Myriad Genetics, Inc.
Q1 2013 Earnings Call Transcript

Published: 6 Nov 2012

[Operator:]

Ladies and gentlemen, thank you for standing by and welcome to the Myriad Genetics First Quarter 2013 Financial Earnings Conference Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer session. (Operator Instructions) As a reminder, this conference is being recorded, Monday, November 5th, 2012. I would now like to turn the conference over to Jim Evans, Chief Financial Officer. Please begin, sir.

[Jim Evans:]

Thank you and good afternoon, everyone, and welcome to the Myriad Genetics First Quarter Fiscal Year 2013 Earnings Call. During the call, we will review the financial results we’ve released today, after which we will host a question-and-answer session. If you have not had a chance to review the earnings release, it can be found in the Investor Relations section of our Web site at myriad.com. Presenting for Myriad today will be Pete Meldrum, President and Chief Executive Officer; and Mark Capone, President, Myriad Genetic Laboratories. Additionally, I will be giving an update on our financial results and future expectations. This call can be heard live via webcast along with a slide presentation at myriad.com. The call is being recorded, and will be archived in the Investors section of our website. Please note that some of the information presented here today may contain projections or other forward-looking statements regarding future events or the future financial performance of the company. These statements are based on management’s current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically, the company’s annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections or forward-looking statements. With that, I’ll now turn the call over to Pete.

[Pete Meldrum:]

Thank you, Jim. Myriad delivered a very strong performance for the first quarter of the 2013 fiscal year. I am pleased to report that the total company revenue increased 21% year over year to reach a new record of $133.4 million dollars. While all of our tests contributed to this excellent performance, BRACAnalysis again demonstrated strong year-over-year growth of 17% as the initiatives that we have put in place to further penetrate the oncology and women’s health care segments continued to progress. COLARIS also contributed and showed impressive growth this quarter as revenues from our colon cancer test grew 26% year over year. With the updated NCCN guideline recommendations and quicker than expected insurance reimbursement, BART revenues increased 188% over the same period of the prior year. Myriad’s other products contributed to our record revenue with a 17% increase compared to the same quarter last year. Both the Oncology and Women’s Health segments performed well during the first fiscal quarter; however, the Women’s Health segment was particularly impressive with a 38% increase in revenue compared to the prior year period. For the quarter, net income increased $30.1 million and diluted earnings per share grew 24% to $0.36. Based on the strong first quarter financial performance, the accelerated growth in Women’s Health segment, and the quicker than expected BART reimbursement, I am pleased to announce that we have increased our guidance for fiscal 2013. We are now projecting revenue in fiscal 2013 to be $570 million to $585 million, which represents a 15% to 18% growth over the prior year. This level of revenue is expected to result in diluted earnings per share of $1.50 to $1.55 in fiscal 2013. Jim will discuss the company’s guidance in more detail later in the call. During our first fiscal quarter, we continued to execute on our strategic directives for long-term revenue growth and product diversification. Underlying this strategy is our commitment to improving patient care through the development and marketing of novel molecular diagnostic tests across multiple medical specialties. Our strategy is focused on reducing inefficiencies and costs in the healthcare system by providing physicians and patients with critical disease information to guide treatment decisions. As a reminder, our three strategic directives are

[Mark Capone:]

Thanks, Pete. I am pleased to provide an update on our strategic directive to grow existing products in our existing markets. Specifically, I will provide commentary on the execution of our strategic initiatives in our Oncology and Women’s Health segments, recent progress on our reimbursement for BART, and an update on the Prolaris launch. To begin, our Oncology segment grew 16% year over year in the first fiscal quarter. With the BRACAnalysis market less than 50% penetrated and the COLARIS market at an earlier stage of development, we continue to believe that significant growth opportunities remain in this segment. The growth was driven by three main initiatives

[Jim Evans:]

