Intuitive Surgical Q4 2024 Earnings Call Transcript

AlphaStreet
Provided by AlphaStreet
January 23, 2025
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Operator

Good day, and thank you for standing-by. Welcome to the Q4 2024 Intuitive Earnings Conference Call. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speakers' presentation, there will be a question-and-answer session. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. I would now like to hand the conference over to your speaker today, Brandon Lamm, Investor Relations for Intuitive Surgical.

Brandon Lamm
Senior Manager, Investor Relations at Intuitive Surgical

Thank you. Good afternoon, and welcome to Intuitive's 4th-quarter earnings conference call. With me today, we have Gary Guthart, our CEO; Jamie Samath, our CFO; Daniel Oh, our Senior Medical Officer. Dave Rosa, our President and regular participant on this call is away from the office this week on a prior business commitment and will not be joining today. Dr. Daniel Oh, Senior Medical Officer and practicing surgeon, will join us on this call to describe clinical highlights. We will also -- we would also like to announce that Dan Connolly will be joining Intuitive as our VP and Head of Investor Relations. Dan has worked at a global investment manager for the last 18 years and has actively followed surgical robotics since 2008. We look-forward to Dan joining Intuitive in early-February. Before we begin, I would like to inform you that comments mentioned on today's call may be deemed to contain forward-looking statements. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in our Securities and Exchange Commission filings, including our most recent Form 10-K for the fiscal year ended, 31 December 2023, and subsequent filings. Our SEC filings can be found through our website or at the SEC's website. Investors are cautioned not to place undue reliance on such forward-looking statements. Please note that this conference call will be available for audio replay on our website at intuitive.com on the Events section under our Investor Relations page. Today's press release and supplementary financial data tables have been posted to our website. Today's format will consist of providing you with highlights of our full-year and 4th-quarter results as described in our press release announced earlier today, followed by a question-and-answer session. Gary will present business and operational highlights. Jamie will provide a review of our financial results and procedure highlights. Dan will present clinical highlights, then I will provide our financial outlook for 2025 and finally, we will host a question-and-answer session. With that, I'll turn it over to Gary.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

Thank you for joining us today. I'll touch on our performance for the full-year 2024 and share our perspective going into 2025. 2024 was a strong year for Intuitive with robust early adoption of our fifth-generation multiport platform, DaVinci 5 and healthy procedure growth in many of our supported indications and countries, resulting in strong financial performance for the year. Adoption of our ION and DaVinci SP platforms continued with new global clearances and increased utilization. Our teams have been hard at-work launching DaVinci 5 and learning from its early experience. We are improving our products across all three of our platforms and helping our customers achieve their programmatic objectives. We started 2024 focused on four main thrusts. First, we expanded indications and launches of our new platforms by region with a particular focus on our first phase of DaVinci 5 launch. Second, we pursued increased adoption for focus procedures by country through training, commercial activities and market access efforts. Third, we drove quality and gross margin improvements in our global operations. And finally, we focused on increasing our productivity, particularly in functions that benefit from industrial scale. Taken together, our team made excellent progress against these objectives. Moving to procedures, growth for the full-year was 17%. Areas of strength included general surgery in the United States and regional performance in countries including the UK and Ireland, Japan and Germany. Distribution markets, including Brazil, Spain and Italy were also strong in the year. This week, we announced the acquisition from AB Medica of the Da Vinci business in Italy, Spain, Portugal and related territories. We're pleased with their performance and we look-forward to welcoming these new staff to our team. In the US, general surgery procedure growth was led by chole cystectomy with forega and appendectomy procedures rising as well. Thoracic procedure growth was also healthy in the year. Bariatric procedures fell modestly for the full-year 2024 given the rise in GLP-1 medications. Procedure growth outside the United States continued to diversify beyond urology with nice growth in categories including general surgery and thoracic surgery. Globally, benigned indications grew approximately 200 basis-points faster in the year than cancer indications. In Flexible robotics ion procedures showed continued strength with 78% growth for the full-year. SP procedure growth accelerated in the year with 72% growth over a full-year, a result of healthy growth in Korea, Japan and Europe and solid growth in the US. On the capital front, we placed 1,430 multiport systems in the full-year 2024 compared with 1,313 multiport systems in 2023. Ion placements for the full-year were 271 versus 213 prior year and SP placements were 96 for the full-year versus 57 systems in the prior year. Globally, placements were strong in the United States, helped by the launch of DaVinci 5. Overall, our systems portfolio of DaVinci 5, DaVinci Xi, DaVinci X, Da Vinci SP and Ion combined with our flexible financing options allows our team to meet our customers' varying needs. Jamie will take you through placement dynamics in more detail later in the call. System utilization remains an important indicator of customer health because it is correlated to patient demand, care team satisfaction and hospital financial health. Multiport utilization grew 3% in the year. SP utilization grew 12% in the year and ion utilization grew 13%. Given our different platforms, their procedure mix and sites of care, teasing apart system utilization by customer segment becomes increasingly important going-forward. For example, a mid-sized community hospital lung program, systems utilization can differ from a high-volume community hospital general surgery program. As robot-assisted surgery moves to the back-half of adoption curves in some procedures, utilization growth rates may differ from prior year trends. Our performance supported revenue of $8.4 billion for the year, of which 84% was recurring and representing 17% growth over 2023. Our operating expenses were at the lower-end of our spend guidance. Our spending reflects three initiatives. First, we continue to invest in R&D to support innovation and adoption of our platforms and digital tools globally. Second, we're expanding our manufacturing and commercial footprints. And lastly, we have sought to leverage our enabling functions given our increased scale. Our product margins also started to improve in the year as increased shipment volume allowed for better factory utilization as well as leverage in our component shipment and other logistics costs. Taken together, our net income grew by 29% in 2024 over 2023. Touching briefly on DaVinci 5, our teams have done a nice job in executing a complex launch. We placed 362 DaVinci 5s in the year and over 2,500 surgeons have performed in total, over 32,000 procedures on DaVinci 5 in 2024. DaVinci 5 has broad clinical indications and over 40 different procedure types have been performed using DaVinci 5 to date. We design our systems to allow for routine sequential upgrades to their capability over-time and DaVinci 5 customers will receive hardware and software upgrades going-forward starting this year. This year's upgrades will focus on digital features supported by our 10,000 time increase in computing power. We'll share more details on these features as we bring them to-market. As we enter 2025, our company priorities are as follows. First, we will focus on the full launch of DaVinci 5, its regional clearances and follow-on feature releases. Second, we'll pursue increased adoption for our focus 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. Jamie, over to you.

