Casey Woodring

Casey Woodring of JPMorgan, on for Rachelle Battensall, asked for details on Europe's performance relative to expectations and its outlook. She also inquired about the expected timing for onshoring and reshoring trends to translate into revenue.

Answer

CFO Shawn Vadala reported that Europe's flat growth was slightly below expectations, with the lab business impacted by market uncertainty. The Q3 outlook for Europe is low-single-digit growth. CEO Patrick Kaltenbach described onshoring as being in its 'early innings,' stating that while the company is in active discussions with customers, he expects the trend to begin materially impacting results in 2026 with further momentum in subsequent years.

Casey Woodring asked for a breakdown of Signatera's new patient starts contribution in the quarter compared to the previous quarter, and which tumor types are showing the most strength, including any early traction from new data readouts like Invigor. He also inquired about expectations for 2026 gross margins, particularly with Signatera's growing mix, and if a similar step-up rate as 2025 is anticipated.

Answer

CEO Steve Chapman noted that new patient starts in Q3 were similar to the "all-time record" growth seen in Q2, indicating continued strong interest across broad tumor types, with significant inbound interest in bladder cancer following the Invigor announcement. CFO Michael Brophy advised modeling 2026 gross margins by stripping out true-ups and anchoring to the pre-true-up number, expecting "reasonably meaningful sequential improvement" but cautioned against expecting the exact same rate as 2025's significant year-on-year change, reiterating the long-term target of 70%.

Casey Woodring inquired about a potential market shift towards liquid biopsy, specifically asking if Tempus AI is observing a similar pickup in xF volumes, and sought an update on the FDA approval process for xF and xR, including the potential for ADLT status and expected Medicare list price upside.

Answer

CEO Eric Lefkofsky noted that Tempus AI, strong across hereditary, therapy selection (solid/liquid), and MRD, hasn't observed a seismic shift from solid to liquid biopsy, with both showing good growth. He acknowledged potential future volume increases for liquid biopsy from serial testing studies. CFO Jim Rogers added that 30% of xT CDX volume has migrated to the FDA-approved version, with plans to move the majority in 2026. He confirmed xF submission to the FDA by year-end, followed by xR, expecting ADLT status to provide upside from the current average reimbursement of $1,600, aiming to close the gap with peers.

Casey Woodring inquired about a potential pickup in xF volumes and a market shift towards liquid biopsy, as well as plans for FDA approval of xF and xR, and the potential upside to Medicare list price from ADLT status.

Answer

Eric Lefkofsky (CEO, Tempus AI) noted good growth in both solid tumor and liquid biopsy assays but no seismic shift from solid to liquid, acknowledging potential future volume increases for liquid from serial testing. Jim Rogers (CFO, Tempus AI) discussed plans to migrate xT CDX volume to FDA-approved versions in 2026, xF submission by year-end, and xR submission later, stating ADLT typically provides upside from the current average reimbursement of $1,600 in Q3.

Casey Woodring asked about the TA business's faster-than-expected recovery and the latest expectations for its performance. He also inquired about the instrument order funnel and the potential runway for the replacement cycle, considering new product launches, the FDA update, and reshoring benefits.

Answer

CFO Amol Chaubal attributed TA's recovery to stabilizing tariff volatility and an improving interest rate outlook. He described a rich and strong instrument funnel driven by large pharma and CDMO replacement cycles, innovation in LC & MS, and advancements in bioanalytical characterization and bioseparations. President and CEO Udit Batra added that the instrument replacement cycle is still in its 'mid-innings' with a low single-digit CAGR versus 2019, and clarified MFN negotiations provide planning relief, boosting confidence in CapEx release for new products.

Casey Woodring inquired about the latest expectations for the TA business, which returned to growth faster than anticipated, and the instrument order funnel, including the runway for the instrument replacement cycle given current strength, new product launches, and regulatory updates.

