Mark Capone
Analyst · Piper Jaffray. Please go ahead
Thanks Bryan. I would like to highlight the progress we have made on our five critical success factors starting with the Hereditary Cancer business. This quarter we were encouraged that the American Society of Breast Surgeons expanded their guidelines to recommend Hereditary Cancer testing for all breast cancer patients. This decision is based upon increasing clinical evidence that the rate of deleterious mutations found in patients is consistent regardless of age. If other guidelines such as the National Comprehensive Cancer Network followed suit this would more than double the number of patients that make criteria in the United States and could lead to higher penetration with dramatically simpler patient identification. Additionally, at ACOG we presented a second study once again showing that 23% of patients at OB/GYN practices met criteria for hereditary breast cancer testing. This data is a result of a number of expansions and testing criteria substantially higher than previously estimated. We believe there are more than 35 million women that qualify for hereditary cancer testing in the United States and that market penetration is less than 5%. We also to continue to expand the market for hereditary cancer testing through a multitude of companion diagnostic programs. This quarter AstraZeneca announced data from their POLO study where patients with pancreatic cancer who are identified as having a germline mutation by BRACAnalysis CDx had both statistically and clinically significant changes in progression free survival compared to patients receiving placebo. Myriad plans to file a supplementary PMA for BRACAnalysis CDx conjunction with AstraZeneca's as new drug applications for this indication. This new companion diagnostic indication would represent 40,000 pancreatic cancer patients per year in the United States. Additionally, we recently expanded our companion diagnostic partnership with AstraZeneca and Merck to provide BRACAnalysis CDx testing and patients with the metastatic castrate resistant prostate cancer. Every year in the United States approximately 30000 men will develop metastatic castrate resistant prostate cancer and like pancreatic cancer current testing penetration rates are less than 5%. Our tumor testing companion diagnostic business achieves a significant milestone in April with the filing of the first PMA module for myChoice HRD CDx in conjunction with niraparib for ovarian cancer patients who have received three or more previous lines of chemotherapy. The submission is based upon the positive results of the QUADRA study where platinum sensitive myChoice HRD positive patients saw an objective response rate of 26% compared to only 4% in myChoice HRD negative population. Proposed intended use for myChoice HRD is for ovarian cancer patients who may become eligible for a PARP inhibitor which includes the 200,000 ovarian cancer survivors. FDA approval for myChoice HRD would provide a pathway to the code and payer coverage for the test. The second critical success factor is to grow new product volume. I would like to start with the prenatal business which grew 7% sequentially. Prenatal strategy has three pillars providing a differentiated test offering through pioneering science, supporting our customers as trusted advisers with a field-based team that is more than double the size of our nearest competitor and offering a frictionless customer experience from Myriad complete application. This quarter we continued to differentiate prequel with the launch of expanded aneuploidy testing for all 23 chromosome pairs rather than the three chromosomes routinely assessed by other laboratories. This increased the sensitivity of the test by approximately 30% and provides an area of differentiation which is difficult to replicate for non-and-GS based technologies. Additionally, data at the American College of Medical Genetics meeting from 58,000 patients study showed that the prequel past was highly accurate in patients even below a 4% fetal fraction cut-off. The presence of a cut-off did not improve the accuracy of the test. This provides a critical area of differentiation as a prequel no call rate is 1 in 1000 patients with competitive laboratories have no call rates of approximately 1 in 20 patients. Importantly patients who receive a no-call on a non-invasive prenatal screening test typically go on to receive highly invasive amniocentesis or eukaryotic testing is both expensive at an average cost of approximately $1,500 and poses a risk of miscarriage of approximately 1 in 200. We also made great strides integrating the Women's Health sales force during the quarter which led to the 7% sequential volume growth in its seasonally weak quarter. These increasing volumes were driven by a 17% increase in total ordering physicians. While we have seen early success week there is still significant upside as our sales team continues their training and gains experience selling these sophisticated products. Our newest commercial opportunity is with myPath Melanoma and we thought it useful to provide an overview of the product after obtaining Medicare reimbursement. Every year in the United States there are approximately 2 million skin biopsies performed from melanoma and approximately 15% of these biopsies are indeterminant after review by board certified dermatopathologists. This translates into300,000 potential tests per year with the revenue potentially exceeding 450 million per year. myPath is a proprietary RNA expression test that evaluates 23 genes associated with immune function cell differentiation and cell signaling pathways. Validation data for myPath is the most active ever in the melanoma diagnostic market therapy large validation studies that have demonstrated 90% to 95% diagnostic accuracy. We also have strong clinical utility data with myPath Melanoma and a study of 218 patients that was published in medicine in 2016, myPath Melanoma reduced indeterminant diagnoses by over 50%. Additionally, a second study published in personalized medicine in 2017 showed an over 80% reduction in accessions for patients receiving a benign test result. To-date, we have limited commercial sales efforts to select dermatopathologists perform more than 30,000 tests. We're in the process of expanding the sales team to eight representatives which will provide reach into 35% of the very concentrated U.S. market with only 1,200 practicing dermatopathologists. Overall, we are excited about our pioneering efforts to personalized medicine to yet another disease state and expect to generate revenue in the second quarter of fiscal 2020 after coding and pricing have established. Our third critical success factor is to increase new product reimbursement a most important initiative in this area