Mason Carrico

Mason Carrico from Stephens Inc. asked if the Pathline acquisition outperformed expectations and for an update on its expected revenue contribution for the year. He also inquired about the level of visibility in the pharma business and whether it is now adequately de-risked.

Answer

CFO Jeff Sherman noted that Pathline performed slightly ahead of expectations, but the company is not changing its overall guidance for the acquisition. President & COO Warren Stone addressed pharma visibility, stating it is very limited—less than a quarter—due to clinical trial uncertainties. He explained this is why a prudent approach was taken in the revised forecast to de-risk the outlook.

Mason Carrico of Stephens Inc. asked for an update on the full-year revenue expectation for the Pathline acquisition and inquired about the level of visibility in the pharma services business.

Answer

CFO Jeff Sherman noted that Pathline's performance was slightly ahead of plan, but its overall guidance contribution remains unchanged. President & COO Warren Stone explained that visibility in the pharma business is very limited (less than one quarter), which prompted a conservative forecast for the remainder of the year.

Mason Carrico of Stephens Inc. asked if expectations for the core NeoGenomics ASP runway have changed and about the mix of volume versus ASP growth for the year. He also inquired about the timeline for driving adoption of the broader NeoGenomics portfolio within the newly acquired Pathline customer base.

Answer

CFO Jeff Sherman stated that revenue growth in 2025 will likely be more heavily weighted to volume than AUP, partly due to business mix, though progress on AUP continues at the modality level. Head of Strategy Kareem Saad explained that cross-selling into the Pathline customer base will see minimal benefit this year, as it will take a couple of quarters to complete test validations in the Pathline lab. He expects a more significant benefit starting in Q4 and more fully in Q1 of the next year.

Mason Carrico asked about the revenue contribution from new products in 2024, the cadence of recent launches, and whether the company has seen benefits from state-level biomarker legislation.

Answer

CCO Warren Stone stated that 13 new products were launched over the past two years, primarily NGS-based, which fueled growth, but specific revenue contribution is not disclosed. CEO Christopher Smith added that progress from biomarker legislation has been slow, describing it as 'hand-to-hand combat' with payers, but it remains a long-term tailwind and part of their RCM initiatives.

Mason Carrico inquired about physician ordering patterns for large solid tumor panels and whether the launch of the PanTracer liquid biopsy could drive more volume for the tissue-based Neo Comprehensive panel.

Answer

CEO Christopher Smith explained that while ordering patterns vary, the company's goal is to become 'sticky' by providing excellent service and a comprehensive menu, which reduces vendor switching. He explicitly confirmed that a key part of their strategy is for the new liquid biopsy to help drive more volume for their existing solid tumor tissue business.

Mason Carrico asked about the concentration of 2025 revenue in large-scale initiatives like the Estonia Biobank and whether a pipeline of similar population genomics projects exists to sustain growth in EMEA into 2026.

Answer

President and CEO Christian Henry explained that while the Estonia project was a contributor, EMEA's growth was broad-based, driven significantly by Revio placements in hospitals for routine clinical rare disease work. He confirmed that several other large-scale population sequencing programs are "percolating" globally and could become significant revenue drivers in 2026.

Mason Carrico asked for additional detail on the change in the cash flow breakeven timeline to exiting 2027, specifically requesting color on the underlying assumptions for revenue and margins required to achieve that target.

Answer

President and CEO Christian Henry explained the revised timeline reflects the lower revenue trajectory from 2024's performance and the uncertain outlook for 2025. The path to breakeven assumes modest revenue growth from the 2025 guidance midpoint in subsequent years, combined with continued gross margin expansion into the 50s over time and disciplined expense management. The shift essentially pushes the original 2026 target out by one year.

Mason Carrico from Stephens Inc. asked for clarification on the expected adoption ramp for the new Vega platform, comparing it to prior launches. He also inquired if Vega's expected gross margin accretion would be immediate or occur after manufacturing scales.

Answer

CEO Christian Henry likened the Vega manufacturing ramp to Revio's, expecting sequential unit growth throughout the next year with shipments starting early in Q1. Regarding gross margin, Henry and CFO Susan Kim clarified that while Vega consumables will be accretive from day one, the instrument itself may be dilutive in Q1 due to higher initial unit costs. However, they expect the platform to be accretive to the company's overall gross margin for the full year.

