LivaNova PLC (LIVN) Business Model Canvas

LivaNova PLC (LIVN): Business Model Canvas [Dec-2025 Updated]

GB | Healthcare | Medical - Devices | NASDAQ
LivaNova PLC (LIVN) Business Model Canvas

Fully Editable: Tailor To Your Needs In Excel Or Sheets

Professional Design: Trusted, Industry-Standard Templates

Investor-Approved Valuation Models

MAC/PC Compatible, Fully Unlocked

No Expertise Is Needed; Easy To Follow

LivaNova PLC (LIVN) Bundle

Get Full Bundle:
$14.99 $9.99
$14.99 $9.99
$14.99 $9.99
$14.99 $9.99
$24.99 $14.99
$14.99 $9.99
$14.99 $9.99
$14.99 $9.99
$14.99 $9.99

TOTAL:

You're digging into LivaNova PLC's (LIVN) engine room, trying to see how they actually make money, and honestly, it boils down to two distinct, high-margin medical device plays. We're talking about their established Vagus Nerve Stimulation (VNS) for epilepsy, which feeds off long-term patient relationships, alongside their Cardiopulmonary business, which runs on a razor-and-blade model with their Essenz™ heart-lung machines. Given their guidance projecting adjusted EPS between $3.80 and $3.90 for 2025 and a drive for adjusted gross margins above 69%, the strategy is clear: drive high-value recurring revenue while pushing their Neuromodulation pipeline forward. Dive into the full Business Model Canvas below to see exactly how their Key Activities and Partnerships support this dual-engine approach.

LivaNova PLC (LIVN) - Canvas Business Model: Key Partnerships

You're looking at the external relationships LivaNova PLC relies on to get its medical technology to patients and secure its financial footing. These partnerships are critical, especially given the regulatory and clinical hurdles in the med-tech space. Honestly, the data we have shows a heavy reliance on clinical validation and government access points.

Clinical research organizations for CORE-VNS and OSPREY studies

LivaNova PLC heavily partners with independent investigators and likely Clinical Research Organizations (CROs) to generate the evidence needed for adoption and reimbursement. The scale of these efforts is significant, as seen in their major studies.

The CORE-VNS study, which is the largest prospective, multinational observational study of VNS Therapy for Drug-Resistant Epilepsy (DRE), enrolled more than 800 people across 61 worldwide sites. The final 36-month data analysis was completed as of June 2025.

For the Obstructive Sleep Apnea (OSA) indication, the OSPREY clinical study provided key data. The 12-month top-line results showed a strong overall responder rate of 65%, with a median reduction in both the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) of 68%.

Here's a quick look at the scale of these clinical partnerships:

  • CORE-VNS Study Sites: 61 worldwide
  • CORE-VNS Enrolled Patients: Over 800
  • OSPREY Study 12-Month Responder Rate: 65%

Key opinion leaders (KOLs) and physician specialists for product adoption

Product adoption hinges on the support of Key Opinion Leaders (KOLs) and physician specialists who champion the therapy in clinical practice. While we don't have a specific count of contracted KOLs, LivaNova PLC actively engages these experts to present and validate their data at major medical meetings, which is a key partnership function. For instance, independent investigators presented five-year data from the THN-3 study and OSPREY data at the International Surgical Sleep Society 2025 Annual Meeting in October 2025.

The company's leadership is clearly focused on ensuring the science is presented by credible external voices to drive adoption across their core areas: Epilepsy, Cardiopulmonary, and the new Sleep Apnea venture.

Global suppliers for critical components and manufacturing capacity

LivaNova PLC maintains a global manufacturing footprint across five countries, relying on numerous suppliers for components and raw materials. Supply chain continuity is a constant focus, especially given past global pressures.

The company is actively managing capacity expansion in its Cardiopulmonary segment. Specifically, LivaNova PLC is expanding manufacturing capacity for oxygenators with the goal of achieving a 60% market share in that product line.

The financial impact of supply chain and operational issues is reflected in guidance adjustments; for example, the first-quarter 2025 guidance incorporated the impact of currently applicable tariffs.

