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GH · Guardant Health, Inc.

99 filings

8-K

GH 8-K Current Reports

Guardant Health, Inc. - 99 current reports

Filing record · 2018–202610-K810-Q248-K99

GH filed 8 annual reports (10-K), 24 quarterly reports (10-Q) and 99 current reports (8-K) between 2018 and 2026.

  1. Leadership change8-K · Oct ’20Oct ’20
  2. Leadership change8-K · Jul ’22Jul ’22
  3. Material agreement8-K · Nov ’25Nov ’25
Showing 1-50 of 99 filings
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Jul 30, 2026)

Guardant Health (GH) reported strong second quarter 2026 results, with total revenue of $335.0 million, up 44% year over year from $232.1 million. The growth was led by Oncology revenue of $219.1 million (up 38%, on approximately 63% higher test volume) and a sharp ramp in Screening revenue to $52.9 million from $14.8 million, driven by roughly 66,000 Shield tests versus 16,000 a year earlier. Biopharma & Data grew a more modest 9% to $60.9 million. Non-GAAP gross margin improved to 67% from 66%. Profitability remains negative and spending is rising. GAAP net loss widened to $120.1 million (from $99.9 million), and non-GAAP net loss was $56.2 million, roughly flat year over year. Non-GAAP operating expenses rose to $288.3 million from $215.3 million, reflecting commercial infrastructure and marketing investment behind Shield and Oncology. Free cash flow was $(69.5) million for the quarter. The company ended June 30, 2026 with about $1.2 billion in cash, cash equivalents, and restricted cash, though it carries roughly $1.5 billion in convertible senior notes. Management raised 2026 revenue guidance to $1.34–$1.36 billion (36%–38% growth, from $1.30–$1.32 billion). The raise is driven by Screening, now expected at $218–$230 million on 270,000–285,000 Shield tests. Guidance for non-GAAP operating expenses ($1.08–$1.10 billion) and free cash flow burn ($195–$205 million) was also increased, reflecting accelerated lab capacity investment. The company held its non-GAAP gross margin guidance at 64%–65%. Investors will likely focus on whether Shield's volume ramp and new coverage can keep pace with rising spending.

Jul 30, 2026
8-K
Shareholder Matters

Guardant Health, Inc. 8-K Report, Shareholder Vote Results (Jun 18, 2026)

Guardant Health, Inc. (GH) held its Annual Meeting of Stockholders on June 17, 2026, with the results detailed in this 8-K filing. Key outcomes include the election of all director nominees and the ratification of Deloitte & Touche LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026. The company also sought advisory votes on executive compensation and the frequency of future advisory votes on executive compensation. While director elections and auditor ratification were strongly supported by shareholders, the advisory vote on executive compensation ("Say-on-Pay") did not receive majority approval. This indicates a potential disconnect between management's compensation practices and shareholder sentiment. Furthermore, shareholders voted overwhelmingly in favor of an annual advisory vote on executive compensation, suggesting a desire for more frequent engagement on this matter.

Jun 18, 2026
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (May 7, 2026)

Guardant Health reported first quarter 2026 revenue of $301.7 million, up 48% year over year from $203.5 million. Growth came mainly from Screening, where Shield revenue rose to $41.6 million from $5.7 million on about 44,000 tests versus 9,000 a year earlier. Oncology revenue grew 36% to $205.0 million on 47% higher test volume (about 86,000 tests), and Biopharma & Data grew 17% to $53.0 million. GAAP gross margin was 65% and non-GAAP gross margin was 66%, both up from the prior year. Profitability remains negative, though the non-GAAP picture is steadier. GAAP net loss widened to $112.1 million ($0.85 per share) from $95.2 million, driven by higher sales and marketing spending (up 62%) to build out Shield and oncology commercial infrastructure. Non-GAAP net loss narrowed to $58.7 million from $61.1 million, and adjusted EBITDA loss was roughly flat at $58.9 million. Free cash flow was negative $71.2 million, compared with negative $67.1 million a year earlier. Cash, cash equivalents, restricted cash and marketable securities totaled about $1.2 billion at March 31, 2026, against $1.5 billion of convertible senior notes on the balance sheet. The stockholders' deficit widened to $181.1 million from $99.3 million. Management raised 2026 revenue guidance to $1.30 to $1.32 billion (32% to 34% growth), up from $1.25 to $1.28 billion. Screening revenue guidance rose to $186 to $198 million on Shield volume of 230,000 to 245,000 tests, and oncology volume growth is now expected to exceed 35%. The company also raised its non-GAAP operating expense outlook to $1.05 to $1.07 billion, while keeping its free cash flow burn guidance at $185 to $195 million and its non-GAAP gross margin guidance at 64% to 65%. Investors will want to track whether Shield volume and reimbursement can keep scaling while operating expenses rise.

May 7, 2026
8-K
Leadership Changes

Guardant Health, Inc. 8-K Report, Executive Changes (Apr 27, 2026)

Guardant Health, Inc. (GH) announced a significant change in its executive leadership with the resignation of its Chief Medical Officer, Craig Eagle, M.D., effective May 8, 2026. This departure marks the end of Dr. Eagle's tenure in a critical role overseeing the company's medical strategy and clinical development, particularly relevant given Guardant Health's focus on cancer diagnostics and precision medicine. Investors will be keen to understand the implications of this change on the company's ongoing research, clinical trial progress, and its overall medical vision moving forward. The company has not yet announced a successor for Dr. Eagle. The absence of immediate plans for a replacement could suggest a period of transition or a strategic review of the CMO role. Investors should closely monitor future filings and communications from Guardant Health for updates on leadership appointments and any potential shifts in the company's medical and scientific direction.

Apr 27, 2026
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Feb 19, 2026)

Guardant Health (GH) reported strong fourth quarter and full year 2025 results, with total revenue of $281.3 million in Q4 (up 39% year-over-year) and $982.0 million for the full year (up 33%). Growth was led by Oncology, where test volume rose 38% in Q4 and 34% for the year, and by the rapid ramp of Shield, the company's blood-based colorectal cancer screening test, which generated $35.1 million in Q4 screening revenue from roughly 38,000 tests versus 6,400 a year earlier. Non-GAAP gross margin expanded to 66% for both the quarter and the full year, and free cash flow burn narrowed to $(233) million in 2025 from $(275) million in 2024. Net loss improved to $(416.3) million for the year from $(436.4) million, and non-GAAP net loss narrowed to $(228.1) million. Management guided 2026 total revenue to $1.25 to $1.28 billion, implying 27% to 30% growth. The outlook calls for Oncology revenue growth of 25% to 27% with approximately 30% volume growth, Biopharma & Data growth in the low double digits, and Screening revenue of $162 to $174 million on 210,000 to 225,000 tests. Non-GAAP gross margin is guided to 64% to 65%, non-GAAP operating expenses to $1.03 to $1.05 billion (up 14% to 16%), and free cash flow burn to $185 to $195 million, an improvement from 2025. The company ended 2025 with about $1.3 billion in cash, cash equivalents, restricted cash and marketable debt securities, after a November 2025 follow-on offering (net proceeds of $327.3 million) and $402.5 million of 0% convertible notes due 2033. Total convertible notes on the balance sheet rose to $1.5 billion, which is a point investors will want to track alongside the path to free cash flow breakeven. The release also highlights strategic progress: a Merck collaboration for companion diagnostics, first Guardant360 CDx companion diagnostic approval in colorectal cancer, expanded tissue-free Guardant Reveal monitoring, TRICARE coverage for Shield, early health system integrations, and the acquisition of MetaSight Diagnostics for $59.0 million upfront plus up to $90.0 million in contingent consideration. Note that the 2026 free cash flow guidance text refers to "2025" in its wording, which appears to be a typographical error for 2026.

