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Myriad Genetics, Inc. (MYGN)

Q3 2016 Earnings Call· Wed, May 4, 2016

$4.87

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by and welcome to the Myriad Genetics Third Quarter 2016 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. As a reminder, this conference is being recorded Tuesday, May 3, 2016. I would now like to turn the conference over to Mr. Scott Gleason, VP-Investor Relations. Please, go ahead, sir.

Scott Gleason - Vice President-Investor Relations

Management

Thank you, Cleona. Good afternoon and welcome to the Myriad Genetics fiscal third quarter earnings call. My name is Scott Gleason. I'm 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 and which will be filed upon the call on Form 8-K. 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 and forward-looking statements. With that, I'd like now turn the call over to Mark. Mark C. Capone - President & Chief Executive Officer: Thanks, Scott. Good afternoon and thank you for joining our call today. I'm pleased…

Bryan Riggsbee - Chief Financial Officer

Management

Thanks, Mark. I am pleased to provide an overview of our financial results for the third quarter. Third quarter total revenues were $190.5 million, compared to $184.4 million in the same period in the prior year. Importantly, we delivered our fourth straight quarter with year-over-year growth with revenue increasing 6% compared to the same quarter in the previous year. Hereditary cancer revenue was $156.3 million in the third quarter and was down 2% year-over-year. As Mark mentioned, we did see a small impact in the quarter from UnitedHealthcare, based upon additional processing time for these samples, but did not believe this impact will repeat in future quarters. Consistent with this expectation, we do expect hereditary cancer revenue to grow on a sequential basis in the fourth quarter. Vectra DA revenue in the third quarter was $12.3 million and was up 17% year-over-year. However, volume was up 18% year-over-year and 11% sequentially. This represents the highest rate of quarter-over-quarter volume growth since we acquired the company. As Mark mentioned, the gap between volume and revenue growth was attributable to the transition to a product-specific CPT code, which requires revisions to our private payer contract and will take a few quarters to implement. Prolaris revenue was $5.2 million in the third quarter and contained approximately $2 million in retrospective payment for past claims by Medicare. This was another record quarter for Prolaris test orders with total volume coming in at almost 4,300 tests, which was up 90% year-over-year and 21% sequentially. Revenue associated with our pharmaceutical and clinical services business was $13.1 million and was up 87% year-over-year. Last year's third quarter only contained one month of clinic revenue compared to a full quarter this year, so much of the growth was driven by the lapping of this comparison. However, our Myriad-RBM…

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. 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 the call.

Operator

Operator

Thank you. One moment, please, for the first question. Our first question comes from the line of Bill Quirk of Piper Jaffray. Please proceed with your question. William R. Quirk - Piper Jaffray & Co (Broker): Great. Thanks, and good afternoon, everybody. I guess the first question I had in terms of both the Vectra as well as the Prolaris volumes, I'm assuming you're going to continue to expect those up sequentially; there's no reason to think that you'd see any slowdown on either one of them. This is of course outside of the $2 million CMS payment? Mark C. Capone - President & Chief Executive Officer: Yeah, thanks, Bill. We do continue to expect to see strong growth in volume for both Vectra and Prolaris. Obviously, this quarter was particularly strong, and we've seen that trend for Prolaris now for a number of quarters in a row. So we are anticipating continued volume growth but we're still in the early stages for those products. A lot of opportunity to penetrate those markets deeper and so we continue to expect strong growth and throughout the entire five year strategic plan, we had planned on that as well. William R. Quirk - Piper Jaffray & Co (Broker): Okay, and then just staying on Prolaris as a follow-up, competitive dynamics have changed recently here with a third company coming into the space kind of roughly within the same indication as yourselves. Just curious kind of how you – looking at the competitive dynamic, Mark, any changes at all from a sales approach or anything like that? Mark C. Capone - President & Chief Executive Officer: Yeah, thanks, Bill. We had seen another entrant into this. This was a company that previously had really been testing only patients post-prostatectomy. They did release some preliminary data on a biopsy test. The last data I saw was on a very small subset of patients – I think there was 57 patients in that study. And so, I think it's probably pretty early to discern whether or not the volume of data we will see from that company and the biopsy application is going to be able to successfully compete with Prolaris which has over 12 studies, 4,000-plus patients, and also correlated to the most important endpoint, which is prostate cancer-specific mortality. So I think there is a – there'll be a lot other work I think for that company to begin to try to amass that level of data. So I don't think we've seen a significant shift in those dynamics, but those are things, of course, we'll continue to watch. But we've been very pleased with how Prolaris has performed in the market and the fact that we believe it is now the market leader as a prostate cancer prognostic test. William R. Quirk - Piper Jaffray & Co (Broker): Got it. Thank you very much.

