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Intuitive Surgical, Inc. (NASDAQ:ISRG)

Q3 2013 Earnings Conference Call

October 17, 2013 04:30 pm ET

Executives

Calvin Darling – Senior Director, Finance

Gary S. Guthart – President and Chief Executive Officer

Marshall L. Mohr – Senior Vice President and Chief Financial Officer

Aleks Cukic – Vice President, Strategy

Analysts

Tycho W. Peterson – JPMorgan Securities LLC

Ben C. Andrew – William Blair & Co. LLC

Tao L. Levy – Wedbush Securities, Inc.

Amit Hazan – SunTrust Robinson Humphrey

Jonathan Demchick – Morgan Stanley & Co. LLC

Bob A. Hopkins – Bank of America Merrill Lynch

Operator

Ladies and gentlemen, thank you for standing by and welcome to the Intuitive Surgical Q3 2013 Earnings Release Conference Call. At this time, all participants are in listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) Also as a reminder, today’s teleconference is being recorded.

And at this time, I will turn the conference call over to our host, Senior Director of Finance for Intuitive Surgical, Mr. Calvin Darling. Please go ahead, sir.

Calvin Darling

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 Aleks Cukic, our Vice President of Strategic Planning.

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, included in our most recent Form 10-K filed on February 4, 2013, and our Form 10-Q filed on July 22, 2013.

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 has been posted to our website.

Today's format will consist of providing you with highlights of our third quarter's 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. Aleks will discuss marketing and clinical highlights, then I will provide an update to our financial forecast for 2013, and finally we will host a question-and-answer session.

With that, I’ll turn it over to Gary.

Gary S. Guthart

Thank you for joining us today. This quarter we continued to see significant pressure on our U.S. business. Trends that started in the first half of the year in gynecology have continued. On the procedure side underlying causes for slowing growth include weaker overall gynecologic admissions which is pressuring surgical volume. There are also lingering yield founded concerns regarding the benefits of da Vinci Surgery compared to the available surgical alternatives.

Since we’re a significant share of hysterectomy, our growth rate is sensitive to these issues. This slow growth has resulted in capacity in our U.S. installed base combined with changes in hospital capital spending associated with the implementation of the Affordable Care Act, U.S. capital sales fell substantially compared to prior year. Overall procedure trends in the quarter were stable rising 16% over prior year.

In the United States general surgery was our fastest growing segment led by Single-Site cholecystectomy and followed by growth in colon and rectal resections. Our gynecology business still grew year-over-year, but at a slower pace than prior quarters and urologic procedures in the U.S. were stable compared to prior year.

In Europe, we are continuing our investments in market access in clinical research. We are seeing early positive results in HTA and reimbursement analysis as a consequence of these efforts. Year-over-year procedure growth accelerated led by urology and early growth in malignant gynecology. Growth was strongest in U.K., France, Italy and the Nordic countries. Procedure growth in Asia was solid off a small base led by growth in urology and general surgery.

With regard to resolution of our FDA warning letter, we are making good progress in addressing the elements of the letter and the Form 43 that preceded it. As part of our work in responding to the letter, we expect to file corrections and updates to our labeling and to file documentation for some past field actions. These activities will be documented on FDA’s websites over the next several weeks.

Turning to our operating performance for the third quarter; procedures grew approximately 16% over the third quarter of 2012. We sold 101 da Vinci Surgical Systems, down from 155 during the third quarter of last year. Total revenue was $499 million, down 7% from last year. Instrument and accessory revenue was $239 million, up 10% over Q3 2012.

Total recurring revenue grew to $341 million, up 11% from prior year and comprising 68% of total revenue. Net income was $157 million, down 14% over last year, and we generated an operating profit of $225 million before non-cash stock option expense, down 13% from the third quarter of last year and representing 45% of Q3 revenue.

We ended the quarter with $2,532 million in cash and investments, down $495 million from last quarter. In the quarter, we generated $204 million in gross cash flow from operations, and we repurchased $694 million of our stock.

Our new products continue to gain acceptance with customers. We expanded our stapling rollout at a measured pace through the first three quarters of this year. Surgeons’ clinical feedback on the Stapler has been strong, and our stapling operations debt has increased substantially. We will accelerate the stapling launch in Q4 and beyond.

This quarter, we received FDA clearance for an expanded indication of our Firefly system to include biliary imaging in combination with normal white light imaging during cholecystectomy. This is another step in providing surgeons with imaging capability that enables them to see anatomical structure beyond what can be seen with the naked eye.

Our Single-Site product line continues to perform well. Single-Site cholecystectomy is moving out of early adopting centers into the broader clinical practice. Single-Site for hysterectomy progressed during the quarter while on limited release. As part of this limited release, customers have requested an additional instrument, a wrist needle driver to complement the product line.

We have designed it, are testing it, and planning to submit an application in early Q1 to the U.S. FDA for 510(k) clearance. We believe the addition of the wrist to Single-Site instruments will optimize the procedure for surgeons who expect EndoWrist functionality. Our Single-Site products are well positioned to deliver increased patient satisfaction with reasonable economics for single incision surgery.

We have great confidence in the safety, efficacy, and cost effectiveness of our products, and we remain deeply positive on the value da Vinci brings to surgery now and in the future. The benefit da Vinci brings as an alternative to open surgery has been demonstrated in hundreds of independent peer-reviewed clinical papers. Increasingly well designed cost studies demonstrate that upfront in operating investments in da Vinci surgery are offset by downstream savings resulting from fewer complications, readmissions, and length of stay.

