美國
證券交易委員會
華盛頓特區20549
表格
(標記一個)
根據1934年證券交易法第13或15(d)條款的季度報告。 |
截至2024年6月30日季度結束
或
根據1934年證券交易法第13或15(d)條款的過渡報告 |
在從 到的過渡期間
委員會檔案編號：
（根據其章程所指定的正式名稱）
(依據所在地或其他管轄區) 的註冊地或組織地點) |
(國稅局雇主識別號碼) |
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(總部辦公地址) |
（郵政編碼） |
註冊人的電話號碼，包括區號：(
根據法案第12(b)條規定註冊的證券：
每種類別的名稱 |
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交易 標的 |
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每個註冊交易所的名稱 |
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勾選標誌表示，公司（1）在過去12個月（或公司需要提交此類報告的較短期間內）已提交《1934年證券交易法》第13條或第15(d)條要求提交的所有報告，且（2）過去90天內履行了相應的提交要求。
請勾選表示，是否在過去12個月內（或要求提交該類文件的更短期間）已按照《S-t規則》第405條規定提交了應提交的每個互動資料文件。
請以勾選方式指示，公司是否為大型加速申報人、加速申報人、非加速申報人、小型報告公司或新興成長型公司。請參見《交易所法》第120條2項中「大型加速申報人」、「加速申報人」、「小型報告公司」和「新興成長型公司」的定義。
大型加速歸檔人 |
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☐ |
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加速歸檔人 |
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☐ |
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☒ |
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小型報告公司 |
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新興成長型企業 |
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如果是新興成長公司，請勾選核准欄，表示已選擇不使用擴展過渡期來遵守依據《交易所法》第13(a)條所提供的任何新的或修訂的財務會計標準。
標示√表示本公司是否屬於外殼公司（根據交易所法令第1202條定義）。 是 ☐ 否
是否以勾選方式表示，登記機構已提交根據1934年證券交易法第12條、第13條或第15(d)條要求提交的所有文件和報告，在法院確認證券發行計劃後。 是 ☒ 否 ☐
如 截至2024年10月25日，登記商擁有
目錄
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頁面 |
第一部分。 |
1 |
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项目1。 |
1 |
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1 |
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2 |
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3 |
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5 |
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7 |
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项目2。 |
24 |
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项目3。 |
36 |
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项目4。 |
36 |
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第二部分。 |
38 |
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项目1。 |
38 |
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项目1A。 |
38 |
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项目2。 |
38 |
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项目3。 |
39 |
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项目4。 |
39 |
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项目5。 |
39 |
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第6項。 |
40 |
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41 |
i
有關前瞻性陳述的特別提示
本10-Q表格的季度報告包含關於我們和我們所在行業的前瞻性陳述，涉及重大風險和不確定性，包括但不限於本季度報告的第II部分“特別提示關於前瞻性陳述”和項目1A“風險因素”所載的內容，以及我們向證券交易委員會（SEC）提交的其他文件中討論的風險，包括在2023年12月31日結束的年度報告10-k的第I部分中描述的風險，該報告於2024年3月1日提交。本10-Q表格的季度報告中除了包含歷史事實的陳述外，包括關於我們未來財務狀況、營運結果、業務策略和計劃以及管理層對未來營運目標的陳述，以及有關行業趨勢的陳述，均屬前瞻性陳述。在某些情況下，您可以通過術語識別前瞻性陳述，如“預期”、“相信”、“繼續”、“可能”、“估計”、“期望”、“打算”、“可能”、“預測”、“應該”、“將”或這些術語的否定形式或其他類似表達。
我們在很大程度上基於我們對未來事件和趨勢的當前期望和預測，我們相信可能影響我們的財務狀況、營運成果、業務策略和財務需求。這些前瞻性陳述受本報告中標題為“風險因素”的部分以及我們於2023年12月31日止年度10-k表格上的“風險因素”部分以及其他地方所描述的一系列風險、不確定性、因素和假設的影響，涉及但不限於：
ii
這些風險並不是極盡情報，此10-Q表格中的其他部分可能包含可能損害我們業務和財務表現的額外因素。新的風險因素可能隨時出現，我們的管理層無法預測所有風險因素，也無法評估所有因素對我們業務的影響程度，或特定因素或各種因素可能導致實際結果與任何前瞻性陳述中包含的，或暗示的結果有實質差異。
您不應該將前瞻性陳述視為未來事件的預測。儘管我們認為前瞻性陳述所反映的期望是合理的，但我們無法保證未來結果、活動水平、表現或成就。除法律要求外，我們不承諾在此季度報告表10-Q之後的任何時間更新任何前瞻性陳述的原因，也不將這些陳述調整為實際結果或我們期望的變化。
此外，"我們相信"等類似陳述反映了我們對相關主題的信念和觀點。這些陳述是基於我們在第10-Q表格的季度報告日可取得的信息，雖然我們認為這些信息為此類陳述提供了合理依據，但這些信息可能有限或不完整，我們的陳述不應被解讀為表明我們對所有可能可用的相關信息進行了詳盡調查或審查。這些陳述具有固有的不確定性，投資者應謹慎避免過度依賴這些陳述。
您應閱讀本第10-Q表格的季度報告，以及我們參考並作為附件提交的文件，並理解我們實際的未來結果、活動水平、表現和成就可能與我們預期的有所不同。我們通過這些警語聲明限定我們所有前瞻性陳述。
iii
第一部分—財務AL資訊
第一項。財務報表。未經審計的財務報表。
BIODESIX，INC。
簡明賬戶表表格
(以千為單位，股份數據除外)
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2024年9月30日 |
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2023年12月31日 |
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資產 |
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流動資產合計 |
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現金及現金等價物 |
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$ |
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$ |
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應收帳款，扣除信用損失准備金 $ |
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其他流動資產 |
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全部流動資產 |
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非流動資產 |
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物業及設備，扣除折舊後淨值 |
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無形資產，扣除累計攤銷 |
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營運租賃權使用資產 |
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商譽 |
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其他長期資產 |
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非流動資產總額 |
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資產總額 |
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$ |
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$ |
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負債及股東權益 |
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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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應付負債 |
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逐步認列的收入 |
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營運租賃負債的流動部分 |
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當前分期款待量 |
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— |
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應付票據的當前部分 |
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其他流動負債 |
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流動負債合計 |
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非流動負債 |
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長期應付票據，扣除當期部分後淨額 |
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長期經營租賃負債 |
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其他長期負債 |
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非流動負債總額 |
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總負債 |
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股東權益 |
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優先股，面額$0.01，授權股數為5,000,000股，發行且流通股數為截至2024年6月30日和2023年12月31日之184,668,188股和181,364,180股。 |
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0.01 |
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資本超額評價 |
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累積虧損 |
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( |
) |
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( |
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股東權益總額 |
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負債總額及股東權益合計 |
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$ |
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$ |
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附註是這些未經審計的簡明基本報表的一部分。
1
BIODESIX，INC。
簡明陳述操作摘要
（以千美元為單位，除每股數據外）
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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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收益 |
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$ |
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$ |
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$ |
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$ |
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營業費用： |
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直接成本和費用 |
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研發費用 |
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銷售、營銷、總務和行政支出 |
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無形資產的減損損失 |
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— |
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— |
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營業費用總計 |
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營運虧損 |
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( |
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( |
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( |
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其他（費用）收入： |
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利息費用 |
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( |
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( |
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清算負債損失 |
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— |
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— |
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( |
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— |
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認股權擔保負債公允價值變動，淨額 |
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— |
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( |
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— |
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( |
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其他收入（費用），淨額 |
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( |
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其他總費用 |
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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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基本和稀釋每股淨損失 |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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$ |
( |
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基本和稀釋平均股數 |
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附註是這些未經審計的簡明基本報表的一部分。
2
BIODESIX，INC。
縮短的敘述： 股東權益（赤字）
（以千為單位）
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普通股 |
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資本公積 |
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累計 |
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股東權益合計 |
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股份 |
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金額 |
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資本 |
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赤字累計 |
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（赤字） |
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截至2023年12月31日的結餘 |
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$ |
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$ |
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$ |
( |
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$ |
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普通股發行，淨額 |
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— |
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員工股票購買計劃下的普通股發行 |
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— |
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— |
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行使股票期權 |
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— |
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— |
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釋放限制股票單位 |
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— |
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— |
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— |
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— |
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股份為基礎的報酬 |
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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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截至2024年3月31日的結餘 |
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( |
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( |
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優先股債務轉換為普通股，淨額 |
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— |
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普通股發行，淨額 |
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— |
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行使股票期權 |
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— |
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— |
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解除限制的股票單位 |
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— |
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— |
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— |
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— |
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股份報酬 |
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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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2024年6月30日的賬目 |
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( |
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普通股發行，淨額 |
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— |
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— |
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( |
) |
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— |
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( |
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員工股票購買計劃下的普通股發行 |
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— |
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— |
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行使股票期權 |
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— |
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— |
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釋放受限制股份單位 |
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— |
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— |
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— |
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— |
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以股份為基礎的補償 |
