ミリアドジェネティクスの適時開示・決算・その他

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

現行レポート

セクション13または15に基づいて(d)

1934年の証券取引所法の

報告日（最も古いイベントの報告日）：2024年1月10日

MYRIAD GENETICS, INC.

(チャーターで指定された登録者の正確な名前)

デラウェア

0-26642

87-0494517

(法人設立の州またはその他の管轄区域)

(CommissionFile Number)

(IRS EmployerIdentification No.)

322 North 2200 West

ユタ州ソルトレイクシティ 84116

(最高経営責任者の住所）（郵便番号)

登録者の電話番号（市外局番を含む）。(801) 584-3600

Not applicable

(前回の報告書以降に変更があった場合、旧姓または旧住所)

Form8-Kの提出が、以下の条項のいずれかに基づく登録者の提出義務を同時に満たすことを意図している場合は、以下の該当するチェックボックスをチェックしてください：


☐			証券法に基づく規則425に従った書面によるコミュニケーション（17 cfr 230.425)

☐			取引所法の下でのルール14a-12（17 cfr 240.14a-12）に基づく資料の勧誘。)

☐			取引所法の規則14d-2(b)に基づく開始前のコミュニケーション（17 cfr 240.14d-2(b))

☐			証券取引法の規則13e-4(c)に基づく開始前のコミュニケーション（17 cfr 240.13e-4(c))

法第12条(b)に従って登録された証券：

Title of each class

TradingSymbol(s)

登録されている各取引所の名称

普通株式、額面0.01ドル

MYGN

Nasdaq Global Select Market

登録者が1933年証券法規則405（本章230.405節）または1934年証券取引法規則12b-2（本章240.12b-2節）で定義される新興成長企業であるかどうかをチェックマークで示す。

Emerging growth company ☐

新興成長企業の場合、登録者が取引所法第13条(a)に従い提供される新規または改訂された財務会計基準に準拠するための移行期間の延長を利用しないことを選択した場合は、チェックマークで示す。☐

ITEM 2.02 経営成績および財政状態。

2024年1月10日、ミリアド・ジェネティクス・インク（以下「当社」）は第42回J.P.モルガン・ヘルスケア・カンファレンスにおいて投資家向けのプレゼンテーションを行いました。このプレゼンテーションに関連し、また2023年12月31日に終了した四半期および通期の速報値に基づき、当社は、2023年11月6日の2023年度第3四半期決算説明会で発表した2023年度の売上高および非GAAPベースのガイダンスを再確認しました。さらに、2023年第4四半期にプラスの調整後営業キャッシュフローを達成する予定であるとのガイダンスを再確認し、2023年末時点の現金、現金同等物および利用可能与信の見積もりに関するガイダンスを提供した。このプレゼンテーションの全文は別紙99.1として提供され、参照することによりここに組み込まれる。

特に、2023年度第4四半期の売上高は約1億9,600万ドルから1億9,700万ドル、希薄化後のGAAPベースの1株当たり利益は（0.35ドル）から（0.36ドル）、調整後の1株当たり利益は0.02ドルから0.03ドル、GAAPベースおよび調整後の売上総利益率は約70％を見込んでいる。当社はさらに、2023会計年度には前年比10％以上の増収、2023年第4四半期には前年比10％以上の出生前数量の伸びを見込んでいることを明らかにした。2023年度第4四半期のnon-GAAPベースの速報値は、比較可能なGAAPベースの財務指標から開始され、株式報酬費用約1,030万ドル、買収に伴う現金支出を伴わない償却約1,070万ドル、変革イニシアチブに関連する費用およびその他の一時的費用約1,410万ドル、訴訟和解費用約060万ドル、税金調整約200万ドルの推定影響を除外しています。

当社は2023年12月31日に終了する四半期および通期の決算を確定している最中であり、前述の財務ガイダンス、データおよびその他の情報は、現在までに入手可能な情報に基づくものであり、予備的な未監査の内部財務報告書に基づくものです。この予備的な未監査の財務情報およびデータは、当社の期末決算および報告プロセス、ならびに2023年12月31日に終了する四半期および通期の財務諸表の最終化に関連して変更される可能性があるため、前述の財務ガイダンス、データ、およびその他の情報は、2023年12月31日に終了する四半期および通期の当社の実際の財務結果を表すものではありません。