U.S. Centers for Medicare and Medicaid Services (CMS) for reimbursement advocacy

Securing and maintaining favorable reimbursement from the U.S. Centers for Medicare and Medicaid Services (CMS) is a top-tier partnership requirement. LivaNova PLC has been highly active in this area as of late 2025.

In June 2025, LivaNova PLC initiated the formal process with CMS to seek reconsideration of national Medicare coverage for VNS Therapy for Treatment-Resistant Depression (TRD), using data from the RECOVER clinical study.

Furthermore, in November 2025, LivaNova announced that its VNS Therapy for Drug-Resistant Epilepsy (DRE) procedures received increased provider reimbursement from CMS.

The company's advocacy efforts are ongoing, as evidenced by the focus on securing reimbursement fixes for 2026 in other areas as well.

Strategic distributors for market access in over 100 countries

LivaNova PLC operates globally, utilizing a network of strategic distributors to achieve broad market access. As of late 2025, the company reports a presence in more than 100 countries.

This global reach supports the company's approximately 3,000 employees worldwide.

The distribution network supports revenue generation across all regions, with Q3 2025 Neuromodulation revenue showing growth across all regions.

The following table summarizes key quantitative aspects of these external relationships as of late 2025:

Partnership Category Key Metric/Data Point Value/Amount
Global Market Access Number of Countries with LivaNova Presence Over 100
Clinical Studies (CORE-VNS) Number of Worldwide Study Sites 61
Clinical Studies (OSPREY) 12-Month Median AHI/ODI Reduction 68%
Manufacturing/Supply Chain Targeted Market Share for Oxygenators 60%
Reimbursement (CMS) Status of TRD Coverage Request Initiated Reconsideration Process (June 2025)

To be fair, managing a global distribution network across over 100 countries while simultaneously navigating CMS coverage decisions requires tight coordination. Finance: draft 13-week cash view by Friday.

LivaNova PLC (LIVN) - Canvas Business Model: Key Activities

You're looking at the core engine of LivaNova PLC, the things the company absolutely must do well to keep the lights on and grow. For LivaNova, this centers on high-stakes R&D, complex production, navigating tough regulatory waters, and selling specialized, high-value medical technology globally. It's a tightrope walk, balancing innovation spend with margin discipline.

Research and development (R&D) for Neuromodulation pipeline (e.g., aura6000)

R&D is about fueling the future, especially in Neuromodulation. LivaNova PLC is actively managing this spend to balance pipeline advancement with profitability goals. For the third quarter ended September 30, 2025, Adjusted R&D expense was reported at $45.0 million. This represented 13% of net revenue for the quarter, a decrease from 15% in the third quarter of 2024. This shift reflects cost optimization efforts, such as those related to the Difficult-to-Treat Depression (DTD) program, as the company continues to advance the aura6000 system.

The aura6000 System, an investigational implantable neurostimulator for obstructive sleep apnea (OSA), requires sustained clinical validation. The OSPREY trial demonstrated significant durability, with a 12-month treatment arm responder rate of 65%. Responders achieved at least a 50% improvement in the apnea-hypopnea index (AHI) and an AHI value below 20. The median reduction in AHI from a baseline median of 34.3 was 68% at 12 months.

Manufacturing of complex implantable devices and high-volume consumables

LivaNova PLC manufactures devices that require precision, like implantable systems, alongside high-volume consumables for its Cardiopulmonary business. Operational success here directly impacts the bottom line. The Cardiopulmonary segment's growth is explicitly tied to two factors:

  • Sales of the Essenz Perfusion System.
  • Strong consumables demand.

The company is scaling production capacity, evidenced by the Q3 2025 launch of the Essenz Perfusion System in China, the second-largest market for heart-lung machines after the United States.

Clinical evidence generation and regulatory submissions (e.g., FDA PMA)

Generating robust clinical evidence is non-negotiable for high-risk Class III devices requiring Premarket Approval (PMA) from the Food and Drug Administration (FDA). LivaNova PLC has already submitted the aura6000 System for PMA based on meeting primary safety and efficacy endpoints from the OSPREY study at six months. The company intends to share the full 12-month dataset with the FDA during its review. Analysts project potential FDA clearance for the aura6000 in the first half of 2026.

