logo
Vagus Nerve Stimulation Has Lasting Effects in People With Severe Depression

Vagus Nerve Stimulation Has Lasting Effects in People With Severe Depression

Yahoo19-04-2025
Stimulating either of a pair of crucial nerves that carry messages from the brain to several major organs could be an effective way to treat people with severe depression.
An international team of researchers conducted a clinical trial on 493 adults whose major depression hadn't previously responded to treatment. Participants were fitted with a device capable of stimulating one of their vagus nerves, which was then activated in half the group to transmit signals to areas of their brain that regulate moods.
Assessments were carried out for roughly ten months, after which participants who received the stimulation treatment showed improvements in their depressive symptoms, in their quality of life, and in their ability to carry out the daily tasks of everyday life.
"On average, each patient had already tried 13 treatments that failed to help them before they enrolled in the trial, and they had spent more than half of their lives sick with depression," says Charles Conway, a professor of psychiatry at Washington University in St Louis.
"But despite that super-high level of sustained illness, we still see statistically significant, measurable improvements in depressive symptoms, quality of life and functional outcomes."
While VNS has shown promise for treating depression before, evidence of its success hasn't always been clear cut, leaving treatment difficult to afford for many in the US on insurance cover.
There are some reasons to be cautious. Based on the study's primary measure of depressive symptoms, the Montgomery-Åsberg Depression Rating Scale (MADRS), there were no differences between the treatment and non-treatment groups.
Very few participants from either group reported a full remission in their depression, and it's also worth noting the study was partly funded and supported by LivaNova USA, which manufactures a VNS therapy system for patients.
Even with those caveats in mind though, the study's results are promising, particularly when it comes to helping people escape the mental paralysis that can come along with major depression.
"What's really important here is that patients themselves were reporting that their lives were improving," says Conway.
"They're saying they are seeing meaningful improvements in their ability to function and live their lives."
Up to 30 percent of those with severe depression fail to benefit from standard antidepressants, with their mental health problems compounded by an increased risk of suicide, hospitalization, and disability.
The same clinical trial is being used to see if VNS can make a difference for people with bipolar too. In addition, the researchers want to continue the trial for another four years, and see if the benefits are particularly noticeable in certain groups of people.
"The nice thing about vagus nerve stimulation, we know from other studies, is that when the patient responds, the effects usually stick," says Conway.
The research has been published in two papers in Brain Stimulation, here and here.
An earlier version of this article was published in January 2025.
Weight Gain Might Be Linked to 'Lifestyle Instability', Not Just Calories
Up to 13% of Dementia Cases May Actually Be a Misdiagnosed Treatable Condition
Study on Mice Suggests Surprising Link Between Nose-Picking And Alzheimer's
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Nature-Inspired Gel Explains Why This Duck Is Stuck
Nature-Inspired Gel Explains Why This Duck Is Stuck

Scientific American

time2 days ago

  • Scientific American

Nature-Inspired Gel Explains Why This Duck Is Stuck

On the shores of a beach in northern Japan, waves pummel a rubber duck stubbornly stuck to a rock. Thanks to a new supersticky hydrogel lining its base, the toy won't budge. Hydrogels are soft, jellylike materials used in many fields. In medicine, they can dress wounds and deliver drugs. In agriculture, they can help soil hold more water. But making substances sticky is tough—and underwater, it's even tougher. The glues typically don't hold well under a wet and salty surf. Nature, however, has a solution. Creatures such as barnacles and mussels naturally produce proteins that let them stick to wet surfaces. Inspired by these adhesive abilities, researchers combed through catalogs of these animals' protein structures to mimic their stickiest features. Then, the scientists incorporated these protein structures into the hydrogels and tested them. After running several experiments, the team fed the results to a machine-learning system so that it could design a hydrogel with even stronger glue. The system came up with three superadhesive designs, composed of different protein structures, which the researchers described this week in Nature. On supporting science journalism If you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today. Jonathan Barnes, a polymer scientist at Washington University in St. Louis, who was not involved in the study, was impressed by the sheer strength of the enhanced hydrogels. In one experiment, the researchers used one of the gels to glue together pairs of plates made of one of three different materials—ceramic, glass and titanium—in a tank of saline. Each glued pair had a kilogram-mass load suspended below it. The gel held on for more than a year. 'To last for a year is incredible,' Barnes says. All three of the artificial-intelligence-designed hydrogels showed similar strength in artificial seawater. But one outperformed the others when tested in deionized water, which is devoid of charge and not found in nature. The differences in strength show that some adhesive materials may be more equipped for specific environments than others. 'We are now working to tune this difference and test them in different conditions,' says study co-author Jian Ping Gong, a polymer scientist at Hokkaido University in Japan. 'We also want to improve and [find] other formulations that can work on metal, for example.' After synthesizing the ultrasticky gels, the scientists took two of them into the field to test their real-world capabilities. The researchers used one gel to seal a hole at the base of a three-meter-long pipe that was filled with tap water to simulate a high-pressure water leak. And they used the other to affix a rubber duck onto a rock to see how well the technology fared in seawater. One day these gels could help researchers develop artificial skin or repair underwater and offshore structures. '[The study] points to tougher, faster and more reliable wet adhesives—for medical sealing, marine infrastructure and emergency repairs,' says Ximin He, a materials scientist who studies biologically inspired materials at the University of California, Los Angeles, and was not involved in the paper. 'The data‑driven playbook they use could shorten the path from idea to material across many applications that affect daily life.'

