On August 13, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal fourth-quarter 2020 and provided an update on recent business activity (Press release, Myriad Genetics, AUG 13, 2020, View Source [SID1234563592]).
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"Following the substantial decline in test volumes at the end of Q3 and beginning of Q4 due to COVID-19 social distancing policies we saw a significant recovery in test volume trends throughout the quarter, with volumes in late June increasing to approximately 75% of the pre-pandemic level," said R. Bryan Riggsbee, interim president and CEO and CFO, Myriad Genetics. "As we look forward to fiscal year 2021, we are prepared to manage the business within whatever constraints that the COVID-19 pandemic imposes, and as such we will be investing in new capabilities such as telemedicine and direct-to-patient sample collection initiatives that will support the increase in test volumes above the Q4 levels towards pre-pandemic levels as quickly as possible. While we cannot predict the course of the pandemic or its full effect on our business we plan execute on several key business during fiscal year 2021 which should allow us to exit the year with growing momentum."
4Q20 Financial Highlights:
While test volumes were detrimentally impacted by the global pandemic, the company saw a significant recovery in overall test volume in the quarter. Averaged across our tests, volumes ended the quarter at approximately 75 percent of their pre-pandemic level.
Generated revenue of $93.2 million in the fiscal fourth-quarter 2020 and reduced total on-GAAP expenses by approximately $41 million from the prior quarter.
Total cash and cash equivalents and marketable securities increased sequentially in the fiscal fourth-quarter to $254.8 million.
Recent Business Highlights:
Received a final local coverage determination (LCD) for pharmacogenomic (PGx) testing by Palmetto GBA and CGS Administrators, LLC, two of the administrative contractors for the Centers for Medicare & Medicaid Services. The new LCD expands coverage for patients to all healthcare providers licensed and qualified to diagnose the condition and prescribe relevant medications (either independently or in an arrangement).
Published a new study for riskScore in the Journal of the American Medical Association Network Open demonstrating the ability of Myriad’s polygenic risk score to modify breast cancer risk stratification in women diagnosed with pathogenic mutations in common breast cancer genes.
Announced a new collaboration with OptraHEALTH to implement a cognitive ChatBOT named Gene which provides genetic and financial assistance information to prospective patients with the ability to answer over 500,000 health related questions.
Launched our proprietary AMPLIFY technology which increases maternal fetal fraction an average of 2.3 times and further increases the already market-leading accuracy of our Prequel non-invasive prenatal screening test.
Published a new study in Genetics in Medicine comprising over 93,000 patients which showed the challenges associated with ethnicity-based guidelines for carrier screening used by both the American College of Medical Genetics and the American College of Gynecology. In the study, following ethnicity-based guidelines from ACOG and ACMG would have resulted in 77 percent of carriers of severe genetic disease being missed.
Launched a new radiographic progression (RP) enhancement tool for the Vectra test report that is personalized based on the age, gender and adiposity of the patient. The new test report will provide individual risk of a patient’s risk of RP within one year.
Received favorable coverage decisions for Prolaris from four new commercial health plans including one of the top five national providers of health insurance. In aggregate the new health plans represent 26 million covered lives.
Received U.S. Food and Drug Administration (FDA) approval for the myChoice CDx test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab.
Financial Guidance
Given the continued unpredictability pertaining to the COVID-19 pandemic and the impact it has had on both customer behavior and our ability to market our tests to physician customers, the company continues to see a wide range of possible financial outcomes for fiscal year 2021. As a result, the company has decided to not provide fiscal year 2021 financial guidance.
Conference Call and Webcast
A conference call will be held today, Thursday, August 13, 2020, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal fourth-quarter and business developments. The dial-in number for domestic callers is 1-800-381-7839. International callers may dial 1-212-239-2905. All callers will be asked to reference reservation number 21966478. 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 be available through a live webcast at www.myriad.com.