Guardant Health(GH) - 2021 Q4 - Annual Report

PART I Business Guardant Health is a precision oncology company providing proprietary blood tests, data sets, and advanced analytics to inform cancer treatment decisions across all stages of the disease - Guardant Health is a precision oncology company focused on conquering cancer through proprietary tests, vast data sets, and advanced analytics, offering products for all stages of the disease, from screening (Guardant SHIELD) to therapy selection in advanced stages (Guardant360) and recurrence monitoring (Guardant Reveal)[19] - The Guardant Health Oncology Platform is built on five key layers: Technology (digital sequencing), Clinical Utility (over 200 peer-reviewed publications), Regulatory Approval (first FDA-approved comprehensive liquid biopsy), Payer Coverage (including Medicare), and Commercial Adoption (used by 11,000 oncologists)[24][25][26][27][28][30] Test Volume Growth (Clinical & Biopharmaceutical) | Customer Type | 2019 | 2020 | 2021 | | :--- | :--- | :--- | :--- | | Clinical Customers | 49,926 | 63,254 | 87,600 | | Biopharmaceutical Customers | 20,643 | 15,983 | 18,600 | Our Products and Development Program The company's product portfolio addresses the full continuum of cancer care, including therapy selection, treatment monitoring, minimal residual disease, and early screening - Guardant360 CDx is the market-leading comprehensive liquid biopsy test, approved by the FDA for tumor mutation profiling in solid tumors and as a companion diagnostic for specific NSCLC therapies[35] - Guardant Reveal, launched in February 2021, is a liquid biopsy test for detecting minimal residual disease and monitoring for recurrence in early-stage cancer, initially for Stage II-III colorectal cancer[42] - Guardant SHIELD is an assay in development for cancer screening in asymptomatic individuals, leveraging both genomic and epigenomic signatures to enhance detection of early-stage cancers[49] - GuardantINFORM is a real-world evidence platform launched in 2020, combining de-identified clinical and genomic data from the Guardant360 test to accelerate biopharma research and development[47][48] Commercialization The company's commercial strategy uses a targeted U.S. sales force, international distributors, and a joint venture to drive global adoption of its oncology products - In the U.S., a specialized sales organization targets oncologists and cancer centers, focusing on both academic institutions and community practices[50][51] - A joint venture with SoftBank, Guardant Health AMEA, Inc., aims to accelerate commercialization in Asia, the Middle East, and Africa; in December 2021, Guardant360 CDx received regulatory approval in Japan[54] - In November 2021, the company exercised its call right to purchase all shares held by SoftBank in the Guardant Health AMEA joint venture, with the transaction expected to close by the end of Q2 2022[54] Payer Coverage and Reimbursement The reimbursement strategy focuses on securing coverage from commercial and government payers by becoming a participating provider and obtaining favorable status like ADLT - The company is actively working to expand contracts with commercial payers as a "participating provider" to achieve higher and more stable reimbursement rates, as non-participating provider payments are lower and more variable[57][58][59] - Medicare provides limited coverage for the Guardant360 test for qualifying patients with solid tumors; in March 2021, CMS granted ADLT status to the Guardant360 CDx test, setting its Medicare reimbursement at the lowest available commercial rate[29][66] - The company is subject to the Protecting Access to Medicare Act (PAMA), which requires reporting of commercial payer rates to CMS to establish Medicare reimbursement rates for clinical laboratory services[64] Competition Guardant Health faces competition from diagnostic companies offering genomic profiling services via liquid or tissue biopsies, as well as firms developing tests for MRD and early screening - Primary competition comes from companies offering genomic profiling through either liquid or tissue-based tests[76] - Key liquid biopsy competitors include Foundation Medicine (Roche), Roche Molecular Systems, Inc, Thermo Fisher Scientific, Inc, Illumina, Inc, Qiagen N.V, Invitae Corporation, and Sysmex Inostics[77] - Competitors in minimal residual disease and early screening include GRAIL, Inc, Natera, Inc, Exact Sciences Corp, and Freenome Holdings, Inc[77] Government Regulations The company operates in a highly regulated environment, adhering to CLIA and state laboratory standards, FDA oversight for medical devices, and various healthcare compliance laws - The company's laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP), and holds licenses in several states, including California and New York[90][92] - Certain tests are marketed as Laboratory Developed Tests (LDTs), which are currently subject to FDA's enforcement discretion; however, potential changes in FDA policy could impose more stringent regulatory requirements[119][120][242] - The Guardant360 CDx test is marketed pursuant to an approved Premarket Approval (PMA) from the FDA, a rigorous process requiring extensive data to demonstrate safety and effectiveness[107] - The company is subject to federal and state fraud and abuse laws, including the Anti-Kickback Statute (AKS), the Stark Law, and the False Claims Act (FCA), which regulate financial relationships with healthcare providers[150][151][153][154] Employees and Human Capital As of December 31, 2021, the company had 1,373 employees and emphasizes a diverse and inclusive workplace, with strong representation of