直覺手術 (ISRG) 2015 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to the Intuitive Surgical Q3 2015 earnings release call.

(Operator Instructions).

And also as a reminder, today's teleconference is being recorded.

And at this time, I will turn the conference call over to your host, Senior Director of Finance, Investor Relations for Intuitive Surgical, Mr. Calvin Darling.

Please go ahead, sir.

Thank you.

Good afternoon and welcome to Intuitive Surgical's third-quarter earnings conference call.

With me today we have Gary Guthart, our President and CEO; Marshall Mohr, our Chief Financial Officer; and Patrick Clingan, Senior Director of Finance and Sales Operations.

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 the Company's Securities and Exchange Commission filings, including our most recent Form 10-K filed on February 5, 2015, and 10-Q filed on July 22, 2015.

These filings can be found through our website or at the SEC's EDGAR database.

Prospective 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 intuitivesurgical.com on the audio archive section under our investor relations page.

In addition, 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 third-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 third-quarter financial results.

Patrick will discuss marketing and clinical highlights.

Then I will provide our updated financial outlook for 2015.

And finally, we will host a question-and-answer session.

With that, I will turn it over to Gary.

Thank you for joining us on the call today.

Overall, Company performance in the quarter was solid, with robust procedure growth, solid capital performance, and improved operating margins.

Starting with procedures, year-over-year growth in the third quarter accelerated to 15% compared with Q3 2014.

Procedure performance mirrored our experience in the first half of the year, with strength in hernia repair, colon and rectal resections, solid growth in prostatectomy, and stable trends in hysterectomy.

Internationally, growth trends in the first half of the year continued in the third quarter.

Growth in Europe, China, and Korea was multidisciplinary, with particular strength in urology.

Patrick will review procedure trends in greater detail later in the call.

Turning to capital sales, we placed 117 systems in the quarter, compared to 111 in the third quarter of 2014.

Capital placements in the United States accounted for most of the growth in system placements year over year.

Customers are preferring our most capable products, and excise systems and dual-console configurations represented a larger proportion of placements in the quarter relative to a year ago.

In Japan, procedure growth was solid and driven by growth in urology.

As we have said on prior calls, the growth of the market in Japan will be paced by continued progress on reimbursement.

Clinical investigators are submitting their partial nephrectomy data to MHLW for review and ISI continues to work with key stakeholders in the reimbursement for additional procedures.

While we have no assurance of additional procedure reimbursement at this time, Japanese authorities will review a reimbursement submission for partial nephrectomy for inclusion in 2016 national coverage.

Conversations regarding reimbursement for other procedures are ongoing.

However, inclusion of other procedures in full reimbursement guidelines in 2016 are unlikely.

Turning to operating performance, our product operations teams have been focused on reducing costs for our new products and we have been managing our fixed expenses carefully.

This quarter was another step in the right direction on gross margins, helped by product mix and some costs coming in at the lower end of their expected ranges.

We will continue to focus on improvements in direct product costs over the next several quarters.

As we look at the long-term financial position of our products, we anticipate making targeted capital investments over the next few quarters in programs that we believe will facilitate better long-term product and operating margins.

Marshall will take you through this and other financial performance in greater detail later in the call.

In summary, our operating performance for the third quarter is as follows.

Procedures grew approximately 15% over the third quarter of last year.

We placed 117 da Vinci Surgical Systems, up from 111 in the third quarter of 2014.

Total pro forma revenue for the quarter was $590 million, up 10% from prior year and up 14% year over year on a constant-currency basis.

Total pro forma instrument and accessory revenue increased to $298 million, up 10% over prior year.

We generated a pro forma operating profit of $240 million in the quarter, compared with $197 million in the third quarter of last year, and pro forma net income was $199 million, compared to $145 million in Q3 of 2014.

We are deeply committed to advancing our technologies and offerings to benefit surgeons, their patients, and hospitals.

We have launched integrated table motion for our Xi in Europe this October and have submitted our US 510(k) application.

Table motion allows surgeons to interactively use gravity for retraction and eases patient management during da Vinci Xi surgical cases.

As many of you saw at the American College of Surgeons meeting earlier this month, initial customer feedback has been strong.

We also submitted our 510(k) for our Single-Site instrument kit for Xi in the third quarter with the intent of bringing our single incision tools to the Xi platform.

In addition, we submitted a 510(k) application for a 30-millimeter stapler for Xi in the third quarter.

This instrument has particular utility in thoracic surgery and includes multiple staple sizes, including green, blue, white, and gray reloads.

Regarding our next-generation single-port technology, our technical teams continue to meet their development milestones for da Vinci Sp, having completed the build of our first 10 Xi compatible systems, five of which are slated for human clinical use.

We anticipate increased clinical evaluations of da Vinci Sp in 2016, particularly in transoral and transabdominal applications.

Lastly, da Vinci systems are sophisticated network computing systems.

The availability of these computational resources allows for both real-time analytics that can provide surgeons relevant information -- for example, the smart [plant] feature implemented in our stapler, as well as anonymized utilization data that administration can use to help optimize the robotic surgery programs.

We are developing increased computational capability in both real-time and program-level applications.

Along with a field force of workflow experts, this analytic capability allows us to aid our customers both during surgery and in optimizing their robotic surgery programs.

