This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk09: Thank you, everyone, for standing by. Welcome to the intuitive fourth quarter 2023 earnings call. At this time, all participants are on a listen-only mode. Later, we will conduct a question and answer session. If you wish to place yourself in queue for questions today, please press 1 and 0 on your telephone keypad. If you want to remove yourself from the Q&A, you may repeat the 1 and 0 command. I will now turn the call over to your host, Head of Investor Relations, Brian King. Please go ahead.
spk07: Good afternoon, and welcome to Intuitive's fourth quarter earnings conference call. With me today, we have Gary Guttart, 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 10, 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 event 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.
spk02: 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 per system 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 UK, and Ireland, to name a few. In the U.S., general surgery procedure growth was led by cholecystectomy, with foregrip procedures rising as well. 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 and likely the result of the uptake of GLP-1 drugs for obesity. Procedure growth outside the United States diversified 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 a full year, driven by acceleration in the United States. On the capital front, we placed 1,313 multiport systems in the full year 23, compared with 1,241 multiport 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 multiport platforms. 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 2022. 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. Product 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. Strength in 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 for patient episode. As we look to 2024, I'd like to share with you that we have submitted to FDA our 510K application for our next generation multiport platform, DaVinci Five. 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 DaVinci 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, DaVinci 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. DaVinci 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 DaVinci 5 for the past several quarters and have completed a comprehensive multicenter IDE trial. This trial finished accruing patients in May of 2023 and we submitted for our 510 to FDA for DaVinci 5 in August last year. We are currently responding to FDA's questions. The timing of the US 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 DaVinci 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 in 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 emerged 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 DaVinci 5 launch once cleared. Second, we'll pursue increased adoption for focus 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 the time over to Jamie.
spk03: Good afternoon. I will describe the highlights of our performance on a non-GAAP or pro forma basis, and will 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 four-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 trading transactions, net new system placements for 2023 grew by 23% over the prior year, with the US 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 for 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, Proforma earnings per share for 2023 grew 22% as compared to last year. Turning to Q4, our core metrics were strong. DaVinci procedures grew 21%. The installed base of systems grew 14% to 8,606 systems. And average system utilization continued 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, US procedures grew 17% driven by growth in general surgery. OUS procedures grew 29% driven by strong performance in China, the UK, 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 US, 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 strengths 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. DaVinci 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 a procedure mix in the U.S. given strong growth in cholecystectomy and lower growth in bariatrics and customer ordering patterns partially offset by the INA price increase implemented 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 installed base of ion systems is now 534 systems, of which 214 are under operating lease arrangements. Our SP platform continued 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 US customers. We continue to make progress in expanding the opportunity for SP, including continued work on regulatory submissions in the US 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 excise 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 DaVinci 5 and Ion system manufacturing in California. and to complete line transfers for ION and SP INA 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. Performer other income was $67.1 million for Q4, higher than $57.9 million in the prior quarter, primarily due to higher interest income. Our performer 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. Gap net income was $606 million, or $1.69 per share, for the fourth quarter of 2023, compared with gap net income of $325 million, or 91 cents per share, for the fourth quarter of 2022. Fourth quarter gap 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 SWIS operations. The adjustments. The adjustments between pro forma and gap 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 multiport system that Gary highlighted and certain assumptions that may impact 2024 modeling. First, since we have not received FDA clearance for DaVinci 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 DaVinci 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 DaVinci 5, we expect a higher proportion of Gen 4 systems will be leased as customers seek flexibility to upgrade to DaVinci 5 when supply allows. For those customers that prefer to purchase a Gen 4 system, we will offer a future trade-in right that can be exercised when there is sufficient DaVinci 5 supply. Purchase contracts containing a trade-in right result in a deferral of a portion of the purchase price, negatively impacting systems revenue. And consistent with our experience bringing four generations of platforms to market, new systems typically start at lower gross margins and rise over a multi-year 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 DaVinci 5, increased depreciation expense, and an adverse mixed 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 DaVinci 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 DaVinci 5. Second, growing into and eventually leveraging the incremental fixed costs 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. Thank you, Jamie.
spk07: 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 and 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 and 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 UK, and France procedure performance led the region. In Germany, we saw strong growth in colon resection and kidney procedures, in the UK 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 the availability of remaining capital budgets. India, while still in the early stage 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. Nicolas De Angelis from Vaujon University Hospital, along with multiple colleagues from the French Society of Parietal Surgery, Club 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, quote, 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 towards 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 would 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 non-cash 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.
