Biosite Q4 2006 Earnings Call Transcript

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Biosite Inc. (BSTE)
Q4 2006 Earnings Call
January 30, 2007 4:30 pm ET

Executives

Nadine Padilla - VP, Corporate and IR
Kim Blickenstaff - Chairman and CEO
Ken Buechler - President and Chief Scientific Officer
Bob Anacone - SVP, Worldwide Sales and Marketing
Chris Twomey - SVP, Finance and CFO

Analysts

Bill Quirk - Piper Jaffray
Alastair Mackay - GARP Securities and Research
Benner Ulrich - UBS
Bruce Cranna - Leerink Swann
Phillip Gross - Adage Capital Management
Stan Mann - Mann Family Investment

Presentation

Operator

Good day, ladies and gentlemen, and welcome to the Biosite Incorporated Fourth Quarter 2006 Earnings Call. My name is Onika and I will be the operator for today. At this time, all participants are in a listen-only mode. We will conduction a question-and-answer session towards the end of this conference. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes.

At this time, I will now like to turn the call over to Ms. Nadine Padilla, Vice President, Corporate and Investor Relations. Please proceed.

Nadine Padilla

Good afternoon and thank you for joining us for today's conference call and webcast. Present today are Kim Blickenstaff, Chairman and CEO; Ken Buechler, President and Chief Scientific Officer; Bob Anacone, Senior Vice President, Worldwide Sales and Marketing; and Chris Twomey, Senior Vice President and Chief Financial Officer.

During this call, we will discuss our results for the fourth quarter and full-year ending December 31st, 2006, along with guidance for 2007. After prepared remarks, we'll conduct a Q&A session. We are expecting a large audience, so please limit yourself to one question and one backup, but feel free to queue up as often as you would like.

First some general information, today's meeting, which is open to the public and the media, is being simulcast on the Internet via our homepage at www.biosite.com. During today's call, we expect to discuss GAAP and non-GAAP financial results which are also included in our press release issued earlier today. A copy of that release is available on our website, and we encourage anyone interested in more detailed information to refer to that information at their convenience.

Because today's conference call includes statements regarding Biosite's anticipated financial results, as well as other forward-looking statements based on current expectations, we would like to remind everyone that our actual results may differ materially from those anticipated. Information on factors that could cause actual results to differ materially from the forward-looking statements is contained in our press release issued today January 30th, 2007, as well as in Biosite's Form 10-K for the year ended December 31st, 2005 and subsequent Form 10-Q. We encourage you to review those carefully. Forward-looking statements represent the Company's judgment as of today. The Company disclaims, however, any intents or obligation to update these forward-looking statements.

And with that, I will turn it over to Kim.

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Kim Blickenstaff

Thank you Nadine, and thank you everybody for joining us to on this rainy dreary day here at San Diego. Please don’t have any sympathy for us our here, but it is rainy. I just want to look back a little bit on the full-year 2006 financial results. In my opening comments, the result for the year, obviously, came in pretty consistent with most recent guidance we gave you last quarter. We saw a 7% increase in revenues for the year with a total coming at about $309 million versus $288 million for 2005. Some of the moving parts were consistent with what we predicted. We saw BNP sales increases of 4% year-over-year for the total year. Good contributions from the Triage BNP test which is designed to be sold on the Beckman platform, as well as sales of Triage BNP in the US physician's office market.

Also, the other cardiovascular product line continues to show very nice increase, year-over-year it's about 39% growth, and revenues for the total year were about $55 million from that combined product line. So it shows the benefit of getting some products improvements into product line and getting some additional growth. Finally, the international revenues with the investments that we have made there grew 24% and total revenues out of Europe now constitutes 15% of our total of Biosite revenues, up from about 9% just a couple of years ago. So that strategy is working out very well for us.

And then, finally, on non-GAAP basis, our net income grew 7% and EPS grew about 10%, both of which were in line with the guidance that we gave you, I think, just during the last conference call. Just looking at 2006, in total, we've generated about $75 million in cash from operations. We've started the year with cash balance of about a $132 million, and during the year we initiated two share repurchase programs. The first was at $30 million program in the first quarter that we purchased about 576,000 shares, and the second accelerated repurchase program for a $100 million has netted a repurchase of about 1.9 million shares to date. So when you combined these programs, we have repurchased about 40% of the outstanding shares on December of 2005, so we are very pleased with that. Obviously, we believe that returning value to shareholders in this really makes tremendous sense. And as Chris will mention in his comments, we will continue to look at this as we go forward and see how our operating cash rolls out during the course of the year.

In terms of guidance, we gave you board guidance last time. We have gone through a detailed budgeting process that we do in the last quarter of the year before Christmas. With all the moving parts there, we are reaffirming the guidance that we gave you in the last call with no changes from that guidance. We see revenues about $326 million in 2007, which is 6% increase over 2006. Again, growth is going to come from the investments we've made in under-penetrated market, such as the physician's office market here in the US for BNP and for the international markets where we did see a tremendous under-penetrated market there as well.

Also growing contribution again from other product lines, the cardiovascular product lines will help us well. Also, as we went through our expense operating budgets, we really had to make some choices on priorities. We are actually going to give guidance here on seeing a slight increase in operating income despite some of those significant investments that we were making in our clinical trials in other programs to support the launch of new products in Europe in 2007, and Chris will go through that detail. So, we have then those two goals of getting 6% top-line growth and seeing a modest increase in our operating income in '07.

As also we talked about in the last call, we really focus or focusing in 2007 to make substantial progress towards the regulatory approval of key products that we have just given, the ones that have the higher potential for commercialization, largest markets, most indications in the shortest time horizon. We have targeted before that is Triage Sepsis Panel, the Triage Cardio ProfiLER with the MPO added to it to improve the overall assessment of patients suffering ACS.

Acute kidney injury is another area of extreme interest to us along with NGAL, the marker that we licensed there. And as well, we'll continue to focus on modifications through our Triage BNP test that will expand the overall market potential for physician office testing here in the US. So those are some of our core group of major impact R&D programs. And during the budget process, we have to absorb substantial incremental expenses in order to support the clinical activities relating to gain the regulatory approval for these products during the coming years.

In general, these clinical trials for these new products and indications are going to be significantly more complex and expensive than our previous submissions in prior years whether they were PMAs or 510(k)s. Couple of major global reasons why this is so. First of all, these are diseases that have no blood markers of selecting a proper gold standard and then finding the sites that can operate with the similar practice standards, so that we have poolable data. This can be very challenging. So it's one of the major prerequisites for our trials going forward. Also, these trials are going to need to be prospective and based on uniform protocols to ensure the poolability of all the data and coming from multiple centers, we are going to have large patient populations to enroll numbers that will meet our end-points.

