iCAD, Inc. (NASDAQ:ICAD)
Q42012 Earnings Call
February 20, 2013 10:00 am ET
Anne Marie Fields - Investor Relations, Lippert/Heilshorn & Associates, Inc.
Ken Ferry - President, Chief Executive Officer
Kevin Burns - Executive Vice President, Finance and Chief Financial Officer
Bill Bonello - Craig-Hallum
Brian Marckx - Zacks Investment Research
Jeb Terry - Aberdeen Investments
Good day, ladies and gentlemen, and welcome to the fourth quarter and year-end 2012 iCAD financial results conference call. My name is Shanae and I will be your coordinator for today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's conference. (Operator Instructions). As a reminder, this conference is being recorded for replay purposes.
I will now turn the presentation over to your host for today, Ms. Anne Marie Fields, LHA. Please proceed, ma'am.
Anne Marie Fields
Thank you, Shane. Good morning, everyone. This is Anne Marie Fields with LHA. Thank you all for participating in today's call. Joining me from iCAD are Ken Ferry, Chief Executive Officer; and Kevin Burns, Executive Vice President of Finance and Chief Financial Officer.
Following the market close yesterday, iCAD announced financial results for the fourth quarter and year-end 2012. If you have not received this news release or if you would like to be added to the company's distribution list, please call LHA in New York at 212-838-3777 and speak with Carolyn Curran.
Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of iCAD. I encourage you to review the company's past and future filings with the Securities and Exchange Commission, including, without limitation, the company's forms 10-K and 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 20, 2013. iCAD undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
So with that said, I would now turn the call over to Ken Ferry. Ken?
Thanks, Anne Marie, and good morning, everyone, and thanks for joining us. Our financial results for the fourth quarter of 2012 reflect continued progress with the execution of our oncology strategy. We were particularly pleased with the entire second half of the year as we achieved total revenues of $16 million which represents 30% revenue growth over the first half of the year with expenses increasing only 3%.
This combination of strong revenue growth and prudence expense management, enabled us to achieve adjusted EBITDA profitability for the second half of the year and positive cash flow for the fourth quarter. The major catalyst was this progress was growth in therapy product sales. Second half therapy revenues of $7.5 million more than doubled versus the first half of the year and well exceeded therapy revenues for all of 2011.
The market drivers for therapy growth have come from the growing interest in breast intraoperative radiation therapy or IORT and from increased demand for the use our system in the treatment of nonmelanoma skin cancers. The fourth quarter 2012 was the year's strongest for our cancer detection products.
The increased demand versus earlier quarters was primarily in service and to some extent digital mammography including our new product PowerLook AMP and by increased annual license sales. So to summarize, we are pleased with the progress in the execution our oncology strategy and the resulting improvement in key financial metrics that have followed.
With that, I will turn the call over to Kevin Burns, our CFO who will provide your with more financial detail on the 2012 fourth quarter and full year financial results. After Kevin's remarks, I will come back and provide a brief business update before we take your questions. Kevin?
Thank you, Ken and good morning, everyone. As Ken mentioned, we saw significant improvement in many financial metrics, including strong revenue growth from our cancer therapy products, a second consecutive quarter of adjusted EBITDA profitability and positive cash flow for the fourth quarter. We are pleased with our performance as these results confirm that our strategy is working and they give us even greater confidence in the future potential of our platform.
As discussed on previous calls, we enhanced our revenue reporting to reflect the two main oncology areas in which we operate, specifically cancer detection and therapy. Our cancer detection revenue includes all of our image analysis and workflow products, including mammography, MRI and CT CAD platforms, as well as service revenue from these product lines. Our cancer therapy revenue encompasses electronic brachytherapy, related accessories and service and source agreements.
Now let's move on to review of our revenue for the fourth quarter. Total revenue for the fourth quarter was $7.8 million, an increase of 18% from the fourth quarter of 2011 driven by 94% increase in our therapy revenue, offset by a 6% decrease in cancer detection revenue. The fourth quarter of 2012 was the year's strongest quarter for our cancer detection products with revenue of $4.7 million, including product revenue of $2.5 million and service revenue of $2.2 million.
The decrease in product revenue when compared to last year's fourth quarter was primarily due to lower sales of our digital mammography products as a result of the loss of market shares by our OEM partners, the near completion of the conversion of this market from film to digital, as well as product mix as we transition our revenue and business model to focus on product upgrades and annual service contracts.
From a recurring revenue standpoint, we are seeing growth in the number of digital mammography products under service and subscription agreements, although, this growth is partially offset by a reduction in the revenue generated from our analog service agreements as the renewal rates on the analog products continued to decline. In addition, in the fourth quarter, we also recognized approximately $400,000 of service revenue related to customization work for our strategic MRI partner that Ken will discuss further in a few minutes.
Therapy revenue continued to post strong growth, increasing 94% to $3.1 million from the fourth quarter of 2011. Product sales, which include controllers, applicators and other accessories, increased 116% to $2.2 million in the fourth quarter, we sold eight controllers and at a record 233 balloon applicators, up from three controllers and 103 balloons a year ago.
