Jonathan Block

Jonathan Block inquired about the specific assumptions embedded in Envista's 2026 guidance regarding the timing and impact of Value-Based Procurement (VBP) for orthodontics and implants in China. He also asked for clarification on the significant deviation of Q4 2025 core growth (10.8%) from the implied 2% based on previous 2025 guidance.

Answer

CEO Paul Keel explained that guidance assumes a second implant VBP in Q2 2026 and an ortho 1.0 VBP in the second half, noting the complexity and uncertainty of VBP timing. CFO Eric Hammes attributed the Q4 growth upside to a shift in China ortho VBP timing and stronger-than-anticipated growth in the implants business, particularly in the digital portfolio.

Jonathan Block asked for clarification on the specific assumptions embedded in Envista's 2026 guidance regarding the timing and impact of Value-Based Procurement (VBP) for orthodontics and implants in China. He also questioned the significant upside deviation in Q4 2025 core growth compared to the implied guidance from three months prior.

Answer

Paul Keel, President and Chief Executive Officer, stated that Envista anticipates a second implant VBP in Q2 2026 and a first ortho VBP in the second half of 2026, acknowledging the difficulty in precise timing due to China's complex VBP landscape. He described the typical pre-VBP inventory drawdown and post-VBP order acceleration. Eric Hammes, Chief Financial Officer, attributed the Q4 2025 core growth upside to a shift in China ortho VBP timing, which strengthened the bracket and wire market, and stronger-than-anticipated growth in the implant business's broad digital portfolio.

Jonathan Block questioned the timeline for Spark's profitability, asking if it's expected to turn EBIT positive in H2 2025, and inquired about any recent pricing changes. He also asked for guidance on the top-line and EBITDA margin phasing for Q3 and Q4.

Answer

CFO Eric Hammes reaffirmed that Spark is on track to become profitable in the second half of 2025, supported by consistent unit cost reductions of nearly 20% year-over-year. He noted Spark pricing was relatively flat. For H2 phasing, he detailed the impacts of the Spark deferral benefit, customer buy-ahead unwind, and tougher comps, while explaining the drivers for the expected two-point margin improvement in H2.

Jonathan Block asked for more details on Envista's current tariff exposure, the specific actions being taken to mitigate the impact, and recent business trends observed in April.

Answer

President and CEO Paul Keel detailed the three primary areas of tariff exposure: U.S. goods to China, Chinese goods to the U.S., and European goods to the U.S. He explained mitigation strategies include shifting implant production for China from the U.S. to Sweden, working with suppliers to absorb costs, and rebalancing the supply chain. Keel also noted that April business trends were stable and consistent with Q1, with no significant shifts in demand for higher-value procedures.

Jonathan Block inquired about the scale of the China brackets and wires business following a 50% decline, the expected cadence of the VBP impact in 2025, and the implant growth assumptions embedded in guidance.

Answer

CFO Eric Hammes confirmed the 50% Q4 decline in China's brackets and wires business due to VBP preparations, projecting a decline in H1 2025 followed by a potential recovery in H2. CEO Paul Keel added that the 2025 implant guidance assumes continued momentum from internal initiatives rather than a significant market upswing, noting that a tangible increase in patient flow is not yet evident.

Jonathan Block from Stifel asked about the drivers of the implant business's improved performance, specifically geographic standouts and the duration of related investments. He also inquired about Spark's path to profitability and gross margin trends.

Answer

CEO Paul Keel attributed the implant improvement to closing the performance gap in North America and confirmed investments will continue into 2025, funded by growth. He also stated that Spark has seen six straight quarters of gross margin improvement and is expected to reach operating margin positive sometime in 2025.

Jonathan Block inquired about the expected 1-2% year-over-year decline in Invisalign ASPs for 2026, considering factors like FX and VAT. He also asked for details on the Q3 to Q4 ASP decline, specifically if it was due to intra-quarter FX or geographic mix, and about the rollout strategy for NoAA products and any potential impact from tax receipts or stimulus in Q1.

