美國
證券交易委員會
華盛頓特區，20549
形式
(標記一)
根據1934年《證券交易法》第13或15(D)條規定的季度報告 |
截至本季度末
或
根據1934年證券交易法第13或15（d）條提交的過渡報告 |
從 到
佣金文件編號
(註冊人的確切姓名載於其章程)
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(述明或其他司法管轄權 |
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(稅務局僱主 |
公司或組織) |
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識別號碼) |
（主要行政辦公室地址，郵政編碼）
(
(註冊人的電話號碼，包括區號)
用複選標記表示註冊人(1)是否在過去12個月內(或註冊人被要求提交此類報告的較短時間內)提交了1934年《證券交易法》第13條或15(D)節要求提交的所有報告，以及(2)在過去90天內是否符合此類提交要求。
用複選標記表示註冊人是否在過去12個月內(或在註冊人被要求提交此類文件的較短時間內)以電子方式提交了根據S-T規則第405條(本章232.405節)要求提交的每個交互數據文件。
用複選標記表示註冊人是大型加速申報公司、加速申報公司、非加速申報公司、較小的報告公司或新興成長型公司。請參閱《交易法》第12b-2條規則中「大型加速申報公司」、「加速申報公司」、「較小申報公司」和「新興成長型公司」的定義。
大型加速文件服務器☐ |
加速的文件服務器☐ |
規模較小的報告公司 |
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新興成長型公司 |
如果是新興成長型公司，請用勾號表明註冊人是否選擇不利用延長的過渡期來遵守根據《交易法》第13（a）條規定的任何新的或修訂的財務會計準則。☐
用複選標記表示註冊人是否是空殼公司(如《交易法》第12b-2條所定義)。是
根據該法第12(B)條登記的證券：
每節課的題目： |
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交易代碼 |
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在其註冊的每個交易所的名稱： |
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這個 |
截至2024年11月13日，已有e（i）
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頁面 |
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1 |
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1 |
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1 |
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2 |
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3 |
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4 |
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8 |
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10 |
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48 |
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63 |
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63 |
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65 |
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65 |
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65 |
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65 |
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65 |
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65 |
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66 |
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67 |
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68 |
第一部分. - 財務信息整形
項目1.簡明綜合財務報表
JAGUAR HEALTH，Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
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9月30日， |
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12月31日， |
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(以千爲單位，不包括每股和每股數據) |
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2024 |
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2023 |
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(未經審計) |
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資產 |
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流動資產： |
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現金 |
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$ |
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$ |
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應收賬款淨額 |
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其他應收賬款 |
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庫存 |
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預付費用和其他流動資產 |
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流動資產總額 |
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財產和設備，淨額 |
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經營租賃-使用權資產 |
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無形資產，淨額 |
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其他資產 |
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總資產 |
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$ |
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$ |
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負債、可贖回優先股和股東權益 |
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流動負債： |
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應付帳款 |
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$ |
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$ |
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應計負債 |
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遞延收入 |
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— |
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經營租賃負債，流動 |
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應付票據，扣除折扣（包括以公允價值期權指定的票據金額爲美元 |
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流動負債總額 |
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經營租賃負債，扣除當期部分 |
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遞延收入-長期 |
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— |
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應付票據，扣除折扣，扣除流動部分（包括按公允價值期權指定的票據金額爲美元 |
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總負債 |
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可贖回優先股：美元 |
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— |
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股東權益 |
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G系列可轉換優先股：美元 |
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H系列可轉換優先股：美元 |
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第一系列可轉換優先股：美元 |
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普通股-投票：美元 |
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— |
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普通股-無投票權：美元 |
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— |
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— |
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額外實收資本 |
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非控股權益 |
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( |
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( |
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累計赤字 |
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( |
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累計其他綜合損失 |
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( |
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股東權益總額 |
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負債總額、可贖回優先股和股東權益 |
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$ |
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$ |
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請參閱該等未經審計的簡明綜合財務報表的隨附註釋。
1
JAGUAR HEALTH，Inc.
濃縮合併運營報表
（未經審計）
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止三個月 |
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九個月結束 |
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9月30日， |
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9月30日， |
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(In數千，份額和每股數據除外） |
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2024 |
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2023 |
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2024 |
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2023 |
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產品收入，淨 |
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$ |
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$ |
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$ |
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$ |
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許可證收入 |
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— |
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— |
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總收入，淨 |
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業務費用 |
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產品收入成本 |
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研發 |
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銷售和市場營銷 |
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一般和行政 |
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總運營費用 |
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經營虧損 |
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( |
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( |
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( |
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( |
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利息收入（費用） |
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( |
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( |
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( |
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指定為公允價值期權的獨立金融工具和混合金融工具的公允價值變化 |
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( |
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( |
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( |
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消除債務的收益 |
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— |
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其他收入（費用） |
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( |
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( |
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( |
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除所得稅開支前虧損 |
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( |
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( |
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( |
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( |
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所得稅開支 |
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— |
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淨虧損 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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歸屬於非控股權益的淨虧損 |
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$ |
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( |
) |
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$ |
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( |
) |
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$ |
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( |
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$ |
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( |
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歸屬於普通股股東的淨虧損 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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每股淨虧損，基本和稀釋 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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加權平均流通普通股、基本股和稀釋股 |
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請參閱該等未經審計的簡明綜合財務報表的隨附註釋。
2
JAGUAR HEALTH，Inc.
綜合損失的濃縮綜合報表
（未經審計）
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止三個月 |
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九個月結束 |
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9月30日， |
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9月30日， |
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(In數千，份額和每股數據除外） |
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2024 |
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2023 |
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2024 |
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2023 |
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淨虧損 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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其他全面虧損 |
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( |
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( |
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( |
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( |
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淨綜合損失 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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普通股股東： |
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歸屬於普通股股東的淨虧損 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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歸屬於普通股股東的其他全面損失 |
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換算調整 |
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( |
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( |
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歸屬於普通股股東的淨全面虧損 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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非控股權益： |
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歸屬於非控股權益的淨虧損 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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歸屬於非控股權益的其他全面損失 |
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換算調整 |
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( |
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歸屬於非控股權益的全面虧損淨額 |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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$ |
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( |
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請參閱該等未經審計的簡明綜合財務報表的隨附註釋。
3
JAGUAR HEALTH，Inc.
濃縮合併變更聲明
在可轉換格式中OC和股東股票
（未經審計）
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可贖回 |
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系列G |
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系列H |
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系列我 |
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共同 |
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共同 |
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額外 |
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非控股 |
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積累 |
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積累 |
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總 |
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(In數千，共享數據除外） |
股份 |
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量 |
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股份 |
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量 |
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股份 |
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量 |
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股份 |
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量 |
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股份 |
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量 |
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股份 |
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量 |
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資本 |
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興趣 |
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赤字 |
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損失 |
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股權 |
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截至2024年6月30日的餘額 |
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$ |
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— |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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在At The Market發行中發行的普通股，扣除美金 |
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發行給伊利亞特的普通股以換取應付票據和應計利息 |
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已發布的RSU |
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股票補償 |
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淨虧損 |
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— |
|
|
|
( |
) |
換算虧損 |
|
— |
|
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|
— |
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|
— |
|
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|
— |
|
|
— |
|
|
|
— |
|
|
— |
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|
— |
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|
— |
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|
— |
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|
— |
|
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|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
截至2024年9月30日的餘額 |
|
|
$ |
|
|
|
— |
|
$ |
|
— |
|
|
— |
|
$ |
|
— |
|
|
— |
|
$ |
|
— |
|
|
|
$ |
|
|
|
|
$ |
|
— |
|
$ |
|
|
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
|
|||||||
請參閱該等未經審計的簡明綜合財務報表的隨附註釋。
4
JAGUAR HEALTH，Inc.
濃縮合併變更聲明
可轉換股票和股東股票
（未經審計）
|
可贖回 |
|
系列G |
|
系列H |
|
系列我 |
|
共同 |
|
共同 |
|
額外 |
|
非控股 |
|
積累 |
|
積累 |
|
總 |
|
||||||||||||||||||||||||||||||||||||||||
(In數千，共享數據除外） |
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
資本 |
|
興趣 |
|
赤字 |
|
損失 |
|
股權 |
|
|||||||||||||||||||||||||||
截至2023年6月30日的餘額 |
|
— |
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
— |
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
$ |
|
|
$ |
|
|
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
|
|||||||
向歐文發行的優先股以換取應付票據和應計利息 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
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|
— |
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|
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|
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|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
在At The Market發行中發行的普通股，扣除美金 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
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|
— |
|
|
— |
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|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
H系列優先股轉換向Streeterville發行的普通股 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
( |
) |
|
|
— |
|
|
— |
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|
|
— |
|
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|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
已發布的RSU |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
通過皇家全球修正案交易所向歐文發出的逮捕令 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
通過皇家全球修正案交易所向斯特里特維爾發出的逮捕令 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
通過皇家全球修正案交易所向伊利亞特發出的逮捕令 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
股票補償 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
淨虧損 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
換算虧損 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
截至2023年9月30日的餘額 |
|
— |
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
$ |
|
|
$ |
|
|
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
|
||||||||
請參閱該等未經審計的簡明綜合財務報表的隨附註釋。
5
JAGUAR HEALTH，Inc.
濃縮合併變更聲明
可轉換股票和股東股票
（未經審計）
|
可贖回 |
|
系列G |
|
系列H |
|
系列我 |
|
共同 |
|
共同 |
|
額外 |
|
非控股 |
|
積累 |
|
積累 |
|
總 |
|
||||||||||||||||||||||||||||||||||||||||
(In數千，共享數據除外） |
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
資本 |
|
興趣 |
|
赤字 |
|
損失 |
|
股權 |
|
||||||||||||||||||||||||||||
截至2024年1月1日的餘額 |
|
— |
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
— |
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
$ |
|
|
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
|
||||||
在市場上發行的普通股，扣除發行和發行成本美金 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
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|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
發行給伊利亞特的普通股以換取應付票據和應計利息 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
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|
— |
|
|
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
向Streeterville發行的優先股以換取應付票據和應計利息 |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
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— |
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— |
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|
— |
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|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
因轉換認購證而發行的普通股 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
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|
— |
|
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— |
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|
— |
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|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
交換J系列優先股向Streeterville發行的普通股 |
|
( |
) |
|
|
( |
) |
|
— |
|
|
|
— |
|
|
— |
|
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|
— |
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— |
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|
— |
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— |
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— |
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|
— |
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|
|
|
— |
|
|
|
|
||||
向第三方發行普通股以換取許可協議 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
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|
— |
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— |
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|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
G系列優先股轉換發行的普通股 |
|
— |
|
|
|
— |
|
|
( |
) |
|
|
— |
|
|
— |
|
|
|
— |
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|
— |
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— |
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|
— |
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— |
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|
— |
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|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
發行給第三方用於服務的普通股 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
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|
— |
|
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|
— |
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|
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|
— |
|
|
— |
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|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||||
通過轉換第一系列優先股向伊利亞特發行的普通股 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
( |
) |
|
|
— |
|
|
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
發行給斯特里特維爾的普通股以換取應付票據和應計利息 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
已發布的RSU |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||||
股票補償 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
淨虧損 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
換算虧損 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
截至2024年9月30日的餘額 |
|
|
$ |
|
|
|
— |
|
$ |
|
— |
|
|
— |
|
$ |
|
— |
|
|
— |
|
$ |
|
— |
|
|
|
$ |
|
|
|
|
$ |
|
— |
|
$ |
|
|
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
|
|||||||
請參閱該等未經審計的簡明綜合財務報表的隨附註釋。
6
JAGUAR HEALTH，Inc.
濃縮合併變更聲明
可轉換股票和股東股票
（未經審計）
|
可贖回 |
|
系列G |
|
系列H |
|
系列我 |
|
共同 |
|
共同 |
|
額外 |
|
非控股 |
|
積累 |
|
積累 |
|
總 |
|
||||||||||||||||||||||||||||||||||||||||
(In數千，共享數據除外） |
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
股份 |
|
量 |
|
資本 |
|
興趣 |
|
赤字 |
|
損失 |
|
股權 |
|
||||||||||||||||||||||||||||
截至2023年1月1日的餘額 |
|
— |
|
$ |
|
— |
|
|
— |
|
$ |
|
— |
|
|
— |
|
$ |
|
— |
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$ |
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|
( |
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$ |
|
( |
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$ |
|
( |
) |
$ |
|
( |
) |
|||
通過PIPE融資發行的優先股，扣除發行和發行成本美金 |
|
— |
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— |
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— |
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— |
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向斯特里特維爾發行的優先股以換取應付票據和應計利息 |
|
— |
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— |
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— |
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— |
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向歐文發行的優先股以換取應付票據和應計利息 |
|
— |
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— |
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— |
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— |
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— |
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在市場上發行的普通股，扣除發行和發行成本美金 |
|
— |
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— |
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— |
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— |
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|||
發行給伊利亞特的普通股以換取應付票據和應計利息 |
|
— |
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— |
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— |
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— |
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— |
|
|
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|
|||
發行給歐文的普通股以換取應付票據和應計利息 |
|
— |
|
|
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— |
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— |
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— |
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— |
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— |
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— |
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H系列優先股轉換向Streeterville發行的普通股 |
|
— |
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— |
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— |
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— |
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( |
) |
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— |
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— |
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因行使限制性股票單位而發行的普通股 |
|
— |
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— |
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— |
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— |
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— |
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— |
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|||
發行給第三方用於服務的普通股 |
|
— |
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— |
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— |
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— |
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— |
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— |
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— |
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|||
已發布的RSU |
|
— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
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— |
|
|
非控股權益的額外投資 |
|
— |
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— |
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— |
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— |
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— |
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— |
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|
||
PIPE融資中發行的憑證 |
|
— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
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|
||
向歐文發出的逮捕令以換取Standstill |
|
— |
|
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
||
向伊利亞特發出的逮捕令以換取Standstill |
|
— |
|
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
|
|
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|
||
通過皇家全球修正案交易所向歐文發出的逮捕令 |
|
— |
|
|
|
— |
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|
— |
|
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
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|
||
通過皇家全球修正案交易所向斯特里特維爾發出的逮捕令 |
|
— |
|
|
|
— |
|
|
— |
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|
— |
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|
— |
|
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
|
|
|
— |
|
|
|
|
||
通過皇家全球修正案交易所向伊利亞特發出的逮捕令 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
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|
— |
|
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
|
|
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— |
|
|
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|
||
股票補償 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
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— |
|
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— |
|
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
||
淨虧損 |
|
— |
|
|
|
— |
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|
— |
|
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— |
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— |
|
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
換算虧損 |
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
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|
— |
|
|
|
— |
|
|
— |
|
|
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— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
截至2023年9月30日的餘額 |
|
— |
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
|
|
$ |
|
— |
|
$ |
|
|
$ |
|
|
$ |
|
( |
) |
$ |
|
( |
) |
$ |
|
|
||||||||
請參閱該等未經審計的簡明綜合財務報表的隨附註釋。
7
JAGUAR HEALTH，Inc.
簡明綜合現金流量表
（未經審計）
|
|
九個月結束 |
|
|||||||
|
|
9月30日， |
|
|||||||
(in數千） |
|
2024 |
|
|
2023 |
|
||||
經營活動產生的現金流量 |
|
|
|
|
|
|
||||
淨綜合損失 |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
將淨全面虧損與經營活動中使用的淨現金進行調節的調整： |
|
|
|
|
|
|
|
|
||
指定為公允價值期權的獨立金融工具和混合金融工具的公允價值變化 |
|
|
|
|
|
|
|
|
||
折舊及攤銷開支 |
|
|
|
|
|
|
|
|
||
基於股票的報酬、歸屬和釋放的限制性股票單位以及已行使的股票期權 |
|
|
|
|
|
|
|
|
||
經營租賃攤銷-使用權-資產 |
|
|
|
|
|
|
|
|
||
債務發行成本攤銷、債務貼現和非現金利息費用 |
|
|
|
|
|
|
|
|
||
分擔合資企業虧損 |
|
|
|
|
|
|
|
|
||
為換取服務而發行的股份 |
|
|
|
|
|
|
|
|
||
消除債務的收益 |
|
|
|
( |
) |
|
|
|
( |
) |
資產負債變化 |
|
|
|
|
|
|
|
|
||
應收帳款 |
|
|
|
|
|
|
|
|
||
其他應收賬款 |
|
|
|
|
|
|
|
|
||
庫存 |
|
|
|
( |
) |
|
|
|
( |
) |
預付費用和其他易變現資產 |
|
|
|
( |
) |
|
|
|
( |
) |
其他資產 |
|
|
|
( |
) |
|
|
|
( |
) |
應付帳款 |
|
|
|
( |
) |
|
|
|
( |
) |
應計負債 |
|
|
|
|
|
|
|
( |
) |
|
遞延收入 |
|
|
|
|
|
|
|
— |
|
|
經營租賃負債 |
|
|
|
( |
) |
|
|
|
( |
) |
經營活動使用的現金總額 |
|
|
|
( |
) |
|
|
|
( |
) |
投資活動的現金流 |
|
|
|
|
|
|
|
|
||
購買設備 |
|
|
|
( |
) |
|
|
|
— |
|
投資活動使用的現金總額 |
|
|
|
( |
) |
|
|
|
— |
|
融資活動現金流量 |
|
|
|
|
|
|
|
|
||
在市場上發行股票的收益，扣除發行和發行成本美金 |
|
|
|
|
|
|
|
|
||
發行普通股以換取許可協議的收益 |
|
|
|
|
|
|
|
— |
|
|
Tempesta紙幣的支付 |
|
|
|
( |
) |
|
|
|
( |
) |
保險融資償還 |
|
|
|
( |
) |
|
|
|
( |
) |
非控股權益投資 |
|
|
|
— |
|
|
|
|
|
|
PIPE融資中發行認購證的收益 |
|
|
|
— |
|
|
|
|
|
|
PIPE融資中發行優先股的收益，扣除發行和發行成本美金 |
|
|
|
— |
|
|
|
|
|
|
融資活動提供的現金總額 |
|
|
|
|
|
|
|
|
||
價位變化對資產和負債的影響 |
|
|
|
|
|
|
|
( |
) |
|
現金淨增加（減少） |
|
|
|
|
|
|
|
( |
) |
|
年初現金 |
|
|
|
|
|
|
|
|
||
年終現金 |
|
$ |
|
|
|
$ |
|
|
||
請參閱該等未經審計的簡明綜合財務報表的隨附註釋。
8
JAGUAR HEALTH，Inc.