Our therapy service and source revenue continued to increase and was up 54% year-over-year to approximately $900,000. This growth reflects the increase in the size of our customer base as well as an increase in the number of minutes customers are purchasing under source usage agreements due to increased procedure volume: Total revenues for 2012 fourth year was $28.3 million, a decrease of 1% compared with total revenue $28.7 million for 2011.
Cancer detection revenue for the full year with down by $5.5 million or 24% to $17.3 million with product revenues declining by $5.8 million offset by $300,000 increase in service revenue. Therapy revenue for 2012 increased 87% to $11 million with product sales increasing by 119% to $8.1 million in service and source revenue growing 32% to $2.9 million.
In 2012, we sold 30 controllers, compared to 13 controllers in 2011. In addition, both breast and skin cancer procedure volumes increased significantly as evidenced by the growth in balloon applicator sales to 664 applicators in 2012 from 205 applicators in 2011, and estimated skin procedure volumes increased from approximately 200 in 2011 to 827 in 2012, of which 417 or more than half of the full year's total occurred in the fourth quarter.
We also ended the year with an annualized recurring revenue stream of $4.6 million from the therapy products, which is up from a run rate of $2.8 million at the end of last year, We have spoken quite a bit about the therapy recurring revenue model and I would like to take a moment to quantify the annual opportunity.
With respect to the treatment of breast cancer, over 100,000 women in the U.S. alone are eligible for breast IORT as an alternative to five to six weeks of whole breast radiation. For each patient treatment, over time we expect to generate approximately $2,500 of recurring revenue due to the provision of the radiation source, service and disposable balloon applicator which is used in the treatment delivery. If you do the math on this, that represents an annual U.S. breast IORT recurring revenue opportunity of greater than $250 million per year.
From a skin treatment standpoint, the U.S. market and recurring revenue opportunity are even higher with an eligible patient population of over 750,000 patients per year. As we have discussed, we are at the very early stages of market penetration in both the skin and breast IORT markets.
Now, turning to the record P&L. Gross profit for the fourth quarter of 2012 was $5.6 million or 71% of revenue, which compares with a gross profit of $4.5 million or 68.1% of revenue for the fourth quarter of 2011, an increase of approximately 300 basis points driven primarily by higher volume. Gross profit for 2012 was $20 million or 70.8% of revenue compared to $20 million or 69.9% of revenue for 2011, an increase of approximately 100 basis points.
As we have indicated, our gross margin percentage will continue to fluctuate based on mix and volume on a quarter-to-quarter basis. While we are also subject to the medical device excise tax effective January 1, 2013, which will be recorded as a cost of revenue, we do not expect this to change our estimated future gross margin range of the low to mid 70%.
Operating expenses continued to benefit from an ongoing expense reduction and realignment initiatives. On a year-over-year basis, we reduced operating expenses by over $9 million and are now on a quarterly run rate of $6.3 million to $6.4 million. Although expenses have been reduced significantly compared to 2011, we continue to invest in our growth strategy including the launch of new clinical trials, investment in new therapy applicators, and the development of next generation CAD products and product enhancements. Looking forward, we expect operating expenses to hold steady in the range of $6.3 million to $6.5 million pre quarter.
Moving on to our profit metrics. Adjusted EBITDA was a profit of $102,000 for the fourth quarter of 2012, compared with a loss of $1.2 million in the prior year's fourth quarter. This was our second consecutive quarter of adjusted EBITDA profitability and a $6.3 million improvement in adjusted EBITDA profitability FY 2012 versus was 2011.
Turning now to other income and expense. During the fourth quarter, we recorded a $1.1 million loss due to the change in fair value of warrants that we issued earlier in 2012 as part of our financing arrangement. On a quarterly basis, we marked that warrants to market and as our share price increases or decreases, we will take a corresponding charge or credit. In addition, net interest expense in the quarter was $866,000 of which $488,000 is cash payable related to the financing arrangement and the balance of $378,000 represents non-cash amortization of financing cost and settlement obligation.
On a per share basis, our non-GAAP adjusted net loss for the fourth quarter was $0.15 per share, compared with a non-GAAP adjusted net loss of $0.21 per share for the fourth quarter of 2011. Our not GAAP adjusted net loss for 2012 was $0.81 per share, compared with a non-GAAP adjusted net loss of $1.14 per share for 2011. Please note that there were no financing charges in 2011 and of the $0.81 per share loss in 2012, $0.28 per share is due to financing charges.
Moving on the balance sheet. We ended the quarter with $13.9 million in cash and cash equivalents compared with $13.8 million as of September 30, 2012 and $4.6 million at the end of 2011. We strengthened our balance sheet in early January of 2012 with the issuance of a $15 million senior secured note to Deerfield Management.
During 2012, we used approximately $4.2 million of cash to fund operations. As previously discussed, our use of cash have significantly declined over the last nine months. In the second quarter, we used approximately $455,000, in the third quarter, our cash use decreased to approximately $282,000 and in the fourth quarter we generated cash from operations of approximately $426,000. Looking forward, we do expect to use cash in the first quarter of 2013.
