Ladies and gentlemen, thank you for standing by. Welcome to the Intuitive Surgical Q4 2012 earnings release call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will be given at that time. If you should require operator assistance during the call, please press star then zero. As a reminder, this conference is being recorded. I will now turn the conference over to Calvin Darling, Senior Director of Finance for Intuitive Surgical. Please go ahead.
Thank you. Good afternoon, and welcome to Intuitive Surgical's fourth quarter earnings conference call. With me today, we have Gary Guthart, our President and CEO, Marshall Mohr, our Chief Financial Officer, and Alex St. John, 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. 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 intuitive.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 fourth 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 fourth quarter financial results. Alex will discuss marketing and clinical highlights. I will provide our financial forecast for 2013. 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. 2012 has been a productive year at Intuitive. In the past year, our focus was in the following four areas. First, continued growth in gynecology and urology worldwide. Second, disciplined execution of our Single-Site and vessel sealing launches. Third, building robust clinical programs with leading customers in emerging procedures in general surgery, thoracic surgery, and transoral surgery. Finally, strengthening our capabilities in international markets. In reviewing the year, I will turn first to procedures. Year-over-year growth in procedures finished at 25%, led by continued uptake in gynecology and growing use of da Vinci in general surgery. Gynecology growth was broad-based with increased use of da Vinci surgery for gynecologic oncology, hysterectomy, myomectomy, and sacrocolpopexy.
General surgery growth was substantial in the year, led by increased use of da Vinci in colorectal procedures and cholecystectomy, the latter driven by interest in da Vinci Single-Site. Globally, urology as a category was up slightly for the year, pressured by a significant reduction in prostatectomies in the U.S. As we've mentioned on prior calls, we believe the reduction in prostatectomies is the result of a combination of factors, including recommendations moving away from the use of PSA testing for early detection and an increase in non-definitive treatment pathways such as watchful waiting. However, we did see a quarterly sequential rise in the U.S. in prostatectomies from the third quarter to the fourth quarter of 2012. Alex will take you through greater detail on our procedure performance later in the call.
Turning to da Vinci surgery outside of the U.S., in 2012, we focused on improving our performance in Asia and in Europe. In Japan, reimbursement approval for da Vinci prostatectomy contributed to significant early uptake of systems and procedures. In the fourth quarter, we received clearance for our da Vinci Si system in Japan, and customer shipments for Si are planned to commence in this first quarter of 2013. We expect progress in Japan to proceed in steps as we pursue additional instrument regulatory clearances and additional procedure reimbursement. In Europe, we made progress in the fourth quarter, seeing a significant increase in system sales as we invested in deepening our organization. Per our commentary through the year, we have more work to do in building our organization to perform in a challenging environment.
We expect these challenges in Europe and our investments to continue for the next several quarters. Our product launches proceeded well in 2012. Response to our da Vinci Vessel Sealer and Single-Site instrument kit was positive in the year, with over 450 Si customers purchasing Single-Site starter kits. Surgeon acceptance of Vessel Sealer has been encouraging, with Vessel Sealer use focused on colorectal surgeons as well as GYN oncologists. We received 510 clearance in the U.S. for our da Vinci Stapler, and we plan to start a controlled rollout over the next several weeks. Our rollout this year for our Stapler will be carefully phased and focused on excellent customer experiences. Per our prior calls, in Q3 of 2012, we submitted a 510 for an additional set of instruments and an expanded indication for Single-Site for use in hysterectomy and oophorectomy.
Our dialogue with FDA on this kit has been constructive. In imaging, we submitted a 510 application to expand indications for our Firefly fluorescence imaging system to use in biliary imaging. We believe this will have application for use in imaging the common bile duct during cholecystectomy and will complement the use of Single-Site. Looking back at the full year 2012, our operating highlights are as follows. Worldwide procedures grew by approximately 25%. We sold 620 da Vinci Surgical Systems in the year, up from 534. Total revenue grew to $2,178 million, up 24% over 2011. Recurring revenue grew to $1,246 million, up 27% and comprising 57% of total revenue. We generated $1,031,000,000 in operating profit before non-cash stock compensation expense, up 24% from last year, and GAAP net income grew to $657 million, up 33% year-over-year. Turning to operating highlights for the fourth quarter.
Procedures grew approximately 25% over the fourth quarter of last year. We sold 175 da Vinci Surgical Systems, up from 152 in the fourth quarter of 2011. Total revenue for the quarter was $609 million, up 23% from the fourth quarter of 2011. Instrument and accessory revenue increased to $254 million, up 29%. We generated an operating profit of $286 million in the quarter before non-cash stock compensation expense, up 22% from the fourth quarter of last year, and GAAP net income grew to $175 million, up 16%. We ended the year with $2,921,000,000 in cash and investments, up $219 million from last quarter and up $749 million from last year. We received $263 million in cash during the year from the exercise of stock options and invested $180 million in intellectual property, working capital, property, plant, and equipment, and $238 million in stock repurchases for the year.
