Myriad Genetics Inc (MYGN) 2017 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Myriad Genetics Third Quarter 2017 Financial Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded, Tuesday, May 2, 2017.

I would now like to turn the conference over to Scott Gleason, Vice President of Investor Relations. Please go ahead.

Thanks, Fran, and good afternoon, everyone, and welcome to the Myriad Genetics Fiscal Third Quarter 2017 Earnings Call. My name is Scott Gleason. I'm the Vice President of Investor Relations. During the call, we will review the financial results we released today, after which, we'll 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 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 archived and will be archived in the Investors section of our website. In addition, there's a slide presentation pertaining to today's earnings call on the Investors section of our website and which will be 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 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 report 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.

Thanks, Scott.

I would like to start today's call by providing the key highlights for the quarter, after which, Bryan will provide a detailed overview of our financial results, and I will finish by providing additional details pertaining to the ongoing execution of our business strategy.

Overall, I am very encouraged by our progress in the fiscal third quarter. All of our products, including hereditary cancer, demonstrated strong sequential volume growth and were able to significantly exceed expectations with revenues totaling $196.9 million and adjusted earnings per share of $0.27. Based upon the strength in the quarter and our expected continued strong volume trends in the fourth quarter, we are raising our annual guidance by $14 million, and we have narrowed our adjusted EPS guidance within the previous range.

Importantly, we once again advanced our 3 strategic imperatives this quarter that include continued leadership in an expanding hereditary cancer market, diversifying our revenue with new products and growing kit products in major international geographies. This quarter, we broke a 5-year trend with hereditary cancer volumes growing on a sequential basis in what is typically a sequentially down quarter. This sequential growth is particularly noteworthy, given the fact that insurance deductibles reset in the third quarter, yet we saw growth in both the oncology and preventive care markets. Combined with the sequential growth in the second quarter, it is evidence that our strategies are working and continue to position Myriad as a clear leader in hereditary cancer testing. In fact, excluding the impact from the ANTHEM accounting change on revenue recognition, hereditary cancer revenue would have grown on a sequential basis.

Our product diversification strategy continued to show significant momentum. This quarter, nonhereditary cancer products and services comprised 68% of total volume and 28% of total revenue. Once again, the Assurex acquisition exceeded our expectations with quarterly GeneSight volume growing 44% year-over-year and 7% sequentially. Importantly, we completed enrollment in our large 1,200-patient clinical utility study during the third quarter and are ahead of schedule to have data available late in calendar year 2017. This quarter, Vectra DA volumes and revenue returned to sequential growth in the quarter after clarifying misperceptions from the inappropriate analysis in the AMPLE publication. We remain optimistic that the strong clinical evidence for Vectra DA will lead to a favorable resolution for the Medicare draft noncoverage LCD.

Prolaris volumes also demonstrated strong growth, increasing 9% sequentially, breaking the 20,000-test annual run rate for the first time. The comment period on the Medicare favorable intermediate LCD has concluded. And if Medicare issues a final LCD, it will expand existing reimbursement coverage by 50%. In the third quarter, we received a major boost to our companion diagnostic program in a new cancer indication with the announcement that AstraZeneca achieved clinically and statistically significant results in the OlympiAD metastatic breast cancer study, which utilized BRACAnalysis CDx as the biomarker to select patients. Based upon this positive result, this could represent the first FDA approval for a PARP inhibitor outside of ovarian cancer and represents an additional 60,000-patient per year testing market for Myriad.

In addition, we launched EndoPredict in the U.S. market in the third quarter and continued to expand reimbursement with over 83 million covered lives. We also have submitted our dossier for EndoPredict to Medicare in the third quarter.

During the quarter, we reached another important milestone for myPath melanoma with the publication of 2 additional pivotal studies and the submission of the coverage dossier to Medicare and other payers.

Finally, international product revenue for the quarter grew 41% year-over-year and represented 5% of total revenue. Overall, we have stabilized our hereditary cancer volumes and simultaneously diversified our portfolio with over 2/3 of our volume now attributed to new products as we continue to expand our opportunities with pivotal advances from EndoPredict, companion diagnostics and myPath melanoma. Given the large untapped markets for these new products, we believe increased adoption and expanded reimbursement will fuel significant future growth.

With that, I will turn the call over to Bryan to provide a financial overview of the fiscal third quarter and additional details surrounding our fiscal year 2017 financial guidance.

Thanks, Mark.

I'm pleased to provide an overview of our financial results for the fiscal third quarter of 2017, followed by additional detail on our updated fiscal year 2017 financial guidance.

Third quarter total revenues were $196.9 million compared to $190.5 million in the same period in the prior year, an increase of 3%. This represents our second straight quarter of delivering positive year-over-year revenue growth. Hereditary cancer in the quarter was $141 million and was down 10% on a year-over-year basis.

Looking at the components of growth. Volume was up slightly on a year-over-year basis, and consequently, the entire year-over-year decline in hereditary cancer revenue this quarter was attributable to pricing and revenue recognition delays from the ANTHEM out-of-network decision. We expect the accounting impact of the ANTHEM out-of-network change to be more significant in the fiscal fourth quarter, given the timing of the out-of-network decisions with the various plans within ANTHEM, and then begin to abate as we move into the first fiscal quarter of next year.

