Greetings, and welcome to the Myriad Genetics Fourth Quarter 2019 Financial Earnings Conference Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-session. [Operator Instructions] As a reminder, this conference is being recorded Tuesday, August 13, 2019.

I would now like to turn the conference over to Scott Gleason, VP, Investor Relations. Please….

Thanks, Kevin. Good afternoon, and welcome to the Myriad Genetics fiscal fourth quarter 2019 earnings call. My name is Scott Gleason, and I'm the Head of Investor Relations and Corporate Strategy at Myriad. During the call, we will review the financial results we released today; after which, we will host the question-and-answer session.

If you've 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 primarily 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 pertained to today's earnings call in the Investors Section of our website, in 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 documents the company filed 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 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 will start today's call by providing the business highlights from fiscal year 2019, after which Bryan Riggsbee will provide our fourth quarter financial results and fiscal year 2020 guidance, and I will finish by outlining our strategies to deliver upside to our fiscal year 2020 outlook.

For the fiscal year, revenue increased 14% with earnings up 18%. Unfortunately, revenue in the fourth quarter was 2% below our expectations with a corresponding impact to earnings that was largely attributed to lower reimbursement for our expanded carrier screening test, as a result of laboratory benefit management programs.

During the fiscal year, the cumulative impact of these laboratory benefit management programs across the portfolio was unprecedented and reduced revenue by over $50 million and adjusted earnings per share by approximately $0.51. After the pricing impact from these programs, the underlying business performance exceeded our expectations for the year.

While this impact was clearly unanticipated at the beginning of the fiscal year, we believe pricing has stabilized at the levels seen in the fourth quarter.

As a result, we believe fiscal 2020 will be a transformational year for the company, with increased volumes and reimbursement translating to record fourth quarter revenues and strong earnings momentum as we exit the fiscal year. Now I would like to review some of the highlights from fiscal year 2019, beginning with our Hereditary Cancer business.

Importantly, the Hereditary Cancer business returned to year-over-year growth for the first time in the last five years. Additional progress across a number of fronts during the fiscal year, positions this market for continued volume growth.

Broadened hereditary cancer guidelines were established for colon, pancreatic and prostate cancer, with companion diagnostic opportunities emerging for the latter two cancers. The cumulative impact of these market expansions totals more than 160,000 incremental patients per year.

In addition, based upon published studies from Myriad and other stakeholders, the American Society of Breast Surgeons updated professional guidelines to recommend hereditary cancer testing for all breast cancer patients. This represents another potential 180,000 patient expansion in hereditary cancer testing guidelines.

Lastly, our proprietary risk or test has accelerated penetration in the preventive care market and provides additional differentiation, which we plan to extend with new scientific developments to be announced in fiscal year 2020.

Myriad also continues its rapid diversification with new product volume growing to approximately 800,000 tests and representing 75% of test volume versus 65% in fiscal year 2018. Leading the way from a growth perspective was GeneSight, where total test volumes increased 17% year-over-year.

During the year, we formed the leading women's health business unit by integrating our legacy Hereditary Cancer sales force with the Counsyl team and see strong leading indicators for future growth, including a 30% year-over-year increase in new ordering physicians and a 21% increase in doctors ordering two or more products.

With our strategy of scientific differentiation, our frictionless customer experience and broad customer reach, I remain optimistic about our long-term growth prospects and the $4 billion prenatal testing market.

From a reimbursement perspective, we made significant progress with GeneSight by publishing the guided and impact studies and submitting our reimbursement dossier to all commercial and public payers.

We were extremely pleased to see our reimbursement efforts translate into our first major coverage decision for GeneSight with the recent UnitedHealthcare Coverage decision. Beyond being the largest commercial payer in the country, UnitedHealthcare is a thought leader in precision medicine and is often a bellwether for additional coverage decisions.

During the year, we also launched new innovative approaches to engage with a broader set of reimbursement decision makers. As a result, we signed our first major employer agreement with Kroger, which includes the Pharmacy Intervention Program.

In addition, we continue to advance our discussions with other Fortune 500 companies evaluating GeneSight and Vectra coverage decisions and have increased investments in this promising new payer market channel.

Another innovative approach to expand coverage is through pharmacy benefit managers, and we expect to sign such an agreement in the near future. And we'll provide more details at that time.

In summary, we remain bullish on our ability to drive additional reimbursement decisions for GeneSight and other new products through positive payer technical assessments, employer agreements, and pharmacy benefit manager programs.

In our inaugural year as a participant in the prenatal market, we laid the foundation for broader reimbursement for our tests. First, we continue to advocate for average risk reimbursement for non-invasive prenatal screening and remain convinced that this will become standard-of-care for the 3.7 million pregnancies every year in the United States.

With ForeSight, our expanded carrier screening product, two pivotal studies were published identifying the approximately 40 genes required to meet published guidelines, providing the scientific evidence required to support reimbursement for the premium-priced expanded carrier screening code.

Finally, we anticipate two new reimbursed products in fiscal 2020 based on our recent Medicare LCD for myPath Melanoma and our FDA submission for myChoice HRD in late-stage ovarian cancer. In international markets, we continue to expand reimbursement for EndoPredict with new coverage decisions in the United Kingdom, Italy, and Greece.

Additionally, we received two new companion diagnostic approvals in Japan in ovarian and metastatic breast cancer, which have propelled Japan to our largest international market. Additionally, we see a meaningful opportunity to expand the market in Japan with the hereditary breast and ovarian cancer approvals in fiscal 2020.

Finally, with Elevate 2020, we continue to make substantial strides in building a more efficient and streamlined organization. This year, our gross margins increased year-over-year, despite the impact of the lower margin prenatal tests as we made significant advances in our DNA, RNA, and protein laboratories.

The company's commitment to this program was evident as the Counsyl acquisition went from a $12 million quarterly loss to profitability in three quarters. We are currently working on implementing additional programs that will benefit fiscal 2020 expenses and beyond.

In summary, while we faced some unanticipated headwinds in fiscal 2019, I'm proud of our team's ability to combat these headwinds through a combination of innovation and disciplined execution.

