Earnings Labs

Myriad Genetics, Inc. (MYGN)

Q1 2017 Earnings Call· Tue, Nov 1, 2016

$4.87

+0.83%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-15.85%

1 Week

-14.26%

1 Month

-14.52%

vs S&P

-18.63%

Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Myriad Genetics First Quarter 2017 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, November 1, 2017 (sic) [2016] (02:09). I would now like to turn the conference over to Mr. Scott Gleason, Vice President of Investor Relations. Please go ahead.

Scott Gleason - Myriad Genetics, Inc.

Management

Thank you, Mike. Good afternoon, and welcome to the Myriad Genetics first quarter 2017 earnings call. My name is Scott Gleason, and I'm the Vice President 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 sections of our website at myriad.com. Presenting today from Myriad 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 we filed following 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 document the company files from time to time with the Securities and Exchange Commission, specifically the company's Annual Report on its 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 will now turn the call over to Mark.

Mark C. Capone - Myriad Genetics, Inc.

Management

Thanks, Scott. I would like to start today's call by providing a summary for the quarter, after which Bryan will provide a detailed overview of our financial results and guidance, and I will finish by providing key highlights pertaining to the execution of our business strategy. Overall, we were pleased with the first quarter, as we met our financial expectations and saw the hereditary cancer business return to more normal volume trends by the end of the quarter, while making significant strides towards our portfolio diversification and international expansion goals. Given that the hereditary cancer volume weakness in the fourth quarter was evident in the oncology segment, it is important to note that we signed agreements with physician networks that represent 70% of community oncologist in the country and which gave an important endorsement by selecting Myriad as their preferred hereditary cancer testing provider. Our diversification efforts continued to advance this quarter, with GeneSight, Prolaris and EndoPredict, each experiencing year-over-year growth rates in excess of 50%. GeneSight is now our second-largest product, and the revenue and volume for this test exceeded our expectations. In total, we have eight commercial products that will fuel our growth and diversification over the next few years. With a full quarter of GeneSight revenue, our non-hereditary cancer revenue would represent 27% of total revenue, compared to 7% three years ago. The most significant challenge in this industry is securing reimbursement, and we have made some important strategic adjustments this past quarter that I will detail later in the call. As a way of quantifying the impact of broader reimbursement, with the test volumes generated from our commercial tests last year, full reimbursement would have generated over $1 billion in revenue and $3.50 per share in earnings. Another important highlight in the quarter was the pivotal…

R. Bryan Riggsbee - Myriad Genetics, Inc.

Management

Thanks, Mark. I'm pleased to provide an overview of our financial results for the fiscal first quarter of 2017 followed by additional detail on our updated fiscal year 2017 financial guidance. First quarter total revenues were $177.5 million compared to $183.5 million in the same period in the prior year, a decline of 3% year-over-year. Hereditary cancer revenue in the quarter was $139.3 million and in line with our expectations when we provided our financial guidance. Looking at the components of our hereditary cancer revenue, we saw a larger impact from volume declines than from price reduction in the quarter. Year-over-year volume declines were primarily attributable to declines in the oncology segment which reflected the weakness we also saw in the fourth quarter, but these trends did return to more normal patterns by the end of the first quarter. Reductions in pricing year-over-year were primarily attributable to the full implementation of our long-term contracts that we signed over the last year. GeneSight revenue in the quarter was $7.2 million and reflected revenue associated with the month of September as we closed the Assurex acquisition one month earlier than expected on August 31. GeneSight volume for the month of September was over 18,000 tests, which was up 70% year-over-year. For the full quarter, GeneSight volume was over 51,000 tests and also was up 70% year-over-year. Vectra DA revenue in the first quarter was $11.6 million, which was up 2% year-over-year. Total volume in the quarter was approximately 39,000 tests, which represented a 4% increase year-over-year. Sequential patterns reflected the typical summer seasonality we see with our Vectra DA business. Prolaris revenue in the quarter was $2.9 million. Prolaris test volumes were up 56% year-over-year, with total test orders coming in at 4,400. Similar to Vectra DA and all of our diagnostics,…

Mark C. Capone - Myriad Genetics, Inc.