Also, we have made a decision with guidance from the FDA that we are going to do two separate prospective trials on each new product or indication. We are going to outline some language [year-to-date] for you in my comments and Kim's comments. And the first term is what we call a training study and the training study is going to help us select markers and algorithms that will give us the best clinical performance to take forward in the second phase and the second phase on a trial is called our validation study that will validate clinical usefulness of the product and will be in what the data that supports our FDA submissions for approval for the products here in the US So, really all these products will have two different steps and two different studies moving forward.

In addition, as we want to try to commercialize products in Europe early, we are going to be supporting clinical activities in the European market, we are adding headcount there, our standard of practices obviously are different by country, different from the US -- USA as it is a bit heterogeneous. So in order to get the products into early marketing and get CD marketing, we'll be investing in resources that support those medical clinical activities in Europe, so we can get underway with early market development activities during 2007.

So, we are very excited about the breadth of the new opportunities and the significant unmet medical needs that these products address. We are not going to rehash, what we think are some of the market potentials on these products in this call today, but if you go back to what we presented back in R&D Day we've spent a lot of time trying to show you that we have very detailed market research that shows the clinical importance of the need for improved diagnostic tools in these areas, there is -- to make it more complex as multiple indications in some of these areas, and our trails that are designed to get those various indications for [years] proved for us. So, we believe they have very large opportunities, several different indications, and overall we think that these product areas parallel the size and importance of BNP for the improvement of diagnosis of heart failure in the advance of that product made in that category.

So our real goal for you this year is to demonstrate tangible evidence of the usefulness of these products from the results of these trials that are underway and to show that we are making a significant progress on these significant events -- investments that we are making. So I want to turn it over to Ken to go through in more details some of the nomenclature of the different clinical trial names that we have for the various testing and validation studies that we have for each of these indications, so take notes and Ken will give you the definitions of all the acronyms.

Ken Buechler

Thank you, Kim. In the fourth quarter end 2006, we made progress in the areas of research and development, and clinical study. As announced in today's press release, we have received clearance for our Triage Protein C assay, and I would like to start off by congratulating our developmental, both clinical and regulatory teams on this accomplishment. As we discussed last year, this test will be used in a clinical trial undertaken by Lilly that will employ a tailored therapy strategy for Lilly's severe sepsis drug, Xigris. The trial called RESPOND will investigate the use of a multipurpose biomarker, Protein C, to be used in conjunction with the administration of Xigris. We are pleased to be working with Lilly on this project, and our business development group continues to search for other opportunities to form similar alliances. I will now move on to discuss our clinical studies.

In the past, we have not spoken extensively about our clinical study process. However, given the number of studies taking place this year and the focus on them, I think it is worthwhile to spend some time acquainting you with the methodology and terminology. As you know, the research and development begins with Biosite Discovery, a program through which we establish preliminary diagnostic utility of biomarkers from disease categories that are of interest to us. Once our business development, marketing, and R&D groups define new product opportunities and an assay for the selected biomarker or biomarkers is developed, the clinical group in conjunction with the R&D and regulatory groups write protocols for clinical studies that will optimize and test the validity of the potential new device. We use the terms training and validation to describe the stages of our clinical studies.

The objective of the training study is to define or revise potential device panels, establish assay cut-offs, and if applicable set the MultiMarker Index or MMX algorithm believed to best define the diagnosis and/or prognosis of the disease or condition we are studying. In some cases, this data may also support CE marking if it meets specific requirements for clinical safety and effectiveness, and device manufacturability. We believe early CE marking would accelerate our ability to perform post-market evaluation with key European thought leaders. Our expectation is that these post-market studies would then ultimately lead to peer-reviewed scientific papers in support of product launches in both international and domestic markets. For these reasons, in most cases we expect to introduce new products into EU markets ahead of the US through limited launches.

The training study protocol will also be used to define the protocol for the validation clinical study, which is the study performed to generate clinical utility data and to validate the safety and effectiveness of the device. The goal, of course, is to use the results of the validation study in support of FDA submission. Under certain conditions, we may also conduct a pilot clinical study prior to the training clinical study. The goal of the pilot study would be to gain data to aid in the refinement of the training clinical study protocol. The time duration for each of these study phases will be a function of the indication through use, prevalence rate of disease or condition, enrollment rate, number of patients required, and the number of clinical sites. Most of our validation studies will be multi-center studies and will typically involve between about 500 and a 1000 patients.

Turning to products and developments, you may remember that we filed a 510(k) Premarket Notification for our MPO test in December of 2005. Although we believe the data obtained from bank samples that were collected from four clinical sites are scientifically found, the patient enrollment criteria used at the four clinical study sites were not identical, and the FDA considered the data were not poolable. Therefore, we have decided to allow the current 510(k) to expire. However, we are already well underway with studies aimed at providing data intended to support a submission and expect to file a new Premarket Notification 510(k) submission for the prognostic use of MPO within the next several months. We expect data from these studies will also be available to support CE marking later this year.

Moving on to our other ongoing studies with MPO, the MIDAS study, which stands for Myeloperoxidase and Multimarkers in the diagnosis of ACS, is a prospective sample collection study obtained from patients who present to emergency department within 6 hours of symptom onset or symptoms suggestive of acute coronary syndrome. The MIDAS samples are intended to support submissions, relating to potential claims for MPO, BNP and to the Multimarker Index algorithm for the Cardio ProfilER. The MIDAS study has already enrolled approximately 80 patients at five site and we expect enrollment to increase as the number of sites expands to 17. In the area of sepsis, we have selected a panel consisting of three markers, which were selected from over 150 different proteins. We are in the final stages of discussion with the FDA regarding the validation of clinical study that we are calling MINDSET, which stands for Multimarker Index for the risk assessment of sepsis in the emergency department.

We anticipate MINDSET will commence this spring, pending final discussions with the FDA. The panel of markers for the Triage Sepsis Panel was selected using data from a training study called Sepsis-1. Sepsis-1 enrolled approximately 1000 patients presenting to emergency departments at 10 clinical sites. We are very enthusiastic about the prognostic performance of the Sepsis Panel and [Dr. Manny Rivers] of the Cleveland Clinic will discuss the preliminary data from the Sepsis-1 study and the markers that the upcoming IFICEM Critical Care Meeting in Belgium in March. We also plan to use the clinical data obtained from Sepsis-1 study to support CE marking later this summer.

Acute renal injury continues to be an important project and as you know, we have obtained an exclusive license to the marker NGAL for use with blood sample. The early data in children on NGAL from the Cincinnati Children's Research Foundation is promising and suggesting that NGAL may be useful in evaluating the potential for kidney injury and particularly predicting acute renal failure. Acute renal failure affects hospitalized patients and particularly patients in the Intensive Care Unit. Patients with acute renal failure and complications with other organ dysfunction can have mortality rates as high as 40% to 70%. And acute renal failure is associated with various high cost medical problems, treatments and procedures. We believe that by rapidly accessing the likelihood and potentially the extent of kidney injury prior to the kidney undergoing irreversible damage, we can give healthcare providers the opportunity to use available treatment options to avoid or reduce injury and significantly improve the outcome of the patient.