Thank you, Mark. It’s my pleasure to present a more detailed look at Myriad’s financial results for the first quarter of fiscal 2013. Diving into Myriad’s revenues for the fiscal first quarter, the summer quarter is a seasonally weak quarter for Myriad, so we were pleased with the record revenue of $133.4 million. This revenue was comprised of molecular diagnostic revenue of $127.3 million, which grew 22% year over year and companion diagnostic services revenue of $6.2 million. The increase in molecular diagnostic revenue was driven by increased patient demand and sample volumes of our existing tests and the strong initial demand for BART. A breakdown of revenue by product reveals that BRACAnalysis provided revenue of about $105 million, COLARIS and COLARIS AP contributed $12.1 million, and BART added $7.6 million. Myriad’s other tests accounted for $2.6 million of revenue. During the month of October, we continued to see strong demand for our products. Turning to Myriad’s operating expenses, this quarter research and development expense increased to $11.4 million, an increase of 34% as compared to the same quarter of last year. This increased R&D expense was associated with the further development of our diagnostic product pipeline such as MELAPATH and the lung cancer prognosis test, as well as support for our nine commercialized products. Myriad currently has 57 clinical studies ongoing and four research papers submitted for publication and progressing through the peer review process. With the recent launch of Prolaris in both pre- and post-prostatectomy settings, the upcoming launch of MELAPATH and the exciting progress in HRD, we are confident that this investment will help drive future growth. First quarter SG&A expense was $56.1 million as compared to $46.1 million in the same period of last year. The 22% increase in SG&A was primarily to support the 21% increase in revenue. At this time last year, Myriad had a sales force of 360 representatives. As we have detailed in our comments today, Myriad currently employs a domestic and international salesforce of 390 representatives. We anticipate modest growth to these numbers during the remainder of the fiscal year as we look to fill out our international sales team and as we build the MELAPATH expeditionary salesforce. Other drivers of the SG&A increase include increased commissions associated with higher revenue, additional investments in our European operations, SG&A costs from Myriad RBM, and a modest increase in bad debt expense versus the prior year. Operating income for the quarter was up 17% to $48.6 million compared to $41.5 million in the first quarter of the prior year, with operating margins coming in at 36.4% or 80 basis points higher than the June 2012 quarter. The first quarter effective tax rate was 39.5%, as compared to 40% in the same period of the prior year. During the quarter, we experienced tax benefits from a number of stock option exercises which helped reduce Myriad’s effective tax rate. We continue to anticipate the effective rate for the fiscal year to come in at approximately 40%. Diluted weighted average shares outstanding were 83.9 million shares and during the first quarter we bought back approximately $40 million or 1.8 million shares of our common stock. As of the end of the first fiscal quarter, Myriad had $53.5 million remaining under our current stock buyback authorization. Diluted earnings per share grew in the first quarter by 24% to equal $0.36. Moving on to the balance sheet and cash flow, we ended the first quarter of fiscal 2013 with $466 million in cash and investments. This compares to $402 million at September 30th, 2011. During that same twelve months, Myriad repurchased $137 million of its current stock – of its common stock and still saw its cash balance increase by 16%. Cash from operating activities equaled $51.4 million during the fiscal 2013 first quarter and capital expenditures were $2.5 million. Through the first fiscal quarter, we were very pleased with the trends that we have seen in sample flows and demand for our tests. That, in combination with the reimbursement decisions for BART and for TRICARE, have resulted in significantly improved expectations for fiscal 2013. As Pete mentioned, revenue is now expected to grow 15% to 18% to a range of $570 million to $585 million. Our original guidance had been $550 million to $565 million, or an 11% to 14% increase. Specifically, molecular diagnostic revenue is now expected to be $545 million to $557 million. Companion diagnostic revenue guidance of $25 million to $28 million remains unchanged. Earnings per diluted share guidance is now $1.50 to $1.55, up from our original guidance of $1.44 to $1.48. The new EPS guidance represents growth in the range of 15% to 19% versus the original EPS growth of 11% to 14%. Other items to be taken into consideration with this updated guidance include, BART has not reached the level of optimization and efficiencies to scale that BRAC and COLARIS have achieved in our lab and will therefore put slight pressure on our gross margins as BART sales levels increase in the future. I don’t see the impact being greater than a single percentage point. We will continue to make investments in research and development with the expectations that R&D expense for the full fiscal year will be approximately 9% of total revenue. In addition to our new sales reps, SG&A will also be impacted by a need for additional customer service and billing representatives to meet the BART demand, as well as by increased sales and marketing efforts to support the launches of Prolaris and MELAPATH. The fiscal 2013 tax rate is still expected to be approximately 40%. Our EPS guidance takes into account the impact of stock buybacks completed to date but does not factor in the impact of any future buybacks. The timing and size of future buybacks will continue to be opportunistic and dependent on market conditions. And finally, we have not been able to fully determine the impact of Sandy on our customers in the Northeast and its potential impact to our revenues from that region. With that, it will be our pleasure to answer any questions you may have. In order to ensure broad participation in today’s Q&A session, please limit your questions to one plus a related follow-up, and then jump back into the queue. Operator, we are now ready for the Q&A portion of the call.