Aug 08 2025 This Week in Cardiology
Aug 08 2025 This Week in Cardiology

Medscape

time2 days ago

  • Medscape

Aug 08 2025 This Week in Cardiology

Please note that the text below is not a full transcript and has not been copyedited. For more insight and commentary on these stories, subscribe to the This Week in Cardiology podcast , download the Medscape app or subscribe on Apple Podcasts, Spotify, or your preferred podcast provider. This podcast is intended for healthcare professionals only. In This Week's Podcast For the week ending August 8, 2025, John Mandrola, MD, comments on the following topics: Listener feedback on SURPASS CVOT, AF ablation and the limits of meta-analyses, a Watchman alert from FDA, and oral anticoagulation choices in elderly patients. A listener sent me a huge meta-analysis published in the Annals of Internal Medicine comparing catheter and surgical ablation to no ablation in randomized controlled trials (RCTs). I had seen the study but ignored it, but when avid listeners say they are keen to know my thoughts, I relooked at it and will discuss it now. A group at Washington University in St Louis led the study. It was a massive meta-analysis encompassing 63 trials with more than 11,000 patients. There were 39 catheter ablation trials and 24 surgical ablation trials. The goal was to bring together all RCTs in the field to assess the primary outcome of ischemic stroke at more than 30 days. Pause there. Stop and Think. This is weird. Why ischemic stroke after 30 days. What if a stroke happens at day 29? How is that less important than a stroke at 31 days? The authors also looked at secondary outcomes of mortality and heart failure hospitalizations. Six news outlets picked up the study—all with positive headlines. But we need to look deeper. The main results were that: Compared with medical therapy, catheter ablation reduced risks for ischemic stroke after 30 days (relative risk [RR], 0.63 [95% CI, 0.43 - 0.92]), mortality (RR, 0.73 [CI, 0.60 - 0.88]), and heart failure hospitalization (RR, 0.68 [CI, 0.55 - 0.85]). However, catheter ablation increased the RR for ischemic stroke at or before 30 days (6.81 [CI, 1.56 - 29.8]) such that the RRs were 0.77 (CI, 0.55 - 1.09) for any ischemic stroke and 0.77 (CI, 0.57 - 1.05) for all strokes. Surgical ablation reduced the RRs for ischemic stroke (0.54 [CI, 0.34 - 0.86]) and stroke from any cause (0.54 [CI, 0.35 - 0.82]) but had uncertain benefit for other outcomes. Ischemic stroke after 30 days in surgical ablation trials — RR was 0.63 (CI, 0.37 - 1.06); and non-significant for mortality and HHF. This is lacking, right? You want to know total stroke, mortality and HHF numbers. You also want to know absolute risk reductions. So here they are: For catheter ablation: Total stroke had a non-significant 33% relative risk reduction (RR, 0.77 (0.57-1.05) ARR 0.6% fewer per 1000 to 1 per 1000 more cases. Total mortality had a significant 37% relative risk reduction (RR, 0.73 (0.6-0.88); ARR was 16 per 1000 fewer. HHF had a 32% relative risk reduction (RR, 0.68 (0.55-0.85) and the ARR was 24 fewer per 1000 HF hospitalization For surgical atrial fibrillation (AF) ablation vs cardiac surgery alone: Total Stroke (Any Cause): Relative Risk: 0.54 (95% CI, 0.35 - 0.82; Absolute difference: 25 fewer per 1000 (35 fewer to 10 fewer) As I said above there were not significant reductions in HHF or mortality with surgical AF ablation. The authors concluded: 'Catheter ablation reduced the risks for ischemic stroke at more than 30 days, mortality, and HF hospitalization. Surgical ablation had uncertain benefit, except for stroke.' A neutral reader could conclude that total stroke, mortality and HHF all trended lower for catheter ablation. I am quite surprised that the accompanying editorial for Beth Isreal Boston key opinion leaders was quite positive. I am not at all positive about this meta-analysis. And I am surprised by how many key opinion leaders in AF there were as sub-authors. I think the main, perhaps only, value of this meta-analysis is how it displays the weaknesses of meta-analyses and what should not be done. Before I mention the specifics of this analysis, it's a good time to do some basics of meta-analyses, which combine studies to, hopefully…ideally…come to a summed effect size. Meta-analyses in my mind can really shine when individual trials are underpowered because of low event rates. If 2 or 3 or 4 trials are similar, you can combine and increase the power. I think of NOAH and ARTESIA, the trials of DOAC in sub-clinical atrial fibrillation. Each had low stroke rates; each were similar and combining them increases power. Another example is the risk of AF with fish oil. Each trial of fish oil showed an elevated risk of AF. Why, I do not know, but together the signal of AF is stronger. Another area where meta-analyses may be helpful is finding a dose-response relationship, like in the fish oil and AF example: trials with the highest fish oil concentration had the highest risk. Another area of meta-analysis might be when individual trials show conflicting results. Here, if the trials are similar, you might sort out the direction and magnitude of effect. But inherent in deriving any benefit from meta-analyzing trials, you need the combined trials to enroll similar populations who have similar interventions, ideally, with similar outcomes. You want the included studies to be high in quality, and of the same clinical scenario. For instance, it's madness to combine ICD trials from the 2000s to now—as HF therapy has changed so much. This meta-analysis fails in nearly all of these facets. It's so weird that this many smart academics thought it a good idea. First problem…the endpoint is mind-boggling. You don't look at stroke before and after 30 days. You look at stroke overall. One group gets a procedure that could increase short term risk of stroke (manipulation of the left atrium) but might reduce stroke in the long-term, by decreasing AF. You only care about stroke—overall. The example in the left atrial appendage occlusion (LAAO) trials where the only positive result was excluding the week after the procedure. This is ridiculous, because no patient can exclude the time after a procedure. Second problem….the authors combined trials from 20 years ago to trials done now. This is almost equally ridiculous, because modern ablation is very different from the hocus pocus we did in 2004. Third problem…the vast majority of included studies had a handful of patients. Combining small studies is a recipe for overestimating effect size. Combining 10, 20, 30, or 40 single-center studies cannot come close to estimating effect size compared with a 2000-patient strong CABANA trial. It's foolish to combine tiny studies with massive studies. Fourth problem…the authors looked at outcomes that were not primary outcomes of the major trials. Without individual patient level data from each trial, who knows if the results are accurate. Fifth problem…the trials varied too much in trial conduct, endpoints, time of study, to combine them together. Heterogeneity is off the charts. In sum, this massive effort yields exactly zero new information. I mean no malice to the authors, but this was destined to fail. Meta-analyses have a role, but this is not it. Catheter ablation should be studied; we should have proper primary endpoints, such as stroke, death, and total (not heart failure) hospitalizations. If you want to study quality of life, there is only one way: you must have a placebo or sham control arm. Otherwise you fail as hard as the tricuspid valve interventionalists have failed. I think air embolism here is not likely related exclusively to the Watchman device; it sounds more like a physiologic phenomenon wherein patients on conscious sedation can take these huge breaths, which, if timed unfortunately during opening of the valve of the sheath could suck in air. We worry about this a lot during AF ablation, and sheath management is crucial. I always remove catheters from sheaths slowly. And I hate catheter exchanges. It's one of the negatives of pulsed field ablation (PFA) technology now, that we have to use a separate mapping catheter and PFA catheter. That will soon change. What Boston Scientific is recommending is basic procedural hygiene when in the LA. I wonder, though, whether this new warning has to do with the new system or is it just more doctors, many of whom are low-volume operators, doing more cases because of the device's popularity. I mean there have been tens of thousands of cases of LAAO since 2016, and now in 2025, we get an alert on specific catheters. If I were an implanter, I would be curious about this question. We've done this procedure for a long time, but now, with the new systems, we see a problem. Why? Are we sure about those valves? I am asking, I don't know. That said, FDA warnings are common with procedures. We learn things during the iterative process—for all procedures. For instance, we did not know about atrioesophageal fistula after AF ablation until tragedies occurred. Thermal ablation evolved to avoid heat stacking in the area of the esophagus. I am glad companies issue such warnings. Transparency is laudable. The larger lesson here is that procedures can cause harm. Their evidentiary basis should be as strong as a new drug. Often it is not. AF ablation