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

Good afternoon. I will describe the highlights of our performance on a non-GAAP or pro-forma basis, and we'll also summarize our GAAP performance later in my prepared remarks. A reconciliation between our pro-forma and GAAP results is posted on our website. Q4 and 2024 revenue procedures and system placements are in-line with our preliminary press release of January 15. I will briefly review full-year 2024 performance before describing our Q4 results in greater detail. The 2024 financial performance was strong. Da Vinci procedures and total revenue each grew 17% over the prior year. Pro-forma gross margin improved 100 basis-points to 69.1% and pro-forma SG&A expenses leveraged as compared to 2023. As a result, pro-forma operating margin for 2024 improved 310 basis-points to 37% and pro-forma EPS increased 28%, building off of the 22% increase in 2023. We placed 362 da Vinci 5 systems in our first year of the limited launch, of which 174 systems were placed in Q4, including our first replacements of Da Vinci 5 in Korea. Turning to Q4, our financial performance was ahead of our expectations, driven by revenue growth of 25% and strength across the rest of the P&L, resulting in pro-forma operating margin of 38%. Q4 revenue reflected a couple of favorable dynamics. First, a higher purchase mix of systems as compared to recent periods, driven by multi-system deals with certain US IDNs that prefer to purchase and a higher mix of placements through distributors. Second, we saw a higher mix of dual console placements for Da Vinci 5 as we increased supply and were able to support more academic customers. And finally, we saw a higher system ASP resulting from a stronger -- mix of da Vinci 5 placements. Underlying core metrics were also strong with da Vinci procedure growth of 18%, growth in the installed-base of DaVinci Systems of 15% and average system utilization growth of 3%. In Q4, US procedures grew 15%, driven by growth in benign general surgery, including accretive growth in procedures performed after hours for emerging care. Bariatric procedures in the US declined in the low-to mid-single-digit range similar to last quarter. OUS procedures grew 25%, driven by relative strength in India, the UK, Italy and Japan. Procedure growth in Korea improved sequentially, in-part driven by strong SP growth. However, our business there continues to be impacted by physician strikes. Consistent with the last couple of quarters, procedure growth in China was slightly below the corporate average, reflecting a continuation of the dynamics we have described on previous calls. Looking at OUS procedure performance in aggregate, we see strong growth in colorectal, benign general surgery and thoracic CAGRs. Reviewing capital performance, we placed 493 systems in the 4th-quarter, 19% higher than the 415 systems we placed in the 4th-quarter of last year. In the US, we placed 284 systems in Q4, an increase of 75 systems as compared to last year, reflecting several large multi-system placements with a number of IDNs and an increase in the supply of Da Vinci 5. Outside the US, we placed 209 systems in the 4th-quarter compared with 206 in the same quarter last year. This quarter, we placed 89 systems in Europe, 43 in Japan and 20 in China compared with 71 in Europe, 70 in Japan and 11 in China in Q4 of last year. Placements in the UK and Germany continue to be impacted by ongoing government budget pressures affecting healthcare capital spending. The 89 system placements in Europe included 39 systems into markets served by our distributors as compared to 24 systems last year. In Japan, financial pressures caused some customers to delay capital investment decisions. 4th-quarter revenue was $2.41 billion, a 25% increase over last year. On a constant-currency basis, revenue growth was 26%. Systems revenue grew 36% year-over-year, driven by a 19% increase in da Vinci system placements, a higher system ASP and the higher purchase mix previously referenced. Additional revenue statistics and trends are as follows: leasing represented 45% of Q4 placements compared with 58% last quarter, driven by the aforementioned mix of system placements from certain IDNs in the US who prefer to purchase and a higher mix of placements with our distributors. However, as we look-forward, we continue to expect that leasing rates will increase over-time. Q4 system average selling prices were $1.59 million as compared to $1.42 million last year, driven by a higher mix of Da Vinci 5 and a higher dual console mix, partially offset by lower pricing in China. We recognized $28 million of lease buyout revenue in the 4th-quarter compared with $21 million last year. Da Vinci instrument and accessory revenue per procedure was approximately $1,860 compared with approximately $1,800 last year. The year-over-year increase in I&A per procedure reflects customer buying patterns and a higher mix of SP procedures, partially offset by procedure mix in the US given a lower mix of bariatric procedures and a higher mix of. Turning to Ion, there were approximately 28,000 Ion procedures performed in the 4th-quarter, an increase of 70% as compared to last year. In Q4, we placed 69 ion systems compared to 44 in Q4 of 2023. As a reminder, supply constraints impacted Ion system placements in the 4th-quarter of last year. Seven of the 69 systems were placed in OUS markets. The installed-base of Ion systems increased 51% from last year to 805 systems and average system utilization increased 13% year-over-year. 4th-quarter SP procedure growth continued to accelerate, growing 81%, driven by Korea and early-stage growth in Europe and Japan, where we have clearance for a broad set of indications. We placed 30 SP systems in Q4 and 96 for the year, up from 57 placements in 2023. 