Answer

CFO John Morici confirmed expectations for ASPs to be down 1-2% in 2026 due to country and product mix. He explained that Q4 ASPs would have been flat without a slight FX change and strong growth in lower list price countries. President and CEO Joseph Hogan stated that North America is viewed as stable for Q1, with tax projections as possible upside but not factored into plans. He noted that NoAA products have varied global profiles, are liked by customers, and will be mostly rolled out by the end of Q1 or Q2.

Jonathan Block of Stifel Financial Corp. questioned the implied strong Q4 sequential growth in the full-year guidance, asked for details on the late-Q2 weakness, and inquired about trends in July and if conversion issues were concentrated in specific markets.

Answer

CFO John Morici attributed the implied Q4 strength to expected sequential growth in Systems and Services and new product initiatives. President & CEO Joe Hogan specified that the Q2 weakness was most prominent in North America, France, and Germany, driven by patient affordability concerns despite high interest. He added that the Q3 forecast assumes the late-Q2 trend will continue.

Jonathan Block sought clarification on the updated 2025 revenue guidance, particularly regarding ASPs, and asked for more detail on the strong teen segment growth, its drivers like IPE, and its future potential.

Answer

CFO John Morici confirmed that the interpretation of the ASP guidance was correct. President and CEO Joe Hogan elaborated on the teen segment's success, attributing the 13.3% year-over-year growth to broad strength across geographies and the powerful synergy between the Invisalign Palate Expander (IPE) and Invisalign First products. He also highlighted the potential of the new Mandibular Advancement feature with occlusal blocks to further drive growth in this segment.

Jonathan Block questioned the rationale for positive full-year revenue guidance versus a Q1 decline and asked about the growth from DSOs, including whether those strategies are transferable to individual practices.

Answer

CEO Joe Hogan explained the Q1 guidance reflects the late-March timing of the iTero restorative launch and the rollout of new products. CFO John Morici added that they are not assuming a macro improvement. Hogan described DSOs as a 'force multiplier' for technology adoption, but confirmed the core strategies are also applied to individual practices, albeit with a slower adoption rate.

Jonathan Block asked about the disparity between U.S. and international performance, questioning if it was due to consumer behavior, go-to-market strategy, or competition. He also sought clarity on the 2025 operating margin expansion commitment and the impact of initiatives like the Costco partnership and new financing options.

Answer

CEO Joe Hogan attributed the U.S. weakness primarily to external economic factors and consumer confidence, not increased competition. CFO John Morici confirmed the company is taking restructuring actions to achieve year-over-year operating margin accretion in 2025 while still investing in growth. Hogan described the Costco initiative as a brand strategy that is not yet material and confirmed the company is exploring financing options to help patient conversion.

Jonathan Block from Stifel Financial Corp. questioned CooperVision's (CVI) fiscal 2026 growth outlook, asking if the core portfolio would perform in line with the market, with MiSight providing an additional boost. He also inquired why the success of the premium MyDay lens was disproportionately impacting the value-oriented Clarity lens and asked about the margin profile difference between the two products.

Answer

President and CEO Al White explained that the portfolio lagged because MyDay availability was constrained, but with that resolved, he expects the core portfolio to perform at least at market levels in fiscal 2026, plus gains from MiSight. He noted the cannibalization of Clarity was surprising and occurred in markets like Japan where the two products were positioned more similarly. CFO Brian Andrews added that Clarity's margins are slightly better than MyDay's.

Jonathan Block asked for an update on inventory levels across the channel and consumer, and how that is factored into guidance. He also noted a change in tone on the fertility business and questioned if the current softness represents a new trend line.

Answer

President & CEO Albert White stated that he expects continued pressure from inventory reduction throughout the fiscal year, which is factored into the revised guidance. On fertility, he acknowledged the market is softer than previously expected and has shifted to a low single-digit growth environment for the year, though he anticipates Q3 and Q4 will show improvement over the first half.

Jonathan Block of Stifel inquired about the sustainability of the strong Q1 gross margin performance and asked for more detail on the drivers of CooperVision's expected growth acceleration, particularly regarding MyDay capacity.

Answer

CFO Brian Andrews attributed the strong gross margin to efficiency gains from higher production volumes, better overhead absorption, and favorable product/regional mix, stating these gains should continue. CEO Al White added that the CVI acceleration is driven by meeting high demand for MyDay as production capacity increases, and confirmed that manufacturing improvements have pulled forward the timeline for resolving constraints, boosting confidence for fiscal '26.

