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DATE
Tuesday, Oct. 21, 2025 at 4:30 p.m. ET
CALL PARTICIPANTS
President – David J. Rosa
Executive Vice President and Chief Financial Officer – Jamie E. Samath
Executive Vice President and Chief Medical Officer – Dan Connolly
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RISKS
Jamie E. Samath said, "We continue to see government budget challenges in Japan and the UK and a constrained and competitive marketplace in China," indicating ongoing difficulties in these regions.
Dan Connolly noted, "domestic bariatric procedures continue to decline at high single digits." This marks roughly six consecutive quarters of mid- to high single-digit declines in domestic bariatric procedures through Q3 2025, and domestic bariatrics now represent "a little less than 3% of overall da Vinci procedures."
Jamie E. Samath stated, "Price pressure on the capital side and on the INA side continue" in China, further emphasizing headwinds.
TAKEAWAYS
Total Procedure Growth -- Worldwide procedure volume grew 20% in Q3 2025 (non-GAAP), driven by 19% da Vinci procedure growth (non-GAAP) and 52% increase in ION procedures.
Revenue -- Reported $2.51 billion in revenue for Q3 2025, reflecting 23% revenue growth on both a reported and constant currency basis.
Operating Margin -- Pro forma operating margin was 39%.
Earnings Per Share -- Pro forma EPS increased 30% to $2.40, and would have been $2.28, excluding discrete tax benefits.
da Vinci System Placements -- 427 da Vinci systems placed, a 13% increase from the same quarter last year, including 240 da Vinci V systems and 30 SP systems were placed.
ION System Growth -- Installed base up 30% to approximately 950, with 50 ION systems placed (down from 58 in Q3 2024).
System Utilization -- Global average da Vinci system utilization grew 4%. ION utilization improved 14%. SP platform utilization up 35%.
Recurring Revenue -- Recurring revenue grew 21%, comprising 85% of total revenue.
Gross Margin -- Pro forma gross margin was 68%, down 1.1 percentage points year-over-year due to tariffs, facility costs, lower margin mix, and increased service costs.
Da Vinci Installed Base -- The installed base of da Vinci systems increased by 13% year-over-year to almost 10,800 systems as of Q3 2025.
Leasing Mix -- Leasing accounted for 54% of da Vinci placements; da Vinci leasing revenue rose 33%.
INA Revenue per Procedure -- Da Vinci INA revenue per procedure was approximately $1,800, and ION INA revenue per procedure was roughly $2,200.
Share Repurchases -- $1.9 billion used for share repurchases, reducing cash and investments to $8.4 billion despite $736 million in free cash flow.
Upgraded 2025 Guidance -- Full-year 2025 da Vinci procedure growth guidance raised to 17%-17.5%, and Pro forma gross margin guidance lifted to 67%-67.5% of revenue for 2025.
FDA Clearances -- Received FDA 510(k) clearances for da Vinci V software (including force gauge, focus mode) and for SP advanced features.
Refurbished XI Systems -- Sold 20 refurbished XI units as of Q3 2025, providing flexible, cost-sensitive options for customers.
Clinical Evidence -- Dan Connolly cited a randomized trial showed ION with cone beam CT achieved an 84.6% diagnostic yield versus 23.1% for conventional bronchoscopy, with comparable complication rates, as presented at the European Respiratory Society's annual conference by University Hospital Zurich.
Force Feedback Study -- A recent analysis of over 400 da Vinci V procedures, published in September in the Journal of Robotic Surgery, showed an approximate 20% reduction in peak force application when force feedback was set higher.
International Segment Performance -- Outside the US, total procedures grew 25%, with da Vinci procedures up 24% and a quadrupling of ION procedures from a low base.
SUMMARY
Intuitive Surgical (ISRG +1.08%) reported accelerated, broad-based growth, with rising da Vinci V adoption contributing to both higher system placements and increased utilization across markets. Upgraded financial guidance reflects cost leverage, persistent procedure demand, and expanded platform capabilities validated by clinical studies and FDA clearances. Strategic focus areas include further rollout and evaluation of new technologies, increased training, and portfolio differentiation through the introduction of refurbished systems and enhanced digital features.
Jamie E. Samath said, "Nearly 90% of da Vinci V procedures used our integrated insufflation technology in Q3 2025," indicating rapid integration of new features.
The company plans to transition to direct sales in Italy, Spain, and Portugal in the first half of 2026, with about 250 employees to transfer, and expects this strategy to be "slightly accretive to pro forma EPS." according to Jamie E. Samath
According to Jamie E. Samath on the Q3 2025 earnings call, procedure growth in US ambulatory surgery centers is "quite a bit accretive" compared to overall US procedure growth, while capital constraints, not instrument costs, remain the main adoption barrier in this channel.
Clinical feedback and early-stage evidence underscore anticipated patient and surgeon benefits from recent innovations, though ongoing studies will be required to confirm impact on outcomes.
INDUSTRY GLOSSARY
INA: Instruments and Accessories revenue, referring to recurring sales of consumables used on Intuitive Surgical’s platforms.
IDN: Integrated Delivery Network, a system of healthcare providers under a parent organization, relevant for system placements and platform standardization.
SP: Single Port, Intuitive Surgical's robotic-assisted surgical system designed to operate through a single incision site.
ASC: Ambulatory Surgery Center, an outpatient facility where surgeries not requiring hospital admission are performed.
HOPD: Hospital Outpatient Department, referring to a facility or department of a hospital providing outpatient services.
510(k) clearance: Regulatory authorization indicating a medical device is substantially equivalent to a legally marketed device in the United States.
Quintuple Aim: Industry framework targeting five goals: improved patient outcomes, enhanced patient experience, better care team experience, lower cost of care, and increased access to care.