has only one placebo controlled trial. Tricuspid interventions have zero, and you all know how I feel about LAAO procedures: Failure of the seminal Watchman trials to show non-inferiority to warfarin. And no compelling evidence for the device in patients not able to take oral anticoagulants. None. And it's been 9 years. But…But….when we intervene on patients with symptomatic AF, or symptomatic tricuspid regurgitation, or symptomatic myocardial infarction, we intervene on patients with an active problem. When we intervene on the LAA, we are doing prevention. We seek probabilistic benefit in the future. Prevention must always have a higher not lower bar of evidence. It doesn't with LAAO, and that is blemish on our profession. Journal of the American College of Cardiology has a nice paper on the issue of switching oral anticoagulants in older patients who have frailty. This comes up a lot. Anticoagulant- naive patients, at least in my neighborhood, get a direct oral anticoagulant (DOAC). I can hardly recall the last time I started warfarin de novo—in any patient with AF. We do this mostly for convenience, but also for efficacy and safety. The issue at hand is whether a patient on warfarin should be switched to DOAC. I reported in 2023 on the FRAIL-AF study, a Dutch study that randomized 1330 patients who were age ≥75 years, frail, and treated with a vitamin K antagonist (VKA) to either switch from VKA to a DOAC (rivaroxaban 54%, apixaban 19%, edoxaban 18%, or dabigatran 9%) or to continue VKA. The trial was stopped prematurely for futility as there was a significant increase in major or clinically relevant nonmajor (CRNM) bleeding, mainly gastrointestinal bleeding, in patients switched to DOAC (HR: 1.69; 95% CI: 1.23-2.32) This was provocative because it was surprising. You would not have thought bleeding would have gone so much higher when switching. Critical appraisal of FRAIL-AF included the very wide confidence intervals, and low number of events, made wider by the early termination of the trial for futility. The TIMI group, led by Dr Robert Gugliano, has formed a COMBINE-AF collaboration, which is patient-level meta-analysis of the four DOAC vs warfarin trials. RELY, ARISTOTLE, ROCKET and ENGAGE. That's a lot of data, and this is a much better use of meta-analyses than the first paper I discussed on AF ablation. This substudy of COMBINE-AF set out to replicate FRAIL-AF in a larger population of the four trials. It's a neat analysis. Here is what they did: They took patients who were on VKA, the so-called VKA experienced arm, when entering the trial, and elderly (older than 75 years old), and frail. For frailty, the investigators had to make a frailty scale based on a number of factors (which is different from the scale used in FRAIL-AF). Also note: VKA and warfarin are almost interchangeable. This group — warfarin-experienced, old, and frail — were then randomized in the trials to DOAC or warfarin. There were about 6000 of these FRAIL-AF like patients in the four trials. Split equally into DOAC or warfarin arms. The authors called these the test groups. They also looked at patients without these characteristics. These were either VKA naive, or non-elderly or non-frail. There were 52,000 of these, and the authors called these the non-test group. The main outcomes were stroke/systemic embolism, major bleeding, and mortality. They also looked at GI bleeding and ICH, but I think these are not as important as the big categories: stroke, bleeding, mortality. Here were the findings: In the FRAIL-AF like population, over 2.5 years: there was a 17% reduction in stroke and systemic embolism that did not reach statistical significance. Absolute risk reduction (ARR) was 0.4%, no difference in mortality and no difference in major bleeding. In the FRAIL-AF like population, randomization to DOAC vs warfarin was associated with an 83% increase in GI bleeding that was significant, and 1.5% absolute risk increase, but a 54% reduction in fatal bleeding, though the ARR was only 0.3%, of course because there were fewer events. When looking at net clinical outcome in the FRAIL-AF-like group the HR was right at 1.01. When compared to the non-FRAIL-AF population, the 52,000 patients who did not have one of the three criteria of VKA naive, elderly, or frail. These results were exactly similar to what you would expect and what was seen in the main trials: DOAC has statistically significant reductions in the risks of stroke and systemic embolism (SE) vs warfarin (HR, 0.81), death (HR, 0.91), and major bleeding (HR, 0.82). GI bleeding was increased with DOAC but it was only a 23% increase rather than the 83% increase. Net clinical outcome was statistically significant at HR 0.89 for DOACs. The authors did a special analysis based on type of DOAC in the FRAIL-AF like group. Recall that in FRAIL-AF, the main DOAC that patients on warfarin were switched to was rivaroxaban. In COMBINE-AF it was apixaban and edoxaban. When the authors simulated this in their data, they found that when using the 'same DOAC mix as FRAIL-AF (rivaroxaban 54%, apixaban 19%, edoxaban ,18% and dabigatran 9%) they found no statistical differences in stroke/SE but now a statistically significant increase in major bleeding HR 1.21 and even larger 2.2x increase in GI bleeding. But on the other hand, when they did an apixaban and edoxaban-only analysis in this FRAIL-AF group, they found similar stroke/SE rates but now a 17% significant reduction in major bleeding and only a 36% non-significant increase in GI bleeding. Like FRAIL-AF, switching from warfarin to DOAC had no sig effect on stroke or SE. Unlike FRAIL-AF, which had to be terminated early for bleeding, the COMBINE-AF FRAIL-AF-like group did not sustain higher rates of major bleeding when switching. GI bleeding was higher with the switch, but fatal bleeding was less. FRAIL-AF therefore does not replicate in this data set. The authors dispute the Euro guidelines which give a new Class IIb recommendation to maintain warfarin in elderly frail patients based on FRAIL-AF. They write (strongly, I would add): 'The findings from this study suggest that switching to a DOAC is a reasonable strategy for frail, elderly, and VKA-experienced patients, particularly for reducing the risk of stroke, systemic embolism, death, and the most severe bleeding events, such as intracranial and fatal bleeding.' First, I think it's worth thinking about why the results were divergent. One that the authors put a lot of weight on is the different frailty scores used in the two trials. COMBINE authors say their patients might have been frailer, or at least different enough to drive results. I am not sure this is true. To be in a global trial requires a degree of robustness. FRAIL-AF, however, included social isolation, inability to walk around in the home, and cognitive impairment, which were not available in the COMBINE-AF data set. Close your eyes and imagine an isolated Dutch patient vs a patient well enough to come in the office and be randomized in a global RCT. Another possibility is that DOAC mix is important. The subanalysis with apixaban and edoxaban looked a lot better for bleeding than did rivaroxaban heavy analysis. But I would be extremely suspect: this is a sub-analysis of a sub-analysis that is not adjusted for multiplicity. I think invoking specific mixes of DOAC is a stretch. The main reason for the difference, in my opinion, comes in Figure 4 of the supplement where the COMBINE authors provide the numbers of events along with Forest plots in the two studies For FRAIL-AF there were only 29 stroke events vs 201 in the COMBINE-AF study. For FRAIL-AF there were only 40 major bleeds vs 551 in COMBINE-AF. If you have access to the paper, take a look at the width of the error bars. It's remarkable. This is not a criticism of FRAIL-AF; the authors did a nice trial of a very special patient population and were looking for a reduction in bleeding. When they found the opposite —an increase — it made ethical sense to stop the trial early. Yet I think the lessons here from the two trials are that single trials with small numbers of events should be translated carefully. You could argue that the Euro guideline authors choice of a weak IIb recommendation for remaining on warfarin is careful. I was enthusiastic when FRAIL-AF came out because it was so darn provocative. I would not have predicted it. And I think it still is a great trial, but this analysis tells us that a) we should be cautious of small numbers of events, and b) as it so often is in clinical medicine, perhaps there is no exact right answer in these patients. So, how I see the clinical question given this new data is that, in sum, for elderly frail patients on warfarin, I don't think we are mandated to do any one specific thing. FRAIL-AF said don't switch when doing well on warfarin. COMBINE says that if you switch, outcomes are similar. There is not a major advantage or disadvantage. But if an elderly, frail patient wanted to switch, say for convenience, COMBINE results would argue that outcomes would be similar. Hence, switching should neither be proscribed nor recommended. It can be a shared decision with the patient and his or her family. Recall also that this is not about initial choice, which I think remains a DOAC. This is about patients on warfarin and considering switching.