We recently updated intuitivesurgical.com with links to high level of evidenced clinical data and adverse event data, and in the next few days, we’ll add abstracts of well-designed, peer-reviewed cost studies comparing da Vinci surgery to open surgery alternatives. We encourage a full and careful examination of the literature by anyone interested in the facts about da Vinci use.

In summary, we continue to see substantial long-term opportunity to fundamentally improve surgery using our technologies, and we are focused on the following. First, educating the surgical community on the facts about da Vinci surgery including its safety, efficacy, and cost of effectiveness; next building da Vinci capability and supporting it’s use in general surgery.

Extending the benefits of minimally invasive surgery using da Vinci in gynecology and urology worldwide, and disciplined execution and expanding our stapling and Single-Site adoption.

I will now pass the time over to Marshall, our Chief Financial Officer.

Marshall L. Mohr

Thank you, Gary. Our third quarter 2013 revenue was $499 million, down 7% compared with $538 million to the third quarter of 2012, and down 14% from last quarter. Third quarter revenues by product category were as follows; third quarter instrument and accessory revenue was $239 million, up 10% compared with $218 million for the third quarter of 2012 and down 10% compared with the second quarter of 2013. The year-over-year increase in instrument and accessory revenue was driven by procedure growth of approximately 16%.

Sales of new products, including Single-Site, Vessel Sealer, and Firefly, partially offset by lower instrument and accessory stocking orders associated with fewer system sales and the timing of customer orders. The sequential decrease in instrument and accessory revenue was driven by lower instrument and accessory stocking orders and the timing of customer orders.

The 16% increase in da Vinci procedures for the quarter reflected growth in general surgery and gynecology procedures in the U.S. and urology procedures outside of the U.S. The lower third quarter growth rate reflects slower growth in U.S. benign gynecologic procedures and flat U.S. DVP volumes.

Factors effecting U.S. benign gynecologic procedures include reduced hospital admissions, a trend by payers toward encouraging conservative disease management and treatment in out-patient settings and negative media reports. Instrument and accessory revenue realized per procedure including initial stocking orders was approximately $1,860 per procedure compared to $1,980 per procedure in the third quarter of 2012, and $2,020 last quarter.

Our third quarter 2013 revenue per procedure reflected fewer stocking orders associated with fewer system sales and the timing of customer orders. Third quarter 2013 systems revenue of $159 million decreased 32% compared with $232 million for the third quarter of 2012 and decreased 27% compared with $216 million last quarter.

Overall, we sold 101 systems in the third quarter of 2013 compared with 155 systems last year and 143 systems last quarter. We sold 65 systems into the U.S. market in the third quarter of 2013 compared with 114 systems last year and 90 systems last quarter. The lower third quarter 2013 U.S. system sales reflected among other things the impacts of moderating growth in U.S. benign gynecologic procedures, increased economic pressure on hospitals, uncertainty related to and spending associated with the Affordable Care Act, and negative media reports.

During the third quarter of 2013, we sold 36 systems in the international market, including 17 into Europe and 13 into Japan, compared with 41 into international markets in the third quarter of 2012, which included 13 into Europe and 16 into Japan and 53 systems into international markets in the second quarter of 2013, which included 21 into Europe and 20 into Japan.

Our third quarter average sales price per system was $1.56 million, compared with $1.48 million realized in the third quarter of 2012 and the $1.5 million realized last quarter. ASPs include all da Vinci models, all simulators in Firefly when configured with the system and exclude upgrades.

Our higher third quarter 2013 ASPs were driven by a higher proportion of dual console configurations and geographic sales mix. 29 of our third quarter 2013 systems involved trade-ins compared with 34 trade-ins last year and 43 trade-ins last quarter.

Service revenue increased to $101 million, up 16% compared with $88 million last year and up 3% compared with $98 million last quarter. The growth in service revenue was driven by larger system installed base.

International revenue results were as follows; third quarter revenue outside the U.S. was $133 million, up 15% compared with revenue of $115 million in the third quarter of last year and down 16% compared with revenue of $158 million last quarter. Our higher year-over-year international revenue was driven by higher recurring instrument, accessory, and service revenue, partially offset by lower system sales. Our lower sequential international revenue primarily reflects summer seasonality.

Third quarter 2013 international procedure volume was approximately 25% higher than the third quarter of 2012 and 6% lower than the second quarter of this year. The growth over the prior year reflects DVP growth in Europe and Japan. The decrease compared to last quarter reflects summer seasonality patterns in Europe.

Moving onto the remainder of the P&L. Gross margin in the third quarter of 2013 was 71.5% compared with 72.5% for the third quarter of 2012 and 70% for the second quarter of 2013. Our lower margin percentage compared to the third quarter of last year resulted primarily from the impact of the medical device excise tax or higher gross margin percentage compared to last quarter was driven primarily by higher system ASPs.

Third quarter 2013 operating expenses of $183 million were up 2% compared with last year and down 2% compared with last quarter. Our higher year-over-year operating expense was driven by headcount additions, partially offset by lower incentive compensation, and lower R&D prototype expenses, a decrease compared to last quarter was driven by lower incentive compensation, partially offset by stock compensation expenses.

Third quarter 2013 operating income was $174 million or 35% of sales compared to $211 million or 39% of sales last year and $219 million or 38% of sales last quarter. Third quarter 2013 operating income included $50 million of non-cash stock compensation expense compared with $47 million last year and $39 million last quarter. The increase in stock compensation expense relative to the prior quarter has to do with the timing of stock option grants in the related testing periods.

