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Intuitive Surgical (ISRG) Q3 2024 Earnings Name Transcript

Date:

Picture supply: The Motley Idiot.

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

Contents:

  • Ready Remarks
  • Questions and Solutions
  • Name Members

Ready Remarks:

Operator

Thanks, everybody, for standing by, and welcome to the Intuitive third quarter 2024 earnings launch. Now, right now, all individuals are on a listen-only mode. Later, we’ll 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 quarterearnings convention name With me right now, we now have Gary Guthart, our CEO; Dave Rosa, our president; and Jamie Samath, our CFO. Earlier than we start, I want to let that Brian King has moved on to pursue his subsequent alternative. We recognize his contributions over the previous 9 years and want him properly in his subsequent endeavor.

A seek for his alternative 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 could 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-Ok for the fiscal 12 months ended December 31, 2023, and subsequent filings.

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Our SEC filings will be discovered by our web site or on the SEC’s web site. Traders are cautioned to not place undue reliance on such forward-looking statements. Please be aware that this convention name will likely be obtainable for audio replay on our web site at intuitive.com on the Occasions part below our Investor Relations web page. At present’s press launch and supplementary monetary information tables have been posted to our web site.

At present’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 medical highlights, Jamie will present a evaluation of our monetary outcomes and process highlights, then I’ll present our up to date monetary outlook for 2024. And eventually, we’ll 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 a great quarter for us with wholesome process development, stable capital placements, and powerful 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. Methods stability taken throughout our multiport product traces has been excellent, setting a typical for dependability. We launched our fifth-generation multi-port system in March this 12 months 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 properly into the method of securing extra 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. At present, the in put in base is 736, of which 722 are in the USA.

Physicians have accomplished greater than 150,000 lung biopsies utilizing Ion so far. Every one among which makes use of a machine learning-created anatomically segmented lung mannequin primarily based on the patient-specific anatomy, customized 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.

Total security and accuracy information has been excellent. Over the previous 12 months, we now have centered on excellence in product high quality, product availability, and buyer expertise. We’ve got up to date Ion with vital 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 techniques past the USA to proceed system and software program innovation to extend utilization in current U.S.

accounts and in continued pursuit of extra 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 so far. 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 medical proof base stands at over 500 peer-reviewed journal articles. SP has discovered stronger uptake outdoors the USA as medical indications in Europe, Japan, Korea, and now Taiwan are broader than the U.S. Our SP crew is targeted on extending our instrument lineup, together with stapling and superior vitality 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 crew is targeted on three enabling pillars, digital instruments that enhance outcomes within the OR and interventional suite, instruments that assist create higher care groups sooner, and instruments that drive efficiencies and a decrease complete price of possession, all whereas pursuing excellent capabilities in cybersecurity and information privateness. Dave will contact on our digital progress shortly. Regionally, we now have been investing to construct balanced nation and regional groups that permit us to serve clients globally with high-quality interactions. These embody 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 outdoors 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 international locations we serve.

That mentioned, we’re nonetheless comparatively early in our alternative to localize our capabilities to serve extra sufferers all over the world. Total, 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 companies and acquiring new medical indications. We have additionally been strengthening our digital ecosystem to help our clients and our firm with high-quality information and perception. The chance to enhance outcomes for sufferers and our clients’ quintuple intention by superior expertise ecosystems like ours is larger 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 medical, 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 common surgical procedure within the U.S. with accretive contributions to the worldwide development fee from Japan, Germany, France, and the U.Ok.

In Asia, we now have blended market circumstances, largely in step with the primary half of the 12 months. Jamie will describe these dynamics later within the name. Turning to capital. We positioned 379 da Vinci techniques within the quarter, together with 110 da Vinci 5 techniques and 21 SP techniques.

We additionally put in 58 Ion techniques within the quarter. Capital placements had been stable within the U.S., Japan, India, and our distribution markets and capital strain in Europe and China continued. System utilization, outlined as procedures for put in medical system per quarter, grew 4% globally 12 months over 12 months 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 capabilities. Jamie will take you thru our funds in better element later within the name. In Q3, we continued our measured rollout of da Vinci 5 inserting 110 techniques because the launch progresses in step with our plans.

We’re inspired by broad use of the platform throughout specialties with clients expressing a desire for da Vinci 5. Final month, about 1,200 healthcare professionals gathered at our annual person convention, Intuitive 360, to focus on varied points of their robotic packages. Prospects have accomplished over 12,000 instances with da Vinci 5, and several other offered their early case information 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 information turns into obtainable.

