Adam Maeder

Adam Maeder from Piper Sandler sought clarification on the sequencing of 2026 sales, asking if Q1 would be the low water mark followed by sequential growth, and if "recovery in the back half" implies positive year-over-year growth. He also asked about the geographies contributing to the modest international revenue in the guide and the latest timing for Japan and China approvals.

Answer

Mark Wilterding, CFO, confirmed Q1 is expected to be seasonally weaker, with summer headwinds in Q3, but year-over-year growth rates are anticipated to improve quarterly due to improving fundamentals and easing comparisons. Ron Kurtz, President and CEO, stated that international revenue would likely come from the EU, UK, South Korea, Singapore, and Australia, where approvals have been received. He noted that regulatory review processes for China and Japan are lengthier, with updates expected later in the year.

Adam Maeder sought clarification on the sequencing of 2026 guidance, asking if Q1 would be the low point followed by sequential growth, and if 'back half recovery' implies positive year-over-year growth. He also inquired about the specific international geographies contributing to modest OUS revenue and the latest timing for Japan and China regulatory approvals.

Answer

CFO Mark Wilterding confirmed that Q1 is expected to be seasonally weaker, with summer headwinds in Q3, but year-over-year growth rates are anticipated to improve over the year, leading to positive year-over-year growth in the second half. President and CEO Dr. Ron Kurtz stated that OUS revenue would likely come from the European Union, U.K., South Korea, Singapore, and Australia, where approvals have been received, and that updates on the lengthy review processes for China and Japan would be provided later in the year.

Adam Maeder from Piper Sandler asked about RxSight's international commercial strategy, specifically regarding the use of direct sales versus distributors, and sought details on the freestanding LDD treatment center initiative.

Answer

President and CEO Dr. Ron Kurtz explained that the international go-to-market strategy is decided on a market-by-market basis, noting that South Korea requires a distributor. He described the third-party LDD treatment center model as an early but promising initiative that has gained traction with growing market awareness, comparing it to successful center models in LASIK.

Adam Maeder asked about LivaNova's 2026 cardiopulmonary growth guidance, specifically inquiring about the breakdown between oxygenator (oxys) and heart-lung machine (HLM) growth, and seeking more details on HLM tenders that shifted from Q4 2025 into 2026, including regions and quantification.

Answer

Alex Shvartsburg, CFO, explained that 2026 growth drivers would mirror 2025, with Essenz upgrades driving double-digit growth and continued market share gains in consumables. He noted prudent assumptions for Essenz price premium moderation and oxygenator output due to third-party supply constraints. He also clarified that the shifted tenders were immaterial and would be fully recaptured in Q1 2026.

Adam Maeder inquired about the 7%-8% cardiopulmonary growth guidance for FY 2026, specifically asking for a breakdown between oxygenator and heart-lung machine (HLM) growth, and details on HLM tenders that shifted from Q4 2025 to 2026, including regions and quantification.

Answer

CFO Alex Shvartsburg stated that Essenz upgrades are expected to drive double-digit growth, with continued market share gains in consumables and price contributing. He noted prudent assumptions include a moderation in Essenz price premium and conservative oxygenator output due to third-party supply constraints. CEO Vladimir Makatsaria and CFO Alex Shvartsburg clarified that the Q4 tender shift was immaterial and would be fully recaptured in Q1 2026.

Adam Maeder of Piper Sandler asked for more details on the Highmark commercial coverage decision for TRD and any visibility on discussions with other payers. He also inquired about the company's latest thinking on the commercialization strategy for its obstructive sleep apnea (OSA) program.

Answer

Chief Innovation Officer Ahmet Tezel described the Highmark decision as a positive step from exception-based approvals to direct coverage, which could influence other insurers. Regarding OSA, CEO Vladimir Makatsaria expressed confidence in commercializing it internally by leveraging existing neuromodulation expertise, but remains open to a partnership if it is beneficial. He highlighted the product's clinical differentiation as a key advantage.

Adam Maeder asked for details on the assumptions behind the manageable tariff impact, including whether price increases were contemplated, and also requested commentary on the quarterly cadence for the updated guidance.

Answer

CFO Alex Shvartsburg explained that LivaNova is well-positioned to manage tariffs due to its manufacturing footprint, with neuromodulation products made in the U.S. for the U.S. market and most cardiopulmonary products made in Europe for the global market. He confirmed the less than $5 million adjusted operating income impact is baked into guidance and assumes some marginal pricing actions. Regarding cadence, he noted the Street's revenue ramp estimates are reasonable but reminded that operating expenses typically ramp up after Q1 and that Q2 will reflect new interest expense accounting.

