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Intuitive Surgical, Inc. (NASDAQ:ISRG)

Goldman Sachs Healthcare Conference

June 11, 2014 13:40 ET

Executives

Baird Radford - Vice President, Finance

Patrick Clingan - Director, Finance

Analysts

David Roman - Goldman Sachs

David Roman - Goldman Sachs

We will go ahead and get started with the next presentation. I'm very pleased to welcome the management from Intuitive Surgical. We have Baird Radford, Vice President of Finance, and Patrick Clingan, Director of Finance here with us today. I think both can speak about any parts of the business. I know there will probably a lot of questions around the financials, but clearly the trends in overall end market dynamics as well.

Maybe we are – I was hoping to start is, I had a group out at Intuitive in March, and I asked Gary a question to which the response is pretty surprising. I asked him, 2013 was – we all know that was a tough year. How do you put 2013 in the context of the long-term evolution of robotic surgery? And his response was immediately to talk about the unintended consequences of the Affordable Care Act. So I'm hoping from your perspective, you could just sort of size up what's going on in your business 2013 was a traumatic year of change for the company. So maybe from your standpoint, how do you put that into context of – sort of your longer term vision, the development of robotics and how do we get out of that route?

Baird Radford

Yes. I think if you start with procedure growth as being one of the leading indicators for our business. In 2013, what we started to see was a lot of slowing in the growth in our U.S. benign gynecology franchise. And some of that is definitely attributable to the ACA particularly as you look towards the beginning of this year with the increase in high deductible insurance plan.

But the other part is also about MIS surgery has reached a bit of a saturation point. And if you look at exiting 2013 between robotic, laparoscopic and – when you look at where we exited 2013, you combine robotic, laparoscopic and vaginal surgery for hysterectomy and actually it's approaching 80%.

And so if you look back to prior robotics, it was all vaginal and laparoscopic surgery represented about 40% of all hysterectomy. And so robotics has been able to expand the market from 40% to 80%. But the days of significant share gains relative to open surgery are largely behind us. And so that's one of the reasons why you saw procedure growth decelerate.

And as you look to Q1, we started to feel like we are growing a lot more along with the market in the U.S. GYN space. And so we turned more of our attention to trying to focus our resources on growth and general surgery in the U.S. And in particularly growth internationally where frankly the robotic uses are lower when it comes to urology and gynecology procedures this year in the U.S.

David Roman - Goldman Sachs

Okay. And as you sort of think about – I think one of the biggest change that's occurred, as you went through a long period of time during which the macro environment had very little bearing on your procedural growth rate. Your penetration has moved up in GYN to a point where you are tethered to things like seasonality, elective procedure volumes, trends in women's health, OB/GYN business et cetera. How do you move beyond that? What are the factors that can move your growth right back to being new markets and new drivers rather than being so depended on sort of top down dynamics?

Baird Radford

I think if you step back and you say, boy, you guys grew very quickly for such a long period of time. If you look at urology as the first wave of procedure growth and where we first saw adoption here in the U.S. The hand-off between urology and gynecology was barely seamless in terms of how it appeared from a total procedure growth perspective. The hand-off is currently taking place between U.S. GYN as the growth driver domestically and U.S. general surgery and our international business as the growth drivers moving forward just hasn't been seamless. And you have seen more of a disruption here. And so I think as we get bigger in general surgery and as we get bigger internationally it will have a favorable impact on that overall top line growth rate.

David Roman - Goldman Sachs

And maybe we can sort of go into each of those pieces separately in a little bit more detail. Let's look at general surgery first because I think that's an area that has a nice big denominator associated with it that you can go after. Maybe I guess with a little bit different from general surgery versus hysterectomy or prostatectomy, it's an amalgamation of a lot of procedures versus one targeted audiences, if there are any, before we go on to kind take 600,000 hysterectomies, as you sat 350,000 addressable, you do X, it's simple math. And maybe we will just talk about the unlocking of the opportunity in general surgery. What is it going to take to penetrate the biggest categories more meaningfully?