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

Pressure Suggestions is a fancy expertise that we now have 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 imagine Pressure Suggestions could speed up studying for care groups, and we’ll proceed to check the usage of Pressure Suggestions with our clients. We anticipate extra publications over the approaching quarters, and our groups proceed working laborious to enhance product margin and improve provide of Pressure Suggestions devices. As we now have mentioned earlier than, maturing these insights will take time.

Turning to our digital efforts. We imagine that digital improvements on our da Vinci and Ion platforms can extract distinctive medical and operational insights, coupled with digital medical document information, these insights ought to change into a core a part of bettering outcomes, studying, and efficiencies sooner or later. To this point, we now have information from thousands and thousands of procedures that allow clients to evaluation operational metrics resembling devices used, process length, and extra. As well as, a whole bunch of hundreds of those instances are related to corresponding de-identified digital medical information, enabling sure medical and operational hypotheses to be examined.

Case Insights is our new analytical device in My Intuitive that may add Kinematic, Pressure Suggestions, and video information to physicians’ postoperative case studies, additional enabling analyses to determine a connection between da Vinci system information and medical or operational outcomes. We’re on the early phases of revolutionary expertise we imagine will likely be highly effective. However it would require fast cycles of innovation and take time to construct validated information 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 delivery our da Vinci 5 broad launch {hardware} and accomplished a software program replace that addresses points of early buyer suggestions. We’re driving towards broad launch midyear of 2025 after 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 varied digital and imaging options. Transferring to devices and equipment.

In Q3, we obtained 510(okay) clearance for our eight-millimeter SureForm 30 stapler, increasing our superior instrument portfolio of SureForm staplers that at present contains 12-millimeter variations of 60-, 45-, and 30-millimeter lengths. Eight-millimeter SureForm 30 is primarily utilized in instances the place the decreased diameter allows 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 techniques and noticed physicians carry out their first instances. We’ll start working with plenty of medical facilities to gather information 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, just like Korea, Japan, and Europe. We additionally accomplished a U.S.

510(okay) submission for a colorectal indication. Commercialization in Europe continues based on plan, and we’re inspired by early buyer curiosity for SP. Now, I might wish to share with you some lately revealed peer evaluation literature that we discovered to be notable. Along with the precise information highlighted on this name, we encourage you to contemplate the broad physique of proof detailing these subjects in revealed 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 offered outcomes from the CONFIRM research. CONFIRM is a potential multicenter research 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 dimension, 155 sufferers from six facilities all through the U.S. had been enrolled.

With a median nodule dimension of 14 millimeters, the built-in platform enabled a device in nodule fee of 99.4%, with a diagnostic yield of 9% and 0 pneumothorax noticed. Subgroup evaluation demonstrated constant outcomes throughout all facilities with excessive diagnostic yields noticed no matter nodule dimension, location, or presence of CT bronchus signal. The offered 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 complicated nodules with reproducible outcomes throughout physicians and establishments.” These outcomes urged that built-in platform could possibly compete with a transthoracic biopsy method in small nodules shut fast. Earlier this 12 months, Dr.

Maegawa from the Division of Surgical procedure at Emory College in Atlanta, Georgia, revealed within the journal Surgical procedure the research evaluating robotic and laparoscopic cholecystectomy procedures for benign indications carried out in 2022. Utilizing the American Faculty of Surgeons’ Nationwide Surgical High quality Enchancment Program database over 59,000 sufferers had been included within the research with over 53,000 within the laparoscopic arm and roughly 5,500 within the robotic-assisted arm by 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 research confirmed that total, robotic cholecystectomies had been independently related to a decrease danger of great problems, decrease fee of conversion to open, and decrease danger of hospitalization better than 24 hours when in comparison with laparoscopy. These findings counsel that the adoption of latest applied sciences would possibly improve the protection of minimally invasive surgical procedure in chosen instances.” 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 capabilities that profit from a worldwide scale. I am going to now flip the time over to Jamie, who will take you thru our funds and process highlights in better 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 techniques 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 common surgical procedure.

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

and India and stable in Japan, Germany, France, and Eli. Process development in South Korea improved from the prior quarter however was nonetheless under longer-term historic tendencies given the continued precision strike. In China, process development was under the company common, given current system placement tendencies reflecting a number of market dynamics that we now have beforehand described and home robotic competitors. With respect to capital efficiency, we positioned 379 techniques within the third quarter in contrast with 312 techniques in Q3 of final 12 months.