In closing, I am very pleased with our progress and the significant improvement in financial and operating results during 2012. We are well positioned to build on this momentum and look forward to continued progress throughout 2013.
With that financial overview, let me now turn the call back to Ken. Ken?
Thanks, Kevin. Let me begin with some comments on the therapy products and then I will move on to an update on cancer detection products. The drivers for today's growth are the treatment of patients with early stage breast cancer or nonmelanoma skin cancer. In addition to selling Axxent eBx system, we provide disposable applicator which is used in the treatment delivery of breast IORT. In 2012, we sold 30 systems versus 13 in 2011, as Kevin mentioned. We sold more than three times the number of applicators than we did in 2011.
While this growth is considerable, we only at 1% penetration of the addressable U.S. market in terms of procedure volumes. In breast IORT, breast surgeons are increasingly interested in offering this therapy option to more than 100,000 women in the United States who each year are eligible for IORT as an alternative to whole breast radiation.
With IORT, the patient typically is treated in one operating room stay, in which she receives breast conserving surgery, radiation therapy and cosmetic reconstruction, all in one setting. The benefits to the patient are obvious and compelling. With a growing body of clinical data and more favorable reimbursement, we anticipate that market adoption for breast IORT will continue to accelerate
We are very pleased with that the U.S. Centers for Medicare & Medicaid Services improved payment policy for IORT as well. In July of 2012, CMS has unveiled the payment code and provided a separate CPT1 reimbursement code and payment value for treatment delivery. Importantly the Final Rule payment value for IORT treatment delivery announced in November of 2012 was more than twice the value included in the proposed rule. This provides greater access to breast IORT and should accelerate the continued adoption of our technology by breast surgeons and radiation oncologists nationwide.
In addition, we are particularly pleased to see the five-year data from the TARGET-A study presented at the San Antonio breast conference in December of 2012. The data continued to show no significant difference in cancer recurrence rates between the IORT and external beam radiotherapy groups. Interestingly the data showed the side effect profile to be more favorable in the IORT group than the external beam radiation therapy group.
Our plan is to continue to invest in the acceleration of market adoption of breast IORT though increased awareness, clinical education, patient follow-up studies and lobbying for higher reimbursement beyond what we have today. We also see growing interest outside of the United States as well for this groundbreaking technology. We have three clinical reference sites treating in Europe and we placed our first system in Asia in the fourth quarter. That unit was placed in Taiwan. We expect the international market to be key to our growth strategy over time.
In the skin cancer segment, we are seeing impressive clinical and cosmetic results with our system when compared to most surgery. This has created a number of new clinical partnerships between dermatologist and radiation oncologists particularly on the U.S. West Coast where skin cancer incidence is high and reimbursement rates are favorable.
According to the American Academy of Dermatology, basal cell carcinoma is the most common form of skin cancer with an estimated 2.8 million diagnosed annually in the U.S.. The squamous cell carcinoma is the second most form of skin cancer with an estimated 700,000 cases diagnosed each year in the United States. These types of skin cancers are rarely fatal but can be highly disfiguring if allowed to grow. So it is not surprising that treatment of these nonmelanoma skin cancers increased by nearly 77% between 1992 and 2006.
We are at the process of launching a major skin study with the Axxent system. The goals of the study are to demonstrate the clinical efficacy and superior cosmetic outcomes of electronic brachytherapy when compared to most surgery. We also intend to use the results of the study to build on our plans to establish national reimbursement for the use of our system.
On the product innovation front, we are in the final phase of development for new applicator to treat cervical cancer. The will come from our existing applicator for the treatment of endometrial cancer and give us a more complete set of therapy delivery products to treat certain gynecological cancers. We hope we will be marketing the new applicator by mid-year.
Now moving on to cancer detection. We continue to make progress transforming our cancer detection business model one with increasing recurring revenue and new product innovation. As I mentioned, the fourth quarter was our strongest of 2012. While we will reach the market saturation for first generation digital mammography systems in the next few years, new growth opportunities are developing through technology refresh upgrades to the install based and through the development of workflow and CAD software for digital breast tomosynthesis. Hologic has successfully introduced the first of these systems into the United States market and other market leaders such as GE and Siemens are in the process of working toward gaining FDA approval for their treating systems as well.
We recently signed a product development agreement with GE to collaborate in the development of a family of workflow tools for interpretation of tomosynthesis images. Over time we agree with the industry experts and analysts who expect the adoption of digital breast tomosynthesis to be similar to the conversion from analog film to first generation digital mammography systems. This conversion should provide us with considerable opportunity to sell our software to customers as they upgrade this next generation breast imaging technology over the coming years.
Moving on to MRI. In order to fully capture the market opportunity for MRI CAD product line, we are pleased to report that we signed a major software and commercial development agreement with a global market leader in MRI, which we will develop advanced MRI image analysis software products that they will incorporate into their suite of MRI product solutions for global commercial sale. We expect the first products in this partnership to be launched in late Q1 or early Q2 of this year.
