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HomeโซลานาIntuitive Surgical (ISRG) Q3 2024 Earnings Name Transcript

Intuitive Surgical (ISRG) Q3 2024 Earnings Name Transcript


ISRG earnings name for the interval ending September 30, 2024.

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Intuitive Surgical (ISRG -0.60%)
Q3 2024 Earnings Name
Oct 17, 2024, 4:30 p.m. ET

Contents:

  • Ready Remarks
  • Questions and Solutions
  • Name Individuals

Ready Remarks:

Operator

Thanks, everybody, for standing by, and welcome to the Intuitive third quarter 2024 earnings launch. Now, presently, all contributors are on a listen-only mode. Later, we are going to conduct a question-and-answer session. [Operator instructions] I’ll now flip the convention over to your host, Brandon Lamm with investor relations for Intuitive.

Please go forward.

Brandon LammSenior Supervisor, Investor Relations

Good afternoon, and welcome to Intuitive’s third quarter earnings convention name. With me right now, we have now Gary Guthart, our CEO; Dave Rosa, our president; and Jamie Samath, our CFO. Earlier than we start, I want to let you understand that Brian King has moved on to pursue his subsequent alternative. We recognize his contributions over the previous 9 years and need him effectively in his subsequent endeavor.

A seek for his substitute is in progress. Transferring on, I want to inform you that feedback talked about on right now’s name could also be deemed to include forward-looking statements. Precise outcomes might differ materially from these expressed or implied because 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 Kind 10-Okay for the fiscal yr ended December 31, 2023, and subsequent filings.

Our SEC filings may be discovered via our web site or on the SEC’s web site. Buyers are cautioned to not place undue reliance on such forward-looking statements. Please observe that this convention name will probably be out there for audio replay on our web site at intuitive.com on the Occasions part beneath our Investor Relations web page. Immediately’s press launch and supplementary monetary knowledge tables have been posted to our web site.

Immediately’s format will include offering you with highlights of our third quarter outcomes as described in our press launch introduced earlier right now, adopted by a question-and-answer session. Gary will introduce the decision and supply a enterprise overview, Dave will current the quarter’s enterprise, operational, and scientific highlights, Jamie will present a evaluate of our monetary outcomes and process highlights, then I’ll present our up to date monetary outlook for 2024. And eventually, we are going to host a question-and-answer session. With that, I’ll flip it over to Gary.

Gary S. GuthartChief Government Officer and Director

Thanks for becoming a member of us right now. Q3 of 2024 was quarter for us with wholesome process development, stable capital placements, and robust operational execution in a dynamic international surroundings. I am going to kick off by offering a perspective on our platforms and our areas. Beginning with our multiport system, we now have an put in base of roughly 9,300 globally.

Our five-year process compound annual development fee in multiport has been 17%, with roughly 16 million complete sufferers handled utilizing da Vinci multiport platforms, of which roughly 10 million had been previously 5 years. Manufacturing, logistics, and repair functionality has elevated over the previous a number of years, serving to guarantee availability for our clients whereas managing margins. Programs stability taken throughout our multiport product strains has been excellent, setting a typical for dependability. We launched our fifth-generation multi-port system in March this yr and have put in 188 right now with over 12,000 procedures accomplished utilizing da Vinci 5 in roughly six months.

Da Vinci 5 is bringing excellent enhancements for surgeons, care groups, and hospitals along with first-of-their-kind options that we predict will enhance affected person outcomes. We’re shifting towards our broad launch and are effectively into the method of securing further international regulatory clearances for da Vinci 5, which you may hear about later within the name. Turning to our endoluminal system, we launched Ion in Q3 of 2019. Immediately, the in put in base is 736, of which 722 are in the US.

Physicians have accomplished greater than 150,000 lung biopsies utilizing Ion to this point. Every considered one of which makes use of a machine learning-created anatomically segmented lung mannequin based mostly on the patient-specific anatomy, personalised digital intervention for each case. Our five-year compound annual development fee for Ion procedures has been 205%. There are over 100 peer-reviewed articles assessing Ion.

General security and accuracy knowledge has been excellent. Over the previous yr, we have now centered on excellence in product high quality, product availability, and buyer expertise. We have now up to date Ion with important characteristic and software program upgrades 5 occasions since its launch and have made dozens of enhancements to our catheters and imaginative and prescient probes. Over the following two years, we’ll broaden our efforts to play programs past the US to proceed system and software program innovation to extend utilization in present U.S.

accounts and in continued pursuit of further indications. We launched da Vinci SP in Q3 of 2018 and the put in base now stands at 243. SP procedures have been rising at a five-year CAGR of 55% with 67,000 complete procedures accomplished to this point. We have seen robust SP efficiency in Korea, encouraging early development in Europe and Japan, and have elevated our cadence of regulatory exercise globally to broaden its applicability.

The SP scientific proof base stands at over 500 peer-reviewed journal articles. SP has discovered stronger uptake exterior the US as scientific indications in Europe, Japan, Korea, and now Taiwan are broader than the U.S. Our SP staff is concentrated on extending our instrument lineup, together with stapling and superior power on rising indications within the U.S. on enabling proctoring networks in international markets and our next-generation SP system innovation.

In our digital efforts, almost 3,000 da Vinci digital actuality simulators are within the put in base and surgeons full roughly 15,000 hours of coaching on simulators per quarter. Our lively surgeon customers for my intuitive app now exceed 14,000. Intuitive Hub is enabled in roughly 2,000 working rooms. We outperformed our analytics program, customized hospital analytics over 4,000 occasions and at a run fee of a number of hundred per quarter.

