On November 4, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal first-quarter 2020, provided an update on recent business highlights and provided revised fiscal year and second-quarter 2020 financial guidance (Press release, Myriad Genetics, NOV 4, 2019, View Source [SID1234550239]).

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"We had a challenging start to fiscal year 2020 as hereditary cancer revenue accrual from small payers was impacted by the deletion of the historical hereditary cancer CPT codes. We had assumed this administrative change would have a minor impact to cash collections, but unfortunately, that has not proven to be the case. While the hereditary cancer business has returned to strong double-digit volume growth, the revenue accrual impact from these changes have led us to lower our financial outlook for the year," said Mark C. Capone, president and CEO, Myriad Genetics. "Despite this setback, we expect earnings to be significantly higher in the second half of the fiscal year and believe that a number of important upsides will materialize during the fiscal year generating momentum as we transition into fiscal year 2021."

Recent Business Highlights

Hereditary Cancer

In the fiscal first-quarter, Myriad made approximately an $11 million reserve adjustment for hereditary cancer revenue due to lower cash collections from small payers as a result of the deletion of the current procedural terminology (CPT) codes 81211 and 81213. As a result, the company has revised its revenue accrual rate, and is forecasting lower hereditary cancer rates for fiscal year 2020. Myriad will provide a detailed summary of the changes on its fiscal first-quarter 2020 earnings call.

Hereditary cancer volumes grew at a double-digit growth rate on a year-over-year basis for both the company’s oncology and women’s health business units.

GeneSight

Announced coverage decision from UnitedHealthcare, the largest commercial payer in the United States, covering GeneSight for patients that have a diagnosis of major depressive disorder or anxiety and have failed at least one prior medication.

Signed master service agreement with a large pharmacy benefit manager in the United States to offer GeneSight to its commercial payer and self-funded employer customers. A Fortune 50 company has already opted into the master service agreement.

Published the precision medicine analysis of the GUIDED study in the Journal of Clinical Psychiatry. The study evaluated 787 patients at baseline who were on medications with known gene drug interactions. The analysis showed that patients who had their treatment guided by GeneSight saw a 70 percent improvement in remission, 42 percent improvement in response, and a 23 percent improvement in symptoms, all of which were statistically significant.

Prenatal

Received acceptance for publication for new data in Prenatal Diagnosis demonstrating that Prequel is the only non-invasive prenatal screening (NIPS) test that outperforms traditional measures of aneuploidy detection across all classes of obesity. Other NIPS testing methodologies can have failure rates up to 24 percent in obese patients leading the American College of Gynecology to recommend against using NIPS in patients with significant obesity.

Prolaris

blished a clinical outcomes study in Personalized Medicine that demonstrated the Prolaris test can identify men with low-risk prostate cancer who can safely select active surveillance (AS) and defer the need for costly treatments such as radiation therapy or surgery. In the study of 664 men with low risk prostate cancer, 82.4 percent selected AS for their initial treatment and only 0.4 percent experienced disease progression. Additionally, the AS decision was durable with 91.2 percent of men remaining on AS at year one and 65.2 percent at year four.

Companion Diagnostics

Filed a supplementary Premarket Approval Application with the U.S. Food and Drug Administration (FDA) to authorize BRACAnalysis CDx as a companion diagnostic test for olaparib in metastatic, castrate-resistant, prostate cancer patients with germline BRCA mutations.

Received the first FDA approval for myChoice CDx as a companion diagnostic to identify women with ovarian cancer who are candidates for Zejula monotherapy in the late-line setting.

Submitted our myChoice CDx test for approval by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in ovarian cancer.

Fiscal Year 2020 and Fiscal Second-Quarter 2020 Financial Guidance

Below is a table summarizing Myriad’s fiscal year 2020 and fiscal second-quarter 2020 financial guidance:

Revenue

Myriad’s fiscal year 2020 and second-quarter 2020 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fiscal first-quarter financial results and fiscal year 2020 financial guidance.

Conference Call and Webcast

A conference call will be held today, Monday, November 4, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-945-0427. International callers may dial 1-212-231-2918. All callers will be asked to reference reservation number 21931991. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.