This partnership represents an important strategy shift and offers us a significant opportunity to accelerate sales of MRI CAD products with a commercial strategy similar to that of our successful mammography business. We anticipate increased revenues throughout this year from the strategic partnership and beyond and expect to realize cost savings as we eliminate duplication of commercial efforts, particularly in the United States. We look forward to reporting on the progress of this strategic alliance on future calls.
Now, lastly, moving on to CT CAD software or virtual colonoscopy. There seems to be a nice pickup in this internationally with Vital Images and intend to continue our efforts to partner with our leading advanced visualization software providers. The key to furthering growth would be Medicare, the impression for CTC screenings is still being evaluated at CMS in the United States.
So, in conclusion, we demonstrated significant progress through therapy products. We will continue to make targeted investments to accelerate market adoption. We are also making good progress with cancer detection products by bringing innovation and new commercial business models to the market to increased demand and lower expenses.
All-in-all, we feel we are back on a growth trajectory while simultaneously reducing operating expenses. Together, these actions are building a stronger company and increasing shareholder value. So with that, we will open up to questions. Operator?
(Operator Instructions) The first question is from the line of Bill Bonello with Craig-Hallum. Please proceed, sir.
Bill Bonello - Craig-Hallum
Good morning, guys, Bill Bonello here. Nice quarter. A few follow-up questions on the therapy side. Can you give us some color on the customer pipeline and what visibility you have in to future control replacements as we look down the year?
Sure, Bill. In terms of the overall pipeline, it is pretty strong. As I take a look at the documentation from our field force, it's growing pretty substantially. It's really a mix of customers that have interest in the product as a platform technology for both breast and skin applications. We have also got some customers in there that are looking at either breast or skin.
But what I would say is, our active funnel, as we describe it, is pretty significant. It is something on the order about 75 deals. I would say good 90% to 95% of those are U.S. base. The total active funnel is probably in the range of $18 million to $20 million. So it’s a very healthy funnel. As you look at growing the business year-over-year, it's going to be extremely important for us to turn that robust funnel in to closed transactions in a timely basis on a quarter-on-quarter basis.
So we see that as a nice increase in what I would call the addressable opportunity versus this time last year. We are very encouraged by that, but also understand that it is at the early stage in the market. So turning all of that opportunity into a timely sales is still going to be little challenging but it is probably a good challenge to have.
Bill Bonello - Craig-Hallum
And just, if we were to try and peg a number out of it, plugging along, maybe eight controller replacements a quarter or so? Is that a reasonable way to think about things?
I would hope so, in a sense that we sold 30 last year. So obviously we are in that 7.5 to eight unit average run rate. So we would certainly like to think that we can achieve that and grow from there this year. We are certainly anticipating a strong growth year in the therapy business. So we should accomplish a number one third beyond the 30 that we did last year if we are to achieve our plan.
Bill Bonello - Craig-Hallum
And then, just in terms of what you are seeing on the therapy in terms of customer utilization patterns? Obviously, you need sequential increase in both skin and breast, but what are you seeing with individual customers? As time goes by, are they increasing their procedure volume and if so, sort of what's key to that happening?
Yes, its an interesting dynamic, though. Obviously, if you just look at the trend, it is clearly in a very high growth mode but what I would say is, it is somewhat of a mixed bag with customers in terms of what they are doing. Often when it comes to breast program, there is a major champion who is a breast surgeon but he needs to be good partnering with radiation oncology and as that is a stable and growing practice, we see very consistent growth in terms of utilization.
But as in any environment, things do change. Breast surgeons move on to different institutions and radiation oncologist change, administrations change. So we have seen examples of where a business opportunity has slowed for just very normal circumstances and then in a period of time, it picks back up.
So its just not a such a mainstream established procedure that every single month, every quarter, every customer is doing more. I do think that our customers have run into reimbursement hurdles with some of their payers and that has caused them some speed bumps as well. So it is kind of a mixed bag and overall, we are seeing dramatic growth, but we are certainly also seeing customers who we think have some significant additional potential to do a lot more procedures with what they have and for a variety of different reasons some are actually doing that and others are moving at a slower pace.
I think that again it is the champions, it is a combination of that with reimbursement. Reimbursement is improving. The CPT1 code for treatment delivery for IORT is a big plus. But with that said, the adoption of that takes time and you will find different payers in different regions at different stages on reimbursement and so we are seeing improvement but it isn’t like you flip a light switch and all of a sudden everyone's paying and the absolute volumes in each account are dramatically increasing.
We would like to think over the course of the year, the improvement in IORT treatment delivery reimbursement, combined with regional or skin progress will get the aggregate customer base treating more on a higher percentage but it is a little bit mixed right now and I think that just reflects the environment and the fact that reimbursement is still a challenge that we see a lot of progress on but we still need to make a lot more progress as well.
Bill Bonello - Craig-Hallum
Okay, thanks. Then just one last question and I will hop in to the queue or whatever. But can you maybe size and maybe you don’t want to but the MRI CAD opportunity with your strategic partner?