In the quarter, we added 170 people to our team, predominantly in our clinical sales force, our manufacturing team, and design functions in Q4, bringing our total team to 2,362 employees. Looking to 2013, our priorities are as follows. First, continued focus on use of da Vinci in gynecology. Second, supporting emerging growth of da Vinci in general surgery. Third, disciplined execution of our da Vinci Stapler and Single-Site for hysterectomy launches focused on outstanding early customer experiences, and finally, continuing to strengthen our capabilities in international markets, particularly Europe and Japan. I'll now pass the time over to Marshall Mohr, our Chief Financial Officer, to take us through our financial performance in greater detail.
Thank you, Gary. Our fourth quarter revenue was $609 million, up 23% compared with $497 million for the fourth quarter of 2011, and up 13% compared with $538 million last quarter. Fourth quarter revenues by product category were as follows. Fourth quarter instrument and accessory revenue was $254 million, up 29% compared with $196 million for the fourth quarter of 2011, and up 16% compared with $218 million in the third quarter of 2012. The year-over-year increase in I&A was driven by procedure growth of approximately 25%. Sales of new instrument and accessory products including Single-Site, Vessel Sealer, and Firefly, and higher stocking orders associated with higher system unit sales. The year-over-year procedure growth was led by U.S. gynecology and general surgery procedures, partially offset by lower growth in Europe and a year-over-year decrease in U.S. DVPs of approximately 17%.
The sequential increase in I&A revenue compared with the last quarter was driven by higher procedure volume benefiting from favorable fourth quarter seasonality of benign procedures, higher new product sales, higher initial stocking orders, and the timing of distributor orders. Instrument and accessory revenue realized per procedure, including initial stocking orders, was approximately $2,050 per procedure, which is higher than the $1,980 realized in the fourth quarter of 2011 and the third quarter of 2012. The sequential year-over-year increases were driven by higher new product sales, including Vessel Sealers, Single-Site kits, and Firefly kits, higher initial stocking orders associated with higher systems unit sales, and the timing of distributor orders. Fourth quarter 2012 systems revenue of $265 million increased 18% compared with $225 million for the fourth quarter of 2011, and increased 14% compared with $232 million for the third quarter of 2012.
We sold 175 systems in the fourth quarter of 2012 compared with 152 systems in the fourth quarter of 2011 and 155 systems in the third quarter of 2012. Our fourth quarter average sales price per system was $1.49 million, slightly above the $1.47 million realized in the fourth quarter of 2011 and the $1.48 million realized last quarter. ASPs include all da Vinci models, all simulators, and Firefly when configured with the system and exclude upgrades. Fourth quarter ASPs benefited from a favorable mix of dual console systems, Firefly-enabled systems, and direct sales to Europe. ASPs will fluctuate quarter-to-quarter based on product, customer, and trade-in mix, as well as foreign exchange rates on direct sales to international customers. We sold 115 simulators during the quarter, mostly in conjunction with new system sales, compared with 123 last year and 87 last quarter.
We sold 32 dual console systems compared with 29 last year and 20 last quarter. 52 of our fourth quarter 2012 system sales involved trade-ins comprised of 40 da Vinci S and 12 standard models. 50 of our fourth quarter 2011 sales involved trade-ins and 34 of our third quarter 2012 sales involved trade-ins. Service revenue increased to $91 million, up 20% compared with $75 million last year and up 3% compared with $88 million last quarter. The growth in service revenue was primarily driven by a larger system installed base. Total fourth quarter recurring revenue, comprised of instrument, accessory, and service revenue, increased to $344 million, up 27% compared with fourth quarter of 2011, and up 13% compared with the third quarter of 2012. Recurring revenue represented 57% of total fourth quarter revenue, compared with 55% in the fourth quarter last year, and 57% last quarter.
International revenue results were as follows. Fourth quarter revenue outside the U.S. was $131 million, up 23% compared with revenue of $107 million in the fourth quarter of 2011, and up 14% compared with revenue of $115 million in the third quarter of 2012. Our year-over-year and quarter-over-quarter international revenue growth was driven by increased procedures and higher system revenue. Fourth quarter 2012 international procedure volume was approximately 21% higher than the fourth quarter of 2011, and 15% higher than the seasonally slower third quarter of 2012. During the fourth quarter of 2012, we sold 42 systems outside the U.S., compared with 39 in the fourth quarter of 2011 and 41 last quarter. We sold 24 systems in Europe this quarter, compared with 23 in the fourth quarter of 2011 and 13 last quarter.
We sold 10 systems in Japan this quarter, compared with five last year and 16 last quarter. A higher mix of systems to direct customers in Europe also contributed to higher system revenue in the fourth quarter of 2012, compared with the third quarter and the fourth quarter of 2011. Alex will provide additional details of international system sales. Moving on to the remainder of the P&L. Gross margin in the fourth quarter of 2012 was 71.9%, compared with 73.1% during the fourth quarter of 2011, and 72.5% last quarter. Our lower year-over-year gross margin percentage resulted primarily from lower margins earned on our newer Single-Site and Vessel Sealer products. Our slight decline in margin percentage compared with the third quarter was mostly due to lower margins on a higher volume of our Vessel Sealer products.