Our digital staff is concentrated on three enabling pillars, digital instruments that enhance outcomes within the OR and interventional suite, instruments that assist create higher care groups quicker, and instruments that drive efficiencies and a decrease complete value of possession, all whereas pursuing excellent capabilities in cybersecurity and knowledge privateness. Dave will contact on our digital progress shortly. Regionally, we have now been investing to construct balanced nation and regional groups that permit us to serve clients globally with high-quality interactions. These embrace industrial exercise, payer engagement, R&D, logistics, and manufacturing capabilities in area.

This has been a multiyear effort that has elevated buyer satisfaction and strengthened our international functionality. Our five-year compound annual development fee for procedures within the Europe area has been 21%. Within the Asia area, our five-year process CAGR has been 25%, and different markets exterior the U.S., it has been 18%. Reimbursement protection for robot-assisted surgical procedure has been obtained or expanded for dozens of procedures in most of the nations we serve.

That stated, we’re nonetheless comparatively early in our alternative to localize our capabilities to serve extra sufferers around the globe. General, our groups have been strengthening our capacity to serve our clients globally at industrial scale, increasing the applicability of robot-assisted surgical procedure and different interventions by pursuing new platforms, merchandise, and providers and acquiring new scientific indications. We have additionally been strengthening our digital ecosystem to help our clients and our firm with high-quality knowledge and perception. The chance to enhance outcomes for sufferers and our clients’ quintuple purpose via superior expertise ecosystems like ours is greater than ever, and we’re centered on disciplined execution to get there.

I am going to now flip the time over to Dave to take you thru scientific, R&D, and operational updates.

Dave RosaPresident

Thanks, Gary. Beginning with procedures, da Vinci process development within the quarter was 18%, aided by a further enterprise day relative to Q3 2023. Progress once more centered on basic surgical procedure within the U.S. with accretive contributions to the worldwide development fee from Japan, Germany, France, and the U.Okay.

In Asia, we have now blended market situations, largely according to the primary half of the yr. Jamie will describe these dynamics later within the name. Turning to capital. We positioned 379 da Vinci programs within the quarter, together with 110 da Vinci 5 programs and 21 SP programs.

We additionally put in 58 Ion programs within the quarter. Capital placements had been stable within the U.S., Japan, India, and our distribution markets and capital stress in Europe and China continued. System utilization, outlined as procedures for put in scientific system per quarter, grew 4% globally yr over yr for our multiport platforms, 9% for SP, and 11% for Ion. Turning to our funds.

Income grew 17% within the quarter, and spending was inside our expectations. Our spending displays funding in analysis and growth to help the expansion of our platforms and digital instruments, enlargement of our manufacturing amenities, and deliberate leverage from our enabling features. Jamie will take you thru our funds in larger element later within the name. In Q3, we continued our measured rollout of da Vinci 5 inserting 110 programs because the launch progresses in step with our plans.

We’re inspired by broad use of the platform throughout specialties with clients expressing a choice for da Vinci 5. Final month, about 1,200 healthcare professionals gathered at our annual consumer convention, Intuitive 360, to spotlight numerous facets of their robotic applications. Prospects have accomplished over 12,000 circumstances with da Vinci 5, and a number of other introduced their early case knowledge round effectivity and power suggestions. Quite a few clients have reported console time financial savings when evaluating da Vinci 5 to Xi, and we look ahead to broader analyses as extra knowledge turns into out there.

Earlier than its suggestions, Dr. Laila Rashidi from MultiCare Well being in Tacoma, a number one voice on gentler surgical procedure and its influence on restoration for her colorectal sufferers, described our outcomes. Even along with her deal with managing surgical forces, Dr. Rashidi preliminary circumstances with da Vinci 5 present an extra discount in power of about 20% when Pressure Suggestions is used.

Pressure Suggestions is a posh expertise that we have now been pursuing for greater than twenty years, and it stems from a perception that much less power on tissue can result in improved affected person experiences. We additionally consider Pressure Suggestions might speed up studying for care groups, and we are going to proceed to check using Pressure Suggestions with our clients. We anticipate extra publications over the approaching quarters, and our groups proceed working arduous to enhance product margin and improve provide of Pressure Suggestions devices. As we have now stated earlier than, maturing these insights will take time.

Turning to our digital efforts. We consider that digital improvements on our da Vinci and Ion platforms can extract distinctive scientific and operational insights, coupled with digital medical file knowledge, these insights ought to develop into a core a part of bettering outcomes, studying, and efficiencies sooner or later. So far, we have now knowledge from thousands and thousands of procedures that allow clients to evaluate operational metrics comparable to devices used, process length, and extra. As well as, lots of of 1000’s of those circumstances are linked to corresponding de-identified digital medical information, enabling sure scientific and operational hypotheses to be examined.

Case Insights is our new analytical software in My Intuitive that may add Kinematic, Pressure Suggestions, and video knowledge to physicians’ postoperative case experiences, additional enabling analyses to determine a connection between da Vinci system knowledge and scientific or operational outcomes. We’re on the early phases of progressive expertise we consider will probably be highly effective. However it can require fast cycles of innovation and take time to construct validated knowledge units. In Q3, we submitted our CE technical file in Europe.

Final week, we obtained clearance for da Vinci 5 in Korea and are forwards and backwards within the regulatory course of in Japan. This quarter, we started transport our da Vinci 5 broad launch {hardware} and accomplished a software program replace that addresses facets of early buyer suggestions. We’re driving towards broad launch midyear of 2025 once we anticipate to be at scale in our manufacturing operations, and we’ll have launched a software program replace enabling the built-in hub and simulator together with numerous digital and imaging options. Transferring to devices and equipment.

