Intuitive Surgical (ISRG) This fall 2024 Earnings Name Transcript

Intuitive Surgical (ISRG -0.29%)
This fall 2024 Earnings Name
Jan 23, 2025, 4:30 p.m. ET

Contents:

• Ready Remarks
• Questions and Solutions
• Name Contributors

Ready Remarks:

Operator

Good day, and thanks for standing by. Welcome to the This fall 2024 Intuitive earnings convention name. At the moment, all members are in a listen-only mode. Please be suggested that right now’s convention is being recorded.

After the audio system’ presentation, there shall be a question-and-answer session. [Operator instructions] I might now like at hand the convention over to your speaker right now, Brandon Lamm, investor relations for Intuitive Surgical.

Brandon Lamm — Senior Supervisor, Investor Relations

Good afternoon, and welcome to Intuitive’s fourth quarter earnings convention Name. With me right now, we now have Gary Guthart, our CEO; Jamie Samath, our CFO; Daniel Oh, our senior medical officer. Dave Rosa, our president and common participant on this name, is away from the workplace this week on a previous enterprise dedication and won’t be becoming a member of right now. Dr.

Daniel Oh, senior medical officer and practising surgeon, will be part of us on this name to explain scientific highlights. We’d additionally wish to announce that Dan Connolly shall be becoming a member of Intuitive as our VP and head of investor relations. Dan has labored as a worldwide funding supervisor for the final 18 years and has actively adopted surgical robotics since 2008. We sit up for Dan becoming a member of Intuitive in early February.

Earlier than we start, I wish to inform you that feedback talked about on right now’s name could also be deemed to comprise forward-looking statements. Precise outcomes might differ materially from these expressed or implied on account of sure dangers and uncertainties. These dangers and uncertainties are described intimately in our Securities and Alternate Fee filings, together with our most up-to-date Type 10-Okay for the fiscal yr ended December thirty first, 2023, and subsequent filings. Our SEC filings could be discovered via our web site or on the SEC’s web site.

Traders are cautioned to not place undue reliance on such forward-looking statements. Please word that this convention name shall be out there for audio replay on our web site at intuitive.com within the occasions part underneath our investor relations web page. Right this moment’s press launch and supplementary monetary knowledge tables have been posted on our web site. Right this moment’s format will include offering you with highlights of our full yr and fourth quarter outcomes as described in our press launch introduced earlier right now, adopted by a question-and-answer session.

Gary will current enterprise and operational highlights. Jamie will present a evaluation of our monetary outcomes and process highlights. Dan will current scientific highlights. Then I’ll present our monetary outlook for 2025.

And eventually, we are going to host a question-and-answer session. With that, I will flip it over to Gary.

Gary S. Guthart — Chief Government Officer and Director

Thanks for becoming a member of us right now. I will contact on our efficiency for the total yr 2024 and share our perspective going into 2025. 2024 was a robust yr for Intuitive with sturdy early adoption of our fifth-generation multiport platform, da Vinci 5, and wholesome process development in a lot of our supported indications in nations, leading to robust monetary efficiency for the yr. Adoption of our Ion and da Vinci SP platforms continued with new world clearances and elevated utilization.

Our groups have been exhausting at work launching da Vinci 5 and studying from its early expertise. We’re enhancing our merchandise throughout all three of our platforms and serving to our prospects obtain their programmatic targets. We began 2024 centered on 4 major thrusts. First, we expanded indications and launches of our new platforms by area, with a specific give attention to our first section of da Vinci 5 launch.

Second, we pursued elevated adoption of centered procedures by nation via coaching, business actions, and market entry efforts. Third, we drove high quality and gross margin enhancements in our world operations. And eventually, we centered on growing our productiveness, significantly in features that profit from industrial scale. Taken collectively, our group made wonderful progress towards these targets.

Transferring to procedures. Progress for the total yr was 17%. Areas of power included common surgical procedure in america and regional efficiency in nations, together with the U.Okay. and Eire, Japan, and Germany.

Distribution markets, together with Brazil, Spain, and Italy had been additionally robust within the yr. This week, we introduced the acquisition from ab medica of the da Vinci enterprise in Italy, Spain, Portugal, and associated territories. We’re happy with their efficiency, and we sit up for welcoming these new workers to our group. Within the U.S., common surgical procedure process development was led by cholecystectomy with foregut and appendectomy procedures rising as effectively.

Thoracic process development was additionally wholesome within the yr. Bariatric procedures fell modestly for the total yr 2024, given the rise in GLP-1 drugs. Process development outdoors america continued to diversify past urology with good development in classes together with common surgical procedure and thoracic surgical procedure. Globally, benign indications grew roughly 200 foundation factors quicker within the yr than most cancers indications.

In versatile robotics, Ion procedures confirmed continued power with 78% development for the total yr. SP process development accelerated within the yr with 72% development over a full yr, a results of wholesome development in Korea, Japan, and Europe and stable development within the U.S. On the capital entrance, we positioned 1,432 port techniques within the full yr 2024, in contrast with 1,313 multiport techniques in 2023. Ion placements for the total yr had been 271, versus 213 prior yr.

And SP placements had been 96 for the total yr, versus 57 techniques within the prior yr. Globally, placements had been robust in america, helped by the launch of da Vinci 5. General, our techniques portfolio of da Vinci 5, da Vinci Xi, da Vinci X, da Vinci SP and Ion, mixed with our versatile financing choices permits our group to fulfill our prospects’ various wants. Jamie will take you thru placement dynamics in additional element later within the name.

System utilization stays an necessary indicator of buyer well being as a result of it’s correlated to affected person demand, care group satisfaction, and hospital monetary well being. Multiport utilization grew 3% within the yr. SP utilization grew 12% within the yr, and Ion utilization grew 13%. Given our totally different platforms, their process combine, and websites of care, teasing aside system utilization by buyer section turns into more and more necessary going ahead.