Full Conference Call Transcript
David will review business and operational highlights, Jamie will provide a review of our financial results and procedure highlights, and I will review clinical highlights and discuss our updated financial outlook for 2025. Finally, we will host a question and answer session. With that, I'll turn it over to David.
David J. Rosa: Good afternoon, and thank you for joining us today. Q3 2025 was an excellent quarter for Intuitive Surgical, Inc., with strength in worldwide procedure growth and capital placements, as well as increasing utilization across all platforms. Globally, customer interest in and adoption of da Vinci V expanded. Domestically, customers responded to our first full quarter of broad da Vinci V availability with increased demand for system upgrades and dual consoles. Internationally, we placed our first systems in Japan and Europe, with surgeons performing initial cases in those geographies. Turning to procedures, 19% and ION procedures were higher by 52%, leading to total worldwide procedure growth of 20%.
Da Vinci procedure growth reflected strength in benign general surgery in the US and accretive growth in general surgery and gynecology internationally. System utilization, defined as procedures per installed clinical system per quarter, grew 4% for our 35% for SP, and 14% for ION. In the first eighteen months since launch, da Vinci utilization is validating our design intent, already outpacing Xi. Procedure demand has been healthy, and as da Vinci V catalyzed upgrades, we saw the multiport installed base utilization ticking up to absorb that demand. This is healthy for our customers and for our company.
Turning to capital, we placed 427 da Vinci systems, including 240 da Vinci V systems and 30 SP systems, as well as 50 ION systems. Demand for da Vinci V upgrades drove strong domestic placements. We believe upgrades are an effective way for customers to expand throughput and capabilities. These capabilities include force sensing, surgeon autonomy, telepresence, and various other digital tools that may lead to enhanced understanding of what great surgery looks like and further adoption of robotic-assisted surgery over time. Additionally, it is our intent to offer refurbished Xi systems as part of our broader portfolio, which will help expand access in certain geographies and sites of care.
Internationally, da Vinci placements reflected ongoing external dynamics in Japan, China, and the UK, offset by broad-based strength in other international markets. Customer adoption of our products resulted in strong financial performance reflected in 23% revenue growth and combined with strong operating discipline, 30% earnings growth. Jamie will provide further details on procedures, systems, and finances later in the call. Last month, we hosted our tenth annual Intuitive 360 user conference in San Diego, where more than 1,100 healthcare professionals representing over 450 institutions from around the world gathered to exchange ideas and shape the future of patient care.
Customers remained acutely focused on improving patient outcomes, reducing clinical and operational variation, driving efficiency, and increasing access to minimally invasive care. More than 30 institutions presented their own clinical and financial outcomes data, which further validated the value of our three existing platforms. I had the opportunity to sit down with multiple customers and dive deep into their robotic programs, including the impact of da Vinci V and potential fleet standardization, site of care dynamics, and their overall lung cancer programs. I was encouraged to see the depth of their data and analyses and how these customers were able to quantify the impact of their Intuitive programs on aspects of the quintuple aim.
Domestically, we remain in limited launch with force feedback instrumentation, and we are working closely with customers to support their analyses of the impact of force feedback on clinical outcomes and learning progression. I am encouraged by early feedback and excited to see where some of these studies are leading. Dan will highlight some of this data later in the call. Across all of our platforms, we consistently upgrade capability and reliability through software and hardware releases. In Q3, we received FDA 510(k) clearance for the first in a series of software updates for da Vinci V.
With the addition of network central configuration management, we are now able to deploy updates remotely, which significantly streamlines workflow for both our customers and Intuitive Surgical, Inc. This release also includes the visual representation of force through force gauge and focus mode, which enables in-console video replay and viewing registration and manipulation of 3D models. These features enhance surgeon awareness and intraoperative decision-making. You will see us continue to make improvements to the platform that advance our vision of delivering real-time insights at the point of care to support clinical efficiency with the aim of improving outcomes. Internationally, we placed our first nine systems in Japan and Europe and have received positive early feedback.
We look forward to engaging customers as they continue to evaluate da Vinci V. Our da Vinci single port platform made further progress in Q3. Procedures increased 91%, led by ongoing growth in Korea, continued early progress in other international markets, and initial domestic use of the SP stapler in colorectal and thoracic procedures. At Intuitive 360, I had a conversation with a longtime da Vinci thoracic surgeon about his initial experience using SP on about 40 patients. He was enthusiastic both about the reduction in length of stay and also his first few cases of using the SP stapler.
I share his enthusiasm about these early results and look forward to seeing more data from colorectal and thoracic procedures as our launch progresses. Recent 510(k) clearances support several advanced features, including sensitive firefly and various control algorithms, further improving SP stapler usability. Since we last spoke with you on our Q2 call, we have completed US regulatory submissions for nipple-sparing mastectomy and other general surgery procedures. We look forward to updating you on these efforts on future calls. Turning to ION, worldwide procedures grew 52% to just under 38,000. We are now delivering ION's differentiated value at scale, providing precise and individualized patient-specific navigation plans, using AI to segment each CT scan and plan the biopsy trajectory.
This quarter, we received FDA clearance for a significant software release that improves workflow and imaging options, including upgraded system software that uses real-time AI to enable even more precise airway navigation and tomosynthesis integration, broadening the suite of imaging offerings when cone beam CT is not available. In closing, we are committed to our 2025 priorities. First, focusing on the full launch of da Vinci V, its regional clearances, and follow-on feature releases. Second, we'll pursue increased adoption of our focused procedures by country through training, commercial activities, and market access efforts. Third, we'll drive continued progress in building industrial scale, product quality, and manufacturing optimization. And finally, we'll focus on excellence and availability of our digital tools.