LivaNova Reports Second-Quarter 2025 Results; Raises 2025 Guidance
LivaNova Reports Second-Quarter 2025 Results; Raises 2025 Guidance

Business Wire

time4 days ago

  • Business Wire

LivaNova Reports Second-Quarter 2025 Results; Raises 2025 Guidance

LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today reported results for the second quarter ended June 30, 2025 and raised full-year 2025 guidance. Financial Summary and Highlights (1) Second-quarter revenue of $352.5 million increased 10.7% on a reported basis, 9.3% on a constant-currency basis, and 10.3% on an organic basis as compared to the prior-year period Second-quarter U.S. GAAP diluted earnings per share of $0.50 and adjusted diluted earnings per share of $1.05 Second-quarter net cash provided by operating activities of $62.9 million and adjusted free cash flow of $47.8 million Raised full-year 2025 revenue growth range 200 basis points to 8.0% to 9.0% on a constant-currency basis and 9.0% to 10.0% on an organic basis. Raised full-year 2025 adjusted diluted earnings per share range by $0.10 at midpoint to $3.70 to $3.80. Raised full-year 2025 adjusted free cash flow range by $5 million at midpoint to $140 million to $160 million Initiated process with U.S. Centers for Medicare and Medicaid Services (CMS) for reconsideration of national Medicare coverage for VNS Therapy in unipolar patients with treatment-resistant depression, supported by five peer-reviewed publications from the RECOVER study Published the fifth critical RECOVER paper in the Journal of Clinical Psychiatry, showing that patients previously treated with electroconvulsive therapy or transcranial magnetic stimulation experienced significant clinical benefits from VNS Therapy Published 24-month data from the CORE-VNS study, which showed adjunctive VNS Therapy is associated with substantial reductions in generalized tonic-clonic seizures in people with drug-resistant epilepsy (DRE) Completed 36-month data analysis of the CORE-VNS study, demonstrating early and lasting outcomes of adjunctive VNS Therapy on severe focal seizures in both children and adults with DRE and further validating the effectiveness of adjunctive VNS Therapy Announcing CMS recently proposed to move DRE end-of-service procedures beginning in 2026 from Level 4 into a Level 5 Ambulatory Payment Classification under the 2026 Medicare Hospital Outpatient Prospective Payment System _________________________________________ (1) Constant-currency percent change, organic revenue percent change, adjusted diluted earnings per share, and adjusted free cash flow are non-GAAP measures. Constant-currency percent change excludes the impact from fluctuations in the various currencies in which the Company operates as compared to reported percent change. Organic revenue percent change excludes the impact of acquisitions, divestitures, and currency translation effects. For an explanation of these and other non-GAAP measures used in this news release, see the section entitled "Use of Non-GAAP Financial Measures." For reconciliations of certain non-GAAP measures, see the tables that accompany this news release. As discussed in the section entitled "Use of Non-GAAP Financial Measures" below, the Company is unable to predict with a reasonable degree of certainty the type and extent of certain items that would be expected to impact GAAP measures but would not impact the non-GAAP measures. Accordingly, the Company is unable to reconcile the forward-looking non-GAAP financial measures included in this paragraph to their most directly comparable forward-looking GAAP financial measures without unreasonable efforts. Expand 'LivaNova delivered another quarter of strong revenue growth, driven by continued momentum in our Cardiopulmonary business and solid Neuromodulation performance across all regions,' said Vladimir Makatsaria, Chief Executive Officer of LivaNova. 'Our disciplined execution contributed to meaningful operating margin expansion and strong cash generation in the second quarter. We're building on this strong foundation by investing behind our core businesses to sustain our market leadership and clinical excellence. Our recent key milestone achievements in obstructive sleep apnea and difficult-to-treat depression support our strategy of leveraging our leading Neuromodulation capabilities into attractive high-growth markets, while delivering life-changing therapies to large patient populations with significant unmet needs.' Second-Quarter 2025 Results The following table summarizes revenue by segment (in millions): (1) 'Other Revenue' includes rental and site services income not allocated to segments. In addition, for 2024, 'Other Revenue' includes revenue from the Company's former ACS reportable segment. (2) Includes the results from the wind-down portion of the Company's former ACS reportable segment. • Numbers may not add precisely due to rounding. Expand Second-quarter 2025 Cardiopulmonary revenue increased 14.7% on a reported basis and 12.7% on a constant-currency basis versus the second quarter of 2024 with growth across all regions, driven by strong consumables demand and Essenz™ Perfusion System sales. Second-quarter 2025 Neuromodulation revenue increased 6.2% on a reported basis and 5.6% on a constant-currency basis versus the second quarter of 2024 with growth across all regions. Earnings Analysis On a U.S. GAAP basis, second-quarter 2025 operating income was $54.2 million, as compared to operating income of $40.2 million for the second quarter of 2024. Adjusted operating income for the second quarter of 2025 was $77.4 million, as compared to adjusted operating income of $66.9 million for the second quarter of 2024. On a U.S. GAAP basis, second-quarter 2025 diluted earnings per share was $0.50 as compared to diluted earnings per share of $0.30 in the second quarter of 2024. Second-quarter 2025 adjusted diluted earnings per share was $1.05, as compared to adjusted diluted earnings per share of $0.93 in the second quarter of 2024. Full-Year 2025 Guidance LivaNova now expects full-year 2025 revenue to grow between 8.0% and 9.0% (versus 6.0% and 7.0% prior) on a constant-currency basis and between 9.0% and 10.0% (versus 7.0% and 8.0% prior) on an organic basis. Foreign currency is now expected to be a tailwind of approximately 1.0% (versus a headwind of 0.0% to 1.0% prior) based on current exchange rates. Adjusted diluted earnings per share for 2025 is now expected to be in the range of $3.70 to $3.80 (versus $3.60 to $3.70 prior), assuming a share count of approximately 55 million for full-year 2025. In 2025, the Company now estimates adjusted free cash flow in the range of $140 million to $160 million (versus $135 million to $155 million prior). As discussed in the section entitled 'Use of Non-GAAP Financial Measures' below, the Company is unable to predict with a reasonable degree of certainty the type and extent of certain items that would be expected to impact GAAP measures but would not impact the non-GAAP measures. Accordingly, the Company is unable to reconcile the forward-looking non-GAAP financial measures included in this section to their most directly comparable forward-looking GAAP financial measures without unreasonable efforts. Webcast and Conference Call Instructions The Company will host a live audiocast at 1 p.m. London time (8 a.m. Eastern Time) on Wed., Aug. 6, 2025 that will be accessible at Listeners should register in advance and log on approximately 10 minutes early to ensure proper setup. To listen to the conference call by telephone, dial +1 833 470 1428 (if dialing from within the U.S.) or +1 929 526 1599 (if dialing from outside the U.S.). The conference call access code is 460430. Within 24 hours of the audiocast, a replay will be available at where it will be archived and accessible for approximately 90 days. About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit Use of Non-GAAP Financial Measures To supplement financial measures presented in accordance with generally accepted accounting principles in the United States (U.S. GAAP or GAAP), management has disclosed certain additional measures not presented in accordance with GAAP known as 'non-GAAP financial measures' or 'adjusted financial measures.' Company management uses these non-GAAP measures to monitor the Company's operational performance and for benchmarking against other medical technology companies. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. These non-GAAP financial measures should be considered along with, but not as alternatives to, operational performance measures as prescribed by GAAP. In this news release, the Company refers to revenue and percentage change in revenue on a comparable, constant-currency, and organic basis. Company management believes that these non-GAAP measures provide a useful way to evaluate the revenue performance of LivaNova and to compare the revenue performance of current periods to prior periods on a consistent basis. Constant-currency percent change measures the change in revenue between current and prior-year periods using average exchange rates in effect during the applicable prior-year period. Organic revenue percent change excludes the impact of acquisitions, divestitures, and currency translation effects. LivaNova calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For example, forward-looking net revenue growth projections are estimated on a constant-currency basis and exclude the impact of foreign currency fluctuations. Forward-looking non-GAAP adjusted diluted earnings per share guidance excludes items such as, but not limited to, changes in fair value of derivatives and contingent consideration arrangements and asset impairment charges that would be included in comparable GAAP financial measures. The most directly comparable GAAP measure for adjusted free cash flow is net cash provided by operating activities. Adjusted free cash flow is defined as net cash provided by operating activities less cash used for the purchase of property, plant, and equipment excluding the impact of 3T litigation settlement payments, cybersecurity incident insurance proceeds, SNIA environmental liability and related financing costs, and gains related to dividends received from investments and further adjusted as needed for other charges, expenses or gains that may not be indicative of the Company's operational performance. However, non-GAAP financial adjustments on a forward-looking basis are subject to uncertainty and variability as they are dependent on many factors, including but not limited to, the effect of foreign currency exchange fluctuations, impacts from potential acquisitions or divestitures, the ultimate outcome of legal proceedings, gains or losses on the potential sale of businesses or other assets, restructuring costs, merger and integration activities, changes in fair value of derivatives, and contingent consideration arrangements, asset impairment charges and the tax impact of the aforementioned items, tax law changes, or other tax matters. Accordingly, the Company does not reconcile non-GAAP financial measures on a forward-looking basis as it is impractical to do so without unreasonable effort. Adjusted financial measures such as organic revenue, adjusted cost of sales, adjusted gross profit, adjusted selling, general, and administrative expense, adjusted research and development expense, adjusted other operating expenses, adjusted operating income, adjusted income before tax, adjusted income tax expense, adjusted net income, and adjusted diluted earnings per share are measures that LivaNova generally uses to facilitate management review of the operational performance of the company, to serve as a basis for strategic planning, and in the design of incentive compensation plans. Additionally, the Company uses the non-GAAP liquidity measure adjusted free cash flow. The Company believes that the presentation of these adjusted financial measures allows investors to evaluate the Company's operational performance for different periods on a more comparable and consistent basis, and with other medical technology companies by adjusting for items that are not related to the operational performance of the Company or incurred in the ordinary course of business. Safe Harbor Statement Certain statements in this news release, other than statements of historical or current fact, are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act. These statements include, but are not limited to, LivaNova's plans, objectives, strategies, financial performance and outlook, trends, the amount and timing of future cash distributions, prospects or future events, and involve known and unknown risks that are difficult to predict. As a result, the Company's actual financial results, performance, achievements, or prospects may differ materially from those expressed or implied by these forward-looking statements. Generally, forward-looking statements can be identified by the use of words such as 'may,' 'could,' 'seek,' 'guidance,' 'predict,' 'potential,' 'likely,' 'believe,' 'will,' 'should,' 'expect,' 'anticipate,' 'estimate,' 'plan,' 'intend,' 'forecast,' 'foresee,' or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based on estimates and assumptions that, while considered reasonable by LivaNova and its management based on their knowledge and understanding of the business and industry, are inherently uncertain. These statements are not guarantees of future performance, and stockholders should not place undue reliance on forward-looking statements. There are a number of risks, uncertainties, and other important factors, many of which are beyond the Company's control, that could cause the Company's actual results to differ materially from the forward-looking statements contained in this news release, and include, but are not limited to, the following risks and uncertainties: volatility in the global market and worldwide economic conditions, including as caused by the invasion of Ukraine, the evolving instability in the Middle East, inflation, changing interest rates, foreign exchange fluctuations, and changes to existing trade agreements and relationships between the U.S. and other countries, including the implementation of tariffs, trade restrictions, and sanctions; adverse changes in export and import costs and other trade restrictions as well as uncertainty over global tariffs; risks relating to supply chain pressures; cybersecurity incidents or other disruptions to the Company's information technology systems or those of third parties with which the Company interacts; costs of complying with privacy and security of personal information requirements and laws; changes in technology, including the development of superior or alternative technology or devices by competitors and/or competition from providers of alternative medical therapies; failure of R&D investments or investment collaborations to be successful; failure to maintain appropriate working relationships with healthcare professionals to aid in the continuing development of products; the risk of quality issues and the impacts thereof; risks relating to recalls, replacement of inventory, enforcement actions, or product liability claims; failure to comply with, or changes in, laws, regulations, or administrative practices affecting government regulation of the Company's products; failure to retain key personnel, succession plan, and negotiate with local works councils; failure to obtain approvals or reimbursement in relation to the Company's products; unfavorable results from clinical studies or failure to meet milestones; pending or existing climate change; global healthcare policy changes that may lead to restricted access and pricing as well as payback requirements and limited reimbursement; changes