For instance, in a midsized group hospital lung program, techniques utilization can differ from a high-volume group hospital common surgical procedure program. As robot-assisted surgical procedure strikes to the again half of adoption curves and a few procedures, utilization development charges might differ from prior-year traits. Our efficiency supported income of $8.4 billion for the yr, of which 84% was recurring and representing 17% development over 2023. Our working bills had been on the decrease finish of our spend steerage.

Our spending displays three initiatives. First, we proceed to spend money on R&D to assist innovation and adoption of our platforms and digital instruments globally. Second, we’re increasing our manufacturing and business footprints. And lastly, we now have sought to leverage our enabling features given our elevated scale.

Our revenue margins additionally began to enhance within the yr as elevated cargo quantity allowed for higher manufacturing facility utilization, in addition to leverage in our part cargo and different logistics prices. Taken collectively, our web earnings grew by 29% in 2024 over 2023. Touching briefly on da Vinci 5, our groups have carried out a pleasant job in executing a posh launch. We positioned 362 da Vinci 5s within the yr, and over 2,500 surgeons have carried out in complete, over 32,000 procedures on da Vinci 5 in 2024.

Da Vinci 5 has broad scientific indications and over 40 totally different process varieties have been carried out utilizing da Vinci 5 up to now. We design our techniques to permit for routine sequential upgrades to their functionality over time. And da Vinci 5 prospects will obtain {hardware} and software program upgrades going ahead beginning this yr. This yr’s upgrades will give attention to digital options supported by our 10,000 will increase in computing energy.

We’ll share extra particulars on these options as we deliver them to market. As we enter 2025, our firm priorities are as follows. First, we are going to give attention to the total launch of da Vinci 5, its regional clearances, and follow-on function releases. Second, we’ll pursue elevated adoption of our centered procedures by nation via coaching business actions and market entry efforts.

Third, we’ll drive continued progress in constructing industrial scale, product high quality, and manufacturing optimization. And eventually, we’ll give attention to excellence and availability of our digital instruments. Jamie, over to you.

Jamie E. Samath — Chief Monetary Officer

Good afternoon. I’ll describe the highlights of our efficiency on a non-GAAP or professional forma foundation, and also will summarize our GAAP efficiency later in my ready remarks. A reconciliation between our professional forma and GAAP outcomes is posted on our web site. This fall and 2024 income procedures and system placements are in step with our preliminary press launch of January fifteenth.

I’ll briefly evaluation full yr 2024 efficiency earlier than describing our This fall ends in larger element. 2024 monetary efficiency was robust. Da Vinci procedures and complete income every grew 17% over the prior yr. Professional forma gross margin improved 100 foundation factors to 69.1% and professional forma SG&A bills leveraged as in comparison with 2023.

Consequently, professional forma working margin for 2024 improved 310 foundation factors to 37%, and professional forma EPS elevated 28%, constructing off of the 22% enhance in 2023. We positioned 362 da Vinci 5 techniques in our first yr of the restricted launch, of which 174 techniques had been positioned in This fall, together with our first replacements of da Vinci 5 in Korea. Turning to This fall. Our monetary efficiency was forward of our expectations, pushed by income development of 25% and power throughout the remainder of the P&L, leading to professional forma working margin of 38%.

This fall income mirrored a few favorable dynamics. First, a better buy mixture of techniques as in comparison with latest durations, pushed by multisystem offers with sure U.S. IDNs that favor to buy and a better mixture of placements via distributors. Second, we noticed a better mixture of twin console placements for da Vinci 5 as we elevated provide and had been in a position to assist extra tutorial prospects.

And eventually, we noticed a better system ASP, ensuing from a stronger mixture of da Vinci 5 placements. Underlying core metrics had been additionally robust with da Vinci process development of 18%, development within the put in base of da Vinci techniques of 15%, and common system utilization development of three%. In This fall, U.S. procedures grew 15%, pushed by development in benign common surgical procedure, together with accretive development in procedures carried out after hours for emergent care.

Bariatric procedures within the U.S. declined within the low to mid-single-digit vary, much like final quarter. OUS procedures grew 25%, pushed by relative power in India, the U.Okay., Italy and Japan. Process development in Korea improved sequentially, partially pushed by robust SP development.

Nonetheless, our enterprise there continues to be impacted by doctor strikes. In keeping with the final couple of quarters, process development in China was barely beneath the company common, reflecting a continuation of the dynamics we now have described on earlier calls. OUS process efficiency in mixture, we see robust development in colorectal, benign common surgical procedure, and thoracic classes. Reviewing capital efficiency.

We positioned 493 techniques within the fourth quarter, 19% greater than the 15 techniques we positioned within the fourth quarter of final yr. Within the U.S., we positioned 284 techniques in This fall, a rise of 75 techniques as in comparison with final yr, reflecting a number of giant multisystem placements with numerous IDNs and a rise within the provide of da Vinci 5. Exterior the U.S., we positioned 209 techniques within the fourth quarter in contrast with 206 in the identical quarter final yr. This quarter, we positioned 89 techniques in Europe, 43 in Japan, and 20 in China in contrast with 71 in Europe, 70 in Japan, and 11 in China in This fall of final yr.

Placements within the U.Okay. and Germany proceed to be impacted by ongoing authorities price range pressures affecting healthcare capital spending. The 89 system placements in Europe included 39 techniques into markets served by our distributors as in comparison with 24 techniques final yr. In Japan, monetary pressures brought about some prospects to delay capital funding selections.

Fourth quarter income was $2.41 billion, a 25% enhance over final yr. On a constant-currency foundation, income development was 26%. Techniques income grew 36% yr over yr, pushed by a 19% enhance in da Vinci system placements, a better system ASP, and the upper buy combine beforehand referenced. Further income statistics and traits are as follows.

Leasing represented 45% of This fall placements, in contrast with 58% final quarter, pushed by the aforementioned mixture of system placements from sure IDNs within the U.S. preferring to buy and a better mixture of placements with our distributors. Nonetheless, as we glance ahead, we proceed to count on that leasing charges will enhance over time. This fall system common promoting costs had been $1.59 million, as in comparison with $1.42 million final yr pushed by greater mixture of da Vinci 5 and a better dual-console combine, partially offset by decrease pricing in China.