As we look forward to fiscal year 2020, we have a solid hereditary cancer foundation and an opportunity for transformational earnings growth with broader commercial coverage and adoption of our new tests. We truly believe we will exit the fourth quarter as a transformed company with record quarterly revenues and outstanding future growth prospects.

I will now turn the call over to Bryan to provide an overview of our financial results and fiscal year 2020 guidance..

Thanks Mark. I would like to start by providing a more in-depth overview of our fiscal fourth quarter financial results. Fourth quarter total revenues of $215 million was up 11% compared to the $194 million reported in the same period in the prior year.

For the full year, our total revenue was $851 million and increased 14% relative to the $744 million reported last year. Of note, we grew this year on an organic basis despite the unprecedented headwinds from laboratory benefit management programs.

Hereditary Cancer revenue in the quarter of $119 million, which was up 1% on a sequential basis due to increased volumes. GeneSight revenue in the quarter was $29.8 million and volume was relatively flat on a sequential basis.

In May, we made the decision to discontinue our analgesic and ADHD products because of the level of clinical evidence did not meet the same high standard set by the GeneSight Psychotropic test in the GUIDED study.

In addition, a few payers expressed similar views and we wanted to eliminate any potential hurdles to commercial payer coverage for the GeneSight Psychotropic. While these tests comprised a smaller portion of revenue, there was a collateral impact to the GeneSight Psychotropic orders from ADHD and analgesic ordering physicians.

The net effect was a 15% reduction in GeneSight revenue in June, which we expect to continue into the first quarter. Nevertheless, we continue to see strong physician ordering trends with over 18,000 ordering doctors in the quarter, including over 2,500 new ordering clinicians.

Revenue from prenatal testing came in below our expectations at $25 million. The shortfall was attributable to a larger than anticipated impact from laboratory benefit management programs, which lowered average selling prices for our carrier screening products in the fiscal fourth quarter.

While the revenue in the fourth quarter was disappointing, from a strategic perspective, we believe pricing is now stabilized with potential upsides as we work with professional societies and payers to move expanded carrier screening and average risk testing into medical policy.

Vectra revenue in the fourth quarter was $12.2 million and grew 8% on a sequential basis, with volumes up for the second straight quarter, following our restructuring of the business units to focus on profitability.

Prolaris revenue in the fourth quarter was $6.3 million with double-digit sequential volume growth offset by a lower average selling price due to unfavorable mix. EndoPredict revenues in the fourth quarter set a new record at $3 million.

Growth in EndoPredict revenue in the quarter was attributed to additional volume and reimbursement in international markets and increased test volumes in the U.S. market.

Lastly, revenue associated with our pharmaceutical and clinical services business was $18.5 million due to strong demand from our pharmaceutical partners, especially in the field of immuno-oncology, where our Myriad RBM team has established clear industry-leading capabilities.

This quarter, we identified a new buyer for the German clinic and are finalizing terms. We plan to complete the sale of the clinic in mid-fiscal year, resulting in lower clinic revenue for the full fiscal year. I would now like to discuss our financial metrics for the quarter.

Adjusted gross margins were 76.8% and excluding the impact of the Counsyl acquisition, were up over 300 basis points year-over-year. This is a testament to the Elevate 2020 program and the significant efforts from our operations team to lower laboratory costs.

Moving on to our operating expenses, on an adjusted basis, our research and development expense was $19.3 million compared to $15.6 million last year, the increase in R&D expenses entirely attributable to the acquisition of Counsyl. Adjusted SG&A expense this quarter was $112.9 million compared to $93.9 million in the fourth quarter of last year.

In the quarter, we saw higher than anticipated expenses primarily associated with the Women's Health sales force integration incentive program. With the start of the new fiscal year, these programs have ended and as a result, we would expect total expenses to decline in the first quarter. Adjusted earnings per share were $0.41 for the fourth quarter.

This quarter, we ended with $233 million outstanding on our credit facility and $192 million in cash and cash equivalents. From a cash flow perspective, our fourth quarter adjusted free cash flow per share was $0.46. Now, I would like to discuss fiscal year 2020 financial guidance.

For fiscal year 2020, we are going -- guiding toward revenue of $865 million to $875 million. This guidance assumes organic revenue growth of 2% to 3% after adjusting for the sale of the clinic and 11 months of Counsyl revenue in fiscal year 2019.

On an adjusted earnings per share basis, we are guiding to total adjusted earnings per share of $1.80 to $1.90, which represents 8% to 14% earnings per share growth.

Given the momentum we expect to generate throughout the fiscal year, we would expect revenue and earnings growth in the fourth quarter to be substantially higher than the average for the year. Now, I would like to discuss the assumptions underlying our guidance from a revenue perspective along with potential upside drivers.

First, for Hereditary Cancer, we continue to expect flat revenue in fiscal year 2020 relative to fiscal year 2019 with the assumption of modest volume growth being offset by modest pricing offsets, given the renewal of a significant portion of our long-term contracts.

Upsides to guidance could result from expanded NCCN breast cancer guidelines, pancreatic cancer and prostate cancer companion diagnostic approval in the U.S. and ovarian cancer companion diagnostic and hereditary breast and ovarian cancer approvals in Japan. For GeneSight, we are anticipating double-digit revenue growth.

While we see a significant benefit from the UnitedHealthcare coverage decision, revenue in the first quarter will reset to a lower base following the discontinuation of the analgesic and ADHD test. As a reminder, the UnitedHealth coverage policy takes effect October 1 and consequently, we will have three quarters of impact this fiscal year.

Additionally, as many of you know, the FDA has recently increased its attention to the area of pharmacogenetic tests, including a safety communication late last year and a warning letter to a laboratory earlier this year.

As we have previously noted, earlier in 2019, we provided the FDA with clinical evidence and other information to support our GeneSight Psychotropic test. More recently, the FDA requested changes to the GeneSight test offering. And we have been in ongoing discussions with the FDA regarding its request.

Although we continue to disagree the changes to the tests are required, on August 10, 2019, we submitted a proposal regarding the reporting of GeneSight test results to healthcare providers that we believe address the FDA's principal concerns.

