In light of the foregoing, investors are urged not to rely on any forward-looking statement or third-party data in reaching any conclusion or making any investment decision about any securities of the Company. High growth core business approaching breakeven with a potentially higher growth pipeline Growth in TissueNext, differentiated by our Lunit-powered Galaxy AI TECHNOLOGY LEADER Pipeline of multi-billion dollar revenue opportunities in early stages Spearheading a new patient-preferred category with Shie ...

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) Provides a comprehensive overview of the company's financial performance, condition, and management's analysis for the reporting period [Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Guardant Health reported **$265.9 million** revenue for the six months ended June 30, 2023, a 30% increase, with a net loss of **$206.3 million** and total assets growing to **$1.84 billion** from a public offering [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of June 30, 2023 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $271,073 | $141,647 | | Short-term marketable debt securities | $953,776 | $869,584 | | Total current assets | $1,397,655 | $1,191,594 | | Total Assets | $1,840,017 | $1,609,985 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $200,933 | $193,220 | | Convertible senior notes, net | $1,138,678 | $1,137,391 | | Total Liabilities | $1,547,291 | $1,549,805 | | Total Stockholders' Equity | $292,726 | $60,180 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Outlines the company's revenues, expenses, and net loss for the three and six months ended June 30, 2023 Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $137,150 | $109,144 | $265,864 | $205,243 | | Loss from operations | $(119,616) | $(130,321) | $(253,671) | $(253,659) | | Net loss | $(72,771) | $(229,432) | $(206,304) | $(352,660) | | Net loss per share, basic and diluted | $(0.67) | $(2.25) | $(1.95) | $(3.46) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Reports the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2023 Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(168,456) | $(140,554) | | Net cash (used in) provided by investing activities | $(83,903) | $37,915 | | Net cash provided by (used in) financing activities | $383,000 | $(172,099) | | Net increase (decrease) in cash | $129,226 | $(276,949) | - Financing activities in the first six months of 2023 were primarily driven by **$402.5 million** in proceeds from a follow-on public offering, which significantly increased the company's cash position[28](index=28&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and additional information regarding the company's accounting policies, business operations, and significant events - The company's business is focused on precision oncology through proprietary tests like Guardant360, Guardant Reveal, and the Shield LDT test for colorectal cancer screening. A premarket approval application for the **Shield blood test** was submitted to the FDA in March 2023[32](index=32&type=chunk)[34](index=34&type=chunk) - Customer B accounted for **32% of total revenue** for the six months ended June 30, 2023, representing a significant customer concentration[48](index=48&type=chunk) - The company holds **$1.15 billion** in 0% Convertible Senior Notes due 2027, with an initial conversion price of approximately **$139.82 per share**[105](index=105&type=chunk)[108](index=108&type=chunk) - In May 2023, the company completed a follow-on public offering, selling **14,375,000 shares** at **$28.00 per share** and receiving net proceeds of **$381.4 million**[130](index=130&type=chunk) - The company is involved in several legal proceedings, including a patent infringement suit with TwinStrand Biosciences and a false advertising dispute with Natera, Inc. It is also cooperating with a Civil Investigative Demand from the U.S. Attorney's office regarding billing practices[124](index=124&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reported **$137.2 million** revenue for Q2 2023, a **26% increase** driven by precision oncology, with operating loss narrowing and liquidity reaching **$1.2 billion** after a public offering [Overview](index=35&type=section&id=Overview) Introduces the company's core business in precision oncology and highlights key strategic developments and financial position - The company is a leading precision oncology firm focused on cancer care through proprietary tests, data sets, and advanced analytics[165](index=165&type=chunk) - Key recent developments include the submission of a premarket approval (PMA) application to the FDA for the **Shield blood test** for colorectal cancer screening in March 2023, following the successful ECLIPSE study[167](index=167&type=chunk) - As of June 30, 2023, the company held approximately **$1.2 billion** in cash, cash equivalents, and marketable debt securities, bolstered by a recent follow-on public offering that raised net proceeds of **$381.4 million**[169](index=169&type=chunk) [Factors affecting our performance](index=36&type=section&id=Factors%20affecting%20our%20performance) Discusses key drivers and challenges influencing the company's financial results, including testing volume, reimbursement, and R&D investments - Performance is heavily influenced by testing volume, pricing, and customer mix, with biopharmaceutical sample testing currently having a **higher average selling price** than clinical tests[170](index=170&type=chunk) - Revenue depends on achieving broad coverage and reimbursement from third-party payers. Medicare revenue represented approximately **43% of clinical precision oncology revenue** in Q2 2023[170](index=170&type=chunk)[179](index=179&type=chunk) - Significant investment in research and development, including