美國
證券交易委員會
華盛頓特區20549
表格
（標記一）
根據1934年證券交易法第13或15(d)節的季度報告 |
截至季度結束日期的財務報告
或者
根據1934年證券交易法第13或15(d)節的轉型報告書 |
過渡期從_____到_____
委託文件編號：001-39866
（依據其憲章指定的註冊名稱）
（國家或其他管轄區的 公司成立或組織） |
（IRS僱主 |
，（主要行政辦公地址） |
(郵政編碼) |
公司電話，包括區號：
在法案第12(b)條的規定下注冊的證券：
每一類的名稱 |
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交易 符號: |
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在其上註冊的交易所的名稱 |
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請在以下複選框中打勾，指示註冊人：(1)在前12個月(或註冊人被要求提交這些報告的更短期間內)已經提交了1934年證券交易法第13或15(d)條規定需要提交的所有報告；以及(2)在過去的90天內一直受到了此類文件提交要求的限制。
請在勾選標誌處表示註冊人是否已經在過去12個月內（或者在註冊人要求提交這些文件的較短時期內）按照規則405 of協議S-T（本章節的§232.405）提交了每個交互式數據文件。 ☒ 沒有 ☐
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。
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加速過濾器 |
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☐ |
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非加速過濾器 |
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☐ |
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規模較小的申報公司 |
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新興成長型公司 |
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如果是新興成長型企業，請勾選複選標記，表明註冊者已選擇不使用延長過渡期來符合根據證券交易法第13(a)條規定提供的任何新財務會計準則。 ☐
請在檢查標記處說明申報人是否爲外殼公司 (見交易所法案 Rule 12b-2 定義)。 是☐ 沒有
截至2024年11月4日，註冊人員已
目錄
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第I部分 |
4 |
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項目1。 |
4 |
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4 |
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5 |
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6 |
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7 |
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9 |
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10 |
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事項二 |
26 |
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第3項。 |
38 |
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事項4。 |
38 |
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第二部分 |
39 |
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項目1。 |
39 |
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項目1A。 |
39 |
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事項二 |
39 |
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第3項。 |
39 |
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事項4。 |
39 |
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項目5。 |
39 |
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項目6。 |
40 |
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41 |
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adaptive biotechnologies公司
前瞻性聲明
此報告包含基於管理層信念和假設以及目前管理層可獲得信息的前瞻性聲明。除歷史事實聲明外，本報告中所有聲明均屬於前瞻性聲明，其中包括但不限於以下聲明：
本報告中的前瞻性聲明還包括關於我們開發、商業化和市場接受我們現有和計劃中的產品和服務的能力，以及我們的研發工作和有關業務戰略、資本使用、經營業績、財務狀況、未來經營計劃和目標等方面的聲明。在某些情況下，您可以從以下詞語中辨認出前瞻性聲明：「可能」，「將」，「可能」，「應該」，「期望」，「打算」，「計劃」，「預期」，「相信」，「估計」，「預測」，「項目」，「潛在」，「繼續」，「正在進行」或這些術語的否定形式或其他類似術語，儘管並非所有前瞻性聲明都包括這些詞語。這些聲明涉及風險、不確定性和其他因素，可能導致實際結果、活動水平、業績或成就與這些前瞻性聲明所表達或暗示的信息有實質性不同。這些風險、不確定性和其他因素在本報告中的「風險因素」、「管理層對財務狀況和經營業績的討論」以及其他地方描述，以及我們不時向證券交易委員會（「SEC」）提交的其他文件中描述。我們警告您，前瞻性聲明基於我們目前已知的事實和因素的組合，以及我們對未來的預測，關於這些事我們不能確定。因此，這些前瞻性聲明可能不會被證實準確。本報告中的前瞻性聲明代表我們截至本報告日期的觀點。
我們不承擔更新任何前瞻性聲明的義務，除非法律要求。
除非另有說明或情境另有指示，「我們」，「我們」，「我們」和類似參照指的是adaptive biotechnologies公司。
3
adaptive biotechnologies公司
第一部分——財務撥號信息
項目1. 財務報表（未經審核的）
彙總的資產負債表（未經審計） 表格
(以千爲單位，除每股數據外)
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2024年9月30日 |
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2023年12月31日 |
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(未經審計) |
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資產 |
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流動資產 |
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現金及現金等價物 |
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$ |
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$ |
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短期市場有價證券（攤銷成本爲$ |
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2,687,823 |
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庫存 |
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預付費用和其他流動資產 |
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總流動資產 |
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長期資產 |
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資產和設備，淨值 |
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經營租賃權使用資產 |
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長期市場證券（攤銷成本爲$ |
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— |
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受限現金 |
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無形資產, 淨額 |
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商譽 |
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其他 |
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資產總額 |
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$ |
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$ |
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負債和股東權益 |
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流動負債 |
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應付賬款 |
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$ |
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$ |
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應計負債 |
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應計的薪酬和福利 |
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經營租賃負債流動部分 |
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遞延營收的當前部分 |
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流動負債合計 |
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長期負債 |
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租賃負債，除去當前部分 |
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遞延營業收入，減去流動部分 |
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營業收入利息負債淨額 |
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其他長期負債 |
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— |
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負債合計 |
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股東權益 |
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4,998,000,000 |
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普通股：$ |
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額外實收資本 |
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累計其他綜合收益 |
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累積赤字 |
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( |
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( |
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自適應生物技術公司的股東權益總額 |
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非控股權益 |
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( |
) |
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( |
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股東權益合計 |
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負債和股東權益總計 |
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$ |
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$ |
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附註是這些簡明合併財務報表的組成部分。
4
adaptive biotechnologies公司
現金流量簡明合併報表操作
(以千爲單位，除每股數據外)
(未經審計)
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截至9月30日的三個月 |
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截至9月30日的九個月 |
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2024 |
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2023 |
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2024 |
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2023 |
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收入 |
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$ |
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$ |
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$ |
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$ |
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運營費用 |
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收入成本 |
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研究和開發 |
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銷售和營銷 |
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一般和行政 |
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無形資產的攤銷 |
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長期資產的減值 |
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— |
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— |
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— |
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運營費用總額 |
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運營損失 |
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( |
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( |
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( |
) |
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( |
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利息和其他收入，淨額 |
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利息支出 |
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( |
) |
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( |
) |
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( |
) |
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( |
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淨虧損 |
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( |
) |
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( |
) |
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( |
) |
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( |
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添加：歸因於非控股權益的淨虧損 |
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歸因於自適應生物技術公司的淨虧損 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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歸屬於適應性生物技術公司普通股股東的每股淨虧損（基本虧損和攤薄後） |
|
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
用於計算歸屬於自適應生物技術公司普通股股東的每股淨虧損的加權平均股份，基本和攤薄後 |
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附註是這些簡明合併財務報表的組成部分。
5
adaptive biotechnologies公司
壓縮綜合財務報表綜合損益表和綜合損失表
（以千爲單位）
(未經審計)
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截至9月30日的三個月 |
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截至9月30日的九個月 |
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2024 |
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2023 |
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2024 |
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2023 |
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淨損失 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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其他綜合收益 |
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投資的未實現收益和損失變動 |
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綜合損失 |
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( |
) |
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( |
) |
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( |
) |
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( |
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添加：歸屬於非控股利益的綜合損失 |
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適用生物技術公司的綜合損失 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
附註是這些簡明合併財務報表的組成部分。
6
adaptive biotechnologies公司
（以千爲單位，除股份數量外）
(未經審計)
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普通股 |
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額外 |
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累積其他 |
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累積 |
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非控制性 |
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總計 |
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股票 |
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金額 |
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實收資本 |
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綜合（虧損）收益 |