Looking ahead, by virtue of our focus on patients, our alignment with customers in pursuit of the quintuple aim, our investments in both industrial scale and innovation, and our commercial excellence, we are well-positioned operationally and financially to further increase value to patients, physicians, hospitals, and payers globally. With that, I'll turn the time over to Jamie to take you through our business and finances in greater detail.
Jamie E. Samath: Good afternoon. I will begin by highlighting our third quarter performance on a non-GAAP or pro forma basis, and I will also summarize our GAAP results later in my remarks. A reconciliation between our pro forma and GAAP results is available on our website. The third quarter was a strong quarter for Intuitive Surgical, Inc. Taking da Vinci and ION together, total procedure growth was 20% compared to 18% growth for 2025. In quarter three, revenue grew 23% to $2.5 billion, pro forma operating margin was 39%, and pro forma earnings per share increased 30%. The strength of our financial results reflects the broad launch of da Vinci V and expanded adoption of our ION and SP platforms.
For our da Vinci business, procedures grew 19%, the installed base of da Vinci systems increased by 13% to almost 10,800 systems, and average system utilization increased by 4%. We continue to see robust growth for our ION platform, with procedures increasing 52%, the installed base up by 30% to approximately 950 systems, and average system utilization increasing by 14%. In the US, total procedures da Vinci and ION increased 18%, reflecting 16% growth in da Vinci procedures and 48% growth in ION procedures. Da Vinci utilization in the US increased 2% in Q3 compared to flat utilization in the first half of this year and 2% growth last year.
Increased growth in US da Vinci utilization reflected strong Q3 procedure growth and a higher mix of da Vinci V in the installed base, where utilization is higher than Xi. This reflects surgeon interest in using our latest technology and efficiency gains from da Vinci V's higher levels of surgeon autonomy and integration. As one example, in quarter three, almost 90% of da Vinci V procedures used our integrated insufflation technology. Outside the US, total procedures da Vinci and ION grew 25%, driven by 24% growth in da Vinci procedures and a quadrupling of ION procedures from a small base. OUS procedure growth had an approximate one percentage point benefit as a result of the timing of certain local holidays.
Da Vinci procedure growth in OUS markets included strong results in India, Canada, Korea, Taiwan, and Brazil, and solid growth in China, the UK, Italy, and France. Procedure growth in Japan was a little lower than our expectations, reflecting lower capital placements over the last several quarters. Globally, we continue to see strong procedure growth for SP at 91% for Q3, with strength in Korea and earlier stage growth in Europe and Japan. In total, for our OUS markets, we saw accretive da Vinci procedure growth across benign general surgery up 39%, colorectal up 28%, hysterectomy which grew 27%, and thoracic procedures which increased 26%. Combined, those categories are approximately 40% of OUS da Vinci procedures.
Average system utilization in OUS markets combined grew 8% in Q3 as compared to 6% in the first half of this year and 4% growth in 2024. Accelerating utilization in Q3 is driven by strong multi-specialty procedure growth in India, Korea, Taiwan, and distributor markets, and customers in countries with capital constraints driving increasing use of the existing installed base. As of Q3, aggregate average system utilization in OUS markets is approximately 20% below that of systems in the US. As a result of our clinical performance, total INA revenue in quarter three grew 20% to $1.5 billion, consistent with overall procedure growth. Da Vinci INA revenue per procedure was approximately $1,800, flat with last quarter and last year.
On a year-over-year basis, we saw downward pressure from lower bariatrics procedures and higher cholecystectomy procedures, offset by higher SP procedures and da Vinci V specific INA. For our ION platform, INA revenue per procedure was approximately $2,200, relatively consistent with prior periods. Turning to capital performance, and starting with our da Vinci business, we placed 427 da Vinci systems in quarter three, a 13% increase from the 379 systems placed in the same quarter last year. 240 of the 427 placements were da Vinci V, including 12 in the OUS markets, following recent clearances in Japan and Europe. The installed base of da Vinci V is now 929 systems.
In the US, we have at least one da Vinci V system in 18 of the largest 20 IDNs, and of hospitals that have three or more multiple systems, 21 of those hospitals have fully standardized to da Vinci V. We saw 141 trading transactions in Q3, up from 38 a year ago, primarily driven by US customers upgrading to da Vinci V. Some customers are shifting budgets to upgrades, partly with the intention of taking advantage of the efficiency potential of da Vinci V. We are also actively working with some customers to acquire da Vinci V and move their XIs to alternative sites within their network.
In the US, we placed 263 systems, up from 219 last year, driven by demand for da Vinci V. Outside the US, we placed 164 systems compared to 160 last year. OUS placements included 63 systems in Europe, 16 in Japan, and 13 in China, compared to 65, 39, and 14 respectively last year. We continue to see government budget challenges in Japan and the UK and a constrained and competitive marketplace in China. Performance in markets served by distributors continued to be relatively strong. In Q3, we placed 64 systems compared to 52 systems last year. Q3 performance was driven by strength in Brazil and the Middle East.
Within the 427 da Vinci placements, we placed 30 SP systems in the third quarter, higher than the 21 systems last year, driven primarily by OUS markets. For our ION platform, we placed 50 systems in the quarter compared to 58 systems last year. Q3 ION placements included nine systems in OUS markets. Lower ION placements in the US primarily reflect a joint focus with our customers on increasing utilization. As a function of our capital performance, quarter three systems revenue grew 33% to $590 million. For our da Vinci business, leasing represented 54% of da Vinci placements, as compared to 49% last quarter and 58% last year, driven primarily by customer mix.