Feb 19, 2026
8-K
Earnings & ResultsRegulation FDExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Jan 12, 2026)

Guardant Health (GH) furnished preliminary, unaudited results for Q4 and full year 2025 via an 8-K filed January 12, 2026, ahead of its J.P. Morgan Healthcare Conference presentation. Fourth-quarter revenue was approximately $280 million, up 39% year over year, driven by strong Oncology and Screening volume. Full-year 2025 revenue was approximately $981 million, up 33%, with growth accelerating through the year. Oncology tests reached roughly 276,000 for the year (up 34%), and Shield screening tests reached roughly 87,000, versus about 6,400 in Q4 2024, reflecting rapid adoption of the blood-based colorectal cancer screening test. The headline growth is offset by cash consumption. Preliminary free cash flow was approximately negative $54 million in Q4 2025 and negative $233 million for the full year, compared with negative $275 million in 2024, so cash burn improved year over year despite the revenue ramp. Cash, cash equivalents, restricted cash, and marketable debt securities totaled approximately $1.3 billion at December 31, 2025, providing a substantial liquidity cushion. Investors should treat these figures with caution. The company explicitly states that its financial statements are not yet complete, that the numbers are preliminary and unaudited, and that the independent auditors may identify items that cause final results to differ materially. Audited fourth-quarter and full-year results are expected during the February 2026 earnings call, and that release will be the reliable basis for valuation.

Jan 12, 2026
8-K
Material AgreementsFinancial EventsSecurities & Listing+2

Guardant Health, Inc. 8-K Report, Material Agreement (Nov 7, 2025)

On November 7, 2025, Guardant Health closed two concurrent capital raises that together bring in roughly $717 million in net proceeds. The first is a public offering of 3,833,332 common shares at $90.00 per share, including the full 499,999-share underwriter option. Net proceeds were about $327.2 million. The second is a private offering of $402.5 million of 0% convertible senior notes due May 15, 2033, including the full $52.5 million option. Net proceeds were about $390.0 million. The company says the proceeds will fund general corporate purposes, which may include repurchasing a portion of its 0% convertible senior notes due 2027. The convertible notes carry an initial conversion price of about $121.50 per share, a 35% premium to the $90.00 offering price. Holders can convert before February 15, 2033 only under specified conditions, including a share-price test and the company's call or certain corporate events. From February 15, 2033, conversion is unrestricted. Guardant may not call the notes before November 20, 2029, and any call requires the stock to trade above 130% of the conversion price. Settlement can be in cash, shares, or a mix, at the company's election. The indenture includes customary events of default, including a $100.0 million cross-acceleration threshold. For investors, the key trade-off is dilution and balance-sheet management. The equity raise adds about 3.8 million shares now, and the notes could add up to about 4.47 million more shares on conversion, though cash settlement would avoid that issuance. The 0% coupon keeps near-term interest cost low. The company is also using the new capital to address its 2027 notes, so the net effect on leverage depends on how much of those notes it actually repurchases. The filing does not state the company's share count or current cash position, so the dilution percentage and liquidity impact cannot be fully quantified from this document alone.

Nov 7, 2025
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Oct 29, 2025)

Guardant Health (GH) reported third quarter 2025 results for the period ended September 30, 2025, with total revenue of $265.2 million, up 39% year over year from $191.5 million. Growth was broad-based: Oncology revenue rose 31% to $184.4 million on a 40% increase in test volume, Screening (Shield) contributed $24.1 million from roughly 24,000 tests versus $1.0 million a year earlier, and Biopharma & Data grew 18% to $54.7 million, partly driven by service-agreement milestone achievements. Non-GAAP gross margin expanded to 66% from 63%, and management noted the company crossed $1 billion in annualized revenue. Profitability improved meaningfully, though the company remains loss-making. GAAP net loss narrowed to $92.7 million from $107.8 million, and non-GAAP net loss improved to $48.3 million from $55.0 million. Adjusted EBITDA loss narrowed to $45.5 million from $56.2 million, and free cash flow burn was $(45.8) million versus $(55.3) million. Cash, cash equivalents and restricted cash totaled $689.5 million at quarter end. Non-GAAP operating expenses rose to $228.9 million from $187.3 million as the company invests in commercial expansion and the Shield launch. The key forward-looking development is a raised 2025 revenue guidance of $965 to $970 million, up from $915 to $925 million and implying about 31% growth. Screening guidance was lifted to $71 to $73 million on Shield volume of 80,000 to 82,000 tests, and the non-GAAP gross margin outlook was raised to 64% to 65%. Management raised non-GAAP operating expense guidance to $865 to $875 million to support the Shield launch, while free cash flow burn guidance of $225 to $235 million was maintained and is an improvement over 2024. The filing is a press-release furnishing under Item 2.02 and is not deemed filed under Section 18 of the Exchange Act.

Oct 29, 2025
8-K
Regulation FD

Guardant Health, Inc. 8-K Report, Regulation FD Disclosure (Sep 24, 2025)

Guardant Health, Inc. (GH) announced an upcoming Investor Day scheduled for September 24, 2025. This event will provide an opportunity for investors to hear directly from co-CEOs Helmy Eltoukhy and AmirAli Talasaz, along with other members of the executive management team. The presentations are expected to focus on the company's operational performance, strategic priorities, and updated financial outlook. This Investor Day presents a crucial opportunity for stakeholders to gain deeper insights into Guardant Health's current business trajectory and future plans. Investors should pay close attention to any new strategic initiatives, market expansion updates, and revisions to financial projections that may be shared during the event, as these could significantly impact the company's valuation and stock performance.

Sep 24, 2025
8-K
Leadership ChangesExhibits & Filings

Guardant Health, Inc. 8-K Report, Executive Changes (Sep 15, 2025)

Guardant Health (GH) filed an 8-K on September 15, 2025 disclosing the appointment of Alex M. Azar II, former U.S. Secretary of Health and Human Services (2018–2021), to its Board of Directors. The Board increased its size from 10 to 11 members and named Azar a Class III director effective September 12, 2025, with a term expiring at the 2027 Annual Meeting. He was also placed on the Nominating and Corporate Governance Committee. The event is governance-focused and carries no disclosed financial impact. Azar's compensation follows the standard Amended Non-Employee Director Compensation Program: a stock option award and a restricted stock unit award, each valued at $362,500. Both vest in installments, with one-quarter vesting on the first anniversary of appointment and the remainder vesting monthly over the following three years, subject to continued service. He is also entering the Company's standard indemnification agreement. The filing reports no arrangements or related-party transactions requiring disclosure under Item 404(a). For investors, the appointment signals an effort to strengthen the Board's policy, government relations, and healthcare access expertise, which management tied to reimbursement, regulatory, and patient-access priorities. The filing itself does not quantify any operational or financial benefit, so the significance will depend on how the Company leverages his experience over time.

Sep 15, 2025
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Jul 30, 2025)

Guardant Health (GH) reported strong second quarter 2025 results, with total revenue of $232.1 million, up 31% year over year. Growth was broad-based: Oncology revenue rose 22% to $158.7 million on 30% test volume growth, Biopharma & Data revenue grew 28% to $56.0 million, and Shield screening contributed $14.8 million from roughly 16,000 tests. Non-GAAP gross margin expanded to 66% from 60%, and non-GAAP net loss narrowed to $55.0 million ($0.44 per share) from $58.5 million. Adjusted EBITDA loss improved to $51.9 million from $61.9 million, and free cash flow improved to $(65.9) million from $(99.1) million, though the year-over-year improvement was partly driven by timing of annual bonus payouts. Management raised 2025 revenue guidance to $915-$925 million (24%-25% growth), up from $880-$890 million. Screening revenue guidance rose to $55-$60 million on 68,000-73,000 Shield tests, and Oncology growth is now expected near 20%. Non-GAAP operating expenses guidance increased to $840-$850 million, reflecting reinvestment of incremental Screening gross profit into the Shield commercial build-out. Management continues to expect full-year free cash flow burn of $225-$235 million, including roughly $200 million of Screening cash burn, and expects the non-Screening business to reach free cash flow breakeven in Q4 2025. Key watch items for investors are the continued cash burn tied to Shield, the GAAP net loss of $99.9 million for the quarter, and the sustainability of Oncology reimbursement gains. Cash, cash equivalents and restricted cash totaled $735.5 million at June 30, 2025, while convertible senior notes principal had declined to $1.09 billion. Stockholders' deficit widened to $(305.5) million, and the company has not yet reached GAAP profitability.

