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Myriad Genetics, Inc. (MYGN)

Q1 2016 Earnings Call· Tue, Nov 3, 2015

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by and welcome to the Myriad Genetics First Quarter 2016 Financial Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer session. As a reminder, this conference is being recorded at Tuesday, November 3, 2015. I would now like to turn the conference over to Mr. Scott Gleason, VP, Investor Relations. Please, go ahead.

Scott Gleason - Vice President-Investor Relations

Management

Thanks, Galina. Good afternoon, and welcome to the Myriad Genetics first quarter earnings call. My name is Scott Gleason, and I am the VP of Investor Relations. During the call, we will review the financial results we 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 on the Investor Relations section of our website at myriad.com. Presenting for Myriad today will be Mark Capone, President and Chief Executive Officer, and Bryan Riggsbee, Chief Financial Officer. This call can be heard live via webcast at myriad.com. The call is being recorded and will be archived in the Investors section of our website. In addition, there is a slide presentation pertaining to today's earnings call on the Investors section of our website. Please note that some of the information presented 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'm pleased to turn the call over to Mark Capone. Mark C. Capone - President & Chief Executive Officer: Thanks, Scott. Good afternoon, and thank you for joining the call today. I'm pleased to provide an overview of our fiscal first quarter 2016…

Bryan Riggsbee - Chief Financial Officer

Management

Thanks, Mark. I am pleased to provide an overview of our financial results for the first quarter. First quarter total revenues were $183.5 million compared to $168.8 million in the same period in the prior year. Importantly, we delivered our second sequential quarter with year-over-year growth with revenue increasing 9%, compared to the same quarter in the previous year. As a reminder, we believe we are in an excellent position to grow on a year-over-year basis throughout each quarter of fiscal year 2016. Hereditary Cancer revenue was $157 million this quarter and was up approximately 4% year-over-year and down approximately 4% on a sequential basis due to summer seasonality. As Mark mentioned, we ended the quarter with 80% of incoming samples being ordered as myRisk. Vectra DA revenue in the first quarter was $11.4 million, which was up 8% year-over-year. As Mark noted earlier, we performed approximately 38,000 tests in the first quarter. Revenue associated with our Pharmaceutical and Clinical Services business was $11.6 million and was up 168% year-over-year. As with last quarter, our German clinic generated approximately $5 million of revenue in the quarter, which accounted for most of the year-over-year increase. Our Myriad RBM subsidiary generated $6.5 million of revenue in the quarter. Gross margins were 80.1% in the first quarter compared to 79.3% during the first quarter of last year. The main driver of gross margin expansion has been improved efficiencies in our myRisk hereditary cancer laboratory, which was offset some by lower margin clinic revenue. Excluding the impact of the clinic in the quarter, our gross margins would have been 81.3%. Looking forward to the second quarter, we should continue to see incremental margin improvement, based upon the positive impact of Medicare reimbursement for Prolaris and higher fixed cost absorption associated with increased hereditary cancer…

Scott Gleason - Vice President-Investor Relations

Management

Thanks, Bryan. As a reminder, during today's call, we use certain non-GAAP financial measures. A reconciliation of GAAP financial results to non-GAAP financial results and a reconciliation of GAAP to non-GAAP financial guidance can be found under the Investor Relations section of our website. Now, we are ready to begin the Q&A session of our call. In order to ensure broad participation in today's Q&A session, we're asking participants to please ask only one question and one follow up. Operator, we're now ready for the Q&A portion of our call.