GeneSight revenue in the quarter exceeded our expectations, coming in at $23.9 million and grew 41% year-over-year. GeneSight volume for the third quarter was over 60,000 tests, which was up 44% year-over-year. Once again this quarter, GeneSight was our highest volume test.

Vectra DA volume in the quarter was approximately 38,500 tests and grew 5% sequentially. Vectra DA revenue in the third quarter was $11.2 million, which was up 5% sequentially. Importantly, we saw Vectra DA volumes rebound in the third quarter, following a challenging second quarter that was impacted by the publication of the AMPLE study.

Prolaris revenue in the quarter was $3.4 million. Prolaris test volumes grew 17% year-over-year and 9% sequentially, with total tests ordered coming in at 5,100 tests.

EndoPredict revenues in the quarter were $2.3 million and grew 109% year-over-year. U.S. EndoPredict revenue was not a meaningful contributor to total EndoPredict revenue in the quarter, given the launch occurred only 2 weeks prior to the end of the quarter.

Lastly, revenue associated with our pharmaceutical and clinical services business was $11.7 million and declined 11% year-over-year. As a reminder, revenue within our pharmaceutical and clinical services segment varies based upon the timing of pharmaceutical and clinical services contracts.

I now would like to discuss our financial metrics for the quarter. Gross margins were 77.5% in the third quarter compared to 78.9% during the third quarter of last year. The year-over-year decline was primarily attributable to product mix with more revenue from lower margin segments as well as the impact of pricing in hereditary cancer. Additionally, the change in revenue recognition for ANTHEM detrimentally impacted gross margins in the quarter based upon the cost of running samples for which revenue recognition has been delayed.

Moving on to our operating expenses. GAAP research and development expenses were $17.6 million in the third quarter compared to $17.2 million in the fiscal third quarter of last year. Excluding research and development expense tied to the Assurex Health acquisition, total research and development expense declined on a year-over-year basis. GAAP SG&A expense this quarter was $122.1 million compared to $90.5 million in the third quarter of last year. On a non-GAAP basis, our adjusted research and development expense was $17.5 million compared to $17.1 million last year and grew 2% year-over-year.

Adjusted SG&A expense this quarter was $111.1 million compared to $87.4 million in the third quarter of fiscal year 2016. Excluding the impact from the Assurex acquisition, total non-GAAP operating expenses increased 3% year-over-year.

Adjusted operating income was $24 million in the third quarter and declined 48% relative to the third quarter of last year. The decline in adjusted operating income is based primarily on lower hereditary cancer revenue, the mix of our volume toward products that are not yet fully reimbursed and dilution associated with the recent Assurex acquisition.

Adjusted earnings per share were $0.27 for the third quarter compared to $0.41 in the third quarter of last year. Our fully diluted share count was essentially flat sequentially with 68.3 million shares outstanding.

We continue to prioritize debt repayment as a near-term use of capital. This quarter, we repaid $37 million in principal on our existing debt and plan to use our excess free cash flow to pay down debt in coming quarters as we plan to make significant milestone payments over the next 12 months associated with the Assurex and Sividon acquisitions.

Our cash and cash equivalent balance at the end of the third quarter was approximately $226 million, which increased from our cash balance of $218 million at the end of the second quarter. We continue to generate meaningful free cash flow with non-GAAP free cash flow in the quarter of approximately $41 million.

Before I move on to our financial guidance, I wanted to highlight one balance sheet item. Our accounts receivable balance was detrimentally impacted by a system issue at a single payer that delayed payment for approximately $15 million in past claims. The issues have been resolved, and we have already begun to see these claims being paid and expect to receive the balance of the cash by the end of May. As these claims are paid, we would expect our accounts receivable balances to return to normal levels.

I would now like to discuss our fiscal year 2017 financial guidance. We are increasing our revenue guidance for the full fiscal year and tightening the range on our adjusted earnings per share guidance. We are now forecasting revenue of $763 million to $765 million, which represents a $14 million increase at the midpoint, and earnings per share of $1.01 to $1.03.

Let me discuss some of the underlying trends supporting our guidance beginning with hereditary cancer. We saw continued improvement in the trajectory of hereditary cancer's sample volumes in the third quarter, and we are anticipating growth in hereditary cancer volumes again in the fourth quarter. However, the accounting impact from the ANTHEM out-of-network decision will be larger in the fourth quarter. And consequently, from a revenue perspective, we are currently expecting hereditary cancer revenue to be flat to slightly down on a sequential basis. This will also have a disproportionate impact on margins and earnings as we absorb the cost without the corresponding revenue.

Moving on to GeneSight with Assurex Health. We continue to be pleased with GeneSight trends as they have consistently outperformed our forecast over the top and bottom line this fiscal year. Importantly, Assurex's operating loss also narrowed in the third quarter, and we believe we remain on track for Assurex to achieve breakeven by the end of the fiscal year.

For Prolaris, we expect to see continued volume growth in the fourth quarter. However, we are not anticipating the recent favorable intermediate LCD from Medicare having any impact in the fourth quarter.