Baird Radford

And I think you have to step back and recognize general surgery is a category with multiple sub-specialties within it. And so if you look at the way in which we grown in general surgery is a lot of different than how we grew in neurology and gynecology where there is really one key procedure like prostatectomy or hysterectomy where our growth came from.

General surgery the early adoption has been fairly broad and across a number of different types of procedures. And the one that gets a lot of talk is called cystectomy, which actually is a lot different from what our historical approach has been. Cholecystectomy, I think if you look across general surgery is a procedure for which there is a very, very high penetration rate of alternative minimally invasive approaches for which there is a very, very low rate of complication.

So already a very – as good established MIS paradigm, but there is other areas within general surgery that are different. Areas like colorectal where – in the colon and rectum there is a significant volume of open surgeries still performed today. So an opportunity to expand minimally invasive surgery into more and more of those procedures. So we are starting to see growth in a number of different areas, some that resembled prostate hysterectomy more closely like a rectal cancer. And some that are just different like choly, where it's less about shifting from open to MIS and more about adding an element of patient preference to the clinical outcome.

David Roman - Goldman Sachs

And yes, I think we will definitely want to talk about XI. I think XI does potentially have a bearing on the rate of adoption in colorectal for example. Maybe just continuing on a bit along that procedure category, we are a little bit surprised that we are still hearing more about you, started more from you on gastric bypass because that is a category when we go out and talk to physicians that we actually get very positive feedback in the opportunity robotic, but it doesn't ever come up to the degree that other procedures doing in your presentation? Why is that?

Baird Radford

It's a good question. As we mentioned growth in general surgery has been broad and bariatrics is one of those sub-specialties for which we are seeing a lot of exciting early positive momentum. Frankly, I have put a ton of resources behind it to drive it. But there are capabilities that our technology brings to the bariatrics surgeon, but it allows them to do things that they even struggle with or have not addressed in a minimally invasive fashion historically.

So we are excited about it, because it kind of has hit our radar screen yet is something that we spend a lot of time talking about, but the early signs are positive.

David Roman - Goldman Sachs

We probably can't leave the U.S. procedure discussion without talking about morcellation. I think there are actually different schools of thought out there. I think there is a prevailing consensus this is a headwind for you on top of what were you facing. Maybe just sort of clarify the role of morcellation in robotic procedures. Have you seen the consensus impact your business as of the last time when you reported earnings and how should we kind of contextualize what we are hearing about the topic on a go forward basis.

Baird Radford

Yes. Just to step back for those of you who may not be familiar with what Dave is talking about. There is an FDA – like a discouragement for the use of power morcellators and the removal of benign fibroids for gynecologic procedures. We don't make our morcellator are going to sell them, they actually do not attach to the da Vinci System. And it's a very, very common for these surgeries to be performed without the use of a power morcellator. So I think just to make sure everyone has that in the right context.

Now said that…

David Roman - Goldman Sachs

Baird, before you finish that thought, how does that compared to hysterectomy done either open or conventional lap, are those using – those all use morcellator, where is the morcellation happening?

Baird Radford

Yes. It will be more common in lap, I don't know, if you open the patient up, you got a big seven inch midline incision. It's increasingly rare for that to be the procedure given all the complications and readmissions and highline associated with it. So you would be – it would be rare for you to see in that situation, but definitely commonly used in laparoscopic procedures as well. Using morcellators you are trying to reduce the size of that fibroid inside the women to way in which you can remove it through one of the ports in the abdomen where it's being used.

Now if you do a total hysterectomy and you remove the cervix as well, you actually have the ability to use the vaginal canal as well for removing some of the larger fibroids where you may not have to. And robotics actually helps enable that procedure relative to that because of the tools themselves enable suturing, it's one of the main advantages of robotics compared to laparoscopic tool. And so if you need to make a large incision and be able to suture from within, it's something that where we can help the part of the solution safely extract tissue where these occult cancers maybe exist.

But in the short run, it's likely to have – it's a very strong statement by the FDA, AGL and ACOG have come out with their own statements where they disagree with the blanket approach, the FDA has taken in their statement. So it will be an interesting dialog over the course this summer. We anticipate there will be some disruption in the marketplace in the near term as patients and surgeons and institutions figure out how to move forward.