We continue to expect that rates of leasing will increase over time, primarily driven by OUS markets. Da Vinci leasing revenue increased 33%, reflecting an 18% expansion of the installed base under operating lease arrangements and a 10% increase in lease revenue per system, driven by a higher mix of da Vinci V. The average selling price for purchased da Vinci systems was $1.6 million in Q3, as compared to $1.5 million last year, driven by a higher mix of da Vinci V and a higher mix of dual console systems, partially offset by higher trade-ins. Lease buyout revenue was $22 million, as compared to $30 million last quarter and $24 million last year.
Quarter three service revenue increased 20% to $396 million, reflecting an increase of the da Vinci installed base of 13% and the ION installed base of 30%. Service revenue per system for our da Vinci installed base increased 5% year over year, primarily reflecting a mix of da Vinci V systems. Total revenue for the quarter was $2.51 billion, representing 23% growth over the prior year. On a constant currency basis, revenue growth was also 23%. Recurring revenue grew 21%, continuing to account for 85% of total revenue. Turning now to the rest of the P&L, pro forma gross margin for the quarter was 68%, down from 69.1% in Q3 of last year.
The year-over-year decline reflects a 90 basis point impact from tariffs, higher facility costs, a greater mix of lower margin da Vinci V and ION revenue, and higher service costs related to da Vinci V, partially offset by cost reductions. Quarter three pro forma operating expenses increased 11% year over year, driven by higher headcount, increased facility costs, and higher R&D prototype expenses, partially offset by lower legal spending. We added approximately 340 employees during the quarter, primarily in our core commercial, engineering, and manufacturing functions. As a reminder, we are planning to go direct in Italy, Spain, and Portugal in the first half of next year. This will involve the transfer of approximately 250 employees.
We expect to describe the impact of this in greater detail at our next earnings call. Pro forma other income was $93 million for the quarter, flat to the prior quarter, reflecting lower interest income offset by a lower FX impact from remeasurement of the balance sheet. Our pro forma effective tax rate for quarter three was 18.3%, lower than our expectations, reflecting the impact of the new US tax provisions for the treatment of R&D expenses and a $16 million discrete benefit from the release of tax reserves associated with statute of limitation expiration. We are still evaluating potential impacts of US tax reform for our 2026 tax rate.
Pro forma net income for the third quarter was $867 million, compared with $669 million last year. Pro forma earnings per share was $2.40 per share. Excluding the benefit to tax expense in Q3 from the US tax reform and release of tax reserve, pro forma EPS would have been $2.28 per share. Now turning to our GAAP results, GAAP net income for the quarter was $704 million, or $1.95 per share, compared to $565 million, or $1.60 per share in Q3 of last year. The differences between our pro forma and GAAP results are outlined and quantified on our website. We ended the quarter with $8.4 billion in cash and investments, down from $9.5 billion last quarter.
In line with our capital allocation priorities, during the quarter we used $1.9 billion of cash to repurchase approximately 4 million of Intuitive Surgical, Inc. shares. The sequential reduction in cash and investments reflects the stock repurchases, partially offset by strong free cash flow of $736 million. With that, I'll turn it over to Dan to discuss recent clinical publications and our updated outlook for 2025.
Dan Connolly: Thank you, Jamie. Turning to the clinical side of our business, I'd like to share data from several notable recent studies. In addition to the specific data highlighted on this call, I encourage you to consider the wide body of evidence detailing these topics and others in published scientific studies over the years. Last month, at the European Respiratory Society's annual conference, we saw continued growth in evidence describing the ION and deluminal systems' impact in geographies outside the United States. At the conference, Dr. Carolyn Steinack from University Hospital Zurich in Switzerland presented an abstract of detailed results from an open-label randomized controlled trial that compared ION plus integrated mobile cone beam CT to conventional bronchoscopy.
Conducted at University Hospital Zurich, this study compared outcomes from pulmonary nodule biopsies performed in 78 patients, with 39 patients in each group. Median nodule size was just 11 millimeters in each group. Results demonstrated an increase in diagnostic yield between the two groups in excess of 60 percentage points, with the ION group at 84.6% and the conventional bronchoscopy group at 23.1%. Procedure times and complication rates in both groups were comparable. Additionally, in the same presentation, the group showed a center-wide increase in early-stage cancer diagnosis after implementation of the integrated ION and mobile cone beam CT system, with an increase of stage 1A non-small cell lung cancer diagnosis of approximately 30 percentage points. Dr.
Steinack concluded that even with minimal training, ION robotic-assisted bronchoscopy with integrated cone beam CT is a pivotal tool for effective early lung cancer diagnosis and a potential driver of a shift towards early-stage diagnosis. On previous calls, we have shared published studies that describe the impact of force feedback technology across multiple specialties. In September, Dr. Peter Nertz from The Ohio State University, in collaboration with other thoracic surgeons and Intuitive Surgical, Inc., published "Force Feedback in Robotic Thoracic Surgery: A One-Year Analysis of da Vinci V Force Feedback" in the Journal of Robotic Surgery. To date, the inability for surgeons to feel force exerted in the operative field has been a meaningful limitation of robotic-assisted thoracic surgery.
This study incorporated data from over 400 common thoracic procedures performed by 70 surgeons with da Vinci V and force feedback technology. The analysis showed that median instrument tip forces decreased stepwise based on force feedback sensitivity setting across all procedures. Moreover, there was a significant difference in the amount of time at peak force greater than 6.5 newtons across force feedback settings, with a reduction of approximately 20% in peak force application when force feedback instruments were set to medium or high. The authors noted that this study provides clinical evidence that force feedback technology may help reduce force during robotic-assisted thoracic surgery and result in objectively gentler surgery.
The first step in evaluating the impact of force feedback is to see an intraoperative difference in applied force. Here, we are encouraged by early results across specialties on the value that we believe force feedback technology brings to patients and surgeons. The next step in evaluating the impact of force feedback is to assess whether changes in forces applied during surgery translate to the patient experience on measures like pain or other functional patient outcomes. These studies are underway, and we look forward to their publication and discussion in the coming quarters and years. I will now turn to our updated financial guidance for 2025.
