Intuitive Surgical Inc (ISRG) — Q1 2021 Earnings Call Transcript

Good afternoon. And welcome to Intuitive’s first quarter earnings conference call. With me today, we have Gary Guthart, our CEO; Marshall Mohr, our Chief Financial Officer; and Jamie Samath, our Senior Vice President, Finance. Before we begin, I would like to inform you that comments mentioned on today’s call may be deemed to contain forward-looking statements. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in our Securities and Exchange Commission filings, including our most recent Form 10-K filed on February 10, 2021. Our SEC filings can be found through our website or at the SEC’s website. Investors are cautioned not to place undue reliance on such forward-looking statements. Please note that this conference call will be available for audio replay on our website at intuitive.com on the Latest Events section under our Investor Relations page. Today’s press release and supplementary financial data tables have been posted to our website. Today’s format will consist of providing you with highlights of our first quarter results, as described in our press release announced earlier today, followed by a question-and-answer session. Gary will present the quarter’s business and operational highlights. Marshall will provide a review of our financial results. I will discuss procedure and clinical highlights. And Jamie will review our financial outlook. Finally, we will host a question-and-answer session. With that, I will turn it over to Gary.

Thank you for joining us today. Our first quarter of 2021 was a step in the right direction. In the quarter, we saw a healthy recovery of surgery and use of our products. Strong capital placements continued in Q1 2021 and utilization of installed systems increased through the quarter, indicating a need by our customers to return to surgery. We are in the early innings of commercialization of two new platforms for Intuitive, while advancing digital enablement of our ecosystem. Our teams are making good progress in all three areas. Overall, we are seeing some pandemic recovery, but improvement has been uneven with significant regional variation. Our experience shows that our business rebounds as COVID drops. Starting with procedures, general surgery in the United States was a source of strength in the quarter, driven by bariatric surgery, cholecystectomy, and other procedures. Bariatric surgery has been on a multi-quarter gross trajectory, the result of a line development in commercial activities, starting with capable systems, using Advanced Instruments combined with a focused commercial team. Ventral hernia surgery is recovering with inguinal hernia tracking behind, aligned to hospital and patient prioritization. In the U.S., gynecology and urology returned to growth after pandemic-related declines. Growth in our second largest market, China, continued to be strong, with multiple specialties contributing. Lastly, procedures that have long diagnostic journeys, such as prostatectomy and thoracic surgery, remain below historical levels. Philip will take you through procedure dynamics in more detail later in the call. On the capital side, new system placements continued to exceed our expectations, with the United States, China, France, and the U.K. standing out in the quarter. We know that new system placements are closely tied to anticipated procedure volumes and system utilization in mature markets. System utilization grew in the quarter on average, with significant regional variance due to pandemic differences. Overall, capital strength indicates anticipation of future procedure opportunities by our customers. A significant number of systems were part of multisystem deals by hospitals and integrated delivery networks, supporting a theme in which customers who know robotic-assisted surgery well continue to invest with us. Lastly, the use of leasing and other alternative capital placement models ticked up again this quarter. Our business in China is growing quickly from a small base, and we are pleased with the performance of our joint venture with Fosun Pharma. We believe there is significant long-term opportunity in China and remind you that it is currently a quota-controlled market. We expect China to be dynamic and competitive in coming years and we are investing in the market to bolster our place as a leading provider to the Chinese healthcare system. In Japan, growth remains healthy, although below pre-pandemic levels. In Europe, our business in France and Germany had performed well considering the pandemic. In the U.K., tightly controlled surgery resulted in procedure declines, but we have also seen an increased commitment to robotic-assisted surgery in the form of increased capital placements, anticipating a return of da Vinci surgery post-pandemic. Italy and Spain are rapidly returning to growth after substantial pandemic impacts. Speaking to our finances in the quarter, procedures recovered nicely in Q1. System placements came in above plan, and I&A revenue per procedure was above our expectations, together driving 18% revenue growth over Q1 2020. Product gross margins were strong in the quarter, largely due to above-average system ASPs, lower than expected excess and obsolescence charges, and higher volumes through our factory. Other spending was constrained in the quarter driven by three factors. First, travel and associated costs did not recur at pre-pandemic levels. This spend will increase as COVID wanes and our customers and staff reach immunity. Second, COVID delayed some work in R&D, leading to some under spending in prototypes. We expect these programs to ramp up as COVID wanes and our labs and development programs recover efficiency. Third, we differed some investments in infrastructure that were unnecessary during the pandemic. We think most of these factors will normalize over time, and we consider them one-time events related to the pandemic. We are still in the early stages of developing robotic-assisted surgery globally, and we will continue investing in R&D and our regional capabilities to realize these opportunities. As I mentioned at the start of the call, we are in the early phases of our commercialization efforts for new platforms, which we expect to play out over future quarters. Our single-port surgery platform, da Vinci SP, has performed our first cases in the U.S. and Korea of an important accessory, our SP access port, which enables surgery close to the body wall and eases assistant surgeon access through the single incision. The access port is important in the SP ecosystem, facilitating access and workflow in many procedures in which SP is used. We have had very strong customer feedback on the port to date. We are also increasing our investments to accelerate new indications in key countries. In the U.S., we have two cleared indications for SP and expect to initiate cases as part of our colorectal IDE this quarter. We have seen strong interest in SP use in various specialties, and we are in the process of designing trials for additional indications, including thoracic surgery and other surgical disciplines. Overall, we have received robust customer feedback for SP use under existing clearances. Turning to our flexible robotics platform, Ion, we installed 14 systems in the quarter. We are covering for our supply backlog and are meeting demand for Ion procedures at all our installed accounts, while working to fill customer inventory stocking requests and our internal inventory goals, which we expect to complete around midyear. Our PRECISE trial evaluating the ability to reach and diagnose suspicious pulmonary lesions is on track to finish enrollment by Q2 this year. Our Ion clinical performance is meeting our expectations, and customer acceptance remains highly encouraging. In our digital ecosystem enablement, we broadened access to our mobile surgeon portal, the My Intuitive app this April as part of our phased launch. My Intuitive is a mobile app that allows surgeons to manage their da Vinci experience, log into da Vinci systems, manage their training, and view their operative data from the palm of their hand. Our Intuitive telepresence program supported 45% of all case observations in Q1 2021, up from less than 5% a year ago, a significant achievement accelerated by the pandemic, improving convenience for our customers and reducing costs for our team. Year-over-year surgical simulation usage in the quarter grew roughly 46% over Q1 2020, validating the power of digital tools. Finally, our team made significant progress in automating customer-facing analytics as part of our robotics program consulting services, which allow our customers to analyze the relative performance of their da Vinci programs, now a routine part of customer engagement in the United States. In conclusion, we are seeing adjustments in the healthcare system that favor our offerings, increased appreciation of high-quality minimally invasive surgery in the current and post-pandemic environment, increased openness to digital technologies, increased use of analytics to assess care, and increasing sensitivity by health systems to the total cost to treat. We have and will continue to position ourselves to perform well in this environment. I will now turn the time over to Marshall to take you through our financial performance in greater detail.