We believe this approach should not affect the benefits that we believe are provided by the GeneSight test, which is reflected in our guidance. Our guidance does not incorporate in any additional private payer reimbursement, the potential impact from an LCD expansion into primary care by Medicare or the impact from an expansion of the sales force.

With the Prenatal business, we are assuming double-digit volume growth that will be partially offset by lower pricing, which we expect to be consistent with pricing in the fourth.

Stronger than anticipated volume growth based upon our expanded sales organization, professional guideline updates for average risk in IPS or expanded carrier screening could be significant sources of upside. For Vectra, Prolaris and EndoPredict, we are assuming modest growth with no increased reimbursement.

Incremental reimbursement coverage for these tests could provide revenue upside. Finally, we are assuming a modest decline in our pharmaceutical services business in fiscal year 2020, based upon lower expected pharmaceutical demand for Myriad RBM services after an exceptionally strong fiscal year 2019.

We also anticipate a decline in clinical services revenue with the planned sale of the clinic at midyear, which will create approximately a $12 million year-over-year headwind. From an earnings perspective, we are anticipating total expenses will be relatively flat year-over-year based upon planned efficiencies under our Elevate 2020 program.

We are anticipating a higher effective tax rate in fiscal year 2020 due to some of the non-recurring tax benefits we received in fiscal year 2019. Additionally, we are assuming a modestly lower share count in fiscal year 2020 based upon our accelerated share repurchase program we completed in fiscal year 2019.

For the fiscal first quarter, we are guiding to revenue of $200 million to $202 million and adjusted earnings per share of $0.30 to $0.32. Our guidance assumes the typical negative summer seasonality, prenatal average selling price consistent with the fourth quarter and a reset to GeneSight revenue based on our previous comments.

While we did experience some headwinds in fiscal year 2019, we successfully offset much of the impact through disciplined cost management. We remain committed to optimizing our cost structure with moderating expense in fiscal year 2020 relative to our fourth quarter run rate.

We have set what we view as an achievable fiscal year 2020 guidance with multiple upside opportunities as we work on driving adoption and reimbursement for new tests. Overall, we remain highly optimistic about the long-term financial prospects for the company. I would now like to turn the call back over to Mark..

Thanks, Bryan. I would like to further elaborate on plans and progress for the upside opportunities that Bryan identified for fiscal 2020, starting with GeneSight.

Looking at the market for GeneSight Psychotropic, our commercial efforts to date have focused on depressed patients treated by psychiatrists, which only represents about 20% of the $13 billion market.

Substantial additional opportunity exists in the primary care market and with patients diagnosed with anxiety, both of which are covered by the recent UnitedHealthcare policy.

Our plans for fiscal 2020 are to publish additional depression data from the GUIDED study to facilitate expanded coverage, to publish data on anxiety from the GUIDED study and to expand our sales force into primary care.

A publication is in the late stages of review that provides additional clinical evidence regarding the clinical utility of GeneSight.

This precision medicine analysis of the GUIDED study evaluates the 70% of patients entering the study on medications with gene-drug interactions that could benefit from GeneSight and excludes those that were not expected to benefit.

The data shows that at the eight-week time point, remission rates increased by 70%, response rates by 42% and symptom improvement increased by 23%, all of which was statistically significant.

In addition, the results continue to improve over the 24 months of the study, with remission rates increasing by 82%, response rates increasing by 64% and symptom improvement increasing by 56%. As a reminder, the original GUIDED publication by Dr.

Graydon included an analysis of patients entering the study on medications with significant gene drug interactions and compared those that switched to those that did not.

This data remains very compelling to medical directors and shows that patients that switch saw 153% improvement in remission rates, a 71% improvement in response rates and a 59% improvement in symptoms and all were highly statistically significant.

We are also submitting a publication regarding the value of the combinatorial GeneSight approach compared to single gene approaches. This data was presented at the CPAC [ph] conference in May and showed that GeneSight was more than twice as predictive of drug blood levels compared to single gene approaches and was statistically significant.

We thought it's useful to provide a scorecard of our progress with GeneSight reimbursement six months after submitting our dossier. We were very pleased to see the pharmacogenomic coverage decision from UnitedHealthcare, the largest payer in the country, and a recognized thought leader in precision medicine.

In this industry, it is unprecedented to see a significant coverage decision in only six months, which is a testament to the quality of the data and the talents of the Myriad team.

The coverage decision is from multi-gene panels of 15 or fewer genes for patients that have a diagnosis of major depressive disorder or anxiety and have failed at least one prior medication. There are no provider limitations, and reimbursement will begin October 1st based upon our previously negotiated price.

In July, GeneSight was part of a Medicare Coverage Advisory Committee meeting where experts unanimously recommended expanding coverage to primary care physicians.

This recommendation is bolstered by strong evidence from the IMPACT study conducted specifically for Medicare, which showed the ability of primary care physicians to achieve outcomes comparable to or better than psychiatrists.

We believe the clinical evidence and physician endorsement strongly supports an expansion of coverage to primary care physicians. We are anticipating this LCD will be reviewed in October.

Finally, we recently received a technical assessment from Evidence Street, which is referenced by Blue Cross Blue Shield affiliates, representing 40% of commercial covered lives. The technical assessment was not specific to GeneSight, but evaluated the entire class of pharmacogenomics tests, which remained experimental and investigational.

However, we also received GeneSight specific feedback, which we believe provides a clear path to a positive coverage determination. The review identified three de minimis evidence gaps, all of which can be readily addressed.

The first was a question regarding patient dropout in the GUIDED study, which was already answered in the supplemental section of the Graydon publication and it's consistent with historical depression studies. Second, the review identified the need to publish the intent-to-treat analysis.

As a reminder, the GUIDED publication already includes the favorable Intent to Treat analysis. Lastly, the review requested the GUIDED power calculations, which are readily available and consistent with typical antidepressant studies.

Given that the evidence gaps are easily addressed, we have secured a meeting to present the dossier and will be submitting a request for an off-cycle review to be conducted specifically on GeneSight as the only tests with clinical validity and utility data.

