Myriad Genetics Reports Fourth Quarter and Full-Year 2024 Financial Results; Full-year 2024 revenue of $838 million grew 11% year-over-year, the second consecutive year of double-digit revenue growth

On February 24, 2025 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its fourth quarter and full-year ended December 31, 2024 and reaffirmed its previously issued financial guidance on business performance for the full-year 2025 (Press release, Myriad Genetics, FEB 24, 2025, View Source [SID1234650477]).

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"There is a lot for Myriad Genetics to be proud of in 2024. We generated 11% revenue growth over 2023, making this our second consecutive year of double-digit growth, and $40 million in adjusted EBITDA. This achievement is the result of the company’s multi-year investment strategy along with our team’s hard work and focus on the needs of our patients and the healthcare providers who serve them," said Paul J. Diaz, President and CEO, of Myriad Genetics.

"We believe 2025 will be another year of opportunity for our stakeholders as Myriad Genetics continues to grow and has the financial flexibility to continue to invest in research and development and technology innovations to achieve our Mission and Vision to advance health and well-being for all by helping people take control of their health. Today’s announcement of our collaboration with PATHOMIQ and their AI-technology platform is an exciting example of how Myriad will continue to deliver innovative insights to patients and clinicians in their fight against cancer. As we look to 2025 and beyond, we are excited about the potential contribution from recent product launches, including Prequel with 8-week Gestational Age, Foresight Universal Plus, and the continuing traction with our Precise Tumor comprehensive genomic panel. In addition, we are excited for the future launches of FirstGene, Precise Liquid, and Precise MRD, which is already available for research use by our pharmaceutical partners.

Lastly, I would emphasize that it has been an honor to serve as Myriad’s President and CEO and help to further its mission. I believe the Company is well positioned for the future and will continue to grow under Sam Raha and the entire executive team’s leadership."

Financial and Operational Highlights
•Test volumes of 374,000 in the fourth quarter of 2024 increased 4% year-over-year and 7% for the twelve months ended December 31, 2024.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:
Three months ended December 31, Twelve Months Ended December 31,
(in thousands)
2024 2023
% Change
2024 2023
% Change
Product volumes:
Hereditary cancer
75 74 1 % 294 281 5 %
Tumor profiling
12 14 (14) % 53 59 (10) %
Prenatal 160 156 3 % 666 625 7 %
Pharmacogenomics
127 116 9 % 507 459 10 %
Total 374 360 4 % 1,520 1,424 7 %

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three months ended December 31, Twelve Months Ended December 31,
(in millions)
2024 2023
% Change
2024 2023
% Change
Product revenues:
Hereditary cancer
$ 94.3 $ 88.9 6 % $ 364.5 $ 327.8 11 %
Tumor profiling
30.8 32.1 (4) % 125.8 135.6 (7) %
Prenatal 44.9 40.0 12 % 177.1 151.3 17 %
Pharmacogenomics
40.6 35.6 14 % 170.2 138.5 23 %
Total $ 210.6 $ 196.6 7 % $ 837.6 $ 753.2 11 %

•GAAP operating expenses in the fourth quarter of 2024 were $189.9 million, increasing $23.5 million year-over-year. Adjusted operating expenses in the fourth quarter of 2024 increased $16.0 million year-over-year to $146.0 million, reflecting increased spending on clinical studies to support the development and launches of FirstGene and Precise MRD and other research and development expense during the fourth quarter 2024.
•GAAP operating loss in the fourth quarter of 2024 was $39.0 million, an increase of $7.6 million year-over-year; adjusted operating income in the fourth quarter of 2024 was $5.6 million.
•Fourth quarter 2024 GAAP cash flow from operations was $6.6 million; adjusted cash flow from operations in the fourth quarter of 2024 was $15.4 million, an increase of $1.9 million year-over-year. Capital expenditures and capitalization of internal use software costs were $5.9 million in the fourth quarter 2024.
•During fourth quarter of 2024, Myriad determined that the contingent payment from the Ravgen settlement is no longer probable and reversed the prior accrued amount of 21.3 million.