spk09: Thank you. Now, if you have not already done so and you wish to ask a question, please press 1 then 0 on your telephone keypad at this time. If you want to remove yourself from the queue, please repeat the 1-0 command. Now, first question will come from the line of Larry Beagleson of Wells Fargo. Please go ahead. Okay, sir, your line is open now.
spk05: Can you hear me?
spk09: Yes, Larry.
spk05: 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 DaVinci 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 on a lease upgrades, you know, will the lease get the ASP lift? You know, we assume you'll have And what will you do with returned XIs? And I had just one follow-up.
spk03: Yeah, I would say the dynamics are quite different between when we launched XI in 2014 versus where we are today. And I think the feature sets of DaVinci 5, which we haven't described, I think are an important context for you all, which we'll do once we have clearance. You look at relative penetration of DaVinci over that period. the extent to which leasing has changed significantly, our OUS penetration. I think there are a number of factors, Larry, where I would not use the kind of XI ramp and progression as a reference point for how DaVinci 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.
spk05: With respect to leasing,
spk03: 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 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 an upgrade. But I think you have to look at all of the other dynamics that we're yet to describe.
spk05: Okay, and then I guess on the new system, I'll try my luck here. Just lastly, do you expect the same indications as XI upon launch? And Gary, is this more about improving outcomes in existing procedures or expanding addressable procedures? Thank you.
spk02: 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 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 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's some really nice indications. to talk about or features to talk about in future calls.
spk05: Thank you.
spk09: Okay, we'll go to the next line. We'll go to Travis Steed, Bank of America. Please go ahead.
spk08: Hey, everybody. Can you hear me okay?
spk02: Yeah. Hi, Travis.
spk08: Great. Maybe just high level, just like you were talking about DaVinci 5 having hundreds of design changes. When you just think about DaVinci 5 and 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 DaVinci 5 versus DaVinci 4? And is it possible we could see a system in 2024, or is it more likely in 2025?
spk02: You know, I laid out in the script kind of what our design methodology was. I am dying to tell you more about DaVinci 5. But I'll wait 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 on 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'd 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 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.
spk08: That's helpful. Would you expect some sort of ASP uplift versus DaVinci 4? And maybe also talk about the manufacturing capacity. How long will it take to – to get to scale on the manufacturing, and, you know, how would that look kind of versus the XI launch? Can you do hundreds a year or thousands a year? Just kind of curious if that's a limiting factor in kind of the availability of these systems going forward. Thanks a lot.
spk02: Yeah, I'll start with just a little bit of color on ASP, and then I'll turn it over to Jamie. 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 XXI 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.
spk03: To some extent, it will obviously depend how that progresses both within our four walls and with our suppliers. Certainly, it's several quarters. I 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.
spk08: All right, great. Thanks a lot, and congrats.
spk09: Thank you. And we'll go next to the line of Robbie Marcus, J.P. Morgan. Please go ahead.
spk06: Great. Thanks for taking the question. Congrats on a really good quarter. I'm going to push my luck again. Gary, one of the things we talked about two weeks ago on stage was big data and the potential to integrate it into your systems. Maybe if we think about just you know, philosophically DaVinci 5, you know, is this something we'll see a lot more software improvements rather than hardware improvements? I realize you're not given specific details, but is software and the ability to add future software updates something we can be looking forward to?
spk02: Yeah, you know, one of the things we talk about in the script is the increase in computational capability of the system, the re-baselining 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. We do want to pull through software capability. It will not just be software that we bring to market, but 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 first year of launch either. It's something that as we build capability and build skill, we can add to over time. And we've done that for years. We will do the same in DV5. It is a platform upon which we can build for many years to come.
spk06: Great. And maybe one for Jamie, you know, OPEX stepping up with the new product launch. You talked about in the midterm seeing operating margin expansion. We're also seeing elevated CapEx this year as you talked about all the manufacturing plants. Maybe addressing them both, 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 is three years a good timeframe to think about for the midterm when we might see these spending trends moderate? Thanks a lot.