In the fourth quarter, we evaluated approximately 600 clinically defined samples obtained from patients previously enrolled in a clinical study, who had undergone cardiac bypass surgery. The literature document said approximately 1% to 5% of patients undergoing cardiac surgery has complications with renal injury. These well-defined bank samples enable us to understand the performance of NGAL in adult patients. We will continue to study the marker prior to commencing the training study termed [EVAL], which stands for evaluation of NGAL in early and evolving acute kidney injury. This multi-center study expected to commence around mid-year will evaluate several hundred patients who are undergoing cardiac surgery. The validation study for NGAL termed KINGPIN, which stands for kidney injury assessment using NGAL in the cardiopulmonary bypass, will be designed based on data obtained from the [EVAL] study and will be submitted to the FDA for a review prior to study initiation.

We had previously expected to launch KINGPIN in the second quarter of 2007, but our decision to perform additional pilot studies in adults has pushed the timeline out by about six months. We do anticipate utilizing the clinical data generated from the bank samples and from the [EVAL] study to support CE marking. Dr. Devarajan from Cincinnati Children's Hospital will be presenting data at the World Congress of Nephrology held in Rio de Janeiro in April from children undergoing coronary bypass surgery with complications of acute kidney injury and death and the measurements of NGAL in these patients.

In the area of stroke, we continue to collect data in the EU from selected hospitals and the researchers are finding that the Triage Stroke Panel performs consistently and is useful in identifying patients with stroke. Recently, a poster was presented in South Africa from studies conducted by [Cesaroni] in Italy, describing the clinical utility of the Triage Stroke Panel, and it was concluded that the panel in addition to standardized stroke scales, was helpful in identifying stroke and TIA patients who maybe under-detected using current clinical assessment techniques. In this study of 122 patients, the Triage Stroke Panel outperformed the Cincinnati pre-hospital stroke scale with a raw curve of 0.73 versus a raw curve of 0.65 for the stroke scale in patients diagnosed with TIA and stroke. Although stroke is a second-tier project now, as a result of its market size relative to ACS, renal injury and sepsis, we continue to work with thought leaders to design a validation study for stroke.

We continue to make progress in the development of the finger-stick application for the Triage BNP test that can be used more easily in physician offices where blood is typically not drawn. Additionally, we are working with thought leaders to design a clinical study demonstrating the benefits of monitoring BNP in the outpatient setting.

And with that, I will turn it over to Bob.

Bob Anacone

Thank you, Ken. Worldwide product sales grew by 6% year-over-year in the quarter to $75.6 million, and 7% for the full year to $303.3 million. Domestic product sales grew 3% year-over-year in the quarter to $63.6 million, and 5% for the full year to $258.7 million. International product revenues continue to grow rapidly, with Q4 growing 26% to $12 million and the full year growing 24% to $44.6 million. International sales continue to grow as a percentage of total product sales, achieving 16% of product sales in Q4 and 15% of product sales for the full year.

On a worldwide basis, total BNP sales continued to grow with year-over-year sales in the quarter growing 2% to $47.6 million, and full year sales increasing 4% to $196.4 million. In addition to continued BNP growth, we realized substantial growth in our other combined cardiovascular products growing 31% year-over-year in the quarter and 39% for the full year. These products include our Cardiac ProfilER and Stroke Panels as well as our D-Dimer test. For example, our Cardio ProfilER and ProfilER SOB panel products grew by 81% and a 114% respectively on a full-year basis. In addition, we saw our Triage TOX product grow by 40% for the full year.

In the high volume automated segment of the BNP market, we continue to realize strong growth with worldwide BNP sales on the Beckman Automated Immunoassay Systems, growing 28% year-over-year for the quarter and 47% on a full-year basis. As I mentioned earlier, total product sales grew 6% or $4.1 million in the quarter versus last year. In terms of price volume breakdown, net sales increased $5.5 million as a result of volume growth, partially offset by a $1.4 million decline in sales due to ASP erosion.

For the full year, sales increased $30 million due to volume growth and decreased $9.5 million due to ASP erosion. In the US, our revenues grew 3% or $1.6 million in the quarter and 5% or $11.8 million for the full year. In the domestic BNP market, we continue to be the leader in terms of share, our total domestic hospital customer base remained stable, and the total BNP Beckman utilization increased 7% for the quarter and 5.5% for the full year. BNP, ASPs declined approximately 5% for the quarter and 6.5% for the full year domestically.

Regarding BNP competition, I mentioned on last quarters call that i-STAT had launched their BNP on their meter. The i-STAT BNP poses a risk in the point-of-care market, as they represent a new significant entrance into the point-of-care segment of the market. Today, we have realized very few account losses to i-STAT BNP. Additionally, their BNP assay performance remains uncertain at this point in time. However, we are seeing aggressive pricing and as a result we have risk of losing some potential new point-of-care opportunities to i-STAT. We believe the i-STAT platform offering is not conducive to large labs with higher volumes. We also believe the Triage meter performs better operationally for smaller volume accounts. In any event, we continue to grow our point-of-care business. In fact, the number of active point-of-care customers grew 47% December to December '06 over '05 with point-of-care sales increasing 41% on the same basis.

In the lab-based BNP business, we continue to face stiff competition seeking to convert our BNP meter-based account base to large fully automated immunoassay analyzers at significantly lower ASPs. Our ability to compete by selling BNP in the Beckman immunoassay analyzers has allowed us to compete effectively for new business and secure our existing customer base. In the overall BNP market, Beckman continues to be a strong automation player. Bayer offers a competitive BNP assay, a strong automated platform presence, and a panel of Hepatitis assays. The NT-pro BNP players specifically Dade, Roche, and Ortho continue to chip away at the market, but acceptance remains somewhat limited. Most recent cap survey to fix NT-pro market shared about 14% of the total BNP market.

Our total product sales to the POL grew by 39% in the quarter and 31% for the full year to 13.7 million. BNP sales to the POL grew by 28% for the year. The growth in the POL segment was largely driven by an increase from the customer base. The number of active accounts for POL grew 27% in 2006 over the prior year. As you know, we were granted CLIA waiver early last year, the BNP CLIA-waived modifier to facilitate billing and reimbursement took place in January 1, 2006. We believe Triage BNP and the Meter is well-suited to capitalize on this large opportunity within the POL segment of the market.