We acknowledged $28 million of lease buyout income within the fourth quarter, in contrast with $21 million final yr. Da Vinci instrument and accent income per process was roughly $1,860, in contrast with roughly $1,800 final yr. The year-over-year enhance in I&A per process displays buyer shopping for patterns and a better mixture of SP procedures, partially offset by process combine within the U.S. given a decrease mixture of bariatric procedures and a better mixture of cholecystectomy.

Turning to Ion. There have been roughly 28,000 Ion procedures carried out within the fourth quarter, a rise of 70% as in comparison with final yr. In This fall, we positioned 69 Ion techniques in comparison with 44 in This fall of 2023. As a reminder, provide constraints impacted Ion system placements within the fourth quarter of final yr.

Seven of the 69 techniques had been positioned in OUS markets. The put in base of Ion techniques elevated 51% from final yr to 805 techniques and common system utilization elevated 13% yr over yr. Fourth quarter SP process development continued to speed up, rising 81%, pushed by Korea and early stage development in Europe and Japan, the place we now have clearance for a broad set of indications. We positioned 30 SP techniques in This fall and 96 for the yr, up from 57 placements in 2023.

Fourth quarter placements included 7 in Korea, 6 in Europe, and 4 in Japan. Common system utilization for our SP platform grew 18% in This fall, reflecting partially development of SP in markets the place we now have a broad set of indications. We have now acquired latest clearances within the U.S. for thoracic and colorectal indications.

Nonetheless, we count on broad business efforts for SP in these process classes to begin as soon as we acquire FDA clearance for a SP stapler. Transferring on to the remainder of the P&L. Professional forma gross margin for the fourth quarter of 2024 was 69.5%, in contrast with 68% for the fourth quarter of 2023. The year-over-year enchancment in gross margin displays mounted overhead leverage given income development, decrease stock reserves, and enhancements in freight and logistics prices.

In 2024, we executed on our plans to considerably enhance product margins for our Ion and SP platforms. Whereas we now have made substantial progress, Ion and SP product margins proceed to be dilutive and our groups have ongoing packages to ship additional enchancment. With respect to our manufacturing growth and capital funding plans. In 2025, we anticipate opening new amenities the da Vinci 5 and Ion system manufacturing in California and new endoscope manufacturing amenities in Germany and Bulgaria.

Consequently, and as we now have beforehand indicated, we count on a big enhance in depreciation expense in 2025. We may even proceed to switch mature merchandise to amenities in Peachtree Corners, Georgia, and Mexicali. Given these actions, we count on elevated stock ranges throughout 2025. As we full this cycle of producing growth that’s pushed by our technique to function at industrial scale, we anticipate decrease ranges of capital expenditures in 2025 and 2026 as in comparison with latest durations.

Fourth quarter professional forma working bills elevated 9% in contrast with final yr, pushed by elevated headcount, greater variable compensation, and elevated authorized bills. Fourth quarter 2024 working bills included a $45 million contribution to the Intuitive Basis, as in comparison with a $40 million contribution in This fall of final yr. working bills for the yr, we delivered on deliberate leverage in SG&A, which improved by 180 foundation factors as a share of income. Whereas we are going to proceed to search for alternatives inside SG&A to leverage as we develop, we might spotlight that in 2025, we count on elevated depreciation bills given latest capital expenditures and better authorized bills given ongoing litigation.

Innovation continues to be crucial to serving to our prospects make progress within the Quintuple Intention and due to this fact, it is best to count on us to prioritize investments in R&D. Professional forma different earnings was $87.6 million for This fall, decrease than $94.6 million within the prior quarter, primarily pushed by FX remeasurement of the stability sheet. Our professional forma efficient tax fee for the fourth quarter was 20.5%, slightly decrease than our expectations, reflecting web discrete advantages of $11 million associated to statute of limitation expirations and different changes to sure tax objects. Fourth quarter 2024 professional forma web earnings was $805 million, or $2.21 per share, in contrast with $574 million or $1.60 per share for the fourth quarter of final yr.

I’ll now summarize our GAAP outcomes. GAAP web earnings was $686 million, or $1.88 per share for the fourth quarter of 2024, in contrast with GAAP web earnings of $606 million, or $1.69 per share for the fourth quarter of 2023. As a reminder, fourth quarter 2023 GAAP tax expense mirrored one-time advantages of $159 million associated to a rise in deferred tax belongings related to the statutory fee enhance in Switzerland and receipt of sure tax advantages associated to our Swiss operations. The changes between professional forma and GAAP web earnings are outlined and quantified on our web site.

We ended the yr with money and investments of $8.8 billion, in contrast with $8.3 billion on the finish of Q3. The sequential enhance in money and investments mirrored money generated from working actions, partially offset by capital expenditures of $312 million. With respect to the plans, we introduced on Tuesday to go direct in Italy, Spain, Portugal, and related territories, the bottom buy value is EUR 290 million with an earn-out of as much as a further EUR 31 million primarily based on 2025 process volumes. Whereas our major motivation is to develop nearer relationships with prospects serving a mixed inhabitants of roughly 118 million folks, we do count on this transaction, which we estimate to shut within the first half of 2026, to be barely accretive to professional forma EPS.

Earlier than I flip it over to Dan to debate scientific highlights, let me deal with the outlook for professional forma working margins for 2025. This fall efficiency of 38% was above our expectations. Looking forward to 2025, we anticipate professional forma working margins in 2025 to be decrease than This fall because of a number of dynamics. First, as beforehand said, leasing charges are anticipated to be greater than This fall, which leads to income and income for associated system placements to be recorded over a number of years versus within the quarter of placement.

Second, we anticipate considerably greater depreciation bills given latest capital expenditures. And eventually, we count on a better mixture of da Vinci 5, Ion, and SP income, which carry product margins beneath the company common. As well as, from a modeling perspective, I might additionally spotlight a few extra concerns. First, income denominated in non-USD currencies represents roughly 25% of our complete income.