現金流濃縮綜合報表（續）
（未經審計）
|
|
九個月結束 |
|
|||||||
|
|
9月30日， |
|
|||||||
|
|
2024 |
|
|
2023 |
|
||||
現金流信息補充時間表 |
|
|
|
|
|
|
|
|
||
支付利息的現金 |
|
$ |
|
|
|
$ |
|
|
||
非現金融資和投資活動補充時間表 |
|
|
|
|
|
|
|
|
||
發行給伊利亞特的普通股以換取應付票據和應計利息 |
|
$ |
|
|
|
$ |
|
|
||
向斯特里特維爾發行的優先股以換取應付票據和應計利息 |
|
$ |
|
|
|
$ |
|
|
||
向斯特里特維爾發行普通股以換取J系列優先股 |
|
$ |
|
|
|
$ |
|
— |
|
|
第一保險融資 |
|
$ |
|
|
|
$ |
|
— |
|
|
經營租賃的確認-使用權資產和經營租賃負債 |
|
$ |
|
|
|
$ |
|
|
||
發行給斯特里特維爾的普通股以換取應付票據和應計利息 |
|
$ |
|
|
|
$ |
|
— |
|
|
雨傘保險融資 |
|
$ |
|
|
|
$ |
|
|
||
向歐文發行的優先股以換取應付票據和應計利息 |
|
$ |
|
— |
|
|
$ |
|
|
|
發行給歐文的普通股以換取應付票據和應計利息 |
|
$ |
|
— |
|
|
$ |
|
|
|
向歐文發出的逮捕令以換取「靜止」 |
|
$ |
|
— |
|
|
$ |
|
|
|
向伊利亞特發出的逮捕令以換取靜止 |
|
$ |
|
— |
|
|
$ |
|
|
|
根據皇家利益全球修正案向歐文發出的逮捕令 |
|
$ |
|
— |
|
|
$ |
|
|
|
根據皇家利益全球修正案向斯特里特維爾發出的逮捕令 |
|
$ |
|
— |
|
|
$ |
|
|
|
根據皇家利益全球修正案向伊利亞特發出的逮捕令 |
|
$ |
|
— |
|
|
$ |
|
|
|
隨附的附註是該等未經審核簡明綜合財務報表的組成部分。
9
JAGUAR HEALTH，Inc.
公司簡明綜合財務報表附註
1.組織機構和業務
捷豹健康公司(“捷豹”或“公司”)於2013年6月6日(創始)在加利福尼亞州舊金山成立，是特拉華州的一家公司。在2015年5月18日公司首次公開募股結束之前，該公司一直是納波製藥公司(“納波”)的多數股權子公司。該公司的成立是為了開發和商業化一流的伴侶動物處方和非處方產品。
於二零一七年七月三十一日，捷豹根據日期為二零一七年三月三十一日的合併協定及計劃，由捷豹、納波、納波收購公司(“合併附屬公司”)及納波代表完成與納波的合併(“合併協定”)。根據合併協定的條款，於合併完成後，Merge Sub與Napo合併並併入Napo，Napo以全資附屬公司的身分繼續存在(“合併”或“Napo合併”)。合併後，捷豹立即從“捷豹動物健康公司”更名。致“美洲豹健康公司”NAPO現在是捷豹的全資子公司，專注於人類健康，包括正在開發的CroFelemer和Mytesi的商業化。
2021年3月15日，捷豹在意大利米蘭成立了NAPO EU S.p.A(2021年12月更名為NAPO治療公司)，作為NAPO的子公司。NAPO Treateutics的核心使命是在歐洲提供CROFELEMER，以解決重要的罕見/孤兒疾病適應症，最初包括兩個關鍵的孤兒目標適應症：伴有腸道衰竭的短腸綜合徵(SBS)和先天性腹瀉疾病(CDD)。
公司通過以下方式管理其運營
納斯達克溝通和合規
最低投標價要求
2023年5月10日，納斯達克的上市資格工作人員(以下簡稱“工作人員”)向本公司發出通知，指其未能遵守美元
流動性和持續經營
本公司自成立以來，經常出現經營虧損和經營現金流為負，累計虧損達$
雖然 該公司計劃通過股權和/或債務融資、與其他實體的合作安排、許可證特許權使用費協議以及未來產品銷售的收入為其運營和現金流需求提供資金，但該公司認為其當前現金餘額不足以為其運營計劃提供資金。發布這些未經審計的簡明綜合財務報表後一年內。無法保證公司將以可接受的條款或及時（如果有的話）獲得額外資金，也無法保證公司將從運營中產生足夠的現金來充分滿足運營需求。如果公司無法獲得長期所需的足夠融資水平
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發展 以及產品的商業化，該公司將需要減少計劃活動並降低成本。這樣做可能會對公司執行業務計劃的能力產生不利影響;因此，對公司繼續作為持續經營企業存在的能力存在很大疑問。隨附的未經審核簡明綜合財務報表不包括該等不確定性的結果可能導致的任何調整。
2.主要會計政策摘要
呈列基準
未經審核簡明綜合財務報表乃根據美國公認的中期財務資料會計原則(“美國公認會計原則”)編制，並以與年度綜合財務報表一致的基準編制，管理層認為該等財務報表反映所有調整，其中只包括公平列報列報期間所需的正常經常性調整。這些中期財務業績不一定代表截至2024年12月31日的年度或未來任何其他年度或中期的預期結果。這些未經審計的簡明綜合財務報表應與截至2023年12月31日的年度報告Form 10-k所載的綜合財務報表及其附註一併閱讀。截至2023年12月31日的簡明綜合資產負債表是從該日經審計的綜合財務報表中得出的，但不包括美國公認會計準則要求的完整財務報表所需的所有披露，包括附註。
在截至2024年9月30日的9個月裡，公司的重大會計政策沒有發生重大變化，而公司在截至2023年12月31日的10-K表格年度報告中的“簡明綜合財務報表附註2”中描述的重大會計政策則沒有重大變化。該表格於2024年4月1日提交給美國證券交易委員會，並於2024年4月17日修訂。
除上文所述外，未經審核簡明綜合財務報表乃按與經審核綜合財務報表相同的基準編制，管理層認為該等簡明綜合財務報表反映所有屬正常經常性性質的調整，以公平地列報截至2024年9月30日、2024年及2023年9月30日止三個月及九個月的財務狀況、截至2024年及2023年9月30日止三個月及九個月的經營業績、截至2024年及2023年9月30日止三個月及九個月的可轉換優先股及股東權益變動，以及截至2024年9月30日及2023年9月30日止九個月的現金流量。中期業績不一定代表未來任何中期或全年的業績。
合併原則
綜合財務報表乃根據美國公認會計準則及美國證券交易委員會(“美國證券交易委員會”)的適用規則及規定編制。)，幷包括本公司及其擁有控股權的子公司的賬目。所有公司間交易和餘額均已在合併中沖銷。該公司的報告貨幣是美元。
非控制性權益
該公司合併了納波治療公司的結果，納波治療公司是
使用估計
根據美國公認會計原則編制簡明綜合財務報表要求公司管理層作出判斷、假設和估計，這些判斷、假設和估計影響其未經審計的簡明綜合財務報表及其附註中報告的金額。反映公司更重要的估計和判斷的會計政策，以及公司認為有助於充分理解和評估其報告的財務業績最關鍵的會計政策是股票期權、限制性股票單位(“RSU”)、按公允價值期權(“FVO”)指定的獨立和混合工具(“FVO”)、認股權證負債、收購的正在進行的研究與開發(“IPR&D”)的估值。(A)長期資產的減值和使用年限；非金融資產的減值評估；超額和陳舊存貨的估值調整；可疑賬戶準備；遞延稅項和遞延稅項資產估值免稅額；或有事項的評估和計量；收入的確認，包括產品退貨估計數。這些估計可能會改變，因此，實際結果可能與這些估計大不相同。
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現金
在一年中的某些時間，公司的存款現金可能會超過美國聯盟保險的限額。該公司在美國某些主要金融機構設有現金賬戶。截至2024年9月30日和2023年12月31日，公司沒有現金等價物.
應收帳款，淨額
應收賬款是扣除及時付款和信用損失的折扣額後入賬的。
於採納ASU編號2013-13(“ASC 326”)後，本公司開始採用現行預期信貸損失(“CECL”)模式下的損失率方法，以釐定其應收客戶的終身預期信貸損失。這種方法根據歷史經驗、信用質量、應收賬款餘額的年齡以及可能影響客戶支付能力的當前和預測的經濟和商業狀況來計算信貸損失估計。在確定損失率時，本公司評估與其歷史虧損相關的資訊，根據現有條件進行調整，並根據可以合理預測的時間段進行進一步調整。截至資產負債表日的事實和情況被用來調整超出可合理預測的期間的估計。
應收賬款的逾期狀態是根據合同付款到期日確定的。如果在合同到期日後30天仍未收到付款，則認為應收賬款已逾期。截至2024年9月30日和2023年12月31日，信用損失準備金並不重要。信貸損失準備金的相應費用反映在一般費用和行政費用中。
當前預期信用損失
本公司確認按攤銷成本列賬的金融資產的信貸損失準備，以顯示截至資產負債表日預計應收回的淨額。該等撥備乃根據預期於資產合約期內產生的信貸損失計算，包括考慮按當前情況調整的過往信貸損失資料及合理及可支持的預測。
信貸損失準備的變化被記錄為信貸損失費用的準備(或沖銷)。當本公司確定該等資產被視為無法收回時，即予以註銷。核銷確認為從信貸損失準備中扣除。先前撇賬金額的預期收回金額不超過先前撇賬金額的總和，計入於資產負債表日釐定的必要撥備。
濃度
現金是一種金融工具，可能使公司面臨集中的信用風險，因為現金存放在銀行，而現金餘額通常超過聯盟存款保險公司(FDIC)的保險限額。
截至2024年和2023年9月30日的三個月和九個月，該公司幾乎所有的收入都來自出售Mytesi。在考察公司對淨收入佔總淨收入的百分比等於或大於
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本公司面臨單一第三方合同製造商Glenmark的集中風險。
其他風險和不確定性
公司未來的經營業績包含許多風險和不確定因素。可能影響公司未來經營結果並導致實際結果與預期大不相同的因素，包括但不限於戰爭、快速的技術變革、獲得第二來源供應商和製造商、美國食品和藥物管理局(FDA)或其他監管機構的監管批准、臨床試驗的結果和里程碑的實現、市場對公司候選產品的接受程度、來自其他產品和較大公司的競爭、對專有技術的保護、戰略關係和對關鍵個人的依賴。
其他全球活動
世界各地的宏觀經濟狀況不斷變化，受到幾個因素的影響，包括持續的高通脹、勞動力市場的結構性弱點、低生產率增長、不利的天氣條件，以及某些地區可能出現的政治動盪。儘管面臨這些全球經濟挑戰，但公司的運營並未發生重大變化。
公平值
公司的金融工具包括應收賬款、淨額、其他應收賬款、應付賬款、應計負債、經營租賃負債和債務。應收賬款、其他應收賬款、應付賬款和應計負債的記錄賬面金額因其短期性質而反映其公允價值。其他財務負債最初按公允價值入賬，其後按公允價值或攤銷成本按實際利息法計量。公允價值計量見附註3。
公允價值期權
ASC 825-10，金融工具 (“ASC 825-10”)提供了FVO選擇，允許公司不可撤銷地選擇使用公允價值作為某些金融資產和負債的初始和後續會計計量屬性。ASC 825-10允許實體選擇按公允價值持續計量符合條件的金融資產和負債。當選FVO的專案的未實現收益和虧損在收益中報告。選舉FVO的決定是在逐個文書的基礎上決定的，必須適用於整個文書，一旦當選，就不可撤銷。根據美國會計準則825-10按公允價值計量的資產和負債必須與使用另一種會計方法計量的工具分開報告。根據ASC 825-10提出的選擇，本公司選擇在簡明綜合資產負債表的同一專案中列報公允價值和非公允價值金額的合計，並在合計金額中附加披露按公允價值計量的金額。本公司金融工具的公允價值反映了在計量日市場參與者之間有序交易中出售一項資產或支付轉移一項負債所收到的金額(退出價格)。這些財務報表中列報的公允價值估計基於本公司截至2024年9月30日和2023年12月31日的資訊。.
