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美國
證券交易委員會
華盛頓特區20549
_____________________
表格 10-Q
_____________________
(標記一)
根據1934年證券交易法第13或15(d)條,季度報告
截至季度結束日期的財務報告2024年9月30日
或者
根據1934年證券交易法第13或15(d)條的過渡報告。
在過渡期從                        到                        
委託文件編號:001-39866001-38683
_____________________
GUARDANT HEALTH,INC。
(依據其憲章指定的註冊名稱)
_____________________
特拉華州
45-4139254
(國家或其他管轄區的
公司成立或組織)
(IRS僱主
唯一識別號碼)
漢諾威街3100號
Palo Alto, CA 94306, 加利福尼亞州, 94304
公司電話號碼,包括區號:(855) 698-8887
_______________

證券 根據該法案第12(b)條款註冊:
每一類的名稱
交易標誌
在其上註冊的交易所的名稱
普通股,每股面值0.00001美元
GH
納斯達克全球精選市場

用勾號指明註冊人 (1) 是否在過去 12 個月內(或在要求註冊人提交此類報告的較短時間內)提交了 1934 年《證券交易法》第 13 條或第 15 (d) 條要求提交的所有報告,以及 (2) 在過去的 90 天內是否受到此類申報要求的約束。是的  沒有
請勾選以下內容。申報人是否已在過去12個月內(或申報人需要提交此類文件的時間較短的期間內)逐個以電子方式提交了根據規則405提交的互動數據文件。這章的交易中規定。    Yes      否  
請勾選標記以說明註冊人是大型快速申報人、加速申報人、非加速申報人、較小的報告公司還是新興成長型公司。請查看《交易所法》第120億.2條中「大型快速申報人」、「加速申報人」、「較小的報告公司」和「新興成長型公司」的定義。
大型加速存取器加速文件申報人
非加速文件提交人
 
更小的報告公司
新興成長公司
如果是新興成長型企業,請勾選此項,表示註冊者已選擇不使用根據《交易所法》第13(a)條提供的任何新的或修訂後的財務會計準則的延長過渡期進行遵守。
請勾選以下內容。申報人是否是外殼公司(根據證券交易法規則12b-2定義)。    是      否  

截至2024年11月1日,註冊人持有 123,554,612股流通在外。



GUARDANT HEALTH,INC。
10-Q表格
目錄

前瞻性聲明
這份10-Q表格的季度報告中包含了標題爲“管理層的財務狀況和經營業績的討論和分析”一節,其中包含關於未來事件和我們未來結果的前瞻性聲明,這些聲明基於我們當前的預期、估計、預測和投影,以及我們管理層的當前信念和假設,其中包括關於我們的業務、財務狀況、經營結果、現金流以及我們經營的行業和環境。包括「相信」、「可能」、「將」、「估計」、「繼續」、「預期」、「將會」、「可能會」、「應該」、「打算」和「期望」等詞彙的聲明,以及這些詞的變體和類似表達,旨在識別前瞻性聲明。這些前瞻性聲明僅適用於本10-Q表格的季度報告日期,並且受難以預測的風險、不確定性和假設影響。因此,實際結果可能與任何前瞻性聲明中表達的結果大不相同且具有負面影響。可能導致或有助於這種差異的因素包括但不限於在我們年度報告的第I部分、項目1A“風險因素”以及我們本年度以12月31日結束的公司年度報告的第II部分、項目1A,“風險因素”以及本10-Q表格的季度報告中的其他地方,以及我們向美國證券交易委員會(SEC)提交的其他報告中討論的內容。儘管前瞻性聲明是基於我們管理層在其發佈時的合理預期,但您不應依賴於它們。我們無須因任何原因(包括基於新信息、未來事件或其他原因),無法公開修訂或更新任何前瞻性聲明,除非法律要求。
本條款中使用的「公司」、「我們」、「我們的」、「我們」等類似術語,除非另有說明,否則均指得克薩斯洲一家名爲Guardant Health, Inc.的公司及其合併子公司。
2

目錄
第一部分——財務信息
未經審計的簡明合併財務報表
Guardant Health,Inc。
壓縮的綜合資產負債表(未經審計)
(以千爲單位,除股份數和每股數據外)
2024年9月30日2023年12月31日
資產
流動資產:
現金、現金等價物和受限制的現金
$688,368 $1,133,537 
短期市場債務證券
310,701 35,097 
2,687,823 
88,465 88,783 
114,467
72,298 61,948 
預付費及其他流動資產,淨額
66,883 27,741 
總流動資產
1,226,715 1,347,106 
資產和設備,淨值
125,169 145,096 
使用權資產,淨額
144,964 157,616 
無形資產, 淨額
7,251 8,979 
商譽
3,290 3,290 
其他資產淨額
31,338 124,334 
總資產
$1,538,727 $1,786,421 
負債和股東權益
流動負債:
應付賬款$15,473 $51,741 
應計的薪資
80,647 72,736 
應計費用
71,671 63,475 
遞延收入
29,554 17,965 
流動負債合計
197,345 205,917 
可轉換的優先票據,淨額1,141,901 1,139,966 
長期經營租賃負債
170,131 185,848 
其他長期負債
89,446 96,006 
總負債
1,598,823 1,627,737 
承諾和不確定事項(注8)

股東權益:
優先股票,每股面值$0.000025-0.0000110,000,000  截至2024年9月30日和2023年12月31日,已發行和流通的股份
  
 -每股--股份數已於2023年7月31日和2024年4月30日授權;0.00001350,000,000 2024年9月30日和2023年12月31日授權股份爲 123,158,418121,629,861 截至2024年9月30日和2023年12月31日分別發行並流通的股份
1 1 
額外實收資本
2,410,416 2,304,220 
累計其他綜合損失
(3,284)(3,675)
累積赤字
(2,467,229)(2,141,862)
股東權益(赤字)總額
(60,096)158,684 
負債合計及股東權益(虧損)
$1,538,727 $1,786,421 
相關附註是這些基本報表的一個不可或缺的部分。
3

目錄
護衛健康有限公司。
縮表合併損益表(未經審計)
(以千美元為單位,除每股數據外)
結束於三個月的期間
九月三十日,
九個月結束了
九月三十日,
2024202320242023
營業收入:
精準腫瘤學測試
$180,604 $133,423 $503,351 $372,060 
開發服務及其他10,872 9,607 33,851 36,834 
營業總收入
191,476 143,030 537,202 408,894 
成本與營業費用:
精準腫瘤檢測成本66,095 53,648 191,116 148,111 
開發服務及其他成本8,394 3,966 21,090 16,424 
研究和開發費用87,306 93,851 254,210 277,338 
銷售和市場營銷費用97,880 68,934 260,172 216,100 
一般及行政費用49,129 36,174 128,243 118,135 
總成本和營業費用
308,804 256,573 854,831 776,108 
營運虧損
(117,328)(113,543)(317,629)(367,214)
利息收入13,257 11,690 42,038 21,477 
利息費用(646)(644)(1,936)(1,933)
其他收入(費用),淨額(3,007)16,885 (47,272)56,490 
所得稅賦前虧損
(107,724)(85,612)(324,799)(291,180)
所得税费用
30 490 568 1,226 
淨損失
$(107,754)$(86,102)$(325,367)$(292,406)
基本和稀釋每股淨損失
$(0.88)$(0.73)$(2.66)$(2.66)
在計算基本和稀釋每股淨損失時使用的加權平均股份
123,051 117,736 122,406 109,791 
相關附註是這些基本報表的一個不可或缺的部分。

4

目錄
護衛健康有限公司。
合併綜合損益表(未經審核)
(以千為單位)
三個月結束
九月三十日
截止九個月
九月三十日
2024202320242023
淨虧損
$(107,754)$(86,102)$(325,367)$(292,406)
其他綜合收益:
可供出售證券未實現收益
456 3,315 466 15,783 
外幣轉換調整1,900 (526)(75)(1,941)
其他綜合收益 2,356 2,789 391 13,842 
全面損失
$(105,398)$(83,313)$(324,976)$(278,564)
相關附註是這些基本報表的一個不可或缺的部分。
5


Guardant Health, Inc.

股東(赤字)權益總表(未經審核)
(以千為單位,股份數據除外)
2024年9月30日結束的三個月
普通股票 額外的已實收入股本
實收
資本
其他累積
綜合虧損
留存
赤字累計
股東總持股數
赤字累計
股份金額
截至2024年7月1日的結餘
122,969,580 $1 $2,363,501 $(5,640)$(2,359,475)$(1,613)
行使股票期權獲發的普通股份4,143 — 20 — — 20 
限制性股票單位獎勵到期發放184,695 — — — — — 
與購回受限制股票單位的凈股結算相關的稅款— — (2,874)— — (2,874)
股份報酬— — 49,769 — — 49,769 
其他綜合收益— — — 2,356 — 2,356 
淨損失— — — — (107,754)(107,754)
2024年9月30日的結餘
123,158,418 $1 $2,410,416 $(3,284)$(2,467,229)$(60,096)

2023年9月30日結束的三個月
普通股額外的已實收入股本
實收
資本
其他累積
綜合損益
留存
赤字累計
股東總持股數
股本
股份金額
於2023年7月1日的結餘
117,662,134 $1 $2,169,911 $(8,469)$(1,868,717)$292,726 
行使股票期權獲發的普通股份8,989 — 70 — — 70 
限制性股票單位獎勵到期發放178,032 — — — — — 
與購回受限制股票單位的凈股結算相關的稅款— — (3,003)— — (3,003)
股份報酬— — 21,819 — — 21,819 
其他綜合收益— — — 2,789 — 2,789 
淨損失— — — — (86,102)(86,102)
2023年9月30日的餘額
117,849,155 $1 $2,188,797 $(5,680)$(1,954,819)$228,299 

6



截至二零二四年九月三十日止九個月
普通股額外
已付款
資本
累積其他
全面損失
 
累積
赤字
股東權益總額(赤字)
股票金額
截至二零二四年一月一日止的餘額
121,629,861 $1 $2,304,220 $(3,675)$(2,141,862)$158,684 
行使股票期權時發行普通股581,495 — 2,597 — — 2,597 
獲得限制股票單位575,236 — — — — — 
根據員工股票購買計劃發行的普通股371,826 — 7,212 — — 7,212 
與限制股份單位淨股結算有關已繳納的稅款— — (7,658)— — (7,658)
基於股票的補償— — 104,045 — — 104,045 
其他綜合收益— — — 391 — 391 
淨虧損— — — — (325,367)(325,367)
截至二零二四年九月三十日止餘額
123,158,418 $1 $2,410,416 $(3,284)$(2,467,229)$(60,096)

2023年9月30日結束的九個月
普通股票 額外的已實收入股本
實收
資本
其他累積
綜合損益
 
留存
赤字累計
股東權益總計
股份金額
2023年1月1日結餘
102,619,383 $1 $1,742,114 $(19,522)$(1,662,413)$60,180 
公開發行普通股,扣除發行成本後的淨額為$21,131
14,375,000 — 381,369 — — 381,369 
行使股票期權獲發的普通股份40,868 — 290 — — 290 
限制性股票單位獎勵到期發放515,123 — — — — — 
員工股票購買計劃下發行的普通股298,781 — 6,697 — — 6,697 
與購回受限制股票單位的凈股結算相關的稅款— — (8,112)— — (8,112)
股份報酬— — 66,439 — — 66,439 
其他綜合收益— — — 13,842 — 13,842 
淨損失— — — — (292,406)(292,406)
2023年9月30日的餘額
117,849,155 $1 $2,188,797 $(5,680)$(1,954,819)$228,299 
相關附註是這些基本報表的一個不可或缺的部分。
7

目錄
護衛健康有限公司。
未經審計的現金流量總表
(以千為單位)
截至9月30日的九個月
20242023
營運活動:
淨虧損
$(325,367)$(292,406)
調整為使淨虧損轉化為經營活動所使用現金:
折舊與攤提31,933 32,013 
經營租賃成本
23,357 22,146 
股份報酬104,045 66,439 
債務發行成本攤銷1,935 1,931 
市場債務證券折扣攤銷(2,815)(10,913)
有形和無形的股票市場證券的未實現和實現損失(收益)47,225 (84,513)
非流通股權證券和其他相關資產之減損 29,054 
其他2,372 334 
營運資產及負債變動之現金影響:
應收帳款淨額316 8,360 
存貨,淨額(10,349)(25,435)
預付費用及其他流動資產淨額(9,192)(2,558)
其他資產,淨額(1,561)2,280 
應付款及應計費用(19,813)26,577 
營業租賃負債(27,029)(22,724)
逐步認列的收入9,598 3,168 
經營活動所使用之淨現金流量(175,345)(246,247)
投資活動:
可銷售債務證券的購買(307,323)(629,902)
可市場負債證券到期日35,000 828,700 
可轉讓股票的銷售量19,195  
購買非可轉讓股票和其他相關資產(2,500)(5,593)
購買固定資產和設備 (16,210)(16,409)
投資活動提供的淨現金流量(使用)(271,838)176,796 
籌資活動:
行使期權後發行普通股的收益 2,597 290 
根據員工股票購買計畫發行普通股的收益7,212 6,697 
與購回受限制股票單位的凈股結算相關的稅款(7,658)(8,112)
跟隨後續公開發行取得的收入 402,500 
支付與後續公開發行相關的發售成本  (20,478)
其他(212)5,910 
籌資活動提供的淨現金1,939 386,807 
匯率變動對現金、現金等價物和受限制現金的淨影響
(75)(1,941)
現金、現金等价物和受限制的現金的净(减少)增加
(445,319)315,415 
現金、現金等價物和受限制現金-期初
1,133,687 141,948 
現金、現金等價物和限制性現金—期末
$688,368 $457,363 
現金、現金等價物和限制性現金的調節:
現金及現金等價物
$585,022 $457,339 
限制性現金 - 包含在現金、現金等價物和限制性現金中103,346 24 
現金、現金等價物和限制性現金的總額$688,368 $457,363 
相關附註是這些基本報表的一個不可或缺的部分。
8