Starting with da Vinci procedure growth, on our last call, we forecast full-year 2025 da Vinci procedure growth within a range of 15.5-17%. We are updating our 2025 da Vinci procedure growth guidance to be within a range of 17-17.5%. Turning to gross profit, on our last call, we forecast pro forma gross profit margin in 2025 to be within a range of 66-67% of revenue. Given Q3 results, which reflected greater leverage of fixed costs and benefits from cost reductions, as well as a lower expected tariff impact for the year, we are updating our estimate of pro forma gross margin to be within a range of 67-67.5% of revenue.
Within that range, we now expect the impact of tariffs for the year to be 70 basis points, plus or minus 10 basis points. We expect pro forma operating expense growth to be between 11-13%, which includes increased depreciation from new facilities and investments to drive our growth objectives. We estimate non-cash stock compensation to be between $785 million and $795 million. We forecast other income, comprised mostly of interest income, to total between $350 million and $360 million. We expect capital expenditures to range between $625 million and $675 million, which reflects planned facility construction activity.
With regard to income tax, due primarily to the lower Q3 non-GAAP effective tax rate that Jamie described earlier, we now estimate our 2025 pro forma income tax rate to be between 21-22%. This concludes our prepared comments. As we open the line for questions, we ask that you please limit yourself to one or two questions.
Operator: Ladies and gentlemen, as a reminder, if you do have a question at this time, please press star 11. Our first question comes from the line of Robert Marcus from JPMorgan. Your question, please.
Robert Marcus: Great. Congratulations on a great quarter here. Two for me. One, I'll start with procedures and then I have one on margin. 20% procedure volume growth was just a really impressive uptick year over year as well as quarter over quarter. Hoping if you could talk to the trends you're seeing both US and outside US that are driving that? How sustainable is it? And how much do you think is attributed to the introduction of da Vinci V?
David J. Rosa: Yeah. I'll take that first, Robert. So if you look at US da Vinci procedure growth, maybe just to frame it, in Q1, it was 13%, 14%, and then in Q3, 16%. So obviously that Q3 US da Vinci procedure growth number was strong relative to recent trends. We saw strong growth in after-hours surgery and acute care, and in a subset of the benign general surgery procedures that I think we've referenced in the past. In cholecystectomy, appendectomy, then there were a couple of categories that were a little above our expectation. Also in benign general surgery, so hernia repair, a couple of the benign GYN procedures.
We have had just anecdotally indications that there may have been, let's say, acceleration of procedures in July and August for elective procedures given all of the noise around Medicare funding and even ACA premium changes. We have looked at third-party data, which obviously lags. It's not clear that's supported by the third-party data. So we don't have evidence to that effect. We've heard it from some customers, and we've heard other commentary to that effect. And so strength that may be an effect in terms of what's reflected in the Q3 US.
I'd just say in terms of OUS da Vinci procedure growth, as I said in the prepared remarks, there is about one percentage point benefit to the growth there relative to just the timing of holidays. There's a set of autumn festivals in Asia markets that last year occurred in September. In this year, they'll occur in October. And, Robert, you had mentioned da Vinci V. You know, as we talked about, it was our intent to design da Vinci V to be easier to learn, easier to use, and support higher efficiencies. The data that we're seeing from the customers who are adopting da Vinci V, it is supporting that design intent.
And so to the extent that customers are adopting da Vinci V, then that too supports some of this utilization within the existing accounts.
Jamie E. Samath: Maybe as a reference point, Robert, there were about 67,000 da Vinci V procedures done in Q3. That compares to 50,000 da Vinci V procedures done in Q2.
Robert Marcus: Great. And I mentioned margins for my second question, but I've actually changed my mind. I want to ask about refurbished XIs. And you mentioned how some of your customers were interested in upgrading and moving their XIs to new sites of care. You know, this is one area. I don't think many street models have XI refurbished units in them. As of now. Maybe you could just speak to how you're thinking about the progress in '20 and beyond in terms of new channels, new countries, just how much greenfield can refurbished XIs add and where do you think clients will be most interested? Thanks a lot.
David J. Rosa: Yes, Robert, maybe I can just speak from a portfolio perspective, and then Jamie, please fill in with any other color. The trade-in cycle, the upgrade cycle that da Vinci V is catalyzing obviously gets us a number of XI systems coming back to Intuitive Surgical, Inc. We're able to repurpose those, offer those within our portfolio. And so what I always think about in terms of satisfying or meeting our customers' needs is having a portfolio that spans a range of capability from X now to the refurbished XI up through da Vinci V. And a range of financial instruments to help customers acquire those portfolios.
And so refurbished XI is going to be an important part of that, certainly for certain sites of care within the US, but also outside the US. And for those customers who are cost-sensitive and trying to really look carefully at the economics of their programs and how they initiate a robust robotic-assisted surgery program, I really think that the refurbished XI is an important component in that. We've sold 20 refurbished XIs so far.
Jamie E. Samath: Our regional leaders are excited to have both that and da Vinci V in the portfolio. And I think it provides some really nice segmentation for those customers that want to be early adopters of the latest technology and for those sites that are cost-sensitive. And that includes all the way to the US and maybe surgery centers. I think we have really nice flexibility in terms of what the pricing might be for a refurbished XI. We're not ready to kind of describe what the range of that might be because we're early. But I think it's giving our commercial team some really nice options.
Robert Marcus: Great. Congrats again. Appreciate the color.
Jamie E. Samath: Thanks, Robert.
Operator: Thank you. And our next question comes from the line of Travis Steed from BofA. Your question, please.