As we have discussed on prior calls, for 2015 we remain focused on expanding the application of da Vinci in general surgery, particularly colorectal surgery and hernia repair; filling out our product line for da Vinci Xi and launching in key markets globally; developing our organizational capabilities in markets in Europe and Asia; advancing our technologies to improve surgery; and lowering our direct product costs.

I will now turn the call over to Marshall, who will review our financial performance.

Thank you, Gary.

I will be describing our results on a non-GAAP or pro forma basis, which excludes the impact of our prior-year Xi trade-in programs, legal claim accruals, stock-based compensation, amortization of purchased IP, and investment in impairments.

We provide pro forma information because we believe that business trends and operating results are easier to understand on a pro forma basis.

I will also summarize our GAAP results later in my script.

We have posted reconciliations of our pro forma results to our GAAP results on our website so that there is no confusion.

Pro forma third-quarter revenue was $590 million, an increase of 10% compared with $534 million for the third quarter of 2014 and an increase of 1% compared with last quarter.

Pro forma revenue for the third quarter of 2014 excludes net revenue associated with the offers made in 2014 to trade out Si product for Xi product.

All trade-out offers were either fulfilled or lapsed in 2014.

Third-quarter 2015 procedures of approximately 162,000 grew approximately 15% compared with the third quarter of 2014 and were approximately equal to the second quarter of 2015.

Revenue highlights are as follows.

Pro forma instrument and accessory revenue grew 10% compared with the third quarter of 2014 and was approximately equal to the second quarter of 2015.

The increase relative to the prior year reflects procedure growth, partially offset by foreign exchange and customer buying patterns.

Instrument and accessory revenue realized per procedure, including stocking orders, was approximately $1,840 per procedure.

This metric has now been trending in a tight range between $1,830 and $1,840 per procedure over the past four quarters, with recent quarters reflecting higher sales of new instruments and the impact of foreign exchange.

Pro forma system revenue of $174 million increased 13% compared with last year and decreased 1% compared with last quarter.

The increase relative to the prior year reflects increased unit sales and higher average system selling prices.

The decrease relative to the second quarter reflects the higher number of operating leases, partially offset by higher average system sales prices.

117 systems were placed in the third quarter, compared with 111 systems in the third quarter of 2014 and 118 systems last quarter.

77% of the systems placed this quarter were Xis, compared with 53% in the third quarter of 2014 and 64% in the second quarter of 2015.

We expect the mix of Xi to Si product to fluctuate quarter to quarter.

Globally, our average system price of $1.6 million increased compared with $1.45 million in the third quarter of 2014 and $1.5 million last quarter.

Our third-quarter 2015 ASP was our highest to date, reflecting an unusually high mix of dual consoles, including a high number of shipments to academic centers.

We shipped 29 dual-console Xis in the third quarter of 2015, compared with 13 last year and 18 last quarter.

We expect to return to our historical mix of dual consoles and therefore expect our future ASP to be lower than this quarter.

ASPs fluctuate quarter to quarter based on geographic and product mix, trade-in volume, and changes in foreign-exchange rates.

Hospitals financed approximately 25% of the systems placed in the third quarter, up from 21% last quarter.

We directly financed 20 systems, including placing the most operating leases, 13, since we began our direct leasing program in the second quarter of 2014.

As of the end of the quarter, there were 36 systems out in the field under operating leases.

Revenue from operating leases was less than $2 million in the third quarter.

We expect the impacts of operating leases from our system -- we exclude the impacts of operating leases from our system ASP calculations.

The number of systems placed under operating leases will vary quarter to quarter.

Service revenue of $117 million increased 8% year over year.

It increased approximately 4% compared with the second quarter of 2015.

The year-over-year and quarter-over-quarter increases reflect the increase in our installed base of da Vinci systems.

Outside of the US, results were as follows.

Third-quarter pro forma revenue outside of the US of $150 million -- $151 million decreased 1% compared with $153 million for the third quarter of 2014 and decreased 10% compared with $168 million last quarter.

The decrease compared with the previous year reflects lower system sales into China and the impact of foreign exchange, partially offset by higher revenue -- higher recurring revenue driven by approximately 28% higher procedure volume.

The decrease compared with the last quarter was driven by lower system unit sales and timing of customer instrument and accessory sales.

Outside the US, we placed 37 systems in the third quarter, compared with 50 in the third quarter of 2014 and 46 systems last quarter.

OUS system placements included nine systems into Japan, compared with seven last year and 13 last quarter; 19 systems into Europe, compared with 25 last year and 22 last quarter; and no systems into China this quarter, compared with 10 last year and none last quarter.

System placements will continue to fluctuate quarter to quarter.

Moving on to the remainder of the P&L, the pro forma gross margin for the third quarter of 2015 was 69.3%, compared with 67.2% for the third quarter of 2014 and 68% for the second quarter of 2015.

Compared with both the second quarter of 2015 and the third quarter of 2014, the higher third-quarter 2015 gross margin reflects higher system ASPs, improved efficiencies, lower inventory charges, among other factors.

The increase in gross margins relative to the third quarter of 2014 also reflects charges to cost of sales related to the Si Stapler recall in 2014.

In 2014, we recorded pretax charges of approximately $82 million, representing the estimated cost of settling a number of product liability legal claims under a tolling agreement.

During 2015, we have refined our estimate of the overall cost of settling claims and recorded additional charges of approximately $14 million in the first half of the year.

There were no charges in the third quarter of 2015.

