UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________________________ FORM 10-K _______________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | |------------------------------------------------------------ ...

Core Insights - Myriad Genetics has announced a research collaboration with the National Cancer Center Hospital East in Japan to study the prognostic and predictive value of molecular residual disease (MRD) testing [1][2] - The SCRUM-MONSTAR-SCREEN-3 study will utilize Myriad's Precise MRD test to monitor circulating tumor DNA (ctDNA) in patients with various solid tumor and hematological cancers [1][2] Company Overview - Myriad Genetics is a leader in genetic testing and precision medicine, focusing on advancing health and well-being through genetic insights that improve patient care and reduce healthcare costs [5] - The company develops genetic tests that assess disease risk and guide treatment decisions across multiple medical specialties [5] Study Details - The SCRUM-MONSTAR-SCREEN-3 study will involve approximately 1,200 patients across more than 20 cancer types, with two of the three cohorts undergoing MRD monitoring using the Precise MRD test [2] - The study aims to generate high-quality clinical evidence supporting the broad application of MRD testing across different cancer types and disease severities [2] Technology and Innovation - Myriad's Precise MRD is a tumor-informed, whole genome sequencing-based test that monitors hundreds to thousands of tumor-specific variants, providing exceptional sensitivity in detecting ctDNA [4] - The test can be utilized throughout a cancer patient's clinical journey, from diagnosis to treatment and surveillance [4] Expert Commentary - Dr. Takayuki Yoshino emphasized the need for a highly sensitive MRD test for cancers with low tumor shedding, highlighting the unique capabilities of Myriad's assay [3] - Dale Muzzey, Chief Scientific Officer at Myriad, expressed enthusiasm for collaborating with NCCHE, noting their leadership in MRD research and the potential impact of the study on cancer care [3]

Core Insights - Myriad Genetics has completed the acquisition of select assets from Intermountain Health's Intermountain Precision Genomics laboratory business, which includes the Precise™ Tumor Test and the Precise Liquid Test [1][2] - The Precise Tumor Test analyzes tumor DNA to identify important variants and match patients with advanced solid tumors to appropriate therapies and clinical trials [1] - The upcoming Precise Liquid Test will provide genomic profiling results from a blood draw and has completed validation studies for Medicare reimbursement [2] Company Overview - Myriad Genetics is a leader in genetic testing and precision medicine, focusing on advancing health and well-being through genetic tests that assess disease risk and guide treatment decisions [3]

Core Insights - Myriad Genetics demonstrates strong growth in the genetic testing and precision medicine sector, with a 23% year-over-year revenue increase to $191.9 million and consistent testing volume growth across various segments [2][4] - The company has revised its revenue guidance upward for 2023 and published guidance for 2024, indicating confidence in continued growth driven by operational improvements and strategic initiatives [2][4] - Strategic acquisitions, such as the purchase of Intermountain Precision Genomics assets, enhance Myriad's operational efficiencies and position in oncology precision medicine [3][11] Financial Performance - The third-quarter financial results show an 18% increase in test volume and a 23% year-over-year revenue increase, reflecting a stable growth trend [4] - GAAP gross margin improved to 70.0%, indicating enhanced profitability and operational efficiency [4] - Adjusted EPS is nearing break-even, suggesting effective cost management despite external pressures [2][6] Product Pipeline - The rebranding of TheraMap to Precise Tumor Test and the upcoming release of Precise Liquid highlight Myriad's commitment to innovation in genomic profiling [7][8] - The Precise Liquid test offers a non-invasive method for comprehensive genomic profiling through blood draws, enhancing patient convenience [8] - The integration of genetic information with patient results through the Precise Treatment Registry supports precision cancer research and patient care advancements [10] Strategic Acquisitions - The acquisition of Intermountain Precision Genomics includes the Precise Tumor Test and Precise Liquid Test, allowing Myriad to internalize testing processes for better quality control and cost-effectiveness [11] - This strategic move positions Myriad to capitalize on the growing demand for precision medicine and genomic testing [11] Partnerships and Collaborations - Long-term agreements with UnitedHealthcare and collaborations with QIAGEN and Illumina are expected to enhance Myriad's market presence and revenue consistency [12] - These partnerships leverage Myriad's expertise in genetic testing and expand its reach in the personalized medicine market [12] Valuation Standing - Myriad's EV/Sales TTM and FWD ratios are at 2.90 and 2.84, respectively, indicating a valuation below the sector median, which reflects growth potential [14] - The Price/Sales TTM and FWD ratios are at 2.52 and 2.68, suggesting a discount to the sector median, while the Price/Book TTM ratio is higher at 2.73, justified by Myriad's niche services and strategic acquisitions [14] Future Outlook - Myriad Genetics is positioned for growth in precision medicine, with projected revenue growth of 9%-11% above the mid-point of the 2023 guidance range [15] - The introduction of new products like Precise Liquid and further development of the Precise Tumor Test align with trends towards individualized treatment plans [15] - The company must navigate regulatory challenges and maintain operational efficiency to enhance profitability and competitiveness in the biotech sector [15]

SALT LAKE CITY, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ:MYGN), a leader in genetic testing and precision medicine, today announced the appointment of George Daneker Jr., MD, as President and Chief Clinical Officer of Oncology, effective March 18, 2024. Dr. Daneker brings more than 30 years of oncology and precision medicine experience deeply rooted in providing accessible and equitable oncology care for all patients. In his new role, he will be responsible for leading the commercial ...