目錄
 護衛健康有限公司。
基本報表未經審核簡明合併財務報表註腳
1.    業務描述
Guardant Health, Inc.,或本公司,是一家領先的精準腫瘤學公司,專注於保護健康,讓每個人多一些免於癌症的時間。該公司通過其尖端的血液和組織檢測以及實際數據為患者護理進行轉型,提供對疾病發展的關鍵洞察。該公司的檢測有助於改善各個護理階段的結果,包括早期篩查尋找癌症,監測早期癌症復發,幫助醫生為晚期癌症患者選擇最佳治療。對於晚期癌症患者,該公司已商業推出Guardant360 LDt和Guardant360 CDx,這是美國食品藥品監督管理局批准的第一款全面液態生物檢驗檢測,用作固體腫瘤的腫瘤突變分析並與非小細胞肺癌(NSCLC)和乳腺癌相關聯的伴隨診斷治療。該公司還推出了Guardant360 TissueNext組織檢測,用於晚期癌症,Guardant Reveal血液檢測以檢測早期結腸、乳腺和肺癌患者的殘留和復發疾病,以及Guardant360 Response血液檢測,可預測患者對免疫療法或靶向治療的反應比當前標準護理成像提前八周。
公司也與生物製藥公司合作進行臨床研究,提供上述測試,以及用於愛文思控股癌症的晚期血液測試GuardantOMNI,以及GuardantINFINITY血液測試,這是一種新一代智能液體活檢,提供關於腫瘤分子檔案和免疫反應的新多維見解,以推進抗癌醫藥研究和治療發展。公司還利用從其測試中收集的數據,開發了GuardantINFORm平臺,幫助生物製藥公司通過這種基於醫學計算的研究平臺加速精準腫瘤學藥物開發,以揭示更多有關腫瘤演變和對抗癌醫藥產生抵抗的更深入見解,跨各類生物驅動的癌症。
為了早期癌症檢測,在2022年5月,該公司推出了Shield LDt測試,以滿足符合結腸直腸癌篩查資格的個人需求。Shield利用一種新穎的多模態方法從簡單的抽血中檢測血液中的結腸直腸癌信號,包括腫瘤散落的DNA。2022年12月,該公司宣布ECLIPSE研究,一項評估其Shield血液檢測用於檢測平均風險成年人結腸直腸癌性能的登記研究,達到共同主要終點。此外,2023年3月,該公司向FDA提交了其Shield血液檢測的預市批准申請(PMA)。2024年7月,該公司獲得FDA批准將其Shield血液檢測用於年齡在45歲及以上且處於平均風險結腸直腸癌篩查的成年人,並於2024年8月,該公司的Shield血液檢測開始在美國商業上市,成為FDA批准用於主要結腸直腸癌篩查的第一個血液檢測,這意味著醫療保健提供者可以像所有其他推薦的非侵入性篩查指南方法一樣提供Shield。Shield也是符合醫療保險Medicare覆蓋要求的結腸直腸癌篩查的第一個血液檢測。
該公司於2011年12月在德拉瓦州成立,總部設於加利福尼亞州帕洛阿爾托。
2.    重要會計政策摘要
報表呈示和合併的基礎
本公司的簡明綜合財務報表已按照美國通用會計準則(GAAP)和美國證券交易委員會(SEC)的規則和條例編製。附帶的簡明綜合財務報表包括健戈公司(Guardant Health, Inc.)及其全資子公司的賬目。所有母公司間的餘額和交易在合併中已被消除。本公司調整了截至2023年12月31日的附帶簡明綜合資產負債表,以分別列示應付賬款和應計費用,包括應計薪酬。此外,對先前期數額的某些其他重分類已經進行,以符合當前期數顯示。經考量量化和質性因素,本公司確定該調整不重要。
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目錄
估計的使用
根據GAAP的要求,製作符合標準的簡明綜合基本報表需要管理層進行某些估計、判斷和假設,這些影響了在簡明綜合基本報表日期時報告的資產和負債金額以及相關披露,以及在呈現期間報告的收入和費用。公司基於歷史經驗和其他市場特定或其他相關的假設來制定估計,並認為這些在當時情況下是合理的。估計數字在多個領域使用,其中包括但不僅限於,變量考量的估計、信用損失的估計、包含多個履行義務的合約中獨立銷售價格分攤、商譽和可識別無形資產、股份報酬、運營租賃的遞增借款利率、未來約定的某些輸入、相關準備的所得稅提供、非流通證券的估值等。這些估計通常涉及複雜的問題,需要判斷,涉及對歷史結果的分析和對未來趨勢的預測,可能需要較長時間才能解決,而且可能因期間而變化。實際結果可能與管理層的估計有實質出入。
未經審核的中期簡明基本報表
隨附之未經審計的簡明合並基本報表,已按照GAAP的暫行財務資訊標準以及根據修訂後的1933年證券法的Form 10-Q和Regulation S-X的第10-01條的規定編製,即《證券法》。 因此,這些基本未經審計的簡明合並基本報表不能包括GAAP所要求的所有完整財務基本報表的信息和附註。 這些未經審計的簡明合並基本報表包括公司認為必要的僅由正常週轉應計項目組成的所有調整,以便根據GAAP公平陳述公司的財務狀況和公司營運以及現金流量的結果。 暫時期間的結果並不一定代表全年或任何後續暫時期間的營運或現金流量結果。
應該閱讀附帶的摘要合併財務報表,並參閱公司截至2023年12月31日年度10-k表格中包含的已審計財務報表及附註。
受限現金
截至2024年9月30日,該公司擁有一筆$的限制性現金結餘。103.3其中一大部分包含在公司的簡明綜合賬表中的現金、現金等價物和限制性現金中,幾乎全部與所描寫的註8 承諾和事件 - 本公司簡明綜合基本報表中關於知識產權爭議的保證債券要求相關的現金。這涉及高盛集團及華盛頓大學之間的知譡產權爭議所需作為抵押品的現金。
非流通證券
公司收購某些私人公司的股權投資,以促進業務和戰略目標。公司對於不具市場流通性的股權證券的投資並不能賦予公司對投資者控制或具有重大影響力的能力。其中一位投資者被認定為變量興盛體,或者簽署協議,但是公司被認為不是主要受益人,因為公司不具有指導對影響該變量興盛體經濟表現最具重大影響的活動的權力。截至2024年9月30日和2023年12月31日,公司的不具市場流通性的股權及其他相關投資總計$11.1百萬和$8.6百萬美元,並納入附帶簡表資產的其他資產中淨額合併平衡表。
非流通證券按成本記錄,定期進行損失審核,並根據有序交易的觀察到的價格變化進行調整。公司對此類非流通證券的損耗評估是基於市場條件和監管或經濟環境不利變化;對投資方的營運表現和財務狀況進行定性和定量分析;投資方的營運結構或管理變化;以及投資方的額外資金需求。作為評估結果,對其一項非流通股權投資,公司記錄了$損失。22.1截至2023年9月30日的九個月,公司的其他收入(費用)中包含了一項$損失,這是由於非流通證券的損耗,在公司的綜合營運表中列示。此外,有關公司購買的非流通證券投資,公司獲得了以預定價格購買投資方的權利,該價格受到投資方業績的額外調整的限制,最遲在2022年12月31日前。2022年9月,公司決定不行使該購買投資方的權利,並在2022年12月31日的年度中記錄了一項$損失,列入公司的綜合營運表中的其他收入(費用)。5.3非流通證券投資方案,公司以預定價格獲得了購買投資方的權利,這價格根據投資方業績進行額外調整,至2022年12月31日或之前。2022年9月,公司決定不行使購買投資方的權利,並在2022年12月31日的年度中記錄了一項$損失,列入公司綜合營運表中的其他收入(費用)。
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Table of Contents
Pursuant to another investment in non-marketable securities purchased by the Company, the Company acquired rights to purchase the investee at a pre-determined price subject to additional adjustments based on the performance of the Company, on or before October 1, 2023, and acquired rights to obtain the exclusive license of the investee's certain technologies. In June 2023, the Company decided not to exercise such rights and recorded an impairment of $7.0 million for the nine months ended September 30, 2023, included in other income (expense), net on the Company's condensed consolidated statements of operations.
No other impairment or downward adjustments to the carrying value of the Company's non-marketable securities have been otherwise recorded.
Concentration of Risk
The Company is subject to credit risk from its portfolio of cash equivalents held at one commercial bank and investments in marketable debt securities. The Company limits its exposure to credit losses by investing in money market funds through a U.S. bank with high credit ratings. The Company’s cash may consist of deposits held with banks that may at times exceed federally insured limits, however, its exposure to credit risk in the event of default by the financial institution is limited to the extent of amounts recorded on the condensed consolidated balance sheets. The Company performs evaluations of the relative credit standing of these financial institutions to limit the amount of credit exposure.
The Company also invests in investment-grade debt instruments and has policy limits for the amount it can invest in any one type of security, except for securities issued or guaranteed by the U.S. government. The goals of the Company’s investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk; liquidity of investments sufficient to meet cash flow requirements; and a competitive after-tax rate of return. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, investment type and issuer, as a result, the Company is not exposed to any significant concentrations of credit risk from these financial instruments.
The Company is subject to credit risk from its accounts receivable. The majority of the Company’s accounts receivable arises from the provision of precision oncology services, and development services and other, primarily with biopharmaceutical companies and international laboratory partners, all of which have high credit ratings. The Company has not experienced any material losses related to receivables from individual customers, or groups of customers. The Company does not require collateral. Accounts receivable are recorded net of allowance for credit losses, if any.
A significant customer is any biopharmaceutical customer, clinical testing payer, or international laboratory partner that represents 10% or more of the Company’s total revenue or accounts receivable balance. Revenue attributable to each significant customer, including its affiliated entities, as a percentage of the Company’s total revenue, for the respective period, and accounts receivable balance attributable to each significant customers, including its affiliated entities, as a percentage of the Company’s total accounts receivable balance, at the respective condensed consolidated balance sheet date, are as follows:
總收入應收帳款淨額
截至九月三十日止三個月,截至九月三十日止九個月二零二四年九月三十日二零三年十二月三十一日
2024202320242023
(未經審核)(未經審核)
客戶 A
****14 %12 %
客戶 B
28 %33 %29 %32 %11 %12 %
客戶 C
*****10 %
*    少於10%
應收帳款淨額
應收帳款代表對商業和政府付款人、生物製藥公司、研究機構、國際實驗室合作夥伴和分銷商的有效索賠,包括未開立發票的應收帳款以及因授權公司技術而應收的來自第三方的權利金支付。未開立發票的應收帳款包括來自生物製藥客戶的餘額,這些餘額與開發服務和其他收入有關,當實現基於成就的里程碑時認列,但在實現合約開立帳單權利之前。截至2024年9月30日和2023年12月31日,公司擁有未開立發票的應收帳款$4.6 百萬美元和4.9 百萬。
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目錄
公司根據歷史收款趨勢、支付合作夥伴的財務狀況以及外部市場因素評估應收賬款的收回能力,並根據管理層對可能信貸損失金額的最佳估計提取信貸損失準備。 公司錄得與應收賬款有關的微不足道的信貸損失,分別是2024年和2023年截至9月30日的三個月和九個月。
商譽和無形資產,淨值
商譽表示購買價格超過淨可辨認資產和負債公平價值的部分。商譽不會攤銷,但至少在第四財政季度每年進行測試以確保不存在減值風險,或者如果情況表明其價值可能無法收回,則會測試可能暴露於風險範圍內。公司持續運營在一年。部門,被視為唯一的報告單元,因此商譽將在企業層面進行減值測試。截至2024年9月30日,目前不存在商譽減值。
有限使用期限的無形資產以成本減除累計攤銷後列報。公司除了商譽外,沒有具有無限使用期限的無形資產。攤銷依據無形資產的使用年限以直線法記錄,其大約為 612
租賃
公司在開始時確定安排是否包含租賃。基於未來最低租金支付的現值,在開始日期按租賃期間承認營運租賃使用權(ROU)資產和營運租賃負債。ROU資產還包括在租賃起始日期或之前發生的任何初始直接成本和任何租金支付,扣除所收到或可收到的租賃獎勵。公司在確定租賃負債時使用基於開始日期可用資訊的增量借款利率,因為公司的租約通常不提供內含利率。租賃期限可能包括是否延長或終止選擇權,在公司合理確定該選擇權將被行使時。租賃支出按照租賃期間採用直線法承認。公司還與租賃和非租賃元件的租賃安排。公司選擇了便利措施,不將非租賃元件與公司設施租賃中的租賃元件分開。公司還選擇應用短期租賃測量和認列豁免,對於租期不超過12個月的租約,不會為ROU資產和租賃負債進行承認。
可轉換債券
可轉換優先票據按其攤銷成本列示為負債。與票據發行相關的交易成本與負債淨額合併,並按票據期限利用有效利率法攤銷至利息支出。
營收認證
公司的營業收入來自於提供精密腫瘤學檢測服務,以及開發服務和其他。精密腫瘤學檢測收入包括從提供公司的精密腫瘤學檢測所得的金額,包括由我們戰略合作夥伴運營的實驗室提供的檢測。開發服務包括伴隨性診斷開發和監管批准,臨床研究建立、監控和維護,檢測開發和支援,GuardantConnect 和 GuardantINFORm。其他收入包括從許可公司的技術、套件履行,以及提供公司的 Shield 篩查檢測所得的金額。公司目前從第三方商業和政府支付者、特定醫院和腫瘤中心、個別患者,以及生物製藥公司、研究機構、國際實驗室合作夥伴和分銷商處收款。
營業收入是在服務控制權轉移給客戶時確認的,金額應反映公司預期為這些服務所應得的考慮。FASb ASC Topic 606 與客戶的合同中的營業收入, 提供一個包括識別與客戶的合同、識別合同中的履行義務、確定交易價格、將交易價格分配給履行義務以及在實體滿足履行義務時或在其滿足履行義務時確認營業收入的五步模型。
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目錄
精準腫瘤學測試
公司從為臨床客戶提供精准腫瘤檢測所產生的營業收入進行認列,包括某些醫院、癌症中心、其他機構和患者,在檢測結果向醫生報告時。大部分由臨床客戶要求的精準腫瘤檢測是在沒有書面協議的情況下銷售的;然而,公司確定與臨床客戶存在一個默示合同。公司將其為臨床客戶銷售的每一次檢驗定為一項單一履約義務。除了與保險公司和其他機構簽訂的某些有限合約安排,交易價格是固定的情況外,未存在明確的合同價格,與臨床客戶的每個默示合同的交易價格代表可變考慮。公司根據投資組合方法估計變動考慮,考慮來自第三方商業和政府支付機構以及患者的歷史報銷數據,以及未反映在歷史數據中的已知或預期的報銷趨勢。公司在每個報告期基於實際現金收款監控投資組合中應收金額的估計,以評估是否需要對估計進行修訂。在估計和任何後續修訂中,包括變動考慮的估計和對此等變動考慮的約束力的應用,均存在不確定性並需要在變動考慮的估計和約束力的應用中使用重要判斷。公司分析實際現金收款與預期報銷期間內的現金收款,並將其與每個投資組合的估計變動考慮進行比較,並將任何差異認可為預期報銷期間後估計收入的調整,並且需考慮未來收入逆轉風險的評估。
精準腫瘤學檢測銷售收益,向生物製藥客戶基於每項檢測的議價或基於一項在特定期間內提供一定檢測成交量的協議。公司將向生物製藥客戶轉移一系列不同檢測的承諾視為單一履約義務。對於提供給生物製藥客戶的精準腫瘤學檢測,通常按每項檢測的固定價格結帳。對於需在特定期間內履約的成交量協議,隨著執行義務隨時間履行,收益將根據執行的檢測數量隨時間確認。公司的精準腫瘤學服務結果通過電子方式提供,因此公司不需支付任何運輸或處理費用,也不會向客戶結帳。
開發服務及其他
該公司利用其精確腫瘤學信息平台為生物製藥客戶提供開發服務。開發服務通常代表一項履行義務,因為該公司提供重要的整合服務,如分析驗證和監管提交。在合同中,個別承諾無法從其他承諾中分辨出來,因此不具有獨立性。然而,在某些合同中,生物製藥客戶可能聘請該公司提供多個不同的開發服務,這些服務可以獨立且可從合同中的其他承諾分辨出來,因此屬於獨立的履行義務。
公司與生物製藥公司合作開發新藥。作為這些合作的一部分,公司提供與規定文件相關的服務,以支持陪伴診斷裝置提交用於公司測試面板的輔助設備。在這些合作中,公司通過達成里程碑目標以及提供持續支持而產生營業收入。就陪伴診斷開發和監管批准服務而言,公司獲得賠償金,方式為結合了預付費用和基於表現的、不可退還的監管和其他發展性里程碑付款。這些合同的交易價格通常代表變量考量。對里程碑付款的變量考慮約束的應用是一個需要有重要判斷的領域。公司考慮因素,如必須經營以實現相應里程碑目標的科學、臨床、監管、商業和其他風險,以及實現相應里程碑目標所需的努力和投資水平。公司在做出此評估時,考慮其對相似里程碑的歷史經驗、與每個里程碑相關的複雜程度和不確定性程度,以及實現里程碑是否取決於除了公司以外的其他方。針對變量考量的約束被應用,以確保當有關隱含變數的不確定性得到解決時,不會出現重大收入反轉。對變量考量約束的應用在每個報告期進行評估和更新,作為估計交易價格的修訂。
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公司將伴隨診斷的發展和監管批准服務所得營業收入,在生物製藥研發服務提供期間逐步確認。具體來說,公司採用輸入法來衡量進度,利用迄今已發生的成本相對於預期總成本的比例作為進度的衡量方法。公司在每個報告期評估對預期總成本估計的變化,以及由於對原始合同範圍進行更改而談判而導致的任何增量費用,以確定收入認識。在這些安排下開發新產品或服務時,在技術可行性確定之前發生的成本被納入公司綜合財務報表中的研究和開發費用,而之後發生的成本則記錄為開發服務和其他成本。
公司亦從其他開發服務中認列營業收入,除了上述的伴隨診斷開發和監管批准服務外,如臨床研究設置、監控與維護、測試開發與支持、GuardantConnect和GuardantINFORm等。這些收入通常是基於輸入法的方式,隨著執行關聯服務的時期而逐步認列。
此外,該公司將其數字序列技術授權給國內客戶和國際實驗室合作夥伴。針對已授權的技術,公司通過基於版稅的支付、不可退還的預付款、保證的最低支付和/或樣本里程碑支付來進行補償。根據技術許可協議的性質,以及考慮到可強制執行的支付權及支付條款等因素,若創建了具有替代用途的資產,則這些收入將在容許版稅銷售發生的期間,技術轉讓完成時,或者在技術轉讓期間內予以確認。其他收入還包括套件配送,當此類產品交付時予以確認。此外,其他收入包括從交付公司Shield篩檢測試所獲得的金額。
For the three and nine months ended September 30, 2024, the Company recorded $18.2 million and $31.9 million, respectively, as revenue related to performance obligations satisfied in prior periods. For the three and nine months ended September 30, 2023, the Company recorded $7.4 million and $12.2 million, respectively, as revenue related to performance obligations satisfied in prior periods.
Contracts with multiple performance obligations
Contracts with biopharmaceutical customers and international laboratory partners may include multiple distinct performance obligations, such as provision of precision oncology testing, the above-mentioned development services, and digital sequencing technology licensing, among others. The Company evaluates the terms and conditions included within its contracts with biopharmaceutical customers and international laboratory partners to ensure appropriate revenue recognition, including whether services are considered distinct performance obligations that should be accounted for separately versus together. The Company first identifies material promises, in contrast to immaterial promises or administrative tasks, under the contract, and then evaluates whether these promises are both capable of being distinct and distinct within the context of the contract. In assessing whether a promised service is capable of being distinct, the Company considers whether the customer could benefit from the service either on its own or together with other resources that are readily available to the customer, including factors such as the research, development, and commercialization capabilities of a third party as well as the availability of the associated expertise in the general marketplace. In assessing whether a promised service is distinct within the context of the contract, the Company considers whether it provides a significant integration of the services, whether the services significantly modify or customize one another, or whether the services are highly interdependent or interrelated.
For contracts with multiple performance obligations, the transaction price is allocated to the separate performance obligations on a relative standalone selling price basis. The Company determines standalone selling price by considering the historical selling price of these performance obligations in similar transactions as well as other factors, including, but not limited to, the price that customers in the market would be willing to pay, competitive pricing of other vendors, industry publications and current pricing practices, and expected costs of satisfying each performance obligation plus appropriate margin; or by using the residual approach if standalone selling price is not observable, by reference to the total transaction price less the sum of the observable standalone selling prices of other performance obligations promised in the contract.
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Deferred revenue
Deferred revenue, which is a contract liability, consists primarily of payments received in advance of revenue recognition from contracts with customers. For example, development services and other contracts with biopharmaceutical customers often contain upfront payments which results in the recording of deferred revenue to the extent cash is received prior to the Company's performance of the related services. Contract liabilities are relieved as the Company performs its obligations under the contract and revenue is consequently recognized. As of September 30, 2024 and December 31, 2023, the deferred revenue balance was $32.5 million and $22.9 million, respectively, of which $3.0 million and $5.0 million was considered long-term and recorded within other long-term liabilities on the accompanying condensed consolidated balance sheets. Revenue recognized in the nine months ended September 30, 2024 that was included in the deferred revenue balance as of December 31, 2023 was $12.6 million, and revenue recognized in the nine months ended September 30, 2023 that was included in the deferred revenue balance as of December 31, 2022 was $12.7 million, respectively.
Transaction price allocated to the remaining performance obligations
Transaction price allocated to remaining performance obligations represents contracted revenue that has not yet been recognized, which includes deferred revenue and non-cancelable amounts that will be invoiced and recognized as revenues in future periods. The Company expects to recognize substantially all of the remaining transaction price in the next 1-2 years.
Costs of Precision Oncology Testing
Cost of precision oncology testing generally consists of cost of materials, cost of labor, including bonus, benefit and stock-based compensation, equipment and infrastructure expenses associated with processing test samples (including sample accessioning, library preparation, sequencing, and quality control analyses), freight, curation of test results for physicians, phlebotomy, and license fees due to third parties. Infrastructure expenses include depreciation of laboratory equipment, lease costs, amortization of leasehold improvements, and information technology costs. Costs associated with performing the Company’s tests are recorded as the tests are performed regardless of whether revenue was recognized with respect to that test.
Cost of Development Services and Other
Cost of development services and other primarily includes costs incurred for the performance of development services requested by the Company’s biopharmaceutical customers, and costs associated with the Company's partnership agreements and delivery of Shield screening tests. For development of new products, costs incurred before technological feasibility has been achieved are reported as research and development expenses, while costs incurred thereafter are reported as cost of development services and other.
Research and Development Expenses
Research and development expenses consist of costs incurred to develop technology and include salaries and benefits including stock-based compensation, reagents and supplies used in research and development laboratory work, infrastructure expenses, including facility occupancy and information technology costs, contract services, other outside costs and costs to develop the Company's technology capabilities. Research and development expenses also include costs related to activities performed under contracts with biopharmaceutical companies before technological feasibility has been achieved. Research and development costs are expensed as incurred. Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as expense in the period in which the related goods are received or services are rendered. Costs to develop technology capabilities are recorded as research and development expenses unless they meet the criteria to be capitalized as internal-use software costs.
Stock-Based Compensation
Stock-based compensation related to stock options granted to the Company’s employees, directors and nonemployees is measured at the grant date based on the fair value of the award. The fair value is recognized as expense over the requisite service period, which is generally the vesting period of the respective awards. Compensation expense for stock options with performance metrics is calculated based upon expected achievement of the metrics specified in the grant.
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The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options granted under the 2012 Stock Plan (as amended and restated), or the 2012 Plan, the 2018 Incentive Award Plan, or the 2018 Plan, the 2023 Employment Inducement Incentive Award Plan, or the 2023 Plan, and stock purchase rights granted under the 2018 Employee Stock Purchase Plan. The Black-Scholes option-pricing model requires assumptions to be made related to the expected term of an award, expected volatility, risk-free rate and expected dividend yield.
The Company measures the grant date fair value of its service-based and performance-based restricted stock units issued to employees and non-employees based on the closing market price of the common stock on the date of grant. For restricted stock units with only service-based vesting conditions, compensation expense is recognized in the Company’s condensed consolidated statement of operations on a straight-line basis over the requisite service period. Compensation expense for restricted stock units with performance metrics, or PSUs, is calculated based upon expected achievement of the metrics specified in the grant, and is recognized in the Company’s condensed consolidated statement of operations using an accelerated attribution model over the requisite service period for each separately vesting portion of the award. No stock-based compensation expense is recorded for PSUs, unless it is determined to be probable that the related performance metrics will be met. In addition, a cumulative adjustment will be recorded in the period when the probability of achieving the related performance metrics is adjusted. Any PSUs that remain unvested at the end of the performance period will be forfeited. Forfeitures are accounted for as they occur.
Net Loss Per Share
The Company calculates basic net loss per share by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period. The diluted net loss per share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period determined using the treasury stock method or the as-if converted method, as appropriate. For purposes of this calculation, stock options, restricted stock units, shares issuable pursuant to the employee stock purchase plan, and contingently issuable shares under the convertible senior notes are considered common stock equivalents but have been excluded from the calculation of diluted net loss per share as their effect is anti-dilutive.
New Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board, or FASB, issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires an enhanced disclosure of significant segment expenses on an annual and interim basis. This guidance will be effective for the annual reporting periods beginning the year ended December 31, 2024, and for interim reporting periods beginning January 1, 2025, with early adoption permitted, and should be applied retrospectively. The Company expects to provide required disclosures upon the effective date.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which amended existing income tax disclosure guidance, primarily requiring more detailed disclosures on the effective tax rate reconciliation and income taxes paid. This guidance will be effective for annual reporting periods beginning the year ended December 31, 2025, with early adoption permitted and can be applied on either a prospective or retroactive basis. The Company expects to provide required disclosures upon the effective date.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement-Reporting Comprehensive Income (Topic 220): Expense Disaggregation Disclosures, which requires additional disclosures of specified information about certain costs and expenses in the notes to financial statements. This guidance will be effective for annual reporting periods beginning the year ended December 31, 2027, and for interim reporting periods beginning January 1, 2028, with early adoption permitted and can be applied on either a prospective or retroactive basis. The Company is currently assessing the impact of adopting this accounting pronouncement on its consolidated financial statements.
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3.     Condensed Consolidated Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consist of the following:
September 30, 2024December 31, 2023
(unaudited)
(in thousands)
Machinery and equipment
$125,296 $118,117 
Leasehold improvements
103,419 102,298 
Computer hardware
36,068 34,417 
Construction in progress
7,250 7,508 
Furniture and fixtures
7,993 7,999 
Computer software
2,063 2,065 
Property and equipment, gross
$282,089 $272,404 
Less: accumulated depreciation
(156,920)(127,308)
Property and equipment, net
$125,169 $145,096 
Depreciation expense related to property and equipment was $10.1 million and $10.3 million for the three months ended September 30, 2024, and 2023, respectively, and $30.2 million and $29.9 million for the nine months ended September 30, 2024, and 2023, respectively.
Accrued Expenses
Accrued expenses consist of the following:
September 30, 2024December 31, 2023
(unaudited)
(in thousands)
Operating lease liabilities$27,383 $27,950 
Contingent consideration arrangements12,500 6,500 
Other
31,788 29,025 
Total accrued expenses
$71,671 $63,475 
4.    Fair Value Measurements, Cash Equivalents and Marketable Securities
Financial instruments consist of cash equivalents, marketable securities, accounts receivable, net, prepaid expenses and other current assets, net, and accounts payable and accrued liabilities. Cash equivalents and marketable securities are stated at fair value. Prepaid expenses and other current assets, net, and accounts payable and accrued liabilities are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date.
Fair value is defined as the exchange price that would be received from sale of an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The identification of market participant assumptions provides a basis for determining what inputs are to be used for pricing each asset or liability. A financial instrument’s classification within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement.
A fair value hierarchy has been established which gives precedence to fair value measurements calculated using observable inputs over those using unobservable inputs. This hierarchy prioritized the inputs into three broad levels as follows:
Level 1 - Quoted prices in active markets for identical assets or liabilities.
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Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The Company’s financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows:
September 30, 2024
Fair ValueLevel 1Level 2Level 3
(unaudited)
(in thousands)
Financial Assets:
Money market funds
$112,142 $112,142 $ $ 
Income deposit funds102,412  102,412  
U.S. government debt securities
398,485  398,485  
Total cash equivalents and restricted cash
$613,039 $112,142 $500,897 $ 
U.S. government debt securities
$310,701 $ $310,701 $ 
Total short-term marketable debt securities
$310,701 $ $310,701 $ 
Short-term marketable equity securities
$31,280 $31,280 $ $ 
Total
$955,020 $143,422 $811,598 $ 
Financial Liabilities:
Contingent consideration
$7,300 $ $ $7,300 
Total
$7,300 $ $ $7,300 
December 31, 2023
Fair ValueLevel 1Level 2Level 3
(in thousands)
Financial Assets:
Money market funds
$1,032,500 $1,032,500 $ $ 
Total cash equivalents
$1,032,500 $1,032,500 $ $ 
U.S. government debt securities
$35,097 $ $35,097 $ 
Total short-term marketable debt securities
$35,097 $ $35,097 $ 
Long-term marketable equity securities
$98,002 $98,002 $ $ 
Total
$1,165,599 $1,130,502 $35,097 $ 
Financial Liabilities:
Contingent consideration
$6,540 $ $ $6,540 
Total
$6,540 $ $ $6,540 
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The Company measures the fair value of money market funds based on quoted prices in active markets for identical securities. Income deposit funds and U.S. government debt securities are valued taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads; benchmark securities; prepayment/default projections based on historical data and other observable inputs.
In July 2022, one of the Company's equity investees, Lunit Inc., or Lunit, completed its initial public offering, or IPO, subsequent to which, the Company started to account for the investment in Lunit at fair value on a recurring basis, and classified the investment as marketable equity securities within Level 1 of the fair value hierarchy as the investment is valued using the quoted market price. The Company was subject to a 2-year lock-up period from Lunit's IPO date, during which the Company shall not transfer Lunit's shares between accounts, establish or cancel pledges, sell, or withdraw such shares, without approval from the Korea Exchange. In November 2023, Lunit issued bonus shares to its existing shareholders by allocating one new share for each existing share, and the Company was subject to the same lock-up period with the same restrictions for these bonus shares which expired in July 2024. In the third quarter of 2024, the Company sold a portion of its investment in Lunit. As of September 30, 2024 and December 31, 2023, the balance of the investment in Lunit was $31.3 million and $98.0 million, included in prepaid expenses and other current assets, net, and other assets, net, respectively, on the Company's condensed consolidated balance sheets. In addition, the Company recorded $1.2 million and $29.3 million unrealized losses during the three and nine months ended September 30, 2024, respectively, on the investment in Lunit held as of September 30, 2024, and recorded $16.6 million and $84.5 million unrealized gains during the three and nine months ended September 30, 2023, respectively, on the investment in Lunit held as of September 30, 2023, included in other income (expense), net on the Company's condensed consolidated statement of operations.
There were no transfers between Level 1, Level 2 and Level 3 during the periods presented.
Acquisition-related contingent consideration is measured at fair value on a quarterly basis and changes in estimated contingent consideration to be paid are included in general and administrative expense in the condensed consolidated statements of operations. The fair value of acquisition-related contingent consideration is estimated using a multiple-outcome discounted cash flow valuation technique. Contingent consideration is classified within Level 3 of the fair value hierarchy, as it is based on a probability that includes significant unobservable inputs. The significant unobservable inputs include a probability-weighted estimate of achievement of certain commercialization milestones, and discount rate to present value the expected payments. A significant change in any of these input factors in isolation could have a material impact to fair value measurement. As of September 30, 2024 and December 31, 2023, the Company's acquisition-related contingent consideration liability was $7.3 million and $6.5 million, respectively, of which $1.8 million and $5.0 million was considered long-term and recorded within other long-term liabilities on the Company's condensed consolidated balance sheets.
The following table summarizes the activities for the Level 3 financial instruments:
Contingent Consideration
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
(unaudited)
(in thousands)
Fair value — beginning of period$6,960 $6,440 $6,540 $6,430 
Increase in fair value
340 220 760 230 
Fair value — end of period$7,300 $6,660 $7,300 $6,660 
The Company considers the fair value of the Convertible Notes as of September 30, 2024, and December 31, 2023, to be a Level 2 measurement. The fair value of the Convertible Notes is primarily affected by the trading price of the Company's common stock and market interest rates. As such, the carrying value of the Convertible Notes does not reflect the market rate. See Note 6, Debt, for additional information related to the fair value of the Convertible Notes.
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以下表格概述了公司的貨幣等值物、限制性現金和有價證券的攤銷成本、淨未實現收益、淨未實現虧損和估計公平價值,按重要投資類別分組:
2024年9月30日
攤銷後成本毛未實現收益毛未實現損失預估公允價值
(未經審計)
(以千為單位)
貨幣市場基金
$112,142 $ $ $112,142 
收入存入資金型基金102,412   102,412 
美國政府債券
708,731 480 (25)709,186 
總計
$923,285 $480 $(25)$923,740 
2023年12月31日
攤銷後成本毛未實現收益毛未實現損失預估公允價值
(以千為單位)
貨幣市場基金
$1,032,500 $ $ $1,032,500 
美國政府債券證券
35,108  (11)35,097 
總計
$1,067,608 $ $(11)$1,067,597 
截至2024年9月30日和2023年12月31日,公司持有的可市場交易債券中並無任何連續未實現虧損已超過一年。
公司的重大會計政策沒有做出任何實質性更改。 對於所呈現的時期內的市場性債務證券獲得或損失有了實現。此外,還有 關於所呈現的時期內的市場性債務證券的信用損失認列
5.    無形資產、淨值和商譽
以下表格呈現截至2024年9月30日和2023年12月31日購買的無形資產詳細資料:
2024年9月30日
毛餘額 累積攤提淨攜帶額剩餘加權平均使用壽命
(未經審計)
(以千為單位)(按年計算)
無形資產需按摊销处理:
已取得許可證$11,886 $(5,516)$6,370 6.0
競爭限制協議和其他契約權利
5,100 (4,219)881 1.3
購入的科技1,600 (1,600) 0.0
總無形資產需攤銷
$18,586 $(11,335)$7,251 
無形資產不受攤提影響:
商譽3,290 — 3,290 
已購買之無形資產總額
$21,876 $(11,335)$10,541 
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2023年12月31日
毛餘額 累積攤提淨攜帶額剩餘加權平均有用壽命
(以千為單位)(按年計算)
無形資產需按摊销处理:
取得執照$11,886 $(4,686)$7,200 6.8
非競爭協議和其他約定權利
5,100 (3,588)1,512 1.9
購入的科技1,600 (1,333)267 0.3
受攤銷影響之無形資產總額
$18,586 $(9,607)$8,979 
無形資產不受攤提影響:
商譽3,290 — 3,290 
已購買之無形資產總額
$21,876 $(9,607)$12,269 
有限壽命無形資產攤銷金額為$0.5 百萬美元和0.7 百萬,截至2024年9月30日和2023年9月30日止,分别为$1.7 百萬美元和2.1 百萬,截至2024年9月30日和2023年9月30日止,分别为$
以下表格總結了有限壽命無形資產的預估未來攤銷支出,扣除後:
截至十二月三十一日年終。
(未經審計)
(以千為單位)
2024年剩餘部分
$491 
20251,670 
20261,212 
20271,107 
20281,109 
2029年及之後
1,662 
總計$7,251 
6. 債務
可轉換債券
2020年11月,公司發行了$1.15 十億本金的可轉換2027年到期的高級票據(即2027票據)。2027票據不帶利息,票據本金不會累增。 0然而,在特定事件(例如未向證券交易委員會提交某些報告或未刪除部分限制性標誌)發生時,2027票據可能以不超過每年 0.50%的利率計提特別利息和追加利息(須視具體情況而定)。除非提前或贖回或轉換,該票據將於2027年11月15日到期。
21