Jonathan Block of Stifel asked for a timeline on when MyDay supply will meet demand, questioning if this constraint was the primary cause for slower growth in the Asia-Pacific (APAC) region. He also noted the narrowing growth gap between specialty lenses (torics/multifocals) and overall CVI growth.

Answer

CEO Al White confirmed that APAC growth was the most negatively impacted by MyDay capacity constraints and that improving supply would strengthen the region's performance. He described catching up on capacity as a "journey" due to long lead times for new manufacturing lines. Regarding the specialty lens growth spread, White suggested it was more an internal factor related to building MyDay toric inventory rather than a shift in the competitive landscape.

Jonathan Block asked about the drivers behind the notably strong growth in CooperVision's Americas business and its connection to capacity initiatives. He also questioned the significant operating expense leverage in the quarter, asking if it was driven by a specific segment or any abnormal spending cadence.

Answer

CEO Al White attributed the strong Americas growth to new manufacturing capacity coming online to meet high demand, particularly for MyDay lenses, noting that demand still exceeds supply. CFO Brian Andrews explained the OpEx leverage was an expected result of prior investments yielding efficiencies across both business segments, a multi-quarter trend he anticipates will continue.

Jonathan Block of Stifel Financial Corp. questioned the stagnant gross pet additions over the past five quarters despite a nearly 20% year-over-year increase in pet acquisition cost (PAC). He followed up by asking why the previously anticipated pickup in gross adds had not materialized and when to expect a return to 'real growth'.

Answer

CEO Margi Tooth responded that the company has been strategically focusing on 'quality over quantity,' targeting pets with higher lifetime value (LTV) and turning off less profitable acquisition channels. This has resulted in a higher LTV for the core book of business. She noted that while PAC spend is up, it remains about 25% below peak 2022 levels. Management expects a modest pickup in gross adds in the second half of the year, consistent with their plan, as they continue to ramp investment.

Jonathan Block asked about the strategic and capital implications of transitioning its Canadian underwriting to its own entity, and questioned the company's market share losses reported by NAPA.

Answer

CEO Margi Tooth explained the move to their own Canadian underwriter is a long-term strategy for vertical integration to reduce frictional costs. CFO Fawwad Qureshi added that the transition was planned and the company is adequately capitalized. Regarding market share, Margi Tooth stated that the company does not chase market share, instead prioritizing disciplined growth and margin expansion.

Jonathan Block asked about the reasons for modest gross pet additions in Q4 2024, the expected timing of a growth inflection, the 2025 revenue guidance split between ARPU and pet growth, and the role of lower-ARPU plans in future growth.

Answer

CEO Margi Tooth stated that the 2024 focus was on margin expansion and balance sheet strength, with the company now pivoting to improving conversion and retention in 2025. She expects PAC spend to build over the next two quarters, driving growth in the second half. CFO Fawwad Qureshi clarified that the revenue growth mix should shift more towards pet count in 2025. Margi Tooth added that the immediate focus is on the core Trupanion product, not lower-ARPU alternatives.

Jonathan Block asked what key variables, such as retention or pet acquisition cost, need to improve for the 'other North American products' to reach target IRRs. He also questioned why it would take up to a year to ramp up gross adds now that margins and capital are healthy.

Answer

CEO Margi Tooth explained that for other products, the focus is on improving retention and learning to acquire pets efficiently in direct-to-consumer channels. She noted spend was pulled back in these areas to focus on the core product. Regarding the growth ramp, she stated that after pivoting to a defensive position, it takes time to shift back to an offensive one, build brand momentum, and ensure incremental dollars are invested wisely within IRR guardrails.

Jonathan Block from Stifel sought clarification on whether the updated $80 million annualized tariff headwind was a gross or net figure. He also asked new CEO Dan Scavilla for his perspective on the continuation of prior initiatives like ERP implementation and SKU rationalization.

Answer

CFO Matt Garth confirmed the $80 million figure is the gross annualized impact. CEO Dan Scavilla endorsed the existing initiatives, stating they are the 'right moves' and that his goal is to 'go deeper and faster.' He reiterated that the primary focus is returning the U.S. business to sustained growth through customer focus, innovation, and supply chain excellence.