From an industry perspective, it is typical for all tests, including, for example, Cologuard to go through an additional Evidence Street review. While we pursue an off-cycle Evidence Street review, we are also reviewing data directly with Blue Cross Blue Shield affiliates, which can and do make independent decisions.

For example, the affirmative from Veracyte is still labeled investigational by Evidence Street. However, it is covered by the vast majority of Blue Cross Blue Shield affiliate plans.

Given the increased coverage and the potential for an expanded LCD with Medicare, we are finalizing plans to expand the GeneSight's sales force in the second half of the fiscal year to increase our reach into the primary care market.

Long-term, we believe GeneSight requires approximately 320 sales territories compared to our current 170 sales territories. We expect the first wave of the expansion to total approximately 65 new territories. And we'll provide more details on this expansion during the fiscal year.

As a reminder, we have not incorporated any primary care expansion into our guidance and would expect that any costs associated with the launch would be more than covered by incremental revenue. Moving onto the Hereditary Cancer business.

As Bryan mentioned, our guidance for the year implies modest Hereditary Cancer volume growth, offset by modest pricing reductions. This outlook is consistent with our strategic goal to diversify the business by building upon a solid hereditary cancer foundation.

However, there are significant potential upsides in fiscal 2020 that could increase volume beyond the levels contemplated in guidance. In the past year, we have seen expansions in medical professional society guidelines that had over 160,000 eligible patients per year in United States with colorectal, prostate, pancreatic or metastatic breast cancer.

All of these indications remain less than 10% penetrated with substantial opportunity for future growth. Our guidance assumes no inflection in demand as a result of these new guidelines.

In addition, a guideline expansion from NCCN consistent with the ASBS guidelines would add more than 180,000 additional eligible breast cancer patients per year for hereditary cancer testing. Typically, these revised guidelines are published in the fall and we would expect them to be quickly incorporated into payer coverage policy.

Besides expanded indications for use, increased clinical utility for hereditary cancer testing will likely drive additional adoption. In fiscal 2020, we expect approval for the BRACAnalysis CDx test as a companion diagnostic in both pancreatic cancer and castrate-resistant metastatic prostate cancer.

Combined, these two indications represent approximately 75,000 patients per year in the United States, and we believe the availability of PARP therapies in these markets will lead to greater clinical emphasis on testing. And again, we have not incorporated this potential upside in our guidance given the pending FDA approval.

Furthermore, the recent approval of BRACAnalysis CDx as a companion diagnostic for patients diagnosed with ovarian cancer in Japan could lead to an increase in testing, as we saw with metastatic breast cancer in fiscal 2019.

Additionally, we believe our hereditary cancer submission for the BRACAnalysis tests to the Japanese Ministry of Health, Labor and Welfare will receive approval in the first half of fiscal 2020, adding up to 30,000 patients per year, because we are still awaiting Japanese regulatory approvals, we have not incorporated this into our guidance for the year.

Moving onto our Prenatal business, we continue to focus on efforts to increase reimbursement in this market with average risk coverage for NIPS testing and broader coverage of expanded carrier screening rather than just basic carrier screening.

While guidance does not assume any progress in these initiatives in fiscal 2020, we believe it is likely at least one more materialize during the fiscal year. We also continue to drive deeper penetration into this market.

This quarter on a year-over-year basis, we increased the ordering base of new physicians by 30% and increased the number of physicians ordering multiple products by 21%.

As a reminder, our market reach increased from 35% to 85% with our sales force expansion, and these leading indicators are consistent with our strategy to move prenatal testing into the mainstream of Ob/Gyn practices.

This is identical to the approach we used with hereditary cancer testing, which ultimately drove a dramatic increase in testing by building a broad base of users. For Vectra, we are anticipating additional developments that could increase both volume and pricing.

From a volume perspective, we are substantially increasing the utility by adding two new few features to the test report. As a reminder, the current test report includes the Vectra score, which is validated measure of disease activity.

In the first half of the fiscal year, we will add the risk of radiographic progression, which quantifies the probability of irreversible bone damage after one year based upon the Vectra score. In the second half of the year, we will add the three-year risk for cardiovascular events based upon the Vectra score and additional clinical parameters.

In market research, physicians saw substantial additional value for Vectra when all three features were included on the test report. This is particularly true for cardiovascular risk, since it is the highest cause of mortality in rheumatoid arthritis patients.

We are also anticipating the release of The American College of Rheumatology Diagnostic Guidelines in late calendar year 2019. We believe that, if Vectra is identified as an option in guidelines, it could provide a catalyst for both test adoption and payer coverage.

With myPath Melanoma, we have completed our sales force hiring and training, and now have a team of eight representatives focused on high volume dermatopathologists. We have not incorporated any material of myPath revenue in our guidance, so increased adoption of the test would represent upside.

Finally, we have submitted a PMA for myChoice HRD, as a companion diagnostic for niraparib in advanced ovarian cancer. Based on typical time frames, we anticipate approval in the first half of the fiscal year along with reimbursement. However, prior to approval, we have not incorporated this into guidance.

In summary, we believe the headwinds we faced in fiscal year 2019 are behind us. We have a solid foundation provided by the Hereditary Cancer business and the opportunity for transformational revenue and earnings growth, with our new products.

In addition, we have a number of upsides that are highly likely to materialize, but have not been incorporated into guidance. We are confident that we will generate financial momentum throughout the fiscal year and will exit the year with record quarterly revenues and substantial growth opportunities.

With that, I would now like to 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 the 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're ready to begin our Q&A session.

In order to ensure broad participation in today's Q&A session. We're asking participants please ask only one question and one follow-up. Operator, we're now ready for the Q&A portion of the call..

Thank you. [Operator Instructions] And first question is from Sung Ji Nam with BTIG. Please go ahead..

Hi. Thanks for taking the question.

Mark, for GeneSight, are there still other payers that are currently reviewing the dossier and might still make the decision – coverage decision in this cycle – I guess, this year's cycle?.

Yeah. Thanks, Sung Ji. Yeah, there are a number of payers that are still in the tech assessment process for GeneSight. Obviously, we never speculate on when those decisions might come, but certainly we are still in those review cycles. I think we are confident in this fiscal year that we will see additional coverage decisions for GeneSight.