Answer

CFO Amol Chaubal attributed TA's recovery to stabilizing tariff volatility and an improving interest rate outlook, unblocking stalled projects. He described the instrument order funnel as rich and strong, driven by large pharma and CDMO replacement cycles, innovation in LC/MS, and advancements in bioanalytical characterization and bioseparations. He noted that CROs, biotechs, and branded generics in China are still on the sidelines but CROs are starting to re-engage. CEO Udit Batra added that the instrument replacement cycle is still in its 'mid-innings' with a low single-digit CAGR versus 2019, and clarity on MFN negotiations provides a more stable planning environment, boosting confidence in CapEx release for new products.

Casey Woodring asked about the revenue recognition timing for the second ATF blockbuster hardware delivered in late Q3 (Q4 2025 or Q1 2026). He also sought further color on emerging biotech revenue reaching a three-year high and associated order trends.

Answer

Olivier Loeillot, President and CEO, stated that the exact revenue timing for the ATF blockbuster is uncertain, depending on customer commissioning and consumable purchases, but likely not Q4, possibly mid-2026. He noted that emerging biotech's rebound was a positive surprise, connecting it to increased biotech funding (Q2 €9B to Q3 €13B) and M&A activity, which could provide tailwinds for early-phase projects.

Casey Woodring followed up on the ATF comments, asking if revenue from the second blockbuster hardware delivered at the end of Q3 is expected in Q4 or Q1 2026. He also inquired about trends in orders for emerging biotech revenue, which reached its highest level in three years, seeking further color despite the company's hesitation to call it a definitive trend.

Answer

President and CEO Olivier Loeillot stated that the exact timing for revenue from the ATF blockbuster hardware is uncertain, depending on commissioning and consumable purchases, but is unlikely in Q4 and more probable mid-next year. He highlighted Repligen's diversified ATF customer base, with over 50 late-stage and commercial drugs, indicating a long runway for growth. Regarding small biotech, Loeillot described its rebound in Q3 as a 'great surprise,' connecting it to increased biotech funding (from EUR 9 billion in Q2 to EUR 13 billion in Q3) and M&A activities where pharma companies are acquiring smaller biotechs, which he sees as a tailwind.

Casey Woodring requested more granularity on the trial mix driving higher pass-throughs, specifically asking if it was solely cardiometabolic. He also inquired about progress on automation and AI for cost management and its potential to offset pricing pressure.

Answer

CFO Nigel Clerkin noted that while cardiometabolic strength is a factor, a particularly active vaccine study in Q3 also contributed to pass-throughs. He reiterated automation as a key lever for efficiency. CEO Barry Balfe emphasized the deployment of AI-enabled technologies, including an end-to-end project management system and a proprietary multi-agent digital assistant called Orbus, to drive efficiency, recruit patients, and manage trials more effectively, creating and capturing value.

Casey Woodring requested more granularity on the trial mix driving higher pass-throughs, specifically if it was all cardiometabolic, and inquired about progress on automation and AI as a margin driver and its ability to offset pricing pressure.

Answer

CFO Nigel Clerkin confirmed cardiometabolic as a factor and noted a particularly active vaccine study in Q3 2025, but reiterated that the general increase in pass-throughs is due to therapeutic mix. CEO Barry Balfe highlighted ongoing investments in AI-enabled technologies, process automation, and external partnerships to enhance efficiency. He specifically mentioned a multi-agent digital assistant called Orbus, which is in early stages but aims to create and capture value by delegating workflows and improving decision-making.

Casey Woodring of JPMorgan Chase & Co. asked about month-over-month demand trends in April and the outlook for the Q2 book-to-bill ratio, given the large upcoming cancellation.

Answer

COO Barry Balfe responded that it was too early to call the Q2 book-to-bill and advised against extrapolating from monthly trends. He reiterated that the company's full-year guidance assumes market conditions will remain roughly consistent for the balance of the year.

Casey Woodring asked for elaboration on customers changing their development models, whether this is leading to a shift in outsourcing versus insourcing spend, and if the long-term assumption of 100-200 basis points of annual outsourcing penetration still holds.