The company also continues to generate evidence for its Vagus Nerve Stimulation (VNS) Therapy, with pivotal articles published in 2025 chronicling the treatment-resistant depression unipolar cohort data from the RECOVER clinical study.

Global commercial execution and direct sales force management

Commercial execution drives revenue across the core segments. For Q3 2025, Neuromodulation revenue grew 6.4% on a constant-currency basis across all regions. The Epilepsy sub-segment showed a 6% overall growth rate, with the U.S. growing at 5% and the combined Europe and Rest of World regions growing at 12%. LivaNova PLC has a direct sales presence in Europe, which is a key component of managing this growth.

Here's a look at the segment revenue performance driving commercial focus:

Segment Q3 2025 Reported Revenue ($M) Q3 2025 YoY Growth (Reported) Key Driver
Cardiopulmonary Not explicitly stated 18.0% Essenz System sales and consumables demand
Neuromodulation $140M to $150M range (Implied from data) 6.9% Growth across all regions

Operational excellence to drive margin expansion above 69% adjusted gross margin

Operational excellence is about turning revenue into profit, a clear focus for LivaNova PLC management. The company reported an Adjusted Gross Margin of 69% for the third quarter of 2025. This is a key metric they are managing, though it was slightly down year-over-year from 70% in Q3 2024 due to factors like unfavorable currency changes and product mix.

The focus on disciplined execution and enhanced productivity is clearly reflected in the operating margins:

  • Total Adjusted Operating Margin (Q3 2025): 22.5%.
  • Adjusted Segment Margin (Neuromodulation, Q3 2025): 41.9%.
  • Adjusted Segment Margin (Cardiopulmonary, Q3 2025): 19.3%.

This operational focus contributed to raising the full-year 2025 Adjusted Diluted EPS guidance to a range of $3.80 to $3.90.

LivaNova PLC (LIVN) - Canvas Business Model: Key Resources

You're looking at the core assets LivaNova PLC uses to deliver value in its Cardiopulmonary and Neuromodulation markets. These aren't just line items on a balance sheet; they are the engines driving the company's projected 9.5% to 10.5% organic revenue growth guidance for the full year 2025.

Proprietary Vagus Nerve Stimulation (VNS) Therapy technology platform

The VNS Therapy platform is a cornerstone, offering a non-penetrating skull treatment for drug-resistant epilepsy (DRE). The technology itself has a long regulatory history, holding a CE Mark since 2001 and a U.S. Food and Drug Administration 510(k) clearance since 2005.

This platform is supported by significant real-world evidence, which is a key resource for driving adoption and reimbursement discussions, especially as LivaNova PLC seeks reconsideration of national coverage for treatment-resistant depression (TRD).

Global intellectual property (IP) portfolio and regulatory approvals

Protecting the VNS technology and the newer Aura6000 System is critical. LivaNova PLC explicitly recognizes the risk associated with the failure to protect its proprietary intellectual property, making the portfolio itself a vital, though intangible, asset. The company's global reach, spanning operations in more than 100 countries, necessitates a broad and actively managed IP strategy across these jurisdictions.

Specialized manufacturing facilities for Cardiopulmonary and Neuromodulation

LivaNova PLC has been actively investing in its production capabilities to meet growing demand, particularly for its Essenz™ Perfusion System consumables. The company increased its manufacturing output by 10% last year (2024), with plans for another 10% increase this year (2025). Furthermore, LivaNova PLC plans to bring an additional manufacturing line online next year (2026) to support future growth, aiming for a 60% market share in oxygenators.

Here's a quick look at the capacity expansion focus:

Metric Target/Status Timeframe/Context
Manufacturing Output Increase 10% Last Year (2024)
Projected Manufacturing Output Increase 10% This Year (2025)
New Manufacturing Line Go-Live Planned Next Year (2026)
Oxygenator Market Share Goal 60% Long-term Goal

Clinical data from large-scale studies like CORE-VNS and RECOVER

The depth of clinical evidence is a major resource, especially for the Neuromodulation segment. The CORE-VNS study, the largest prospective study of VNS Therapy to date, provides robust, long-term data. The patient retention rate throughout the three years of follow-up was 82%.