目錄
在2027年8月15日之前,2027年票據持有人只有在以下情況下才有權將其2027年票據轉換為其他形式:
在2021年3月31日結束的日歷季度後(僅在該日歷季度內),如果公司普通股最後報告的售價超過 130至少連續 20 在前一個財政季度結束的連續交易日期間進行交易(無論是否連續),在該交易日的最後報告的我們普通股的成交價格大於或等於 30 個交易日中的每一個轉換價格的%
連續業務日為期的第 連續交易日期間,或者稱為測量期,如果債券每1,000美元本金的交易價格低於測量期每個交易日的備註公司普通股最後報告的銷售價格和該交易日的換股率的乘積的%; 98公司的普通股在該交易日的最後報告的銷售價格和該交易日的換股率的產品的%;或
當特定企業事件發生時
從2027年8月15日起,2027票據持有人可以在任何時候根據自己的選擇將2027票據轉換為到期日期前倒數第二個預定交易日的業務結束時。
公司將以支付現金、交付普通股股份或支付現金和交付普通股股份的組合方式來結算轉換,視情況而定,由公司選擇。
最初的換股價為每2027年票面金額1,000美元的普通股7.1523股,代表了約$ 的初始換股價。139.82 每股普通股的初始換股價為每股。換股比率和換股價格將根據某些事件的發生而經受慣例性調整。此外,如果發生某些構成“足額基本改變”的公司事件,則在某些情況下,換股比率將在一定時間內增加。
公司可能選擇在2024年11月20日前的任何時間,以其自行選擇的方式不贖回2027年票據。票據將在2024年11月20日後及到期日期前第25個預定交易日前的任何時間,由公司自行選擇地,全部或部分贖回,以相等於應贖回票據的本金金額加上應贖回日之前到但不包括贖回日的應計及未支付的特別利息和額外利息的現金贖回價格贖回,但前提是公司普通股的每股最後報價高於 130每股轉換價格的%,通過(i)在截止於和包括發出有關贖回通知的日期之前的至少的 20 個交易日中,無論連續與否,在結束於發送公司相關贖回通知日期的連續 30 個連續交易日及(ii)在公司發出該通知之前的交易日或包括該日期。此外,贖回任何票據將構成涉及該票據的補償基本變更,在這種情況下,如果在責令贖回後轉換該票據,則轉換該票據的轉換比例將在某些情況下增加。
如果發生某些構成「根本性變革」的公司事件,那麼除了某些現金合併的有限例外情況外,持有人可要求公司以現金回購他們的2027年債券,回購價格等於要回購的2027年債券本金金額加上應付但未支付的特別利息和額外利息,若有的話,直至但不包括根本性變革回購日期。根本性變革的定義包括涉及公司的某些業務組合交易以及涉及公司普通股的某些停牌事件。
自2024年9月30日和2023年12月31日起,2027年票據不可兌換,故2027年票據的淨攜帶金額被歸類為長期負債。
以下表格列出了截至2024年9月30日和2023年12月31日的2027年債券的淨攜帶金額:
2024年9月30日2023年12月31日
(未經審計)
(以千為單位)
本金$1,150,000 $1,150,000 
減少:債務發行成本,淨攤銷(8,099)(10,034)
淨攜帶金額$1,141,901 $1,139,966 
22