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赤字 |
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利息 |
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股東權益 |
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截至 2023 年 6 月 30 日的餘額 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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$ |
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在行使股票期權時以現金髮行普通股 |
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— |
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— |
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— |
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— |
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限制性股票單位的歸屬 |
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— |
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— |
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— |
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— |
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— |
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— |
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基於股份的薪酬支出 |
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— |
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— |
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— |
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— |
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— |
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其他綜合收入 |
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— |
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— |
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— |
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— |
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— |
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淨虧損 |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
截至 2023 年 9 月 30 日的餘額 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
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截至 2024 年 6 月 30 日的餘額 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
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在行使股票期權時以現金髮行普通股 |
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— |
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— |
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— |
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— |
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限制性股票單位的歸屬 |
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— |
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— |
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— |
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— |
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— |
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— |
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基於股份的薪酬支出 |
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— |
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— |
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— |
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— |
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— |
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其他綜合收入 |
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— |
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— |
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— |
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— |
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— |
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淨虧損 |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
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截至 2024 年 9 月 30 日的餘額 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
|
$ |
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附註是這些簡明合併財務報表的組成部分。
7
adaptive biotechnologies公司
綜合股東權益簡明合併報表（續）
（以千爲單位，除股份數量外）
(未經審計)
|
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普通股 |
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額外的 |
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其他積累 |
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累積的 |
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非控制權益 |
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總計 |
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股份 |
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金額 |
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實收資本 |
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綜合（損失）盈利 |
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赤字 |
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利息 |
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股東權益 |
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|||||||
2022年12月31日結存餘額 |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
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$ |
( |
) |
|
$ |
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發行普通股以換取期權現金 |
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— |
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— |
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— |
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— |
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受限制股票單位解除限制 |
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— |
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— |
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— |
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— |
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— |
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— |
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基於股份的報酬支出 |
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— |
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— |
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— |
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— |
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— |
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其他綜合收益 |
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— |
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— |
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— |
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— |
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— |
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淨損失 |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
2023年9月30日結餘 |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
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$ |
( |
) |
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$ |
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||||
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2023年12月31日結餘爲 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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|||||
發行普通股以換取期權現金 |
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— |
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— |
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— |
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— |
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受限制股單位的分配，淨值 |
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— |
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— |
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— |
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— |
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— |
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— |
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基於股份的報酬支出 |
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— |
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— |
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— |
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— |
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— |
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||
其他綜合收益 |
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— |
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— |
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— |
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— |
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— |
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淨損失 |
|
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— |
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— |
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— |
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|
|
— |
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|
( |
) |
|
|
( |
) |
|
|
( |
) |
2024年9月30日的餘額 |
|
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|
$ |
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|
$ |
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|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|||||
附註是這些簡明合併財務報表的組成部分。
8
adaptive biotechnologies公司
現金流量簡明合併報表現金流量表
（以千爲單位）
(未經審計)
|
|
截至9月30日的九個月 |
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|||||
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|
2024 |
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2023 |
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||
經營活動 |
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淨損失 |
|
$ |
( |
) |
|
$ |
( |
) |
調整淨虧損爲經營活動使用的現金淨額 |
|
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||
折舊費用 |
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非現金租賃費用 |
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基於股份的報酬支出 |
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無形資產攤銷 |
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投資攤銷 |
|
|
( |
) |
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( |
) |
長期資產減值 |
|
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— |
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|
庫存準備 |
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||
非現金利息支出 |
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其他 |
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||
營運資產和負債的變化 |
|
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||
2,687,823 |
|
|
( |
) |
|
|
|
|
庫存 |
|
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|
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|
( |
) |
|
預付費用和其他流動資產 |
|
|
( |
) |
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( |
) |
應付賬款及應計費用 |
|
|
( |
) |
|
|
( |
) |
經營租賃權益資產和負債 |
|
|
( |
) |
|
|
( |
) |
遞延收入 |
|
|
( |
) |
|
|
( |
) |
其他 |
|
|
|
|
|
( |
) |
|
經營活動使用的淨現金流量 |
|
|
( |
) |
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( |
) |
投資活動 |
|
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|
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||
購買固定資產 |
|
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( |
) |
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( |
) |
購買有市場流通的證券 |
|
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( |
) |
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( |
) |
可市場出售證券到期款 |
|
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||
投資活動提供的淨現金流量 |
|
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籌資活動 |
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||
行使股票期權所得 |
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||
籌資活動產生的現金淨額 |
|
|
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|
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|
||
現金、現金等價物和受限制現金淨減少額 |
|
|
( |
) |
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|
( |
) |
年初現金、現金等價物和受限制的現金餘額 |
|
|
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|
||
期末現金、現金等價物及受限制的現金餘額 |
|
$ |
|
|
$ |
|
||
非現金投資活動 |
|
|
|
|
|
|
||
設備採購已計入應付賬款和預提費用 |
|
$ |
|
|
$ |
|
||
現金流量補充披露 |
|
|
|
|
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|
||
支付的利息現金 |
