Yuko Oku

Yuko Oku asked if NeoGenomics is observing an uptick in interest from pharma partners in integrating MRD testing into their clinical trial designs, citing the Invigor 011 trial. She also requested an update on the Adaptive partnership, including key learnings and feedback from the pilot program.

Answer

COO Warren Stone confirmed robust pharma interest in MRD since the product's August launch, noting strong engagement at the ESMO conference for various purposes, including endpoint integration. Regarding the Adaptive partnership, he stated that progress is favorable, with a pilot initiative started in Q3 to understand operational workflows. This pilot is expanding into three phases, with the first phase rolling out holistically in Q4 and phases two and three scheduled for 2026.

Yuko Oku asked if NeoGenomics is observing an increased interest from pharma partners in integrating MRD testing into their clinical trial designs, citing the IMvigor011 trial, and requested an update on the Adaptive partnership, including key learnings and feedback from the pilot program.

Answer

COO Warren Stone confirmed robust pharma interest in MRD since the August launch, noting strong engagement at the ESMO conference for various purposes, including endpoint analysis. He described favorable progress with Adaptive, detailing a Q3 pilot initiative focused on operational workflows to ensure a sound customer experience. This pilot is expanding into three phases, with Phase I rolling out holistically in Q4 2025 and Phases II and III quickly following in 2026.

Yuko Oku from Morgan Stanley inquired about the potential for portfolio pruning and how the company balances being a comprehensive 'one-stop-shop' against focusing resources on high-growth, profitable products. She also requested an update on the RADR ID litigation.

Answer

CEO Tony Zook and President & COO Warren Stone explained that while the broad portfolio is a competitive strength, the strategy is to invest heavily in high-growth areas like therapy selection and MRD, which includes ongoing portfolio simplification. Regarding litigation, Zook confirmed the trial is scheduled for October and stated the company remains committed to the MRD space through its Adaptive partnership and next-gen MRD development. He noted they oppose the recent motion for a bench trial.

Yuko Oku of Morgan Stanley inquired about NeoGenomics' strategy for portfolio management, specifically balancing its broad menu with a focus on high-growth NGS tests, and also requested an update on the RADR ID litigation.

Answer

CEO Tony Zook and President & COO Warren Stone affirmed that while the broad portfolio is a key competitive advantage, the company is strategically investing in high-growth areas like therapy selection and MRD, with ongoing portfolio simplification. Regarding litigation, Zook confirmed the October trial date and the company's commitment to the MRD market, regardless of the outcome.

Yuko Oku of Morgan Stanley inquired about GRAIL's customer support infrastructure for MCED testing and future investments ahead of potential FDA approval. She also asked about the statistical power and primary endpoint of the NHS Galleri study.

Answer

CEO Bob Ragusa stated that customer support is scaling with business growth and that the company will continue to invest in customer-facing teams, as confirmed by Chief Commercial Officer Andy Partridge. President of International Business Harpal Kumar explained that the NHS study is powered to detect a statistically significant reduction in late-stage (Stage 3 and 4) cancers, which serves as its primary endpoint.

Yuko Oku from Morgan Stanley inquired about the expected cadence of Average Selling Price (ASP) for the remainder of the year, considering the migration of XT volumes to CDx and the ramp-up of the unreimbursed XM test. She also asked if Tempus plans to add features like RNA and epigenomic markers to its tissue tests.

Answer

CFO Jim Rogers explained that while the migration to higher-value CDx tests continues toward the 40% year-end goal, a mix shift to lower-reimbursement assays like XM will temper the uplift. He anticipates small, incremental ASP gains over the year rather than a significant step-up. CEO Eric Lefkofsky added that Tempus has performed whole transcriptome RNA sequencing from the beginning and has a comprehensive panel, suggesting future advancements are more likely on the DNA side, such as migrating to whole genome sequencing.

Jason, on behalf of Yuko Oku, asked about the types of applications being run on the Vega system compared to Revio, and whether customers can easily transition between the two platforms as their throughput needs change.