Charges made related to this agreement are excluded from our pro forma results and are included in our GAAP results.

At the end of the third quarter, $30 million remained accrued on our balance sheet, as a significant portion of the estimated costs have been paid.

Pro forma operating costs, which exclude the reserves for legal claims, stock compensation expense, and the amortization of purchased IP, increased 4% compared with the third quarter of 2014 and were less -- 1% less than last quarter.

The year-over-year increase in pro forma operating expenses primarily reflects headcount additions and higher incentive compensation.

Our pro forma effective tax rate for the third quarter was 18.4%, compared with an effective tax rate of 27.2% for the third quarter of 2014 and 25.6% last quarter.

The effective tax rate for the third quarter of 2015 included tax benefits of $29 million, or $0.77 per share, related to a recent favorable tax court ruling involving an independent third party.

Our tax rate will fluctuate with changes in the mix of OUS and US income and will not reflect a federal research and development credit unless such credit is reinstated.

Our third-quarter 2015 pro forma income was $199 million, or $5.24 per share, compared with $145 million, or $3.92 per share, for the third quarter of 2014 and $173 million, or $4.57 per share, for the second quarter of 2015.

Excluding the prior-period tax benefits, our third-quarter 2015 pro forma net income was $170 million, or $4.47 per share.

As I indicated earlier, pro forma income provides an easier comparison of our financial results and business trends.

I will now summarize our GAAP results.

GAAP revenue was $590 million for the third quarter of 2015, compared with $550 million for the third quarter of 2014 and $586 million for the second quarter of 2015.

GAAP net income was $167 million, or $4.40 per share, for the third quarter of 2015, compared with $124 million, or $3.35 per share, for the third quarter of 2014 and $135 million, or $3.56 per share, for the second quarter of 2015.

We ended the quarter with cash and investments of $3.1 billion, up from $2.9 billion as of June 30, 2015.

The increase was primarily driven by cash generated from operations and proceeds from stock option exercises, partially offset by stock buybacks.

During the quarter, we repurchased approximately 70,000 shares for $36 million, an average purchase price of $509 per share.

This brings our total stock repurchases to approximately $100 million for the year.

And with that, I would like to turn it over to Patrick, who will go over our procedure and clinical highlights.

Thanks, Marshall.

As mentioned earlier, total third-quarter year-over-year procedures grew approximately 15%, with US procedures growing approximately 12% and international procedures growing approximately 28%.

In the US, third-quarter procedure growth of approximately 12% accelerated modestly from first-half growth of approximately 10%, driven by an uptick in the growth of general surgery procedures, with solid contribution coming from mature procedures, despite already high levels of market penetration.

It remains uncertain how sustainable the year-to-date growth in these mature procedures will be in future periods.

In urology, trends observed during the first half of the year continued through the third quarter.

Growth in da Vinci Prostatectomy and kidney cancer procedures continued at similar rates as the first half of 2015, with da Vinci Prostatectomy growth again exceeding our expectations.

We continue to believe that our US prostatectomy volumes have been tracking to the broader prostate surgery market.

In gynecology, third-quarter procedures grew modestly year over year, with growth in malignant and complex hysterectomy partially offset by declines in benign procedures.

Similar to the first half of the year, the increased proportion of total hysterectomy procedures have been performed by gynecologic oncologists.

Third-quarter growth in general surgery increased compared to the first half of the year, with robust growth in hernia repair and an uptick in colorectal procedures being partially offset by continued declines in cholecystectomies.

Hernia repair continued to drive the majority of growth in general surgery procedures during the quarter.

Earlier this month at the American College of Surgeons meeting, several presentations highlighted the emerging role of da Vinci surgery in ventral and inguinal hernia repair.

Surgeons commented on the advantages of da Vinci surgery, which included precise dissection, improved visualization, secure closure of the primary defect, plication of the abdominal wall, suture fixation of mesh, and a reduction in postoperative pain for patients.

Specific to ventral hernia repair, Dr. Ballecer from the Banner Health network compared 180 da Vinci hernia repairs to over 60,000 lap and open hernia repairs from the ACS National Surgical Quality Improvement Program database and found that a reduction in hospital length of stay and complications saved approximately $550 per case compared to the laparoscopy and over $700 per case compared to open surgery.

We are encouraged by these early clinical and economic validations around the use of da Vinci surgery in hernia repair.

Regarding our Single-Site cholecystectomy business, as we have stated over the past four quarters our total cholecystectomy procedures have declined through the rate -- though the rate of decline moderated in the third quarter as growth in multiport cholecystectomies offset much of the decline in Single-Site cholecystectomies.

It is our belief that customers are finding added value in a more complex patient population, therefore gravitating to the traditional Da Vinci multiport approach.

Firefly technology was used in approximately 40% of da Vinci cholecystectomies in the quarter.

Looking abroad during the third quarter, the approximate 28% international procedure growth was led by global adoption of da Vinci Prostatectomy, with solid contributions from kidney procedures, malignant hysterectomies, and colorectal resections.

Procedure growth in Europe remained steady through the first nine months of the year, while the acceleration in procedure growth in Asia that began during the first half of the year continued into the third quarter.

During the quarter, the global evidence supporting the cost effectiveness of da Vinci prostatectomy in international markets continued to build.

A recent economic analysis from the Peter MacCallum Cancer Centre in Australia, published in BJU International, reviewed nearly 6,000 prostatectomies from the Victorian Admitted Episode Dataset.