Well, it’s a pretty significant opportunity. What I would say is that, and we hope in the next quarter so, the press release will have a lot more details about who we are working with and the types of products and go to market strategies that we will have, but this company is a leader in software as well as a number of other products and accessories within the MRI segment and basically their installed base is well over 1,000 systems and they are the market leader. It is obviously seven, eight, nine times the size of our installed base.
So it’s a pretty considerable installed base. The opportunity for us is a combination of new customers and upgrades to the installed base. The systems that we will provide them, they are substantially different and they are very, very different next-generation thin client platform like their working on today with their installed base. So the opportunity. we have over a 1,000 customers in installed base and they are the market leader in terms of new sales, for us very, very considerable over time.
So when you look at that total software installed base, I am going to guess, it's probably somewhere between the 2,000 to 2,500 United States accounts and maybe 10% to 20% of that OUS. So it’s a pretty sizable addressable market and there have been historically two major players that own that market. We were number three in the space and reached a point where this type of business model where we will really creating the innovation for the partner, then the partner, through its commercial channels, is marketing globally, provides us with a global opportunity that we did not really have. Our opportunity was more U.S. focused.
Secondly it gives us an opportunity in very large, north of 1,000 system installed base to sell a nice technology and refresh upgrades. Then it essentially provides our products on new sales opportunities where they have the largest direct sales force in the United States and OUS as well. So it’s a considerable opportunity over time. We are excited about it. We think it is gong to really allow us to realize the potential of some very innovative technologies and we had our own challenges with from a reach standpoint to customers over the next several years.
Bill Bonello - Craig-Hallum
Excellent. Thank you very much.
(Operator Instructions) Your next question comes from the line of Brian Marckx with Zacks Investment Research. Please proceed.
Brian Marckx - Zacks Investment Research
Hi, guys, congratulations on the quarter.
Brian Marckx - Zacks Investment Research
Can you talk a little bit about the sales process and the length of time with Axxent from initial engagement until a customer would commit to a purchase?
Sure. Brian, it’s an interesting market in that we are closing sales today that, in some cases, literally took two years, start to finish. We are also closing sales that probably took 90 days, start to finish. So it's very fluid in terms of the timing from prospect to close and it somewhat falls along the type of organization structure that you are dealing with.
Obviously, in a hospital system, it’s a longer sales process. Many more reviewers from clinicians to administration and the O levels and to get all that alignment, often it really involves a strategic decision on breast health or on women's health in general. Then ultimately the investment in our technology to be a market leader with state-of-the-art choices as it relates radiation therapy.
So that can really be something that is committee based and it can take quite a bit of time, lot of due diligence on our customers parts, relative to their local reimbursement environment and so forth. So those transactions probably are the ones that take the longest, the most difficult to predict when they are going to actually close. The flipside of that would be in the skin market where it is interesting that these entrepreneurs, as we would like to describe them, that are dermatologists and radiation oncologists can really get together and have a discussion one day and then one or two months later could literally be signing an agreement between the two specialties to offer our system in the treatment of nonmelanoma skin cancer.
So we can see orders in the matter of months in the skin market and you certainly don’t have all of the layers of review that you would have within a hospital system. So obviously kind of a sole proprietor type approach or joint venture skin and radiation oncology can move much, much more quickly and often those opportunities do.
With that said, the hospital dynamic, as most people experienced, are capital equipment sales can be a long and at times bureaucratic process. So we see a mixed bag and that does make it, at times, a little bit challenging to really predict the timing of the orders. But we certainly have made some very good progress over the course of 2012, in particular, in understanding those dynamics and addressing issues and barriers and then ultimately getting to close but it is still not perfect science. We are still seeing business commit in the first month of a new quarter that we had often really expected to see the quarter prior.
Brian Marckx - Zacks Investment Research
With the Final Rule on IORT reimbursement, from your perspective, have you seen additional interest or perhaps a quicker commit to a purchase?
Specific question, Brian. I think the way I would describe it is, there is different buckets of customers. There's those that have been looking at IORT for several years but have been uncomfortable that the reimbursement would come to fruition. In those cases, a lot of those customers have gone from a dormant state to an active state. With that said, it still takes time to determine when their payers are going to adopt and begin to pay.
In some cases, we are immediately seeing some new business and in other cases, they look at it as a directionally correct situation that will clearly put them into this service but it’s a question of whether its this quarter or next quarter or quite frankly next year. So you really see a mix in the reaction relative to the reimbursement. But I also think what we are finding is that a lot of customers that see the strategic value of IORT are now buying because they view this as, we will get reimbursed at a equitable levels at some point in the near future, and it is not that important today because we are really investing in a service that we believe, over the next five to 10 years, is going to be real differentiator for us and a real benefit to our patients.
So it's really all over the map in terms of what the, call it the, reaction is to the code but certainly the overall environment is much more favorable and I think that every quarter that goes by, we will gain more and more payers relative to the code on the region by region basis. That should bode well for the momentum of the business.
