GAAP gross margins, which were above 41% in Q1, are expected to remain strong and could potentially increase in the second half of the year.

Andrew Cooper sought more context on Precision Diagnostics customer wins that slipped into Q1 2025 and their impact on the guide. He also asked if the Anatomic Pathology turnaround was due to recapturing lost share or new business, and questioned the total cash utilization for the therapeutics pipeline in 2025.

Answer

CCO Brandon Perthuis clarified that the delayed wins were large accounts with complex onboarding, which is progressing well. CFO Paul Kim noted that despite the slip, 2025 quarterly guidance for Precision Diagnostics is higher than Q4's achievement, driving gross margins above 40%. Regarding Anatomic Pathology, Perthuis explained they first stabilized the base business and are now layering on new wins, with growth across multiple service lines. CEO Ming Hsieh confirmed the expected cash burn for the therapeutics unit is approximately $25 million for 2025.

Andrew Cooper of Raymond James questioned if recent M&A in the diagnostics space, such as the Tempus-Ambry deal, creates competitive disruption or opportunities for Fulgent. He also asked about the impact of changing coverage decisions for pharmacogenomics (PGx) and sought clarity on the VA contract's nature as a 'hunting license' and its revenue potential.

Answer

Chief Commercial Officer Brandon Perthuis stated that recent industry M&A does not significantly affect Fulgent's operations and that the management team remains active in evaluating its own M&A opportunities. He clarified that the PGx business with the VA is not exposed to third-party reimbursement changes. Perthuis confirmed the VA contract is a 'hunting license' that makes it possible to pursue this new, entirely incremental revenue stream, which will take time to scale but is expected to contribute meaningfully in 2025.

Andrew Cooper of Raymond James Financial asked for more detail on the math behind the clinical revenue guidance cut, questioning if it was solely due to the PANTRACER delay or also a general de-risking. He also requested specifics on the improvements made to the PANTRACER liquid biopsy test.

Answer

CEO Tony Zook explained the clinical guidance adjustment was due to the PANTRACER launch delay, a slight negative impact from test mix, and a conscious effort to set a more confidently achievable target. President & COO Warren Stone detailed the PANTRACER improvements, which include a lower sample input requirement (reducing QNS rates), a faster turnaround time, and an enhanced ability to detect certain genes, making the product more competitive.

Andrew Cooper of Raymond James Financial requested a more detailed breakdown of the clinical revenue guidance reduction and asked for specific improvements made to the PANTRACER liquid biopsy product profile.

Answer

CEO Tony Zook and CFO Jeff Sherman attributed the clinical guidance adjustment to the PANTRACER launch delay and a slight shift in NGS test mix. President & COO Warren Stone detailed that the updated PANTRACER product features a lower sample input requirement, faster turnaround times, and improved gene detection, making it highly competitive.

Andrew Cooper of Raymond James asked for a reminder of the hurdles for achieving operational readiness for the RaDaR 1.1 MRD test and the stage gates for its commercial launch. He also inquired about the P&L trajectory for R&D and Sales & Marketing expenses for the remainder of the year.

Answer

CIO Andrew Lukowiak outlined two main focus areas for RaDaR 1.1 readiness: completing bridging studies to transfer reimbursement claims from version 1.0, and exercising the 'operational muscle' to ensure systems and commercial teams are prepared. CFO Jeff Sherman projected that sales and marketing expenses will continue to grow with revenue and incremental hires, while R&D expense, which was higher in Q1 due to validation work, will likely decrease slightly as the year progresses.

Andrew Cooper asked for a breakdown of the drivers for clinical AUP growth in 2025 (RCM, mix, price) and inquired about any lingering financial impact from Q4 natural disasters like hurricanes.

Answer

CFO Jeff Sherman explained that AUP growth in 2025 would likely mirror 2024, where roughly 60% of the increase came from the NGS mix, with the balance from other initiatives. CEO Christopher Smith noted that while natural disasters cause temporary disruptions, the non-elective nature of their testing means volume is typically delayed, not lost, and lab redundancy helps manage workflow.

Andrew Cooper asked for details on the new Neo Helix digital platform, its integration of Trapelo's clinical decision support, and for thoughts on a recent large M&A deal in the diagnostics space.

Answer

President of Informatics Melody Harris described Neo Helix as a new, mobile-enabled platform launching in 2025 to create a seamless customer experience, with the initial focus on usability rather than monetizing decision support. Regarding industry M&A, CEO Christopher Smith gave a high-level response, stating NeoGenomics evaluates all opportunities based on its own strategy and what is best for its shareholders.