Answer

COO Barry Bell explained that 'changing models' refers to ICON's ability to customize blended solutions that match a client's evolving mix of in-house, insourced, and outsourced work. CEO Dr. Steve Cutler affirmed a constructive long-term view, stating that outsourcing penetration continues to increase by approximately 100 basis points per year on average, driven by the value the CRO industry provides.

Casey Woodring asked about the progression of the preclinical and discovery pipeline and whether the current slowdown is a short-term dynamic or the beginning of a longer-term trend.

Answer

CEO Dr. Steve Cutler unequivocally stated the current issues are not related to preclinical pipeline progression, calling the link to late-stage work tenuous in the short term. He reiterated his belief that the challenges are isolated and short-term. SVP Kate Haven added that activity in the early-phase (Phase I) business has actually been a bright spot, with strong performance on the awards front.

Casey Woodring from J.P. Morgan asked for the expected cadence of Sterigenics' volume and mix growth in the second half of the year and inquired about the normalized growth outlook for Nelson Labs in 2026.

Answer

CFO Jonathan Lyons indicated that Sterigenics' second-half growth would be in the mid-to-high single-digit range, though slightly muted compared to Q2 due to maintenance downtime. CEO Michael Petras deferred 2026 guidance for Nelson Labs but emphasized the near-term focus is on driving core lab volume growth, as the Expert Advisory Services business is not a primary long-term growth driver.

Casey Woodring of JPMorgan inquired about the expected 2025 performance of Sterigenics' different end markets (med device, pharma, bioprocessing). He also asked about the pacing of CapEx and the margin impact of new greenfield facilities.

Answer

CEO Michael Petras anticipates improvement across med device and pharma, with the commercial market being 'choppier.' He noted bioprocessing volume is expected to continue its recovery. CFO Jon Lyons added that one greenfield facility is coming online in 2025 with no significant margin impact, and the company remains on track to lower CapEx to its 2027 target, with the final greenfield now expected in 2027.

Casey Woodring from JPMorgan Chase & Co. requested a breakdown of Nelson Labs' Q3 performance across its service lines and the outlook for Q4. She also asked about risks from pharma R&D spending and details on the reduced full-year CapEx guidance.

Answer

CEO Michael Petras noted that validation testing remained strong in Q3, with routine testing showing progress. CFO Jon Lyons explained the CapEx reduction was primarily due to timing shifts in cobalt development programs and some vendor-related delays on growth projects, not facility enhancements. He added that peak CapEx is now expected in 2025.

Casey Woodring asked about the business dynamics in Europe, where overall growth was strong but Sample Tech was down, and also inquired about the back-half cadence for the QDI business given its SaaS transition and customer mix.

Answer

CEO Thierry Bernard clarified that the strategic focus on automated solutions within Sample Technologies is showing growth in the EMEA region. For the QIAGEN Digital Insights (QDI) business, he noted the customer split is moving toward a 50/50 balance between clinical and research, and the transition to SaaS-based subscriptions is expected to continue through the second half of the year.

Casey Woodring asked for a more specific timeline for achieving the 31% midterm margin goal and for details on the expected revenue and growth from companion diagnostics (CDx) partnerships.

Answer

CFO Roland Sackers confirmed the 31% margin goal would be reached 'well ahead of 2028' but deferred giving a specific year, stating an update would come with 2026 planning. CEO Thierry Bernard projected continued double-digit growth for the CDx business, driven by a portfolio of over 35 pharma partnerships and an expanding technology offering that now includes PCR, NGS, digital PCR, and syndromic testing solutions.

Casey Woodring inquired about the expected number of QIAstat placements for 2025 and the impact of new panel approvals. He also asked for the rationale behind the recent corporate reorganization into two functional teams.

Answer

CEO Thierry Bernard stated that placing over 600 QIAstat systems per year, including the Rise equivalent, would be a satisfactory growth trajectory. Regarding the reorganization, he explained it moves away from siloed business units to better serve hybrid research/clinical customers and build sustainable ecosystems around platforms like Sample Tech, Digital PCR, and QIAstat, which span multiple end markets.