Brian Marckx - Zacks Investment Research
And one on operating expenses. You mentioned that $6 million to $6.5 million projected per quarter, at least for this year. The skin study, does that start this year too?
Kevin, you want to comment on that?
Our skin study is going to be launched here in Q1, early Q2. So that will certainly increase expenses. We also have been, and continue to, realign our expenses as well with the change in direction from a commercial standpoint. On MRI, we were able to reduce expenses there and again further investment in other programs as well. So we are able to continue invest more so on the therapy side by reducing some expenses in the cancer detection side.
Brian Marckx - Zacks Investment Research
Okay, great. Thanks a lot guys.
Your next question comes from the line of Jeb Terry with Aberdeen Investments. Please proceed.
Jeb Terry - Aberdeen Investments
Good morning, Ken and Kevin. Can you tell us a little bit about what is going on in terms of patient education or doctor education relative to results on IORT? I know that seems to have been a ratio in past where you were just getting people up to speed on it and then furthermore how the TARGET-A study may be impacting that?
Sure, Jack. What I would say is education to your question is key still and what we are seeing is, on a national meeting or international meetings a level whether it be breast surgeons or radiation oncology or just oncology in general, there is much more emphasis on speakers presenting the technology and its use and their experiences. So I think that the clinicians are gaining more exposure. They are gaining more experience through speakers at the national and international meetings as this topic has become more and more important.
So that’s one that, obviously we are very pleased with. We are working to sponsor speakers, if at all possible, some of the real thought leaders at some of the key meetings as part of our commercial strategy, which I think would help. So that’s certainly one angle. We are doing webinars with customers often related to a region of the country where we will invite a large number to dial-in and online view of all the materials around the clinical and the economic angles to using the technologies. So that has been successful.
We have actually held some regional symposiums where we invite physicians in parts of the country like, as an example, in California where we have a number of installations and customers, in many cases, can drive to the site and see a presentation and then mix with their peers that are advocates for the technology. So we are definitely making quite a bit of an effort relative to education. We think it is extremely important and we are still at a stage where education is going to be a critical driver as it relates to the overall adoption.
I need to ask you, what was the second question, if you had?
Jeb Terry - Aberdeen Investments
Well, I guess, related to the education part, is the patient awareness and obviously training at some point. I know you were talking about it, setting up a training facility in Florida. Where do things stand with that?
I think, again, education is great in both of the clinical as well as on the consumer side. There has been a significant amount of media hits and just extra fun reading on national news and a lot of these online journals and so forth, that the consumer is seeing. So my hope is that at some point, if it starts to have the same feel as film to digital mammography in women becoming aware team that study and become advocates for this technology. But I would say that we are working that angle. It is a large and broad and challenging scenario but we are making some progress there.
As it relates to the training center, we are still in discussions with a strategic partner in Orlando that has a world-class training facility as part of their hospital system so that we can provide training both on-site and at a world-class training center. That is not up and running yet but we would hope to, at some point this year, have that training facility running. I think we need to be somewhat nimble in that, a number of our customers really enjoy going to a site offsite and dedicating the time and that is, given their caseload and busy schedules, they need to have us come on site and do it.
So we were trying to be nimble and to provide really a menu of means to be trained, relative to our customer base. So it's going well. Obviously we have, on our own staff, a dedicated breast surgeon. We have physicists, clinical trainers. So we bring in a very senior team with a lot of experience to train our customers and overall it is going well.
As we scale our volume, though, clearly, we are going to look for ways to do that in a much more efficient manner without any degradation in the quality of the training delivery. So that’s where these regional centers play a role and over the next one to two years, I think we would like to have one or more up and running in the United States, particularly.
Jeb Terry - Aberdeen Investments
Okay, and I am sorry, I may have missed it. You were mentioning, I think working on the upgrade cycle of the service cycle with CAD with your installed base in CAD. If you could just perhaps review what is your effort there and what you are looking at this year and next? How that’s going to progress?
Sure, we have basically an installed base that, and if you look at it, it is really something that really got going from a volume standpoint in 2007. So here we are in 2013. So you have hardware that’s aging and failing more frequently. There is obviously the opportunity to add new, innovative capabilities and so forth.
So we have a very nice new digital mammography CAD platform and it adds new functionality. It also can host third-party applications, typically breast density is one that we are finding a lot of interest in with customers today. I would say, in general, we are doing well with that.
We are seeing a lot more interest in an annual license or the subscription model versus the outright purchase of an upgrade. We are seeing that pretty much across the board with customers that have been using the technology for a lot of years, where people would really like the new functionality. The fact that it is done through more of an annual subscription, you obviously are going to recognize that revenue radically and it is not going have a huge impact in early phase, as where we are today, but we definitely think as you look out to 2014 and 2015, the sizeable effect will kick in, then the number of customers in that segment will really grow and they will upgrade.
We are also very ambitiously adding to our service contract base in the overall installed base as well and part of that is establishing new business relationships around service with our current OEM partners like GE and Siemens and others. So we are hopeful to use a, call it, subcontracting business model with the OEMs. We would be the primary source of service, were in the past they have taken it on themselves. That should give us an opportunity in this recurring revenue opportunity with the installed base.