Answer

President and CEO Christian Henry explained that applications are consistent across the instrument portfolio, and the choice between Vega and Revio is driven by a customer's sample scale and lab workflow. He confirmed that customers can easily move between the platforms, using Vega for smaller projects and seamlessly transitioning to Revio for larger-scale work, which provides valuable flexibility.

Yuko Oku of Morgan Stanley asked for early feedback on the digital pathology offering and its potential for broader commercialization. She also inquired about which cancer types beyond bladder cancer the company's unique whole-genome MRD platform might be best suited for.

Answer

CEO Marc Stapley described digital pathology as a nascent, complementary technology and reiterated the company's strategy to focus on robust, collaborator-led research via the GRID platform before any clinical launch. Regarding MRD expansion, Stapley indicated that indications where Veracyte has an existing commercial presence, such as urology, breast, and lung cancer, are logical areas for future launches.

Yuko Oku from Morgan Stanley, on behalf of Tejas Savant, asked about the extent of market development needed to drive adoption for Decipher in the new metastatic prostate cancer setting. She also sought to clarify if the Bethesda V LCD would drive new Afirma volume or primarily impact ASP for existing tests.

Answer

CEO Marc Stapley stated that since the customer base is largely the same urologists, market development will be an extension of current efforts and not require a significant change in spending. CFO Rebecca Chambers and Stapley explained the Bethesda V opportunity is a modest tailwind for both volume and ASP, as it's a small portion of the total population and the Medicare cohort is smaller than the commercial one.

Edmund Tu, on behalf of Yuko Oku from Morgan Stanley, asked for an updated estimate on the impact of policy headwinds on the biopharma business and inquired about NextPersonal's differentiation following a competitor's recent coverage determination, as well as the balance between near-term margin pressure from investments and future revenue.

Answer

CFO & COO Aaron Tachibana confirmed the biopharma guidance was revised down due to project delays in the translational research business. CEO Christopher Hall positioned a competitor's recent reimbursement as a positive sign for the field, expressing confidence that Personalis's data also meets the bar for coverage. Tachibana addressed the investment balance by stating the company is prioritizing volume growth ahead of reimbursement to maximize the revenue run-rate once coverage is secured, noting the current margin guidance of 22-24% already accounts for these unreimbursed test costs.

Yuko Oku asked if the optimal 4-week blood draw timing from the VICTORI study is applicable to other cancers, questioned the role of pharma partnerships in the development strategy, and inquired about the value of patient stratification for biopharma clients.

Answer

Executive Richard Chen explained that optimal testing time varies by cancer type due to different ctDNA shedding rates. Executive Christopher Hall described biopharma partnerships as crucial for accelerating clinical trials and enriching patient selection, leveraging relationships built via the ImmunoID NeXT platform. Chen confirmed that the ability to stratify patients by risk level using their ultrasensitive assay is of significant interest to biopharma partners for optimizing trial design.

Yuko Oku inquired about the rationale for increasing NeXT Personal sample volumes with Tempus ahead of reimbursement and asked about the expected gross margin cadence into 2025.

Answer

CEO Christopher Hall explained that the expansion with Tempus is a strategic move to train a large sales force, positioning the company for explosive growth once reimbursement is secured. CFO Aaron Tachibana added that Tempus's capital injection supports this pre-reimbursement ramp. Regarding margins, Tachibana projected significant headwinds of 15-18 percentage points in 2025 due to unreimbursed test costs, which could cause margins to decline from 2024 levels, with formal guidance to be provided later.

Yuko Oku from Morgan Stanley inquired about the importance of the CHMP positive opinion for pharma customers and its potential to increase focus on ex-U.S. opportunities. She also asked for physician feedback on the MIDUS trial data and whether it was driving clonoSEQ volume.