clinical studies for Guardant Reveal (ORACLE study) and Shield (ECLIPSE and SHIELD LUNG studies), is critical for physician adoption and payer coverage[174](index=174&type=chunk) - International expansion is a key long-term growth strategy, pursued through distributor relationships, direct contracts, and partnerships[174](index=174&type=chunk) [Results of operations](index=40&type=section&id=Results%20of%20operations) Analyzes the company's revenue and operating expenses, detailing changes and their underlying causes for the reporting period Revenue Comparison (in thousands) | Revenue Source | Q2 2023 | Q2 2022 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Precision oncology testing | $125,244 | $92,062 | $33,182 | 36% | | Development services and other | $11,906 | $17,082 | $(5,176) | (30)% | | **Total revenue** | **$137,150** | **$109,144** | **$28,006** | **26%** | - The **36% increase** in Q2 2023 precision oncology revenue was driven by higher sample volume. Clinical test volume grew to **~43,500** from **~29,300** YoY, and biopharmaceutical test volume grew to **~6,700** from **~6,000** YoY[197](index=197&type=chunk)[198](index=198&type=chunk) Operating Expenses Comparison - Q2 (in thousands) | Expense Category | Q2 2023 | Q2 2022 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Cost of revenue | $53,848 | $36,727 | $17,121 | 47% | | Research and development | $90,359 | $85,455 | $4,904 | 6% | | Sales and marketing | $71,043 | $73,603 | $(2,560) | (3)% | | General and administrative | $41,516 | $43,680 | $(2,164) | (5)% | - General and administrative expenses decreased by **5%** in Q2 2023, primarily due to a **$5.6 million** decrease in stock-based compensation as market-based RSUs for Co-CEOs were fully expensed by June 30, 2022[205](index=205&type=chunk) [Liquidity and capital resources](index=47&type=section&id=Liquidity%20and%20capital%20resources) Assesses the company's ability to meet its short-term and long-term financial obligations, including cash position and financing activities - As of June 30, 2023, the company had **$271.1 million** in cash and cash equivalents and **$953.8 million** in marketable debt securities[228](index=228&type=chunk) - The company believes its current cash, marketable securities, and anticipated cash flows from operations will be sufficient to meet cash requirements for **more than 12 months**[229](index=229&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2023, was **$168.5 million**, compared to **$140.6 million** in the prior-year period[231](index=231&type=chunk)[232](index=232&type=chunk) - Net cash provided by financing activities was **$383.0 million** for the first six months of 2023, mainly from a follow-on public offering, a significant reversal from the **$172.1 million** used in the same period of 2022 which included a **$177.8 million** payment for the Joint Venture Acquisition[231](index=231&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on its **$1.2 billion** cash and marketable securities, with a 100 basis point rate change impacting fair value by **$3.0 million**, while foreign currency risk remains immaterial - The primary market risk is interest rate sensitivity on cash, cash equivalents, and marketable debt securities totaling approximately **$1.2 billion**[242](index=242&type=chunk) - A hypothetical **100 basis point increase** in interest rates would result in an approximate **$3.0 million decline** in the fair value of the company's available-for-sale securities[242](index=242&type=chunk) - Foreign currency risk is currently considered insignificant as the majority of revenue is generated in the U.S., but this exposure is expected to increase with international expansion[243](index=243&type=chunk) [Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - The Co-CEOs and CFO concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2023[245](index=245&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[246](index=246&type=chunk) [PART II – OTHER INFORMATION](index=51&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) Contains supplementary information not covered in the financial statements, including legal matters and risk factors [Legal Proceedings](index=51&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the detailed legal proceedings information from Note 9 of the financial statements - This section incorporates by reference the legal proceedings information from **Note 9** to the unaudited condensed consolidated financial statements[249](index=249&type=chunk) [Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) No material changes occurred to the company's previously disclosed risk factors from its 2022 Form 10-K during the second quarter of fiscal 2023 - During the second quarter of fiscal 2023, there were **no material changes** to the company's previously disclosed risk factors from its 2022 Form 10-K[250](index=250&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[252](index=252&type=chunk) [Exhibits](index=52&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including Sarbanes-Oxley Act certifications from the Co-CEOs and CFO - The exhibits filed with this report include Sarbanes-Oxley Act certifications from the Co-Chief Executive Officers and the Chief Financial Officer[257](index=257&type=chunk)

Safe harbor achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this presentation are made only as of the date hereof. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to the business of the Company in general, see the Company's periodic filings with the Securities and Exchange Commission, i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________ FORM 10-Q _____________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38683 _____________________ GUARDANT HEALTH, INC. (Exact Name of Registrant as Specif ...