For Vectra DA, we are forecasting continued improvement in business fundamentals as we move beyond the AMPLE study. Additionally, our guidance reflects our expectation of having continued Medicare reimbursement, given the strength of the data supporting the clinical validity and clinical utility of the test.

Additionally, we are not forecasting any significant U.S. revenue from the recent EndoPredict launch since we are still in the early stages of the product launch in the U.S. market.

In conclusion, we were encouraged by the commercial progress on our strategic imperatives in the third quarter, and I am proud that we were able to increase revenue guidance for the year despite an unanticipated $10 million headwind from the ANTHEM out-of-network decision. We continue to believe that our diversification strategy will lead to significant revenue and profitability growth in the coming years, and the company is focused on enhancing that growth through strategically sound capital deployment.

With that, I will now turn the call back over to Mark to discuss our key business highlights in the quarter.

Thanks, Bryan.

I'm happy to provide some additional details around the execution of our business strategy, starting with our progress in the hereditary cancer market.

We were extremely pleased to see strong sequential hereditary cancer volume growth for what is typically a seasonally weak quarter. Importantly, we saw volume growth sequentially in both our preventive care segment as well as our oncology segment. Oncology is especially noteworthy, since this represents the second quarter in a row for sequential growth, which we have not seen since the Supreme Court decision. We also saw volume on a year-over-year basis return to growth this quarter. In fact, this was a near-record third quarter for hereditary cancer volumes. We attribute the volume growth to 3 factors: sales force productivity, a recently signed U.S. oncology and ION collaborations that covers 70% of community oncologists, and the launch of our customized panels for specific cancers.

From a sales force perspective, our staffing levels remain high, and we have seen minimal sales force turnover in the last few quarters. Additionally, the representatives we hired over the summer are rapidly increasing their impact in the field. Also, the U.S. Oncology and ION organizations have been exceptional partners in advocating for the higher quality testing that only Myriad can provide and further strengthening our leadership position in the community oncology market. Additionally, we have seen significant interest in our customized panels from academic customers and are focused on a series of customer service and interface improvements that will continue to further distinguish Myriad's hereditary cancer offering. As a result, we believe market share in the academic segment has stabilized and, in some institutions, has started to increase. Also, it is important to note that volumes for out-of-network providers also grew on a sequential basis.

Our sales and customer service teams have done an outstanding job to minimize any impact from out-of-network decisions. Physicians continue to demand the highest quality for their patients, which is why we continue to be in network with greater than 95% of commercial plans across the country.

This quarter, we had some notable publications surrounding hereditary cancer. The first publication in The Oncologist by William Gradishar and researchers at Northwestern University compared 4,250 variants from ClinVar to those from Myriad Genetics. In the study, only 73.2% of the classifications in ClinVar were consistent with Myriad classifications, where 26.7% were nonconcordant. This study is remarkably consistent with the PROMPT study led by researchers at Memorial Sloan-Kettering, which found a 26% rate of discordance between major commercial laboratories.

Another important publication in the April issue of Journal of Clinical Oncology showed that 40% to 50% of women who receive a variant of unknown significance test result will pursue prophylactic mastectomy. The Gradishar study found that Myriad can definitely classify up to 60% of the U.S. results of other laboratories, leading to substantial healthcare cost savings, given that the total cost of a mastectomy and reconstruction can exceed $50,000. Combined, these 2 studies highlight the superior value proposition that only Myriad can provide.

Next, I would like to provide an update on our new products and our efforts to secure broader reimbursement coverage for these tests. As I previously stated, greater than 2/3 of our testing volume is associated with new products, and we expect this percentage to continue to climb in the future. This quarter, the average selling price for a composite of our new products was about 22% of our targeted average selling price. If these new products were fully reimbursed this quarter, the run rate would have been greater than $650 million in annual revenue, which is still only a fraction of their $16 billion global market potential.

Our highest volume test is now GeneSight, which approached a run rate of 0.25 million tests per year in the third quarter. Assurex hit a major milestone this quarter, performing over 5,000 tests -- 500,000 tests in their fifth full year of the commercial launch, which is faster than any previous advanced diagnostic. With our expectation that Assurex achieves breakeven in the fourth quarter, it will also be the fastest advanced diagnostic to ever achieve profitability. If GeneSight was fully reimbursed, the current revenue run rate for the test would be approximately $500 million. Consequently, we are aggressively pursuing value-based reimbursement for the test.

This quarter, we completed enrollment in our large prospective 1,200-patient study for GeneSight, which has a primary endpoint of changes in HAM-D17 scores, the clinical measure of depressive symptoms. Patients will be assessed at 8 weeks and 6 months, following enrollment in the study, allowing us to complete analysis in calendar year 2017.

We also continue to work with insurance providers to generate real-world claims data to support the health economics surrounding GeneSight. We announced last quarter that we are conducting 3 payer-demonstration projects, the first of which is utilizing UnitedHealth's Optum dataset. This study is now complete, and we plan to publish the results in a major managed care journal in the near future. We have similar studies underway with Humana and ANTHEM's HealthCore subsidiary, which we expect to be completed by the end of this fiscal year. Furthermore, we have engaged in a broad demonstration project looking at national claims data which can be sub-analyzed for any specific payer in the country to assess GeneSight performance in their patient population.