David Roman - Goldman Sachs

As the exit disruption comes from a further reduction overall in hysterectomy or some how it impacts robotic procedures?

Baird Radford

I think more on the performance. So specific to impact minimally invasive surgery for gynecologic procedures for the removal of benign fibroids, and more specifically -- more likely to have just a decrease in the total volume with patients back in therapy or provider sort of differing on treating these patients.

David Roman - Goldman Sachs

Because we read it and actually I read those but potentially good for you, which we (indiscernible) significant disagreement. But the view we had was well these procedures are going to be done, so if you are not mostly seen as robotics maybe that actually helps the penetration of robotics, but sounds like the piece we may have missed is the impact on the top down decline in the overall category.

Baird Radford

Yes. I think there is a short-term disruption in the long run to the extent that the added capabilities of our system enable safer extraction of tissue where there is a concern for occult cancer could potentially be a tell in the long run. A lot of chips to fall though, in the next couple of months since the panel meeting is convened, see what happens.

David Roman - Goldman Sachs

Maybe we should talk about x U.S., I mean it's not your piece of business to get the ton of attention based on your disclosure around increases in R&D and SG&A spending, it sounds like it is a major focus for the company going forward. What are the key things that you guys are focused on outside the U.S. to key markets, key procedures and what should we be watching?

Patrick Clingan

I will take that one. So per context, our OUS business is roughly 20% of our business. We also had been signaling through the last year, the importance of expansion of the product capabilities outside of the U.S. Last year, we also talked about the importance of making sure we had the right leadership in place in Europe in particular and making sure that we were getting the – not quite back office, but commercial basing activities of each countries. So each country will have different economics and different market circumstances. And making sure that we have experts in those major markets that are focused on the economies that are relevant to the customers in those countries is really important to us.

We think about Europe has multiple countries not as a collective whole because the dynamics facing them are all different. So with that as context, we find ourselves focused on where do we think we have the most value, where do we have the best opportunity to advance surgery from open procedures with longer length of stay and higher complication rates and greater risks to a minimally invasive robotic surgery where our product can assist surgeons and assist patients and are achieving better outcomes.

And so we find ourselves focused on the places where we made greater progress in the U.S. particularly related to prostatectomy so removal of prostate for cancer as well as uterine cancer removal. The place where Europe differs from the next approach for the – that we saw in the U.S. was the next place in Europe is likely in that colon and rectal cancer space places where a large degree of the open procedures are already taking place and there is quite a bit of clinical value of moving those to minimally invasive and laparoscopic procedures over that period of time have not been able to reduce the number of open surgeries at the speed that patients are looking to receive.

So Europe that's our area of focus really on those core cancer driven procedures. We also are focused outside of Europe and Asia. And so our business is in Japan. We have reimbursement for one nationally reimbursed procedure and that's prostate. Japanese cycle is on an every two year approach with the next cycle being in April of 2016. So we are dedicated in the Japanese market making sure surgeons are able to get the products, surgeons are able to actually have the outcomes that they want in prostate to hopefully lead the way to additionally procedures in the future in that market.

Korea is another market that we are focused on, so what you are finding here is that seem among Western Europe, Japan and Korea of great growth opportunities for us in these what I would call high patient value, high economies outside the U.S. without yet getting into the smaller economies that many other med-advice companies are going after for their growth at this stage like India, Russia, China.

David Roman - Goldman Sachs

And Japan, I think is pretty clear the way that works, right, the reimbursement every two years, unlike the U.S. more direct, it's not -- that's why company directed it's going to be medical society directed, I want the next indications but it maybe just give us some perspective on what it takes to really unlock that value outside the U.S., how are you going to penetrate those markets and how long does that take what's – is there any objectives in terms of x U.S. mix that you can share that will be helpful barometers in our kind of sizing up the OUS opportunity?

