Intuitive Surgical (ISRG) Q4 2023 Earnings Call Transcript

Intuitive Surgical (ISRG -1.17%)
Q4 2023 Earnings Call
Jan 23, 2024, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Thank you, everyone, for standing by. Welcome to the Intuitive fourth-quarter 2023 earnings call. At this time, all participants on a listen-only mode. Later, we will conduct a question-and-answer session.

[Operator instructions] I will now turn the call over to your host, head of investor relations, Brian King. Please go ahead.

Brian King — Treasurer and Head of Investor Relations

Good afternoon and welcome to Intuitive’s fourth-quarter earnings conference call. With me today, we have Gary Guthart, our CEO; and Jamie Samath, our CFO. 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 filed on February 10th, 2023 and form 10-Q filed on October 20, 2023. 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 four-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, then I will discuss procedure and clinical highlights and provide our financial outlook for 2024, and finally, we will host a question-and-answer session. And with that, I will turn it over to Gary.

Gary Guthart — Chief Executive Officer

Thank you for joining us today. I’ll touch on our performance last quarter and for the full-year 2023 and share our perspective on 2024. The past year was a good one for Intuitive with use of our platforms growing nicely, hospitals building additional system capacity to support that growth, and increased average utilization persistent per year for each of our platforms. Our teams have been delivering to meet customer demand, driving quality and availability improvements, running clinical trials, and readying new products and services for the market. We’ll touch on a few of those efforts on this call.

Starting first with procedures. Growth for the full year was 22%. Areas of strength included general surgery in the United States and regional performance in countries including Germany, France, the U.K., and Ireland to name a few. In the U.S. general surgery procedure growth was led by cholecystectomy with foregut procedures rising as well.

Colon — colon and hernia procedure growth was also healthy for the year. Bariatric procedures grew year over year. However, we saw continued deceleration of growth throughout 2023, likely the result of the uptake of GLP-1 drugs for obesity. Procedure growth outside the United States diversify beyond urology with nice growth in categories including gynecology and general surgery. In flexible robotics, Ion procedures showed continued strength with 129% growth for the full year.

SP procedure growth was accretive in the year with 48% growth over the full year driven by acceleration in the United States. On the capital front, we placed 1,313 multi-port systems in the full-year ’23, compared with 1,241 multi-port systems in 2022. Ion placements for the year were 213 versus 192 prior year, and SP placements were 57 for the full year versus 23 systems in the prior year. Globally, placements were strong in the United States and Japan in the year. The use of flexible financing arrangements was substantial in the quarter, particularly in the United States as customers seek to build capacity, balance their da Vinci system portfolios to improve access, and lastly, to allow flexibility to upgrade to future systems. Jamie will take you through placement dynamics in more detail later in the call. System utilization, defined as procedures per installed clinical system per quarter, grew 9% globally year over year for our multi-port platform, reaching a new high as customers adopt a broad mix of procedures on our systems.

Utilization grew 15% for SP in the year, while it grew 6% for Ion over 2022. Utilization is an important indicator of customer health because it is correlated to patient demand, care team satisfaction, and hospital financial health. The above performance reported revenue of 7.1 billion for the year, 14% growth over ’22. Our capital and operating expenses were on the upper end of our spend guidance, reflecting continued investments in R&D to support growth of our platforms and digital tools, expansion of our manufacturing and commercial footprints, and capital amortization. Profit margins were challenged in the full year as a result of higher-than-expected costs primarily for our newer platforms.

Jamie will take you through our financial performance in greater detail later in the call. Strengthened procedures, growth in the clinical install base, and increased utilization signal continued belief by our customers that our platforms make a difference in their efforts to pursue the quadruple aim: better outcomes, better patient experiences, better care team experiences, and lower total cost to treat per patient episode. As we look to 2024, I’d like to share with you that we have submitted to FDA our 510(k) application for our next-generation multi-port platform, da Vinci 5. Our design priorities for our new platforms are as follows: First, we look for opportunities to bring better minimally invasive care to more patients.

Second, we work to improve the performance of our platforms and existing procedures. Third, we seek to improve care team satisfaction through product utility, dependability, and usability improvements. And finally, we strive to help lower the total cost to treat per patient episode. Once cleared, we believe da Vinci 5 will make a positive impact on each of these objectives through hundreds of design changes that respond to surgeon and care team inputs and fulfill our design priorities. As just one example, da Vinci 5 possesses four orders of magnitude greater processing power than our generation 4 products. That means 10,000 times the processing power to gather data, improve sensing, and deliver better digital and analytic performance.

Given the sophistication of the technologies involved, we plan a phased launch in the first several quarters after clearance, giving us time to mature our supply and manufacturing processes for the new system. Da Vinci 5 will join our existing robotic surgical system portfolio alongside multi-port systems X and Xi, and single-port system SP, offering surgeons and hospitals their choice of highly capable proven solutions from Intuitive. We have been in communication with FDA on da Vinci 5 for the past several quarters and have completed a comprehensive multi-center IDE trial. This trial finished accruing patients in May of 2023, and we submitted for our 510(k) to FDA for da Vinci 5 in August last year. We are currently responding to FDA’s questions.

The timing of the U.S. launch will depend on the time required to resolve these questions. So, far we believe the questions asked fall within normal expectations for a submission of this type. In addition to FDA, we have initiated conversations on da Vinci 5 with regulators in Japan and in Korea and will report our progress toward commercialization in countries outside the United States as we know more. Once FDA cleared, we will communicate features and benefits in greater depth.