Shield LDT screening commercial team • Implementing efficiencies and workforce reduction across all areas of the business • Therapy Selection on-track to be breakeven in ~12 months • $1B cash balance provides >3 year runway and will fund continued investments in MRD and Screening 16 FY 2023 guidance ▪ Total Revenue: $525 – $540 million, growth of 17% to 20% y/y ▪ Precision Oncology Revenue: >20% growth over 2022 ▪ Development Services & Other Revenue: > $50 million ▪ Operating Expenses: below FY 2022 ▪ Free ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2022 was $126.9 million, up 17% from $108.1 million in the prior year quarter [51] - Full year revenue reached $449.5 million, representing a 20% increase from $373.7 million in the previous year [23] - Gross profit for Q4 2022 was $79.8 million, compared to $74.7 million in the same period of the prior year, with a gross margin of 63% [22] - Operating expenses for Q4 2022 were $225.9 million, an increase of 31% compared to $172.9 million in Q4 2021 [23] - Net loss for Q4 2022 was $139.9 million, or $1.36 per share, compared to a net loss of $90.9 million, or $0.89 per share, in Q4 2021 [23] Business Line Data and Key Metrics Changes - Precision oncology revenue from clinical tests was $83.7 million, up 13% from $64.2 million for the prior year quarter [5] - Clinical test volume for the year grew to 124,800, up 42% year-over-year from 87,600 tests [25] - Biopharma testing revenue in Q4 totaled $30.1 million, up 23% from $24.5 million in the prior year quarter [20] - Development services and other revenue in Q4 totaled $13.1 million, down 33% from the prior year quarter [21] Market Data and Key Metrics Changes - Guardant360 ASP was in the range of $2,600 to $2,700, consistent with the last few quarters [19] - Blended clinical ASP for 2022 was approximately $2,400, lower than the $2,700 in 2021 [25] - Biopharma ASP in the full year was approximately $3,610, slightly down from $3,650 in the prior year [26] Company Strategy and Development Direction - The company aims to reduce operating expenses below 2022 levels and improve free cash outflow to $350 million in 2023 [32] - Focus on maximizing opportunities in precision oncology while managing costs and expanding market penetration for new products [33] - The company plans to continue investing in clinical data development for reimbursement and technical development for lung and other cancers [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future of the Shield screening test and its potential to improve compliance and save lives [4][3] - The company expects full year 2023 revenue to be in the range of $525 million to $540 million, representing growth of approximately 17% to 20% compared to 2022 [34] - Management highlighted the importance of operational efficiencies and infrastructure to support growth in oncology diagnostics [32] Other Important Information - The company has initiated a prospective study, U-Screen, to examine whether Shield improves overall CRC screening in medically underserved populations [49] - The company ended 2022 with approximately $1 billion in cash, reflecting a free cash outflow of $387 million [31] Q&A Session Summary Question: Insights on Reveal assumptions for 2023 revenue guidance - Management indicated optimism about Reveal's growth, projecting low double-digit millions in revenue for 2023, driven by increasing traction in key tumor types [10] Question: Dynamics in the biopharma market and competitive landscape - Management acknowledged headwinds from the Inflation Reduction Act but maintained a strong pipeline and order book for 2023 [84][103] Question: Expected timeline for FDA approval and publication of ECLIPSE data - Management expects PMA submission to the FDA by the end of the quarter and anticipates approval in early 2024 [71][105] Question: Importance of U-Screen study for guideline inclusion - Management emphasized that U-Screen is part of a broader strategy to generate evidence supporting guideline inclusion and commercial adoption of the Shield test [112]

Part I [Business](index=5&type=section&id=Item%201.%20Business) Guardant Health is a precision oncology company offering proprietary tests and analytics for cancer care, generating revenue from clinical testing and biopharmaceutical collaborations, subject to extensive regulation and focused on international expansion - The company focuses on precision oncology, offering proprietary tests such as **Guardant360 CDx**, **Guardant Reveal**, and the new **Shield LDT** for colorectal cancer screening[21](index=21&type=chunk)[23](index=23&type=chunk) - International expansion is a key strategy, highlighted by the full acquisition of the Guardant Health AMEA joint venture for **$177.8 million** in June 2022, enhancing control over operations in Asia, the Middle East, and Africa[49](index=49&type=chunk)[50](index=50&type=chunk) - Significant investment in clinical evidence includes the **20,000-patient ECLIPSE study** for the Shield