Fourth quarter 2012 operating expenses of $190 million were up 16% compared with the fourth quarter of 2011, and up 6% compared with the third quarter of 2012. Our higher fourth quarter 2012 operating expenses were primarily driven by variable compensation associated with our higher fourth quarter revenue and headcount additions. Fourth quarter 2012 operating income was $248 million, or 41% of sales, compared with $200 million, or 40% of sales for the fourth quarter of 2011, and $211 million, or 39% of sales for the third quarter of 2012. Fourth quarter 2012 operating income reflected $38 million of non-cash stock compensation expense, compared with $35 million for the fourth quarter of 2011 and $47 million last quarter. Our effective tax rate for the fourth quarter was 31%, compared with 26% for the fourth quarter of 2011, and 15% last quarter.
I want to remind you that the third quarter of 2012 tax rate of 15% included discrete tax benefits of $38 million associated with the expiration of the statute of limitations. The fourth quarter 2011 rate of 26% reflected a federal R&D credit and discrete benefits associated with state tax returns. Our fourth quarter 2012 rate of 31% is in line with our expectations and excluded the impact of the federal R&D credit reinstatement, which was enacted in 2013 and will be reflected as a discrete item in the first quarter of 2013. We estimate the R&D tax credit benefit for 2012 will be between $6 million and $8 million. Our net income was $175 million, or $4.25 per share, compared with $151 million, or $3.75 per share for the fourth quarter of 2011, and $183 million, or $4.46 per share for the third quarter of 2012.
Excluding the third quarter discrete tax benefit of $38 million, our third quarter net income would've been $145 million, or $3.54 per share. Let me quickly summarize our results for the full year of 2012. Procedures grew by 25% to approximately 450,000. Total revenue was $2,179 million, up 24% compared with $1,757 million last year. The revenue increase included recurring revenue growth of 27% and an increase in systems revenue of 20%. Full-year operating income was $878 million, up 26% compared with $695 million last year. Operating income included $153 million of stock-based compensation charges, compared with $136 million in 2011. Net income was $657 million, or $15.94 per share, compared with $495 million, or $12.32 per share last year. 2012 net income included approximately $46 million associated with statute of limitations and a change in rules for 199 tax credits.
Excluding these items, net income would've been $610 million, or $14.85 per share. Year-to-date cash flow from operations was $814 million, compared with $678 million last year. Moving on to cash flows. We ended the fourth quarter with cash and investments of $2.9 billion, up $220 million compared with September 30, 2012. The increase was driven by $217 million of cash flows from operations, plus $87 million from the exercise of stock options, partially offset by $53 million in stock buybacks and $61 million of capital and IP purchases. We bought back 102,000 shares at an average price of $524 per share, and we have $330 million board-authorized buybacks remaining. With that, I'd like to turn it over to Alex, who'll go over our sales, marketing, and clinical highlights.
Thank you, Marshall. During the fourth quarter, we sold 175 da Vinci systems, 133 in the U.S., 24 into Europe, and 18 into rest of world markets. As part of the 175 system sales, 12 standard da Vinci systems and 40 da Vinci S systems were traded in for credit against sales for new da Vinci Si systems. We had a net 123 system additions to the installed base during the quarter, which brings to 2,585 the cumulative number of da Vinci systems worldwide. 1,878 in the U.S., 416 in Europe, and 291 in rest of world markets. 114 of the 175 systems installed during the quarter represented repeat system sales to existing customers. 167 of the 175 systems sold represented da Vinci Si or Si systems, which included 32 dual-console systems.
The 42 system sales internationally included 10 into Japan, four into Italy, and three into the countries of Denmark, Switzerland, and Canada. Our da Vinci sales remained strong through the year, totaling 620 systems. Clinically, we finished the year strong with Q4 year-over-year procedure growth of approximately 25%. The specialties of GYN and general surgery were responsible for most of this growth. DVP, more specifically U.S. DVP, a topic we've extensively discussed over the past several quarters, declined 17% on a Q4-over-Q4 basis, but was up 2% on a sequential basis. While the rate of decline has tempered a bit, we are not in position to declare an endpoint to its decline. Our fourth quarter growth rate matched our 2012 overall procedure growth rate of 25%. U.S. procedure growth for the year was approximately 26% as compared to 23% for our international markets.
The specialties of GYN and general surgery contributed the overwhelming majority of 2012 procedure growth. Benign hysterectomy, cholecystectomy, colon and rectal resections, endometriosis resection, partial nephrectomy, and sacrocolpopexy were the largest individual contributors to procedure growth, which more than offset the decline within our 2012 U.S. DVP business. The U.S. procedure breakdown for 2012 was as follows. Total procedures grew to approximately 373,000, up from 292,000 in 2011. Total GYN grew to approximately 222,000 procedures, up from 170,000 in 2011. DVH accounted for approximately 176,000 procedures, up from 140,000 in 2011. Urology accounted for approximately 88,000 procedures, which were down from approximately 93,000 in 2011. U.S. DVP declined from approximately 73,000 to 62,000 procedures. General surgery procedures increased to approximately 42,000, up from 15,000 in 2011, representing a 173% increase. Recently released new products continue to do well, notably Single-Site.