We started 2023 focused on increased adoption of our priority procedures and countries through outstanding training, commercial, and market access execution. We pursued expanded indications and launches for Ion and SP. We focused on excellence and continuity of supply, product quality, and services provision as we emerge from pandemic stresses. And finally, we pursued increased productivity in our functions that benefit from scale.

Taken together, our team made good progress against these objectives. As we enter 2024, our company priorities are as follows: First, we’ll focus on innovation through expanded indication and launches of our new platforms by region, including our first phase of da Vinci 5 launch once cleared. Second, we’ll pursue increased adoption for focused procedures by country through training, commercial activities, and market access efforts. Third, we will drive quality and gross margin improvements. And finally, we continue to focus on increasing our productivity, particularly in functions that benefit from industrial scale. I’ll now turn — I’ll now turn the time over to Jamie.

Jamie Samath — Chief Financial Officer

Good afternoon. I would describe the highlights of our performance on a non-GAAP or performer basis and 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 2023 revenue procedures and system placements are in line with our preliminary press release of January 9th.

I will briefly review full-year 2023 performance before describing our Q4 results in greater detail. 2023 procedures grew by 22% as compared to last year, or 17% on a four-year compound-annual-growth-rate basis. As we’ve discussed on previous calls, 2023 procedure growth was above our longer-term trend primarily because of the need to address patient backlogs. During the year, we placed 1,370 systems with customers, an increase of 8% year over year. Excluding trade-in transactions, net new system placements for 2023 grew by 23% over the prior year, with the U.S. up 26% driven primarily by customer need for additional capacity.

Trading volumes declined by 105 systems to a total of 240 trading transactions for the year. Recurring revenue, which is correlated to ongoing use of our products, represented 83% of total revenue and grew 21% over the prior year. Total revenue of $7.1 billion increased 14%. And for the first time, our advanced instrument portfolio of stapler and energy devices exceeded $1 billion in revenue, growing 21% in 2023. During the year, we repurchased $416 million of our stock, or approximately 1.7 million shares at an average price of $241 per share. We have a remaining authorization to repurchase our shares of $1.1 billion.

Given these results, pro forma earnings per share for 2023 grew 22% as compared to last year. Turning to Q4, our core metrics were strong. Da Vinci procedures grew 21%. The installed base of systems grew 14% to 8,606 systems.

And average system utilization continue to be above long-term trends, increasing by 9% for the full year of 2023. Higher system utilization reflects both a higher mix of shorter-duration benign procedures and the need to address patient backlogs. In Q4, U.S. procedures grew 17% driven by growth in general surgery. OUS procedures grew 29% driven by strong performance in China, the U.K., Germany, and Japan, with notable strength across multiple OUS markets in general surgery, which grew 44% in Q4.

As a reminder, procedures in China in the fourth quarter of last year were adversely impacted by increasing COVID cases, resulting in negative growth in Q4 of 2022. Turning to capital. We placed 415 systems in the fourth quarter, 12% higher than the 369 systems we placed in the fourth quarter of last year. In the U.S., we placed 209 systems in Q4, 28 more than last year, driven by capacity expansion for procedure growth and higher greenfield placements at existing IDN customers. We placed 70 systems in Japan with strength — strength driven by greenfield placements and customer use of remaining capital budgets. Consistent with last quarter, we have seen delayed tenders and lower system placements in China due to ongoing anti-corruption efforts by the government.

We expect system placements in China to be at lower levels at least through the first half of 2024. Globally, there were 51 trading transactions in the quarter, as compared to 110 last year. As of the end of Q4, there are approximately 375 Sis remaining in the installed base, 60 of which are in the U.S. Fourth-quarter revenue is $1.93 billion, an increase of 17% from last year.

On a constant-currency basis, revenue growth was also 17%. Additional revenue statistics and trends are as follows: Leasing represented 48% of Q4 placements, compared with 42% last year. The increasing lease mix we have seen over time is primarily driven by customers in the U.S., particularly those who have acquired systems under usage-based arrangements. These arrangements provide customers greater financial flexibility to expand their robotics programs independent of capital budgets. These arrangements also incorporate technology obsolescence protection for next-generation technology.

Q4 system average selling prices were $1.42 million, as compared to $1.43 million last year. System ASPs were negatively impacted by regional mix, partially offset by lower trade-ins. We recognized $21 million of lease buyout revenue in the fourth quarter, compared with $17 million last quarter and last year. Da Vinci instrument and accessory revenue per procedure was approximately $1,800, compared with approximately $1,820 last year. The year-over-year decline in I&A per procedure is primarily a result of procedure mix in the U.S. given strong growth in cholecystectomy and lower growth in bariatrics and customer ordering patterns, partially offset by the I&A price increase implemented in mid-2023.

Turning to Ion. There were approximately 16,500 Ion procedures in the fourth quarter, an increase of 108% as compared to last year. In Q4, we placed 44 Ion systems, compared to 67 in Q4 of 2022 and 55 last quarter. We experienced supply challenges for our Ion catheter and vision probe and limited Ion system placements during the quarter to ensure customers could effectively launch their programs. There is strong customer demand for Ion, which contributed to backlog growth in the quarter. We are working hard and making progress to resolve these supply challenges.