Good afternoon. I would describe the highlights of our performance on a non-GAAP or pro forma basis. I will also summarize our GAAP performance later in my prepared remarks. A reconciliation between our pro forma and GAAP results is posted to our website. Key business metrics for the first quarter were as follows. First quarter 2021 procedures increased approximately 16% compared with the first quarter of 2020, which was approximately the same as last quarter. On a day-adjusted basis, procedures grew 18% year-over-year. First quarter system placements of 298 systems increased 26% compared with 237 systems for the first quarter of 2020 and decreased 9% compared with 326 systems last quarter. We expanded our installed base of da Vinci systems over the last year by 8% to approximately 6,142 systems. This growth rate compares with 11% last year and 7% last quarter. Utilization of clinical systems in the field measured by procedures per system increased approximately 8% compared with last year and decreased 2% compared with last quarter. The impact of COVID on da Vinci procedures varied by region. In the U.S., COVID resurgence that affected procedures later in the fourth quarter continued well into January. Then, as COVID subsided, procedures experienced a steady improvement through February and March. In Europe, the spread of COVID varied regionally, and procedure growth rates were mixed, with strength in France and a year-over-year decline in the U.K. While there have been COVID hotspots within some of our Asia-Pacific markets, they tended to be isolated, and in general, procedures performed well. China growth was far higher than other regions, reflecting the severity of the COVID impact on China in the first quarter of last year and the additional system installations over the past year. Philip will provide additional procedure commentary later in this call. Despite the fact that hospitals are better equipped to handle COVID patients today compared with the outset of the pandemic, resurgences of COVID-19 and its variants like those currently being experienced in parts of Europe and the U.S. have challenged hospital care capabilities and have negatively impacted da Vinci procedures. In addition, delays in diagnosis and treatment of underlying conditions have continued to negatively impact da Vinci procedures. While there is a backlog of patients, it is unpredictable when those patients will ultimately seek diagnosis and treatment and whether they will be treated with surgery. Jamie will be providing procedure guidance later in this call. That guidance is based on our experience in the first quarter and the pace at which vaccines have been and are forecasted to be rolled out. Changes in the spread of COVID and its variants in the pace of vaccine rollouts could significantly impact our guidance. Moving on to capital placements, placements in the quarter reflected procedure growth, hospitals purchasing systems in preparation for a post-pandemic environment, and hospitals upgrading in order to access or standardize on fourth-generation capabilities. First quarter capital placements exceeded our expectations. We believe that generally, COVID has had less of an impact on hospital capital spending capacity and that customers recognize that da Vinci surgery meets their quadruple aim objectives better than other surgical approaches. Looking forward, we see the following capital revenue dynamics. Procedure growth drives capital purchases in many of our markets, to the extent that COVID impacts procedures, it will also impact capital purchases. Leasing and alternative financing arrangements have enabled customers access to capital. We believe leasing will increase as a percentage of sales over time, which will result in a deferral of otherwise current revenue into future periods. The trade-in cycle has been a tailwind to system placements. However, as the installed base of older generation products declines, the number of trade-ins will also decline. Macroeconomic conditions created by COVID could regionally impact hospital capital spending, and as we face competition in various markets, we may experience longer selling cycles and price pressures. Additional revenue statistics and trends are as follows. Total first quarter revenue was $1.292 billion, representing an 18% increase from last year and a 3% decrease from last quarter. First quarter revenue growth reflected procedure growth and higher than expected system placements. Leasing represented 43% of current quarter placements, compared with 32% last year and 37% last quarter. Leasing as a percentage of total sales has and will continue to fluctuate with customer and geographic mix. However, given hospital needs, we anticipate more customers will seek leasing or alternative financing arrangements than reflected in historical run rates. 44% of systems placed in the first quarter involved trade-ins, which is lower than the 57% last year and the 49% last quarter. Trade-in activity can fluctuate and be difficult to predict. First quarter system average selling prices increased to $1.65 million from $1.44 million last year and $1.43 million in the fourth quarter. The increase relative to last year reflects a higher mix of systems placed in China and our direct markets relative to our indirect markets, a higher mix of dual console systems, and the lower proportion of trade-in transactions. The increase relative to last quarter reflects a higher mix of dual consoles and a lower proportion of trade-in transactions. We recognized $19 million of lease buyout revenue in the first quarter, compared with $12 million last year and $14 million last quarter. Lease buyout revenue has varied significantly quarter-to-quarter and will likely continue to do so. Instrument and accessory revenue per procedure for the first quarter of $1,950 decreased compared with $1,990 per procedure for the first quarter of last year and $2,060 per procedure in the fourth quarter of 2020. Extended Use Instruments were introduced in the U.S. and Europe in the fourth quarter. While we saw increased usage of Extended Use Instruments in these markets, full adoption