or reduction in reimbursement for the Company's products or failure to comply with rules relating to reimbursement of healthcare goods and services; failure to comply with rules relating to healthcare goods and services as well as anti-bribery laws; product liability, intellectual property, shareholder-related, environmental-related, income tax, and other litigation, disputes, losses, and costs, including in the case of the Company's 3T Heater-Cooler litigation; risks associated with environmental laws and regulations as well as environmental liabilities, violations, and litigation, including in the case of Saluggia and SNIA; failure to protect the Company's proprietary intellectual property; risks relating to the Company's indebtedness; failure of divestitures and/or new acquisitions to further the Company's strategic objectives or strengthen the Company's existing businesses; the potential for impairments of intangible assets, goodwill, and other long-lived assets; changes in tax laws and regulations, including exposure to additional income tax liabilities; effectiveness of the Company's internal controls over financial reporting; changes in the Company's profitability and/or failure to manage costs and expenses; fluctuations in future quarterly operating results and/or variations in revenue and operating expenses relative to estimates; and other unknown or unpredictable factors that could harm the Company's financial performance. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company's business, including those described in the 'Risk Factors' section of the Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the U.S. Securities and Exchange Commission by LivaNova. Readers are cautioned not to place undue reliance on the Company's forward-looking statements, which speak only as of the date of this news release. The Company undertakes no obligation to update publicly any of the forward-looking statements in this news release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If LivaNova updates one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect to those or other forward-looking statements. VNS Therapy and Essenz are trademarks of LivaNova USA, Inc. (1) 'Europe' includes the UK, Germany, France, Italy, the Netherlands, Spain, Belgium, Poland, Sweden, Switzerland, Austria, Norway, Portugal, Finland, and Denmark. Excluding Europe and the U.S., 'Rest of World' includes all other countries where LivaNova operates. (2) 'Other Revenue' includes rental and site services income not allocated to segments. In addition, for 2024, 'Other Revenue' includes revenue from the Company's former ACS reportable segment. • Numbers may not add precisely due to rounding. Expand (1) 'Europe' includes the UK, Germany, France, Italy, the Netherlands, Spain, Belgium, Poland, Sweden, Switzerland, Austria, Norway, Portugal, Finland, and Denmark. Excluding Europe and the U.S., 'Rest of World' includes all other countries where LivaNova operates. (2) 'Other Revenue' includes rental and site services income not allocated to segments. In addition, for 2024, 'Other Revenue' includes revenue from the Company's former ACS reportable segment. • Numbers may not add precisely due to rounding. Expand LIVANOVA PLC AND SUBSIDIARIES (U.S. dollars in millions, except per share amounts) Three Months Ended June 30, 2025 2024 (1) Net revenue $352.5 $318.6 Cost of sales 113.5 103.7 Gross profit 239.0 214.9 Operating expenses: Selling, general, and administrative 137.8 125.1 Research and development 47.2 44.7 Other operating expense (0.2 ) 4.8 Operating income 54.2 40.2 SNIA environmental liability expense (1.7 ) — Interest expense (12.3 ) (15.5 ) Loss on debt extinguishment (2.7 ) — Foreign exchange and other income/(expense) (4.3 ) (3.0 ) Income before tax 33.3 21.6 Income tax expense 6.2 5.2 Net income $27.2 $16.3 Basic income per share $0.50 $0.30 Diluted income per share $0.50 $0.30 Weighted average common shares outstanding: Basic 54.6 54.2 Diluted 54.7 54.6 • Numbers may not add precisely due to rounding. Expand (1) Cost of sales, gross profit, selling, general, and administrative expense, and the related financial measures included in this news release for the three months ended June 30, 2024, have been revised. For additional information, please refer to the supplemental unaudited revised financial information and non-GAAP measures table within this news release. Expand Adjusted Financial Measures (U.S. dollars in millions, except per share amounts) - Unaudited Three Months Ended June 30, 2025 2024 Adjusted SG&A $121.4 $108.7 Adjusted R&D 44.0 41.3 Adjusted operating income 77.4 66.9 Adjusted net income 57.4 50.8 Adjusted diluted earnings per share $1.05 $0.93 Expand Statistics (as a % of net revenue, except for income tax rate) - Unaudited GAAP Three Months Ended June 30, Adjusted Three Months Ended June 30, 2025 2024 2025 2024 Gross profit 67.8 % 67.4 % 68.9 % 68.1 % SG&A 39.1 % 39.3 % 34.4 % 34.1 % R&D 13.4 % 14.0 % 12.5 % 12.9 % Operating income 15.4 % 12.6 % 21.9 % 21.0 % Net income 7.7 % 5.1 % 16.3 % 15.9 % Income tax rate 18.5 % 24.2 % 22.0 % 20.8 % Expand LIVANOVA PLC AND SUBSIDIARIES (U.S. dollars in millions, except per share amounts) Six Months Ended June 30, 2025 2024 (1) Net revenue $669.4 $613.5 Cost of sales 214.1 195.4 Gross profit 455.2 418.1 Operating expenses: Selling, general, and administrative 266.9 250.8 Research and development 85.1 90.4 Other operating expense 0.5 20.5 Operating income 102.8 56.4 SNIA environmental liability expense (362.1 ) — Interest expense (27.6 ) (31.4 ) Loss on debt extinguishment (2.7 ) (25.5 ) Foreign exchange and other income/(expense) 7.2 (12.1 ) Loss before tax (282.3 ) (12.6 ) Income tax expense 17.8 12.9 Loss from equity method investments — (0.1 ) Net loss ($300.2 ) ($25.6 ) Basic loss per share ($5.51 ) ($0.47 ) Diluted loss per share ($5.51 ) ($0.47 ) Weighted average common shares outstanding: Basic 54.5 54.2 Diluted 54.5 54.2 • Numbers may not add precisely due to rounding. Expand (1) Cost of sales, gross profit, selling, general, and administrative expense, and the related financial measures included in this news release for the six months ended June 30, 2024, have been revised. For additional information, please refer to the supplemental unaudited revised financial information and non-GAAP measures table within this news release. Expand Adjusted Financial Measures (U.S. dollars in millions, except per share amounts) - Unaudited Six Months Ended June 30, 2025 2024 Adjusted SG&A $237.1 $217.8 Adjusted R&D 82.2 84.1 Adjusted operating income 141.9 120.0 Adjusted net income 105.5 90.8 Adjusted diluted earnings per share $1.93 $1.66 Expand RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES - UNAUDITED (U.S. dollars in millions, except per share amounts) Specified Items Cost of sales $113.5 $— ($1.7 ) $— ($1.6 ) $— ($0.6 ) $— $— $109.7 Gross profit percent 67.8 % — % 0.5 % — % 0.4 % — % 0.2 % — % — % 68.9 % Selling, general, and administrative 137.8 — (2.6 ) — — (6.7 ) (7.1 ) — — 121.4 Selling, general, and administrative as a percent of net revenue 39.1 % — % (0.7 )% — % — % (1.9 )% (2.0 )% — % — % 34.4 % Research and development 47.2 — — — (1.2 ) (0.4 ) (1.6 ) — — 44.0 Research and development as a percent of net revenue 13.4 % — % — % — % (0.3 )% (0.1 )% (0.4 )% — % — % 12.5 % Other operating expense (0.2 ) 0.1 — — — 0.1 — — — — Operating income 54.2 (0.1 ) 4.2 — 2.8 7.1 9.2 — — 77.4 Operating margin percent 15.4 % — % 1.2 % — % 0.8 % 2.0 % 2.6 % — % — % 21.9 % Net income 27.2 (0.1 ) 4.2 9.6 2.8 8.8 9.2 (10.0 ) 5.7 57.4 Net income as a percent of net revenue 7.7 % — % 1.2 % 2.7 % 0.8 % 2.5 % 2.6 % (2.8 )% 1.6 % 16.3 % Diluted EPS $0.50 $— $0.08 $0.18 $0.05 $0.16 $0.17 ($0.18 ) $0.10 $1.05 Expand GAAP results for the three months ended June 30, 2025 include: (1) Restructuring expenses related to organizational changes (2) Depreciation