is to expand coverage for the GeneSight test, if submitted our complete dossier to payers representing over 90% of commercial covered lives and continue to have positive discussions to continue strengthening the dossier, we are publishing data on two additional analysis from the guided study. First analysis evaluates the subset of patients that entered the [indiscernible] medications with Gene drug interactions which is consistent with the indications for use for GeneSight. GeneSight is indicated for use by physicians contemplating an alteration in neuropsychiatric medications for patients with moderate to severe depression after at least one medication failure. Obviously, patients entering the study on green medications are no longer being considered for alterations in their medication. As such those patients were excluded in this analysis and the patients in the GeneSight arm had better outcomes in all three clinical endpoints of permission, response and symptom improvement. The results were statistically significant. In another guided analysis the GeneSight combinatorial approach was compared to a single gene approach to demonstrate the additional value of the test in one specific example in this study GeneSight appropriately declassified 24% of patients classified as in the intermediate metabolizers by single gene tests into a lower metabolizer category. Consistent with this reclassification, these patients had a clinically and statistically significant 58% increase in drug exposure with normal metabolizing patients. While these two additional studies are progressing through the publication process they will be available for payers although to-date we have had very few requests for additional data. This quarter we also engaged with a large number of senior human resource executives from Fortune 500 companies to outline the value the GeneSight and Vectra provide by improving employee wellness and increasing their health care spend. I'm pleased to announce that we have now finalized the GeneSight implementation agreement with Kroger, the fourth largest employer in the United States, which follows the Vectra agreement announced in July. As part of this agreement, Kroger is implementing a medical intervention step from Kroger pharmacists, patients treating physician discuss GeneSight. Kroger currently has 3% market share among retail pharmacies in the United States with over 2,200 locations. They are also in late stage discussions for coverage with an additional Fortune 500 company and have eight additional Fortune 500 employers in early stage discussions on GeneSight and Vectra. These employers are typically among the largest customers of national commercial insurers and are often a catalyst for changes in commercial payer coverage. Another reimbursement goal is to increase reimbursement for ForeSight and to that end we announced an important new publication in genetics and medicine, which was the first data driven evaluation of commonly stated panel inclusion criteria for expanded carrier screening in over 55,000 patients. The study evaluated the frequency of at risk carriers for 176 genes included in the ForeSight test and found that by applying the recommended 1 in 100 panel inclusion criteria, 38 of the conditions in ForeSight met all criteria. A second independent study recently published in genetics and medicine evaluated 415 genes to cross 123,136 patients showed strikingly similar results finding that 40 genes would be appropriate for testing to meet 1 and 100 criteria. We believe these studies will be pivotal to broadening expanded carrier screening guidelines from ACOG and ACMG that currently only recommend advances in spinal muscular atrophy testing screening for all ethnicities. Expanded guidelines will provide an opportunity to broaden coverage for the newly established expanded carrier screenings code. With Prolaris, I'm pleased to announce several additional coverage decisions including group Blue Cross Blue Shield of Kansas, SmartHealth; Blue Cross Blue Shield of Northeastern New York; and Blue Cross Blue Shield of Western New York bringing the total number of covered commercial lives in the United States approximately 27 million patients. Lastly with myPath Melanoma, we have now received reimbursement from eight commercial payers and a final local coverage determination from Meridian Healthcare Solutions or Medicare Administrative Contractor which becomes effective in June. Note that Medicare patients comprise approximately 35% of the melanoma diagnostic mark. myPath Melanoma also has been recognized in the American Academy of Dermatology and NCCN guidelines, which recognize the potential of myPath Melanoma to aid in the diagnosis of equivocal lesions. We are continuing to engage with commercial payers to expand reimbursement coverage for myPath Melanoma and believe the reimbursement dossier is well positioned for broader coverage. Moving on to the international business, this quarter we received approval from the Japanese Ministry of Health Labor and Welfare for BRACAnalysis CDx as the companion diagnostic in first line ovarian cancer with olaparib. Coupled with the metastatic breast cancer indication where we already have approval there are now approximately 22,000 cancer patients in Japan every year eligible for companion diagnostic testing. As a reminder in the fiscal second quarter, we also submitted our application to the Japanese Ministry of Health Labor and Welfare for BRACAnalysis in Hereditary Cancer patients. Its application initially seeks approval for affected women with breast cancer or ovarian cancer, but could expand in the future to include unaffected patients as well. Within EndoPredict, we have seen several recent reimbursement advances in the international market, first, nice improved EndoPredict for reimbursement in the United Kingdom in December. Additionally, the first region in Italy has announced they will begin reimbursing EndoPredict and Greece has now announced coverage for all breast cancer prognostic tests as well. In summary, we remain very encouraged with our progress and the potential to transform the financial performance of the company. Hereditary cancer business has returned to growth for two consecutive quarters. We are expecting stable revenue in fiscal year 2020. We have two material growth drivers with GeneSight and the women's health business with both have meaningful near-term catalysts. Additionally, we continue to generate operating leverage and double-digit earnings growth as we execute on our Elevate 2020 program. With strong new product volume growth and increased reimbursement coverage, we continue to believe we have the ability to more than triple the earnings power for the company in the future. With that, I would like to now turn the call back over to Scott.