Jonathan Block questioned why the full-year guidance was not raised after a strong Q1 performance and asked about the company's long-term strategy to compete and win in the clear aligner market once its software is enhanced.

Answer

CEO Simon Campion characterized the decision to maintain guidance as 'prudent' amid macroeconomic uncertainty. For the SureSmile strategy, he outlined a multi-faceted approach focused on leveraging the integrated DS Core and scanner ecosystem, maintaining competitive pricing, and emphasizing a clinical value proposition of efficiency with fewer refinements to win share in the orthodontist channel.

Jonathan Block questioned the math on the Q4 Byte impact, noting the $0.24 EPS headwind seemed disproportionate to the $29 million revenue hit. He also asked how the Byte business could be accretive to 2025 EPS year-over-year while its revenue is projected to decline by approximately $80 million.

Answer

Interim CFO Herman Cueto explained that the large Q4 EPS impact was driven by a significant increase in the tax rate due to jurisdictional income mix. For 2025, he clarified that the EPS accretion is possible because of the removal of substantial operating costs, particularly in marketing, that were previously invested in the Byte P&L.

Jonathan Block asked for help in deconstructing the implied Q4 organic revenue guidance to arrive at a normalized core run rate, adjusting for the Byte situation and the pull-forward of EDS sales. He also inquired about the potential impact of reduced dental benefits on the implant market.

Answer

CEO Simon Campion confirmed the Q4 organic growth outlook implies a high single-digit decline, which is attributable to a $20 million consumables revenue pull-forward into Q3 and the removal of Byte revenue after October 24. He also acknowledged that reductions in patient dental benefits are an additional headwind, likely impacting elective procedures like implants.

Jonathan Block of Stifel asked about the drivers behind the incremental $10 million in accelerated investments, the potential for business leverage in 2026 both with and without the 'Elanco Ascend' initiative, and the long-term sustainability of mid-single-digit growth, specifically questioning the future performance of the base business versus innovation.

Answer

President and CEO Jeffrey Simmons explained the investments are primarily for direct-to-consumer (DTC) marketing for Credelio Quattro, which is outperforming expectations, and for R&D to advance the next wave of blockbusters. CFO Bob VanHimbergen added that for 2026, EBITDA growth will come from innovation, a stable base, and efficiencies from the 'Ascend' program, which will focus on leveraging AI, digital capabilities, and cost controls in manufacturing and G&A, while continuing to invest in launches and R&D.

Jonathan Block asked about the cadence of Q2 2025 operating expense investments and their impact on near-term EBITDA, the potential FX upside being held back due to tariff uncertainty, and the more upbeat tone regarding the Zenrelia label change.

Answer

CFO Todd Young explained the Q2 OpEx increase is for 'no-regrets' launches of Credelio Quattro and AdTab during the peak season, with revenue benefits expected in the second half. He confirmed a potential $25M EBITDA upside from FX is being held back due to tariff uncertainty. CEO Jeff Simmons added that dialogue with the FDA on the Zenrelia label is constructive, with data for a language change under review and an answer expected in H2 2025.

Jonathan Block inquired about the potential U.S. clinic penetration and market share for Zenrelia by year-end 2025, its performance in international markets, and the key drivers for the company's accelerating revenue growth forecast beyond Q1 2025.

Answer

President and CEO Jeff Simmons stated that Zenrelia is in approximately 8,000 U.S. clinics, with adoption driven by an aggressive sampling program and positive efficacy feedback. He noted strong performance in international markets like Brazil and Japan, with expectations for upcoming European approvals. CFO Todd Young added that the full-year revenue growth acceleration from 4% to 6% is supported by the seasonal ramp of Zenrelia and Adtab in Q2/Q3, continued growth across the innovation portfolio, and lapping prior year headwinds in international farm animal.

Jonathan Block of Stifel asked about the expected cadence of the low single-digit adjusted EBITDA growth in 2025, questioning if it would be back-end weighted due to front-loaded launch investments. He also sought to understand the initial reception of Zenrelia's label, asking if a significant percentage of veterinary practices considered it a "nonstarter" and how this feedback compared to internal expectations.