Within the U.S., we positioned 219 techniques in Quarter 3 in comparison with 159 techniques positioned in Q3 of final 12 months. 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 12 months, we anticipate the placements within the U.S.

will progressively shift towards trade-ins. Exterior the U.S., we positioned 160 techniques in Quarter 3 in contrast with 153 techniques final 12 months. Excluding buying and selling transactions, web new system placements in OUS markets elevated 28% 12 months over 12 months. 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 12 months.

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 12 months 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%. Extra income statistics and tendencies 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 better proportion of our clients desire to lease techniques. Q3 system common promoting costs had been $1.51 million as in comparison with $1.4 million final 12 months. 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 12 months.

Da Vinci instrument and accent income per process was roughly $1,800, flat to the prior quarter and decrease than final 12 months’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 techniques in comparison with 55% final 12 months 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 techniques elevated 50% 12 months over 12 months to 736 techniques, of which 296 are below 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 techniques positioned within the quarter had been SP techniques, of which 15 placements had been in OUS markets. The SP put in base grew 54% from the year-ago quarter to 243 techniques. 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 part 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 techniques at that website. We additionally opened our new international functionality heart in Bangalore, India, the place we’re co-locating our native industrial and coaching groups and the International Middle for IT and different shared service sources.

As a reminder, given current and ongoing capital investments, we anticipate a big improve in depreciation expense in 2025 as we carry on-line extra amenities. Third-quarter professional forma working bills elevated 13% in contrast with final 12 months, pushed by increased head rely, elevated authorized bills, and better customer-facing actions. In keeping with the final couple of years, we now have held professional forma R&D bills of roughly 11% of income given our prioritization of investments in innovation that drive the quintuple intention 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, by 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 12 months. Professional forma different earnings was $94.6 million for Q3, increased than $79.4 million within the prior quarter primarily as a consequence of increased curiosity earnings.

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 property. Third quarter 2024 professional forma web earnings was $669 million or $1.84 per share in contrast with $524 million or $1.46 per share for the third quarter of final 12 months. I’ll now summarize our GAAP outcomes.

GAAP web earnings was $565 million or $1.56 per share for the third quarter of 2024 in contrast with GAAP web earnings of $416 million or $1.16 per share for the third quarter of 2023. The changes between professional forma and GAAP web earnings are outlined and quantified on our web site and embody extra tax advantages related to worker fairness plans, worker stock-based compensation, amortization of intangibles, litigation prices, and good points 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 12 months 2024 process development inside a variety of 15.5% and 17%.

We are actually elevating the low finish from 15.5% and to 16% and anticipate full 12 months 2024 process development inside a variety 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 techniques 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 vital impression 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 variety of 68.5% and 69% of web income. Our precise gross revenue margin will fluctuate quarter to quarter, relying largely on product, regional, and trade-in combine, and the impression of latest product introductions. Turning to working bills.

On our final name, we forecasted full 12 months 2024 professional forma working expense development to be inside a variety of 10% and 13%. We are actually reducing the excessive finish of our estimate and anticipate full 12 months 2024 professional forma working expense development to be inside a variety 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 earnings, which is comprised largely of curiosity earnings to complete between $325 million and $345 million in 2024.

With regard to capital expenditures, we proceed to estimate a variety of $1 billion to $1.2 billion, primarily for deliberate facility development actions. With regard to earnings tax, we anticipate the professional forma earnings tax fee for 2024 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] And we’ll undergo the primary query in queue. Travis Steed, Financial institution of America. Please go forward.

Travis SteedAnalyst

Certain. Perhaps just a bit extra on fascinated by 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 might like to dig in a little bit bit on the shopper actions to a number of the contribution margin advantages, contribution margin advantages of dV5 type of on the early information and the hospital CFOs are resonating with a few of that pretty worthwhile information 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 will see these come out on a semi-routine foundation. We’ve got to get to broad launch, as described in my feedback, we now have a launch that may allow a few of that {hardware} and a few extra software program options in that broad launch time-frame. For the availability facet of dV5, we anticipate that to extend modestly quarter over quarter as we get into subsequent 12 months and into broad launch. On the contribution margin facet, 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 good points that an establishment would possibly get given what we’re seeing with respect to effectivity. We’ve got plenty of early surgeons which can be KOLs which have sophistication by way of use of da Vinci which can be 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 might 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 plenty of our surgeons has been centered on the effectivity good points 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 individuals anticipated. Do you could have provide to launch that immediately? 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 evaluation 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’ve got not outlined timing in Japan.