Myriad Genetics (MYGN) , a front-runner in genetic testing and precision medicine, recently announced its plans to acquire select assets from Intermountain Precision Genomics (IPG). This acquisition, including the Precise Tumor Test, the Precise Liquid Test and the Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory in St. George, UT, is set to close on Feb 1, 2024.The financial terms of the deal were not disclosed.The Deal and its BenefitsBy bringing the Precise Tumor and Precise Liquid ...

SALT LAKE CITY, Jan. 18, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ:MYGN), a leader in genetic testing and precision medicine, today announced it has entered into a definitive agreement to acquire select assets from Intermountain Precision Genomics' (IPG) laboratory business, including the Precise™ Tumor Test, the Precise Liquid Test, and IPG's CLIA-certified laboratory in St. George, Utah where the Precise Tumor Test is currently performed. The acquisition is expected to close on February 1, 2 ...

SALT LAKE CITY, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ:MYGN), a leader in genetic testing and precision medicine, today announced its support for the American Society of Clinical Oncology (ASCO)—Society of Surgical Oncology (SSO) guideline for germline testing in patients with breast cancer. The new guideline offers multi-pronged, evidence-based clinical practice recommendations. Among the guidance includes: All patients with a current or previous diagnosis of invasive breast cance ...

Financial Data and Key Metrics Changes - The company reported a 14% year-over-year revenue growth in Q3 2023, marking four consecutive quarters of double-digit revenue growth [21][26] - Adjusted gross margin improved to approximately 70.4%, compared to 68% in Q3 of the previous year [23][26] - The adjusted operating loss was reduced significantly to $2.2 million from an operating loss of $20.6 million in Q3 of last year [10][26] Business Line Data and Key Metrics Changes - Hereditary cancer testing volumes grew 18% year-over-year in Q3, driven by competitive account wins and increased adoption of myRisk [9][19] - Women's Health business saw a 22% increase in hereditary cancer testing volumes and a 20% growth in prenatal testing volumes, marking five consecutive quarters of positive volume growth [14][19] - GeneSight volumes increased by 19% year-over-year, with approximately 4,000 new clinicians added to the franchise [16][19] Market Data and Key Metrics Changes - The company gained market share across all product lines, with significant volume growth in hereditary cancer and prenatal testing [9][19] - The prenatal testing business, excluding contributions from SneakPeek, grew 20% in Q3, reflecting ongoing commercial execution [9][19] - Prolaris, the prostate cancer test, saw a revenue increase of 18% year-over-year, supported by a new positive medical policy from UnitedHealthcare [13][19] Company Strategy and Development Direction - The company is focused on a multiyear transformation journey with four key objectives: team reenergization, modernization of lab and IT capabilities, restoration of organic growth and profitability, and strengthening R&D and product management [5][6] - The company aims to improve patient and provider experiences, as evidenced by strong Net Promoter Scores and increased provider retention [6][7] - New partnerships, such as with QIAGEN and Onsite Women's Health, are expected to enhance service offerings and market reach [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving adjusted profitability and positive adjusted operating cash flow in Q4 2023 [24][26] - The company raised its full-year revenue guidance, reflecting strong business momentum and confidence in long-term growth targets [26][29] - Management highlighted the importance of continuous quality improvement and customer satisfaction as key drivers for long-term growth [28][29] Other Important Information - The company resolved several legacy litigation matters, providing more legal and financial visibility moving forward [8][10] - A new Chief Operating Officer, Sam Raha, will join the company to focus on improving the patient-provider journey and overall customer experience [11] Q&A Session Summary Question: Progress on addressing zero pays and impact on margins - Management reported significant progress with $6.2 million in net out-of-period cash collections and improved gross margins, expressing optimism about future ASP improvements [31] Question: Market penetration within myRisk - Management clarified that the 15% market penetration refers to the unaffected market, with ongoing efforts to drive growth in both affected and unaffected populations [32] Question: Commentary on gross margin and expectations for Q4 - Management noted productivity improvements and cost management as key factors for expected gross margin growth, with confidence in achieving over 70% margins next year [35][36] Question: Guidance for 2024 - Management expressed confidence in the 2024 revenue guidance of $815 million to $835 million, citing strong year-to-date performance and market adoption [42][43] Question: Updates on GeneSight publications and pipeline - Management indicated that additional publications supporting GeneSight's utility are expected next year, with ongoing clinical validation efforts [46][49] Question: Clarification on cash bridge and litigation payments - Management confirmed that the $5 million payment to Ravgen is included in the cash flow expectations for the fourth quarter [51][52] Question: LDT regulation and GeneSight - Management expressed confidence in navigating regulatory changes, noting that many quality assurance processes are already in place [55] Question: $40 million ASP opportunity and its impact on 2024 guidance - Management highlighted ongoing progress in ASP improvements and cash collections, contributing to margin expansion expectations for 2024 [58][59]