Business Performance and Highlights
Oncology
The Oncology business delivered revenue of $82.8 million in the fourth quarter of 2024.
•Fourth quarter 2024 hereditary cancer testing revenue in Oncology grew 8% year-over-year.
•In February 2025, Myriad exclusively licensed PATHOMIQ’s AI technology platform for prostate cancer in the United States. This agreement marks a strategic expansion of Myriad’s clinical oncology portfolio and complements the company’s Prolaris Prostate Cancer Prognostic Test. Myriad plans to leverage PATHOMIQ’s prognostic and predictive biomarker capabilities across different phases of the patient journey in prostate cancer and potentially for other cancer indications. Myriad intends to commercially launch its first AI-driven prostate cancer test later in 2025, which would enable Myriad to offer both AI and molecular testing options for prostate cancer, eventually spanning all phases of the prostate cancer patient journey – including at the time of biopsy and post-radical prostatectomy (post-RP).
•Updated Prostate Cancer Guidelines from the National Comprehensive Cancer Network (NCCN) underscore the critical role of Myriad’s portfolio of offerings across the patient’s prostate cancer journey. Myriad’s full suite of prostate cancer products is uniquely aligned with the updated NCCN Guidelines, offering integrated genetic and tumor genomic insights that identify germline risk, provide valuable insights into tumor biology, simplify therapy selection, and help identify clinical trial eligibility for patients.
•In January 2025, The University of Texas MD Anderson Cancer Center and Myriad Genetics announced a five-year strategic alliance to accelerate the clinical evaluation and development of Myriad’s molecular residual disease (MRD) assay. This strategic alliance aims to create a portfolio of studies to evaluate the clinical validity and utility of Myriad’s Precise MRD in breast, gastrointestinal, genitourinary, and gynecological cancers.
•In February 2025, the United States Patent and Trademark Office issued two new patents that further advance Myriad’s ability to bring Precise MRD, its tumor-informed, high-definition, MRD assay to market. This action builds on the three patents issued in 2024 that are related to foundational platform MRD technology and cell-free DNA preparation methods. The Precise MRD test is currently being evaluated in several studies and is processed in the company’s new state-of-the-art laboratory facility in Salt Lake City.

Women’s Health
The Women’s Health business delivered revenue of $87.2 million in the fourth quarter of 2024.
•Prenatal testing revenue in the fourth quarter of 2024 grew 12% year-over-year.
•In the fourth quarter of 2024, Myriad signed a strategic partnership with jscreen, a national organization that delivers education and access to genetic testing with a focus on high-risk populations. The collaboration combines Myriad’s high-quality hereditary cancer and reproductive genetics products, MyRisk with RiskScore and Foresight Carrier Screen, with jscreen’s trusted education and genetic care navigation program.
•In January 2025, Myriad unveiled groundbreaking research at the annual Society for Maternal-Fetal Medicine Conference (SMFM). The company’s "Fetal fraction amplification enables accurate prenatal cell-free DNA (cfDNA) screening at eight weeks gestation" study was awarded SMFM’s "Dru Carlson Memorial Award for Best Research in Ultrasound and Genetics."

Pharmacogenomics
In the pharmacogenomics business, GeneSight test revenue was $40.6 million in the fourth quarter of 2024.
•In the fourth quarter 2024, UnitedHealthcare (UNH) updated its medical policy for commercial and individual exchange benefit plans as well as certain managed Medicaid plans to discontinue coverage of multi-gene panel pharmacogenetic testing, including the company’s GeneSight test, effective in the first half of 2025. Myriad Genetics generated approximately $45 million of GeneSight current period revenue from UNH’s commercial and select managed Medicaid populations in 2024, consisting of approximately $40.0 million for UNH commercial and approximately $5.0 million for impacted UNH managed Medicaid plans.
•While Myriad Genetics continues to pursue a resolution with UNH that allows for its commercial and managed Medicaid enrollees to continue to have access to the GeneSight test, there is no guarantee that these efforts will be successful and Myriad has streamlined operations and cost structure accordingly.

Cash Flow and Liquidity
As of the end of the fourth quarter of 2024, the company had cash and cash equivalents of $102 million and the ability to access an incremental $56 million of availability under its asset-based credit facility (ABL Facility). The company had combined liquidity from its unrestricted cash and cash equivalents and available borrowing under the ABL Facility of $158 million.

Financial Guidance
Myriad Genetics does not provide forward-looking guidance on a GAAP basis for the measures on which it provides forward-looking non-GAAP guidance as the company is unable to provide a quantitative reconciliation of forward-looking non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, are dependent on various factors, are out of the company’s control, or cannot be reasonably predicted. Such adjustments include, but are not limited to, real estate optimization and transformation initiatives, certain litigation charges and loss contingencies, costs related to acquisitions/divestitures and the related amortization, impairment and related charges, and other adjustments. For example, stock-based compensation may fluctuate based on the timing of employee stock transactions and unpredictable fluctuations in the company’s stock price. Any associated estimate of these items and its impact on GAAP performance could vary materially.

Below is a table summarizing Myriad Genetics’ full-year 2025 financial guidance*:
(in millions, except per share amounts) FY 2025 Guidance FY 2025 Comments
Revenue $840 – $860 2025 revenue range reflects annual growth of between 9% – 11% over 2024, excluding impact from the change in UNH PGx medical policy and divested businesses.

Q1’25 revenue is expected to be between $196 and $204 million.
Gross margin % 69.5% – 70.5% Gross margins expected to fluctuate in any quarter given product mix and pricing trends.
Adjusted OPEX $575 – $595
Adjusted EBITDA** $25 – $35
Adjusted EPS*** $0.07 – $0.11 Q1’25 adjusted EPS is expected to be between $(0.04) and $(0.08).
* Assumes currency rates as of February 24, 2025.
** Adjusted EBITDA is defined as Net Income (loss) plus income tax expense (benefit), total other income (expense), non-cash operating expenses, such as amortization of intangible assets, depreciation, impairment of long-lived assets, and share-based compensation expense, and one-time expenses such as expenses from real estate optimization initiatives, transformation initiatives, legal settlements, and divestitures and acquisitions.
*** Full-year 2025 adjusted EPS is based on a 93 million share count.