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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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截至2024年9月30日的結餘 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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附註是這些未經審計的簡明基本報表的一部分。
3
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普通股 |
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資本公積 |
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累計 |
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股東權益總計（赤字） |
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股份 |
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金額 |
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資本 |
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赤字累計 |
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股權 |
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2022年12月31日餘額 |
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$ |
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$ |
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$ |
( |
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$ |
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普通股發行，淨額 |
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— |
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— |
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( |
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— |
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( |
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員工股票購買計劃下的普通股發行 |
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— |
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— |
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行使股票期權 |
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— |
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— |
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釋放受限制股份單位 |
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— |
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— |
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— |
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— |
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以股份為基礎的補償 |
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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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截至2023年3月31日的餘額 |
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( |
) |
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行使股票期權 |
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— |
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— |
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釋放受限制股份單位 |
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— |
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— |
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發行 warrants |
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— |
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— |
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— |
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以股份為基礎的補償 |
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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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Balance - June 30, 2023 |
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( |
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( |
) |
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普通股發行，淨額 |
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— |
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員工股票購買計劃下的普通股發行 |
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行使股票期權 |
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釋放受限制股份單位 |
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— |
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— |
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— |
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— |
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以股份為基礎的補償 |
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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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賬目餘額 - 2023年9月30日 |
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$ |
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$ |
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$ |
( |
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$ |
( |
) |
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附註是這些未經審計的簡明基本報表的一部分。
4
BIODESIX，INC。
縮短的敘述： 現金流量
（以千為單位）
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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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來自經營活動的現金流量 |
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淨損失 |
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$ |
( |
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$ |
( |
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調整以將淨虧損調解為淨現金、現金及受限制 |
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折舊與攤提 |
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租賃使用權資產的（貶值）攤銷 |
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( |
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清算負債損失 |
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— |
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股份報酬成本 |
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認股權擔保負債公允價值變動，淨額 |
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— |
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呆帳費用 |
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應計利息、債務發行成本攤銷及其他 |
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存貨過剩和淘汰 |
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無形資產的減損損失 |
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營運資產和負債的變化： |
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應收帳款 |
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( |
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( |
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其他流動資產 |
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其他長期資產 |
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( |
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應付帳款及其他應計負債 |
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( |
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逐步認列的收入 |
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( |
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條件付款 |
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( |
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— |
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收到租戶裝修津貼 |
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— |
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短期和長期營運租約負債 |
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( |
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用於營運活動的淨現金及現金等價物和受限制現金 |
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( |
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投資活動產生的現金流量 |
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購買不動產和設備 |
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( |
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( |
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專利費用和無形資產收購淨額 |
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( |
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( |
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投資活動中使用的淨現金及現金等價物和限制性現金 |
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( |
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( |
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財務活動中的現金流量 |
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普通股發行所得 |
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從員工股票購買計劃發行普通股所得 |
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行使股票期權所得 |
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支付條件掛鉤款項 |
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— |
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( |
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償還定期貸款和應付票據 |
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( |
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( |
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發行債務成本支付 |
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( |
) |
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( |
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股本籌融成本 |
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( |
) |
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( |
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其他 |
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( |
) |
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( |
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融資活動提供的淨現金及現金等價物和受限現金 |
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現金及現金等價物和限制性現金的淨增加（減少） |
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( |
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現金、現金等價物和受限現金－期初 |
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期末現金、現金等價物和受限現金 |
|
$ |
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|
$ |
|
||
附註是這些未經審計的簡明基本報表的一部分。
5
BIODESIX，INC。
現金流量表
（以千為單位）
(接續上一頁)
補充現金流量資訊:
|
|
截至9月30日的九個月 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
發行Perceptive warrants |
|
$ |
— |
|
|
$ |
|
|
在交易所獲得的營業租賃權資產，以換取租賃負債 |
|
|
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||
在交易所獲得的融資租賃使用權資產，以換取租賃負債 |
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||
支付利息的現金 |
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購買的資產和設備包括應付款項和應計負債 |
|
|
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|
|
|
||
附註是這些未經審計的簡明基本報表的一部分。
6
BIODESIX，INC。
未經審核簡明財務附註伊亞爾聲明
註 1 — 業務的組織及描述
比奧迪西克公司（以下簡稱「公司」、「生物德西克斯」、「我們」、「我們」和「我們」），前身為埃爾斯頓科技股份有限公司，於 2005 年在特拉華州成立。公司總部位於科羅拉多州，公司在位於科羅拉多州路易斯維爾和堪薩斯州德索托的實驗室中進行基於血液診斷測試。本公司在一個法人實體內進行其所有業務。Biodesix 是一家主要的診斷解決方案公司，專注於肺疾病。公司採用多元化方法開發診斷測試，以利用不同技術的優勢，這些技術最適合解決重要臨床問題。我們的收入來自兩個來源：(i) 提供與五項血型肺檢測（診斷測試）相關的診斷測試服務；(ii) 為生物製藥公司提供診斷研究、臨床研究、開發和測試服務，一般在臨床環境外提供，並由與第三方的個別合同規管，以及配套診斷的開發和商業化的服務。我們還承認其他服務的收入，包括來自授權我們的技術（生物製藥服務等）獲得的金額。
血液肺檢查
本公司提供
診斷
治療與監測
在開發本公司產品時，我們制定或設計了一項監管策略，從而獲得批准、產品開發和臨床敏銳度、生物儲存庫、專有和專利技術、樣本收集套件製造能力和生物信息學方法，這些方法相信對開發新的針對性療法、確定臨床試驗資格和指導治療選擇非常重要。本公司的測試服務是透過其臨床實驗室提供。
附註2 – 重大會計政策摘要
報告基礎
隨附的未經審計的簡明基本報表已根據10-Q表格的說明和S-X規則10-01以及中期財務信息的要求編製，並反映出對公司的財務狀況、經營成果和現金流量進行公正陳述所需的所有調整。所有這些調整均為正常的週期性調整。中期的結果不能反映整個財政年度的結果。應該將隨附的未經審計的簡明基本報表和公司年度報告中截至2023年12月31日的10-k表格內包含的經審計的基本報表一同閱讀。包括重要的會計政策在內的某些信息和腳註披露通常包括按照普遍公認的會計原則編制的財政年度基本報表。
7
BIODESIX，INC。
未經審計的簡明財務報表附註
美國（GAAP）已經壓縮或省略。截至 2023 年 12 月 31 日的簡明資產負債表取自經審核的財務報表。
流動性和資本資源
截至 2024 年 9 月 30 日，我們維持現金及現金等值 $
我們在到期時履行責任的能力可能會受到我們保持遵守我們的認知定期貸款設施中遵守財務條約的能力的影響（請參閱註 6 — 債務) 或獲得影響相關條約的豁免或修訂。截至 2024 年 9 月 30 日，本公司遵守與其借款有關的所有限制性和財務條約。
在未來十二個月內，我們能夠在接下來的十二個月內根據我們的認知定期貸款安排維持財務契約的能力部分取決於執行我們目前的營運計劃。如果我們未執行目前的營運計劃並維持我們的財務條約，這可能導致違約事件（如認知定期貸款設施中的定義），導致未償還餘額的加速和還款。本公司必須符合截至 2023 年 3 月 31 日截至截至截至 2023 年 3 月 31 日的財政季度開始，截至截至每個財政季度最後一天，本公司與 Perceptive 達成一定最低淨收入門檻金額。於 2023 年期間，本公司就認知定期貸款機構進行了多項修訂，以降低相關最低淨收入門檻。二零二四年二月二十九日，本公司就《認知定期貸款安排》進行第三次修訂，在遵守第三項修訂條款及細則下，修訂《最低淨收入公約》，將至截至 2025 年 12 月 31 日止財政季度降低相關門檻（見註 6 — 債務)。截至二零二四年六月三十日止三個月內，本公司完成普通股認購及並行私募股（2024 年 4 月發行）。公司集體籌集所得款項淨額約 $
如果我們未執行目前的營運計劃，我們可能需要繼續從外部來源籌集額外資金，例如通過發行債務或股票證券。我們也可能會籌集額外資金來重組現有債務或用於一般營運資金目的，或兩者兩者。如果我們通過債務融資籌集額外資金，我們可能會受到約束，限制或限制我們採取特定行動的能力，例如承擔額外債務、進行資本支出或申報股息。如果我們通過股票發行籌集額外資本，我們現有股東的所有權益將被稀釋，並且這些證券的條款可能包括清盤或其他優惠，這些權益對我們現有股東權利有利影響。我們無法保證我們將提供額外資金，或者如果有，將以足夠的金額或按我們可接受的條款或及時提供。
我們預計在短期內將繼續承受營運虧損，同時進行投資以支持預期增長。我們維持財務契約的能力部分取決於執行我們目前的營運計劃，並與上述項目一起，對於公司能夠在財務報表發布日期後一年內繼續作為持續性企業的能力，引發了重大的懷疑問。我們的未經審核財務報表已經擬定，假設我們將繼續保持持續經營業務，並不包括如果我們無法繼續繼續進行的情況下，可能需要的任何調整。
估算的使用
根據 GAAP 準備財務報表，管理層需要做出預估和假設，以影響已報告資產和負債金額、資產負債日期的可應資產和負債披露，以及報告期內報告收入和支出金額的報告。實際結果可能與這些估計不同。
8
BIODESIX，INC。
未經審計的簡明財務報表附註
信用風險集中和其他不確定性
幾乎所有的公司現金及現金等價物存放在美國的一家主要金融機構。公司持續監控與其持有現金的金融機構的位置和信用質量。公司全年定期在各種營運和貨幣市場帳戶中保持餘額，超出聯邦保險極限。公司在現金及現金等價物存款上並未遭受任何損失。
公司某些樣本收集套件、測試試劑和測試系統的元件來自單一來源供應商。如果這些單一來源供應商未能及時滿足公司的要求，公司可能會遭遇交付診斷方案遇到延遲、可能損失營業收入，或增加成本，任一情況都可能對其營運業績產生不利影響。
論及2024年9月30日和2023年12月31日應收帳款信用風險集中，請參見註9 營業收入和應收帳款信用集中.
受限現金
受限現金包括與公司企業信用卡相關的存款。截至2024年9月30日和2023年12月31日的兩個期間公司有未確認的工資支出，金額為$
存貨
存貨主要由消耗於測試服務中的物料供應品組成，計入『直接成本及費用』。存貨以成本計入並在簡明賬目中報告在『其他流動資產』內。在簡明賬目中報告，存貨為$賬目。
其他資產
公司有一個$
金融工具的公允價值
美國公認會計準則為公平價值設立了一個以輸入類型為基礎的優先次序，該次序基於各種估值技術（市場法、收益法和成本法）所使用的輸入類型。我們利用市場法和收益法的組合來評估我們的金融工具。我們的金融資產和金融負債使用來自公平價值層次結構的三個層次的輸入來衡量。根據用於判斷公平價值的最重要輸入的最低層次，將公平價值衡量分類為公平價值層次中。
該層次結構及相關輸入如下：
階層 |
|
重要輸入數 |
1 |
|
相同資產和負債在活躍市場中的未調整報價。 |
2 |
|
類似資產和負債在活躍市場中的未調整報價； |
|
|
在非活躍市場中，相同或相似資產或負債的未調整報價。 |
|
|
資產除報價價格外，還有其他可觀察到的輸入。 |
3 |
|
對於資產或負債不可觀測的投入。 |
包括現金及現金等價物、應收帳款、預付費用和其他流動資產、其他長期資產、應付帳款和應計負債的攤銷金額大致等於公允價值，因其到期日相對較短。
參見註4 — 合理價值 有關估計公平值的更多討論，請參閱註4。
9
BIODESIX，INC。
未經審計的簡明財務報表附註
附註3 - 最近發布的會計準則
正在評估的標準
2023年11月，FASB發佈ASU No. 2023-07，《分節報告（TOPIC 280）：改進報告的分節披露》。這次更新通過增強顯示重要分節支出的披露來改進報告的分節披露要求。本更新的修改應適用於合併財務報表中呈報的所有先前期間，並在2023年12月31日後開始的財政年度和2024年12月31日後開始的財政年度中的中期期間內生效。允許提前採用。公司目前正在評估本指南對其簡明合併財務報表的潛在影響。 分部報告：改進可報告部門披露 (ASC主題280). 這項ASU要求所有上市實體提供有關實體可報告部門的附加披露，以及有關可報告部門支出的更詳細信息。該指南將於2024年1月1日開始生效，並於2025年1月1日開始生效。公司目前正在評估這項指南，並評估對其基本報表的總體影響。
在2023年12月，FASB發布了2023-09號ASU 所得稅（主題740）：所得稅披露的改進這項ASU透過要求所得稅披露在稅率調解和依司法管轄區支付的所得稅方面具有一致的分類和更大的細分；提高了所得稅披露的透明度。這項指南將於2025年1月1日開始生效，可提前採納。公司目前正在評估這項指南，並評估對其基本報表的總體影響。
附註4 - 公允價值
定期公允價值測量
我們所借入的工具在簡化資產負債表中按其攤銷價值記錄，這可能不同於相應的公允價值。截至2024年9月30日，借款的公允價值主要與2022年11月與Perceptive Credit Holdings IV，LP簽訂的Perceptive Term Loan Facility有關，並且是使用折現現金流分析確定的，不包括與交易同時發行的Perceptive Warrant（如下文所定義）的公允價值。截至2024年9月30日和2023年12月31日，未償還借款的攤銷價值約當於公允價值。.