Key efficacy findings from the CORE-VNS study include:

  • Study enrolled over 800 people from 61 worldwide sites.
  • Median reduction in Generalized Tonic-Clonic (GTC) seizure frequency at 24 months: 77%.
  • Percentage of people reporting GTC seizure freedom at 24 months: 43%.
  • Median reduction in Focal Impaired Awareness (FIA) motor seizures in children 4 to 18 years old at 36 months: 87%.
  • Percentage of adults with FIA motor seizures reporting 100% seizure reduction at 36 months: 34%.

For the RECOVER study in treatment-resistant depression, the unipolar cohort's 12-month follow-up was completed in March 2024. The active treatment arm showed statistically significant and clinically meaningful improvement in select secondary endpoints, supporting five peer-reviewed publications used for the CMS reconsideration process.

Global sales and clinical support team of approximately 2,900 employees

LivaNova PLC's human capital is substantial, with approximately 2,900 employees worldwide. This team supports operations across more than 100 countries, which is essential for the global commercialization of both the Essenz™ Perfusion System and VNS Therapy. The company's Q3 2025 performance, with adjusted diluted EPS of $1.11 for the quarter, reflects the productivity of this workforce.

The scale of the workforce supports the financial projections, with the full-year 2025 adjusted diluted EPS guidance set between $3.80 and $3.90, based on an assumed share count of approximately 55 million ordinary shares.

LivaNova PLC (LIVN) - Canvas Business Model: Value Propositions

You're looking at the core reasons why customers choose LivaNova PLC's products, and honestly, the numbers back up the claims across their main areas of focus.

VNS Therapy: Long-term seizure reduction for Drug-Resistant Epilepsy (DRE) patients

The value proposition here is sustained, life-changing seizure control for patients who haven't found relief elsewhere. The CORE-VNS study, which followed more than 800 people with epilepsy treated with VNS Therapy worldwide, provides the real-world evidence you need to see this in action. The data is quite compelling, showing deep, lasting impact.

Here's a quick look at the 36-month outcomes from the CORE-VNS study for disabling seizures:

Seizure Type Patient Group Median Reduction at 36 Months Reported 100% Seizure Freedom
Focal Impaired Awareness (FIA) Motor Seizures Children (4 to 18 years old) 87% N/A (Data not specified for this subgroup)
Focal Impaired Awareness (FIA) Motor Seizures All Ages (Including Adults) 80% 34% of patients
Focal to Bilateral Tonic-Clonic (FBTC) Seizures Children (4 to 18 years old) 100% N/A (Data not specified for this subgroup)
Focal to Bilateral Tonic-Clonic (FBTC) Seizures All Ages (Including Adults) 95% 49% of patients

Also, the value is amplified by earlier intervention; patients treated earlier in their treatment algorithm (after 2-3 anti-seizure medications) achieved a 94% median reduction in seizure frequency at 36 months, compared to only 57% for those treated after more than 10 medication failures. Furthermore, LivaNova PLC is actively pursuing reimbursement, having initiated the process with the U.S. Centers for Medicare and Medicaid Services (CMS) for reconsideration of national Medicare coverage for VNS Therapy in unipolar patients with difficult-to-treat depression.

Cardiopulmonary: Reliable, next-generation heart-lung machines (Essenz™) and consumables

For cardiac surgery, the value is in providing a reliable, next-generation platform that supports data-driven perfusion during life-saving cardiopulmonary bypass (CPB) procedures. The Essenz Perfusion System, which integrates the HLM, Patient Monitor, and In-Line Blood Monitor (ILBM), has already supported over 100,000 patients worldwide since its initial launch in February 2023. This technology is expanding into major markets, like China, where approximately 185,000 adult and 23,500 pediatric extracorporeal circulation (ECC) procedures are projected for 2025 alone.

The financial performance reflects this strong value proposition:

  • The total annual cardiopulmonary market is estimated around $2 billion, split between capital equipment (like Essenz) at about $800 million and disposables at about $1.2 billion.
  • LivaNova PLC holds an estimated 70% share in the heart-lung machine segment, based on an installed base of some 7,000 units globally.
  • Cardiopulmonary revenue growth was strong through the first three quarters of 2025, showing a 18.0% reported increase in Q3 2025 versus Q3 2024, and a 14.7% reported increase in Q2 2025 versus Q2 2024.