Their analysis found da Vinci Prostatectomy to be cost equivalent to open prostatectomy, where 140 da Vinci procedures per year were performed on the system, well below the global third-quarter annualized average of approximately 190 procedures per system.

During the study period from 2010 to 2013, the rate of open prostatectomies declined from approximately 73% to 47% among public hospitals in Victoria, due to an increase in the adoption of da Vinci Prostatectomy.

This concludes my remarks and I thank you for your time.

I will now turn the call over to Calvin.

Thank you, Patrick.

I will be providing you with our updated financial outlook for 2015.

Starting with procedures, on our last call we estimated full-year 2015 procedure growth of between 11% and 13%, above the approximately 570,000 procedures performed in 2014.

We are now increasing our procedure estimate for 2015.

We now anticipate full-year 2015 procedure growth of between 13% and 14%.

Turning to gross profit, our outlook for gross profit has again modestly improved compared to last quarter.

We expect our fourth-quarter 2015 pro forma gross profit margin to be between a range of 67.5% and 68.5% of revenue.

Note that this range is a bit lower than our third-quarter gross margin, as Q3 benefitted from favorable product mix and other factors, which we expect to return to more typical patterns in Q4.

Our actual gross profit margin will vary quarter to quarter, depending largely on product and regional mix, systems production volume, and foreign-exchange rates.

Turning to operating expenses, consistent with our last call, we continue to expect to grow pro forma 2015 operating expenses towards the lower end of a range of between 7% and 10% above 2014 levels.

Also consistent with our last call, we expect our 2015 non-cash stock compensation expense to come in towards the lower end of a $170 million to $180 million range, roughly flat compared to $169 million in 2014.

We continue to expect other income, which is comprised mostly of interest income, to total between $16 million and $18 million in 2015.

With regard to income tax, for Q4 we expect our pro forma income tax rate to be between 28% and 30% of pretax income, consistent with our previous estimates.

This forecast does not assume the reinstatement of the R&D tax credit in 2015.

That concludes our prepared remarks.

We will now open the call to your questions.

(Operator Instructions).

Ben Andrew, William Blair.

Thank you for taking the questions.

I guess two things for us.

If you look at the legacy US procedures, Gary, we talked in August about some of the hospital systems looking more carefully at cost/benefit analysis.

Do you think that's supporting the complex dVH and dVP and are you getting more evidence that that's the case?

Yes, we have seen -- I can speak to anecdotes.

Anecdotally, the dVPs and some of the more complex procedures we have seen have been well supported by analyses done at the IDN level.

They're getting more sophisticated in those analyses and I think they are getting more confident in them.

Okay, and then as far as the international procedure growth, that was an exceptional acceleration.

How durable is that as we look at 2016 with Europe steady growth, US obviously a little bit above plan, but that Asian piece, it really sticks out?

Yes, it depends on the country.

So as you go country by country in Asia, I think Korea has been building nicely.

I don't see radical changes one way or the other.

Japan, we have talked about.

I think that there's a lot of interest and a lot of organic activity, but major penetration is going to require reimbursement.

China, we saw a lot of acceleration.

The pacing there will be in part driven by capital placements, and as you know well, there is a quota system in China, so there are some systems remaining on the quota that can be placed.

There is a point at which you need a new quota to keep going.

So we can get some growth in the existing installed base, although to really accelerate quickly you need additional systems and that's something that Calvin can take you through a little later in the Q&A.

Sure, and just last thing is the China zero last quarter, zero this quarter.

Anything to read there?

Is it kind of a bolus effect into year-end?

And obviously the quota being the quota, but how do we think about that from a consistency perspective over time?

Thanks.

Yes, this is Marshall.

There is a process behind it.

The quota was provided a year and a half ago, two years ago, and there are 18 systems that remained on the quota, but there is a tender process that each of the hospitals have to undertake and the tender process is unpredictable in terms of when it will complete.

It turns out that they have been completing in boluses, as you suggested, but the fact that none were completed in the last -- or no systems were shipped in the last two quarters I don't necessarily believe is indicative of whether we will ship more or less in the next couple quarters.

So we will see how the tenders play out and we will see what we wind up with.

Great, thank you very much.

David Roman, Goldman Sachs.

Thank you and good afternoon, everybody.

I wanted just to start with the overall procedure volume environment, and understandably some of your comments, Patrick, regarding the sustainability of some of the mature procedures make sense.

But if I look at the overall procedure volumes in the quarter, they were flat sequentially.

I can't remember when in the third quarter you did not see a sequential decline, whether that was related to seasonality or some of the other factors that were influencing your business.

So could you maybe just talk about what's going on in the overall environment and whether what we are seeing now is the impact of sunsetting some of the concerns that surfaced a couple years ago, and maybe what maybe materialized in the third quarter that might have made for the outsized performance?

I will speak to a couple of things, and Patrick, you can jump in.

At the dVP level in the US, we really think that's the flow back into treatment of some folks who had sat out in watchful waiting and then had disease progression.

How long that persists is a little bit hard to predict, based on the changes in PSA diagnostics.

On the hysterectomy market, we are seeing a rotation of patients away from some of the lower-volume surgeons in general and into higher-volume and dedicated surgeons, so GYN oncologists.

That appears to be pretty durable.

I think that trend makes sense and I think that pivot is likely to continue.