will occur over the next few quarters as customers burn off lower use products. In addition, we saw customers begin to adjust their instrument buying patterns to reduce their inventory levels to reflect the additional uses per instrument. Increased usage of Extended Use Instruments and customer buying patterns are the primary reasons for the decrease in instrument and accessory revenue per procedure in the first quarter relative to prior quarters. We expect this trend to continue over the next few quarters. While we expect price elasticity associated with Extended Use Instruments to enable greater penetration into available markets, that benefit is delayed by COVID and will take time. 6% of the systems placed in the first quarter were SP systems, reflecting a continued measured rollout of SP. Our installed base of SP systems is now 75, eight in Korea and 67 in the U.S. Our rollout of the SP surgical system continues to be measured, putting systems in the hands of experienced da Vinci users while we pursue additional indications and optimize training pathways in our supply chain. We expect to initiate the first cases associated with the U.S. colorectal trial in the next few months. We placed 14 Ion systems in the quarter, bringing the installed base to 50 systems. Ion system placements and procedures are excluded from our overall system and procedure counts. The supply issues we called out last quarter had less of an impact on Ion placements and procedures this quarter. We expect to resolve those supply issues this quarter. Our rollout of Ion will continue to be measured while we optimize training pathways in our supply chain. Procedures under the PRECISE study are expected to complete this quarter. Outside of the U.S., we placed 108 systems in the first quarter, compared with 55 in the first quarter of 2020 and 130 systems last quarter. Current quarter system placements included 59 into Europe, eight into Japan and 23 into China, compared with 25 into Europe, 10 into Japan and nine into China in the first quarter of 2020. 22 of the 59 systems placed in Europe this quarter were in the U.K. Placements in many markets like the U.K. can vary significantly quarter-to-quarter. While we were pleased with the performance of the U.K. team, we do not anticipate this level of placements in the U.K. in future quarters. Moving on to gross margin and operating expenses. Pro forma gross margin for the first quarter of 2020 was 71.8%, compared with 69.7% for both the first and fourth quarters of 2020. The first and fourth quarters of 2020 included higher period costs associated with lower production and higher excess and obsolete inventory charges. In addition, the first quarter of 2021 reflected leveraging fixed costs over higher production levels. Product and customer mix fluctuate quarter to quarter, which can cause fluctuations in gross margins. In addition, if revenues are pressured by COVID-19, production levels may operate at below normal levels, which may result in higher labor costs and under absorbed overhead and reduced product margins. COVID has impacted global supplies of semiconductors and other materials used in our products. While we carry safety stocks of critical components and are otherwise working to secure supply necessary to ensure fulfillment of customer demand, global shortages could result in higher production costs or production delays. Pro forma operating expenses increased 5% compared with the first quarter of 2020 and increased 2% compared with the fourth quarter of 2020. The fourth quarter of 2020 included a $25 million contribution to the Intuitive Foundation, while there were no contributions in the first quarters of 2021 and 2020. The increase compared to the prior year reflects costs associated with higher headcount and increased variable compensation, partially offset by lower spending in areas impacted by COVID. First quarter spending was below our expectations for the reasons outlined by Gary in his opening remarks. Looking to the remainder of the year, we expect spending impacted by COVID-19, including clinical development, in-person training, marketing events, and travel costs, to increase as COVID’s impacts decrease, and spending deferred due to COVID and other timing matters to increase. Jamie will provide spend guidance later in this call. Our pro forma effective tax rate for the first quarter was approximately 20%, meeting our expectations. Our actual tax rate will fluctuate with changes in the geographic mix of income, changes in taxation made by local authorities, and with the impact of one-time items. Our pro forma first quarter 2021 net income was $427 million or $3.52 per share, compared with $323 million or $2.69 per share for the first quarter of 2020 and $434 million or $3.58 per share for last quarter. I will now summarize our GAAP results. GAAP net income was $426 million or $3.51 per share for the first quarter of 2021, compared with GAAP net income of $314 million or $2.62 per share for the first quarter of 2020 and GAAP net income of $365 million or $3.02 per share for last quarter. The adjustments between pro forma and GAAP net income are outlined and quantified on our website and include excess tax benefits associated with employee stock awards, employee stock-based compensation and IP charges, amortization of intangibles, acquisition-related items, and legal settlements. GAAP net income for the fourth quarter of 2020 and the first quarter of 2021 also included pretax gains of $4.7 million and $14.3 million on our investments in private companies resulting from our purchases of certain technologies. The EPS impact of these gains net of tax was $0.03 per share in the fourth quarter and $0.09 per share in the first quarter. These gains are excluded from our pro forma results. We ended the quarter with cash and investments of $7.2 billion, compared with $6.9 billion at December 31, 2020. The increase in cash in the first quarter primarily reflected cash from operations and stock exercises. We did not repurchase any shares in the quarter. And with that, I’d like to turn it over to Philip who will go over procedure performance.