This quarter, we also saw the publication in Clinical Therapeutics of another study supporting the health economic value of GeneSight. The study utilized pharmacy claims data from 2,168 patients, whose treatment was either congruent or noncongruent with the GeneSight test result. In the study, primary care physicians, whose patients followed GeneSight recommendations, saw first-year savings of $3,998. And patients treated by psychiatrists saved, on average, $1,308 after paying for the cost of the test.

Lastly, I would like to highlight the results of our early-stage pilot study in the preventive care market with GeneSight. By the end of the third quarter, our average sales representative was generating annualized sample volumes of approximately 300 tests per year. It is important to point out that this volume of testing was generated among their current physician targets rather than high-volume antidepressant prescribers. Additionally, it was generated without impacting their ability to sell hereditary cancer testing. The success of this pilot validates one of the strategic justifications for the acquisition of Assurex and demonstrates the promise of the 4 and 6 strategy to grow revenue and profitability by adding additional products into existing sales channels.

Moving on to Vectra DA. We were encouraged to see Vectra DA volumes return to growth this quarter as our team corrected misperceptions about the AMPLE study. The open comment period for the Medicare Vectra DA noncoverage LCD ended in late March, and Myriad provided robust data supporting both the clinical validity and utility of the test. The clinical publications on Vectra DA have increased from 8 at the time of initial coverage to 35 currently.

Additionally, the AMPLE study, upon which the noncoverage LCD was based, has received significant criticism from key opinion leaders given the unconventional analysis utilized in the study. This was highlighted by Dr. Curtis' letter to the editor, which was published in the April issue of Arthritis and Rheumatology. Medicare has no statutory time line to make a decision on the local coverage determination. We know they received a significant amount of support for continued coverage from physicians, patient advocacy groups and other stakeholders. Overall, we believe the level of scientific evidence for Vectra DA is highly supportive of continued Medicare coverage for the test.

We are also pleased to see that Vectra DA is increasingly being recognized by professional medical guidelines. In December, United Rheumatology, which represents 10% of rheumatologists in the country, included Vectra DA in their guidelines. And recently, Vectra DA was added to guidelines by Creaky Joints, one of the top patient advocacy organizations for rheumatoid arthritis. We also are aware that the American College of Rheumatology is conducting a professional guideline review this fall, and we believe they will be assessing Vectra DA for potential inclusion in the diagnostic guidelines.

Transitioning to Prolaris. We have now moved beyond the end of the open comment period for Medicare's draft LCD for favorable intermediate patients. Favorable intermediate patients comprise over 1/4 of Prolaris volume, given higher physician utilization in patients determined to be intermediate risk by pathology. At the upcoming American Urology Association, Myriad will be presenting a 767-patient study demonstrating the ability of Prolaris to predict metastases with a high degree of statistical significance. Based upon the size of the second study on metastases, Myriad has now added the risk of metastases to its Prolaris test report, providing further differentiation from competitive tests.

Additionally, it is important to highlight that Prolaris remains the only test validated for biochemical recurrence, metastases and prostate cancer specific mortality in patients prior to having their prostate removed. We were encouraged to see that United States Preventive Services Task Force has issued draft guidance that would reinstate the recommendation for PSA testing based upon patients and physician choice. We believe the previous USPSTF recommendation, a decrease the diagnosis of prostate cancer and led to more patients being diagnosed at later stages of the disease. Consequently, this recommendation will likely favorable -- favorably impact Prolaris over time.

Next, I would like to discuss our U.S. launch of EndoPredict. In mid-March, we launched EndoPredict and are seeing increasing physician and payer interest in the test. One of the key differentiation points for physicians is the 10-year data used during development. When the first-generation breast prognostic tests were developed, they were only developed utilizing 5-year data, but more than 50% of recurrences happen after the fifth year. As a second-generation test, EndoPredict was developed with 10-year data. During the development, it was noted that proliferation genes predicted recurrence risk in the first 5 years, but an entirely different set of hormonal receptor genes predicted risk in the 5- to 10-year time frame.

Additionally, the inclusion of clinical pathological features were determined to be critical to predicting later recurrence risk and are automatically included in the EndoPredict result. This is why the TransATAC cohort showed that EndoPredict was exceptional at detecting these late-stage recurrences, and the first-generation test failed to do so with statistical significance. Finally, it is important to note that there was no intermediate risk classification, meaning all patients received a definitive high or low risk result.

I'm also pleased to announce that we signed several additional payers for EndoPredict in the quarter. We now have over 83 million lives under coverage for EndoPredict and have submitted our Medicare dossier. If covered by Medicare, we would have over 2/3 of covered lives in the United States.

Moving on to our companion diagnostic programs. We had several important announcements in the quarter. First, AstraZeneca announced that the OlympiAD study with olaparib resulted in both a statistically and clinically significant benefit in progression-free survival for patients in the study. We are highly encouraged by this data since it represents the potential for a substantial new testing opportunity with BRACAnalysis CDx. Every year in the United States, approximately 100,000 women are either diagnosed with or progress to metastatic breast cancer, of which approximately 60,000 are HER2 negative. Of these 60,000 women, only about 1/3 currently qualify for hereditary cancer screening.