PART I - Financial Information [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company reported increased net losses for the three and nine months ended September 30, 2023, driven by legal charges, with total assets and stockholders' equity decreasing despite improved operating cash flow [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, total assets decreased to **$1,149.1 million** while total liabilities increased, leading to a sharp decline in stockholders' equity due to an increased accumulated deficit Condensed Consolidated Balance Sheet Highlights (in millions) | Account | Sep 30, 2023 | Dec 31, 2022 | Change | | :--- | :--- | :--- | :--- | | **Total Assets** | **$1,149.1** | **$1,198.7** | **($49.6)** | | Cash and cash equivalents | $76.0 | $56.9 | $19.1 | | Marketable investment securities (Current & Long-term) | $10.3 | $112.8 | ($102.5) | | **Total Liabilities** | **$465.7** | **$312.9** | **$152.8** | | Accrued liabilities | $157.6 | $94.3 | $63.3 | | Long-term debt | $38.5 | $0.0 | $38.5 | | **Total Stockholders' Equity** | **$683.4** | **$885.8** | **($202.4)** | | Accumulated deficit | ($598.3) | ($366.2) | ($232.1) | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 and the nine months ended September 30, 2023, revenue increased, but significant legal charges led to a substantial rise in net loss compared to the prior year Statement of Operations Summary (in millions, except per share data) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Testing revenue | $191.9 | $156.4 | $556.6 | $500.6 | | Total costs and expenses | $252.0 | $201.4 | $782.6 | $589.0 | | *incl. Legal charges pending settlement* | *$34.3* | *$0.0* | *$111.8* | *$0.0* | | Operating loss | ($60.1) | ($45.0) | ($226.0) | ($88.4) | | Net loss | ($61.3) | ($35.1) | ($232.1) | ($69.7) | | Net loss per share (basic and diluted) | ($0.75) | ($0.43) | ($2.84) | ($0.87) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operations improved, while investing activities provided cash, and financing activities generated inflow from new debt Cash Flow Summary for the Nine Months Ended September 30 (in millions) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($56.2) | ($99.0) | | Net cash provided by (used in) investing activities | $43.9 | ($41.9) | | Net cash provided by (used in) financing activities | $31.0 | ($5.9) | | Net increase (decrease) in cash | $18.6 | ($148.1) | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail revenue recognition, significant legal contingencies totaling **$111.8 million** for settlements, and the establishment of a new **$115.0 million** asset-based revolving credit facility Testing Revenue by Product (Q3 2023 vs Q3 2022, in millions) | Product Category | Q3 2023 Revenue | Q3 2022 Revenue | Change | | :--- | :--- | :--- | :--- | | Hereditary Cancer | $86.5 | $70.5 | +22.7% | | Tumor Profiling | $30.2 | $30.8 | -1.9% | | Prenatal | $39.5 | $22.1 | +78.7% | | Pharmacogenomics | $35.7 | $33.0 | +8.2% | | **Total Revenue** | **$191.9** | **$156.4** | **+22.7%** | - The company accrued **$77.5 million** for a securities class action settlement, with **$20 million** paid in cash and the remaining **$57.5 million** payable in cash or common stock[85](index=85&type=chunk)[87](index=87&type=chunk) - The company settled a patent lawsuit with Ravgen, Inc. for a minimum of **$12.75 million** and a potential additional **$21.25 million** contingent on future events, with **$34.0 million** accrued for this matter[93](index=93&type=chunk) - In June 2023, the company entered a new asset-based revolving credit facility (ABL Facility) for up to **$90.0 million** and had drawn **$40.0 million** as of September 30, 2023, with the facility upsized to **$115.0 million** in October 2023[51](index=51&type=chunk)[110](index=110&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes Q3 2023 revenue growth to increased testing volumes, while operating expenses rose significantly due to compensation and **$111.8 million** in legal accruals, with liquidity supported by cash and a new ABL facility [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Q3 2023 revenue grew **23%** year-over-year driven by testing volumes, but increased costs, SG&A expenses, and **$34.3 million** in legal charges widened the operating loss for both the quarter and nine-month period - Q3 2023 testing volumes grew **40%** year-over-year (**18%** excluding SneakPeek), driven by strong performance in MyRisk (**+18%**), GeneSight (**+19%**), and Prenatal (**+20%** excluding SneakPeek)[120](index=120&type=chunk) Revenue by Product (Q3 2023 vs Q3 2022, in millions) | Product Category | Q3 2023 | Q3 2022 | Change | | :--- | :--- | :--- | :--- | | Hereditary Cancer | $86.5 | $70.5 | +$16.0 | | Tumor Profiling | $30.2 | $30.8 | ($0.6) | | Prenatal | $39.5 | $22.1 | +$17.4 | | Pharmacogenomics | $35.7 | $33.0 | +$2.7 | | **Total Revenue** | **$191.9** | **$156.4** | **+$35.5** | - For the nine months ended Sep 30, 2023, legal charges pending settlement amounted to **$111.8 million**, with no corresponding charges