Thank you, Marshall. Our overall first quarter procedure growth was 16% year-over-year, compared to 10% growth during the first quarter of 2020 and 6% growth last quarter. Our Q1 procedure growth was driven by 14% year-over-year growth in the U.S. and 23% growth OUS. Procedures in the U.S. recovered steadily after January as COVID cases declined and the associated impact on hospital resources improved. In the U.S. within general surgery, bariatric, cholecystectomy, and hernia were the largest contributors to procedure growth within the quarter. Bariatrics growth remained strong with positive customer feedback on our Advanced Instrument portfolio. Cholecystectomy growth was driven by the continued expansion of robotic procedures by general surgeons throughout their total practice. Inguinal hernia growth trailed ventral growth in the quarter. With respect to our more mature procedure categories in the U.S., Q1 gynecology procedures grew double-digit against the prior year growth comparison that was negative due to COVID. While dVP in the U.S. stabilized in Q1 from previous declines, it remains unclear when patients who have been impacted from delays in diagnosis and treatment will ultimately come back. In aggregate, worldwide prostatectomy in the first quarter largely stabilized. More broadly, OUS procedure growth was driven by urology, earlier stage growth in general surgery, gynecology, and thoracic procedures. With respect to OUS markets, China procedure growth was strong and benefited from the severe first quarter of 2020 impact of COVID-19 and an increase in the installed base over the past year. China had broad-based growth in all procedure categories. In Japan, procedure growth moderated somewhat due to restrictions associated with COVID. Procedure growth in South Korea was encouraging, with SP utilization continuing to be above Xi. In Europe, France had a solid quarter, with broad-based strength in a wide range of procedure categories. The U.K. remained challenged due to COVID. Now turning to the clinical side of our business, each quarter on these calls, we highlight certain recently published studies that we deem to be notable. However, to gain a more complete understanding of the body of evidence, we encourage all stakeholders to thoroughly review the extensive detail of scientific studies that have been published over the years. A recent article by Dr. Mohamed A. Abd El Aziz, Fabian Grass, and David Larson with colleagues from the Mayo Clinic published in Surgical Endoscopy provided results from a real-world study aimed to analyze national trends of conversion during elective colectomies in addition to MIS utilization trends. Using the ATF national surgical quality improvement program database for elective laparoscopic or robotic-assisted colectomy between January 2013 and December 2018, a total of 66,652 patients were identified. Overall conversion rates from MIS to open were approximately 42% lower for robotic-assisted procedures when compared to laparoscopic procedures, 4.9% versus 8.5%. The rate was also lower for obese patients with a BMI greater than or equal to 30, 6% versus 10.3%. The authors concluded in part, quote, this large scale study identified a decreasing trend in conversion rates over the six-year inclusion period, both overall and in patients with obesity paralleling increased utilization of the robotics platform. Given the potential negative impact of conversion on patient outcomes, individual institutions should consider a review of their conversion data, as this may represent an opportunity for quality improvement, unquote. In February of this year, Dr. Amir Bastawrous of the Swedish Cancer Institute in Seattle, Washington and Dr. Robert Cleary of St. Joseph Mercy Hospital in Ann Arbor, Michigan, published a real-world observational study, which compared the rates of long-term opioid prescriptions for patients who underwent minimally invasive and open colectomies. This study utilized the IBM market scan research database and analyzed 14,887 eligible patients who underwent colon resection via the open laparoscopic or robotic-assisted approach between 2013 and 2017. In the one-to-one propensity score matched analysis comparing the MIS and open approaches with over 5,000 patients in each arm, the MIS approach has significantly lower incident rates of long-term prescriptions of any opioid by approximately 36%, 13.3% versus 20.9%, Schedule 2 and 3 opioids by approximately 39%, 11.7% versus 19.2%, and high-dose opioids by approximately 44%, 4.3% versus 7.7% from 90 days to 180 days postoperatively. Looking at the matched analysis between robotic-assisted surgery and laparoscopy with overall 1,100 subjects in each group, the robotic-assisted approach demonstrated approximately 45% lower long-term prescription rates of high-dose opioids, 2.1% versus 3.8% when compared to the laparoscopic approach. Furthermore, in subgroup analyses, the robotic-assisted approach showed significant lower rates of long-term prescriptions in any opioids, Schedule 2 and 3 opioids, and high-dose opioids compared to the laparoscopic approach for subjects undergoing a colectomy for nonmalignant conditions. The authors concluded in part, quote, choosing an MIS option in robotic-assisted surgery for some colorectal operations is a modifiable factor that may contribute to less long-term opioid use, unquote. And with that, I’d like to turn it over to Jamie who will review our financial outlook.