In Q3, we obtained 510(ok) clearance for our eight-millimeter SureForm 30 stapler, increasing our superior instrument portfolio of SureForm staplers that at present consists of 12-millimeter variations of 60-, 45-, and 30-millimeter lengths. Eight-millimeter SureForm 30 is primarily utilized in circumstances the place the decreased diameter permits surgeons to higher visualize and entry tissue and tight areas as typically seen in thoracic or kidney procedures. We’re beginning our industrial journey in China with Ion, the place we positioned two programs and noticed physicians carry out their first circumstances. We’ll start working with a variety of medical facilities to gather knowledge that may inform our broader commercialization technique within the nation.

In Europe, our early launch expanded into Germany and Italy. Turning to SP. Within the quarter, we obtained clearance with broad indications in Taiwan, much like Korea, Japan, and Europe. We additionally accomplished a U.S.

510(ok) submission for a colorectal indication. Commercialization in Europe continues in response to plan, and we’re inspired by early buyer curiosity for SP. Now, I would wish to share with you some lately printed peer evaluate literature that we discovered to be notable. Along with the precise knowledge highlighted on this name, we encourage you to contemplate the vast physique of proof detailing these subjects in printed scientific research through the years.

In August, on the 2024 American Affiliation for Oncology and Interventional Pulmonology Annual Convention, Dr. Bryan Husta from Memorial Sloan Kettering Most cancers Middle introduced outcomes from the CONFIRM examine. CONFIRM is a potential multicenter examine evaluating outcomes from the built-in Ion endoluminal system and cellular cone beam CT within the biopsy of pulmonary nodules, lower than two centimeters in measurement, 155 sufferers from six facilities all through the U.S. had been enrolled.

With a median nodule measurement of 14 millimeters, the built-in platform enabled a software in nodule fee of 99.4%, with a diagnostic yield of 9% and nil pneumothorax noticed. Subgroup evaluation demonstrated constant outcomes throughout all facilities with excessive diagnostic yields noticed no matter nodule measurement, location, or presence of CT bronchus signal. The introduced conclusion famous “built-in shape-sensing robotic-assisted bronchoscopy and international cone beam CT demonstrated a excessive diagnostic yield and excel the protection for small advanced nodules with reproducible outcomes throughout physicians and establishments.” These outcomes steered that built-in platform could possibly compete with a transthoracic biopsy method in small nodules shut fast. Earlier this yr, Dr.

Maegawa from the Division of Surgical procedure at Emory College in Atlanta, Georgia, printed within the journal Surgical procedure the examine evaluating robotic and laparoscopic cholecystectomy procedures for benign indications carried out in 2022. Utilizing the American School of Surgeons’ Nationwide Surgical High quality Enchancment Program database over 59,000 sufferers had been included within the examine with over 53,000 within the laparoscopic arm and roughly 5,500 within the robotic-assisted arm via a multivariable logistic regression evaluation, which managed for confounding elements. Sufferers present process a robotic-assisted cholecystectomy at an 18% decrease likelihood of experiencing a severe implication, in addition to a 56% decrease likelihood of a conversion to open and 24% decrease danger of requiring hospitalization for greater than 24 hours. The authors additionally checked out elective cholecystectomies solely and reported a 46% decrease likelihood of conversion to open 59% decrease likelihood of reoperation and 30% decrease odds of hospitalization over 24 hours related to robotic-assisted cholecystectomies.

The authors concluded “utilizing a big and up to date nationwide surgical database. The examine confirmed that total, robotic cholecystectomies had been independently related to a decrease danger of great issues, decrease fee of conversion to open, and decrease danger of hospitalization larger than 24 hours when in comparison with laparoscopy. These findings recommend that the adoption of latest applied sciences may improve the protection of minimally invasive surgical procedure in chosen circumstances.” In closing, we’re dedicated to our 2024 priorities, supporting our measured launch of da Vinci 5 and our different new platforms by area, supporting surgeons’ adoption of centered procedures persevering with to enhance product high quality and margins; and at last, bettering productiveness in these features that profit from a world scale. I am going to now flip the time over to Jamie, who will take you thru our funds and process highlights in larger element.

Jamie E. SamathChief 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. Core metrics continued to be robust in Q3 with da Vinci process development of 18%, put in base development of da Vinci programs of 15%, and total da Vinci system utilization up 3%.

Process development in Q3 benefited from a better variety of enterprise days in comparison with the year-ago interval. On a day-adjusted foundation, Q3 process development was 17%. U.S. procedures grew 16%, pushed by development in benign basic surgical procedure.

On a day-adjusted foundation, bariatric procedures within the U.S. declined within the mid-single-digit vary, much like final quarter. OUS procedures grew 24%, reflecting robust development basically surgical procedure, gynecology, and thoracic procedures. Inside our OUS markets, development was robust within the U.Okay.

and India and stable in Japan, Germany, France, and Eli. Process development in South Korea improved from the prior quarter however was nonetheless beneath longer-term historic traits given the continuing precision strike. In China, process development was beneath the company common, given current system placement traits reflecting a number of market dynamics that we have now beforehand described and home robotic competitors. With respect to capital efficiency, we positioned 379 programs within the third quarter in contrast with 312 programs in Q3 of final yr.