Early customer feedback has been positive, and our initial sales have been strong. Through the fourth quarter, we've sold Single-Site instrument and accessory kits to approximately 450 U.S. customers. Our recently launched Vessel Sealer product continues to pick up clinical momentum, with most of the interest coming from colorectal, advanced general, and GYN clinicians. The customer adoption for both da Vinci Simulator and Firefly continues to expand, with 115 customers purchasing a da Vinci Simulator and 88 customers purchasing Firefly systems as part of their da Vinci purchase this quarter. During the quarter, several hundred robotic abstracts and papers representing a variety of surgical specialties were published within various peer-reviewed journals. Quarterly clinical conferences produced several live da Vinci procedure transmissions, post-graduate robotic courses, podium presentations, and clinical poster sessions.
Some of our early general surgery success is rooted within complex procedures, which are often considered difficult to perform through traditional laparoscopic technique. Laparoscopic mid and low rectal cancer resections have for years proved challenging for even the most advanced laparoscopic surgeons, and as a result, clinical adoption remains low. The added benefit of da Vinci's articulated instrumentation, intuitive movement, and magnified 3D HD vision has provided a new foundation for MIS advancement in this field. A recent three-arm comparison out of the Department of Surgery at Yonsei University College of Medicine was published in the "Annals of Surgery." The study reported on pathologic results, morbidity, perioperative recovery, and short-term oncologic results of 165 patients undergoing robotic, laparoscopic, and open mid and low rectal cancer procedures.
The findings from this case match study revealed that robotic surgery for the treatment of mid to low rectal cancer resulted in significant decreases in the amount of analgesia used, postoperative pain, and length of stay. Although sphincter-preserving procedures were frequently performed with robotic surgery, the incidence of circumferential margin involvement and immediate post-op voiding problems showed a significant decrease with robotic surgery as compared with open surgery. Robotic surgery showed better recovery outcomes than lap surgery with regard to time to resume soft diet and length of hospital stay.
The visual analog scale was significantly lower in robotic surgery than in laparoscopic surgery and open surgery from postoperative days one through five, and no significant differences were found in 2-year disease-free survival rates between the three groups, causing the authors to conclude, and I quote, "Robotic surgery may be an effective tool in the effort to maximize the advantages of minimally invasive surgery in the management of mid and low rectal cancers." The clinical pursuit toward nephron-sparing kidney surgery has increased significantly over the past several years, with more and more urologists adopting partial nephrectomy. A 500-patient study out of the Cleveland Clinic entitled "Comparative Outcomes and Assessment of Trifecta in 500 Robotic and Laparoscopic Partial Nephrectomies" was published in the journal, "Urology." Trifecta is defined as a partial nephrectomy where warm ischemia time is kept below 25 minutes, with negative surgical margins and no perioperative complications.
The study reported that even with the more complex tumor profiles found in the da Vinci cohort, operating times were nearly 22 minutes less as compared to the laparoscopic cohort, 169 minutes versus 191 minutes. Intraoperative complications associated with da Vinci patients were less than half when compared to laparoscopy, 2.6% as compared to 5.6%. Postoperative complications were 24.5% in the da Vinci cohort as compared to 32% for patients within the laparoscopic arm. Positive surgical margins were 2.9% in the da Vinci cohort as compared to 5.9% for laparoscopy. The overall Trifecta rate was significantly higher in the da Vinci cohort at 58.7% as compared to 31.6% for the laparoscopic group. These findings led to the author's conclusion, and I quote, "Our large analysis shows that robotic partial nephrectomy offers a wider range of indications, better operative outcomes, and lower perioperative morbidity compared to laparoscopic partial nephrectomy.
Overall, the quest for Trifecta seems to be better accomplished by robotic partial nephrectomy, thus likely to become the new standard technique for minimally invasive partial nephrectomy. Once again, the category of GYN contributed greater total procedure growth than any specialty we serve. da Vinci sacrocolpopexy volume trails only da Vinci hysterectomy within this specialty, and it continued its solid growth during the year. In a recent edition of "Female Pelvic Medicine & Reconstructive Surgery," physicians from the University of South Florida reported the results of their 164-patient study comparing da Vinci sacrocolpopexy to open sacrocolpopexy. This retrospective study focused on cost, operative time, and the length of stay for each group. Within this study, both system cost and maintenance costs were considered and included. The authors reported that the median operative time for open sacrocolpopexy and da Vinci sacrocolpopexy was 166 minutes and 212 minutes, respectively.
Estimated blood loss averaged 150 milliliters in the open sacrocolpopexy as compared to just 50 milliliters within the da Vinci patient cohort. Length of stay for the da Vinci group averaged two days as compared to three days for the open sacrocolpopexy group. However, 48% of the women treated within the da Vinci group experienced a length of stay of less than 24 hours as compared to just 1% for the women undergoing an open sacrocolpopexy. The median direct cost reported for the da Vinci group was $6,668 as compared to $7,804 for the open group. The overall cost reported for the robotics group was $9,725 as compared to $12,485 for the open sacrocolpopexy group, with similar readmission rates at 30 days post-op.
The author stated that while da Vinci sacrocolpopexy took slightly longer to perform than an open sacrocolpopexy, both the direct and indirect cost for the da Vinci sacrocolpopexy was less than for open sacrocolpopexy. This concludes my remarks, and I'll now turn the time over to Calvin.