Management

Thanks, Bryan. I'm pleased to provide a more detailed review of key initiatives in the company. As those following this industry recognize reimbursement remains the critical opportunity to accelerate future growth. It is a hurdle that has only gotten higher as payers struggle to absorb unexpected costs from new markets. As we stated last earnings call, based on our volumes last year, we would've generated an additional $300 million of revenue and $2.00 per share in incremental earnings per share if we received full reimbursement for test volumes run in fiscal 2016. We recognize that we need to employ new strategies if we are going to change the current reimbursement paradigm and made a number of important shifts this past quarter. First, I added an executive to my team, Chip Parkinson, our Executive Vice President of Reimbursement Strategy. Chip has an exceptional level of experience with managed care in the pharmaceutical industry and diagnostic industry. Most recently, he worked for Cambia Health Solutions as President of OmedaRx and MedSavvy and was the Chief Pharmacy Officer for Regence Blue Cross Blue Shield health plans, with responsibility for over $1 billion in pharmacy spend. Chip brings to Myriad a depth and breadth of knowledge with an insider's perspective on managed care organizations. He is providing important insights on the best way to communicate the value proposition for Myriad's broad portfolio to the appropriate level of decision-maker at insurance providers. Every product Myriad develops has a strong health economic argument, and our suite of products in totality offer unprecedented savings to payers that typically operate with low-single digit margins. One of the realities of personalized medicine is that the cost in savings for our products reside in very different parts of a managed care organization, and internal incentive systems can hinder coverage. Executives…

Scott Gleason - Myriad Genetics, Inc.

Management

Thanks, Mark. As a reminder, during today's call, we use certain non-GAAP financial measures. A reconciliation of the GAAP financial results to non-GAAP financial results and 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 are asking participants to please ask only one question and one follow-up. Operator, we are now ready for the Q&A portion of the call.

Operator

Operator

Thank you. One moment please for the first question, which comes from the line of Bill Quirk with Piper Jaffray. Please go ahead. Alexander D. Nowak - Piper Jaffray & Co.: Great. Good afternoon, everyone. This is Alex Nowak filling in for Bill today. So first question from me is on Prolaris and Vectra DA. Both of those tests declined sequentially when looking at number of tests delivered and on the revenue, and you attributed this to seasonality. But I mean, when we look at the tests, I mean, specifically Prolaris, we would think that it would be flat to slightly up since the penetration is so low and the test is new. Just curious if you're seeing anything else new within these tests that would explain the sequential decline.

Mark C. Capone - Myriad Genetics, Inc.

Management

Yeah. Thanks, Alex. No, this really was attributed – and we actually see this across the board in the summer. This was really totally attributable to what we see in summer, impacted by physicians, patients and so we haven't been able to discern really anything. I think for us because of the seasonality in the business, it's year-over-year comparisons that we find the most useful. I think obviously in the case of Prolaris, we saw very strong volume growth in excess of 50%, so I think it's really maintained that. I think also importantly for us is we generally look to see if momentum returns in September, which is also consistent with the fact that people start to return to normal routines, and that's exactly what we saw with Prolaris. September was our second largest month ever and so we saw that same sort of return that we see – for example, we saw with hereditary cancer as well, a return to more normal patterns that we've typically seen in September.

Operator

Operator

Your next question comes from the line of Jack Meehan with Barclays. Please go ahead.

Jack Meehan - Barclays Capital, Inc.

Analyst · Barclays. Please go ahead.

Hi. Good afternoon, guys. I wanted to start and ask about the hereditary trends in the quarter, just whether you would be willing to share 11% decline in revenue. Was there a bigger contribution either from volume or rate? And just a little bit more commentary around the sales force and how you expect them to ramp-up over the next nine months.