Mason Carrico asked about the maturity of the Xenium sales force in Europe and how the sales funnel and conversion rates have evolved during 2025.

Answer

CEO Serge Saxonov confirmed the European Xenium sales team is now fully in place and ramping well, leading to improved execution and a growing sales funnel. However, he noted that the challenging CapEx environment is causing opportunities to take longer to close, with funding being the primary bottleneck for customers.

An analyst on behalf of Mason Carrico asked about the recent headcount reduction and OpEx initiatives, and how these actions impact the commercial teams and the company's ability to grow.

Answer

CEO Serge Saxonov stated that the cost reductions were company-wide but that direct sales roles were less impacted to protect the recently expanded commercial organization, which is seen as a foundation for future growth. CFO Adam Taich quantified the impact, noting the measures are expected to reduce 2025 operating expenses by over $50 million compared to 2024.

Mason Carrico asked about the expected customer conversion rate to the new, lower-priced Chromium assays. He sought to understand the impact on revenue growth over the next several quarters and at what point the company would fully lap these pricing headwinds, questioning if another year of flat or declining Chromium revenue is possible.

Answer

CEO Serge Saxonov stated that based on past experience, it typically takes 3 to 4 quarters for the volume uplift from price elasticity to fully compensate for the initial price decrease and drive incremental top-line growth. He confirmed that in the interim, the company expects to see some near-term pressure and headwinds on revenue as customers gradually transition to the new, lower-priced products.

Mason Carrico of Stephens Inc. asked about the progress of the permanent consignment inventory initiative and requested an update on the U.S. sales force expansion.

Answer

CEO Peter Caldini reported that the consignment initiative is proceeding well, with permanent inventory now placed in over 100 accounts, which helps improve utilization. He also stated that the U.S. sales force currently stands at 43 representatives, with plans to add another 10 to 15 reps next year to support deeper penetration and the upcoming Preservay launch.

Mason Carrico asked for an update on the 'halo effect' from the FDA approval on OUS account wins and whether the company has visibility into the number of OUS clinics that exclusively use FDA-approved products. He also inquired about the utilization rates seen from surgeons onboarded at different stages of the U.S. launch.

Answer

CEO Peter Caldini stated that the FDA approval and U.S. momentum continue to help convert OUS clinics, though it is difficult to quantify the exact number of 'FDA-only' accounts. Regarding utilization, he explained that once a surgeon uses Motiva, conversion and reordering accelerate, with some accounts now placing over 100 orders.

Harrison Parsons, on behalf of Mason Carrico, asked for the specific assumptions baked into the $35 million U.S. Motiva revenue guidance for 2025, such as year-end account numbers and sales reps. He also asked for confirmation that Motiva supply challenges have been fully resolved.

Answer

Executive Rajbir Denhoy confirmed the $35 million-plus guidance but declined to provide granular forward-looking metrics, stating the current 40-rep team is sufficient to achieve the target. CEO Juan Jose Quiros affirmed that supply challenges are resolved, noting that manufacturing capacity was ramped up with a third shift post-approval and no further issues are expected.

Mason Carrico of Stephens Inc. asked if the new metastatic indication has improved Decipher's marketability to new urologists and accelerated new account acquisition. He also inquired about the commercial payer landscape for metastatic patients.

Answer

CEO Marc Stapley confirmed the metastatic launch enhances Decipher's marketability across the care continuum and noted a positive trend in high-risk testing interest. CFO Rebecca Chambers clarified that an LCD is already in place with Medicare, which covers approximately two-thirds of the metastatic patient population, providing a strong reimbursement foundation at launch.

Mason Carrico from Stephens inquired about the expected revenue contribution from the new Decipher metastatic indication in 2025, asking for details on its cadence and the potential for accelerating its launch.

Answer

CEO Marc Stapley stated the launch is deliberately planned for the second half of 2025 to ensure a successful rollout without disrupting the core business. CFO Rebecca Chambers added that the guidance assumes a relatively small contribution from the metastatic test in 2025, noting that outperformance in the core Decipher business is a more significant potential upside driver for the year.