At the beginning of 2006, we embarked upon a POL initiative that called for the formation of a dedicated sales, marketing and support organization to focus our efforts on this opportunity. Currently, we've a staff of 14 dedicated POL sales representatives as well as two dedicated sales managers. To ensure this POL sales group is properly supported, we have hired and trained seven full-time based POL. What we call CC or TCs, clinical consultants and technical consultants, to support this effort. This field-based technical and clinical support group should have the effective freeing up additional time for our sales reps to focus on closing new accounts and increasing utilization at our existing customer base. Additionally, we are in late stage discussions with other distributors who have experience and successful track records in building POL sales. We believe these potential distributors will augment the efforts of our existing distributors and result in accelerated sales for this segment of the BNP market. We are pleased with our POL investment and successes in 2006. Based on information to-date, we are confident in our projections for POL revenue to grow significantly in 2007.

On the international front, our international business as projected continues to grow at a faster rate than the US. International product sales grew by 26% in the quarter and 24% for the full year to $44.6 million, contributing 15% of total worldwide product sales for the year. International BNP sales grew 33% in the quarter and 26% for the full year. In addition, we experienced significant growth rates with some of our other products. For example, our Triage TOX product grew 84% for the full year, our other cardiovascular products also grew very rapidly, both our D-Dimer and Profiler SOB products grew greater than 100% for the year.

From an operations perspective, I mentioned in last quarter's call that we have established a foundation of direct commercial operations in Western Europe. Specifically in the first half of 2006, we commenced direct operations in The Netherlands and Switzerland, adding to our existing direct operations in France, Germany, Belgium, UK and Italy. From an organizational perspective, we've established a new European headquarters in Morges, Switzerland where we are adding infrastructure and personnel to support our growing European commercial operations.

In 2006, our sales -- sell-through our direct selling organization in Europe grew 32% to comprise 62% of total international sales. In order to support anticipated growth in 2007, we are planning a further expansion of our direct sales organization with parallel investments in field support personnel. In total, we expect to hire more than 15 incremental sales and support staff in 2007.

In the Asia-Pacific area, I mentioned in a previous call that we have hired a GM for Asia-Pacific and opened our Biosite office in Hong Kong. Over the coming year, we will develop strategies to capitalize on the opportunity in the Asia-Pacific regional office.

In closing, we remain pleased with the resilience demonstrated by our BNP franchise. We believe we have developed additional strategies that will allow us to continue to affectively compete in the competitive BNP testing market in 2007. We are enthusiastic about continued growth opportunities, both in the international markets and the domestic POL markets. We are excited about the potential of our product pipeline and look forward to discussing this with you on future calls.

Kim Blickenstaff

Thanks Bob. I will try to wrap things up here and just to provide a little more details on the financial results. Bob's provided most of the details on the revenues; so I will provide some of the details behind the margins and operating expenses. Also, touch briefly on the balance sheet and cash flows and provide an update on our stock buyback programs in 2006. And I will finish it off with the discussion of our guidance for 2007.

My comments on the current quarter will be limited primarily to non-GAAP numbers so to exclude the impact of FAS 123 that relates to stock-based comp. However, moving forward in 2007 where we have comparable year-over-year measures, I'll be discussing guidance primarily on a GAAP basis, which will then include the impact of FAS 123R.

Looking at the revenues I think our product sales, as Kim indicated, were very solid they were in-lined with our guidance we gave last quarter as well as the current analyst consensus. Bob gave most of the details on the revenues, but I would add that the Q4 reductions in stocking levels of our product at Fischer were approximately $1.5 million in the quarter and they were about $900,000 in reduced levels for the full-year.

On the margin basis, overall gross margins this quarter were 6% to 9%. On a non-GAAP basis, full year 2006 gross margin was 70% and continue to hover close to 70% for all of 2005 and 2006, despite declining BNP prices in the US hospital markets. So this was offset by improvements and manufacturing efficiencies, as well as improvements or increases in the sales of our higher price products like Cardio ProfilER, as Bob indicated. Growth in the POL market has also helped offset the hospital price decline.

On an operating expense basis, sequentially our SG&A and R&D expenses increased by about $1.3 million in the quarter, this was primarily due to increases in headcount and material and supply cost associated with our products that are approaching clinical trials as well as some additional license fees.

On income taxes, as noted in the press release, we were able to release amounts from a liability reserve for a potential California State Audit Exposure. Upon completion of the audit this quarter, during the fourth quarter, it was no longer necessary to maintain this reserves which resulted in a benefits to the P&L of approximately $1 million or $0.06 a share. So, on a balance sheet basis, the cash was about $64 million at the end of the quarter, which was down about $95 million from September 30. Of course, we used about $100 million in cash for the stock buy-back program we announced last quarter, bringing the total stock buy-back for the year to about $130 million. I'll give a little more detail on that in a minute. Cash flow from operations was -- again strong $8.3 million for the quarter, and over $75 million again the cash flow from operations for the year. Our CapEx for the quarter was about $4.3 million and for the year it was about $24 million, which includes about $6.4 million investment in our San Clemente plastic facility which took place in September.

So on this buyback -- on the stock buyback program, as Kim indicated, we were able to repurchase and retire about 1.9 million shares under the buyback, under the $100 million buyback we announced in October. This amounted to roughly 11% of our outstanding shares. The accretive effect on our non-GAAP EPS in Q4 was about $0.03 a share or about 4%. Having expected termination date for this program is the end of July 2007 and the ultimate number of shares repurchased and subject to certain collar provisions as I indicated last time that established maximum and minimum number of shares through repurchase. At the current price, we would not expect to buyback any additional shares under this repurchase program, however, fluctuation or decreases in the stock price over the next several months could results in additional purchases.

So when you include the 576,000 share repurchased from Q1, we've repurchased and retired 2.5 million shares in 2006. The expected accretive effect of our 2006 repurchase program is expected to be about 9% on a GAAP basis for 2007. Now if we continue to generate cash flows at high level and our operating cash needs continue at manageable rates and our stock price remains at levels, we believe to be under that, we will consider continuing to repurchase additional shares. So finishing up here on our 2007 guidance again this is on a GAAP basis, we will only be providing guidance for the full year from this point on. So many of the details are included in the press release, I won't rehash all of those

Also as I mentioned, now that we have comparable year-over-year financial data, we will be discussing guidance and future quarter results only on a GAAP basis. From a revenue perspective, we are maintaining the guidance as we've indicated at $326 million or 6%, the BNP sales will be about 200 million, that's up about 2% year-over-year, and some of the end-user assumptions, we expect in the US, end-user kit volumes to be up 5% for 2007 over 2006. And as opposed to a 9% increase in 2006 over 2005, the price erosion about 7% year-over-year, which is similar to what we had in '06. Our other cardiovascular products, such Cardiac Profilers, D-Dimer and Stroke product should be up about 24% year-over-year. We will have some limited new product contributions in 2007 as Ken and Bob indicated, but they will probably be less than $1 million. This is our MPO products and international launches for our sepsis and NGAL acute injury, acute kidney injury products.