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截至日期 |
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2024年9月30日 |
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2023年12月31日 |
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攜帶價值 |
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公平價值 |
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攜帶價值 |
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公平價值 |
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||||
借款 |
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$ |
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$ |
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$ |
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$ |
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||||
以估計公平價值記錄並再現性地記錄的財務負債包括我們與Indi先前收購相關的條件性考慮金，作為Perceptive Term Loan Facility的考慮而授予的認股權負債（請參見附註6 - 債務），以及授予給部分先前轉換的F系列優先股持有人的條件價值權，這些被視為負債且透過我們簡明財務報表來重新衡量。
下表顯示了有關待定對價和認股權負債的報告公允價值，這些負債被歸類為公允價值層次中的第3級，截至所指示的日期（以千為單位）：
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截至日期 |
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描述 |
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2024年9月30日 |
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2023年12月31日 |
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條件付款 |
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$ |
— |
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$ |
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認股權負債 |
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$ |
— |
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$ |
— |
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預期價值權益 |
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$ |
— |
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$ |
— |
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以下表格呈現指定日期的條件性考慮變動（以千為單位）：
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截至九個月結束時 |
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Level 3 Rollforward |
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待定先決條件 |
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賬戶餘額-2024年1月1日 |
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$ |
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利息費用 |
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清算負債損失 |
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付款 |
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( |
) |
截至2024年9月30日的結餘 |
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$ |
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10
BIODESIX，INC。
未經審計的簡明財務報表附註
下表列出指定日期的可定代價及認股證負債的變動 (以千計)：
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在結束的九個月 |
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等級 3 向前推 |
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有效考慮 |
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認股證責任 |
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||
初期餘額-二零二三年一月一日 |
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$ |
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$ |
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||
公平價值淨值變動 |
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— |
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利息支出 |
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— |
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付款 |
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( |
) |
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— |
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截止餘額-二零二三年九月三十日 |
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$ |
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|
$ |
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||
有效考慮
與 2018 年收購 Indi 有關，該公司根據資產購買協議（英迪 APA）的條款，對於因迪的賣出股東應付出發生的額外支付的金額記錄了可定性的代價。有效代價安排
2021 年 8 月，公司就原始協議訂立了修訂，其中各方同意放棄發行普通股，並同意該公司將取代該公司每季分期六次約 $
2022 年 4 月 7 日，該公司簽署《印地安排》第三號修正案，當事人同意重組里程碑付款。公司製作
有關可定代價負債按公平價格進行帳目，並須依據某些不可觀察的輸入。評估公平價值時使用的重大不可觀察的輸入包括成功實現指定產品毛利目標的機率、預期實現目標的期間以及以下的折扣率
截至二零二四年九月三十日止的三個月和九個月內，本公司錄得 $
根據 ASC 230 號規定， 現金流量表，支付用於結算收購日期以公平價計算的可定代價負債（包括評估期間調整）的現金應反映為融資活動的現金流出，而支付金額的剩餘部分應在現金流報表中反映為營運活動的現金流出。所有 2024 年里程碑付款在本公司的現金流量表中，均歸類為營運活動的現金流出。
認股證責任
二零二二年十一月二十一日，作為認知定期貸款設施的考慮（見註 6- 債務)，該公司發出 Perceptive 認股權證，購買最多
11
BIODESIX，INC。
未經審計的簡明財務報表附註
定義 詳見註8 - 股本 以及Tranche b和C認股權證。初始認股權證歸類為權益項目（詳見註8 - ），而Tranche b和C認股權證最初被歸類為負債並按公允價值認列。2023年12月15日（Tranche b融資日期）公司行使了提領Tranche b貸款的權利（詳見註6 – ）。有關Tranche b提領，公司重新評估了通過Tranche b融資日期的Tranche b認股權證並記錄了公允價值的變化，隨後將公允價值重新分類為資本公積金（詳見註8 – 股權） 債務) 股權）。使用Black-Scholes模型確定Tranche C認股權的公允價值，並受到某些不可觀察的輸入變數的影響。在衡量公允價值時所使用的重要不可觀察變數包括公司普通股的公允價值、無風險利率、普通股的波動率以及預計借款的機率。Tranche C貸款具有截止日期，截至2024年9月30日，公司未行使提取Tranche C貸款的權利。因此，相關的Tranche C認股權已到期，不再可行使。
在截至2024年9月30日的三個月和九個月內，公司記錄
條件價值權
在2016年1月，公司發行了Series F優先股（Series F Offering），後來在2020年10月與公司的首次公開募股交易中轉換為普通股。有關Series F Offering，購買的投資者超過他們在融資中應得的部分的人，將獲得計算出來的一定數量的條件價值權(CVRs)。每一個CVR代表了公司對於該藥物ficlatuzumab的一定利益的%；該藥物在2024年1月開始進行第3期臨床試驗（請參見第13條 - 下文）。在2016年1月，公司發行了 CVRs，或
Note 5 – Supplementary Balance Sheet Information
Property and equipment consist of the following (in thousands):
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As of |
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|||||
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September 30, 2024 |
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December 31, 2023 |
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Lab equipment |
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$ |
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$ |
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Leasehold improvements |
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Computer equipment |
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Furniture and fixtures |
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Software |
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Vehicles |
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Construction in process |
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— |
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Less accumulated depreciation |
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( |
) |
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( |
) |
Total property and equipment, net |
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$ |
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$ |
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||
Depreciation expense for the three and nine months ended September 30, 2024 was $
12
BIODESIX，INC。
未經審計的簡明財務報表附註
無形資產（不包括商譽）包括以下各項（以千為單位）：
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2024年9月30日 |
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2023年12月31日 |
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成本 |
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累計 |
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淨攜帶價值 |
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成本 |
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累計 |
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淨攜帶價值 |
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應分期攤銷的無形資產 |
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專利年限 |
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$ |
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$ |
( |
) |
|
$ |
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$ |
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$ |
( |
) |
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$ |
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||||
購買的科技 |
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( |
) |
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( |
) |
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無形資產不受 |
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商標 |
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— |
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— |
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總計 |
|
$ |
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$ |
( |
) |
|
$ |
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|
$ |
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|
$ |
( |
) |
|
$ |
|
||||
與有限壽命無形資產相關的攤銷費用分別為 $
無形資產未來預計的攤銷費用（以千計）：
|
|
截至 |
|
|
2024年剩餘部分 |
|
$ |
|
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2025 |
|
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2026 |
|
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2027 |
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2028 |
|
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2029年及之後 |
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總計 |
|
$ |
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|
應計負債由以下項目（以千為單位）組成：
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截至日期 |
|
|||||
|
|
2024年9月30日 |
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2023年12月31日 |
|
||
與補償相關的應計項目 |
|
$ |
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$ |
|
||
累積的臨床試驗費用 |
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||
其他費用 |
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總計應計負債 |
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$ |
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$ |
|
||
附註6 - 負債
我們的長期負債主要包括與我們的Perceptive Term Loan Facility相關的應付票據，該設施將在以下更詳細說明。
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截至日期 |
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2024年9月30日 |
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2023年12月31日 |
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Perceptive Term Loan Facility |
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$ |
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$ |
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||
其他 |
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未攤銷的債務折扣和債務發行成本 |
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( |
) |
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( |
) |
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從當前到期日減少 |
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長期應付票據 |
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$ |
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$ |
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||
Perceptive Term Loan Facility
2024年7月31日，trane technologies plc發布新聞稿宣布其2024年第一季度的業績。 2022年11月16日（結業日），公司與Perceptive Credit Holdings IV，LP作為貸款人和行政代理（貸方），簽訂了信貸協議和擔保（信貸協議）。信貸協議提供了與Perceptive Advisors LLC（Perceptive）（Perceptive Term Loan Facility）進行的優先擔保延後放款設施。A階段貸款,
13
BIODESIX，INC。
未經審計的簡明財務報表附註
在 總金額高達 $
利率
認知定期貸款設施將按年利率累積利息，按年利率等於 (a) 由 CME Group Inc. 公司發布的前瞻性一個月期 SOFRR 以及 (b)
攤銷及預付款
於到期日，本公司須向貸款人支付認知定期貸款基礎的總未償還本金額，以及其所有累計及未付利息。在到期日之前，「感知定期貸款設施」不會計劃支付本金。認知定期貸款設施可隨時預付，並須支付相等於以下的預繳保費
保證工具及認股權證
根據公司與貸款人之間的保證協議日期（「證券協議」）日期為止，本公司在信貸協議下的所有責任均以本公司所有資產的首次抵押完善保證權保證權保證，但不包括常規例外。
作為信貸協議的代價，本公司已於融資日發出最多的認知認證
除了初始認股權證和第 b 期權證外，其他認股權證將可行使
陳述、保證、約定和違約事件
信用協議包含類似融資通常需要的某些聲明和擔保、肯定契約、負約、財務約定以及條件。確定條款除其他事項之外，要求本公司承擔各項報告及通知要求，維持保險，並維持全面有效並實施公司業務運作合理必要的所有監管批准、重大協議、重大知識產權（每一項均定義在信用協議中定義）以及其他權利、利益或資產（無形或無形）。負約限制或限制公司在信用協議中的某些例外情況下產生新債務；對資產建立抵押；參與某些基本公司變更，例如合併或收購，或更改公司業務活動；進行某些投資或限制付款（每一項信用協議定義）；更改財政年度；支付股息；償還其他部分債務進行某些聯盟交易；或進行、修改或終止任何其他有影響公司根據信貸協議還款的能力的影響的協議。此外，公司必須 (i) 在到期日前的任何時間維持最低現金餘額為 $
開啟 五月 2023 年 10 日，本公司與貸款人簽訂第一修正案，根據第一修訂條款及細則，修訂最低淨收入公約（如信貸協議中定義），以降低截至 2023 年 6 月 30 日止財政季度開始至截止財政季度的每個財政季度的相關門檻
14
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
March 31, 2024. As consideration for the First Amendment, the Company agreed to issue to Perceptive a warrant to purchase up to
On August 4, 2023 (the Second Amendment Effective Date), the Company entered into the Second Amendment to the Credit Agreement and Guaranty (the Second Amendment) with Perceptive as lender and administrative agent and the Company, as borrower, whereby subject to the terms and conditions of the Second Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending June 30, 2024 through and including the fiscal quarter ending December 31, 2025.
Under the terms of the Second Amendment, the conditions precedent for drawing on the Tranche B Loan were amended to (i) reduce the trailing twelve-month revenue milestone and (ii) add the receipt of aggregate cash proceeds of at least $
On February 29, 2024 (the Third Amendment Effective Date), the Company entered into the Third Amendment to the Credit Agreement and Guaranty (the Third Amendment) with Perceptive as lender and administrative agent and the Company, as borrower, whereby subject to the terms and conditions of the Third Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending March 31, 2024 through and including the fiscal quarter ending December 31, 2025.
The Credit Agreement also contains certain customary Events of Default which include, among others, non-payment of principal, interest, or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material judgments, cross-defaults to material contracts, certain regulatory-related events and events constituting a change of control. As of September 30, 2024, the Company was in compliance with all restrictive and financial covenants associated with its borrowings. The occurrence of an Event of Default could result in, among other things, the declaration that all outstanding principal and interest under the Perceptive Term Loan Facility are immediately due and payable in whole or in part.
On the Closing Date, the Initial Warrants and Additional Warrants were valued at $
Scheduled principal repayments (maturities) of long-term obligations were as follows (in thousands):
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As of |
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Remainder of 2024 |
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$ |
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2025 |
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2026 |
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2027 and thereafter |
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Total |
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$ |
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|
Note 7 – Leases
Operating Leases
The Company acts as a lessee under all its lease agreements. In January 2024 the Company relocated its corporate headquarters and laboratory facilities to Louisville, Colorado. The Company also leases laboratory and office space in De Soto, Kansas, under a non-cancelable lease agreement for approximately
Centennial Valley Properties I, LLC Lease Agreement
On March 11, 2022, the Company entered into a Lease Agreement (the Lease) with Centennial Valley Properties I, LLC and subsequently assigned to CVP I Owner LLC, a Colorado limited liability company (the Landlord) for office and laboratory space in Louisville, Colorado (the Leased Premises).
15
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
date, which was
Under the Lease, the Company is leasing approximately
The Lease includes various covenants, indemnities, defaults, termination rights, and other provisions customary for lease transactions of this nature. During the three months ended September 30, 2022, a $
Operating lease expense for all operating leases was $
Future minimum lease payments associated with our operating leases were as follows (in thousands):
|
|
As of |
|
|
Remainder of 2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 and thereafter |
|
|
|
|
Total future minimum lease payments |
|
|
|
|
Less amount representing interest |
|
|
( |
) |
Total lease liabilities |
|
$ |
|
|
Note 8 – Equity
Equity Financing Programs
The Company maintains
In November 2021, the Company entered into a sales agreement with a financial institution, pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $
16
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on the NASDAQ Global Market, or any other existing trading market for our common stock.
On March 7, 2022 (the LPC Effective Date), the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (the Purchase Agreement), pursuant to which Lincoln Park has committed to purchase up to $
On the LPC Effective Date, the Company issued
During the nine months ended September 30, 2024, the Company raised approximately $
April 2024 Offering Summary
On April 9, 2024, the Company closed an underwritten offering of common stock and a concurrent private placement. Collectively, the Company raised net proceeds of approximately $
Underwritten Offering
On April 9, 2024, the Company closed an underwritten offering (the Offering) of
The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act, other obligations of the parties and termination provisions. The Underwriting Agreement also includes lock up restrictions that will be in effect during the period ending 90 days subsequent to April 5, 2024. The representations, warranties, and agreements contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.
17
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
The Offering was made pursuant to the Company’s effective Registration Statement on Form S-3 (File No. 333-261095) previously filed with the SEC on November 29, 2021 and a prospectus supplement, dated April 5, 2024 relating to the Offering.
