On February 27, 2024 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, 2023 and provided its outlook on business performance for its first quarter and full-year 2024 (Press release, Myriad Genetics, FEB 27, 2024, View Source [SID1234640523]).
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" Myriad Genetics took another important step forward in 2023 as we generated double digit revenue growth over the prior year and achieved positive adjusted EPS in the fourth quarter. This achievement is the result of 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 2024 will be an exciting year as we plan to continue to accelerate our market share gains and improve reimbursement for our products and services. We are also pleased to see the progress advancing our Labs of the Future strategy and technology investments, including EMR integrations, designed to enhance our ability to serve more patients seamlessly and efficiently. At a time, when unfortunately many other molecular diagnostic laboratories are struggling, Myriad Genetics is growing, projecting to be profitable on an adjusted earnings per share basis for full year 2024, and has the financial flexibility to continue to invest in R&D and technology innovations to achieve our Mission and Vision to reach more patients with life-saving precision medicine. As we look beyond 2024, we are excited about the new product launches we expect in the second half of 2024 or early 2025 including, Foresight Universal Plus, FirstGene, Precise Tumor (relaunch) and Liquid, and Precise MRD for research use by our pharma partners."
Financial and Operational Highlights:
•Test volumes of approximately 360,000 in the fourth quarter of 2023 increased 20% year-over-year and 15% year-over-year excluding SneakPeek. Hereditary cancer and pharmacogenomics volumes grew 8% and 21%, respectively, in the fourth quarter of 2023 compared to the fourth quarter of 2022.
•The following table summarizes year-over-year volume changes in the company’s core product categories:
Three months ended December 31, Year ended December 31,
2023 2023
Product volumes:
Hereditary cancer 8 % 17 %
Tumor profiling (2) % 2 %
Prenatal 29 % 62 %
Prenatal, ex-SneakPeek
17 % 15 %
Pharmacogenomics 21 % 24 %
Total 20 % 35 %
Total, ex-SneakPeek
15 % 18 %
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•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three months ended Twelve months ended
(in millions, except percentages)
December 31, 2023 December 31, 2022 % Change December 31, 2023 December 31, 2022 % Change
Product revenues*:
Hereditary cancer $ 88.9 $ 84.9 5 % $ 327.8 $ 305.5 7 %
Tumor profiling 32.1 31.7 1 % 135.6 128.6 5 %
Prenatal 40.0 29.1 37 % 151.3 116.4 30 %
Pharmacogenomics 35.6 32.1 11 % 138.5 127.6 9 %
Total $ 196.6 $ 177.8 11 % $ 753.2 $ 678.1 11 %
*This table includes revenue from the company’s core products and excludes the $0.3 million of Other revenue in the twelve months ended December 31, 2022 as it was attributable to divested businesses
•GAAP gross margins of 68.6% in the fourth quarter of 2023 decreased 100 basis points year-over-year, reflecting changes in product and volume mix. Adjusted gross margins in the fourth quarter of 2023 were 69.0%, a decrease of 110 basis points year-over-year.
•GAAP operating expenses in the fourth quarter of 2023 were $166.4 million, decreasing $9.7 million year-over-year. Adjusted operating expenses in the fourth quarter of 2023 decreased $8.6 million year-over-year to $130.0 million, reflecting incremental cost control measures during the fourth quarter 2023.
•GAAP operating loss in the fourth quarter of 2023 was $31.4 million, improving $20.8 million year-over-year; adjusted operating income in the fourth quarter of 2023 was $5.7 million, improving $19.6 million year-over-year from adjusted operating loss of $13.9 million in the fourth quarter of 2022.
•Fourth quarter 2023 GAAP cash flow from operations was $(55) million; adjusted cash flow from operations in the fourth quarter of 2023 was $14 million, an increase of $10 million year-over-year. Capital expenditures and capitalization of internal use software costs were $14 million in the fourth quarter 2023 and are expected to moderate in 2024.