|
$ |
|
|
$ |
|
||
附註是這些簡明合併財務報表的組成部分。
9
adaptive biotechnologies公司
簡明聯合財務報表附註(未經審計)
(未經審計)
1. 業務的組織和描述
adaptive biotechnologies公司（「我們」或「我們的」）是一家商業階段公司，通過利用適應性免疫系統的固有生物學來推動免疫醫學領域的發展，從而改變疾病的診斷和治療。我們相信適應性免疫系統是大自然調諧最精細的用於大多數疾病的診斷和治療的工具，但是由於無法解碼它，醫療界無法充分利用其能力。我們的免疫醫學平台應用我們的專有技術來讀取患者免疫系統的多樣基因密碼，並準確了解免疫系統如何檢測和治療該患者的疾病。我們將這些洞察力記錄在我們動態臨床免疫學數據庫和相關抗原註釋中，這些信息由計算生物學和機器學習支持，用於開發和商業化可根據個體患者需要定製的臨床產品和服務。我們擁有商業產品和服務以及一系列臨床產品和服務的強大管道，我們正在設計這些產品和服務以診斷、監測和促進治療癌症和自身免疫性疾病等疾病。
我們成立於2009年9月8日，是一家總部位於華盛頓州的公司，最初的名字爲Adaptive TCR Corporation。在2011年12月21日，我們將公司更名爲adaptive biotechnologies 公司，總部位於華盛頓州西雅圖。
2。重要會計政策
列報基礎和合並原則
未經審計的簡明合併財務報表包括自適應生物技術公司、我們的全資子公司Adaptive Biotechnologies B.V. 和我們的公司子公司Digital Biotechnologies, Inc. 的賬目
估算值的使用
根據美利堅合衆國普遍接受的會計原則（「GAAP」）編制簡明合併財務報表要求管理層做出某些估計、判斷和假設，這些估計、判斷和假設會影響簡明合併財務報表之日報告的資產負債金額和相關披露，以及報告期內報告的收入和支出金額。我們的估計基於歷史經驗和其他我們認爲在當時情況下合理的相關假設。估算值用於多個領域，包括但不限於對某些履約義務迄今爲止進展的估算以及與客戶簽訂的某些合同的交易價格、基於股份的薪酬、我們的收入利息購買協議（「收購協議」）的估算利息、包括相關儲備金在內的所得稅準備金、商譽減值分析以及長期資產的可收回性和減值等。這些估計通常涉及複雜的問題，需要作出判斷，涉及對歷史結果的分析和對未來趨勢的預測，可能需要很長時間才能解決，並且可能因時期而異。實際結果可能與管理層的估計存在重大差異。
未經審計的中期簡明合併財務報表
我們認爲，隨附的未經審計的簡明合併財務報表是根據中期財務信息的公認會計原則編制的。這些未經審計的簡明合併財務報表包括根據公認會計原則公允陳述我們的財務狀況以及中期經營業績和現金流所必需的所有調整。所有這些調整都是正常的、經常性的。中期業績不一定代表全年或任何後續中期的經營業績或現金流量。
隨附的未經審計的簡明合併財務報表應與我們在2024年2月29日向美國證券交易委員會（「SEC」）提交的截至2023年12月31日止年度的10-k表年度報告中包含的經審計的合併財務報表和附註一起閱讀。
細分信息
我們的運作方式是
10
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
限制性現金
截至2024年9月30日和2023年12月31日，我們的受限現金餘額爲 $
商譽
商譽代表收購價格高於以公允價值計量的商業組合中獲得的可識別資產和承擔的負債的淨額的部分。我們每年在10月1日評估商譽的減值情況，或者如果事件或情況的變化更有可能將我們一個或兩個報告單位的公允價值降低至它們各自的賬面價值以下，則更頻繁地進行評估。我們首先評估定性因素來判斷我們一個或兩個報告單位的公允價值是否很可能低於它們各自的賬面價值。如果我們做出這樣的判斷，或者選擇跳過定性評估，我們將進行數量化商譽減值測試。如果存在減值，分配的商譽賬面價值將通過在綜合損益表中記錄的減值損失減少至其公允價值。到目前爲止，我們尚未確認任何商譽減值。
風險集中
我們面臨來自有限數量供應商的風險集中，或在某些情況下，來自單一供應商的風險，用於一些實驗室儀器和材料。通過制定多餘庫存的數量來管理這種風險。
現金、現金等價物和有市場的證券是潛在使我們面臨信用風險集中的金融工具。我們投資於貨幣市場基金、美國政府國債和機構債券、高素質認可的金融機構的企業債券和商業票據。
收入確認
對於所有產生營業收入的合同，我們執行以下步驟來確定應確認的營業收入金額：(1)確認合同或合同；(2)判斷承諾的貨物或服務是否履行義務，包括它們在合同背景中是否是獨立的；(3)測量交易價格，包括對變量考慮的限制；(4)根據估計的銷售價格將交易價格分配給履行義務；以及(5)在滿足每項履行義務時（或按照這樣的方式）確認營業收入。
我們通過在我們的MRD和免疫醫學業務領域提供診斷和研究服務來獲得營業收入。我們的MRD營收包括從（1）向臨床客戶提供我們的clonoSEQ報告；（2）向生物製藥客戶和某些學術機構提供MRD樣品測試服務，包括研究者主導的臨床試驗；以及（3）通過技術轉移向特定國際實驗室站點提供我們的clonoSEQ報告或結果所產生的收入。我們的免疫醫學收入包括通過向生物製藥客戶和學術機構提供商業研究產品Adaptive Immunosequencing的樣品測試服務以及與Genentech公司（「Genentech」）和其他生物製藥客戶在藥物和靶標發現領域的合作協議所產生的收入。
對於我們向醫生提供clonoSEQ報告的協議，我們確定一個履行義務：交付clonoSEQ報告。我們向商業、政府和醫療機構支付方接收這些交易的賬單和款項。由於來自各方付款人的支付可能基於各種報銷率和患者責任而有所不同，我們認爲交易價格是可變的，並在交付時將交易價格的估計（受變量考慮約束）作爲營收記錄。交易價格的估計基於與各付款人的歷史和預期的報銷率，這些報銷率在隨後的期間進行監測，並根據實際收款經驗進行必要的調整。
關於我們在醫療保險下的clonoSEQ覆蓋範圍，當我們交付首次符合條件的測試報告時，我們會向一個治療週期內的患者進行一次治療的賬單。這項計費考慮了患者治療週期內所需的所有必要測試，目前估計每個患者大約需要進行四次測試，包括最初的序列鑑定測試。營業收入的確認從交付首次可計費測試報告的時候開始，並根據至今交付的累積測試來計算。我們根據患者按指標進行歷史測試的頻率，估計我們預計在患者治療週期內進行的測試次數。這些估計可能會隨着我們隨時間獲得更多關於利用率的信息而發生變化。來自初始可計費測試的任何未認可的營業收入會被記錄爲遞延收入，或者會在我們交付了患者治療週期內剩餘測試的估計時予以確認，或者在患者不太可能接受額外測試時予以確認。
11
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
我們與生物製藥客戶簽訂的合同交易價格，用於進一步開發和商業化其治療藥物的協議，可能由不可退還的預付款、單獨定價的MRD測試費以及在我們客戶達到特定監管批准時獲得的里程碑費用組成。根據合同的不同，這些協議包括單個或多個履約義務。此類履約義務包括提供支持服務，支持客戶治療藥物的開發工作，包括在我們的技術將作爲客戶註冊試驗的一部分而被使用的情況下提供監管支持，爲我們的數據制定分析計劃，參與聯合委員會，協助完成監管提交，併爲客戶提交的樣本提供MRD測試服務。通常情況下，除MRD測試服務外的支持服務在合同範圍內不具備明顯區分性，因此被視爲單一履約義務。分配給各個履約義務的交易價格是根據調整後的市場評估方法來估計監管支持服務的價格以及估計MRD測試服務的獨立銷售價格。當MRD樣本測試服務作爲單獨定價的客戶期權時，我們將評估是否存在重要權利，如果不存在，則不將購買額外MRD樣本測試服務的客戶期權視爲合同的一部分。我們根據所交付樣本結果所佔的比例以及預期交付的總樣本結果量來隨時間確認與MRD測試服務相關的營業收入，以輸出法爲基礎，當能夠忠實呈現進展時。我們使用同樣的方法來確認監管支持服務。當基於交付的樣本結果比例的輸出法無法忠實展示進展時，我們會使用基於成本的輸入法，根據完成工作量的估計情況。選擇衡量進展的方法和估計迄今爲止的進展需要進行重大判斷。除了任何不可退還的預付款外，其他形式的報酬都代表着變量報酬。在合同初衷時，我們會完全限制與監管里程碑相關的任何考慮，因爲此類里程碑的達成取決於第三方監管批准以及客戶自身的提交決策。與監管里程碑相關的變量考慮是使用最可能金額法來估計的，在確認之前，變量考慮都會受到限制，以確保不會發生重大累計收入的逆轉。監管批准里程碑付款，這取決於不在客戶控制範圍內的審批，直到獲得這些批准後才被視爲可能實現。確定監管里程碑付款是否可能實現是一個需要進行重大判斷的領域。在進行此評估時，我們評估科學、臨床、監管以及其他風險，以及實現各個里程碑所需的努力和投資水平。
對於使用我們的MRD或自適應免疫測序服務的研究客戶，合同通常包括預付款項（「預付款」）和隨後的賬單，隨着樣本結果交付給客戶。收到的預付款項被記錄爲遞延營業收入，我們在履行績效義務後將其確認爲營業收入。我們已確定研究服務合同條款下的兩種典型績效義務：（1）爲客戶提供樣本的MRD數據或自適應免疫測序的交付；和（2）相關數據分析。隨着樣本結果交付給客戶，我們爲已確認的兩項績效義務確認營業收入。在樣本估算減少或客戶項目取消的情況下，且在兩種情況下我們仍有相關的遞延收入餘額時，我們根據已交付樣本數量佔預期總樣本數量的比例採用累計補足方法確認營業收入。
尚未採用新的會計準則
2013年11月，財務會計準則委員會（「FASB」）發佈了會計準則更新（「ASU」）2023-07。 黑石礦產有限合夥企業及附屬企業（主題280）： 報告業務板塊披露的改進，旨在加強關於重大業務部門支出的可報告細分披露。本指引適用於2023年12月15日後開始的財政年度以及2024年12月15日後開始的財政年度內的中期時段。允許提前採用，並且指引要求以追溯方式應用。我們目前正在評估本指引對我們的合併財務報表和相關披露的影響。
2023年12月，FASB發佈了ASU No. 2023-09， 所得稅 （話題740） 所得稅披露改進主要意圖是增強利率對賬和所得稅支付披露。該指南對於從2024年12月15日之後開始的年度期間生效。允許提前採納，並建議展望式應用；允許追溯應用。我們目前正在評估該指南對我們的合併財務報表和相關披露的影響。
2024年11月，FASB發佈了ASU No. 2024-03， 損益表-報告綜合收益-費用細分披露 (子課題220-40)損益表開支分項披露旨在通過要求對特定費用類別的額外信息披露來改進財務報告的指導意見。本指導意見適用於2026年12月15日後開始的年度報告期和2027年12月15日後開始的中期報告期。允許提前採納，指導意見應按照前瞻性應用，並可按照回顧性應用。我們目前正在評估此指導對我們的合併財務報表和相關披露的影響。
12
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
3. 營業收入
我們通過按業務領域和安排類型細分合同與客戶的收入，因爲我們認爲這樣最能準確展示我們的營業收入和現金流量在經濟因素影響下的性質、金額、時間和不確定性。
以下表格顯示了我們所列出時段的細分營業收入（以千爲單位）：
|
|
截至9月30日的三個月 |
|
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截至9月30日的九個月 |
|
||||||||||
|
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2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
MRD 營業收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
服務收入 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
監管里程碑營業收入 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
MRD總營業收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
免疫藥物營業收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
服務收入 |
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|
|
|
|
|
|
|
|
|
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|
||||
合作收入 |
|
|
|
|
|
|
|
|
|
|
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|
||||
免疫藥物總營業收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
總收入 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
2024年9月30日結束的三個月內，我們確認了$
2024年9月30日結束的九個月裏，我們確認了營業收入$
截至2024年9月30日，如果我們的客戶在MRD產品產生的MRD數據方面獲得某些監管批准，我們將在未來的時期內最多可收到額外的百萬美元里程碑付款 $
基因泰克合作協議
2018年12月，我們與幹諾德（「幹諾德協議」）簽署了一項全球合作和許可協議，以利用我們在腫瘤學中開發細胞療法的能力。在2019年1月獲得監管批准後，我們於2019年2月收到了$百萬的不可退還的預付款。此外，我們在2023年收到了$百萬的里程碑款。我們可能有資格收到$
根據基尼科技協議的條款，我們向基尼科技授予了在腫瘤領域開發和商業化基於TCR的細胞療法的排他性全球許可，包括對現有共享抗原數據包的許可。此外，基尼科技有權判斷要進一步開發哪種產品候選者用於商業化目的。我們判斷這一安排符合《會計準則法典》（「ASC」）主題808中規定的標準。 合作安排 《ASC 808》，因爲雙方都是活躍參與者, 並且根據活動的商業失敗或成功承擔重大風險和回報。由於ASC 808對如何處理協作安排下的活動沒有提供指導，我們應用了ASC話題606中的指導。與客戶簽訂合同的收入 《ASC 606》，以負責與Genentech協議相關的活動。
13
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
在應用ASC 606標準時，我們在協議簽訂時確定了以下履約義務：
我們確定，在合同範圍內，許可證、研發服務或參與各種委員會的義務中，沒有一個是獨立的，因爲這些權利和活動高度相關，並且需要進行大量額外的研發工作來進一步開發這些許可證。我們考慮了諸如各自現有抗原數據包的開發階段、後續開發將需要確定和提交潛在的靶點以便根據兩項產品途徑提交新藥申請的驗收要求，以及在研發途徑上的變化性，因爲Genentech控制產品商業化。具體來說，在Genentech協議下，Genentech並非必須追求與兩個產品途徑相關的開發或商業化活動，並且可以選擇繼續進行其中之一。因此，我們確定所有確定的履約義務都歸因於一個總的履約義務，即推動我們的TCR特異性平台的進一步發展，包括數據包，並繼續使我們的TCR鑑定流程可供Genentech使用以追求任一產品途徑。
另外，我們有責任向Genentech簽訂供應和製造協議，以生產特定患者的TCR，作爲任何個性化產品治療的一部分。我們確定這是Genentech的一個選擇權，如果他們選擇商業化個性化產品療法。由於由於開發初期的不確定性，我們與Genentech合作的新穎方法，以及我們對未來商業里程碑和版稅支付的權利，我們確定這個選擇權不是一個應在開始階段計入的重要權利。因此，當雙方簽訂供應和製造協議時，我們將對其進行覈算。
我們確定初始交易價格僅由$組成
由於可能需要實質性的發展，Genentech可能能夠指導，我們確定我們將應用比例履行模型來識別我們的履約義務的營業收入。我們使用基於已發生成本相對於研究和開發工作的總估計成本的輸入法來度量比例履行。繼續追求Shared Products和Personalized Product路徑的開發活動。當潛在的監管和開發里程碑不再受到完全限制幷包含在交易價格中時，將使用累計補償法基於當時的比例履行時間來確認這些金額。我們目前預計將在約
總共，我們承認了 $
14
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
4。遞延收入
基因泰克協議的遞延收入是 $
截至2024年9月30日的九個月中，遞延收入的變化如下（以千計）：
截至 2023 年 12 月 31 日的遞延收入餘額 |
|
$ |
|
|
該期間遞延收入的增加 |
|
|
|
|
該期間確認的收入 |
|
|
( |
) |
截至 2024 年 9 月 30 日的遞延收入餘額 |
|
$ |
|
截至 2024 年 9 月 30 日， $
5. 公允價值計量
以下表格列出了截至2024年9月30日和2023年12月31日按照重複計量公允價值的金融資產的公允價值（以千爲單位）：
|
|
2024年9月30日 |
|
|||||||||||||
|
|
一級 |
|
|
二級 |
|
|
Level 3 |
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總計 |
|
||||
金融資產 |
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|
|
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|
|
|
|
|
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||||
貨幣市場基金 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
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|
$ |
|
||
商業票據 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
美國政府國庫和機構債券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
公司債券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
所有財務資產 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
|
|
2023年12月31日 |
|
|||||||||||||
|
|
一級 |
|
|
二級 |
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|
Level 3 |
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總計 |
|
||||
金融資產 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
貨幣市場基金 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
商業票據 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
美國政府國債和機構債券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
公司債券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
所有財務資產 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
一級證券包括高度流動的貨幣市場基金，其公允價值我們基於相同資產或負債在活躍市場上的報價來衡量。 二級證券包括美國政府國庫券、機構證券、公司債券和商業票據，並根據在不活躍市場上證券的最近交易或類似工具的報價市場價格以及其他可從可觀察市場數據派生或證實的重要輸入進行估值。
15
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
6. 投資
截至2024年9月30日和2023年12月31日，可供出售投資如下（以千計）：
|
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2024年9月30日 |
|
|||||||||||||
|
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攤銷成本 |
|
|
|
|
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未實現損失 |
|
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估算公允價值 |
|
||||
短期市場證券 |
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|
|
|
|
|
|
|
|
|
|
|
||||
商業票據 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
美國政府國債和機構債券 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
公司債券 |
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|
|
|
|
|
|
|
— |
|
|
|
|
|||
總的短期市場有價證券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
長期有價證券 |
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|
|
|
|
|
|
|
|
|
|
|
||||
美國政府國債 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
總的長期市場有價證券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
2023年12月31日 |
|
|||||||||||||
|
|
攤銷成本 |
|
|
|
|
|
未實現損失 |
|
|
估算公允價值 |
|
||||
短期市場證券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
商業票據 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
美國政府國債和機構債券 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
公司債券 |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
總的短期市場有價證券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
所有美國政府國債和機構債券、公司債券和短期可變現證券，其有效到期日等於或少於各自的簡明綜合資產負債表日期距離一年。那些被指定爲長期可變現證券的，其有效到期日則超過了各自的簡明綜合資產負債表日期一年。
應計利息應收款被排除在我們可變現證券的攤銷成本和預估公允價值之外。截至2024年9月30日未經審計的簡明綜合資產負債表和分別截至2023年12月31日的簡明綜合資產負債表中，應計利息應收款分別在預付費用和其他流動資產餘額內單獨呈現。 $
以下表格顯示了截至2024年9月30日處於未實現虧損位置的投資的毛未實現持有虧損和公允價值，以及個別證券處於持續虧損位置的時間長度（以千元計）。
|
|
不足12個月 |
|
|
持有12個月或以上 |
|
||||||||||
|
|
公正價值 |
|
|
未實現虧損 |
|
|
公允價值 |
|
|
未實現虧損 |
|
||||
美國政府國債和機構債券 |
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
所有可供出售證券總額 |
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
我們定期審查我們可供出售的證券，以評估信用損失。評估損失的一些考慮因素包括公允價值低於攤銷成本基礎的程度，與證券相關的不利條件，行業或地理區域，證券評級或行業信用評級的變化以及其他相關市場數據。
截至2024年9月30日，我們並不打算在可攤銷成本基礎恢復之前出售我們的可供出售投資，這可能是到期。根據我們的評估，截至2024年9月30日的所有損失都是由於除信用損失以外的因素，例如利率變動。未確認信貸準備金，我們可供出售證券的減值已記錄在其他綜合損失中。
7. 租賃
我們在華盛頓州西雅圖、加利福尼亞州南舊金山和華盛頓州Bothell擁有實驗室、辦公室和倉庫設施的經營租賃協議。2024年6月30日結束的三個月內，我們搬離了加利福尼亞州南舊金山的某些租賃空間，併發生了相關的減值損失。詳情請參閱第12條註釋。 重組 截至2024年9月30日，我們沒有參與任何融資租賃。
16
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
以下表格將我們未折現的經營租賃現金流與2024年9月30日的經營租賃負債（以千爲單位）進行了調節，減去當前部分餘額：
2024年（不包括2024年9月30日結束的九個月） |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
此後 |
|
|
|
|
總未折扣租賃付款 |
|
|
|
|
減：隱含利率 |
|
|
( |
) |
總營業租賃負債 |
|
|
|
|
減：當前部分 |
|
|
( |
) |
租賃負債，除去當前部分 |
|
$ |
|
在2024年和2023年截至九個月的期間，用於計量租賃負債的支付現金爲 $
我們有
8. 營業收入利益購買協議
2022年9月，我們與OrbiMed Royalty & Credit Opportunities IV，LP（「OrbiMed」）簽訂了購買協議，OrbiMed爲奧卑梅德顧問有限責任公司的關聯公司，擔任抵押代理人和購買者方的行政代理人（「購買者」）。根據購買協議，我們在交割時從購買者那裏收到$
作爲這些付款的對價，購買者有權根據所有GAAP營業收入的一定百分比收取特定的營業收入利益（「營業收入利益」）。有關營業收入利益的支付應在每個財務季度結束後的第X天內進行季度支付（每個，一個「營業收入利益支付」）。