Within the U.S., we positioned 219 programs in Quarter 3 in comparison with 159 programs positioned in Q3 of final yr. U.S. system placements within the quarter included 110 da Vinci 5 placements. As provide of da Vinci 5 will increase and we transfer into broad launch mid-next yr, we anticipate the placements within the U.S.

will progressively shift towards trade-ins. Outdoors the U.S., we positioned 160 programs in Quarter 3 in contrast with 153 programs final yr. Excluding buying and selling transactions, web new system placements in OUS markets elevated 28% yr over yr. Q3 system placements included 65 into Europe, 39 into Japan, and 14 into China in contrast with 60 into Europe, 32 into Japan, and 10 into China in Quarter 3 of final yr.

Placements in Europe continued to be challenged by ongoing authorities funds pressures impacting healthcare capital spending. Third quarter income was $2 billion, a rise of 17% from final yr pushed by da Vinci process development, enlargement of the da Vinci put in base, and development in our ion enterprise. On a constant-currency foundation, income development was additionally 17%. Further income statistics and traits are as follows: Leasing represented 58% of Q3 placements, increased than current intervals, reflecting relative capital power within the U.S.

the place a a lot larger proportion of our clients want to lease programs. Q3 system common promoting costs had been $1.51 million as in comparison with $1.4 million final yr. Greater year-over-year system ASPs mirrored a better mixture of da Vinci 5 and a decrease mixture of trade-ins. We acknowledged $24 million of lease buyout income in Quarter 3 in contrast with $28 million final quarter and $17 million final yr.

Da Vinci instrument and accent income per process was roughly $1,800, flat to the prior quarter and decrease than final yr’s $1,830. The year-over-year decline in I&A per process was primarily pushed by a decrease mixture of bariatric procedures and a better mixture of procedures in markets served by distributors. Turning to our Ion platform. Procedures grew 73% to roughly 25,000 procedures within the third quarter.

In Q3, we positioned 58 Ion programs in comparison with 55% final yr and 74% final quarter. As a reminder, first-half Ion placements mirrored a catch-up of backlog as provide of catheters and imaginative and prescient probes improved. Q3 Ion system placements included three placements in Europe and our first two placements in China. The put in base of Ion programs elevated 50% yr over yr to 736 programs, of which 296 are beneath working lease preparations.

Third quarter SP process development was 70% with robust multi-specialty development in Korea, robust development within the U.S., and early stage development in Japan and Europe. Twenty-one of the programs positioned within the quarter had been SP programs, of which 15 placements had been in OUS markets. The SP put in base grew 54% from the year-ago quarter to 243 programs. Transferring on to the remainder of the P&L.

Professional forma gross margin for the third quarter of 2024 was 69.1% in contrast with 68.8% for the third quarter of 2023 and 70% final quarter. The year-over-year enchancment in professional forma gross margin primarily displays leverage to fastened overhead, decrease element prices and decrease logistics prices partially offset by increased stock reserves. Through the quarter, we opened our new system manufacturing facility at our East Coast hub in Peachtree Corners, Georgia, commencing manufacturing of X and Xi programs at that web site. We additionally opened our new international functionality middle in Bangalore, India, the place we’re co-locating our native industrial and coaching groups and the World Middle for IT and different shared service assets.

As a reminder, given current and ongoing capital investments, we anticipate a big improve in depreciation expense in 2025 as we carry on-line further amenities. Third-quarter professional forma working bills elevated 13% in contrast with final yr, pushed by increased head rely, elevated authorized bills, and better customer-facing actions. In keeping with the final couple of years, we have now held professional forma R&D bills of roughly 11% of income given our prioritization of investments in innovation that drive the quintuple purpose and our development. SG&A bills proceed to leverage as we profit from prior investments that permit us to scale effectively with development.

Through the quarter, we added roughly 670 staff, of which simply over half had been in our high-volume INA manufacturing facility in Mexicali to help process development. On a year-to-date foundation, via Q3 2024, professional forma working margin was 36% of income, a rise of 184 foundation factors in comparison with the identical interval in 2023, pushed by increased gross margin and leverage of SG&A bills because of income development and better working margins. On a year-to-date foundation, professional forma EPS elevated 25% from the prior yr. Professional forma different revenue was $94.6 million for Q3, increased than $79.4 million within the prior quarter primarily as a consequence of increased curiosity revenue.

Given the rate of interest surroundings, we anticipate the common curiosity yield on our money and investments will decline going into 2025. Our professional forma efficient tax fee for the third quarter was 20.5%, reflecting discrete advantages of roughly $12 million, primarily referring to the expiration of statutory limitations for sure tax reserves and an adjustment to our deferred tax belongings. Third quarter 2024 professional forma web revenue was $669 million or $1.84 per share in contrast with $524 million or $1.46 per share for the third quarter of final yr. I’ll now summarize our GAAP outcomes.

GAAP web revenue was $565 million or $1.56 per share for the third quarter of 2024 in contrast with GAAP web revenue of $416 million or $1.16 per share for the third quarter of 2023. The changes between professional forma and GAAP web revenue are outlined and quantified on our web site and embrace extra tax advantages related to worker fairness plans, worker stock-based compensation, amortization of intangibles, litigation prices, and features and losses on strategic investments. We ended Q3 with money and investments of $8.3 billion, increased than the $7.7 billion we ended final quarter. The sequential improve in money and investments mirrored money generated from working actions, partially offset by capital expenditures of $248 million.

And with that, I want to flip it over to Brandon to debate our up to date outlook.

Brandon LammSenior Supervisor, Investor Relations

Thanks, Jamie. I’ll now flip to our monetary outlook for 2021. Beginning with procedures. On our final name, we forecasted full yr 2024 process development inside a spread of 15.5% and 17%.