Obviously, there's also the Medicare LCD that would potentially provide expansion into primary care that we're excited about, and we feel optimistic about that as well, which would be another significant opportunity. And so, we continue to see very positive feedback.

I think one of the interesting things to note is, on the day of the UnitedHealthcare policy decision, there were up – there were a significant numbers of payers that have access now that policy decision.

And so it's very helpful as others are in the review process to have a template from one of the most widely respected large volume payers in the country that they can now use as a potential template.

So we have seen a lot of interest in that policy decision and I think timing was perfect in that, it can now fall right into the latter stages where we have others that are doing the review.

I'd also call attention that not only do we potentially see that pathway for payers, but as I mentioned in our comments that employers, we think – we are very confident we will see additional employers sign on to GeneSight coverage like we've seen with Kroger.

And as I noted, our pharmacy benefit managers, we think are another very interesting opportunity for both GeneSight and Vectra. And we're anticipating the ability to sign some agreements with them this fiscal year as well.

So, I think when you combine all of that, tech assessments, the PBMs, employers, we are still very confident that we're going to see increased coverage opportunities for new products and specifically GeneSight this year..

Okay. Thank you. And then just one for Bryan.

Did you -- sorry, if I missed that, but have you guys broken out what the cost savings could be from Elevate 2020 for fiscal year 2020?.

Yeah. We haven't provided any update on Elevate 2020 for next year..

Okay. Thank you..

Welcome..

Next question is from Patrick Donnelly with Goldman Sachs. Please go ahead..

Great, thanks. Mark, maybe just one for you on the guidance philosophy, I guess, with UNH relatively set, I guess why didn't you guys roll that into guides? Are there more variables that need to play out? So, maybe just talk us through kind of the process. I'm sure you guys deliberated back and forth. Why that isn't rolled into guidance.

And then, if you can help us kind of size what the upside could be, that would be helpful as well..

Yeah. Thanks, Patrick. Just to be clear, when we look at UnitedHealthcare, we know that there is going to be three quarters of benefits and the coverage will start October 1. So we have incorporated the upside expectations from UnitedHealthcare into our guidance for this fiscal year.

And there's obviously a couple of things to note that also work with that. One is, of course, as Bryan mentioned, we saw a 15% reduction in revenue in June for GeneSight as a result of discontinuing ADHD and analgesic and that, of course, carries over and also unfortunately impacts volume for UnitedHealthcare as well.

The other thing just to note is that, we were getting some reimbursement from United prior to this coverage decision. So, it's not as if there was no reimbursement. Obviously, now we're getting -- we will get fully reimbursed at the contracted price, but it's not like we were working from no level of the reimbursement.

So, those were the puts and takes as we approach this benefit of the United coverage..

Okay. And then, are you able to just talk through kind of the GeneSight sales force build-out.

I know you kind of talked about the longer-term plans, what's baked into kind of this next year or so, and what your expectation is in the traction there?.

Yeah. Thanks, Patrick. So, just also to be clear, we have not incorporated into guidance any revenue or costs impact of the expanded primary care sales force. As I noted, based on the way we've modeled this, we believe the incremental revenue delivered by that expanded sales team will more than offset the cost.

So that would all be upside obviously on both the revenue and the earnings line. We're finalizing those plans and would expect to go into more detail on that, but we wanted to give at least a big picture vision of where this will progress over the next year or so.

So just to step back, we have 170 representatives now, and we expect that we will ultimately need 320 representatives and that would cover the largest prescribing primary care physicians. And we'll detail that out in some additional calls in the future.

We expect the first wave, we would add 65 of those 150 new additions, and that's the wave that we would expect to do in the second half of this fiscal year. Obviously, then that leaves the next wave or two for fiscal year '21. And so, that's how we're thinking about this expansion.

And one of the reasons we won't do everybody at once is, we want to make sure that we do this right that anytime you hire that many sales people, you want to make sure they're effective hires and we want to ensure that's the case.

We also want to take advantage of where we have coverage, so that we're doing so in a very appropriate cost conscious manner. So, for example, we know with UnitedHealthcare, we have the ability to look by ZIP code level at where we have higher levels of UnitedHealthcare coverage.

And so, we actually have modeled for each ZIP code what the ASP impacts are, for example, of a United decision and a Medicare LCD expansion. And so, we will target territories based specifically on those modeled ASPs, and that's why we think that first wave is going to be somewhere around a 65 salesperson size.

So, not only do we have the increase of reimbursement for GeneSight, but as you know Patrick, adding that many additional sales people actually has the opportunity to double the market potential just in a number of physicians that we're calling on.

So I think we've got two opportunities here for some pretty substantial GeneSight expansion over the next couple of years..

Appreciate it, thanks..

[Operator Instructions] Next question is from Bill Quirk with Piper Jaffray. Please go ahead..

Great. Thanks. Good afternoon, everyone. Question for Bryan on Counsyl, looks like it is off, you think it was 18% sequentially. Bryan, were there any ASC 606 accounting changes or anything like that that was going on there, or is this just straight up lower reimbursement and so we had to make the adjustments..

Yes. I mean, I would just -- I would make one general comment relative to ASC 606 is that, every quarter we're going to have positive and negatives adjustments based on what we collect in terms of cash.

But relative to the prenatal business, specifically, as I noted earlier, I would attribute the entirety of that delta really to the impact that we saw from the LBMs on our carrier screening business. So I think that would be where I'd point you for that, for the sequential decline that you saw..

Okay. Got it. And then, as a follow up and kind of working off of Sung Ji's question a little bit. Any updates, Mark, specifically around eviCore or Anthem as it relates to GeneSight. .

We're still in discussion, so let's take eviCore as the first. One of the things that we're working with eviCore on is that, there were some factual corrections to the policy decision they made earlier in the year. And again, just as a reflection with eviCore, was really a quick review with a guided study as opposed to the entire dossier.

So, a couple things we'll do. We'll review the entire dossier, and we're also correcting some of the factual errors that were in that.