On a revenue-weighted foundation, utilizing present alternate charges, the U.S. greenback is roughly 4% stronger than charges realized in This fall. Second, as we transfer into broad launch of da Vinci 5 in the course of the yr and prospects have the chance to improve their fleets, we might count on buying and selling credit for Xi to be considerably greater than latest durations adversely impacting system ASPs. Lastly, given the growing alternative prospects have, as opponents deliver robotic techniques to the market and search geographical clearances, we might even see capital promoting cycles lengthen as prospects consider options.

Brandon will present our outlook for 2025 later on this name. And with that, I wish to flip it over to Dan.

Daniel Oh — Vice President and Senior Medical Officer

Thanks, Jamie. I would wish to share with you some just lately printed peer-reviewed literature that we discovered to be notable. Along with the precise knowledge highlighted on this name, we encourage you to contemplate the huge physique of proof detailing these matters in printed scientific research through the years. Right this moment, we’ll give an replace on two latest publications.

Within the first research, Dr. Rocco Ricciardi and colleagues from the Massachusetts Common Hospital in Boston collaborated with the analysis group at Intuitive for the COMPARE research printed within the Annals of Surgical procedure. This landmark research in contrast perioperative outcomes of da Vinci robotic-assisted surgical procedure, to laparoscopic or thoracoscopic surgical procedure, in addition to to open procedures. This was a meta-analysis, which analyzes outcomes from beforehand printed proof over time to acquire an summary of cumulative knowledge.

On this research, the investigators pooled knowledge from randomized managed trials, potential comparative cohort research, and huge real-world proof database research from the previous 12 years. In an effort to consider whether or not da Vinci procedures had been related to an enchancment in short-term affected person outcomes throughout seven generally carried out oncologic procedures from totally different specialties. Notably, over 1 million sufferers had been included in every of the da Vinci, laparoscopic thoracoscopic, and open affected person teams, and included knowledge from 22 nations. The authors discovered that in comparison with commonplace minimally invasive surgical procedure, sufferers present process da Vinci procedures had favorable perioperative outcomes.

Particularly, da Vinci sufferers had a 56% decrease probability of conversion to open, 21% decrease probability of receiving a blood transfusion, and 10% much less probability to expertise a complication inside 30 days of the process. As well as, the size of keep was considerably shorter with decrease 30-day readmission and mortality charges. Comparable favorable outcomes had been discovered for da Vinci sufferers when in comparison with the open strategy with even larger magnitude variations between the 2 approaches. The authors concluded that this meta-analysis demonstrated a number of advantages for da Vinci procedures when in comparison with various minimally invasive or open approaches, noting that these outcomes shall be useful to decision-makers contemplating the usage of robotics in multi-specialty settings.

Within the second research, Dr. Michael Awad from Washington College Faculty of Drugs and different colleagues printed in Surgical Endoscopy the outcomes of a preclinical research utilizing Intuitive’s novel pressure suggestions expertise integrated in da Vinci 5. Throughout 28 surgeons with various ranges of expertise, this research evaluated the forces utilized to tissue when having pressure suggestions expertise on or off throughout core surgical exams, together with retraction, dissection and suturing in a tissue mannequin. Outcomes from this research demonstrated a big discount in each the common and most forces exerted on tissue for all three surgical exams, no matter surgeon expertise ranges.

Notably, when utilizing the best sensitivity setting, as much as a 55% discount of the utmost pressure exerted on tissue throughout suturing was noticed. The authors concluded that this research demonstrated that pressure suggestions expertise might considerably lower the forces utilized on the tissue degree when performing widespread surgical exams throughout novice, intermediates, and skilled surgeons. They continued to notice, “This modern expertise has the potential to allow safer and gentler surgical procedures, leading to higher surgical outcomes for sufferers present process robotic-assisted surgical procedure.” To me, the notable discovering on this research is that the good thing about pressure suggestions was noticed not simply in novice surgeons, which one may count on, but additionally in inexperienced surgeons who had accomplished no less than 200 da Vinci procedures. Now I will flip it over to Brandon.

Brandon Lamm — Senior Supervisor, Investor Relations

Thanks, Dan. I’ll now flip to our monetary outlook for 2025. Beginning with procedures. As described in our announcement earlier this month, complete of 2024 da Vinci procedures grew roughly 17% yr over yr to over 2,680,000 procedures carried out worldwide.

For 2025, we anticipate full yr process development inside a variety of 13% and 16%. The low finish of the vary assumes development in China continues to be impacted by environmental and aggressive dynamics. European governments proceed to constrain hospital capex budgets limiting the growth of capability within the subject and bariatric process declines proceed at charges much like 2024. On the excessive finish, we assume China’s process development recovers relative to 2024, the capex surroundings improves in Europe and bariatric process declines reasonably.

Q1 and full yr 2025 can have roughly one fewer working day in 2024 because of the intercalary year. Turning to gross revenue. In 2024, our professional forma gross revenue margin was 69%. In 2025, we count on our professional forma gross revenue margin to be inside a variety of 67% and 68% of web income.

The decrease estimate of professional forma gross revenue margin in 2025 displays vital incremental depreciation as we deliver on new amenities, the influence of development in newer merchandise, and the influence of the stronger U.S. greenback. Our precise gross revenue margin will fluctuate quarter to quarter relying largely on product, regional, and trade-in combine and pricing. The vary doesn’t embody any potential influence of latest tariffs on our enterprise, which may very well be materials.

Turning to working bills. In 2024, our professional forma working bills grew 10%. In 2025, we count on our professional forma working expense development to be inside a variety of 10% and 15%. The expansion in working bills displays elevated depreciation from new amenities, investments in innovation to drive our development targets, and a rise in authorized bills.

We count on our noncash inventory compensation expense to vary between $760 million and $790 million in 2025. We count on different earnings, which is comprised largely of curiosity earnings, to complete between $370 million and $400 million in 2025. With regard to capital expenditures, we count on the vary to complete between $650 million and $800 million, primarily for deliberate facility development actions. With regard to earnings tax, in 2024, our professional forma earnings tax fee was 21.4%.