Adam Maeder from Piper Sandler asked about the pricing assumptions within the 2025 top-line guidance, requesting the contribution from price in 2024 and the expected price/mix benefit in 2025. He also requested more detail on the obstructive sleep apnea (OSA) product development, specifically work on recharge burden, MRI compatibility, and a potential primary cell device.

Answer

CEO Vladimir Makatsaria stated that price, excluding equipment, contributed 250-300 basis points of growth in 2024 and that pricing capability is well-reflected in the 2025 guidance. He noted upside would come from share gains and Essenz penetration. Chief Innovation Officer Ahmet Tezel explained that the OSA device will be MRI compatible at full commercial launch. He stated the company is not actively working on a primary cell, as the current rechargeable design allows for more energy-intensive, personalized therapy via its unique 6-electrode architecture, which is a key focus for future upgrades.

Adam Maeder sought confirmation of the previously guided $20 million+ in pretax cost savings from the DTD program in 2025. He also asked about the obstructive sleep apnea (OSA) program, questioning what would constitute a 'good result' from the upcoming 7-month data and its importance relative to the 12-month data.

Answer

CFO Alex Shvartsburg confirmed the $20 million pretax savings from DTD would drop through to 2025 earnings. CEO Vladimir Makatsaria stated that for OSA, a 'good result' would be clinical data competitive with the current standard of care. Chief Innovation Officer Ahmet Tezel highlighted the program's advantages, including not requiring a DICE procedure and the early study truncation based on a high probability of success.

Adam Maeder inquired about the breakdown of Glaukos' FY 2026 top-line guidance of $600 million-$620 million, specifically asking for quantitative or qualitative color on iDose TR, the US stent business, and corneal health with Epioxa. He also sought more detail on the quarterly revenue cadence for 2026, particularly regarding the Epioxa transition and the Street's Q1 revenue modeling.

Answer

Joe Gilliam, President and COO, outlined expectations for 2026: high single-digit international glaucoma growth, 30% US glaucoma growth driven entirely by iDose TR (with non-iDose flat), and modest year-over-year corneal health growth with Q2/Q3 volatility due to the Epioxa transition. He detailed a Q1 with modest corneal health growth, a Q2 dip, a flattish Q3, and a strong Q4 exit for corneal health, while iDose TR is expected to grow sequentially each quarter.

Adam Maeder inquired about the breakdown of Glaukos's FY 2026 top-line guidance of $600 million-$620 million, specifically asking for quantitative or qualitative color on iDose TR contribution, the U.S. stent business, and corneal health with Epioxa. He also sought more detail on the expected quarterly revenue cadence for 2026, particularly for Q1, given the Epioxa transition.

Answer

Joe Gilliam, President and COO, Glaukos, outlined the FY 2026 guidance, projecting high single-digit growth for international glaucoma, approximately 30% year-over-year growth for U.S. glaucoma driven entirely by iDose TR (with non-iDose flat), and modest year-over-year growth for corneal health with expected volatility in Q2 and Q3 due to the Epioxa launch. Mr. Gilliam further detailed the quarterly cadence, anticipating sequential iDose TR growth, modest Q1 corneal health growth (Photrexa), a material Q2 dip (Epioxa transition), a flattish Q3 (J-code online), and a strong Q4 exit.

Adam Maeder of Piper Sandler asked about the updated timeline for the FDA's decision on iDose TR reimplantation, which moved to early 2026. He also requested a finer point on the timelines for iDose Trio and unlocking the in-office procedure opportunity.

Answer

Chairman & CEO Tom Burns clarified the FDA classified the reimplantation petition as an NDA supplement, establishing a PDUFA date of January 28, 2026. For iDose Trio, he stated a U.S. clinical trial is targeted by year-end, with a potential approval by year-end 2027. He emphasized that creating non-facility payment codes with MACs is a key parallel step for enabling in-office use.

Adam Maeder asked for an update on the FDA submission for iDose reimplantation and for commentary on the expected quarterly revenue cadence for the remainder of the year, specifically asking about Q2 consensus estimates.