The install base of Ion systems is now 534 systems, of which 214 are under operating lease arrangements. Our SP platform continue to make progress in 2023. Fourth-quarter SP procedure growth accelerated to 58%. We placed 19 systems in Q4 and 57 for the year, up from 23 placements in 2022.

Fourth-quarter placements included five in Korea and two in Japan. Average system utilization for our SP platform grew 15% in 2023, reflecting increased usage by U.S. customers. We continue to make progress in expanding the opportunity for SP, including continued work on regulatory submissions in the U.S. for colorectal and thoracic indications and a system submission in China. In January, we received clearance for SP in Europe across a broad procedure set and are planning for a measured rollout as we build local KOLs and establish local proctoring and training capabilities.

Moving on to the rest of the P&L. Pro forma gross margin for the fourth quarter of 2023 was 68%, compared with 68.2% for the fourth quarter of 2022. The year-over-year decline in pro forma gross margin reflects increased inventory reserves and a higher mix of new platform revenue that currently carry dilutive gross margins, partially offset by the I&A price increase implemented mid-last year. With respect to our manufacturing capabilities and capital investment plans, during the quarter, we initiated local Xi system production in China, allowing us to participate in tenders that require a domestically produced system. We also completed the transfer of X system production to our East Coast hub near Atlanta, Georgia. And during 2024, we are planning to transfer Xi system production from California to our East Coast hub.

Over the next 18 months, we expect to open new manufacturing facilities for da Vinci 5 and Ion system manufacturing in California, and to complete line transfers for Ion and SP I&A to our Mexicali facility. We believe these activities will position Intuitive to serve our customers with best-in-class supply availability, product quality, and product cost. Fourth-quarter pro forma operating expenses increased 15% compared with last year driven by increased headcount and higher variable compensation. In addition, fourth-quarter 2023 operating expenses included a $40 million contribution to the Intuitive Foundation. We did not make a contribution in 2022. Pro forma other income was $67.1 million for Q4, higher than $57.9 million in the prior quarter, primarily due to higher interest income.

Our pro forma effective tax rate for the fourth quarter was 15.9%, lower than prior quarters, primarily because of the release of certain tax reserves associated with the expiration of related statutes and a favorable earnings mix. Fourth-quarter 2023 pro forma net income was $574 million, or $1.60 per share, compared with $439 million, or $1.23 per share, for the fourth quarter of last year. I will now summarize our GAAP results. GAAP net income was $606 million, or $1.69 per share, for the fourth quarter of 2023, compared with GAAP net income of $325 million, or $0.91 per share, for the fourth quarter of 2022. Fourth-quarter GAAP tax expense reflected one-time benefits of $159 million associated with an increase in deferred tax assets associated with a statutory rate increase in Switzerland and receipt of certain tax benefits associated with our Swiss operations. The adjustments — 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 $7.3 billion, compared with $7.5 billion at the end of Q3. The sequential reduction in cash and investments reflected capital expenditures of $435 million, partially offset by cash generated from operating activities. Let me take a moment to address the new multi-port system that Gary highlighted and certain assumptions that may impact 2024 modeling. First, since we have not received FDA clearance for da Vinci 5, we cannot provide specificity on launch timing and pricing. Second, once cleared, we are planning a phased launch period over several quarters.

Noting that we are at the end of the Si trading cycle and that da Vinci 5 will be in a phased rollout, we expect total trading volumes to be lower in 2024 than the prior year. Given that and our procedure guidance of 13% to 16% growth, we also expect total system placements for 2024 to be lower than 2023. As a result of the phased rollout of da Vinci 5, we expect a higher proportion of gen 4 systems will be leased as customers seek flexibility to upgrade to da Vinci 5 when supply allows. For those customers that prefer to purchase a gen 4 system, we will offer a future trading rate that can be exercised when there is sufficient da Vinci 5 supply. Purchase contracts containing a trading rate result in a deferral of a portion of the purchase price, negatively impacting systems revenue.

Finally and consistent with our experience bringing four generations of platforms to market, new systems typically start at lower gross margins and rise over a multiyear period as we build volume and optimize design, manufacturing, and supply chains. Brian will describe our gross margin guidance in more detail later in the call. Before I turn it over to Brian to discuss clinical highlights and our outlook for 2024, let me address operating margins. 2023 pro forma operating margin was 34% of revenue, compared to 35% in the prior year. We expect operating margins to be under pressure in 2024 given the anticipated launch of da Vinci 5, increased depreciation expense, and an adverse mix impact to gross margin from the growth in new platforms.

However, as we look to the medium term, we see opportunity for operating margin expansion based on the following dynamics: one, moving to broad launch in da Vinci 5, allowing customers the opportunity to upgrade their existing fleet to the latest technology; two, improving gross margin, we aspire to be above the 70% level over time; and three, leveraging those functions that can take advantage of scale as we grow. Improvements to gross margin will be driven by the following actions: first, improving the product cost of new platforms including da Vinci 5; second, growing into and eventually leveraging the incremental fixed cost from new manufacturing facilities; and third, the return of resources that have been deployed to supply continuity given the impact of the pandemic to returning to routine manufacturing and product cost reduction activities. We have the teams and capability to deliver on these efforts over the next several years. And with that, I would like to turn it over to Brian.

Brian King — Treasurer and Head of Investor Relations

Thank you, Jamie. Overall procedure growth for full-year 2023 was 22% year over year, compared to 18% for the full year of 2022. Overall procedure growth was comprised of 19% growth in the U.S. and 27% growth outside of the U.S.