Looking beyond the incidence population to the survivor population for metastatic breast cancer, there are approximately 150,000 women, of which we estimate only 25,000 have received hereditary cancer testing. Unfortunately, there are limited treatment alternatives for metastatic breast cancer. And consequently, we believe approval of a new therapeutic option will encourage many of these patients to seek out testing and access to olaparib, if approved by the FDA.

During the quarter, we also signed several additional companion diagnostic agreements. First, we signed a research collaboration with BeiGene, which is a global pharmaceutical company looking to commercialize a PARP inhibitor in the United States. Additionally, we signed a collaboration with Clovis Oncology to perform BRACAnalysis CDx testing. Following these agreements, Myriad is now working with every major developer of PARP inhibitors in the United States.

Additionally, we recently submitted a regulatory filing in Japan for BRACAnalysis CDx as the companion diagnostic for Lynparza in conjunction with our collaboration with AstraZeneca. We continue to expect a substantial number of data readouts from major PARP inhibitor studies over the next 12 months and believe companion diagnostics could be an area of significant growth for the company in the coming years.

Next, I would like to discuss our progress with myPath Melanoma. This quarter, we published our third important validation study for myPath Melanoma in cancer epidemiology that evaluated the performance of myPath Melanoma relative to known real-world outcomes. The study evaluated 99 primary melanomas with distant metastases and 83 benign moles. In this study, myPath Melanoma was able to differentiate melanoma from benign lesions with 95% diagnostic accuracy. Based upon this publication and the publication of our second clinical utility study, we have now submitted our myPath Melanoma dossier to Medicare and have begun discussion with private insurers.

Lastly, I would like to comment on our success expanding our contribution from international markets through our kit-based strategy. This quarter, international revenue comprised 5% of our total revenue, and international product revenue grew 41% on a year-over-year basis. EndoPredict generated $2.3 million in revenue this quarter and grew 109% year-over-year. The majority of the growth in EndoPredict is attributed to recent reimbursement coverage decisions in France, where we now have a growing number of sites actively using the test. We also are optimistic regarding the German market, and there are currently several potential initiatives underway to ease the reimbursement process for local labs wishing to perform breast cancer prognostic testing. Our applications for reimbursement coverage for EndoPredict in the U.K. and Canada have been submitted, and we expect to have updates in these markets in early calendar 2018.

We also continue to make progress in our kit-based versions of Prolaris and myPath Melanoma for the international market and anticipate filing for CE Mark for Prolaris in calendar 2018.

In conclusion, we believe our business strategies and execution are demonstrating success. We were encouraged to see hereditary cancer testing continue to show sequential volume growth this quarter. And with greater than 2/3 of our volume delivered from new products, additional reimbursement will drive a meaningful growth -- meaningful change in the growth and profitability trajectory of this company.

Finally, I would like to thank our extremely talented and committed Myriad team. As pioneers in this industry, our employees navigate challenges with grit and determination, and as a result, we stand on the cusp of an exceptionally bright future.

With that, I will turn the call back over to Scott.

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 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. (Operator Instructions) Operator, we're now ready for the Q&A portion of the call.

(Operator Instructions) The first question comes from the line of Jack Meehan with Barclays.

Mark, I was wondering if you could opine a little bit more on the broad sequential improvement in volumes. I think it's unusual, given the calendar turnover of deductibles. You highlighted a few things with the initiatives you've done. But was there anything that stood out, just across the portfolio that's worth highlighting?

Thanks, Jack. You're right, it is very unusual for us to see sequential growth in hereditary cancer. We showed one slide that you could see in the last 5 years. Certainly, we've never seen the magnitude of the growth that we saw this quarter in the last 5 years. And in fact, having been here 15 years, it's hard for me to remember actually a third quarter where we saw the type of sequential growth that we did this quarter in hereditary cancer. It's a trend, of course, that started in the second quarter, so we've really seen some strategies and tactics that we began to implement even in the first quarter, pay off in the second quarter and continue this quarter.

And I think there was equal contribution amongst the 3 things that I spelled out. First, increasing productivity by our sales team as we filled some of the empty territories, particularly in oncology. Second, we've seen community oncologists' nice growth as a result of the initiatives that we have with ION and US Oncology to emphasize the quality of our products. And then the third thing is in the academic segment, where, as you know, historically, we've seen most of the share decline had been isolated in that segment. The introduction of our customized panel have allowed us to win back business in those academic accounts and begin to see those grow in some circumstances as well. And since the Supreme Court, that's a segment that we had been seeing decline. And so I think it's the combination of all 3 of those that have really led to the team's execution in the quarter, which, again, we felt very pleased with.

Great. That's helpful. And then just as a follow-up. I think this is also the first time I can think of where the guidance you laid out for the following quarter is actually higher than our expectations in the Street. It doesn't sound, as expected, ANTHEM is going to continue to be headwind, not much build-in for EndoPredict. Just what do you think is driving the optimism at this point?

