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Myriad Genetics Reports Strong First Quarter 2024 Financial Results; Achieves 12% Revenue Growth Year-Over-Year; Significantly Improved Year-Over-Year Net Loss and Generated Positive Adjusted EBITDA

Highlights: First quarter revenue of $202 million grew 12% year-over-year, driven by Prenatal (22%), Pharmacogenomics (21%), and Hereditary Cancer (16%). First quarter average revenue per test improved by 2% over the prior year period, reflecting no-pay reduction efforts. First quarter GAAP net loss of $26 million and positive adjusted EBITDA of $4 million; net loss and adjusted EBITDA improved significantly from $55 million and $(19) million, respectively, in the first quarter of 2023. First quarter GAAP earnings per share and adjusted earnings per share of $(0.29) and $(0.01), respectively, improved significantly as compared to $(0.67) and $(0.21), respectively, in the first quarter of 2023. On May 6, announced the reorganization of its European operations and sale of its EndoPredict business, while retaining U.S. EndoPredict licensing rights. Reiterates 2024 financial guidance issued on February 27, 2024. SALT LAKE CITY, May 07, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in genetic testing and precision medicine, today announced financial results for its first quarter ended March 31, 2024 and reiterated its previously issued outlook on business performance for the full-year 2024. "Myriad Genetics entered 2024 with positive momentum as we generated double digit revenue growth over the prior year period, significantly improved year-over-year net loss, and achieved positive adjusted EBITDA in the first quarter," said Paul J. Diaz, President and CEO of Myriad Genetics. "First quarter saw early indications of market share gains in hereditary cancer and prenatal testing and we expect this trend to accelerate as we move through the year. In addition, first quarter average revenue per test across our product portfolio benefited from expanded coverage and our ongoing efforts in revenue cycle management. We also remain optimistic about the evolution of our product portfolio as we continue to produce additional clinical validation studies and move closer to the launch of our new products. At the same time, we continue to advance a number of enhancements to improve access and ease of use for our customers, including electronic medical record (EMR) integrations and make meaningful progress in our Labs of the Future initiative. Myriad Genetics is growing, delivering improved financial results, and is continuing to invest in the innovation required to achieve our Mission and Vision to reach more patients with life-saving precision medicine." Financial and Operational Highlights: Test volumes of 381,000 in the first quarter of 2024 increased 9% year-over-year. The following table summarizes year-over-year testing volume changes in the company's core product categories:   Three months ended       March 31, 2024   March 31, 2023   % Change Product volumes:               Hereditary cancer 71,149     65,484     9 % Tumor profiling 13,602     16,154     (16 )% Prenatal 171,857     158,020     9 % Pharmacogenomics 124,067     109,695     13 % Total 380,675     349,353     9 %   The following table summarizes year-over-year revenue changes in the company's core product categories:   Three months ended (in millions) March 31, 2024   March 31, 2023   % Change Product revenues:                   Hereditary cancer $ 88.1     $ 75.7     16 % Tumor profiling   30.9       37.3     (17 )% Prenatal   44.3       36.2     22 % Pharmacogenomics   38.9       32.0     21 % Total $ 202.2     $ 181.2     12 %   Gross margin of 68.1% in the first quarter of 2024 increased 70 basis points year-over-year, reflecting operating leverage and improved ASPs. Adjusted gross margin in the first quarter of 2024 was 68.5%, an increase of 80 basis points year-over-year. First quarter of 2024 operating expenses were $165.5 million, while adjusted operating expenses were $139.1 million. Operating loss in the first quarter of 2024 was $27.9 million, improving $24.3 million year-over-year; adjusted operating loss in the first quarter of 2024 was $0.6 million, improving $21.3 million year-over-year. Business Performance and Highlights: OncologyThe Oncology business delivered revenue of $79.4 million in the first quarter of 2024. First quarter 2024 hereditary cancer testing volumes and revenue in Oncology grew 10% and 20% year-over-year, respectively, reflecting market share gains, and ongoing initiatives to improve average revenue per test. Prolaris first quarter 2024 revenue grew 9% year-over-year, benefiting, in part, from improved payer coverage. First quarter 2024 tumor profiling testing revenue of $30.9 million, decreased 17% year-over-year, reflecting, to a large degree, a strong contribution from biopharma in the year ago period. Established a research collaboration with the National Cancer Center Hospital East in Japan to study the prognostic and predictive value of MRD testing using Myriad Genetics' highly-sensitive test, Precise MRD. Advanced the integration of the recently acquired