R. Bryan Riggsbee - Myriad Genetics, Inc.

Management

Yeah, Jack, this is Bryan. Just in terms of what we saw during the quarter, consistent with the last quarter we noticed the same trends as we entered the quarter in our oncology business. As we trended towards the end of the quarter, we saw the business – the hereditary cancer business return to more normal trends, and therefore that's consistent with our guidance. We would expect to see sequential growth as we enter the second quarter, which is seasonally stronger.

Mark C. Capone - Myriad Genetics, Inc.

Management

And your other question, Jack, from a volume and price perspective, we obviously provide a little color in this. When you look at that – the year-over-year decline, we said the majority of that was associated with volume as opposed to price. So that gives you some sense of what we saw, which to Bryan's point was consistent with what we saw actually in the fourth quarter. From a sales force perspective, we are fully – we've got the sales force now filled, all the territories filled. So I think we've been able to address the turnover that we saw. As Bryan mentioned, we typically expect those people to take nine months to get to be fully productive, and that's the trend that we are on right now, and that's what we have assumed from the standpoint of our guidance is that our typical ramp-up for new salespeople will apply in this particular case.

Operator

Operator

Your next question comes from the line of Amanda Murphy with William Blair. Please go ahead.

Unknown Speaker

Analyst · William Blair. Please go ahead.

Hi, this is (45:27) in for Amanda. Just a question regarding your competitors' entrance into United. I was just wondering what kind of impacts have you seen come through from changes in prior authorization requirements given the probably lower prices of your competitor these days.

Mark C. Capone - Myriad Genetics, Inc.

Management

Thanks. From a prior authorization standpoint, if – I will see if I answer your question, really for United, that is something that actually went into effect in January. As a recap of that, what they wanted to ensure is that there was genetic counseling occurring before the tests that were ordered. And so that was a change that actually has been made now quite a while ago from United. Now, as we've reminded everybody, the genetic counseling requirements have always been in place, have always been in policy, but United was putting in place a procedure to enforce that. For somebody like Myriad, this wasn't really a significant change for us. Our processes were robust enough for us to be able to provide that documentation in an appropriate way. I know that probably wasn't the case for other laboratories that weren't necessarily used to providing that information, but for Myriad, it was something that we had traditionally done. So we haven't really seen any changes from United in that regard since that policy came out. And we haven't seen any others that have pursued any other further documentation requirements from a preauthorization standpoint. Again, most payers already have some level of preauthorization and have had that for many years. I think the only other thing that I will note is, there was a study that was published recently that actually looked at a genetic counselor requirement. So again, to differentiate that from genetic counseling, that's a requirement that testing must be done by a genetic counselor. And there was a study done by authors from the American Society for (47:41). What those authors showed is in fact that requiring access through a genetic counselor actually significantly reduced access to the testing from patients without increasing the positive rates associated with that, which means it did not increase appropriate utilization. So these are people that met NCCN criteria that just didn't follow through with testing. And particularly hard hit were those in minority populations. And so I think that's why you haven't seen others try to implement a genetic counselor requirement beyond a few payers that did that quite a few years ago.

Operator

Operator

Your next question comes from the line of Tycho Peterson with JPMorgan. Please go ahead.

Unknown Speaker

Analyst · JPMorgan. Please go ahead.

Hey, guys. This is Steve on for Tycho. Thanks for taking my question. Can you give us a sense of what percentage of your myRisk test volume is now being sold in this customizable format, how the pricing compares to the full panel? And is this customizable option available to everyone or is that just to certain customer segments? Thanks.

Mark C. Capone - Myriad Genetics, Inc.