women and minorities Employee Headcount and Diversity (as of Dec 31, 2021) | Metric | Value | | :--- | :--- | | Total Full-Time Employees | 1,373 | | Racially/Ethnically Diverse (Overall) | 56% | | Female (Overall) | 55% | | Racially/Ethnically Diverse (Leadership) | 34% | | Female (Leadership) | 38% | | Female (Independent Directors) | 57% | - The company has implemented supportive measures in response to COVID-19, including free testing, enhanced safety protocols, remote work options, and unlimited sick leave for COVID-related needs, without any salary or wage cuts[171] Risk Factors The company faces significant risks from its history of net losses, reliance on key products and suppliers, intense competition, and a complex regulatory environment Risks Related to Business and Strategy The company has a history of significant net losses, depends heavily on a few payers like Medicare, relies on limited suppliers, and faces ongoing disruption from COVID-19 - The company has a history of significant losses, with a net loss of $384.8 million in 2021 and an accumulated deficit of $1.0 billion as of December 31, 2021[177] - Revenue from patients covered by Medicare represented approximately 45% of precision oncology revenue from clinical customers for the year ended December 31, 2021[199] - The company relies on a limited number of suppliers, including Illumina as the sole supplier for sequencers and their maintenance, creating significant supply chain risk[216] - The COVID-19 pandemic has adversely impacted the business by reducing customer access, disrupting the supply chain for critical reagents and equipment, and negatively affecting clinical trial enrollment[219][220] Risks Related to Highly Regulated Industry The company faces risks from potential FDA regulation of LDTs, uncertainty in payer reimbursement, and strict compliance requirements for healthcare and data privacy laws - Several key tests are marketed as Laboratory Developed Tests (LDTs); future changes in the FDA's policy of enforcement discretion could subject these tests to more significant regulatory requirements, including premarket approval[242][243] - Commercial success is heavily dependent on obtaining and maintaining coverage and adequate reimbursement from third-party payers like Medicare and private insurers, which is a complex and uncertain process[255] - The company is subject to numerous federal and state healthcare laws, including the Anti-Kickback Statute (AKS), Stark Law, and the False Claims Act (FCA); non-compliance could lead to significant penalties[295][296] - The business is subject to extensive data privacy and security laws, such as HIPAA in the U.S. and GDPR in Europe; failure to comply or a data breach could result in significant liability and reputational harm[315][316][321] Risks Related to Intellectual Property The company's success depends on protecting its intellectual property through patents and trade secrets, which is challenged by an uncertain legal landscape and costly litigation - The company relies on a combination of patents, trademarks, and trade secrets to protect its proprietary technologies, but these may not provide adequate protection[331] - The patent landscape for genomic diagnostic tests is highly uncertain, with evolving legal standards that may affect the ability to obtain and enforce patents covering the company's technology[337] - The company is and may continue to be involved in costly and time-intensive intellectual property litigation to enforce its rights or defend against infringement claims[363][364] - The company relies on in-licensed technology from third parties; loss of these licenses could limit the ability to commercialize products and may lead to litigation[347] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on Nasdaq under "GH," and it does not anticipate paying cash dividends, retaining earnings for business growth - The company's common stock is traded on the Nasdaq Global Select Market under the symbol "GH"[426] - The company has never declared or paid dividends and intends to retain all future earnings to finance business operations and expansion[427] Management's Discussion and Analysis of Financial Condition and Results of Operations In 2021, revenue grew 30% to $373.7 million, but net loss widened to $384.8 million due to sharply higher R&D and sales expenses, while liquidity remains strong at $1.6 billion Results of Operations In 2021, revenue grew 30% to $373.7 million, but net loss widened to $384.8 million due to a 76% increase in R&D and an 80% increase in sales and marketing expenses Consolidated Statements of Operations (2021 vs 2020) | Account | 2021 (in thousands) | 2020 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenue | $373,653 | $286,730 | 30% | | Precision oncology testing | $304,312 | $236,324 | 29% | | Development services and other | $69,341 | $50,406 | 38% | | Total costs and operating expenses | $784,654 | $541,680 | 45% | | Cost of precision oncology testing | $110,396 | $74,769 | 48% | | Research and development expense | $263,221 | $149,862 | 76% | | Sales and marketing expense | $191,881 | $106,513 | 80% | | General and administrative expense | $206,640 | $192,770 | 7% | | Loss from operations | ($411,001) | ($254,950) | 61% | | Net loss | ($384,770) | ($246,283) | 56% | - The increase in clinical testing revenue was driven by higher sample volumes for Guardant360 LDT and CDx tests, and an increased average selling price for the CDx test due to receiving ADLT status from Medicare[464] - The 76% increase in R&D expense was primarily due to a $49.7 million increase in personnel-related costs, a $32.7 million increase in material costs, and