Conference Call and Webcast
A conference call will be held today, Monday, February 24, 2025, at 4:30 p.m. EST to discuss Myriad Genetics’ financial results and business developments for the fourth quarter and full-year 2024. A live webcast of the conference call can be accessed on Myriad Genetics’ Investor Relations website at investor.myriad.com. To participate in the live conference call via telephone, please register at https://register.vevent.com/register/BId9d5a2edc11e4b3fbbce726836037dc9. Upon registering, a dial-in number and unique PIN will be provided to join the conference call. Following the conference call, an archived webcast of the call will be available at investor.myriad.com.

Merck to Participate in the TD Cowen 45th Annual Health Care Conference

On February 24, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 2:30 p.m. EST (Press release, Merck & Co, FEB 24, 2025, View Source [SID1234650476]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

IN8bio to Present at the H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference

On February 24, 2025 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and co-founder, will be presenting at the (Press release, In8bio, FEB 24, 2025, View Source [SID1234650475]):

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H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference
Date/Time Tuesday, February 25, 2025, at 11:00 a.m. ET.
Webcast Link View Source

A live webcast and replay will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

GSK completes acquisition of IDRx, Inc.

On February 24, 2025 GSK plc (LSE/NYSE: GSK) reported that it has completed the acquisition of IDRx, Inc. (IDRx), a Boston-based, clinical-stage biopharmaceutical company dedicated to developing precision therapeutics for the treatment of gastrointestinal stromal tumours (GIST) (Press release, GlaxoSmithKline, FEB 24, 2025, View Source [SID1234650474]).

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As announced previously1, the acquisition includes lead molecule IDRX-42, an investigational, highly selective tyrosine kinase inhibitor (TKI) that is designed to improve outcomes for patients with GIST. IDRX-42 has demonstrated activity against all clinically relevant primary and secondary KIT mutations, a key medical need in current GIST treatment. GIST typically presents in the gastrointestinal (GI) tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation, and survival of tumour cells (primary or activating mutations).2 90% of patients treated in the first line develop new KIT mutations (secondary or resistance mutations) that typically lead to relapse with limited therapeutic options.3

Hesham Abdullah, Senior Vice President, Global Head Oncology R&D, GSK, said: "This acquisition adds to GSK’s growing pipeline of targeted therapeutics for cancers originating in the gastrointestinal tract. We plan to advance IDRX-42 for second line treatment of gastrointestinal stromal tumours, where there are no approved treatments to effectively address all resistance mutations, and accelerate development in an earlier setting."

Financial Considerations
The total cash consideration for this acquisition amounts to up to $1.15 billion. This includes an upfront payment of $1 billion, with the possibility of an additional $150 million milestone payment contingent upon success-based regulatory approval. GSK will also be responsible for success-based milestone payments as well as tiered royalties for IDRX-42 owed to Merck KGaA, Darmstadt, Germany.

About GIST
GIST represent the most prevalent form of soft tissue sarcoma, with an estimated annual global diagnosis of 80,000 to 120,000 patients.4 GIST commonly manifests in the GI tract, with approximately 80% of cases being attributed to mutations in the KIT gene.5 These mutations, known as primary or activating mutations in exons 9 and 11, drive the growth, proliferation, and survival of tumour cells. In the first line of treatment, around 90% of patients develop secondary or resistance mutations in exons 13 and 17 of the KIT gene, leading to relapse with limited therapeutic alternatives.6 Notably, there are currently no approved TKIs capable of effectively targeting the full range of clinically significant primary and secondary mutations in KIT.

About IDRX-42
IDRX-42 is a highly selective, investigational small molecule TKI designed to target all key KIT mutations in GIST. The U.S. Food and Drug Administration (FDA) has granted IDRX-42 Fast Track designation for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and Orphan Drug designations for the treatment of GIST.

Galapagos to Present at Upcoming Investor Conferences

On February 24, 2025 Galapagos NV (Euronext & NASDAQ: GLPG), a global biotechnology company dedicated to transforming patient outcomes through life-changing science and innovation, reported that its management will present at the following investor conferences in March (Press release, Galapagos, FEB 24, 2025, View Source [SID1234650473]):

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TD Cowen 45th Annual Healthcare Conference
Date: Tuesday, March 4, 2025
Location: Boston, MA
Corporate Presentation: 1:50 – 2:20 PM ET / 7:50 – 8:20 PM CET
Live Webcast Link: Here

Barclays 27th Annual Global Healthcare Conference
Date: Wednesday, March 12, 2025
Location: Miami, FL
Corporate Presentation: 11:00 – 11:25 AM ET / 5:00 – 5:25 PM CET
Live Webcast Link: Here

A live webcast of the presentations can also be accessed on the Investors page of the Company’s website at www.glpg.com/investors. Replays of the webcasts will be available following the completion of the event and will be archived for up to 90 days.