and amortization associated with purchase price accounting (3) Mark-to-market adjustments for the 2025 and 2029 Notes embedded and capped call derivatives and loss on debt extinguishment (4) Remeasurement of contingent consideration related to the ImThera acquisition (5) Legal expenses primarily related to 3T Heater-Cooler defense, cybersecurity incident costs, 3T Heater-Cooler litigation provision, SNIA environmental liability, and Medical Device Regulation ("MDR") costs (6) Non-cash expenses associated with stock-based compensation costs (7) The impact of valuation allowances, discrete tax items, the tax impact of intercompany transactions, and the tax impact on non-GAAP adjustments (8) Non-cash interest expense • Numbers may not add precisely due to rounding. Expand RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES - UNAUDITED (U.S. dollars in millions, except per share amounts) Specified Items Cost of sales $103.7 $— ($1.7 ) $— $— ($0.1 ) $— ($0.1 ) $— $— $101.8 Gross profit percent 67.4 % — % 0.5 % — % — % — % — % — % — % — % 68.1 % Selling, general, and administrative 125.1 — (2.6 ) — — — (7.7 ) (6.1 ) — — 108.7 Selling, general, and administrative as a percent of net revenue 39.3 % — % (0.8 )% — % — % — % (2.4 )% (1.9 )% — % — % 34.1 % Research and development 44.7 — — — — (0.3 ) (1.3 ) (2.0 ) — — 41.3 Research and development as a percent of net revenue 14.0 % — % — % — % — % (0.1 )% (0.4 )% (0.6 )% — % — % 12.9 % Other operating expense 4.8 (2.1 ) — — — — (2.7 ) — — — — Operating income 40.2 2.1 4.3 — — 0.4 11.7 8.2 — — 66.9 Operating margin percent 12.6 % 0.7 % 1.3 % — % — % 0.1 % 3.7 % 2.6 % — % — % 21.0 % Net income 16.3 2.1 4.3 5.8 2.6 0.4 11.7 8.2 (8.1 ) 7.6 50.8 Net income as a percent of net revenue 5.1 % 0.7 % 1.3 % 1.8 % 0.8 % 0.1 % 3.7 % 2.6 % (2.5 )% 2.4 % 15.9 % Diluted EPS $0.30 $0.04 $0.08 $0.11 $0.05 $0.01 $0.21 $0.15 ($0.15 ) $0.14 $0.93 Expand GAAP results for the three months ended June 30, 2024 include: (1) Restructuring expenses related to organizational changes (2) Depreciation and amortization associated with purchase price accounting (3) Impairment of investment in ShiraTronics, Inc. (4) Mark-to-market adjustments for the 2025 and 2029 Notes embedded and capped call derivatives (5) Remeasurement of contingent consideration related to ImThera acquisition (6) 3T Heater-Cooler litigation provision, legal expenses primarily related to 3T Heater-Cooler defense, cybersecurity incident costs, and MDR costs (7) Non-cash expenses associated with stock-based compensation costs (8) The impact of valuation allowances, discrete tax items, the tax impact of intercompany transactions, and the tax impact on non-GAAP adjustments (9) Interest expense on the Term Facilities, non-cash interest expense on the 2025 & 2029 Notes and Revolving Credit Facility, and interest income on the collateral for the SNIA litigation guarantee and delayed draw on Term Facilities • Numbers may not add precisely due to rounding. Expand (U.S. dollars in millions, except per share amounts) Specified Items Cost of sales $214.1 $— ($3.4 ) $— ($1.8 ) $— ($0.7 ) $— $— $208.2 Gross profit percent 68.0 % — % 0.5 % — % 0.3 % — % 0.1 % — % — % 68.9 % Selling, general, and administrative 266.9 — (5.0 ) — — (11.3 ) (13.5 ) — — 237.1 Selling, general, and administrative as a percent of net revenue 39.9 % — % (0.8 )% — % — % (1.7 )% (2.0 )% — % — % 35.4 % Research and development 85.1 — 0.1 — (1.9 ) 1.6 (2.7 ) — — 82.2 Research and development as a percent of net revenue 12.7 % — % — % — % (0.3 )% 0.2 % (0.4 )% — % — % 12.3 % Other operating expense 0.5 0.2 — — — (0.6 ) — — — — Operating income 102.8 (0.2 ) 8.3 — 3.7 10.3 17.0 — — 141.9 Operating margin percent 15.4 % — % 1.2 % — % 0.6 % 1.5 % 2.5 % — % — % 21.2 % Net (loss) income (300.2 ) (0.2 ) 8.3 4.0 3.7 372.4 17.0 (13.7 ) 14.2 105.5 Net (loss) income as a percent of net revenue (44.8 )% — % 1.2 % 0.6 % 0.6 % 55.6 % 2.5 % (2.0 )% 2.1 % 15.8 % Diluted EPS ($5.51 ) $— $0.15 $0.07 $0.07 $6.81 $0.31 ($0.25 ) $0.26 $1.93 Expand GAAP results for the six months ended June 30, 2025 include: (1) (2) Depreciation and amortization associated with purchase price accounting (3) Mark-to-market adjustments for the 2025 & 2029 Notes embedded and capped call derivatives and loss on debt extinguishment (4) Remeasurement of contingent consideration related to the ImThera acquisition (5) SNIA environmental liability, legal expenses primarily related to 3T Heater-Cooler defense, 3T Heater-Cooler litigation provision, cybersecurity incident costs net of insurance reimbursement, MDR costs, and R&D tax incentive (6) Non-cash expenses associated with stock-based compensation costs (7) The impact of valuation allowances, discrete tax items, the tax impact of intercompany transactions, and the tax impact on non-GAAP adjustments (8) Interest expense on the Term Facilities, non-cash interest expense on the 2025 & 2029 Notes and Revolving Credit Facility, and interest income on the collateral for the SNIA litigation guarantee and delayed draw on Term Facilities • Numbers may not add precisely due to rounding. Expand Specified Items Cost of sales $195.4 $— ($3.4 ) $— $— $0.1 $— ($0.5 ) $— $— $191.6 Gross profit percent 68.1 % — % 0.6 % — % — % — % — % 0.1 % — % — % 68.8 % Selling, general, and administrative 250.8 — (5.3 ) — — — (13.8 ) (13.9 ) — — 217.8 Selling, general, and administrative as a percent of net revenue 40.9 % — % (0.9 )% — % — % — % (2.3 )% (2.3 )% — % — % 35.5 % Research and development 90.4 — 0.1 — — (0.4 ) (2.0 ) (4.0 ) — — 84.1 Research and development as a percent of net revenue 14.7 % — % — % — % — % (0.1 )% (0.3 )% (0.6 )% — % — % 13.7 % Other operating expense 20.5 (11.4 ) — — — — (9.1 ) — — — — Operating income 56.4 11.4 8.6 — — 0.3 24.9 18.4 — — 120.0 Operating margin percent 9.2 % 1.9 % 1.4 % — % — % — % 4.1 % 3.0 % — % — % 19.6 % Net (loss) income (25.6 ) 11.4 8.6 5.8 42.8 0.3 24.9 18.4 (10.9 ) 15.1 90.8 Net (loss) income as a percent of net revenue (4.2 )% 1.9 % 1.4 % 0.9 % 7.0 % — % 4.1 % 3.0 % (1.8 )% 2.5 % 14.8 % Diluted EPS ($0.47 ) $0.21 $0.16 $0.11 $0.78 $— $0.46 $0.34 ($0.20 ) $0.28 $1.66 Expand GAAP results for the six months ended June 30, 2024 include: (1) (2) Depreciation and amortization associated with purchase price accounting (3) Impairment of investment in ShiraTronics, Inc. (4) Mark-to-market adjustments for the 2025 & 2029 Notes embedded and capped call derivatives and loss on debt extinguishment (5) Remeasurement of contingent consideration related to ImThera acquisition (6) 3T Heater-Cooler litigation provision, legal expenses primarily related to 3T Heater-Cooler defense, cybersecurity incident costs, MDR costs, and costs related to the SNIA matter (7) Non-cash expenses associated with stock-based compensation costs (8) The impact of valuation allowances, discrete tax items, the tax impact of intercompany transactions, and the tax impact on non-GAAP adjustments (9) Interest expense on the Term Facilities, non-cash interest expense on the 2025 and 2029 Notes and Revolving Credit Facility, and interest income on the collateral for the SNIA litigation guarantee and delayed draw on Term Facilities • Numbers may not add precisely due to rounding. Expand LIVANOVA PLC AND SUBSIDIARIES (U.S. dollars in millions) December 31, 2024 ASSETS Current Assets: Cash and cash equivalents $593.6 $428.9 Restricted cash — 294.7 Accounts receivable, net of allowance 220.2 193.2 Inventories 165.4 147.6 Prepaid and refundable taxes 32.8 30.5 Prepaid expenses and other current assets 54.2 32.4 Total Current Assets 1,066.1 1,127.2 Property, plant, and equipment, net 195.4 170.3 Goodwill 793.4 750.0 Intangible assets, net 239.1 237.3 Operating lease assets 50.7 46.8 Investments 16.2 25.1 Deferred tax assets 109.8 111.9 Long-term derivative assets 21.7 23.7 Other assets 14.3 14.1 Total Assets $2,506.7 $2,506.4 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Current