Differentiated technology for Obstructive Sleep Apnea (OSA) patients with high BMI

The value here is offering an alternative, potentially less burdensome therapy for OSA, especially for patients who struggle with traditional CPAP compliance. LivaNova PLC completed the Premarket Approval (PMA) submission to the FDA for its aura6000™ System, which uses proximal hypoglossal nerve stimulation. This is supported by 12-month, top-line OSPREY data showing a strong response. The broader market context shows the opportunity: the global sleep apnea devices market is estimated at USD 9.7 billion in 2025, with adherence issues being a key challenge for existing therapies.

Potential for life-changing therapy for Difficult-to-Treat Depression (DTD)

This proposition centers on expanding the utility of VNS Therapy to a new, significant patient population. LivaNova PLC is actively working to secure broader access by initiating the process with the U.S. CMS for reconsideration of national Medicare coverage for VNS Therapy in unipolar patients suffering from treatment-resistant depression. This opens up a significant unmet need within the broader Neuromodulation segment.

High-quality, recurring consumables for cardiac surgery procedures

This is the recurring revenue backbone supporting the capital equipment sales. The value is in the consistent need for high-quality disposables during every CPB procedure performed using LivaNova PLC's systems. This demand is a clear driver of financial performance; for instance, the strong consumables demand was cited as a key factor in the 18.0% reported revenue increase for the Cardiopulmonary segment in Q3 2025. These disposables represent the larger portion of the estimated $1.2 billion annual value in the cardiopulmonary disposables market.

Finance: confirm Q4 2025 consumables revenue contribution by end of January.

LivaNova PLC (LIVN) - Canvas Business Model: Customer Relationships

You're looking at how LivaNova PLC keeps its high-value customers-hospitals and physicians-engaged, especially with complex, high-cost therapies like the Essenz Perfusion System and VNS Therapy. This isn't a transactional business; it requires deep, ongoing partnership.

Dedicated clinical specialists for device implantation and titration support.

The relationship starts with highly specialized, hands-on support. Think of the clinical team as an extension of the hospital staff during critical procedures. For the Cardiopulmonary segment, this means ensuring the proper use and calibration of the Essenz Perfusion System. For Neuromodulation, it involves detailed titration support for VNS Therapy to optimize patient outcomes for Drug-Resistant Epilepsy (DRE) and Difficult-to-Treat Depression (DTD).

LivaNova PLC supports its global footprint, which spans more than 100 countries, with a dedicated team, part of its approximately 2,900 employees, focused on these high-touch interactions.

Long-term, high-touch support for hospital capital equipment and consumables.

Capital equipment sales, like the Essenz System, are just the entry point. The real recurring revenue comes from consumables, which demand consistent, high-touch service. If a hospital is running a cardiopulmonary bypass procedure, they need absolute assurance on uptime and performance. This necessitates a robust service infrastructure that goes beyond a simple help desk. This long-term commitment builds significant switching costs for the customer.

The company's focus on operational excellence is designed to support this, as evidenced by their strong financial performance, which underpins their ability to maintain these service levels.

Direct engagement with physician groups to build clinical evidence.

For LivaNova PLC to expand the use of its therapies, especially in areas like DTD where they are pursuing reconsideration of national coverage with the U.S. Centers for Medicare & Medicaid Services (CMS), physician buy-in is everything. This engagement isn't just about sales training; it's about collaboration on research. They actively support investigator-initiated research and publish pivotal data, such as the long-term, real-world evidence from the CORE-VNS Study and the RECOVER study data for DTD.

This evidence-building directly influences physician adoption and advocacy.

Regulatory and reimbursement support for complex, high-cost therapies.

Dealing with complex devices and therapies means navigating a maze of payer policies. LivaNova PLC provides support to help providers secure reimbursement for procedures using their technology. This is crucial for high-cost interventions. For instance, they initiated the process with CMS for reconsideration of national coverage for VNS Therapy for treatment-resistant depression, a direct effort to secure broad patient access and, by extension, support the providers who use the system.

This support de-risks the financial decision for the hospital to adopt the technology.

Investor relations focused on clear guidance, projecting $3.80 to $3.90 adjusted EPS.