目錄
2027年票據的總估計公允價值為$。897.0 百萬美元和809.3 截至2024年9月30日和2023年12月31日,2027年票據的公允價值分別為百萬美元。該公允價值係基於交易期最後一日的每$2027年票據的收盤價確定。100 2027年票據最後一個交易日的每$的收盤交易價格確定該公允價值。
與債務發行成本攤銷相關的利息費用為$。0.6 百萬美元和1.9 在2024年和2023年截至9月30日的三個月和九個月分別為百萬美元,分別代表了有效利率。 0.22024年6月30日和2023年12月31日的時間點,公司從Thrivel Earlier Detection Corporation(“Thrive”),Ashion Analytics,LLC(“Ashion”)和OmicEra的收購中記錄的關於監管和產品開發里程碑的待定支付負債的公允價值總和為2.779億和2.887億美元。公司使用概率加權情境折現現金流模型評估預期的待定支付負債和相應的與監管和產品開發里程碑相關的負債的公允價值,該方法與預期待定支付負債的初始計量一致。每個潛在情境應用成功概率,然後通過現值因子計算折扣,得出相應的現值。時間的流逝以及草擬的里程碑實現時間,現值因子,實現度(如適用)和成功概率的變化可能導致公允價值測量的調整。與監管和產品開發里程碑相關的待定支付負債的公允價值是以2024年6月30日和2023年12月31日的加權平均成功概率和現值因子計算的,成功概率分別為%和%,現值因子分別為%和%。付款範圍的預測財政年度範圍為2025年至2031年。所使用的不可觀察的輸入值按待定支付負債的相對公允價值加權。 0.2在2024年和2023年截至9月30日的三個月和九個月分別為%,分別代表了有效利率。
筆記樹籬
為盡量減少轉換 2027 年債券時潛在經濟稀釋的影響,本公司就其普通股與發行債券同時進行可換股票對沖交易或 2027 年債券對沖交易。2027 年債券對沖包括根據該債券最初的基礎之普通股數目,視乎慣常調整而言。2027 年債券對沖的行使價最初將約為美元182.60 每股,代表每股的保費為 75超過本公司普通股價格為 $ 上次報告的百分比104.34 每股於 2020 年 11 月 16 日,並根據 2027 年債券對沖條款進行某些調整。
2027年期票據對沖將於2027年期票據到期時到期。2027年期票據對沖是獨立的交易,並不屬於2027年期票據的條款。持有2027年期票據的持有人將不享有任何涉及2027年期票據對沖的權利。與2027年期票據對沖相關的應收股份已從稀釋每股收益的計算中排除,因為它們具有防稀釋性。
由於這些交易符合某些會計標準,2027年的注記避險措施已記錄在股東權益中,並未列為衍生工具。公司支付了總額為$的2027年注記避險措施,已記錄為對股本的減少,並不會重新評價。90.0百萬美元用於2027年的注記避險,這已記錄為對額外實收資本的減少,不會進行重新評價。
7. 租賃
公司已簽訂各種營運租賃協議,用於辦公空間、idc概念、實驗室和倉庫使用,剩餘期限不等,有部分包含一個或多個繼續期權。隨著租賃接近到期,公司會考慮各種因素,例如市場條件和存在的任何續租選擇條款,以判斷是否續租租賃。因此,公司在計算租賃負債時不包括續租選擇,因為續租選擇讓公司保持營運靈活性,並且公司目前不確定是否會在租賃開始時行使這些續租選擇。 0.2 天從發票日期計算,被視為商業合理。 8.8 公司已簽訂各種營運租賃協議,用於辦公空間、idc概念、實驗室和倉庫使用,剩餘期限不等,有部分包含一個或多個繼續期權。隨著租賃接近到期,公司會考慮各種因素,例如市場條件和存在的任何續租選擇條款,以判斷是否續租租賃。因此,公司在計算租賃負債時不包括續租選擇,因為續租選擇讓公司保持營運靈活性,並且公司目前不確定是否會在租賃開始時行使這些續租選擇。
截至2024年6月30日止的三個月,營業租賃費用為$千元,分別是2024年和2023年。截至2024年6月30日止的六個月,營業租賃費用為$百萬,分別是2024年和2023年。8.1 百萬美元和7.4 百萬,截至2024年9月30日和2023年9月30日止,分别为$23.4 百萬美元和22.1 分別為截至2024年及2023年九個月的利潤為XX百萬,其中包括租賃元件和非租賃元件(主要是共用區域維護費和財產稅)。
2024年9月30日2023年12月31日
(未經審計)
加權平均剩餘租約期限(年)
7.78.3
加權平均折現利率
3.82 %3.87 %
23

目錄
以下表格彙總了公司截至2024年9月30日的未來主要營運租賃承諾。
截至十二月三十一日年終。
(未經審計)
(以千為單位)
2024年剩餘部分
$8,924 
202533,733 
202629,369 
202725,717 
202824,238 
2029年及之後
103,780 
總營運租賃付款$225,761 
減:隱含利息(28,247)
總經營租賃負債$197,514 
融資租賃對公司的簡明合併基本報表並無重大影響。
8.    承諾事項和或有事項
法律訴訟
除了業務日常中承擔的承諾和義務外,公司可能時常面臨各種索賠和法律訴訟,包括來自客戶和供應商的索賠、損害賠償的現有和潛在法律訴訟、政府調查及其他事項。例如,公司已經收到,並且將來可能繼續收到來自他人指控虛偽廣告、侵犯專利、違反就業慣例和商標侵權的信函、索賠或投訴。公司同樣已經提起過,並且將來可能提起進一步的法律訴訟以維護其權利並尋求補救措施,例如金錢賠償、禁令救濟和宣告救濟。公司無法預測任何此類爭執的結果,儘管可能的結果存在,這些爭端的存在可能對公司產生不良重大影響,因為從管理時間和注意力的分散以及解決此類爭端所涉及的財務成本。
本公司及其聯屬公司是下文所述法律索賠和訴訟的當事人。本公司正積極為自己辯護,反對這些訴訟和訴訟。下文描述了這些事項的重大進展。如果本公司未能成功辯護,或者決定和解任何這些事項,則可能需要支付巨額款項,受到禁令,或被迫改變業務運作方式,這可能對其財務狀況或營運成果產生重大不利影響。
除非另有說明,否則公司無法合理估計下列事項的損失或損失區間。通常情況下,公司無法判斷對一項索賠是否存在損失的概率,或合理估計損失金額或損失區間,因為資訊有限且未來事件及第三方(如法庭和監管機構)的決定可能對索賠的最終解決產生影響。許多所述事項都處於初步階段,提出新型的法律責任理論或要求不明確金額的賠償。索賠通常需要若干年進行解決並非罕見。公司至少每季度審查損失擔保,以判斷損失概率是否發生變化,並是否可以合理估計可能的損失或損失區間。當公司判斷對某項索賠的損失概率和合理估計可能時,將記錄其對最終損失的估計金額。公司亦會在可能出現損失或可能超過其記錄擔保金額的情況下提供披露。
24

目錄
知識產權爭議
在2021年8月,TwinStrand Biosciences, Inc.或TwinStrand Biosciences以及華盛頓大學在美國特拉華地區法院提起侵犯專利訴訟,指控公司侵犯美國專利號碼10,287,631;10,689,699;10,752,951和10,760,127。公司在2021年10月回應了這項訴訟,否認TwinStrand Biosciences的指控並主張專利無效、不可強制執行以及侵權。 此案的發現階段已經結束。2023年10月,地方法院駁回並帶有偏見地關於美國專利號碼10,689,699和10,752,951的TwinStrand的侵權主張。
2023年11月14日,陪審團對TwinStrand Biosciences和華盛頓大學做出了有利於他們並不利於公司的裁決。陪審團發現公司故意侵犯了美國專利號10,287,631和10,760,127,並裁定賠償TwinStrand Biosciences和華盛頓大學$83.4百萬美元的損害賠償,代表過去銷售額的 6%的權利金。因此,公司在2023年第四季度記錄了一筆$83.4百萬的責任,反映為其他營業費用的負擔在其合併營業報表中,並作為其他長期負債的構成部分出現在其合併資產負債表上。審判後運作已於2024年3月4日提出,公司申請撤銷陪審團的裁決,要求重新審判,和/或修訂判決,TwinStrand Biosciences則根據陪審團對故意侵權的認定,要求加重賠償、判決前後利息和按讚運行權利金。審判後動議的聆訊日期尚未確定。公司對陪審團的裁決強烈不同意,並將透過運行,如有必要,通過上訴到美國聯邦巡迴上訴法院來堅決反對該裁決和判決。
2023 年 8 月 1 日,公司公開宣布與 Illumina Inc. 或 Illumina 簽訂了合作和和解協議,或合作協議。根據合作協議的條款,雙方同意擴展長期的商業關係,通過同意共享樣本樣本以促進癌症研究,並簽訂新的長期購買和供應承諾。此外,當事人同意以影響地解除 Illumina 在美國特拉華州地區法院提出的 2022 年 3 月訴訟, 伊魯米納公司訴瓜達特健康有限公司等, 案件編號 1:22-CV-00334-GBW-CJB,包括任何與該主體知識產權有關的指控。
2024年6月11日,公司向特邁普斯人工智能公司(Tempus AI, Inc.)提交了一項專利侵權訴訟,指稱特邁普斯侵犯了美國特拉华州地方法院的特拉瑪特專利號碼有:11,149,306;9,902,992;10,501,810;10,793,916和11,643,693。公司正在尋求停止特邁普斯的侵權以及賠償損失的禁令。此案 Guardant Health, Inc. 對特邁普斯人工智能公司的訴訟案件,案件編號1:24-cv-00687,分配給Richard Andrews法官,尚未制定進度訂單。2024年10月21日,特邁普斯提出解除公司訴訟的動議,指稱某些主張的專利無效。公司持不同意見,將會相應作出回應。
虛假廣告糾紛
2021年5月,公司還在美國加州北區地方法院對Natera, Inc.提起訴訟,指控Natera在公司的新腫瘤檢測Guardant Reveal的性能方面欺騙了醫療提供者,暗示該檢測不準確和/或不靈敏,比Natera的Signatera檢測更差。公司正在尋求禁令,阻止Natera繼續發表虛假和誤導性語言,並要求Natera採取糾正行動。Natera主張迴響聲稱公司進行了虛假和誤導性陳述,虛假廣告,非法的商業行為和不正當競爭。公司要求法院駁回Natera的反訴,並於2022年1月,在部分核發和拒絕了公司的駁回動議。公司和Natera都已提出針對各項指控的結案裁定動議,法院部分核發了各方提出的非決定性動議。審判定於2024年11月開始。
民事調查需求
2022年1月,公司收到了來自加州北區聯邦檢察官辦公室的民事偵查要求(CID),該要求涉及根據虛假索賠法進行的調查。CID要求有關公司名為Guardant360的基因檢測面板向政府資助計劃的帳單資訊和文件。公司正在全力配合調查。目前,公司無法預測此調查的結果。
25