Management

Yeah. Thanks, Steve. There's no difference from a pricing perspective. This is similar to the full panel. Initially, we've done a limited access launch to this, primarily to genetics customers. Those are the ones that really are most interested in and particularly picking genes. We haven't really seen that same level of interest from other community providers that really would prefer just to get the entire panel because those providers recognize this is really a once-in-a-lifetime test and they want to get as much information as they can on the first one. So we really segmented this to only genetic providers. We haven't split out volumes on what percent is in customizable form versus the full panel, and probably not something we'll necessarily do to provide that level of detail. But I think our expectation is that it would probably still be limited to genetics professionals that are in a much better position to select a subset of genes.

Operator

Operator

Next question comes from the line of Sung Ji Nam with Avondale Partners. Go ahead, please.

Sung Ji Nam - Avondale Partners LLC

Analyst · Avondale Partners. Go ahead, please.

Hi. Thanks for taking the questions. Mark, could you remind us, AstraZeneca continues to talk about a significant increase in BRCA testing from their perspective due to Lynparza. Is that still too small to move the needle for Myriad? And then, what's the potential implication for Myriad if Lynparza gets maintenance treatment indication? Would that move the needle a bit more?

Mark C. Capone - Myriad Genetics, Inc.

Management

Yeah. Thanks, Sung Ji. So we continue to have – our testing for BRACAnalysis CDx is lumped in with our hereditary cancer revenue numbers. So we haven't broken that out. The reason is that because the indications for ovarian cancer patients are either in hereditary cancer testing or the BRACAnalysis CDx and we see customers that don't necessarily differentiate when they may use those tests. We just don't think it's very insightful to break BRACAnalysis CDx out separately because it's really just cannibalizing the ovarian cancer patients that we've always been able to test. And so we don't think it would make sense to do that. It probably wouldn't provide any clarity and something that we are not necessarily plan on doing. And I think with the additional Lymparza data on SOLO2, obviously, they haven't released the actual data. But their commentary suggested that they saw results that were very favorable and, in fact, better than what they had seen in Study 19. And so, obviously, that's a good result for patients. I think using BRACAnalysis CDx once again as the companion diagnostic for that test; we think that's favorable for the test. I think it just reinforces for customers that there's one FDA-approved test and that's Myriad's test. So we think that's favorable, but again, it's still drawing from the ovarian cancer group that would be eligible for hereditary cancer testing.

Operator

Operator

Your next question comes from the line of Isaac Ro with Goldman Sachs. Please go ahead. Joel Harrison Kaufman - Goldman Sachs & Co.: Thanks for the question. It's actually Joel in for Isaac. Just following up on the comments you guys have made regarding the initiatives in the oncologist population, what incremental investments do you think you need to make to retain your strong market position and lion's share within the GP population?

Mark C. Capone - Myriad Genetics, Inc.

Management

Thanks, Joel. Well, I think in the preventive care, I think one of the most important assets we continue to have is our sales and marketing expertise, and the customer service that goes with that. I think those are the three pillars that – there are three pillars that are most important to that customer segment. First is the most accurate test. And between Myriad's sequencing accuracy and interpretation accuracy, that continues to be number one with a group that wants to be able to trust those results when they are sitting down with patients, which -again, most of these patients are unaffected. So they're going to be making decisions about potentially doing prophylactic surgeries, and they have to be absolutely certain in the accuracy. That's first. The second is the presence of our sales team, our genetic counselors that are in the field is very important to that customer group because they need to know who is appropriate for testing, how to interpret results, how to incorporate this into their practice. And so that white glove service, if you will, that we provide in the field is very important. And the third thing is our customer service team that has to work through the preauthorizations that we've discussed and ensure that patients understand any of their financial obligations and all those customer service elements. So those investments already exist. And obviously, that's something that we continue to leverage as we look at maintaining that share in the market where, as you mentioned or inferred here is, we just – we haven't seen significant share erosion in that particular segment. And I think it's because of the strength of all three of those pillars.

Operator

Operator

There are no further questions at this time. I will now turn the call back to you. Please continue with the presentation and/or closing remarks.

Scott Gleason - Myriad Genetics, Inc.

Management

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