Jul 30, 2025
8-K
Shareholder Matters

Guardant Health, Inc. 8-K Report, Shareholder Vote Results (Jun 20, 2025)

Guardant Health, Inc. (GH) held its annual meeting of stockholders on June 18, 2025. The primary outcomes reported in this 8-K filing pertain to the election of directors, ratification of the independent auditor, and advisory approval of executive compensation. All director nominees presented in the proxy statement were elected, indicating strong shareholder confidence in the current board's composition and strategy. Additionally, shareholders overwhelmingly ratified Deloitte & Touche LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, a standard but important procedural approval for financial oversight. Furthermore, a non-binding advisory vote on the compensation of the company's named executive officers received majority approval. While the overall outcomes reflect shareholder support, investors should note the breakdown of votes for director nominee Musa Tariq, which showed a higher percentage of 'votes withheld' compared to other nominees. This is a point for potential further scrutiny or understanding of specific shareholder concerns. The strong ratification of the auditor and executive compensation proposals generally signal a stable governance environment.

Jun 20, 2025
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Apr 30, 2025)

Guardant Health (GH) reported first quarter 2025 results on April 30, 2025, with total revenue of $203.5 million, up 21% year over year from $168.5 million. Growth was broad-based: oncology revenue rose 20% to $150.6 million on 25% oncology test volume growth, biopharma & data revenue grew 21% to $45.4 million, and Shield screening contributed $5.7 million from roughly 9,000 tests. Gross margin improved to 63% GAAP (65% non-GAAP) from 61% (63%), and management said Shield and Reveal both reached positive gross margins in the quarter, driven by lower testing costs. Profitability remained negative but improved on a GAAP basis. GAAP net loss narrowed to $95.2 million ($0.77 per share) from $115.0 million ($0.94 per share), aided by a $13.7 million gain on extinguishment of convertible notes and a $7.9 million other income line. Non-GAAP net loss was $61.1 million ($0.49 per share) versus $56.4 million a year earlier, and adjusted EBITDA loss improved slightly to $58.5 million from $61.1 million. Operating expenses rose to $239.8 million GAAP, driven by commercial expansion and the Shield launch. Free cash flow was negative $67.1 million, worse than the prior year's $37.2 million, mainly due to timing of annual bonus payments. Cash, cash equivalents and restricted cash totaled $803.9 million at quarter end, and convertible notes principal fell to $1.09 billion from $1.15 billion. The company raised 2025 revenue guidance to $880-890 million (19-20% growth), up from $850-860 million, with screening revenue guidance lifted to $40-45 million on 52,000-58,000 Shield tests. Non-GAAP operating expense guidance rose to $830-840 million to fund accelerated Shield commercial buildout, and full-year free cash flow burn is expected at $225-235 million, including about $200 million of screening cash burn. Management expects the non-screening business to reach free cash flow breakeven in Q4 2025. The 8-K is a routine Item 2.02 furnishing of the earnings release; the information is furnished, not filed.

Apr 30, 2025
8-K
Material AgreementsFinancial EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Material Agreement (Apr 9, 2025)

Guardant Health, Inc. has filed a Form 8-K to report on a material definitive agreement, specifically the third amendment to its existing lease for its Redwood City, California facilities. This amendment extends the lease term for various buildings within the facility to either December 31, 2030, or December 31, 2031. This extension comes with a commitment of approximately $50 million over the extended period, with base rent set to increase by 3% annually starting in 2026.

Apr 9, 2025
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Feb 20, 2025)

Guardant Health (GH) reported Q4 and full-year 2024 results on February 20, 2025, with total revenue of $739.0 million for FY2024, up 31% year over year, and Q4 revenue of $201.8 million, up 30%. Precision oncology revenue grew 34% for the year to $687.9 million, though management disclosed an approximately $22 million non-recurring, out-of-period revenue benefit from better-than-expected cash collections on prior-year claims, which flatters the growth rate. Clinical oncology volume grew 20% for the year, and biopharma test volume grew 35%. Shield, the company's blood-based colorectal cancer screening test, began contributing revenue after FDA approval, generating $5.1 million in 2024 and roughly 6,400 screening tests in Q4 alone. Profitability improved mainly because 2023 included an $83.4 million non-recurring legal accrual. GAAP net loss narrowed to $436.4 million ($3.56 per share) from $479.4 million, and non-GAAP net loss improved to $247.2 million from $352.3 million. Free cash flow burn narrowed to $274.9 million from $345.5 million. Balance sheet activity was significant: in February 2025 the company exchanged $659.3 million of its 0% 2027 convertible notes for $600.0 million of new 1.25% notes due 2031, and repurchased $45.0 million of stock at $46.09 per share. Pro forma cash and marketable securities would be about $886.8 million, against $490.7 million of remaining 2027 notes. For 2025, management guided to total revenue of $850-860 million (15-16% growth, or 19-20% excluding the 2024 non-recurring item), screening revenue of $25-30 million on 45,000-50,000 Shield tests, non-GAAP gross margin of 62-63%, non-GAAP operating expenses of $815-825 million, and free cash flow burn of $225-235 million, including about $200 million of screening cash burn. Management expects the non-screening business to reach free cash flow breakeven in Q4 2025.

Feb 20, 2025
8-K
Material AgreementsFinancial EventsSecurities & Listing+1

Guardant Health, Inc. 8-K Report, Material Agreement (Feb 14, 2025)

Guardant Health, Inc. (GH) announced a significant debt restructuring through privately negotiated exchange agreements, resulting in the issuance of $600 million aggregate principal amount of 1.25% Convertible Senior Notes due 2031 (New Notes). These New Notes were exchanged for approximately $659.3 million principal amount of its outstanding 0% Convertible Senior Notes due 2027. This transaction effectively reduced the principal amount of outstanding convertible debt by approximately $59.3 million while extending the maturity profile of a portion of its debt to 2031 and introducing a modest interest cost. Investors should note that the company has strategically extended its debt maturity and reduced its near-term debt principal. The New Notes carry a 1.25% annual interest rate and are convertible into Guardant Health common stock at an initial conversion price of approximately $62.22 per share, representing a conversion premium of about 35% to the stock price on February 6, 2025. This convertible note structure allows the company to potentially issue shares at a premium, which could mitigate dilution compared to a cash repayment, while also providing flexibility for future capital management.

Feb 14, 2025
8-K
Material AgreementsSecurities & ListingExhibits & Filings

Guardant Health, Inc. 8-K Report, Material Agreement (Feb 7, 2025)

On February 6, 2025, Guardant Health entered into privately negotiated exchange agreements with certain holders of its 0% Convertible Senior Notes due 2027. The company will issue $600 million of new 1.25% Convertible Senior Notes due 2031 in exchange for retiring about $659.3 million of the 2027 Notes, which leaves roughly $490.7 million of the 2027 Notes outstanding on unchanged terms. The transaction is expected to close on or about February 14, 2025. Alongside the exchange, Guardant plans to repurchase about $80 million of its common stock in total: about $45 million from the company directly and about $35 million through the exchange agent, both at the February 6, 2025 last reported sale price. The company is effectively extending its debt maturity from 2027 to 2031 and cutting the principal outstanding by about $59 million, while adding a new coupon of 1.25%. The main investor takeaways are the lower leverage and the cost trade-off. The company's cash interest expense rises by about $7.5 million per year on the new notes, since the retired 2027 Notes carried no coupon. In exchange, Guardant gets about four additional years before the 2027 maturity wall and a conversion price of about $62.22, which is roughly a 35% premium to the February 6, 2025 reference price (implying a reference price of about $46.09). The initial conversion rate implies about 9.6 million shares on the $600 million of new notes, rising to a maximum of about 13.0 million shares under the maximum conversion rate after anti-dilution adjustments. Those shares would be issued under the Section 3(a)(9) exemption. The new notes have investor protections that matter for valuation and risk. Holders cannot convert before November 15, 2030 except upon specified events. The company cannot call the notes before February 21, 2028, and can then redeem them only if the stock trades above 130% of the conversion price (about $80.89) for a specified period. Calling a note triggers a make-whole conversion rate increase. Events of default include cross-acceleration on at least $100 million of debt. Investors should weigh the reduced refinancing risk against the modest increase in cash interest, the dilution potential from the conversion shares, and the partly offsetting effect of the stock repurchases.