Then with all of that said, I think the real significant opportunity that I don’t want to miss, is having a workflow software and CAD and for digital breast tomosynthesis. Then we really are seeing the momentum that Hologic has achieved. We are pretty excited that our number one customer GE anticipates FDA clearance of their system before the end of this calendar year.
We did have a demonstration at the RSNA back in November of digital breast tomosynthesis CAD. It went over exceptionally well particularly with their advisory board. We signed a new development agreement with them and our hope is, by the end of the year or early in 2014, is to have a workflow software tool for tomosynthesis CAD, and then to have a more traditional CAD product later because the regulatory requirements around reader studies and so forth would be more significant there.
So our intention is to have a multiphase rollout but we really believe that between now and say, 2018 or so, pick a date. This entire market is going to move from the first generation digital mammography systems to tomosynthesis as the next generation for both screening and diagnostic use. So if that were to occur over the next say, five to six years, it’s a similar opportunity, we believe, as when the market went from film and analog technology to first generation digital.
That could be a very, very big opportunity for us, given the size of our installed base as well as the technology, obviously that the OEM partners like GE could bring which could address this market share paradigm with Hologic. So I think starting in 2014, we will have not just a recurring revenue opportunity in our 2D installed base by offering refresh but we should have something addressing tomosynthesis workflow followed sometime later by a CAD product and that opportunity, we think, is significantly greater and should in the '14, '15, '16 timeframe really provide us with a large addressable market as a more and more substantial number of systems move from first generation digital to tomosynthesis.
So that’s kid of how we are looking at recurring revenue. Its really a balance of getting new refresh into the installed base but at the same time, hopefully within 12 months or so, bringing out a major new product which would address tomosynthesis and our hope is, of course, that GE, by year-end, has FDA cleared product. That could certainly have a much significant impact for us on 2014 CAD revenues it that all comes together.
Jeb Terry - Aberdeen Investments
Pretty good. Thank you very much.
Your next question comes from the line of [Harry Kovelman with Hi Consulting]. Please proceed.
Yes, gentlemen, congratulations on many fronts. You alluded to the diversity in the (inaudible) space, you alluded to the diversity of your customers. At least, as I see it, in the United States, it seem that many of the independent surgical centers are moving towards, as they are acquired right and left by integrated healthcare systems, it seems to me that you would be doing more with that sort of customer than the independents. Obviously, its not happening all at once but there is clearly a shift in that way. You want to comment on that, particularly given the fact that the controller is a capital acquisition item and have you thought of any other ways of approaching the system such that basically to get into the game that they wouldn’t have to make the capital acquisition maybe perhaps along the lines of a subscription model that you alluded to for your CAD?
Thanks, that’s a good question. We certainly see some of the consolidation that you are talking about, whether it be in surgical centers or really in therapy centers too. Those that have these freestanding therapy center for radiation delivery also are turning into all small clusters or national change, if you will, of providing a service. So obviously our challenge there is to obviously work both the headquarters and the local level and we are doing both of those things.
Certainly, depending on the potential, whether it be a contract over some period of time or years, we could certainly be creative as to how we would structure the terms. As it gets down to a subscription level or a procedure based level, it’s a little more challenging in the sense that unless these site can really commit to a significant number of procedures, it is little bit challenging for us to do.
The area that I think has the most potential for that type of model is skin, because obviously a patient goes in anywhere from six to eight or ten skin treatments as part of their therapy and so the procedure volume of skin it is probably more conducive some sort of an annual subscription or a procedure based model. On the breast size, it’s a little bit more challenging because we are still in the hundreds of procedures versus thousands.
I think though as the overall procedure volumes grow, we will certainly look at a capital light, if you will, approach but obviously the overall financials have to work to do that. Today what we try to do is to be flexible in using third party financing company, as an example, to help those customers that really want to pay overtime and have tried to maintain a complete transaction rather than in some sort of a procedure based or subscription-based model for the system.
But our cost of goods is fairly attractive in that product area. So I do think we have some flexibility as we would adapt to different business models that we think makes sense and have some real significant potential.
But I think it is quickly flexible because it seems to me that the more controllers are getting the play, the more likely it is that you are going to have a variable cost side unutilized and at least the health-care system will work in supply chain for anything above a $50,000 had to be part of the capital budget and if you miss the timing of that, you are looking at another year. That becomes a substantial delay in the adoption of treatment that is clearly advantageous. On the other side, it seems to me that, and you mentioned this, but I think it is a really important point and that is simply that the systems that get into this early on are going to have a differentiator versus others. I think that’s very important. You have got a game changing technology and if they are not offering to their patient's, they are going to be on the sideline and they are going to have problems. Just to emphasize.
It is interesting and that’s a good point because a lot of our sales has been because a institution wants to be the first in their market or one of their competitors was first and they certainly don’t want to not have competitive edge against all others. So we have definitely seen adopters through both of those mechanisms. Clearly, at some point, a procedure volume driven financial model would be attractive, to your point, to avoid a capital budgeting cycle. There is no question.