•Ended the fourth quarter of 2023 with $140.9 million in cash, cash equivalents and marketable investment securities as compared to $86.3 million at the beginning of the quarter. The increase was driven primarily by the November 2023 equity offering, partly offset by legal settlement payments and ongoing capital expenditures.
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Business Performance and Highlights:
Oncology
The Oncology business delivered revenue of $80.2 million in the fourth quarter of 2023.
•Fourth quarter 2023 hereditary cancer testing volumes and revenue in Oncology grew 7% and 9% year-over-year, respectively. In addition, Prolaris fourth quarter 2023 revenue grew 14% year-over-year.
•In February 2024, Myriad Genetics acquired select assets from IPG’s laboratory business, including the Precise Tumor Test, the Precise Liquid Test, and a CLIA-certified laboratory. With this acquisition, Myriad Genetics deepened its commitment to advancing precision oncology care by providing comprehensive genomic profiling options to providers that can help guide clinical care and improve patient outcomes.
•In January 2024, Myriad Genetics appointed George Daneker Jr., MD, as President & Chief Clinical Officer of Oncology, effective March 18, 2024.
•In January 2024, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)—Society of Surgical Oncology (SSO) updated and expanded its guidelines regarding germline testing in patients with breast cancer.
•Launched the Myriad Collaborative Research Registry (MCRR) that includes data across germline and tumor testing results from Myriad Genetics’ cancer products on more than one million patients. With this sizeable, well curated data, MCRR provides a powerful interface for clinicians and researchers to access and assess germline and tumor genetics data to ultimately advance patient care.
Women’s Health
The Women’s Health business delivered revenue of $80.8 million in the fourth quarter of 2023.
•Fourth quarter 2023 hereditary cancer testing volumes in Women’s Health grew 10% year-over-year and were higher than any prior quarter in 2023.
•Excluding the contribution from SneakPeek, prenatal testing volumes in the fourth quarter of 2023 grew 17% year-over-year.
Pharmacogenomics
In the pharmacogenomics category, the GeneSight test recorded revenue of $35.6 million in the fourth quarter of 2023.
•Fourth quarter 2023 GeneSight testing volumes grew 21% year-over-year.
•In the fourth quarter of 2023, Myriad Genetics added over 4,000 clinicians who ordered GeneSight for the first time.
•In the fourth quarter of 2023, Myriad Genetics participated in a number of clinical conferences, such as American College of Neuropsychopharmacology (ACNP).
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Financial Guidance
Myriad Genetics does not provide forward-looking guidance on a GAAP basis 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 and percentages)
FY 2024 FY 2024 Comments
Revenue $820 – $840
Raised 2024 revenue range by $5 million for the full year. Updated revenue range reflects annual growth of between 9% – 11% over 2023.
Q1’24 revenue expected to grow at a mid-to-high single digit percentage rate year-over-year; and this growth rate is expected to accelerate throughout the rest of the year.
Gross margin % 69.5% – 70.5%
GM expected to fluctuate in any quarter given product mix, pricing trends and seasonality.
Q1’24 GM expected to reflect typical seasonality, with Q1’24 margins lower than Q4’23 gross margins and ramping up throughout rest of 2024.
Adjusted OPEX $572 – $582
Adjusted EBITDA**
$20 – $30
Introducing adjusted EBITDA in the financial guidance table to provide additional insights into earnings trajectory.
Adjusted EPS***
$0.00 – $0.05
Q1’24 adjusted EPS expected to be negative reflecting seasonality.
* Assumes currency rates as of February 27, 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.
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Conference Call and Webcast
A conference call will be held today, Tuesday, February 27, 2024, at 4:30 p.m. EST to discuss Myriad Genetics’ financial results and business developments for the fourth quarter and full year 2023. 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/BI57ae456b4c754e4892c0ad52f22fdc25. 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.