We are a large part of the dVH market, and so I think the macro trend will go as the macro dVH market goes in the United States.

Are we putting on a preview tomorrow?

Can you send it to me, please?

Sorry about that.

Patrick.

The one thing to bear in mind is that for the past handful of years, the number of benign hysterectomies in total has been declining, and so that will continue to counterbalance the hysterectomy market.

So on the upside, I think we're in the beginnings of our experience in a lot of our markets.

In Europe, we are still in the meaty part of adoption in many of the countries that we are in.

We are really excited about what can happen in Asia in the various markets that we have talked about.

In general surgery, I think we're also more at the beginnings of some of the adoption that we see in colon, rectal, and hernia.

So I think as you think about the future, it is a little bit of the puts and takes there of how fast do mature markets moderate and how quickly do our emerging markets grow.

Okay, that's helpful.

And then, I just want to make sure I understand what you are saying explicitly about Japan for next year.

Obviously, you have the dVP reimbursing.

You talked about the society submitting on partial nephrectomy.

What are the next steps in gaining additional reimbursements in Japan and how will we -- how will that be disseminated?

Yes, so there are multiple conversations from multiple stakeholders in Japan.

Surgical societies pay a role, as well as government societies, in deciding what data is required and in what sequence they want to address those different procedures.

So from thoracic surgery to general surgery, things in the colon and others are -- and gynecology are of interest to Japanese surgeons and are in active discussion.

To get into the national reimbursement, there are a couple of different pathways.

We're in one of them called [senchinero b] for the process that we are in for partial nephrectomy.

The government has asked to see that data and is going to review it, so we are not guaranteed what and when, but it is part of the formal process.

Other ones are not yet in that formal process.

The government can choose to send it down a different reimbursement process.

If that happens, then -- and we have some assurance that is likely, then we will report that out to you.

So I think in terms of the near term in national coverage, partial nephrectomy is the one to keep your eye on.

I am not generally upset about progress.

I think that there is a fair amount of interest.

I think the conversations are active and it is just continuing to push forward.

Maybe lastly, Gary, as you reflect on the business and look at the progress that you have made over the past, call it, 18 months, can you put all the moving parts together where it is macro and one thing you had designated as the, quote, unintended consequence of the Affordable Care Act or economic pressures in Europe or the state of your business?

How would you just compare your view of the forward outlook today versus how you might have felt a year ago and your level of confidence?

You know, I think that we are seeing a lot of validation for our products in the hands of our customers.

I am pleased with the response from general surgeons, the level of engagement they have with the Company, the interest and satisfaction they have with the products, and their interest and demand for new and different things that I think we can provide.

In European markets, we have been investing in both capability of our own organization and getting closer to those customers.

Again, I think customer demand is really strong and that bodes really well for us.

I think we can do better in terms of some of our own team and processes and we're working on it.

I think that the Company is growing and is focused on those efforts and I expect to see greater capability in the next several quarters.

Okay, thank you for all the detail.

Bob Hopkins, Bank of America.

Thanks for taking the question and congrats on a really good quarter.

Two things, first I just want to start out for Marshall on the OpEx growth in the quarter.

It was one thing that surprised us.

It looks like the operating expense growth in Q3 was a lot lower than we would have thought, so I was just wondering if you could highlight that and it sounds like things will pick back up in Q4.

But is 7% to 8% still the right way to think about OpEx growth longer term?

And just, again, what happened in Q3 with the lower growth in OpEx?

Certainly for the rest of this year, Calvin has given you guidance in the lower end of the 7% to 10% range and more like the 7%.

But I think that we are focused on controlling costs and watching them carefully.

There are some costs that happen when they happen, and that includes prototypes in the engineering group and some of those didn't happen this quarter and will happen next quarter and so that's why you get some of this fluctuation between quarters.

But overall, I think we are managing to the bottom line.

Okay.

And then just back on -- Gary, back on Japan.

I just want to be clear on the message there because on the Q2 call, you talked about partial nephrectomy, but then also four additional procedures.

And it sounds like you are not as optimistic on those four additional procedures.

So I was wondering if you could just give some color on what has happened there.

And can we look to Japan as a source of real incremental procedure volume growth in 2016 or is that not the case, given what you are articulating here?

Yes, so I think in terms of partial nephrectomy, that is moving forward with a formal process into review for the national coverage.

The conversations and the work being done on other procedures is ongoing, but is not yet at that level of rigor for the 2016 review, and as a result, I don't think it's likely that they will be included in the 2016 book.

We are not ready yet to give you the 2016 procedure guidance, and we're working through that and rolling that up, and that's something we'll talk about in general in the next call.

You can anticipate that additional reimbursements accelerates this in Japan and lack of it will put more pressure on procedures, and that will be part of the conversation as we go through our forecasting.

And then, any quick update on Sp in terms of timing?

I heard the comments you made on the call here, but just what is the year where you think you can start to generate revenues from Sp?

Yes, we are making good progress in terms of our technology and customer evaluations of the product in the lab are encouraging.

Quite exciting.

In terms of when we expect real revenue, we are not ready to tell you yet exactly where the revenue launch will be.

We are definitely looking forward to human clinical interactions in 2016 and we will color that up more as we go forward in future calls.

Great, thanks for taking the questions.

Rick Wise, Stifel.

Let me start with hernia.

Gary, anecdotally talking to general surgeons about Xi adoption, it sounds like a lot of the folks we have talked to start with a ventral procedure because of the suturing benefits and then seem to move quickly to inguinal as they get comfortable.