Jack, this is Bryan. I think the way I would look at the quarter and given that we have 1 quarter left in the year in terms of raising our guidance, if you look at it sequentially, we've said that we would expect the ANTHEM out-of-network to be greater in Q4, and so what you see is revenue that's slightly down from where we are today but consistent performance from products like GeneSight and other parts of the portfolio that really keep us at a level that's slightly lower than where we were in Q4.

The only thing I'd add, Jack, that Bryan highlighted, of course, we're able to look at trends in all the products as we're a month into the quarter. And so obviously, that factors into that. The continued strong trends in hereditary cancer are things, of course, we can factor into the fourth quarter as well. So...

And the next question comes from the line of Tim Evans with Wells Fargo.

Did I catch correctly that you said that your GeneSight volume actually exceeds your hereditary test volume? And then if I did hear that correctly, how did the number of prescribers for GeneSight -- how does that compare, I guess, to, say, a year ago? And how does that compare to the broader target pool?

Thanks, Tim. You are correct. The volume for GeneSight is actually our largest volume product. It was in the second quarter as well. I think it's a real testament to Gina Drosos and her team and in how much progress they've made in penetrating the market. Largely, the focus has been in the psychiatrist market, although we also do get some volume from primary care market. We've had over 10,000 physicians have ordered GeneSight, and that continues to grow. I don't have the year-over-year numbers at -- on hand, but that continues to grow very robustly.

There are about 16,000 psychiatrists that are really high-volume psychiatrists that account for about 80% of the volume, and we've seen over 10,000 physicians that have ordered GeneSight. So there's actually been very nice penetration into the psychiatry market, which is where traditionally most of the focus has been. And we continue to grow, continue to see new psychiatrists added in. And we also continue to see increasing depth in those psychiatrists after they use the test, which are all positive signs for a product that's bringing value to that.

I will add that we, of course, also launched a small pilot in the preventive care segment because we know the majority of the market for antidepressants is actually in the primary care segment, and we wanted to begin to get some experience in how to penetrate that market. That exceeded our expectations. We were very pleased to see the volume of samples that those salespeople were able to generate as they were now carrying 2 products in their bag, and so that will be another focus for ours as we increase reimbursement because there's also somewhere around 18,000 high volume prescribers in the primary care market, and those ultimately are ones that we will be able to target with our sales team, our preventive care sales team. And so increasing over time with reimbursement, we'll be able to even begin to access that broader market, which we really only scratched the surface in.

Okay. And just housekeeping question for Bryan. Can you quantify the impact of ASU 2016-09 to your tax rate in the quarter?

Yes, Tim, I believe we have that -- you should be able to look when we file the 10-Q tomorrow and get that piece of information.

Tim, we break that out in our non-GAAP earnings, so the non-GAAP earnings exclude any changes associated with ASU 2016-09.

And the next question comes from the line of Drew Jones with Stephens Inc.

Mark, was going to follow-up on the question on GeneSight. Given the cost benefit data that you kind of walked through and some of the things you're seeing in the United database, what should be the time line as far as seeking that indication for the GP market?

Yes, thanks, Drew. Obviously, the data was very strong, and we're active discussion with private payers to be able to show them the health economic data, the clinical utility and validity data, and we're very aggressively pursuing that. We're not necessarily waiting on the larger study because we think there's ample data without that. And so we're in the middle of those discussions now, and we'll continue to aggressively pursue that.

We do think it's compelling information. I think payers are very interested in this because antidepressants are a very big portion of their spend. And particularly, for these patients that are treatment-resistant depressed patients, generally, they begin an odyssey after their first failed antidepressant. That is extraordinarily expensive for a payer. And so they are very interested in this discussion and in the data, and we're going to aggressively pursue that.

Our belief is that, from a commercial payer perspective, they're not going to draw a distinction between the psychiatric market and the primary care market like we've seen in Medicare. I think private payers are well aware that the majority of patients are being treated in the primary care market. And in fact, the benefit of the test is actually probably even higher in that particular segment of the market, not only the financial benefits, which you can see in the data that we've shown, but also even in helping a very busy primary care physician avoid that medical odyssey. So we don't believe there will be a distinction between the 2 markets and that when coverage comes in the private pay, commercial payers, that it will be for both primary care and the psychiatric market.

Okay. And then jumping over to hereditary cancer really quickly. Understanding you're in the midst of a transition with the ANTHEM relationship. If you look back over the past 3 quarters, how have ANTHEM volumes trended here recently?

Yes, I think one of the things that we saw in this quarter is that we actually or all of our network -- out-of-network providers, which is primarily ANTHEM, a few smaller ones, we actually saw sequential volume growth in the third quarter with all of our out-of-network providers. And since most of the out-of-network decisions really were fully impacted in the third quarter, that was the quarter that's probably the most relevant.

So seeing sequential volume growth, I think, is an indication that the out-of-network status hasn't dissuaded physicians and patients from seeking out the best test, the highest quality test for what is an extraordinarily important decision that will impact not only the patient but generations of family members to come. So we have seen strong volume growth there, very consistent with what we saw throughout the nation. And so I think it's encouraging that, that out-of-network situation really hasn't affected that.

And the next question comes from the line of Amanda Murphy with William Blair.