Travis Steed: Hey, congrats on the good quarter. Maybe just a follow-up on that. You talked also about some of the XIs are being redeployed within the same hospitals to be used in alternative sites. And curious, like, when you see the hospital buy the da Vinci V and keep the older XI and redeploy it, what are you seeing in terms of utilization on that system? New categories getting opened up? Is it tending to go into the ASC or just help us understand how that's working and how many hospitals are taking up on an opportunity?
David J. Rosa: You know, one of the dynamics that we do see when hospitals engage with da Vinci V and move XI to other sites of care, the nice thing is the systems are able or were designed to have very consistent user interfaces. So those surgeons could work back and forth across those platforms. If it happens to be where the da Vinci V's in the flagship hospital, and the XI was moved to an alternative site of care like an ASC, then it allows those surgeons to move back and forth in the care teams easily. There's not retraining or relearning to do.
The other nice thing is, I think you know, is the inventory of instruments across both XI and da Vinci V can largely be used interchangeably. And so that's another advantage that allows our customers to deploy these fleets as they need to suit what they're trying to get done via decanting their main OR into ambulatory environments, or perhaps adjusting where they're trying to treat patients within their larger IDN. And so we think that's a powerful component of the da Vinci V upgrade cycle that will allow some of our customers some flexibility in how they build out their fleets.
Travis Steed: Great. And I have a follow-up. Jamie, do you have anything else? Jump in.
Jamie E. Samath: No. All good from my side.
Travis Steed: Okay. But I had a follow-up on you mentioned new platforms recently and maybe opening up new disease states. Curious if you could elaborate on that. Cardio is an area that you guys are clearly investing in, and curious what you see as the problems with the current standard of care and places you could kind of apply the quintuple aim to cardio?
David J. Rosa: Sure, sure. It has kind of two separate components in there. So maybe starting with the cardiac side of things, we've talked about for a long time cardiac surgeons have been using off of a very small base, our current systems, X and XI, to perform cardiac surgery. And with the capabilities of da Vinci V around precision motion control, integration of imaging, we think that those capabilities, coupled with some new instrumentation that we need to develop, really bring some differentiated capability to cardiac surgery. And so if you look within the cardiac surgery patient community, many are served well with percutaneous approaches. But there's a subsegment of patients where surgery is the best option for them.
And minimally invasive surgery, I think with da Vinci, is a better option for them. So we think that it's a meaningful segment of the market and that da Vinci V, plus ongoing development with instruments and software and other areas, can make a difference for cardiac surgeons and their patients. When you look at new platforms, here's the way that I think about it. So in Intuitive Surgical, Inc., if you say, what is Intuitive Surgical, Inc. good at?
I think we're really good at advanced robotic platforms that include precision motion control, integration of advanced imaging and other types of sensors, the very precise control of complex, rigid, and flexible instrumentation, the integration of digital tools in the emerging field of AI. And so you say those are our core capabilities. Then I look out in the world and say, where are there problems, healthcare problems to be solved? Where existing solutions aren't meeting the needs of physicians and their patients. And there are many. And where those two intersect, our capabilities plus an unmet need, I think that's where some magic can happen. And so that's where we're looking.
And we believe there are, we have some opportunities where those do intersect. We have ongoing R&D in those areas. And just look forward to updating you more in the future.
Travis Steed: Great. Can't wait to see some of the magic. Thanks a lot.
Operator: Thank you. And our next question comes from the line of Larry Biegelsen from Wells Fargo. Your question, please.
Larry Biegelsen: Congrats on a great quarter. Excuse me. Thanks for taking the question. Just two for me. One on the US, one on margins. Are you, David or Jamie, how are you thinking about utilization in the US going forward as da Vinci V becomes a higher percent of the installed base? Could we continue to see it trend higher? And net placements have been down recently year over year. I think that's primarily because of a tough comp last year. But how do you think about that metric? Investors have been or some investors are focused on it. And I have one follow-up.
Jamie E. Samath: Yeah. I'm gonna maybe zoom out for a second, Larry, and recognize the discussion on net placements that's been occurring. In terms of our approach, we're first focused on aligning with customers in ways where they need extra capacity for da Vinci because it brings patient benefit, patient value. And so we actually look first and foremost at procedure growth as our primary metric of success because obviously, that reflects adoption and use of our technology for patients. So therefore, we take a customer-by-customer approach in terms of how we engage with them on the capital side.
And we're as happy to help them expand their installed base as a way to increase capacity, as we are to do an upgrade given da Vinci V, particularly in the context of what we see opportunities to have efficiency benefits in da Vinci V, that in effect also create a capacity expansion opportunity. And so you see that reflected in Q3 results now that we're in broad launch and that you have 900 plus systems in the field. And we think whichever way we go, as long as it's in alignment with the customer, it's healthy for them and for us, and I think that's well illustrated in Q3 results.
Now in terms of the question, what will long-term US utilization growth be? I think we're focused more on the segments of customers than the US average. Because I do think, as we've talked about in the past, there are likely some mixed dynamics, particularly as we look to capture benign procedures that are in community and rural hospitals that are gonna have smaller programs. But think of larger institutions with a larger number of procedures utilizing da Vinci V, we'd expect them to better drive improvements to utilization. Where that nets out to, I think we'll see because it's so early with respect to the da Vinci V launch.
Larry Biegelsen: That's super helpful. Jamie, on margins, excuse me, it looks like the implied gross margin in Q4 at the midpoint of the guidance range is slightly below 67%. So my question is on next year. Just what are some of the puts and takes to consider? Is that kind of Q4 number a good starting point for next year for the gross margin? Or are there additional headwinds or tailwinds to consider? And any directional color on the impact of going direct in those three markets you called out? Net positive, negative, or just anything directional? Thank you.