The relationship with the financial community is managed through transparent communication of performance and outlook. This clarity builds investor confidence, which ultimately supports the company's valuation and ability to invest in the customer-facing infrastructure described above. Following strong Q3 2025 results, LivaNova PLC raised its full-year guidance, signaling confidence in its execution across both Cardiopulmonary and Neuromodulation segments.

Here's a look at the key financial metrics guiding that investor relationship:

Metric 2025 Guidance Range Basis/Context
Adjusted Diluted EPS $3.80 to $3.90 Raised from prior guidance
Revenue Growth (Constant Currency) 8.5% to 9.5% Raised from prior guidance
Adjusted Free Cash Flow $160 million to $180 million Raised from prior guidance

The Q3 2025 adjusted diluted EPS came in at $1.11, which was well above the consensus estimate of $0.91. This strong operational performance directly validates the customer-facing strategy.

The core relationship strategy relies on these pillars:

  • Dedicated clinical specialists for device implantation.
  • High-touch support for Essenz consumables.
  • Active publication of clinical evidence.
  • Proactive reimbursement support efforts.
  • Delivering on financial guidance, targeting $3.80 to $3.90 adjusted EPS.

Finance: draft 13-week cash view by Friday.

LivaNova PLC (LIVN) - Canvas Business Model: Channels

LivaNova PLC utilizes a multi-pronged channel strategy to bring its Cardiopulmonary and Neuromodulation technologies to market, focusing on direct engagement where possible and leveraging established networks internationally.

The company maintains a direct sales force presence, supporting its operations across more than 100 countries as of late 2025. LivaNova PLC employs approximately 2,900 employees globally, a significant portion of whom are dedicated to commercial execution.

For its Cardiopulmonary segment, LivaNova PLC relies on specialized distributors in international markets, complementing its direct reach. Historical data suggests a model involving direct presence in over 35 countries and sales via distributors in over 65 countries.

Direct-to-physician marketing is heavily grounded in clinical evidence and collaborative development. The Essenz™ Perfusion System, for example, was designed in collaboration with more than 300 perfusionists globally to ensure its features met evolving operating room needs.

The regulatory pathway acts as a primary channel gate for new product entry. LivaNova PLC completed the Premarket Approval (PMA) submission for the aura6000™ System, intended for obstructive sleep apnea, during the first quarter of 2025.

The launch of the Essenz™ Perfusion System in China represents a major channel activation in late 2025. This launch followed regulatory approval from China's National Medical Products Administration (NMPA) on or around August 18, 2025. China is LivaNova's second-largest market for heart-lung machines (HLMs) after the United States.

The strategic importance of this channel is underscored by the market potential:

  • Approximately 330 million individuals in China are affected by cardiovascular disease.
  • About 700 hospitals in China currently perform cardiac surgery.
  • Projections indicate approximately 185,000 adult and 23,500 pediatric extracorporeal circulation procedures will occur there in 2025.

The Essenz system itself has supported over 100,000 patients worldwide since its initial launch in February 2023.

To frame the scale of LivaNova PLC's operations supporting these channels as of late 2025, consider these key financial and operational metrics:

Metric Value/Amount Period/Context
Q3 2025 Reported Revenue $357.8 million Three Months Ended September 30, 2025
Q3 2025 Adjusted Diluted EPS $1.11 Three Months Ended September 30, 2025
Full-Year 2025 Projected Revenue Growth (Organic) 9.5% to 10.5% Raised Guidance
Full-Year 2025 Projected Adjusted Diluted EPS $3.80 to $3.90 Raised Guidance
Cardiopulmonary Revenue Growth (Reported) 18.0% Q3 2025 vs Q3 2024
Market Capitalization $2.91B As of September 29, 2025
Essenz Patients Supported Worldwide Over 100,000 Since February 2023 launch

The Cardiopulmonary segment's channel execution is strong, with Q3 2025 revenue increasing 18.0% on a reported basis versus the third quarter of 2024, driven by Essenz sales and consumables demand.

LivaNova PLC (LIVN) - Canvas Business Model: Customer Segments

You're looking at the core groups LivaNova PLC serves with its medical technologies, which really breaks down into two main franchises: Neuromodulation and Cardiopulmonary.