In the U.S., fourth-quarter 2023 procedure growth was 17% year over year, compared to 18% for the fourth quarter of 2022 and 17% last quarter. Fourth-quarter growth was led by procedures within general surgery with strength in cholecystectomy, colon resection, and foregut procedures. As Gary noted, bariatric procedures continued to grow year over year but growth moderated into the mid-single digits. Looking outside of the U.S., over the years, we have made investments in countries and international markets to support customers and their adoption of da Vinci procedures. Looking back over the past decade, OUS procedures have grown 20% on a compound-annual-growth basis and have consistently been accretive to total procedure growth. OUS procedures have grown from about 20% of total global procedures to now about a third.

While market maturity and levels of adoption differ by region and country, broadly, we now see more than half of OUS growth being led by procedures beyond urology, reflecting customers growing adoption of general surgery, gynecology, and thoracic procedures, the results of which I will highlight below. Focusing on the fourth quarter, OUS procedure volume grew 29%, compared with 18% for the fourth quarter of 2022 and 24% last quarter. Growth was led by strength in colon resection, followed by growth in hysterectomy and lung resection procedures. Growth in urology continued to be healthy, led by kidney procedures, along with continued double-digit growth in prostatectomy. In Europe, fourth-quarter growth was led by general surgery and gynecology procedure categories. Germany, the U.K., and France procedure performance led the region.

In Germany, we saw strong growth in colon resection and kidney procedures; in the U.K., from growth in hysterectomy and rectal resection; and in France, from growth in colorectal and lung resection procedures. In Asia, growth in the fourth quarter was led by China, reflecting a benefit from lower procedure volumes in the fourth quarter of 2022 due to COVID. In Japan, our third-largest market by procedure volume, procedure growth was healthy and led by prostatectomy and colorectal procedures. We placed 70 systems in Japan, reflecting the continued adoption of robotic surgery for a growing number of procedures and availability of remaining capital budgets. India, while still in the early stages of adoption, saw continued strength in general surgery and gynecology procedures. Now, turning to the clinical side of our business.

Each quarter, on these calls, we highlight certain recently published studies that we deem to be notable; however, to gain a more complete understanding of the body of evidence, we encourage all stakeholders to thoroughly review the extensive detail of scientific studies that have been published over the years. In the fourth quarter, Dr. Nicola De’Angelis from [Inaudible] University Hospital, along with multiple colleagues from the French Society of Parietal Surgery for Hernia and French Society of Digestive and Visceral Surgery published a systematic review and meta-analysis describing robotic surgery for inguinal and ventral hernias in surgical endoscopy. In this analysis, authors reviewed publications between September 2014 and July 2022 and published pooled outcomes comparing the robotic-assisted approach for both inguinal and ventral hernia repairs to both laparoscopy and the open approach. With regards to inguinal hernia, when compared to laparoscopy, the robotic-assisted approach was associated with a 46% lower risk of hernia recurrence. Furthermore, subjects undergoing a robotic-assisted approach were associated with a 54% lower rate of opioid use relative to the open approach. For ventral hernia repairs, the robotic-assisted approach had a 49% lower risk of conversion to open and 41% lower risk of intraoperative bowel injuries relative to laparoscopy. When comparing to an open repair for ventral hernias, the robotic-assisted approach was associated with a 3.4-day shorter length of stay, 34% lower risk of 30-day readmissions, 39% lower risk of overall complications, and more specifically, a 53% lower risk of surgical site infections.

The authors concluded, “The present systematic review and meta-analysis supports the use of robotic surgery for abdominal wall hernia repair. Pooled data analyses show improved outcomes over laparoscopy and open surgery, particularly for ventral hernia repair. Overall, these results, based on 64 studies, support robotic surgery as a safe, effective, and viable alternative to traditional open and laparoscopic surgery for inguinal and ventral hernia repair and may contribute to dismiss the residual skepticism and increase the interest toward this minimally invasive surgical technique.” I will now turn to our financial outlook for 2024. Starting with procedures. As described in our announcement earlier this month, total 2023 da Vinci procedures grew approximately 22% year over year to over 2,280,000 procedures performed worldwide.

For 2024, we anticipate full-year procedure growth within a range of 13% and 16%. Our overall procedure guidance range assumes that growth moderates from last year given the elevated backlog benefit we experienced in 2023. The low end of the range assumes a modest decline in bariatric procedures, along with challenges in China from increasing competition and anti-corruption activities impacting capital placements, and therefore, procedure growth. We also assume there is no impact from patient backlog in the year. At the high end of the range, we assume bariatrics continues at current growth rates and factors in China do not have a significant impact on our business.

In addition, we assume any backlog of patients with decline throughout the year. Finally, we would expect that procedure seasonality will follow normalized historical patterns, resulting in a tough comparison for the first half of 2024 given the strong procedure growth in the first half of last year. Turning to gross profit. Our full-year 2023 pro forma gross profit margin was 68%.

In 2024, We expect our pro forma gross profit margin to be within 67% and 68% of net revenue. The lower estimate of pro forma gross profit margin in 2024 reflects the impact of growth in our newer products and the impact of capital investments that will come on to support the growth of our business. Our actual gross profit margin will vary quarter to quarter, depending largely on product, regional, and trade-in mix, impact of new product introductions, and pricing. Turning to operating expenses. In 2023, our pro forma operating expenses grew 14%.