As we glance ahead, we estimate our 2025 professional forma earnings tax fee to be inside a variety of twenty-two% and 23% of pre-tax earnings. That concludes our ready feedback. We’ll now open the decision to your questions.

Questions & Solutions:

Operator

Thanks. [Operator instructions] Once more, another for our questions. Our first query comes from Larry Biegelsen with Wells Fargo. It’s possible you’ll proceed.

Larry Biegelsen — Analyst

Good afternoon. Thanks for taking the query and congrats on a very robust end to the yr. One for Gary, one for Jamie. So, Gary, traditionally, you mentioned procedures drive placements within the second half of ’24.

U.S. system placements grew over 35%. Utilization was about 2%. Is that this a number one indicator of extra procedures? Or will we now have a digestion interval to revive regular utilization? And I’ve one follow-up.

Gary S. Guthart — Chief Government Officer and Director

Yeah. I feel a few issues are occurring there. One among them is as I mentioned within the ready remarks, as we get to the again half of some curves, the expectations of a few of these packages could also be totally different by way of utilization as they take part. In different phrases, not each account goes to be a high-volume account.

And I feel that is OK. I feel the economics can work and I feel we will provide them. So, a few of that is occurring. I feel the opposite factor is new capital alternatives.

New capital options can pull ahead or in any other case have folks delay slightly bit after which purchase techniques that may put a wave or a ripple via utilization. And we’re simply going to need to see if that ripple performs via. So, each of these results are probably occurring. It’s truly extraordinarily exhausting analytically to tease them out.

I feel within the U.S., over time, you are going to see utilization development charges in multiport begin to settle slightly bit. I do not assume they’re going to preserve galloping. On the identical time, I feel SP utilization has room to run and Ion utilization has room to run.

Larry Biegelsen — Analyst

Thanks, Gary. And Jamie, on the Q3 name, you mentioned the gross margin shall be slightly decrease in 2025 versus 2024. I feel the 67% to 68% steerage was most likely slightly bit decrease than anticipated. Are you able to quantify the drivers from the 69.1% this yr in 2024 to 67% to 68%.

And the way to consider the trail again to your aim of 70%? Thanks.

Jamie E. Samath — Chief Monetary Officer

Yeah. There’s actually three drivers, Larry, the biggest of which is the influence of depreciation expense and related mounted prices. So, there’s deleverage within the ’24 to ’25 comparability, roughly ish, relying on what you’ve gotten the income mannequin for ’25. That is about 1 level of the 160-point delta when you go from ’24 precise to a midpoint of ’25.

The opposite two dynamics roughly equal-ish by way of influence are product combine with dV5 Ion and SP being a larger proportion of the income. All of them carry presently margins beneath the company common, so have a dilutive impact from a mixture perspective. After which I feel what’s new from the final name is the influence of FX. So, these three issues are the drivers.

There are some offsetting value reductions. The groups are delivering inside that type of gross margin vary. I feel what we have mentioned with respect to gross margin is over the midterm, we expect we will get again past 70%. That’s going to require us, as soon as we get previous this sort of incremental depreciation to leverage over a multiyear interval as we develop.

We even have, as we have mentioned, the work on product margins in Ion and SP. There’s nonetheless some work to be carried out there. After which on a extra routine foundation, our groups need to ship value downs.

Larry Biegelsen — Analyst

Thanks, Jamie.

Operator

Thanks. Our subsequent query comes from Robbie Marcus with J.P. Morgan. It’s possible you’ll proceed.

Robbie Marcus — Analyst

Nice. And I will echo congratulations on a unbelievable fourth quarter. Two for me. First, perhaps for Gary, you gave numerous element on the decision a couple of midyear full launch and trade-in cycle.

Would love to simply get your qualitative feedback round the way you’re fascinated about the combination of da Vinci 5 versus Xi going ahead. The need or the velocity at which an improve cycle can begin? And the way you are fascinated about Xi versus da Vinci 5 placements by way of the combination going ahead outdoors the U.S. on approval begin rolling in? All of it has implications for the mannequin, so I would like to get your ideas on that. Thanks.

Gary S. Guthart — Chief Government Officer and Director

I used to be going to say — I will inform you slightly bit about, I feel, maybe the environmental elements of that type of the wrapping round it, I will flip it over to Jamie for any modeling implications. What goes — two issues are driving what we name broad launch. One among them is getting our provide chains as much as scale and quantity for what we count on. Demand may very well be after we begin going out and issues like trade-ins and likewise beginning to get clearances world wide.

So, that is thrilling. The subsequent one is software program updates, and people software program updates replicate each suggestions from the sector after which the combination of a number of the applied sciences in our digital area from hub to a number of the imaging issues we will do this begin to come out within the first set of launches, which is admittedly nice. I feel these are digital instruments that our prospects and surgeons will respect and begins giving them numerous entry to knowledge that helps them analyze the efficiency of themselves and of their packages. How compelling that’s, we’ll decide how briskly prospects need to improve.

I feel the improve cycle comes right down to this sort of query of differential worth. X and Xi are excellent machines. They’re workhorses. They work rather well.

We’re delighted to assist them and assist our prospects who use them as they discovered the growing worth within the options and content material we deliver to da Vinci 5, whether or not it is analytics or pressure reflection or ergonomics or higher imaging, then that drives the buying and selling cycle. The query, and I perceive your modeling query effectively of how briskly does all of it transfer and what does that seem like? It may be tough to foretell. Jamie, I would flip it over to you and allow you to add your commentary.

Jamie E. Samath — Chief Monetary Officer

Yeah. Whereas we do not have a selected share, the influence of transferring to broad launch, the influence of getting extra geographical clearances, clearly then says, directionally, over time, the proportion of placements which can be dV5 usually ought to enhance. Though I might acknowledge that Xi is a succesful system. And in some unspecified time in the future, we now have the chance for a refurbished Xi.