Good afternoon. While there continues to be uncertainty regarding the ongoing impact of COVID-19, given moderating COVID-19 hospitalization trends and vaccination progress particularly in the U.S. which accounted for approximately 70% of our 2020 procedures, we are reestablishing our financial guidance. In providing this guidance, we know that there are emerging supply constraints in our supply chain, for example, in the semiconductor industry. The outlook we are providing does not reflect any potential significant disruption or additional costs related to the supply constraints. Our financial outlook for 2021 is as follows. Starting with procedures, total 2020 da Vinci procedures grew approximately 1% to roughly 1,243,000 procedures performed worldwide. For 2021, we anticipate full year procedure growth within a range of 22% to 26%. We expect 2021 procedure growth to continue to be driven by U.S. general surgery and procedures outside the United States where we were at earlier stages of adoption. The high end of the range assumes that COVID cases and their impact on da Vinci procedures continue to decline throughout the year, the vaccine rollouts continue at the level currently expected by governments around the world and that recovery of patient backlogs will progress. Modeling quarterly results is difficult, given the impact that COVID had on 2020 procedures. Therefore, with respect to seasonality, we expect similar quarterly patterns to 2019. With respect to capital, system placements are generally driven by procedure demand, prompting hospitals to establish or expand robotic system capacity. System placement demand is also the result of customers standardizing our fourth-generation technology through trade-ins. Capital sales can vary substantially from period to period based upon many factors, including government healthcare policies, hospital capital spending cycles, reimbursement and government quotas, product cycles, economic cycles, and competitive factors. Within this framework, we expect 2021 capital placements to generally be driven by procedures and the adequacy of existing capacity in the installed base. During the first quarter of 2021, 43% of system placements were under operating leases. We expect the proportion of systems placed under operating leases will vary from quarter-to-quarter and could continue to trend up in the future. Turning to gross profit, our full year 2020 pro forma gross profit margin was 68.4%, reflecting the impact of fixed overhead costs relative to revenue, higher excess and obsolete inventory charges and the customer relief program that was implemented in the second quarter of 2020. Our full year 2019 pro forma gross profit margin was 71.7%. In 2021, we expect our pro forma gross profit margin to be within a range of between 70% and 71% of revenue. Our actual gross profit margin will vary quarter-to-quarter depending largely on product, regional and trade-in mix, the impact of current cost reductions, manufacturing efficiencies, and competitive pricing pressure. With respect to operating expenses, in 2019, our pro forma operating expenses grew 27%, and in 2020, given the impact of the pandemic, they grew 3%. In 2021, we expect pro forma full-year operating expense growth to be between 18% and 22%, reflecting increases in investments in our digital ecosystem, Ion, SP, OUS expansion, higher regulatory-related costs and infrastructure investments to allow us to scale. 2021 spending is also expected to be impacted by a return over the course of the year to higher rates of travel, increased customer training, and a greater proportion of marketing events being held in-person and by variable compensation. We expect our non-cash stock compensation expense to range between $450 million and $470 million in 2021, compared to $396 million in 2020. We expect pro forma other income, which is comprised mostly of interest income, to total between $45 million and $55 million in 2021, reflecting lower interest rates relative to 2020. With regard to income tax, in 2020, our pro forma income tax rate was 22.5%. As we look forward, we estimate our 2021 pro forma tax rate to be between 20% and 21% of pretax income. Our 2021 outlook for the pro forma tax rate does not reflect any potential change in U.S. tax rates. That concludes our prepared comments, and we will now open the call to your questions.