Thank you, Alex. I will be providing you with our financial forecast for 2013, including procedures, revenues, and other elements of the income statement on a GAAP basis. I will also provide estimates of significant non-cash expenses to provide you with visibility into our expected future cash flows. Starting with procedures. In 2013, we expect procedure growth to be driven by U.S. gynecology, U.S. general surgery, and international DVP procedures. We expect our 2013 total procedures to grow approximately 20%-23% from the base of approximately 450,000 procedures performed in 2012. Based on an increasing proportion of benign short-term elective procedures in our procedure mix, we anticipate a more pronounced quarterly seasonality impact in 2013 as compared to 2012, resulting in proportionally lower Q1 and Q3 procedure volumes and proportionally higher Q4 volumes. Moving on to revenues.
In 2013, we expect to achieve annual revenue growth of between 16% and 19%. We expect typical capital sales seasonality in 2013, with the proportion of full-year system units sold in each quarter to follow a pattern fairly consistent with 2012. We would expect fewer systems to be sold in the upcoming seasonally slower first quarter than in the recently completed seasonally stronger fourth quarter. As a result, total first quarter 2013 revenue is likely to be lower than the fourth quarter of 2012. All 2013 revenues, particularly capital sales, are subject to the impacts of economic conditions. Now turning to operating income. Our full year 2012 operating income was 40.3% of revenue. In 2013, as we reviewed on our last call, the Medical Device Tax has become effective.
Based upon our 2012 regional and product mix, we would estimate the tax to equate to roughly 1.1% of our consolidated revenue. We plan to record the expense as a component of cost of sales, thus impacting both gross and operating profit margins. We also expect the impact of new products to shift our overall gross margin percentage slightly lower in 2013. In addition, we expect to continue to invest in field sales and training resources to support procedure adoption. Based upon these factors, we expect our 2013 operating income to fall within a range of between 38% and 39% of revenue. Consistent with prior years, we would expect our operating income as a percentage of revenue to be lower in the first quarter of 2013, reflecting system sales and procedure seasonality.
2013 operating expenses should follow a quarterly growth pattern similar to 2012, with Q1 reflecting the full quarter impact of our Q4 new hires. We expect our non-cash stock compensation charges to increase from $153 million recorded in 2012 to approximately $184 million-$192 million in 2013. Amortization of purchased intellectual property, which is mostly recorded as R&D expense, is expected to increase from $23 million in 2012 to $28 million-$30 million in 2013. Other income, which is mainly comprised of interest income, was approximately $16 million in 2012. We expect other income to grow to between $18 million and $22 million in 2013. With regard to income tax. On our last call, we have estimated a 2013 income tax rate of between 29% and 31% of pre-tax income.
Now, including the impact of the reinstatement of the R&D Tax Credit for 2013, we anticipate our base full-year tax rate to fall within a range of between 28% and 30% of pre-tax income. As Marshall mentioned, we expect to recognize a discrete benefit of between $6 million and $8 million during the first quarter of 2013 related to the reinstatement of the 2012 R&D Tax Credit. This discrete item will result in a downward adjustment of our Q1 2013 income tax expense from the 28%-30% full-year rate. We estimate our share count for calculating EPS in Q1 2013 will be approximately 41.2 million shares. That concludes our prepared remarks. We will now open the call for your questions.
ladies and gentlemen, if you would like to ask a question, please press star then one on your phone keypad. You'll hear a tone indicating you've been placed in queue. You may remove yourself from the queue by pressing the pound key. Once again, if anyone would like to ask a question, please press star then one at this time. Our first question is from Lennox Ketner with Bank of America.
Hi. Can you hear me okay?
We can.
Great. Congratulations on a good quarter. I guess first, I just wanted to touch base on general surgery and the growth that you're seeing in cholecystectomies. I'm wondering, at this point in the year, if it's possible to speak kind of either quantitatively or qualitatively to how much of that uptake you think is trialing versus sticky procedure? I don't know if you can give any sense as to what percentage of the 450 customers that have bought Single-Site kits have bought second kits, or if it's possible to speak at all to how much you think is trialing versus sticky procedures.
Well, I think it's really too early to say what is a trend, what is ultimately a long-term expectation. What we can say at this point, and it's our belief that with 450 U.S. customers purchasing starter kits, that there's a lot of interest in people moving toward single incision surgery. Trying to define how many of those we will have going forward that are part of the initial purchases is difficult to say. I think we're most pleased with the fact that it is indeed a large number of U.S. customers that are going through the purchasing activity and actually doing these procedures today.
Okay. Just as a follow-up, there was some concern around the recent AAGL statement regarding robotic hysterectomies and the fact that the AAGL doesn't believe it should be used to replace laparoscopic hysterectomies. I know that most of your hysterectomy procedures that are being done right now are actually replacing open surgeries, I'm wondering if you could maybe just frame for people, on a go-forward basis, what % of the hysterectomy market you think is still being done as open procedures, just so people have a sense as to what the remaining opportunity is there, just in terms of simply converting open procedures to robotic.
Well, you are right. I think many of the studies that were cited in the AAGL statement actually compared robotic surgery to laparoscopic surgery and really failed to recognize that the majority of the robotic cases would have probably previously been done via laparotomy. We had, as you recall, as we've gone through our sizing, if you will, of our target market, we've talked about this pretty specifically over the years. When we started really with the da Vinci hysterectomy, I think it was estimated that somewhere along the lines of 66% of the hysterectomies performed in the U.S. were being performed through laparotomy.