Concurrent Private Placement
On April 5, 2024, the Company entered into securities purchase agreements (the Securities Purchase Agreements) with various investors, including certain members of management, certain of its directors and funds affiliated with those directors (the Investors) for the issuance and sale by the Company of an aggregate of
Pursuant to the Securities Purchase Agreements, the Investors purchased the Preferred Stock at a purchase price of $
Registration Rights Agreement
In connection with the Concurrent Private Placement, the Company also entered into a Registration Rights Agreement, dated April 5, 2024 (the Registration Rights Agreement), with the Investors, which provides that the Company will register the resale of the shares of Common Stock issuable upon conversion of the Preferred Stock. Pursuant to the Registration Rights Agreement, the Company was required to prepare and file an initial registration statement with the SEC as soon as reasonably practicable, but in no event later than April 23, 2024 (the Filing Deadline), and to use reasonable best efforts to have the registration statement declared effective within 50 days after the closing of the Concurrent Private Placement, subject to the approval of the conversion of the Private Placement Shares being received at the Company’s 2024 annual meeting of stockholders.
On April 8, 2024, the Company filed a Certificate of Designations of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock with the Secretary of State of the State of Delaware (the Certificate of Designations) in connection with the Concurrent Private Placement. The Certificate of Designations provided for the issuance of up to
Following stockholder approval of the Conversion Proposal, each share of Series A Preferred Stock automatically converted into
On May 21, 2024, the Company held its 2024 annual meeting of stockholders in which the Conversion Proposal and Issuance Proposal were approved by the Company's stockholders. Upon approval, each share of Series A Preferred Stock automatically converted into
Warrants
During 2018, the Company issued warrants to purchase shares of convertible preferred stock in conjunction with the sale of certain convertible preferred shares and issuance of debt. The Company issued to the lender a warrant to purchase
On November 21, 2022, as consideration for the Perceptive Term Loan Facility (see Note 6 – Debt), the Company issued the Perceptive Warrant to purchase up to
18
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
On May 10, 2023, as consideration for the First Amendment (see Note 6 – Debt), the Company agreed to issue to Perceptive a warrant to purchase up to
On December 15, 2023 (the Tranche B Borrowing Date), the Company exercised its ability to draw the Tranche B loan (see Note 8 – Debt). In connection with the Tranche B draw, the Company remeasured the Tranche B Warrants through the Tranche B Borrowing Date and recorded the change in fair value through the statements of operations and, subsequently, reclassified the fair value to additional paid-in capital. The Tranche B Warrants are now equity classified and immediately exercisable upon issuance and expire on
Note 9 – Revenue and Accounts Receivable Credit Concentration
Diagnostic test revenues consist of blood-based lung tests which are recognized in the amount expected to be received in exchange for diagnostic tests when the diagnostic tests are delivered. The Company conducts diagnostic tests and delivers the completed test results to the prescribing physician or patient, as applicable. The fees for diagnostic tests are billed either to a third party such as Medicare, medical facilities, commercial insurance payers, or to the patient. The Company determines the transaction price related to its diagnostic test contracts by considering the nature of the payer, test type, and historical price concessions granted to groups of customers. For diagnostic test revenue, the Company estimates the transaction price, which is the amount of consideration it expects to be entitled to receive in exchange for providing services based on its historical collection experience, using a portfolio approach. The Company recognizes revenues for diagnostic tests upon delivery of the tests to the physicians requesting the tests or patient, as applicable.
Services revenue consists of on-market tests, pipeline tests, custom diagnostic testing, and other scientific services for a purpose as defined by any individual customer, which is often with biopharmaceutical companies. The performance obligations and related revenue for these sales is defined by a written agreement between the Company and the customer. These services are generally completed upon the delivery of testing results, or other contractually defined milestone(s), to the customer. Revenue for these services is recognized upon delivery of the completed test results, or upon completion of the contractual milestone(s). In addition, other revenue includes amounts derived from licensing our digital sequencing technologies to our international laboratory partners. We are compensated through royalty-based payments for the licensed technology, and depending on the nature of the technology licensing arrangements and considering factors including but not limited to enforceable right to payment and payment terms, and if an asset with alternative use is created, these revenues are recognized in the period when royalty-bearing sales occur.
Revenues consisted of the following (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Diagnostic Tests |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Biopharmaceutical Services and other |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Deferred Revenue
Deferred revenue consists of cash payments from customers received in advance of delivery. As test results are delivered, the Company recognizes the deferred revenue in ‘Revenues’ in the condensed statements of operations. The Company had $
19
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
revenue’ recorded in the condensed balance sheet as of December 31, 2023 and $
The Company’s customers in excess of 10% of total revenue and their related revenue as a percentage of total revenue were as follows:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
United Healthcare |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
In addition to the above table, we collect reimbursement on behalf of customers covered by Medicare, which accounted for
The Company is subject to credit risk from its accounts receivable related to services provided to its customers.
|
|
As of |
|
|||||
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Medicare |
|
|
% |
|
|
% |
||
Note 10 – Share-Based Compensation
The Company’s share-based compensation awards are issued under the 2020 Equity Incentive Plan (2020 Plan), the predecessor 2016 Equity Incentive Plan (2016 Plan) and 2006 Equity Incentive Plan (2006 Plan). Any awards that expire or are forfeited under the 2016 Plan or 2006 Plan become available for issuance under the 2020 Plan. As of September 30, 2024,
Share-Based Compensation Expense
Share-based compensation expense reported in the Company’s condensed statements of operations was (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Direct costs and expenses |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
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|
||||
Sales, marketing, general and administrative |
|
|
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|
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|
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|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The unrecognized remaining share-based compensation expense for options and RSUs was approximately $
20
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Stock Options
Stock option activity during the nine months ended September 30, 2024, excluding the Bonus Option Program described below, was (in thousands, except weighted average exercise price and weighted average contractual life):
|
|
Number of |
|
|
Weighted Average |
|
|
Weighted Average |
|
|
Aggregate |
|
||||
Outstanding - January 1, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Forfeited/canceled |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
Exercised |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
Outstanding ‑ September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable ‑ September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Restricted Stock Unit Activity
Restricted stock unit activity during the nine months ended September 30, 2024 was (in thousands, except weighted average grant date fair value per share):
|
|
Number of Shares |
|
|
Weighted Average |
|
||
Outstanding ‑ January 1, 2024 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Forfeited/canceled |
|
|
( |
) |
|
|
|
|
Released |
|
|
( |
) |
|
|
|
|
Outstanding ‑ September 30, 2024 |
|
|
|
|
$ |
|
||
Bonus-to-Options Program
The Company also has a Bonus-to-Options Program (the Bonus Option Program) which allows participants who so elect to convert a portion of their annual cash bonus into fully vested, non-qualified stock options to purchase shares of common stock. Participation is limited to the Chief Executive Officer, direct reports to the Chief Executive Officer and Vice Presidents of the Company.
|
|
Number of |
|
|
Weighted Average |
|
|
Weighted Average |
|
|
Aggregate |
|
||||
Outstanding ‑ January 1, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Forfeited/canceled |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
Exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Outstanding ‑ September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable ‑ September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The Company recorded $
Employee Stock Purchase Plan
The
21
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Note 11 – Net Loss per Common Share
Basic net loss per share excludes dilution and is computed by dividing net loss attributable to the common stockholders by the weighted-average shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised, resulting in the issuance of shares of common stock that would then share in the earnings or losses of the Company.
Basic and diluted loss per share for the three and nine months ended September 30, 2024 and 2023 were (in thousands, except per share amounts):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Numerator |
|
|
|
|
|
|
|
|
|
|
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|
||||
Net loss attributable to common stockholders |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
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|
|
|
||||
Denominator |
|
|
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|
||||
Weighted-average shares outstanding used |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The following outstanding common stock equivalents were excluded from diluted net loss attributable to common stockholders for the periods presented because inclusion would be anti-dilutive (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Options to purchase common stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Shares committed under ESPP |
|
|
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|
||||
Warrants |
|
|
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|
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|
||||
Restricted stock units |
|
|
|
|
|
|
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|
|
|
||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Note 12 – Income Taxes
Since inception, the Company has incurred net taxable losses, and accordingly,
Note 13 – Commitments and Contingencies
Co-Development Agreement
In April 2014 and amended in October 2016, the Company entered into a worldwide agreement with AVEO to develop and commercialize AVEO's hepatocyte growth factor inhibitory antibody ficlatuzumab with the Company's proprietary companion diagnostic test, BDX004, a version of the Company’s serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). Under the terms of the agreement, AVEO conducted a proof of concept (POC) clinical study of ficlatuzumab for NSCLC in which BDX004 was used to select clinical trial subjects (the NSCLC POC Trial). Under the agreement, the Company and AVEO shared equally in the costs of the NSCLC POC Trial, and each were responsible for
In September 2020, the Company exercised its opt-out right with AVEO for the payment of
22
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
License Agreements
In August 2019, we entered into a non-exclusive license agreement with Bio-Rad Laboratories, Inc. (Bio-Rad) (the Bio-Rad License). Under the terms of the Bio-Rad License, the Company received a non-exclusive license, without the right to grant sublicenses, to utilize certain of Bio-Rad’s intellectual property, machinery, materials, reagents, supplies and know-how necessary for the performance of Droplet Digital PCR™ (ddPCR) in cancer detection testing for third parties in the United States. The Company also agreed to purchase all of the necessary supplies and reagents for such testing exclusively from Bio-Rad, pursuant to a separately executed supply agreement (the Supply Agreement) with Bio-Rad. The Bio-Rad License was set to expire in
On May 13, 2021 (the CellCarta Effective Date), we reached agreement with CellCarta Biosciences Inc. (formerly “Caprion Biosciences, Inc.”) (the CellCarta License) on a new royalty bearing license agreement for the Nodify XL2 test. The parties agreed to terminate all prior agreements and replace with this new arrangement, which has a
On October 31, 2019, we completed an acquisition of Freenome's United States operations (formerly "Oncimmune USA" or "Oncimmune") including its COLA/CLIA lab in De Soto, Kansas and its pulmonary nodule malignancy test, then marketed in the United States as the EarlyCDT Lung® test. We renamed and relaunched the test on February 28, 2020 as the Nodify CDT test. As part of the acquisition of the assets of Oncimmune, the Company entered into several agreements to govern the relationship between the parties. The Company agreed to a license agreement and royalty payment related to the Nodify CDT test of
Litigation, Claims and Assessments
From time to time, we may become involved in legal proceedings or investigations which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. We are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, results of operations, financial condition, or cash flows.
Note 14 – Subsequent Events
On October 30, 2024 (the Fourth Amendment Effective Date), the Company entered into the Fourth Amendment to the Credit Agreement and Guaranty (the Fourth Amendment) with Perceptive, as lender and administrative agent, and the Company, as borrower, whereby subject to the terms and conditions of the Fourth Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending June 30, 2025 through and including the fiscal quarter ending December 31, 2027.
On November 1, 2024, the Company expects to file a shelf registration statement on Form S-3 and enter into a new sales agreement with a financial institution, pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $50.0 million, subject to terms and conditions (the 2024 ATM Program). The shares of common stock offered pursuant to the 2024 ATM Program will be offered and sold by the Company pursuant to its registration statement on Form S-3 once declared effective by the SEC. Sales of common stock under the 2024 ATM Program, if any, will be made at market prices by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on the NASDAQ Global Market, or any other existing trading market for our common stock. In connection with establishing the 2024 ATM Program, the Company terminated its prior $50.0 million ATM program established in November 2021, and no additional stock can be issued thereunder.
23
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Biodesix, Inc. is referred to throughout this Quarterly Report on Form 10-Q for the period ended September 30, 2024 (Form 10-Q) as “we”, “us”, “our” or the “Company”.
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2023 (Form 10-K) and the Condensed Financial Statements as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023, included in Part I, Item 1 of this Form 10-Q, which provide additional information regarding our financial position, results of operations and cash flows. To the extent that the following MD&A contains statements which are not of a historical nature, such statements are forward-looking statements, which involve risks and uncertainties, including but not limited to those set forth under the caption “Special Note Regarding Forward-Looking Statements” and Item 1A. “Risk Factors” of Part II in this Quarterly Report on Form 10-Q and those discussed in our other filings with the Securities and Exchange Commission (SEC), including the risks described in Item 1A. “Risk Factors” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed on March 1, 2024.
The following MD&A discussion is provided to supplement the Condensed Financial Statements as of September 30, 2024 and 2023 and for the three and nine months then ended included in Part I, Item 1 of this Quarterly Report on Form 10-Q. We intend for this discussion to provide you with information that will assist you in understanding our financial statements, the changes in key items in those financial statements from period to period, and the primary factors that accounted for those changes.