Answer

CFO Todd Young confirmed the logic that investments for Zenrelia and Credelio Quattro would be more front-end loaded, ahead of the sales ramp, suggesting a back-weighted cadence for EBITDA growth in 2025. CEO Jeff Simmons addressed the Zenrelia label reception, stating they are not seeing practices stop adoption but rather a segment that requires more scientific discussion and education, which may lead to a longer selling cycle or smaller initial orders.

Jonathan Block asked for the specific companion animal growth rate in the alternate channel during the quarter and requested quantification of any related product stocking. He also inquired about the drivers behind the growth deceleration for Librela in international markets.

Answer

EVP & CFO Wetteny Joseph reported that the alternate channel, now about 22% of U.S. Companion Animal sales, grew in the mid-20% range. He noted that retail stocking was largely offset by a headwind from the prior year's Apoquel Chewable stocking, resulting in a neutral net impact. CEO Kristin Peck explained the international Librela slowdown was primarily due to a 'bleed over' of U.S. social media headwinds into other English-speaking markets.

Jonathan Block requested a detailed bridge for the $0.20 increase in the 2025 EPS guidance. He also asked directly if U.S. Librela revenue is expected to be flat in the near term and whether the upcoming long-acting OA product will have a new brand name.

Answer

CFO Wetteny Joseph explained the EPS guidance increase was almost entirely due to favorable foreign exchange rate changes, which reversed a previously expected headwind. He quantified the net tariff headwind at about $20 million. CEO Kristin Peck stated the company is actively investing to grow Librela now and is not waiting for the long-acting version, which she confirmed will have a unique brand name.

Jonathan Block inquired about the expected revenue cadence for 2025, given competitive pressures in the back half of the year, and asked if the flat R&D spend signals a new phase of operating leverage.

Answer

CFO Wetteny Joseph indicated that strong momentum from 2024 is carrying into 2025, with competitive impacts factored into the second half, implying a stronger first half. He clarified that Q4 was not an easy comparison, citing 9% organic operational growth. Regarding R&D, he explained that spending is driven by pipeline needs rather than being managed for leverage, though it is normalizing toward the top-line growth rate as previously guided.

Jonathan Block of Stifel asked if the sales force strategy for U.S. Librela is shifting from driving adoption to increasing utilization, and requested high-level revenue building blocks for 2025, including the impact of China and key franchises.

Answer

CEO Kristin Peck stated there are no new 'marching orders' for the sales force; the focus remains on expanding use into moderate OA cases and converting patients from NSAIDs by highlighting safety and efficacy. CFO Wetteny Joseph provided 2025 building blocks, including continued strong growth from OA, dermatology, and Simparica franchises, more normalized pricing slightly above historical levels, and the normalization of a nearly 1-point growth headwind from China seen in 2024.

Jonathan Block from Stifel Financial Corp. asked about the availability of Inspire IV in the U.S. for 2026 and sought clarification on the implied EBIT margins for the second half of 2025 based on the revised EPS guidance.

Answer

CEO Tim Herbert stated that Inspire IV will remain available for select U.S. sites in 2026, though the primary inventory focus is on Europe. CFO Rick Buchholz confirmed that the revised guidance implies higher operating expense growth of 18% for the year, up from a prior 16% plan, which will pressure back-half margins. Herbert linked this increased spending directly to investments in marketing and footprint expansion intended to drive revenue acceleration in 2026.

Jonathan Block of Stifel asked about the pervasiveness of patient delays for Inspire V, questioning if it was concentrated or widespread. He also sought clarification on the conversion timeline, asking if the company now expects a full conversion by the end of Q2 instead of year-end 2025 and how patient safety is managed with a faster rollout.

Answer

CEO Tim Herbert described the patient delay phenomenon as a qualitative feeling that grew across the board as awareness spread, rather than a quantifiable event at specific centers. He clarified that the goal remains a full transition by year-end, not Q2. The May launch makes the device available, but the rollout will be a phased process, starting with high-volume centers, to ensure proper training and prioritize patient safety.

Jonathan Block asked for more detail on the Inspire V ramp throughout 2025 and inquired about a recent UnitedHealthcare coverage change that appeared to reimplement the DISE procedure.