I believe the Solucient database, which is a division of Thomson Reuters, I think in their most recent publication, I think goes through 2011, they estimated that only 39% of the procedures in the U.S. now, the hysterectomy procedures, are being performed through a laparotomy. Vaginal, I think, was something like 14%, laparoscopy was around 16%, and the remainder was through da Vinci. Our objective really is to move these complex procedures from open, invasive incisions to minimally invasive surgery. I believe that the record shows that that's taking place.
Okay, thanks very much. I'll let someone else hop in.
Next we'll go to the line of Benjamin Andrew with William Blair. Please go ahead.
Good afternoon, guys. Two questions for me. First, can you talk about the adoption curve that you've seen in gen surg so far, and if you adjust for the installed base change, how it compares to maybe DVH most appropriately?
Well, it's interesting in general surgery versus, let's say, DVH, is we're talking about a category. Within the general surgery category, if I'm not mistaken, there have been somewhere around 40-plus procedures that have gone into the category of general surgery that have been performed with da Vinci. It's difficult to really compare apples to apples between a category and, let's say, something like DVH, which is a single procedure. It's even more difficult comparing it to, let's say, DVP, which is a single procedure that is always done for a single disease, which is cancer. In other words, there's just too many inconsistencies between the three. What we will say is within the category of general surgery, that the two procedures that are driving a great deal of that growth are cholecystectomy and colon surgery.
Not just low anterior resection, but right colons, left colons, transverse colons, et cetera.
Alex, can you talk a little bit about the typical experience for a new general surgeon starting out and sort of wanting to do Single-Site chole or whatever. Is there a typical kind of process they go through, and how quickly people are coming up that curve?
A lot of that depends on what their experience is going into that case. In other words, are they completely laparoscopically trained? Are they laparoscopically naive? Are they robotically trained, robotically naive? I think each one of those is a little bit different. I would say that by and large, you will have people that will do multi-incision cholecystectomies with the traditional da Vinci system, or they'll do some other procedures prior to moving into the single incision surgeries. I don't know that I can say that there's a typical profile and/or a typical experience.
Okay. Then just maybe a quick question for Marshall. Can you talk a little bit about the expectations on guidance and specifically thinking about Europe, if you've guided at 20%-23% procedure growth, does that give you 25% U.S. and 15% Europe or international more broadly? Just characterize for us what you've built in there, please. Thanks.
We haven't broken it down, we've given you a range because there's some uncertainty associated with certain elements of the guidance itself. I'm not going to break it down into details.
All right. Thank you.
Yep.
Next, we'll go to the line of David Lewis with Morgan Stanley. Please go ahead.
Good afternoon. Alex, I wonder if you could tell us maybe in the back half of 2012 or for all of 2012, you think about total general surgery procedures, either in terms of adoption curve steepness, either in Single-Site chole versus LAR, where you're seeing a steeper relative adoption curve or where the contribution to growth is stronger?
Well, it's too early to say. As you know, with adoption curves, it's dangerous to try to project steepness too early in the equation. Trying to really pull out an individual point today and draw a lot of conclusions from it is probably dangerous. In terms of overall growth, cholecystectomy is, as we've said, I think in our previous call, is our third largest overall procedure, and that's all of cholecystectomy, including Single-Site and four incision cholecystectomy. That one would be growing at a steeper rate.
Okay. Very helpful. Marshall, just a quick question on margins. It sounds like some of the dynamic is mixed with some of your higher growth procedures coming in and maybe a slightly lower GM. How much of that is simply temporary? When you start getting real scale advantages, back half 2013 into 2014, does that sort of vanish when we get back to a corporate gross margin for consumables that's more appropriate? Are we always going to see some sort of a drag here, just based on how you're pricing some of these individual units?
The variation in margin really has to do with the introduction of new products and the margins that are earned on those new products. Initially, you're dealing with low volumes. You're dealing with maybe not optimized manufacturing and design. Those products we work on reducing those costs over time, increasing the volumes and reducing those costs over time. Some of those products are more complex than the products we've had in the past, it's not practical to predict that they'll actually get to the same level of margin of, let's say, a simple product that we have. Some improve quickly in margin, and some take a greater investment and longer time to improve.
Okay. Thank you very much.
Next, we'll go to the line of Tycho Peterson with JPMorgan. Please go ahead.
Hey, good afternoon. Question maybe first on DVP. Your sequential performance here was a little bit better than we've been modeling. I know you're somewhat reluctant to kind of call the bottom here, but can you talk about whether there's any change in your own expectations from kind of the peak to trough drop off in DVP? Is it too early to start to think about some of those that have dropped out coming back in for surgery?
I think as you started out in your question, I think you accurately stated the way we feel about it. It is too early for us to call. 90 days have passed since the last time we talked, we've watched it a little closer. We've seen a favorable Q4, recognizing that Q3 is historically a seasonally slower quarter. I think trying to draw too many conclusions at this stage is probably not in anyone's best interest. I can say that we didn't see a great deal of difference other than the numbers in terms of the discussions with the physicians. I think people are pretty much in the same place today as they were in Q3. However, the numbers have shown an improvement, we'll watch it, and we'll see when it feels safe to call a trough.