And then, one of the things that they had noted was, they wanted some additional information on symptom improvement, and so that data that I outlined to precision medicine analysis, Bill, that I outlined in the slides, that data is very important to them, because it answers that question, which is that, if you exclude the patients that you don't expect to benefit from GeneSight and analyze the patients where you did, you will see statistical significance on everything, including symptom improvement.

So I think the acceptance of that manuscript is actually going to be important for our ongoing discussions with eviCore. From an Anthem perspective, we do continue to have active dialogue.

I think, given that Kroger, which is a very big customer of Anthem, was very impressed with the data and obviously chose to cover this and is also working on a pharmacy intervention. I think all of that piqued the interest of Anthem, as obviously they want to be as a payer in a position to be able to bring those type of solutions to their customers.

And so, that has enabled us to go back and to continue to have very productive dialogue with Anthem and review the dossier in much greater detail. So, those discussions are ongoing..

Next question is from Dan Leonard with Deutsche Bank. Please go ahead..

Thank you. So my question and follow-up will both be on GeneSight.

So first off, Mark, can you elaborate on what changes to the GeneSight report that you proposed to the FDA?.

Yeah. Thanks, Dan. I can't really have it -- don't have any other additional comments other than those that Bryan made. I think the only thing I would point you into -- point you to in his statement is the comment that we believe the approach should not affect the benefits that we believe are provided by the GeneSight test.

So, no comments beyond that, Dan..

Okay. And then my follow-up. I'm trying to better understand how pulling the analgesic and ADHD test from the market could add such a big impact on total GeneSight revenue in the month of June and then year forward. So is there anything further you could offer to help me better understand the knock-on effects? Thank you..

Yeah. Thanks, Dan. Good and understandable question. Yeah. As we noted, the tests themselves were a smaller percentage of revenue, but when you look at the fact that there were a number of very large ordering physicians that ordered both analgesic and ADHD and GeneSight Psychotropic.

So I think when -- we obviously saw the direct impact of the pulling ADHD and analgesic, but the collateral to those large orders, the collateral impact was that consequently there, GeneSight psychotropic volume came down as well.

And so, it was certainly disproportionate to the volumes of those two smaller products, but it was really because there are large volume ordering physicians that ordered the entire set of products. Whether those physicians went to other laboratories or whether they stopped ordering entirely, probably a little mix of both of those.

Obviously, we're in there with those customers try to win them back on both fronts. And -- but as we give guidance, we can't assume that we're going to win that back. And so, we've obviously set our guidance based on the impact that we saw. And again, I want to underscore the rationale for what we did.

First, we have a pretty high standard for what it means to be able to have clinical evidence. And with the GUIDED study and what we promote the physician that the level of evidence with GeneSight psychotropic is unmatched, that's a level of standard we want to hold ourselves to.

And we obviously don't have those type of prospective studies on analgesic and ADHD, so we wanted to be credible when we're in front of physicians, and therefore chose to take those off the market. I do think I want to underscore as well that we did wanted to be an obstacle for payers.

You'll note for those who have looked at the UnitedHealthcare policy, they specifically excluded coverage for GeneSight, analgesic and ADHD. And so I think that's a good example of why we didn't want products out there that somehow could impact our ability to get additional coverage decisions from payers..

Okay. Thank you..

Next question is from Puneet Souda with SVB Leerink Partners. And your line is open..

Yes. Thanks, Mark. First question around lab benefit managers, I mean, that's been a sizable impact this year and now in career screening.

So just could you provide us a clear view of among all the tests that you have, where could -- where the lab benefit managers actively looking at and what potentially the other areas that they can potentially look at? And I just want to get a clear sense of, is that contemplated fully in your guidance for 2020?.

Yes, thanks, Puneet. It really was concentrated in two tests, GeneSight and ForeSight. And the reason is that those two tests don't have specific codes that are associated with those.

And so as a result of that, you're doing multiple genes and I think it's those scenarios where you don't have a specific code with a specific contract price that we've seen the interventions from a lab benefit management program.

It's not something we expect for the rest of the tests that have codes and that's why we really didn't see any of that in the fiscal year with the other tests.

Now, what we saw with GeneSight is, as you know earlier in the year, we saw the impact for a couple of quarters that rebased and for the last two quarters now we've had consistent pricing for GeneSight. That was our expectation with ForeSight, this is now the second quarter that we have seen an impact.

And of course, we can see what's happening as we go into the first fiscal quarter. And we're seeing a similar pattern with pricing having reset after a couple quarters and stabilizing after that.

So based on that experience of what we saw this year, we were comfortable assuming pricing would be stable in this fiscal year and that's what we used to base our guidance. I mean, obviously to your point, it was unanticipated by us and it was significant.

When you look at a $50 million impact for the year and $0.51 per year, $0.51 in earnings, it was a pretty remarkable impact that Bryan and his team and many others did a great job cushioning the blow from that through many of the Elevate 2020 initiatives. But we think that's really behind us at this point..

Okay. Thanks. And just on the follow-up on the earlier question around the FDA's recent changes on August 10 that they requested, so if you could just -- I know it's tough to give details around that.

But if you could maybe at a high level, would this impact what is actually sort of desired by the physicians or what impact the current CMS reimbursement on it or United coverage or other coverage that's in place? And maybe if you could provide a few, if that's giving you any rethinking on the primary care sales force and just help us around -- also if you could around the timing of this, when do you think this can potentially get resolved? Thank you..

Yeah. Thanks, Puneet. I appreciate the question. Yeah. We really can't provide any other comments other than the ones that Bryan provided. I would just rearticulate that we believe this approach does not affect the benefits that we are provided by genes -- that are provided by GeneSight.

And other than that, I can't really provide any additional comments..

Okay. Thank you. If I could just squeeze in last one on my part, what's your expectation there in terms of increasing the sales force? I mean, the dermatology practices around the country are fairly widespread. So just wanted to get a sense of your investment into that test. Thank you..

Thanks, Puneet. We think the sales team that ultimately would be required to get to that entire market, which by the way we size at about $400 million market potential, is 16 sales people. So we're about halfway there with this expansion.