會計處理
我們將這筆交易列爲按攤銷成本計入的債務，使用有效利率法。
爲了判斷購買協議義務的攤銷，我們需要根據對未來營業收入的時間和金額的估計，計算將該義務攤銷至的有效利率。
根據購買協議，我們發生了債務發行成本達
確定債務的預期償還期限和發行成本的攤銷期所使用的假設需要我們進行估計，可能會影響這些成本的短期和長期分類，以及這些成本將攤銷的期間。我們定期評估基於內部預測的預期營業收入利息支付的金額和時間。在這些支付額大於或小於我們的初始估計，或者支付時間與我們最初的估計有重大不同的情況下，我們將前瞻性地調整營業收入利息負債和有效利率的攤銷。
17
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
以下表格詳細列出了2024年9月30日終了的九個月內的營業收入利息負債、淨活動（以千爲單位）：
2023年12月31日的營業收入利息負債淨額 |
|
$ |
|
|
利息支出 |
|
|
|
|
營業收入利息應付 |
|
|
( |
) |
2024年3月31日的營業收入利息負債淨額 |
|
|
|
|
利息支出 |
|
|
|
|
營業收入利息應付 |
|
|
( |
) |
2024年6月30日的營業收入利息負債淨額 |
|
|
|
|
利息支出 |
|
|
|
|
應付利息收入 |
|
|
( |
) |
2024年9月30日應付的利息收入負債淨額 |
|
$ |
|
應付的利息收入爲$
9. 承諾和或有事項
法律訴訟
我們經常會在業務的正常過程中受到索賠和評估。當可能已經發生責任且金額可以合理估計時，我們將爲此類事項計提負債。當只能確定可能損失的區間時，我們會計提區間內最有可能發生的金額。如果在該區間內沒有比其他更好的估算金額，則會計提區間內最小的金額。截至2024年9月30日，我們沒有參與任何重大法律訴訟。
保護協議
在業務的正常過程中，我們可能會向供應商、出租人、客戶和其他方提供各種程度和條款的補償，涉及某些事項，包括但不限於由他們與我們簽訂的協議違約或第三方提出的知識產權侵權索賠而產生的損失。此外，我們已與董事會成員和某些高管簽訂了補償協議，要求我們對可能因他們作爲董事或高管的身份或服務而產生的某些責任進行賠償。根據這些補償協議，我們將來可能需要支付的最大潛在金額在許多情況下是無限制的。截至目前，我們尚未因此類賠償而產生任何重大成本，並且目前也沒有意識到任何賠償要求。
10.股東權益
普通股
我們的普通股沒有任何偏好或特權，也不可贖回。
的當時可發行的股份數量增加，增加數量爲以下兩者中較小者：
此外，我們的員工股票購買計劃（「ESPP」）規定，2020年1月1日及以後的每個1月1日，根據以下最小數量的股份數量增加：
自2024年1月1日起，我們2019計劃和ESPP儲備增加了
18
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
截至2024年9月30日，我們已爲以下股份預留了普通股：
行使已發放的在外流通期權後可發行的股份 |
|
|
|
|
可發行的在外流通受限股份單元已確定釋放和最大未行使的市場爲基礎的受限股份單元 |
|
|
|
|
2019年股權激勵計劃下用於未來授予的股份 |
|
|
|
|
員工股票購買計劃下用於未來授予的股份 |
|
|
|
|
未來發行的普通股總數 |
|
|
|
11.股權激勵計劃
2009股權激勵計劃
我們於2009年採納了一項股權激勵計劃（以下簡稱「2009計劃」），該計劃規定發行激勵性和非合格普通股期權以及其他股票爲公司員工、董事和顧問提供激勵。根據2009計劃，激勵性和非合格股票期權的行權價格不得低於授予日期我公司普通股的公允市場價。根據該計劃授予的股票期權在授予之日起不遲於到期，而受限制股權的確立時間是在授予時確定的。根據2019計劃的條款，根據2009計劃最初授予的未行權、到期或因任何原因終止的股票期權而未向持有人交付股份的股份，將可用於根據2019計劃授予的獎勵。儘管2009計劃下尚有股份用於未來授予，但該計劃仍管轄在該計劃下已授予的未行權股權獎勵。
2019年股權激勵計劃
2019年計劃在2019年7月首次公開招股之前立即生效。2019年計劃規定向僱員、董事和顧問發放股票期權和其他以股票爲基礎的獎勵。根據2019年計劃，每股股票的行權價格不得低於授予日期當天股票的公允市值，除非在1986年《內部收入法典》的第409A條款或第424(a)條款的規定下明確合格。另外，除非另有規定，根據該計劃授予的股票期權應在授予日起","之前到期，授予的時間在授予日確定。除非特定獎勵授予給非僱員董事，否則在2019年計劃下授予的股票期權和受限制的股票單位通常在一個","期內解鎖，視持續服務至每個適用解鎖日期而定。截至2024年9月30日，我們在2019年計劃授權發行的普通股爲","股。
2024年9月30日結束的九個月內，用於授予的股份發生了以下變化：
|
|
可授予的股票 |
|
|
2023年12月31日可以授予的股份 |
|
|
|
|
2019年股權激勵計劃儲備增加，自2024年1月1日起生效 |
|
|
|
|
授予的股票期權和限制性股票單位，以及最大市場爲基礎的限制性股票單位的授予資格 |
|
|
( |
) |
股票期權、限制性股票單位以及最大市場爲基礎的限制性股票單位的被放棄或到期情況 |
|
|
|
|
2024年9月30日可以授予的股份 |
|
|
|
|
19
adaptive biotechnologies公司
未審計的簡明綜合財務報表附註（續）
(未經審計)
股票期權
2009計劃和2019計劃在2024年9月30日結束的九個月內的股票期權活動如下：
|
|
發行的受限股份 |
|
|
加權平均行使 |
|
|
總內在價值 |
|
|||
2023年12月31日未行使的股票期權 |
|
|
|
|
$ |
|
|
|
|
|||
期權授予 |
|
|
|
|
|
|
|
|
|
|||
股票期權被放棄 |
|
|
( |
) |
|
|
|
|
|
|
||
股票期權到期 |
|
|
( |
) |
|
|
|
|
|
|
||
期權行權 |
|
|
( |
) |
|
|
|
|
|
|
||
2024年9月30日未行使的股票期權 |
|
|
|
|
$ |
|
|
$ |
|
|||
2024年9月30日已授予並可行使的股票期權 |
|
|
|
|
$ |
|
|
$ |
|
|||
截至2024年9月30日，未行使股票期權的加權平均剩餘合約期限爲
受限股票單位
根據2019年計劃，截至2024年9月30日結束的九個月內的受限制股份單位活動情況如下:
|
|
受限股票單位 |
|
|
加權平均授予日期 |
|
||
2023年12月31日未獲授的受限制股單位未歸還 |
|
|
|
|
$ |
|
||
授予的限制性股票單位數 |
|
|
|
|
|
|
||
被取消的限制股單位 |
|
|
( |
) |
|
|
|
|
已授予限制性股份單位 |
|
|
( |
) |
|
|
|
|
2024年9月30日未獲授的受限制股單位未歸還 |
|
|
|
|
$ |
|
||
市場限制股票單位
除上述受限制股單位外，我們董事會於2024年3月向我們的首席執行官、前首席財務官、總裁/首席運營官和首席科學官授予了基於市場的受限制股單位獎勵，並於2024年5月向我們現任首席財務官授予了基於市場的受限制股單位獎勵。根據授予給我們的首席執行官、前首席財務官(在其與公司分離前)、總裁/首席運營官、首席科學官和現任首席財務官的獎勵，可獲得的普通股股份數量在
20
自適應生物技術公司
未經審計的簡明合併財務報表附註（續）
（未經審計）
授予日期的期權、限制股票單位和市場限制股票單位的公允價值
2024年和2023年9月30日結束的九個月內授予的期權的估計授予日期公允價值是使用Black-Scholes期權定價模型和以下假設估算的：
|
|
截至9月30日的九個月 |
||
|
|
2024 |
|
2023 |
普通股的公允價值 |
|
$ |
|
$ |
預計期限（年） |
|
|
||
無風險利率 |
|
|
||
預期波動率 |
|
|
||
預期股息收益 |
|
— |
|
— |
使用Black-Scholes期權定價模型判斷授予的股票期權授予日期公平價值受我們普通股公平價值的影響，以及涉及一系列主觀變量的假設，通常需要判斷來確定。估值假設如下確定：
普通股的公允價值——每股普通股的公允價值基於我們普通股在授予日期或其他相關確定日期的收盤價，如納斯達克全球精選市場報告的價格。
預期期限—授予給員工和非僱員董事的股票期權的預期期限是使用ASC 718主題中所示的「簡化」方法確定的，因爲我們沒有足夠的行權歷史來確定預期期限的更好估計。根據這種方法，預期期限是基於股票期權的認購日期和合同期限結束日期之間的中點。 報酬-股票報酬，因爲我們沒有足夠的行權歷史來確定預期期限的更好估計。根據這種方法，預期期限是基於股票期權的認購日期和合同期限結束日期之間的中點。
無風險利率在期權估值模型中，我們使用無風險利率，基於美國國債零息券的問題，剩餘期限與股票期權的預期期限類似。
預期波動率直至2024年，由於我們的普通股沒有足夠的交易歷史，預期波動率基於我們公開交易的行業同行的歷史波動率，利用與我們預期期限一致的一段時間。自2024年開始，預期波動率是基於我們歷史波動率和公開交易的行業同行的歷史波動率的加權平均值，利用與我們預期期限一致的一段時間。
預期股息收益我們不預計在可預見的將來支付任何現金分紅，因此，在期權估值模型中使用預期股息收益率爲
2024年9月30日至2023年9月30日結束的九個月內授予的每股期權授予日期加權平均公允價值爲 $
用於計算授予的受限股票單位的授予日期公平價值基於授予日或其他相關判斷日期的我們普通股收盤價，如在納斯達克全球精選市場報告的。截至2024年9月30日和2023年九個月結束時，每股授予的受限股票單位的加權平均授予日期公平價值爲 $
截至2024年9月30日和2023年九個月結束時，每股授予的以市場爲基礎的受限股票單位的加權平均授予日期公平價值爲$
21
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
The compensation cost related to stock options, restricted stock units and market-based restricted stock units for the three and nine months ended September 30, 2024 and 2023, respectively, are included on the unaudited condensed consolidated statements of operations as follows (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Cost of revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
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|
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|
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||||
Sales and marketing |
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|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
As of September 30, 2024, unrecognized share-based compensation expense and the remaining weighted-average recognition period were as follows:
|
|
Unrecognized Share-Based |
|
|
Remaining Weighted-Average |
|
||
Nonvested stock options |
|
$ |
|
|
|
|
||
Nonvested restricted stock units |
|
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|
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|
||
Nonvested market-based restricted stock units |
|
|
|
|
|
|
||
十二.重組
在截至 2024 年 3 月 31 日止的三個月期間，我們實施了一項重組計劃，以更好地將我們的組織與我們的一致性。
截至 2024 年 6 月 30 日止的三個月內，我們實施了額外的重組措施，這些措施影響了某些計劃的軟體增強功能，並導致某些研究和開發工作流程的整合。受影響的軟體增強功能主要與我們的實驗室資訊管理系統有關。作為這些重組的一部分，我們擁有長壽的資產不再被利用，並且我們在加利福尼亞州南三藩市的某些租賃空間放置了。因此，我們對相關資產的減值進行評估，方法是先將其帳面值與預計在其餘租賃條款或折舊期間產生的未來未經折扣現金流進行比較，視適用情況而產生的未來未經折扣現金流。所有記錄價值均被發現無法回收，因此我們評估資產的公平價值。資產的帳面價值超過其公平價值的程度代表要承認的減值成本。根據我們的評估結果，我們認識到 $
此外，我們產生的整體重組成本為 $
總計，我們承認的重組成本為 $
22
adaptive biotechnologies 公司
未經核數的簡明綜合基本報表附註（續）
(未經審計)
每股損失歸屬於adaptive biotechnologies股份有限公司普通股股東
以下表格列出了截至2024年9月30日及2023年9月30日的三個月和九個月的基本和稀釋的每股淨損，以千為單位，股份和每股金額除外：
|
|
截至9月30日三個月結束時， |
|
|
截至9月30日九個月結束時， |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
歸屬於adaptive biotechnologies股份有限公司的淨損 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
計算歸屬於adaptive biotechnologies股份有限公司普通股股東的每股淨損的基本和稀釋的加權平均股份 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
歸屬於adaptive biotechnologies股份有限公司普通股股東的每股淨損，基本和稀釋 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
鑑於所有期間的虧損狀況，我們的普通股股東應佔的基本每股淨損與應佔的稀釋每股淨損相同，因為所有潛在的已發行普通股股份的含入將會導致抗稀釋。
以下加權平均普通股等效證券未納入截至2024年和2023年9月30日止三個月和九個月的稀釋每股淨虧損計算中，因其具有抗稀釋效應：
|
|
截至9月30日三個月結束時， |
|
|
截至9月30日九個月結束時， |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
尚未行使的股票期權 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
未投資的受限制股票單位尚未實現 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
最大非投資型市場限制股票單位，有資格獲得 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
總計 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
十四.區段資訊
在 2024 年，與組織重新調整有關，我們開始經營我們的業務
MRD 業務專注於使用我們高度敏感的下一代定序測試測量血液惡性腫瘤患者的 MRD。它包括我們向臨床醫生提供的 ClonoSeq 臨床診斷測試，以及我們向生物製藥合作夥伴提供的 ClonoSeq 測試組成，以促進藥物開發工作。我們的 MRD 收入包括來自 (1) 向臨床客戶提供 ClonoSeq 報告；(2) 向生物製藥客戶和某些學術機構提供 MRD 樣本測試服務，包括研究人員主導的臨床試驗；以及 (3) 通過技術轉移向某些國際化驗室提供我們的 ClonoSeq 報告或結果給某些國際實驗場所產生的收入。
免疫醫學業務利用我們的專有能力來大規模對 TCR 和 b 細胞受體（「BCR」）進行序列、映射、配對和特徵。我們創建了一個強大的數據引擎，以推動新型療法的開發。我們的免疫醫學收入包括（1）為我們的商業研究產品「適應免疫測序」向生物製藥客戶和學術機構提供樣品測試服務的收入；以及 (2) 我們與 Genentech 和其他生物製藥客戶在藥物和目標發現領域的合作協議所得的收入。
23
adaptive biotechnologies 公司
未經核數的簡明綜合基本報表附註（續）
(未經審計)
有
以下表格列出了我們截至2024年和2023年9月30日三個月和九個月的部門信息（以千為單位）:
|
|
2024年9月30日結束的三個月 |
|
|||||||||||||
|
|
MRD |
|
|
免疫醫學 |
|
|
未分配公司 |
|
|
總計 |
|
||||
營收 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
營業費用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
調整後的EBITDA(1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
將淨損調整為調整後的EBITDA： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
淨虧損 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
歸屬於非控制權益的淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
歸屬於adaptive biotechnologies股份有限公司的淨損 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
利息收益及其他淨收入 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
利息支出(2) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
折舊和攤銷費用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
重組費用(3) |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
股份報酬成本(4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
調整後的EBITDA(1) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
2023年9月30日結束的三個月 |
|
|||||||||||||
|
|
MRD |
|
|
Immune Medicine |
|
|
Unallocated Corporate |
|
|
總計 |
|
||||
營收 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
營業費用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
調整後的EBITDA(1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
調解淨損盈額至調整後EBITDA: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
淨虧損 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
歸屬於非控制權益的淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
歸屬於adaptive biotechnologies股份有限公司的淨損 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
利息收益及其他淨收入 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
利息支出(2) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
折舊和攤銷費用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
股份報酬成本(4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
調整後的EBITDA(1) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
24
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
|
|
Nine Months Ended September 30, 2024 |
|
|||||||||||||
|
|
MRD |
|
|
Immune Medicine |
|
|
Unallocated Corporate |
|
|
Total |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Reconciliation of Net Loss to Adjusted EBITDA: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss attributable to noncontrolling interest |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Net loss attributable to Adaptive Biotechnologies Corporation |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Interest and other income, net |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Interest expense(2) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Depreciation and amortization expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Impairment of long-lived assets(3) |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Restructuring expense(3) |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Share-based compensation expense(4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
Nine Months Ended September 30, 2023 |
|
|||||||||||||
|
|
MRD |
|
|
Immune Medicine |
|
|
Unallocated Corporate |
|
|
Total |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Reconciliation of Net Loss to Adjusted EBITDA: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss attributable to noncontrolling interest |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Net loss attributable to Adaptive Biotechnologies Corporation |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Interest and other income, net |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Interest expense(2) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Depreciation and amortization expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Share-based compensation expense(4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
(1)
(2)
(3)
(4)
Segment information for the three and nine months ended September 30, 2023 is presented on a comparable basis to that of the current periods and is based on judgments and allocation methods from our organizational changes implemented during the three months ended March 31, 2024.
