Myriad Genetics Provides Transformation Update, Pursues Strategic Alternatives for Autoimmune Business, Realigns International Operations
Focus on Women’s Health, Oncology, Mental Health to Improve Execution and Accelerate Growth
SALT LAKE CITY, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced the substantial completion of its strategic business unit and products review which will enable the company to better serve patients and healthcare providers and further expand its leadership in Women’s Health, Oncology and Mental Health.
“As part of our transformation and growth plan, we are pursuing strategic alternatives for our Autoimmune business and realigning our International business unit to streamline operations, reduce complexity and cost, and concentrate on our biggest growth opportunities. These actions are among the key initiatives we have undertaken over the last several months to improve our competitive position, commercial capabilities, and focus on operational excellence,” said Paul J. Diaz, president and CEO, Myriad Genetics. “As we start the New Year, I would like to thank my teammates for their dedication and hard work to meet the needs of our patients and healthcare providers in the most difficult operating environment any of us have ever seen. While the recent surge in the coronavirus pandemic continues to impact doctor visits, elective procedures and testing trends, we are excited about the opportunities the New Year brings for all our stakeholders.”
Strategic Alternatives for Autoimmune Business
Myriad’s Autoimmune business includes the Vectra® assay, an advanced multi-protein biomarker blood test to help patients and healthcare providers gain an objective measure of rheumatoid arthritis (RA) disease activity. The Vectra score is designed to reveal the effectiveness of a given RA treatment plan, predicting radiographic progression, and guiding personalized medical management decisions to improve outcomes. Prior to the coronavirus pandemic, revenue for Vectra consistently exceeded $40 million per year.
“We strongly believe in the long-term growth prospects for Vectra. We are committed to supporting our teammates in this business and ensuring that Vectra continues to positively impact the lives of patients with autoimmune disease. We believe the growth prospects for this product are even more significant in an organization with greater focus and complementary capabilities in autoimmune disease,” Diaz said.
In November on its earnings call, Myriad Genetics announced that it is also pursuing strategic alternatives for two other businesses: Myriad RBM, which provides contract research services for the pharmaceutical industry, and Myriad Dermatology, which includes the myPath® Melanoma diagnostic test.
Restructuring International Operations
The restructuring of Myriad International operations will focus direct selling efforts on high-growth market opportunities in Germany, France, and Japan, where there is increasing demand for companion diagnostic, hereditary cancer, and kit-based products. Remaining international markets will be served through alternative business models, including authorized distributor partnerships. This realignment is designed to reduce operating costs and support growth, leading to approximately $5 million in incremental cost savings upon full implementation.
Myriad recently announced that the German Federal Joint Committee (G-BA) successfully completed the method evaluation assessment for the EndoPredict® breast cancer prognostic test and reached a positive reimbursement decision. The company also announced that it is in the process of licensing its myChoice® CDx companion diagnostic test to leading pathology institutes in Germany and France.
In addition, Myriad will focus on large Asian markets such as Japan, which now represent the largest segments of its international business. Myriad has seen significant increases in BRACAnalysis CDx test volume in Japan with total revenue increasing 200% year-over-year to $7.5 million in the September 2020 quarter. Myriad also recently received Japanese regulatory approval for BRACAnalysis CDx as a companion diagnostic for the PARP inhibitor olaparib for use in pancreatic and prostate cancer. These approvals increase the total addressable market for Myriad’s companion diagnostic tests in Japan to approximately 60,000 patients per year.
About Myriad Genetics
Myriad Genetics Inc., is a leading precision medicine company dedicated improving and transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. For more information, please visit the company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to pursuing strategic alternatives for the Autoimmune business and the Vectra test; realigning the Company’s international operations to focus on high-growth market opportunities and distribution for companion diagnostic and kit-based products in key markets in Europe (France and Germany) and Asia (Japan); streamlining operations, reducing complexity and cost, and concentrating on the Company’s biggest growth opportunities; these plans dramatically simplify the Company’s operations; the long-term growth prospects for Vectra; ensuring that Vectra continues to positively impact the lives of patients with autoimmune disease; the Company’s focus on large Asian markets such as Japan; serving remaining international markets through alternative business models, including authorized distributor partnerships; the international realignment reducing operating costs, contributing to higher growth, and leading to approximately $5 million in incremental cost savings upon full implementation; the recent impact of the COVID pandemic on the Company’s business; the Company’s strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
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