目錄
9.    普通股
公司的普通股股東在董事會宣布分紅派息時有資格獲得分紅派息。截至2024年9月30日和2023年12月31日, 董事會已宣布發放公司普通股的分紅派息。
公司的普通股已為以下可能的未來發行而保留:
2024年9月30日2023年12月31日
(未經審計)
優先認股權下的在外股
3,742,8814,012,903
未獲配的限制性股份單位下的股份
4,965,5674,346,785
未獲配的基於市場的限制性股份單位下的股份2,260,764
未獲配的基於績效的限制性股份單位下的股份1,291,889412,490
2018年激勵獎勵計劃下可發行的股份11,441,4007,053,406
2018年員工股票購買計劃可發行的股份2,414,5091,679,635
2023年就業誘因獎勵計劃可發行的股份
4,126,8684,949,988
總計27,983,11424,715,971
股票發行
2023年5月,公司完成了一項跟隨承銷的公開發行,發行並售出了股票,並在扣除承銷折扣和佣金以及其他發行成本後,獲得了淨收益$ 14,375,000 每股價格為$3.7028.00 每股,淨收益為$381.4百萬,在扣除承銷折扣和佣金以及其他發行成本$21.12023年12月,公司與一家投資管理公司完成了一項註冊直接發行,發行並出售了其普通股股份,每股售價為$ 3,387,446 ,並獲得淨收益$26.77 每股90.6百萬。
市場公開發行計畫
2024年8月,公司與Jefferies LLC(代理人)達成了一項公開市場銷售協議,或稱為銷售協議,涉及公司可能根據自身決定不時推出並賣出其普通股股份,總計總收益高達$400.0百萬透過代理商進行,受銷售協議條款和條件約束。在2024年9月30日結束的三個月內, 公司的普通股股份在銷售協議下賣出。
10.    基於股份的薪酬
2023年度就業誘因獎勵計劃
在2023年8月,公司的董事會通過了2023年度僱用誘因獎勵計劃,或稱為2023計劃,在此計劃下,公司可以專屬地向新員工授予獎勵,作為員工加入公司的誘因。根據納斯達克上市規則5635(c)(4)條款,公司的董事會在未經股東批准的情況下批准了2023計劃。
26

目錄
期權活動
2012計劃、2018計劃和2023計劃下公司股票期權活動摘要及相關信息如下:
期權未行使
股份
可供發放
股份受期權在外影響加權平均執行價格加權平均剩餘合約期間(年)總內在價值
(未經審計)
(以千為單位)
2024年1月1日的餘額
12,003,3944,012,903$31.76 6.6$39,115 
2018年計畫年度增加(1)
3,689,000
已授予股份(478,263)478,26323.96 
行使(581,495)4.47 
取消166,790(166,790)50.77 
已授予限制性股票單位
(1,874,273)— 
已取消限制性股票單位
682,506— 
市場期權單位被取消2,260,764— 
授予基於績效的期權單位(870,268)— 
調整基於表現成就的期權單位(48,234)— 
取消基於表現的期權單位36,852— 
2024年9月30日的結餘
15,568,2683,742,881$34.15 6.7$21,302 
自2024年9月30日起已授予並可行使
2,178,301$33.96 5.1$20,696 
(1)截至2024年1月1日生效,根据2018计划,另外 3,689,000 股普通股股份可用于发行,因为其中的年度自动增加规定的控制項。
綜合內在價值表示估計的基礎普通股公正價值與在進位期內和錢的期權行使價格之間的差異。行使的期權的總內在價值為$0.1 百萬美元和0.2 百萬,截至2024年9月30日和2023年9月30日止,分别为$9.1 百萬美元和0.9 百萬,截至2024年9月30日和2023年9月30日止,分别为$
期權授予的加權平均授予日期公平價值為$。19.42 15.124.42 截至2024年9月30日及2023年分別每股$,股票的期權授予的加權平均授予日期公平價值。15.35 $2023年12月31日和$2024年6月30日時現金逃跑價值分別是22.39 截至2024年9月30日及2023年分別每股$,股票的期權授予的加權平均授予日期公平價值。
2024年9月30日之前未彌賦的期權的未來股票報酬為$29.3 加權平均期間是$。 1.9
27

目錄
限制性股票單位
公司有關限制性股票單位活動的摘要,不包括2018計劃和2023計劃下的基於績效和市場的限制性股票單位,相關信息如下:
尚未行使的限制性股票單位加權平均授予日公允價值
(未經審計)
2024年1月1日的餘額
4,346,785$42.63 
已授予股份1,874,27321.31 
已授予且解鎖(572,985)53.74 
取消(682,506)46.73 
2024年9月30日的結餘
4,965,567$32.74 
未來截至2024年9月30日的未授予限制股票單位的股票型報酬為$119.1 加權平均期間是$。 2.0
基於績效的限制性股票單位
自二零二零年十一月起,董事會薪酬委員會開始批准,並開始向其僱員和非僱員授予以績效為基礎的限制股票單位(PSU)。授予的 PSU 包括在大約的績效期間內達到的財務和/或營運指標 0.64 年以及額外的服務期限要求最高可達 2 在達到績效指標後的數年。此外,當符合特定績效指標時,授予的單位可能會進行調整。預計 PSU 將在大約的期間內支出 0.64.5 年份視乎符合各自的績效指標和服務要求而定。
在2020年11月和2021年5月,作為這些PSU計劃的一部分,公司授予了PSUs,包括一個表現期的 4 年,再加上符合額外服務期要求的 剩余的六个月,即2024年12月31日屆滿时和2025年12月31日結束时。 ,如果達到授予標準,則對應每股公允價值為$113.40 每股$的平均加權授予日期公平價值為有限制的股票單位。148.19 。在2024年第三季度之前,因為未能達到計提標準,這些PSUs的報酬費用已被記錄。到2024年第三季度,這些PSUs的表現指標被認為已實現;因此公司記錄了累計費用$ 23.5與這些PSU相關的基於股票的補償費用高達百萬美元。 221,347 股票授予的股數的公允價值為$。113.40 每股$的平均加權授予日期公平價值為有限制的股票單位。148.19 美元/股。
2018年計劃下公司PSU活動摘要及相關資訊如下:
基於業績的限制性股票單元仍在流通。加權平均授予日公允價值
(未經審計)
2024年1月1日的餘額
412,490$91.25 
已授予股份870,26818.09 
已授予且解鎖(2,251)32.86 
根據業績成就調整後48,23432.84 
取消(36,852)76.65 
2024年9月30日的結餘
1,291,889$40.30 
截至2024年9月30日止,記錄的PSU股份報酬為$22.7 百萬美元和0.8 百萬,截至2024年9月30日和2023年9月30日止,分别为$26.3 百萬美元和1.3 分別為2024年9月30日結束的九個月和2023年。截至2024年9月30日,有概率在此日期前實現的未發行PSU未來股份報酬為$13.9 加權平均期間是$。 1.9
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目錄
基於市場的限制性股票單位
2020 年 5 月,董事會批准並批准 1,695,574 根據《2018 年計劃》的市場限制股票單位(MSU)向本公司每位聯合行政總裁提供,以達成董事會所訂立的市場基礎股價目標而定。MSU 包括 分別分期及每份分期的授權,須在公司的普通股票收市價維持在或高於預定的股價目標,在一段期間內 30 連續的日曆日。MSU 的授予日期公平價值是使用每個分期的蒙特卡洛估價模式來確定。每個分期的相關股票賠償費用是根據估計衍生服務期間的加速歸因方法來計算,這是 Monte Carlo 估值模型模擬的成功股價路徑達成每個分期價目標的持續時間中位數。
2021年1月1日,MSU第1部分因達到服務要求和市場績效指標而已經授予。至2022年6月30日,所有3個部分的MSU均已完全費用化。截至2023年12月31日, 2,260,764 所有板塊的股份中,2018計劃下以$ 所有板塊平均授予日公允價值為每股 $65.20 仍未授予的MSU於2024年3月被董事會批准取消,並同時批准向聯席執行長發放新獎勵,這被視為修改,然而由於公司的聯席執行長已完成服務要求,因此沒有被取消股權報酬支出。
股份補償費用
以下表格顯示員工與非員工相關的股票報酬費用效應:
三個月結束
九月三十日
截止九個月
九月三十日
2024202320242023
(未經審核)
(以千計)
精確腫瘤檢測成本
$1,484 $1,092 $4,020 $3,470 
開發服務費用及其他2,410 436 3,400 1,387 
研發費用
18,643 8,491 38,413 25,390 
銷售和營銷費用
13,215 5,061 27,633 18,387 
一般和行政費用
14,017 6,739 30,579 17,805 
基於股票的補償費用總計
$49,769 $21,819 $104,045 $66,439 
股票期權的估值
股票期權的授予日公允價值是使用Black-Scholes期權定價模型估算的,該模型採用以下加權平均假設:
結束於三個月的期間
九月三十日,
九個月結束了
九月三十日,
2024202320242023
(未經審計)
預期期限(年)
5.81 - 6.09
5.97
5.50 - 6.09
5.506.10
預期波動性
68.7% - 69.2%
69.4%
67.8% - 69.4%
69.4% –70.5%
無風險利率
3.8% - 4.1%
4.2%
3.8% - 4.5%
3.4% – 4.2%
預期股息收益率
%
%
%
%
使用Black-Scholes期權定價模型判斷授予日期股票期權的公允價值受公司普通股估計公允價值的影響,以及涉及多個複雜、主觀和通常需要重大判斷力來確定的變數的假設。評估假設如下所示:
普通股的公平價值
公司普通股的公平價值,由其普通股在納斯達克全球貨幣所成交的收盤價確定。
29

目錄
預期期限
預期期限代表期權授予的預期有效期,並且是使用簡化方法(基於設購日期和合約期限結束時間之中點)來確定,因為該公司已經得出結論,其股票期權行使歷史不足以提供可靠依據來估計預期期限。
預期波動性
在2018年10月4日與公司首次公開招股(IPO)相關的納斯達克全球精選市場上的普通股交易開始前,公司普通股並無活躍的交易市場。由於公司普通股的交易歷史數據有限,預期的波動性是基於同行業可比公開交易對等公司的平均波動性加上公司對可用期間的預期波動性進行估計。這些可比公司是根據它們的規模、生命週期階段或專業領域的相似性而選擇的。
無風險利率
無風險利率基於美國國庫券利率,其到期日與股票期權的預期期限相似。
預期股息率
公司未來可見不預期支付任何分紅派息,因此使用了預期的股息率為 零級.
2018員工股票購買計劃
2018年9月,公司董事會通過並獲股東批准了2018年員工股票購買計劃(ESPP)。ESPP初期已為發行保留了總共股份。 922,250 股份最初為ESPP發行預留。自2020年1月1日、2023年3月2日和2024年2月23日起,又有股份可供在ESPP下發行。 942,614, 1,026,1941,106,700 ESPP下發行的普通股份又增加了。
根據任何計劃限制,員工股票購買計劃(ESPP)允許符合資格的員工通常通過薪酬扣除,貢獻最多%的收入,以優惠價格每股購買公司的普通股。10購買ESPP下的普通股的價格等於發售期間首日或最後一天的公司普通股公允市值%較低者。85ESPP設有分開的發售期,分別開始於每年的5月15日和11月15日。二零二三年十二月,公司通過一家新成立的子公司(「2023 NSA 成員」),與由Heitman Capital Management LLC建議的州公積金基金(「2023 JV 投資者」,連同2023 NSA 成員「2023 JV 成員」)簽署了一份協議(「2023 JV 協議」),以收購和運營自存倉物業。2023 JV 協議規定,在為期24個月的投資期內(如果2023 JV 成員都同意,則可以有6個月的延長期限),2023 JV 成員可以提供高達$期權 million的權益資本,其中,2023 JV 投資者持有Venture %的所有權,2023 NSA 成員持有剩餘部分的所有權。 每年5月15日和11月15日開始的不同發售期。
在員工股票計劃下購買的普通股票份額為 nil 分別為截至2024年和2023年的九月三十日之三個月的 371,826298,781 分別為截至2024年和2023年的九月三十日之九個月的
員工股票購買計劃下授予的董事會采購權益的授予日公平價值,是根據每個發行期的第一天,使用Black-Scholes期權定價模型估計的。所使用的估值假設,與用於估值股票期權的假設基本一致,特別之處在於預期期限採用每次購買期的期限。
沒有 股票購買權是在2024年和2023年9月30日結束的三個月內根據ESPP授予的。 在2024年和2023年9月30日結束的九個月內,在ESPP下授予的股票購買權的授權日期公平價值是使用Black-Scholes期權定價模型估算的,其假設如下:
截至9月30日的九個月
20242023
(未經審計)
預期期限(年)
0.50
0.50
預期波動性
64.2%
76.6%
無風險利率
5.4%
5.2%
預期股息收益率
%
%
30