blood test, demonstrating **83% sensitivity** in detecting colorectal cancer[33](index=33&type=chunk)[43](index=43&type=chunk) - The company relies on a limited number of suppliers, including a long-term agreement with **Illumina** for sequencers and consumables until **January 2033**[69](index=69&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including significant net losses, market acceptance challenges, intense competition, complex regulatory hurdles for LDTs, and cybersecurity threats - The company has a history of significant financial losses, with a **net loss of $654.6 million** in 2022 and an accumulated deficit of **$1.7 billion** as of December 31, 2022, making profitability a primary risk[165](index=165&type=chunk) - A significant portion of revenue is from a limited number of payers, with **Medicare accounting for approximately 45%** of precision oncology revenue in 2022, posing a risk from policy changes[185](index=185&type=chunk) - Regulatory changes for Laboratory Developed Tests (LDTs) like **Guardant360** and **Guardant Reveal** pose a key risk, potentially leading to more stringent and costly FDA requirements[218](index=218&type=chunk)[219](index=219&type=chunk) - Intense competition exists from liquid biopsy and traditional genomic profiling companies, including **Foundation Medicine (Roche)**, **GRAIL**, and **Exact Sciences**, some with greater resources[187](index=187&type=chunk)[188](index=188&type=chunk)[189](index=189&type=chunk) - Cybersecurity is a notable risk due to handling sensitive patient health information (PHI), where a breach could result in substantial liability and reputational harm[393](index=393&type=chunk)[394](index=394&type=chunk) [Properties](index=82&type=section&id=Item%202.%20Properties) Guardant Health's headquarters are in Palo Alto, California, with primary CAP-accredited and CLIA-certified laboratories in Redwood City and San Diego, California - The company's headquarters are in **Palo Alto, CA**, with a **12-year lease** for approximately **249,500 sq. ft.** from July 2020[400](index=400&type=chunk) - Primary laboratory operations are in **Redwood City, CA**, and **San Diego, CA**, totaling approximately **200,000 sq. ft.**[400](index=400&type=chunk) [Legal Proceedings](index=82&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in significant legal proceedings, including patent infringement lawsuits and a civil investigative demand regarding billing practices, with uncertain outcomes - The company is engaged in ongoing patent infringement litigation with **TwinStrand Biosciences** and a separate suit with **Illumina** alleging trade secret misappropriation[657](index=657&type=chunk)[658](index=658&type=chunk) - In January 2022, Guardant Health received a Civil Investigative Demand (CID) from the U.S. Attorney's Office regarding an investigation under the **False Claims Act** concerning billing for its **Guardant360** test[660](index=660&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=82&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Guardant Health's common stock trades on Nasdaq under "GH"; the company has never paid cash dividends and intends to retain all earnings for growth - The company's common stock trades on the **Nasdaq Global Select Market** under the symbol **"GH"**[403](index=403&type=chunk) - Guardant Health has never declared or paid dividends, intending to retain all future earnings for business operations and expansion[404](index=404&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=83&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In fiscal year 2022, total revenue grew **20%** to **$449.5 million**, driven by precision oncology testing, though net loss widened to **$654.6 million** due to fair value adjustments and increased operating expenses, while maintaining strong liquidity Key Financial Results (2022 vs. 2021) | Metric | 2022 (in millions) | 2021 (in millions) | Change (%) | | :--- | :--- | :--- | :--- | | **Total Revenue** | **$449.5** | **$373.7** | **+20%** | | Precision Oncology Testing Revenue | $392.0 | $304.3 | +29% | | Development Services & Other Revenue | $57.5 | $69.3 | -17% | | **Net Loss** | **($654.6)** | **($384.8)** | **+70%** | | R&D Expense | $373.8 | $263.2 | +42% | | Sales & Marketing Expense | $299.8 | $191.9 | +56% | - Precision oncology revenue growth was driven by a significant increase in clinical test volume, from approximately **87,600 tests** in 2021 to **124,800** in 2022[445](index=445&type=chunk) - The 2022 net loss included a **$99.8 million non-cash charge** for fair value adjustments related to the full acquisition of the Guardant Health AMEA joint venture[458](index=458&type=chunk)[467](index=467&type=chunk) - As of December 31, 2022, the company maintained a strong liquidity position with approximately **$1.0 billion** in cash, cash equivalents, and marketable debt securities[414](index=414&type=chunk)[463](index=463&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=102&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure on its investment portfolio, with foreign currency risk expected to increase with international expansion - The company faces interest rate risk on its investment portfolio; a hypothetical **100 basis point** change would impact available-for-sale securities by approximately **$4.2 million** as of year-end 2022[512](index=512&type=chunk) - Foreign currency risk is currently insignificant due to U.S.