Data for the three and nine months ended September 30, 2024 and 2023 has been derived from our unaudited condensed financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Overview
We are a leading diagnostic solutions company with a focus on lung disease. By combining a multi-omic approach with a holistic view of the patient’s disease state, we believe our solutions provide physicians with greater insights to help personalize their patient’s care and meaningfully improve disease detection, evaluation, and treatment. Our unique approach to precision medicine provides timely and actionable clinical information, which we believe helps improve overall patient outcomes and lowers the overall healthcare cost by reducing the use of ineffective and unnecessary treatments and procedures. In addition to our diagnostic tests, we provide biopharmaceutical companies with services that include diagnostic research, clinical trial testing, and the discovery, development, and commercialization of companion diagnostics. We also recognize revenue from other services, including amounts derived from licensing our technologies.
Our core belief is that no single technology will answer all clinical questions that we encounter. Therefore, we employ multiple technologies, including genomics, transcriptomics, proteomics, radiomics, and artificial intelligence enabled informatics to discover innovative diagnostic tests for potential clinical use. Our multi-omic approach is designed to enable us to discover diagnostic tests that answer critical clinical questions faced by physicians, researchers, and biopharmaceutical companies.
We regularly engage with our customers, key opinion leaders, and scientific experts to stay ahead of the rapidly evolving diagnostic treatment landscape to identify additional clinical unmet needs where a diagnostic test could help improve patient care. Additionally, we incorporate clinical and molecular profiling data from our commercial clinical testing, research studies, clinical trials, and biopharmaceutical customers or other collaborative partnerships, to continue to advance our platform. We have a variety of samples with associated data in our biobank, including tumor profiles and immune profiles, which are used for both internal and external research and development initiatives.
We have commercialized five diagnostic tests for our lung diagnostic business, each of which have Medicare coverage, which are currently available for use by physicians. Our Nodify CDT and Nodify XL2 tests, marketed as Nodify Lung Nodule Risk Assessment, assess the risk of lung cancer to help identify the most appropriate treatment pathway. The Nodify CDT and XL2 tests have an established average turnaround time of one and five business days, respectively, from receipt of the blood sample, providing physicians with timely results to guide diagnostic planning. The Nodify Lung Nodule Risk Assessment has resulted in a change in the calculated risk of malignancy in 80-85% of the cases. We believe we are the only company to offer two commercial blood-based tests to help physicians reclassify risk of malignancy in patients with suspicious lung nodules. Our GeneStrat ddPCR, GeneStrat NGS, and VeriStrat tests, marketed as the IQLung testing strategy, are used following diagnosis of lung cancer to measure the presence of mutations in the tumor and the state of the patient’s immune system to establish the patient’s prognosis and help guide treatment decisions. The GeneStrat targeted tumor profiling test and the VeriStrat immune profiling test have an established average turnaround time of two business days. The GeneStrat NGS test is our blood-based NGS test and has an established average turnaround time of three business days. The 52-gene panel includes guideline recommended mutations to help physicians treating advanced-stage lung cancer patients identify all four major mutation classes and genes, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.
24
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
In addition to the five diagnostic tests currently on the market, we offer a broad range of assays for research use as part of our laboratory services which have been used by over 65 biopharmaceutical companies and academic partners. All of our diagnostic and services testing is performed at one of our two accredited, high-complexity clinical laboratories in Louisville, Colorado and De Soto, Kansas.
Since our inception, we have performed over 600,000 clinical diagnostic tests and continue to generate a large and growing body of clinical evidence consisting of over 300 clinical and scientific peer-reviewed publications, presentations, and abstracts. Through ongoing study of each of our tests, we continue to grow our depth of understanding of disease biology and the broad utility of each of our tests. We believe we are poised for rapid growth by leveraging our scientific and clinical development and laboratory operations expertise along with our commercial infrastructure which includes sales, marketing, reimbursement, and regulatory affairs.
In the United States, we market our tests to clinical customers through our direct sales organization, which includes sales representatives that are engaged in sales efforts and promotional activities primarily to pulmonologists, oncologists, cancer centers and nodule clinics. We market our tests and services to biopharmaceutical companies globally through our targeted business development team, which promotes the broad utility of our tests and testing capabilities throughout drug development and commercialization which is of value to pharmaceutical companies and their drug-development process.
Factors Affecting Our Performance
We believe there are several important factors that have impacted our operating performance and results of operations, including:
Historically, we have experienced situations where commercial payers proactively reduced the amounts they were willing to reimburse for our tests, and in other situations, commercial payers have determined that the amounts they previously paid were too high and have sought to recover those perceived excess payments by deducting such amounts from payments otherwise being made. When we contract to serve as a participating provider, reimbursements are made pursuant to a negotiated fee schedule and are limited to only covered indications. Becoming a participating provider generally results in higher reimbursement for covered indications and lack of reimbursement for non-covered indications. As a result, the impact of becoming a participating provider with a specific payer will vary. If we are not able to obtain or maintain coverage and adequate reimbursement from third-party payers, we may not be able to effectively increase our testing volume and revenue as expected. Additionally, retrospective reimbursement adjustments can negatively impact our revenue and cause our financial results to fluctuate.
On July 6, 2023, the Company announced that the Centers for Medicare & Medicaid Services (CMS) has designated the Nodify CDT Test as an Advanced Diagnostic Laboratory Test (ADLT) effective June 30, 2023. Obtaining ADLT status is a recognition that the Nodify CDT test meets the stringent criteria established under the Protecting Access to Medicare Act of 2014. ADLT status is reserved for innovative tests with Medicare coverage that provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests. Nodify CDT joins our Nodify XL2 and VeriStrat tests with the ADLT designation.
25
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
The ongoing INSIGHT study was designed to expand our clinical understanding of the predictive and prognostic value of the VeriStrat test. On June 27, 2023, we completed enrollment of 5,000 patients with non-small cell lung cancer. All study participants currently enrolled in the study are expected to complete study follow-up by 2026. The participant data will be monitored, and sites will be closed accordingly throughout 2025.
On July 12, 2023, we announced the prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test) achieved the primary endpoint of a statistically significant change in the proportion of benign lung nodules managed by Nodify XL2 experiencing invasive procedures. The ORACLE study showed patients with benign nodules managed with the Nodify XL2 test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group. The ORACLE study officially closed on May 28, 2024.
The ALTITUDE study is a randomized control study, launched during the fourth quarter 2020, seeking to further demonstrate the utility of the Nodify CDT and XL2 tests.
On October 8, 2024, at the CHEST Annual Meeting, the Company presented the experience of healthcare providers using the Nodify Lung Nodule Risk Assessment in over 35,000 patients consecutively tested in a real-world clinical setting. The Company also announced a new clinical study, CLARIFY, that will collect patient outcomes and other clinical information on a subset of the patients featured in the CHEST presentation. CLARIFY is designed to confirm performance of the Nodify CDT and Nodify XL2 tests in diverse patient subgroups through a retrospective chart review of up to 4,000 patients that were tested in a real-world clinical setting. The study's intent is to expand the extensive evidence characterizing the validation and utility of Nodify Lung testing.
Our clinical research has resulted in approximately 90 peer-reviewed publications for our tests. In addition to clinical studies, we are collaborating with investigators from multiple academic cancer centers. On June 3, 2022, we announced the intent to develop a new novel molecular minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and the Company also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer. On March 25, 2024, we announced a new master collaborative research agreement (MCRA) with MSK under which the teams will collaborate on a development plan for diagnostic tests aimed at improving the treatment of cancer. Biodesix will utilize its array of genomics, proteomics, and data mining capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Bio-Rad will provide its industry-leading digital PCR assay technology in support of this important work. We believe these studies and collaborative arrangements are critical to gaining physician adoption and driving favorable coverage decisions by payers and expect our investments in research and development to increase. Further we also expect to increase our research and development expenses to fund further innovation and develop new clinically relevant tests.
26
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
While each of these areas present significant opportunities for us, they also pose significant risks and challenges that we must address. See Part II, Item 1A. “Risk Factors” within this Form 10-Q and Item 1A. “Risk Factors” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2023 for more information.
Third Quarter 2024 Financial and Operational Highlights
The following were significant developments affecting our business, capital structure and liquidity during the three months ended September 30, 2024 as compared to the same period in 2023 unless otherwise noted:
Components of Operating Results
Revenues
We derive our revenue from two primary sources: (i) providing diagnostic testing in the clinical setting (Diagnostic Tests); and (ii) providing biopharmaceutical companies with services that include diagnostic research, clinical research, clinical trial testing, development and testing services generally provided outside the clinical setting and governed by individual contracts with third parties as well as development and commercialization of companion diagnostics. We also recognize revenue from other services, including amounts derived from licensing our technologies (Biopharmaceutical Services and other).
Diagnostic Tests
Diagnostic test revenue is generated from delivery of results from our diagnostic tests. In the United States, we performed tests as both an in-network and out-of-network service provider depending on the test performed and the contracted status of the insurer. We consider diagnostic testing to be completed upon the delivery of test results to our customer, either the prescribing physician or third-party to which we contracted for services to be performed, which is considered the performance obligation. The fees for such services are billed either to a third party such as Medicare, medical facilities, commercial insurance payers, or to the patient. We determine the transaction price related to our contracts by considering the nature of the payer, test type, the historical amount of time until payment by a payer and historical price concessions granted to groups of customers.
Biopharmaceutical Services and other
Biopharmaceutical Services revenue is generated from the delivery of our on-market tests, pipeline tests, custom diagnostic testing, and other scientific services for a purpose as defined by any individual customer. At times we collaborate with large biopharmaceutical companies in an attempt to discover biomarkers that would be helpful in their drug development or marketing. The performance
27
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
obligations and related revenue for these sales is defined by a written agreement between us and our customer. These services are generally completed upon the delivery of testing results, or other contractually defined milestone(s), to the customer, which is considered the performance obligation. Customers for these services are typically large pharmaceutical companies where collectability is reasonably assured and therefore revenue is accrued upon completion of the performance obligations. Revenue derived from services is often unpredictable and can cause significant swings in our overall net revenue line from quarter to quarter.
In addition, other revenue includes amounts derived from licensing our digital sequencing technologies to our international laboratory partners. We are compensated through royalty-based payments for the licensed technology, and depending on the nature of the technology licensing arrangements, and considering factors including, but not limited to: enforceable right to payment and payment terms, and if an asset with alternative use is created, these revenues are recognized in the period when royalty-bearing sales occur.
Operating Expenses
Direct costs and expenses
Cost of diagnostic testing generally consists of cost of materials, direct labor, including bonuses, employee benefits, share-based compensation, equipment and infrastructure expenses associated with acquiring and processing test samples, including sample accessioning, test performance, quality control analyses, charges to collect and transport samples; curation of test results for physicians; and in some cases, license or royalty fees due to third parties. Costs associated with performing our tests are recorded as the tests are processed regardless of whether revenue was recognized with respect to the tests. Infrastructure expenses include allocated depreciation of laboratory equipment, rent costs, amortization of leasehold improvements and information technology costs. Royalties for licensed technology are calculated as a percentage of revenues generated using the associated technology and recorded as expense at the time the related revenue is recognized. One-time royalty payments related to signing of license agreements or other milestones, such as issuance of new patents, are amortized to expense over the expected useful life of the patents. While we do not believe the technologies underlying these licenses are necessary to permit us to provide our tests, we do believe these technologies are potentially valuable and of possible strategic importance to us or our competitors. Under these license agreements, we are obligated to pay aggregate royalties ranging from 1% to 8% of sales in which the patents or know-how are used in the product or service sold, sometimes subject to minimum annual royalties or fees in certain agreements.
We expect the aggregate cost of diagnostic testing to increase in line with the increase in the number of tests we perform, but the cost per test to decrease modestly over time due to the efficiencies we may gain as test volume increases, and from automation and other cost reductions. Cost of services includes costs incurred for the performance of development services requested by our customers. Costs of development services will vary depending on the nature, timing and scope of customer projects.
Research and development
Research and development expenses consist of costs incurred to develop technology and include salaries, share-based compensation and benefits, reagents and supplies used in research and development laboratory work, clinical trials infrastructure expenses, including allocated facility occupancy and information technology costs, contract services, quality and regulatory support, other outside costs and costs to develop our technology capabilities. Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal costs incurred in connection with the discovery and development of our product candidates.