Answer

Chairman and CEO Thomas Burns announced that the post-approval supplement for iDose reimplantation was filed in Q1, ahead of schedule, and a decision from the FDA is expected by year-end. CFO Alex Thurman provided quarterly seasonality guidance, suggesting Q2 revenue would be in the 23-24% range of the full-year midpoint, followed by 24-25% in Q3 and 28-30% in Q4.

Adam Maeder asked about the expected clarity and timeline for the 10%-50% professional fee reduction associated with the -52 modifier for Inspire 5 procedures, and the company's strategy to minimize this impact. He also questioned why Inspire Medical Systems isn't more aggressively promoting the Inspire 4 system, given its established reimbursement.

Answer

Tim Herbert (Chairman and CEO) explained that Inspire Medical Systems is proactively engaging with MACs and commercial payers to clarify and minimize the -52 modifier's impact, aiming for consistency. He noted the long-term plan to pursue a new CPT code for Inspire 5, expected by January 1, 2028. While Inspire 4 inventory is available, the company prioritizes Inspire 5 due to its superior performance and reduced surgical time.

Adam Maeder inquired about the expected timeline for clarity on the physician fee reduction (10%-50%) for the Inspire V procedure using CPT code 64582 with a -52 modifier, and the company's and medical societies' involvement in these discussions. He also asked about the pathway for a dedicated CPT code for Gen 5 and why Inspire isn't more aggressively pushing the Gen 4 system given its stable reimbursement.

Answer

Tim Herbert, Chairman and CEO, explained that facilities should bill to current policies, and Inspire will proactively work with MACs and commercial payers to document differences between Inspire IV and V, leveraging 2025's 10,000 Inspire V procedures under CPT code 64568 to justify a smaller reduction and drive consistency. He noted that a -52 modifier is not a long-term solution, hence the pursuit of a new CPT code, expected online by January 1, 2028. Herbert also confirmed that Inspire IV inventory is available for centers preferring that system.

Adam Maeder of Piper Sandler Companies asked for a ranking of the headwinds impacting the revised 2025 guidance and inquired if revenue growth would re-accelerate in 2026.

Answer

CEO Tim Herbert identified the two predominant headwinds as the slower-than-expected commercial rollout of Inspire V, specifically challenges with center training and SleepSync implementation, and Medicare billing delays for the new CPT code which were resolved on July 1. He affirmed the company's expectation for revenue growth to accelerate in 2026, surpassing the 12-13% guided for 2025, driven by increased marketing spend and footprint expansion in the second half of the year.

Adam Maeder of Piper Sandler asked about the company's confidence in proceeding with the full launch of Inspire V, focusing on manufacturing readiness, reimbursement, and device performance. He also addressed market speculation about why the product rollout had not occurred faster.

Answer

CEO Tim Herbert affirmed high confidence in the device, which is fully FDA-approved with a robust data set. He explained the primary reason for the rollout timing was the need to scale up manufacturing to build sufficient inventory for a full launch, a challenge that has now been overcome. Herbert also confirmed that reimbursement is secured with the new CPT code and that feedback from the limited release has been positive.

Adam Maeder asked how Inspire ensures that increased OR capacity from the faster Inspire V procedure is allocated to Inspire cases, and for more detail on the gross margin impact from the launch.

Answer

Chairman and CEO Tim Herbert explained that Inspire is a high-reimbursement procedure and the key to securing OR time is building efficiencies, such as using APPs and establishing dedicated 'Inspire days' to streamline operations. Chief Financial Officer Rick Buchholz added that the 100 basis point increase in the 2025 gross margin guidance already accounts for the Inspire V tailwind, with a more pronounced impact expected in 2026.

Adam Maeder from Piper Sandler asked about potential headwinds for 2025, such as device competition and GLP-1 drugs. He also requested more details on the Inspire V (Gen 5) rollout, including the definition of a 'soft launch,' manufacturing readiness, and whether it would be gross margin accretive.

Answer

CEO Tim Herbert expressed confidence in Inspire's established position against potential competition and viewed GLP-1s as a complementary tailwind. Regarding Inspire V, he explained the launch timing depends on building sufficient inventory and completing operational readiness, including new contracts and training. He confirmed that eliminating the sensing lead will reduce COGS, making the new device slightly gross margin accretive over time despite price parity.

Sought specifics on what technical issues led to the conclusion that the system is not ready for first-in-human trials. He also asked about the potential magnitude of the timeline delay, questioning if it would be a minor slip or a more significant push-out.