So the international POL markets are the two areas that we expect to drive most of our growth this year, continuing to build on the momentum from '06. As Bob mentioned, we're making significant investments in both of these areas designed to grow our presence in installed bases. Margins for the year for 2007 should be at 68.5%, again on a GAAP basis this is down slightly from the '06 number, primarily due to BNP price declines. And as Kim discussed, we intend to initiate several clinical trials in '07. Investments in our clinical trials and infrastructure for these trials is expected to be an increase of about $3.5 million over the 2006 levels.

Operating margins should be consistent from '06 to '07, and we are expecting an increase in operating income of over $3 million or 6% on a GAAP basis. As indicated in the press release, our FAS 123 stock compensation expense in 2007 is going to be about $20 million on a pre-tax basis which is down from $25 million on a pre-tax basis in 2006. This is about a 20% decline year-over-year in the stock compensation expense.

Our full year EPS should be around $2.33 a share, a 6% increase over 2006 levels. For the cash flows basis again we are not assuming any additional repurchases. I am expecting $80 million cash flow from operations, which is consistent with our 2006 level and our CapEx should be roughly about $25 million, again that's consistent with what we had in 2006. A lot of numbers there, a lot of details but with that I will turn it over to question and answers.

Question-and-Answer Session

Operator

(Operator Instructions). Your first question comes from the line of Bill Quirk with Piper Jaffray. Please proceed.

Bill Quirk - Piper Jaffray

Thanks. Good afternoon and thanks so much for all the background on the clinical trial process. First off a quick housekeeping question, did I hear you correctly when you said that the -- Beckman BNP was up 28% year-over-year for the quarter, is that correct?

Kim Blickenstaff

Checking, checking.

Bill Quirk - Piper Jaffray

Alright. And may be I will just jump in the next one then. Ken, question on the sepsis side. The training study, did this include the specific three-marker panel that you are going to take to the validation study or was it a different one?

Ken Buechler

Well, the training study we used to define that panel, right. So the training study in general will be used to either validate a single marker, for example like NGAL where we are looking at the performance of it to verify the performance or it will -- the training study will be used to define the panel. So the Sepsis-1 clinical trial where we measured all those 150 different proteins and found the panel with three markers. So we feel very strongly about that data and about that panel and we are putting together, we have put together a protocol which is called MINDSET to evaluate the performance of that panel of three markers. And that will be the validation trial.

Bill Quirk - Piper Jaffray

Okay, and so the data that’s going to be presented in Belgium in March, that is going to be on what exactly? I am sure that I missed that.

Ken Buechler

Yeah, that’s okay. That will obviously have to be on the training set because the validation study hasn’t started yet.

Bill Quirk - Piper Jaffray

Okay and so we should expect to see some type of release or if we try to state it down that it should basically be multiple data set scan or will there actually specifically be a data set on those three marker panel?

Ken Buechler

Yeah, there will be a data set on these three markers.

Bill Quirk - Piper Jaffray

Okay, got it. And then last question and I will jump back into the queue. Is it just with respect to the three marker panel, are any of these novel or how should we think about IP as this could we method patent or perhaps you can --

Ken Buechler

Well, clearly the panel is novel. The panel of the three is novel. And if you want to wait till March, you can answer your own question. Because Dr. Rivers will say what the markers are?

Bill Quirk - Piper Jaffray

Okay, I understood, thanks very much.

Bob Anacone

This is Bob Anacone and I will respond to your earlier question in Beckman sales. So sales on the worldwide BNP sales in the Beckman Automated Immunoassay Systems grew 28% year-over-year for the quarter to $16.8 million and 47% well on a full-year basis.

Bill Quirk - Piper Jaffray

Very helpful. Thank you.

Bob Anacone

Sure.

Operator

Your next question comes from the line of Alastair Mackay with GARP Securities and Research. Please proceed.

Alastair Mackay - GARP Securities and Research

Hi, good afternoon. The quick question on the myeloperoxidase, 510(k) that's to be resubmitted in a few months. Could you say how many patient samples you'll be submitting for that and how many sites were used? Thanks.

Bob Anacone

Hi, Alastair. We -- well, there will be at least 500 patient samples and clinical sites probably be around 5 or 6. We already have a lot of those 500.

Alastair Mackay - GARP Securities and Research

Sorry, could you say that again?

Bob Anacone

So, there'll be at least 500 samples.

Alastair Mackay - GARP Securities and Research

Okay.

Bob Anacone

And as I pointed out here, those clinical trials are already ongoing for collecting those samples.

Alastair Mackay - GARP Securities and Research

Great. Okay. That's it for me, thank you.

Operator

(Operator Instructions). Your next question comes from the line of Benner Ulrich with UBS. Please proceed.

Benner Ulrich - UBS

Hi, guys.

Bob Anacone

Hey Benner.

Benner Ulrich - UBS

Just a follow-up first on the question regarding BNP on the Beckman platform. What percentage of the volume is now on the Beckman platform?

Ken Buechler

35.

Benner Ulrich - UBS

Okay.

Ken Buechler

Of volume.

Benner Ulrich - UBS

And if I recall that's up from about 32% in the last quarter?

Ken Buechler

Actually, let us just take a look at that. I believe the revenue is 35 --

Kim Blickenstaff

Yes, total revenue is 35% of the total. Are you actually asking about unit volumes?

Benner Ulrich - UBS

Yes.

Kim Blickenstaff

Yes, that would take a little bit to look up, but that's what we have.

Bob Anacone

Total dollar is about 35.

Benner Ulrich - UBS

Okay. And then just as a follow-up. I think on the last call, you had mentioned that in terms of the competitive landscape you had estimated maybe (inaudible) gained about a percent of market share year-to-date, this would have been when you reported the last quarter. How did that look as you got to the end of the year?

Kim Blickenstaff

So, the CAP data was probably the best estimate, right. Total market shares for NT-pro.

Ken Buechler

Total market share is about the latest CAP services depicts about 14% market share for NT-pro.

Kim Blickenstaff

Versus we were 12 a year ago?

Ken Buechler

Versus 11 a year ago.

Benner Ulrich - UBS

Okay.

Ken Buechler

In 2005.

Kim Blickenstaff

Yeah, back to the question on Beckman volume as a percent of total kit volume, it's about 48%.

Benner Ulrich - UBS

Okay. And then so, I would imagine that's up a bit from the last quarter?

Ken Buechler

Yeah, I have about -- this is again US only, 40% of the volume was fourth quarter, it was 39% third quarter, 35% in the second quarter.

Benner Ulrich - UBS

Got it. Thank you very much.

Operator

(Operator Instructions). Your next question comes from the line of Bruce Cranna with Leerink Swann. Please proceed.

Bruce Cranna - Leerink Swann

Thank you, good afternoon everyone.

Bob Anacone

Hi.

Bruce Cranna - Leerink Swann

Bob, I am sorry if I missed it, but if you didn't could you perhaps give us the BNP number? On a dollar basis what was in the quarter OUS? And sorry if I missed it.

Bob Anacone

The BNP number for the US?

Bruce Cranna - Leerink Swann

No, OUS.