庫存
存貨按成本或可變現淨值中較低者列報。成本是使用先進先出的方法確定的。成本最初按第三方加工商、Probos和CorFasac提供的服務或原料藥的發票金額入賬，包括將庫存恢復到現有條件和地點的合格支出和費用的總和。庫存分為原材料、在製品和產成品。原料由天然植物乳膠(“CPL”)組成)，在收穫時確認為庫存，按成本計價，包括購置和收穫支出。僅當CPL已轉換為原料藥並正在運輸到Patheon時，才確認在製品庫存，成本包括直接材料、人工和適用的管理費用。成品是指可供銷售的成品，按成本計價，其中包括生產過程中分配的直接材料、勞動力和製造費用。當條件表明可變現淨值因實物變質、使用、陳舊、預計未來需求減少或銷售價格降低而低於成本時，公司計算庫存估值調整。存貨減值是指存貨成本與可變現淨值之間的差額。該公司做到了
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投放前庫存
該公司的政策是在藥物開發階段將上市前庫存的成本資本化，這證明該產品合理地可能是成功的關鍵屬性是存在和可行的，而根據管理層的假設，失敗的關鍵原因是不存在的。可以為發射前庫存資本化的成本被記錄為“預付費用和其他流動資產”。
物業及設備
土地按成本列報，反映物業於2017年7月31日，即納波合併日期的公允價值。設備按扣除累計折舊後的成本列報。設備投入使用後開始折舊。折舊是使用直線法計算估計的使用壽命，範圍為 到
維修和維護資產的支出在發生時計入費用。主要增加和改進的成本在其估計使用年限內以直線為基礎進行資本化和折舊。於退回或出售時，出售資產的成本及相關累計折舊將從賬目中撇除，任何由此產生的收益或虧損將計入未經審核的簡明綜合經營報表。
為內部使用而開發的軟體
該公司將開發供內部使用的軟體的成本資本化。這些成本包括購買的軟體和內部開發的軟體。在確定技術可行性之前，開發軟體的成本都是要花費的。此後，所有成本都被資本化，並以未攤銷成本或可變現淨值中的較低者入賬。內部開發和購買的軟體成本一般在
本公司根據ASC 360-10評估了截至2023年12月31日的內部使用軟體成本的賬面價值。應持有或使用的長期資產的減值。根據評估，本公司確定內部使用軟體成本-登記處於2023年12月31日的賬面價值不再可收回，並記錄了相應的減值損失。減值損失計算為登記處賬面價值與其於2023年12月31日的估計公允價值之間的差額。公允價值是使用貼現現金流(DCF)模型來確定的，該模型是ASC 820下的一種3級評估技術，公平值 測量結果(“ASC 820”)。貼現現金流模型利用了關於未來銷售量、定價和成本的特定於實體的假設。這些假設考慮了一些因素，如現有客戶關係的連續性、經濟狀況的潛在變化以及其他相關的市場影響。然後，使用反映貨幣時間價值和與預期現金流量相關的固有用途的比率，將該模型產生的淨現金流量貼現為現值。貼現率是根據管理層認為適當的可比債務工具計算的。鑑於不斷變化的市場狀況，用來確定登記處公允價值的估計數有可能在不久的將來需要調整。假設的任何此類變化都可能導致進一步的減值費用。公司確認了截至2023年12月31日的年度支出以及由於減值而導致的內部使用軟體登記處賬面價值的相應減少。
長期資產
本公司定期檢討其所有長期資產的賬面價值及估計使用年限，包括物業及設備及確定使用年限的無形資產，以確定是否存在需要對賬面價值或估計使用年限作出調整的減值指標。這項評估使用的決定因素包括管理層對資產在未來期間從運營中產生正收益和正現金流的能力的估計，以及資產對公司業務目標的戰略意義。如果本公司確定事件或情況變化表明資產組的賬面價值可能無法收回，本公司根據使用和最終處置的預計未貼現現金流量與相關資產的賬面價值的比較來評估其長期資產(資產組)的變現能力。任何減值(根據公允價值和資產賬面價值之間的差額計量)被視為資產(資產組)賬面金額的永久性減少。
無限年期的無形資產
收購的IPR & D是2017年7月Napo合併中收購的無形資產。ASC 80以下， 業務合併、IPR & D最初按公允價值確認，並分類為無限壽命資產，直至相關研究和開發工作成功完成或放棄。在開發期間，這些資產不會作為費用攤銷
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相反，這些資產將每年接受減值測試，如果確定了減值指標，將進行更頻繁的測試。減值損失是根據賬面價值超過資產公允價值來計量的。《公司記錄》d
租賃
本公司根據ASC 842對其租約進行會計處理，租賃 (“ASC 842”)。
於一項安排開始時，本公司會根據當時的獨特事實及情況決定該項安排是否為租約或包含租約。經營性租賃負債及其相應的使用權資產根據預期租賃期內租賃付款的現值入賬。由於租賃合同中隱含的利率通常不容易確定，本公司利用其遞增借款利率，即在類似期限內以抵押為基礎借款的利率，相當於類似經濟環境下的租賃付款。對於支付的初始直接費用或收到的獎勵等專案，可能需要對使用權資產進行某些調整。
該公司選擇將租賃和非租賃組成部分作為一個單獨組成部分納入，並將其作為租賃進行核算。
修改租約
ASC 842將租賃修改定義為對合同條款和條件的更改，從而導致租賃範圍或對價的變化。租賃修改可以產生一個單獨的新合同，該合同與原始合同分開核算，也可以產生一個修改後的合同。
如果對合同的修改授予承租人未包括在原始租賃中的額外使用權，並且租賃付款與額外使用權的獨立價格相稱，並根據特定合同的情況進行調整，則公司應將合同的修改作為一份單獨的合同進行會計處理。當公司認為租約修改應作為獨立於原始租約的新合同入賬時，應評估新合同是租約還是包含嵌入租約。如果新合同是租約或包含嵌入租約，新租約應與任何其他新租約一樣入賬。新租約記錄在新租約開始之日，也就是承租人獲得租賃資產之日。
如果租賃修改沒有作為單獨的合同計入，公司應重新評估合同是否包含租賃。如果修改後的合同是租賃或包含嵌入租賃，承租人應重新分配合同對價，重新評估租賃分類，重新計量租賃負債，並調整使用權資產。
研發費用
研究開發費用包括進行研究開發活動所發生的費用，包括相關工資、臨床試驗及相關藥品和非藥品產品成本、合同服務以及其他外部服務費用。研究和開發費用計入發生期間的營業費用。
臨床試驗應計費用
臨床試驗費用是研究和開發費用的一個組成部分。本公司根據與臨床研究機構和臨床站點達成的協定完成的實際工作為第三方進行的臨床試驗活動計提費用。本公司根據與外部服務提供商就試驗或服務的完成進度或階段的確認以及為此類服務支付的商定費用來確定應記錄的成本。
收入確認
本公司根據ASC 606確認收入，客戶合約收益 （「ASC 606」）。
如果產品損壞、有缺陷或產品過期而無法使用，公司的政策通常允許退貨。對於將在三個月內到期或在到期日後一年內到期的產品，接受退貨。對過期產品預期退貨的估計主要基於對我們歷史退貨模式的持續分析。
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公司根據ASC 606的核心原則確認收入，或者當承諾的商品或服務的控制權轉移給客戶時，其金額反映了公司預期有權獲得的對價，以換取這些商品或服務。
如果本公司本應確認的資產的攤銷期限為一年或更短時間，則本公司將獲得合同的增量成本在發生時確認為支出。
如果在合同開始時，承諾的貨物或服務的轉讓與客戶付款之間的預期期間不超過一年，則公司不會調整重大融資部分的影響的對價金額。
該公司已選擇將運輸和搬運活動視為履行成本。
此外，公司選擇記錄扣除銷售和其他類似稅項後的收入淨額。
合同-總代理商
該公司的Canalevia-CA1和Neonorm產品主要銷售給分銷商，分銷商再將產品銷售給最終客戶。自2021年以來，本公司已簽訂
履約義務
對於本公司銷售的動物保健品，上文確定的單一履約義務是本公司承諾根據安排中指定的付款和發貨條款將本公司的動物保健品轉讓給經銷商。產品保固是不代表履行義務的保證類型的保固。對於公司的人類健康產品Mytesi，以上確定的單一履行義務是公司承諾根據公司與紅衣主教健康於2019年1月16日簽訂的獨家經銷協定中概述的特定付款和發貨條款，將Mytesi轉移到專業藥店。
成交價
對於與紅衣主教健康和其他分銷商的合同，交易價格是公司預期為轉讓承諾的商品或服務而收取的對價金額。Mytesi的交易價格是批發商收購成本(WAC)，Canalevia-CA1和Neonorm的交易價格是製造商的標價，扣除折扣、退貨和價格調整後的淨價。
分配成交價
對於與經銷商簽訂的合同，整個交易價格分配給每個合同中包含的單個履約義務。
收入確認
對於與紅衣主教健康的合同，當控制權(包括所有權和所有風險)轉移到客戶手中時，在每個合同的離岸價格(FOB)條款的某個時間點履行單一履約義務。
產品收入的細分
人類
Mytesi的銷售在產品交付給專業藥店時被確認為收入。出售Mytesi的淨收入為$
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動物
該公司確認Canalevia-CA1產品收入為$
該公司確認Canalevia-CA1產品收入為$
合同-專科藥房
自2020年10月1日起，本公司聘請一傢俬人公司作為本公司Mytesi產品的授權專業藥房供應商。根據專業產品分銷協定，公司應按訂購的數量直接向私人公司的專業藥店供應產品。沒有最低購買量或庫存要求。專業藥店是Mytesi所有國家藥品編碼的授權經銷商。
自2021年4月20日起，該公司聘請了另一傢俬人公司作為Mytesi的授權專業藥房提供商。根據專科藥房分銷和服務協定，私營公司應將直接從該公司訂購的Mytesi以商定的價格銷售和分發給協定確定的地區內的患者。
本公司已與以下公司簽訂協定
履約義務
單一履約義務是該公司承諾根據協定中概述的具體付款和運輸條款，將Mytesi轉移到專業藥店。
成交價
交易價格是公司預計收取的對價金額，以換取轉讓承諾的商品或服務。Mytesi的交易價格為WAC，扣除估計折扣、退貨和價格調整。
分配交易價格
整個交易價格分配給每份合同中包含的單一履行義務。
收入確認
單一履行義務是在每個合同的船上交貨價條款的某個時間點履行的，此時控制權（包括所有權和所有風險）已轉移給客戶。
產品收入
Mytesi的銷售額在產品交付至專業藥房時確認為收入。將Mytesi出售給專業藥房的淨收入為 $
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合同-許可協定
自2024年3月18日起，本公司與Gen Ilac ve Saglik Urunleri Sanayi ve Ticaret，A.S.(“Gen”)(“被許可人”)簽訂了一份證券購買協定，並補充了一份具有約束力的條款說明書。該公司授予Gen訪問其知識產權的權利，以獲得公司FDA批准的處方藥CroFelemer，並在獲得許可的東歐地區將CroFelemer成品商業化，代價包括許可費、版稅和產品銷售。該協定和具有約束力的條款說明書共同符合ASC 606規定的有效合同的條件。
履約義務
該公司確定了
成交價
交易價格是指實體為向客戶轉讓承諾的貨物或服務而預期有權獲得的對價金額，不包括代表第三方收取的金額。在與Gen的合同中，交易價格包括固定和可變兩種考慮因素。
就許可交易而言，固定代價按相關股份發行所得款項與已發行股份公允價值之間的差額計量。以特許權使用費形式的可變對價是根據被許可人銷售使用克羅費勒姆的藥品所得收入的百分比計算的。對於CroFelemer原料藥的供應，可變對價是使用各種可能數額的期望值來確定的。
分配成交價
整個交易價格分配給合同中包含的單一履約義務。
收入確認
隨著時間的推移，單一履行義務被履行，在整個過程中
許可證收入
在截至2024年9月30日的三個月和九個月裡，從與Gen的合同中確認的許可費為$
協作收入
協作協定的收入確認需要重大判斷。該公司的評估和估計是基於合同條款、歷史經驗和一般行業慣例。在修訂期間，對這些價值或估計的修訂會增加或減少協作收入。
2018年9月24日，公司與奈特治療公司(“奈特”)簽訂了分銷、許可和供應協定(“許可協定”)。許可協定的期限為
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對負債分類票據的修改
在對債務修改和交換交易進行會計處理時，本公司的政策是首先根據ASC 470-60提供的指導確定其是否符合問題債務重組(TDR)的資格。Debtors的債務問題債務重組(“ASC 470-60”)。不在ASC 470-60範圍內的債務修改或交換交易在ASC 470-50下核算，改裝和滅火(“ASC 470-50”)，以確定交易是純粹的修改還是終止。
在截至2024年9月30日和2023年9月30日的9個月內，本公司已對其專利權使用費權益和購買協定條款進行了修訂。 這些修正的累積影響導致了某些終止和修改(見附註7)。
對股權分類工具的修改
在對股權分類權證的修改進行會計處理時，公司的政策是參照ASC 718的基於股份的薪酬指導來確定影響。薪酬--股票薪酬(“ASC 718”)。在ASC 718-20-35-3中闡述了被分類為股權並且在修改之後仍被分類為股權的經修改的基於股份的支付獎勵的模型，薪酬-股票薪酬-歸類為股權的獎勵-後續衡量。根據該指引，在經修訂的工具具有較高公允價值的範圍內，因修訂而增加的公允價值在經營報表中確認為開支；然而，在某些情況下，例如當一整類認股權證被修訂時，根據權證修訂的性質，經計量的公允價值增加可能更適合記為視為股息。
本公司沒有修改截至2024年9月30日和2023年9月30日的三個月和九個月的任何股權分類認股權證。
在對優先股的修訂進行會計核算時，公司的政策是通過類比ASC 470-50來衡量影響，以確定此類修訂是終止還是修改。如果修改導致終止，本公司遵循ASC260-10-S99-2中的美國證券交易委員會員工指導，每股收益-整體-美國證券交易委員會材料和ASC 470-20，債務--帶有轉換和其他選項的債務。如果修改導致修改，公司將遵循ASC 718或ASC 470-50中的模式，具體取決於修改的性質。
截至2024年和2023年9月30日的三個月和九個月，公司沒有修改任何股權分類優先股.
股票補償
公司的股票激勵計劃(見附註12)規定授予股票期權、限制性股票和限制性股票單位獎勵。本公司按授予日授予僱員、非僱員和董事的股票獎勵的估計公允價值計量，並確認獎勵在與獎勵歸屬期間相對應的必要服務期內扣除估計沒收後的相應補償費用。如有必要，沒收在發放時進行估計，如果實際沒收不同於這些估計，則在隨後的期間進行修訂。本公司發行的股票獎勵只包含服務類歸屬條件，並使用直線法記錄這些獎勵的補償費用。
該公司使用其普通股授予日期的公平市場價值來確定授予員工、非員工和董事的期權的授予日期的公平價值。公司根據授予日授予員工和董事的所有股票期權和RSU的估計公允價值計量和確認所有股票期權和RSU的補償費用。該公司使用布萊克-斯科爾斯估值模型來估計股票期權獎勵的公允價值。公允價值在必要的服務期內確認為扣除估計罰沒後的費用，該服務期通常是按直線計算的相應授標的授權期。本公司認為，授予非僱員的股票期權的公允價值比所接受服務的公允價值更可靠地計量。使用期權定價模型確定授予日期期權的公允價值受公司估計的普通股公允價值的影響，需要管理層做出許多假設，包括期權的預期壽命、標的股票的波動性、無風險利率和預期股息。
公司使用布萊克-斯科爾斯期權估值模型估計股票期權的公允價值。員工股票期權的公允價值將在獎勵的必要服務期內按直線攤銷。普通股的公平市場價值是以授予之日報告的公司普通股的收盤價為基礎的。
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所得稅
本公司採用資產負債法核算所得稅。根據這種方法，遞延稅項資產和負債是根據財務報告與資產和負債的稅基之間的差異來確定的，並使用頒佈的稅率和法律進行計量，這些稅率和法律將在差異預期逆轉時生效。當遞延稅項資產的部分或全部很可能無法變現時，提供估值準備。
本公司已採用ASC 740的規定，所得稅。根據這些原則，稅務頭寸的評估分兩步進行。本公司首先確定稅務狀況是否更有可能在審查後得以維持。如果稅務頭寸達到了更有可能確認的門檻，則對其進行衡量，以確定要在財務報表中確認的利益金額。稅收狀況是最顯著的好處，最終和解時實現的可能性超過50%。
本公司為其相關實體提交一份綜合納稅申報表。
外幣重新計量和換算
納波治療公司的功能貨幣是歐元。本公司遵循ASC 830，外幣事務(“ASC 830”)。ASC 830要求使用該外國業務的本位幣來計量該外國業務的資產、負債和業務結果。以功能貨幣以外的貨幣重新計量交易和貨幣賬戶的匯兌損益計入當期損益。
對於某些子公司，折算調整是將子公司財務報表的本位幣折算為美元報告貨幣。該等換算調整在未經審核的簡明綜合資產負債表中單獨列報並累計，作為累計其他全面損益的組成部分。
全面虧損
本公司遵循ASC 220，損益表-報告全面收益建立了在全套通用財務報表中報告和顯示全面收益及其組成部分(收入、費用、損益)的標準。
截至2024年9月30日和2023年9月30日的三個月，換算調整的其他綜合虧損為$
普通股每股基本和稀釋淨虧損
普通股每股基本淨虧損的計算方法是將該年度普通股股東應佔淨虧損除以該年度已發行普通股的加權平均數。每股攤薄淨虧損的計算方法是將本年度普通股股東應佔淨虧損除以普通股的加權平均數，其中包括假設潛在攤薄證券的攤薄效應的潛在攤薄普通股。公司採用庫存股方法計算稀釋後每股淨虧損。在公司報告淨虧損的年度，每股攤薄淨虧損與每股基本淨虧損相同，因為它們的影響對每股淨虧損的計算是反攤薄的。在截至2023年9月30日的三個月和九個月裡，該公司報告了普通股的基本淨虧損和每股攤薄虧損。普通股每股攤薄淨虧損與截至2024年9月30日的三個月和九個月普通股每股基本淨虧損相同.
最近的會計聲明
最近採用的會計聲明
分部報告
2023年11月，FASB發佈了ASU 2023-07，分部報告--對可報告分部披露的改進其通過要求每個可報告的段的更詳細的費用資訊來增強段報告來修正主題280。根據《指導意見》，公共實體必須披露(1)定期提供給首席運營決策者(CODM)的每個可報告部門的重大費用類別和金額，以及CODM如何使用報告的部門損益衡量標準來評估部門業績並決定如何分配資源(2)金額和
20
composition of other segment items included in reported segment profit or loss, and (3) the CODM’s position and title. Additionally, multiple measures of a segment’s profit or loss may be reported, under certain conditions, and single reportable segment entities must apply Topic 280 in its entirety.
The ASU requires all segment profit or loss and assets disclosures to be provided on an annual and interim basis. For each interim period, the total of the reportable segments’ amount for the measures of profit or loss is to be reconciled to the public entity's consolidated income before income taxes and discontinued operations. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company early adopted the ASU on its interim period reporting as of and for the period ended September 30, 2024.
Debt with Conversion and Other Options
In August 2020, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2020-06, titled “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity.” This update simplifies the accounting for convertible instruments by removing the requirement to separate the debt and equity components of such instruments. This ASU has no impact in the Company’s financial statements.
Recently Issued Accounting Pronouncements Not Yet Adopted
Stock Compensation
In March 2024, the FASB issued ASU 2024-01, Compensation – Stock Compensation (Topic 718): Scope Application of Profit Interest and Similar Awards. This update clarifies how companies account for profit interest and similar awards given to employees or non-employees, which helps determine whether such award fall under stock compensation or general compensation accounting standards. The amendments in this update are effective for annual periods beginning after December 15, 2025, and interim periods within those annual periods for entities other than public business entities. The Company has elected not to early adopt but will monitor the effects of the additional disclosures.
Joint Venture Formations
In August 2023, the FASB issued ASU 2023-05, Business Combinations—Joint Venture Formations (Subtopic 805-60): Recognition and Initial Measurement. This update outlines the recognition and initial measurement requirements for these joint ventures. The amendments are effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company has elected not to early adopt but will monitor the impact of the additional disclosures.
3. Fair Value Measurements
ASC 820, Fair Value Measurements, defines fair value, establishes a framework for measuring fair value under U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value under ASC 820 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following:
The following tables set forth the fair value of the Company’s financial instruments that were measured at fair value on a recurring basis as of September 30, 2024 and December 31, 2023.