Our effective tax rate for the third quarter was 12% compared with 15% for the third quarter of 2012 and 28.6% in last quarter. Both the third quarter of 2013 and the third quarter of 2012 tax rates benefited from the release of reserves specific to tax year where the statutory limitations have now expired. Excluding one-time benefits, our third quarter 2013 tax provision would have been approximately $26 million higher and our third quarter 2012 tax provision would have been approximately $35 million higher.

Our net income was $157 million or $3.99 per share compared with $183 million or $4.46 per share for the third quarter of 2012 and $159 million or $3.90 per share for the second quarter of 2013. Excluding the one-time tax benefits, our third quarter 2013 net income would have been $131 million or $3.32 per share and our third quarter 2012 net income would have been $148 million or $3.61 per share.

Now moving to cash flows; we ended the third quarter with cash and investments of $2.5 billion, down $495 million compared with June 30, 2013. The decrease was driven by $694 million used to repurchase our common stock and $34 million of capital and IP acquisitions, partially offset by $204 million in cash flow generated from operations.

During the third quarter we bought back approximately 1.74 million shares at an average price of $399 dollars per share. We ended the quarter with approximately $1 billion authorized by the Board for future share buybacks.

And with that, I would like to turn it over to Aleks who will go over our sales, marketing and clinical highlights.

Aleks Cukic

Thank you Marshall. During the third quarter, we sold 101 da Vinci systems; 65 in the United States, 17 into Europe and 19 in rest of world markets. As part of the 101 system sales, five standard da Vinci systems and 24 da Vinci S systems were traded in for credit against sales for new da Vinci Si systems. We finished the quarter with a net 72 system additions to the installed base, bringing to 2,871 the cumulative number of da Vinci systems worldwide; 2,042 in the U.S., 455 in Europe and 374 in rest of world markets.

48 of the 101 systems installed during the quarter represented repeat system sales to existing customers. In total, 100 of the 101 systems sold represented da Vinci Si or Si-e systems, which included 32 dual consoles. The 36 system sales internationally included 13 into Japan and six into France.

Clinically, Q3 year-over-year procedure growth was approximately 16%, which was led by the category of general surgery and paced by cholecystectomy, followed by colon rectal resections, and bariatric procedures. Our U.S. urology business was stable, while growth in the international urology business was solid.

As expected, the growth rate in the U.S. for benign dVH was slightly down from Q2, which continued to place pressure on U.S. system sales. Demand for recently released new products continues to be strong. Through Q3, 2013, we sold Single-Site instruments and accessory kits to approximately 825 U.S. customers. Our Vessel Sealer product utilization trend continues to strengthen with most of the interest coming from the specialties of colorectal, advanced general and GYN surgery.

The customer adoption for both da Vinci Simulator and Firefly continues to expand, with 63 customers purchasing a da Vinci Simulator and 48 customers purchasing Firefly systems, as part of their initial system purchases this quarter.

In addition, we've expanded our phased rollout of both the da Vinci surgical stapling system and Single-Site hysterectomy products to several new sites. These rollouts will be expanded in a measured fashion, so we do not expect them to contribute materially in the near term.

During the quarter, several 100 robotic abstracts and papers, representing a variety of surgical specialties were published within peer-reviewed journals, many focused specifically on safety and/or efficacy. Clinical conferences also produced several live da Vinci procedure transmissions, postgraduate robotic courses, podium presentations and clinical poster sessions, several with emphasis on safety and/or efficacy.

I’ll take a moment to summarize a few. da Vinci hysterectomy is the single largest procedure that our customers perform. It is widely accepted that when compared to open hysterectomy the benefits provided to a patient through an MIS approach are significant. As the data supports, the rapid conversion to open hysterectomy to a minimally invasive approach continues to be led by da Vinci’s incorporation in to GYN practices.

In a recent addition of the journal of the Society of Laparoendoscopic Surgery, a group out of the Department of Obstetrics and Gynecology at Yale University, published a study entitled Robotic versus Abdominal Hysterectomy in Women with very large uteri. The study compared the results of 60 hysterectomies, 30 abdominal, and 30 dVHs in patients with uteri greater than 1,000 grams in weight.

It is generally understood that the larger the uterus the more complex the surgery. Often necessitating an abdominal hysterectomy, and the statical scale uteri in excess of 1,000 grams are considered very large. The uteri in both cohorts study ranged in size from between 1,000 grams to just over 3,500 grams. The published results were as follows: median length of hospitalization for patients in the da Vinci cohort was one day with a range from one to two days as compared to 2.5 days with a range from two to nine days for patients in the abdominal cohorts.

Estimated blood loss was 150 milliliter for the da Vinci patients versus 425 milliliters to the abdominal approach. Transfusion rates for the da Vinci cohort was 3.3% versus 13.3% with the abdominal approach. Conversion rates from da Vinci hysterectomy to an abdominal surgery was zero, as with the hernias.

In their commentary, the authors pointed out the following findings. First, hysterectomy is for very large uteri are challenging procedures. Second, obesity and morbid obesity and/or previous surgeries compound the difficulty. Despite these challenges patients who are obese experience some of the greatest differential benefits for minimally invasive surgery. Finally, morbid obesity and/or previous procedures appear to not be an impediment for completing these procedures robotically.