Answer

Co-Founder Adam Sachs explained the decision was about resource allocation, not a critical failure. He gave an example of the surgeon console failing EMC testing, which would require workarounds and extra testing to use in a trial. The new CEO directed the team to fix such issues properly rather than patching them for an early trial. CEO Stephen From responded that he cannot yet quantify the delay's length and needs to complete his assessment to provide an accurate timeline.

Adam Maeder sought confirmation on the supply chain issues being resolved but still causing a delay, asked for timing on the technical dossier submission, and requested more detail on the V1.0 system integration.

Answer

President Randolph A. Clark confirmed that supply chain issues were the cause of the delay to late 2025 for first-in-human cases but are now resolved. CEO Adam Sachs stated the technical dossier submission is planned for around mid-2025. He elaborated that the V1.0 integration involved successful cadaver and bench tests that built confidence in the system, and that a final design lock will occur after all performance and safety testing is complete.

Sought confirmation that supply chain issues are resolved but still resulted in a delay to the first-in-human trial, asked for the timing of the technical dossier submission, and requested details on the V1.0 integration process, including cadaver procedures and design lock status.

Answer

Management confirmed the characterization of the supply chain impact and timeline was correct. The technical dossier submission is planned for around the middle of the year. The V1.0 integration involved a handful of cadavers and extensive bench tests, which built confidence in the system's reliability. A final design lock will happen after all essential performance and safety testing is completed.

Asked for details on the 2025 verification and validation process, the number of patients in the initial OUS study, and the company's outlook on 2025 cash burn and runway.

Answer

The executive explained the first study will have up to 5 patients and detailed the verification and validation process. The CFO projected the 2025 cash burn to be similar to 2024's, with the current cash runway lasting into 2026.

Adam Maeder inquired about the specifics of the verification and validation (V&V) process for the upcoming year, the number of patients in the initial OUS study, the cash burn outlook for 2025, and the company's current cash runway.

Answer

Adam Sachs, Co-Founder and CEO, clarified that the first clinical study will include up to five patients and detailed the V&V process, which involves both bench testing (verification) and user needs assessment (validation). Bill Kelly, CFO, stated that the 2025 cash burn is expected to be in the ballpark of 2024's projected $50 million, with the company's current cash runway extending into 2026.

Adam Maeder from Piper Sandler Companies sought specific details on the technical issues that deemed the system not ready for first-in-human trials and asked whether the resulting delay would be a minor slip or a more significant push-out requiring redesigns.

Answer

Co-Founder & President Adam Sachs provided a specific example of the surgeon console failing EMC testing due to emissions from its ergonomic stages. He explained that while a workaround was possible, it would divert significant resources away from the primary goal of finalizing the production system. CEO Stephen From reiterated that the scope of the delay is unknown pending the internal assessment, but emphasized they can 'see the goalpost' and are not facing a fundamental restart.

Adam Maeder of Piper Sandler Companies inquired about the initial U.S. commercial progress for CGuard Prime since its late June approval, asking for details on account openings and any future targets for revenue or market share. He also asked for the rationale behind the updated 2027 timeline for the CGuardians three TCAR study, which was previously expected in late 2026.

Answer

Chief Commercial Officer Shane Gleason stated that in the six weeks since approval, the company has already conducted procedures with double-digit physicians and secured initial stocking orders. CEO Marvin Slosman added that while the market reception is strong, the updated 2027 timeline for the proprietary TCAR device simply reflects a broader window to account for the inherent uncertainties in development, clinical enrollment, and regulatory review, rather than a specific setback.

The analyst inquired about the initial U.S. launch progress for CGuard Prime, including account openings and any future guidance or targets. He also asked for clarification on the timeline delay for the CGuardians three trial and the Switchgard TCAR device.

Answer

The company is pleased with the initial CGuard Prime launch, having already performed procedures with numerous physicians and secured stocking orders. They are expanding the sales team but are not providing specific forward-looking targets yet. The timeline for their proprietary TCAR device (Switchgard) was adjusted to 2027 to realistically account for the inherent variabilities in development, clinical enrollment, and regulatory review, not due to a specific issue.

Adam Maeder inquired about the U.S. approval timeline for the CGuard Prime stent, asking for details on FDA dialogue and any potential macro-related delays. He also sought updates on the C-GUARDIANS II and III trial enrollment and timelines, specifically for the SwitchGuard approval. Finally, he asked for a high-level business outlook for 2025, comparing the established international business with the nascent U.S. launch.