25
Adaptive Biotechnologies Corporation
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 and the other financial information appearing elsewhere in this report, as well as the other financial information we file with the SEC from time to time. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties relating to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements.
As a result of many factors, including those factors set forth in the “Risk Factors” section of this report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are advancing the field of immune medicine by harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our immune medicine platform applies our proprietary technologies to read the diverse genetic code of a patient’s immune system and understand precisely how the immune system detects and treats disease in that patient. We capture these insights in our dynamic clinical immunomics database and related antigen annotations, which are underpinned by computational biology and machine learning, and use them to develop and commercialize clinical products and services that can be tailored to the needs of individual patients. Our existing and future commercial products and services are aligned to two business areas which we refer to as MRD and Immune Medicine.
Our current product and service offerings in MRD related to the MRD market are our clonoSEQ clinical diagnostic test, offered to clinicians, and our clonoSEQ or MRD assay, offered to biopharmaceutical partners to advance drug development efforts (“MRD Pharma”). Our first clinical diagnostic product, clonoSEQ, is the first test authorized by the Food and Drug Administration for the detection and monitoring of MRD in patients with multiple myeloma, B cell acute lymphoblastic leukemia and chronic lymphocytic leukemia, and is also available as a CLIA-validated laboratory developed test for patients with other lymphoid cancers, including diffuse large B-cell lymphoma. With the use of clonoSEQ, we are transforming how lymphoid cancers are treated by working with providers, pharmaceutical partners and payors.
Immune Medicine leverages our proprietary ability to sequence, map, pair and characterize T cell receptors (“TCRs”) and B cell receptors (“BCRs”) at scale to drive opportunities in cancer, autoimmune disorders, infectious diseases and neurodegenerative disorders. Our core research product, Adaptive Immunosequencing, serves as our underlying research and development engine and generates revenue from biopharmaceutical and academic customers. Leveraging our collaboration with Microsoft Corporation, we are creating the TCR-Antigen Map. We are using the TCR-Antigen Map to identify and validate disease signatures to improve the diagnosis and treatment of many diseases. In Drug Discovery, we use our proprietary capabilities to discover new drug targets and leverage our validated TCR and BCR discovery approaches to discover and develop TCR or antibody therapeutic assets. Drug Discovery includes our worldwide collaboration and license agreement with Genentech (the “Genentech Agreement”).
We recognized revenue of $46.4 million and $37.9 million for the three months ended September 30, 2024 and 2023, respectively, and $131.5 million and $124.5 million for the nine months ended September 30, 2024 and 2023, respectively. Net loss attributable to Adaptive Biotechnologies Corporation was $32.1 million and $50.3 million for the three months ended September 30, 2024 and 2023, respectively, and $125.8 million and $155.8 million for the nine months ended September 30, 2024 and 2023, respectively. We have funded our operations to date principally from the sale of convertible preferred stock and common stock and, to a lesser extent, revenue and proceeds from the revenue interest purchase agreement we entered into in September 2022 with OrbiMed Royalty & Credit Opportunities IV, LP, an affiliate of OrbiMed Advisors LLC, as collateral agent and administrative agent for the purchasers party thereto (the “Purchase Agreement”). As of September 30, 2024 and December 31, 2023, we had cash, cash equivalents and marketable securities of $267.2 million and $346.4 million, respectively.
Restructurings
During the nine months ended September 30, 2024, we implemented various restructuring plans which better aligned our organization to our two operating segments, impacted certain planned software enhancements and resulted in the consolidation of certain research and development workflows, among other things. The software enhancements were primarily associated with our laboratory information management systems. As part of these restructurings, we reduced our workforce, had long-lived assets that were no longer being utilized and vacated certain leased space in South San Francisco, California. As such, we recognized restructuring costs of $0.2 million and $9.1 million during the three and nine months ended September 30, 2024, respectively. Of the $9.1 million restructuring costs recognized, $7.2 million related to impairment charges. The activities related to these restructurings were primarily completed as of September 30, 2024 and are expected to be fully complete as of December 31, 2024.
26
Adaptive Biotechnologies Corporation
Segment Information
In 2024, in connection with an organizational realignment, we began operating our business as two reporting segments: MRD and Immune Medicine. These segments are organized by market opportunity in commercial diagnostics and drug discovery, respectively. See Note 14, Segment Information of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information regarding our segments and the assumptions used to allocate shared expenses. See “Management's Discussion and Analysis of Financial Condition and Results of Operations—2023 Quarterly Segment Information” included in our Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 7, 2024 for quarterly 2023 segment information.
Components of Results of Operations
Revenue
We derive revenue by providing diagnostic and research services in our MRD and Immune Medicine business areas. Our MRD revenue consists of revenue generated from (1) providing our clonoSEQ report to clinical customers; (2) providing MRD sample testing services to biopharmaceutical customers and certain academic institutions, including investigator-led clinical trials; and (3) providing our clonoSEQ report or results to certain international laboratory sites through technology transfers. We disclose our clonoSEQ test volume, which includes the number of clonoSEQ reports and results we have provided to ordering physicians in the United States (“U.S.”) and international technology transfer sites. These volumes do not include sample results from our biopharmaceutical customers or academic institutions utilizing our MRD services. Our Immune Medicine revenue consists of revenue generated from (1) providing sample testing services for our commercial research product, Adaptive Immunosequencing, to biopharmaceutical customers and academic institutions; and (2) our collaboration agreements with Genentech and other biopharmaceutical customers in areas of drug and target discovery.
For our clinical customers, we primarily derive revenue from providing our clonoSEQ report to ordering physicians. We bill commercial, government and medical institution payors based on reports delivered to ordering physicians. Amounts paid for clonoSEQ by commercial, government and medical institution payors vary based on respective reimbursement rates and patient responsibilities, which may differ from our targeted list price. We recognize clinical revenue by evaluating customer payment history, contracted reimbursement rates, if applicable, and other adjustments to estimate the amount of revenue that is collectible.
For our clonoSEQ coverage under Medicare, we bill an episode of treatment when we deliver the first eligible test report. This billing contemplates all necessary tests required during a patient’s treatment cycle, which is currently estimated at approximately four tests per patient, including the initial sequence identification test. Revenue recognition commences at the time the initial billable test report is delivered and is based upon cumulative tests delivered to date. Any unrecognized revenue from the initial billable test is recorded as deferred revenue and recognized either as we deliver our estimate of the remaining tests in a patient’s treatment cycle or when the likelihood becomes remote that a patient will receive additional testing.
For our research customers, which include biopharmaceutical customers and academic institutions for both our MRD and Adaptive Immunosequencing services, delivery of the respective test results may include some level of professional support and analysis. Terms with biopharmaceutical customers generally include non-refundable payments made in advance of services (“upfront payments”), which we record as deferred revenue. For all research customers, we recognize revenue as we deliver sequencing results. From time to time, we offer discounts in order to gain rights and access to certain datasets. Revenue is recognized net of these discounts and costs associated with these services are reflected in cost of revenue. In periods where our sample estimates are reduced or a customer project is cancelled and, in either case, we have remaining related deferred revenue, we recognize revenue using a cumulative catch-up approach based on the proportion of samples delivered to date relative to the total samples expected to be delivered. Certain of our MRD revenue arrangements with biopharmaceutical customers include cash consideration from the achievement of regulatory milestones of the respective biopharmaceutical customers’ therapeutics. Such revenue is constrained from recognition until it becomes probable that such milestone will be achieved.
Under certain agreements with our biopharmaceutical customers who seek access to our platform to support their therapeutic development activities, revenues are generated from research and development support services that we provide. These agreements may include substantial non-refundable upfront payments, which we recognize over time as we perform the respective services. Revenue recognized from these activities relate primarily to the Genentech Agreement.
We expect our MRD revenue to increase in the long term as we continue to increase our MRD clinical testing volume through increased penetration in our existing covered patient populations, expand into new patient populations and optimize payor coverage. Our MRD revenue may fluctuate period to period due to the uncertain timing of receipt of our biopharmaceutical customer samples, which may cause uncertainty in the delivery of our products and services, the recognition of milestones related to regulatory approvals of our biopharmaceutical customers’ therapeutics and changes in estimates of our clinical revenue reimbursement rates.
27
Adaptive Biotechnologies Corporation
We expect our Immune Medicine revenue to increase in the long term as we or our collaborators advance therapies to commercialization. Our Immune Medicine revenue may fluctuate from period to period due to the timing of expenses incurred, changes in estimates of total anticipated costs related to the Genentech Agreement and other events not within our control, including the recognition of milestones under the Genentech Agreement and the timing of receipt of customer samples from our biopharmaceutical customers.
Cost of Revenue
Cost of revenue includes the cost of materials, personnel-related expenses (including salaries, benefits and share-based compensation), shipping and handling expenses, equipment costs, allocated facility costs associated with processing samples and professional support costs related to our service revenue activities. Allocated facility costs include depreciation of laboratory equipment, as well as allocated facility occupancy and information technology costs. Costs associated with processing samples are recorded as expense, regardless of the timing of revenue recognition. As such, cost of revenue and related volume does not always trend in the same direction as revenue recognition and related volume. Additionally, costs to support the Genentech Agreement are a component of our research and development expenses.