I just had a couple more on hereditary cancer. I guess, first, we've at least gotten a lot of questions around some of the, I guess, contracts that are coming up for renewal. I think that they're all starting in fiscal '18 for you, so I was just wondering if you had an update there. And then I had a question around broader growth, but I guess, starting with the payer question.

Sure. Thanks, Amanda. I think the contract probably we've gotten the most questions on is really the United contract that is up for renewal beginning in fiscal year 2018. I think all we can say is that we continue to have very productive discussions with United about hereditary cancer and the value that Myriad's hereditary cancer products can bring to their members, so those discussions are productive and ongoing. And I think when that contract is ultimately assigned, we'll of course make a public announcement given the materiality of that contract, so everybody will be aware when that occurs.

Okay. Got it. And then just thinking longer term, just factoring all the dynamics that you've spoken to. So obviously, you're seeing the sequential growth in volumes in hereditary cancer. You've got the CDx side of that as well, customized panels, et cetera. Do you think that we could see growth in this business from a revenue perspective in 2018? Or I guess, just thinking more 12 to 24 months, recognizing you're not giving guidance per se, but going back to some of the commentary you've made historically about market growth, expansion opportunities, et cetera. Getting a sense of your thoughts there would be helpful.

Yes, thanks, Amanda. I don't think we're quite prepared to make comments about fiscal '18 yet and what type of guidance that we're going to provide for fiscal year '18, so that's something that August will obviously give a fulsome discussion about where that might be. Obviously, as you mentioned, I think what is important is that 2/3 of the volume of this business now is in products other than hereditary cancer. These products continue to grow very nicely from a volume perspective. And of course, as soon as we secure reimbursement for those products, that's going to ultimately flow directly to the bottom line, which is going to provide some significant leverage from an earnings perspective.

So long term, we continue to see those new products as significant opportunities for growth. And from a hereditary cancer standpoint, we still continue to see that as an underpenetrated market that's got opportunity for long-term growth with the market as currently defined. But as we expand indications, which we've talked about we continue to work on, it provides even a larger potential market for us to work on. So we think long term, this is a business that has -- certainly has significant growth potential. I think to the specifics of 2018, we'll outline all the puts and takes on 2018 when we give guidance in August.

And the next question comes from the line of Bill Quirk with Piper Jaffray.

Three what should be really quick ones from me. First is, when do you anticipate hearing an update on the draft LCDs? A question for Bryan on the tax rate. Even when we back it out, it still looks like it's just a shade over 20%. And then a second question for Bryan, just -- and forgive me if there's a really simple answer to this. But why should ANTHEM have a more significant impact in the fourth quarter versus the third quarter?

So I'll take the first, and then Bryan can take the other 2. Thanks, Bill. From a draft LCD perspective, so we obviously have a couple in play right now. We've got the Prolaris. And the open comment period has ended for the Prolaris draft LCD for favorable intermediate and the draft noncoverage for Vectra, so the public comment period is over. At this point, Medicare is assimilating all those comments. There is no statutory time line for that, Bill. So presumably, they can take whatever time they believe is necessary to fully evaluate any of the public comments that they've received. So it's hard to give any sort of guidance on when we might hear about those.

We do know, of course, for Vectra that there was pretty substantial comments received because of the very high level of interest in patients and providers continuing to maintain access to that, and so we would expect that would take some additional time to get through all those positive comments. So that's a significant amount of work, and that may delay the final decision until those comments can be fully reviewed and assimilated. So obviously, that's something could happen anytime, and we'll just have to stand by and wait for Medicare to make a final determination. Bryan, you want to take the others?

Yes, so for the other 2 questions, in terms of the tax rate, again, it is one that is hard to predict in terms of a non-GAAP tax rate, so we've continued to guide to a GAAP tax rate of around 38%. Given the large component of our non-GAAP net income that's noncash amortization, which is not deductible for tax purposes, our non-GAAP rate tends to be significantly lower than the statutory rate.

So again, I can understand how it's difficult sometimes to reconcile that, but it's a function of the -- really primarily driven by the noncash amortization expense. In terms of your second question related to ANTHEM and why it would be more pronounced in the fourth quarter than the third quarter, it really just relates to the timing of the plans and when some of those plans went out of network through the third quarter and fourth quarter. So that's really the driving factor of that difference.

And the next question comes from the line of Tycho Peterson with JPMorgan.

First on Assurex, just given the Medicaid exposure there, I think around 37%, can you just talk on potential risk of ACA repeal, given the original Obamacare Medicare expansion that the business saw?

Yes, thanks, Tycho. You're right, mental health, in general, Medicaid is a disproportionate portion of the market. I think the reality is that because reimbursement for Medicaid, for GeneSight, is in its infancies, and I know that the Myriad team is starting to work on that, the reality is there's a very small portion of revenue or volume currently that -- for GeneSight that comes from Medicaid or from patients that are signed up through the exchanges. I think we're talking about less than a couple percent of revenue that would be tied to patients in the ACA exchanges. So right now, that's not a significant component of the business. And wherever that lands, we don't really see a material impact from that.

And then on pricing dynamics for hereditary, I mean, backing out some of the ANTHEM noise, it still seems like you had some erosion there. Can you maybe just talk a little bit about the dynamics there? I know you talked in the past about new contracts taking effect and the rollover impact. But can you maybe just quantify how much price declines contributed to the 10% year-over-year decline in hereditary?