Answer

Marvin Slosman, an executive, confirmed continued optimism for a first-half 2025 approval, citing a productive and interactive review process with the FDA and no material impact from external factors. He reaffirmed that the C-GUARDIANS II supplement is on track for an early 2026 launch and the full SwitchGuard TCAR system for a second-half 2026 launch. Regarding the 2025 outlook, Slosman described the OUS business as strong and growing, while characterizing the post-approval period in the U.S. as a 'foundational building time' focused on onboarding sales reps and navigating hospital access.

Adam Maeder asked for updates on U.S. launch preparations, including sales force hiring and manufacturing capacity at the new Miami headquarters. He also inquired about the initial U.S. commercial strategy, specifically regarding target accounts and physician specialties. Finally, he requested details on the C-Guardians 2 trial design and the features and differentiation of the SwitchGuard neuroprotection system.

Answer

Executive Marvin Slosman and executive Shane Gleason addressed the questions. Mr. Slosman confirmed the new Miami headquarters is operational and that manufacturing supply for the U.S. launch will be met through their existing Tel Aviv facility, contract manufacturing, and a future internal build-out. Mr. Gleason detailed the commercial hiring plan, noting senior leadership is in place with field team hiring to begin early next year. He explained the initial commercial strategy will target interventional cardiologists and neuro-interventionalists performing CAS procedures, leveraging trial sites and claims data. Regarding the pipeline, Mr. Gleason outlined the C-Guardians 2 IDE study (50 patients, using CGuard Prime with an existing NPS) and stated the SwitchGuard system is designed for superior usability, access, and deliverability, incorporating extensive surgeon feedback for a 'next level' TCAR product.

Representing Adam Maeder of Piper Sandler, an analyst asked about the revenue guidance cadence for the second half of the year, noting the implied steep ramp from Q3 to Q4. They also sought clarity on the medium-term trajectory for gross margins into 2026, given the recent guidance revision.

Answer

EVP and CFO Steven Pfanstiel explained that the Q3 to Q4 ramp is consistent with historical seasonality, where Q3 is typically slower due to summer holidays before a significant rebound in Q4. Regarding gross margins, he stated the primary driver is the revenue mix between the NeuroStar and Green Brook businesses. He anticipates margin improvement from leveraging fixed clinical infrastructure as volume grows and from optimizing the profitability of the SPRAVATO buy-and-bill model relative to its Q2 baseline.

Adam Maeder sought to confirm if the stand-alone Neuronetics revenue guidance of $65-$70 million for the year was still valid. He also requested more detail on the Greenbrook clinics' revenue mix between TMS and SPRAVATO and asked for an explanation for the Q1 gross margin of 49%, as well as the expected cadence for the remainder of the year to reach the 55% annual target.

Answer

Executive Stephen Furlong confirmed the previously communicated revenue guidance split between Neuronetics and Greenbrook remains the target. Executive Keith Sullivan noted that in Q1, TMS revenue was roughly double SPRAVATO revenue at Greenbrook clinics, but he expects this ratio to change significantly as the buy-and-bill model for SPRAVATO is rolled out. Stephen Furlong added that the 49% Q1 gross margin was in line with internal plans and expects margins to improve sequentially in Q2 and Q3 due to revenue scale, approaching the 55% target.

Adam Maeder asked for details on the quarterly revenue sequencing for 2025 and the contribution of the SPRAVATO medical management opportunity to the Greenbrook revenue forecast.

Answer

CFO Steve Furlong outlined the company's typical seasonality, with Q1 representing 19-20% of annual revenue, followed by a ramp to ~25% each for Q2 and Q3, and ~30% in Q4. He specified that SPRAVATO accounts for approximately 75% of Greenbrook's projected growth, with minimal revenue from medical management. He also noted the buy-and-bill transition is a months-long process per site due to payer contracting.

Adam Maeder of Piper Sandler asked about the recently FDA-approved curved Vessel Sealer, seeking details on its technological benefits, the procedures it will be used in, and any impact on pricing or INA per procedure.

Answer

CFO Jamie Samath explained that the new curved Vessel Sealer has a slimmer profile and is ideal for procedures in narrow anatomical spaces like thoracic, colorectal, and hiatal hernia surgeries. He stated that while it doesn't open new procedure categories, it is expected to increase penetration of advanced energy in these areas and improve surgeon stick rates. He noted it has a minor positive impact on INA per procedure, reflecting its value proposition.