Mason Carrico from Stephens Inc. asked about the handpiece ASP outlook for 2026 and whether the company is using flexible purchasing options to close capital deals.

Answer

EVP & CFO Kevin Waters advised a conservative modeling approach for 2026 handpiece ASPs but noted the increasing mix of Hydros should drive low single-digit price increases over time. He confirmed that while the company works with third-party leasing firms and has done some flexible deals, the primary model of direct capital sales remains unchanged.

Mason Carrico of Stephens Inc. requested an update on the PRECISE Liquid biopsy product and its launch timeline. He also asked how the long-range plan balances contributions from average selling price (ASP) gains versus volume growth, given recent revenue cycle management successes.

Answer

President and CEO Sam Raha announced a strategic shift, stating the company will likely not launch its internally developed PRECISE Liquid product and will instead pursue a partnership to address the liquid biopsy CGP market. CFO Scott Leffler addressed the long-range plan, reiterating the expectation that revenue cycle and payer initiatives will continue to contribute 100-200 basis points of growth annually, even with the recent strong progress in expanded carrier screening coverage.

Speaking for Mason Carrico, an analyst from Stephens Inc. asked where the resources to address the UnitedHealthcare decision would come from and how the company prioritizes investment across GeneSight versus other future growth initiatives like oncology.

Answer

President and CEO Paul Diaz explained that having rationalized the portfolio, the company is positioned to invest in clinical evidence across all products, including GeneSight. He emphasized that while all areas are important, the biggest opportunity to push the company into mid-teens growth lies in oncology with products like Precise Tumor and MRD, and that capital will be invested wisely where the biggest returns are for patients and investors.

Mason Carrico from Stephens Inc. asked about the productivity ramp for the gastroenterology sales force and the utilization trends for DecisionDx-Melanoma since the sales team refocused its efforts.

Answer

Founder, CEO, & President Derek Maetzold stated that the GI sales team, scaled up near the end of last year, is expected to reach full maturity in Q3 and Q4 2025. He noted it was too early to provide data on a melanoma utilization shift, as the change in sales focus occurred late in the quarter.

Mason Carrico of Stephens Inc. asked for more color on the gross margin guidance, specifically the underlying assumptions for DecisionDx-SCC volumes. He also inquired about the growth strategy for DecisionDx-Melanoma.

Answer

CFO Frank Stokes anticipated a slowing of SCC volume growth as promotional efforts shift to melanoma but noted the test's high value might sustain demand. CEO Derek Maetzold explained their growth algorithm for melanoma involves splitting territories when they reach a certain revenue threshold, allowing reps to balance nurturing existing accounts and hunting for new ones.

Speaking on behalf of Mason Carrico, Ben asked about the potential for Q4 patient volume, delayed by holidays, to be captured in Q1 and sought detail on the gross margin cadence as DecisionDx-SCC revenue is expected to cease in April.

Answer

CFO Frank Stokes explained that it is difficult to determine when or if delayed patients are rescheduled, likening the situation to a canceled flight with limited open seats, and said the company expects typical Q1 seasonality. He clarified that the negative impact on gross margin from the loss of SCC reimbursement would be immediate at the end of April, not phased in over time.

Mason Carrico inquired about the current sales representative count for the GI team and future expansion plans, as well as the reimbursement path forward for DecisionDx-SCC with Medicare contractors.

Answer

CEO Derek Maetzold shared that the GI team expanded to around 40 territories and is expected to grow into the low- to mid-60s based on performance data. Regarding DecisionDx-SCC, he reiterated that the test remains covered by Medicare via Novitas and highlighted significant new clinical evidence, including the Aaron et al. and Ruiz et al. studies, which he believes strengthens the case for continued coverage.

Mason Carrico asked about Vericel's confidence in sustaining mid-to-high single-digit MACI price increases without payer pushback and requested an update on the international expansion strategy and timeline.

Answer

CEO Dominick Colangelo expressed high confidence in their pricing strategy, noting that the mid-90% prior approval rate has remained stable despite historical price increases. Regarding international expansion, he stated that a roadmap is expected by year-end, with Europe prioritized for a potential launch in the 2027-2028 timeframe.