[Operator:]

Thank you. (Operator Instructions) And our first question from the line of Bill Quirk from Piper Jaffray. You may proceed.

[Bill Quirk:]

Great. Thanks. Good afternoon, everybody, and nice quarter.

[Jim Evans:]

Thank you.

[Bill Quirk:]

First question, just thinking about the – Mark, I think you mentioned during your prepared comments, in terms of starting to combine BART plus BRACAnalysis, can you elaborate on that a little bit? I assume you’re going to continue to price those differently and I guess, could you speak then the context that obviously working with Noridian to talk about obviously trying to do a gapfill for one task? Some additional color there will be great. Thank you.

[Mark Capone:]

Sure. Thanks, Bill. Yes. So, historically, if a customer wanted to order BART, they would, on our test request form, they would check a comprehensive BRACAnalysis box and then they would write in that they were also interested in the BART test on a patient. So they were two distinct ordering points on our test request form. We will be rolling out a new test request form that now integrates those two, and in fact, that will be the exact title on a test request form which would be integrated BRACAnalysis, which will then get a physician both the sequencing products and the large rearrangement test as well. So that will become our de facto product. As I mentioned, we anticipate over 50% of patients will have BART reimbursed this quarter. And so as that now becomes the majority of our tests, we think for customers it will be a lot easier to be able to order the integrated product. You’re right, these are – they do have separate list prices, but the BRACAnalysis, comprehensive BRACAnalysis is a $3,340 list price, BART is a $700 list price, and they will continue to be billed as separate codes because in the new molecular pathology coding, they are identified as separate tasks. And so they will be billed separately. In our discussions with Noridian, as we go through the gap-filling process, each of those code, as well as all of the other codes that Myriad has in addition to the others, will all be priced separately in the Noridian cont – in the Noridian discussions. And so we will be gap-filling each of those in a separate process. The last thing I will add is that historically, we have seen about an 8% discount off of list prices for comprehensive BRACAnalysis. We expect for BART that we will see a higher discount off of list price. And I think we’ll provide more clarity on that as we continue to get reimbursement from more payers in the future.

[Bill Quirk:]

That’s great color, guys. I appreciate that. If I could sneak in just two quick housekeeping questions, one is just – can you just – quick comment, Jim, on what the OUS revenue was in the quarter given that you’re building out your team there. And then just secondly to the extent you can give us any comparison on BART, what it was say last quarter and then perhaps if you’re feeling generous fill in the other couple of quarters outside of the first from last year. Thanks.

[Jim Evans:]

Well, we are receiving samples and reporting our results from our European operation. It’s still very early on in its development. We are really getting into the need of building out our sales and marketing capabilities. But revenues from Europe continue to be very modest, but we do feel we are on pace to meet our goal of over $50 million in European revenues by fiscal 2016. As far as the BART breakout of additional information from past quarters, I don’t have that in front of me. I can tell you that a year ago it was $2.6 million versus the $7.6 million that we did this year, but I don’t have information in front of me for those other quarters.

[Bill Quirk:]

Got it. Thanks, guys.

[Operator:]

Our next question is from the line of Derik De Bruin with Bank of America. You may proceed.

[Derik De Bruin:]

Hi, good afternoon.

[Jim Evans:]

Hi, Derik.

[Derik De Bruin:]

Can you hear me?

[Jim Evans:]

Yes.

[Derik De Bruin:]

Hi, good. Sorry, I’m out of the office today for a little bit. So, the – just curious, the – when can we expect results from the Prolaris Phase IV study?