Bob Anacone

OUS. I think it was $5.9 million -- $5.9 million.

Bruce Cranna - Leerink Swann

And could you quantify in the US, the POLs or not?

Bob Anacone

$2.4 million. It's in the quarter. For the quarter, $2.4 million

Bruce Cranna - Leerink Swann

2.4 for the quarter. Now did that slow down sequentially or is my model wrong?

Nadine Padilla

I think last year -- last quarter's number was for all of the POL, one that you probably have. So there is another portion in it.

Ken Buechler

So the total POL business was $3.8 million for the quarter. But the BNP was only 2.4 or that 3.8.

Bob Anacone

Total year sales for the POL was about 13.7.

Bruce Cranna - Leerink Swann

Okay, so the BNP piece is 2.4.

Bob Anacone

Yeah.

Bruce Cranna - Leerink Swann

Okay, I got it. And then I guess -- I am a bit confused on MIDAS, and just help me out a little bit is -- does MIDAS support two indications or two filings then, sort of MPO standalone and then on a panel?

Ken Buechler

Yeah, MIDAS would support a number of things like I said. So MIDAS will support MPO, MIDAS will support BNP, and MIDAS will also support the MMX algorithm for the Cardio ProfilER. So that last one, the Cardio ProfilER, as you know measures BNP, troponin, CK-MB, myoglobin. And then we will add MPO to that with the MMX algorithm.

Bruce Cranna - Leerink Swann

Okay, thank you. And last from me and I'll get back in the queue. Just Chris quickly, I want to understand the buyback a little, the math on the press release makes -- look like 52 bucks per share give or take. I guess that's totaled earlier in '06 and also the recent $100 million slug?

Chris Twomey

Yeah, I think they are both around at 52 unchanged.

Bruce Cranna - Leerink Swann

So, can you just help me think about settling with (inaudible) that goes or may be you settle in July, it's not clear to me. But how is that going to work again and their potential cash flow is one way or the other between the two here?

Ken Buechler

Sure. Yeah there's no additional cash flows. So as of now, the price is averaging out in the $52 range. If the price would average something lower than that, we would receive additional shares. But as of this last couple weeks, the price has been above that $52 price. So it has to come back down in order for us to get additional shares, but there is no other cash back and forth.

Bruce Cranna - Leerink Swann

So what would normally be the share count?

Ken Buechler

Pardon me.

Bruce Cranna - Leerink Swann

So what would -- would be the share count?

Ken Buechler

Yeah, right.

Bruce Cranna - Leerink Swann

And your guidance kind of looks like maybe where we have for '07 sort of -- little over 16 million shares give or take?

Bob Anacone

I think it was more like 17 million. Yeah, 17.2 million.

Bruce Cranna - Leerink Swann

I must have another bad sale in the spreadsheet here. So figure around sort of 17 is for the share count for '07?

Bob Anacone

Yeah. Let me just make sure if you got that right. On a GAAP basis, 17.1 million.

Bruce Cranna - Leerink Swann

Okay, thank you.

Operator

(Operator Instructions) Your next question is a follow-up from the line of Bill Quirk with Piper Jaffray, please proceed.

Bill Quirk - Piper Jaffray

Yeah, thank you. Just one last quick draw question on kidney injury, and specifically as we think about the additional trial that we are going to work through here. Is this specific idea and maybe you mentioned it Ken I perhaps could have missed it, but that we want in essence here replicate the children, the data that was from the children population and adult population, is that the idea prior to move in thus far?

Ken Buechler

Yeah, that’s the idea. So for kidney injury, kidney injury can be caused by a whole number of condition where at this point it's going to go after cardiac surgery condition and that will be the [EVAL] trial.

Bob Anacone

Sure, the idea being we just want to make sure that this wasn't something that was normal in children and obviously I just wanted to make sure this replicate in adults.

Bill Quirk - Piper Jaffray

Okay, understood. Thank you.

Operator

Your next question comes from the line of Phillip Gross with Adage Capital Management. Please proceed.

Phillip Gross - Adage Capital Management

Hi -- when do we expect these big clinical trials from MINDSET, MIDAS, KINGPIN to complete? How does that -- how long does that take?

Ken Buechler

Phil, it’s a very good question. As I pointed out in my script, I believe that it's all a function of the enrollment rates. So it's really hard to predict and we've tried to do it in the past and we were usually wrong about it. And so at this point what we're going to do is give you updates as we go along with respect to patient enrollment, give you an idea of where we, the status of them. But, in general, if you're enrolling between 500 and 1000 patients, you have a decent number of sites like 8 to 10 going. You can plan on 3 to 6 months roughly.

Phillip Gross - Adage Capital Management

Okay. Then how long it will take you to kind of analyze the data, prepare for -- I gather it's -- what's the submission going to be? It's not going to be a 510(k)?

Ken Buechler

For which one?

Phillip Gross - Adage Capital Management

For any of them.

Ken Buechler

Well, it's -- yeah, that’s up to the FDA really, and we work with the FDA to serve the most expedited review process. So, it's very difficult to say at this point. We of course believe MPO will be a 510(k) that I can tell you with fair certainty, but the other ones are under negotiation with the FDA at this point, so I can't really comment.

Phillip Gross - Adage Capital Management

Okay. And how long does it take to run the trials and note a kind of collect the data and submit whatever the dossier to FDA?

Ken Buechler

A month or two.

Phillip Gross - Adage Capital Management

A month or two after that?

Ken Buechler

Yeah, don't hope me to it though.

Phillip Gross - Adage Capital Management

No, I understand. I am just trying to get the rough idea. And then people are kind of getting to getting to this number, what -- how should we think about the hospital-based business, it's not the Beckman business? I guess there is two ways to think about. One is that, there is substituting Beckman, so you really can't separate it into two buckets. The other is, the people that are using Beckman, it's either on-board in their hospital or it's not and so that kind of got its own growth rate, that's 27%. And the hospital business which has the old system is getting eroded out by the automated systems and they are not switching to Beckman. Do you see what I am saying? So, I am wondering how we should think about this going forward and what was the growth in the non-Beckman hospital-based business? And how quickly can you get more Beckman systems into those hospitals to kind of get that business to grow or to switch over to automation?

Ken Buechler

Sure. The Meter -- Triage Meter-based hospital business declined marginally in 2006 over 2005. Some of that decline obviously going -- converting over to the automated Beckman system. So, we maintain and secure that business. Some of that has lost the competition.

Phillip Gross - Adage Capital Management

But if the overall BNP was up 2% and point-of-care was up a lot, OUS was up a lot more, Beckman was up 27%. And if you do the math then the hospital-based system must have been down -- hospital-based meter-based system must be down a lot. Am I missing something there, just on this for this quarter, if I look at those numbers and everything else grew.

Bob Anacone

I think one thing you are doing as you are mixing products, so for a point-of-care that was up. That was primarily the cardiac products and not necessarily BNP.