And so, we're going to let these salespeople get in place, get the territory set, let's see what kind of experience we have with the sales team and then we'll decide when to expand to the broader market at that point.

But I think that is one of the attractive things about this market, is if you can cover a $400 million market with 16 sales people, obviously it's one that we're very excited about. As I noted, we have not included that in our guidance for the year, because we're still in the early stages of that sales force expansion.

So to the extent that we are successful and that team is able to drive significant revenues in myPath, it would be something that's not contemplated in our current guidance, nor is an expansion of that team contemplated in our current guidance..

Okay. Thanks, Mark..

Next question is from Derik De Bruin with Bank of America Merrill Lynch. And your line is open..

Hi, this is Ivy Ma on for Derik today. Thank you for taking my question. My two questions will be on GeneSight.

So first, could you update us what's the assumption for commercial reimbursement rates for GeneSight in ongoing conversations that we discussed earlier, especially given multiple offerings on the market and competition might be -- some of the competition might be at a much lower rate? Thank you..

Yes. We have not -- from a guidance perspective, we don't incorporate any additional anticipated reimbursement. We only incorporate reimbursement that we know of at this point. And so, as I noted to Patrick's comment that we have incorporated our expectations around United. But other than that, we have not incorporated anything for the Medicare LCD.

We have not incorporated any of the other potential positive coverage decisions in our guidance at this point. So, those would all represent upside. Now, I think from a competitive standpoint, there are others in this space. There are not many large competitors.

And I would note again that all that data that I showed again on this call, GeneSight is the only test that has been able to show clinical validity and utility data that in fact patients have better outcomes when doctors have the information provided by GeneSight.

And so we've also, as a result of that, been able to show substantial cost savings to the healthcare system $6,000 in the first year. No other test has been able to demonstrate those types of cost savings.

So, when we're able to go into a payer, demonstrate that utility data, the validity data, and the cost savings data, whereas others are unable to do that, we think we present a very strong value proposition for payers. And that's why we remain bullish on additional coverage..

Great. Thanks. I just wanted to clarify the question is more on what's the broader side regarding commercial pricing range. I know previously, you mentioned is around $2,000, so I just wanted to clarify that.

And then the follow-up question is on anxiety, wanted to see if there's any additional color on how long does it take to show the anxiety data from the guided study, and when can we expect to see that to add to that site? Thanks..

Thank you. Sorry, I probably missed that. We're still targeting a $2,000 ASP for GeneSight, so that remains our target. And again with $6,000 first year savings, we think that the return on investment is substantial.

Note that $6,000 does not include increased productivity, which really employers find to be one of the strongest value propositions for GeneSight. From the timing standpoint for anxiety, we haven't -- I don't think we're prepared yet to discuss when we might see an anxiety publication from GUIDED. That is something we expect in this fiscal year.

We would note obviously UnitedHealthcare has already covered anxiety, and it's important to know that that's 40 million people a year diagnosed with anxiety, much more than depression. So, that's an important consideration for payers and for providers. So it is one that we are quite interested in, and you will see anxiety data this year from GUIDED..

Great. Thank you for the colors..

Operator, can we take our next question please?.

And the next question is from Steve Unger with Needham. Please go ahead..

Hi, thanks. Just on GeneSight and Kroger, I was wondering if you could provide more details as to how that program is rolling out. I guess it's my understanding that it's a literature drop for patients picking up prescriptions to inform them of GeneSight, but maybe more color there would be helpful.

And then, is it possible for you to quantify the revenue opportunity within United and what United represents in the current mix of volume?.

Yeah. Thanks, Steve. From a Kroger perspective, obviously there's a couple things. First, there's coverage for their own employees, but I think you're probably speaking specifically to the pharmacy intervention.

So that's one that Kroger is actually piloting or preparing to pilot, whereby they would actually have their pharmacies intervene with the patient's healthcare provider in order to make them aware of the fact that there is an alternative for patients that have failed on one or more medications.

And that this is a patient that would potentially qualify for that and solicit involvement from the healthcare provider in providing GeneSight test, provide some additional aid in selecting that next medication. So it's actually an active pharmacy intervention program. We're in the early days.

It's hard to know exactly how this is going to impact, ultimately, patient care and volumes. But certainly, it's a very intriguing opportunity. With a successful pilot, we can then roll that out to a couple of thousand stores instead of 500.

And then, of course, we can look to other pharmacy programs that might be interested in offering that type of valued service. So, I think there's benefit beyond just what we might see with the Kroger program per se.

I'm sorry, what was your second question, Steve?.

Just on United, is it possible for you to quantify the -- just the overall revenue opportunity within the United membership and what the current mix is in the volume of the United?.

Yeah, I think we haven't given specifically, but I think you can just assume generally it's consistent with their market share in the commercial payer landscape. So we generally see volumes pretty consistent with the payer market share, so..

Got it, okay. Thank you..

Next question is from Tycho Peterson with JPMorgan. Please go ahead..

Hey, thanks. I want to follow-up on the FDA dynamic. I understand you don't want to say a lot, but our understanding is they're actually -- actively making calls to companies telling them they cannot report, which drugs or drug classes to take this on a pharmacogenetic testing.

Are you able to comment on whether that's the case, whether you receive that call from them? And are you able to talk about what you're actually reporting to United? For example, can you report out the red and green buckets, suggesting specific drug products anymore?.

Yeah. Thanks, Tycho. Really I can't make any additional comments other than those that Bryan made in his statement..

Okay.

Given that United owns behavioral health centers with access to genetic counselors, I guess, is there a view that this is maybe just more of a marketing tool that drives volume for their behavioral health centers? Can you comment on that dynamic?.

From the perspective of United, Tycho, you mean?.

Yeah, correct..

Well, I definitely think United -- I think there's opportunities to do more with United. Obviously, we’re in the early days of a coverage decision, but I think with any coverage decision, typically we will follow-up and talk to any payer about what other programs they may want to wrap around a coverage decision.

And we're actually in active discussions with multiple payers about those types of programs. So, United and Optum, obviously, do a substantial number of programs. And so I think there's opportunities that we can and will explore with them and with others on other ways to provide services.