Operator

Operator

Thank you. Our next question comes from the line of Doug Schenkel of Cowen & Co. Please proceed with your question. Adam Wieschhaus - Cowen & Co. LLC: Hi, there. This is Adam Wieschhaus actually on for Doug. Thanks for taking my questions. My first one was you mentioned you're beginning to address the endometrial and colon indications. Can you comment further on the sales strategy that you have in mind to address these new indications? Mark C. Capone - President & Chief Executive Officer: Yeah. Thanks for the question. The – I think from an endometrial cancer standpoint, there is two physician channels that really generally see those patients diagnosed with endometrial cancer. First and foremost is gynecological oncologist. That's a call point that we already call on because of the ovarian cancer indications that we have, either for hereditary cancer or for BRACAnalysis CDx and use of PARP inhibitors. And so they also see a number of women within the endometrial cancers, and so it's very easy for our sales team to now include that as another hereditary cancer indication for that same call point. In addition, endometrial cancers are seen by Ob/Gyns. And once again, we obviously have a very extensive commercial team calling on Ob/Gyns. So it's also quite easy for them to insert that discussion into the indications that we're previously appropriate for hereditary cancer testing. On a calling cancer side, again, we're largely calling on all of the call points already, that make sense for those, that would either be medical oncologists or GIs and we do have active sales calls on both of those physician groups. And so, once again, it's really about us just broadening what their understanding is for red flags for hereditary cancer. That being said, any time we approach…

Operator

Operator

Thank you. Our next question comes from the line of Amanda Murphy of William Blair. Please proceed with your question.

Unknown Speaker

Analyst · your question.

Hi. This is (46:57) for Amanda. I'm just wondering, if you could perhaps speak to the dynamics that drove the guidance range narrowing, and maybe what changed there. And then maybe the one piece of that is in hereditary cancer segment. What it would have looked like, if you'd exclude companion diagnostics? Thanks.

Bryan Riggsbee - Chief Financial Officer

Management

Yeah. This is Bryan. I'll take the question. I think the dynamics that went into our guidance, as we laid out on the last call with respect to some of the puts and takes with respect to Prolaris back pay, the Vectra CPT code change, and then also the United impact that we saw on the current quarter was a factor in that. I think those were the things that we looked at. When we look at our business on a sequential basis, and we see growth in the hereditary cancer business, I think that's what would be expected in our fiscal fourth quarter. From a companion diagnostics perspective, as we've always said, ovarian cancer patients, which were the initial indication for BRAC CDx, were always within guidelines and therefore, we believe that was just a cannibalization of our existing business.

Unknown Speaker

Analyst · your question.

Thanks. That's helpful. I guess only one question, right? Thank you. Appreciate it. Mark C. Capone - President & Chief Executive Officer: Operator, are we still connected?