Are you seeing that kind of progression, maybe to what extent, and is this process what is driving the solid hernia adoption?

You know, we see different pathways, actually.

As you talk to different general surgeons, I wouldn't characterize the one you have described as the most common or the only path that folks take.

It is certainly a path.

No doubt that ventral hernia is something that benefits from precise control, great visualization suturing, the ability to close the primary defect directly with suture, as well as supporting (technical difficulty).

So there are some advantages there.

As general surgeons get comfortable, then they start to explore other things that they can do with the tool, and sometimes it goes ventral, then inguinal, sometimes the reverse, and from there it can take them into more complex cases or cases where there is an acute cholecystectomy that they might want to try.

So there are different pathways that can happen.

I wouldn't characterize one as the only.

Okay.

And coming back to procedures one more time, I feel like I have to ask.

If I am looking at the numbers correctly, procedures, you've had a really strong year.

Procedure growth through the nine months, up 14%.

In the third quarter, up 15%.

And yet, Marshall, you're guiding us to -- if I'm understanding all these numbers correctly -- 13% to 14% for the year, which suggests a softer fourth quarter against a similar comp to the third quarter.

I think you grew 10% or so in both the third and fourth quarters last year.

Can you help us just understand your thinking?

And just given the mature procedures seem to be stable to improving and the growing stuff is still growing, what do we need to understand about the fourth quarter?

Yes, Rick, this is Calvin, and absolutely overall we are pleased with our procedure growth trends and this is actually the third quarter in a row that we have increased our guidance for procedures, and the revised procedure growth assumptions generally reflect a continuation of the trends we have seen through three quarters, with growth coming from US general surgery and international procedures, as I described.

In our updated view, 13% to 14%, it is -- it is lower than the 15% in Q3.

We're sitting at 14% on a year-to-date basis, and the fact is in Q4, the comps get more difficult for those mature categories, the dVPs in the United States and other mature categories, whereas Patrick described, I think, maintaining the rate that you saw in the first nine months will become more challenging in the fourth quarter.

Thanks very much.

Tycho Peterson, JPMorgan.

The first one may be a bit of a subtlety, but Gary, in your comments you talked more about the network effect and in the press release you commented on the technology ecosystem.

Can you maybe just elaborate on that a little bit?

Are you directing additional resources to software and informatics?

Do you have what you need?

Are customers asking for more?

We have over the last few years increased our capabilities in real-time software and guidance tools for the surgeon, as well as off-line informatics.

So that's not an immediate thing.

That has actually been a rising trend.

When you think about the ecosystem, stepping back as a whole, one of these products is the robot itself; the imaging system, sometimes with molecules like Firefly; instrumentation, everything from needle drivers to staplers and vessel sealers; training technologies like simulators and dual console; and then this other piece, which is informatics.

Informatics has been powerful for us.

At the surgeon level, it is what data can you give me in real time that helps the surgeon make a decision.

At the institutional level, it comes down to what kind of instruments are you using, how long are you on the systems, what does that look like relative to national norms.

And they have been interested in that data and we have been supplying that data now for over a year, and those conversations have been really healthy.

And I think it will only grow.

And then, I guess that's helping them figure out the cost side of the equation as well?

It lets them understand a couple of things.

It lets them model their costs really carefully and really get the value right.

The big thing in any of these conversations is total cost to treat, not price, and so that helps them really understand total cost to treat, and it is -- we've found it to be an extremely productive and rich conversation with the customer base.

So, they like that.

And it also gives them some sense of variation amongst different procedures and different surgeons, so they get a sense of how much variability they see within their institutions.

Okay, and then on margins, you talked about reengineering some of the newer products.

I know last quarter you talked a little bit about longer-term gross margins.

Should we expect to see an impact from some of the reengineering programs in the next couple quarters or how do we think about the potential there?

Marshall.

So, yes, we have talked about the fact that when we introduce new products, the margins are lower than mature products and lower than they will be ultimately once that product has been around for a while, both because we are able to drive down the cost of vendors through volume, as well as be able to redesign the products.

And, yes, we have undertaken some redesigns, as well as increasing volumes.

I think what we have said before is that those efforts are well underway.

We are happy with where they are going.

They won't drive a lot of benefit this quarter.

More of the benefit will be in 2016 and even more in 2017.

Okay, and then you had more operating leases this quarter.

Can you maybe just talk about that and your willingness to use that as a lever to place more system placements, in particular maybe outside the US?

You have more (multiple speakers)

Yes, I think what we're trying to do is to be flexible with our customers and our customers are looking for that flexibility, and once we get a system installed, obviously it drives procedures and instrument and accessory volume, so it is a win, win, win all the way around.

We did 13 this quarter.

We have 36 outstanding -- operating leases outstanding.

We're also doing capital leases.

We have a number of capital leases out there.

I think on the operating lease side, some of these have turned into purchases where the customers ultimately bought the product, and so it -- again, it feels like a real win situation for us to leverage our balance sheet and provide our customers' flexibility to get into robotics.

They have been generally satisfied with it and we have, too.

Okay, great.

And then just lastly on hernia, are you comfortable with the sustainability of the trends here for both ventral and inguinal?

I think on the -- on both sides, there are subsegments in those markets, and so getting the total available market in those is a little bit hard to forecast.