Within general surgery procedures related to the colon and rectal disease management have been among our most promising. Right and left co-intersections, sigma intersections, low anterior resection and rectopexy continue to exhibit solid growth. With the exception of right hemicolectomy and rectopexy, laparoscopic penetration has been modest with inter colon rectal surgery.

Rectopexy is a procedure designed to address pelvic floor disorders or PFDs. Among other things, PFDs obstruct the patient’s ability to defecate. A recent French study compared the results of patients undergoing a laparoscopic rectopexy versus a da Vinci rectopexy. 118 patients were evaluated in the study, 44 da Vinci as compared to 74 laps. The study evaluated OR time, blood life, complications, length of hospitalization and postoperative ODS scores for obstructed defecation syndrome.

Regarding total OR time which included system time, the da Vinci rectopexy took approximately 15% longer than the laparoscopic approach, but the authors noted that their times came down over their last 20 patient and were expected to continue to trend down.

Blood loss was difficult to even to test during the da Vinci rectopexy and measured only 8 milliliters as compared to 42 milliliters in the lap cohorts. Complications with the da Vinci approach were 2% as compared to 11% in the lap patients. Hospitalization was reduced by a full day when using da Vinci with the authors attributed to less strenuous tissue manipulation due to improved vision and dexterity.

Post op ODS scores improved for patients in both groups. However the difference in improvement for patients in the da Vinci cohort was substantial in being statically significant. In their conclusions the author stated and I quote, ‘although not a randomized comparison this study shows that ventral mesh rectopexy performed by robots was followed by better functions than lap rectopexy’. Da Vinci thoracic procedures specifically lobectomy and segmental resection has been steadily expanding over the past few years. Similar to colon and rectal surgery, the presence of minimally invasive resections has been minor as compared to open surgery.

In a recent edition of the Annals of Thoracic Surgery, physician and healthcare economists from both Harvard Medical School and Cornell Medical Center collaborated on the study which compared open surgery, video assisted thoracoscopic or VAS and da Vinci resections.

The study evaluated the results of over 33,000 patients who have received pulmonary resection within the eight stage study cohort. While the mix of patients was dominated by patients undergoing an open resection, the rate of growth for da Vinci surgery was significant over the three year study period. Da Vinci expanded from 0.2 of the pulmonary resection studied in the first year to 3.4 by the third year, numbering 430 in total.

da Vinci procedures were performed in all stages of study with 38 being performed in community hospitals. The results in a propensity matched analysis da Vinci resections were associated with significant reductions in mortality, 0.2% versus 2.0% for open surgery. Length of stay was 5.9 days for the da Vinci patients versus 8.2 days for the open surgery.

Overall complication rate was 43.8% for da Vinci versus 54.1% for open surgery. These improvements were all considered statistically significant and propensity matched analysis versus path. da Vinci lumpectomy demonstrated directional improvements in mortality and length of stay.

In their summary, the authors wrote, and I quote, ‘case volume for pulmonary resections have increased significantly during the study period of thoracic surgeon, and thoracic surgeons have been able to adopt the robotic approach safely. Robotic resection appears to be an appropriate alternative to that and is associated with improved outcomes compared with open thoracotomy.’

This concludes my remarks and I will now turn the time over to Calvin.

Calvin Darling

Thank you, Aleks. I will be providing you with an update to our financial forecast for 2013 on a GAAP basis. I will also provide estimates of significant non-cash expenses.

Starting with procedures, on our last call, we projected our full year 2013 procedures to grow between 15% and 18%, above the base of approximately 450,000 procedures performed in 2012. Now, with one quarter remaining in 2013 we are refining our estimate for full year 2013 procedure growth to a range of between 16% and 17%.

Moving to revenues, as has been discussed several factors are pressuring our business, making it difficult to predict system sales volumes. On our last call, we projected full year 2013 revenue to range from approximately flat to 7% growth. We now expect full year revenue growth in the lower half of that range.

Turning to operating income; on our last call, we forecasted operating income to fall within a range of between 37% and 38% of net revenue. We are taking steps to scale back our expenses while not comprising our longer term expansion strategies. We continue to anticipate full year 2013 operating income to fall within the range of between 37% and 38% of revenue.

Now, with regard to non-cash stock compensation expenses; we are refining our forecast to between $169 million and $172 million for the year. We expect other income, which is comprised mostly of interest income to total between $16 million and $17 million in 2013.

With regard to income tax, as Marshall described, our Q3 tax rate benefited from non-recurring discrete events. For Q4 2013 we’d expect our tax rate to be approximately 28% of pre-tax income, slightly lower than previously forecast, primarily due to the geographic mix of our pre-tax income.

Our share count for calculating EPS in Q3 2013 was approximately 39.3 million shares, declining 1.5 million shares in the quarter primarily due to buyback activities. In Q4 we expect our share count to decline approximately 600,000 shares further based upon the full quarter impact of our Q3 buybacks. The actual Q4 share count will depend on several factors, including the magnitude and timing of additional share buybacks if any.

That concludes our prepared remarks. We will now open the call to your questions.

Question-and-Answer Session

Operator

Thank you very much. (Operator Instructions) Our first question will come from Tycho Peterson with JPMorgan. Please go ahead.

Tycho W. Peterson – JPMorgan Securities LLC

Hey, thanks for taking the question. I guess, first of all, just kind of given the change of procedures in ACA uncertainty, can you just talk about whether we should be assuming that there will be U.S. placements only if system utilization continues to increase sequentially, and how are you thinking about where system utilization could ultimately go in the next couple of years?