[Mark Capone:]

So, we have completed that. It’s in the process of being submitted to journals for publication; probably hard to predict how long that process takes. Typically, we see anything from six to nine months to ultimately end up with a publication, but the study has been completed. We’ve seen what we expected to see which was a look at the distribution of Prolaris scores across a contemporary set of patients here in the United States.

[Derik De Bruin:]

Okay. And how should we think about the run rate of the BART? Is $7 million – is this – sort of the number we saw this quarter relative, accelerating that over the next couple of quarters the way you think about that?

[Jim Evans:]

Yes. I would think, as Mark detailed out, we – as more patients get reimbursement or as we get more reimbursement covering additional patients, we should see that BART number continue to grow as the year progresses.

[Derik De Bruin:]

Great. Thanks. I’ll get back in the queue.

[Operator:]

The next question is from the line of Isaac Ro from Goldman Sachs.

[Isaac Ro:]

Good afternoon. Thanks for taking the question. I just want to ask on the BART impact you mentioned on margins. Could you clarify what you said there? I think you said 100 basis points or less. Is that the gross margin level, number one? And number two, is that for the year?

[Jim Evans:]

Yes. It is on the gross margin level. We think the maximum impact will be 1%. It really depends on how fast it ramps up. Currently, it doesn’t have the same margins as the tests, BRACAnalysis and COLARIS enjoy. And so there would be a modest impact on our gross margins as we get up to scale on the BART test. I think we saw a minimal impact on gross margins in this first quarter. I would think by the end of the year, you might see that type of impact on an individual quarter. I’m not sure if we’d see it build all the way through for the year’s gross margin.

[Isaac Ro:]

Okay. That’s helpful. And then, secondly, just the hurricane, I know you guys are still assessing it. But maybe could you give us qualitatively speaking some framework as you think about what are the puts and takes there? What are the logistical issues that you were considering there and whatever color you can provide there will be helpful.

[Jim Evans:]

Sure. Thanks, Isaac. Yes, first just our thoughts and prayers are with everybody out in the northeast and I’m pleased to say that all of our Myriad employees are safe although some are still inconvenienced with power outages but at least everybody is safe after Sandy. As you mentioned, we are still assessing that. We will see some short-term impact from Sandy on our sample volumes but I think it’s always difficult to tell how that would translate because as many patients will reschedule those visits that they missed with physicians later on in this quarter, it’s difficult to say exactly how that will translate into sample volume. That being said, we have tracked that very closely over the last week as we reviewed our revised guidance for the rest of this year. We took into consideration any of the things that we may have seen from Sandy and we still feel very comfortable with the guidance that has been revised and we’ve discussed on the call.

[Isaac Ro:]

Got it. Okay, that’s all my questions. Thanks a bunch.

[Operator:]

Our next question is from the line of Doug Schenkel with Cowen & Co. Please proceed.

[Doug Schenkel:]

Good afternoon. You indicated that you expect 50% of BRACA patients to have coverage for BART in fiscal Q2 and this is – you’ve pointed this out in the context of talking about now selling or at least I guess basically having the default product being integrated BRACAnalysis. With that in mind, what are you – what percentage of patients do you expect to have the integrated BRACAnalysis products run on, I guess in the context of what your model – what you’re incorporating into full-year guidance?

[Mark Capone:]

Yes. I think – thanks, Doug. As I mentioned in my prepared comments, we saw 35% in the first quarter; in the second quarter we’re anticipating over 50% will end up having BART reimbursed with BRACAnalysis which is why we’re shifting to the integrated product on our test request form for the second half of the year. As far as the actual percentage above that, it’s a little difficult to say at this point as we’re still in discussions with all of our payers. We have – as we anticipated guidance, we have taken into consideration that 50% that we see here in the second quarter and expect that obviously to continue through the rest of this year. We do think in the cases where BART is not being reimbursed, generally it’s unlikely that a patient would necessarily pay those costs out of pocket and so, for the most part, our expectations around BART are really consistent with the level of reimbursement that payers are providing since out-of- pocket costs generally patients have shied away from those. So we’ll provide some additional color on the next call on where we are above 50% but at least for now, that’s our current status.