There are definitely segments in both where we think there is really good, long-term, sustainable value.

How big those segments become, I think it is going to be hard to predict.

We're just going to have to work through it.

Okay, thank you.

Tao Levy, Wedbush.

So first question, I was wondering if maybe you can explain if there is any difference between the excise Single-Site instruments and what is available with the Si.?

And I guess, again, I scratched my head as to why someone would want to use an Xi Single-Site and just -- for chole.

Yes, fair question.

So, in terms of functionally, they are functionally equivalent, so there are some small technical differences, but from in terms with a surgeon can do, they're pretty similar.

Xi offers a couple of advantages, having to do with the way the arms work.

But I think, for the most part, you can think of them as equivalent.

The reason people have an interest in them are a certain number of hospitals have really room in their program for a single robotic system.

If they want that mix to include Single-Site and they want to be able to upgrade to the Xi technology, this gives them that option, so for those one system sites that let them do the full portfolio of the things they want to do.

In terms of utilization of Firefly in chole, I think you mentioned about 40%.

What about in other areas, like colorectal surgeries?

Are you seeing any adoption of Firefly in those areas?

I will look to Patrick.

I don't have the numbers at my fingertips in terms of colorectal perfusion.

Yes, we have been seeing just use of the technology across a broad section of procedures and it has ramped nicely over time.

So just following up on that in my last question, at the ACS conference the Company talked a lot about imaging being one of the biggest areas of investment for the Company.

So maybe if you could expand on that a little bit.

What areas are you guys working on that is going to really improve patient outcomes specifically around imaging and the benefits that brings either the patients or surgeon comfort?

Yes, as we have spoken before, there are a few things that I think are coming together that can really benefit surgeons.

One of them is that sensor technology has been advancing rapidly around the world, having to do with technology development for other things, like cell phones.

We can take advantage of that for applications in surgical applications by developing sensors and products that are specific to what surgeons want to do and see.

That's one dimension.

The other dimension is to use other types of imaging modalities, sometimes other frequency bands, sometimes molecules, to allow surgeons to see things that are not visible with the naked eye, so highlight structures or highlight anatomical organisms that a surgeon wants to see during the surgery.

And that, since Firefly, is really a platform idea, not just a single molecule.

And so over time, we think there are things that we can bring to market that will allow surgeons to see more and to customize their vision for the -- a procedure they want to be in.

Is this five years out or two years away?

Some of them are long time frames and some of them are a little sooner, so it is really a mixture there, and not ready to go into detail with you on this call as to each of the sequences.

But the investments we have made in distal chip imaging, the step into Xi, is a set of investments that we think gives us a long runway in terms of the variety of endoscopes we can deliver and the kinds of technologies we can deliver on that platform.

Thank you.

David Lewis, Morgan Stanley.

Gary, just two quick questions.

I guess the first is we think it's pretty early to be getting excited about competitive systems that no one on earth has seen, to put it mildly.

But if you were to comment on one element at a high level, I wonder, and that's the theme emerging from some of these competitors one day is that they are talking about a smaller capital footprint, which seems to be lower-priced systems.

And, I guess, do you see lower-priced capital systems being more important going forward or can you continue to price to value and keep system ASPs high?

And a quick follow-up.

You know, I think on that first one, really that's a question that is going to be determined by the customer, and we understand the technology pretty well and have been thoughtful about it in terms of what we have developed.

As you refer to in your question, and I completely agree, it is about value, not price, and the question is, what are the outcomes that are going to be derived by these kinds of systems and what's the price point at which you can offer them?

We have a wide range from Xi down to Si-es and Si recerts, and that range is very large.

And what we find is that the majority of our customers buy capability.

I think in this last quarter you can look at what the Xi to Si exchange -- what that mix was.

We explore and we think about where are there other positions and price points that make sense.

Certainly we hear the same kinds of customer commentary that you hear and others hear, and I think the real question is not what you show on the show floor.

It's what do these systems do in surgery.

And that's going to come down to what can they deliver, what kind of outcomes can they deliver, and that's how we think about it.

Okay, very helpful.

And then just a follow-up on Tycho's on margins, so if I take commentary from you and Marshall the last couple of quarters, there is two data points that come out.

It feels like gross margins above 68% and EBIT margins above 40% are going to be challenging, but then based on this quarter, it's very clear you certainly have the ability to surpass those two margin objectives.

So, Gary, if I think about 68% gross and 40% margins, do these goal posts reflect the reality of the investments you're going to have to make the next several years or things about product mix or do they just simply reflect conservative outlook?

I am not quite sure I understood the question.

I think -- just stepping in, I will tell you what we care about and where we are headed.

I think that these technologies, they are -- as we said before, they are complex mixtures of robotics and imaging and instrumentation, and there is a certain amount of investment that is required to put them in position that they are cost effective for the Company and that gives us the opportunity to have them be cost effective for the customer.

Those are good things to invest in.

There is a point at which we believe we're early in the adoption of robotic surgery globally.

And so, some of the gross margin is around the cost to us and some of it is around price.

And what we want to be able to do is lower the cost point to us and that gives us flexibility with regard to the price point.

And so, that's what we are doing and that's what we are focused on.

Where it will go long term will depend a lot on, we think, both what we can do in terms of our supply chain and our design and where we think the customer value creation is.

But in the quarter, the two points that you are referencing were more a result of product mix and an alignment of positives that, as I said in my script, we don't expect to recur.