Braid Radford

I think if you just focus on prostatectomy, hysterectomy and colorectal resection, we got a slide on our Investor Day deck on this. It's a significant opportunity. If you include the U.S. along with sort of developed Western Europe, we will be looking in Japan and Korea and Australia and Canada. We are looking at almost the million procedures that are done either in an open surgical fashion of which significant amount of evidence exists where robotics surgery can affect a better outcome by reducing the rate of open surgery.

And so we have a tremendous amount of potential runway to just bring prostatectomy and other and kidney cancer as well as some other malignant GYN procedures in colorectal up to U.S. level. And so that's going to be our primary focus from a markets perspective.

David Roman - Goldman Sachs

Okay. I want to open it up to questions in the audiences, if there are any before we go to kind of the – sorry, I cut you off, do you want to finish your thought then maybe we will move to the capital side of the business.

Patrick Clingan

The only thing I would add to the international side is, it's recognized that it's a growing area for us. And we are going from early levels of penetration to hopefully driving to higher greater levels of adoption. So you will see the lumpiness in the business whether it's the capital system sale or whether it's the procedural growth rate as we move through procedural categories expect that kind of lumpiness as you go forward, its not just simply a straight line curve up and to the right.

David Roman - Goldman Sachs

Okay. That's helpful context. I think that's also probably additionally true because as you talk about Europe, it's a lot of different countries not one block. On the system side of the business, one of the questions I got from investors very frequently last year particularly if you went from the second quarter onward with – we didn't see that big a deceleration in procedure volumes Q1 – Q4, Q1, Q2, 2012 in the first two quarters of 2013. But we did see a massive decline in systems.

So one of the things that seemed perplexing to some was that a small change in procedure volume could have that traumatic impact on the systems though a lot of sort of terms that got thrown at me were over-capacity, under utilization, help us think about that and why the – I understand that you were connected, but why such a significant reaction on one side to a small move on the other?

Baird Radford

I think one of the ways we always talk about is procedure growth lead to expansion of the installed base and that will require capital sales. So step back and you think about what causes the customer to want to buy a system either they don't have them and they need one. The one they have doesn't have the technology they want, so we have added stapling and vessel sealing, fluorescent imaging simulation and single side technologies to our platforms over time, so if yours doesn't have that you may want – need it. And with XI, we are going to further enable greater capabilities and multi-quadrant, multi-access procedures with cameras that can do both (indiscernible) and instruments that are longer and it's a much easier to set up and deploy and smaller profile arms which allow for greater access throughout the abdomen.

So those are things are important to you and you don't have them on your current platform, you may upgrade it. And then finally, where you are doing those surgeries, so if you have a system and its fully utilized and you want to expand your robotics program into either colorectal or thoracic or something like single incision cholecystectomy you may need another system that system maybe needed another part of the hospital or within the footprint of the facility. So if you want to do all out patients benign hys and cholecystectomy you may need a system and a dedicated outpatient operating room, if you want to do colorectal thoracic procedures and you want multi-quadrant access you may feel you are going to need XI for (indiscernible).

I think those are the drivers that cause customers have to purchase and certainly as you have seen the deceleration in procedure growth particularly in the U.S., you have seen an impact that has on capital system placements and growth in the install base.

David Roman - Goldman Sachs

So I guess is, why wouldn't this sort of big declines you saw in capital last year against sort of early part of the year small flowing in volumes and why isn't a better reflection of too many systems being out there?

Baird Radford

I guess depending upon what your view of the future is in terms of where robotics goes from here that can impact whether you really think there is too many out there or not enough, right? So I think depending upon how you model our adoption in the procedures that we have been talking about can impact how many ultimately you need to have in the marketplace.

David Roman - Goldman Sachs

Okay. Maybe we should shift gears to XI, its been couple of months, think in stages, there was tremendous amount of enthusiasm around the technology maybe just sort of help ground us on the XI launch, how we should think about it in terms of it's impact on your business and why your customer conversation have been like relative to that phasing?

Baird Radford

So the early feedback we have gotten from discussions with surgeon and customers has been positive. There is a lot of excitement about what the system can do particularly if you are talking to folks who are doing multi-quadrant and more complex surgery things that are largely done in – still done in an open fashion today. They are excited about the extra reach and the ability for them until we get around the abdomen in a more comprehensive fashion. So signs have been positive. We are excited about the enthusiasm in the marketplace what technology can do. That said, there are some instruments that we are still looking on bringing to the market we just recently received approval for our vessel sealer. And we have submitted for our stapling and fluorescent imaging technology.