Adam Maeder of Piper Sandler Companies asked about the recently FDA-approved curved vessel sealer, seeking details on its technological benefits, the procedures it will be used in, and any impact on pricing or INA per procedure.

Answer

CFO Jamie Samath explained that the new curved vessel sealer has a slimmer profile, a 7mm sealing indication, and a tip designed for better tissue manipulation, making it ideal for procedures in narrow spaces like thoracic, colorectal, and hiatal hernia. He stated the goal is to increase penetration of advanced energy in these procedures and improve surgeon stick rates. While it doesn't open new procedure categories, it will have a minor positive impact on the INA per procedure metric due to its value proposition.

Adam Maeder asked a multipart question on force feedback technology, seeking color on the percentage of da Vinci 5 cases using it, the number of instruments in the portfolio with this capability, and the company's forward-looking clinical strategy to validate the technology.

Answer

Executive Jamie Samath stated that six different instruments currently have force feedback capability and that 'many thousands' of cases have been performed using them. He outlined a clinical data strategy that progresses from small, single-institution studies to larger, more statistically relevant studies over time. Executive Gary Guthart added that early results are confirming their hypotheses about improved surgeon learning and outcomes. He also clarified that current usage is limited by manufacturing supply constraints for the force-sensing instruments, not by demand.

Adam Maeder asked for additional color on the capital equipment environment, inquiring about hospital budgets and purchasing appetite heading into year-end and 2025. He also sought to clarify if the pressures in Europe and China are worsening or remaining status quo.

Answer

CFO Jamie Samath characterized the U.S. capital environment as 'relatively stable,' while noting that capital spending pressures in European countries like the U.K. and Germany have been consistent for the last quarter. CEO Gary Guthart added that China is experiencing broad stress across its healthcare market, including price caps and the entry of domestic competitors with provincial preferences, and he expects these pressures to persist for some quarters.

Adam Maeder of Piper Sandler Companies requested an update on the infant formula litigation and sought more detail on the dual analyte sensor, including launch timing, pricing strategy, and pump integration plans.

Answer

Chairman and CEO Robert Ford declined to comment on specific litigation details but reiterated that Abbott stands behind the product's safety, which is supported by the medical and regulatory communities. Regarding the dual analyte sensor, he did not provide specific timing or pricing but confirmed that partnerships with insulin pump companies are in place to ensure rapid integration and availability upon approval.

Adam Maeder questioned the basis for the company's confidence in a Q2 FDA approval, asked for an update on the timing of the DREAM Journal publication, and sought clarity on the expected pace of operating expense spending for the remainder of the year.

Answer

CEO Olivier Taelman reiterated confidence in a Q2 approval by outlining the final regulatory steps post-inspection and projected the DREAM publication would be released before the summer. CFO John Landry added that while some costs are deferred pending approval, full-year R&D spending is expected to be in line with 2024, while SG&A will more than double, with spending weighted towards the first half of the year.

Adam Maeder asked about Nyxoah's reimbursement strategy, questioning if the selected CPT code 64568 is sufficient to drive physician adoption, and inquired about the expected trajectory of the U.S. launch, including the pace of new account openings in 2025.

Answer

CEO Olivier Taelman acknowledged the CPT code's physician fee isn't the strongest but stressed the value of having an established code at launch. He noted Nyxoah will explore options to enhance reimbursement based on Genio's unique bilateral stimulation. For the launch, he outlined a focused strategy targeting 300-350 high-volume centers, starting with 75+ trained physicians, with plans to scale the 50-person sales team quarterly to cover all target accounts within 12-18 months.

An analyst on behalf of Adam Maeder asked for Nyxoah's reaction to the recently released SURMOUNT OSA study data and whether the company's view on the impact of GLP-1 drugs on its business has changed.

Answer

CEO Olivier Taelman stated that Nyxoah welcomes GLP-1s, viewing them as a market expander for OSA treatment. He pointed out that while GLP-1s reduce AHI, the reduction is less than that shown by hypoglossal nerve stimulation. Taelman emphasized that GLP-1s can help patients lower their BMI, making them better candidates for Genio therapy and ultimately increasing the patient funnel for hypoglossal nerve stimulation.

Adam Maeder of Piper Sandler inquired about the capital equipment backlog for Genesis and GenesisX across the U.S. and Europe, the health of the capital environment, and potential U.S. purchase deferrals. He also asked for feedback on the European adoption of the MAGiC catheter, its performance, and scaling expectations.