Feb 7, 2025
8-K
Earnings & ResultsRegulation FDExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Jan 13, 2025)

Guardant Health (GH) filed an 8-K on January 13, 2025 furnishing preliminary, unaudited results for Q4 and full year 2024 ahead of the J.P. Morgan Healthcare Conference. Full-year 2024 revenue was approximately $737 million, up 31% year over year, driven by clinical and biopharma test volume growth and rising Guardant360 average selling prices (ASPs). Oncology clinical tests (excluding Shield) rose about 20% to roughly 206,700, and biopharma tests rose about 35% to roughly 40,500. Q4 revenue was approximately $200 million, up 29%, and the company reported about 6,400 Shield screening tests generating roughly $4 million of revenue in the first full quarter of Shield's commercial launch. The key concern for investors is cash burn. Preliminary free cash flow was approximately negative $275 million for full-year 2024 (versus negative $345 million in 2023) and approximately negative $84 million in Q4. Cash, cash equivalents, restricted cash and marketable debt securities totaled $944 million at December 31, 2024. In Q4, the company received $34 million from the sale of part of its Lunit investment, which is recorded in investing activities, and sold no shares under its at-the-market (ATM) program with Jefferies. The figures are explicitly preliminary and subject to change during year-end close and auditor review, and the company has not yet completed its financial statements. Audited results are expected during the February 2025 earnings call. The company is also scaling commercial infrastructure for Shield, which will likely require continued investment.

Jan 13, 2025
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Nov 6, 2024)

Guardant Health reported third quarter 2024 revenue of $191.5 million, up 34% year over year from $143.0 million, driven by clinical test volume growth of 21% (excluding Shield), biopharma test volume growth of 40%, and higher Guardant360 reimbursement, including Medicare pricing of $5,000 effective January 1, 2024. Precision oncology revenue rose 35% to $180.6 million. GAAP gross margin was 61% and non-GAAP gross margin excluding screening costs was 65%. GAAP net loss widened to $107.8 million from $86.1 million, largely because of an $18.3 million increase in unrealized and realized losses on the company's Lunit investment. Non-GAAP net loss improved to $55.0 million from $79.2 million, and adjusted EBITDA loss narrowed to $56.2 million from $79.7 million. Management raised full-year 2024 revenue guidance to $720 to $725 million, representing 28% to 29% growth, from the prior range of $690 to $700 million. This is the third guidance increase of the year. Free cash flow guidance was revised to a $(265) to $(275) million outflow, an improvement of $70 to $80 million versus 2023. Non-GAAP operating expense guidance of $720 to $730 million and the 61% to 63% non-GAAP gross margin excluding screening outlook were unchanged. The quarter also marked the commercial launch of Shield IVD following FDA approval, with a Medicare price of $920 effective August 1, 2024. Cash, cash equivalents, restricted cash and marketable debt securities totaled $1.0 billion at quarter end. Investors should weigh the strong top-line momentum and improving cash burn against continued GAAP losses, high sales and marketing spend, and the volatility introduced by equity investment marks.

Nov 6, 2024
8-K
Leadership ChangesExhibits & Filings

Guardant Health, Inc. 8-K Report, Executive Changes (Oct 24, 2024)

Guardant Health (Nasdaq: GH) filed an 8-K on October 24, 2024 to report a board change rather than a financial or operational event. Effective October 21, 2024, the Board increased its size to ten directors and appointed Roberto A. Mignone as a Class I director, with a term expiring at the 2025 Annual Meeting. He was also placed on the Audit Committee. Mignone is the Founder and Managing Partner of Bridger Management LLC, a long-term equity investment firm with a healthcare focus, and he previously co-founded Blue Ridge Capital LLC. The filing contains no financial results, guidance, or disclosed transaction amounts beyond standard director compensation. Mignone receives the Company's standard non-employee director package under its Amended Non-Employee Director Compensation Program: a stock option award and an RSU award, each valued at $362,500. Both vest over roughly three years, with 25% vesting on the first anniversary of his appointment and the remainder vesting monthly thereafter. He is also entering the Company's standard indemnification agreement. The filing states there are no arrangements under which he was selected and no related-party transactions reportable under Item 404(a). For investors, the main significance is governance. Adding a healthcare-focused investor with long-term equity experience to the Audit Committee may signal shareholder engagement and oversight, and the press release links the appointment to strengthening product offerings across the care continuum following the FDA approval of Shield for early-stage colorectal cancer screening. The filing itself does not link the appointment to any specific strategic or financial outcome.

Oct 24, 2024
8-K
Material AgreementsExhibits & Filings

Guardant Health, Inc. 8-K Report, Material Agreement (Aug 23, 2024)

Guardant Health, Inc. (GH) has entered into an Open Market Sale Agreement with Jefferies LLC, establishing an at-the-market (ATM) offering program. This agreement allows the company to sell up to $400.0 million of its common stock from time to time, at its discretion, through Jefferies acting as the sales agent. The offering will be conducted under the company's existing shelf registration statement on Form S-3, filed on May 22, 2023, with a prospectus supplement filed concurrently with this report. This strategic move provides Guardant Health with flexibility to raise capital as needed to support its ongoing operations, growth initiatives, or strategic opportunities without needing to file a new registration statement immediately.

Aug 23, 2024
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Aug 7, 2024)

Guardant Health (Nasdaq: GH) reported second quarter 2024 results on August 7, 2024, with total revenue of $177.2 million, up 29% year over year from $137.2 million. Precision oncology revenue grew 33% to $166.5 million, driven by clinical test volume growth of 14% and biopharma test volume growth of 56%, plus higher Medicare reimbursement for Guardant360 LDT ($5,000, effective January 1, 2024) and improved Medicare Advantage and commercial payer rates. Development services revenue declined to $10.7 million from $11.9 million. GAAP gross margin was 59% versus 61% a year earlier, and non-GAAP gross margin was 60% versus 62%, with development services margin compressing sharply to 37% from 62%. GAAP net loss widened to $102.6 million ($0.84 per share) from $72.8 million ($0.67 per share), primarily because of a $79.5 million year-over-year increase in unrealized losses on the company's equity security investment, which offset a prior-year $23.6 million impairment and a $19.0 million improvement in operating loss. Non-GAAP net loss narrowed to $58.5 million ($0.48 per share) from $88.7 million ($0.82 per share). Adjusted EBITDA loss improved to $61.9 million from $85.2 million, and free cash flow was $(99.1) million versus $(100.5) million, with $1.0 billion in cash, cash equivalents and restricted cash at June 30, 2024. Management raised full-year 2024 revenue guidance excluding screening to $690-$700 million (22%-24% growth) from $675-$685 million, while reaffirming non-GAAP gross margin excluding screening of 61%-63%, non-GAAP operating expenses of $720-$730 million, and free cash flow of $(275)-$(285) million. The quarter also included FDA approval of Shield as a first-line colorectal cancer screening option, the commercial launch of Shield IVD, and Medicare coverage covering roughly 45 million eligible individuals.

Aug 7, 2024
8-K
Other EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Corporate Update (Jul 29, 2024)

Guardant Health (Nasdaq: GH) disclosed in an 8-K filed July 29, 2024 that the FDA approved its Shield blood test as a primary screening option for colorectal cancer (CRC) in adults aged 45 and older who are at average risk. Shield is described as the first blood-based CRC screening test approved by the FDA as a primary screening option and the first to meet performance requirements for Medicare coverage under NCD 210.3. The approval followed a strong recommendation from an FDA Advisory Committee panel in May 2024 and is supported by the 20,000+ patient ECLIPSE registrational study, which reported 83% CRC sensitivity and 90% specificity for advanced neoplasia. For investors, the key implication is a potential expansion of Guardant's addressable screening market. The company states that Shield's real-world adherence rate has exceeded 90% since its May 2022 LDT launch, compared with 28-71% for colonoscopy and stool-based tests, and that the test is expected to be covered for eligible Medicare beneficiaries. Management said it is preparing to launch the test in the near future. Commercial coverage is expected to broaden further once the American Cancer Society and the U.S. Preventive Services Task Force include Shield in their guidelines, which is anticipated but not yet done. The filing is primarily a press release disclosure under Item 8.01 (Other Events). It contains no financial results, guidance, or quantitative commercial targets. Investors should weigh the regulatory milestone against the uncertainties the filing itself flags: the timing of the commercial launch, the pace of Medicare and commercial reimbursement, the pending guideline inclusion, and the forward-looking statement risks tied to the company's 10-K for fiscal 2023.