We expect cost of revenue to increase in absolute dollars in the long term as we grow our sample testing volume, but the cost per sample to decrease over the long term due to the efficiencies we may gain as assay volume increases from improved utilization of our laboratory capacity, automation and other value engineering initiatives. If our sample volume throughput is reduced, cost of revenue as a percentage of total revenue may be adversely impacted due to fixed overhead costs.
Research and Development Expenses
Research and development expenses consist of laboratory materials costs, personnel-related expenses (including salaries, benefits and share-based compensation), equipment costs, allocated facility and information technology costs and contract service expenses. Research and development activities support further development and refinement of existing assays and products, discovery of new technologies and investments in our immune medicine platform. We also include in research and development expenses the costs associated with software development of applications to support future commercial opportunities, as well as development activities to support laboratory scaling and workflow. We are currently conducting research and development activities for several products and services and we typically use our laboratory materials, personnel, facilities, information technology and other development resources across multiple development programs. Additionally, certain of these research and development activities benefit more than one of our product opportunities. We have not historically tracked research and development expenses by specific product candidates.
The costs to support the Genentech Agreement are a component of our research and development expenses. Additionally, a component of our research and development expenses are costs supporting clinical and analytical validations to obtain regulatory approval for future clinical products and services. Some of these activities have generated and may in the future generate revenue.
We expect research and development expenses to decrease in the short term and to decrease as a percentage of revenue in the long term, although the percentage may fluctuate from period to period due to the timing and extent of our development and commercialization efforts.
Sales and Marketing Expenses
Sales and marketing expenses include personnel-related expenses (including salaries, benefits and share-based compensation) for commercial sales, product and account management, marketing, reimbursement, medical education and business development personnel that support commercialization of our platform products. In addition, these expenses include external costs such as advertising expenses, customer education and promotional expenses, market analysis expenses, conference fees, travel expenses and allocated facility and information technology costs.
We expect sales and marketing expenses to experience moderate increases in the short term. In the long term, we expect sales and marketing expenses to increase in absolute dollars as we increase marketing activities to drive awareness and adoption of our products and services. However, we expect sales and marketing expenses to decrease as a percentage of revenue in the long term, subject to fluctuations from period to period due to the timing and magnitude of these expenses.
General and Administrative Expenses
General and administrative expenses include personnel-related expenses (including salaries, benefits and share-based compensation) for our personnel in executive, legal, finance and accounting, human resources and other administrative functions, including third-party clinical billing services. In addition, these expenses include insurance costs, external legal costs, accounting and tax service expenses, consulting fees and allocated facility and information technology costs.
28
Adaptive Biotechnologies Corporation
We expect general and administrative expenses to remain relatively consistent in the short term and to decrease as a percentage of revenue in the long term.
Interest Expense
Interest expense includes costs associated with our revenue interest liability related to the Purchase Agreement and noncash interest costs associated with the amortization of the related deferred issuance costs. We impute interest expense using the effective interest rate method. We calculate an effective interest rate which will amortize our related obligation to zero over the anticipated repayment period. A significant increase or decrease in or changes in timing of forecasted revenue will prospectively impact our interest expense.
Statements of Operations Data and Other Financial and Operating Data
The following table sets forth our statements of operations data and other financial and operating data for the periods presented (in thousands, except share and per share amounts):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue |
|
$ |
46,435 |
|
|
$ |
37,919 |
|
|
$ |
131,498 |
|
|
$ |
124,492 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of revenue |
|
|
16,667 |
|
|
|
19,346 |
|
|
|
54,035 |
|
|
|
55,937 |
|
Research and development |
|
|
24,163 |
|
|
|
28,533 |
|
|
|
79,761 |
|
|
|
93,371 |
|
Sales and marketing |
|
|
20,551 |
|
|
|
20,493 |
|
|
|
63,184 |
|
|
|
66,673 |
|
General and administrative |
|
|
17,258 |
|
|
|
20,075 |
|
|
|
54,750 |
|
|
|
63,208 |
|
Amortization of intangible assets |
|
|
428 |
|
|
|
428 |
|
|
|
1,275 |
|
|
|
1,270 |
|
Impairment of long-lived assets |
|
|
— |
|
|
|
— |
|
|
|
7,205 |
|
|
|
— |
|
Total operating expenses |
|
|
79,067 |
|
|
|
88,875 |
|
|
|
260,210 |
|
|
|
280,459 |
|
Loss from operations |
|
|
(32,632 |
) |
|
|
(50,956 |
) |
|
|
(128,712 |
) |
|
|
(155,967 |
) |
Interest and other income, net |
|
|
3,474 |
|
|
|
4,282 |
|
|
|
11,462 |
|
|
|
10,918 |
|
Interest expense |
|
|
(2,939 |
) |
|
|
(3,652 |
) |
|
|
(8,628 |
) |
|
|
(10,788 |
) |
Net loss |
|
|
(32,097 |
) |
|
|
(50,326 |
) |
|
|
(125,878 |
) |
|
|
(155,837 |
) |
Add: Net loss attributable to noncontrolling interest |
|
|
26 |
|
|
|
26 |
|
|
|
78 |
|
|
|
28 |
|
Net loss attributable to Adaptive Biotechnologies Corporation |
|
$ |
(32,071 |
) |
|
$ |
(50,300 |
) |
|
$ |
(125,800 |
) |
|
$ |
(155,809 |
) |
Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.86 |
) |
|
$ |
(1.08 |
) |
Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
|
147,516,398 |
|
|
|
144,704,868 |
|
|
|
146,908,234 |
|
|
|
144,208,940 |
|
Other Financial and Operating Data: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
$ |
(14,300 |
) |
|
$ |
(29,831 |
) |
|
$ |
(63,926 |
) |
|
$ |
(91,748 |
) |
(1) Adjusted EBITDA is a non-GAAP financial measure that we define as net loss attributable to Adaptive Biotechnologies Corporation adjusted for interest and other income, net, interest expense, income tax (expense) benefit, depreciation and amortization expense, impairment costs for long-lived assets, restructuring expense and share-based compensation expense. See “Adjusted EBITDA” below for a reconciliation between Adjusted EBITDA and net loss attributable to Adaptive Biotechnologies Corporation, the most directly comparable GAAP financial measure, and a discussion about the limitations of Adjusted EBITDA.
29
Adaptive Biotechnologies Corporation
Comparison of the Three Months Ended September 30, 2024 and 2023
Revenue
|
|
Three Months Ended September 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
|
2024 |
|
|
2023 |
|
||||||
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Service revenue |
|
$ |
32,470 |
|
|
$ |
24,668 |
|
|
$ |
7,802 |
|
|
|
32 |
% |
|
|
|
|
|
|
||
Regulatory milestone revenue |
|
|
5,000 |
|
|
|
— |
|
|
|
5,000 |
|
|
* |
|
|
|
|
|
|
|
|||
Total MRD revenue |
|
|
37,470 |
|
|
|
24,668 |
|
|
|
12,802 |
|
|
|
52 |
|
|
|
81 |
% |
|
|
65 |
% |
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Service revenue |
|
|
5,453 |
|
|
|
5,238 |
|
|
|
215 |
|
|
|
4 |
|
|
|
|
|
|
|
||
Collaboration revenue |
|
|
3,512 |
|
|
|
8,013 |
|
|
|
(4,501 |
) |
|
|
(56 |
) |
|
|
|
|
|
|
||
Total Immune Medicine revenue |
|
|
8,965 |
|
|
|
13,251 |
|
|
|
(4,286 |
) |
|
|
(32 |
) |
|
|
19 |
% |
|
|
35 |
% |
Total revenue |
|
$ |
46,435 |
|
|
$ |
37,919 |
|
|
$ |
8,516 |
|
|
|
22 |
|
|
|
100 |
% |
|
|
100 |
% |
* Not applicable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
The $12.8 million increase in MRD revenue was primarily due to a $5.6 million increase in revenue generated from providing clonoSEQ to clinical customers, a $5.0 million increase in revenue recognized upon the achievement of certain regulatory milestones by one of our biopharmaceutical customers, a $2.0 million increase in revenue generated from providing MRD sample testing services to biopharmaceutical customers and a $0.4 million increase in revenue generated from providing MRD sample testing services to investigator-led clinical trials. Our clonoSEQ test volume increased by 30% to 19,600 tests delivered in the three months ended September 30, 2024 from 15,072 tests delivered in the three months ended September 30, 2023.
The $4.3 million decrease in Immune Medicine revenue was primarily due to a $4.5 million decrease in revenue generated from the Genentech Agreement, which resulted from decreased collaboration expenses, partially offset by a $0.2 million increase in revenue generated from our biopharmaceutical and academic customers.
Cost of Revenue
|
|
Three Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Cost of revenue |
|
$ |
16,667 |
|
|
$ |
19,346 |
|
|
$ |
(2,679 |
) |
|
(14)% |
|
|
36 |
% |
|
|
51 |
% |
The $2.7 million decrease in cost of revenue was primarily attributable to a $4.0 million decrease in labor and overhead costs, which was largely driven by laboratory relocation and consolidation activities, a $0.3 million decrease in cost of materials primarily due to a reduction in inventory reserve expense and a $0.2 million decrease in shipping and handling expenses. These decreases were partially offset by a $1.3 million increase related to higher usage of our production laboratory to process revenue samples versus research and development samples and a $0.7 million increase in materials cost resulting from increased revenue sample volume.
Research and Development
|
|
Three Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Research and development |
|
$ |
24,163 |
|
|
$ |
28,533 |
|
|
$ |
(4,370 |
) |
|
(15)% |
|
|
52 |
% |
|
|
75 |
% |
The following table presents disaggregated research and development expenses by cost classification for the periods presented:
|
|
Three Months Ended September 30, |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Research and development materials and allocated production laboratory expenses |
|
$ |
3,976 |
|
|
$ |
4,063 |
|
|
$ |
(87 |
) |
Personnel expenses |
|
|
14,305 |
|
|
|
17,979 |
|
|
|
(3,674 |
) |
Allocable facilities and information technology expenses |
|
|
2,609 |
|
|
|
2,931 |
|
|
|
(322 |
) |
Software and cloud services expenses |
|
|
1,242 |
|
|
|
697 |
|
|
|
545 |
|
Depreciation and other expenses |
|
|
2,031 |
|
|
|
2,863 |
|
|
|
(832 |
) |
Total |
|
$ |
24,163 |
|
|
$ |
28,533 |
|
|
$ |
(4,370 |
) |
30
Adaptive Biotechnologies Corporation
The $4.4 million decrease in research and development expenses was primarily attributable to a $3.7 million decrease in personnel costs and a $0.8 million decrease in depreciation and other expenses.
Sales and Marketing
|
|
Three Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Sales and marketing |
|
$ |
20,551 |
|
|
$ |
20,493 |
|
|
$ |
58 |
|
|
* |
|
|
44 |
% |
|
|
54 |
% |
* Increase is less than 1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
The $0.1 million increase in sales and marketing expenses was primarily attributable to a $0.6 million increase in computer and software expenses and a $0.4 million increase in allocated overhead expenses. These increases were partially offset by a $0.5 million decrease in personnel costs and a $0.4 million decrease in marketing expenses, which was largely driven by reduced clonoSEQ and research marketing activities.
General and Administrative
|
|
Three Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
General and administrative |
|
$ |
17,258 |
|
|
$ |
20,075 |
|
|
$ |
(2,817 |
) |
|
(14)% |
|
|
37 |
% |
|
|
53 |
% |
The $2.8 million decrease in general and administrative expenses was primarily attributable to a $1.2 million decrease in personnel costs, a $0.6 million decrease in building, facility, overhead and depreciation related expenses largely driven by office space transitions made to support laboratory consolidation activities and a $0.4 million decrease in legal fees. These decreases were partially offset by a $0.3 million increase in third-party billing service fees.
Interest and Other Income, Net
|
|
Three Months Ended September 30, |
|
|
Change |
|||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|||
Interest and other income, net |
|
$ |
3,474 |
|
|
$ |
4,282 |
|
|
$ |
(808 |
) |
|
(19)% |
The $0.8 million decrease in interest and other income, net was primarily attributable to a decrease in net interest income and investment amortization driven by decreased interest rates and related yields of our invested cash and cash equivalents and marketable securities.