[Doug Schenkel:]

Okay, thanks for that. And one, I guess, unrelated follow-up and I apologize if I missed this in your prepared remarks. R&D as a percentage of sales in the quarter was a little bit lower than we expected. This may just be a function of the revenue beat but again, you guided to – guided R&D expense to 9% of sales for the full year. I’m just curious, were there any R&D expenses that shifted out of Q1 into subsequent quarters just for timing reasons?

[Jim Evans:]

Yes. That’s something that we do see as we have our research and development expenses come through that it is a little bit lumpy and it all depends on when samples are received, when we’re able to enter into additional clinical studies and how they progress. So it is a lumpy number. We do still anticipate having for the full year R&D come in at about that 9% of revenues. As revenues have come in higher than we had originally anticipated for the quarter, we are looking at other research and development projects that make sense to be funded. So that is something I would think we will catch back up to in the coming quarters.

[Doug Schenkel:]

Okay. Thanks again.

[Operator:]

Our next question from the line of Scott Gleason with Stephens.

[Scott Gleason:]

Hey, guys, congratulations on a good quarter. I guess, first off, Pete, you mentioned MELAPATH as a new product that you guys are going to be launching, here in the second half of the year. Can you talk a little bit about your strategy from a clinical validation standpoint and reimbursement standpoint? And I guess, when we think about expenses, the salesforce, can you give us an idea of how large that’s going to be?

[Pete Meldrum:]

Yes. The MELAPATH product is going to be marketed primarily to dermatopathologists. As I mentioned we’ll have an initial salesforce of one national sales manager and six sales reps. We’ll continue to expand that as MELAPATH begins to show progress and take off. It’s hard to project right now but it’s a fairly concentrated physician market so it’s not going to be a huge salesforce but probably something in line with our urology salesforce for Prolaris. We are working at the present time in terms of preparing groundwork for getting reimbursement for MELAPATH and we feel very comfortable with the clinical utility and the value it offers. In terms of being able to identify in so many of these patients, almost 300,000, where they can’t identify whether it’s a malignant or benign nevi, that this is very critical information in the treatment of those patients. And so we’re optimistic about reimbursement coverage. Until we get reimbursement coverage, like with all of our products, we don’t anticipate significant sales ramp. And so we really are focused right now on getting professional society guidelines in place and insurance reimbursement.

[Scott Gleason:]

Great, thanks. And then just one other quick question. I guess when we look at BART testing, you guys mentioned that you’re getting a larger discount to list price. I guess can you give us any kind of idea of kind of where you’re getting paid today when we’re thinking about the model going forward?

[Mark Capone:]

Thanks, Scott. So when you say where we’re getting paid, are you referring to specific insurers or...?

[Scott Gleason:]

Not just from average reimbursement dollar amount.

[Mark Capone:]

Right. Yes, I think as I mentioned, we are discounting more than we would have traditionally on BART. It’s probably a little premature to talk about ASP just because we still have quite a few insurance companies to ultimately contract with. And so while I say the discount is higher than our traditional 8%, it’s still – they’re still pretty attractive reimbursement level where we are today, and I think on our next call, we’ll probably be in a better position to provide a little more accurate ASP on a go-forward basis.

[Scott Gleason:]

Okay. Thanks for taking my questions, guys.

[Operator:]

Our next question from the line of Jon Wood from Jefferies. You may proceed.

[Jon Wood:]

Hey, thanks a lot. So, either Mark or Pete, just another BART one, sorry. You guys have kind of projected up to 50% in the second quarter and then you’ve leveled it out in the back half of the year at 50%. Did I understand that correctly?

[Mark Capone:]

Well, what we have said is we expect in excess of 50% this quarter and we – our guidance presumes that that type of reimbursement level will continue throughout the second half.

[Pete Meldrum:]

Again, that’s totally dependent upon our ability to negotiate with some of the remainder of the insurance companies that don’t yet cover BART, and that’s hard to project at this time. So we’re forecasting maintaining at 50%, but we’re certainly going to try to expand that in the third and fourth quarters.

[Jon Wood:]

All right, understood. And so that would give me something around $45 million of revenue in 2013. Is that about right, Jim, from a modeling perspective?

[Jim Evans:]

It’s difficult to say, as Pete said, exactly where that’s going to come in. That’s probably not too far out of the ballpark of what we were expecting in our models.