Jul 29, 2024
8-K
Leadership ChangesExhibits & Filings

Guardant Health, Inc. 8-K Report, Executive Changes (Jul 18, 2024)

Guardant Health (Nasdaq: GH) filed an 8-K on July 18, 2024 to disclose the appointment of Dr. Manuel Hidalgo Medina to its Board of Directors. The Board increased its size from eight to nine members on July 17, 2024, and appointed Dr. Hidalgo as a Class II director with a term expiring at the 2026 Annual Meeting of Stockholders. He was also placed on the Nominating and Corporate Governance Committee. The filing is a governance event rather than a financial disclosure, and it includes no reported financial results, guidance, or material operational changes. Dr. Hidalgo is Chief of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, and he is the Walter B. Wriston Professor of Pancreatic Cancer Research. He has more than 20 years of experience in translational and clinical anticancer drug development, with a focus on gastrointestinal cancers and early clinical development for pancreatic cancer. He previously led hematology at Beth Israel Deaconess Medical Center and served as Clinical Director of the Rosenberg Clinical Cancer Center from 2015 to 2019. He also sits on the board of Bristol-Myers Squibb. For Guardant, his oncology expertise adds clinical and drug-development perspective to the board, which is relevant to a company whose tests span screening, recurrence monitoring, and treatment selection. His compensation follows the standard non-employee director program. He receives a stock option award and a restricted stock unit award, each valued at $362,500, vesting over roughly three years, with one-quarter vesting at the first anniversary and the remainder vesting monthly thereafter. The Company is also entering into its standard indemnification agreement with him. The filing reports no related-party transactions requiring disclosure under Item 404(a) of Regulation S-K, and no arrangements with other persons under which he was selected. Investors should view this as a routine board refresh with limited direct financial impact.

Jul 18, 2024
8-K
Shareholder Matters

Guardant Health, Inc. 8-K Report, Shareholder Vote Results (Jun 14, 2024)

Guardant Health, Inc. (GH) reported the results of its 2024 Annual Meeting of Stockholders held on June 12, 2024. The meeting saw the election of all director nominees, indicating strong shareholder confidence in the current board's leadership and strategic direction. Furthermore, shareholders ratified the appointment of Deloitte & Touche LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2024, which is a standard procedural approval. However, a notable outcome was the advisory vote on executive compensation; the proposal to approve the compensation of named executive officers did not pass on a non-binding basis. This suggests some shareholder concerns or dissatisfaction regarding executive pay, which the company will need to address.

Jun 14, 2024
8-K
Leadership Changes

Guardant Health, Inc. 8-K Report, Executive Changes (May 31, 2024)

Guardant Health, Inc. (GH) filed an 8-K on May 31, 2024, detailing amendments to its Executive Severance Plan. These changes, effective May 24, 2024, primarily impact the severance packages for executive employees, particularly in scenarios involving termination without cause or for good reason, and in connection with a change in control. The amendments standardize severance benefits, with increased payouts and accelerated equity vesting for Co-CEOs Helmy Eltoukhy and AmirAli Talasaz, especially during a change in control event. The revised plan provides for enhanced severance benefits, including extended salary and COBRA payments, and accelerated vesting of equity awards. Notably, these enhanced benefits are more generous for Co-CEOs, with provisions for 18 to 24 months of salary and COBRA payments, and full or significantly accelerated vesting of their equity awards under specific termination conditions and change in control scenarios. These updates reflect a strategic review and aim to align executive compensation and retention with potential future corporate events.

May 31, 2024
8-K
Other EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Corporate Update (May 24, 2024)

On May 23, 2024, Guardant Health (Nasdaq: GH) announced that the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee strongly recommended approval of its Shield blood test for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk. The panel voted 8-1 that Shield is reasonably safe, 6-3 that it is reasonably effective, and 7-2 that its benefits outweigh its risks. The recommendation is non-binding, and the FDA will weigh it alongside other factors in its ongoing premarket approval (PMA) review, with a decision expected later in 2024. The committee's support rests on the pivotal ECLIPSE study, published in the March 2024 New England Journal of Medicine, which reported 83% sensitivity for CRC and 90% specificity for advanced neoplasia. Management notes that the sensitivity is within the 67%-92% range of existing stool-based primary screening tests. The company positions Shield as a blood-draw alternative for patients who are deterred by stool-based testing, and states that the test is on track to become the first FDA-approved blood test meeting Medicare coverage performance requirements under NCD 210.3. For investors, the key takeaway is that a favorable panel vote materially de-risks the Shield approval pathway and supports the commercial thesis for the company's screening franchise. However, this is an advisory opinion rather than an approval, and the filing does not disclose the FDA's timing with certainty, the commercial or reimbursement impact, or revenue expectations. The 6-3 effectiveness vote, the narrowest of the three, is a point worth monitoring in the final FDA decision.

May 24, 2024
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (May 9, 2024)

Guardant Health (GH) reported first quarter 2024 results on May 9, 2024, with total revenue of $168.5 million, up 31% year over year from $128.7 million. Precision oncology revenue grew 38% to $156.2 million, driven by clinical test volume growth of 20% (46,900 tests), biopharma test volume growth of 37% (8,450 tests), and higher reimbursement, including an increase in the Medicare rate for Guardant360 LDT to $5,000 effective January 1, 2024. GAAP gross margin improved to 61% from 59%, and non-GAAP gross margin excluding screening reached 64%. Operating performance improved meaningfully: GAAP loss from operations narrowed to $99.7 million from $134.1 million, and free cash flow improved to $(37.2) million from $(82.0) million. Management noted the first quarter of positive cash flow in the Therapy Selection business. The company raised its full-year 2024 revenue guidance (excluding screening) to $675-$685 million, implying 20-21% growth, up from $655-$670 million. It also improved its free cash flow outlook to $(275)-$(285) million from $(320)-$(330) million and lowered its non-GAAP operating expense guidance to $720-$730 million. Management highlighted an upcoming FDA Advisory Committee review of Shield IVD on May 23, 2024, with a product launch expected shortly after anticipated FDA approval in 2024. Net loss narrowed to $115.0 million ($0.94 per share) from $133.5 million ($1.30 per share), but the GAAP comparison was pressured by a $30.1 million unrealized loss on the company's marketable equity securities (investment in Lunit), partly offset by higher interest income. Non-GAAP net loss was $56.4 million ($0.46 per share). The company held $1.1 billion in cash, cash equivalents and restricted cash at March 31, 2024, against $1.14 billion in convertible senior notes, and total stockholders' equity fell to $68.3 million from $158.7 million.

May 9, 2024
8-K
Leadership ChangesExhibits & Filings

Guardant Health, Inc. 8-K Report, Executive Changes (Mar 22, 2024)

Guardant Health, Inc. (GH) announced updates to the compensation arrangements for its Co-CEOs, Helmy Eltoukhy and AmirAli Talasaz, effective January 1, 2024. The company has entered into new letter agreements that primarily adjust the incentive compensation structure, moving away from traditional salaries and cash bonuses towards equity awards. This move signals a continued focus on aligning executive compensation with long-term company performance and shareholder value creation. Key changes include maintaining a nominal base salary of $1 per year, with future salary adjustments to be determined by the Compensation Committee. Instead of salary and annual bonuses, each Co-CEO will receive annual grants of Restricted Stock Units (RSUs) and Performance-based RSUs (PSUs) valued at $800,000. Additionally, they will receive significant long-term awards of RSUs and PSUs valued at $5,000,000 each, tied to multi-year performance metrics. The cancellation of prior PSU awards is also noted. These adjustments underscore a strong emphasis on performance-driven incentives and long-term commitment from the leadership team.

Mar 22, 2024
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Feb 22, 2024)

Guardant Health (GH) reported Q4 and full-year 2023 results on February 22, 2024, with full-year revenue of $563.9 million, up 25% year over year, driven by clinical test volume growth of 39%. Precision oncology revenue grew 31% to $514.2 million, while development services and other revenue fell 14% to $49.7 million on lower companion diagnostic milestone timing and reduced royalties. Gross margin declined to 60% from 65%, mainly due to product mix and the cost of processing Shield LDT samples for which the company is booking minimal revenue. Free cash flow improved to negative $345.5 million from negative $386.9 million, and the company ended the year with $1.2 billion in cash, cash equivalents and marketable debt securities. GAAP results were distorted by an $83.4 million non-recurring legal accrual recorded in Q4 2023, which pushed the full-year GAAP net loss to $479.4 million (or $4.28 per share), versus $654.6 million in 2022. Excluding the accrual and other non-GAAP adjustments, non-GAAP net loss was $352.3 million, or $3.15 per share, compared with $4.26 per share in 2022. Adjusted EBITDA loss narrowed to $344.2 million from $403.4 million. Management noted that the Therapy Selection business reached cash flow breakeven by year-end 2023. Looking ahead, Guardant guided 2024 revenue (excluding screening) to $655–$670 million, implying 16%–19% growth, with non-GAAP gross margin excluding screening of 60%–62%, non-GAAP operating expenses of $740–$750 million, and free cash flow of negative $320–$330 million. The company is awaiting FDA approval of its Shield blood-based colorectal cancer screening test, with an Advisory Committee Panel expected as the next step; the Shield IVD launch is planned for later in 2024 following approval. Investors should watch the FDA review outcome, the Guardant360 LDT reimbursement increase from $3,500 to $5,000 effective January 1, 2024, and whether the legal accrual represents a one-time charge.