4th-quarter placements included seven in Korea, six in Europe and four in Japan. Average system utilization for our SP platform grew 18% in Q4, reflecting in-part growth of SP in-markets where we have a broad set of indications. We have received recent clearances in the US for thoracic and colorectal indications. However, we expect broad commercial efforts for SP in those procedure categories to commence once we obtain FDA clearance for a SP stapler. Moving on to the rest of the P&L, pro-forma gross margin for the 4th-quarter of 2024 was 69.5% compared with 68% for the 4th-quarter of 2023. The year-over-year improvement in gross margin reflects fixed overhead leverage given revenue growth, lower inventory reserves and improvements in freight and logistics costs. In 2024, we execute on our plans to significantly improve product margins for our ION and SP platforms. While we have made substantial progress, Ion and SP product margins continue to be dilutive and our teams have ongoing programs to deliver further improvement. With respect to our manufacturing expansion and capital investment plans, in 2025, we anticipate opening new facilities for Da Vinci 5 and ion system manufacturing in California and new endoscope manufacturing facilities in Germany and Bulgaria. As a result, and as we have previously indicated, we expect a significant increase in depreciation expense in 2025. We will also continue to transfer mature products to facilities in Corners, Georgia and Mexically. Given these activities, we expect elevated inventory levels during 2025. As we complete this cycle of manufacturing expansion that is driven by our strategy to operate at industrial scale, we anticipate lower levels of capital expenditures in 2025 and 2026 as compared to recent periods. 4th-quarter pro-forma operating expenses increased 9% compared with last year, driven by increased headcount, higher variable compensation and increased legal expenses. 4th-quarter 2024 operating expenses included a $45 million contribution to the intuitive foundation as compared to a $40 million contribution in Q4 of last year. Looking at operating expenses for the year, we delivered on planned leverage in SG&A, which improved by 180 basis-points as a percentage of revenue. While we will continue to look for opportunities within SG&A to leverage as we grow, we would highlight that in 2025, we expect increased depreciation expenses given recent capital expenditures and higher legal expenses given ongoing litigation. Innovation continues to be critical to helping our customers make progress in the aim and therefore, you should expect us to prioritize investments in R&D. Pro-forma other income was $87.6 million for Q4, lower than $94.6 million in the prior quarter, primarily driven by FX remeasurement of the balance sheet. Our pro-forma effective tax-rate for the 4th-quarter was 20.5%, a little lower than our expectations, reflecting net discrete benefits of $11 million related to statue of limitation expirations and other adjustments to certain tax items. 4th-quarter 2024 pro-forma net income was $805 million or $2.21 per share compared with $574 million or $1.60 per share for the 4th-quarter of last year. I will now summarize our GAAP results. GAAP net income was $686 million or $1.88 per share for the 4th-quarter of 2024 compared with GAAP net income of $606 million or $1.69 per share for the 4th-quarter of 2023. As a reminder, 4th-quarter 2023 GAAP tax expense reflected one-time benefits of $159 million related to an increase in deferred tax assets associated with a statutory rate increase in Switzerland and receipt of certain tax benefits related to our Swiss operations. The adjustments between pro-forma and GAAP net income are outlined and quantified on our website. We ended the year with cash and investments of $8.8 billion compared with $8.3 billion at the end of Q3. The sequential increase in cash and investments reflected cash generated from operating activities, partially offset by capital expenditures of $312 million. With respect to the plans we announced on Tuesday to go-direct in Italy, Spain, Portugal and associated territories, the base purchase price is EUR290 million with an earn-out of up to an additional EUR31 million based on 2025 procedure volumes. While our primary motivation is to develop closer relationships with the customers serving a combined population of approximately 118 million people. We do expect this transaction, which we estimate to close-in the first-half of 2026 to be slightly accretive to pro-forma EPS. Before I turn it over to Dan to discuss clinical highlights, let me address the outlook for pro-forma operating margins for 2025. Q4 performance of 38% was above our expectations. Looking ahead to 2025, we anticipate pro-forma operating margins in 2025 to be lower than Q4 due to several dynamics. First, as previously-stated, leasing rates are expected to be higher than Q4, which results in revenue and profits for related system placements to be recorded over multiple years versus in the quarter of placement. Second, we anticipate significantly higher depreciation expense given recent capital expenditures. And finally, we expect a higher mix of DaVinci 5, Ion and SP revenue, which carry product margins below the corporate average. In addition, from a modeling perspective, I would also highlight a couple of additional considerations. First, revenue denominated in non-USD currencies represents approximately 25% of our total revenue. On a revenue weighted basis, using current exchange rates, the US dollar is approximately 4% stronger than rates realized in Q4. Second, as we move into broad launch of DaVinci 5 in the middle of the year and customers have the opportunity to upgrade their fleets, we would expect trading credits for NXI to be significantly higher than recent periods, adversely impacting system ASPs. Finally, given the increasing choice customers have as competitors bring robotic systems to the market and seek a geographical clearances, we may see capital selling cycles lengthen as customers evaluate alternatives. Brandon will provide our outlook for 2025 later in this call. And with that, I would like to turn it over to Dan.