Operator

Operator

Thank you. Our first question comes from the line of Amanda Murphy of Blair William (sic) [William Blair]. Please, go ahead. Amanda L. Murphy - William Blair & Co. LLC: Hi, good afternoon. So I had a couple of questions on the CDx product, actually the first one really is about the Hereditary Cancer business. So in terms of the growth rate this quarter, you know, you guys I think said before that you expected kind of market share losses to offset any market growth. So I was just curious, given the 4% growth this quarter kind of how to think about the contribution from the CDx product vis-a-vis kind of broader market growth, just trying to get a sense of those two dynamics in the quarter? Mark C. Capone - President & Chief Executive Officer: Yeah, thanks, Amanda. Couple of comments, I think from the CDx product perspective, as we've discussed in other calls, we include BRACAnalysis CDx in the Hereditary Cancer only because the patients that are eligible for that are all ovarian cancer patients, and that's the same patient group that's eligible for an hereditary cancer test. And because of that, it's difficult to tease those out separately, so we include CDx in that number. So that 4% year-over-year number would include any additional patients that – ovarian cancer patients that had BRACAnalysis CDx, but recognize some of those ovarian cancer patients may have had, in the prior year, may have had a myRisk test, so that's why it gets difficult to actually tease that apart. So we look at all of that as a singular line item in Hereditary Cancer. I think the 4% year-over-year growth that we saw in the first quarter, just as a reminder, in the guidance that we provided, we provided guidance…

Operator

Operator

Thank you. Our next question comes from the line of Doug Schenkel of – sorry, of Cowen & Co. Please, go ahead. Doug Schenkel - Cowen & Co. LLC: Okay. Good afternoon, guys, and thank you for taking the question. Some nice continued momentum outside the U.S. I apologize if I missed this in your prepared remarks, but is your expectation that as a percentage of sales, international sales will continue to grow from here? And if that is the case, would that imply that you're expecting U.S. hereditary cancer testing revenue growth in the low single-digit level? And I guess related to that, if that is the case, recognizing you believe share loss has stabilized and that there is continued market growth, should we conclude that there is some assumed pricing headwind built into guidance, and is that likely a function of the fact that you are maybe giving up a little bit of price opportunistically to lock-in payers over three-year periods? Thank you. Mark C. Capone - President & Chief Executive Officer: Okay. Thank you, Doug. I'll see if I collected all those questions with the answer. So first from an expectation on the international piece, we don't provide specific guidance for the international segment of the business separately. What we did say for the quarter is that we saw 4% of revenues attributed to the international business. That was consistent with what we had seen in the fourth quarter. We also have stated that we expect the international business to grow at – to 10% of total revenue over the next five-year timeframe, but recognize that's, of course, on a base that's growing, as well. So that would represent some pretty nice growth for the international business over that five-year timeframe. From an Hereditary Cancer perspective, what…

Operator

Operator

Thank you. Our next question comes from the line of Jack Meehan of Barclays. Please, go ahead.

Jack Meehan - Barclays Capital, Inc.

Analyst

Hi. Thanks, and good afternoon. I wanted to start and just ask one more about the gross margins, and I appreciate the commentary about breaking out the clinic. I was wondering if you could just maybe give a little bit more granularity around the Hereditary business versus maybe what the sort of headwind from Prolaris and Vectra was if you have that available? Mark C. Capone - President & Chief Executive Officer: Thanks, Jack. I think probably the best we can do is to break out the clinic impact, and as we said, once you break that out, you have an 81.3% gross margin number. Recognize that in this quarter because we didn't see any revenue from Prolaris, that there really wasn't any change in the relative impact of Prolaris to that gross margin. And so, we didn't see that in this quarter. Bryan, any other comments?

Bryan Riggsbee - Chief Financial Officer

Management

Yeah. I would just say that we've continued to see the improvements in the myRisk lab that we had talked about last year, and that has certainly taken place, and you've seen nice improvement year-over-year. So I think that's about all we can say.

Jack Meehan - Barclays Capital, Inc.

Analyst

Got it. One on Vectra DA and just the volumes and the trajectory from here. I was curious if maybe you can just talk anecdotally how things or what sort of – what happened in the operating environment after the LabCorp agreement kicked in and just the level of visibility into some of the sales practices kicking in? Mark C. Capone - President & Chief Executive Officer: Yeah. Thanks, Jack. Obviously early in the LabCorp agreement at this point. We've been very pleased with the partnership in the month or so that we've been working together, or in the couple of months we've been working together. As we mentioned, there is a quarter of rheumatologists that don't have access to phlebotomy services, and so that logistic for this protein-based test really made it very difficult if not impossible for them to use the test. And so, we've been very pleased at the receptivity by those doctors about the logistics now that we're able to access the PSCs from LabCorp. So early to report on any trends, but certainly we've so far been very pleased with that ability to at least broaden the penetration into that market. And then from – the other major initiative, of course, is practice integration. We saw enough promising signs of that, that we've now begun training a larger portion of the sales force earlier than we had originally anticipated. So we'll train 20% of them this quarter, and then we'll be training the rest of them in the third quarter, so that we can begin to roll out this program. So, again, probably too early to make broad commentary since we just have started that additional training, but all the early signs would suggest that the success we've had with that approach in the Preventive Care segment is one that we would hope to replicate in the rheumatology segment.