Feb 22, 2024
8-K
Leadership Changes

Guardant Health, Inc. 8-K Report, Executive Changes (Feb 1, 2024)

Guardant Health, Inc. (GH) announced a change in its Board of Directors through an 8-K filing on February 1, 2024. Specifically, Mr. Samir Kaul has notified the Board of his intention to resign as a director and as a member of the compensation committee, effective February 1, 2024. This departure is stated to be amicable, with no disputes or disagreements cited as the reason for his resignation. Following Mr. Kaul's resignation, the size of the Board will be reduced from nine to eight directors. Investors should note that while this filing details a director's departure, it does not appear to be related to any operational or policy disagreements, suggesting a smooth transition. The reduction in board size is a minor structural adjustment and is not expected to have a significant immediate impact on the company's strategic direction or operational performance.

Feb 1, 2024
8-K
Earnings & ResultsRegulation FDExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Jan 8, 2024)

Guardant Health (GH) released preliminary, unaudited results for the fourth quarter and full year ended December 31, 2023, ahead of the J.P. Morgan Healthcare Conference. Full-year revenue is expected to be between $562 million and $563 million, up 25% year over year. Clinical test volume grew 39% to 172,900 tests, and biopharma test volume grew 15% to 29,900. Fourth-quarter revenue is expected to be between $153 million and $154 million, up 21%, with clinical tests up 29% to 46,400 and biopharma tests up 16% to 9,500. Profitability and cash burn remain the central investor concerns. Management said the therapy selection business reached breakeven, which it attributes to tailwinds during the year. Free cash flow was approximately negative $84 million in the fourth quarter and negative $347 million for the full year, compared with negative $387 million in 2022. The reconciliation shows full-year operating cash outflow of $328 million plus $19 million in capital expenditures. Cash, cash equivalents and marketable debt securities totaled $1.2 billion at year-end. The figures are not final. Guardant has not completed its year-end close, and its independent accountants may identify items that cause final results to differ materially. Audited results are due on the February 2024 earnings call. Management is focused on the anticipated launch of Shield IVD in 2024 following FDA approval, which it expects to be transformative for colorectal cancer screening.

Jan 8, 2024
8-K
Material AgreementsOther EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Material Agreement (Dec 21, 2023)

On December 20, 2023, Guardant Health (Nasdaq: GH) agreed to sell 3,387,446 shares of common stock to institutional investors in a registered direct offering at $26.77 per share, for gross proceeds of approximately $90.7 million. The sale closed on December 21, 2023, with estimated net proceeds of about $90.6 million after offering expenses. Baillie Gifford, acting as agent and representative for the participating investors, led the transaction. The shares were issued under the company's automatic shelf registration on Form S-3 (File No. 333-272121), filed May 22, 2023. The company states it will use the proceeds primarily for general corporate purposes, including working capital, operating expenses and capital expenditures. The filing does not specify a particular project or acquisition, so the capital is best viewed as balance-sheet flexibility rather than a funded strategic initiative. Investors should also note that the issuance adds roughly 3.4 million shares to the outstanding count; the filing does not disclose the total share count, so the precise dilution percentage cannot be computed from this document alone. From an investor perspective, the event is a modest, primarily financing-driven update. The transaction was priced at a premium to typical market levels only if compared against the prevailing share price, which the filing does not report, and the endorsement by a large long-term institutional holder is the most notable qualitative element. Readers should review the company's latest 10-Q or 10-K for current cash, debt, and share count to assess the offering's significance relative to the balance sheet.

Dec 21, 2023
8-K
Other EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Corporate Update (Dec 19, 2023)

Guardant Health (Nasdaq: GH) filed an 8-K on December 19, 2023 to disclose that the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval (PMA) application for its Shield blood test for colorectal cancer screening on March 28, 2024. The date is not final and remains subject to FDA confirmation and publication in the Federal Register. The company had submitted the final module of its PMA on March 10, 2023, supported by the ECLIPSE registrational study of more than 20,000 average-risk adults. For investors, the event is a meaningful regulatory milestone rather than a financial one. An advisory panel review is typically a precursor to a final FDA decision, and management stated that the proposed timing aligns with its expectation to complete the PMA process and launch Shield as an in-vitro diagnostic (IVD) in 2024. The filing contains no financial results, guidance changes, or quantitative disclosures on revenue or commercial impact. The key uncertainties are that the panel date could shift, the panel's vote and FDA's eventual decision are not guaranteed, and the filing does not address reimbursement, pricing, or expected market size for Shield. Investors should treat the announcement as a positive catalyst on the regulatory timeline while recognizing that approval outcomes and commercial adoption remain open questions.

Dec 19, 2023
8-K
Other EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Corporate Update (Nov 15, 2023)

On November 14, 2023, a federal jury in the U.S. District Court for the District of Delaware returned a verdict in favor of TwinStrand Biosciences and the University of Washington against Guardant Health in a patent infringement case. The jury found that Guardant willfully infringed U.S. Patent Nos. 10,287,631 and 10,760,127 and awarded plaintiffs $83.4 million, equal to a 6% royalty on past sales. The judgment is expected to be entered in the coming weeks, after which plaintiffs may seek to enhance damages up to three times given the willfulness finding. Guardant strongly disputes the verdict and plans to contest it through post-trial motions in the district court, including motions to overturn the verdict, seek a new trial, or amend the judgment, and then through appeal to the U.S. Court of Appeals for the Federal Circuit. The company states that it does not expect the verdict to materially affect its business. However, it cautions that if the verdict is upheld on appeal, the court may require royalty payments on future sales, which could increase future expenses. For investors, the immediate financial exposure is the $83.4 million award, with a potential enhancement of up to roughly $250 million if trebled, though the outcome remains subject to lengthy post-trial and appellate review. The filing also includes a press release in which management reiterates its confidence that Guardant did not infringe the asserted patents. The key uncertainties are the final judgment amount, the outcome of post-trial motions and appeal, and any ongoing royalty obligation on future sales.

Nov 15, 2023
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Nov 6, 2023)

Guardant Health (GH) reported third quarter 2023 results on November 6, 2023, with revenue of $143.0 million, up 22% year over year, driven by 35% growth in clinical test volume to 43,900 tests. Precision oncology revenue grew 31%, though development services and other revenue fell 37% on the timing of partnership milestones and lower royalties. The quarter also included a $3.6 million Medicare appeal payment covering 2018–2020 claims, which flatters the top line and should be viewed as non-recurring. Management raised full-year 2023 revenue guidance to $553–556 million (23%–24% growth), up from the prior range, and reiterated expectations for operating expenses below 2022 levels and free cash flow of approximately negative $350 million. Profitability improved meaningfully. GAAP net loss narrowed to $86.1 million ($0.73 per share) from $162.0 million a year earlier, helped by a $31.1 million improvement in operating loss and a $29.9 million swing in unrealized gains, which are non-operating and non-recurring in nature. Non-GAAP net loss was $79.2 million ($0.67 per share) versus $120.8 million, and Adjusted EBITDA loss narrowed to $79.7 million from $112.8 million. Gross margin compressed to 60% from 66%, primarily because development services margins fell sharply and product mix shifted, while precision oncology gross margin held near 60%. Liquidity remains substantial at $1.2 billion in cash, cash equivalents and marketable debt securities as of September 30, 2023, though quarterly free cash flow was negative $80.2 million and nine-month free cash flow was negative $262.7 million, so the company continues to consume cash. Operationally, management highlighted Medicare coverage uplifts for Guardant360 ASPs, first PEGASUS MRD de-escalation trial data at ESMO, and progress on the Shield blood-based colorectal cancer screening test. Investors should monitor whether the revenue acceleration and expense discipline can sustain the path toward reduced cash burn.