a $21.2 million increase in development consulting fees[472] Liquidity and Capital Resources The company holds $1.6 billion in cash and marketable securities against a $1.0 billion accumulated deficit, with operating cash use increasing to $209.0 million in 2021 - As of December 31, 2021, the company had $1.6 billion in cash, cash equivalents, and marketable securities and an accumulated deficit of $1.0 billion[436][483][484] Summary of Cash Flows (2021 vs 2020) | Cash Flow Activity | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($209,017) | ($103,927) | | Net cash used in investing activities | ($63,155) | ($617,086) | | Net cash (used in) provided by financing activities | ($66,824) | $1,410,307 | - The increase in cash used in operating activities in 2021 was primarily due to a higher net loss and a $44.4 million increase in accounts receivable[488] Financial Statements and Supplementary Data The company's audited financial statements show total assets of $2.20 billion, a net loss of $384.8 million for 2021, and a year-end cash balance of $1.6 billion Consolidated Balance Sheets As of December 31, 2021, total assets were $2.20 billion, while total liabilities increased to $1.56 billion, primarily due to convertible senior notes Consolidated Balance Sheet Highlights (as of Dec 31) | Account | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $1,630,782 | $2,041,477 | | Total Assets | $2,204,499 | $2,271,781 | | Convertible senior notes, net | $1,134,821 | $806,292 | | Total Liabilities | $1,559,494 | $916,186 | | Accumulated deficit | ($1,007,825) | ($606,592) | | Total Stockholders' Equity | $645,005 | $1,298,495 | Consolidated Statements of Operations For fiscal year 2021, revenues grew 30% to $373.7 million, but a faster rise in operating expenses led to a net loss of $405.7 million, or ($4.00) per share Consolidated Statements of Operations (Years Ended Dec 31) | Account | 2021 (in thousands) | 2020 (in thousands) | 2019 (in thousands) | | :--- | :--- | :--- | :--- | | Total Revenue | $373,653 | $286,730 | $214,375 | | Total costs and operating expenses | $784,654 | $541,680 | $296,746 | | Loss from operations | ($411,001) | ($254,950) | ($82,371) | | Net loss | ($384,770) | ($246,283) | ($67,851) | | Net loss per share, basic and diluted | ($4.00) | ($2.60) | ($0.84) | Notes to Consolidated Financial Statements The notes detail key accounting policies, the acquisition of the AMEA joint venture, the $1.15 billion convertible notes, legal proceedings, and the company's tax position - In November 2021, the company exercised its call right to purchase all shares held by SoftBank in the Guardant Health AMEA joint venture; the minimum purchase price of $78.0 million was recorded as a current liability[636] - In November 2020, the company issued $1.15 billion in 0% Convertible Senior Notes due 2027, with an initial conversion price of approximately $139.82 per share[656][659] - In December 2021, the company entered into a Settlement and License Agreement with Foundation Medicine, resolving all pending patent litigation worldwide between the parties[682] - In January 2022, the company received a Civil Investigative Demand (CID) from the U.S. Attorney's Office in connection with a False Claims Act investigation regarding billing of government-funded programs[686] Controls and Procedures Management and the independent auditor both concluded that the company's disclosure controls and internal control over financial reporting were effective as of year-end 2021 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2021[747] - Based on the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2021[748] - The independent registered public accounting firm issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2021[755] PART III Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance is incorporated by reference from the company's forthcoming 2022 Proxy Statement - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the forthcoming 2022 Proxy Statement[766] Executive Compensation Information detailing executive compensation is incorporated by reference from the company's forthcoming 2022 Proxy Statement - Information regarding executive compensation is incorporated by reference from the forthcoming 2022 Proxy Statement[767] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information on security ownership by beneficial owners and management is incorporated by reference from the company's forthcoming 2022 Proxy Statement - Information regarding security ownership is incorporated by reference from the forthcoming 2022 Proxy Statement[768] Certain Relationships and Related Transactions, and Director Independence Information on related party transactions and director independence is incorporated by reference from the company's forthcoming 2022 Proxy Statement - Information regarding related transactions and director independence is incorporated by reference from the forthcoming 2022 Proxy Statement[769] Principal Accounting Fees and Services Information detailing principal accounting fees and services is incorporated by reference from the company's forthcoming 2022 Proxy Statement - Information regarding principal accounting fees and services is incorporated by reference from the forthcoming 2022 Proxy Statement[770] PART IV Exhibits, Financial Statement Schedules This section lists all documents filed with the Form 10-K, including financial statements and material contracts, while omitting inapplicable schedules - This section includes the consolidated financial statements, an index of all exhibits filed with the report, and notes that financial statement schedules have been omitted[771][772][773]