Phillip Gross - Adage Capital Management

Okay.

Bob Anacone

So, you got to be careful about keeping the same product line.

Phillip Gross - Adage Capital Management

Let's talk about that then. The point-of-care business was $2.4 million for BNP, what was it a year ago?

Nadine Padilla

Phil, you are asking really good questions to get information and I don't want to risk giving you the wrong answers with it.

Phillip Gross - Adage Capital Management

Okay.

Nadine Padilla

You have got to be treat the patients. So, why don't I call you after this call and we can talk about that.

Phillip Gross - Adage Capital Management

Okay.

Nadine Padilla

For anyone else who wants the information or (inaudible) line of questions, just let me know.

Phillip Gross - Adage Capital Management

Great.

Nadine Padilla

I just don't want to risk giving you -- putting that information out here right now and I think this requires a thoughtful answer.

Phillip Gross - Adage Capital Management

And then, in terms of the thoughtful response, should we think about this as sort of the Beckman business being kind of down getting in the hospital labs that you need to get now or should we think about it that who cares if the hospital business is shrinking ex-Beckman? Because it's shrinking because Beckman is able to essentially replace the system, I mean, to what proportion is that happening now to maintain the flattish growth in the BNP business? I am just trying to understand whether you kind of done everything, Ken, with Beckman or are people continuing to switch to the Beckman at a rapid pace, so we shouldn't think about that as two different buckets, we should think about as one bucket?

Ken Buechler

There was a rapid pace, but you can continue to get penetration with Beckman systems. And the extent to which we can minimize losses on our own Triage platform, that's -- it needs a stable platform or the stable business on which to build the increased revenues from Beckman, so I think both contribute.

Kim Blickenstaff

Yeah, I can comment.

Phillip Gross - Adage Capital Management

Okay.

Kim Blickenstaff

A significant portion of the Beckman BNP closes are often customers who had never purchased Triage BNP, so they are incremental new closes.

Phillip Gross - Adage Capital Management

Yeah.

Kim Blickenstaff

And that's more than 50% of the new closes.

Phillip Gross - Adage Capital Management

Okay. More than 50?

Kim Blickenstaff

Yes.

Phillip Gross - Adage Capital Management

And when a hospital switches from your own system to Beckman -- this is my last question, sorry about taking so much time, but when the hospital goes from your Triage to a Beckman you are indifferent to the economics on a [protest] basis.

Kim Blickenstaff

Actually, it's not indifferent. You see the utilization jump by about four times over a period of 12 months, and used to it with a small decline in ASP, but the utilization ramps up significantly.

Phillip Gross - Adage Capital Management

Okay, great. Thanks for the answers. I'll call back.

Nadine Padilla

Okay.

Phillip Gross - Adage Capital Management

Thanks.

Operator

(Operator Instructions). Your next question is a follow-up from the line of Benner Ulrich with UBS, please proceed.

Benner Ulrich - UBS

Hey, just another question on Beckman, sorry to pull over this point, what percentage of your customer base that you overlap with Beckman?

Kim Blickenstaff

You mean that is both of Beckman system and a Triage system?

Benner Ulrich - UBS

Yeah or I guess --

Kim Blickenstaff

It's less than 10%.

Benner Ulrich - UBS

Okay. And then do you have any sense for, just kind of based on what your overlap is or what the Beckman footprint is? Or maybe, what their market share is? Is there a point at which there is a maximum percentage of BNP sales or whatever be on the Beckman instrument?

Kim Blickenstaff

Well, probably with the saturation of their installed-base?

Benner Ulrich - UBS

Right.

Kim Blickenstaff

Incrementally they don't gain much year-to-year, but--

Benner Ulrich - UBS

Right.

Kim Blickenstaff

Probably it would be yes.

Benner Ulrich - UBS

Yes. Okay, is there, do you have any sense for where you are in terms of converting their installed-base over to BNP or over to your customer?

Ken Buechler

No, I can tell you that it's not a de-saturation point.

Benner Ulrich - UBS

Okay.

Bob Anacone

I think it's also important to point out that most of the hospitals out there have adopted some sort of natriuretic peptides and so it's not as these people waiting on the sidelines tend to put their platform in place. So, any competition now is perhaps between a Beckman and an Abbott up the high end or Bayer on the high end and we have a pretty good stand on the lower end and so I don't think there's a lot of large volume analyzers going to take our small volume business. That's it.

Ken Buechler

The movement is as utilization grows on our Meter business, there's a natural incentive to move it onto a fully automated Immunoassay analyzer and that's where the movement is in the market.

Benner Ulrich - UBS

Okay.

Ken Buechler

As Chris comment there's a very little movement in mixing of market share amongst the big players as large volume hospitals have already adapted BNP and put it on a large automated systems.

Benner Ulrich - UBS

Okay, so that's 50% of new close is coming hospitals that don't use BNP, that is not a number that would necessarily, that we should expect going forward given that a lot of the hospitals have either a BNP or pro BNP test.

Ken Buechler

Right.

Benner Ulrich - UBS

Okay, thanks.

Operator

Your next question is a follow-up from the line of Phillip Gross with Adage Capital Management, please proceed.

Phillip Gross - Adage Capital Management

Hi. In answer to the last question, it sounds like we really should think about these as two different buckets given there's only 10% overlap and therefore watch the Beckman business as the way to keep growing the BNP business. Is that -- because if there's only 10% overlap that implies that the hospital, they are two separate businesses. Am I thinking about that right or am I doing my math wrong?

Bob Anacone

Yes.

Phillip Gross - Adage Capital Management

Okay, the -- we talked about ASP, are you going to be able to cut cost on the production so that, and is there a different gross profit margin from the Beckman, or you're making obviously a different assay than you're making for the Triage system with a gross profit margins, not ASP? Are the gross profit margins similar on both those two products?

Ken Buechler

The margin on the product that we sell for the Beckman assay platform is lower. So the economics aren't necessarily the same. But again we've had this dynamic from when we owned the 100% of the market to where we are today, and our margins, because of other efficiencies including the new facilities here in light have been able to offset the vast majority of that price decline and that's our guidance since '07.

Phillip Gross - Adage Capital Management

Okay, great.

Ken Buechler

And then in addition, as we convert business to our combined Profiler platforms, the ASPs on those actually are higher than the individual BNP test. So, we have a lot of different dynamics here, the physician's office lab has higher pricing. So, there's a lot of moving parts.

Phillip Gross - Adage Capital Management

Okay, great. That’s helpful, thank you.

Operator

Your next question comes from the line of [Stan Mann with Mann Family Investment], please proceed.

Stan Mann - Mann Family Investment

Hi gentlemen. A question on the purchase of Abbott's Diagnostic business by GE. Do you foresee any positive or negative effect from that changeover?