Answer

CCO Susan Bobulsky explained that the CHMP opinion was an important affirmation of existing pharma expectations and supports the growing global acceptance of MRD as an endpoint. She confirmed it helps prioritize a European expansion in the 'not distant future.' Regarding the MIDUS trial, she said physician feedback has been positive, especially in the community, as it opens up dialogue with patients about transplant decisions, though it's too early to point to a direct volume inflection.

Yuko Oku, on for Tejas Savant at Morgan Stanley, asked if EMR integrations are generating cost savings and whether pharma partner cost-cutting is shifting contracts towards more back-end loaded milestone payments.

Answer

Executive Susan Bobulsky confirmed operational efficiencies from EMRs are being realized, citing a 90% drop in order callbacks at one large account, but these savings are not yet in the 2025 guidance. CEO Chad Robins added that for pharma contracts, Adaptive is actively moving toward more front-loaded, recurring fee-for-service models to reduce revenue lumpiness, not the other way around.

Yuko Oku of Morgan Stanley asked if the company is experiencing broad pricing pressure from pharma customers and questioned the expected cadence of margin improvement in the Engineering segment for the second half of the year.

Answer

CEO Franco Stevanato stated that for high-value products, clients prioritize supply chain security and quality over price, highlighting the strength of their Nexa technology. CFO Marco Dal Lago said the company models for sequential margin improvement in Engineering in Q3 and Q4, contingent on finalizing new contracts that shifted from Q2.

Yuko Oku from Morgan Stanley asked about the potential market split between comprehensive panels like Guardant360 and simpler hotspot tests for monitoring ESR1 mutations following the SERENO-six trial, and also inquired about the broader impact of Medicaid cuts on cancer testing.

Answer

Chairman & Co-CEO Helmy Eltoukhy positioned the SERENO-six application as a 'beachhead' for a new adaptive disease management paradigm. As the enrolling assay and future companion diagnostic for camisestrant, he believes Guardant360 is positioned to capture the majority of this new opportunity. VP of Investor Relations Zarak Khurshid and CFO Michael Bell later clarified that Medicaid represents a minimal portion of overall volume and revenue, so any cuts would not have a material impact.

Yuko Oku of Morgan Stanley inquired about the specifics of the assay and surface chemistry changes, the technical issues they address, and their impact on the platform's initial specifications, cost structure, and pricing.

Answer

Parag Mallick, Co-Founder and Chief Scientist, explained the changes aim to enhance the specific binding of affinity reagents and reduce non-specific binding. CEO Sujal Patel added that this approach de-risks development and increases the yield of functional probes, which should improve proteome coverage. Patel also confirmed the changes should not negatively impact costs and that the target pricing of approximately $1 million for an initial instrument bundle remains appropriate given the platform's differentiated data quality.

Yuko Oku of Morgan Stanley inquired about the higher-than-expected fallout rate for affinity probe candidates and the progress of proteoform capabilities relative to the broad-scale discovery platform.

Answer

Parag Mallick, Co-Founder and Chief Scientist, explained that the high fallout rate is due to an extensive characterization process that tests kinetics, binding diversity, and manufacturability. He noted that while a wide distribution in probe performance was expected, the diversity of epitopes the probes can target is a significant positive. Mallick also clarified that while the broad-scale and proteoform platforms share a common core, they have matured at different rates. Customer interest has driven the company to prioritize proving out the proteoform opportunity in the first half of 2025 through collaborations, which will also help harden the platform for the broad-scale early access launch planned for the second half of 2025.

Yuko Oku, on for Tejas Savant, requested general guidance on potential margin expansion for the upcoming year and asked if the recent election outcome could affect government contracts, specifically the one with BARDA.

Answer

Chief Financial Officer Kevin Herde stated that margin expansion is primarily dependent on leveraging revenue growth over the company's largely fixed cost base. Chief Executive Officer William Martin added that the costs for the new Flanders facility are already being absorbed. Regarding government contracts, Martin expressed confidence that there would be no impact, noting BARDA recently reaffirmed its 10-year arrangement.