With respect to trade-ins, you do not actually see buying and selling begin to decide up till you get to broad launch, which is the center of the yr, and it may be a operate of the dynamics that Gary indicated. In fact, we will look again at what occurred on the Xi launch and the way these upgrades went, and we now have some indication from prospects in our pipelines. I feel one of the best that lets say at this level, given it is so early is that any buying and selling cycle could be progressive.

Gary S. Guthart — Chief Government Officer and Director

Closing level I will make, and I feel you had requested, Robbie, the query is a part of that is, is there a possibility for depreciated belongings like X and Xi, that are extremely succesful? We all know the right way to service, and we all know the right way to assist or — to these open or create different alternatives in different markets which may be extra capital value delicate and the reply to that’s sure.

Robbie Marcus — Analyst

Nice. Possibly only one fast follow-up. Gary, you all the time give us a common state of the union on the well being of the capital tools surroundings world wide. U.S., OUS, and I am significantly considering of China the place you had a very robust placement quarter and fourth quarter.

So, any ideas there could be nice as we head into 2025. Thanks.

Gary S. Guthart — Chief Government Officer and Director

Yeah. I feel Jamie often does that. Jamie, why do not you deal with that?

Jamie E. Samath — Chief Monetary Officer

I would first say I do not assume we characterised the 20 techniques we positioned in China in This fall as robust. Possibly it’s on a year-over-year comparability foundation. However the surroundings in China continues to be dynamic and difficult as we have mentioned, impacted by each home competitors and a set of actions applied by the federal government there. So, I characterize the surroundings as comparatively constant and difficult.

When it comes to capital general, I feel within the U.S. It has been robust. A part of that’s curiosity in da Vinci 5 given it is a new product. And also you see, to some extent, much less sensitivity to capital budgets given simply the proportion of placements within the U.S.

particularly, no less than. We have highlighted the challenges within the U.Okay. and Germany. And new for us in This fall for Japan was some delays due to the profitability in sure prospects there.

So, I would say we have seen comparatively robust power within the U.S., some combined dynamics within the OUS markets. We do not actually have sufficient tea leaves to foretell how that performs out in ’25.

Robbie Marcus — Analyst

Thanks very a lot.

Operator

Thanks. Our subsequent query comes from Travis Steed with Financial institution of America Securities. It’s possible you’ll proceed.

Travis Steed — Analyst

Hey, congrats as effectively. Gary, I needed to ask a bigger-picture query. You are type of crossing over $1 billion a yr in R&D now and even after launching dV5. So, perhaps assist us perceive the R&D funding alternative over the medium time period and doubtlessly transferring into type of new inexperienced area.

Is that going to be extra via than the Endoluminal platform? Or are there nonetheless chunky classes like cardio that may very well be amenable to robotics? Or is it extra in regards to the geographic growth aspect of care? Simply to large perceive type of the true alternative left on the market to seize.

Gary S. Guthart — Chief Government Officer and Director

I feel it is a mixture of all three of the stuff you simply described. I feel there are improvements and applied sciences, a few of that are extensions to platforms you understand about, a few of that are platforms which can be years away and you do not know about that I feel open new alternatives for us over time. And we’re diligent about them. They take some time.

They take some funding they usually take follow-through. There are present platforms that might use extra indications, and people could be geographic, wherein case, there’s the regulatory and scientific work to safe these indications. And so, we spend cash on that and go do it. After which there’s extra indications that come from issues like extra devices and equipment and imaging capabilities on present platforms that if we develop them, we will deliver to market and open the marketplace for others.

We additionally spent some cash ensuring that latecomers to robotics get what they want. It isn’t simply that latecomers simply want time to simmer and ultimately, they arrive discover you. They generally have totally different wants, whether or not these wants or studying wants or financial wants. And it takes some work.

However we expect that work is price it. And a number of the stuff you see in da Vinci 5 are these kinds of issues. So, brief story is that we see alternative in all of these buckets. We run a course of that tries to stability these alternatives in order that we’re not completely overexposed to 1 or the opposite, and as an alternative, we now have a multiyear horizon and multi-specialty horizon and it is geographically combined.

Travis Steed — Analyst

Useful. After which, Jamie, perhaps only a shorter-term opex query on the ten% to fifteen% development, type of the excessive and low finish, how a lot of that is R&D versus SG&A? And any colour there on how that may form up and type of what drives the excessive and low finish? And doubtlessly, since you probably did point out tariffs. Simply type of curious the right way to dimension that or a possible method to mitigate that, when you can. Simply needed to type of observe up on Larry’s margin query.

Thanks.

Jamie E. Samath — Chief Monetary Officer

Yeah. With respect to how R&D and SG&A may develop, I would characterize it as related wealthy by way of — for that 10% to fifteen%. Clearly, R&D is a precedence, as we have said. In SG&A, what you will see is we add reps and business people to assist the process development.

We even have mentioned that there will be greater authorized bills in SG&A given ongoing litigation and a portion of the capex outcomes and depreciation that goes into our SG&A bills. And so, they’re going to develop roughly ish about the identical fee. When it comes to the vary of 10% to fifteen%, most of that’s pushed by the process vary, which means, clearly, to some extent, we’ll handle our bills in accordance with how our enterprise performs out. There are some alternatives for us to speculate incrementally in R&D, however we’ll do this as we make progress and obtain milestones.

When it comes to tariffs, Clearly, we see lots within the information the place we’re monitoring these occasions intently. We’re internally evaluating what the influence of any potential tariff is likely to be and due to this fact, how we’d reply. We will say that the numerous portion of our devices are presently manufactured in Mexico. And so, to the extent, there are vital tariffs applied there that might have a cloth influence for us.

And naturally, one response then that any firm may think about is what would you do with pricing. Nothing that we have determined there. And clearly, we’re balancing the wants of our prospects and their targets with the wants of our personal enterprise. So, keep tuned is what I would say.

Travis Steed — Analyst

Nice. Thanks.

Operator

Thanks. Our subsequent query comes from Rick Smart with Stifel. It’s possible you’ll proceed.