Kim Blickenstaff

Well -- I think in general that GE is probably going to take more of a global systems approach of integrating, imaging and in vitro diagnostic modalities. They tend to be a value-added company where ancillary support services in software and training and support so forth are a part of how they build the business. Obviously, they try to be a dominant player in any given business. And I think they may operate with a bit more pricing integrity than what we've seen out of Abbott where they tend to buy market share through pricing. I think GE tends to buy sort of a customer [mind] share through a total packet of services. So, they operate businesses well and I think that they may operate Abbott a little bit differently than it has been done in the past because it's going to be a part of a broader product offering. But no one really is going to know until the integration's complete and everybody is operating together as a unified company. I would say that the management of Abbott probably comes from a very different new business mindset than GE. So that will be interest in culturally to see how those folks integrate, but I would tend to believe that you are going to see a more value added approach to a global number of products than you have seen in the past.

Stan Mann - Mann Family Investment

And a second question on Doctor-office penetration, where do you think you are now, where do you think you are going to move to?

Ken Buechler

We are in the very early stages.

Stan Mann - Mann Family Investment

Not even the first space on that of.

Ken Buechler

It’s a very big market opportunity and we are just beginning to break into it.

Kim Blickenstaff

Yeah, it puts off the bag though.

Ken Buechler

Yeah right.

Stan Mann - Mann Family Investment

It's BSSI though your distributor?

Bob Anacone

Pardon me.

Stan Mann - Mann Family Investment

You're distributor, your few distribution model.

Ken Buechler

Yes, its one of the distributors, yes.

Stan Mann - Mann Family Investment

And it’s your prime distributor or do you have two or three.

Kim Blickenstaff

We had Fischer and we also --

Nadine Padilla

Henry Schein

Kim Blickenstaff

And Henry Schein, I am sorry.

Stan Mann - Mann Family Investment

And overseas, international.

Kim Blickenstaff

That depends on the country.

Bob Anacone

Are you talking about the physician's office land Philips?

Stan Mann - Mann Family Investment

Yes.

Bob Anacone

Well that market really doesn’t exist today.

Stan Mann - Mann Family Investment

Then where at PSS where they are going and Henry Schein.

Ken Buechler

They growing the U.S. POL business for us, so it's physician office space, that's roughly greater than 12,000 clear wave of -- wait less in the U.S. We are just beginning to break into that results another 1800 surgery centers that represent opportunity for both BNP and our ProfiLER products. So its early days.

Stan Mann - Mann Family Investment

That penetration is under 5% kind of like U.S.?

Ken Buechler

Sure. Yes.

Stan Mann - Mann Family Investment

Okay, great. Good. Thank you.

Ken Buechler

Plenty of opportunity.

Operator

(Operator Instructions). At this time there are no questions in queue. I would now like to turn the call back over to Mr. Kim Blickenstaff for closing remarks.

Kim Blickenstaff

Okay. I just like to wrap up by saying that during the last year or two we have been laying the ground work for this growing portfolio of products that we have coming out of R&D. And we really have always taken a long-term view of -- we wanted to add the resources that are necessary to support the successful development and approval of the next phase of products that will give us our next phase to grow. So as we have talked about in detail we have added resources both in the POL and the international markets where we think there is significant penetration to be gained by having more bodies in the field or products that are currently available. I think from a certain return on investment both of those decisions have been very wise and it will be contributed to our revenue growth in 2007.

Also we have made the decision on a business basis the change the way we operate in clinical regulatory, our submissions going forward as I said are much more challenging than some of the 510(k)s and slightly accretive PMAs than we had in the year's passed, but this eases the gold standards, indications, reviews, multiple indications are all more challenging than what we have had. And we have made those investments in order to be able to successfully move those products through the clinic and get quality of submissions that will increase the likelihood that will get FDA approvals in the nearest possible timeframe that we can.

Also you have heard us talk about several positive developments during the year, good growth in POL on the international, other cardiovascular product-lines with improvements that are showing good growth, the clearance of the protein CS ratios that we were getting regulatory response and we are making progress there. The commencement of the MINDSET study indicates we are getting our clinical programs well underway with all the protocols necessary and we are staffing and moving ahead on them. And finally, what we can and again we read, we try to built shareholder value if you stock repurchase and have that 2.5 million share reduction over the course of the last year is a major milestone.

So looking forward, in 2007 I think the things to look at is, some of the progress that we are going to be making on the R&D front, we have several clinical studies that are either active or protocols are in development. There is going to be, we will be supporting these products, primary product initiatives, MPO was the next generation for the CardioProfilER sepsis and acute kidney injury and we expect to file for CE-Mark and all of these products in 2007, we will follow-up with post-marketing study in limited launches and furthermore, we think there will be substantial progress with regulatory submission and clearances for these products in the U.S. during the course of 2007.

So we have been operating into these programs since they were relatively new a year ago and advanced by rapidly. They've operated sort of on a stealth basis, there is going to be more opportunity in 2007 to talk about them in a more public forum and we will try to balance being conservative and being responsible on what information we will provide, but obviously with an eye toward investors meeting to know, the latest that we know about how these products perform. I think we will

These are the latest that we know about how these products perform. I think, we'll see during 2007 some late stage developments or from the training trials or some of these products that should provide you some insight as to the products performance. Also, when we launch these products in Europe, you are going to be seeing package insert data will give you better idea of how these products perform. Also, during the year, there will be a number of key events that Kim alluded to. We have the American College of Cardiology conference, it's going to be in late March, in New Orleans, and there is going to various abstracts that will be presented there. There is this International Symposium on Intensive Care and Emergency Medicine, that's going to be taking place in Brussels and Dr. Rivers will be talking about the sepsis data from -- in that particular conference. Also in the World Congress of Nephrology at April, it's going to be several symposia with leading renal experts that we will talk about some of the data what we're finding in terms of our program on acute kidney injury. So, there is going to be a lot of chance, I think to learn about how these products are performing, you get higher confidence about the data that we're producing actually and will result in commercially successful products.

Finally, we'll have our earnings call in late April, I think it's April 25th or on 23rd. And in May, we'll be doing one of our first marketing trips with [Garb], and we'll have the specific days and the time we can see these later on. So, if you want to participate in that Road Show, you can.

And finally, we got to do something little bit different for our R&D Day, we're going to move it up this year. The American Association for Clinical Chemistry will actually be here in Southern California. So, we're going to have our R&D Day here on site at Biosite on Tuesday, July 17th. It will be a 5-hour program at our headquarters. I think it will give you a good idea of -- a good opportunity to see firsthand how the new facility is laid out. How Discovery interfaces with research and development, clinical trial activities and so forth, so you get a better feel, of course and liable about what's going on in these major programs. So, I'll close with those comments, and thank you for listening in on the call and we will talk to you during our next quarterly conference call.

Operator

Ladies and gentlemen, this concludes the presentation. You may now disconnect, thank you and have a good day.

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