Andrew Cooper of Raymond James & Associates asked for an update on customer interest and feedback regarding the new Cytek Muse system. He also inquired about current trends in the pharma, biotech, and CRO markets, particularly if postponed orders were beginning to materialize in May.

Answer

CEO Wenbin Jiang explained that the new Cytek Muse is aimed at the gene and cell therapy markets and is currently in a sampling and evaluation phase, with the goal of adding new applications and driving reagent sales. CFO William McCombe noted that the cautious spending environment in pharma was similar to that in the academic sector and that all current trends are incorporated into the annual guidance. He added that Q2 is typically stronger than Q1 and that big pharma continues to show a strong preference for Cytek's harmonizable systems.

Andrew Cooper asked about the potential impact of Chinese stimulus programs, the company's visibility into the Q4 order book, and for an update on the progress of the clinical pathway in the U.S.

Answer

CEO Wenbin Jiang expressed confidence that Cytek will benefit from Chinese stimulus funds due to its well-established advanced technology. Regarding Q4, he noted it was too early to comment on visibility as most orders arrive in the final weeks of the quarter. On the U.S. clinical front, he confirmed the company is making good progress on both its 510(k) process and LDT applications with partner labs.

Andrew Cooper of Raymond James questioned the deployment timeline for the new $40 million stock repurchase program. He also asked about broader capital deployment strategy, including the appetite for M&A and whether management is seeing more attractive asset valuations.

Answer

CFO Ken McGrath explained the $40 million buyback is authorized over two years and can be thought of as being deployed evenly, around $5 million per quarter, with no purchases made in Q1 due to timing. CEO Carrie Eglinton Manner affirmed that M&A remains a key focus to accelerate growth and innovation, alongside internal investments like the Sherlock molecular diagnostics platform and its clinical trial for the CT/NG test.

Andrew Cooper sought to confirm that the scrap expense was separate from the inventory reserve for the discontinued business. He also asked for a breakdown of the factors contributing to the wide Q1 guidance range and questioned the potential for PEPFAR-related headwinds to persist beyond Q1.

Answer

CFO Ken McGrath confirmed the scrap expense was separate from the risk assessment business inventory write-down. President and CEO Carrie Eglinton Manner explained the wide Q1 range is due to timing uncertainty around a large consumer genomics customer's orders and the PEPFAR headwind of just under $1 million. She expressed long-term optimism for PEPFAR due to its bipartisan support and life-saving mission, but noted a lack of near-term visibility.

Andrew Cooper of Raymond James inquired about the importance of international growth for the core business, its long-term effect on the margin ramp to 50%, and the potential need for incremental investments to drive future core growth.

Answer

CFO Ken McGrath stated that international is a healthy, growing part of the business and that company-wide operational efficiencies provide visibility to the 50% margin target. CEO Carrie Eglinton Manner highlighted their strong credibility with global funders and patient preference for oral fluid tests as key international advantages. Both executives indicated that growth initiatives are largely covered by the current operating expense run rate, with a focus on leveraging existing capabilities rather than requiring large new investments.

Andrew Cooper of Raymond James sought to clarify if the GeneSight weakness was driven more by Myriad's own resource reallocation than the direct UnitedHealthcare impact. He also asked for the key drivers of the $35 million annual revenue guidance reduction and for lessons learned from the delayed FirstGene launch.

Answer

CFO Scott Leffler confirmed the GeneSight outlook was impacted by both the known UHC policy and a new, lower volume expectation from resource reallocation. He identified the GeneSight volume revision and the slower ramp in unaffected hereditary cancer as the two main drivers of the guidance cut. CEO Samraat Raha stated the upcoming FirstGene launch reflects a renewed focus on execution excellence and creating a more predictable product development and launch process.

Andrew Cooper asked for an update on the diagnostics funding situation in Africa and whether the company sees it as a temporary issue or a new normal. He also sought more detail on the services business model and the strategic desire to grow it.

Answer

CEO Stephen MacMillan stated they are assuming the Africa revenue is 'gone' and have removed it from the forecast, treating any return as upside. COO Essex Mitchell added that the testing infrastructure on the continent is now 'effectively broken.' CFO Karleen Oberton confirmed the services line is mostly gantry service and Biotheranostics, and that the company is keen to grow this business to increase customer stickiness.