When you think about – let's just use colorectal, for example, if you are colorectal surgeon and you want to be doing those procedures robotically. You don't want to have those instruments. So there maybe some short-term launch differences between which customers can purchase immediately versus those who have gone away for the full product suite to be available before making a purchase.

David Roman - Goldman Sachs

And one of the things they talked about is the impact on sales outside the U.S. because you don't have full approval there and everyone knows that's coming now. So potentially some sort of freezing probably the word that you want me to use, but you are slowing it in existing system sales outside the U.S.?

Baird Radford

Yes. Certainly in Western Europe and Japan and other areas we have seen a lot of system sales in the recent past. They are going to want to know kind of what the timeline and when it's going to feel the previous technology. But that said, yes, it's not a very capable system and depending upon which procedures you are pursuing and if you are looking at just doing pelvic type surgeries like prostrate and hysterectomy, SI have been extremely capable piece of equipment so to the extent that you are ready to get in today.

But there will be some pause in some customers mind until they have a chance to understand the timelines to XI coming to the country and what it can do from a capability perspective relative to SI.

David Roman - Goldman Sachs

As we have got XI as a platform technology that this is a base sort of architecture often which you can have a number of add-ons whether it's different arms or different instruments or single site or I'm not sure you got single site approved Xi. Is that – is this sort of the next workhorse system for you as it set the way we should think about it?

Baird Radford

Based on XI.

David Roman - Goldman Sachs

XI.

Baird Radford

So we don't have single site approved on XI. XI is definitely a platform that we will innovate. I think the best way to kind of talk about it, if you look at what happen when we launched the SI platform. It had a dual console is that a lot of the technologies that we brought to market since then were not available at launch things like SI sealing, stapling, or SI imaging single site. None of those were part of the technology package. We are not done. We will continue to innovate and try to develop things on the XI platform. For those of you who are familiar with the da Vinci SP platform that is a product that we plan to bring to market in the second half of 2015 that will be compatible with the XI. We already have future innovations that we will be bringing to that platform.

David Roman - Goldman Sachs

Sorry, that's what I was referencing. Yes, sorry. So if I kind of listen to your commentary and try to wrap this together it seems like the business is still facing more headwinds than tailwinds at least in the immediate future? There you are facing the pressure around hysterectomy in the U.S., prostate has stabilized, but is there a growth driver. XI is probably going to ramp slowly given waiting for some of this additional approval, so all that makes the – sort of view 2014 as a transitional type year with a return to more meaningful growth next year? Is that a fair way to characterize the outlook or…

Baird Radford

Without directly talking about next year, I think as you step out and you look at 2014 in the system broadly with the impacts of the ACA, I mean, you laid off with Gary's comment on the unintended consequences. There is a lot going on in the market right now that creates some uncertainty. But as we think about the role of robotic surgery and the ability to make outcome – improved outcomes for patients and to broaden minimally invasive surgery and all the benefits that accrues to a broad population of patients. We were very optimistic about the role that we can play in the long-term.

So as we look out, I think we are very excited about the ability to further innovate on the technology side as well as to broaden MIS and listen to these more and more complex procedures in an area where it is still common – where open surgery is still common.

David Roman - Goldman Sachs

But I guess from an adoption curve perspective, I think the new therapies you are going after have very different dynamics from the therapies that made you successful on a trailing basis. I mean the competitive landscape is Covidien and in some cases I mean is that a fair representation or…

Braid Radford

To an extent if you look at the benign hysterectomy before robotics entered the market, it was 40% minimally invasive. If you look at colon reception, it's about 45% laparoscopy. If you look at video assisted thorascopic surgery, it's about 40 some percent of lobectomy. So it's not that different when you think of the number of open surgeries that are out there. And certainly you would love to see minimally invasive surgery reaching a 5% platform in those types of procedures and we are hoping to – with the tools we are bringing to the market that would be capable.