21
|
|
September 30, 2024 |
|
|||||||||||||||||
|
|
(unaudited) |
|
|||||||||||||||||
(in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||||||
Iliad |
|
$ |
|
— |
|
|
$ |
|
— |
|
|
$ |
|
|
|
$ |
|
|
||
Uptown |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
||
Streeterville 2 |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
||
Streeterville Note |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
||
Total fair value |
|
$ |
|
— |
|
|
$ |
|
— |
|
|
$ |
|
|
|
$ |
|
|
||
|
|
December 31, 2023 |
|
|||||||||||||||||
(in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||||||
Iliad |
|
$ |
|
— |
|
|
$ |
|
— |
|
|
$ |
|
|
|
$ |
|
|
||
Uptown |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
||
Streeterville 2 |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
||
Streeterville Note |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
||
Total fair value |
|
$ |
|
— |
|
|
$ |
|
— |
|
|
$ |
|
|
|
$ |
|
|
||
The change in the estimated fair value of Level 3 liabilities is summarized below:
|
|
Nine Months Ended |
|
|||||||||||||||||
|
|
September 30, 2024 |
|
|||||||||||||||||
|
|
(unaudited) |
|
|||||||||||||||||
(in thousands) |
|
Iliad |
|
|
Uptown |
|
|
Streeterville 2 |
|
|
Streeterville Note |
|
||||||||
Beginning fair value of Level 3 liability |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
||||
Additions |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
Exchanges |
|
|
|
( |
) |
|
|
|
— |
|
|
|
|
( |
) |
|
|
|
— |
|
Settlements |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
Change in fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Ending fair value of Level 3 liability |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
||||
|
|
Year Ended |
|
|||||||||||||||||
|
|
December 31, |
|
|||||||||||||||||
(in thousands) |
|
Iliad |
|
|
Uptown |
|
|
Streeterville 2 |
|
|
Streeterville Note |
|
||||||||
Beginning fair value of Level 3 liability |
|
$ |
|
— |
|
|
$ |
|
— |
|
|
$ |
|
|
|
$ |
|
|
||
Additions |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Exchanges |
|
|
|
( |
) |
|
|
|
( |
) |
|
|
|
— |
|
|
|
|
— |
|
Change in fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Ending fair value of Level 3 liability |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
||||
The fair value of the Streeterville Note recognized as a Level 3 liability at the date of issuance and as of September 30, 2024, amounted to $
The Company determined and performed the valuations with the assistance of an independent valuation service provider. On a quarterly basis, the Company considers the main Level 3 inputs for hybrid instruments used derived as follows:
22
The following table summarizes the quantitative information about the significant unobservable inputs used in Level 3 fair value measurement for the Streeterville Note:
|
|
Range of Inputs |
|
|
||
|
|
(probability-weighted average) |
|
Relationship of unobservable inputs |
||
Unobservable Inputs |
|
2024 |
2023 |
to fair value |
||
Risk Adjusted Discount Rate |
|
|
|
If the discount rate is adjusted to a total of additional |
||
Sales Proceeds: Amount of comparable TDPRV |
|
$ |
|
$ |
|
If expected cash flows by Management were considered the highest amount of market indications for vouchers, FV would have decreased by $ |
Range of Probability for Timing of Cash Flows: |
|
|
|
If expected cash flows by management were considered the scenario with the least indicated value, FV would have decreased by $ |
||
For the additional notes designated at FVO that are freestanding, the Company considers only the discount rate which was determined using a comparison of various effective yields on bonds as of valuation date.
The following table summarizes the quantitative information about the significant unobservable inputs used in Level 3 fair value measurement for the remaining instruments that are not classified as hybrid instruments:
|
|
Range of Inputs |
|
|
||
|
|
(probability-weighted average) |
|
Relationship of unobservable inputs |
||
Unobservable Inputs |
|
2024 |
2023 |
to fair value |
||
Risk Adjusted Discount Rate |
|
|
|
If the discount rate is adjusted to a total of an additional |
||
Fair Value Option
The Company elected to apply the FVO accounting to certain freestanding instruments and to the entire class of hybrid instruments, including structured notes, of which there are assessed embedded derivatives that would be eligible for bifurcation, to align the measurement attributes of those instruments under U.S. GAAP and to simplify the accounting model applied to these financial instruments.
The valuations of these instruments were predominantly driven by the discount rate and the derivative features embedded within the instruments. The Company determined and performed the valuations of the freestanding and hybrid instruments with the assistance of an independent valuation service provider. The valuation methodology utilized is consistent with the income approach for estimating the fair value of the interest-bearing portion of the instruments and the related derivatives. Cash flows of the financial instruments in their entirety, including the embedded derivatives, are discounted at an appropriate rate for the applicable duration of the instrument. Interests on the interest-bearing portion of the instruments held to maturity and mark-to-market adjustments are aggregated in the change in fair value of freestanding and hybrid financial instruments designated at FVO in the unaudited condensed consolidated statements of operations. As of September 30, 2024 and December 31, 2023, the Company did not note any fair value movement on FVO liabilities attributable to any instrument-specific credit risk, which should be recorded in other comprehensive income (loss).
23
The following tables summarize the fair value and outstanding balance for items the Company accounts for under FVO:
(in thousands) |
|
Fair value |
|
|
Unpaid Principal Balance |
|
|
Accrued Interest |
|
|
Fair Value Over (Under) Outstanding Balance |
|
||||||||
At September 30, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Iliad |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
( |
) |
|||
Uptown |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Streeterville 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Streeterville Note |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(in thousands) |
|
Fair value |
|
|
Unpaid Principal Balance |
|
|
Accrued Interest |
|
|
Fair Value Over (Under) Outstanding Balance |
|
||||||||
At December 31, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Iliad |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
( |
) |
|||
Uptown |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Streeterville 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Streeterville Note |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
4. Balance Sheet Components
Inventory
Inventory at September 30, 2024 and December 31, 2023 consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
2024 |
|
|
2023 |
|
||||
(in thousands) |
|
(unaudited) |
|
|
|
|
||||
Raw material |
|
$ |
|
|
|
$ |
|
|
||
Work in process |
|
|
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
|
|
||
Inventory |
|
$ |
|
|
|
$ |
|
|
||
Prelaunch Inventory
Costs capitalized for the Company’s lyophilized drug amounting to $
Property and Equipment, net
Property and equipment, net at September 30, 2024 and December 31, 2023, consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
2024 |
|
|
2023 |
|
||||
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|||
Land |
|
$ |
|
|
|
$ |
|
|
||
Lab equipment |
|
|
|
|
|
|
|
|
||
Software |
|
|
|
|
|
|
|
|
||
Furniture and fixtures |
|
|
|
|
|
|
|
|
||
Computers and peripherals |
|
|
|
|
|
|
|
|
||
Total property and equipment at cost |
|
|
|
|
|
|
|
|
||
Accumulated depreciation |
|
|
|
( |
) |
|
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
|
$ |
|
|
||
Depreciation and amortization expenses were $
24
Depreciation and amortization expenses were $
Intangible Assets, net
Intangible assets consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
2024 |
|
|
2023 |
|
||||
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|||
Developed technology |
|
$ |
|
|
|
$ |
|
|
||
Accumulated developed technology amortization |
|
|
|
( |
) |
|
|
|
( |
) |
Developed technology, net |
|
|
|
|
|
|
|
|
||
In-process research and development |
|
|
|
|
|
|
|
|
||
In process research and development, net |
|
|
|
|
|
|
|
|
||
Trademarks |
|
|
|
|
|
|
|
|
||
Accumulated trademark amortization |
|
|
|
( |
) |
|
|
|
( |
) |
Trademarks, net |
|
|
|
|
|
|
|
|
||
Internal use software costs - registry |
|
|
|
|
|
|
|
|
||
Accumulated internal use software costs impairment |
|
|
|
( |
) |
|
|
|
( |
) |
Accumulated internal use software costs amortization |
|
|
|
( |
) |
|
|
|
( |
) |
Internal use software costs - registry, net |
|
|
|
|
|
|
|
|
||
Patents |
|
|
|
|
|
|
|
|
||
Accumulated patents amortization |
|
|
|
( |
) |
|
|
|
( |
) |
Patents, net |
|
|
|
|
|
|
|
|
||
License |
|
|
|
|
|
|
|
— |
|
|
Accumulated license amortization |
|
|
|
— |
|
|
|
|
— |
|
License, net |
|
|
|
|
|
|
|
— |
|
|
Total intangible assets, net |
|
$ |
|
|
|
$ |
|
|
||
Amortization expense of finite-lived intangible assets was $
The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of September 30, 2024:
(in thousands) |
|
|
Amounts |
|
|
Remainder of 2024 |
|
$ |
|
|
|
2025 |
|
|
|
|
|
2026 |
|
|
|
|
|
2027 |
|
|
|
|
|
2028 |
|
|
|
|
|
Thereafter |
|
|
|
|
|
|
|
$ |
|
|
|
5. Related Party Transactions
Board of Directors (“BOD”) Cash Compensation
The Company makes BOD cash compensation quarterly based on the Director Compensation Program. For the three months ended September 30, 2024 and 2023, the Company paid its directors approximately $
25
6. Commitments and Contingencies
Commitments
Leases
On April 6, 2021, the Company entered into an office lease agreement of approximately
The base rent under the lease office was $
On October 7, 2021, the Company entered an agreement for the lease of office premises from November 1, 2021, to April 30, 2022, subject to automatic renewal for subsequent periods until terminated by either party. Base rent amounted to €
On October 25, 2023, the Company entered a second amendment to extend the lease of the office premises whereby Suite 600 shall extend until February 28, 2025, while Suite 400 shall be accounted for as a separate lease commencing on September 1, 2023, and expiring on August 31, 2030. Under the second lease amendment, the office lease premises were remeasured separately, with Suite 400 measuring approximately
On October 10, 2021, the Company also entered a short-term office lease in Milan, Italy. The term of the lease began on November 1, 2021, subject to automatic renewal equal to the present term until terminated by mutual agreement. On January 26, 2022, the lease agreement was amended, whereby the term was extended by
On December 8, 2023, the Company entered a
On December 22, 2021, the Company entered an agreement for the lease of
On January 25, 2022, the Company entered an agreement for the lease of office premises from March 1, 2022, to December 31, 2023, subject to automatic renewal for subsequent periods until terminated by either party. Base rent amounted to €
26
increased in line with the index of relevant inflation at each annual expiration of the contract's start date. The lessor has the right to decline the renewal of the contracts. Upon the happening of certain specified events, the lessor may immediately withdraw from the contracts. The Company is required to leave the occupied spaces immediately in the same conditions in which they were found in the event of contract termination or expiry. The Company paid a deposit of €
In May 2022, the Company entered an agreement for the lease of
In October 2022, the Company entered an agreement for the lease of
In November 2022, the Company entered an agreement for the lease of
The table below provides additional details of the office space and vehicle leases presented in the unaudited condensed consolidated balance sheet as of September 30, 2024, and December 31, 2023:
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
2024 |
|
|
2023 |
|
||||
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|||
Operating lease - right-of-use asset - office space |
|
|
|
|
|
|
|
|
||
Operating lease - right-of-use asset - vehicles |
|
|
|
|
|
|
|
|
||
Total |
|
$ |
|
|
|
$ |
|
|
||
|
|
|
|
|
|
|
|
|
||
Weighted-average remaining life (years) |
|
|
|
|
|
|
|
|
||
Weighted-average discount rate |
|
|
|
% |
|
|
|
% |
||
Lease costs included in general and administrative expenses in the unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2024, were approximately $
For the nine months ended September 30, 2024 and 2023, respectively, cash paid for operating lease liabilities recognized under operating cash flows amounted to $
Non-cash investing and financing activities for the nine months ended September 30, 2024 and 2023, including addition to right-of-use assets obtained from new and modified operating liabilities, amount to $
27
The following table summarizes the undiscounted cash payment obligations for operating lease liability as of September 30, 2024 and December 31, 2023.
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
2024 |
|
|
2023 |
|
||||
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|||
2024 |
|
$ |
|
|
|
$ |
|
|
||
2025 |
|
|
|
|
|
|
|
|
||
2026 |
|
|
|
|
|
|
|
|
||
2027 |
|
|
|
|
|
|
|
|
||
2028 |
|
|
|
|
|
|
|
|
||
2029 |
|
|
|
|
|
|
|
|
||
2030 |
|
|
|
— |
|
|
|
|
|
|
Total undiscounted operating lease payments |
|
|
|
|
|
|
|
|
||
Imputed interest expenses |
|
|
|
( |
) |
|
|
|
( |
) |
Total operating lease liability |
|
|
|
|
|
|
|
|
||
Less: Operating lease liability, current |
|
|
|
|
|
|
|
|
||
Operating lease liability, net of current portion |
|
$ |
|
|
|
$ |
|
|
||
Purchase Commitment
On September 3, 2020, the Company entered into a manufacturing and supply agreement (the “Agreement”) with Glenmark Life Sciences Limited (“Glenmark”), pursuant to which Glenmark will continue to serve as the Company’s manufacturer of crofelemer for use in Mytesi, the Company’s human prescription drug product approved by the FDA, and for other crofelemer-based products manufactured by the Company or its affiliates for human or animal use. The term of the Agreement is approximately
Master Services Agreement
On October 5, 2020, the Company entered into an MSA for clinical research organization services (the “2020 MSA”) and a service order under such 2020 MSA with Integrium, LLC (“Integrium”). The service order covers the Company’s upcoming pivotal Phase 3 clinical trial for cancer-therapy-related diarrhea. As consideration for its services, the Company would pay Integrium a total amount of up to approximately $
Asset Transfer and Transition Commitment
On September 25, 2017, the Company entered into the Termination, Asset Transfer, and Transition Agreement with Glenmark dated September 22, 2017. As a result of the agreement, the Company now controls commercial rights for Mytesi for all indications, territories, and patient populations globally and also holds commercial rights to the existing regulatory approvals for crofelemer in Brazil, Ecuador, Zimbabwe, and Botswana. In exchange, the Company agrees to pay Glenmark
28
Revenue Sharing Commitment Update
On December 14, 2017, the Company announced its entry into a collaboration agreement with Seed Mena Businessmen Services LLC (“SEED”) for Equilevia™, the Company's non-prescription, personalized, premium product for total gut health in equine athletes. According to the terms of the Agreement, the Company will pay SEED
Joint Venture - Magdalena Biosciences, Inc.
In January 2023, Jaguar and Filament Health (“Filament”), with Funding from One Small Planet, formed the U.S.-based joint venture Magdalena Biosciences, Inc. (“Magdalena”). Magdalena’s focus is on the development of novel, natural prescription medicines derived from plants for mental health indications, including, initially, attention-deficit/hyperactivity disorder (“ADHD”) in adults. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders and to partner with a potential future licensee to develop and commercialize these novel plant-based drugs. This venture aligns with Jaguar's mental health Entheogen Therapeutics Initiative (“ETI”) and Filament's corporate mission to develop novel, natural prescription medicines from plants. Magdalena will leverage Jaguar's proprietary medicinal plant library and Filament's proprietary drug development technology. Jaguar’s library of
The Company accounted for its
|
|
Nine Months Ended |
|
||
|
|
September 30, |
|
||
|
|
2024 |
|
||
(in thousands) |
|
(unaudited) |
|
||
Revenue |
|
$ |
|
|
|
Operating expenses |
|
|
|
( |
) |
Loss before income tax |
|
|
|
( |
) |
Income tax expense |
|
|
|
|
|
Net loss |
|
$ |
|
( |
) |
Net loss attributable to the Company |
|
$ |
|
( |
) |
Securities Purchase and Licensing Agreement
On March 18, 2024, the Company entered into a privately negotiated securities purchase agreement with Gen Ilac Ve Saglik Urunleri Sanayi Ve Ticaret, A.S., ("Gen") pursuant to which the Company issued
The Company determined that the issuance of shares and the license grant should be accounted for as a single arrangement under ASC 606. The fair value of the common stock issued was excluded from the consideration allocated to the revenue unit of account following the separation and initial measurement requirements. The deferred revenue amounting to $
April 2024 Agreement for Gelclair
On April 12, 2024, the Company entered into an exclusive
29
510(k) cleared oral mucositis prescription product, Gelclair for the U.S. market. The agreement grants the Company the exclusive rights to market Venture Life's FDA-approved oral mucositis prescription product, Gelclair, within the U.S. market. The agreement will automatically be renewed for an additional five-year term, totaling ten years, if the Company meets all Minimum Purchase Obligations (“MPOs”) and minimum net sales obligations.
The Company paid a non-refundable license fee of €
The Company commenced the commercial launch of Gelclair in October 2024. Consequently,
Contingencies
From time to time, the Company may become a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value) to adequately address any liabilities related to legal proceedings and other loss contingencies. A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision. The Company did not have any material accruals for any currently active legal action in its unaudited condensed consolidated balance sheets as of September 30, 2024, as the Company could not predict the ultimate outcome of these matters or reasonably estimate the potential exposure.