Neurosurgeons and neurologists treating Drug-Resistant Epilepsy (DRE).

  • This group treats patients where one out of every three individuals with epilepsy faces ongoing seizures despite medication.
  • LivaNova PLC's VNS Therapy is clinically proven as an add-on treatment for patients 4 years of age and older in the United States.
  • The CORE-VNS study, a comprehensive assessment, has enrolled more than 800 people across 61 worldwide sites.
  • The neuromodulation market size specifically for DRE in 2025 is estimated at $700M.
  • For Medicare patients, provider reimbursement for VNS Therapy DRE procedures is set to increase by approximately 48% for new patient implants and 47% for end-of-service procedures versus 2025 rates, effective January 1, 2026.

Cardiac surgeons and perfusionists in hospital operating rooms.

This customer base relies on LivaNova PLC's Cardiopulmonary segment, which operates in a $2 billion global market. You can see the demand reflected in recent revenue performance:

Metric Value/Rate (as of late 2025)
Q3 2025 Cardiopulmonary Revenue Growth (Reported vs Q3 2024) 18.0%
Six Months Ended June 30, 2025 Cardiopulmonary Revenue $375.6 million
Q2 2025 Cardiopulmonary Revenue Growth (Reported vs Q2 2024) 14.7%

Patients with moderate-to-severe Obstructive Sleep Apnea (OSA).

  • LivaNova PLC targets the segment of adult patients with moderate to severe OSA who have failed or are unwilling to use positive airway pressure treatment.
  • The addressable population is substantial, with nearly 2 million patients with moderate to severe OSA having failed first-line therapies.
  • The OSPREY trial demonstrated a treatment arm responder rate of 65% at 12 months of therapy.
  • The OSA treatment devices market was estimated at $9.7 billion in 2024.
  • LivaNova PLC projects the OSA business to generate $200 million to $400 million in revenue by 2030.

Patients with Difficult-to-Treat Depression (DTD) refractory to other treatments.

  • LivaNova PLC manufactures the VNS Therapy system for the treatment of DTD.
  • The company is actively pursuing reconsideration of national Medicare coverage with the U.S. Centers for Medicare & Medicaid Services (CMS) for VNS Therapy in unipolar patients with DTD.
  • DTD represents significant upside optionality, as it is not currently included in the company's long-range financial projections pending CMS coverage.

Global healthcare systems and payers seeking cost-effective, long-term solutions.

  • LivaNova PLC has a presence in more than 100 countries.
  • Trailing Twelve Months (TTM) revenue as of September 30, 2025, was $1.35B.
  • The company expects full-year 2025 organic revenue growth between 9.0% and 10.0%.
  • For 2025, LivaNova PLC expects adjusted free cash flow in the range of $160 million to $180 million.

LivaNova PLC (LIVN) - Canvas Business Model: Cost Structure

You're looking at the major drains on LivaNova PLC's cash flow, the things that keep the lights on and the innovation engine running. For a medical device company like LivaNova PLC, the cost structure is heavily weighted toward future product development and regulatory hurdles, not just making the widgets.

The investment in future growth is substantial, showing up clearly in the operating expenses. For the year-to-date period ending with Q2 2025, the commitment to Research and Development (R&D) investment stood at $177.1 million. That's the money going into next-generation devices and proving out new therapies. Also, the day-to-day running of the business, which includes sales force costs, marketing, and corporate overhead, results in significant Selling, General, and Administrative (SG&A) expenses. For that same Q2 2025 year-to-date period, SG&A hit $538.7 million. Honestly, these two buckets make up the bulk of the operating spend.

Here's a quick look at the major cost components based on the Q2 2025 reporting period:

Cost Category Financial Amount (Q2 2025 Period) Context/Notes
R&D Investment (YTD) $177.1 million Investment in product design, clinical studies, and regulatory activities.
SG&A Expenses (YTD) $538.7 million Selling, marketing, and general corporate overhead costs.
Cost of Revenue (Q2) $404.9 million Direct costs associated with producing goods sold in the second quarter.
Capital Expenditure Context (Q2) $144.7 million Net cash outflow in Q2 2025 attributed partly to increased capital expenditures.
Inventory Write-Down (Q1 End) $17.5 million Adjustment to record inventory at lower of cost or net realizable value as of March 31, 2025.