We are actually elevating the low finish from 15.5% and to 16% and anticipate full yr 2024 process development inside a spread of 16% and 17%. The low finish of the vary assumes additional softening in bariatric procedures together with rising headwinds in Asia from doctor strikes in Korea and from delayed tenders in home robotic programs in China impacting capital placements and subsequently, process development. On the excessive finish of the vary, we assume bariatric stabilizes at present quarter development charges and headwinds in Korea and China don’t worsen. The vary doesn’t mirror important influence to elective procedures because of IV shortages or different hurricane-related impacts.

Turning to gross revenue. We proceed to anticipate professional forma gross revenue margin to be inside a spread of 68.5% and 69% of web income. Our precise gross revenue margin will differ quarter to quarter, relying largely on product, regional, and trade-in combine, and the influence of latest product introductions. Turning to working bills.

On our final name, we forecasted full yr 2024 professional forma working expense development to be inside a spread of 10% and 13%. We are actually reducing the excessive finish of our estimate and anticipate full yr 2024 professional forma working expense development to be inside a spread of 10% and 12%. We anticipate noncash inventory compensation expense to vary between $670 million and $690 million in 2024. We’re rising our estimate for different revenue, which is comprised largely of curiosity revenue to complete between $325 million and $345 million in 2024.

With regard to capital expenditures, we proceed to estimate a spread of $1 billion to $1.2 billion, primarily for deliberate facility development actions. With regard to revenue tax, we anticipate the professional forma revenue tax fee for 2024 to be inside a spread of twenty-two% and 23% of pre-tax revenue. That concludes our ready feedback. We’ll now open the decision to your questions.

Questions & Solutions:

Operator

Thanks. [Operator instructions] And we’ll undergo the primary query in queue. Travis Steed, Financial institution of America. Please go forward.

Travis SteedAnalyst

Positive. Perhaps just a bit extra on serious about the dV5 ramp between now and the mid-2025 broad launch. Do you anticipate to make any extra upgrades or advert software program? And I would like to dig in a bit of bit on the client actions to a number of the contribution margin advantages, contribution margin advantages of dV5 type of on the early knowledge and the hospital CFOs are resonating with a few of that pretty worthwhile knowledge with dV5.

Dave RosaPresident

Yeah. Hey, Travis, that is Dave. I’ll reply a few of your questions round type of the place are we going from right here to broad launch. So, by way of software program updates, we’ll proceed to make them as they’re scheduled in our plans.

And you may see these come out on a semi-routine foundation. We have now to get to broad launch, as described in my feedback, we have now a launch that may allow a few of that {hardware} and a few further software program options in that broad launch timeframe. For the provision aspect of dV5, we anticipate that to extend modestly quarter over quarter as we get into subsequent yr and into broad launch. On the contribution margin aspect, perhaps, Jamie, we are able to transfer to you.

Jamie E. SamathChief Monetary Officer

Yeah. I would just say that, clearly, there was a publication in {one of the} government publications that we assisted with. It was illustrative by way of the contribution margin features that an establishment may get given what we’re seeing with respect to effectivity. We have now a variety of early surgeons which are KOLs which have sophistication by way of use of da Vinci which are reporting enhancements in console time, and that enables for each effectivity in a given process and maybe the chance to have increased throughput on the platform.

And I feel that is a part of the dialog with administration. I would say that is early, and I feel we glance to gather proof and validation as we get into the broad launch, however early suggestions from a variety of our surgeons has been centered on the effectivity features they’ve seen.

Operator

And we’ll go to the following query. Larry Biegelsen, Wells Fargo. Please go forward.

Larry BiegelsenAnalyst

Thanks for taking the query. One on worldwide for me, one on procedures, if I’ll. The Korean approval, I feel, got here sooner than folks anticipated. Do you may have provide to launch that straight away? And simply what is the replace on Japan timing? I heard the forwards and backwards within the ready remarks.

And the way lengthy are you anticipating the evaluate course of in Europe to take? And I’ve one follow-up.

Dave RosaPresident

Yeah. We do have provide to have the ability to help Korea demand. And so, that’s true. We have now not outlined timing in Japan.

So, we stay in that forwards and backwards. After which with respect to CE Mark in Europe, no completely different from final quarter the place we anticipate that close to the tip of subsequent yr 2025.

Larry BiegelsenAnalyst

Acquired it. That is useful. And for Dave or Gary, we have heard you and key opinion leaders lately began speaking about new procedures comparable to appendectomy, foregut, hepatobiliary, and emergent procedures. Might you please inform us the place you might be in addressing these from a scientific, regulatory, and industrial standpoint? And the way would you measurement a few of these new procedures? Thanks.

Jamie E. SamathChief Monetary Officer

Yeah. With respect to foregut and HPB, we have truly been in these procedures within the U.S. for a while. They have been rising properly for us.

At the moment, the expansion charges for them are accretive to the U.S. common. They’re each comparatively small classes, and that is most likely why they have not gone quite a lot of the airtime by way of our commentary appendectomy is way earlier for us. It is fairly a small process.

It is usually accretive development. I feel what you are seeing with appendectomy is as surgeons have adopted Xi over time, as they’ve expanded, they’re type of taking a apply method to basic surgical procedure. What you see is that then will get prolonged into the emergent care settings, acute care settings they usually begin to use Xi extra routinely. We have now accomplished some scientific work on appendectomy.

We do have a sign with the FDA within the U.S. and appendectomy, that is a small process for us, and clearly, it is concentrated in emergent settings.