In terms of the quarter, in terms of placements, are you able to call out the impact of the VA order at all? We've had a few people asking about that.
The VA contract was for about $34 million of product. That was a contract for both systems, initial stocking of instruments and accessories, as well as other things that go with it, like simulators. We did ship a majority of what was under that contract in the last quarter.
Okay. Just last one, as we think about full ramp of the stapler here, I know you're kind of still in the trialing period and working with KOLs, when should we think about that moving into kind of full commercial launch?
We'll be advancing it carefully the first half of this year, likely through the full year. In the first half, we expect to be out in customers in this first quarter, we'll advance it slowly as we get customer feedback and really make sure that we've optimized their experience. This will be a conservative launch, really focused on the fact that stapling is subtle, and we want to make sure that our customers are having great experiences.
Great. Thank you.
We will go to the line of Lawrence Keusch with Raymond James. Please go ahead.
Thanks. Alex, maybe you could talk a little bit about prostate and the experience in Europe. I guess there had been some concern that some of the changes in the U.S. here would have a pronounced effect over there. If you have any thoughts on that would be great.
Well, I think as we've said in the past, the world is getting smaller. Information is shared quickly, and there are the same census, if you will, of participants at both national and international meetings. I think there is some effect. It is in some markets, it's probably felt a little bit more than in others. In other words, in a place like Japan where you're starting relatively new, there's a lot of growth ahead of us, and you're probably powering through that. Any concerns, if there were some concerns about whether or not PSA screening is appropriate or conservative treatment, whereas in other countries, it's probably a little bit more pronounced. I don't know that we can necessarily label Europe
Homogeneously and believe, or international for that matter, and believe that it's something that each country resembles the next. I think there's probably some markets where it's a little bit more pronounced than others.
Like in the U.S., it's a hard thing to model.
Got it. Just two other quick ones. Just relative to the 510(k) clearance that you guys are anticipating for Firefly in biliary. Could you talk about how important that is to push the adoption of Single-Site chole? It seems to me that obviously if you can reduce common bile duct injuries, that would be a positive with that technology. Separately, I think last quarter you provided some feel for in the U.S. what procedures grew if you were to adjust for the declines in prostatectomy. I was wondering if you could help us with that in the fourth quarter.
Just speaking to the first one, the 510(k) submission for Firefly biliary imaging, that has just been submitted this quarter. In terms of when we expect a clearance, no endpoint to tell you about yet. We do think that biliary imaging in real time is interesting and meaningful for cholecystectomy for the reason that you indicate, that a common bile duct injury is a serious complication. We think that Firefly can augment the white light imaging and be a complement to cholangiography. That's the intent. We've just started that conversation with FDA, as it proceeds and we have something more material to share, we will. With regard to the breakouts on kind of the adjustments and the procedure mix, I'll turn it to Alex.
Yeah, I think it's pretty consistent with what I had mentioned earlier in terms of hysterectomy, cholecystectomy, colon rectal surgery, endometriosis resection, partial nephrectomy. Those procedures are the ones that I think primarily are the strength for the quarter and for the year.
Just looking at the numbers on a full year basis. DVP on a full year basis was down 15% as Alex described in his notes. If you back that out in the U.S., everything else was up about 39%. Thanks so much.
We'll go to the line of David Roman with Goldman Sachs. Please go ahead.
Good evening, everyone. Just really echoing the comments earlier on a very strong quarter here, so congrats. Nice way to start end the year and start 2013. Wanted just to focus a little bit on the general surgery application and more specifically, can you give some perspective on where the procedures you're doing are coming from? I guess really what I'm asking is, are these procedures that were done in a laparoscopic setting, were they done open? Are these people who wouldn't otherwise do the procedures? Are you adding growth to the market? Maybe just any perspective you can give us on the competitive modalities would be helpful.
I think if you look at, again, we believe we talked about 42,000 procedures, up from 15,000 in 2011. If you look at the biggest contributor there, it's cholecystectomy. Almost all of those procedures had been done laparoscopically because the standard of care is laparoscopic cholecystectomy. That one I think is fairly simple to say where it's coming from. If you look at bowel surgery and specifically large bowel or colon, you have left colons. You start on the other side. You have right colons, transverse, left sigmoid, moving down into the rectum, and then you have total colectomy. Depending on which procedure, each of those are counted as a different procedure. Depending on which of those procedures you're talking about, if you did it inversely and you started at the most difficult or the lowest penetrated laparoscopically, it would be low rectal cancer.
There you're talking about data would suggest that it's single-digit penetration of laparoscopy, whereas if you're talking about right colon, it's double-digit, and I've seen numbers perhaps as high as 20 or 21 or 22%, that is laparoscopic. You have a range of where those patients would have gone, either to a open surgery or a laparoscopic surgery. You have a smattering of procedures that range from some open, that would've been done open, whether it be distal pancreatectomy or liver surgery, and then you have other procedures such as Nissen that may have been done laparoscopically. There's a lot of movement that's going on, which is, I think it was an earlier question that Ben had asked about general surgery. You have what amounts to, I think, 40-some procedures that have been done.