7. Debt
Notes payable at September 30, 2024 and December 31, 2023 consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
2024 |
|
|
2023 |
|
||||
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|||
Notes designated at Fair Value Option |
|
$ |
|
|
|
$ |
|
|
||
Insurance Financing |
|
|
|
|
|
|
|
|
||
Tempesta Note |
|
|
|
|
|
|
|
|
||
Royalty Interest* |
|
|
|
— |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
||
Less: Unamortized discount and debt issuance costs |
|
|
|
— |
|
|
|
|
( |
) |
Note payable, net of discount |
|
$ |
|
|
|
$ |
|
|
||
Notes payable - non-current, net |
|
$ |
|
|
|
$ |
|
|
||
Notes payable - current, net |
|
$ |
|
|
|
$ |
|
|
||
|
|
|
|
|
|
|
|
|
||
Weighted average interest rate on short-term borrowings |
|
|
|
% |
|
|
|
% |
||
*Notes with royalty interest not designated at FVO.
The Company paid $
All notes payable not designated at FVO are expected to mature in 2026. Future maturities are based on contractual minimum payments. The timing of maturities may fluctuate based on future revenue.
Sale of Future Royalty Interest
October 2020 Purchase Agreement
On October 8, 2020, the Company entered into a royalty interest purchase agreement (the “October 2020 Purchase Agreement”) with Iliad Research and Trading, L.P. (“Iliad”), pursuant to which the Company sold to Iliad a royalty interest entitling Iliad to receive $
30
Until the Royalty Repayment Amount has been paid in full, the Company will pay Iliad
The Royalty Interest amount of $
Pursuant to the October 2020 Purchase Agreement, if the weekly volume weighted average price (“VWAP”) of the Company’s common stock is not equal to or greater than the minimum VWAP of $
The company entered into several exchange agreements from April 13, 2021, to March 9, 2022, whereby the Company agreed to partition $
On April 14, 2022, the Company entered into amendments (the “Royalty Interest Global Amendments”) to its existing royalty interests, including the Royalty Interest in the original principal amount of $
The Company entered into several exchange agreements after the Royalty Interest Global Amendments from May 13, 2022, to November 18, 2022, whereby the Company agreed to partition $
On March 17 and 23, 2023, the Company entered into another exchange agreement with Iliad, pursuant to which the parties agreed to partition $
The exchanges that occurred within the 12 months before the May 13, 2022 exchange were previously accounted for as extinguishment; therefore, cumulative assessment was no longer performed.
31
On May 8, 2023, the Company entered into a standstill agreement (as amended, the “Standstill Agreement”) with Iliad, Uptown Capital, LLC (f/k/a Irving Park Capital, LLC) (“Uptown”) and Streeterville Capital, LLC (“Streeterville”, and together with Iliad and Uptown, collectively, “Investor”) to allow the Company to refrain from making royalty payments with respect to
On June 28, 2023, the Company entered into the first amendment to the Standstill Agreement, pursuant to which the Standstill Agreement was amended to, among other things, permit (i) the Company to issue an aggregate of
On June 30, 2023, the Company entered into a binding memorandum of understanding (the “Binding MOU”) with the Investor to modify the allocation of the warrants as set forth in the Standstill Agreement such that the Company issued (i) Iliad warrants to purchase up to
On August 14, 2023, the Company entered into an amendment (“the Second Amendment”) to the Standstill Agreement with Iliad and Uptown (together, “Standstill Investor”) to (i) permit the Company to offer and sell securities without triggering the termination of the Standstill Period, and (ii) remove the restriction on Standstill Investor’s ability to buy, sell, or otherwise trade in shares of the Company’s common stock during the Standstill Period.
On September 29, 2023, the Company entered into the Global Amendment No. 2 to the October 2020 Royalty Interest with Iliad, pursuant to which, beginning on January 1, 2026, the monthly Royalty Payment under the October 2020 Royalty Interest shall be the greater of (a) $
The cumulative effect of the exchanges to the October 2020 Royalty Interest resulted in significant modifications and was accounted for as extinguishment. The Company recorded an extinguishment gain in the unaudited condensed consolidated statements of operations amounting to $
The Company irrevocably elected to initially and subsequently apply the FVO accounting to the entire royalty interest. The Company used the valuation report from an independent valuation service provided to measure the reporting date fair value of the royalty interest.
On December 28, 2023, the Company entered into a privately negotiated exchange agreement with Iliad, pursuant to which the Company issued an aggregate of
On January 29, 2024, the Company entered into a privately negotiated exchange agreement with Iliad pursuant to which the Company issued an aggregate of
32
On June 7, 2024, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $
On July 15, 2024, the Company entered into a privately negotiated exchange agreement with Iliad pursuant to which the Company issued an aggregate of
On July 18, 2024, the Company entered into a privately negotiated exchange agreement with Iliad pursuant to which the Company issued an aggregate of
On September 30, 2024 and December 31, 2023, the fair value of Iliad's royalty interests was determined to be $
December 2020 Purchase Agreement
On December 22, 2020, the Company entered into a royalty interest purchase agreement (the “December 2020 Purchase Agreement”) with Uptown Capital, LLC(f/k/a Irving Park Capital, LLC) (“Uptown”), a company affiliated with CVP, pursuant to which the Company sold to Uptown a royalty interest entitling Uptown to receive $
Until such time as the Royalty Repayment Amount has been paid in full, the Company will pay Uptown
At initial recognition, the December 2020 Royalty Interest amount of $
On April 14, 2022, under the Royalty Interest Global Amendments, the Company was granted, at its sole discretion, the right to exchange, from time to time, all or any of the Royalty Interest under the original principal amount of $
On February 8, 2023, the Company entered into an exchange agreement with Uptown, pursuant to which the parties agreed to partition $
On May 8, 2023, the Company entered into an exchange agreement with Uptown to (i) partition a new royalty interest in the royalty repayment amount of $
On the same date, the Company entered into the Standstill Agreement as described above, pursuant to which the Company may refrain from making royalty payments on the December 2020 Royalty Interest during the Standstill Period.
On September 29, 2023, the Company entered into the Global Amendment No. 2 to the December 2020 Royalty Interest with Uptown, pursuant to which, beginning on January 1, 2026, the monthly Royalty Payment under the December 2020 Royalty Interest shall be the greater of (a) $
33
the terms of the December 2020 Royalty Interest. As a material consideration for Uptown’s agreement to enter into this amendment, the Company agreed to issue to Uptown warrants to purchase up to
On the same date, the Company entered into a privately negotiated exchange agreement with Uptown (the “Exchange Agreement”), pursuant to which the Company issued an aggregate of
The cumulative effect of the exchanges to the December 2020 Royalty Interest resulted in significant modifications and was accounted for as extinguishment. The Company recorded an extinguishment gain in the unaudited condensed consolidated statements of operations amounting to $
The Company irrevocably elected to initially and subsequently apply the FVO accounting to the entire royalty interest. The Company used the valuation report from an independent valuation service provided to measure the reporting date fair value of the royalty interest.
On September 30, 2024 and December 31, 2023, the fair value of Uptown's royalty interests was determined to be $
March 2021 Purchase Agreement
On March 8, 2021, the Company entered into a purchase agreement (the “March 2021 Purchase Agreement”) with Streeterville Capital, LLC (“Streeterville”), a company affiliated with CVP, pursuant to which the Company sold a royalty interest entitling Streeterville to $
The Company will be obligated to make minimum royalty payments on a monthly basis beginning at the earlier of (a) 36 months following the closing date or (b)
At initial recognition, the March 2021 Royalty Interest amount of $
34
On April 14, 2022, under the Royalty Interest Global Amendments, the Company is granted, at its sole discretion, the right to exchange, from time to time, all or any of the Royalty Interest under the original principal amount of $
The Company entered into several exchange agreements after the Royalty Interest Global Amendments from August 17, 2022, to September 30, 2022, whereby the Company agreed to partition $
On March 1, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued an aggregate of
The exchanges of Series J Preferred Stock were accounted for as extinguishment. Because the fair value of the common stock transferred is less than the carrying amount of the Series J Preferred Stock surrendered, the difference was credited to retained earnings and added to earnings available to common shareholders.
Interest expenses were $
August 2022 Purchase Agreement
On August 24, 2022, the Company entered into another royalty interest purchase agreement (the “August 2022 Purchase Agreement”) with Streeterville, pursuant to which the Company sold Streeterville a royalty interest to receive $
The Company will be obligated to make minimum royalty payments on a monthly basis beginning on January 1, 2024 in an amount equal to the greater of (A) $
Pursuant to the terms of the August 2022 Royalty Interest, the Company has the right to exchange from time to time at the Company’s sole discretion all or any portion of the Royalty Interest for shares of common stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of the date of the applicable exchange. At issuance, based on projected cash outflows from future revenue streams, the discount rate was
On September 29, 2023, the Company entered into a Global Amendment No. 2 (the “Global Amendment”) with the Investor as described further above, such that the Company issued Streeterville warrants to purchase
35
per share. Such warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on September 29, 2023 (the “Issuance Date”) and ending on the
The cumulative effect of the exchanges to the August 2022 Royalty Interest resulted in significant modifications, which were accounted for as extinguishment. The Company recorded an extinguishment loss in the unaudited condensed consolidated statements of operations amounting to $
The Company irrevocably elected to initially and subsequently apply the FVO accounting to the entire royalty interest. The Company used the valuation report from an independent valuation service provided to measure the reporting date fair value of the royalty interest.
On January 29, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville pursuant to which the Company issued
On September 30, 2024 and December 31, 2023, the fair value of Streeterville's royalty interests was determined to be $
Streeterville Note
On January 13, 2021, the Company issued a secured promissory note to Streeterville in the original principal amount of $
At any time following the occurrence of a trial failure which refers to any of the following: (i) the Company abandons the clinical trial with NP-300 for an indication for the symptomatic relief of infectious diarrhea for cholera; (ii) the Company fails to start the Phase 1 clinical trial of NP-300 for the symptomatic relief of infectious diarrhea for cholera by July 1, 2022; or (iii) the Company fails to meet all primary endpoints in the pivotal trials of NP-300 for the symptomatic relief if infectious diarrhea for cholera with statistical significance, Streeterville may elect to increase the outstanding balance as of the date of the trial failure by
Streeterville is entitled to a maximum of
Beginning on the earlier of (a)
After Streeterville becomes aware of the occurrence of any default, Streeterville may accelerate the note, with the outstanding balance becoming immediately due and payable in cash at the Mandatory Default Amount (i.e., the outstanding balance following the application of the Default Effect). Streeterville reserves the right to declare the outstanding balance immediately due and payable at
36
any time following the default. Default Effect means multiplying the outstanding balance as of the date of default by
In connection with the note issuance, the Company has entered into a security agreement with Streeterville, pursuant to which Streeterville will receive a first priority security interest in all existing and future NP-300 technology and any TDPRV and the sale proceeds therefrom that may be granted to the Company by the FDA in connection with the development of NP-300 for the cholera indication. The Company also agreed, with certain exceptions, not to grant any lien on any of the collateral securing the note and not to grant any license under any of the intellectual property relating to such collateral. The grant of security interest has become effective upon the receipt of the Salix Waiver on April 6, 2021, in observance of the requirement of the settlement agreement previously entered by the Company with Salix Pharmaceuticals, Inc.
The Company irrevocably elected to initially and subsequently apply the FVO accounting to the entire note. The fair value at the transaction date was equal to the cash proceeds received of $
On September 30, 2024 and December 31, 2023, the fair value of the Streeterville note was determined to be $
Insurance Financing
May 2023 First Insurance Financing
In May 2023, the Company entered into a premium finance agreement for $
March 2024 First Insurance Financing
In March 2024, the Company entered into a premium finance agreement for $
May 2024 First Insurance Financing
In May 2024, the Company entered into a premium finance agreement for $
2019 Tempesta Note
In October 2019, the Company entered into a License Termination and Settlement Agreement with Dr. Michael Tempesta, pursuant to which certain royalty payment disputes between the Company and Tempesta were settled. Per the terms of the Agreement, Tempesta received $
37
interest beginning on March 1, 2020, until the Note is paid in full. Interest expense for the three and nine months ended September 30, 2024, was $
8. Warrants
The following table summarizes information about warrants outstanding and exercisable into shares of the Company’s common stock as of September 30, 2024, and December 31, 2023:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
|
|
(unaudited) |
|
|
|
|
||
Warrants outstanding, beginning balance |
|
|
|
|
|
|
||
Issuances |
|
|
— |
|
|
|
|
|
Exercises |
|
|
( |
) |
|
|
— |
|
Expirations and cancelations |
|
|
( |
) |
|
|
— |
|
Warrants outstanding, ending balance |
|
|
|
|
|
|
||
As of September 30, 2024 and 2023, the Company’s outstanding warrants have an exercise price ranging from $
PIPE Warrants
On May 8, 2023, the Company entered into a Securities Purchase Agreement (the “PIPE Purchase Agreement”) with certain investors named therein (collectively, the “Purchasers”), pursuant to which the Company agreed to issue and sell to the Purchasers in a private placement an aggregate of (i)
The PIPE Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on the later of (i) January 1, 2024, and (ii) the date on which the approval by the Company’s stockholders (the “Stockholder Approval”) to remove both the Voting Cap and the Conversion Cap (both as defined below) is obtained (the “PIPE Warrants Initial Exercise Date”) and ending on the anniversary of the PIPE Warrants Initial Exercise Date.
On May 10, 2023, the Company issued warrants equivalent to
The PIPE Purchase Agreement provides that during the period commencing on the signing of the PIPE Purchase Agreement and ending October 22, 2023, the Company will not affect or enter into any agreement to (i) issue securities in exchange for any securities of the Company issued and outstanding on the date of the PIPE Purchase Agreement pursuant to Section 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”), or (ii) effect issuance by the Company of common stock or Common Stock Equivalents (as defined in the PIPE Purchase Agreement), subject to certain customary exceptions set forth in the PIPE Purchase Agreement including, among others, issuance of shares of common stock pursuant to the At The Market Offering Agreement, dated December 10, 2021, by and between the Company and Ladenburg Thalmann & Co. Inc., as amended (the “Ladenburg Thalmann ATM”), provided that such issuance in the Ladenburg Thalmann ATM has consented.
On August 14, 2023, the Company entered into an amendment (“the First Amendment”) to the PIPE Purchase Agreement with certain holders (the “Holders”) named in the PIPE Purchase Agreement, pursuant to which the parties agreed to terminate the restriction on subsequent equity sales by the Company. In exchange for the Holders’ agreement to enter into the First Amendment, the Company agreed to issue the Holders warrants to purchase
38
At the date of the PIPE Amendment Warrants, the warrants were valued at $
On February 27, 2024, pursuant to the PIPE Purchase Agreement, each of the PIPE investors entered into an exchange agreement with the Company (each, a “PIPE Warrant Exchange Agreement” and collectively, the “PIPE Warrant Exchange Agreements”). Pursuant to the PIPE Warrant Exchange Agreements, the Company agreed to exchange the PIPE Warrants for shares of common stock at an exchange ratio of
On February 29, 2024, the PIPE investors converted
Standstill Agreement
Pursuant to the Company’s entry in the Standstill Agreement, as amended by the Binding MOU, as described further above, the Company agreed to issue (i) Iliad warrants to purchase up to
The Standstill Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on the later of (i) January 1, 2024, and (ii) the date on which the Stockholder Approval is obtained (the “Standstill Warrant Initial Exercise Date”) and ending on the
At the date of the Standstill Agreement, the warrants were valued at $
Royalty Interest Global Amendments
On September 29, 2023, the Company entered into amendments Royalty Interest Global Amendments to (i) the October 2020 Royalty Interest with Iliad, (ii) the December 2020 Royalty Interest with Uptown, and (iii) the August 2022 Royalty Interest with Streeterville, pursuant to which, among other things, the Company agreed to issue to (i) Iliad warrants to purchase up to
The Royalty Interest Global Amendment Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on September 29, 2023 (the “Royalty Interest Global Amendment Initial Exercise Date”) and ending on the
At the date of the Royalty Interest Global Amendments, the warrants were valued at $
39
9. Preferred Stock
As at September 30, 2024 and December 31, 2023, preferred stock consisted of the following:
September 30, 2024 |
|
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Liquidation |
|
|||||
(in thousands, except share and per share data) |
|
Shares |
|
|
Issued and |
|
|
Carrying |
|
|
Preference |
|
||||||
Series |
|
Designated |
|
|
Outstanding |
|
|
Value |
|
|
per Share |
|
||||||
A |
|
|
|
|
|
|
|
$ |
|
— |
|
|
$ |
|
— |
|
||
B |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
B-1 |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
B-2 |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
C |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
D |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
E |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
F |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
G |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
H |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
I |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
J |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
Total |
|
|
|
|
|
|
|
$ |
|
— |
|
|
$ |
|
— |
|
||
December 31, 2023 |
|
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Liquidation |
|
|||||
(in thousands, except share and per share data) |
|
Shares |
|
|
Issued and |
|
|
Carrying |
|
|
Preference |
|
||||||
Series |
|
Designated |
|
|
Outstanding |
|
|
Value |
|
|
per Share |
|
||||||
A |
|
|
|
|
|
|
|
$ |
|
— |
|
|
$ |
|
— |
|
||
B |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
B-1 |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
B-2 |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
C |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
D |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
E |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
F |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
G |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
H |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
I |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
Total |
|
|
|
|
|
|
|
$ |
|
— |
|
|
$ |
|
— |
|
||
The Company is authorized to issue a total of
Series G Preferred Stock
On May 8, 2023, the Company entered into a securities purchase agreement with certain investors, pursuant to which the Company agreed to issue to such investors (i)
On February 29, 2024, the PIPE investors converted
Series H Preferred Stock
On June 28, 2023, the Company entered into privately negotiated exchange agreements with Uptown and Streeterville, under which the Company issued
40
reduction in the outstanding balance of the December 2020 Royalty Interest and a $
Series I Preferred Stock
On September 29, 2023, the Company entered into a privately negotiated exchange agreement with Uptown, pursuant to which the Company issued an aggregate of
On January 15, 2024, Uptown converted
10. Temporary Equity
On March 1, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued an aggregate of
The Company determined that the nature of the Series J Preferred Stock host was more analogous to a debt instrument and that the economic characteristics and risks of the embedded redemption features were clearly and closely related to the Series J Preferred Stock host. As such, the redemption features were not required to be bifurcated under ASC 815, Derivatives and Hedging. Since the Series J Preferred Stock is redeemable in certain circumstances upon the occurrence of an event that is not solely within the Company’s control, they have been classified as mezzanine equity in the condensed consolidated balance sheets.