Answer

Chairman and CEO Tim Herbert agreed with the general description of a gradual Inspire V ramp, starting low in Q1 and growing to a full transition by year-end. Regarding UnitedHealthcare, he stated they are in discussions and believe the payer's intent is to ensure proper patient qualification, not necessarily to force DISE. He noted the forthcoming PREDICTOR study manuscript will help clarify the diagnostic pathway with payers.

Jonathan Block of Stifel asked if Inspire is seeing early interest from ENTs looking to get trained on the therapy due to the simpler Inspire V procedure. He also asked for an explanation for the significant sequential decrease in operating expenses, which came in well below prior guidance.

Answer

CEO Tim Herbert responded that they are not yet marketing Inspire V and thus have not seen an influx of training requests, but he anticipates this will be a positive driver for surgeon adoption in 2025. CFO Rick Buchholz explained the lower OpEx was due to costs for Inspire V shifting from R&D to operational readiness, lower DTC spend, and the timing of stock-based compensation.

Jonathan Block of Stifel Financial Corp. asked about business trends throughout Q2 and the reasons for the continued divergence between strong international and more moderate U.S. CAG Diagnostic recurring revenue growth. He also questioned why the "IDEXX premium" to market growth is not guided to accelerate in the second half of the year despite new product ramps.

Answer

CFO Andrew Emerson stated there were no specific intra-quarter trends to call out and noted that U.S. growth improved from Q1 on a days-adjusted basis, driven by innovation. President and CEO Jay Mazelsky added that while U.S. launches happen first, international markets show rapid uptake for new tests. Emerson explained the second-half outlook is calibrated for dynamic clinical visit trends but does anticipate benefits from innovation and pricing.

Jonathan Block asked about intra-quarter trends and the persistent growth divergence between the strong international business and the mid-single-digit U.S. CAG Diagnostic recurring revenue. He also questioned why the guidance implies the strong 'IDEXX premium' over visit growth seen in Q2 might not be sustained, despite new innovations ramping up.

Answer

CFO Andrew Emerson noted no specific intra-quarter trends to highlight but pointed out that U.S. growth improved from Q1. CEO Jay Mazelsky added that U.S. launches typically precede international ones, but uptake on specialty tests is rapid globally. Regarding the growth premium, Emerson explained that the second-half outlook remains strong and reflects a balance between the positive impact of innovation and the dynamic, pressured clinical visit environment.

Jonathan Block asked a series of detailed questions about the IDEXX inVue Dx, requesting an updated order number, more specific timing for the F&A menu expansion, and the reason for the accelerated shipment rate in April. He also asked for clarification on Q2 guidance.

Answer

CEO Jay Mazelsky explained the inVue shipment acceleration was due to moving from a controlled to a full launch, not a specific bottleneck resolution, and stated they would no longer disclose order backlogs. He reiterated the F&A menu is planned for later in 2025. Executive Andrew Emerson clarified that Q2 guidance is not materially impacted by business days and that the FX headwind is planned at ~1%.

Jonathan Block asked what drove the strong growth premium over clinical visits in Q4 2024, before major new innovations were fully rolled out. He also questioned if current pricing levels could be a headwind for wellness visits and asked for a reconciliation of the higher 2025 interest expense forecast.

Answer

Outgoing CFO Brian McKeon attributed the strong Q4 premium to robust consumable growth from an expanded instrument base, benefits from recent innovations like the Pancreatic Lipase slide, and strong international momentum. CEO Jay Mazelsky defended the pricing strategy, highlighting value-add programs and the affordability of new tests like Cancer Dx. Incoming CFO Andrew Emerson confirmed the higher interest expense is a direct result of the increased $1.5 billion share repurchase plan for 2025.

Jonathan Block asked about the 50-basis-point delta between the guidance reduction for total organic revenue versus CAG-recurring revenue, and inquired about the realized ASP for the new inVue analyzer. He also questioned the rationale for shipping only a small fraction of the 700 inVue preorders in 2024 and asked for more color on the impact of corporate account renewals.