FORWARD-LOOKING STATEMENTS

This Current Report on Form 8-K and Exhibit 99.1 contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the Company’s fiscal year 2023 financial guidance, preliminary fourth quarter 2023 financial and operating results, 2024 revenue guidance and long-term financial targets through 2026, the Company’s expectation to achieve positive adjusted operating cash flow in the fourth quarter of 2023, the Company's expectation of 10%+ revenue growth in 2024 through 2026, the Company’s estimated total available cash and credit at year end 2023, roadmaps of expected business highlights in 2024 and 2025, the expected timeline to complete certain enterprise infrastructure and capability investments, and the expected timing of the launch or enhancement of certain new or existing products. These “forward-looking statements” are management’s present expectations of future events as of the date hereof and are subject to a number of known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. These risks include, but are not limited to: the risk that sales and profit margins of the Company’s existing tests may decline or that the Company may not be able to operate its business on a profitable basis; risks related to the Company’s ability to achieve certain revenue growth targets and generate sufficient revenue from its existing product portfolio or in launching and commercializing new tests to be profitable; risks related to changes in governmental or private insurers’ coverage and reimbursement levels for the Company’s tests or the Company’s ability to obtain reimbursement for its new tests at comparable levels to its existing tests; risks related to increased competition and the development of new competing tests; the risk that the Company may be unable to develop or achieve commercial success for additional tests in a timely manner, or at all; the risk that the Company may not successfully develop new markets or channels for its tests, including the Company’s ability to successfully generate substantial revenue outside the United States; the risk that licenses to the technology underlying the Company’s tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with constructing and operating the Company’s laboratory testing facilities; risks related to public concern over genetic testing in general or the Company’s tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to the Company’s ability to obtain new corporate collaborations or licenses and acquire or develop new technologies or businesses on satisfactory terms, if at all; risks related to the Company’s ability to successfully integrate and derive benefits from any technologies or businesses that it licenses, acquires or develops; the risk that the Company is not able to secure additional financing to fund its business, if needed, in a timely manner or on favorable terms, if it all; risks related to the Company’s projections or estimates about the potential market opportunity for the Company’s current and future products; the risk that the Company or its licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying the Company’s tests; the risk of patent-infringement claims or challenges to the validity of the Company’s patents; risks related to changes in intellectual property laws covering the Company’s tests, or patents or enforcement, in the United States and foreign countries; risks related to security breaches, loss of data and other disruptions, including from cyberattacks; risks of new, changing and competitive technologies in the United States and internationally and that the Company may not be able to keep pace with the rapid technology changes in its industry, or properly leverage new technologies to achieve or sustain competitive advantages in its products; the risk that the Company may be unable to comply with financial operating covenants under the Company’s credit or lending agreements; risks related to the Company’s inability to achieve and maintain effective disclosure controls and procedures and internal control over financial reporting; risks related to current and future investigations, claims or lawsuits, including derivative claims, product or professional liability claims, and other factors discussed under the heading “Risk Factors” contained in Item 1A of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 1, 2023 as updated in the Company’s Quarterly Reports on Form 10-Q filed with the SEC on May 4, 2023, August 4, 2023 and November 7, 2023, as well as any further updates to those risk factors filed from time to time in the Company’s Current Reports on Form 8-K. The Company is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

ITEM 9.01 財務諸表および添付資料


ExhibitNumber						Description
99.1						2024年1月10日付投資家向けプレゼンテーション。

104						cover page interactive data file (インラインxbrl文書内に埋め込まれている)。

展示資料には、当社ウェブサイトまたは他者のウェブサイト上の情報へのハイパーテキスト・リンクが含まれている場合があります。当社ウェブサイトおよび他社のウェブサイト上の情報は、参照により本Form 8-Kに組み込まれるものではなく、本Form 8-Kの一部を構成するものでもありません。

Form 8-Kの一般教示B-2に従い、項目2.02および別紙99.1に記載された情報は、改正1934年証券取引所法（以下「取引所法」）第18条に照らして「提出」されたとはみなされず、また同条の法的責任の対象ともみなされず、当該提出書類において特定の参照により明示的に記載される場合を除き、改正1933年証券取引所法または取引所法に基づき提出された登録届出書またはその他の書類に参照により組み込まれることはないものとする。

SIGNATURES

1934年証券取引法の要件に従い、登録者は本報告書に正式に権限を付与された署名者により、登録者を代表して署名させた。


	MYRIAD GENETICS, INC.