You can't ignore the big, lumpy costs associated with getting new technologies approved. LivaNova PLC faced a major regulatory cost event with the SNIA matter. Specifically, in the first quarter of 2025, the company recorded an environmental liability of $360.4 million as of March 31, 2025, following a ruling by the Italian Supreme Court. This single item heavily influences the GAAP cost profile.

The ongoing clinical pipeline demands continuous funding. You see this investment in:

  • Costs associated with the CORE-VNS study, validating long-term VNS Therapy efficacy.
  • Expenditures for the OSPREY clinical study, supporting the aura6000 System for obstructive sleep apnea.
  • Fees related to the ongoing process with the U.S. Centers for Medicare and Medicaid Services (CMS) for VNS Therapy coverage reconsideration.

Manufacturing costs are tied directly to the complex nature of their devices and the necessary consumables. For the Cardiopulmonary segment, growth in Essenz Perfusion System sales and consumables demand drives the Cost of Revenue. The need to maintain high quality for complex medical devices means manufacturing overhead and inventory management are critical cost centers. As of March 31, 2025, LivaNova PLC had to record an inventory adjustment of $17.5 million to bring balances down to net realizable value, which is a direct hit to the cost of goods sold.

Capital expenditure is targeted for capacity. While a specific CapEx number for the period isn't isolated, the Q2 2025 net cash outflow of $144.7 million was partly driven by increased capital expenditures, which you can assume is going toward expanding Cardiopulmonary capacity and necessary IT infrastructure upgrades to support global operations. Finance: draft 13-week cash view by Friday.

LivaNova PLC (LIVN) - Canvas Business Model: Revenue Streams

You're looking at the hard numbers driving LivaNova PLC's top line as of late 2025. It's a mix of high-ticket equipment sales and the steady flow from consumables, which is always a good sign for predictable revenue.

The company's latest full-year outlook suggests strong momentum carrying through. Full-year 2025 organic revenue growth is guided to be between 9.5% and 10.5%.

Here's a look at the revenue components based on the third quarter of 2025 results:

Revenue Stream Component Q3 2025 Revenue (in millions USD) Reported YoY Growth (Q3 2025 vs Q3 2024)
Cardiopulmonary Revenue $203.2 18.0%
Neuromodulation Revenue $149.5 6.9%
Other Revenue (includes Service/Rental) $5.0 (16.8)%
Total Net Revenue $357.8 12.5%

Sales of Neuromodulation implantable devices (VNS Therapy Systems) contributed $149.5 million to net revenue in the third quarter of 2025. This segment saw a constant-currency increase of 6.4% for the quarter.

Sales of Cardiopulmonary capital equipment (Essenz™ Perfusion System) are a key driver here, alongside the recurring revenue component. The entire Cardiopulmonary segment generated $203.2 million in the third quarter of 2025. The constant-currency growth for this segment was 15.9% in the third quarter, directly attributed to Essenz Perfusion System sales and strong consumables demand.

That recurring, high-margin revenue from Cardiopulmonary consumables is the classic razor-and-blade model in action. The strong 15.9% constant-currency growth in the Cardiopulmonary business in Q3 2025 was explicitly driven by this strong consumables demand, supporting that model.

Service and rental income from Cardiopulmonary equipment is captured within the Other Revenue line item. For the third quarter of 2025, Other Revenue was $5.0 million, which the company notes includes rental and site services income not allocated to segments.

You can see the relative contribution of the two main product areas:

  • Sales of Neuromodulation implantable devices (VNS Therapy Systems) accounted for approximately 41.8% of the $357.8 million total net revenue in Q3 2025 ($149.5M / $357.8M).
  • Sales of Cardiopulmonary equipment and consumables accounted for approximately 56.8% of the $357.8 million total net revenue in Q3 2025 (($203.2M + $5.0M - $5.0M) / $357.8M, using Other Revenue as a proxy for non-core/service). More simply, Cardiopulmonary revenue was $203.2 million out of $357.8 million.

Disclaimer

All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.

We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.

All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.