Operator

Operator

Next – we are still connected. You're ready for the next question? It comes from the line of Isaac Ro from Goldman Sachs. Please proceed with your question. Joel Harrison Kaufman - Goldman Sachs & Co.: Thanks for the question, it's actually Joel in for Isaac. Just driving further into the comments regarding the impact from UNH in the quarter, just any more detail on what gives you confidence that this is only a temporary hiccup rather than ongoing headwind? And then, may be are you taking any proactive steps with other payers to prevent this dynamic from playing out in the future? Mark C. Capone - President & Chief Executive Officer: Thanks, Joel. As we look at the impact – again, first, it's important to note that virtually every payer has some preauthorization requirements and, in fact, some of those preauthorization requirements are very similar to United. So this has really been the trend in the industry for at least a decade, because everybody – all payers want to make sure that only appropriate patients are being tested. And so we long ago put in very extensive quality control measures to ensure that only appropriate patients were getting tested. And in fact, we've published data on the extent of our quality systems and how effective they are at ensuring only patients generally that meet NCCN criteria are being tested. So for us this is really nothing new. We built up the processes and the relationships with our physicians in order to comply with all these preauthorization requirement. Now we do understand for many other laboratories, this is very unique and cumbersome and I know for some of them that it has posed some challenges, but in our view this is just the requirements for engaging in hereditary cancer testing.…

Operator

Operator

Thank you. Our next question comes from the line of Tim Evans of Wells Fargo. Please proceed with your question.

Tim C. Evans - Wells Fargo Securities LLC

Analyst · your question.

Thank you. I kind of, I wanted to follow on that similar statement of that last question there. Understanding that there's going to be a point in which you go through a renegotiation process with the private payers on your hereditary testing. I guess, I wonder, how you feel about your positioning there, and if there is pressure on that the CMS rates, could that been influence the private rates, which then come back and influence the CMS rates again, after PAMA, it's kind of a complicated situation there. But what I'm trying to get it is, how you feel about your negotiating position when it comes time to kind of renew those three-year contracts that you have right now? Mark C. Capone - President & Chief Executive Officer: Yeah. Thanks, Tim. Well, as you know, as we negotiated these contracts over the last three years, there's been a variety of laboratories out there, advertising a very wide, wide range of prices, even in the panel markets. And we've been very effective at sitting down with payers and talking about the value that myRisk provides relative to other alternatives that are out there. Again you have to remember from their perspective that a wrong answer in this industry, in this particularly application is extraordinarily expensive to a payer. A false positive means that a patient is going to undergo very expensive interventions that are unnecessary, and a false negative means that a patient that could have prevented a cancer may very well end up getting a cancer. And this isn't just for the patient, this is an impact that's felt across the entire family because, generations will live with those wrong answers. And it's been those very effective arguments that we've been able to make that – here's the value…

Tim C. Evans - Wells Fargo Securities LLC

Analyst · your question.

Okay. And if I may sneak one more in for Bryan, can you help us think about how you want to prioritize capital deployment going forward? I mean, you don't typically include share repurchases in your forward earnings guidance and should we really be modeling those going forward? You throw off a lot of free cash, I'm just trying to get at how should we be modeling your use of free cash at this point?

Bryan Riggsbee - Chief Financial Officer

Management

Yeah, thanks. I think we continue to stick to the capital deployment strategy that we laid out previously with respect to prioritizing R&D first, M&A second, and then share repurchase, and our stated goal has been to match free cash flow to share repurchases. But to your point, we don't include share repurchases in our guidance. So, I guess, that's all I can really say about that. It's just that – again we state that we're going to – we plan to match free cash flow to share repurchases. If you want to build that in, that's up to you.

Tim C. Evans - Wells Fargo Securities LLC

Analyst · your question.

All right. And is there anything more you can say about any changes to M&A landscape? Has there been any increase in the stuff in your funnel given recent valuations recently anything like that?

Bryan Riggsbee - Chief Financial Officer

Management

I wouldn't characterize it any differently than what it has been in the past, but it's a market with a lot of companies out there with a negative burn rate, burning cash. In terms of the market dynamics, certainly, what's happened recently I think has probably put a lot more of those potentially in play, but I wouldn't characterize it is as different than what we've seen in the past.

Tim C. Evans - Wells Fargo Securities LLC

Analyst · your question.

Got you. Thanks for the color. Mark C. Capone - President & Chief Executive Officer: No problem.

Operator

Operator

Thank you. Our next question comes from the line of Jack Meehan of Barclays. Please proceed with your question.