Answer

Executive Brian McKeon attributed the guidance delta to softer LPD results and instrument revenue timing effects from strong inVue preorders, confirming a 'low teens' ASP for inVue. CEO Jay Mazelsky explained the limited initial inVue shipment is a standard, controlled launch strategy to ensure a high-quality customer experience. Regarding corporate renewals, he described them as expansions focused on driving organic growth. McKeon added the pricing impact is concentrated in U.S. labs and will create favorable lapping dynamics in the latter half of 2025.

Jonathan Block asked for details on the current FDA site inspection compared to the initial one and inquired about the company's go-to-market strategy, specifically the outreach to ENTs versus sleep doctors and the positioning of key differentiators like supine sleep data.

Answer

CEO Olivier Taelman clarified that the ongoing FDA inspection is a standard final step to validate a specific manufacturing process that was already accepted by the agency. He outlined a two-pronged commercial strategy targeting high-volume implanting centers and developing networks with sleep physicians. Taelman also expressed confidence that the final product label will reflect Genio's unique clinical data for supine sleep and will not list CCC as a contraindication.

Jonathan Block questioned the basis for Nyxoah's confidence in a March 2025 FDA approval given potential agency disruptions and asked about expectations for the product's label, specifically regarding supine efficacy claims and CCC contraindications. He also asked about the onboarding timeline for commercial payers.

Answer

CEO Olivier Taelman stated that their FDA review has been highly interactive and remains on track, with the 90-day review clock ending in March underpinning their confidence. He confirmed they are actively discussing the inclusion of supine data and the absence of a CCC contraindication in the label. Regarding payers, he expects the first commercial payer coverage in Q3 or Q4 2025, leveraging preauthorizations at launch, while anticipating coverage from government payers like CMS from the start.

Jonathan Block of Stifel asked if the strong Q1 gross margin is a new run rate, questioned the difference in consumable utilization across device tiers, and probed the potential long-term impact of tariffs beyond the guided $5 million for 2025.

Answer

Executive Michael Monahan clarified that Q1's strong gross margin was driven by supply chain efficiencies and a favorable sales mix, but he expects it to decline due to a higher equipment mix and tariff impacts later in the year. He noted it's too early to project the 2026 tariff impact. Executive Marla Beck added that Syndeo devices historically drive higher booster usage due to on-screen prompts, though all devices use the same core solutions.

Jonathan Block inquired if the 'good' device could be priced low enough to bypass financing hurdles and asked for the strategic rationale behind shifting China to a distributor model, including the financial impact.

Answer

Executive Michael Monahan responded that used Elite systems are being sold at lower price points to address financing challenges, with about 500 units planned for sale this year. CEO Marla Beck explained the China decision was driven by a need to focus capital on core markets while partnering with a local expert to capture the market's potential. Monahan quantified the move as a $10-$15 million annual revenue headwind but expects the China business to move from a slight loss to EBITDA neutral in 2025, excluding transition costs.

Jonathan Block asked for clarification on the financial impact of the ending partnership with Sephora, including the percentage of revenue it represented. He also questioned the logic behind the weak Q4 guidance, given the easier year-over-year comparison and typical seasonality, and asked if the company would commit to top-line growth in 2025.

Answer

CEO Marla Beck clarified the Sephora partnership was for the 'Perk by Hydrafacial' treatment and was not a significant revenue contributor in the last year. CFO Michael Monahan deferred commentary on 2025 growth but explained the Q4 guidance reflects persistent global pressure on device sales, particularly in APAC, which is offsetting expected seasonal strength and growth in the Americas.

Jonathan Block inquired about the impact of the U.S. dollar on Henry Schein's revenue guidance and bottom line, and asked for an update on the business environment and sales momentum into April.

Answer

CFO Ron South explained that while Q1 faced a 1.5% foreign exchange headwind, the company expects FX to be largely neutral for the remainder of the year, which is factored into the current sales guidance. CEO Stanley Bergman added that April was a decent month with stable patient traffic in dental and medical. He noted a positive mood at recent industry events and signs of new practice build-outs, indicating a stable U.S. market.

Jonathan Block of Stifel questioned why 2025 EPS growth guidance is only in line with revenue growth, given positive drivers like restructuring and buybacks. He also asked about the innovation pipeline from manufacturing partners ahead of the upcoming IDS conference.