Nov 6, 2023
8-K
Leadership Changes

Guardant Health, Inc. 8-K Report, Executive Changes (Nov 3, 2023)

Guardant Health, Inc. (GH) announced the resignation of its Chief Operating Officer, Ms. Ines Dahne-Steuber, effective November 10, 2023. While she will be departing from her COO role, Ms. Dahne-Steuber will continue to be employed by the company until December 1, 2023, to ensure a smooth transition of her responsibilities. This development marks a significant change in the company's executive leadership team, and investors will be keen to understand the reasons behind the departure and the plan for succession. The company has not yet announced a replacement for the COO position. The transition period through December 1st suggests an orderly handover is being prioritized. Investors should monitor future filings and announcements for updates on the new COO appointment and any strategic implications this change may have on Guardant Health's operations and growth trajectory.

Nov 3, 2023
8-K
Regulation FD

Guardant Health, Inc. 8-K Report, Regulation FD Disclosure (Sep 7, 2023)

Guardant Health, Inc. announced its upcoming Investor Day event scheduled for September 7, 2023. This event will feature presentations from co-CEOs Helmy Eltoukhy and AmirAli Talasaz, along with other executive management members. The primary focus will be on providing updates regarding the company's operations, key strategic priorities, and its financial outlook. Investors are encouraged to attend or access the live and archived webcast of the presentation through the "Investors" section of Guardant Health's website. This disclosure is made under Regulation FD, and while it provides important forward-looking information, it is furnished and not deemed "filed" under the Securities Exchange Act of 1934, meaning it does not carry the same liability as formally filed documents.

Sep 7, 2023
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Aug 3, 2023)

Guardant Health (GH) reported second quarter 2023 results for the quarter ended June 30, 2023, showing total revenue of $137.2 million, up 26% year over year, driven by a 49% increase in clinical test volume to 43,500 tests and a 12% increase in biopharma tests to 6,700. Precision oncology revenue grew 36%, while development services and other revenue fell 30% on the timing of partnership milestones. Gross margin compressed to 61% from 66%, reflecting clinical/biopharma mix shifts, lower blended clinical pricing from growth in Reveal, TissueNext and Response volumes, and inclusion of Shield LDT sample processing costs in development services. Operating expenses were roughly flat at $202.9 million, and GAAP net loss narrowed to $72.8 million ($0.67 per share) from $229.4 million, though that comparison is flattered by a $99.8 million non-recurring charge in the prior-year period and a $64.0 million unrealized gain on the company's Lunit equity stake. Non-GAAP net loss was $88.7 million ($0.82 per share) versus $101.8 million a year earlier, and Adjusted EBITDA loss narrowed to $85.2 million from $94.3 million. Free cash flow was negative $100.5 million for the quarter, and the company ended the period with $1.2 billion in cash, cash equivalents and marketable debt securities after a public offering that raised $381 million in net proceeds. Management raised full-year 2023 revenue guidance to $545 to $550 million from $535 to $545 million, reiterated that 2023 operating expenses will be below 2022 levels, and reiterated expected full-year free cash flow of approximately negative $350 million. The quarter's results were encouraging on the top line and in clinical volume growth, but the headline net loss improvement relies heavily on non-operating items, particularly the Lunit mark-to-market gain, which may not recur. Investors will likely focus on the path to Therapy Selection cash-flow breakeven (targeted within 3-6 months), the gross margin trend as lower-priced products scale, and the regulatory and commercial timeline for Shield, including the pending FDA decision for colorectal cancer and the planned 2024 IVD launch.

Aug 3, 2023
8-K
Other EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Corporate Update (Aug 1, 2023)

On August 1, 2023, Guardant Health (GH) disclosed a Collaboration and Settlement Agreement with Illumina (ILMN) that resolves the March 2022 patent litigation Illumina brought in the U.S. District Court for the District of Delaware (Case No. 1:22-cv-00334-GBW-CJB). The parties agreed to dismiss the suit with prejudice, including all allegations related to the subject intellectual property, so the dispute is closed without a damages or royalty payment being disclosed in the filing. The agreement also extends the companies' long-standing commercial relationship. It includes a joint commitment to collaborate on sharing specimen samples for cancer research and a new long-term purchase and supply commitment, which the press release describes as a three-year agreement. The filing does not quantify the purchase commitment, so investors cannot yet gauge its revenue or cost impact. For investors, the main takeaway is reduced legal overhang and a more stable supplier relationship with Illumina, a key sequencing partner. The 8-K is limited to Items 8.01 and 9.01, and it omits financial terms such as settlement payments, royalty changes, or effects on revenue guidance. Those details would need to come from future disclosures or management commentary.

Aug 1, 2023
8-K
Shareholder Matters

Guardant Health, Inc. 8-K Report, Shareholder Vote Results (Jun 20, 2023)

Guardant Health, Inc. (GH) filed an 8-K on June 20, 2023, detailing the outcomes of its Annual Meeting of Stockholders held on June 14, 2023. The report indicates that all director nominees were elected and the company's independent registered public accounting firm, Deloitte & Touche LLP, was ratified for the fiscal year ending December 31, 2023. Additionally, a proposal to approve, on an advisory basis, the compensation of the company's named executive officers received stockholder approval. These outcomes suggest continued investor confidence in the company's leadership and its chosen auditor. The strong approval for the ratification of the independent auditor and the advisory vote on executive compensation are positive signs for corporate governance. Investors will likely view the re-election of directors as a vote of confidence in the current board's strategy and oversight.

Jun 20, 2023
8-K
Other EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Corporate Update (May 25, 2023)

Guardant Health, Inc. (GH) announced the closing of a successful secondary offering of its common stock on May 25, 2023, raising approximately $380.5 million in net proceeds. The offering included the sale of 14,375,000 shares at a public price of $28.00 per share, with the underwriters exercising their option to purchase additional shares in full. This capital infusion provides the company with significant financial flexibility to support its ongoing operations, research and development, and growth initiatives in the precision oncology market.

May 25, 2023
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (May 9, 2023)

Guardant Health reported first quarter 2023 results (quarter ended March 31, 2023) that showed strong top-line momentum but continued heavy losses. Revenue rose 34% year over year to $128.7 million, driven by a 45% increase in clinical test volume to 39,100 tests and a 21% increase in biopharma test volume to 6,150 tests. Management raised full-year 2023 revenue guidance to $535–$545 million (from $525–$540 million), implying 19%–21% growth, and reiterated expectations for lower 2023 operating expenses versus 2022 and free cash outflow of about $350 million. Profitability remained a concern. Gross margin fell to 59% from 67% a year earlier, reflecting product mix, lower blended clinical average selling prices as Reveal, TissueNext and Response volumes grew, and a one-time partnership cost. GAAP operating expenses rose 12% to $209.7 million, and the GAAP net loss widened to $133.5 million ($1.30 per share) from $123.2 million. Adjusted EBITDA loss was $101.0 million, and free cash outflow was $82.0 million, up from $51.3 million a year earlier. Cash, cash equivalents and marketable debt securities totaled $937.0 million at quarter end, a sizable liquidity cushion against $1.14 billion of convertible senior notes. The most important non-financial catalyst is the Shield blood-based colorectal cancer screening test. Guardant has submitted a premarket approval (PMA) application to the FDA, and review is underway. Management cited 83% overall CRC sensitivity at 90% specificity in its pivotal study. Investors should weigh the revenue acceleration and the Shield regulatory outcome against the company's ongoing losses and cash burn.