In 2024, we expect pro forma operating expense growth to be between 11% and 15%. The operating expense growth reflects increased depreciation expense as we bring on new facilities and investments to drive our growth objectives. We expect our noncash stock compensation expense to range between 680 million to 710 million in 2024. We expect other income, which is comprised mostly of interest income, to total between 290 million and 320 million in 2024. With regard to capital expenditures, we expect the range to total between $1 billion to $1.2 billion, primarily for planned facility construction activities. With regard to income tax, in 2023, our pro forma income tax rate was 20.6%.

As we look forward, we estimate our 2024 pro forma tax rate to be between 22% and 24% of pre-tax income. That concludes our prepared comments. We will now open the call to your questions.

Questions & Answers:

Operator

Thank you. [Operator instructions] And our first question will come from the line of Larry Biegelsen of Wells Fargo. Please go ahead. OK, sir, your line is open now.

Larry Biegelsen — Wells Fargo Securities — Analyst

Can you hear me?

Gary Guthart — Chief Executive Officer

Yes.

Jamie Samath — Chief Financial Officer

Hey, Larry.

Larry Biegelsen — Wells Fargo Securities — Analyst

Oh, you can hear me. Great. Thanks for taking the question. Congrats on a nice end to the year here.

Thanks for all the color on da Vinci 5. So, obviously, a few questions on that. I’d love to start with just, Jamie, maybe a framework for how to think about the financial implications of a new system. Beyond 2024, is the Xi launch a good analog from a pacing standpoint? And what are the ramifications of leasing? You know, if a customer is up on lease upgrades, you know, will the lease get the ASP lift, you know, we assume you’ll have? And what will you do with the returned Xis? And I had just one follow-up.

Jamie Samath — Chief Financial Officer

Yeah, I would say the — the dynamics are quite different between when we launched Xi in 2014 versus where we are today. And I think the — the feature sets of da Vinci 5, which we haven’t described, I think are important context for you all, which we’ll do once we have clearance. You look at relative penetration of da Vinci over that period. The extent to which leasing has — has changed significantly our U.S.

penetration, I think there are a number of factors, Larry, where I would not use the kind of Xi ramp and progression as a — as a reference point for how da Vinci 5 might progress. But I think that I would make any further comments on that once we get through clearance and are able to talk to you about the feature set. So, there is —

Larry Biegelsen — Wells Fargo Securities — Analyst

Do you have any color — yeah, Jamie, please?

Jamie Samath — Chief Financial Officer

With respect to these leases, so, I think there are a number of dynamics that, in the end, will motivate a customer to look at a trade even if they have an existing system under lease. If I — if I hold everything else equal and just look at the fact that the asset is leased, I do think there is some benefit to the customer insofar as they can avoid a capital budget barrier to executing a — an upgrade. But — but I think you have to look at all of the other dynamics that we’re yet to describe.

Larry Biegelsen — Wells Fargo Securities — Analyst

OK, and then, I guess on the new system, you know, I’ll try my luck here. You know, just lastly, do you expect the same indications on — as Xi upon launch? And, Gary, is this more about improving outcomes in existing procedures or expanding addressable procedures? Thank you.

Gary Guthart — Chief Executive Officer

Yeah, we submitted for broad indications. And in the IDE trial, it was a broad indication trial. What that looks like in the end will — will come down to how we answer some of the questions that come back and forth. So, I’m not telling you what the endpoint is, but I can tell you what our starting point is.

In terms of kind of breadth and depth, we think that it will allow for additional penetration into some of the categories we’re in already. And maybe an analogy is you could do some general surgery with Si, the earlier system, we had clearances there, but Xi had some product improvements and — and some really nice forward progress that allowed us for greater penetration depth. So, there’s opportunity for depth. We think, over time, there’s opportunity for additional indications. Those are unlikely to occur right out of the gate.

And we think that there are some really nice indications to — to talk about in — or features to talk about in future calls.

Larry Biegelsen — Wells Fargo Securities — Analyst

Thank you.

Operator

OK, we’ll go to the next line. We go to Travis Steed, Bank of America. Please go ahead.

Travis Steed — Bank of America Merrill Lynch — Analyst

Hey, everybody. Can you hear me OK?

Gary Guthart — Chief Executive Officer

Yeah. Hi, Travis.

Travis Steed — Bank of America Merrill Lynch — Analyst

All right, great. Maybe just high level, just like you were talking about da Vinci 5 having hundreds of design changes, when you just think about da Vinci 5 and, you know, kind of driving the quad aim, maybe just kind of talk about high level more what you’re trying to solve for with some of those design changes. You know, what’s different about da Vinci 5 versus da Vinci 4? And is it possible we could see a system in 2024, or is it more likely in 2025?

Gary Guthart — Chief Executive Officer

You know, I laid out in the script kind of what our design methodology was. I am dying to tell you more about da Vinci 5, but I’ll — but I’ll wait for — for clearance and for the final back and forth with FDA, so we can do that with a little more care. So, that’s kind of where we are in that set. We’re excited about it.

I think it is substantive, and I think some of the improvements that we can bring are going to be interesting and exciting. We are submitted and we’re in the back and forth with FDA. It is our hope that it is a ’24 launch. They ultimately are the arbiters of when we get the clearance.

But what I would say, based on past experience with them, is that we’re in a constructive conversation that we understand. And if that goes the way we want, then — then certainly, it’s something we’d be excited about in ’24. But I can’t guarantee it because I don’t have the clearance in hand.