Thanks very much. Can you hear me okay?

We can.

Great. I will maybe start with the first question on just the guidance. Obviously appreciate that just given all the uncertainty on the procedure side. And so given that you gave that number, we will see if you would go a step further and just give us a little bit more color as to how you got there. We are obviously all trying to figure out recovery back to normal, but also these potential buckets of recapturing backlog of procedure categories for you, particularly in prostate I’d suspect. Can you just talk to how you thought about those backlog of patients and that return to normal as you developed this guide for the rest of the year on the procedure side?

Sure. This is Jamie. I'll begin with the lower end of the procedure guidance. We considered three factors for this. First, we recognize the potential for ongoing effects of COVID in specific international regions, where vaccine rollouts have been slower and there have been resurgences, particularly in parts of Europe. Secondly, the guidance reflects a slower recovery of diagnostic processes that were disrupted during the pandemic. Finally, we also took into account the chance of localized COVID resurgences in the U.S. as we move towards vaccine distribution and ultimately reach herd immunity. Regarding the backlog, it has built up due to three main reasons: reduced diagnostic pipelines, postponed elective surgeries as hospitals deal with COVID cases, and patients' hesitance to undergo surgery amid COVID spikes. We believe these elements will recover over varying timeframes. The backlog is continually fluctuating between increases and recoveries, making it hard to predict the total accumulated backlog and the recovery rate, but we expect it to extend into 2022. The procedure guidance for 2021 represents our best estimate regarding the backlog's impact this year.

I appreciate that. I want to revisit a previously discussed topic, particularly in light of COVID, which is the issue of ambulatory surgery centers and lower acuity procedures. Given the current situation, it seems like it would be an ideal time for Intuitive to explore this segment of the market more actively. However, we still haven't heard much from you about it. This raises the question of what's preventing you from pursuing this opportunity. The typical response seems to focus on reimbursement challenges, yet when I consider the advantages you highlight to hospitals—such as the benefits for surgeons and improved outcomes—those factors appear to be significantly more important than reimbursement issues. Can you help clarify why ambulatory surgery centers aren't being prioritized more at this time?

Yeah. This is Gary. We are already in ambulatory surgery environments with our customers, different types, and we see healthy programs there. I don’t think we are struggling from the point of view of having a product that can help them or services that can help them or a way to have a conversation. I think all those things are in place. I do believe that over time reimbursement matters, particularly in customers that operate in both environments, hospitals and ASCs. For them, reimbursement matters. If they are going to move a patient, but they get a big difference in the revenue, then they are going to make those decisions. It may change over time, depending on what payers ultimately decide to do and whether they want to create some incentives to help things move into ASCs. We will be ready. Long-term, I am bullish on that. I think the environment makes sense, but economics and incentives really matter. It doesn’t clear up your question; it reinforces our position.

Okay. Thank you for that. I will step back in queue.

Good afternoon. Thanks for taking my question. Gary, can you please provide more color on the Intuitive telepresence feature that you mentioned on this call? It’s the first time I’d heard you talk about it, and that 45% of procedures was a pretty impressive number. Is that through your agreement with InTouch? How is it being used by customers? What are the benefits? And how do you see that playing out post-COVID? And I have one follow-up.

Yeah. So, you are right, it is the result of the technology and a collaborative agreement we signed with InTouch many years ago. We brought a team over, as well as some of the technology and have put it in our hands. The use case I was talking about there is the ability for people who are interested in observing a case by an expert to log in online through a secure network, high-speed streaming, and view that case on da Vinci accounts. That’s an important part of both knowledge transfer from those high-volume accounts, as well as an introductory exposure for surgeons who are thinking about it. So that has been great. There are other use cases for streaming connections, video streaming connections, into our products that I won’t detail now. It’s pretty neat, and so prior to starting that, I was a believer, or we as a company were believers that those kinds of access, think of it as kind of surgical FaceTime or surgical Skype over a distance. That kind of access would be important to folks, and the pandemic really accelerated it. We had the technology infrastructure in place, and as people started to be more open to the use of digital tools to do their learning and exposure and wanted to stay off of planes and out of cars, we saw it really accelerate, and that’s what we have been touching on there.

That’s very helpful. And then lastly, what response are you getting from the Extended Use Program you introduced in Q4 2020? Any changes to kind of the impact that we could see from that and any color yet on demand elasticity? Thanks for taking the questions.

Yeah. Sure. So we introduced Extended Use Instruments into Europe and into the U.S. in Q4. We did see increased usage of Extended Use Instruments. They still have some level of inventory of shorter-life used instruments, and they are burning that off. We also had commented last quarter that we saw stocking orders of Extended Use Instruments, and we are seeing some adjustment of their buying patterns to recognize the increased number of uses per instrument. So, this quarter, as I called out, instrument and accessory revenue per procedure was lower than last quarter, and that primarily reflects those factors, like the turn of use of Extended Instruments and adjustments of inventory buying patterns. I don’t think it’s exhausted the whole impact, and 130 if you go back to our previous script, you see that we said that had you implemented this in 2019, it would have affected total revenue by about $150 million to $170 million or about 7% of INA per procedure, and we have only seen a part of that so far. When the rest of it will hit is questionable. It will roll out over time as they continue to use those instruments and as we roll it out to other countries.