[Jon Wood:]

Okay, great. And then one last one, just, if you look at the Oncology versus the Women’s Health segments, can you help with what percent of BART is going into each of those buckets? I guess what I’m looking for, is BART skewed heavily or – more heavily to either one of those from a contribution perspective?

[Mark Capone:]

No. It’s pretty consistent, Jon, across both in proportion to the number of comprehensive BRACAnalysis that are ordered. So we don’t see – the ratio of BART to comp BRAC really is the same in both of the segments. We don’t really see a material difference.

[Jon Wood:]

Okay, great. All right, thanks a lot.

[Operator:]

Our next question from the line of Michael Yee from RBC Capital Markets. Please proceed.

[Michael Yee:]

Thanks. Sorry to ask another BART question, but I’m trying to do the back-of-the-envelope math and you said that $7.5 million this quarter and $2.5 million or so last year is a little more than a doubling. But if you’re saying there’s 35% of coverage of BRAC testing was now covered by BART; can you just sort of tie together that math? Did all 35% of BRAC patients actually get billed and booked for BART, or is it a percent of the 35% that’s covered? Help me explain and walk through that math there. How many tests, let’s say, how many tests were actually done for BART this quarter?

[Mark Capone:]

Sure. Thanks, Michael. So the 35% is – of the patients that got comprehensive BRACAnalysis test results, 35% of those patients also got BART results, so that’s where that $7.6 million comes from, are those 35% of the comprehensive BRAC patients that also got BART testing.

[Michael Yee:]

And so you think that 50% of them would be getting comprehensive testing and now getting BART and that’s – because I’m not tying up the numbers right, maybe you can tell me how many actually got tested, how many tests and then versus last year?

[Mark Capone:]

Yes, I don’t actually have number of tests in front of me. We can – maybe this is something we can even talk about in some other detail. What we were saying is for the second quarter we would expect in excess of 50% of the patients that had comprehensive BRACAnalysis test results, we’d expect an excess of 50% of those to also receive a BART test for the second quarter. So, we have mentioned that average list price for comprehensive BRACAnalysis is $3,140 for the private payers, $3,340 for Medicare, so you can get some sense of volume of comprehensive BRACAnalysis tests, and then 35% of that for Q1, 50% of that for Q2 will give you some idea on the number of tests for BART.

[Michael Yee:]

Okay, thanks.

[Operator:]

(Operator Instructions) Our next question is from the line of Amanda Murphy from William Blair. Please proceed.

[Amanda Murphy:]

Hi, thanks. I have a follow-up from a previous question on the two different segments, Oncology and Women’s Health. So, if you chip out BART at this point, obviously that’s growing too. But how are you guys thinking about the underlying growth rates for these two businesses at this point and if you think about the next year or so?

[Mark Capone:]

Yes, thanks, Amanda. If you take out the impact, as Jim mentioned there was a – year over year about a $5 million revenue impact and so that equates to roughly 4% of that 21% growth. So, where you could back that out and look at organic growth in the absence of those BART revenues, I think you’re still looking at what we would consider to be very healthy growth in both the Oncology segment, which grew at 16% inclusive of BART, and the Women’s Health segment, which grew 38% inclusive of BART. So the both of those segments, backing out the BART impact, we still saw some very nice growth rate, in particular I think in the Women’s Health segment, which continues to see accelerating year-over-year growth rates.

[Amanda Murphy:]

And you think that that’s reasonably sustainable?

[Mark Capone:]

Well, I think we always come back to what is the untapped market potential. For Women’s Health, we know we’re less than 10% penetrated in that market, so there’s still significant untapped potential. We think we have a very good idea what’s driving the growth in that marketplace, and those are the strategic initiatives that we went through. And so we continue to think there’s good opportunity for growth in that segment. And on the Oncology segment, same thing. We know the growth drivers, we’re focused on executing those three growth drivers, so being less than 50% penetrated in Oncology, there’s still opportunity for growth in that market, so...

[Pete Meldrum:]

And, Amanda, I think if you look at our revised upward guidance, 15% to 18%, we have confidence for continued growth in both the Oncology and the Women’s Health segments.

[Amanda Murphy:]

And then how are you guys thinking about potential pricing coming out of Noridian in terms of your guidance at this point?

[Jim Evans:]

Right now, we’re not expecting any cuts to our current level of reimbursement as we’ve put our guidance together.