Jack Meehan - Barclays Capital, Inc.

Analyst

Got it. Okay, thanks, guys.

Operator

Operator

Thank you. Our next question comes from the line of Tycho Peterson from JPMorgan. Please, go ahead.

Tycho W. Peterson - JPMorgan Securities LLC

Analyst

Hey, thanks. Wondering if you can kind of call out, there were some kind of one-timers I guess in the quarter, Prolaris, the impact of CMS reimbursement from October 15 versus the original expectation of October 1. And then on Hereditary, you lost a week a year ago, so the comp was quite easy. So can you maybe talk about what the normalized growth would have been against the Hereditary business if you didn't have that missing week a year ago? Mark C. Capone - President & Chief Executive Officer: Yeah, thanks, Tycho. Yeah, when we did the call last, I think, last quarter, we had expected reimbursement beginning on October 1. That in the final LCD actually slipped to October 15. Obviously, that's a couple of weeks that we will have to rely on retrospective reimbursement as opposed to prospective reimbursement. As Bryan mentioned, we are obviously pursuing retrospective reimbursement because the final LCD was posted by Palmetto in January of 2015. And so, those two weeks would fall into that category of retrospective reimbursement, if in fact, we're successful at obtaining any of that. Despite that two weeks, that's obviously offset by the good news that Tufts Health Plan has decided to cover Prolaris, and importantly, decided to cover Prolaris across all risk categories. So as a result, we've got some upside to that that was not built into additional guidance, offset by a couple of weeks that would have to be retrospective, and the net of that is we chose not to modify our guidance for Prolaris in this year. I think from an Hereditary Cancer comparable, I think you're referring to the last year when we were in the midst of transitioning a large percentage of the market from traditional single syndrome testing to myRisk testing, which we did see an impact from that transition last year. And so, that 4% year-over-year number would be modified by any of the impact we saw from that transition a year ago. Obviously, we took all that into consideration when we provided guidance in the first place, and that's – that was all incorporated into that 1% guidance revenue increase for myRisk this year for Hereditary Cancer this year. So all of that was factored into that. And again, we saw 4% year-over-year, which was ahead of our expectations and have maintained our year-end guidance of a 1% growth in Hereditary Cancer.

Tycho W. Peterson - JPMorgan Securities LLC

Analyst

And then, I know you don't like to give a lot of granularity on specific payer plans, but United I think has kind of come out with a policy now to require genetic counseling from third parties as of January 1. This has kind of been out there for a while, but it seems like they've formalized it a bit. Can you maybe just talk on that dynamic and whether you see other payers potentially following suit? Mark C. Capone - President & Chief Executive Officer: Yeah. I think the United Healthcare policy requires a appropriate authorized healthcare provider to provide genetic counseling prior to testing. This has been a recommendation actually from a variety of sources for many years that a healthcare provider ensure that they have appropriate education and training in order to provide counseling, and that's what United formalized. They will require an attestation from a physician that, in fact, they are capable of providing that genetic counseling, and the details of that attestation have yet to be finalized on exactly what that might look like. I know that a variety of medical professional societies, including SGO, SABS (58:04), ASCO, ACOG, all firmly believe they've invested millions of dollars in training their healthcare providers for decades, and in that fact that those healthcare providers are capable of providing this type of counseling as they do with many other situations that they face as a healthcare provider. And so, I think they certainly believe that by that fact that those – their healthcare providers would all be appropriate to provide this type of counseling. Those are all details that I think are being worked out. But from our perspective, we don't see an impact to our business since we've invested heavily, as well, in training for all the variety of healthcare providers, as well as all these other medical professional societies have invested in their training, as well. So we'll have to see as that finalizes here over the next few weeks and takes effect in January 1, but we expect all our very experienced healthcare providers to attest that they have the expertise to provide this.