The other thing, it's a little different about them is, when you think about the addition of stapling and vessels sealing technology, they have enabled us to get more revenue per procedure in those colorectal and thoracic type procedures compared to some of the pelvic procedures that has been – in our past.

And we are not adding cost to the customer by getting that as revenue per procedure. We are actually just shifting some dollars from other third-party products. And so that's exciting too when you think about growth from those types of complex procedures where stapling and vessel sealing are used.

David Roman - Goldman Sachs

And maybe talk about specifically on the 2014 guidance; you were pretty wide range out there for procedure growth estimates. Can you just maybe sort of talk about the error bars like what drives the bottom end of the range, what drives the top end of the range?

Braid Radford

Yes. I think if you look through what's happening in the marketplace. There is a significant amount of volatility in what's going with elective benign procedures, things that a patient can put off for a period of time as high deductible insurance plans has become increasingly common patients have a greater economic exposure to when and where they receive therapy. What therapy they may receive?

So I think that creates one element of increased volatility that's caused us to widen out the range of our guidance. Issues like morcellation that you brought up that create a lot of uncertainty in the marketplace and what may transpire over the course of the summer between the FDA and the Surgical Society on how to ensure that patients still have an access to minimally invasive surgery with safe tissue extraction technique that could impact procedure volumes with given the U.S. GYN is still our largest area. And so there is a number of swing variables that caused us to widen it out from a range that's broader than what we had historically done.

David Roman - Goldman Sachs

And what makes it better, like how do we get back to the (indiscernible) kind of dynamic with the da Vinci? What needs to transpire to see if the – I'm not trying to pin you down with 9%, 10% or 11%, what has to happen for that to materialize?

Braid Radford

I think couple of things. Firstly, we would love to see some more stabilization in the U.S. GYN landscape. There is lot of factors moving right now. And they are making that uncertain. And then bigger picture – those businesses that are growing and growing quite robustly like U.S. general surgery and our international business just needs to get bigger and that has a positive impact on the overall growth rate. And so if we can continue to be successful of driving adoption of robotic surgery into this market. Yes, I think we aspire to – the growth rates higher than what we posted during Q1.

David Roman - Goldman Sachs

Okay. That's helpful. And you sort of – it's a tricky sort of set of analytics that if you haven't provided total top line guidance for 2014, but I think your tone has been pretty clear around what's happening in the market? Do you think that investors are in the sell side are hitting the caution that you are out there expressing about the environment or you said that's not being fully digested?

Braid Radford

I don't think you want to comment specifically on how people are perceiving. We are trying to be help people understand the issues and understand what we are seeing in the marketplace and how it's impacting our business and so they can make the most informed decisions when building a model.

David Roman - Goldman Sachs

Okay. So the last question, I will ask, we are ticking down on time, it's just – if there is similar context you had a lot of investors through headquarters. You have been at these conferences, you are meeting with people here, is there anything that you would really want to point out where you don't think people are spending enough time that you think is an interesting – a material driver that isn't getting enough air time?

Braid Radford

Yes. I think we touched on international couple of times in these conversations. But, if you go out and you look at the opportunities for us, it's larger than U.S. opportunity given some of the underlying to the states and where open surgery is still very, very common. So if we can make these investments and build the infrastructure to be more successful internationally there is a long tail of growth there for us.

And in addition to that I think when people look at the types of procedures where we are growing, yes, what's becoming -- we report on the number of metrics for you. And so the average is becoming less and less relevant. If you think about a single cystectomy at $700, $800, 9 or 8 per procedure and a colorectal resection with the vessel sealer and stapling is in much, much higher than that in the $3000 range.

Depending upon what you're believing where you are going to see robotic expand those can have significant difference in terms of what the overall economic picture is. So I would encourage folks to think of those two things as areas to deeper.

David Roman - Goldman Sachs

Okay. Well, we are almost exactly out of time. We did well here I think today. Thank you for your continued participation in this conference, for making the trip south to LA.

Braid Radford

Thanks.

Question-and-Answer Session

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