Operator

OK. And we’ll go to the following query from Robbie Marcus, JPMorgan. Please go forward.

Robbie MarcusAnalyst

Yeah. Congrats on a terrific quarter. Two for me, may each be for Jamie. I am going to allow you to determine.

Perhaps first, the margins had been as soon as once more actually spectacular, each gross margin and working margin. Actually, the query is how far more room do you are feeling like there’s to go? We’re simply beginning to see da Vinci 5 move via. And I do know there’s positively some depreciation profit flowing via this yr that most likely wanes into subsequent yr. And we’re coming off a really heavy funding interval.

So, I suppose the query is, as we transfer ahead, how ought to we take into consideration the margin development as you may have these new merchandise flowing via and the combo begins to evolve?

Jamie E. SamathChief Monetary Officer

Yeah. Perhaps just a few framing first. I feel we have constantly stated we glance to have margins which are type of top-tier with respect to our med tech friends. We have additionally stated that we do not have a administration expectation to have op margins above 40%.

I do know they had been — had that stage again pre-COVID, however we do not have a administration goal to be again at that stage, and that is simply us balancing the speed of funding with what we predict is the correct stage of profitability. We had been 37% of margin this quarter, 36% yr to this point. What I’d anticipate is for 2025 on the gross margin entrance, simply given the numerous incremental depreciation that we have described, you need to anticipate gross margins to be a bit of decrease subsequent yr as we begin to tackle board that incremental depreciation expense. And you will have a interval, as these new amenities come on-line, the place, the truth is, we’re interval expensing that depreciation since you’re early within the section of type of ramping manufacturing in these amenities versus capitalizing them into stock.

I feel what we have stated within the midterm is we have now the chance, we predict, on gross margin to get again to 70%. That is our aspiration. But when you consider the place we’re proper now, yr to this point, 36%, we do not have a administration goal to be above 40 is a comparatively slender vary over the midterm to enhance. The query of what we do on that midterm will even be balanced by how a lot we put money into R&D, which goes to be a operate of the alternatives that we see.

Robbie MarcusAnalyst

Nice. Recognize that. After which as a follow-up, as we transfer into subsequent yr and also you talked about anticipate extra of the trade-ins coming from da Vinci 5 as you progress into full launch. There’s a chance, clearly, to repurpose and resell a number of the refurbished is that you simply get traded in.

Simply perhaps communicate to the chance there, how we must always take into consideration that? And any rapid plans you’ll be able to speak about? Thanks quite a bit.

Jamie E. SamathChief Monetary Officer

Yeah. So, you need to anticipate us to because the buying and selling cycle happens, which, by the way in which, we predict will probably be progressive and can happen over multiples of years, as Xis come again, we are going to, as we have accomplished previously, refurbish these. That does permit for segmentation that may very well be web site of care segmentation, for instance, within the U.S. and segmentation in markets internationally which are extra value delicate.

We have not labored via precisely how — what these plans will probably be, however you could possibly anticipate inside that framing, that is type of what we’ll do with respect to refurbished Xis.

Operator

And we’ll go to the following line right here, David Roman, Goldman Sachs. Please go forward.

David RomanAnalyst

Thanks, and good afternoon, all people. Perhaps we are able to begin on Ion. I feel when you look in a wide range of public boards, there’s been a substantial quantity of promotional exercise, each within the U.S. and Europe as you’ve got launched in new markets.

Perhaps you could possibly assist us take into consideration the place we’re within the Ion launch and adoption curve in every of the goal geographies and the way we must always take into consideration development in that phase on a go-forward foundation. After which I’ve one P&L follow-up.

Gary S. GuthartChief Government Officer and Director

Positive. I am going to take that one, David. It is Gary. Within the U.S., I feel Ion is progressing effectively, in its first indication, biopsy of suspicious lung nodules.

We predict it is crossed the chasm. It must be in double-digit prevalence by way of complete biopsy use. So, I feel there, the main focus is a bit of bit much less now on the earliest clients. I feel the early clients have accomplished nice.

We’re fairly deeply penetrated into these websites of care, and the main focus there will probably be on excessive utilization, excessive buyer satisfaction, some innovation, and pursuit of further indications contained in the lung utilizing the Ion platform. We’re a lot earlier in our journey exterior of the US. So, early experiences to date in Europe first began within the U.Okay. They’re constructing some momentum off an early base after which early, early steps into Germany, likewise, early, early steps into China.

So, it is a bit of little bit of a two-phased method right here within the U.S. robust transfer towards excessive utilization, excessive satisfaction shifting out of the primary concentrated set of consumers. And in OUS, it is actually initiating the journey in numerous markets.

David RomanAnalyst

That is tremendous useful. After which perhaps only a follow-up on the P&L. One of many issues that was notable this quarter and has been the previous couple is the elevated share of programs being positioned beneath utilization agreements. I feel it is gone from about 12% earlier this yr to about 15% now.

Are you able to assist us take into consideration the trajectory of that contribution to the position mannequin and what meaning for the P&L?

Jamie E. SamathChief Monetary Officer

Nicely, so these preparations are a subset of working leases. And clearly, these preparations are the place the client pays for system and repair as they use the system. These preparations with the shoppers have an expectation of what the procedures will probably be accomplished per yr that is mirrored within the association. And so, then at goal economics, you need to consider it as much like a daily providing, at the least it is a fastened cost association and working leases basically are barely accretive to buy due to the embedded rate of interest in there.