Travis Steed — Bank of America Merrill Lynch — Analyst

That’s helpful. And would you expect some sort of ASP uplift versus da Vinci 4? And — and maybe also talk about the manufacturing capacity. You know, how — how long will it take to — to get to scale on the manufacturing? And you know, how would that look kind of versus the — the Xi launch? Can you do hundreds a year or thousands a year? Just kind of curious where — if that’s a limiting factor in kind of the availability of these systems going forward. Thanks a lot.

Gary Guthart — Chief Executive Officer

Yeah, I’ll start with the — just a little bit of color on ASP, and then — and then I’ll turn it over to Jamie. We won’t — we won’t call any ASP right now. We want to both get through the final clearances. What I will say is there are some differences relative to — to X, Xi that make that discussion a little detailed.

And it’s important for it to be detailed and clear for the customer to understand what they’re going to be buying. So, we’re going to pause that for now. With regard to manufacturing ramp, clearly, we’re going to be in a phased launch. I think we’ll be supply constrained in the early side of that, kind of intentionally as we work through manufacturing process. But in terms of pacing and what that might feel like, Jamie, let me turn it over to you.

Jamie Samath — Chief Financial Officer

To some extent, it will obviously depend how that progresses both within our four walls and with our suppliers. Certainly, is several quarters — would take several quarters as to be something that’s beyond a year, but I think you have to watch us make progress here and we’ll keep you updated.

Travis Steed — Bank of America Merrill Lynch — Analyst

All right, great. Thanks a lot and congrats.

Gary Guthart — Chief Executive Officer

Thank you.

Operator

And we’ll go next to the line of Robbie Marcus, J.P. Morgan. Please go ahead.

Robbie Marcus — JPMorgan Chase and Company — Analyst

Great. Thanks for taking the question. Congrats on a really good quarter. I’m going to — I’m going to push my luck again.

Gary, you know, one of the things we talked about two weeks ago on stage was big data and, you know, the potential to integrate it into your systems. You know, maybe if we think about just, you know, philosophically, da Vinci 5, you know, is this something we’ll see a lot more software improvements rather than hardware improvements? I realize you’re not giving specific details, but is software and the ability to add future software updates something we can be looking forward to?

Gary Guthart — Chief Executive Officer

Yeah, you know, one of the things we talked about in the script is the — is the increase in computational capability of the system, the rebaselining of that system. And one of the reasons for that is future programmability. Some of the things that we’ll be able to bring out of the gate are pretty exciting, but it also gives us the opportunity to build on that base in sequential software releases. So, it’s a good pull-through, Robbie.

The point you make is a good one, and we do — we do want to pull through software capability. It will not just be software that we bring to market, but it’s — it’s a starting point. Just to remind everybody, back in the Xi launch period, Xi didn’t have everything that we could possibly do with it at — at first year of launch either. It’s something that as we — as we build capability and build scale, we can add to over time, and we’ve done that for years. We will do the same in DV 5.

That is a platform upon which we can build for many years to come.

Robbie Marcus — JPMorgan Chase and Company — Analyst

Great. And maybe one for Jamie. You know, opex stepping up with the new product launch, you talked about, you know, in the mid-term seeing operating margin expansion. We’re also seeing elevated capex this year, as you talked about, in all the manufacturing plants.

Maybe addressing them both, you know, how should we think about where all of these expenses are going, particularly in opex this year, R&D versus SG&A, and what types of activities in each? And then, you know, is three years a good time frame to think about for the midterm when we might see these spending trends moderate? Thanks a lot.

Jamie Samath — Chief Financial Officer

Yeah, let me take capex first. In ’23 and ’24, the majority of those capital investments are for manufacturing facilities and to add manufacturing capacity, in particular, to our Mexicali factory. So, a significant portion of the depreciation that comes with that will show up in cost of sales, and that’s reflected in part in the — in the ’24 gross margin guidance. Some of it will show up in opex, and that will therefore be reflected in — in SG&A. If I look at the relative growth in R&D and SG&A in ’24, I think it’s — it’s relatively similar.

Obviously, innovation and R&D is important to us, but you will have a little bit of an impact in — in ’24 at least for incremental depreciation. We still see opportunity to leverage some of our enabling functions. There are some other functions that also can leverage as we scale and grow. And so, we’ll look to do that over the next couple of years. With respect to the kind of operating margin expansion opportunity that I described in my prepared remarks, we said, over the medium term, I’d kind of broadly say that’s a three- to five-year horizon, we have a specific set of actions and plans that we need to execute.

Those — those teams have those as goals. There’s some variability obviously in terms of how that gets executed, and there’s some interrelationship between the set of actions that need to be completed. So, there are dynamics there that can — can impact the speed at which that gets executed. And of course, we have to run our business in the meantime.

Robbie Marcus — JPMorgan Chase and Company — Analyst

Great. Thanks for the thoughts.

Operator

And we’ll go over to the line of Rick Wise, Stifel. Please go ahead.

Rick Wise — Stifel Financial Corp. — Analyst

Hey, everybody, and great to see the gen 5 announcement. Maybe I’m going to go in a slightly different direction. Maybe we can get some updates and more details — more color on Ion and SP. SP, Gary, the strongest quarter ever.

I’m just curious, your thoughts about ’24 and the next couple of years. What’s next, you know? How are you — what are the team priorities for ’24? And on the Ion side, maybe more for Jamie, you — you gave us some good color about demand’s strong and supply constraints continue. How are you thinking and what are you dialing into your thinking for ’24 about resolution of the catheter and the vision probe limitations? When are you hoping that that gets largely better result?