Date: January 16, 2024	By:	/s/ R. Bryan Riggsbee
		R. Bryan Riggsbee
		Chief Financial Officer

EX-99.1 2 jpm_livepresentationxfin.htm EX-99.1 jpm_livepresentationxfin

©2024 Myriad Genetics, Inc. Some of the information presented here today contains projections or other forward-looking statements regarding future events or the future financial performance of the Company. FORWARD-LOOKING STATEMENTS AND DISCLAIMERS These statements are based on management’s current expectations and the actual events or results may differ materially and adversely from these expectations. We refer you to the documents the Company files from time to time with the Securities and Exchange Commission, specifically, the Company’s annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in the Company’s projections or forward-looking statements. All third-party marks—® and ™—are the property of their respective owners. Certain market and industry data has been obtained from third- party sources, which the Company believes are reliable, but the Company has not independently verified the information provided by third-party sources. Unless otherwise noted, market growth rates used in this presentation are estimates based on Company and third-party industry research. NON-GAAP FINANCIAL MEASURES In this presentation, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. Management believes that presentation of operating results using non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. Definitions of the non-GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial results are provided in the Appendix to this presentation. Forward-looking statements and Non-GAAP financial measures 2

©2024 Myriad Genetics, Inc. Moving from transformation to innovation and growth Revealing the power of genetic science – for everyone Mission We advance health and well-being for all, empowering every individual by revealing the answers inside each of us. Vision As a leader in genetic testing and precision medicine, we provide insights that help people take control of their health and enable healthcare providers to better detect, treat and prevent disease. 3

©2024 Myriad Genetics, Inc. Myriad Genetics at-a-glance 45,000+ active ordering healthcare providers1 10%+ annual revenue growth for fourth consecutive quarter3 Commercial execution driving volume growth; price stability A leader in genetic testing Established franchises in hereditary cancer, pharmacogenomics, and prenatal testing 30+ years of scientific and commercial achievements 69 net promoter score1 ~2,700 employees2 1,000+ scientific publications and counting Market-leading gross margins; healthy balance sheet Innovation in ‘24 and beyond Expect to launch multiple differentiated tests in prenatal and oncology through 2026 1. As of September 2023 2. As of year-end 2023 3. As of third quarter 2023 and excludes contribution from change of revenue estimates 4

©2024 Myriad Genetics, Inc. Top-tier science delivering products that are clinically validated and demonstrate proven utility (quality, access and cost) in real world clinical settings Automated, scalable and cost- effective laboratory operations and technology platform Strong digitally enabled commercial platform Advanced regulatory, reimbursement, and revenue cycle capabilities Science and innovation Technology enabled operations Elevated customer experience and commercial execution Scalable commercial, lab operations and administrative support services 5 Pillars of long-term growth and profitability

©2024 Myriad Genetics, Inc. 3 focus areas: Oncology, Women's Health and Pharmacogenomics Using genetic insights to help physicians understand how genetic alterations impact patient response to antidepressants and other drugs. Psychiatrist Primary Care Nurse Practitioner/Physician Assistant $5 Billion Pharmacogenomics Actionable Market Size* Business Channel Customer Source: Data as of 2022 from third-party global consulting firm and internal Company estimates 6 A leader in health and wellness with differentiated genetic insights for women of all ancestries, assessing cancer risk and offering prenatal solutions. OB/GYN Maternal Fetal Medicine Primary Care Genetic Counselor $5 Billion Women’s Health Clarifying cancer treatment with genetic and genomic insights and companion diagnostic tests that are designed to work with corresponding drugs and treatments. Oncologist Surgeon Urologist Genetic Counselor $23 Billion Oncology 2024E Launch expected 2024E Launch expected 2025E Launch expected

©2024 Myriad Genetics, Inc. Oncology Women’s Health PGx AFFECTED HCT + GERMLINE TUMOR PROFILING3 MRD HRD2 UROLOGY PRENATAL UNAFFECTED HCT PGx Actionable Market Opp.1 $1.2B $500M $20B+ $350M $600M $2.3B $3B $5B Market Penetration ~65% ~45% <5% ~40% ~35% ~50% <15% ~15% Myriad Products Diversified portfolio within large, fragmented, actionable markets 1: Actionable market indicated against cancers of commercial focus 2: In ovarian, breast, prostate, pancreatic cancers only 3: Reflective of IHC partnership Data as of 2022 from third-party global consulting firm and internal Company estimates <20% of market share concentrated among Top 3 participants <40% average market penetration across all categories Myriad holds Top 3 position in 6 out of 7 active product categories 7 >$30B of actionable market opportunity