Jack Meehan - Barclays Capital, Inc.

Analyst · your question.

Hi. Thanks. Good afternoon. I want to start with Prolaris and the 28 million new lives under contract. Can you give any additional granularity on that? Is it just low-risk patients? Any intermediate? Was it structured with any pay-for-value around it? And then finally, is this commercial lives or does it include any MA as well? Mark C. Capone - President & Chief Executive Officer: Yeah. Thanks, Jack. These contracts are all commercial lives and not Medicare Advantage lives. We generally include those when we talk about the Medicare segment because the coverage decisions made by Medicare are obviously enforced in Medicare Advantage. So these 28 million were actually in the commercial side. Some of these are low-risk, some or all patients. We're not going to probably provide that level of granularity nor necessarily payer information per se. But – and some of these could have a value component to those, so there were multiple payers in here and so, each of those contracts as you might imagine are a little payer specific, but overall, it was really some very nice progress from our managed care team just in the last three months.

Jack Meehan - Barclays Capital, Inc.

Analyst · your question.

Okay. And that's helpful. Another on Prolaris. Just getting back to the sustainability of the test order rate, I think, I just looked back over the last eight quarters, I think – is it roughly 20% sequential growth just over that period? Have you thought about expanding the sales force yet or just trying to dive deeper into the urologist pool? Do you think now is the right time to do that? And how much – how sustainable do you think that level of growth is for the next year or two without having to expand the sales force further at this point? Mark C. Capone - President & Chief Executive Officer: Yeah. Great question, Jack. Obviously, we only cover a portion of the urologists with the sales team we currently have out there. We have about 40 sales people out there. And so in order to deepen that penetration, it is something that we are evaluating now to see when it would be appropriate to add additional sales people into that channel so that we can deepen penetration. Given the level of reimbursement, we're starting to obtain, we think it is an appropriate consideration. And so we're going through that process as we speak and as we prepare for our fiscal 2017 budget. Obviously at that point as we give fiscal 2017 guidance, we can provide some additional color on what that the long-term or what that the fiscal 2017 outlook is for Prolaris. We've been very pleased with the growth rates that we've seen. You did see in our five-year plans that we had over 30% compounded annual growth rates for Prolaris. So you can see at least from the five-year plans that we made public that we do believe there's opportunity for continued and sustainable significant growth over the next five years.

Jack Meehan - Barclays Capital, Inc.

Analyst · your question.

Great. And that is the nice segue into my final quick question. Can you just, I know you're not giving the 2017 guidance today. But maybe just the framework that you plan to use in August, just because some things like additional Prolaris coverage or Vectra coverage we don't know today. And then also some of the FDA decisions with your companion diagnostic partnerships. We don't know today, but I should probably assume there is some level of growth next year. How are you going to put that together, when you get to August? Thanks. Mark C. Capone - President & Chief Executive Officer: Yeah. Thanks, Jack. Good question. I think we're going to stay with the philosophy that we used this year. As everyone on the call is well aware, predicting reimbursement is difficult to do in this environment globally. And so, as we look to provide guidance for fiscal 2017, we'll stay with the same approach we used, which is that we'll only factor in known reimbursement for the guidance. And then we'll characterize as we did last year what our upsides and potential downsides to whatever that guidance is that we might provide which of course upsides then would be additional reimbursement that we don't have line of sight to. So, we think that's the only reasonable way to address that uncertainty. But at least, we can quantify the magnitude of what some of those upsides could be were reimbursement to potentially come for other products through fiscal year 2017.

Operator

Operator

And that is our last and final question. We will now turn the conference over back to Mr. Gleason. Please continue.

Scott Gleason - Vice President-Investor Relations

Management

Thanks, Cleona. This concludes our earnings call. A replay will be available via webcast on our website for one week. Thanks for everyone for joining us this afternoon.

Operator

Operator

Ladies and gentlemen, that does conclude the conference call for today. We thank you for your participation and ask that you please disconnect your line.