Rick Smart — Analyst

Thanks. Good afternoon. Gary, in your very considerate feedback through the JPMorgan convention, I feel you talked about new digital options, and also you definitely, right now, once more mentioned {hardware} and software program digital options coming. I hoped — and certain you are not prepared to offer us really specifics on all these.

However perhaps assist us perceive what areas this — in what manner this may improve da Vinci 5? Will it open up new procedures? Will or not it’s about productiveness? Will or not it’s about — will it allow you to make use of the da Vinci 5 in a distinct setting? How does this develop the imaginative and prescient or the chances of da Vinci 5 within the close to time period? After which I will have a follow-up if I may.

Gary S. Guthart — Chief Government Officer and Director

Yeah. In early considering right here, simply consider it in three classes. If we will make it simpler to get nice outcomes for extra care groups by giving them instruments within the OR, simply real-time instruments, we expect that creates alternatives for them. I feel it builds confidence.

I feel you get higher care groups quicker that manner. And this sort of — does that provide you with entry to new procedures? I feel the way in which to say that’s it most likely provides you entry to extra sufferers. Are they new process classes? Not all the time, however there are sufferers that turn into simpler for these surgeons and care groups to achieve as a result of they’re extra assured to achieve them. So, can it assist us that manner? Yeah, I feel it may well.

I feel that is one set of classes. The subsequent one is constructing confidence in care groups shortly is in all people’s finest curiosity. It is nice for the hospital. It provides them quicker returns and better confidence.

It is nice for the care groups. They construct confidence they usually get there quicker. And I feel numerous our instruments may help do this, may help speed up studying, not only for the surgeon however for others. After which lastly, I feel numerous these instruments permit for worth evaluation by the shopper utilizing their very own knowledge in their very own arms.

And that, I feel, builds confidence additionally and illuminates alternative for them, and that helps them and it helps us. So, for dV5 and type of the area we’re in proper now, that is the way you ought to consider it. One of many neat issues that Lonnie used to say, and he is proper is that each time you construct a functionality after which safe that, you’ve gotten it, you perceive it effectively. It opens a brand new door.

As a result of a surgeon, like Dr. Oh right here, we’ll take that new functionality and begin to discover it. The place can it lead me? What can I do subsequent? And I feel a number of the issues that we’re engaged on in dV5, a number of the imaging and augmented actuality issues will begin to encourage the subsequent set of surgeons. And with that inspiration comes alternative.

Rick Smart — Analyst

Nice. And if I may observe up briefly with Jamie. Jamie, clearly, Ion and SP each had terrific years final yr. What accelerates — what drives the subsequent section of development there? And particularly, when is — what degree of gross sales or what has to occur? And is it a yr or 5 away? When are these two wonderful merchandise not a margin drag? Thanks.

Jamie E. Samath — Chief Monetary Officer

Yeah. When it comes to the general enterprise, what’s driving procedures and income? If I have a look at Ion with 28,000 procedures in This fall, you’ll be able to see that is a run fee of over 100,000 procedures virtually solely within the U.S. So, you are beginning to rise up the adoption curve within the U.S. for Ion and a big remaining portion is in transthoracic needle aspiration by way of the strategy versus bronchoscopic approaches by way of the place we have adopted within the early interval.

So, what you see primarily based on the place you might be within the adoption curve within the U.S. for biopsy for Ion is prospects will are inclined to extra give attention to enhancements in utilization. And as you get to that time within the adoption curve, once more, biopsy within the U.S., you simply naturally on an S-curve begin to see process development charges come down. And you’ve got seen that when you have a look at the final three or 4 quarters.

And so, for our Ion enterprise, type of subsequent set of focus. Clearly, we have to complete the U.S. is the markets wherein we’re launching internationally with the clearance in Europe, Korea, and China. And on a longer-term foundation, there’s the chance for Ion as a platform to get into new indications that will be within the lung first, and there is potential for different locations within the physique down the highway.

From a product value perspective, it’s a set of packages that take fairly a while. It is the on a regular basis battle within the manufacturing group and there’s some engineering work that should occur to type of get to the product value. And I would say that is additionally within the midterm, in keeping with our general gross margin targets. With respect to SP adoption.

Once more, we have additionally acquired worldwide launches there. Europe and Japan, each have broad indications. You see Korea, which we have had within the market for a while, actually robust utilization. And so, for SP, it is actually as we glance to the U.S., is the extra indications.

We have thoracic and colorectal. You might have the chance to increase that over some interval. You see the expansion fee accelerating properly in SP. Margin work in SP is, to illustrate, not the identical degree of effort as Ion as a result of we’re extra leveraged.

The search and imaginative and prescient console of widespread with Xi, however by no means much less work to do. That can be, I characterize as one thing that occurs over the midterm.

Rick Smart — Analyst

Thanks, Jamie.

Operator

Thanks. Our subsequent query comes from David Roman with Goldman Sachs. It’s possible you’ll proceed.

David Roman — Analyst

Thanks and good afternoon, all people. I needed simply to start out with a remark you made within the ready remarks concerning competitors and promoting cycles. Is that this one thing that you just’re observing right now as you speak to prospects outdoors the U.S. and even within the U.S.? Or are you simply calling out a theoretical influence of what may occur as new entrants come to market? After which I’ve one follow-up.

Jamie E. Samath — Chief Monetary Officer

We have now seen it clearly in China with the growing variety of home opponents there. I would say that by way of the influence of competitors to promoting cycles in different worldwide markets has been comparatively steady. However what you are seeing is an growing variety of opponents get clearances in varied markets, together with within the U.S., there are a variety of opponents within the U.S. and clearly, there’s one bigger firm that is trying to make a submission in So, we’re simply acknowledging that as competitors will increase, there’s the chance outdoors of China, the promoting cycles may lengthen.