Casey Woodring inquired about the outlook for instrument revenue in Q4 and asked how QIAGEN's capabilities in liquid biopsy are expected to drive future consumables growth.

Answer

CFO Roland Sackers stated that Q4 instrument revenue is expected to improve sequentially but remain negative year-over-year. CEO Thierry Bernard positioned QIAGEN as a key 'enabler' in liquid biopsy, providing essential technologies to major labs. He emphasized this strategy allows QIAGEN to benefit from market growth while limiting exposure to risks like reimbursement changes, and confirmed continued investment in high-value liquid biopsy consumables.

Casey Woodring of J.P. Morgan asked for details on the drivers behind increased cancellations in longer-term, post-IND work and whether this trend might continue. He also questioned the forward outlook regarding potential headwinds from drug pricing policies and tariffs on large pharma spending.

Answer

CEO James Foster explained that the cancellations were driven by client-specific portfolio prioritization rather than a broader trend and did not have a significant margin differential. Regarding macro headwinds, he stated that while they have seen minimal impact to date, the company's guidance is prudent and assumes some uncertainty, with any major impact more likely to materialize in 2026.

Casey Woodring asked for an updated outlook on the biotech business within DSA given the weak funding environment, and inquired about conversations with large pharma clients regarding potential tariffs.

Answer

CFO Flavia Pease stated that tariff discussions are not currently impacting client R&D spending, and any direct impact to Charles River would be modest and passed on. CEO James Foster acknowledged the challenging funding environment for biotech but emphasized that they remain an important client base that values the company's high-quality science and regulatory expertise.

Casey Woodring asked for commentary on the potential impact of proposed pharmaceutical import tariffs on client spending and whether customers are expressing concern about potential changes to drug approval scrutiny under a new administration.

Answer

Chair, President & CEO James Foster stated that any commentary would be speculation at this point. He noted the company is not hearing much from clients on the RFK situation and that proposed tariffs are intended to support U.S. drug development, which could be beneficial, but it's too early to know the outcome.

Casey Woodring of JPMorgan Chase & Co. asked for more detail on the synergies between the CDMO and Biologics Testing businesses, including the client attach rate. He also inquired about any changes in communication with large pharma clients to improve visibility following last quarter's surprising demand drop.

Answer

Chairman, President and CEO James Foster highlighted that the synergy is a key competitive advantage, with over 50% of CDMO clients also using their Biologics Testing services, a capability some competitors lack. Regarding client communication, he noted that while they deal with the same R&D heads, upcoming Q4 discussions around 2025 budgets should provide a clearer, 'zero-based' view of future demand.

Casey Woodring of JPMorgan asked for an outlook on free cash flow for the second half of the year and the company's visibility into achieving its full-year cash flow conversion target. She also requested more detail on the timing of the $30-50 million in incremental cost savings.

Answer

CFO Joseph Busky expressed confidence in achieving the 25-30% recurring free cash flow to adjusted EBITDA target, citing the business's seasonality and strong second-half performance in the prior year. He confirmed the $30-50 million in savings from indirect procurement is on track and will be weighted towards the second half of 2025.

Casey Woodring requested more detail on why only a small percentage of shipments into China are currently subject to tariffs, the company's visibility into this situation continuing, and the potential risk of a larger portion being tariffed in the future.

Answer

CEO Brian Blaser and CFO Joe Busky reiterated that their commentary is based on direct experience with shipments over the past several weeks. In practice, the bulk of their products are not being tariffed. They stated there is currently no indication that this situation will change, though they acknowledged it is a fluid environment.

Casey Woodring from JPMorgan Chase & Co. requested a forecast for Q1 performance across business lines, with a specific focus on the respiratory and flu outlook given the recent spike in influenza-like illness (ILI) rates.

Answer

Chief Executive Officer Brian Blaser acknowledged the recent spike in flu activity but noted the full-year guidance already assumes an average flu season of 50-55 million tests. He stated that while the season's peak was high, the key variable is the duration of the season's tail, which the company is monitoring closely. The company is maintaining its full-year guidance based on an average season assumption.