Calvin Darling

So, I think in the near-term the factors that place new systems will be a few as you know. So one of them is procedure growth, one of them is access to technologies for folks who have older technology, and then last one is point-of-care where in the hospital they want to use the devices, and by far the biggest driver of those three is the procedure side. So I think utilization over time, I think people are going to look at it and look as capital owners to drive it up. It can be lumpy though. I don’t know that it has to progress linearly in terms of increases. As I said before, if you have an S platform and you want to have access to stapling that requires an Si, that they can make changes as we go through.

Tycho W. Peterson – JPMorgan Securities LLC

And then on Japan, given that you’re not likely to have reimbursement for additional procedures until 2016, could you maybe just talk about how you think about the trend there, is there going to be kind of a pause in investments beyond this initial round of placements in [indiscernible] procedures?

Calvin Darling

I think, in terms of the process for reimbursement, just so everybody knows that there will be a set of clinical data collection that’s going on out there and that will involve some hospitals getting limited approval from the government to collect that data, so we’ll see that. I think that capital sales by the broad market will be really lumpy in this period. I think it will be very hard to predict accurately what the sales profile will look like as people go through that set of clinical data and trial data. I think the commentary from the Japanese market as to their interest is strong.

Tycho W. Peterson – JPMorgan Securities LLC

Okay. And then one last one for Marshall, just quickly on inventories $200 million, can you just comment on why they were that high?

Marshall L. Mohr

So we run on – we have lead times that we provide to our suppliers, particularly the system itself, and we obviously didn’t sell the number of systems we had anticipated until [indiscernible]. We are still taking that inventory and we don’t think there is any exposure there. We’re talking about Si, and Si is a very capable unit and capable of doing all of the surgeries we see in our near-term future.

Tycho W. Peterson – JPMorgan Securities LLC

Okay. Thank you.

Operator

Thank you. Our next question in queue will come from Ben Andrew with William Blair. Please go ahead.

Ben C. Andrew – William Blair & Co. LLC

Good afternoon. Maybe Gary talk a bit about any shift in the spending plans that Calvin referred to, and if you can give us a little bit of detail on that and over what time frame we might see that pullback?

Calvin Darling

I think there are some things that makes sense in the next quarter or two in terms of spending, something that just scale with production volume and things like that that make a lot of sense. The other side is being careful in prioritizing the investments that we make, both in terms of prototype spending and in terms of expansion plans. We have a pretty clear set of priorities in terms of the kinds of products and the markets we want to invest in. We will not short those, but for things that are perhaps a little further out or a little bit more on the edges, then we’ll be careful about where we put our investment.

Ben C. Andrew – William Blair & Co. LLC

Okay. And then on the clinical side, what sort of role do you have in data collection for things like complications and other clinical data sets relative to procedures like Chole where there is an opportunity to maybe transform the space further with a strong registry set or clinical study, and is that a material kind of investment for you all at this point?

Gary S. Guthart

We do have programs where we invest in clinical research. We also invest in things like supporting registries. Also we’ll go out and provide materials and access to training and other types of resources to allow people to design trials, so we perform that way. We also fund fellowship training. We also fund residency training in different places. So we have a set of things that we do. There are institutions that will look for our health, and there are institutions who want to do things at arms length and that make sense too. So there is a combination of all of those things.

I think the areas of study are diverse from very large population studies that occur in more mature procedures to smaller cohorts that are direct comparisons across one or two centers for things that are emerging, so as you think about cholecystectomy and use of Single-Site and things like Firefly Imaging, you’ll see the smaller cohort study start and those will get bigger as time goes on.

Ben C. Andrew – William Blair & Co. LLC

Okay. And then finally for me, in terms of the pipeline for system sales in the quarter, did you see a shift in terms of how people characterize them as a delay or cancellation or any other trends there? Thank you.

Gary S. Guthart

Well, that’s pretty similar to last quarter. We had a number of systems that – where we got the approvals that we’re accustomed to, but then at the end, we couldn’t get the CEO or CFO and there was a hesitation there on the basis of their own concerns, uncertainties, I should say their own uncertainties around spending capital. And then of course, there’s some capital spending that’s required under the ACA for IT and so forth. And so, I think those are also capturing a greater part of the pie than we’re used to. But I don’t know that there was anything in particular I would point out.

Operator

Thank you. Our next question in queue will come from the line of Tao Levy with Wedbush. Please go ahead.

Tao L. Levy – Wedbush Securities, Inc.

Good afternoon. So one of the questions I had was just jumping on what Dan had just asked, is there anything that you are doing differently now on the activities or investments that you weren’t doing previously just to address some of the challenges that have cropped up over the last few quarters?

Gary S. Guthart

No, I think the things that are – perhaps front and center is making sure that people have access to all the data that’s out there. There is an enormous amount of published literature on da Vinci. People looking for proof points can absolutely find them. I think the total publication database now is greater than 5,000 peer-review general articles on da Vinci. The number of Level 2 evidence and above, high level evidence is greater than 200. The issue was not a dearth of clinical data. There are cost studies, we’ll be posting them on links to them on the web. I mean, there is a fair amount out there. What we can do better is make sure people know it and see it and are able to digest it, so we’ve been doing that kind of activity.

We’ve talked about both in Japan and in Europe. The economic analysis that needs to be done with regard to reimbursement from government payers is work that we can do and we’re having success in that work. The data is out there, the analysis can be done and so we’re making those kinds of investments, and so we’ve been scaling.