-centric revenue, but is expected to increase with international expansion[513](index=513&type=chunk) [Financial Statements and Supplementary Data](index=103&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents Guardant Health's audited consolidated financial statements for fiscal year 2022, including balance sheets, statements of operations, and cash flows, reflecting **$1.61 billion** in total assets and a **$654.6 million** net loss [Consolidated Balance Sheets](index=106&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2022, total assets decreased to **$1.61 billion**, total liabilities were **$1.55 billion**, and total stockholders' equity significantly decreased to **$60.2 million** due to the net loss Consolidated Balance Sheet Highlights (as of Dec 31) | Account | 2022 (in millions) | 2021 (in millions) | | :--- | :--- | :--- | | Cash, cash equivalents, & marketable securities | $1,011.2 | $1,630.8 | | Total Assets | $1,610.0 | $2,204.5 | | Convertible senior notes, net | $1,137.4 | $1,134.8 | | Total Liabilities | $1,549.8 | $1,559.5 | | Total Stockholders' Equity | $60.2 | $645.0 | [Consolidated Statements of Operations](index=108&type=section&id=Consolidated%20Statements%20of%20Operations) For 2022, total revenue increased to **$449.5 million**, but loss from operations widened to **$544.4 million**, resulting in a net loss of **$654.6 million** or **($6.41) per share**, exacerbated by fair value adjustments Consolidated Statement of Operations (Year Ended Dec 31) | Metric | 2022 (in millions) | 2021 (in millions) | 2020 (in millions) | | :--- | :--- | :--- | :--- | | Total Revenue | $449.5 | $373.7 | $286.7 | | Total Costs and Operating Expenses | $993.9 | $784.7 | $541.7 | | Loss from Operations | ($544.4) | ($411.0) | ($255.0) | | Net Loss | ($654.6) | ($384.8) | ($246.3) | | Net Loss Per Share | ($6.41) | ($4.00) | ($2.60) | [Consolidated Statements of Cash Flows](index=111&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For 2022, net cash used in operating activities increased to **$309.5 million**, while investing activities provided **$149.8 million**, and financing activities used **$189.1 million**, resulting in a **$350.3 million** net decrease in cash Consolidated Cash Flow Summary (Year Ended Dec 31) | Activity | 2022 (in millions) | 2021 (in millions) | | :--- | :--- | :--- | | Net cash used in operating activities | ($309.5) | ($209.0) | | Net cash provided by (used in) investing activities | $149.8 | ($63.2) | | Net cash used in financing activities | ($189.1) | ($66.8) | | **Net decrease in cash, cash equivalents and restricted cash** | **($350.3)** | **($340.7)** | [Controls and Procedures](index=147&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022, a conclusion affirmed by the independent auditor - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2022**[718](index=718&type=chunk) - Based on the **COSO framework**, management concluded that internal control over financial reporting was effective as of **December 31, 2022**, a conclusion audited and confirmed by the independent registered public accounting firm[719](index=719&type=chunk)[724](index=724&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=150&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the forthcoming 2023 Proxy Statement - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the forthcoming **2023 Proxy Statement**[732](index=732&type=chunk) [Executive Compensation](index=150&type=section&id=Item%2011.%20Executive%20Compensation) Information concerning executive compensation is incorporated by reference from the forthcoming 2023 Proxy Statement - Information regarding executive compensation is incorporated by reference from the forthcoming **2023 Proxy Statement**[733](index=733&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=150&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information concerning security ownership of certain beneficial owners and management is incorporated by reference from the forthcoming 2023 Proxy Statement - Information regarding security ownership is incorporated by reference from the forthcoming **2023 Proxy Statement**[734](index=734&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=150&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information concerning certain relationships, related transactions, and director independence is incorporated by reference from the forthcoming 2023 Proxy Statement - Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the forthcoming **2023 Proxy Statement**[735](index=735&type=chunk) [Principal