Casey Woodring sought clarification on a "second tranche" of cost savings for 2025-2026 and asked for an updated view on the competitive landscape and market share for the respiratory testing business.

Answer

CFO Joe Busky confirmed a second tranche of savings will impact 2025 and 2026, driven by a continuous improvement culture and the exit of the dilutive donor screening business. He also stated QuidelOrtho remains the leader in respiratory testing and assumes a similar market share to 2023 in its guidance, while internally aiming to grow it.

Casey Woodring asked for a breakdown of the Q3 breast imaging revenue, questioning why it declined sequentially if gantry placements grew, and also inquired about the diagnostics growth setup for fiscal 2026.

Answer

CFO Karleen Oberton clarified that while 3D gantry revenue grew sequentially, other components within the broader imaging line were down, causing the total to decline. For FY26, she expects diagnostics to grow in the mid-single-digit range due to first-half headwinds. CEO Stephen MacMillan added that the long-term outlook for diagnostics remains strong.

Casey Woodring asked about the drivers of the strong 12% non-product revenue growth, its sustainability, and the specific growth contribution from the Biotheranostics business.

Answer

CFO Karleen Oberton credited the growth to 'great execution' by the service team, including optimizing pricing and increasing attach rates on a growing installed base. Executive Michael Watts clarified that the growing Biotheranostics oncology business is also included in this line item. Karleen Oberton added that Biotheranostics growth was accretive to the overall molecular business but benefited from an easy comparison to the prior year's Q2.

Casey Woodring asked for a geographic breakdown of the Breast Health business performance and inquired about the timing and potential margin impact of the planned manufacturing facility consolidation.

Answer

CFO Karleen Oberton reported that Breast Health declined in the mid-single digits in both the U.S. and internationally, with the international decline being slightly higher. Regarding manufacturing, she confirmed the consolidation is on track for 2026 but does not expect a significant change to the overall margin profile, as benefits from consolidation and higher ASP on the new gantry will likely be offset by higher component costs.

Casey Woodring requested a breakdown of the Q1 guidance by business segment to understand the expected growth acceleration. He also asked about the outlook for international versus domestic growth in 2025 and whether the 19.5% tax rate guidance includes benefits from supply chain moves.

Answer

Chief Financial Officer Karleen Oberton indicated that Diagnostics would see the least impact from headwinds with mid-single-digit growth in Q1, while other businesses would be lower. Chief Operating Officer Essex Mitchell confirmed international is expected to grow faster than domestic. On taxes, CFO Karleen Oberton noted the 19.5% rate is already a reduction from fiscal 2024 and the company is not committing to a lower rate at this time.

Casey Woodring inquired about the BARDA contract, asking about the burn rate of the initial $7.5 million and the timeline to unlock the additional funds. He also asked for details on the one-off scrap expense that impacted gross margin and the drivers for margin expansion towards 50% in 2025.

Answer

President and CEO Carrie Eglinton Manner noted the $7.5 million BARDA funding is back-end loaded and tied to milestones. CFO Ken McGrath explained the scrap expense was a one-time event related to expired materials. He detailed that gross margin expansion will be driven by new HIV test packaging, automation from reel-to-reel manufacturing, and in-sourcing of contract manufacturing and critical reagents.

Casey Woodring from JPMorgan asked for a breakdown of the 13% diagnostics growth, an updated view on the consumer genomics market amid recent turmoil, and details on the go-to-market strategy and addressable market for the new blood proteomics solution.

Answer

CFO Ken McGrath attributed the diagnostics growth primarily to strength in the international HIV business. CEO Carrie Eglinton Manner acknowledged softness in consumer genomics but expressed confidence in the market's durability and highlighted growth from new customers in other segments. For proteomics, she outlined a go-to-market strategy starting with a research-use-only (RUO) product targeting existing academic and pharma customers, with the market expected to ramp up over time as applications in oncology and neurology emerge.