Tao L. Levy – Wedbush Securities, Inc.

Okay. And if you can maybe comment on sort of how we should think about prices per procedure over the near-term until, I guess, systems start to recover? Is it here sort of in the 1850, 1860?

Gary S. Guthart

I’ll let Calvin go into the modeling and the mix, but before he does just I have a comment. I think there are a couple of things going on. On the things like Single-Site and some of the benign procedures that are more cost-sensitive, we have offerings that reflect that greater cost sensitivity, and we’re happy to provide them. I think that they make sense and they fit the procedure profile.

And at the other end, on the more complex procedures, the cancers, some of the more reconstructive procedures, we have a set of products that carry higher ASPs, Stapler, and Vessel Sealer, and alike. And so, I’ll let Calvin go through the modeling dynamics for you, but those are the push and pull of this kind of conversation.

Calvin Darling

Great. And as Marshall described on the call, the Q3, the lower revenue per procedure in Q3 specifically was driven by lower stocking orders associated with the lower system sales in Q3 as well as timing of orders. We saw hospitals reducing inventory levels in the quarter as well.

Longer term, Gary was mentioning, the initial sales have an increased utilization of Vessel Sealer product, Firefly, and Stapler will help us garner a larger portion of the overall procedure revenue and serve to bolster our revenue per procedure, but then offsetting that would be diminishing impacts of stocking orders as well as procedure mix as we move deeper into benign procedures, and they become a larger portion of our overall business. It’s likely in the much longer term that this procedure mix could serve to trend the overall revenue per procedure down.

Tao L. Levy – Wedbush Securities, Inc.

So should we keep it in sort of at this 1860 level or higher?

Calvin Darling

Yes, and there are a lot of factors. I think there were some specific factors that impacted Q3 that will be pretty relevant now as you look at Q4 and next year and some of these other things are longer term.

Tao L. Levy – Wedbush Securities, Inc.

Okay. So can I just ask last question. And procedure trends in the quarter, it seems like September might have been particularly strong for you guys on a worldwide basis. Is that the case for September year-over-year was pretty much the same?

Gary S. Guthart

Generally speaking, you see people coming back from vacations globally in September and so the seasonality there is such that September is stronger than the prior months and we do expect that. And then the other piece is that as our business has a greater share of benign surgeries in it over time, those tend to be more subject to seasonality. So the mix is becoming a more seasonal mix, relative to prior years and so you see that bulk of those effects kind of compound.

Tao L. Levy – Wedbush Securities, Inc.

Thanks.

Operator

Thank you. Our next question in queue will come from David Roman with Goldman Sachs. Please go ahead.

Unidentified Analyst

Hi, guys. This is Chris in for David. Can you hear me okay?

Gary S. Guthart

Yes.

Unidentified Analyst

Wonderful. Thank you for taking the questions. First question, I feel like historically the monitor has always been that that procedure growth tries just in utilization. But at this point it feels like the rate of change and the delta per procedure is a lot slower than what’s happening at the system level and that’s kind of given rise to this over capacity debate a little bit and I’m little bit curious about how your visibility and given the revised guidance, where the confidence is coming from and the revised outlook on systems growth, what has changed in the conversations with the administrators for some of the pipeline accounts that makes you feel that these guys are still on the pipeline that they won’t push out, their decision making in another six months, nine months or 12 months and maybe you could share a couple of other anecdotes of specific conversations that are happening to get, let’s have a better feel for it?

Gary S. Guthart

I’ll answer the last part first. On the system side, I think that we’ve given you a pretty broad range for the results for Q4, and Calvin even said this in his script, that reflects uncertainty as to how capital will close. And so I don’t think we exited any particular confidence on what will happen in Q4 relative to Q3.

Our visibility to procedures is better. It is imperfect, but it is better than into capital purchasing decisions, particularly in the U.S. where you’re seeing some market dynamic changes. And so, we’ve given you a broad range and the reason for that broad range is it’s hard to predict how hospital administration will make some of their decisions. And right now some of the anecdotes are that hospital administrators are trying to project what their revenues will look like as the elements of the ACA get implemented and that revenue uncertainty on their side just flows through into the capital decision making uncertainty and down the line.

Unidentified Analyst

Great. That’s very helpful. Thank you. And if I could have a follow-up here, I’m curious I noted there is a lot of work being done on the share repurchase side, but given the significant amount of cash that you guys have in the financial flexibility, is there any reason that you wouldn’t be able to up the R&D spending and really focus on addressing some of the concerns that have been out in the media and some of the major bodies recently to help, address some of the perception issues that seem to kind of keep coming up and potentially could be impacting some of the near-term system placement sales. And I feel like with the financial flexibility that more repurchases could also up that level of spending. Is that something that is on the table or has been considered or not?

Gary S. Guthart

There’s a couple of things wrapped together there, just kind of teasing them apart. With regard to the R&D spend side, we’re thoughtful and serious about our R&D priorities and the spending that goes with it. We listen really carefully to surgeons and hospital customers about what we think they need and what they think they need to make for both great surgery and surgery whose economics make sense for all the players. And so that’s the product enrollment pipeline and something that we do continuously.

With regard to R&D being the solution to some of the concerns in the press, I’d encourage you to go, look at our website, look at the data. Safety profile of da Vinci is outstanding when it’s compared with the surgical alternatives that people have. So I think on that side that’s not really an R&D investment sort of issue. With regard to the use of cash and buybacks and how we think about that alternates, Marshall?