Tycho W. Peterson - JPMorgan Securities LLC

Analyst

Okay. Thank you.

Operator

Operator

Thank you. Our next question comes from the line of Bill Quirk of Piper Jaffray. Please go ahead. William R. Quirk - Piper Jaffray & Co (Broker): Great, thanks. And good afternoon. First question, Mark, I just wanted to clarify, in your prepared comments, you mentioned that 50% of all revenue is under long-term contracts. I think in the past you referred specifically to 45% and referred to myRisk. So I just wanted to clarify, is that 50% number related to myRisk, or you're talking about the entire business? Thanks. Mark C. Capone - President & Chief Executive Officer: Yeah. Thanks, Bill. That 50% and, in fact, given the complexities of this – the way we've really talked about this I think at Investor Day and even before that is the percent of our Hereditary Cancer business because trying to tease that out separately gets very difficult. And so, it's 50% of our Hereditary Cancer revenue is under long-term contracts. Now, you're correct, that was 45% when we had Investor Day in September. Over the past few months, we've been able to expand that through additional Blue Cross Blue Shield contracts, and that's what's now driven that number from 45% to 50% of our Hereditary Cancer revenue is under long-term contract. William R. Quirk - Piper Jaffray & Co (Broker): Got it. And then, as a follow-up, just I guess kind of a competitive dynamic question. You mentioned at the Analyst Day that your market share, specifically within the OB and the Onco channel, remains particularly strong relative to the genetic counseling segment. And I'm just curious whether or not you've seen any increased competitive activity in those two other physician groups, or is it still – are they still predominantly calling on the genetic counselors? Thank you. Mark C.…

Operator

Operator

Thank you. Our next question comes from the line of Anne Edelstein of Bank of America Merrill Lynch. Please go ahead.

Anne M. Edelstein - Bank of America Merrill Lynch

Analyst

Hey. This is Anne calling in for Derik. The first question is maybe how much more do you guys expect to drive out of the lab optimizations, the myRisk lab optimizations that have helped you in the last couple of quarters? And then, a longer term question on the PAMA legislation, I think that there's a sense and some confusion around how that impacts you when it goes into effect in 2017. Just thinking about the reimbursement risks of the 2016 preliminary schedule out for Vectra, how exactly do the 2016 CLFS reimbursement determination play into your fee under PAMA?

Bryan Riggsbee - Chief Financial Officer

Management

Yeah, Anne, this is Bryan. I'll take the margin question. We haven't talked – we would expect to continue to gain efficiencies in the myRisk lab as we implement new processes, work with vendors and suppliers. What we have guided on for the year is 200 basis points to 300 basis points expansion in our operating margins, and we think we're well on track to do that, so we'll continue to work on those through the year. As we said on the call, we expect – we were a little light in our R&D and SG&A spend in the quarter, so that was a helper this quarter and is what got us already to the 25% to 25.3% level adjusted. But we would expect to continue to drive efficiencies in that lab. Mark C. Capone - President & Chief Executive Officer: And then, Anne, on the PAMA legislation. So I think the intent of PAMA was to begin to take effect in 2017. We're obviously in the period of time where CMS has to promulgate regulations consistent with that legislation. Those have been late by six months, and we're now just in the – saw the first draft, the proposed regulations around PAMA that we are all actively commenting on. I think from a big picture perspective, the idea behind PAMA was to ensure that Medicare is paying the median weighted price, private payer price for diagnostic tests, which gives us as an advanced diagnostic company some line of sight into exactly how Medicare is going to price products, and any changes in pricing would be reflected in that same mechanism. So to the extent that private payer pricing remains consistent and constant, so would Medicare pricing. So I think for advanced diagnostics, it provides that line of sight and visibility and transparency on precisely how pricing will be determined, which we think overall is a very good thing for the industry and for Medicare that has consistently had questions about how their payments compared to private payers.

Operator

Operator

Thank you. We now turn the conference over back to Mr. Scott Gleason.

Scott Gleason - Vice President-Investor Relations

Management

Thank you. This concludes our earnings call. A replay will be available via webcast on our website for one week. Thanks again for joining us this afternoon.