Daniel Oh
Vice President and Senior Medical Officer at Intuitive Surgical

Thank you, Jamie. I'd like to share with you some recently published peer-review literature that we found to be notable. In addition to the specific data highlighted on this call, we encourage you to consider the widebody of evidence detailing these topics and published scientific studies over the years. Today, we'll give an update on two recent publications. In the first study, Dr Roko and colleagues from the Massachusetts General Hospital in Boston collaborated with the research team at Intuitive for the COMPARE study published in the Analys of Surgery. This landmark study compared perioperative outcomes of da Vinci robotic-assisted surgery to laparoscopic or surgery as well as to open procedures. This was a meta-analysis which analyzes results from previously published evidence over-time to obtain an overview of cumulative data. In this study, the investigators pool data from randomized controlled trials, prospective comparative cohort studies and large real-world evidence database studies from the past 12 years in order to evaluate whether da Vinci procedures were associated with an improvement in short-term patient outcomes across seven commonly performed oncologic procedures from different specialties. Notably, over 1 million patients were included in each of the da Vinci, hyparoscopic, and open patient groups and included data from 22 countries. The authors found that compared to standard minimally-invasive surgery, patients undergoing da Vinci procedures had favorable perioperative outcomes. Specifically, da Vinci patients had a 56% lower chance of conversion to open, 21% lower chance of receiving a blood transfusion, and 10% less likelihood to experience a complication within 30 days of the procedure. In addition, length of stay was significantly shorter with lower 30 -day readmission and mortality rates. Similar favorable outcomes were found for da Vinci patients when compared to the open approach, with even greater magnitude differences between the two approaches. The authors concluded that this meta-analysis demonstrated multiple benefits for da Vinci procedures when compared to alternative, minimally-invasive or open approaches, noting that these results will be helpful to decision-makers considering the use of robotics in multi-specialty settings. In the second study, Dr Michael from Washington University School of Medicine and other colleagues published in Surgical Endoscopy the results of a preclinical study using intuitive novel force feedback technology incorporated in DaVinci 5. Across 28 surgeons with varying levels of experience, this study evaluated the forces applied to tissue when having force feedback technology on or off during core surgical tests, including retraction, dissection and suturing in a tissue model. Results from this study demonstrated a significant reduction in both the average and maximal forces exerted on tissue for all three surgical tasks, irrespective of surgeon experience levels. Notably, when using the highest sensitivity setting, up to a 55% reduction of the maximal force exerted on tissue during suturing was observed. The authors concluded that this study demonstrated that force feedback technology may significantly decrease the forces applied at the tissue level when performing common surgical tests across novice, intermediate and experienced surgeons. They continue to note, this innovative technology has the potential to enable safer and gentler surgeries, resulting in better surgical outcomes for patients undergoing robotic-assisted surgery. To me, the notable finding in this study is that the benefit of forced feedback was observed not just in novice surgeons, which one might expect, but also inexperienced surgeons who had completed at least 200 da Vinci procedures. Now, I'll turn it over to Brandon.

Brandon Lamm
Senior Manager, Investor Relations at Intuitive Surgical

Thank you, Dan. I will now turn to our financial outlook for 2025. Starting with procedures. As described in our announcement earlier this month, total 2024 da Vinci procedures grew approximately 17% year-over-year to over 2,680,000 procedures performed worldwide. For 2025, we anticipate full-year procedure growth within a range of 13% and 16%. The low-end of the range assumes growth in China continues to be impacted by environmental and competitive dynamics. European governments continue to constrain hospital capex budgets, limiting the expansion of capacity in the field and bariatric procedure declines continue at rates similar to 2024. At the high-end, we assume China procedure growth recovers relative to 2024, the capex environment improves in Europe and bariatric procedure declines moderate. Q1 and full-year 2025 will have approximately one fewer working day than 2024 due to the leap year. Turning to gross profit. In 2024, our pro-forma gross profit margin was 69%. In 2025, we expect our pro-forma gross profit margin to be within a range of 67% and 68% of net revenue. The lower estimate of pro-forma gross profit margin in 2025 reflects significant incremental depreciation as we bring on new facilities, the impact of growth in newer products and the impact of the stronger US dollar. Our actual gross profit margin will vary quarter-to-quarter depending largely on product, regional and trade-in mix and pricing. The range does not include any potential impact of new tariffs on our business, which could be material. Turning to operating expenses, in 2024, our pro-forma operating expenses grew 10%. In 2025, we expect our pro-forma operating expense growth to be within a range of 10% and 15%. The growth in operating expenses reflects increased depreciation from new facilities, investments in innovation to drive our growth objectives and an increase in legal expenses. We expect our non-cash stock-compensation expense to range between $760 million and $790 million in 2025. We expect other income, which is comprised mostly of interest income to total between $370 million and $400 million in 2025. With regard to capital expenditures, we expect the range to total between $650 million and $800 million, primarily for planned facility construction activities. With regard to income tax, in 2024, our pro-forma income tax-rate was 21.4%. As we look-forward, we estimate our 2025 pro-forma income tax-rate to be within a range of 22% and 23% of pre-tax income. That concludes our prepared comments. We will now open the call to your questions.

