Strategic Drivers and Operational Execution
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Cardiopulmonary growth was driven by record Essence heart-lung machine placements and internal manufacturing optimizations that increased oxygenator output to meet high market demand.
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Epilepsy performance benefited from a combination of volume growth and reduced discounting, supported by improved U.S. reimbursement and long-term clinical evidence from the CORE-VNS study.
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Management is leveraging existing neuromodulation infrastructure, supply chain, and market access competencies from the epilepsy business to build a foundation for the obstructive sleep apnea (OSA) market entry.
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Operational initiatives, including the now-operational new oxygenator production line and the Thermo Fisher component agreement, are positioned to drive double-digit capacity expansion in 2027.
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The company attributes its 'clear right to win' in OSA to differentiated technology that addresses a broader patient population by eliminating the triple-c contraindication.
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Cardiopulmonary consumables grew low double digits, supported by improvements in third-party component availability and internal manufacturing optimization.
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Management noted that oxygenator market demand continues to exceed the industry's ability to supply, representing a significant opportunity to expand market position.
Strategic Outlook and Guidance Assumptions
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Full-year 2026 revenue guidance was raised to 9% to 10% growth, reflecting sustained momentum in core franchises and an improved business outlook for the remainder of the year.
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The 2026 EPS range was increased to $4.40 to $4.50, incorporating stronger operational performance and a $0.03 benefit from the shifted timing of the SNIA payment to the fourth quarter.
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Management expects the Essence HLM upgrade cycle to continue, forecasting that Essence will represent 80% of annual unit placements in 2026, up from 55% in 2025.
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The OSA strategy assumes a PMA supplement submission on the previously communicated timeline, followed by a limited launch in 2027 and a full commercial ramp in 2028.
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Future growth in epilepsy is expected to be supported by the 2027 launch of a next-generation IPG and digital health platform designed to enable remote titration.
Strategic Developments and Risk Factors
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The establishment of new Category 1 CPT codes for pHGNS, effective January 1, 2028, is expected to bolster long-term reimbursement and patient access for the OSA technology.
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The timing of the approximately $400 million SNIA payment shifted from the third quarter to the fourth quarter of 2026, providing a near-term EPS benefit while the company maintains sufficient resources to satisfy the liability.
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A new dedicated manufacturing line for oxygenators is now live and operational, which is expected to drive a double-digit increase in output for 2027.
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The company reported a net impact from tariffs of less than $5 million on full-year adjusted operating income, inclusive of current and anticipated future tariffs.
Q&A Session Highlights
Cardiopulmonary growth drivers and manufacturing expansion for 2027
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Management expects the new manufacturing line to drive double-digit growth in oxygenator output for 2027 compared to 2026.
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The heater-cooler and Air Manager products remain on track for a phased launch, with material revenue impact expected to begin in 2028.
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Commercialization strategy and market opportunity for OSA
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Regulatory submission is considered 'time zero,' with a limited launch planned for 2027 and significant commercial investment starting in 2028.
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Management believes the OSA market remains attractive due to high unmet needs, noting that HGNS penetration remains below 5% among patients who discontinue CPAP.
Sustainability of epilepsy pricing and volume tailwinds
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Realized price is trending at approximately 2x normal levels due to reduced discounting following successful contract renegotiations.
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Management expects some incremental realized price benefit to carry into 2027 as they continue to address remaining accounts.
Clinical differentiation and responder rates in the OSA market
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PolySync technology is designed to increase cumulative responder rates from 65% to 85% by customizing therapy for patients with complex needs.
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The absence of a triple-c contraindication is expected to immediately expand the addressable market by approximately 25% upon entry.
Status of CMS discussions regarding VNS therapy for depression
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The 36-month RECOVER data has been shared with CMS and submitted to a peer-reviewed journal, showing strong durability of therapy.
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Management remains in active dialogue with CMS but will only update on a formal NCD review submission when appropriate.