spk03: 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. 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 24 gross margin guidance. Some of it will show up in OPEX, and that will therefore be reflected in SG&A. If I look at the relative growth in R&D and SG&A in 24, I think it's relatively similar. Obviously, innovation in R&D is important to us. but you will have a little bit of an impact 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 sort of 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 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 impact the speed at which that gets executed. And, of course, we have to run our business in the meantime.
spk06: Great. Thanks for the thoughts.
spk09: And we'll go over to the line of Rick Wise. Stiefel, please go ahead.
spk04: Good afternoon, 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? What are the team priorities for 24? And on the ION side, maybe more for Jamie, You gave us some good color about demand 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 resolved?
spk02: Thanks, Rick. On the SP front, we're pleased with the step forward they took in 23. It was good. We're seeing more focused efforts in our commercial team in the U.S., which has 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 24, and that's another nice step, and I think that's a broader set of clinical indications as it was in Korea and Japan, so it gives a little more freedom to operate. which is great. In the US, we have trials that had finished accrual and have been submitted or will be submitted soon in thoracic and colorectal that will give our US customers more opportunity to use SP in a multi-platform, a multi-specialty environment. So I think SP continues to be a nice build. So 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 a narrow access surgery thereafter. So that's kind of where we are in SP. So far, so good.
spk03: I'll turn it over to Jamie and talk about I. I'm 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 there's a little bit of variability in terms of when we get to the point where that's behind us. So 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 that particular area. It's really just us being able to execute, again, a line transfer as the business is doubling and the team are making great progress. But stay tuned.
spk04: Gotcha. 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 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, how do all those dynamics work? Is this good? Better for sales that this transition occurs or is it going to be more complicated?
spk03: 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 customers are motivated to have the protection that's in those clauses so that they can upgrade to DaVinci 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 DaVinci 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 a full launch? So I don't see that particularly as somehow a revenue benefit 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.
spk02: It's 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 I don't see it as an accelerant.
spk04: Thank you.
spk09: Okay, and we'll go to the line of Adam Mader. Piper Sandler, please go ahead.
spk00: Hi, good afternoon. 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 by system placements should 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 in that geography regarding anti-corruption campaign would be very appreciated. Thank you.
spk03: Indications so far have been that that anti-corruption effort is a year-long effort which would take us to the middle of 2024. And so 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 in a position where we can predict that at this point.
spk00: That's helpful color, Jamie. Thanks for that. And for the follow-up, I 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 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.
spk07: Let me start with seasonality. And I'm not going to be specific on quarterly cadence, but I do think I tried to emphasize in our prepared remarks that we believe that the first half will be a tougher comp 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 make an assumption on what those growth rates could be by quarter. Let's talk about factors in the procedure guidance. There's really three primary factors. 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 the system. And so backlog also being primarily a U.S. factor, but could still be broader. 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's some impact in China at the low end of the range, just from the discussion 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.
spk03: In soft tissue surgery, I would just say 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 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.
spk00: Thanks very much.
spk09: And we'll go to the next line. Go to the line of Drew Ranieri, Morgan Stanley. Just go ahead.
spk01: Gary, just maybe just broadly on DaVinci 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 Coley, hernia, colorectal, bariatrics, just to help us level set because it sounds like this could be another progression in general surgery for the company. And then I'd follow up.
spk02: Sure. Jamie, I'll let you take the kind of characterization of where we are in the adoption curves of general surgery, hernia, benign, Coley, and so on.
spk03: 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 were in the second quartile, bariatrics also the second quartile, actually cholecystectomy and hernia all in the second quartile in terms of where they are along the adoption curve. So that obviously gives us some continuing runway to grow, and that's 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.
spk02: With regard to DV5, I won't call out what the specific targeting has been. We'll talk more about DV5 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?
spk01: Sure, yeah. Just on DaVinci 5, can you maybe just talk about how it might be able to improve access 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-port systems in the portfolio? Thanks.
spk02: Yeah, thank you for the question. 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. A lot of give people choice. Some of that choice will have to do with how they view their practice. Some of it 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. In closing, we continue to believe there is a substantial and durable opportunity to fundamentally improve surgery and acute interventions. Our teams continue to work closely with hospitals, physicians, and care teams in pursuit of what our customers have termed the quadruple aim, better, more predictable patient outcomes, better experiences for patients, better experiences for their 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.
spk09: Thank you, everyone, for joining today's conference call. We do thank you for joining. You may now disconnect. Have a good day.
Disclaimer