So, we stay in that forwards and backwards. After which with respect to CE Mark in Europe, no totally different from final quarter the place we anticipate that close to the top of subsequent 12 months 2025.

Larry BiegelsenAnalyst

Bought it. That is useful. And for Dave or Gary, we have heard you and key opinion leaders lately began speaking about new procedures resembling appendectomy, foregut, hepatobiliary, and emergent procedures. Might you please inform us the place you’re in addressing these from a medical, regulatory, and industrial standpoint? And the way would you dimension a few of these new procedures? Thanks.

Jamie E. SamathChief Monetary Officer

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

Presently, 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 a number of the airtime by way of our commentary appendectomy is way earlier for us. It is fairly a small process.

Additionally it is 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 observe method to common 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’ve got performed some medical 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 an awesome quarter. Two for me, would possibly each be for Jamie. I am going to allow you to resolve.

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 movement by. And I do know there’s undoubtedly some depreciation profit flowing by this 12 months that most likely wanes into subsequent 12 months. 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 could have these new merchandise flowing by and the combination begins to evolve?

Jamie E. SamathChief Monetary Officer

Yeah. Perhaps just a few framing first. I feel we have constantly mentioned we glance to have margins which can be type of top-tier with respect to our med tech friends. We have additionally mentioned 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 best stage of profitability. We had been 37% of margin this quarter, 36% 12 months so far. What I might anticipate is for 2025 on the gross margin entrance, simply given the numerous incremental depreciation that we have described, you must anticipate gross margins to be a little bit decrease subsequent 12 months 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 part of type of ramping manufacturing in these amenities versus capitalizing them into stock.

I feel what we have mentioned within the midterm is we now have the chance, we predict, on gross margin to get again to 70%. That is our aspiration. But when you concentrate on the place we’re proper now, 12 months so far, 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 may even be balanced by how a lot we spend money on R&D, which goes to be a perform of the alternatives that we see.

Robbie MarcusAnalyst

Nice. Admire that. After which as a follow-up, as we transfer into subsequent 12 months 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 possibility, clearly, to repurpose and resell a number of the refurbished is that you just get traded in.

Simply perhaps communicate to the chance there, how we must always take into consideration that? And any rapid plans you may discuss? Thanks lots.

Jamie E. SamathChief Monetary Officer

Yeah. So, you must anticipate us to because the buying and selling cycle happens, which, by the best way, we predict will likely be progressive and can happen over multiples of years, as Xis come again, we’ll, as we have performed previously, refurbish these. That does permit for segmentation that might be website of care segmentation, for instance, within the U.S. and segmentation in markets internationally which can be extra price delicate.

We have not labored by precisely how — what these plans will likely be, however you might 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, everyone. Perhaps we are able to begin on Ion. I feel in the event 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 have launched in new markets.

Perhaps you might 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 section on a go-forward foundation. After which I’ve one P&L follow-up.

Gary S. GuthartChief Government Officer and Director

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

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

We’re fairly deeply penetrated into these websites of care, and the main target there will likely be on excessive utilization, excessive buyer satisfaction, some innovation, and pursuit of extra indications contained in the lung utilizing the Ion platform. We’re a lot earlier in our journey outdoors of the USA. So, early experiences up to now in Europe first began within the U.Ok. 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 little bit 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 shoppers. And in OUS, it is actually initiating the journey in several 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 techniques being positioned below utilization agreements. I feel it is gone from about 12% earlier this 12 months to about 15% now.

Are you able to assist us take into consideration the trajectory of that contribution to the location 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 shopper pays for system and repair as they use the system. These preparations with the shoppers have an expectation of what the procedures will likely be performed per 12 months that is mirrored within the association. And so, then at goal economics, you must consider it as just like an everyday providing, no less than it is a fastened fee association and working leases typically 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 could have the chance of what’s the precise utilization by the shopper in these usage-based preparations. We’ve got a distribution, as you’d anticipate by way of what the utilization charges are and we interact with the shoppers repeatedly with respect to what their enterprise plans are, notably once they’re not on the goal. When it comes to trajectory, clearly, you have seen it develop. It’s in style with clients.

It’s a option to each entry extra capability with out having to devour capital budgets, and it does decrease the chance for the shopper by way of taking a brand new system relative to how properly that is going to be utilized. We’ve got provisions and protections in these preparations for us and for the shopper, and we have a look at these routinely. I might anticipate it to proceed to develop, however it’s comparatively extremely penetrated within the U.S. And so, the speed of development will doubtless 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, everyone, we proceed to have a number of conversations with surgeons who’re or doubtlessly taken with 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 educational 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 just’re extra centered proper now on, I am going to name it, mid- to smaller establishments, nonacademic.