On March 5, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued
On March 19, 2024, the Company entered into another privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued
As of September 30, 2024 and December 31, 2023, the Company had
11. Stockholders' Equity
As of September 30, 2024 and December 31, 2023, the Company had reserved shares of common stock, on an as-if converted basis, for issuance as follows:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
|
|
(unaudited) |
|
|
|
|
||
Options issued and outstanding |
|
|
|
|
|
|
||
Inducement options issued and outstanding |
|
|
|
|
|
|
||
Options available for grant under stock option plans |
|
|
|
|
|
|
||
Restricted stock unit awards issued and outstanding |
|
|
|
|
|
|
||
Warrants issued and outstanding |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
41
Common Stock
The holders of common stock are entitled to
The holders of non-voting common stock are not entitled to vote, except on an as-converted basis with respect to any change of control of the Company that is submitted to the stockholders of the Company for approval. Shares of the Company's non-voting common stock have the same rights to dividends and other distributions and are convertible into shares of the Company's common stock on a
At a special meeting of stockholders of Jaguar Health, Inc. held on September 30, 2022 to effect an increase in the number of authorized shares of the Company’s voting common stock, par value $
The Company is now authorized to issue a total number of
Reverse Stock Split
On May 17, 2024, the Company approved an eighth amendment to the Company’s Third Amended and Restated Certificate of Incorporation to effect a -for-60 reverse stock split of the Company’s issued and outstanding shares of voting common stock, effective May 23, 2024.
The reverse stock split reduces the number of shares of common stock issuable upon the conversion of the Company’s outstanding non-voting common stock and the exercise or vesting of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and causes a proportionate increase in the conversion and exercise prices of such non-voting common stock, stock options, and warrants. In addition, the number of shares reserved for issuance under the Company’s equity compensation plans immediately prior to the effective time will be reduced proportionately. The reverse stock split did not change the total number of authorized shares of common stock or preferred stock. All share and per share amounts of the Company’s common stock, as well as stock options and restricted stock units (“RSUs”), included in the accompanying condensed consolidated financial statements have been retroactively adjusted to give effect to the reverse stock split for all periods presented, unless indicated otherwise.
At the Market Offering (“ATM”)
December 2021 ATM Agreement
On December 10, 2021, the Company entered into an ATM Agreement (as amended, the “December 2021 ATM Agreement”) with Ladenburg, pursuant to which the Company may offer and sell, from time to time through Ladenburg, shares of common stock having an aggregate offering price of up to $
On February 2, 2022, the Company entered into an amendment to the December 2021 ATM Agreement, pursuant to which, the aggregate offering amount of the shares of the Company’s common stock which the Company may sell and issue through Ladenburg, as the sales agent, was increased from $
On May 17, 2024, the Company entered into an amendment to the December 2021 ATM Agreement, pursuant to the February 2, 2022 amendment, the previous $
On July 17, 2024, the Company entered into an amendment to the December 2021 ATM Agreement with Ladenburg and Lucid Capital Markets, LLC (“Lucid”). Pursuant to the July 17, 2024 amendment, Lucid was added as a party and manager under the agreement, effective beginning July 17, 2024 and ending on September 30, 2024, unless extended by the parties to the agreement. If not amended or extended prior to September 30, 2024, then after such date Ladenburg will be the sole manager, and Lucid will no longer be a manager under the agreement. The agreement was not amended nor extended as of September 30, 2024.
42
During the nine months ended September 30, 2024, the Company issued an aggregate of
Noncontrolling Interest
As a result of the merger on November 3, 2021 between Napo EU and Dragon SPAC, the Company assumed a noncontrolling interest amounting to $
During the three and nine months ended September 30, 2024, noncontrolling interest decreased by $
12. Stock-based Compensation
2013 Equity Incentive Plan
In November 2013, the Company's BOD and sole stockholder adopted the Jaguar Health, Inc. 2013 Equity Incentive Plan (the “2013 Plan”). The 2013 Plan allows the Company's BOD to grant stock options, restricted stock awards, and RSUs to employees, officers, directors, and consultants. Following the effective date of the Initial Public Offering (“IPO”) and after the effectiveness of any grants under the 2013 Plan contingent on the IPO,
2014 Stock Incentive Plan
Effective May 12, 2015, the Company adopted the Jaguar Health, Inc. 2014 Stock Incentive Plan (“2014 Plan”). The 2014 Plan provides options, restricted stock, and RSUs to eligible employees, directors, and consultants to purchase the Company's common stock. The term of an incentive stock option may not exceed
On April 13, 2022, the BOD of the Company approved a Registration Statement to register an additional
As of September 30, 2024,
2020 New Employee Inducement Award Plan
Effective June 16, 2020, the Company adopted the Jaguar Health, Inc. New Employee Inducement Award Plan (“2020 Inducement Award Plan”) and, subject to the adjustment provisions of the Inducement Award Plan, reserved
On April 13, 2022, the BOD of the Company approved an amendment to the 2020 Inducement Award Plan to reserve an additional
43
On May 15, 2023, the BOD of the Company approved an amendment to the 2020 Inducement Award Plan to reserve an additional
On August 13, 2024, the BOD of the Company approved an amendment to the 2020 Inducement Award Plan to reserve an additional
As of September 30, 2024,
Stock Options and Restricted Stock Units (“RSUs”)
The following table summarizes the incentive plan activity for the nine months ended September 30, 2024, and the year ended December 31, 2023:
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|||||||
|
|
Shares |
|
|
Stock |
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
||||||||
|
|
Available |
|
|
Options |
|
|
RSUs |
|
|
Stock Option |
|
|
Contractual Life |
|
|
Intrinsic |
|
||||||||
(in thousands, except share and per share data) |
|
for Grant |
|
|
Outstanding |
|
|
Outstanding |
|
|
Exercise Price |
|
|
(Years) |
|
|
Value* |
|
||||||||
Outstanding at January 1, 2023 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
$ |
|
— |
|
|||||
Additional shares authorized |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
Options granted |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
Options exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
Options canceled |
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
RSUs granted |
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
RSUs vested and released |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
RSUs cancelled |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
Outstanding at December 31, 2023 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
$ |
|
— |
|
|||||
Additional shares authorized |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
Options granted |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
Options exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
Options canceled |
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
— |
|
||
RSUs granted |
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
RSUs exercised |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
RSUs cancelled |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
Outstanding at September 30, 2024 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
$ |
|
— |
|
|||||
Exercisable at September 30, 2024 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
$ |
|
— |
|
|||||
Vested and expected to vest at September 30, 2024 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
$ |
|
— |
|
|||||
* The fair market value of Jaguar stock on September 30, 2024, was $
The intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the Company's common stock for in-the-money options.
The number of options exercised during the nine months ended September 30, 2024, and the year ended December 31, 2023, were
The weighted average grant date fair value of stock options granted was dollar per share during the nine months ended September 30, 2024, for the year ended December 31, 2023.
The number of options that were vested for the nine months ended September 30, 2024, and for the year ended December 31, 2023, was
44
Stock-Based Compensation
The following table summarizes stock-based compensation expenses related to stock options, inducement stock options, and RSUs for the three and nine months ended September 30, 2024 and 2023, and are included in the unaudited condensed consolidated statements of operations as follows:
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
||||||||||||||
|
|
September 30, |
|
|
September 30, |
|
|
||||||||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
||||||||
|
|
(unaudited) |
|
|
(unaudited) |
|
|
||||||||||||||
Research and development expense |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
||||
Sales and marketing expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
||||
As of September 30, 2024, the Company had
No range of assumptions was set forth and used in calculating the fair value of options granted during the nine months ended September 30, 2024 and 2023, respectively.
401(k) Plan
The Company sponsors a 401(k) defined contribution plan covering all employees.
13. Net Loss Per Share
The following table presents the calculation of basic and diluted net loss per share of common stock for the periods indicated:
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||||||
(In thousands, except share and per share data) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||||||
|
|
(unaudited) |
|
|
(unaudited) |
|
||||||||||||||
Net loss attributable to common stockholders |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
Shares used to compute net loss per common stock, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
Basic net loss per share is calculated by dividing net loss by the weighted average number of common stock outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of shares of common stock, convertible preferred stock, and certain common stock equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. The Company's potential securities, including warrants, convertible preferred series stock and other common stock equivalents, were excluded because their effect is anti-dilutive. For the prior periods presented, there is no difference in the number of shares used to compute basic and diluted shares outstanding.
The following are the other common stock equivalents of the Company for the nine months ended September 30, 2024 and for the year ended December 31, 2023:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
|
|
(unaudited) |
|
|
|
|
||
Options issued and outstanding |
|
|
|
|
|
|
||
Inducement options issued and outstanding |
|
|
|
|
|
|
||
Restricted stock units issued and outstanding |
|
|
|
|
|
|
||
Warrants issued and outstanding |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
45
As of November 13, 2024,
14. Segment Data
The Company has
The accounting policies used in the segment reporting are the same as those described in the summary significant accounting policies (Note 2). The Company’s CODM is the chief financial officer. The CODM primarily utilizes segment's net comprehensive profit or loss as the key indicator in assessing the segment's performance and allocating resources.
The Company's reportable segments net revenues and net loss for the three and nine months ended September 30, 2024 and 2023, consisted of the following:
|
|
Nine Months Ended |
|
|
Nine Months Ended |
|
||||||||||||||||||||||||
|
|
September 30, 2024 |
|
|
September 30, 2023 |
|
||||||||||||||||||||||||
(in thousands) |
|
(unaudited) |
|
|
(unaudited) |
|
||||||||||||||||||||||||
|
|
Human Health |
|
|
Animal Health |
|
|
Total |
|
|
Human Health |
|
|
Animal Health |
|
|
Total |
|
||||||||||||
External revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
||||||
Less: Segment expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Cost of revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Other segment items* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
( |
) |
||||
Segment expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Segment net comprehensive loss |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Reconciliation of net comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Adjustments and reconciling items** |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Consolidated net comprehensive loss |
|
|
|
|
|
|
|
|
|
$ |
|
( |
) |
|
|
|
|
|
|
|
|
|
$ |
|
( |
) |
||||
|
|
Three Months Ended |
|
|
Three Months Ended |
|
||||||||||||||||||||||||
|
|
September 30, 2024 |
|
|
September 30, 2023 |
|
||||||||||||||||||||||||
(in thousands) |
|
(unaudited) |
|
|
(unaudited) |
|
||||||||||||||||||||||||
|
|
Human Health |
|
|
Animal Health |
|
|
Total |
|
|
Human Health |
|
|
Animal Health |
|
|
Total |
|
||||||||||||
External revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
||||||
Less: Segment expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Cost of revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Interest |
|
|
|
|
|
|
|
( |
) |
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other segment items* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
( |
) |
||||
Segment expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Segment net comprehensive loss |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Reconciliation of net comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Adjustments and reconciling items** |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Consolidated net comprehensive loss |
|
|
|
|
|
|
|
|
|
$ |
|
( |
) |
|
|
|
|
|
|
|
|
|
$ |
|
( |
) |
||||
*Other segment items for each reportable segment include:
**Adjustments and reconciling items include intercompany elimination entries
46
The Company's reportable segments assets consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
2024 |
|
|
2023 |
|
||||
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|||
Segment assets |
|
|
|
|
|
|
|
|||
Human Health |
|
$ |
|
|
|
$ |
|
|
||
Animal Health |
|
|
|
|
|
|
|
|
||
Total |
|
$ |
|
|
|
$ |
|
|
||
The reconciliation of segments assets to the consolidated assets is as follows:
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
2024 |
|
|
2023 |
|
||||
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|||
Total assets for reportable segments |
|
$ |
|
|
|
$ |
|
|
||
Less: Investment in subsidiary |
|
|
|
( |
) |
|
|
|
( |
) |
Less: Intercompany loan |
|
|
|
( |
) |
|
|
|
( |
) |
Consolidated Totals |
|
$ |
|
|
|
$ |
|
|
||
15. Subsequent Events
December 2021 ATM Agreement
From October 1, 2024 to November 13, 2024, the Company issued an aggregate of
47
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and the related notes included in Item 1 of Part I of this Quarterly Report on Form 10‑Q and with our audited consolidated financial statements and the related notes included in our Annual Report on Form 10‑K as of and for the year ended December 31, 2023 which was filed to the SEC on April 1, 2024 and amended on April 17, 2024.
Overview
Jaguar Health, Inc. (“Jaguar” or the “Company”) is a commercial-stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with gastrointestinal (“GI”) distress, including chronic, debilitating diarrhea. Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, Inc. (“Napo”), focuses on developing and commercializing proprietary plant-based human prescriptions from plants for essential supportive care and management of neglected GI symptoms across multiple complicated disease states. Our crofelemer drug product candidate is the subject of the OnTarget study, a recently completed pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. The recently completed analysis of the prespecified subgroup of adult patients with breast cancer from OnTarget indicates that crofelemer achieved statistical significance in this subgroup. Patients with breast cancer accounted for nearly 180 of the 287 participants in this unprecedented prophylactic clinical trial in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy. This data in breast cancer patients has been submitted to a relevant oncology conference by the study's primary investigators, and a full study report for the breast cancer results is expected to be submitted to a peer-reviewed journal. Additional analyses of OnTarget prespecified subgroups are ongoing, and we believe data from additional analyses may result in future submissions to peer-reviewed forums. As announced, the initial top line results from the OnTarget study showed that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary estimand for the prespecified analysis of all tumor types. The subgroup analysis in adult breast cancer patients demonstrates that crofelemer provides clinically meaningful improvement in this patient population, and suggests that crofelemer has the potential to help breast cancer patients to better adhere to their cancer therapies. The subgroup analyses also show that crofelemer provides clinically meaningful improvement in the prespecified subgroup of lung cancer patients.
As part of our strategy to expand our commercial footprint beyond HIV-related supportive care to include cancer-related supportive care, on April 12, 2024, we entered into an exclusive 5-year in-license agreement with United Kingdom-based Venture Life Group PLC (“Venture Life”), an international consumer health company focused on the global self-care market, for Venture Life's 510(k) cleared oral mucositis prescription product, Gelclair, for the U.S. market. Gelclair is a 510(k) cleared prescription product and can be commercialized without any clinical development costs for Jaguar. We initiated the commercial launch in October 2024 for Gelclair. Oral mucositis is among the most common, painful, and debilitating cancer treatment-related side effects. Gelclair is a protective gel with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth.
Jaguar is the majority stockholder of Napo Therapeutics S.p.A. (“Napo Therapeutics”), an Italian corporation established by Jaguar in Milan, Italy, in 2021, focusing on expanding crofelemer access in Europe. Napo Therapeutics’ core mission is to provide access to crofelemer in Europe to address significant rare/orphan disease indications, including, initially, two key rare disease target indications: Short bowel syndrome (“SBS”) with intestinal failure and microvillus inclusion disease (“MVID”) an ultrarare congenital diarrheal disorders ("CDD"). Jaguar Animal Health is a tradename of Jaguar Health. Magdalena Biosciences Inc. (“Magdalena”), a joint venture formed by Jaguar and Filament Health Corp. (“Filament”) that emerged from Jaguar’s Entheogen Therapeutics Initiative (“ETI”), is focused on identifying the next generation of plant-based first-in-class agents for treatment of mental health conditions.
Jaguar was founded in San Francisco, California as a Delaware corporation on June 6, 2013 (inception). The Company was a majority-owned subsidiary of Napo until the close of the Company's initial public offering on May 18, 2015. The Company was formed to develop and commercialize first-in-class prescription and non-prescription products for companion animals.