Thanks, Marshall.

Great. Thank you and good afternoon. I wanted to ask a question or a few questions on just the first quarter procedure volume numbers that you provided, because it was obviously a lot stronger than consensus estimates. And so, Gary, I was just wondering, a couple quick things. Is it safe to assume that the end of the quarter was materially stronger than the beginning and middle of the quarter in terms of procedure growth? And then I was just wondering what stood out to you, Gary, either geographically or by procedure type in the quarter that you think is worth calling out?

Thank you for the question. Regarding the first point, we definitely experienced growth throughout the quarter, which was encouraging. There seems to be an interesting mix in the types of procedures that are being prioritized as patients return to hospitals. This mix reflects both patient preferences based on their perceived conditions, such as bariatrics, and the urgency prioritization by hospitals and surgeons, particularly concerning diagnosed cancers and challenges in the diagnostic pipeline. I was pleased with the performance of U.S. general surgery, which has shown resilience largely due to benign procedures, and that has positively impacted our models. Overall, things are looking good.

And then one follow-up just on that also to get a little bit of a better flavor for procedure volumes in the quarter by geography, I am just curious on Europe, what’s your take on, how bad are things there in your view and just curious maybe how far below 16% was Europe in the quarter?

I won't provide specific numbers, but I can share some qualitative insights. In the U.K., NHS has been making firm priority decisions, which is reflected in the suppressed procedure performance. However, we are witnessing commitments to minimally invasive surgery in terms of capital acquisition and other factors that suggest a shift in focus toward it. There's a mixed scenario here. Despite the complexities surrounding COVID, France and Germany have performed surprisingly well. In Spain and Italy, we observe that as COVID eases, surgical procedures are resuming along with it. Overall, we are confident in our leadership teams in these countries and believe we maintain strong connections with the healthcare systems. We are being agile and adaptable to meet their needs, which helps us manage what we can control. In that regard, I think the company is performing well. Marshall, do you have anything to add?

I think that was great color. I think the only other thing I would add is the, we have talked about in the past that a lot of the procedures we are performing are urologic, and we are in the process in certain countries of pivoting. We are starting to see some adoption in GYN and general surgeries in some countries but we still have work to do.

Great. Thank you.

Hey. Thanks. A couple follow-ups. I am curious what’s baked into guidance on utilization given the Extended Use Instruments in the commentary before. What are you kind of modeling for utilization for the year?

Yeah. I think I would refer, Tycho, back to 2019 patterns in terms of utilization. Obviously, we knew capital was going to be driven by procedure performance. So I think I would just refer to seasonal patterns in 2019 as a starting point.

Okay. And then you have commented a couple of times on this call and other calls on the diagnostic pipelines being under pressure. Can you just talk a little bit about how they are looking as a leading indicator to some of the more mature procedures, dVP in particular?

Yeah. Jamie, why don’t you jump in?

We have some market data for the U.S. through February 2021. Most diagnostic tests, such as PSA testing, CT scans, and lung cancer screenings, have been suppressed during this period. We have not observed any signs of recovery in the data we have collected so far. There seems to be a correlation with the related procedures, as PSA dVP has been relatively weak during this time, along with lobectomies. At this point, there is no evidence of recovery in diagnostic testing in the U.S.

There are some anecdotes that it’s starting to get better in March. We will see as it plays out. Even after the diagnostic gets done there is a workup pipeline that has to be done. That said, I don’t feel like we have any evidence that it’s moving away from surgery. So it appears in those kinds of cases that it’s building a backlog that ultimately will flow through. If PSA testing back in 2012 is a guide, it will take several quarters for that to work its way out.

Okay. And then last one on SP, two quick ones actually. Can you confirm you started the IDE trial for colorectal in the quarter? And then, Gary, you mentioned thoracic surgery and other disciplines, I am just curious if you could talk a little bit about the roadmap for other areas you might go after with SP?

Sure. On the SP side, on the IDEs, the first cases are scheduled. We have got all the paperwork done in our research institutions that we are working through, at least the first starting ones, and we expect that to happen. The first cases have not yet gone through. They should happen here in the next few weeks. Thoracic, that's the first time we've been telling you that we think there’s potential. There are single port opportunities for thoracic surgery, and we are excited by them. We are working through what those trials look like and having conversations with regulatory bodies to get it going. Given the current environment, we will have concurrent trials for the colorectal and then thoracic procedures. There are a couple more indications beyond that. For competitive and other reasons, we are not yet ready to guess what those are going to be for us, but SP is a platform, and we are excited about it. As we get closer and those things get closer to being filed as IDEs and trials, then we will describe them more fully.

Okay. Thank you.