They’re making choices sooner. 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 obtainable center of subsequent 12 months 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 only twin console availability and what is going on on there, after which we are able to communicate a little bit bit to what the tendencies are. We’ll reply the remainder of the questions.

Dave RosaPresident

Hey, Rick. And also you mentioned 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’ll begin producing extra consoles for twin system placements.

When it comes to prioritization and whether or not being prioritized, I feel our crew is working with a broad set of shoppers and to grasp what their wants are. And if da Vinci 5 is the best system to fulfill their wants for his or her program. And I haven’t got a number of details about how which will differ between smaller clients as you place it or in teachers or bigger establishments.

Gary S. GuthartChief Government Officer and Director

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

And in the event you do, do it, I think the variations will likely be comparatively small relative to what we anticipate.

Rick SensibleAnalyst

And a fast follow-up, if I might, on Hub. I feel it was thrilling to listen to you are in over 2,000 ORs. Simply assist us suppose by 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 Technology 4 compatibility in addition to these which can be linked to Gen 5, what does it do? It is a robust information recorder and media administration system. Loads of these early installs are on-premise implementations versus the cloud. Prospects get pleasure from it for his or her capacity to trace their information 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 offers them a number of leverage there’s lots that we like about it. I feel the core functionality is admittedly good. There are some issues we wish 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 the start of the Hub journey, each by way of penetration and by way of characteristic content material, not the top of it.

And I am happy with the progress the crew 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 needed to ask for some extra colour across the capital surroundings and the way you are fascinated by hospital budgets and urge for food for bigger piece of the capital heading into the top of the 12 months in 2025.

And I heard the commentary round Europe and China, it appears like there’s continued strain there. Simply curious, is that type of establishment versus the primary half of the 12 months? 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 might characterize U.S. is comparatively steady, albeit with a number 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 might characterize the general capital surroundings is comparatively steady. In Europe, what you are seeing notably in international locations just like the U.Ok. and Germany is strain on capital spending within the healthcare house, once more, associated to authorities funds pressures that exist there. And I feel that is been related for the final quarter or so.

Within the case of Europe, we now have 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 adjustments 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 by in addition to a number of the worth caps which have gone by in our finish of the market. So, I feel that strain 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 rivals that are likely to get provincial preferences, the province through which they’re headquartered tends to have a desire 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 while, too. So, for us, I feel it isn’t a shock given the 12 months we have had. I feel finally, this stuff will wash by, how lengthy it takes for it to clean by 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 understand, you could have a great quantity of da Vinci 5 techniques on the market. I used to be simply curious in the event you might examine and distinction.

Are there any type of distinctive insights that you’ve in that da Vinci 5 put in base, whether or not it is what kinds of procedures they’re doing or utilization inside these accounts, are these techniques 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 little bit bit — it appears like innovation on a go-forward foundation is admittedly going to be coming lots from software program. Are you able to type of examine and distinction the innovation cycle, the pace at which you’ll be able to launch new options on the software program facet versus what has traditionally been, I might guess, a little bit 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 facet 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 examine 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 a great information set to make these comparisons. On the software program facet, there’s type of two buckets that we function in there are units of software program and merchandise which can be 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(okay) or ruled by regulatory processes across the globe. And people will usually observe an extended cadence, most likely nonetheless a bit faster than you’d see in main {hardware} adjustments and issues like that. And so, on the common, you doubtless 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 would problem the idea a little bit bit. I feel there’s nonetheless some {hardware} we wish 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 just simply described. I feel it is nice, however we get an opportunity to do each. Operator, we’ll take yet one more 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 in the event you’re trying on the U.S.

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

Gary S. GuthartChief Government Officer and Director

Yeah. Thanks, Matt. It is an awesome query. I prefer it.

I feel within the U.S., we’re — I will not provide the precise cut 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 method? 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 wish to be sure to’re in search of, we wish to be sure we’re in search of 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 really in multiport, there’s some alternative and new indication additionally, though they will are typically extra area of interest markets than actually massive ones. Over time, over the approaching quarters, we’ll inform you extra about that as these alternatives mature. So, thanks.

That was our final query. In closing, we imagine there is a substantial and sturdy alternative to essentially enhance surgical procedure and acute intervention. Our groups proceed to work carefully 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 can be entry to nice care, and finally, a decrease complete price of care. We imagine 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 illnesses 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]

Length: 0 minutes

Name individuals:

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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