in the prior year[136](index=136&type=chunk) - SG&A expense for the nine months ended Sep 30, 2023 increased by **$60.3 million** compared to the prior year, driven by higher compensation costs, legal expenses, depreciation, and rent[135](index=135&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity, comprising **$86.3 million** in cash and marketable securities and a **$115.0 million** ABL facility, is deemed sufficient for the next 12 months, despite ongoing operational cash use and litigation costs Liquidity Position (in millions) | Item | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $76.0 | $56.9 | | Marketable investment securities | $10.3 | $112.8 | | **Total Cash & Marketable Securities** | **$86.3** | **$169.7** | - The company entered an ABL facility in June 2023, subsequently increased to **$115.0 million**, with **$40.0 million** outstanding and **$48.5 million** available as of Sep 30, 2023[144](index=144&type=chunk) - Cash used in operating activities for the nine months ended Sep 30, 2023, was **$56.2 million**, compared to **$99.0 million** in the prior-year period, primarily due to the timing of legal settlement payments[152](index=152&type=chunk)[153](index=153&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rate fluctuations on its ABL Facility and foreign currency exposure, primarily from Japanese yen-denominated revenues, without using derivative hedging instruments - The company is exposed to interest rate risk through its ABL Facility, where a **100 basis point** change would alter annual interest expense by **$0.4 million** based on the **$40.0 million** debt outstanding at September 30, 2023[160](index=160&type=chunk) - Approximately **10%** of revenues are denominated in foreign currencies, primarily the Japanese yen, where a hypothetical **10%** change in its value would cause a **1%** change in total revenues[161](index=161&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[163](index=163&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the nine months ended September 30, 2023[164](index=164&type=chunk) PART II - Other Information [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings.) The company refers to Note 13 of the financial statements for details on current legal proceedings, including settled securities class action and patent infringement lawsuits - For information on legal proceedings, the report directs readers to Note 13, "Commitments and Contingencies" in the Notes to Condensed Consolidated Financial Statements[166](index=166&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors.) The company faces material risks including potential funding insufficiency, significant litigation costs from settlements like Ravgen's, ongoing pressure from third-party payors, and regulatory uncertainty regarding FDA oversight of Laboratory Developed Tests - The company may need additional funding if cash flow is insufficient, and its ABL Facility contains covenants that could limit its ability to incur more debt[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk) - The company settled a patent infringement lawsuit with Ravgen, Inc. and is required to pay a minimum of **$12.75 million**, with potential for an additional **$21.25 million** in contingent payments[174](index=174&type=chunk) - Failure of third-party payors to provide adequate coverage and payment remains a significant risk, noting ongoing pricing pressure, PAMA impact, and a recent legal victory preventing California from making its PNS program the exclusive provider of cfDNA screening[176](index=176&type=chunk)[178](index=178&type=chunk)[180](index=180&type=chunk) - Potential changes in FDA regulation of Laboratory Developed Tests (LDTs), through a proposed rule or legislation like the VALID Act, could result in significant delays, additional expenses, and adversely impact operations, with the GeneSight test specifically noted as facing FDA scrutiny[184](index=184&type=chunk)[187](index=187&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company has a **$200.0 million** share repurchase program with **$110.7 million** remaining available, and no shares were repurchased during the nine months ended September 30, 2023 - As of September 30, 2023, **$110.7 million** remains under the company's **$200.0 million** share repurchase authorization, with no repurchases made in the first nine months of 2023[191](index=191&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information.) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading plans during the fiscal quarter ended September 30, 2023 - No directors or executive officers adopted, modified, or terminated a Rule 10b5-1 trading plan during the third quarter of 2023[193](index=193&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits.) The filing includes key exhibits such as new employment and separation agreements, alongside required CEO and CFO certifications - Key exhibits filed include new employment and separation agreements, as well as required CEO and CFO certifications[195](index=195&type=chunk)