In fact, the distinction for the usage-based association is then you may have the danger of what’s the precise utilization by the client in these usage-based preparations. We have now a distribution, as you’d anticipate by way of what the utilization charges are and we interact with the shoppers commonly with respect to what their enterprise plans are, significantly after they’re not on the goal. By way of trajectory, clearly, you’ve got seen it develop. It’s fashionable with clients.

It’s a solution to each entry further capability with out having to eat capital budgets, and it does decrease the danger for the client by way of taking a brand new system relative to how effectively that is going to be utilized. We have now provisions and protections in these preparations for us and for the client, and we have a look at these routinely. I’d anticipate it to proceed to develop, however it’s comparatively extremely penetrated within the U.S. And so, the speed of development will probably average.

Within the worldwide markets, we’re at a a lot earlier stage. So, I feel that is too early to name by way of how that may develop.

Operator

And we’ll go to the road of Rick Sensible of Stifel. Please go forward.

Rick SensibleAnalyst

Gary, Dave, all people, we proceed to have quite a lot of conversations with surgeons who’re or doubtlessly thinking about da Vinci 5. And I am not saying that is an correct pattern, however simply it is our pattern. I get to see a number of the bigger hospitals, the tutorial facilities that they are extra ready, they’re ready for twin console availability. And so they’re saying to me, as our smaller hospitals that you simply’re extra centered proper now on, I am going to name it, mid- to smaller establishments, nonacademic.

They’re making choices quicker. They’re much less depending on twin console. Is that proper? Is that what is going on on? And I’m wondering what — a few issues, whether or not process development implications are affected positively or negatively by that. And when twin console is extra out there center of subsequent yr if you’re full-launched, I assume — will we see an acceleration in kind of multisystem, greater hospital decision-making?

Gary S. GuthartChief Government Officer and Director

Dave, I am going to allow you to communicate to simply twin console availability and what is going on on there, after which we are able to communicate a bit of bit to what the traits are. We’ll reply the remainder of the questions.

Dave RosaPresident

Hey, Rick. And also you stated it. So, on this, as we’re ramping our provide capabilities, twin console is being prioritized with incremental single-system offers. And so, as we construct our capability, we are going to begin producing further consoles for twin system placements.

By way of prioritization and whether or not being prioritized, I feel our staff is working with a broad set of consumers and to know what their wants are. And if da Vinci 5 is the correct system to satisfy their wants for his or her program. And I haven’t got quite a lot of details about how that will differ between smaller clients as you set it or in lecturers or bigger establishments.

Gary S. GuthartChief Government Officer and Director

I would not anticipate a big forecast mannequin change a technique or one other. I feel as we go to broad launch and the pipe opens up, we are going to search to serve all these clients. I do not suppose it inflects process development fee a technique or one other due to twin console and enormous versus small. I believe that is a tough evaluation to do.

And when you do, do it, I believe the variations will probably be comparatively small relative to what we anticipate.

Rick SensibleAnalyst

And a fast follow-up, if I may, on Hub. I feel it was thrilling to listen to you are in over 2,000 ORs. Simply assist us suppose via the early expertise there and perhaps the implications for each da Vinci 5 and, once more, procedures. Thanks.

Gary S. GuthartChief Government Officer and Director

Yeah. So, Hub, because it exists right now, and that features our Era 4 compatibility in addition to these which are linked to Gen 5, what does it do? It is a robust knowledge recorder and media administration system. Quite a lot of these early installs are on-premise implementations versus the cloud. Prospects take pleasure in it for his or her capacity to trace their knowledge and to evaluate post-op efficiency, which has been nice.

Over time, as we transfer ahead and transfer towards cloud implementations and different issues, I feel that it supplies them quite a lot of leverage there’s quite a bit that we like about it. I feel the core functionality is actually good. There are some issues we need to work on. I feel refinement, workflow, making these issues very easy integration in dV5 goes to be nice.

We’re actually enthusiastic about it. I feel it issues. So, far, so good. I feel we’re at first of the Hub journey, each by way of penetration and by way of characteristic content material, not the tip of it.

And I am pleased with the progress the staff is making.

Operator

We’ll go over to the road of Adam Maeder, Piper Sandler. Please go forward.

Adam MaederPiper Sandler — Analyst

Hello. Good afternoon. Congrats on the quarter. I wished to ask for some further coloration across the capital surroundings and the way you are serious about hospital budgets and urge for food for bigger piece of the capital heading into the tip of the yr in 2025.

And I heard the commentary round Europe and China, it seems like there’s continued stress there. Simply curious, is that type of established order versus the primary half of the yr? Is it getting worse? And type of how do you anticipate that to evolve going ahead? After which I’ve a follow-up. Thanks.

Gary S. GuthartChief Government Officer and Director

Jamie, why do not you are taking the broad reply? After which I am going to contact on China on the finish.

Jamie E. SamathChief Monetary Officer

Yeah. I feel I would characterize U.S. is comparatively steady, albeit with quite a lot of curiosity in da Vinci 5. I feel that is type of raised the profile once more in curiosity in robotics to some extent.

However I would characterize the general capital surroundings is comparatively steady. In Europe, what you are seeing significantly in nations just like the U.Okay. and Germany is stress on capital spending within the healthcare house, once more, associated to authorities funds pressures that exist there. And I feel that is been comparable for the final quarter or so.

Within the case of Europe, we have now some government-related occasions that come within the subsequent couple of quarters, however too early to foretell how that may play out by way of then modifications within the capital dynamics.