On July 31, 2017, Jaguar completed a merger with Napo pursuant to the Agreement and Plan of Merger dated March 31, 2017, by and among Jaguar, Napo, Napo Acquisition Corporation (“Merger Sub”), and Napo's representative (the “Merger Agreement”). In accordance with the terms of the Merger Agreement, upon the completion of the merger, Merger Sub merged with and into Napo, with Napo surviving as the wholly owned subsidiary (the “Merger” or “Napo Merger”). Immediately following the merger, Jaguar changed its name from “Jaguar Animal Health, Inc.” to “Jaguar Health, Inc.” Napo now operates as a wholly owned subsidiary of Jaguar focused on human health, including the ongoing development of crofelemer and commercialization of Mytesi.
Napo’s marketed drug Mytesi (crofelemer 125 mg delayed-release tablets) is a first-in-class oral botanical drug product approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. To date, this is the only oral plant-based botanical prescription medicine approved under the FDA’s Botanical Guidance. The Company’s
48
Canalevia-CA1 (crofelemer delayed-release tablets) drug is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (“CID”) in dogs.
Crofelemer was granted Orphan Drug Designation (“ODD”) by the FDA in February 2023 for MVID and granted ODD for MVID by the European Medicines Agency (“EMA”) in October 2022. Crofelemer was granted ODD for SBS by the EMA in December 2021 and by the FDA in August 2017. In August 2023, Napo’s Investigational New Drug (“IND”) application was activated by the FDA for a new crofelemer powder for oral solution formulation for treating MVID. Our global MVID phase 2 trial for Jaguar is being conducted under this IND. The global phase 2 trial of crofelemer in adults with SBS with intestinal failure is taking place under a Clinical Trial Application (CTA) approved by European health authorities. These phase 2 studies are planned to initiate in the fourth quarter of 2024. We expect that enrollment will continue in 2025 for each of these phase 2 trials, with data expected in the beginning of 2026 for both trials. Additionally, Jaguar is supporting independent investigator-initiated proof-of-concept (“POC”) studies of crofelemer for the rare disease indications of SBS with intestinal failure and MVID, focused on obtaining POC data showing reduction of requirements of parenteral support, including parenteral nutrition and IV fluids. In accordance with the guidelines of specific European Union countries, publications of data from POC trials and Phase 2 trials could support participation in early patient access programs for crofelemer for SBS or MVID, especially for patients with intestinal failure requiring parenteral support. Participation in early access programs, which do not exist in the United States, provides an opportunity for reimbursement while impacting the morbidity and high cost of care for these chronic unmet needs.
Napo Therapeutics is initiating efforts to commence clinical development of crofelemer in SBS patients in support of the Company’s key focus on leveraging the EMA’s accelerated conditional marketing authorization pathway in Europe for these rare diseases. SBS affects approximately 10,000 to 20,000 people in the U.S., according to the Crohn's & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size. Despite limited treatment options, the global SBS market exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027, according to a report by Vision Research Reports.
Most of the activities of the Company are focused on the development and commercialization of Mytesi, the ongoing clinical development of crofelemer for the prophylaxis of diarrhea in adult patients receiving targeted cancer therapy, the ongoing commercial launch of Gelclair, and our prioritized clinical program centered around investigator-initiated POC trials of crofelemer for SBS and CDD.
In the field of animal health, we are continuing limited activities related to developing and commercializing first-in-class GI products for dogs, dairy calves, and foals.
Crofelemer is a novel, first-in-class anti-secretory antidiarrheal drug that has a normalizing effect on electrolyte and fluid balance in the gut, and this mechanism of action has the potential to benefit multiple disorders that cause GI distress, including diarrhea and abdominal discomfort. Crofelemer is in development for multiple possible follow-on indications, including for our lead Phase 3 program in cancer therapy-related diarrhea (“CTD”), investigating prophylaxis of diarrhea related to targeted therapy with or without standard chemotherapy. Crofelemer delayed-release tablets are also being evaluated in diarrhea-predominant irritable bowel syndrome (“IBS-D”) and being evaluated for chronic idiopathic/functional diarrhea in investigator-initiated trials.
Crofelemer powder for oral solution is being developed to support orphan or rare disease indications for adults with SBS with intestinal failure and for pediatric MVID patients.
In addition, a second-generation proprietary anti-secretory antidiarrheal drug (“NP-300”) is in development for symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, from bacterial, viral, and parasitic infections, including Vibrio cholerae, the bacterium that causes cholera. This program is being pursued with the potential targeted incentive from the FDA for a tropical disease priority review voucher.
In January 2023, Jaguar and Filament, with funding from One Small Planet, formed the U.S.-based joint venture Magdalena. Magdalena’s focus is on the development of novel, natural prescription medicines derived from plants for mental health indications, including, initially, attention-deficit/hyperactivity disorder (“ADHD”) in adults. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders and to partner with a potential future licensee to develop and commercialize these novel plant-based drugs. This venture aligns with Jaguar's ETI program and Filament's corporate mission to develop novel, natural prescription medicines from plants. Magdalena will leverage Jaguar's proprietary medicinal plant library and Filament's proprietary drug development technology. Jaguar’s library of 2,300 highly characterized medicinal plants and 3,500 plant extracts, all from firsthand ethnobotanical investigation by Jaguar and members of the ETI Scientific Strategy Team, is a key asset we have generated over 30 years that bridges the knowledge of traditional healers and Western medicine. Magdalena holds an exclusive license to plants and plant extracts in Jaguar's library, not including any sources of crofelemer or NP-300, for specific indications and is in the process of
49
identifying plant candidates in the library that may prove beneficial for addressing indications such as ADHD. Magdalena is approximately 40-percent owned by Jaguar.
As announced, Jaguar recently executed an out-license deal with Magdalena for a botanical drug candidate for possible schizophrenia and psychoses indications and for development with potential corporate partners. Sourced from a medicinal plant that has a long history of use by traditional healers, the drug candidate demonstrates antipsychotic activity and has a mechanism of action distinct from currently FDA-approved therapies for schizophrenia and other mental conditions that present psychotic symptoms. The drug candidate may have the potential to be the first in a new class of plant-based antipsychotic compounds.
In December 2021, we received conditional approval from the FDA to market Canalevia-CA1 (crofelemer delayed-release tablets), our oral plant-based prescription drug and the only available veterinary drug for the treatment of CID in dogs, and Canalevia-CA1 is now available to multiple leading veterinary distributors in the U.S. Canalevia-CA1 is a tablet that is given orally and can be prescribed for home treatment of CID. The FDA conditionally approves Canalevia-CA1 under application number 141-552. Conditional approval allows for product commercialization while Jaguar Animal Health continues to collect the substantial evidence of effectiveness required for full approval. We have received a Minor Use in a Major Species (“MUMS”) designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a “small number” threshold for minor use in each of the seven major species covered by the MUMS Act. The small number threshold is currently 80,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over a year and still have the use qualify as a minor use.
We believe Jaguar is poised to realize a number of synergistic, value-adding benefits—an expanded pipeline of potential blockbuster human follow-on indications of crofelemer and a second-generation anti-secretory agent—upon which to build global partnerships. Jaguar, through Napo, holds global unencumbered rights for crofelemer, Mytesi, and Canalevia-CA1. Additionally, several drug product opportunities in Jaguar’s crofelemer pipeline are backed by Phase 2 and POC evidence from human clinical trials.
Financial Operations Overview
On a consolidated basis, we have not yet generated enough revenue to date to achieve break-even or positive cash flows, and we expect to continue to incur significant research and development and other expenses. Our net loss was $29.0 million and $32.6 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had a total stockholders' equity of $13.1 million, an accumulated deficit of $336.6 million, and cash of $13.3 million. We expect to continue to incur losses, and experience increased expenditures for the foreseeable future as we expand our product development activities, seek necessary approvals for our product candidates, conduct species-specific formulation studies for our non-prescription products, establish API manufacturing capabilities and begin additional commercialization activities. Payments of cash compensation to directors under the Director Compensation Program or the three and nine months ended September 30, 2024 amounted to $109,000 and $218,000, respectively.
Revenues
Our product and license revenue consists of the following:
See “Results of Operations” below for a more detailed discussion on revenues.
50
Costs of Product Revenue
The cost of revenue consists of direct drug substance and drug product materials expenses, direct labor, distribution fees, royalties, and other related expenses associated with the sale of our products.
Research and Development
Research and development expenses consist primarily of clinical and contract manufacturing, personnel and related benefits, stock-based compensation, employee travel, and reforestation expenses. Clinical and contract manufacturing expenses consist primarily of costs for stability, safety, and efficacy studies and manufacturing startup at an outsourced API provider in Italy. It also includes expenses with a third-party provider for transferring the Mytesi manufacturing process and the related feasibility and validation activities.
We typically use our employee and infrastructure resources across multiple development programs. We track outsourced development costs by prescription drug product candidate and non-prescription product, and we track personnel or other internal costs related to the development of specific programs or development compounds.
As of September 30, 2024, the Company has incurred approximately $4.8 million on its primary R&D projects. The timing and amount of our research and development expenses will depend largely upon the outcomes of current and future trials for our prescription drug product candidates, as well as the related regulatory requirements, the outcomes of current and future species-specific formulation studies for our non-prescription products, manufacturing costs and any costs associated with the advancement of our line extension programs. We cannot determine with certainty the duration and completion costs of the current or future development activities. The total project costs remain uncertain due to regulatory and clinical trial complexities. Management continues to monitor timelines closely to address any risks that could impact timely project completion and future operations.
The duration, costs, and timing of trials, formulation studies, and development of our prescription drug and non-prescription products will depend on a variety of factors, including:
A change in the outcome of any of these variables with respect to the development of a prescription drug product candidate or non-prescription product could mean a significant change in the costs and timing associated with our development activities.
We expect research and development expenses to decrease with the Phase 3 OnTarget Trial completion in the first half of 2025; though we expect start-up costs associated with our clinical trials for other indications.
Materials expense and tree planting refers to the Company's ongoing environmental costs related to the sustainable sourcing of crofelemer and reforestation activities in the Amazon Rainforest. These expenses include capital investments in seedling nurseries and tree planting. As of September 30, 2024, no significant non-recurring environmental remediation costs are anticipated. The Company continues to monitor its environmental impact and may incur future costs as needed.
Sales and Marketing
Sales and marketing expenses consist of personnel and related benefits, stock-based compensation, direct sales and marketing, employee travel, and management consulting expenses. We currently incur sales and marketing expenses to promote Mytesi and GelClair. We do not have significant marketing or promotional expenses related to Canalevia and Neonorm Calf or Neonorm Foal for the nine months ended September 30, 2024 and 2023.
We expect sales and marketing expenses to increase going forward as we focus on expanding our market access activities and commercial partnerships to develop follow-on indications of Mytesi, GelClair and crofelemer.
51
General and Administrative
General and administrative expenses consist of personnel and related benefits expenses, stock-based compensation expenses, employee travel expenses, legal and accounting fees, rent and facilities expenses, and management consulting expenses.
In the near term, we expect general and administrative expenses to remain flat as we focus on our pipeline development and market access expansion. This will include efforts to grow the business.
Interest Expense
Interest expense consists primarily of non-cash and cash interest costs related to our borrowings.
Change in Fair Value of Financial Instruments and Hybrid Instrument Designated at FVO
Change in fair value of financial instruments and hybrid instruments designated at FVO consists of gain or loss recognized related to fair values changes of our instruments designated at FVO.
Gain on Debt Extinguishment
Gain on debt extinguishment consists of gain incurred related to the exchanges resulting from the extinguishment of our borrowings.
Critical Accounting Policies and Significant Judgments and Estimates
Preparing condensed consolidated financial statements in conformity with U.S. GAAP requires using estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosures in the consolidated financial statements. Critical accounting policies are those accounting policies that may be material due to the levels of subjectivity and judgment necessary to account for highly uncertain matters or the susceptibility of such matters to change and that have a material impact on financial condition or operating performance. While we base our estimates and judgments on our experience and various other factors that we believe to be reasonable, actual results may differ from these estimates under different assumptions or conditions. Note 2 of the unaudited condensed consolidated financial statements describes our significant accounting policies. Our critical accounting policies and estimates were described in Part II, Item 7, Critical Accounting Policies and Estimates, in our Annual Report on Form 10-K for the year ended December 31, 2023.
Potential Material Effects of Trends, Events, and Uncertainties
Inflation Reduction Act
The Inflation Reduction Act, effective January 1, 2023, introduces several provisions that may impact the Company's operations and financial results. While the full effects of the Act on future results are uncertain, management acknowledges potential changes in market conditions, tax incentives, and regulatory requirements that could arise as a result of this legislation. Management is currently unable to predict the likelihood or timing of these changes and their specific implications for the Company’s financial performance. The pharmaceutical industry may face impacts from new pricing regulations and changes in tax incentives for research and development.
Management will continue to monitor developments closely and assess any potential impacts. However, at this time, it is not possible to determine a range of likely effects on future results. Should circumstances warrant, the Company will disclose any material impacts as they become known.
Lease Commitments
The Company's lease obligations constitute a significant portion of its operating expenses and are anticipated to affect future cash flows. As of September 30, 2024, the Company has committed to multiple lease agreements, including a primary office lease in San Francisco that commenced on September 1, 2021, and extends until February 28, 2025. This lease includes a structured rent increase, beginning at $42,000 per month and escalating to $45,000 by the final year.
52
Additionally, the Company has entered into a lease for Suite 400, which commenced on September 1, 2023, and extends through August 31, 2030, with initial monthly rent set at $18,000. The lease agreements also incorporate provisions for periodic rent increases tied to inflation, which may introduce variability in future cash flows.
Given these escalating lease commitments, particularly the planned increases in base rent and the uncertainties surrounding the potential exercise of extension options, the Company is focused on maintaining effective liquidity management strategies to address potential cash flow impacts. Moreover, fluctuations in occupancy rates or operational changes may affect the utilization of leased spaces, thereby influencing amortization expenses associated with right-of-use assets.
The Company regularly evaluates its lease portfolio and market conditions to make informed decisions regarding future lease renewals or new lease agreements. Effective management of these lease liabilities will be essential for ensuring operational flexibility and financial stability in the upcoming years.
Results of Operations
Comparison for the nine months ended September 30, 2024 and 2023
The following table summarizes the Company’s operations results for the items outlined in the table for the nine months ended September 30, 2024 and 2023, together with the change in such items in dollars and as a percentage.
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Product revenue, net |
|
$ |
|
8,095 |
|
|
$ |
|
7,461 |
|
|
$ |
|
634 |
|
|
|
8.5 |
|
% |
License revenue |
|
|
|
85 |
|
|
|
|
— |
|
|
|
|
85 |
|
|
|
— |
|
% |
Total revenue |
|
|
|
8,180 |
|
|
|
|
7,461 |
|
|
|
|
719 |
|
|
|
9.6 |
|
% |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of product revenue |
|
|
|
1,398 |
|
|
|
|
1,350 |
|
|
|
|
48 |
|
|
|
3.6 |
|
% |
Research and development |
|
|
|
12,008 |
|
|
|
|
15,133 |
|
|
|
|
(3,125 |
) |
|
|
(20.7 |
) |
% |
Sales and marketing |
|
|
|
4,977 |
|
|
|
|
4,929 |
|
|
|
|
48 |
|
|
|
1.0 |
|
% |
General and administrative |
|
|
|
12,471 |
|
|
|
|
12,783 |
|
|
|
|
(312 |
) |
|
|
(2.4 |
) |
% |
Total operating expenses |
|
|
|
30,854 |
|
|
|
|
34,195 |
|
|
|
|
(3,341 |
) |
|
|
(9.8 |
) |
% |
Loss from operations |
|
|
|
(22,674 |
) |
|
|
|
(26,734 |
) |
|
|
|
4,060 |
|
|
|
(15.2 |
) |
% |
Interest income (expense) |
|
|
|
(341 |
) |
|
|
|
(6,134 |
) |
|
|
|
5,793 |
|
|
|
(94.4 |
) |
% |
Changes in fair value of freestanding and hybrid financial instruments designated at Fair Value Option |
|
|
|
(6,920 |
) |
|
|
|
(3,365 |
) |
|
|
|
(3,555 |
) |
|
|
105.6 |
|
% |
Gain on extinguishment of debt |
|
|
|
1,245 |
|
|
|
|
3,697 |
|
|
|
|
(2,452 |
) |
|
|
(66.3 |
) |
% |
Other income (expense) |
|
|
|
(327 |
) |
|
|
|
(56 |
) |
|
|
|
(271 |
) |
|
|
483.9 |
|
% |
Loss before income tax expense |
|
|
|
(29,017 |
) |
|
|
|
(32,592 |
) |
|
|
|
3,575 |
|
|
|
(11.0 |
) |
% |
Income tax expense |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
% |
Net loss |
|
$ |
|
(29,017 |
) |
|
$ |
|
(32,592 |
) |
|
$ |
|
3,575 |
|
|
|
(11.0 |
) |
% |
Net loss attributable to noncontrolling interest |
|
$ |
|
(445 |
) |
|
$ |
|
(462 |
) |
|
$ |
|
17 |
|
|
|
(3.7 |
) |
% |
Net loss attributable to common stockholders |
|
$ |
|
(28,572 |
) |
|
$ |
|
(32,130 |
) |
|
$ |
|
3,558 |
|
|
|
(11.1 |
) |
% |
Revenue
Product revenue
Sales discounts were $838,000 and $811,000 for the nine months ended September 30, 2024 and 2023, respectively, an increase of $27,000, relative to the increase in sales volume.