David Roman — Analyst

That is useful. And perhaps simply type of a segue on that one. As you consider the chance in devices and equipment, both on a per-procedure foundation or a complete addressable market foundation, are you able to assist us assume via which components of type of the surgical ecosystem you’ve got captured right now? And perhaps give us some sense of the place that is likely to be going over time? We perceive that is the fourth sensing piece of the launch of — with dV5 and the way that may influence mainly an upgraded instrument and corresponding ASP inside that INA line. However as you have a look at type of different components of the surgical ecosystem that you may seize to additional entrench your self, are you able to assist us perceive what these is likely to be and perhaps dimension a few of them? And the way type of you consider that when type of your advertising and strategic planning groups?

Gary S. Guthart — Chief Government Officer and Director

Yeah. Possibly I will begin with type of the ideas we use to consider how we will deliver extra worth to procedures we already take part in. And beneath, I feel you’ve gotten a modeling query, and I will let Jamie take that. On the principal aspect, we glance round and say, if there’s one thing occurring within the working room that our prospects are presently spending on, they’re shopping for from anyone else.

And we expect that both we now have design capabilities or integration capabilities that will make for that have to be higher for them and value-creating. It is both clinically value-creating or it is economically value-creating, then we’ll search to do this. Generally in partnership, you see we’re doing that with Huron on the desk. And typically it is one thing that we’ll attempt to do ourselves take in-house and the way in which we have carried out some issues just like the cannula seals and stapling.

So, we glance throughout it. If we see an actual place the place it is true worth creation, not simply one thing the place it modifications the income line by doing precisely what anyone else does, we’re not very excited about that. But when we expect the combination or the design creates a greater consequence for the shopper, both economically or clinically, hopefully, each, then we’ll step ahead and we’ll do this. We do not assume we’re carried out.

In case you have a look at da Vinci 5, you noticed some issues come into da Vinci 5 that had been benefited by integration, and we expect it is working nice. So, we search for these issues. They take some time. They are not speedy.

So, our technique and our product planners are in search of value-creation alternatives there, nevertheless it would not begin with how briskly can the income development be. It begins with what is the worth creation and what may that be. For sensing devices, force-reflecting devices are such an instance. They’re extra advanced.

They’ve a better ASP. We expect they carry worth. We have now to reveal that worth and off we go. Jamie, I feel the modeling query is tremendous exhausting, however I’ll provide you with a shot.

Jamie E. Samath — Chief Monetary Officer

So, I might simply say that the 2 examples I would reference by way of the place you may, to illustrate, get larger share of pockets, when you can deliver worth, our pressure suggestions devices and insufflation each on da Vinci 5. Drive suggestions, we do not count on to be type of a broad provide till the top of ’25. So, the type of influence that has on I&A per process is gated by after we get to broad provide with respect to inflation. So, far, the proportion of instances that use that has been fairly excessive and that may have an effect as da Vinci 5 process volumes develop.

I might simply say if I zoom out by way of I&A per process in complete, the bigger driver goes to be the process combine. A larger proportion of type of the place we see development coming from is in benign procedures. Gary type of described that in newer outcomes. However when you consider cholecystectomy and different benign procedures, you will have a process combine dynamic that signifies that we expect, no less than over the subsequent couple of years.

I&A per process drifts down slowly over time.

Gary S. Guthart — Chief Government Officer and Director

We have now time for only one final query.

Operator

Thanks. And our final query comes from Patrick Wooden with Morgan Stanley. It’s possible you’ll proceed.

Patrick Wooden — Morgan Stanley — Analyst

Lovely. Thanks a lot. A little bit of a bizarre conceptual one. I am simply type of interested by it.

However when you consider the efficiencies out of your put in base density. So, over time, as you are inserting increasingly techniques and in particular person areas and areas, the put in base density goes up. Is there actually a margin implication for that from extra efficiencies in promoting into the shopper base, and servicing the techniques? Are you able to see that in some areas or areas or markets the place you’ve got acquired numerous density versus these the place you’ve gotten barely much less scale? I am simply conceptually attempting to grasp the impact of that over the long run. Thanks.

Jamie E. Samath — Chief Monetary Officer

Properly, usually, the I&A income are at greater margins than capital. And so, as you drive utilization development, then a larger proportion of the income over some interval comes from the upper revenue streams. Properly, let me ask Patrick. Is that the essence of your query?

Patrick Wooden — Morgan Stanley — Analyst

It was extra across the service and the effectivity of driving into these present accounts relatively than the combination between the 2.

Gary S. Guthart — Chief Government Officer and Director

I will reply shortly simply in gentle of time. We do get some benefits of scale with geographic density by way of value to assist an account. So, service, service depots, gross sales assist, coaching assist, as that turns into extra dense, it does give us some value benefits to serve them. Is that the place you are headed?

Patrick Wooden — Morgan Stanley — Analyst

That is the way in which. Thanks a lot.

Gary S. Guthart — Chief Government Officer and Director

OK. Thanks a lot. That was our final query. In closing, we consider there is a substantial and sturdy alternative to essentially enhance surgical procedure and acute intervention.

Our groups proceed to work intently with hospitals, physicians, and care groups in pursuit of what our prospects have termed the Quintuple Intention: higher, extra predictable affected person outcomes, higher experiences for sufferers which can be experiences for his or her care groups, which can be entry to nice care and finally, a decrease complete value of care. We consider worth creation in surgical procedure and acute care is foundationally human. It flows from respect for and understanding of sufferers and care groups, their wants, and their surroundings. At Intuitive, we envision a way forward for care that’s much less invasive and profoundly higher the place ailments are recognized earlier and handled shortly so sufferers can get again to what issues most.

Thanks in your assist on this extraordinary journey. And we sit up for speaking with you once more in three months.

Operator

[Operator signoff]

Length: 0 minutes

Name members:

Brandon Lamm — Senior Supervisor, Investor Relations

Gary S. Guthart — Chief Government Officer and Director

Jamie E. Samath — Chief Monetary Officer

Daniel Oh — Vice President and Senior Medical Officer

Larry Biegelsen — Analyst

Gary Guthart — Chief Government Officer and Director

Jamie Samath — Chief Monetary Officer

Robbie Marcus — Analyst

Travis Steed — Analyst

Rick Smart — Analyst

David Roman — Analyst

Patrick Wooden — Morgan Stanley — Analyst

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