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Operator

Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press Star-1 again. One moment for questions. Our first question comes from Larry Biegelsen with Wells Fargo. You may proceed.

Lawrence Biegelsen
Analyst at Wells Fargo Securities

Good afternoon. Thanks for taking the question and congrats on a really strong finish to the year. One for Gary, one for Jamie. So Gary, historically you said procedures drive placement. In the second-half of '24, US system placements grew over 35%, utilization was about 2%. Is this a leading indicator of more procedures or will we have a digestion period to restore normal utilization? And I had one follow-up.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

Yeah, I think a couple of things are going on there. One of them is the -- as I said in the prepared remarks, as we get to the back-half of some curves of the expectations of some of those programs may be different in terms of utilization as they participate. In other words, not every account is going to be a high-volume account. And I think that's okay. I think the economics can work and I think we can supply them. So some of that is going on. I think the other thing is new -- new capital opportunities, new capital features can pull-forward or otherwise have people delay a little bit and then and then acquire systems that can put a wave or a ripple through utilization. And we're just going to have to see if that ripple plays through. So both of those effects are likely going on. It is actually extremely hard analytically to tease them out. I think in the US over-time, you're going to see utilization growth rates in multiport start to settle a little bit. I don't think they'll keep galloping. At the same time, I think SP utilization has room to run and on utilization has room to run.

Lawrence Biegelsen
Analyst at Wells Fargo Securities

Thanks, Gary. And Jamie, on the Q3 call, you said the gross margin will be a little lower in 2025 versus 2024. I think the 67% to 68% guidance was probably a little bit lower-than-expected. Can you quantify the drivers from the 69.1% this year in 2024 to the 67% to 68% and how to think about the path back to your goal of 70%? Thank you.

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

Yeah, there's really three drivers, Larry, the largest of which is the impact of depreciation expense and associated fixed costs. So there's deleverage in the '24 to '25 comparison, roughly-ish depending on where you have the revenue model for '25, that's about a point of the 160 point delta if you go from '24 actual to midpoint of '25. The other two dynamics, roughly equilish in terms of impact are our product mix with DV5, Ion and SP being a greater proportion of the revenue, they all carry currently margins below the corporate average, so have a dilutive effect from a mix perspective. And then I think what's new from the last call is the impact of FX. So those three things are the drivers. There are some offsetting of cost reductions the teams are delivering within that kind of gross margin range. I think what we've said with respect to gross margin is over the mid-term, we think we can get back beyond 70% and that is going to require us once we get past this kind of incremental depreciation to leverage over a multiyear period as we grow. And we also have, as we've said, the work on product margins in Ion and SP. There's still some work to be done there. And then on a more routine basis, our teams have to deliver cost downs.

Lawrence Biegelsen
Analyst at Wells Fargo Securities

Thanks, Jamie.

Operator

Thank you. Our next question comes from Robbie Marcus with JPMorgan. You may proceed.

Robert Marcus
Analyst at J.P. Morgan Securities

Okay. Thank you. And I'll echo congratulations on a fantastic 4th-quarter. Two from me. First, maybe for Gary. You gave a lot of detail in the call about a midyear full launch and trade-in cycle. Would love to just get your qualitative comments around how you're thinking about the mix of DaVinci 5 versus Xi going-forward? And the necessity or the speed of which an upgrade cycle can start and how you're thinking about Xi versus DaVinci 5 placements in terms of mix going-forward outside the US once approvals start rolling in? It all has implications for the model. So I'd love to get your thoughts on that.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

I was going to say I'll tell you a little bit about, I think perhaps the environmental aspects of that kind of the wrapping around it, I'll turn it over to Jamie for any modeling implications. I just you know what those -- two things are driving what we call broad launch. One of them is getting our supply chains up to scale and volume for what we expect demand could be when we start going out and looking at things like trade-ins and also starting to get clearances around the world. So that's exciting. The next one is software updates and those software updates reflect both feedback from the field and then the integration of some of the technologies in our digital space from hub to some of the imaging things we can do that start to come out in the first set of launches, which is really great. I think those are digital tools that our customers and surgeons will appreciate and starts giving them a lot of access to data that helps them analyze the performance of themselves and of their programs. How compelling that is will determine how fast customers want to upgrade. I think the upgrade cycle comes down to this kind of question of differential value. X and XI are outstanding machines. They work -- they are workhorses. They work really well. We're delighted to support them and support our customers who use them as they found increasing value in the features and content we bring to DaVinci 5, whether it's analytics or force reflection or ergonomics or better imaging, then that drives the trading cycle. The question, and I understand your modeling question well of how fast does it all move and what does that look like can be difficult to predict. Jamie, I'll turn it over to you and let you add your commentary.