Interest Expense
|
|
Three Months Ended September 30, |
|
|
Change |
|||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|||
Interest expense |
|
$ |
(2,939 |
) |
|
$ |
(3,652 |
) |
|
$ |
713 |
|
|
(20)% |
The $0.7 million decrease in interest expense was attributable to a change in our assumptions regarding the timeframe in which our Purchase Agreement will be fully repaid.
Segment Adjusted EBITDA
|
|
Three Months Ended September 30, |
|
|
Change |
|
||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||
MRD Adjusted EBITDA(1) |
|
$ |
(6,120 |
) |
|
$ |
(21,616 |
) |
|
$ |
15,496 |
|
|
(72)% |
|
|
Immune Medicine Adjusted EBITDA(1) |
|
|
(5,212 |
) |
|
|
(4,986 |
) |
|
|
(226 |
) |
|
|
5 |
|
(1)Adjusted EBITDA is a non-GAAP financial measure. See “Adjusted EBITDA” below for an explanation of how it is calculated and used by management.
31
Adaptive Biotechnologies Corporation
The $15.5 million reduction in MRD Adjusted EBITDA deficit was primarily attributable to a $12.8 million increase in MRD revenue and a reduction in operating expenses, excluding those identified as reconciling items between net loss and adjusted EBITDA. The primary drivers of the operating expense reduction relate to general and administrative activities and cost of revenue activities.
The $0.2 million increase in Immune Medicine Adjusted EBITDA deficit was primarily attributable to a $4.3 million reduction in Immune Medicine revenue, which was largely offset by a reduction in operating expenses, excluding those identified as reconciling items between net loss and adjusted EBITDA. The primary drivers of the operating expense reduction relate to research and development activities and cost of revenue activities.
Comparison of the Nine Months Ended September 30, 2024 and 2023
Revenue
|
|
Nine Months Ended September 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
|
2024 |
|
|
2023 |
|
||||||
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Service revenue |
|
$ |
92,880 |
|
|
$ |
71,977 |
|
|
$ |
20,903 |
|
|
|
29 |
% |
|
|
|
|
|
|
||
Regulatory milestone revenue |
|
|
12,500 |
|
|
|
— |
|
|
|
12,500 |
|
|
* |
|
|
|
|
|
|
|
|||
Total MRD revenue |
|
|
105,380 |
|
|
|
71,977 |
|
|
|
33,403 |
|
|
|
46 |
|
|
|
80 |
% |
|
|
58 |
% |
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Service revenue |
|
|
16,160 |
|
|
|
17,848 |
|
|
|
(1,688 |
) |
|
|
(9 |
) |
|
|
|
|
|
|
||
Collaboration revenue |
|
|
9,958 |
|
|
|
34,667 |
|
|
|
(24,709 |
) |
|
|
(71 |
) |
|
|
|
|
|
|
||
Total Immune Medicine revenue |
|
|
26,118 |
|
|
|
52,515 |
|
|
|
(26,397 |
) |
|
|
(50 |
) |
|
|
20 |
% |
|
|
42 |
% |
Total revenue |
|
$ |
131,498 |
|
|
$ |
124,492 |
|
|
$ |
7,006 |
|
|
|
6 |
|
|
|
100 |
% |
|
|
100 |
% |
* Not applicable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
The $33.4 million increase in MRD revenue was primarily due to a $18.7 million increase in revenue generated from providing clonoSEQ to clinical customers, a $12.5 million increase in revenue recognized upon the achievement of regulatory milestones by our biopharmaceutical customers and a $3.5 million increase in revenue generated from providing MRD sample testing services to biopharmaceutical customers. These increases were partially offset by a $1.1 million decrease in revenue generated from providing MRD sample testing services to investigator-led clinical trials. Our clonoSEQ test volume increased by 35% to 55,160 tests delivered in the nine months ended September 30, 2024 from 40,816 tests delivered in the nine months ended September 30, 2023.
The $26.4 million decrease in Immune Medicine revenue was primarily due to a $24.7 million decrease in revenue generated from the Genentech Agreement, which resulted from decreased collaboration expenses and decreased revenue recognized from the $10.0 million regulatory milestone achieved in May 2023, and a $1.7 million decrease in revenue generated from our biopharmaceutical and academic customers.
Cost of Revenue
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Cost of revenue |
|
$ |
54,035 |
|
|
$ |
55,937 |
|
|
$ |
(1,902 |
) |
|
(3)% |
|
|
41 |
% |
|
|
45 |
% |
The $1.9 million decrease in cost of revenue was primarily attributable to a $7.9 million decrease in overhead costs, which was largely driven by laboratory relocation and consolidation activities. This decrease was partially offset by a $2.8 million increase in cost of materials, $2.4 million of which resulted from increased revenue sample volume and $0.4 million of which was primarily related to an increase in inventory reserve expense, a $2.4 million increase related to higher usage of our production laboratory to process revenue samples versus research and development samples and a $0.4 million increase in shipping and handling expenses.
Research and Development
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Research and development |
|
$ |
79,761 |
|
|
$ |
93,371 |
|
|
$ |
(13,610 |
) |
|
(15)% |
|
|
61 |
% |
|
|
75 |
% |
32
Adaptive Biotechnologies Corporation
The following table presents disaggregated research and development expenses by cost classification for the periods presented:
|
|
Nine Months Ended September 30, |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Research and development materials and allocated production laboratory expenses |
|
$ |
12,381 |
|
|
$ |
16,130 |
|
|
$ |
(3,749 |
) |
Personnel expenses |
|
|
48,834 |
|
|
|
56,598 |
|
|
|
(7,764 |
) |
Allocable facilities and information technology expenses |
|
|
8,156 |
|
|
|
8,817 |
|
|
|
(661 |
) |
Software and cloud services expenses |
|
|
3,684 |
|
|
|
2,424 |
|
|
|
1,260 |
|
Depreciation and other expenses |
|
|
6,706 |
|
|
|
9,402 |
|
|
|
(2,696 |
) |
Total |
|
$ |
79,761 |
|
|
$ |
93,371 |
|
|
$ |
(13,610 |
) |
The $13.6 million decrease in research and development expenses was primarily attributable to a $7.8 million decrease in personnel costs and a $3.7 million decrease in cost of materials and allocated production laboratory expenses, which was driven primarily by decreased investments in drug discovery efforts, including collaboration efforts with Genentech, and TCR-Antigen Map development activities, partially offset by an increase in investments related to clonoSEQ. There was also a $2.7 million decrease in depreciation and other expenses, inclusive of a $1.9 million decrease in costs related to collaboration studies primarily related to Immune Medicine, and a $0.7 million decrease in allocable facilities expenses. These decreases were partially offset by a $1.3 million increase in software and cloud services expenses.
Sales and Marketing
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Sales and marketing |
|
$ |
63,184 |
|
|
$ |
66,673 |
|
|
$ |
(3,489 |
) |
|
(5)% |
|
|
48 |
% |
|
|
54 |
% |
The $3.5 million decrease in sales and marketing expenses was primarily attributable to a $3.8 million decrease in personnel costs. There was also a $1.2 million decrease in marketing expenses, which was largely driven by reduced clonoSEQ marketing activities, followed by reduced research and corporate marketing activities, and a $0.7 million decrease in travel and customer event related expenses. These decreases were partially offset by a $2.1 million increase in computer and software expenses and a $0.4 million increase in allocated facility and overhead expenses.
General and Administrative
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
General and administrative |
|
$ |
54,750 |
|
|
$ |
63,208 |
|
|
$ |
(8,458 |
) |
|
(13)% |
|
|
42 |
% |
|
|
51 |
% |
The $8.5 million decrease in general and administrative expenses was primarily attributable to a $4.2 million decrease in personnel costs, a $2.6 million decrease in building, facility, overhead and depreciation related expenses largely driven by office space transitions made to support laboratory consolidation activities, a $1.1 million decrease in legal fees, a $0.8 million decrease in insurance costs and a $0.6 million decrease in consultant costs. These decreases were partially offset by a $1.4 million increase in third-party billing service fees.
Impairment of Long-Lived Assets
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Impairment of long-lived assets |
|
$ |
7,205 |
|
|
$ |
— |
|
|
$ |
7,205 |
|
|
* |
|
|
5 |
% |
|
|
0 |
% |
* Not applicable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
The $7.2 million increase in impairment of long-lived assets expenses was attributable to us impairing certain long-lived assets and us vacating certain leased space as a result of various restructuring activities in 2024.
33
Adaptive Biotechnologies Corporation
Interest and Other Income, Net
|
|
Nine Months Ended September 30, |
|
|
Change |
|
||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||
Interest and other income, net |
|
$ |
11,462 |
|
|
$ |
10,918 |
|
|
$ |
544 |
|
|
|
5 |
% |
The $0.5 million increase in interest and other income, net was primarily attributable to an increase in investment amortization driven by increased related yields of our invested cash and cash equivalents and marketable securities.
Interest Expense
|
|
Nine Months Ended September 30, |
|
|
Change |
|||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|||
Interest expense |
|
$ |
(8,628 |
) |
|
$ |
(10,788 |
) |
|
$ |
2,160 |
|
|
(20)% |
The $2.2 million decrease in interest expense was attributable to a change in our assumptions regarding the timeframe in which our Purchase Agreement will be fully repaid.
Segment Adjusted EBITDA
|
|
Nine Months Ended September 30, |
|
|
Change |
|
||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||
MRD Adjusted EBITDA(1) |
|
$ |
(34,668 |
) |
|
$ |
(71,081 |
) |
|
$ |
36,413 |
|
|
(51)% |
|
|
Immune Medicine Adjusted EBITDA(1) |
|
|
(19,172 |
) |
|
|
(11,149 |
) |
|
|
(8,023 |
) |
|
|
72 |
|
(1)Adjusted EBITDA is a non-GAAP financial measure. See “Adjusted EBITDA” below for an explanation of how it is calculated and used by management.
The $36.4 million reduction in MRD Adjusted EBITDA deficit was primarily attributable to a $33.4 million increase in MRD revenue and a reduction in operating expenses, excluding those identified as reconciling items between net loss and adjusted EBITDA. The primary driver of the operating expense reduction relates to general and administrative activities.
The $8.0 million increase in Immune Medicine Adjusted EBITDA deficit was primarily attributable to a $26.4 million reduction in Immune Medicine revenue, which was partially offset by a reduction in operating expenses, excluding those identified as reconciling items between net loss and adjusted EBITDA. The primary driver of the operating expense reduction relates to research and development activities.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that we define as net loss attributable to Adaptive Biotechnologies Corporation adjusted for interest and other income, net, interest expense, income tax (expense) benefit, depreciation and amortization expense, impairment costs for long-lived assets, restructuring expense and share-based compensation expense. We define our segment Adjusted EBITDA in the same way to the extent the net loss attributable to Adaptive Biotechnologies Corporation and adjustments are allocable to each segment. See Note 14, Segment Information of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information regarding segment Adjusted EBITDA.
Management uses Adjusted EBITDA, including segment Adjusted EBITDA, to evaluate the financial performance of our business and segments and to evaluate the effectiveness of our strategies. We present these figures because we believe it is frequently used by analysts, investors and other interested parties to evaluate companies in our industry and it facilitates comparisons on a consistent basis across reporting periods. Further, we believe it is helpful in highlighting trends in our operating results because it excludes items that are not indicative of our core operating performance.
Adjusted EBITDA, including segment Adjusted EBITDA, has limitations as an analytical tool and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. We may in the future incur expenses similar to the adjustments we make. In particular, we expect to incur meaningful share-based compensation expense in the future. Other limitations include that Adjusted EBITDA, including segment Adjusted EBITDA, does not reflect:
34
Adaptive Biotechnologies Corporation
In addition, Adjusted EBITDA may not be comparable to similarly titled measures used by other companies in our industry or across different industries.