External expenses include: (i) payments to third parties in connection with the clinical development of our product candidates, including contract research organizations and consultants; (ii) the cost of manufacturing products for use in our preclinical studies and clinical trials, including payments to contract manufacturing organizations (CMOs) and consultants; (iii) scientific development services, consulting research fees and for sponsored research arrangements with third parties; (iv) laboratory supplies; and (v) allocated facilities, depreciation and other expenses, which include direct or allocated expenses for IT, rent and maintenance of facilities. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We track external costs by the stage of program, clinical or preclinical.
Internal expenses include employee-related costs, including salaries, share-based compensation and related benefits for employees engaged in research and development functions. We do not track internal costs by product candidate because these costs are deployed across multiple programs and, as such, are not separately classified.
Research and development costs are expensed as incurred. Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as expense in the period in which the related goods are received or services are rendered. Costs to develop our technology capabilities are recorded as research and development.
28
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
We expect our research and development expenses to increase as we continue to innovate and develop additional products and expand our data management resources. As our services revenue grows, an increasing portion of research and development dollars are expected to be allocated to cost of services for biopharmaceutical service contracts. This expense, though expected to increase in dollars, is expected to decrease as a percentage of revenue in the long term, though it may fluctuate as a percentage of our revenues from period to period due to the timing and extent of these expenses.
Sales, marketing, general and administrative
Our sales and marketing expenses are expensed as incurred and include costs associated with our sales organization, including our direct sales force and sales management, client services, marketing, public relations, communications and reimbursement, as well as business development personnel who are focused on our biopharmaceutical customers. These expenses consist primarily of salaries, commissions, bonuses, employee benefits, share-based compensation, and travel, as well as marketing and educational activities and allocated overhead expenses. We expect our sales and marketing expenses to increase in dollars as we expand our sales force, increase our presence within the United States, and increase our marketing activities to drive further awareness and adoption of our tests and our future products and services. These expenses, though expected to increase in dollars, are expected to decrease as a percentage of revenue in the long term, though they may fluctuate as a percentage of our revenues from period to period due to the timing and nature of these expenses.
Our general and administrative expenses include costs for our executive, accounting, finance, legal and human resources functions. These expenses consist principally of salaries, bonuses, employee benefits, share-based compensation, and travel, as well as professional services fees such as consulting, audit, tax and legal fees, and general corporate costs and allocated overhead expenses. We expect that our general and administrative expenses will continue to increase in dollars, primarily due to increased headcount and costs associated with operating as a public company, including expenses related to legal, accounting, regulatory, maintaining compliance with exchange listing and requirements of the SEC, director and officer insurance premiums and investor relations. These expenses, though expected to increase in dollars, are expected to decrease as a percentage of revenue in the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses.
Non-Operating Expenses
Interest expense and interest income
For the three and nine months ended September 30, 2024 and 2023, interest expense consists of cash and non-cash interest from the Perceptive Term Loan Facility and changes in the value of our contingent consideration associated with the passage of time subsequent to the achievement of the gross margin target in the second quarter 2021. Interest income, which is included in ‘Other income, net’ in the condensed statements of operations consists of income earned on our cash and cash equivalents.
29
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Results of Operations
The following table sets forth the significant components of our results of operations for the periods presented (in thousands, except percentages):
|
|
Three Months Ended September 30, |
|
|
Change |
|
|
Nine Months Ended September 30, |
|
|
Change |
|
||||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||||||
Revenues |
|
$ |
18,151 |
|
|
$ |
13,491 |
|
|
$ |
4,660 |
|
|
|
35 |
% |
|
$ |
50,894 |
|
|
$ |
34,419 |
|
|
$ |
16,475 |
|
|
|
48 |
% |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Direct costs and expenses |
|
|
4,179 |
|
|
|
3,229 |
|
|
|
950 |
|
|
|
29 |
% |
|
|
11,231 |
|
|
|
9,636 |
|
|
|
1,595 |
|
|
|
17 |
% |
Research and development |
|
|
2,547 |
|
|
|
1,938 |
|
|
|
609 |
|
|
|
31 |
% |
|
|
7,145 |
|
|
|
8,099 |
|
|
|
(954 |
) |
|
|
(12 |
)% |
Sales, marketing, general and administrative |
|
|
20,016 |
|
|
|
15,496 |
|
|
|
4,520 |
|
|
|
29 |
% |
|
|
60,232 |
|
|
|
51,136 |
|
|
|
9,096 |
|
|
|
18 |
% |
Impairment loss on intangible assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
% |
|
|
135 |
|
|
|
20 |
|
|
|
115 |
|
|
|
575 |
% |
Total operating expenses |
|
|
26,742 |
|
|
|
20,663 |
|
|
|
6,079 |
|
|
|
29 |
% |
|
|
78,743 |
|
|
|
68,891 |
|
|
|
9,852 |
|
|
|
14 |
% |
Loss from operations |
|
|
(8,591 |
) |
|
|
(7,172 |
) |
|
|
(1,419 |
) |
|
|
(20 |
)% |
|
|
(27,849 |
) |
|
|
(34,472 |
) |
|
|
6,623 |
|
|
|
19 |
% |
Other (expense) income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Interest expense |
|
|
(2,041 |
) |
|
|
(2,386 |
) |
|
|
345 |
|
|
|
14 |
% |
|
|
(6,506 |
) |
|
|
(7,207 |
) |
|
|
701 |
|
|
|
10 |
% |
Loss on extinguishment of liabilities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
% |
|
|
(248 |
) |
|
|
— |
|
|
|
(248 |
) |
|
|
(100 |
)% |
Change in fair value of warrant liability, net |
|
|
— |
|
|
|
(1,393 |
) |
|
|
1,393 |
|
|
|
100 |
% |
|
|
— |
|
|
|
(1,332 |
) |
|
|
1,332 |
|
|
|
(100 |
)% |
Other (expense) income, net |
|
|
374 |
|
|
|
2 |
|
|
|
372 |
|
|
|
18,600 |
% |
|
|
(77 |
) |
|
|
4 |
|
|
|
(81 |
) |
|
|
(2,025 |
)% |
Total other expense |
|
|
(1,667 |
) |
|
|
(3,777 |
) |
|
|
2,110 |
|
|
|
56 |
% |
|
|
(6,831 |
) |
|
|
(8,535 |
) |
|
|
1,704 |
|
|
|
20 |
% |
Net loss |
|
$ |
(10,258 |
) |
|
$ |
(10,949 |
) |
|
$ |
691 |
|
|
|
6 |
% |
|
$ |
(34,680 |
) |
|
$ |
(43,007 |
) |
|
$ |
8,327 |
|
|
|
19 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Share-based compensation (1) |
|
$ |
1,515 |
|
|
$ |
954 |
|
|
$ |
561 |
|
|
|
59 |
% |
|
$ |
5,373 |
|
|
$ |
4,292 |
|
|
$ |
1,081 |
|
|
|
25 |
% |
Revenues
We generate revenue by providing laboratory testing of our diagnostic tests and services. Our revenues for the periods indicated were as follows (in thousands, except percentages):
|
|
Three Months Ended September 30, |
|
|
Change |
|
|
Nine Months Ended September 30, |
|
|
Change |
|
||||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||||||
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Diagnostic Testing revenue |
|
|
17,168 |
|
|
|
12,301 |
|
|
|
4,867 |
|
|
|
40 |
% |
|
$ |
47,503 |
|
|
$ |
32,395 |
|
|
$ |
15,108 |
|
|
|
47 |
% |
Biopharmaceutical Services and other revenue |
|
|
983 |
|
|
|
1,190 |
|
|
|
(207 |
) |
|
|
(17 |
)% |
|
|
3,391 |
|
|
|
2,024 |
|
|
|
1,367 |
|
|
|
68 |
% |
Total revenues |
|
$ |
18,151 |
|
|
$ |
13,491 |
|
|
$ |
4,660 |
|
|
|
35 |
% |
|
$ |
50,894 |
|
|
$ |
34,419 |
|
|
$ |
16,475 |
|
|
|
48 |
% |
Total revenue increased $4.7 million or 35%, and increased $16.5 million or 48% for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023.
Diagnostic test revenue increased $4.9 million or 40%, and increased $15.1 million or 47% for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023. The increases are primarily due to an increase of $4.7 million and $15.8 million, respectively, in the Nodify Lung Nodule Risk Assessment testing strategy driven by an increase in tests delivered as our sales efforts continue to focus on Nodify CDT and XL2 tests. The increase in revenue for the nine months ended September 30, 2024 was partially offset by a $0.7 million decrease in the IQLung testing strategy. The Company’s diagnostic testing sales efforts continued to gain momentum during the three and nine months ended September 30, 2024 as the number of tests delivered reached the highest in Company history for seven consecutive quarters.
Biopharmaceutical Services and other revenue decreased $0.2 million or 17%, and increased $1.4 million or 68% for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023. The decrease in revenue for the three months ended September 30, 2024 was primarily due to the timing of sample receipts from certain biopharmaceutical partners, while the increase
30
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
in revenue for the nine months ended September 30, 2024 was primarily a result of delivering against our expanding book of business and securing new agreements.
Operating Expenses
Direct costs and expenses
Direct costs and expenses related to revenue increased $1.0 million or 29%, and increased $1.6 million or 17% for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023, primarily driven by the increase in testing volume compared to the same periods in 2023, partially offset by the optimization of testing workflows that resulted in improvements in costs per test.
Research and development
Research and development expenses increased $0.6 million or 31%, and decreased $1.0 million or 12% for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023. The increase in costs for the three months ended September 30, 2024 was due primarily to an increase in internal expenses associated with compensation and benefit costs resulting from an increase in headcount, while the decrease for the nine months ended September 30, 2024 was primarily a result of a decrease in external costs associated with clinical trials and data acquisition costs.
The following table summarizes our external and internal costs for the three and nine months ended September 30, 2024 and 2023 (in thousands, except percentages):
|
|
Three Months Ended September 30, |
|
|
Change |
|
|
Nine Months Ended September 30, |
|
|
Change |
|
||||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||||||
External expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Clinical trials and associated costs |
|
$ |
268 |
|
|
$ |
393 |
|
|
$ |
(125 |
) |
|
|
(32 |
)% |
|
$ |
911 |
|
|
$ |
1,609 |
|
|
$ |
(698 |
) |
|
|
(43 |
)% |
Other external costs |
|
|
730 |
|
|
|
563 |
|
|
|
167 |
|
|
|
30 |
% |
|
|
2,044 |
|
|
|
2,230 |
|
|
|
(186 |
) |
|
|
(8 |
)% |
Total external costs |
|
|
998 |
|
|
|
956 |
|
|
|
42 |
|
|
|
4 |
% |
|
|
2,955 |
|
|
|
3,839 |
|
|
|
(884 |
) |
|
|
(23 |
)% |
Internal expenses |
|
|
1,549 |
|
|
|
982 |
|
|
|
567 |
|
|
|
58 |
% |
|
|
4,190 |
|
|
|
4,260 |
|
|
|
(70 |
) |
|
|
(2 |
)% |
Total research and development expenses |
|
$ |
2,547 |
|
|
$ |
1,938 |
|
|
$ |
609 |
|
|
|
31 |
% |
|
$ |
7,145 |
|
|
$ |
8,099 |
|
|
$ |
(954 |
) |
|
|
(12 |
)% |
Sales, marketing, general and administrative
Sales, marketing, general and administrative expenses increased $4.5 million or 29%, and increased $9.1 million or 18% for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023. The increase for the three and nine months ended September 30, 2024 was driven primarily by increases in employee compensation and benefits associated with an increase in headcount and variable compensation as well as increases in non-employee costs associated with increased spending on various sales meetings and sales fulfillment during 2024 as compared to 2023. Of the $4.5 million and $9.1 million increase, $0.7 million and $2.1 million, respectively, is associated with the increase in depreciation expense related to the leasehold improvements in our new Louisville headquarters and laboratory.
Non-operating Expenses
Interest expense
Interest expense decreased $0.3 million or 14%, and decreased $0.7 million or 10% for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023. The decrease in interest expense for the three and nine months ended September 30, 2024 was primarily related to the interest associated with the declining contingent consideration balance as the remaining Milestone Payments and final exit fee payment were made.
