10-K: Myriad Genetics Reports FY2024 Results, Navigates Reimbursement Challenges

Myriad Genetics announces its FY2024 financial results, highlighting revenue growth across key segments while addressing challenges related to reimbursement coverage.

Summary

• Myriad Genetics reported total revenue of $837.6 million for the year ended December 31, 2024, representing an 11% increase compared to the previous year.
• The company experienced a net loss of $127.3 million, with a basic and diluted loss per share of $1.41.
• Revenue growth was driven by a 23% increase in Pharmacogenomics, a 17% increase in Prenatal, and an 11% increase in Hereditary Cancer testing.
• The company is addressing challenges related to UnitedHealthcare's decision to no longer cover certain multi-gene panel pharmacogenetic tests, including GeneSight.
• Myriad is implementing a strategic growth plan focused on EMR integrations, sales channel expansion, cross-selling, product enhancement, and revenue cycle optimization.
• The company completed the acquisition of Precise Tumor Test, Precise Liquid Test, and a CLIA certified laboratory from Intermountain Healthcare in February 2024.
• Myriad is investing in research and development, with expenses totaling $113.4 million in 2024, to drive innovation and new product development.
• The company plans to complete the transition of all laboratory activities to next-generation facilities in early 2025 to improve operational efficiency.
• Myriad is focused on corporate responsibility, including patient assistance, advocacy, sustainability, scholarship, and philanthropy.

Sentiment

Score: 5

Explanation: The document presents a mixed sentiment. While there is revenue growth in some areas, the net loss, reimbursement challenges, and impairment charges temper the positive aspects. The future outlook is uncertain due to the reimbursement issues.

Positives

• The company achieved revenue growth of 11% year-over-year.
• Myriad is expanding its prenatal screening offerings with the launch of Foresight Universal Plus and plans for FirstGene.
• The company is collaborating with leading institutions on MRD research.
• Myriad has a strong Net Promoter Score (NPS) above 70, indicating high customer satisfaction.
• The company is committed to corporate responsibility and sustainability.
• Myriad is expanding its presence in retail stores with the SneakPeek product.

Negatives

• The company reported a net loss of $127.3 million for FY2024.
• Myriad is facing reimbursement challenges due to UnitedHealthcare's coverage policy change for GeneSight, which is expected to negatively impact revenue, profitability, and cash flow in 2025 and thereafter.
• Tumor Profiling revenues decreased by $9.8 million due to declines in volume from MyChoice CDx studies.
• The company recognized $43.0 million of impairment expense related to the GeneSight test due to the UnitedHealthcare coverage policy change.
• The company has a history of net losses and expects to continue to incur net losses in future years.

Risks

• The company may not be able to generate sufficient revenue from existing tests or develop new tests to be profitable.
• The strategic growth plan may not achieve the anticipated results.
• Failure to comply with laws and regulations could result in significant monetary damages and penalties.
• Security breaches, loss of data, and other disruptions could compromise sensitive information.
• The company depends on a limited number of third-party suppliers for equipment, reagents, and specimen collection services.
• Ethical, legal, and social concerns related to the use of genetic information could reduce demand for the company's tests.
• Planned changes in the way the FDA regulates tests performed by laboratories like Myriad could result in delay and/or additional expense in offering tests.
• The company's stock price is highly volatile, and its stock may lose all or a significant part of its value.

Future Outlook

Myriad Genetics anticipates that the change in UnitedHealthcare coverage will negatively impact its revenue, profitability, and cash flow in 2025 and thereafter. The company is focused on executing its strategic growth plan and investing in research and development to drive future growth.

Management Comments

• Management is focused on executing its strategic growth plan.
• The company is committed to making molecular testing accessible and actionable for patients and providers while driving long-term growth and profitability.

Industry Context

The healthcare industry is evolving to be more patient-centered and value-based, with increasing demand for high-quality, clinically validated diagnostics that support early detection and targeted treatment strategies. The market is also seeing accelerating shifts in consumer engagement, early detection, home-based care models, and the rise of low-cost sequencing, telemedicine, and virtual care.

Comparison to Industry Standards

• Competitors in the oncology market include Natera, Inc., Foundation Medicine, Inc., Caris Life Sciences, Tempus, Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, and Veracyte, Inc.
• Competitors in the women's health market include Natera, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, BillionToOne, Inc., Tempus AI, Inc., and Peekaboo Early Detection Gender DNA Test.
• Competitors in the pharmacogenomics market include Genomind, Tempus, Quest Diagnostics Incorporated, and Laboratory Corporation of America Holdings.
• Myriad's NPS score above 70 indicates a high level of user satisfaction and advocacy compared to industry averages.

Management Changes

Legal Proceedings

• In June 2023, the Company received a civil investigative demand pursuant to the False Claims Act from the United States Department of Justice concerning whether the Company offered or paid remuneration to physicians at Carolina Urology Partners, PLLC, in exchange for referrals.
• On January 22, 2025, the U.S. District Court for the Western District of North Carolina unsealed a qui tam complaint, filed on November 3, 2022, against Carolina Urology Partners, PLLC, and certain of its current or former physician partners, and the Company and certain of its former employees, alleging violations of the False Claims Act.

Stakeholder Impact

• Shareholders may be concerned about the net loss and reimbursement challenges.
• Employees may be affected by potential cost-cutting measures or changes in strategy.
• Customers (healthcare providers and patients) may experience changes in access to or coverage of Myriad's tests.
• Suppliers and creditors may be impacted by the company's financial performance and strategic decisions.

Next Steps

• The company plans to accelerate electronic medical records (EMR) integrations.
• Myriad intends to expand its sales channels, including into large health systems.
• The company will continue to cross-sell its portfolio of testing products to providers.
• Myriad plans to enhance its testing products within medical guidelines.
• The company will demonstrate its clinical differentiation and value compared to the standard of care.
• Myriad intends to optimize its revenue cycle processes.
• The company plans to complete the transition of all laboratory activities to next-generation facilities in early 2025.
• The company will continue its engagement with UnitedHealthcare regarding its decision to change its GeneSight coverage policy.

Key Dates

Keywords

Myriad Genetics, molecular diagnostics, precision medicine, genetic testing, oncology, women's health, pharmacogenomics, GeneSight, BRACAnalysis CDx, MyChoice CDx, Prequel, Foresight, revenue, reimbursement, FDA, CLIA, UnitedHealthcare