Gary S. GuthartChief Government Officer and Director

Yeah. Simply turning to China. There’s clearly broad stress throughout the healthcare market in complete in China, there’s type of a rebaselining there in a number of the value-based pricing that has gone via in addition to a number of the value caps which have gone via in our finish of the market. So, I feel that stress continues to be there.

I feel will probably be there for some quarters. I do not suppose that resolves shortly. There’s additionally, in our universe, the entry of some home opponents that are likely to get provincial preferences, the province during which they’re headquartered tends to have a choice for them as they launch. And so, you see that type of present up as popcorn because it goes round.

I feel that may persist for a short time, too. So, for us, I feel it isn’t a shock given the yr we have had. I feel finally, these items will wash via, how lengthy it takes for it to clean via and stabilizes is but unknown.

Operator

We’ll go to the road of Brandon Vazquez, William Blair. Please go forward.

Brandon VazquezAnalyst

Hello, everybody. Thanks for taking the query. You recognize, you may have quantity of da Vinci 5 programs on the market. I used to be simply curious when you may evaluate and distinction.

Are there any type of distinctive insights that you’ve got in that da Vinci 5 put in base, whether or not it is what forms of procedures they’re doing or utilization inside these accounts, are these programs relative to the remainder of the Xi base? After which perhaps only one fast follow-up, I am going to throw right here now. Are you able to discuss a bit of bit — it seems like innovation on a go-forward foundation is actually going to be coming quite a bit from software program. Are you able to type of evaluate and distinction the innovation cycle, the velocity at which you’ll be able to launch new options on the software program aspect versus what has traditionally been, I’d guess, a bit of little bit of an extended cycle in {hardware}? Thanks.

Jamie E. SamathChief Monetary Officer

Yeah. So, let me attempt to hit each of these. On the da Vinci 5 aspect and the comparability to Xi, {one of the} issues that we’re happy with is it’s getting used throughout a broad set of procedures. And so, clients with the restricted provide are actually utilizing them to their fullest.

With respect to how do you evaluate da Vinci 5 utilization to Xi, it is actually too quickly to say. The put in base is not sufficiently big with an extended sufficient historical past but to present us knowledge set to make these comparisons. On the software program aspect, there’s type of two buckets that we function in there are units of software program and merchandise which are nonmedical system. And people are in a position to have extra fast cycles of innovation and our capacity to roll it out to the sphere.

After which there’s a second set that our 510(ok) or ruled by regulatory processes across the globe. And people will usually comply with an extended cadence, most likely nonetheless a bit faster than you’d see in main {hardware} modifications and issues like that. And so, on the common, you probably will see software program upgrades and updates occur on a extra — on a better cadence, however it type of will depend on which bucket they fall into.

Gary S. GuthartChief Government Officer and Director

I’d problem the belief a bit of bit. I feel there’s nonetheless some {hardware} we need to do. I do not suppose {hardware} goes away. I feel that is going to proceed and dV5 has some alternatives for that, too.

And we’ll do the software program that you simply simply described. I feel it is nice, however we get an opportunity to do each. Operator, we’ll take another questioner, after which we’ll shut.

Operator

And that is from the road of Matt Miksic, Barclays. Please go forward.

Matt MiksicAnalyst

Thanks a lot for squeezing me in. Perhaps only a massive image type of a follow-on query. I get some model of this query typically from traders, speaking about development drivers, alternatives in process development. And so, perhaps when you’re trying on the U.S.

market and the speed that you simply’re rising now, clearly, the place penetration is and the place it may go over time. Do you anticipate perhaps within the subsequent couple of years or three years to be pushed extra by driving deeper into present procedures and classes? Or do you see any kind of new, massive segments, necessary segments that you simply anticipate to assist drive that development? I imply, what would you say the combo seems like? Or any coloration you’d be capable of add, it might be tremendous useful. Thanks.

Gary S. GuthartChief Government Officer and Director

Yeah. Thanks, Matt. It is a terrific query. I prefer it.

I feel within the U.S., we’re — I will not provide the precise break up, however I feel it is a balanced perspective. Clearly, we’re approaching the again half of some curves and a few procedures the place it is actually about depth. What do the parents, who haven’t but participated or are taking part absolutely, what do they want from us to maintain going and to serve the sufferers that means? There’s nonetheless alternative there. In some methods, there’s loads of alternative.

On the identical time, as you begin attending to the again half, you need to be sure to’re searching for, we need to be certain that we’re searching for new alternatives and alternatives to serve a unique set of sufferers that we have not engaged earlier than, and also you’re beginning to see us try this, whether or not it is in new indications for Ion or SP. And we predict truly in multiport, there’s some alternative and new indication additionally, though they will are usually extra area of interest markets than actually massive ones. Over time, over the approaching quarters, we’ll let you know extra about that as these alternatives mature. So, thanks.

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 clients have termed the quintupling: higher, extra predictable affected person outcomes, higher experiences for sufferers, higher experiences for his or her care groups which are 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 once more in your help on this extraordinary journey. We look ahead to speaking with you once more in three months.

Operator

[Operator signoff]

Period: 0 minutes

Name contributors:

Brandon LammSenior Supervisor, Investor Relations

Gary S. GuthartChief Government Officer and Director

Dave RosaPresident

Jamie E. SamathChief Monetary Officer

Travis SteedAnalyst

Jamie SamathChief Monetary Officer

Larry BiegelsenAnalyst

Robbie MarcusAnalyst

David RomanAnalyst

Gary GuthartChief Government Officer and Director

Rick SensibleAnalyst

Adam MaederPiper Sandler — Analyst

Brandon VazquezAnalyst

Matt MiksicAnalyst

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