Loss on extinguishment of liabilities
Loss on extinguishment of liabilities increased $0.2 million or 100% for the nine months ended September 30, 2024, compared to the same period in 2023. On April 22, 2024, the Company obtained consent from Perceptive and prepaid the July 1, 2024 contingent consideration Milestone Payment of $8.4 million to Indi. As a result of prepaying the Milestone Payment, the Company performed a fair value analysis through April 22, 2024 and recorded a loss on early extinguishment of $0.2 million.
31
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Change in fair value of warrant liability, net
During the three and nine months ended September 30, 2024, the Company recorded no change in fair value of warrant liability in the condensed statements of operations. The Tranche C loan had a commitment date through September 30, 2024 and, as of that date, the Company did not exercise its ability to draw the Tranche C loan. Therefore, the associated Tranche C Warrants expired and are no longer exercisable. During the three and nine months ended September 30, 2023, the Company recorded a $1.4 million and $1.3 million net loss, respectively, as a change in fair value through the condensed statements of operations due to changes in unobservable inputs. This was a result of changes in the probability of our ability to draw on Tranche B and C loans.
Other (expense) income, net
During the three and nine months ended September 30, 2024, the Company recorded other income, net of $0.4 million and other expense, net of $0.1 million, respectively. The other income, net for the three months ended September 30, 2024 was comprised primarily of interest income. The other expense, net for the nine months ended September 30, 2024 primarily consisted of deferred offering costs of approximately $0.7 million as a result of changes in the probability of our ability to fully utilize the LPC Facility prior to the termination date, offset by $0.6 million of interest and other income.
Liquidity and Capital Resources
We are an emerging growth company and, as such, have yet to generate positive cash flows from operations. We have funded our operations to date principally from net proceeds from the sale of our common stock, the sale of convertible preferred stock, revenue from diagnostic testing and services, and the incurrence of indebtedness.
The Company amended the Indi APA agreement in April 2022 in which all parties agreed to restructure the Milestone Payments whereby the Company will make five quarterly installments of $2.0 million each beginning in April 2022, three quarterly installments of $3.0 million beginning in July 2023, one installment of $5.0 million in April 2024, and one installment of approximately $8.4 million in July 2024. In addition, the Company agreed to an exit fee of approximately $6.1 million in October 2024. Interest shall accrue on the difference between the payment schedule as agreed in the August 2021 amendment and the April 2022 amended payment schedule, at an aggregate per annum rate equal to 10%, with such interest to be payable quarterly on the following installment payment date. Our ability to make these payments is subject to ongoing compliance under the Perceptive Term Loan and commencing January 1, 2024, consent from Perceptive. On April 22, 2024, the Company obtained consent from Perceptive and prepaid the July 1, 2024 Milestone Payment of $8.4 million to Indi. On September 30, 2024, the Company obtained consent from Perceptive and prepaid the October 1, 2024 exit fee of $6.1 million to Indi. The Company has no remaining obligations to Indi.
On November 21, 2022, the Company entered into a Credit Agreement and Guaranty (the Credit Agreement) with Perceptive Credit Holdings IV, LP (Perceptive) as lender and administrative agent (the Lender) for up to $50.0 million, with funding of $30.0 million and the issuance of warrants exercisable into 3,000,000 shares of the Company’s common stock occurring on November 21, 2022, and two additional contingently issuable tranches of $10.0 million each subject to certain terms and conditions, including revenue milestones. The Tranche C loan had a commitment date through September 30, 2024 and, as of that date, the Company did not exercise its ability to draw the Tranche C loan.
On April 7, 2023, the Company entered into a limited waiver under which the Lender agreed to waive the minimum revenue requirement for the three months ended March 31, 2023 (Limited Waiver). In addition, on May 10, 2023, the Company entered into the First Amendment to the Credit Agreement (First Amendment) with Perceptive as lender and administrative agent and the Company, as borrower, whereby subject to the terms and conditions of the First Amendment, the Minimum Net Revenue Covenant, as defined in the Credit Agreement, was modified to reduce the threshold through the twelve month period ended March 31, 2024.
On August 3, 2023, the Company entered into subscription agreements (the Subscription Agreements) with all of the members of our Board of Directors, all Section 16 officers, and additional members of the Biodesix leadership team for the issuance and sale by the Company of an aggregate of 16,975,298 of the Company’s common stock for an aggregate purchase price of approximately $27.5 million. During the three months ended September 30, 2023, the Company received $15.3 million in proceeds and issued 9,454,927 shares of common stock. On September 27, 2023, the Company entered into an amendment to delay final closing on one subscription agreement. The remaining $12.2 million in proceeds was received and 7,520,371 shares of common stock was issued during the three months ended December 31, 2023.
On August 4, 2023, the Company entered into the Second Amendment to the Credit Agreement (the Second Amendment) with Perceptive as lender and administrative agent and the Company, as borrower, whereby subject to the terms and conditions of the Second Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending June 30, 2024 through and including the fiscal quarter ending December 31, 2025.
32
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Pursuant to the original terms of the Credit Agreement entered into on November 21, 2022, the Perceptive Term Loan Facility includes an additional Tranche B Loan, in an aggregate amount of up to $10.0 million, which is accessible by the Company so long as the Company satisfies certain customary conditions precedent, including revenue milestones. Under the terms of the Second Amendment, the conditions precedent for drawing on the Tranche B Loan were amended to (i) reduce the trailing twelve-month revenue milestone and (ii) add the receipt of aggregate cash proceeds of at least $27.5 million from an equity offering of the Company's common stock. During the three months ended December 31, 2023, the Company met the remaining conditions precedent associated with the Tranche B Loan and, on December 15, 2023, the Company exercised its ability to draw the Tranche B loan for $10.0 million (the Tranche B Loan).
On February 29, 2024 (the Third Amendment Effective Date), the Company entered into the Third Amendment to the Credit Agreement (the Third Amendment) with Perceptive as lender and administrative agent and the Company, as borrower, whereby subject to the terms and conditions of the Third Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending March 31, 2024 through and including the fiscal quarter ending December 31, 2025.
On April 9, 2024, the Company closed an underwritten offering of common stock and a concurrent private placement. Collectively, the Company raised net proceeds of approximately $51.3 million.
As of September 30, 2024, the Company had remaining available capacity for share issuances of up to $46.9 million under the LPC Facility, subject to the restrictions and limitations of the underlying facilities. On April 5, 2024, the Company filed Supplement No. 1 to the ATM Prospectus Supplement dated December 22, 2021. To comply with volume limitations under applicable SEC rules and regulations, Supplement No. 1 reduced the aggregate offering price to up to $100,000 of shares in order to maximize the amount the Company could offer under the April 2024 Offering. Following the successful completion of the Company’s April 2024 Offering, the Company is no longer subject to volume limitations under applicable SEC rules and regulations that limit their availability as sources of funding. On August 7, 2024, the Company filed Supplement No. 2 to the ATM Prospectus Supplement dated December 22, 2021 to increase the aggregate offering price under the ATM facility up to the original $50.0 million of shares. As of September 30, 2024, the Company had remaining available capacity for share issuances of up to $28.2 million under the ATM facility. On November 1, 2024, the Company expects to file a shelf registration statement on Form S-3 and enter into a new sales agreement with a financial institution, pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $50.0 million, subject to terms and conditions (the 2024 ATM Program). The shares of common stock offered pursuant to the 2024 ATM Program will be offered and sold by the Company pursuant to its registration statement on Form S-3 once declared effective by the SEC. Sales of common stock under the 2024 ATM Program, if any, will be made at market prices by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on the NASDAQ Global Market, or any other existing trading market for our common stock. In connection with establishing the 2024 ATM Program, the Company terminated its prior $50.0 million ATM program established in November 2021, and no additional stock can be issued thereunder.
As of September 30, 2024, we maintained cash and cash equivalents of $31.4 million and we have $40.0 million in outstanding aggregate principal amount on our Perceptive Term Loan Facility. We have incurred significant losses since inception and, as a result, we have funded our operations to date primarily through the sale of common stock, the sale of convertible preferred stock, the issuance of notes payable, and from our two primary revenue sources: (i) diagnostic testing, which includes lung diagnostic testing and (ii) providing biopharmaceutical companies with development and testing services and licensing our technologies. In accordance with Accounting Standards Update 2014-15 (ASC Topic 205-40), Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, the Company is required to evaluate whether there is substantial doubt about its ability to continue as a going concern each reporting period, including interim periods. In evaluating the Company’s ability to continue as a going concern, management projected its cash flow sources and evaluated the conditions and events that could raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements were issued. Management considered the Company’s current projections of future cash flows, our ability to execute our current operating plan, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of this Form 10-Q in considering whether it has the ability to meet its obligations.
Our ability to meet our obligations as they come due may be impacted by our ability to remain compliant with financial covenants in our Perceptive Term Loan Facility or to obtain waivers or amendments that impact the related covenants. As of September 30, 2024, the Company was in compliance with all restrictive and financial covenants associated with its borrowings. In addition, on October 30, 2024, the Company entered into the Fourth Amendment to the Credit Agreement (the Fourth Amendment), whereby, subject to the terms and conditions of the Fourth Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending June 30, 2025 through and including the fiscal quarter ending December 31, 2027.
33
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Our ability to maintain our financial covenants under our Perceptive Term Loan Facility during the next twelve months is, in part, dependent upon executing our current operating plan. If we do not execute our current operating plan and maintain our financial covenants, this could result in an Event of Default (as defined in the Perceptive Term Loan Facility), causing an acceleration and repayment of the outstanding balances. The Perceptive Term Loan Facility requires the Company to meet certain Minimum Net Revenue threshold amounts agreed to between the Company and Perceptive as of the last day of each fiscal quarter, which commenced with the fiscal quarter ending March 31, 2023. We have taken steps to improve our liquidity through raising debt and equity capital and have also undertaken several proactive measures including, among other things, the reduction of planned capital expenditures and certain operating expenses. If we do not execute our current operating plan, we may need to consider further measures to reduce our operating expenses. These measures would limit or reduce our operations and could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring capital expenditures, and reducing other operating costs.
If we do not execute our current operating plan we may need to continue to raise additional funds from external sources, such as through the issuance of debt or equity securities. We may also raise additional capital to restructure our existing debt or for general working capital purposes, or both. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we do raise additional capital through equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. There can be no assurance that additional capital will be available to us or, if available, will be available in sufficient amounts or on terms acceptable to us or on a timely basis.
We expect to continue to incur operating losses in the near term while we make investments to support our anticipated growth. Our ability to maintain our financial covenants is, in part, dependent upon executing our current operating plan and, along with the items noted above, raises substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. Our unaudited financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments that might be necessary should we be unable to continue as a going concern.
Cash Flows
The following summarizes our cash flows for the periods indicated (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Net cash flows provided by (used in): |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(44,553 |
) |
|
$ |
(10,587 |
) |
Investing activities |
|
|
(2,556 |
) |
|
|
(20,061 |
) |
Financing activities |
|
|
52,231 |
|
|
|
7,401 |
|
Net increase (decrease) in cash and cash equivalents and restricted cash |
|
$ |
5,122 |
|
|
$ |
(23,247 |
) |
Our cash flows resulted in a net increase in cash and cash equivalents and restricted cash of $5.1 million during the nine months ended September 30, 2024 as compared to the net decrease in cash of $23.2 million for the nine months ended September 30, 2023. For the nine months ended September 30, 2024, net cash used in operating activities totaled $44.6 million, an increase of approximately $34.0 million compared to the same period in 2023 primarily due to unfavorable changes in net working capital of $40.4 million, which includes $23.2 million of payments made for contingent consideration during the nine months ended September 30, 2024 and an $18.3 million decrease in tenant improvement allowances received for capital expenditures and leasehold improvements related to the CVP Lease. This is partially offset by a year-over-year decrease in net loss from operations of $8.3 million.
Net cash used in investing activities during the nine months ended September 30, 2024 totaled $2.6 million, a decrease of $17.5 million compared to the same period in 2023. The decrease in net cash used in investing activities was primarily due to decreases in purchases of property and equipment and capital expenditures primarily for leasehold improvements related to the CVP Lease. These leasehold improvements were tenant improvements and were reimbursed from the Landlord.