©2024 Myriad Genetics, Inc. MyRisk addresses the needs of large and growing markets **Expected ***In cancers of focus Unaffected Market – Hereditary Screening Affected Market – Germline Screening TOTAL U.S. POPULATION ~332M TOTAL U.S. POPULATION WHO WOULD QUALIFY FOR HCT ~50M* TOTAL NUMBER OF WOMEN WHO QUALIFY FOR HCT ~25M WOMEN WHO QUALIFY FOR HCT AND ARE ACTIVELY INVOLVED IN THEIR HEALTHCARE ~13M TOTAL NUMBER OF WOMEN WHO ARE NEWLY ELIGBILE FOR HCT IN THE PAST YEAR ~800K TOTAL NEWLY DX PATIENTS ELIGIBLE TO RECEIVE GERMLINE SCREENING ANNUALLY***~860K PATIENTS RECEIVING GERMLINE TESTING ANNUALLY~550K Actionable market size (US only) Market penetration* Market growth** MYGN market share ~$3B 15% High single digits 30% - 35% Actionable market size (US only) Market penetration Market growth** MYGN market share ~$1.2B 65% Mid single digits ~20% 8 *Data as of 2022 from third-party global consulting firm and internal Company estimates

©2024 Myriad Genetics, Inc. 55 65 Q3 '22 Q4 '22 Q1 '23 Q2 '23 Q3 '23 +24% +20% +18% +16% YOY Growth +4% Significant opportunity to accelerate MyRisk growth across Women’s Health, Imaging, Oncology and Urology Figures in thousands MyRisk patient portal MyRisk Medical Management Tool Enhancements RiskScore studies Breast Cancer Risk Assessment Program Panel Expansion | WES (whole exome sequencing) BRAC CDx to NGS 2024 2025 Q3’23 LTM Volume Growth (YOY) 9 +19% Hereditary cancer test volume Roadmap of expected highlights

©2024 Myriad Genetics, Inc. GeneSight is the market-leading PGx test helping address the Nation’s mental health crisis Ordered by tens of thousands of clinicians to inform medication selection and dosing GeneSight designed to help physicians understand how patients will respond to medications used to treat depression, anxiety, ADHD, and other psychiatric conditions. Designed to help physicians and patients avoid multiple medication trials by informing which medications may require dose adjustments, be less likely to work, or have increased risk of side effects. Market-leading psychiatric PGx test and the only test backed by seven clinical studies published in peer-reviewed journals Measures multiple genomic variants for each individual to categorize medications and provide clinical considerations 2 Million + people have taken the GeneSight test 7 Clinical Studies published in peer reviewed journals, including independent randomized controlled trial in JAMA 10

©2024 Myriad Genetics, Inc. 85 95 105 115 125 Q3 '22 Q4 '22 Q1 '23 Q2 '23 Q3 '23 +31% +23% +19% +22% YOY Growth +34% Roadmap of expected highlights 2024 2025 Strong commercial execution driving significant volume growth in the last twelve months Health Economic Outcome Research (HEOR) study*** Significant opportunity to improve payor coverage and ASP Postpartum Clin Dev Protocol & Study Actionable market size (US only)* Market penetration* Market growth** MYGN market share* ~$5B 15% Mid teens 55-60% ***This study used data from the Optum Labs Data Warehouse, composed of de-identified administrative claims data for both commercially insured and Medicare Advantage enrollees. The claims data were linked on a de-identified basis with PGx test results. 11 Figures in thousands Q3’23 LTM Volume Growth (YOY) +24% GeneSight test volume *Data as of 2022 from third-party global consulting firm and internal Company estimates **Expected

©2024 Myriad Genetics, Inc. Prolaris designed to help determine optimal treatment planning for patients with localized prostate cancer Prolaris utilizes two validated thresholds to identify men that are: • Safe for active surveillance (low-risk patients) • Candidates for a singular type of therapy (medium-risk patients) • Candidates for multiple types of therapy at once (high-risk patients) Prolaris identified >86% of low-risk patients as candidates for active surveillance* RESEARCH VALIDATION *Hu, J. C., et al. Clinical Utility of Gene Expression Classifiers in Men With Newly Diagnosed Prostate Cancer. JCO Precision Oncology, 2018; 1-15 doi:10.1200/po.18.00163 1212 Active surveillance (low-risk patients) Single-modal treatment (medium-risk patients) Multi-modal treatment (high-risk patients) LOWER PROLARIS SCORE HIGHER PROLARIS SCORE

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