Gary Guthart — Chief Executive Officer

Yeah, thanks — thanks, Rick. On the SP front, we’re pleased with the step forward they took in ’23. It was good. We’re seeing more of focused efforts in our commercial team in — in the U.S., which have been good.

We’re excited about its entry into Japan, and we’re starting to see a build of activity in Japan too. So, that’s been good. We expect to see it in Europe in — in ’24, and that’s another nice step. And I think that’s a broader set of clinical indications, as — as it was in Korea and Japan. So, it gives a little more freedom to operate, which is great.

In the U.S., we have trials that had finished accrual and have been submitted — or will be submitted soon in thoracic and colorectal. That will give our U.S. customers more opportunity to use SP in a multi-platform — multi-specialty environment. So, I think SP continues to be a nice build. So, that — that looks good.

And the team has their marching orders and is working down that set of processes. We have a breast oncology trial that’s ongoing that we’re excited about. Also, that will not make a big impact in ’24 but starts to open additional opportunity for narrow access surgery thereafter. So, that’s kind of where we are in SP. So far, so good.

I’ll turn it over to Jamie and talk about Ion.

Jamie Samath — Chief Financial Officer

Not ready to be particularly specific yet on when the supply chain challenges are behind us. For catheter, you have three dynamics. So, we had a specific supplier constraint that impacted us. We are, at the same time, transferring a number of catheter lines to Mexicali, and we’re doing that as the business is effectively doubling. So, you’re bringing on new staff, you’re having to train them.

So, that’s a real effort that takes some time. And I think that’s a little bit of variability in terms of when we get to the point where — where that’s behind us. So, I’m going to — I’m going to let us have another quarter before we talk about when that’s resolved. The teams are making clear progress, but there’s work still to be done. On the vision probe, I think it’s a relatively simpler problem for us to address.

There isn’t a supplier dependency within — within that particular area. It’s really just us being able to execute again a line transfer as the business is doubling and the teams are making great progress. But stay tuned.

Rick Wise — Stifel Financial Corp. — Analyst

Got you. And just one follow-up on gen 5 and what’s next, you said, Jamie, and it makes sense, that probably in the next couple of quarters or until you launch, customers probably will lean more toward the leases with an upgrade clause, if I understood you. But I was just reflecting on it. Should we imagine that that could accelerate, this — you know, this sort of leasing approach in the near term for Xi? And — and as people, I guess, preferentially potentially — possibly maybe line up to get gen 5 and that puts them in a more favorable position, how does that all parallel — those dynamics, work? Is this good, better for sales that this transition occurs, or is it going to be more complicated?

Jamie Samath — Chief Financial Officer

Well, I think the first effect is we’ll see the operating lease proportion of placements increase from where it’s been. And again, that’s because customer — customers are motivated to have the protection that’s in those clauses so that they can upgrade to da Vinci 5 when it becomes more broadly available. So, that was the first kind of message we wanted to provide in terms of 2024 modeling. In terms of then how that gets upgraded, it’s really a function of when does da Vinci 5 launch which, obviously, we can’t be specific about right now and there’s some things to work through with FDA, and then, what’s the period of time over which we then go from a constrained or phased launch to — to a full launch.

So, I don’t — I don’t see that particularly as somehow a revenue benefit in — in ’24. I think what we’re saying is you’ll have more of the placements that are leased, and therefore, that revenue is spread over time.

Gary Guthart — Chief Executive Officer

It’s more — more likely to be a slight negative than a slight positive. And I think the things we’ve put in place for customer transparency, the ability to see it, work to mitigate the feeling of having to wait, and they’ll get a chance to put their hands on it and see it. But — but I don’t see it as an accelerant.

Rick Wise — Stifel Financial Corp. — Analyst

Thank you.

Operator

OK, and we’ll go to the line of Adam Maeder, Piper Sandler. Please go ahead.

Adam Maeder — Piper Sandler — Analyst

Hi, good afternoon, and thank you for taking the questions, and congrats on a great year. I wanted to start on China and ask about the quota that went effective last summer, as well as the anti-corruption campaign. If I heard the commentary correctly, it sounds like you expect systems to be impacted — system placements would be impacted through the first half of 2024. Does that mean there’s some optimism that placements could get better in the back half of the year? And just any additional color on what you’re seeing, you know, in that geography regarding anti-corruption campaign would be — would be very appreciated. Thank you.

Jamie Samath — Chief Financial Officer

Indications, so far, have been that — that anti-corruption effort is a year-long effort, which would take us to the middle of ’24. And so, that’s — that’s why we indicated that we would expect delayed tenders through the period in which that effort is ongoing. We don’t have great visibility, frankly, beyond the first half of ’24, and that’s why in the prepared remarks we said at least through the first half of ’24. So, yes, if that effort was to be resolved and if things started to normalize in terms of the pace at which tenders occurred, then you could see some opportunity for that to recover. But we’re not at a position where we can predict that at this point.

Adam Maeder — Piper Sandler — Analyst

That’s helpful color, Jamie. Thanks for that. And for the follow-up, wanted to ask about the procedure growth guidance, the 13% to 16% for this year. Maybe you could flesh that out for a little bit — a little bit by geography, U.S.

versus international, how you’re thinking about that, as well as, I guess, Europe versus Asia specifically. And just any color on quarterly cadence would be appreciated as well. Thanks again.