Net cash provided by financing activities during the nine months ended September 30, 2024 totaled $52.2 million, an increase of $44.8 million compared to the same period in 2023. The net cash provided by financing activities for the nine months ended September 30, 2024 primarily resulted from $51.3 million in net proceeds from the issuance of common stock from an underwritten offering of common stock and a concurrent private placement, $0.6 million from the issuance of common stock from our ATM facility, and $0.3 million from our ESPP. The net cash provided by financing activities for the nine months ended September 30, 2023 primarily resulted from $15.3 million net proceeds from the issuance of common stock from the Subscription Agreements, partially offset by milestone payments to Indi of $7.6 million and payments of debt issuance costs of $0.8 million.
34
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Contractual Obligations and Commitments
The following table summarizes our non-cancelable contractual obligations and commitments as of September 30, 2024 (in thousands):
|
|
Payments due by period (1) |
|
|||||||||||||||||
|
|
Total |
|
|
Less than |
|
|
1 to 3 |
|
|
4 to 5 |
|
|
More than |
|
|||||
Borrowings and interest (2) |
|
$ |
57,835 |
|
|
$ |
5,650 |
|
|
$ |
11,246 |
|
|
$ |
40,939 |
|
|
$ |
— |
|
Operating lease obligations |
|
|
45,103 |
|
|
|
3,535 |
|
|
|
8,283 |
|
|
|
8,349 |
|
|
|
24,936 |
|
Finance lease obligations |
|
|
1,022 |
|
|
|
624 |
|
|
|
398 |
|
|
|
— |
|
|
|
— |
|
Total |
|
$ |
103,960 |
|
|
$ |
9,809 |
|
|
$ |
19,927 |
|
|
$ |
49,288 |
|
|
$ |
24,936 |
|
There have been no other significant changes to our future contractual obligations as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.
Off-Balance Sheet Arrangements
As of September 30, 2024, we have not entered into any off-balance sheet arrangements.
Critical Accounting Policies and Significant Judgments and Estimates
In accordance with accounting principles generally accepted in the United States, we are required to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Certain of these estimates significantly influence the portrayal of our financial condition and results of operations and require us to make difficult, subjective or complex judgments. Our critical accounting policies are described in greater detail below and in Note 2 to our condensed financial statements in Part 1 of this Quarterly Report on Form 10-Q as well as Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed on March 1, 2024.
Revenue Recognition
We recognize revenue when our customers obtain control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for our goods or services. To determine revenue recognition for our arrangements with our customers, we perform a five-step process, which includes: (i) identifying the contract(s) with a customer; (ii) identifying the performance obligations in the contract; (iii) determining the transaction price; (iv) allocating the transaction price to the performance obligations in the contract; and (v) recognizing revenue when (or as) we satisfy our performance obligations. The Company generates revenues from (i) Diagnostic Tests and (ii) assay development, testing services, and licensing our technologies (Biopharmaceutical Services and other revenue).
The Company recognizes revenues related to blood-based lung diagnostic billings based on estimates of the amounts ultimately expected to be collected from customers on a portfolio approach. In determining the amount to accrue for a delivered test, the Company considers factors such as test type, payment history, payer coverage, whether there is a reimbursement contract between the payer and the Company, payment as a percentage of agreed upon rate (if applicable), amount paid per test and any current developments or changes that could impact reimbursement. Variable consideration, if any, is estimated based on an analysis of historical experience and adjusted as better estimates become available. These estimates require significant judgment by management.
The Company also provides services to patients with whom the Company does not have contracts as defined in Financial Accounting Standards Board (FASB) Accounting Standards Codification 606 (ASC 606). The Company recognizes revenue for these patients when contracts, as defined in ASC 606, are established at the amount of consideration to which it expects to be entitled, or when the Company receives substantially all of the consideration subsequent to satisfaction and delivery of the performance obligations.
In addition, other revenue includes amounts derived from licensing our PCR technologies to our international laboratory partners. We are compensated through royalty-based payments for the licensed technology and, depending on the nature of the technology licensing arrangements and considering factors including but not limited to enforceable right to payment and payment terms, and if an asset with alternative use is created, these revenues are recognized in the period when royalty-bearing sales occur.
35
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Implications of Being an Emerging Growth Company and Smaller Reporting Company
We are an “emerging growth company” within the meaning of the Jumpstart Our Business Startups Act (JOBS Act). As an emerging growth company, we may take advantage of certain exemptions from various public company reporting requirements, including the requirement that our internal control over financial reporting be audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), certain requirements related to the disclosure of executive compensation in our periodic reports and proxy statements, the requirement that we hold a nonbinding advisory vote on executive compensation and any golden parachute payments. We may take advantage of these exemptions until we are no longer an emerging growth company. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We have elected to take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of the reduced disclosure requirements available to emerging growth companies. As a result of the accounting standards election, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies, which may make comparison of our financials to those of other public companies more difficult.
We will remain an emerging growth company until the earliest to occur of (i) the last day of the fiscal year in which we have more than $1.24 billion in annual revenue; (ii) the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates; (iii) the date on which we have issued, in any three-year period, more than $1.0 billion in non-convertible debt securities; and (iv) until December 31, 2025 (the year ended December 31st following the fifth anniversary of our initial public offering).
Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which: (i) the market value of our common shares held by non-affiliates exceeds $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our common shares held by non-affiliates exceeds $700 million as of the end of that year’s second fiscal quarter.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risk in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates.
Interest Rate Risk
We are exposed to market risk for changes in interest rates related primarily to our cash and cash equivalents, marketable securities and our indebtedness, including our outstanding Perceptive Term Loan. As of September 30, 2024, we had $40.0 million outstanding on the Perceptive Term Loan Facility which has an annual rate equal to the greater of (a) forward-looking one-month term SOFR as posted by CME Group Inc. and (b) 3.0% per annum, plus an applicable margin of 9.0%. Historically, we have not entered into derivative agreements such as interest rate caps and swaps to manage our floating interest rate exposure.
Periodically throughout the year, we have maintained balances in various operating accounts in excess of federally insured limits. Our cash and cash equivalents are funds held in checking and bank savings accounts, primarily at one U.S. financial institution. We consider all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. We continually monitor our positions with, and the credit quality of, the financial institutions with which we invest.
As of September 30, 2024, a hypothetical 100 basis point increase in interest rates would have an estimated $0.4 million impact per year on our financial position and results of operations, based on the current Perceptive Term Loan principal remaining outstanding through maturity.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain "disclosure controls and procedures," as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, or Exchange Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well
36
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
There were no changes to our internal control over financial reporting during the three months ended September 30, 2024 that have materially affected, or are reasonable likely to materially effect, our internal controls over financial reporting.
37
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in legal proceedings or investigations which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. We are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, results of operations, financial condition, or cash flows.
Item 1A. Risk Factors.
“Item 1A. Risk Factors” of our Annual Report on Form 10-K as of and for the year ended December 31, 2023, filed March 1, 2024, and subsequent quarterly reports on Form 10-Q, if applicable, include a discussion of our risk factors. The information presented below updates, and should be read in conjunction with, the risk factors and information we previously disclosed and, except as presented below, there have been no material changes from the risk factors described in our Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q. These risk factors may not describe every risk facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial could materially and adversely affect our business, financial condition and results of operations.
FDA is phasing out its general policy of enforcement discretion and will regulate laboratory developed tests as medical devices.
On September 29, 2023, FDA announced a proposed rule to amend its regulations to explicitly regulate laboratory developed tests (LDTs) as in vitro diagnostic tests in accordance with the agency’s regulatory authority over medical devices. The FDA finalized its rule on May 6, 2024 and announced that the agency will phase-out its LDT enforcement discretion policy in gradual stages over a total period of four years. LDTs that fall within targeted enforcement discretion policies may be exempt from some of these requirements.
Under the final rule, our tests that are currently offered as LDTs could become subject to certain statutory and regulatory provisions that are applicable to medical devices, including but not limited to, medical device reporting and correction and removal reporting requirements, quality systems regulations, registration and listing requirements, and premarket review requirements. Laboratories offering “high-risk tests that will be subject to premarket authorization application requirements or licensure under Section 351 of the Public Health Service Act, will need to ensure that the appropriate submission is received by the FDA before November 6, 2027. Laboratories offering “moderate-risk” or “low-risk” tests that will be subject to De Novo authorization or premarket notification submissions will need to ensure that the appropriate submission is received by the FDA before May 6, 2028. Other regulatory requirements will be gradually phased in beginning on May 6, 2025.
Failure to comply with applicable requirements under the relevant timeframes could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial enforcement actions, which in turn may have an adverse impact on our business, financial condition, and results of operations. For more information regarding these risks, see Item 1A “Risk Factors” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed on March 1, 2024, under the heading "— Risks Related to our Governmental Regulation—Our current line of diagnostic tests is covered under CLIA and CMS, but the FDA may end its general policy of enforcement discretion and regulate laboratory developed tests as medical devices. Changes in the way the FDA regulates tests performed by laboratories like ours could result in delay or additional expense in offering our tests and tests that we may develop in the future."
Legal challenges have been filed in federal district court over the agency’s authority to regulate LDTs as medical devices, and the outcome of such litigation and its impact on FDA’s plan to implement the requirements are uncertain. Congress has also considered legislation to establish a new comprehensive regulatory framework that would provide oversight over LDTs.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On April 5, 2024, we entered into the Securities Purchase Agreements, pursuant to which we sold 760,857 shares of our Series A Preferred Stock, which, subject to stockholder approval and certain beneficial ownership limitations set by each holder pursuant to the Series A Certificate of Designation, would automatically convert into 40 shares of Common Stock for each share of Series A Preferred Stock, for an aggregate of up to 30,434,280 shares of our common stock and an aggregate purchase price of $35.0 million. The Private Placement Preferred Shares were offered and sold in transactions exempt from registration under the Securities Act, in reliance on Section 4(a)(2) thereof. Each of the investors represented that it was an “accredited investor,” as defined in Regulation D, and acquired the securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof. The Private Placement Preferred Shares have not been registered under the Securities Act and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws. The Company expects to use the net proceeds from the Concurrent Private Placement for commercial expansion of sales, supporting its product pipeline, research and development and for general corporate purposes.
38
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
In connection with the Concurrent Private Placement, the Company also entered into a Registration Rights Agreement, dated April 5, 2024 (the Registration Rights Agreement), with the Investors, which provides that the Company will register the resale of the shares of Common Stock issuable upon conversion of the Preferred Stock. Pursuant to the Registration Rights Agreement, the Company was required to prepare and file an initial registration statement with the SEC as soon as reasonably practicable, but in no event later than April 23, 2024 (the Filing Deadline), and to use reasonable best efforts to have the registration statement declared effective within 50 days after the closing of the Concurrent Private Placement, subject to the approval of the conversion of the Concurrent Private Placement Shares being received at the Company’s 2024 annual meeting of stockholders.
On May 21, 2024, the Company held its 2024 annual meeting of stockholders in which the Conversion Proposal and Issuance Proposal were approved by the Company's stockholders. Upon approval, each share of Series A Preferred Stock automatically converted into 40 shares of Common Stock and, on May 23, 2024, the Company issued 30,434,280 shares of Common Stock in exchange for all Series A Preferred Stock.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None of our directors or officers
39
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
Item 6. Exhibits.
Exhibit Number |
|
Description |
|
|
|
|
|
10.1* |
|
|
|
|
|
|
|
31.1* |
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|
|
|
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|
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31.2* |
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||
|
|
|
|
32.1** |
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||
|
|
|
|
32.2** |
|
||
|
|
|
|
101.INS* |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
|
|
|
|
|
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents |
|
|
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
|
* Filed herewith.
** Furnished herewith.
*** Previously filed.
40
BIODESIX, INC.
Notes to Unaudited Condensed Financial Statements
SIGNATURE
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.
|
|
Biodesix, Inc. |
|
|
|
|
|
Date: November 1, 2024 |
|
By: |
/s/ CHRISTOPHER C. VAZQUEZ |
|
|
|
Christopher C. Vazquez |
|
|
|
Chief Accounting Officer |
|
|
|
(Principal Accounting Officer) |
|
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|
|
41