Okay, thank you very much.

Richard Newitter, Leerink Partners.

Thanks for taking the questions.

Marshall, maybe just a continuation of the last question on margins.

Can you give us just broad-strokes view the puts and takes that we should be thinking of going forward, even into next year, on the margin side and then -- gross margin, that is?

And then if you can just tell us or remind us how you guys view operating leverage materializing in the business model going forward?

From a margin perspective, there are a number of different influences.

One is product mix and the product -- the margins on I&A are greater than they are on systems, so to the extent that we have systems doing well or not doing well, then that will swing the margin.

We also have geographic mix where we sell in the United States in dollars, obviously.

We sell to our distributors at a discount to that.

We sell to -- in certain markets in foreign currencies, and depending on foreign exchange, that could have some impact on the amount of revenue that we have.

And then, we have expanding opportunities at -- in our newer products and those newer products happen to have lower margins.

And so to the extent that we are successful in, let's say, stapling and vessel sealing, it is a positive for the Company because you're taking greater share of wallet, but in terms of the gross margin percentage, it will push down the gross margin percentage because the margins on those products are not as high as our mature products.

So there is a number of different things that can affect gross margin.

As far as leverage, we manage the Company wisely.

We try to improve margins.

We have a number of programs, like we said, in place to reduce the cost of products, but we are also -- as Gary said, we are new in a lot of markets and we will expand -- we will sacrifice a point of margin for expansion of market.

The way we think about it is you have opportunities for scale and leverage in things like instruments and accessories, to some degree in imaging, and in mature procedures, the commercial part.

But you have opportunities for investment and that's in new products and cost reductions and new geographies, and we're balancing those two, so we think about both.

Great, and then just one last one.

Si-e sales looked like they were zero this quarter, first time since, I think, you launched that product.

Gary, can you just comment on what you are seeing in the marketplace as far as demand goes for the lower price point in the context of more complex and the systems like the Xi that you're launching and the steam that might be building behind that?

What does this mean, if anything, for demand trends for Si-e or the lower -- the low end of the spectrum?

We're happy to provide the customer a system that meets their needs as to where they want to go and how they do their robotics programs.

And I think the results speak for themselves.

I think that Xi is being well adopted.

I think as we finish the product set and complete the product set, that has made it more attractive to those who may be waiting for that completion.

We still sell Si refurbs and Si-es.

I think the difference between an Si-e and a four arm is value people see.

I think that while there are a lot of procedures you can do through arm, people really enjoy that or value that fourth arm, and so you see fewer Si-es.

I think it's simple as that.

Thank you.

Operator, we have time for just one more questioner, please.

Vijay Kumar, Evercore.

Thanks for squeezing me in and congrats on a nice quarter.

Maybe one on the margins here.

I know that you mentioned mix, right, and when you think about mix, you had a higher proportion of Xi.

And if I remember correctly, on the last call you said Xi, you are still scaling up, margins were low, but Xi was higher, but then offsetting that, you had a higher proportion of system sales coming in from the US.

So I am just trying to think how those two trade off and how they benefit your gross margins.

Calvin, go ahead.

Yes, I think this quarter specifically we benefited from the product mix in that there was a high proportion of the dual-console Xis.

And when you look at the product cost side, the extra surgeon console, that's the mature technology with the lower cost on that and you get the extra price to run through margin.

So, that helped us out.

As Marshall said, there were negligible inventory charges in the quarter and other costs -- other charges to cost of sales were pretty minor.

So a lot of things lined up pretty well for us in the fourth quarter -- or in the third quarter.

In the fourth quarter, we think it will probably revert to a more typical pattern in terms of the product mix and some of the other costs.

In a seasonally stronger capital quarter, if you have more system sales, those carry lower margins than the recurring revenue side.

And we will have more definitive comments about 2016 on the next call.

Great, and one follow-up.

Marshall, on cap allocation, just wondering what your priorities are.

Buyback was a little anemic in the quarter.

I was just wondering what the moving parts were.

Yes, there is no change in our philosophy.

We will continue to purchase shares at the right opportunity.

Keep in mind that the stock has been depressed over the last 30, 40 days, and yet that is a period in which we cannot be in the market because it is a blackout period for the Company.

And so, anyway, we will continue that philosophy, and you have seen us purchase -- repurchase over $2.5 billion worth of stock over the last couple of years and we think at the right prices.

That was helpful.

Thanks, guys.

That was our last question.

As we have said previously, while we focus on financial metrics such as revenues, profits, and cash flow during these conference calls, our organizational focus remains on helping surgeons increase patient value by improving surgical outcomes and reducing surgical trauma.

The following quote by Dr. Parekh, an experienced urologist at the University of Miami, sheds light on how our customers' view our systems.

Quote, the latest version of the da Vinci System Xi allows us to offer more minimally invasive surgical options to more patients.

Hard-to-reach tumors or those encompassing more than one organ can potentially now be approached with this more agile and visually enhanced device.

We have built our Company to take surgery beyond the limits of the human hand and I assure you that we remain committed to driving the vital few things that truly make a difference.

This concludes today's call.

We thank you for your participation and support on this extraordinary journey to improve surgery and we look forward to talking with you again in three months.

Thank you, and ladies and gentlemen, that does conclude your conference call for today.

We do thank you for your participation and for using AT&T's Executive Teleconference.

You may now disconnect.