CLIA-certified laboratory and Precise Tumor and Liquid assays from Intermountain Precision Genomics. Today announced the reorganization of its European operations and sale of its EndoPredict business to Eurobio Scientific, while retaining a license to produce and sell EndoPredict in the U.S., to better align company resources to its domestic opportunities while continuing to serve key biopharma partners and patients outside the U.S.; Myriad will also license to Eurobio the right to sell Prolaris in vitro diagnostic kits outside the U.S. Women's Health The Women's Health business delivered revenue of $83.9 million in the first quarter of 2024. First quarter 2024 hereditary cancer testing volumes and revenue in Women's Health grew 7% and 12% year-over-year, respectively. Prenatal testing volumes and revenue in the first quarter of 2024 grew 9% and 22% year-over-year, respectively, reflecting market share gains, and ongoing initiatives to improve average revenue per test. In April 2024, Prenatal Diagnosis published a study demonstrating exceptional positive predictive value for 22q11.2 microdeletion screening using Myriad's prenatal cell-free DNA (pcfDNA) screen, Prequel®, which incorporates fetal fraction amplification. The American College of Medical Genetics and Genomics recently recommended that 22q11.2 screening be offered to all pregnant patients. Pharmacogenomics In the pharmacogenomics category, GeneSight test revenue was $38.9 million in the first quarter of 2024. First quarter 2024 GeneSight testing volumes and revenue grew 13% and 21% year-over-year, respectively, reflecting ongoing initiatives to improve average revenue per test. On April 8, 2024, study results presented at the American Association of Psychiatric Pharmacists (AAPP) conference indicated those with major depressive disorder had reduced healthcare utilization after taking the GeneSight® Psychotropic test. Financial GuidanceMyriad 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' fiscal year 2024 financial guidance*: (in millions, except per share amounts) FY 2024   Expected Year-Over-Year Change         Revenue $820 - $840   9% - 11% Gross margin % 69.5% - 70.5%   50 - 150 bps Adjusted OPEX $572 - $582   5% - 7% Adjusted EBITDA** $20 - $30   $31 - $41 Adjusted EPS*** $0.00 - $0.05   $0.27 - $0.32 *Assumes currency rates as of May 7, 2024 ** 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 2024 adjusted EPS is based on a 90 million share count.   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. Conference Call and WebcastA conference call will be held today, Tuesday, May 7, 2024, at 4:30 p.m. EDT to discuss Myriad Genetics' financial results and business developments for the first quarter 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/BIa6e5709e0e9d43a6a8b0070d0b806384. 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. About Myriad GeneticsMyriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics provides insights that help people take control of their health and enable healthcare providers to better detect, treat, and prevent disease. Myriad Genetics develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com. Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, ColarisAP, MyRisk, Myriad myRisk, MyRisk Hereditary Cancer, myChoice, Tumor BRACAnalysis CDx, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Foresight Universal Plus, Precise Tumor, Precise Oncology Solutions, Precise Liquid, Precise MRD, FirstGene, SneakPeek, SneakPeek Early Gender DNA Test, SneakPeek Snap, Urosuite, Mygenehistory, Health.Illuminated., RiskScore, Prolaris, GeneSight, and EndoPredict are registered trademarks or trademarks of Myriad Genetics, Inc.. All third-party marks—® and ™—are the property of their respective owners. © 2024 Myriad Genetics, Inc. All rights reserved. Revenue by Product (Unaudited):   Three months ended March 31 (in millions) 2024   2023       WH ONC PGx Total   WH ONC PGx Total   % Change Hereditary Cancer $ 39.6   $ 48.5   $ —   $ 88.1     $ 35.3   $ 40.4   $ —   $ 75.7     16 % Tumor Profiling   —     30.9     —     30.9       —     37.3     —     37.3     (17 )% Prenatal   44.3     —     —     44.3       36.2     —     —     36.2     22 % Pharmacogenomics   —     —     38.9     38.9       —     —     32.0     32.0     22 % Total Revenue $ 83.9   $ 79.4   $ 38.9   $ 202.2     $ 71.5   $ 77.7   $ 32.0   $ 181.2     12 %                                                           Business Units:WH = Women's HealthONC = OncologyPGx = Pharmacogenomics Product Categories:Hereditary Cancer – MyRisk, BRACAnalysis, BRACAnalysis CDxTumor Profiling – myChoice CDx, Prolaris, Precise Tumor, EndoPredictPrenatal – Foresight, Prequel, SneakPeekPharmacogenomics – GeneSight   MYRIAD GENETICS, INC.AND SUBSIDIARIESCondensed Consolidated Statements of Operations (in millions, except per share amounts)     Three months endedMarch 31,   2024   2023   (unaudited) Testing revenue $ 202.2     $ 181.2   Costs and expenses:       Cost of testing revenue   64.6       59.2   Research and development expense   24.9       22.5   Selling, general, and administrative expense   140.6       151.7   Total costs and expenses   230.1