Andrew Cooper asked about the potential for Panther Fusion adoption to grow beyond the current 40% attachment rate and sought clarity on the expected operating margin trajectory for the remainder of the year.

Answer

CEO Stephen MacMillan stated he believes the Panther Fusion attachment rate could ultimately get close to 100% over time through steady, incremental customer additions driven by new menu rollouts. On margins, CFO Karleen Oberton confirmed that operating margin will improve through the year from the Q1 level but cautioned against using the Q4 exit rate as a direct jumping-off point for fiscal 2026 due to seasonal expense patterns.

Andrew Cooper asked for more detail on the factors driving the guided 50 to 100 basis points of margin expansion during fiscal 2025, specifically the relative impact of lapsing transitory headwinds versus benefits from network optimization.

Answer

Chief Financial Officer Karleen Oberton acknowledged that both factors contribute to the expected margin improvement. She reiterated that the transitory headwinds are depressing margins in the first half of the year, and as they clear, the company will realize the associated margin benefit, but did not provide a specific quantification of each contributing factor.

Andrew Cooper of Raymond James questioned the 2025 adjusted EBITDA guidance given lower legal spend, asked why programs like IOTA might not drive faster surveillance adoption, and inquired about the ROI on new hires and its effect on ASP.

Answer

CFO Abhishek Jain explained the EBITDA guidance reflects a significant incremental margin drop-through, even with investments to scale operations, and noted that lower legal spend was already reflected in 2024's results. CEO John Hanna agreed that IOTA is a major driver for AlloSure adoption and the company is actively engaging with centers. Jain added that the ASP guidance of $1,360 for 2025 already bakes in low single-digit growth, with potential upside from the new RCM team's efforts.

Andrew Cooper of Raymond James questioned the Precision Oncology guidance, asking why growth isn't faster given the ExactNexus tailwind and Oncodetect launch. He also asked for details on the incremental sales and marketing investment for Oncodetect.

Answer

CFO Aaron Bloomer explained the guide implies steady core growth, led by strong double-digit international Oncotype DX growth. He noted they are making intelligent investments in S&M to ensure a successful Oncodetect launch and are also investing heavily in clinical evidence generation, including multiple large prospective studies for colorectal, breast, and multi-solid tumors.

Andrew Cooper questioned the Precision Oncology guidance, suggesting it seemed slow given tailwinds from the Nexus platform transition and the Oncodetect launch. He also asked for details on the incremental sales and marketing spend for Oncodetect.

Answer

CFO Aaron Bloomer clarified that the guidance reflects steady underlying growth, led by strong double-digit international growth for Oncotype DX, offset partially by FX headwinds. Regarding Oncodetect, he stated the company is making intelligent sales and marketing investments for a successful launch while also investing heavily in building clinical evidence through multiple large-scale studies for colorectal, breast, and multi-cancer applications.

Asked to reconcile the comments that doctors are promotionally responsive while at the same time it's taking longer to ramp new reps, questioning if this points to a change in doctor behavior rather than just company execution.

Answer

Management explained that the two points are reconciled by their plan to use data and analytics to better focus their sales force on the healthcare providers who are most responsive. Their data shows a clear link between sales calls and order frequency, giving them confidence that a more focused deployment will drive stronger growth, addressing the execution gap.

Andrew Cooper from Raymond James asked to reconcile the comments that doctors are 'promotionally responsive' with the fact that it's 'taking longer to ramp new reps,' questioning if there's a change in doctor behavior versus just an execution issue.

Answer

CEO Kevin Conroy explained that the company's extensive data shows a direct correlation between sales calls and provider ordering frequency. He expressed confidence that by using analytics to better deploy the field force and focus their efforts on the most responsive healthcare providers (HCPs), they can drive stronger growth in the core Cologuard business, confirming it is an execution opportunity.

Andrew Cooper from Raymond James asked for help reconciling the statement that doctors are 'promotionally responsive' with the simultaneous comment that new reps are taking longer to ramp, questioning if this indicates a change in physician behavior.

Answer

CEO Kevin Conroy explained that the two points are linked by execution. He stated the company has extensive data showing a direct correlation between the frequency of sales calls and provider ordering. The plan is to use analytics to better deploy the field force to focus on the most responsive healthcare providers (HCPs). This data-driven focus gives them confidence that they can drive stronger growth in the core Cologuard business, suggesting the issue is focus, not a fundamental change in physician responsiveness.