Marshall L. Mohr

We look for opportunities or discontinuities in the share price relative to the market and we did some buybacks this last quarter. It’s really a Board decision. We’ll be having those discussions on an ongoing basis with the Board and you’ll see what comes out of it.

Unidentified Analyst

All right, great, very helpful. Thank you, guys.

Operator

Thank you. Our next question in queue will come from Amit Hazan with Sun Trust. Please go ahead.

Amit Hazan – SunTrust Robinson Humphrey

Thanks very much. Good afternoon guys. I thought may be I’d ask the first question about existing versus new customers, just regarding the U.S. system side if you can distinguish between existing customers adding capacity and then new customers. I think if we think about last quarter you seem to be saying that most of the weakness came from existing customers you choose to differ. It seems like that’s the case again here. What has been happening more on the new customer side, new customer additions and the trend line there?

Marshall L. Mohr

All right. So just to kind of review the numbers that was mentioned there were 65 total system sales in the third quarter, 22 of them went to brand new customers, Greenfield as we call them and 43 were to existing customers. So and then let’s see, 24 involved trade-ins, so that means 19 added systems for capacity reasons in the quarter.

So I think when you look at the capital environment, we talked about the issuing and I believe that the issue is described whether it’d be capacity from the decreasing growth in benign hysterectomy or the various macro issues including the ACA. I think they really impacted all of these categories.

Amit Hazan – SunTrust Robinson Humphrey

Okay. And then moving on to the procedure side, I want to address the question, so it’s very clear, I think you might have touched on it, but if we go through the U.S. benign hysterectomy side and think about how to model it for the next several quarters and how you saw this quarter versus last quarter. Is the impact that you are seeing there and obviously I am referring to the developments earlier in the year more than anything. Has it gotten, did it get worse this quarter or was it something that you saw as stable versus last quarter?

Gary S. Guthart

As we mentioned in the script, I think it’s following a pretty normal trajectory or trend from what we introduced in Q2 and in Q3, the Q1, Q2, Q3. So it was pretty stable and I would say, seasonally stable going into a Q3. So not much of a change between the two course.

Amit Hazan – SunTrust Robinson Humphrey

Great. And then just the last one from me; in terms of the impact from that same noise on other procedure categories; urology or general surgery in the U.S., do you feel at all that hospitals has applied more scrutiny to those as well because of the noise factor coming out of the first half of this year?

Gary S. Guthart

That’s an interesting question Amit. You really have to tease it apart and you have to take a look at the underlying condition, the surgical specialty itself, the alternative opportunity, the alternative treatment. In other words, when you are looking at urology and you are talking about kidney cancer, bladder cancer, prostate cancer. I think it’s safe to say that, you are more immune to some of these sort of allegations that people are throwing out in the media than you are versus let’s say a benign procedure that has some benign therapies and they will high line cost and some incorrect comparators. And so I would say that the majority of that noise that we have heard and have felt is probably been in the benign GYN ide, more than anything else we have seen thus far. And I think that continues.

Amit Hazan – SunTrust Robinson Humphrey

Okay. Thanks guys.

Operator

Thank you. Our next question in queue will come from David Lewis with Morgan Stanley. Please go ahead.

Jonathan Demchick – Morgan Stanley & Co. LLC

Hello, this is actually Jon Demchick in for David. Thanks for taking the questions. A quick question on I guess a few pipeline products for you guys; starting with Single-Site, had a question about having restricted capabilities, you mentioned I guess the Needle Driver that should be submitted for 510(k) approval next year, where there plans to expand the restricted capabilities across other aspects of the Single-Site platform like what are the main obstacles in doing this and what impact do you believe that this could have on broader adoption?

Aleks Cukic

I think the first question is limited to Needle Driver, can it be good taking more broadly. I think that the Needle Driver is clearly the first one to go with, with regard to Single-Site and applied to hysterectomy. I think that once you have that architecture you can start to broaden and in terms of what’s possible and the decision that would be made is to which ones coming next and why we’ll have a lot to do with which indications are the next most interesting indications for Single-Site and so that will be a process. If you follow this for a while you’d see same kind of behavior that as indications change then you bring instruments and help you optimize that set of indications.

Jonathan Demchick – Morgan Stanley & Co. LLC

Okay. And then second also, I guess moving on to the Stapler rollout and as you continue with the rollout I was just wondering if there was a potential timeline on expanding the Stapler offering the different sizes to maybe deal in one effective bariatric surgery or other surgeries?

Gary S. Guthart

So our first expansion will really be in terms of number of site supported with the existing Stapler. So the Stapler we have today is really targeted and optimized for colorectal procedures in terms of how big it is and what these Staple Reloads look like. And so we are going to do that and that’s where we are focused on in the near-term. Longer-term, we are working on prototypes and developing the capabilities for other types of reloads focused on other types of procedures and we will do that. That will be further out. That’s not a near-term.

Jonathan Demchick – Morgan Stanley & Co. LLC

Okay, very helpful and just had a quick follow-up on the procedure guidance. I know you guys have given a little bit of detail here, but I just wanted to push a little further. I think it implies roughly 13% to 17% procedure growth in the fourth quarter and I was wondering if maybe you could discuss some of the assumptions across the product categories that you revealed in that guidance, and if you see any significant acceleration or deceleration across any of the large groups.