I think to your point, it's astute that many of these payers are in competitive markets and they want to attract additional clients based on services that they can provide that clients appreciate. And mental health is tops on the list of most employers.

And so as a payer, if you can bring additional services to those employers, it's something that is very beneficial as you compete with others in this marketplace.

And so that's certainly something you're seeing, and that's part of the reason we've been so -- investing so heavily on the employer side is that we really see some different dynamics here, that in this mental health space that we have not seen in some of our other products..

All right. If I could ask one more. You made comments about prenatal pricing bottoming out.

I'm just curious -- given competitive dynamics, [with BK and others], why you think that's the case? Why it couldn't get worse?.

Yes, I think the comments we're making on the pricing is really related to the fact that lab benefit manager impact that we saw and the fact that we've seen two quarters of impact, but we're seeing that stabilize in the first quarter.

I think from a pricing standpoint, as we look at expanding carrier screening, which is really where this dynamic has played out, I think what's important to look at strategically is that basic carrier screening is still the only testing that is broadly reimbursed, expanded carrier screening is not.

And as you know, Tycho, there's a specific code for expanded carrier screening, the Medicare price of that code is $2,400.

What we are working on is to provide the evidence to get guidelines and broad coverage for expanded carrier screening and not just basic carrier screening, which by the way only identifies somewhere around 30% of affected couples.

And so as we are successful in broadening guidelines and coverage consistent with that guidelines we think there is the opportunity to shift to a code that is obviously priced, at least with Medicare, significantly higher than where we are. So I think this market is going to move to expanded carrier screening. I think the evidence is very striking.

And I think as it does, we're going to see, I think, a different dynamic from a pricing perspective. .

Okay. Thank you..

Next question is from Doug Schenkel with Cowen & Company. Please go ahead. .

[indiscernible] on for Doug. I appreciate all the color you disclosed about where you are in the coverage decisions with major payers for GeneSight.

I believe with United do you actually establish a contract right ahead of their coverage decision? Have you disclosed that you have established contracting decisions with any of the major payers at this point? I'm just trying to get a sense of that may be a leading indicator for future coverage decisions..

Yeah. Good question. We actually have contracts in place with commercial payers that represent more than 25% of all covered lives in the country. United was part of that. We haven't disclosed anybody else outside of United on where we had a contract in place. And so, we won't do that just because we don't have agreement to do so.

But I think that frames the opportunity that there still obviously is a significant number that have GeneSight in contract, where we don't have a coverage decision yet. And of course, we're actively working with those..

Okay. And the United decision, I think had an effective date roughly two months from initial coverage announcement.

Should we expect a similar timeline to other major payers? Were it to issue coverage decision or would it take longer since maybe some of those payers don't have the contracting decision in place?.

I think a month or two to actually have a policy be effective is pretty typical. There are some that actually make effective dates even faster than that. So – but it's relatively short time frame from coverage to effective date typically..

Okay. Thank you..

Next question is from Brandon Couillard with Jefferies. Please go ahead..

Hi, thanks. Good afternoon. Bryan, just on the guidance, you kind of pointed to the fourth quarter being substantially higher in terms of revenues.

You should, sort of, speak to the factors behind that back-end loaded outlook, level of confidence and perhaps relative growth rate kind of exiting the year in the fourth quarter?.

Sure. Thanks, Brandon. Yeah. A few comments, I would make, I mean, first of all, we talked about an organic rate of 2% to 3% for the year.

As you mentioned, trending higher through the year, I think the things to note there are one, when you look at the reset in terms of the LBM impact on our prenatal business and the impact of removing the two products from the GeneSight portfolio, that's going to reset you at a lower base at the beginning of the year and then you'll grow from there.

And then, also as you know, the United coverage decision is effective October 1. So we'll get three quarters of that.

So, that was the rationale for the statement around trending higher through the year again, because you'll be one building off of a bigger base and then you'll have a catalyst that'll kick in, as we get in – move into the second quarter..

One other thing, I'd probably note is that seasonally, Q1 is a very weak quarter. So you're – when you look at something like a Q4, which is one of our stronger quarters, you've got seasonality advantages that are pretty significant. First quarter, really does face headwinds throughout all the summer for all of our products..

Thanks.

And then one more, Bryan, can you be more specific about the tax rate you've penciled in for the year?.

Yeah. So we didn't update on the tax rate – the only commentary we made was that it would be higher than it was this year. And really, the reason for that again – there was – there were some of the discrete items that we had in the current year, the benefits that will not be recurring next year..

Okay. Good. Thanks..

And next question is from Jack Meehan with Barclays. Please go ahead. Your line is open..

Hey, thanks. This is actually Mitch Petersen on for Jack this afternoon. In 2017, you commented that UnitedHealthcare fully reimbursed for GeneSight, it would be roughly $40 million of revenue and EBIT, thinking more on an annualized basis, is this still a rough framework that we could use to help us size the opportunity? Thanks..

Yes, Thanks. I think, as we noted there, that was fully reimbursed and that's still a reasonable number to think about. I think, as we think about the impact for this fiscal year, probably a couple of things to remember is that, we've got only three quarters obviously that we're going to be able to see the benefit of United.

We have seen this reduction in volume of 15% that I mentioned previously. So, those two things obviously weigh on what that number is for the fiscal year, but I think that's still a reasonable number to think about..

Okay. And then maybe on hereditary, just to confirm, are you still billing code 81162 for Medicare? And if you could just refresh us on the rationale behind using that code over 81432 that would be helpful? Thank you..

Yes. Thanks, Mitch. The codes we bill are very much dependent upon what happens to be in the contract or contracts for our payers, and as you might imagine, with hundreds of contracts, it's extraordinarily complex.

So, it's not something we really elaborate on, because frankly it's mind-numbingly complex on whatever payers may have in their particular contract. So, it's not a detail that we actually go into..

Okay. Thank you..

There are no further questions. I'll turn the call back to you..

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

So, thank you for attending everyone. That does indeed conclude our conference call for today. We thank you for participating and you may now disconnect..