Jamie E. Samath: Yes. I understand the question on gross margins for '26. Larry, we're going to wait till January to provide color on what the outlook is there. With respect to going direct in Italy, Spain, and Portugal, we continue to expect that to be slightly accretive to pro forma EPS upon going direct. And that's really a function of eliminating the margin of the distributor, and that gets partially offset by the team that we take on the transfers from them to us.
Larry Biegelsen: Alright. Thanks so much, Jamie.
Operator: Thank you. And our next question comes from the line of Rick Wise from Stifel. Your question, please.
Rick Wise: Good afternoon, everybody. Thanks for another stellar quarter. I guess I'll start with let me start with two softer areas that you talked about, David. The downward pressure on the bariatric side and China, you just described the environment as constrained and competitive. Maybe you could talk about both of these. And when do we get past the when is bariatrics less of a drag? Seems like it's been going on for a while. We should be almost largely over that impact at some point. I don't know. Maybe you can share some thoughts there. And China, how do we think about the outlook from here? Then I have one follow-up. Thank you.
Dan Connolly: Hey, Rick, it's Dan. On bariatrics domestically, you know, we haven't seen a change in trajectory. I think in Q3, domestic bariatric procedures continue to decline at high single digits. So it's roughly six quarters of down mid-single digits to down high single digits. I think in total, domestic bariatrics is a little less than 3% of overall da Vinci procedures. Maybe I'll pass it to Jamie on the China question.
Jamie E. Samath: Maybe just on bariatrics for a second. David and I actually met with about 25 bariatric surgeons earlier this week. We met with another group about that size about six weeks ago. And obviously had an exchange here about the impact of GLP-1s and what they're seeing in their practices. They are not yet at a position where they feel like they can predict when the declines are gonna end. They're not seeing the dynamics in the practice that gives them the confidence to make that prediction. So honestly, it feels like we're still in this realm where you have some patients that have been on GLP-1s and are starting to come off because of costs and side effects.
But that's offset by new patients starting on the regimen of the drugs. But none of the surgeons we engage with are yet at a point where predicting a change in trajectory. On China, and David and I were recently in China several weeks ago, I'd say the environment is quite consistent from what we've seen over the last year or so in terms of tenders are slow. Competition is pretty healthy. I think there's generally a preference technology-wise for da Vinci. And I think that there are many local preference provinces that want the local player to win. And so we're just navigating and executing within that environment.
Price pressure on the capital side and on the INA side continue.
Rick Wise: Gotcha. And just as a follow-up question, I was curious to what extent is hub what's its role in driving some of this da Vinci uptake? When I talk to doctors, I'm just continually struck by their interest in and what sounds like the potential utilization of hub features. Just this quarter, I saw that you got approval for system software modifications to include something called surgeon cloud accounts. Just you talk my question is sort of can you talk about what inning are we here in the hub story, the hub evolution, the potential to enhance da Vinci V performance users? Just any color and direction you could give us would be great. Thank you so much.
David J. Rosa: Sure. Sure. Let me take that question. And so, you know, I might just reframe it a bit from hub but just to kind of the digital foundation of da Vinci V that we've talked about. You know, when we launched the system, we were talking about its 10,000 times increased compute power. And the hub is a part of that story. So we now have the integrated hub hardware that is foundational to collecting some of the video data and getting it processed by Intuitive Surgical, Inc. and then returned back to customers through case insights and kind of, said simply.
And so this digital promise, if you will, of how it's going to impact surgery through da Vinci V and more. You have to remember, it has layers. It's gonna be a progressive kind of growth over time. And it starts with really good data. And we've talked about that before. So different sources of data, one of which is video data, and that's where hub is integral in collecting that video data and getting it to Intuitive Surgical, Inc. so it can be segmented and have other measures analyses performed. There are all sorts of other kinds of data, including kinematic data, and force data, electronic medical record data for certain customers when we have an agreement signed.
So you take those data, and then you can start analyzing the data using these powerful tools that we have increasingly available to us with AI and machine learning. And you start drawing meaningful insights from those data. So that's that progression, ultimately leading, we think, to augmented dexterity or intraoperative guidance to really bring to life how do we help surgeons and care teams make better decisions, different decisions, to optimize outcomes, economics, or other measures of surgery. And so that is that progression. And hub, your question specifically, is really an important part of that because of its integration around video.
But overall, we're excited about this area and what it can mean to progress in the quintuple aim. And so da Vinci V's that foundational platform that will bring aspects of our AI/ML digital world to life and impact surgery.
Rick Wise: Thanks so much, David.
Operator: Thank you. And our next question comes from the line of Patrick Wood from Morgan Stanley. Your question, please.
Patrick Wood: Beautiful. Thank you so much. I'll keep it to one in the interest of time. I'd love to do more on the alternative side of care side of things. And I know you guys have talked in the past about XIs going into the ASC. I guess my question is, how much do you think the original capital cost is versus Medicare coverage and commercial rates? Relative to INA instrumentation costs. And then there's also like that sterilization challenge in there. So I guess, the crux of the question is, how much do you guys think you need to continue to bend the cost curve down for INA to make it work in the ASC?
And you feel like the sterilization challenge is small enough that it kind of doesn't really matter and you don't need to develop, like, disposable instrumentation or something like that. Thanks.
Jamie E. Samath: Yeah. I would just say maybe our experience so far in the US is by some way, the greater constraint is on the capital side. A number of the systems we have in ASCs have been leased. The majority of systems in US ASCs are XI, but we do have a number of Xs just obviously because of the lower price point. While it's a relatively small installed base, procedure growth in ASCs in the US is quite a bit accretive to what we see in terms of overall US procedure growth. I think that with XI, ASCs are going to be an area of increased interest and focus for us. And obviously, we're gonna look carefully at the economics.