Good afternoon, everyone. I wanted to discuss Ion a bit more, Gary. We received numerous physician calls about a month ago, and the feedback has been really positive, with doctors reporting early signs of improved diagnostic yields, especially in complex cases, along with noticeable functional benefits and features. This gives me hope for the PRECISE trial. So, are you feeling optimistic about PRECISE? I believe you mentioned it would be concluded by midyear. When can we expect to see the data? The doctors are eager to review it. With some logistical issues now resolved, can we expect a faster uptake of Ion in the latter half of the year and into 2022? Thank you.

Sure. On the issue of the PRECISE trial, Philip, I will turn to you in terms of timing.

Sure. We confirmed that we expect enrollment to end this quarter in Q2 and then you would have final data readout in the back half of next year, 2022.

On the issue of how we are feeling about it, I think we are reading and hearing what you are reading and hearing also in terms of talking to our customers about the ability of Ion to deliver on its promises, to reach into the lung to get to diagnostic yields that folks have not seen with other technologies and to work in complex cases. So I am feeling enthusiastic and bullish about it. With regard to ramp, we are expecting Ion to continue to ramp through the year and into next year. I don’t see a step function change. I think it’s a sequential ramp as we go, and that’s because it’s been interesting and sophisticated technology. So a lot of what we are working on is making sure that we can get the manufacturability to where we need it, getting supply chain stability, quality, and predictability where we need it, iterating our design for manufacturing, and working on additional indications because it’s a platform, and we are doing all four of those things. But I don’t think investors, because of the way these things work, should expect that you flip a switch and it just goes to the next level. I think that it will climb each quarter and that’s what we are working on. That beats our expectation and our experience in these kinds of functions.

Thanks very much.

Sure.

Hi. Thanks for taking the question. Just one on operating expense guidance. Thanks for the full year outlook. Just could you give us an extent of the quarterly pacing or would it be safe to assume the 2019 cadence commentary for procedures applies to operating expenses too?

Yeah. I think you should see sequentially operating expenses generally increase across the rest of the year. It’s really going to be a function of the extent to which COVID continues to impact our ability to travel, accelerate customer training and hold marketing events in person. But generally, I would expect it to increase across the balance of the year.

Got it. And just same kind of topic here, on geographic investment and expansion that you started to get more aggressive on pre-pandemic, especially in India. Just in light of what’s been going on in that region specifically with the COVID problem. Should we be thinking of some of those initiatives postponed even further out to 2022 and beyond, or are those things that could resume as early as this year? Thanks.

Yeah. I am sorry. I had a little bit of a hard time hearing you regarding the referenced trial. So go ahead and re-ask the question, if you would.

Sorry. My connection is off. But just India, should we think of reinvestment in that region starting now, or in light of COVID and the situation there, is that something 2022 and beyond? Is that part of the spending and geographic expansion you referred to today?

Yeah. So with regard to India, clearly, the current situation there is such that current procedures are impacted. That said, I think that the long-term commitment we have to the market is intact. Our teams are making really nice progress building a footprint in relationships to hospital systems. And so I expect as COVID starts to become managed there a little bit more forcefully and it starts to recover we will see a recovery on our side. It has not had a retreat. Other places around the world, whether it’s Japan or China or Europe, we continue to be interested and committed, so not just India, but others as well.

Hi. Yeah. Thank you very much for taking the question. I guess it was good to see the strong return of capital spending. You are talking about customers looking forward to prepare for volumes and commitment to robotic surgeries. Do you think that there was a little bit of a bolus of kind of pent-up spending that came through in Q1 or do you think this is the start of a new pattern of purchasing based on your backlog and what you are seeing with your orders?

That is a subject of fearsome debate amongst us as a company. Marshall, why don’t you share your opinion?

I’d like to present a few different factors to think about as we move forward. It’s always challenging to predict based on just one quarter's results. We have experienced a couple of decent quarters. Regarding your question about pent-up spending, I can't say for sure if that was the case, but it's clear that hospitals had more capital available to spend than we had expected. The primary factor driving their spending on da Vinci capital is the growth in procedures. Procedure growth is the main driver of capital. Additionally, the trade-in cycle and the interest in accessing fourth-generation products, such as the Extended Use Instruments we discussed earlier, are also significant. Finally, they are preparing for the post-pandemic environment and recognizing that da Vinci Surgery better aligns with their goals compared to other methods.

Great. Okay, guys. Thanks. I will leave it there. Appreciate it.

All right. Well, thank you. Okay. Well, that was our last question. In closing, we continue to believe there’s a substantial and durable opportunity of fundamentally improved surgery and acute interventions. Our teams continue to work closely with hospitals, physicians, and care teams in pursuit of what our customers have termed the quadruple aim: better, more predictable patient outcomes, better experiences for patients, better experiences for their care teams, and ultimately, a lower total cost of care. We believe value creation in surgery and acute care is foundationally human. It follows from respect for and understanding of patients and care teams, their needs, and their environments. Thank you for your support on this extraordinary journey, and we look forward to talking with you again in three months.