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

Yeah, while we don't have a specific percentage of the impact of moving to broad launch, the impact of getting additional geographical clearances, obviously then says directionally over-time the proportion of placements that are DV5 generally should increase, although I would recognize that Xi is a capable system and at some point, we have the opportunity for a refurbished Xi. With respect to trade-ins, you don't really see trade-ins start to pick-up until you get to broad launch, which is the middle of the year, and it's going to be a function of the dynamics that Gary indicated. Of course, we can look-back at what happened on the Xi launch and how those upgrades went and we have some indication from customers in our pipelines. I think the best that we could say at this point, given it's so early is that any trading cycle would be progressive.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

The final point I'll make and I think you had asked Robbie, the question is part of this is, is there an opportunity for depreciated assets like X and Xi, which are highly capable, we know-how to service and we know-how to support or do those open or create other opportunities in other markets that may be more capital price-sensitive? And the answer to that is yes.

Robert Marcus
Analyst at J.P. Morgan Securities

Great. Maybe just one quick follow-up. Gary, you always give us a general state-of-the union on the health of the capital equipment environment around the world, US, OUS and I'm particularly thinking of China where you had a really strong placement quarter and 4th-quarter. So any thoughts there would be great as we head into 2025? Thanks.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

Yeah. I think Jamie usually does that. Jamie, why don't you take care of that?

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

I'd first say, I don't think we characterize the 20 systems we placed in China in Q4 as strong. It maybe it is on a year-over-year comparison basis, but the environment in China continues to be dynamic and challenging, as we've said, impacted by both domestic competition and a set of activity. Activities implemented by the government there. So I characterize the environment as relatively consistent and challenging. I mean in terms of capital, overall, I think in the US, it's been strong. Part of that is interest in DaVinci 5 given it's a new product. And you see to some extent, less sensitivity to capital budgets given just the proportion of placements in the US in particular that at least. We've highlighted the challenges in the UK and Germany. And new for us in Q4 for Japan was some delays because of the profitability in certain customers there. So I'd say we've seen relative strong strength in the US, some mix dynamics in the OUS markets. We don't really have enough TVs to predict how that plays out in '25.

Robert Marcus
Analyst at J.P. Morgan Securities

Thank you very much.

Operator

Thank you. Our next question comes from Travis Steed with Bank of America Securities. You may proceed.

Travis Steed
Analyst at BofA Securities

Hey, congrats as well. Gary, I wanted to ask a bigger-picture question. You're kind of crossing over to $1 billion a year in R&D now and even after launching DV5. So maybe help us understand the R&D investment opportunity over the medium-term and potentially moving into kind of new green spaces? Is that going to be more through the luminal platform? Or are there still chunky categories like cardio that could be amenable to robotics? Or is it more about geographic expansion, site of care? Just begin to understand kind of the true opportunities left out there to capture.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

I think it's a mix of all three of the things you just described. I think there are innovations and technologies, some of which are extensions to platforms you know about, some of which are platforms that are years away and you don't know about that I think open new opportunities for us over-time. And we're diligent about them. They take a while, they take some investment and they take follows. There are existing platforms that could use additional indications and those can be geographic, in which case there's the regulatory and clinical work to secure those indications, and so we spend money on that and go do it. And then there's additional indications that come from things like additional instruments and accessories and imaging capabilities on existing platforms that if we develop them, we can bring to-market and open the market for others. We also spend some money-making sure that late comers to robotics get what they need. It's not just that late comers just need time to simmer and sooner or later, they come find you. They sometimes have different needs, whether those needs are learning needs or economics needs and it takes some work and -- but we think that work is worth it. And some of the things you see in DaVinci 5 are those types of things. So short story is that we see opportunity in all of those buckets, we run a process that tries to balance those opportunities so that we're not totally overexposed to one or the other in that incent we have multiyear horizon and a multi-specialty horizon and it's geographically mixed.

Travis Steed
Analyst at BofA Securities

Helpful. Thanks. And then Jamie, maybe just a shorter-term opex question on the 10% to 15% growth kind of high and low-end, how much of that's R&D versus SG&A? Any color there on how that can shape up and kind of what drives the high and low-end? And potentially since you did mention tariffs, just kind of curious how to size that or potential ways to mitigate that if you can. I just wanted to kind of follow-up on Larry's margin question. Thank you.

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

Yeah. With respect to how R&D and SG&A might grow, I'd characterize it as similarish in terms of for that 10% to 15%. Obviously, R&D is a priority as we've stated. In SG&A, what you'll see us is add reps and commercial folks to support the procedure growth. And we also have said that there'll be higher legal expenses in SG&A given -- given ongoing litigation and a portion of the capex results and depreciation that goes into our SG&A expenses. And so they'll grow roughly ish about the same rate. In terms of the range of 10% to 15%, most of that is driven by the procedure range, meaning obviously to some extent, we'll manage our expenses in accordance with how our business plays out. There are some opportunities for us to invest incrementally in R&D, but we'll do that as we make progress and achieve milestones. In terms of tariffs, obviously, we see a lot in the news where we're monitoring those events closely. We are internally evaluating what the impact of any potential tariff might be and therefore how we might respond. We can say that the significant portion of our instruments are currently manufactured in Mexico. And so to the extent there are significant tariffs implemented there that could have a material impact for us. And of course, one response then that any company might consider is what would you do with pricing, nothing that we've decided there. And obviously, we're balancing the needs of our customers and their objective is with the needs of our own business. And so stay-tuned is what I'd say.

Travis Steed
Analyst at BofA Securities

Thank you.

Operator

Thank you. Our next question comes from Rick Wise with Stifel. You may proceed.

Frederick Wise
Analyst at Stifel Nicolaus & Co., Inc.