Mason Carrico asked how recent trade war headlines have influenced Vericel's perspective on expanding MACI internationally. He also inquired about the company's strategy for prioritizing MACI Arthro training among different surgeon groups and the amount of sales force time dedicated to recruiting new, arthroscopy-focused surgeons.

Answer

CEO Nick Colangelo responded that the company is monitoring the fluid situation with trade tariffs and will incorporate any potential impacts into its final decision on international expansion. Regarding training, he explained the strategy prioritizes existing MACI customers as the 'low-hanging fruit.' The sales force uses efficient methods like group sessions and synthetic models to train surgeons before moving on to prospect new users, making the process streamlined.

Mason Carrico inquired about the MACI Arthro surgeon training programs, asking about adoption trends post-training and the timeline to biopsy. He also sought details on the initial target markets and required infrastructure for the potential international MACI expansion.

Answer

CEO Dominick Colangelo explained that multiple training options exist and noted that biopsy growth from trained surgeons is already significantly outpacing others. For international expansion, he highlighted Europe as a key target, noting a pivotal study was already conducted there, which should streamline the regulatory process. He mentioned the commercial model would be decided on a country-by-country basis, potentially using direct sales, partners, or distributors.

Mason Carrico of Stephens Inc. asked about expectations for iDose TR's placement in commercial payer coverage policies, specifically if it could be a first-line therapy. He also inquired at what point iDose TR becomes accretive to the company's overall gross margin.

Answer

President & COO Joe Gilliam stated that over 50% of commercial and Medicare Advantage lives already have a positive policy, typically positioning iDose TR as a second or third-line therapy, and the company will work to move it closer to first-line over time. SVP & CFO Alex Thurman noted that iDose TR is a high-margin product and that the company is already starting to see modest gross margin accretion.

Mason Carrico asked about the initial physician reception to the Phase IV data for iDose used in combination with cataract surgery and whether it has impacted utilization. He also inquired about the utilization mix in the combo-cataract setting within MAC jurisdictions where reimbursement is most established.

Answer

President and COO Joe Gilliam confirmed the combo-cataract data has been well-received. In MACs with more established reimbursement, he noted broad growth, primarily in stand-alone procedures. However, as physicians gain confidence, they are beginning to increase their use of iDose in combination with cataract surgery. Gilliam reiterated that the company's primary strategic focus remains on driving the much larger stand-alone interventional glaucoma market.

Inquired about the market impact of the iota model, potential friction between transplant centers and physicians on test adoption, and the focus of the upcoming final Q-Sub meeting with the FDA.

Answer

The iota model is expected to increase demand for testing by encouraging the use of more marginal organs. The company believes physician choice will drive adoption and is confident its test will perform well in comparisons. The final Q-Sub meeting with the FDA is imminent and will focus on five key questions to gain alignment for the final submission. Central IRB approval for the trial has already been secured.

Asked about post-approval clinical evidence priorities, how centers will balance the economics of the new assay versus established LDTs, early utilization dynamics before broad commercial coverage, and the ease of integrating the product into existing lab workflows.

Answer

Post-approval, the focus will be on kidney, followed by heart, liver, and lung. The company believes its clinical data is favorable and will bridge reimbursement from its service lab to the kitted product within the MolDX jurisdiction to drive early adoption. They expect a gradual ramp-up as centers integrate the product. The workflow is described as very simple, with just two pipetting steps, making it an easy addition for the 75-80% of transplant centers already performing HLA testing in-house.

Mason Carrico asked for an update on the competitive landscape in molecular diagnostics and inquired about the long-term growth strategy for the segment as the key BV CV/TV assay matures beyond its 'middle innings.'

Answer

CEO Stephen MacMillan responded that while the BV CV/TV assay is in its middle innings, it's a 'long game' with significant runway left. He emphasized that long-term growth for the diagnostics business will be driven by continuously adding new assays to the menu, which is enabled by placing more Fusion sidecars onto the massive installed base of Panther systems, ensuring 'years and years of very nice growth.'