目錄
有關員工股票購買計劃的總補償費用為$0.9 ...美元和...美元,作為承租人租賃有關的現金收到的保證金已納入附表期末合併資產負債表的應付帳款及應計負債。0.8 百萬,截至2024年9月30日和2023年9月30日止,分别为$3.4 百萬美元和3.8 九個月截至2024年9月30日和2023年分別是百萬美元。截至2024年9月30日,關於員工股票購買計劃的未認列股票報酬費用為$0.5 百萬美元,預計將於剩餘發行期間的其餘期間予以確認 0.1
11.    Net Loss Per Share
The following table sets forth the computation of the basic and diluted net loss per share:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024202320242023
(unaudited)
(in thousands, except per share data)
Net loss, basic and diluted$(107,754)$(86,102)$(325,367)$(292,406)
Net loss per share, basic and diluted$(0.88)$(0.73)$(2.66)$(2.66)
Weighted-average shares used in computing net loss per share, basic and diluted123,051 117,736 122,406 109,791 
Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share, as the inclusion of all potential shares of common stock outstanding would have been anti-dilutive. The following weighted-average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented as they had an anti-dilutive effect:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024202320242023
(unaudited)
(in thousands)
Stock options 3,7533,6623,8923,485
Restricted stock units5,1043,2194,9383,382
MSUs2,2616462,261
PSUs1,2924381,071379
ESPP obligation197132228191
Convertible senior notes8,2258,2258,2258,225
Total18,57117,93719,00017,923
12.    Income Taxes
The income tax expense for the three and nine months ended September 30, 2024 was determined based upon estimates of the Company’s effective income tax rates in various jurisdictions. The difference between the Company’s effective income tax rate and the U.S. federal statutory rate is primarily attributable to state income taxes, foreign income taxes, the effect of certain permanent differences, and full valuation allowance against domestic net deferred tax assets.
The income tax expense for the three and nine months ended September 30, 2024, and 2023, relates primarily to state minimum income tax and income tax on the Company’s earnings in foreign jurisdictions.
13.    Segment and Geographic Information
The Company operates as one operating segment. The Company's chief operating decision makers are its Co-Chief Executive Officers, who review financial information presented on a consolidated basis for the purposes of making operating decisions, assessing financial performance and allocating resources.
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Table of Contents
The following table sets forth the Company’s revenue by geographic areas based on the customers’ locations:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024202320242023
(unaudited)
(in thousands)
United States$180,105 $135,735 $505,568 $383,908 
International11,371 7,295 31,634 24,986 
Total revenue
$191,476 $143,030 $537,202 $408,894 
As of September 30, 2024, and December 31, 2023, 99% and 98%, respectively, of the Company’s long-lived assets and right-of-use assets are located in the United States.
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Table of Contents
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, beliefs, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2023 and in Part II, Item 1A, “Risk Factors” of this Quarterly Report on Form 10-Q.
Overview
We are a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. We are transforming patient care by providing critical insights into what drives disease through our advanced blood and tissue tests, and real-world data. Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For patients with advanced-stage cancer, we have commercially launched Guardant360 laboratory developed test, or LDT, and Guardant360 CDx, the first comprehensive liquid biopsy test approved by the U.S. Food and Drug Administration, or the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer, or NSCLC, and breast cancer. We have also launched the Guardant360 TissueNext tissue test for advanced-stage cancer, Guardant Reveal blood test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients, and Guardant360 Response blood test to predict patient response to immunotherapy or targeted therapy eight weeks earlier than current standard-of-care imaging.
We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantOMNI blood test for advanced-stage cancer, and the GuardantINFINITY blood test, a next-generation smart liquid biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development. Using data collected from our tests, we have also developed our GuardantINFORM platform to help biopharmaceutical companies accelerate precision oncology drug development through the use of this in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.
For early cancer detection, in May 2022, we launched the Shield LDT test to address the needs of individuals eligible for colorectal cancer screening. From a simple blood draw, Shield uses a novel multimodal approach to detect colorectal cancer signals in the bloodstream, including DNA that is shed by tumors. In December 2022, we announced that the ECLIPSE study, a registrational study evaluating the performance of our Shield blood test for detecting colorectal cancer in average-risk adults, met co-primary endpoints. In addition, in March 2023, we submitted a premarket approval application, or PMA, for our Shield blood test to the FDA. In July 2024, we received FDA approval of our Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease, and in August 2024, our Shield blood test became commercially available in the U.S. as the first blood test approved by the FDA for primary colorectal cancer screening, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare. We also expect to expand into lung and multi-cancer screening with our investigational, next-generation Shield assay.
We currently perform clinical, research use only, and investigation use only tests in our laboratory located in Redwood City, California. Our Redwood City laboratory is certified pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, permitted by the New York State Department of Health, or NYSDOH, and licensed in California and four other states. We also perform research use only tests in our laboratory located in San Diego, California. In addition, our Redwood City, San Diego and Palo Alto, California laboratories are currently operated as centers for our research and technology development.
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We generated total revenue of $191.5 million and $143.0 million for the three months ended September 30, 2024, and 2023, respectively, and $537.2 million and $408.9 million for the nine months ended September 30, 2024, and 2023, respectively. We also incurred net losses of $107.8 million and $86.1 million for the three months ended September 30, 2024, and 2023, respectively, and $325.4 million and $292.4 million for the nine months ended September 30, 2024, and 2023, respectively. We have funded our operations to date principally from the sale of our stock, convertible senior notes, and revenue from our precision oncology testing and development services and other. In May 2023, we completed a follow-on underwritten public offering, in which we issued and sold 14,375,000 shares of our common stock at a price of $28.00 per share and received net proceeds of $381.4 million after deducting underwriting discounts and commissions and other offering costs of $21.1 million. In December 2023, we completed a registered direct offering with an investment management firm, in which we issued and sold 3,387,446 shares of our common stock at a price of $26.77 per share, and received net proceeds of $90.6 million. As of September 30, 2024, we had cash, cash equivalents, restricted cash and marketable debt securities of approximately $1.0 billion.
Factors affecting our performance
We believe there are several important factors that have impacted and that we expect will impact our operating performance and results of operations, including:
Testing volume, pricing and customer mix. Our revenue and costs are affected by the volume of testing and mix of customers from period to period. We evaluate both the volume of tests that we perform for patients on behalf of clinicians and the number of tests we perform for biopharmaceutical companies. Our performance depends on our ability to retain and broaden adoption with existing customers, as well as attract new customers. We believe that the test volume we receive from clinicians and biopharmaceutical companies are indicators of growth in each of these customer verticals. Customer mix for our tests has the potential to significantly affect our results of operations, as the average selling price for biopharmaceutical sample testing is currently higher than our average reimbursement for clinical tests because we are not a contracted provider for, or our tests are not covered by clinical patients’ insurance for, the majority of the tests that we perform for patients on behalf of clinicians. Precision oncology revenue from clinical tests for patients covered by Medicare represented approximately 38% and 45% of our precision oncology revenue from clinical customers for the three months ended September 30, 2024, and 2023, respectively, and approximately 40% and 44% of our precision oncology revenue from clinical customers for the nine months ended September 30, 2024, and 2023, respectively.
Payer coverage and reimbursement. Our revenue depends on achieving broad coverage and reimbursement for our tests from third-party payers, including both commercial and government payers. Precision oncology revenue from tests for clinical customers is calculated based on our expected cash collections, using the estimated variable consideration. The variable consideration is estimated based on historical collection patterns as well as the potential for changes in future reimbursement behavior by one or more payers. Estimation of the impact of the potential for changes in reimbursement requires significant judgment and considers payers' past patterns of changes in reimbursement as well as any stated plans to implement changes. Any cash collections over the expected reimbursement period exceeding the estimated variable consideration are recorded in future periods based on actual cash received. Payment from commercial payers can vary depending on whether we have entered into a contract with the payers as a “participating provider” or do not have a contract and are considered a “non-participating provider”. Payers often reimburse non-participating providers, if at all, at a lower amount than participating providers. Because we are not contracted with these payers, they determine the amount that they are willing to reimburse us for any of our tests and they can prospectively and retrospectively adjust the amount of reimbursement, adding to the complexity in estimating the variable consideration. When we contract with a payer to serve as a participating provider, reimbursements by the payer are generally made pursuant to a negotiated fee schedule and are limited to only covered indications or where prior approval has been obtained. Becoming a participating provider can result in higher reimbursement amounts for covered uses of our tests and, potentially, no reimbursement for non-covered uses identified under the payer’s policies or the contract. As a result, the potential for more favorable reimbursement associated with becoming a participating provider may be offset by a potential loss of reimbursement for non-covered uses of our tests. Current Procedural Terminology, or CPT, coding plays a significant role in how our tests are reimbursed both from commercial and governmental payers. In addition, Z-Code Identifiers are used by certain payers, including under Medicare's Molecular Diagnostic Services Program, or MolDx, to supplement CPT codes for our molecular diagnostics tests. Changes to the codes used to report to payers may result in significant changes in its reimbursement. If their policies were to change in the future to cover additional cancer indications, we anticipate that our total reimbursement would increase. In January 2021, a proprietary laboratory analyses, or PLA code was issued for our Guardant360 CDx with an effective date in April 2021. Additionally, based on this new PLA code, we applied to the Centers for Medicare and Medicaid Services, or CMS, for our Guardant360
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CDx test to become an advanced diagnostic laboratory test, or ADLT. In March 2021, CMS approved ADLT status to the Guardant360 CDx test, based on which Medicare paid us at the lowest available commercial rate per test, from April 1, 2021 to December 31, 2021. Effective January 1, 2022, Medicare started to reimburse Guardant360 CDx services at the median rate of claims paid by commercial payers. In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, conveyed coverage for our Guardant360 TissueNext test under the existing local coverage determination. The policy covers our Guardant360 TissueNext test for Medicare fee-for-service patients with advanced solid tumor cancers. In July 2022, Palmetto GBA conveyed coverage for our Guardant Reveal test for fee-for-service Medicare patients in the United States with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy, with an effective date of December 2021. In April 2023, Palmetto GBA conveyed coverage for our Guardant360 Response test for fee-for-service Medicare patients in the U.S. with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy, tested four to ten weeks from therapy initiation. Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 LDT test to the same rate as our Guardant360 CDx test.
In August 2024, following the FDA approval, our Shield blood test met the coverage requirements by Medicare based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests. The test is covered once every three years for eligible Medicare beneficiaries.
Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received differs from the revenue recorded. Due to this variability and unpredictability, previously recorded revenue adjustments are not indicative of future revenue adjustments from actual cash collections, which may fluctuate significantly. Additionally, if coding changes were to occur, payments for certain uses of our tests could be reduced, put on hold, or eliminated. This variability and unpredictability could increase the risk of future revenue reversal and result in our failing to meet any previously publicly stated guidance we may provide.
Biopharmaceutical customers. Our revenue also depends on our ability to attract, maintain and expand relationships with biopharmaceutical customers. As we continue to develop these relationships, we expect to support a growing number of clinical studies globally and continue to have opportunities to offer our platform to such customers for development services, including companion diagnostic development, novel target discovery and validation, as well as clinical study enrollment. For example, our tests are being developed as companion diagnostics under collaborations with biopharmaceutical companies.
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Research and development. A significant aspect of our business is our investment in research and development, including the development of new products. In particular, we have invested heavily in clinical studies as we believe these studies are critical to gaining physician adoption and driving favorable coverage decisions by payers. With respect to Guardant Reveal, in October 2021, we initiated a 1,000-patient prospective, observational, multi-center study, which we refer to as the ORACLE study, designed to evaluate the performance of our Guardant Reveal liquid biopsy test to predict cancer recurrence after curative intent treatment, across 11 solid tumor types. In addition, with respect to Guardant Reveal, in December 2022, we entered into a partnership with Susan G. Komen®, the world’s leading breast cancer organization, to bring the patient perspective to the development of clinical studies that help identify early-stage breast cancer patients who are at high risk of disease recurrence and may benefit from additional monitoring or therapy. With respect to Shield, in December 2022, we announced that the ECLIPSE study, a registrational study evaluating the performance of our Shield blood test for detecting colorectal cancer in average-risk adults, met co-primary endpoints. The test demonstrated 83% sensitivity in detecting individuals with colorectal cancer. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. These results exceed the performance criteria set forth by the CMS for reimbursement. This test also demonstrated 13% sensitivity in detecting advanced adenomas. Based on these study results, in March 2023, we submitted a PMA to the FDA for our Shield blood test. In July 2024, we received FDA approval of our Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease, and in August 2024, our Shield blood test became commercially available in the U.S. as the first blood test approved by the FDA for primary colorectal cancer screening, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare. In addition, to evaluate the performance of our investigational, next-generation Shield assay in detecting lung cancer in high-risk individuals ages 50-80, in January 2022, we initiated a nearly 10,000-patient prospective, registrational study, which we refer to as the SHIELD LUNG study. We have expended considerable resources, and expect to increase such expenditures over the next few years, to support our research and development programs with the goal of fueling further innovation.
International expansion. A component of our long-term growth strategy is to expand our commercial footprint internationally, and we expect to increase our sales and marketing expense to execute on this strategy. We currently offer our tests in countries outside the United States primarily through distributor relationships, direct contracts with hospitals, and partnerships with local research organizations and laboratory companies.
In May 2018, we formed and capitalized Guardant Health AMEA, Inc., with SoftBank, relating to the sale, marketing and distribution of our tests generally outside the Americas and Europe, and to accelerate commercialization of our products in Asia, the Middle East and Africa. In June 2022, we purchased all of the shares held by SoftBank and its affiliates, and upon completion of the transaction, we obtained full control over operations of Guardant Health AMEA, Inc. In July 2023, Japan's Ministry of Health, Labour and Welfare granted national reimbursement approval for our Guardant360 CDx test for patients with advanced or metastatic solid tumor cancers in Japan.
In December 2020, we signed our first public private partnership agreement with Vall D'Hebron Institute of Oncology, or VHIO, one of Europe’s leading cancer research institutions, and in May 2022, the first blood-based cancer testing services in Europe based on our digital sequencing platform became available at the VHIO testing facility in Spain. In October 2021, we signed a partnership agreement with The Royal Marsden NHS Foundation Trust, or Royal Marsden, a premier cancer center within the United Kingdom, or the UK, for patient care, research and teaching of all types of cancer, and in April 2023, the blood-based cancer testing services based on our digital sequencing platform became available at Royal Marsden testing facility in the UK. In September 2024, we signed a partnership agreement with the Agostino Gemelli University Polyclinic Foundation IRCCS, one of Italy’s largest and most renowned hospitals known for its advanced oncology services, including diagnostics, treatment, and research, to establish an in-house liquid biopsy testing service within its hospital system.
In June 2022, we signed a strategic partnership agreement with Adicon Holdings Limited, or Adicon, a leading independent clinical laboratory company based in China, and in December 2023, the blood-based cancer testing services based on our digital sequencing platform became available at Adicon's testing facility, which offers our industry-leading comprehensive genomic profiling tests to biopharmaceutical companies to advance clinical research and the development of new cancer therapies in China.
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The success of our international expansion strategy depends on a number of factors, including the internal and external constraints placed on our international laboratory partners and biopharmaceutical companies in the context of broader global, regional and U.S. economic and geopolitical conditions. For example, deterioration in the bilateral relationship between the United States and China may impact international trade, government spending, regional stability and macroeconomic conditions. The impact of these potential developments, including any resulting sanctions, export controls or other restrictive actions that may be imposed against governmental or other entities in, for example, China, may contribute to disruption of our international partnerships and instability and volatility in the global markets, which in turn could adversely impact our operations and weaken our financial results.
Sales and marketing expense. Our financial results have historically, and will likely continue to, fluctuate significantly based upon the impact of our sales and marketing expense, increase in headcount, and in particular, our various marketing programs around existing and new product introductions.
General and administrative expense. Our financial results have historically, and will likely continue to, fluctuate significantly based upon the impact of our general and administrative expense, and in particular, our stock-based compensation expense. Our equity awards, including performance-based restricted stock units, are intended to retain and incentivize employees to lead us to sustained, long-term superior financial and operational performance.
While each of these areas presents significant opportunities for us, they also pose significant risks and challenges that we must address. See Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023, and Part II, Item 1A, “Risk Factors” of this Quarterly Report on Form 10-Q, for more information.
Components of results of operations
Revenue
We derive our revenue from two sources: (i) precision oncology testing, and (ii) development services and other.
Precision oncology testing. Precision oncology testing revenue is generated from sales of our tests to clinical and biopharmaceutical customers, including those tests delivered by labs operated by our strategic partners. In the United States, through September 30, 2024, we generally performed tests as an out-of-network service provider without contracts with health insurance companies. We submit claims for payment for tests performed for patients covered by U.S. private payers. We also submit claims to Medicare for reimbursement for our Guardant360 CDx, Guardant360 LDT, Guardant360 TissueNext, Guardant Reveal and Guardant360 Response clinical testing performed for qualifying patients. Precision oncology revenue from clinical tests for patients covered by Medicare represented approximately 38% and 45% of our precision oncology revenue from clinical customers during the three months ended September 30, 2024, and 2023, respectively, and 40% and 44% of our precision oncology revenue from clinical customers during the nine months ended September 30, 2024, and 2023, respectively.
Development services and other. Development services revenue primarily represents services that we provide to biopharmaceutical companies, large medical institutions and international laboratory partners. We collaborate with biopharmaceutical companies in the development and clinical studies of new drugs. As part of these collaborations, we provide services related to regulatory filings to support companion diagnostic device submissions for our test panels. Under these arrangements, we generate revenue from progression of our collaboration efforts, as well as from provision of on-going support. In addition to companion diagnostic development and regulatory approval services, we also provide other development services, including clinical study setup, monitoring and maintenance, testing development and support, GuardantConnect and GuardantINFORM. Other revenue includes amounts derived from licensing our technologies, kit fulfillment, and delivery of our Shield screening tests.
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Costs and operating expenses
Cost of precision oncology testing. Cost of precision oncology testing generally consists of cost of materials, including inventory write-downs; cost of labor, including employee benefits, bonus, and stock-based compensation; equipment and infrastructure expenses associated with processing test samples, such as sample accessioning, library preparation, sequencing, and quality control analyses; freight; curation of test results for physicians; phlebotomy; and license fees due to third parties. Infrastructure expenses include depreciation of laboratory equipment, rent costs, depreciation of leasehold improvements and information technology costs. Costs associated with performing our tests are recorded as the tests are performed regardless of whether revenue was recognized with respect to the tests. While we do not believe the technologies underlying the third-party licenses are necessary to permit us to provide our tests, we do believe these technologies are potentially valuable and of possible strategic importance to us or our competitors.
We expect the cost of precision oncology testing to generally increase in line with the increase in the number of tests we perform, but we expect the cost per test to decrease modestly over time due to the efficiencies we may gain as test volume increases, and from automation and other cost reductions.
Cost of development services and other. Cost of development services and other primarily includes costs incurred for the performance of development services requested by our biopharmaceutical customers, and costs associated with our partnership agreements and delivery of Shield screening tests, which comprise of labor and material costs including any inventory write-downs. For development of new products, costs incurred before technological feasibility has been achieved are reported as research and development expenses, while costs incurred thereafter are reported as cost of revenue. Cost of development services and other will vary depending on the nature, timing and scope of customer projects.
Research and development expense. Research and development expenses consist of costs incurred to develop technology and include salaries and benefits including stock-based compensation, reagents and supplies used in research and development laboratory work, infrastructure expenses, including facility occupancy and information technology costs, contract services, other outside costs and costs to develop our technology capabilities. Research and development expenses also include costs related to activities performed under contracts with biopharmaceutical companies before technological feasibility has been achieved. Research and development costs are expensed as incurred. Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as expense in the period in which the related goods are received or services are rendered. Costs to develop our technology capabilities are recorded as research and development unless they meet the criteria to be capitalized as internal-use software costs. We expect that our research and development expenses will continue to increase in absolute dollars as we continue to innovate and develop additional products, expand our genomic and medical data management resources and conduct our ongoing and new clinical studies.
Sales and marketing expense. Our sales and marketing expenses are expensed as incurred and include costs associated with our sales organization, including our direct sales force and sales management, client services, marketing and reimbursement, medical affairs, as well as business development personnel who are focused on our biopharmaceutical customers. These expenses consist primarily of salaries, commissions, bonuses, employee benefits, travel expenses and stock-based compensation, as well as marketing, sales incentives, and educational activities and overhead expenses. We expect our sales and marketing expenses to increase in absolute dollars as we expand our sales force, increase our presence within and outside of the United States, and increase our marketing activities to drive further awareness and adoption of our tests.
General and administrative expense. Our general and administrative expenses include costs for our executive, accounting and finance, information technology, legal and human resources functions. These expenses consist principally of salaries, bonuses, employee benefits, travel expenses and stock-based compensation, as well as professional services fees such as consulting, audit, tax and legal fees, and general corporate costs and overhead expenses. In addition, our general and administrative expenses also include severance costs related to workforce reduction. We expect that our general and administrative expenses will continue to increase as we incur additional costs to support the growth of our business. These expenses, though expected to increase in absolute dollars, are expected to decrease modestly as a percentage of revenue in the long term, though they may fluctuate as a percentage of revenue from period to period due to the timing and extent of these expenses being incurred.
Interest income
Interest income consists of interest earned on our cash, cash equivalents, restricted cash and marketable debt securities.
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Interest expense
Interest expense consists primarily of charges relating to amortization of debt issuance costs.
Other income (expense), net
Other income (expense), net consists of foreign currency exchange gains and losses, unrealized and realized gains and losses of marketable equity securities, and impairment of non-marketable equity securities and other related assets. We expect our foreign currency gains and losses to continue to fluctuate in the future due to changes in foreign currency exchange rates.
Results of operations
The following tables set forth the significant components of our results of operations for the periods presented.
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024202320242023
(unaudited)
(in thousands)
Revenue:
Precision oncology testing$180,604 $133,423 $503,351 $372,060 
Development services and other10,872 9,607 33,851 36,834 
Total revenue
191,476 143,030 537,202 408,894 
Costs and operating expenses:
Cost of precision oncology testing(1)
66,095 53,648 191,116 148,111 
Cost of development services and other(1)
8,394 3,966 21,090 16,424 
Research and development expense(1)
87,306 93,851 254,210 277,338 
Sales and marketing expense(1)
97,880 68,934 260,172 216,100 
General and administrative expense(1)
49,129 36,174 128,243 118,135 
Total costs and operating expenses
308,804 256,573 854,831 776,108 
Loss from operations
(117,328)(113,543)(317,629)(367,214)
Interest income13,257 11,690 42,038 21,477 
Interest expense(646)(644)(1,936)(1,933)
Other income (expense), net(3,007)16,885 (47,272)56,490 
Loss before provision for income taxes
(107,724)(85,612)(324,799)(291,180)
Provision for income taxes
30 490 568 1,226 
Net loss
$(107,754)$(86,102)$(325,367)$(292,406)
(1)Amounts include stock-based compensation expense as follows:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024202320242023
(unaudited)
(in thousands)
Cost of precision oncology testing$1,484 $1,092 $4,020 $3,470 
Cost of development services and other2,410 436 3,400 1,387 
Research and development expense18,643 8,491 38,413 25,390 
Sales and marketing expense13,215 5,061 27,633 18,387 
General and administrative expense14,017 6,739 30,579 17,805 
    Total stock-based compensation expense
$49,769 $21,819 $104,045 $66,439 
In November 2020 and May 2021, we granted restricted stock units with certain performance metrics, or PSUs, consisting of a performance period of 4 years combined with an additional service period requirement of six months
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should the vesting criteria be met, with a grant date fair value of $113.40 per share and $148.19 per share, respectively. Before the third quarter of 2024, no compensation expense for these PSUs had been recorded since the achievement of the performance metrics did not meet the criteria for accrual. In the third quarter of 2024, the performance metrics of these PSUs were considered to be achieved; as such we recorded a cumulative charge of $23.5 million in stock-based compensation expense related to these PSUs, based on 221,347 shares granted with fair values of $113.40 per share and $148.19 per share, of which $2.2 million was recorded to cost of development services and other, and $11.1 million, $6.3 million and $3.9 million was recorded as components of research and development expense, sales and marketing expense, and general and administrative expense, respectively.
Comparison of the Three Months Ended September 30, 2024 and 2023
Revenue
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Precision oncology testing
$180,604 $133,423 $47,181 35 %
Development services and other
10,872 9,607 1,265 13 %
Total revenue
$191,476 $143,030 $48,446 34 %
Total revenue was $191.5 million for the three months ended September 30, 2024, compared to $143.0 million for the three months ended September 30, 2023, an increase of $48.4 million, or 34%.
Precision oncology testing revenue increased to $180.6 million for the three months ended September 30, 2024, from $133.4 million for the three months ended September 30, 2023, an increase of $47.2 million, or 35%.
Precision oncology revenue from tests for clinical customers was $141.2 million for the three months ended September 30, 2024, up 36% from $103.9 million for the three months ended September 30, 2023. This increase in clinical testing revenue was driven primarily by an increase in sample volume and increase in reimbursement for our tests. Total tests for clinical customers increased to approximately 53,100 for the three months ended September 30, 2024, from approximately 43,900 for the three months ended September 30, 2023. The increase in reimbursement for our tests for the three months ended September 30, 2024 was primarily attributable to an increase in Medicare reimbursement for our Guardant360 LDT test to $5,000, effective January 1, 2024; and an increase in both Medicare Advantage and commercial payer reimbursement.
Precision oncology revenue from tests for biopharmaceutical customers was $39.4 million for the three months ended September 30, 2024, up 34% from $29.5 million for the three months ended September 30, 2023. This increase in revenue was driven primarily by an increase in sample volume. Total tests for biopharmaceutical customers increased to approximately 10,500 for the three months ended September 30, 2024, from approximately 7,500 for the three months ended September 30, 2023.
Development services and other revenue increased to $10.9 million for the three months ended September 30, 2024, from $9.6 million for the three months ended September 30, 2023, an increase of $1.3 million. Other revenue includes amounts derived from delivery of our Shield screening tests during the three months ended September 30, 2024.
Cost of Revenue
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Cost of precision oncology testing$66,095 $53,648 $12,447 23 %
Cost of development services and other8,394 3,966 4,428 112 %
Total cost of revenue $74,489 $57,614 $16,875 29 %
Total cost of revenue was $74.5 million for the three months ended September 30, 2024, compared to $57.6 million for the three months ended September 30, 2023, an increase of $16.9 million, or 29%.
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Cost of precision oncology testing was $66.1 million for the three months ended September 30, 2024, compared to $53.6 million for the three months ended September 30, 2023, an increase of $12.4 million, or 23%. This increase in cost of precision oncology testing was primarily attributable to an increase in sample volumes, resulting in a $10.3 million increase in material costs, and a $1.5 million increase in production labor and overhead costs.
Cost of development services and other was $8.4 million for the three months ended September 30, 2024, compared to $4.0 million for the three months ended September 30, 2023, an increase of $4.4 million. This increase in cost of development services and other was primarily due to costs associated with providing Shield screening tests, and costs associated with our companion diagnostics collaboration projects and other service agreements with biopharmaceutical customers during the three months ended September 30, 2024.
Operating Expenses
Research and development expense
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Research and development expense
$87,306 $93,851 $(6,545)(7)%
Research and development expenses were $87.3 million for the three months ended September 30, 2024, compared to $93.9 million for the three months ended September 30, 2023, a decrease of $6.5 million, or 7%. This decrease was primarily due to a decrease of $15.4 million in outside services costs primarily driven by a reduction in the ECLIPSE clinical study costs as the study nears completion, and a decrease of $3.9 million in material costs, partially offset by an increase of $11.1 million in stock-based compensation primarily related to the PSUs discussed in the Results of operations section above.
Sales and marketing expense
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Sales and marketing expense
$97,880 $68,934 $28,946 42 %
Sales and marketing expenses were $97.9 million for the three months ended September 30, 2024, compared to $68.9 million for the three months ended September 30, 2023, an increase of $28.9 million, or 42%. This increase was related to commercial team buildout and marketing activities to support existing products and the Shield product launch, primarily resulting in an increase of $10.1 million in other personnel costs, an increase of $7.7 million in marketing activity related costs, and an increase of $3.2 million in information technology infrastructure costs. This increase was also attributable to an increase of $8.2 million in stock-based compensation, primarily related to the PSUs of $6.3 million discussed in the Results of operations section above.
General and administrative expense
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
General and administrative expense
$49,129 $36,174 $12,955 36 %
General and administrative expenses were $49.1 million for the three months ended September 30, 2024, compared to $36.2 million for the three months ended September 30, 2023, an increase of $13.0 million, or 36%. This increase was primarily due to an increase of $7.3 million in stock-based compensation, including $3.9 million related to the PSUs discussed in the Results of operations section above, and an increase of $3.0 million in other personnel costs.
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Interest income
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Interest income
$13,257 $11,690 $1,567 13 %
Interest income was $13.3 million for the three months ended September 30, 2024, compared to $11.7 million for the three months ended September 30, 2023, an increase of $1.6 million, or 13%, primarily attributable to higher rates of return on our investments.
Interest expense
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Interest expense
$(646)$(644)$(2)— %
Interest expense was primarily attributable to the amortization of debt issuance costs related to our convertible senior notes issued in November 2020, for the three months ended September 30, 2024, and 2023.
Other income (expense), net
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Other income (expense), net
$(3,007)$16,885 $(19,892)(118)%
Other income (expense), net was a $3.0 million expense for the three months ended September 30, 2024, primarily attributable to $1.7 million of net unrealized and realized losses recorded for our marketable equity security investment in Lunit, Inc. during the period. Other income (expense), net was a $16.9 million income for the three months ended September 30, 2023, primarily attributable to $16.6 million of unrealized gains recorded for our marketable equity security investment in Lunit, Inc. during the period.
Provision for income taxes
Three Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Provision for income taxes
$30 $490 $(460)(94)%
Provision for income taxes was immaterial for the three months ended September 30, 2024, and 2023.
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Comparison of the Nine Months Ended September 30, 2024 and 2023
Revenue
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Precision oncology testing
$503,351 $372,060 $131,291 35 %
Development services and other
33,851 36,834 (2,983)(8)%
Total revenue
$537,202 $408,894 $128,308 31 %
Total revenue was $537.2 million for the nine months ended September 30, 2024, compared to $408.9 million for the nine months ended September 30, 2023, an increase of $128.3 million, or 31%.
Precision oncology testing revenue increased to $503.4 million for the nine months ended September 30, 2024, from $372.1 million for the nine months ended September 30, 2023, an increase of $131.3 million, or 35%.
Precision oncology revenue from tests for clinical customers was $397.2 million for the nine months ended September 30, 2024, up 34% from $295.7 million for the nine months ended September 30, 2023. This increase in clinical testing revenue was driven primarily by an increase in sample volume and increase in reimbursement for our tests. Total tests for clinical customers increased to approximately 149,400 for the nine months ended September 30, 2024, from approximately 126,500 for the nine months ended September 30, 2023. The increase in reimbursement for our tests for the nine months ended September 30, 2024 was primarily attributable to an increase in Medicare reimbursement for our Guardant360 LDT test to $5,000, effective January 1, 2024; and an increase in both Medicare Advantage and commercial payer reimbursement.
Precision oncology revenue from tests for biopharmaceutical customers was $106.1 million for the nine months ended September 30, 2024, up 39% from $76.4 million for the nine months ended September 30, 2023. This increase in revenue was primarily due to an increase in sample volume. Total tests for biopharmaceutical customers increased to approximately 29,425 for the nine months ended September 30, 2024, from approximately 20,350 for the nine months ended September 30, 2023.
Development services and other revenue decreased to $33.9 million for the nine months ended September 30, 2024, from $36.8 million for the nine months ended September 30, 2023, a decrease of $3.0 million. Other revenue includes amounts derived from delivery of our Shield screening tests during the nine months ended September 30, 2024.
Cost of Revenue
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(dollars in thousands)
Cost of precision oncology testing$191,116 $148,111 $43,005 29 %
Cost of development services and other21,090 16,424 4,666 28 %
Total cost of revenue$212,206 $164,535 $47,671 29 %
Total cost of revenue was $212.2 million for the nine months ended September 30, 2024, compared to $164.5 million for the nine months ended September 30, 2023, an increase of $47.7 million, or 29%.
Cost of precision oncology testing was $191.1 million for the nine months ended September 30, 2024, compared to $148.1 million for the nine months ended September 30, 2023, an increase of $43.0 million, or 29%. This increase in cost of precision oncology testing was primarily attributable to an increase in sample volumes, and an increase in average cost per sample primarily due to changes in product mix, resulting in a $33.7 million increase in material costs, a $6.4 million increase in production labor and overhead costs, and a $2.4 million increase in other costs, including costs related to collection kits, freight and professional services.
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Cost of development services and other was $21.1 million for the nine months ended September 30, 2024, compared to $16.4 million for the nine months ended September 30, 2023, an increase of $4.7 million. This increase in cost of development services and other was primarily due to costs associated with our companion diagnostics collaboration projects and other service agreements with biopharmaceutical customers, and costs associated with providing Shield screening tests during the nine months ended September 30, 2024.
Operating Expenses
Research and development expense
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Research and development
$254,210 $277,338 $(23,128)(8)%
Research and development expenses were $254.2 million for the nine months ended September 30, 2024, compared to $277.3 million for the nine months ended September 30, 2023, a decrease of $23.1 million, or 8%. This decrease was primarily due to a decrease of $30.4 million in outside services costs primarily driven by a reduction in the ECLIPSE clinical study costs as the study nears completion, a decrease of $10.5 million in material costs, and a decrease of $3.0 million in information technology infrastructure costs, partially offset by an increase of $13.0 million in stock-based compensation, primarily related to the PSUs of $11.1 million discussed in the Results of operations section above, and an increase of $7.7 million in other personnel costs.
Sales and marketing expense
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Sales and marketing
$260,172 $216,100 $44,072 20 %
Sales and marketing expenses were $260.2 million for the nine months ended September 30, 2024, compared to $216.1 million for the nine months ended September 30, 2023, an increase of $44.1 million, or 20%. This increase was related to commercial team buildout and marketing activities to support existing products and the Shield product launch, primarily resulting in an increase of $19.1 million in other personnel costs, an increase of $9.3 million in marketing activity related costs, and an increase of $8.3 million in information technology infrastructure costs. This increase was also attributable to an increase of $9.2 million in stock-based compensation, primarily related to the PSUs of $6.3 million discussed in the Results of operations section above.
General and administrative expense
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
General and administrative
$128,243 $118,135 $10,108 %
General and administrative expenses were $128.2 million for the nine months ended September 30, 2024, compared to $118.1 million for the nine months ended September 30, 2023, an increase of $10.1 million, or 9%. This increase was primarily due to an increase of $12.8 million in stock-based compensation, including $3.9 million related to the PSUs discussed in the Results of operations section above, and an increase of $10.1 million in other personnel costs, partially offset by a decrease of $7.5 million in severance costs related to a workforce reduction incurred in the first quarter of 2023, and a decrease of $7.1 million in legal expenses.
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Interest income
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Interest income
$42,038 $21,477 $20,561 96 %
Interest income was $42.0 million for the nine months ended September 30, 2024, compared to $21.5 million for the nine months ended September 30, 2023, an increase of $20.6 million, primarily attributable to higher rates of return on our investments.
Interest expense
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Interest expense
$(1,936)$(1,933)$(3)— %
Interest expense was primarily attributable to the amortization of debt issuance costs related to our convertible senior notes issued in November 2020, for the nine months ended September 30, 2024, and 2023.
Other income (expense), net
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Other income (expense), net
$(47,272)$56,490 $(103,762)(184)%
Other income (expense), net was a $47.3 million expense for the nine months ended September 30, 2024, primarily attributable to $47.2 million of net unrealized and realized losses recorded for our marketable equity security investment in Lunit, Inc. during the period. Other income (expense), net was a $56.5 million income for the nine months ended September 30, 2023, primarily attributable to $84.5 million of unrealized gains recorded for our marketable equity security investment in Lunit, Inc., partially offset by $29.1 million of impairment recorded for our non-marketable equity security investments and other related assets during the period.
Provision for income taxes
Nine Months Ended September 30,
Change
20242023
$
%
(unaudited)
(in thousands)
Provision for income taxes
$568 $1,226 $(658)(54)%
Provision for income taxes was immaterial for the nine months ended September 30, 2024, and 2023.
Liquidity and capital resources
We have incurred losses and negative cash flows from operations since our inception, and as of September 30, 2024, we had an accumulated deficit of $2.5 billion. We expect to incur additional operating losses in the near future and our operating expenses will increase as we continue to invest in clinical studies and develop new products, expand our sales organization, and increase our marketing efforts to drive market adoption of our tests. As demand for our tests are expected to continue to increase from physicians and biopharmaceutical companies, we anticipate that our capital expenditure requirements could also increase if we require additional laboratory capacity.
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We have funded our operations to date principally from the sale of stock, convertible debt and through revenue from precision oncology testing and development services and other. As of September 30, 2024, we had cash, cash equivalents, restricted cash and marketable debt securities of $1.0 billion. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to provide liquidity while ensuring capital preservation.
Based on our current business plan, we believe our current cash, cash equivalents and restricted cash and anticipated cash flows from operations, will be sufficient to meet our anticipated cash requirements for more than 12 months from the date of this Quarterly Report on Form 10-Q. We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. As revenue from precision oncology testing and development services and other is expected to grow long-term, we expect our accounts receivable and inventory balances to increase. Any increase in accounts receivable and inventory may not be completely offset by increases in accounts payable and accrued liabilities, which could impact our working capital balances.
如果由於顧客支付比我們預期的低得多的匯款率或本《Form 10-Q季度報告》和截至2023年12月31日的我們10-K表格中描述的其他風險,使得我們手頭現金、現金等價物和受限現金以及預期的營運現金流不足以滿足我們的流動性需求,我們可能會尋求出售額外的普通或優先股權或可轉換債務證券,設立信貸額度,或採取第三方融資或尋求其他債務融資形式。出售股權和可轉換債券證券可能會導致對我們股東的稀釋,對於優先股權證券或可轉換債務而言,這些證券可能設定具有優先權、偏好或特權的條款,優於我們普通股。發行的債券證券條款或根據信貸協議的融資方式可能會對我們業務實施重大限制。 如果我們通過合作和許可安排籌集資金,我們可能需要放棄對我們平台技術或產品的重大權利,或以對我們不利的條款授予許可。可能無法以合理條件或根本無法為我們提供額外資本。
市場公開發行計畫
2024年8月,我們與Jefferies LLC(代理商)簽署了一項公開市場銷售協議,即銷售協議,涉及一項根據我們自行決定,可能不時提供和賣出我們普通股股份的在市場的發行計劃,總額最多400.0百萬美元,透過代理商,根據銷售協議的條款和條件。在2024年9月30日結束的三個月裡,沒有股份在銷售協議下賣出。
現金流量
以下表格概述了我們所報告期間的現金流量:
截至9月30日的九個月
20242023
(未經審計)
(以千為單位)
經營活動所使用之淨現金流量$(175,345)$(246,247)
投資活動提供的淨現金流量(使用)$(271,838)$176,796 
籌資活動提供的淨現金$1,939 $386,807 
營運活動
2024年9月30日結束的九個月內,營業活動使用的現金為17530萬美元,這是由於凈損失32540萬美元和我們營運資產和負債的現金影響凈變動5800萬美元所致,部分抵銷了20810萬美元的非現金費用。非現金費用主要包括10400萬美元的股票報酬、4720萬美元的Lunit, Inc.可轉讓權益證券投資的淨未實現和實現虧損、3190萬美元的折舊和攤銷以及2340萬美元的營運租賃成本。我們營運資產和負債的現金影響凈變動主要是由營運租賃負債支付2700萬美元(扣除租戶改善津貼收入)、應付帳款及應付款項減少1980萬美元、存貨淨增加1030萬美元以及預付費用和其他流動資產淨增加920萬美元,部分抵銷了逕期收入增加960萬美元。
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目錄
2023年9月30日結束的九個月,經營活動使用現金$24620萬,主要由於$29240萬的淨虧損和$1030萬的營運資產及負債淨變動現金影響所致,部分抵銷了$5650萬的非現金費用。非現金費用主要包括$6640萬的股票報酬、$3200萬的折舊和攤提、$2910萬的非流通股權證券和其他相關資產減損,以及$2210萬的營運租賃成本,部分抵銷了$8450萬的Lunit, Inc市場股權投資未實現收益,以及$1090萬的市場債券折價攤提。營運資產及負債淨變動現金影響主要是由於存貨淨額增加$2540萬,因預測檢測量增加,以及營運租賃負債支付淨值$2270萬並收到租戶裝修津貼,部分抵銷了應付帳款及應計負債增加$2660萬,主要由於商品和服務採購增加,應收帳款淨額減少$840萬,及逆向初始營收增加$320萬。
投資活動
2024年9月30日結束的九個月中,投資活動使用的現金為27180萬美元,主要來自購買30730萬美元的有價證券、購買1620萬美元的固定資產和設備,以及購買250萬美元的非流通股票,部分抵銷了3500萬美元的有價證券到期和在Lunit, Inc.出售1920萬美元的有價股票投資。
2023年9月30日結束的九個月期間,投資活動提供的現金為$17680萬,主要是來自$82870萬有價證券到期,部分抵銷了$62990萬有價證券的購買,以及$1640萬資產的購買,和$560萬非流通股票和其他相關資產的購買。
融資活動
2024年截至9月30日的九個月期間,籠絡自籌資金活動的現金為190萬美元,主要歸因於我們員工股票購買計劃下普通股發行所籌集的720萬美元,以及股份期權行使所籌得的260萬美元,部分抵扣與限制性股份單位淨股份結算相關支付的770萬美元。
在截至2023年9月30日的九個月期間,籌資活動提供的現金為38680萬美元,主要來自於再次公開發售所籌集的40250萬美元,以及在我們的員工股票購買計劃下發行普通股所獲得的670萬美元,部分抵銷了與再次公開發售有關的發售成本支付2050萬美元,以及與限制股單位淨股份折算有關的支付810萬美元的稅款。
關鍵會計政策和估計
我們根據在美國普遍適用的會計原則(GAAP)編製了我們的合併基本報表。我們準備這些合併基本報表需要我們對資產、負債、費用以及相關披露的金額,以及報告期間錄得的營業收入和費用所做的估計、假設和判斷產生影響。我們持續評估我們的估計和判斷。我們的估計基於歷史經驗以及我們認為在該情況下是合理的各種其他因素,其結果形成對於不容易從其他來源得知的資產和負債攜帶金額做出判斷的基礎。因此,根據不同的假設或條件,實際結果可能與這些估計有顯著差異。
我們的重要會計政策詳細說明在本季度報告表格10-Q中第2項及我們的未經審核簡明合併基本報表中,亦記載在本年度12月31日結束之財務年度年報表10-K的第7項。管理層對財務狀況和營運成果的討論與分析截至2024年9月30日結束的三個月和九個月,我們的關鍵會計政策與之前討論的沒有實質變化。
最近的會計聲明
請參閱附註2。 重要會計政策摘要以獲取更多資訊,請讀取本季度報告表格10-Q中其他地方包含的簡明綜合基本報表。
47