Answer

David Fischel (executive) detailed the distinct capital environments in the U.S., Europe, and China, noting the U.S. is more challenged pending MAGiC and GenesisX approvals, while Europe has a more robust pipeline. He explained that physician confidence in GenesisX is building but needs real-world validation. Regarding MAGiC, Fischel stated the reception is very positive, consistent with clinical study results, and it's being used across a full spectrum of procedures. He reiterated guidance for MAGiC in Europe to reach a ~$1 million quarterly run rate by year-end.

Adam Maeder of Piper Sandler questioned the seemingly conservative 2025 system revenue guidance, given positive factors like new product launches and a strong backlog. He also sought updates on the U.S. commercial timeline for GenesisX and the strategic plan for the new EMAGIN vascular catheter.

Answer

Executive David Fischel explained the system revenue guidance reflects conservatism due to historical revenue recognition volatility and uncertainty in the Chinese market. He anticipates U.S. GenesisX approval ahead of compatible catheters, with a commercial launch planned for the second half of the year. Fischel clarified that the EMAGIN catheter has minimal revenue impact in 2025 guidance but holds immense strategic value in expanding the robot's use into a multi-specialty endovascular platform.

Asked about the company's readiness to supply the market with the MAGIC catheter upon European approval, requested a refresher on the size of the European and U.S. sales forces, and inquired about the latest progress on the PFA program.

Answer

The company is confident in its ability to supply MAGIC, working with its partner Osypka to ramp up manufacturing and build inventory. The European sales team consists of about a dozen people, with plans to hire more dedicated reps as MAGIC is launched. The PFA program is advancing well with preclinical studies, and the company expects to be in first-in-human studies next year, with potential European regulatory clearance also possible next year for one of the programs.

Adam Maeder inquired about the 2025 adjusted EBITDA guidance, which is projected to be flat to slightly down, contrasting with past years of strong leverage. He also asked about the expected quarterly cadence for 2025 and if the head and neck opportunity is factored into guidance.

Answer

CEO Sheri Dodd and CFO Elaine Birkemeyer explained the guidance reflects a conscious decision to make strategic investments in personnel (specialist headcount) and technology (CRM modernization) to support long-term, sustainable growth. Birkemeyer stated the company's strong P&L and balance sheet afford them the ability to make these investments. Regarding cadence, management noted a typical seasonal pattern with a stronger H2, adding that the new CRM rollout might cause a short-term learning curve in H1. Dodd confirmed the head and neck opportunity is only conservatively factored into the back half of the year, pending study publication.

Adam Maeder asked about the commercial impact of the EVOQUE NTAP since its October 1st effective date and how much the newly approved 56-millimeter valve size expands the addressable patient population.

Answer

Daveen Chopra, Global Leader of TMTT, explained that while the NTAP provides a tailwind and encourages some centers, the overall demand for EVOQUE remains consistently strong regardless. He estimated that the new 56mm valve size could expand the addressable patient pool by approximately 20% to 25% based on data from previously screened patients.

Inquired about the commercial momentum and monthly progression in Q4 and early Q1, and asked what competitive pressures are factored into the 2024 guidance.

Answer

The company saw strong momentum in late Q4 that carried into a strong start for Q1. They feel confident about their plan and see catalysts for growth throughout the year. The 2024 guidance incorporates expected competition in an attractive market, but the company remains focused on market growth and is confident in maintaining its market leadership position due to its products, data, and commercial team.

Inquired about pricing assumptions for 2024 with the HFX iQ launch and asked for more details on the teased 'new revenue streams' and 'new indications for SCS', including their nature and timing.

Answer

The company expects pricing to be 'flat to slightly up' in 2024 due to the mix shift towards the higher-priced HFX iQ system. Regarding the pipeline, new products will leverage the existing sales channel and 'stay close to home', but no specifics on the product type or timing (2024 vs 2025) were provided for competitive reasons.

Asked about the international business, specifically the potential impact of gaining F15 (recharge-free) approval on market share and growth outside the U.S.

Answer

The international business is currently modest, with a small sales team. Gaining approval for the F15 non-rechargeable system is critical for competing effectively, especially in single-payer markets. The company is actively engaged with regulatory bodies in Australia and Europe and expects approvals in a matter of months, which should have a positive and measurable impact on international SNM revenue in 2024.