Brian King — Treasurer and Head of Investor Relations

Let me start with seasonality, and I’m not going to be specific on quarterly cadence, but I do think I try to emphasize in our prepared remarks that we believe that the first half will be a tougher comp versus, you know — versus last year. And so, using that, the comparison from last year and then also thinking about our historical sort of cadence throughout the year, I think you can look at that history and just make an assumption on — on what that growth rates — what those growth rates could be by quarter. Let’s talk about factors in the procedure guidance. So, there’s really three primary factors, right? You have — we’ve called out bariatric growth rates, and that’s primarily a U.S.

factor. We talked a bit about, from an OUS perspective, China and then also backlog in — in — in the system. And so, backlog also being primarily a U.S. factor but could still be broader. But so, I’m not going to go into specifics as far as U.S.

versus OUS. But I think I’d go back and — and just really center you on our comments around bariatric growth rates, right? Low end of the range assumes that there’s some continued moderation in bariatric procedures. And at the high end of the range that it assumes current growth rates, that there are some impact in China at the low end of the range, just from the discussion that you had right now on anti-corruption and how long that actually persists, and then the benefit of backlog and how that will persist throughout the year.

Jamie Samath — Chief Financial Officer

In soft tissue surgery, I would just say, if you look at — if you look at ’23, the two primary growth drivers that we’ve called out is general surgery in the U.S. that grew 25% in — in 2023. And for OUS, beyond urology, that grew 35% in ’23. And at the core, we think those continue to be growth drivers for the business.

Adam Maeder — Piper Sandler — Analyst

Thanks very much.

Operator

And we’ll go to the next line. We’ll go to the line of Drew Ranieri, Morgan Stanley. Please go ahead.

Drew Ranieri — Morgan Stanley — Analyst

I think, Gary, just maybe just broadly on da Vinci 5 and just the TAM that you kind of updated at a conference earlier this month, how are you — could you maybe just update us maybe on how you’re thinking about penetration today in general surgery, where you are with chole, hernia, colorectal, bariatric just to help us level set? Because it sounds like this could be a — another progression in general surgery for — for the company. And then, I had a follow-up.

Gary Guthart — Chief Executive Officer

Sure. I’ll — Jamie, I’ll let you take the kind of characterization of where we are in the adoption curves of — of general surgery, hernia, benign, chole, and so on.

Jamie Samath — Chief Financial Officer

If you — if you take a look at the U.S., and I’m going to put this in quartiles for a second in terms of where we are in the adoption curve, colorectal, we’re in the second quartile; bariatric, also the second quartile; actually, cholecystectomy and hernia all in the second quartile all in terms of where they are along the adoption curve. So, that obviously gives us some continuing runway to — to grow and as a driver behind the U.S. general surgery growth rates that we’ve seen. In the international markets, by the way, just in terms of general surgery, for the most part, in most of the larger markets, we’re in the first quarter of adoption. It’s early. What we’re seeing is growth start to stick and those start to be on early growth rates, particularly in the cancer procedures, colorectal, and beyond general surgery, in hysterectomy and thoracic.

Gary Guthart — Chief Executive Officer

With regard to DV 5, I won’t call out, you know, what a specific targeting has been. We’ll talk about more about DV 5 when we get a chance to talk about clearance. We do think that it’s something that can help improve outcomes in multiple places. And we’ll look forward to talking to you about that when we have the opportunity. If you have one follow-up, Drew, I’ll take the follow-up.

Otherwise, we’ll close the call. So, Drew, do you have one more?

Drew Ranieri — Morgan Stanley — Analyst

Sure, yeah. Just on da Vinci 5, can you maybe just talk about how it might be able to improve access to — to hospitals? I know that you have many IDNs that have added more and more systems, but do you see that more as an opportunity? Or do you see just maybe better access for even smaller hospitals with having multi — multi — multi-port systems in the portfolio? Thanks.

Gary Guthart — Chief Executive Officer

Yeah, thank you for the question. We — we think that having a portfolio of choices makes a ton of sense for hospitals. And this will be a part of that portfolio, we talked about it in the prepared script, that will give people choice. Some of that choice will have to do with how they view their practice. Some of it may — may have to do with what their side of care looks like and feels like.

So, that gives us some optionality and gives our customers optionality. I think that’s really healthy. So, thank you, Drew, appreciate the question. That was our last question.

And in closing, we continue to believe there is a substantial and durable opportunity to fundamentally improve surgery in acute interventions. Our teams continue to work closely with hospitals, physicians, and care team in pursuit of what our customers have termed the quadruple aim: better, more predictable patient outcomes; better experiences for patients; better experiences for the care teams; and ultimately, a lower total cost to treat. We believe value creation in surgery and acute care is foundationally human. It flows from respect for and understanding of patients and care teams, their needs and in 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

[Operator signoff]

Duration: 0 minutes

Call participants:

Brian King — Treasurer and Head of Investor Relations

Gary Guthart — Chief Executive Officer

Jamie Samath — Chief Financial Officer

Larry Biegelsen — Wells Fargo Securities — Analyst

Travis Steed — Bank of America Merrill Lynch — Analyst

Robbie Marcus — JPMorgan Chase and Company — Analyst

Rick Wise — Stifel Financial Corp. — Analyst

Adam Maeder — Piper Sandler — Analyst

Drew Ranieri — Morgan Stanley — Analyst

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