The following is a reconciliation of net loss attributable to Adaptive Biotechnologies Corporation, the most directly comparable GAAP financial measure, to Adjusted EBITDA for the periods presented (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Net loss attributable to Adaptive Biotechnologies Corporation |
|
$ |
(32,071 |
) |
|
$ |
(50,300 |
) |
|
$ |
(125,800 |
) |
|
$ |
(155,809 |
) |
Interest and other income, net |
|
|
(3,474 |
) |
|
|
(4,282 |
) |
|
|
(11,462 |
) |
|
|
(10,918 |
) |
Interest expense(1) |
|
|
2,939 |
|
|
|
3,652 |
|
|
|
8,628 |
|
|
|
10,788 |
|
Depreciation and amortization expense |
|
|
4,591 |
|
|
|
5,763 |
|
|
|
14,808 |
|
|
|
16,839 |
|
Impairment of long-lived assets(2) |
|
|
— |
|
|
|
— |
|
|
|
7,205 |
|
|
|
— |
|
Restructuring expense(2) |
|
|
193 |
|
|
|
— |
|
|
|
1,917 |
|
|
|
— |
|
Share-based compensation expense(3) |
|
|
13,522 |
|
|
|
15,336 |
|
|
|
40,778 |
|
|
|
47,352 |
|
Adjusted EBITDA |
|
$ |
(14,300 |
) |
|
$ |
(29,831 |
) |
|
$ |
(63,926 |
) |
|
$ |
(91,748 |
) |
(1) Represents costs associated with our revenue interest liability and noncash interest costs associated with the amortization of the related deferred issuance costs. See Note 8, Revenue Interest Purchase Agreement of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for details on the Purchase Agreement.
(2) Represents expenses recognized in conjunction with restructuring activities. See Note 12, Restructurings of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for details on our restructuring expenses.
(3) Represents share-based compensation expense related to stock option, restricted stock unit and market-based restricted stock unit awards. See Note 11, Equity Incentive Plans of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for details on our share-based compensation expense.
Liquidity and Capital Resources
We have incurred losses since inception and have incurred negative cash flows from operations since inception through September 30, 2024, with the exception of certain 2019 periods for which we had positive cash flows from operations. As of September 30, 2024, we had an accumulated deficit of $1.3 billion.
We have funded our operations to date principally from the sale of convertible preferred stock and common stock, and, to a lesser extent, revenue and proceeds from the Purchase Agreement. Pursuant to the Purchase Agreement entered into in September 2022, we received net cash proceeds of $124.4 million, after deducting issuance costs. We are also entitled to receive up to $125.0 million in subsequent installments as follows: (i) $75.0 million upon our request occurring no later than September 12, 2025 and (ii) $50.0 million upon our request in connection with certain permitted acquisitions occurring no later than September 12, 2025, in each case subject to certain funding conditions. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $267.2 million.
We believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months. We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons.
35
Adaptive Biotechnologies Corporation
If our available cash, cash equivalents and marketable securities balances and anticipated cash flows are insufficient to satisfy our liquidity requirements, we may request an additional installment under the Purchase Agreement, seek to sell additional equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to our shareholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. This additional capital may not be available on reasonable terms, or at all.
We plan to utilize the existing cash, cash equivalents and marketable securities on hand primarily to fund our commercial and marketing activities associated with clonoSEQ, our continued investments in streamlining our laboratory operations and our continued research and development initiatives related to drug discovery. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to capital preservation and liquidity. Currently, our funds are held in money market funds and marketable securities consisting of U.S. government treasury and agency securities, corporate bonds and commercial paper.
While we may experience variability in revenue in the near term, over the long-term we expect revenue from our current and future products and services to grow. Accordingly, we expect our accounts receivable and inventory balances to increase. Our levels of accounts receivable may fluctuate relative to our revenue for a number of reasons, including the timing of milestone triggers and related payment of those milestones, as well as reductions in revenue derived from the upfront payment received under the Genentech Agreement and an increase in revenue generated from clinical customers, which may result in more billings in arrears as opposed to upfront payments. Any increase in accounts receivable and inventory may not be completely offset by increases in accounts payable and accrued expenses, which could result in greater working capital requirements.
Contractual Obligations
There have been no material changes outside the ordinary course of business to our contractual obligations and commitments as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024.
See Note 7, Leases and Note 8, Revenue Interest Purchase Agreement of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information regarding our contractual obligations relating to lease agreements and the Purchase Agreement, respectively.
Cash Flows
The following table summarizes our uses and sources of cash for the nine months ended September 30, 2024 and 2023 (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Net cash used in operating activities |
|
$ |
(82,721 |
) |
|
$ |
(129,392 |
) |
Net cash provided by investing activities |
|
|
55,673 |
|
|
|
126,440 |
|
Net cash provided by financing activities |
|
|
114 |
|
|
|
2,158 |
|
Operating Activities
Cash used in operating activities during the nine months ended September 30, 2024 was $82.7 million, which was primarily attributable to a net loss of $125.9 million and a net change in operating assets and liabilities of $20.5 million, partially offset by noncash share-based compensation of $40.8 million, noncash depreciation and amortization of $8.1 million, noncash impairment of long-lived assets of $7.2 million related to our restructuring activities, noncash lease expense of $4.0 million, noncash interest expense related to the Purchase Agreement of $2.0 million and inventory reserve expense of $1.4 million. The net change in operating assets and liabilities was primarily driven by an $8.8 million reduction in deferred revenue largely driven by revenue recognized for Genentech, a $6.4 million decrease in operating lease right-of-use assets and liabilities, a $3.6 million reduction in accounts payable and accrued liabilities, a $2.8 million increase in accounts receivable, net and a $0.9 million increase in prepaid expenses and other current assets. These changes were partially offset by a $2.0 million decrease in inventory.
36
Adaptive Biotechnologies Corporation
Cash used in operating activities during the nine months ended September 30, 2023 was $129.4 million, which was primarily attributable to a net loss of $155.8 million and a net change in operating assets and liabilities of $42.7 million, partially offset by noncash share-based compensation of $47.4 million, noncash depreciation and amortization of $10.6 million, noncash lease expense of $5.5 million, noncash interest expense related to the Purchase Agreement of $4.6 million and inventory reserve expense of $0.9 million. The net change in operating assets and liabilities was primarily driven by a $23.2 million reduction in deferred revenue related primarily to revenue recognized from the Genentech Agreement, a $10.7 million reduction in accounts payable and accrued liabilities largely driven by the payout of our corporate bonus during the three months ended March 31, 2023, a $6.8 million increase in inventory, a $6.7 million decrease in operating lease right-of-use assets and liabilities and a $4.0 million increase in prepaid expenses and other current assets largely driven by an increase in prepaid software charges. These changes were partially offset by an $8.8 million decrease in accounts receivable, net primarily related to collections from our biopharmaceutical customers.
Investing Activities
Cash provided by investing activities during the nine months ended September 30, 2024 was $55.7 million, which was primarily attributable to proceeds from maturities of marketable securities of $258.7 million, partially offset by purchases of marketable securities of $199.5 million and purchases of property and equipment of $3.6 million.
Cash provided by investing activities during the nine months ended September 30, 2023 was $126.4 million, which was primarily attributable to proceeds from maturities of marketable securities of $443.4 million, partially offset by purchases of marketable securities of $307.6 million and purchases of property and equipment of $9.4 million.
Financing Activities
Cash provided by financing activities during the nine months ended September 30, 2024 was $0.1 million, which was attributable to proceeds from the exercise of stock options.
Cash provided by financing activities during the nine months ended September 30, 2023 was $2.2 million, which was attributable to proceeds from the exercise of stock options.
Net Operating Loss Carryforwards
Utilization of our net operating loss (“NOL”) carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986 (“Section 382”) and similar state provisions. The annual limitation may result in the expiration of NOL carryforwards and credits before utilization. If there should be an ownership change, our ability to utilize our NOL carryforwards and credits could be limited. We have completed a Section 382 analysis for changes in ownership through December 31, 2023 and continue to monitor for changes that could trigger a limitation. Based on this analysis, we do not expect to have any permanent limitations on the utilization of our federal NOLs. Under the Tax Cuts and Jobs Act of 2017, federal NOLs incurred in 2018 and future years may be carried forward indefinitely, but the deductibility of such federal NOLs is subject to an annual limitation. NOLs generated prior to 2018 are eligible to be carried forward up to 20 years. Based on the available objective evidence, management determined that it was more likely than not that the net deferred tax assets would not be realizable as of December 31, 2023. Accordingly, management applied a full valuation allowance against net deferred tax assets as of December 31, 2023.
Critical Accounting Policies and Estimates
We have prepared the unaudited condensed consolidated financial statements in accordance with GAAP. Our preparation of these unaudited condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities and related disclosures at the date of the unaudited condensed consolidated financial statements, as well as revenue and expense recorded during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and other relevant assumptions that we believe to be reasonable under the circumstances. Estimates are used in several areas, including, but not limited to, estimates of progress to date for certain performance obligations and the transaction price for certain contracts with customers, imputing interest for the Purchase Agreement, the provision for income taxes, including related reserves, the analysis of goodwill impairment and the recoverability and impairment of long-lived assets, among others. These estimates generally involve complex issues and require judgments, involve the analysis of historical results and prediction of future trends, can require extended periods of time to resolve and are subject to change from period to period. Actual results may differ materially from management’s estimates.
37
Adaptive Biotechnologies Corporation
While our significant accounting policies are described in more detail in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024, as well as in Note 2, Significant Accounting Policies of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report, we believe the following accounting policies are critical to the judgments and estimates used in the preparation of the unaudited condensed consolidated financial statements:
There have been no material changes to our critical accounting policies and estimates as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024.
Recent Accounting Pronouncements
See Note 2, Significant Accounting Policies of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
We are exposed to market risk for changes in interest rates related primarily to our cash and cash equivalents and marketable securities. As of September 30, 2024, there have been no material changes to our market risks as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024. We do not enter into investments for trading purposes and have not used any derivative financial instruments to manage our interest rate risk exposure.
Item 4. Controls and Procedures
Under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) as of the end of the period covered by this report. Based on that evaluation, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures were effective as of September 30, 2024. There was not any change in our internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act) during the three months ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
38
Adaptive Biotechnologies Corporation
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control. In addition to the other information set forth in this report, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I, Item 1A under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024. The risk factors may be important to understanding other statements in this report and should be read in conjunction with the unaudited condensed consolidated financial statements and related notes in this report. The occurrence of any single risk or any combination of risks could materially and adversely affect our business, operations, product pipeline, operating results, financial condition or liquidity, and consequently, the value of our securities. Further, additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business, financial condition, operating results and prospects. There have been no material changes to the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
On
Additionally, on
39
Adaptive Biotechnologies Corporation
Item 6. Exhibits
|
|
|
Incorporated by Reference |
|
|||
Exhibit Number |
|
Exhibit Title |
Form |
File No. |
Exhibit |
Filing Date |
Filed/ Furnished with This Report |
3.1 |
|
8-K |
001-38957 |
3.1 |
7/1/2019 |
|
|
3.2 |
|
8-K |
001-38957 |
3.2 |
7/1/2019 |
|
|
4.1 |
|
S-1 |
333-231838 |
4.1 |
5/30/2019 |
|
|
31.1 |
|
|
|
|
|
X |
|
31.2 |
|
|
|
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32.1 |
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X |
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32.2 |
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X |
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
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X |
101.SCH |
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Inline XBRL Taxonomy Extension Schema With Embedded Linkbases Document |
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X |
104 |
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Cover Page Interactive Data File (formatted in Inline XBRL and included in Exhibit 101) |
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X |
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40
Adaptive Biotechnologies Corporation
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Adaptive Biotechnologies Corporation |
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Date: November 7, 2024 |
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By: |
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/s/ Chad Robins |
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Chad Robins |
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Chief Executive Officer and Director (Principal Executive Officer) |
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Date: November 7, 2024 |
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By: |
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/s/ Kyle Piskel |
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Kyle Piskel |
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Chief Financial Officer (Principal Financial Officer) |
41