Thanks. Good afternoon. Gary, in your very thoughtful comments during the J.P. Morgan conference to you. I think you talked about new digital features and you should today again said hardware and software digital features coming. I was hoping -- and I'm sure you're not ready to give us truly specific specifics on all these, but maybe help us understand are what areas this -- in what ways this might enhance the DaVinci 5? Will it open up new procedures? Will it be about productivity? Will it be about -- will it enable you to use the DaVinci 5 in a different setting? How does this expand the vision or the possibilities of in the near-term? And then I'll have a follow-up, if I could.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

Yeah, an early thinking here, just I think of it in three categories. If we can make it easier to get great outcomes for more care teams by giving them tools in the OR, just real-time tools. We think that creates opportunities for them. I think it builds confidence. I think you get better care teams faster that way. And this kind of -- does that give you access to new procedures? I think the way to say that is it probably gives you access to more patients. Are they new procedure categories, not always, but there are patients that become easier for those surgeon and care teams to reach because they're more confident to reach them. So can it help us that way? Yeah, I think it can. I think that's one set of categories. The next one is, building confidence in care teams quickly is in everybody's best interest. It's great for the hospital, it gives them faster returns and higher confidence. It's great for the care teams. They build confidence and they get there faster. And I think a lot of our tools can help -- can help do that, can help accelerate learning not just for the surgeon, but for others. And then finally, I think a lot of these tools allow for a value analysis by the customer using their own data in their own hands and that I think builds confidence also and illuminates opportunity for them and that helps them and it helps us. So for DV5 and kind of the space we're in right now, that's how you ought to think about it. One of the neat things that used to say, and he's right is that every time you build a capability and then and then secure that, you have it, you understand it well, it opens a new door because a surgeon like Dr O here will take that new capability and start to explore with it, where can it be meet? What can I do next? And I think some of the things that we're working on in DV5, some of the imaging and augmented reality things will start to inspire the next set of surgeons. And with that inspiration comes opportunity?

Frederick Wise
Analyst at Stifel Nicolaus & Co., Inc.

Great. If I could follow-up briefly with Jamie. Jamie, obviously, Ion and FT both had terrific years last year. What accelerates what drives the next phase of growth there? And specifically, when -- is it what level of sales or what has to happen? And is it a year or five away? When are these two excellent products no longer a margin drag? Thank you.

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

Yeah. In terms of the overall business, what's driving procedures and revenue, if I look at Ion with 28,000 procedures in Q4, you can see that's a run-rate of over 100,000 procedures almost entirely in the US. So you're starting to get up the adoption curve in the US for Ion and a significant remaining portion is in a trans thoracic needle aspiration in terms of the approach versus bronchoscopic approaches in terms of where we've adopted in the early period. And so what you see based on where you are in the adoption curve in the US for biopsy for Ion is customers will tend to more focus on improvements in utilization. And as you get to that point in the adoption curve, again, biopsy in the US, you just naturally on an S-curve start to see procedure growth rates come down and you've seen that if you look at the last three or four quarters. And so for our business, kind of next set of focus, obviously, we've got to finish the US is the markets in which we're launching internationally with the clearance in Europe, Korea and China, and on a longer-term basis, there is the opportunity for Ion as a platform to get into new indications that would be in the lung first and there's potential for other places in the body down the road. From a product cost perspective, it is a set of programs that take quite some time. It's the everyday battle in the manufacturing team and there is some engineering work that needs to happen to kind of get to the product costs. And I'd say that's also in the mid-term, consistent with our overall gross margin objectives. And with respect to SP adoption, again, we've also got international launches there, Europe and Japan, both with broad indications. You see Korea, which we've had in the marketplace for some time, really strong utilization. And so for SP, it's really as we look to the US, it's the additional indications. We've got thoracic and colorectal. We have the opportunity to extend that over some period. You see the growth rate accelerating nicely in SP. Margin work-in SP is, let's say, not the same level of effort as Ion because we're more leveraged the surgeon and vision console are common with Xi, but nevertheless work to do. That is also I'd characterize as something that happens over the mid-term.

Frederick Wise
Analyst at Stifel Nicolaus & Co., Inc.

Thank you, Jamie.

Operator

Thank you. Our next question comes from David Roman with Goldman Sachs. You may proceed.

David Roman
Analyst at The Goldman Sachs Group

Thank you and good afternoon, everybody. I wanted just to start with a comment you made in the prepared remarks regarding competition and selling cycles. Is this something that you're observing today as you talk to customers outside the US or even in the US or are you just calling out a theoretical impact of what might happen as new entrants come to-market? And I have one follow-up.

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

We have seen it clearly in China with the increasing number of domestic competitors there. I'd say that in terms of impact of competition to selling cycles in other international markets has been relatively stable. But what you're seeing is an increasing number -- number of competitors get clearances in various markets, including in the US, there are a number of competitors in the US and obviously, there's one larger company that some looking to make a submission in Q1. And so we're just acknowledging that as competition increases, there is the possibility outside of China that selling cycles could lengthen.

David Roman
Analyst at The Goldman Sachs Group

Got it. That's helpful. And maybe just kind of a segue on that one. As you think about the opportunity in instruments and accessories, either on a per procedure basis or a total addressable market basis. Can you help us think through which parts of sort of the surgical ecosystem you've captured today? And maybe give us some sense of where that might be going over-time. We understand as the fourth sensing piece of the launch with DV5 and how that might impact basically an upgraded instrument and corresponding ASP within that INA line. But as you look at kind of other parts of the surgical ecosystem that you could capture to further entrench yourself. Can you help us understand what those might be and maybe size some of them and how kind of you think about that when kind of your marketing and strategic planning teams?