But it is a bi t challenging because there is still enough fixed cost between the hardware and the reusables and disposables and then resources to go on site that we are, I will just say, open to it but a little bit cautious at this time. But as market adoption increases significantly in terms of procedure volumes, I think it lends more and more flexibility around the non-capital approach to business terms.
It worked well for J&J's Biosense Webster division. I experienced it personally through their 3D mapping system and its worked well for the Hanson Robotics. Its worked well and in other words, there are other contemporary type game changing therapies that have done well with that approach. Last question, do you have any interest on the part, you guys are clearly in an important space on the number one killer of women, skin cancer, patient population and everything. The demographics are all in favor of you guys. Has there been any interest from a business development standpoint, something the larger players, because they are going to realize that there is no way that they can get into this. It seems to me.
I think that’s a good question and I do believe that the larger players in the space are now starting to look at brachytherapy and electronic versus iridium as a legitimate segment. I think up until now as the larger players all have offered a brachytherapy product line that has been iridium-based, it has been, and assuming that this technology needed to prove itself because if it did it would become an extremely convenient technology relative to its mobility and obviously without the handling requirements and so forth and site prep from a faults and shielding standpoint. So I definitely think the larger companies, particularly in the last 12 months with the progress we have made, have really now started to pay attention and I believe they see this as a growing segment and in some cases they see it as an emerging market, attractive technology because of the lack of need for infrastructure and so forth.
So definitely there is increasing interest, and I think in our case, excuse me, what we really love to be able to do is to partner with one or more of these major players, particularly in the international markets, which for us are a challenge to get to. We don’t have the luxury of global footprint. We do a very solid footprint in the United States. So to the extent there is an opportunity to partner on distribution and potentially technology cooperation, we would certainly be interested in that and I think we have seen some interest from some of the larger players in potentially working together as they see this as a complementary segment to what they are doing versus a novel technology that hasn’t achieved enough traction. I think we are starting to get past that and hopefully it will help us to get a more global reach for us and solution in the next 12 to 24 months.
That’s a great report and I am really excited for you guys. congratulations.
You have a follow-up question from the line of Bill Bonello. Please proceed.
Bill Bonello - Craig-Hallum
Hi, guys. Thanks for taking my follow-up. I just wanted to circle back one more time to this MRI deal. Again, as I am pushing you for more details than you want to give, I understand it, but just as we think of the economic mile there, can you refresh us on at least in the normal circumstance, what the installation is of CAD for an MRI customer, the revenue associated with that? Then also whether there is a service opportunity with this installed base as well?
Sure. The way this agreement will work, Bill, is just something we are pretty excited about, is that we will collaborate with our partner on the definition of the product roadmap. Then we essentially will do all of the product innovation and product development and we will actually get paid NRE money from our partner to do this work. So it’s a nice stream of cost relief for the engineering work that needs to be done.
Then they will take the product into the market on a global basis and we will receive a royalty for each license that is sold and we will also receive a royalty for every service agreements sold post warranty. Clearly there is two types of post-warranty opportunity within the install base.
One is traditional support. As the MRI application is fairly technically and clinically intensive, so having a support agreement is important both from a break fix, as well as from a clinical education standpoint. Then there is the ability to add new functionality over time as well. I think the market opportunity is pretty significant for upgrades and enhancements in technology refresh combined with new applications and new areas.
So our initial offering is to be very much what where have been which is in breast and prostate but this other opportunity whether it be orthopedic or neuro, other parts of the body where MRI imaging is done and there needs to be interpretive analysis. So we see this is a blend of new opportunity on a global basis, a nice recurring revenue opportunity from upgrades and support as well. We essentially are the "Intel Inside", if you will, developing this technology and then the market leaders out there aggressively marketing it as part of a broader set of products to the MRI marketplace.
So there is a lot of potential overtime. We are pretty excited. We think the business model, given that we have invested a significant amount in this platform on our own, we just did not have the resources to capture the commercial potential. This is a much better balanced approach for us and its really truly something where we think we could increase our revenues in that space, while we decrease our costs because the decrease in cost is a combination of having the engineering reimbursed as well as a decrease in our own commercial efforts in that space considerably. So any time you can increase revenue and decrease cost, I am in.
Bill Bonello - Craig-Hallum
Okay, great. Thank you.
I would now like to turn the call over to Mr. Ken Ferry for closing remarks.
I would like to thank everyone for your interest in iCAD and our cancer detection and therapy products businesses. We are really, really pleased with the progress that we have been able to make, particularly in the second half of 2012. We will continue to make very targeted investments in both cancer detection and the therapy businesses, as we continue into 2013.
With that said, we are encouraged by the progress. Hopefully, we will continue our strong topline growth and combine that with prudent expense management, as I said earlier, really create a very, very strong growing company and at same time increase shareholder value. So thank you all very much for your interest. We look forward to speaking with you again at the conclusion of Q1 as we communicate our first quarter of 2013 results. So thanks again for your interest and your participation on the call and have a good day
Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Good day.
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