項目3.有關市場風險的定量和質量披露
我們在業務的日常運作中面臨市場風險。市場風險代表著可能影響我們財務狀況的損失風險,因為金融市場價格和利率發生不利變化。
利率風險
我們面對市場風險,主要源於與我們的現金、現金等價物、受限現金、可銷售債務證券和我們的負債相關的利率變動。截至2024年9月30日,我們持有主要存款、貨幣市場基金和美國政府債務證券共10億美元的現金、現金等價物、受限現金和可銷售債務證券。我們主要受市場風險的影響是利息收入敏感性,這受美國利率一般水平變動的影響。截至2024年9月30日,假設利率增加或減少100個基點,將導致我們投資的公平價值微不足道的下降或增加。此估算基於一個敏感性模型,該模型測量當利率變動時,市場價值的變化。
外匯風險
我們營業收入的大部分產生於美國。截至2024年9月30日,我們以外幣計價的收入極少。隨著我們在國際市場擴展業務,我們預計營業結果和現金流將越來越受外幣兌換匯率變動的影響,未來可能因外匯匯率變動而受到不利影響。截至2024年9月30日,假設外幣兌換匯率變動10%,對我們的財務狀況或營業結果影響不大。迄今為止,我們尚未就外幣風險進行任何避險安排。隨著我們國際業務的擴展,我們將繼續重新評估我們管理貨幣匯率波動風險的方法。
第四項。控制和程序
檢視公開披露控制與程序
我們的聯席執行長,或聯席首席執行官,以及我們的致富金融(臨時代碼),在其他管理成員的參與下,已經評估了我們的“披露控制和程序”的效用(如《1934年證券交易法》修訂的第13a-15(e)條和15d-15(e)條所定義的那樣,或《交易法》), 截至2024年9月30日,我們的聯席首席執行官和我們的財務長已總結,根據《交易法》第13a-15或15d-15條的b款要求,他們對這些控制和程序的評估後,確認我們的披露控制和程序是有效的。
內部控制的變化
本季度10-Q表格所覆蓋的時期內,與《交易所法》第13a-15(d)條和15d-15(d)條要求的評估有關的我們財務報告內部控制未發現任何變化,該變化對我們的內部控制未發生重大影響,或者是合理可能對我們的內部控制產生重大影響。