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

Yeah. Maybe I'll start with kind of the principles we use to think about how we can bring additional value to procedures we already participate in. And underneath, I think you have a modeling question and I'll let Jamie take that. On the principal side, we look around and say, if there's something going on in the operating room that our customers are currently spending on, they're buying from somebody else. And we think that either we have design capabilities or integration capabilities that would make for that experience to be better for them and value-creating. It's either clinically value-creating or it's economically value-creating, then we'll seek to do that. Sometimes in partnership, you see that -- doing that with on-table and sometimes it's something that we'll try to do ourselves take in-house the way we've done some, some things like the candula seals and stapling. So we look across it, if we see a real place that it's true value-creation, not just something where it changes the revenue line by doing exactly what somebody else does, we're not very interested in that. But if we think the integration or the design creates a better outcome for the customer, either economically or clinically, hopefully both, then we'll step forward and we'll do that. We don't think we're done. If you look at DaViti 5, you saw some things come into DaVinci 5 that were benefited by integration and we think it's working great. So we look for those things. They take a while. They're not immediate. So our strategy and our product planners are looking for value-creation opportunities there, but it doesn't start with how fast can the revenue growth be. It starts with what's the value-creation and what could that be? Four sensing instruments, first reflecting instruments are such an example. They're more complex. They have a higher ASP. We think they bring value. We have to demonstrate that value and off we go. Jamie, I think the modeling question is super hard, but I'm going to give you a shot.

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

Yeah. So I would just say that the two examples I'd reference in terms of where you could, let's say, get greater share of wallet if you can bring value our force feedback instruments and insulation both on Da Vinci 5. False feedback, we don't expect to be kind of at broad supply until the end of end of '25. So the kind of net impact that has on INA per procedure is gated by when we get to broad supply. With respect to inslation. So-far, the proportion of cases that use that has been pretty high and that can have an impact as procedure volumes grow. I would just say, if I zoom out in terms of INA per procedure in total, the larger driver is going to be procedure mix, a greater proportion of kind of where we see growth coming from is in benign procedures. Gary kind of described that in more recent results. But when you think about cholly and other benign procedures, you'll have a procedure mix dynamic that means that we think at least over the next couple of years, INA per procedure drifts down slowly over-time we have time for just one last question.

Operator

Thank you. Thank you. And our last question comes from Patrick Wood with Morgan Stanley. You may proceed.

Patrick Wood
Analyst at Morgan Stanley & Co. LLC

Beautiful. Thank you so much. A bit of a weird conceptual one, I'm just kind of curious about. But if you think of the efficiencies from your installed-base, so over-time as you're placing more-and-more systems and in individual areas and regions, the installed-base densities going up, like is there really a margin implication for that from more efficiencies in selling into the customer-base, servicing the systems? Can you see that in some areas or regions or markets where you've got a lot of density versus those where you have slightly less scale? I'm just conceptually trying to understand the effect of that over the long-term. Thanks.

Jamie E. Samath
Executive Vice President, Chief Financial Officer and Enterprise Technology Leader at Intuitive Surgical

Well, generally, the INA revenue are at higher margins than capital. And so as you drive utilization growth, then a greater proportion of the revenue over some period comes from the higher profit streams. And so, well, let me ask, Patrick, is that the essence of your question?

Patrick Wood
Analyst at Morgan Stanley & Co. LLC

It was more around the service and the efficiency of driving into those existing accounts rather than the mix between the two.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

I'll answer quickly just in light of time. We do get some advantages of scale with geographic density in terms of cost to support an account. So service, service depots, sales support, training support. As that gets -- gets become -- as that becomes more dense, it does give us some cost advantages to serve them. Is that where you're headed?

Patrick Wood
Analyst at Morgan Stanley & Co. LLC

That's the way. Thank you so much.

Gary S. Guthart
Chief Executive Officer and Member of the Board of Directors at Intuitive Surgical

Thanks so much. That was our last question. In closing, we believe there's a substantial and durable opportunity to fundamentally improve surgery and acute intervention. Our teams continue to work closely with hospitals, physicians and care teams in pursuit of what our customers have termed the, better, more predictable patient outcomes, better experiences for patients, better experiences for their care teams, better access to great care and ultimately a lower total cost of care. We believe value-creation in surgery and acute-care is foundationally human. It flows from respect for an understanding of patients and care teams, their needs and their environment. At intuitive, 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 for your support on this extraordinary journey, and we look-forward to talking with you again in three months.

Operator

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

Corporate Executives
  • Brandon Lamm
    Senior Manager, Investor Relations
  • Gary S. Guthart
    Chief Executive Officer and Member of the Board of Directors
  • Jamie E. Samath
    Executive Vice President, Chief Financial Officer and Enterprise Technology Leader
  • Daniel Oh
    Vice President and Senior Medical Officer
Analysts
  • Lawrence Biegelsen, Wells Fargo Securities
  • Robert Marcus, J.P. Morgan Securities
  • Travis Steed, BofA Securities
  • Frederick Wise, Stifel Nicolaus & Co., Inc.
  • David Roman, The Goldman Sachs Group, Inc.
  • Patrick Wood, Morgan Stanley & Co. LLC

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