Yes, it's one that, as we stated, the year-over-year decline was really 2 components: the ANTHEM revenue recognition component as well as some price reductions. Obviously, so your -- the price reductions are obviously less than 10% because the entire impact or the entire reduction was 10% for hereditary cancer revenues, so it's less than a 10% impact. And you are right, Tycho, that's really related to some of the long-term contracts that we've signed with payers as we negotiated those with longer time frames. Obviously, the longer time frame gives us longer visibility, but in exchange for that, we did make some price concessions that were reflected in that year-over-year comparison.

Okay. And then just 2 quick accounting ones. On accounts receivable, I know you called out the system glitch at a payer unquantified debt, but DSOs did go up from last year, I think, around to 52 days or so. Can you maybe just talk on dynamics there? And then on -- particularly, on the tax rate, you're coming in at 20%. I think you had guided 38%. Can you just clarify the delta there?

Yes, first, on the tax rate question. We had guided to 38% on a GAAP basis, and where we're coming at more around 20% is on a non-GAAP basis. So I think that's really the difference there. In terms of the other -- what was the -- can you repeat the first question, Tycho?

Yes, just on the DSOs. I know you quantified the system glitch at your payer, but they did their wrap-up I think around 52 days versus 43 or so a year ago.

Yes, I think the -- as I said before, we've already -- that issue has already been corrected. We started to see the cash come in, so we would expect to see our AR and DSO numbers come more in line with where they've been. I think when you look at the year-over-year, one thing you have to appreciate is the impact of the Assurex acquisition and the fact that typically business like that would have a longer DSO than what you would -- given their non-contracted status in a lot of cases, given -- versus what you would see in terms of our hereditary cancer business. So -- but I guess, the point would be we would expect to see those numbers return to more normal level.

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

First one had to do with a little bit of a longer-term topic, which is, the FDA has recently allowed direct-to-consumer sales of some genetic tests for risk assessment. That includes, I think, things like BRCA and related conditions. So I'm just curious how you're thinking about the long-term impact of that trend. Do you think it will help draw more patients into the testing market, and therefore, you can sort of benefit indirectly? Or could you see some kind of near-term disruption as patients try to kind of go out there and explore their own risk for themselves? I'd be interested in your views there.

Thanks, Isaac. Yes, I think the decision obviously for 23andMe, in particular, consumer by the FDA was a step forward from their viewpoint of where they were a couple of years ago. I think one of the things they've been very careful to call out is that it would not in their mind include things like BRCA testing, which requires supervision of a physician. And from a clinical perspective, it's obviously a very serious decision that would be made as a result of that. So they specifically called out germline testing for BRCA as something that would not fall under this view of something that might be appropriate for consumer testing.

So I think you're -- I think they're trying to accommodate a segment of tests that have been used probably more for informational purposes and less for diagnostic and clinical treatment. I think we continue to believe that for those that are -- they believe are associated with either high or moderate risk, which would include our entire portfolio, that their view is that those should be mediated by doctors. And FDA certainly believes they should have to be reviewed by the FDA for those moderate and high-risk tests.

Obviously, as you've seen, there is legislation that's been introduced in the House to do exactly that to have the FDA regulate both high and moderate risk. We'll see how that progresses through the legislative process, but we certainly know the FDA's position continues to be that it is appropriate for them to have a role in those. And so long term, all of our tests, we think, will continue to remain in that category as opposed to probably the consumer-mediated.

I think to your point, though, I think any awareness on this is helpful for all of us in this business. I think patient awareness, getting patients to the window of physicians' office and ask about these tests is a good thing for our business. I think it's a good thing for this entire industry. So I think patient awareness is something where we've always invested in, and we've always seen benefit from that.

Great. And then a quick follow-up on Vectra. Can you just talk about the percent of rheumatologists out there that are now using the test? And maybe talk a little bit about the distribution of heavy users versus new physicians. Because as I recall, the number of doctors out there to target with that product is not massive, so be interested in just how far along you are in at least getting all docs sort of at least aware and hopefully onboard with some level of testing.

Yes, thanks, Isaac. You're right, there's about 3,500 rheumatologists in the country, so it doesn't take a very substantial sales team to cover all of those rheumatologists. And we're sized at this point to really target the vast majority of the rheumatologists that at least have sufficient patient populations to make it an appropriate thing to target. We've seen about 75% of all rheumatologists in the country have ordered Vectra. So overall, awareness is quite high. And in any given quarter, that may be somewhere of 50% to 60% of rheumatologists may order on any given quarter.

And so we still see a distribution, though. And part of the reason you don't see this market as highly penetrated is, while a number of rheumatologists have ordered the test, the numbers that are ordering at the frequency which would be appropriate is still a relatively small number. So most of the opportunity we have with Vectra is really depth of utilization within their practices. And those are things that we're working on with programs like practice integration, things that we've done elsewhere in Myriad. So good breadth, still significant opportunity for depth.

This concludes our earnings call. A replay will be available via webcast on our website for 1 week. Thanks again for joining us this afternoon.

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