May 9, 2023
8-K
Regulation FDExhibits & Filings

Guardant Health, Inc. 8-K Report, Regulation FD Disclosure (May 9, 2023)

Guardant Health (GH) filed an 8-K under Regulation FD on May 9, 2023 to furnish a press release presenting additional data from the ECLIPSE registrational study of its Shield blood-based colorectal cancer (CRC) screening test at the 2023 Digestive Disease Week. The study enrolled over 20,000 average-risk adults and reported 83% overall sensitivity for CRC and 90% specificity. Sensitivity was 81% for Stages I-III and 72% for localized disease (Stages I-II), with stage-specific sensitivity of 55% for Stage I, and 100% for Stages II, III and IV. The company states these figures fall within the 74-92% overall sensitivity range of other guideline-recommended non-invasive screening modalities, and compares favorably to FIT (73% for Stage I-III, 70% for localized disease). The data elaborates on top-line results announced in December 2022 and is not expected by the filing itself to be a new financial disclosure. The filing is primarily a clinical and commercial communication rather than a financial one. It includes no revenue, earnings, guidance, or balance sheet figures. Management highlighted the Shield test's reported real-world adherence rate of greater than 90% since its May 2022 laboratory-developed test (LDT) launch, which the company argues could help it detect more cancers at a curable stage. The company positions Shield as a longitudinal screening test taken every three years, and its co-CEO characterized it as a new patient-preferred category in CRC screening. Investors should weigh that the Shield test is offered as an LDT and is intended to complement, not replace, existing screening methods, and that a negative result does not rule out cancer. The data's reception by regulators, payers, and guideline bodies, and the test's adoption and commercial traction, will be central to the investment case. The filing contains forward-looking statements subject to risks described in the company's 2022 Form 10-K.

May 9, 2023
8-K
Leadership ChangesExhibits & Filings

Guardant Health, Inc. 8-K Report, Executive Changes (May 8, 2023)

Guardant Health (GH) filed an 8-K on May 8, 2023 to disclose a leadership expansion centered on operations and technology. The company appointed Ines Dahne-Steuber as Chief Operations Officer, effective May 3, 2023, and promoted Darya Chudova to Chief Technology Officer, a newly created role. Dahne-Steuber brings more than 20 years of healthcare operations experience, most recently as senior vice president of operational excellence and president of Spectra Laboratories at Fresenius Medical Care. The filing is an executive-compensation and leadership update rather than a financial disclosure, so it contains no revenue, earnings, or guidance information. Under her offer letter, Dahne-Steuber receives a $490,000 base salary and a 50% target bonus. The company will recommend equity grants of roughly $2 million in RSUs (vesting ratably over four years) and roughly $2 million in stock options (25% after one year, then monthly over the remaining three years). She also receives a $50,000 signing bonus and a relocation allowance of up to $50,000, both subject to prorated clawback if she leaves within 12 months. Total targeted annual cash and equity value is modest relative to a company of Guardant's scale, so the hire is unlikely to be financially material on its own. The strategic signal is the more important takeaway. Management stated that combining research and development across oncology and screening under a single CTO, with a unified platform, is intended to scale more efficiently as global operations grow. Chudova's promotion also gives a clear internal owner for development of the Shield blood-based colorectal cancer screening test, which the press release notes is under FDA review. Investors may watch whether these organizational changes support execution on product launches and the operating leverage management is targeting.

May 8, 2023
8-K
Financial EventsExhibits & Filings

Guardant Health, Inc. 8-K Report, Auditor Change (Apr 10, 2023)

Guardant Health, Inc. has announced a change in its independent registered public accounting firm. Effective immediately as of April 4, 2023, the company has dismissed Ernst & Young LLP and engaged Deloitte & Touche LLP as its auditor for the fiscal year ending December 31, 2023. This change appears to be a routine transition, as the filing indicates no disagreements or reportable events with Ernst & Young during their tenure. The company has confirmed this with Ernst & Young, whose letter of agreement is filed as an exhibit. Investors should note this change in auditors is not accompanied by any adverse findings or specific concerns raised by the outgoing auditor, suggesting a standard rotation or strategic decision by Guardant Health's Audit Committee.

Apr 10, 2023
8-K
Regulation FD

Guardant Health, Inc. 8-K Report, Regulation FD Disclosure (Mar 13, 2023)

Guardant Health, Inc. (GH) has filed a Form 8-K to address potential investor concerns following the Federal Deposit Insurance Corporation's (FDIC) takeover of Silicon Valley Bank (SVB). The company explicitly states that it does not hold any deposits or investments with SVB, thereby mitigating direct financial exposure to the recent banking turmoil. This disclosure aims to provide clarity and reassurance to stakeholders regarding the company's financial stability in light of broader market events.

Mar 13, 2023
8-K
Leadership ChangesExhibits & Filings

Guardant Health, Inc. 8-K Report, Executive Changes (Feb 27, 2023)

Guardant Health's February 27, 2023 Form 8-K is a routine governance filing. On February 21, 2023, the Board increased its size from eight to nine directors and appointed Musa Tariq as a Class I director, effective March 6, 2023, with a term expiring at the 2025 Annual Meeting. Tariq was also placed on the Nominating and Corporate Governance Committee. He currently serves as Chief Marketing Officer of GoFundMe and previously held senior marketing roles at Airbnb, Ford, Apple, Nike and Burberry. Compensation for Tariq follows the Company's standard non-employee director program. He receives a stock option award and a restricted stock unit award, each valued at $362,500, vesting over roughly three years: one-fourth at the first anniversary of his appointment, with the remainder vesting monthly thereafter. The Company is also entering its standard indemnification agreement with him. The filing states there are no related-party transactions requiring disclosure under Item 404(a) and no arrangements under which he was selected as a director. For investors, this filing has limited financial significance. It does not disclose any change in operations, financial results, guidance, or capital structure. The appointment is mainly relevant as a signal of board refresh and brand-building focus, consistent with the press release's emphasis on consumer marketing expertise. The equity grants are modest and in line with standard director pay, and the filing contains no evidence of a governance concern.

Feb 27, 2023
8-K
Earnings & ResultsExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Feb 23, 2023)

Guardant Health (GH) reported Q4 and full-year 2022 results on February 23, 2023, with revenue growing 17% year over year to $126.9 million for the quarter and 20% to $449.5 million for the full year. Clinical test volumes rose 41% in Q4 and 42% for the year, while biopharma volumes grew 24% and 40%, respectively, showing strong demand for the core precision oncology platform. Gross margin compressed to 63% in Q4 from 69% a year earlier, and full-year gross margin fell to 65% from 67%. Profitability remains the central concern. Q4 GAAP net loss widened to $139.9 million from $90.9 million, and full-year GAAP net loss reached $654.6 million, or $6.41 per share, versus $405.7 million in 2021. Operating expenses rose 27% for the year to $837.6 million, and adjusted EBITDA loss was $403.4 million. The full-year net loss also includes a $99.8 million non-cash fair value adjustment on the noncontrolling interest liability. Cash, cash equivalents and marketable debt securities totaled $1.0 billion at year-end, down from roughly $1.6 billion a year earlier, and management guided to approximately $350 million of free cash outflow in 2023. For 2023, management guided revenue to $525–540 million (17–20% growth) and expects operating expenses to fall below 2022 levels. Key catalysts include the planned Q1 2023 FDA submission for the Shield colorectal cancer screening test, following 83% sensitivity and 90% specificity in the pivotal ECLIPSE study, and the FDA approval of Guardant360 CDx as a companion diagnostic for ORSERDU in ESR1-mutated breast cancer. Investors will be watching whether revenue growth accelerates while cash burn and operating expense discipline improve.

Feb 23, 2023
8-K
Earnings & ResultsRegulation FDExhibits & Filings

Guardant Health, Inc. 8-K Report, Financial Results (Jan 9, 2023)

Guardant Health (Nasdaq: GH) filed this Form 8-K on January 9, 2023 to furnish preliminary, unaudited results for the fourth quarter and full year ended December 31, 2022, via Exhibit 99.1, and to note a presentation for the 2023 J.P. Morgan Healthcare Conference. The headline is strong volume growth: full-year clinical tests rose 42% to 124,800 and biopharma tests rose 40% to 26,000. Full-year revenue is preliminarily estimated at $447 million to $450 million, up about 20%, while fourth-quarter revenue of $124 million to $127 million implies 15% to 17% growth. Cash, cash equivalents and marketable debt securities totaled roughly $1.0 billion at year-end. Investors should treat these figures as provisional. The company states that its financial statements are not yet complete, that its auditors may identify items that materially change the results, and that final numbers may differ from these ranges. Full audited results are scheduled for the February 2023 earnings call. The filing does not give 2023 guidance, although management says it expects "continued strong double-digit revenue growth" in 2023. Management also highlighted the positive ECLIPSE trial readout for the Shield blood test in the fourth quarter and plans to extend Shield to other cancers, including lung cancer. The Shield pipeline and the ability to convert volume growth into revenue growth are the key items to watch in the coming quarters.

Jan 9, 2023
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