It's fair to say that as we stand today, the reimbursement in an ASC is a fraction of the reimbursement in a HOPD, and so that creates a barrier, particularly for ASCs owned by IDNs. Have not had a lot of pushback on INA prices at this point in ASCs. I think from a strategic perspective, within the quintuple aim, we look to lower total cost to treat, and I think, therefore, it's a topic of strategic interest to us. It is. And, you know, to your last kind of part of your question around sterilization and INA.
You know, my experience in the ASCs that I visited and talking with our teams is that sterilization hasn't been an impediment to the overall program and the consideration of placing a robotic system there. And so I don't believe that single-use INA is a requirement to go into the ASC environment.
Patrick Wood: Super clear. Thanks for taking the question, guys.
Operator: Thank you. And our next question comes from the line of David Roman from Goldman Sachs. Your question, please.
David Roman: Good afternoon. Thank you for taking the question. I had one on and a follow-up on ION and SP. Maybe starting on the haptics and force feedback side, I think a little over a year ago when you launched da Vinci V, you got the question on an earnings call. What are the specific procedure categories where you see da Vinci V most applicable? And I think your response was something to the effect of da Vinci V is about making robotic surgery ubiquitous. Today, you're talking about, I think, expansion of procedures into benign general surgery.
I don't know if that's a reflection of that strategy of making robotic surgery ubiquitous, but maybe you sort of talk to how you're seeing that unfold and where force feedback fits into that trajectory.
David J. Rosa: Sure. Let me start with the force feedback side. So you heard from Dan a little bit about the journey of force feedback and what it's gonna take. You know, starting with instruments that are robust enough to be used on a daily basis in getting sterilized and getting to scale for our customers. And we're well on our way there. And then what we've seen is data, and Dan did talk about this, data that shows that through the use of force feedback, you can see lower forces in surgery.
And so now we have to connect that to outcomes and see whether or not that lower force is actually leading to either improved outcomes or speeding up of learning. And so that is where we are today. We've seen some early data that shows, you know, it's very interesting, and I think very aligned to the hypothesis of force feedback, which says if we can actually apply lower forces, we do expect that to have an improvement on outcomes. And so that has to happen procedure by procedure. Because as you look inside of each procedure, it's likely that those forces will impact outcomes in a different way.
For example, with prostatectomy, you might be looking at functional outcomes as a result of how much force is applied to nerves. If you're in nephrectomies or other colorectal procedures, you might be looking at recovery of bowel function as a result of how much force is applied to the bowel during those procedures. And so each one of those will happen in varying ways. And I think as that evidence emerges, that's the catalyst. That's the catalyst to broader adoption and how you see now force feedback impact aspects of the quintuple aim at scale. And so that just goes to, I think, the overall thesis of robotic-assisted surgery improving aspects of the quintuple aim.
We've seen that throughout our history. And now with the addition of force feedback, that's just one more piece of the puzzle here.
David Roman: That's very helpful. And then maybe quickly, just I'll follow-up on ION and SP. I think you talked about a little over 50% procedure growth in ION and I think I heard 91% in SP. You've had a number of SP clearances over the past six months or so. Maybe just help us contextualize performance in those segments and how we should think about them on a go-forward basis.
David J. Rosa: You know, here is the way I think about SP. It is doing great. We're seeing a growing body of evidence that there's patient value beyond cosmesis. You are right, growth in SP procedures at 92% is strong. Utilization in Korea outpaces that of Xi. And our team is focused on continuing to deliver software and instruments and other enhancements to the platform to continue to increase its capability. You know, another area we're working hard in, in the US in particular, are clearances. And so we know that a broad set of clearances is important for the use of single port. You see that in Korea. We see that elsewhere.
So in the US, we are on the pathway to continue to add more clearances to SP, and that will be a part of how that grows and continues to grow in the future.
Operator: Thank you. And our next question comes from the line of Adam Maeder from Piper Sandler. Your question, please.
Adam Maeder: Hi, good afternoon. Congrats on the quarter and thank you for squeezing me in here. I will keep it to one. I wanted to ask about the da Vinci V OUS launch in Europe and Japan. And I was wondering if you could share just a little bit more kind of early feedback that you've gathered to date. Help us better understand the rollout strategy there. And, you know, any broad color around the pace of da Vinci V placements outside the US and sub-quarters into 2026 would be much appreciated. Thank you for taking the question.
Jamie E. Samath: Yeah. I'd just say, it's relatively early. We take a local approach to each of those launches. Obviously, we have a pipeline in Europe and in Japan. You see the larger institutions and those institutions that want to be early adopters and want to get hold of the latest technology to be those that are most interested. There is a little bit more of a segmentation discussion in terms of some incremental cost sensitivity to the da Vinci V pricing relative to, say, the US market. I think we have a healthy pipeline in both markets. But there's work to be done to have customers work through the evaluation process.
David J. Rosa: Okay. That was our last question. Thank you for all the interesting questions. In closing, we continue to believe there's a substantial and durable opportunity to fundamentally improve surgery and acute interventions. Our teams continue to work closely with hospitals, physicians, and care teams in pursuit of what our customers have termed the quintuple aim: better and more predictable patient outcomes, better experiences for patients, better experiences for their care teams, lower total cost of care, and finally, increased access to care. We believe value creation in surgery and acute care is foundationally human. It flows from respect for and understanding of patients and care teams and their needs in their environment.
At Intuitive Surgical, Inc., we envision a future of care that is less invasive and profoundly better, where diseases are identified earlier and treated quickly so patients can get back to what matters most. Thank you again for your support on this extraordinary journey. We look forward to talking with you again in three months.
Operator: Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.