Trying to build an individual profile for general surgery is a challenge.
Maybe just to follow up on the guidance, obviously 20%-23% procedure guidance is a solid number. Look at that contrasted with the total revenue guidance. It does imply a fairly sharp slowing on the system side of the business. Anything particular to call out there? Is it comps? Is it lapping the Japan reimbursement? Anything to help us understand why that business would slow to the degree that the guidance implies?
Yeah, I'm not sure that the conclusion is absolutely right. There are a lot of factors in the guidance, including the average selling prices of the systems and the procedures and so on. Don't necessarily agree with the conclusion.
I think we've lived in
In a good world of good mix on systems. I'm not sure that we believe that system mix and that ASP will hold for the whole year. I think on the I&A front, as we move out in time, as we've always said, stocking orders will become a smaller part of the picture and have less impact. We would see some level of pressure on pricing on I&A. In general, I think we've shown over the years, procedure growth outpaces revenue growth because of systems generally are not at the same level.
Lastly, just to clarify on the share count, I think you said 141.2 million shares. Is that a comment regarding the first quarter or the full year of 2013?
That's the first quarter comment.
Okay. Got it. Thank you.
Next, we'll go to the line of Rick Wise with Stifel Nicolaus. Please go ahead.
Good afternoon, everybody.
All right, Rick.
If you could just give us a little more color on some of the structural changes you're making in Europe. Gary, you indicated that you're making significant progress as you've deepened the organization. Just a couple of things. How long do you envision this investment, sort of maybe extraordinary investment process continuing? Maybe give us a little more details about some of the specific actions, if you could, that you're taking place and maybe how you're approaching the market or pan-Europe or company specific. Anything to understand a little better some of the things that are happening there. Thank you.
Sure. Yeah. I think with regard to the progress we've made, I think we've made some progress. I'm not ready to call it significant progress yet. I think that our investments have really been in kind of three areas. One has been getting the right sales reps in the right territories, pretty straightforward. We've done that, and we'll continue to do so. That runs on a set of coverage metrics and kind of market analyses that are pretty straightforward. We've been making some more targeted investments. This is in casts of thousands, but in terms of understanding reimbursement and regulatory and the resources that are required to perform in different markets. That's been a more targeted set of investments. We've invested in some better kind of top-line leadership, and I think investments in all three of those are encouraging. They're early.
I think that we'll continue to invest for the next several quarters. It isn't huge dollar value investments. They're more targeted in that way, but they're important. So far, I think that we've made the right first steps. I think we need to continue on that pathway.
Thank you for that. You'd think that the major thrust is completed this year or by mid-year, or just again, any sense of timing?
I think we'll be concentrating on it through the year, and about this time next year, we ought to ask that same set of questions.
Okay.
Just time for one more question, if you will.
Okay. Japan, just again, I think you said significant demand. With the da Vinci Si approval in hand, is this going to be an incremental driver? Are we going to see more upgrades maybe in 2013? Again, help frame that for us. Thank you.
Yeah. I think there's really two things to say with regard to Si approval in Japan. The first one is, we're excited about the approval, in large part because it allows us to bring to Japan with follow-on clearances, a set of technologies that we think have really made a benefit in the rest of the world and things like Single-Site and Firefly and vessel sealing and dual console and simulator, a bunch of things that we've invested on the Si system side. We're excited about that. I think structurally, though, in the longer term, the Japanese market penetration will be paced by additional procedure reimbursement. Near term, it's a great thing to get in the hands of the Japanese customer. We need to continue to work on reimbursements beyond prostatectomy, and we'll continue to do so.
Thank you so much.
Thank you. That was our last question. As we've 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 and by improving surgical outcomes and reducing surgical trauma. I hope the following experience from Warren in California gives you some sense of what this means in the lives of our patients. Quote, "Last year, I made a donation to the Sutter Maternity & Surgery Center for the da Vinci fund. I had no idea that someday I might benefit by the use of this system. Having an electrical engineering background, I am interested in innovations that benefit people. I considered this system to be a must-have tool for our surgical centers. A few months ago, after successive urine samples showed traces of blood, my nurse practitioner urged me to see a urologist.
Dr. Joe Franks discovered a small cancer in my bladder, which he removed on May 8th, 2012. A follow-up CT scan on May 25th showed a tumor in my left kidney. Because I am 88, I was considered borderline for surgery, and if the mass appeared to be stable, I might be lucky enough to outlive the tumor. Such was not to be. By late July, I was passing visible blood in my urine. On August 1st, Dr. Franks agreed we should go ahead with surgery if my internist gave the okay. On Friday, August 3rd, the internist pronounced me to be fit, and I was on the list for surgery. On Saturday, Dr. Franks called me to say there was a surgery cancellation for that Monday morning, August 6th, using the new da Vinci system. I eagerly accepted.
Dr. Franks said that all my stars must have been in alignment, as the procedure only took about two hours, not counting the admissions procedure. The next day, I walked out of the hospital without having to take any pain medication. Much easier than a root canal. Without da Vinci, the hospital stay would've been several days." End quote. Patients like Warren are the strongest advocates for da Vinci surgery and form the very foundation of our operating performance. 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.