Answer

CFO Ron South identified two key offsets: increased depreciation from the new global e-commerce platform and a return to normal levels of management incentive compensation. CEO Stanley Bergman stated he expects only marginal, incremental innovation at IDS, mainly in digital dentistry, but noted continued strong innovation in the specialty implant sector.

Jonathan Block asked for the key drivers behind management's conviction that dental and medical end markets will improve in 2025. He also sought more detail on the strong North American implant performance, questioning if it was solely due to the new tapered pro conical implant or if there was a broader halo effect.

Answer

Stanley Bergman, Chairman and CEO, cited strong practitioner interest in digital technology investment as a driver for equipment sales, which could be accelerated by lower interest rates. For implants, he explained that the new product launch is capitalizing on years of groundwork by the sales team, building confidence and attracting new customers, including DSOs, to the entire BioHorizons portfolio.

Sought clarification on the recently announced $16 million in annual cost savings, asking about the timing of its run rate and whether it's a net figure after reinvestments. He also asked about the persistently weak dental equipment market, inquiring what catalysts beyond lower interest rates or new product innovation could stimulate a recovery.

Answer

The $16 million in cost savings will see its primary benefit in the second half of the fiscal year. The savings are viewed as a balance, helping the bottom line while also providing headroom for strategic investments. For the dental equipment market, the company reiterated that lower interest rates and new product innovation are the two primary catalysts needed for a recovery, along with a general improvement in the macroeconomic environment.

Asked about the sustainability of dental consumables growth, the impact of a competitor's disruption, and the reasons for the lag in the companion animal business.

Answer

The company estimated the competitor's issues added about 2 percentage points to their strong underlying 5% consumables growth, which they believe is sustainable share. The lag in companion animal is due to a disciplined focus on customer profitability, a dynamic that may continue, but they are excited about new products and services.

Asked for early feedback on the new Xeo Plus platform and the potential for upgrading the existing installed base, and inquired about the go-to-market strategy for refurbished AviClear systems as they are returned.

Answer

The executive reported positive feedback on Xeo Plus, highlighting its improved handpiece design and faster treatments, and noted that the upgrade opportunity for the existing 2,500 units is more significant than new placements in the current macro environment. For returned AviClear systems, the strategy is to refurbish them and selectively place them (along with new systems) in high-potential accounts, primarily aesthetic dermatology practices, focusing on long-term success rather than rapid placement.

Jonathan Block from Stifel inquired about Sonendo's Q1 console sales, specifically the mix between new placements and the high number of G4 upgrades. He also asked about the strong average selling price (ASP) despite the upgrade mix, the expected quarterly progression of gross margins toward the year-end target, and the strategic priority of the 'cavity' initiative given the company's renewed focus on endodontists over general dentists.

Answer

Executive Bjarne Bergheim clarified that prioritizing G4 upgrades is an intentional strategy to replace older G3 consoles with the more reliable new model, which improves customer satisfaction and reduces service costs. He stated the high upgrade percentage will moderate over time. Regarding the strong ASP, Bergheim noted the company intentionally limited discounts in Q1. He confirmed gross margins are expected to improve gradually and sequentially throughout 2024. On the 'cavity' initiative, he explained that while the company remains excited, the current focus is firmly on the core endodontist market and executing the strategic reset.

Jonathan Block of Stifel Financial Corp. questioned Sonendo's 2024 revenue guidance of $28-$30 million, noting it appears low compared to a pro forma Q4 2023 annualized run-rate of approximately $36 million after the TDO software divestiture. He also sought clarity on the 2024 gross margin outlook, which was previously guided in the 40% range, and questioned why recent commercial initiatives to stimulate capital sales have not yet yielded more significant results.

Answer

Executive Bjarne Bergheim explained the conservative 2024 guidance reflects a period of commercial restructuring aimed at improving sales efficiency and achieving a quicker path to profitability, with growth expected to return as changes take hold. Executive Michael Watts clarified that the full-year gross margin target is now in the mid-30s, exiting the year in the mid-to-high 30s, impacted by the TDO sale but set to improve with manufacturing efficiencies. Bergheim detailed numerous changes to the commercial team, including new playbooks, compensation structures, and a focus on high-ROI activities, to address past inefficiencies and drive future capital placement and utilization.