Accounting Fees and Services](index=150&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information concerning principal accounting fees and services is incorporated by reference from the forthcoming 2023 Proxy Statement - Information regarding principal accounting fees and services is incorporated by reference from the forthcoming **2023 Proxy Statement**[736](index=736&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=150&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists exhibits filed with the 10-K, noting the omission of financial statement schedules as information is included elsewhere or not applicable - All financial statement schedules have been omitted as the required information is either not applicable or included within the consolidated financial statements or notes[738](index=738&type=chunk)

Financial Data and Key Metrics Changes - Guardant Health reported record revenue of $117 million for Q3 2022, representing a 24% increase year-over-year [12][45] - Precision oncology revenue reached $102.1 million, up 29% compared to the prior year [45] - Gross profit for Q3 2022 was $76.9 million, with a gross margin of 66%, slightly down from 67% in the prior year [52] - The net loss for Q3 2022 was $162 million, or $1.58 per share, compared to a net loss of $107.5 million, or $1.06 per share, in Q3 2021 [53] Business Line Data and Key Metrics Changes - Clinical test volume increased to over 32,400 tests, a 42% rise compared to the prior year [13][47] - Biopharma volume reached 6,750 samples, up 40% year-over-year [17][50] - Development services and other revenue totaled $15.4 million, down 1% from the prior year [51] Market Data and Key Metrics Changes - The company noted a significant increase in the number of oncologists ordering multiple Guardant products, contributing to growth despite staffing shortages and access restrictions [14][60] - The Medicare reimbursement rate for Guardant Reveal for colorectal cancer increased from approximately $3,600 to over $4,900 [16][46] Company Strategy and Development Direction - Guardant Health is focused on expanding its oncology product pipeline and enhancing its commercial infrastructure, particularly for the Shield LDT test [55][65] - The company aims to address the unmet need in colorectal cancer screening, targeting the noncompliant population with its Shield test [11][27] - Guardant Health is optimistic about the potential of its new smart liquid biopsy platform, Guardant Infinity, which is expected to drive future growth [18][23] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the operating environment, including staffing shortages and lingering access restrictions, which have impacted growth expectations [59][60] - Despite lowering revenue guidance for 2022 to a range of $440 million to $450 million, management remains confident in the core business's strength, citing a 40% year-over-year volume growth [58][63] - The company is preparing for continued growth in 2023, although it anticipates a lower growth rate compared to previous expectations [100] Other Important Information - The company has a strong cash position, ending Q3 2022 with approximately $1.1 billion in cash and equivalents, allowing it to fund operations for the foreseeable future [57] - Guardant Health is actively pursuing FDA approval for its Shield test and plans to submit its final PMA module for the ECLIPSE study in Q4 [26][65] Q&A Session Summary Question: Timeline and learnings from the Shield launch - Management confirmed that the ECLIPSE trial readout is expected in Q4, with database locking imminent [71] - Performance data from the Shield LDT is anecdotal, making it difficult to assess true sensitivity and specificity [72] Question: Staffing challenges and competition - Management noted that while growth is strong, it has not met initial expectations due to slower recovery from COVID-19 impacts [75] - The company believes it is still gaining market share in the liquid biopsy field despite competitive pressures [77] Question: Reveal reimbursement and cost management - The price increase for Reveal was due to ongoing discussions with MolDX, reflecting the test's value [81] - Management is carefully managing operating expenses to mitigate the impact of reduced revenue guidance [84] Question: Future growth expectations - Management is cautious about providing specific 2023 guidance but is comfortable with a growth rate around 20% based on current trends [100] Question: Shield test commercialization and sales force - The current sales force is about 100 people, with plans to expand as the company builds ASP and approaches FDA approval [115]

Q3 2022 Earnings Call November 3, 2022 Safe Harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially differe ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________ FORM 10-Q _____________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38683 _____________________ GUARDANT HEALTH, INC. (Exact Name of Registrant as Sp ...