[Amanda Murphy:]

Got it. Okay. And that means the range that you’ve put out there does not – basically just assumes flat reimbursement?

[Jim Evans:]

Correct, yes. There’s really no pricing impact.

[Amanda Murphy:]

(Inaudible). Okay, thanks.

[Operator:]

Our next question is from the line of Tycho Peterson from JP Morgan.

[Tycho Peterson:]

Hey, good afternoon. First question on COLARIS. This is the last quarter I think you do, before you anniversary the addition of PMS2. Can you just talk us through – are you still thinking that that goes back to mid-teens growth going forward or do you think there’s a chance you could actually do a little bit better?

[Mark Capone:]

Yes. Thanks, Tycho. This is the first – as you mentioned, this is the first quarter actually where we have comped out the impact of PMS2 and so the growth rate we saw this quarter year over year of 26% really factors out that PMS2 impact. So you’re right, that COLARIS growth in Q1 exceeded that mid-teens guidance we provided on the last call. We are encouraged about COLARIS and as we have increased overall guidance for the rest of this fiscal year, certainly with the first quarter’s growth, you’d expect that that mid-teens is something that’s certainly doable for the rest of this year. We’ll have to see how the rest of the year plays out but 26% in the first quarter was above our initial expectations.

[Tycho Peterson:]

And was there something specific that drove that? Was it the realignment of the salesforce or something from your end that drove that?

[Mark Capone:]

I think there’s a couple of things. You mentioned one which is that now that we’ve put in the colon-focused specialist team in the Oncology segment, clearly that was responsible for some of that growth we saw, over a doubling of sales in the colon specialist team quarter over quarter, so that was certainly part of that. Now that we’ve added two additional teams and as they get trained, we would expect their impact to probably – that they would have some impact in the last two quarters of the year. That was one of the reasons. The other is we’ve really been successful at just driving increased awareness and demand with physicians. I think overall colon cancer awareness clearly has been on the rise for the last few years, and I think we’ve been able to drive some additional awareness, not only from the market perspective but even with our physicians, as more and more physicians become comfortable with genetic testing in general, so that’s the second component, is just overall increasing demand. And the third thing is, we think we’re successfully competing for market share in that segment. As you know, that’s a segment that is not proprietary and so there are other laboratories that do testing and we think we’ve been successful like competing for some of that other share. We believe we’re the market leader with over 70% share, but we continue to believe that we gained some share because of the benefits that we offer with customer service, turnaround time and the highest sensitive test on the market.

[Tycho Peterson:]

And then on the... yes, sorry.

[Pete Meldrum:]

All of these as you’ll note will continue into future quarters. So there was nothing unusual or special about this quarter.

[Tycho Peterson:]

And then on the regulatory front, can you just talk what you’re expecting out of forthcoming LDT regulations?

[Mark Capone:]

Yes, I think obviously that the activity around laboratory developed test regulation has waned in the past year or so. I think as the FDA asked for public comments, it probably that – the level of comments and the complexity probably exceeded their initial expectation. So I know the FDA has continually thought about what is the most appropriate way to potentially have additional regulation around LDTs. What we do know is that there was legislation passed that would require the FDA to provide six months’ notice before they were to publish even what would be considered draft guidance around laboratory developed test regulations. And so we will have at least a six-month window before any sort of LDT guidance would be issued. As we look at their work products for their fiscal 2013, it was not necessarily clear that laboratory developed tests would be one of those work products. So it’s an area we continue to monitor but it is certainly one that is quite complex and I know the FDA has really tried to sort out all of the various comments they’ve had and figure out how to regulate, if they’re going to regulate, in a way other than what they have historically.

[Tycho Peterson:]

Okay. Thank you.

[Operator:]

Mr. Evans, it appears we have no further questions at this time. Sir, I will turn the call back to you for your closing remarks.

[Jim Evans:]

Great. Thank you very much. Thanks, everyone, for your participation on the call today. This does conclude our earnings call. A replay will be available via webcast on our website for a week. Thank you again for joining us and we’ll talk to you next quarter.

[Operator:]

Ladies and gentlemen, this does conclude the conference call for today. We thank you all for your participation. Have a great evening, everyone.