debt obligations $82.1 $78.0 Accounts payable 86.9 69.7 Accrued liabilities and other 103.2 118.5 SNIA environmental liability 392.3 — Current contingent consideration 48.3 — Current litigation provision liability 12.2 12.9 Taxes payable 34.5 32.5 Accrued employee compensation and related benefits 67.6 80.5 Total Current Liabilities 827.1 392.1 Long-term debt obligations 348.5 549.6 Long-term contingent consideration 39.7 84.2 Deferred tax liabilities 11.4 10.9 Long-term operating lease liabilities 42.8 40.1 Long-term employee compensation and related benefits 13.7 12.8 Long-term derivative liabilities 48.1 51.8 Other long-term liabilities 52.7 44.5 Total Liabilities 1,383.9 1,186.1 Total Stockholders' Equity 1,122.8 1,320.3 Total Liabilities and Stockholders' Equity $2,506.7 $2,506.4 Expand • Numbers may not add precisely due to rounding. Expand LIVANOVA PLC AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - UNAUDITED (U.S. dollars in millions) Six Months Ended June 30, 2025 2024 Operating Activities: Net loss ($300.2 ) ($25.6 ) Adjustments to reconcile net loss to net cash provided by operating activities: Remeasurement of derivative instruments (27.3 ) 12.5 Stock-based compensation 17.0 18.4 Depreciation 13.3 12.4 Amortization of debt issuance costs 11.4 10.2 Amortization of intangible assets 8.7 8.6 Amortization of operating lease assets 7.8 4.4 Remeasurement of contingent consideration to fair value 3.7 0.3 Loss on investment revaluation - Ceribell, Inc. 3.6 — Deferred income tax expense 2.8 5.6 Loss on debt extinguishment 2.7 25.5 Impairment of investment in ShiraTronics, Inc. — 5.8 Other 1.0 0.7 Changes in operating assets and liabilities: Accounts receivable, net (13.7 ) 8.4 Inventories (6.0 ) (10.9 ) Other current and non-current assets 35.5 (3.4 ) Accounts payable and accrued current and non-current liabilities (33.2 ) (25.4 ) Taxes payable (0.9 ) 0.8 SNIA environmental liability 362.1 — Litigation provision liability (1.3 ) 5.1 Net cash provided by operating activities 86.9 53.3 Investing Activities: Purchases of property, plant, and equipment (25.9 ) (18.6 ) Proceeds from investments 6.5 — Other (0.2 ) (0.4 ) Net cash used in investing activities (19.6 ) (18.9 ) Financing Activities: Repayment of long-term debt obligations (210.3 ) (238.8 ) Shares repurchased from employees for minimum tax withholding (3.9 ) (8.1 ) Proceeds from long-term debt obligations — 335.5 Payment of debt extinguishment costs — (39.0 ) Purchase of capped calls — (31.6 ) Proceeds from unwind of capped calls — 22.5 Payment of contingent consideration — (13.8 ) Payment of debt issuance costs — (5.7 ) Proceeds from exercise of stock options — 3.7 Other 0.7 0.5 Net cash (used in) provided by financing activities (213.4 ) 25.3 Effect of exchange rate changes on cash, cash equivalents, and restricted cash 16.2 (4.4 ) Net (decrease) increase in cash, cash equivalents, and restricted cash (129.9 ) 55.2 Cash, cash equivalents, and restricted cash at beginning of period 723.6 577.9 Cash, cash equivalents, and restricted cash at end of period $593.6 $633.1 Expand • Numbers may not add precisely due to rounding. Expand RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES - UNAUDITED (U.S. dollars in millions) Three Months Ended June 30, 2025 2024 GAAP Financial Measures Certain Tax Adjustments Adjusted Financial Measures GAAP Financial Measures Certain Tax Adjustments Adjusted Financial Measures Income before tax $33.3 $— $73.5 $21.6 $— $64.1 Income tax expense 6.2 10.0 16.1 5.2 8.1 13.3 Net income $27.2 ($10.0 ) $57.4 $16.3 ($8.1 ) $50.8 Income tax rate 18.5 % 22.0 % 24.2 % 20.8 % Expand Six Months Ended June 30, 2025 2024 GAAP Financial Measures Certain Tax Adjustments Adjusted Financial Measures GAAP Financial Measures Certain Tax Adjustments Adjusted Financial Measures (Loss) income before tax ($282.3 ) $— $137.0 ($12.6 ) $— $114.7 Income tax expense 17.8 13.7 31.5 12.9 10.9 23.9 Loss from equity method investments — — — (0.1 ) — (0.1 ) Net (loss) income ($300.2 ) ($13.7 ) $105.5 ($25.6 ) ($10.9 ) $90.8 Income tax rate (6.3 )% 23.0 % (102.6 )% 20.8 % Expand • Numbers may not add precisely due to rounding. Expand RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES - UNAUDITED (U.S. dollars in millions) Three Months Ended June 30, % Change Constant-Currency % Change 2025 2024 GAAP net revenue $352.5 $318.6 10.7 % 9.3 % Less: ACS (1) — 3.0 (100.0 )% (100.0 )% Organic net revenue $352.5 $315.6 N/A 10.3 % Expand Six Months Ended June 30, % Change Constant-Currency % Change 2025 2024 GAAP net revenue $669.4 $613.5 9.1 % 9.1 % Less: ACS (1) — 7.1 (100.0 )% (100.0 )% Organic net revenue $669.4 $606.4 N/A 10.4 % Expand (1) Includes net revenue from the Company's former ACS reportable segment. • Numbers may not add precisely due to rounding. Expand RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES - UNAUDITED (U.S. dollars in millions) Three Months Ended June 30, 2025 Net cash provided by operating activities $62.9 Less: Purchases of plant, property, and equipment (15.1 ) Less: Cybersecurity incident insurance proceeds (1.0 ) Less: Dividends received from investments (0.4 ) Add: 3T Heater-Cooler litigation payments 1.5 Adjusted free cash flow $47.8 Expand • Numbers may not add precisely due to rounding. Expand The following table presents the reconciliation of GAAP diluted weighted average shares outstanding, used in the computation of GAAP diluted net loss per common share, to adjusted diluted weighted average shares outstanding, used in the computation of adjusted diluted earnings per common share (in millions of shares): • Numbers may not add precisely due to rounding. Expand During the second quarter of 2025, the Company identified and corrected an immaterial error related to the classification of certain employee costs in the Cardiopulmonary segment between cost of sales and selling, general, and administrative expense in the consolidated statements of income (loss). This misclassification understated cost of sales and overstated selling, general, and administrative expense by equal and offsetting amounts, with no impact to operating income (loss) or net income (loss) for annual and interim periods for the years ended December 31, 2023 and 2024 and the three months ended March 31, 2025. The table below shows the as-reported amounts compared to the revised results with respect to the impacted metrics for the periods presented. SUPPLEMENTAL UNAUDITED REVISED FINANCIAL INFORMATION AND NON-GAAP MEASURES (U.S. dollars in millions, except statistics amounts) Three Months Ended Twelve Months Ended Three Months Ended March 31, 2024 June 30, 2024 September 30, 2024 December 31, 2024 December 31, 2024 March 31, 2025 GAAP Cost of sales $87.5 $91.7 $99.7 $103.7 $92.9 $97.1 $102.5 $107.5 $382.6 $400.0 $96.1 $100.6 Gross profit 207.4 203.2 218.9 214.9 225.3 221.0 219.4 214.4 870.9 $853.5 220.8 216.3 Selling, general, and administrative 129.9 125.7 129.1 125.1 131.7 127.4 135.6 130.6 526.3 $508.9 133.7 129.1 Statistics (as a percent of net revenue): Gross profit 70.3 % 68.9 % 68.7 % 67.4 % 70.8 % 69.5 % 68.2 % 66.6 % 69.5 % 68.1 % 69.7 % 68.3 % Selling, general, and administrative 44.0 % 42.6 % 40.5 % 39.3 % 41.4 % 40.1 % 42.1 % 40.6 % 42.0 % 40.6 % 42.2 % 40.8 % Non-GAAP Cost of sales $85.6 $89.8 $97.8 $101.8 $91.7 $95.9 $98.9 $103.9 $374.0 $391.4 $94.0 $98.5 Gross profit 209.3 205.1 220.8 216.8 226.5 222.2 222.9 217.9 879.5 $862.1 222.9 218.4 Selling, general, and administrative 113.3 109.1 112.7 108.7 116.1 111.9 127.0 122.0 469.1 $451.7 120.2 115.6 Statistics (as a percent of net revenue): Gross profit 71.0 % 69.5 % 69.3 % 68.1 % 71.2 % 69.9 % 69.3 % 67.7 % 70.2 % 68.8 % 70.3 % 68.9 % Selling, general, and administrative 38.4 % 37.0 % 35.4 % 34.1 % 36.5 % 35.2 % 39.5 % 37.9 % 37.4 % 36.0 % 37.9 % 36.5 % Expand

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store