On behalf of Mason Carrico, an analyst asked about the timeline and margin impact of the previously mentioned facility integrations within the Breast Health business. He also inquired if the company has moved past the margin drag from higher-cost semiconductor chips.

Answer

Chief Financial Officer Karleen Oberton stated that the facility migration is expected to be completed over the course of the year and will contribute to the overall margin improvement in 2025, though specific figures were not provided. She also confirmed that Hologic is on the tail end of working through higher-cost chips and expects to move past the issue during fiscal 2025.

Mason Carrico of Stephens Inc. asked for additional details on the recovery of surveillance volumes, questioning if the benefit was being pulled forward into Q2. He also inquired about the company's positioning regarding potential new Medicare LCDs for transplant testing.

Answer

CEO John Hanna clarified that the company is not suggesting a pull-forward of benefits but is seeing progress on surveillance testing that is on pace with annual guidance. Regarding potential new LCDs, Hanna expressed confidence in CareDx's position, citing the growing body of clinical evidence, such as the submitted KOAR study manuscript, which is expected to support coverage for kidney surveillance.

Mason Carrico from Stephens requested an update on the number of surveillance protocols in place and asked for a breakdown of surveillance volume between centers with formal protocols versus those without.

Answer

CEO John Hanna stated that the company no longer provides a specific protocol count but confirmed that kidney testing outpaced other organs in Q4. He elaborated that surveillance volume comes from two sources: centers with newly initiated protocols that ramp up over time with new patients, and centers without formal protocols where individual clinicians use AlloSure for surveillance based on their positive clinical experience in detecting subclinical rejection.

Mason Carrico asked for clarification on the surveillance opportunity, specifically whether the near-term strategy targets newly transplanted patients or also includes expanding to patients who are several years post-transplant.

Answer

CEO John Hanna explained the primary focus is on implementing surveillance protocols for patients in their first year post-transplant, where rejection risk is highest. He added that for patients further out, there is growing interest in for-cause testing, especially as new therapeutics for antibody-mediated rejection become available, which AlloSure can detect early.

Mason Carrico asked for insight into the sources of incremental growth for Guardant360 in the U.S., specifically whether it's coming from capturing market share, higher utilization in existing accounts, or new accounts.

Answer

Co-CEO Helmy Eltoukhy explained that the growth is largely driven by greater depth of adoption within existing accounts, as a majority of U.S. oncologists already use the test. He noted that the advanced capabilities of the upgraded G360 Liquid platform are encouraging physicians to increase utilization and test more of their patients.

Mason Carrico of Stephens sought clarification on the mechanics of the second-half China revenue guidance. He asked if the underlying procedure volume range (-10% to +10%) was for the full year or just the second half, and whether the guidance assumes inventory levels fully normalize or if it includes a dynamic step-up in reorders.

Answer

CFO Patrick Williams clarified that the -10% to +10% procedure volume range is an assumption for the overall China refractive market for the full fiscal year. He explained that the company's goal is to work down distributor inventory to contractual levels during the first half. The provided H2 revenue range of $75M to $125M reflects the uncertainty in how quickly this normalization occurs and when re-orders will resume based on the market's recovery.

Inquired about the company's confidence in reaccelerating top-line growth in the next year, the reasons for instrument sales volatility, and whether the competitive environment has changed.

Answer

Management expressed confidence in 2025 growth, driven by new reagent offerings and the clinical trial pipeline, with conservative expectations for instruments. The volatility in instrument sales was attributed to extended sales cycles and fluctuating conversion rates due to the macroeconomic environment, particularly in North American academia, rather than increased competition.

Mason Carrico asked for more detail on the strength in the APAC region, particularly regarding China's performance, and sought clarity on the geographic assumptions driving the Q4 revenue forecast.

Answer

CEO Wenbin Jiang explained that APAC strength was broad-based, including Australia, New Zealand, Japan, and India. He acknowledged that China has seen an impact similar to that reported by peers, though less severe, and expects a return to normal in the next year. CFO William McCombe noted that for Q4, Cytek expects continued momentum in EMEA and APAC, with the U.S. showing some recovery but likely being the lowest-growth region.