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目錄
控制和程序有效性的限制
我們的管理層,包括我們的聯席首席執行官和我們的首席財務官,相信我們的揭露控制和程序以及內部財務報告控制的設計旨在為實現其目標提供合理的保證,並且在合理保證水平上是有效的。但是,我們的管理層不認為我們的揭露控制和程序或我們的內部財務報告控制將防止所有錯誤和所有詐欺。無論控制系統的設計和運作多麼完善,都只能提供合理的,而非絕對的保證,控制系統的目標得以實現。此外,控制系統的設計必須反映資源限制的事實,並且必須考慮到控制的好處相對於成本。由於所有控制系統的固有限制,對控制的任何評估都無法確保所有的控制問題和詐欺情況(如有)已被檢測到。這些固有限制包括這樣的現實,即在決策中做出的判斷可能有誤,並且由於簡單錯誤或失誤可能出現故障。此外,控制可以被某些人的個人行為或兩個或更多人的勾結,或管理層對控制的覆蓋所繞過。任何一套控制系統的設計在一定程度上也是基於關於未來事件可能性的某些假設,並且無法保證任何設計在所有可能未來條件下都能成功實現其聲明的目標;隨著時間的推移,由於條件變化,控制可能變得不足,或者遵守政策或程序的程度可能下降。由於一套具有成本效益的控制系統的固有限制,由於錯誤或詐欺導致的錯誤可能會發生並且不會被檢測到。
49

目錄
第二部份──其他資訊
項目1. 法律訴訟
標題下的信息」承諾和應變 — 法律程序」本第 10-Q 季度報告的未經審核簡明綜合財務報表附註 8 內,有關本公司涉及的若干法律程序,載於本公司參與的若干法律程序。解決任何此類法律程序的情況均存在於固有的不確定性,並可能對我們的財務狀況、現金流量或營運結果產生重大不利影響。
第1A項。風險因素
我們的業務、財務狀況和經營結果受到眾多因素的影響,無論是已知或未知的,包括對我們或醫療保健行業特有的風險,以及影響一般企業的風險。除了本季度10-Q表格中所列的資訊外,您應詳細考慮我們2023年12月31日結束的年度報告10-K中第I部分第1A項“風險因素”中討論的因素,該報告於2024年2月22日提交給證券交易委員會(SEC)。風險和不確定因素 在該年度報告和本季度報告中披露的風險可能對我們的業務、財務狀況、現金流或營運結果產生重大不利影響,進而影響我們的股票價格。在2024財政第三季度期間,我們先前披露的風險因素並無實質變化。
這些風險因素可能對理解本季度報告中的其他描述至關重要,應該與第I部分第1項“基本報表的未經審核簡明合併財務報表及有關附註”一起閱讀。基本報表”並與本季度報告的第I部分第2項“”一起閱讀。管理層對財務狀況和業績的討論與分析由於這些風險因素以及影響我們財務狀況和營運業績的其他因素,過去的財務績效不應視為未來表現的可靠指標,投資者不應使用歷史趨勢來預期未來期間的結果或趨勢。
第二項。未註冊的股權銷售和資金用途。
無。
第3條。 違約高於優先證券。
暫不適用。
項目4.礦山安全披露。
暫不適用。
第5項。其他資訊。
內幕交易安排

在截至2024年9月30日的財政季度內,我們的董事或高管中沒有人...... 採用終止 根據S-k條例第408條中定義的「第10b5-1條例交易安排」或「非第10b5-1條例交易安排」,除了下表中的描述之外:
內部人員的姓名和職稱採納、修改或終止適用日期交易安排的期限
10b5-1規則的交易安排?
(是 / 否) (1)
受交易安排約束的證券總數
Meghan Joyce, 董事採納8/13/202411/13/2024 – 9/2/2025Y6,633
Musa Tariq,董事採用9/11/202412/13/2024 – 12/31/2025Y6,809
(2)
______________
(1)當採納時,表示交易計劃是否意在滿足第10b5-1(c)規則的積極軍工股辯護。
(2)塔里克先生的10b5-1交易計劃規定出售我們普通股的(i)1,972股以及(ii)10,422股我們普通股的46.4%,這些股票是特定限制股獎勵所對應的,在交易安排的期間內將會兌現。
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第6項。展品。
展品編號描述表格文件編號展覽申報日期已提交/附上
3.18-K001-386833.110/9/2018
3.28-K001-386833.210/9/2018
10.18-K001-386831.18/23/2024
31.1*
31.2*
31.3*
32.1**
32.2**
32.3**
101.INSInline XBRL 實例文件 - 實例文件在交互式數據文件中未出現,因為其XBRL標籤嵌入在Inline XBRL文件中。*
101.SCH
行內 XBRL分類擴展模式文檔
*
101.CAL
內聯 XBRL分類擴展計算鏈結庫文檔
*
101.DEF
內聯 XBRL分類擴展定義鏈結庫文檔
*
101.LAB
內聯 XBRL分類擴展標籤鏈接庫文檔
*
101.PRE
內聯 XBRL分類擴展展示鏈結庫文檔
*
104封面互動數據文件(格式化為內聯XBRL,附有展示101中包含的適用稅項擴展信息)*
___________________________
* 附帶提交。
備有如下物品。
# 表示管理合同或補償計劃。

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目錄
簽名
根據1934年證券交易所法案的要求,申報人已授權使該報告得以由簽署人代表正式簽署。
守護者健康公司。
日期:2024年11月6日作者:/s/ Helmy Eltoukhy
名字:
Helmy Eltoukhy
職稱:
聯席執行長
(首席執行官)
日期:2024年11月6日作者:/s/ AmirAli Talasaz
名字:
AmirAli Talasaz
職稱:
聯席執行長
(首席執行官)
日期:2024年11月6日作者:/s/ Michael Bell
名字:Michael Bell
職稱:財務長
(首席會計師及信安金融主管)
52