Gary S. Guthart

Yes, I think it’s probably similar to the commentary we had last quarter and at the higher end of the range you’re talking about a continuation of the trends that we’re on from benign gynecology, general surgery and prostatectomy in the U.S. as well as international growth rates. At the lower end of the guidance it’ll just be contemplation of other factors coming to play in terms of a further decline in benign, demand for benign procedures. You’re entering a quarter that’s typically very strong seasonally and if it comes out less strong for some reason that’d be considered as well as if you see any changing trends in the cholecystectomy or prostatectomy that will be reflective in the lower end.

Jonathan Demchick – Morgan Stanley & Co. LLC

Thank you, very helpful.

Operator

Thank you. Our next question in queue will come from Bob Hopkins with Bank of America. Please go ahead.

Bob A. Hopkins – Bank of America Merrill Lynch

Thanks. Can you hear me okay?

Gary S. Guthart

Yes, we can. Yes.

Bob A. Hopkins – Bank of America Merrill Lynch

Great. Good afternoon. So I just wanted to ask you a big picture question on procedure volume growth. If I look at the model going back to the first quarter of 2012, your procedure volume growth was close to 30% and it’s kind of going down a little bit each quarter and now we’re at 16% this quarter and you’re looking at fourth quarter maybe being at the same level or a little bit lower. And so I guess just from a big picture perspective I want to get a sense of your confidence that this sort of mid-teens procedure volume growth rate is close to a bottom or is the bottom? Any thoughts there would be helpful.

Gary S. Guthart

I don’t think we are ready to give really 2014 guidance. What I’d say here in terms of what are that dynamics, what’s going on underneath these things. I think we have a large category that in the U.S. were quickly and is now growing more slowly and that was gynecology and we have a large category in the U.S. in general surgery that’s on the early part of this adoption and I think the answer to your question is going to come down to the rates of that growth on both of those sides and I think what you would expect of the company is to manage the activities that would support growth and so in the U.S. our activities are focused on supporting surgical growth and that comes down to making sure the product set makes sense for that customer, making sure that our training capability is aligned and ready to go, our sales force is capable of doing what they need to do and we have opportunity for growth or accelerate growth in U.S. markets, in Japan, where we’re making investments in Europe. So those are the underlying drivers and how it shapes out in future quarters we’ll report to you as we have greater…

Bob A. Hopkins – Bank of America Merrill Lynch

I appreciate that and I wasn’t really asking about any particular quarter, just asking about all the different trends that are impacting growth and where we stand now and just trying to kind of gauge your confidence on. At this point there are more positives to negatives and again just trying to gauge confidence as to sort of where we are in the cycle right now and your confidence that this is obviously critically important metric to your company that we have your best sense as to where that’s going to fall out.

Gary S. Guthart

One of the challenges, Bob has always been trying to read the assumptions that we’ve given you and hold them for long periods of time. In other words, we’re almost – the way the question is framed, it’s almost asking us to sort of freeze the assumption as the final assumptions and not take into consideration things like potential expansion of, let’s say Single-Site hysterectomy and/or international market growth where we’re putting in a lot of resources and training centers and so on and so forth.

So I would say from a confidence standpoint, we believe there are a lot of future drivers and present drivers in the business and it becomes as it always does, an execution story, both downstream and upstream execution of what we think are great opportunities and that’s what you should judge us on and that’s where our focus is.

Calvin Darling

Bob, time for one more follow-up question.

Bob A. Hopkins – Bank of America Merrill Lynch

Thanks. Just one real quick one on utilization, that’s also a challenging part of the model going forward. How do you think that we should be thinking about utilization sort of per system going forward? I assume that that needs to continue to climb up, but just any general thoughts on kind of utilization per installed base as we look forward.

Gary S. Guthart

Yes, I mean if you look at just the trends right, coming up prior to 2013, we’ve seen gradual increases in utilization per system as measured by procedures done in a quarter as a numerator and a denominator of the systems installed at the beginning of the quarter. We’ve seen that gradually increasing. Now you get to 2013 with the moderating growth in benign gynecology. Now you’re seeing moderate decreases in each of the first three quarters of this year.

Yeah, ultimately I think we’d still say procedures are really what drive this business here. There are other factors that impact the timing of system sales, which we’ve been through, but again procedures and the greater growth there is going to be the key and I think the ultimate utilization is going to depend on a lot of factors; hospitals gaining efficiency, Affordable Care Act, procedure mix. So the ultimate direction, it’s hard to really say.

Bob A. Hopkins – Bank of America Merrill Lynch

Thanks very much.

Gary S. Guthart

That was the 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 increasing patient value by improving surgical outcomes and reducing surgical trauma.

The following is a part of an interview published by Medscape with Dr. Joseph Colella, Director of Robotic Surgery at Magee Women’s Hospital, part of UPMC.

When he was asked about the future of robotic assisted surgery, the answer is follows, “As a potential patient stop for a moment and put on the commonsense hat. Your surgeon tells you that he can see 100% better in three dimensions that he can sew better and in the future, he will be able to do every procedure through one incision. You can imagine that the sky is the limit in employing robotic surgery. It’s an enabling technology. I firmly believe that we are finding new and beneficial applications, almost on a monthly basis. For instance, nobody ever thought you would be able to resect tumors of larynx without taking half of the face apart to get to them. With the robot in the right hands, you can do those operations in an hour and the patient goes home the next day.”

This concludes our today’s call. We thank you for your participation and support on this extraordinary journey to improve surgery and we look forward to next three months.

Operator

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 Executive Teleconference. You may now disconnect.

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