Medicaid and AIDS Drug Assistance Program (“ADAP”) rebates accounted for $1.9 million and $1.5 million for the nine months ended September 30, 2024 and 2023, respectively, an increase of $435,000, relative to the increase sales volume.
License revenue
License revenues increased by $85,000 from $0 for the nine months ended September 30, 2023, to $85,000 in the same period in 2024, due to license agreement entered by the Company with Gen on March 18, 2024. The license revenue is recognized as
53
the Licensee receives and consumes the benefits from the Company’s performance of providing access to its intellectual property evenly over the license period of 5 years.
Due to the Company’s arrangements, including elements of variable consideration, gross product sales are reduced to reflect the expected consideration to arrive at net product sales. Deductions to reduce gross product sales to net product sales for the nine months ended September 30, 2024 and 2023 were as follows:
|
Nine Months Ended |
|
|
|
|||||||||||||||
|
September 30, |
|
|
|
|||||||||||||||
(in thousands) |
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Gross product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Mytesi |
$ |
|
10,841 |
|
|
$ |
|
9,871 |
|
|
$ |
|
970 |
|
|
|
9.8 |
|
% |
Canalevia |
|
|
115 |
|
|
|
|
91 |
|
|
|
|
24 |
|
|
|
26.4 |
|
% |
Neonorm |
|
|
27 |
|
|
|
|
35 |
|
|
|
|
(8 |
) |
|
|
(22.9 |
) |
% |
Total gross product sales |
|
|
10,983 |
|
|
|
|
9,997 |
|
|
|
|
986 |
|
|
|
9.9 |
|
% |
Medicaid rebates |
|
|
(1,889 |
) |
|
|
|
(1,454 |
) |
|
|
|
(435 |
) |
|
|
29.9 |
|
% |
Sales discounts |
|
|
(838 |
) |
|
|
|
(811 |
) |
|
|
|
(27 |
) |
|
|
3.3 |
|
% |
Sales returns |
|
|
(161 |
) |
|
|
|
(271 |
) |
|
|
|
110 |
|
|
|
(40.6 |
) |
% |
Net product sales |
$ |
|
8,095 |
|
|
$ |
|
7,461 |
|
|
$ |
|
634 |
|
|
|
8.5 |
|
% |
Our gross product revenues were $11.0 million and $10.0 million for the nine months ended September 30, 2024 and 2023, respectively. These periods reflect revenue from the sale of our human drug Mytesi and our animal products branded as Canalevia-CA1, Neonorm Calf and Neonorm Foal.
The increase in gross product revenue of $1.0 million for the nine months ended September 30, 2024, compared to the same period in 2023 was primarily due to the increase in the volume of sales of Mytesi and Canalevia, an increase of $970,000 and $24,000, respectively. The Company launched Gelclair during the quarter. However, revenue recognition will commence in the following quarters, in alignment with the timing of product sales and revenue recognition principles.
Cost of Product Revenue
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Cost of Product Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Direct labor |
|
$ |
|
633 |
|
|
$ |
|
794 |
|
|
$ |
|
(161 |
) |
|
|
(20.3 |
) |
% |
Material cost |
|
|
|
583 |
|
|
|
|
638 |
|
|
|
|
(55 |
) |
|
|
(8.6 |
) |
% |
Distribution fees |
|
|
|
137 |
|
|
|
|
(17 |
) |
|
|
|
154 |
|
|
|
(905.9 |
) |
% |
Royalties |
|
|
|
— |
|
|
|
|
26 |
|
|
|
|
(26 |
) |
|
|
(100.0 |
) |
% |
Other |
|
|
|
45 |
|
|
|
|
(91 |
) |
|
|
|
136 |
|
|
|
(149.5 |
) |
% |
Total |
|
$ |
|
1,398 |
|
|
$ |
|
1,350 |
|
|
$ |
|
48 |
|
|
|
3.6 |
|
% |
The increase in cost of product revenue of $48,000 for the nine months ended September 30, 2024, compared to the same period in 2023 was primarily due to:
54
Research and Development
The following table presents the components of research and development (“R&D”) expense for the nine months ended September 30, 2024 and 2023 together with the change in such components in dollars and as a percentage:
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Research and Development: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical and contract manufacturing |
|
$ |
|
4,778 |
|
|
$ |
|
6,678 |
|
|
$ |
|
(1,900 |
) |
|
|
(28.5 |
) |
% |
Personnel and related benefits |
|
|
|
4,661 |
|
|
|
|
4,450 |
|
|
|
|
211 |
|
|
|
4.7 |
|
% |
Stock-based compensation |
|
|
|
562 |
|
|
|
|
756 |
|
|
|
|
(194 |
) |
|
|
(25.7 |
) |
% |
Materials expense and tree planting |
|
|
|
255 |
|
|
|
|
276 |
|
|
|
|
(21 |
) |
|
|
(7.6 |
) |
% |
Travel and other expenses |
|
|
|
133 |
|
|
|
|
273 |
|
|
|
|
(140 |
) |
|
|
(51.3 |
) |
% |
Other |
|
|
|
1,619 |
|
|
|
|
2,700 |
|
|
|
|
(1,081 |
) |
|
|
(40.0 |
) |
% |
Total |
|
$ |
|
12,008 |
|
|
$ |
|
15,133 |
|
|
$ |
|
(3,125 |
) |
|
|
(20.7 |
) |
% |
The decrease in R&D expense of $3.1 million for the nine months ended September 30, 2024, compared to the same period in 2023 was largely due to:
Sales and Marketing
The following table presents the components of sales and marketing (“S&M”) expense for the nine months ended September 30, 2024 and 2023 together with the change in such components in dollars and as a percentage:
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Sales and Marketing: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel and related benefits |
|
$ |
|
2,321 |
|
|
$ |
|
2,297 |
|
|
$ |
|
24 |
|
|
|
1.0 |
|
% |
Direct marketing fees and expense |
|
|
|
949 |
|
|
|
|
1,480 |
|
|
|
|
(531 |
) |
|
|
(35.9 |
) |
% |
Stock-based compensation |
|
|
|
104 |
|
|
|
|
175 |
|
|
|
|
(71 |
) |
|
|
(40.6 |
) |
% |
Other |
|
|
|
1,603 |
|
|
|
|
977 |
|
|
|
|
626 |
|
|
|
64.1 |
|
% |
Total |
|
$ |
|
4,977 |
|
|
$ |
|
4,929 |
|
|
$ |
|
48 |
|
|
|
1.0 |
|
% |
The increase in S&M expense of $48,000 for the nine months ended September 30, 2024, compared to the same period in 2023 was largely due to:
55
General and Administrative
The following table presents the components of general and administrative (“G&A”) expense for the nine months ended September 30, 2024 and 2023 together with the change in such components in dollars and as a percentage:
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
General and Administrative: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel and related benefits |
|
$ |
|
3,301 |
|
|
$ |
|
3,464 |
|
|
$ |
|
(163 |
) |
|
|
(4.7 |
) |
% |
Legal services |
|
|
|
1,591 |
|
|
|
|
1,658 |
|
|
|
|
(67 |
) |
|
|
(4.0 |
) |
% |
Public company expense |
|
|
|
1,354 |
|
|
|
|
1,347 |
|
|
|
|
7 |
|
|
|
0.5 |
|
% |
Third-party consulting services |
|
|
|
1,019 |
|
|
|
|
501 |
|
|
|
|
518 |
|
|
|
103.4 |
|
% |
Audit, tax and accounting services |
|
|
|
667 |
|
|
|
|
1,087 |
|
|
|
|
(420 |
) |
|
|
(38.6 |
) |
% |
Lease expense |
|
|
|
648 |
|
|
|
|
614 |
|
|
|
|
34 |
|
|
|
5.5 |
|
% |
Stock-based compensation |
|
|
|
608 |
|
|
|
|
604 |
|
|
|
|
4 |
|
|
|
0.7 |
|
% |
Travel and other expenses |
|
|
|
380 |
|
|
|
|
323 |
|
|
|
|
57 |
|
|
|
17.6 |
|
% |
Other |
|
|
|
2,903 |
|
|
|
|
3,185 |
|
|
|
|
(282 |
) |
|
|
(8.9 |
) |
% |
Total |
|
$ |
|
12,471 |
|
|
$ |
|
12,783 |
|
|
$ |
|
(312 |
) |
|
|
(2.4 |
) |
% |
The decrease in G&A expenses of $312,000 for the nine months ended September 30, 2024, compared to the same period in 2023 was largely due to:
Interest Expense
Interest expense decreased by $5.8 million from $6.1 million for the nine months ended September 30, 2023, to $341,000 in the same period in 2024, primarily due to changes in accounting of certain debt instruments to FVO. The lower interest expense was offset by a higher loss in change in fair value of freestanding and hybrid financial instruments designated at FVO.
56
Change in Fair Value of Financial Instruments and Hybrid Instrument Designated at FVO
The fair value of financial instrument and hybrid instrument designated at FVO decreased by 3.6 million, from a loss of $3.4 million in the nine months ended September 30, 2023, to a loss of $6.9 million in the same period in 2024 primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.
Gain on Extinguishment of Debt
Gain on extinguishment of debt decreased by $2.5 million from $3.7 million in the nine months ended September 30, 2023, to $1.2 million in the same period in 2024 primarily due to significant modifications of royalty interest agreements resulting to extinguishment accounting.
Segment Data
The Company has two reportable segments: animal health and human health. The animal health segment develops and commercializes products for animals, while the human health segment focuses on human products, specifically Mytesi, which is approved for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
Comparison of the three months ended September 30, 2024 and 2023
The following table summarizes the Company’s operations results to the items outlined in the table for the three months ended September 30, 2024 and 2023, together with the change in such items in dollars and as a percentage.
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Product revenue |
|
$ |
|
3,066 |
|
|
$ |
|
2,813 |
|
|
$ |
|
253 |
|
|
|
9.0 |
|
% |
License revenue |
|
|
|
42 |
|
|
|
|
— |
|
|
|
|
42 |
|
|
|
100.0 |
|
% |
Total revenue |
|
|
|
3,108 |
|
|
|
|
2,813 |
|
|
|
|
295 |
|
|
|
10.5 |
|
% |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of product revenue |
|
|
|
541 |
|
|
|
|
514 |
|
|
|
|
27 |
|
|
|
5.3 |
|
% |
Research and development |
|
|
|
4,043 |
|
|
|
|
6,081 |
|
|
|
|
(2,038 |
) |
|
|
(33.5 |
) |
% |
Sales and marketing |
|
|
|
2,010 |
|
|
|
|
1,472 |
|
|
|
|
538 |
|
|
|
36.5 |
|
% |
General and administrative |
|
|
|
3,776 |
|
|
|
|
3,533 |
|
|
|
|
243 |
|
|
|
6.9 |
|
% |
Total operating expenses |
|
|
|
10,370 |
|
|
|
|
11,600 |
|
|
|
|
(1,230 |
) |
|
|
(10.6 |
) |
% |
Loss from operations |
|
|
|
(7,262 |
) |
|
|
|
(8,787 |
) |
|
|
|
1,525 |
|
|
|
(17.4 |
) |
% |
Interest income (expense) |
|
|
|
162 |
|
|
|
|
(500 |
) |
|
|
|
662 |
|
|
|
(132.4 |
) |
% |
Changes in fair value of freestanding and hybrid financial instruments designated at Fair Value Option |
|
|
|
(3,089 |
) |
|
|
|
(2,244 |
) |
|
|
|
(845 |
) |
|
|
37.7 |
|
% |
Gain on extinguishment of debt |
|
|
|
— |
|
|
|
|
3,697 |
|
|
|
|
(3,697 |
) |
|
|
(100.0 |
) |
% |
Other income (expense) |
|
|
|
168 |
|
|
|
|
(70 |
) |
|
|
|
238 |
|
|
|
(340.0 |
) |
% |
Loss before income tax expense |
|
|
|
(10,021 |
) |
|
|
|
(7,904 |
) |
|
|
|
(2,117 |
) |
|
|
26.8 |
|
% |
Income tax expense |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
% |
Net loss |
|
$ |
|
(10,021 |
) |
|
$ |
|
(7,904 |
) |
|
$ |
|
(2,117 |
) |
|
|
26.8 |
|
% |
Net loss attributable to noncontrolling interest |
|
$ |
|
(167 |
) |
|
$ |
|
(126 |
) |
|
$ |
|
(41 |
) |
|
|
32.5 |
|
% |
Net loss attributable to common stockholders |
|
$ |
|
(9,854 |
) |
|
$ |
|
(7,778 |
) |
|
$ |
|
(2,076 |
) |
|
|
26.7 |
|
% |
Revenue
Product revenue
Sales discounts were $327,000 and $296,000 for the three months ended September 30, 2024 and 2023, respectively, a decrease of $31,000.
Medicaid and AIDS Drug Assistance Program (“ADAP”) rebates accounted for $553,000 and $437,000 for the three months ended September 30, 2024 and 2023, respectively, a decrease of $116,000.
57
License revenue
License revenues increased by $42,000 from $0 for the three months ended September 30, 2023, to $42,000 in the same period in 2024, due to license agreement entered by the Company with Gen on March 18, 2024. The license revenue is recognized as the Licensee receives and consumes the benefits from the Company’s performance of providing access to its intellectual property evenly over the license period of 5 years.
Gross product sales equal the number of bottles sold multiplied by WAC. Due to the Company’s arrangements, including elements of variable consideration, gross product sales are reduced in order to reflect the expected consideration to arrive at net product sales. Deductions to reduce gross product sales to net product sales in the three months ended September 30, 2024 and 2023 were as follows:
|
Three Months Ended |
|
|
|
|||||||||||||||
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|
|
|||||||
Gross product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Mytesi |
$ |
|
3,928 |
|
|
$ |
|
3,662 |
|
|
$ |
|
266 |
|
|
|
7.3 |
|
% |
Canalevia |
|
|
49 |
|
|
|
|
24 |
|
|
|
|
25 |
|
|
|
104.2 |
|
% |
Neonorm |
|
|
4 |
|
|
|
|
7 |
|
|
|
|
(3 |
) |
|
|
(42.9 |
) |
% |
Total gross product sales |
|
|
3,981 |
|
|
|
|
3,693 |
|
|
|
|
288 |
|
|
|
7.8 |
|
% |
Medicaid rebates |
|
|
(553 |
) |
|
|
|
(437 |
) |
|
|
|
(116 |
) |
|
|
26.5 |
|
% |
Sales discounts |
|
|
(327 |
) |
|
|
|
(296 |
) |
|
|
|
(31 |
) |
|
|
10.5 |
|
% |
Sales returns |
|
|
(35 |
) |
|
|
|
(147 |
) |
|
|
|
112 |
|
|
|
(76.2 |
) |
% |
Net product sales |
$ |
|
3,066 |
|
|
$ |
|
2,813 |
|
|
$ |
|
253 |
|
|
|
9.0 |
|
% |
Our gross product revenues were $4.0 million and $3.7 million for the three months ended September 30, 2024 and 2023, respectively. These periods reflect revenue from the sale of our human drug Mytesi and our animal products branded as Canalevia-CA1, Neonorm Calf and Neonorm Foal.
The increase in gross product revenue of $330,000 for the three months ended September 30, 2024, compared to the same period 2023 was primarily due to the increase in the volume of sales of Mytesi and Canalevia, an increase of $266,000 and $25,000, respectively. The Company launched Gelclair during the quarter. However, revenue recognition will commence in the following quarters, in alignment with the timing of product sales and revenue recognition principles.
Cost of Product Revenue
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Cost of Product Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Direct labor |
|
$ |
|
233 |
|
|
$ |
|
250 |
|
|
$ |
|
(17 |
) |
|
|
(6.8 |
) |
% |
Material cost |
|
|
|
255 |
|
|
|
|
231 |
|
|
|
|
24 |
|
|
|
10.4 |
|
% |
Distribution fees |
|
|
|
38 |
|
|
|
|
15 |
|
|
|
|
23 |
|
|
|
153.3 |
|
% |
Royalties |
|
|
|
— |
|
|
|
|
9 |
|
|
|
|
(9 |
) |
|
|
(100.0 |
) |
% |
Other |
|
|
|
15 |
|
|
|
|
9 |
|
|
|
|
6 |
|
|
|
66.7 |
|
% |
Total |
|
$ |
|
541 |
|
|
$ |
|
514 |
|
|
$ |
|
27 |
|
|
|
5.3 |
|
% |
The increase in cost of product revenue of $27,000 for the three months ended September 30, 2024, compared to the same period in 2023 was primarily due to:
58
Research and Development
The following table presents the components of R&D expense for the three months ended September 30, 2024 and 2023, together with the change in such components in dollars and as a percentage:
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Research and Development: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical and contract manufacturing |
|
$ |
|
1,499 |
|
|
$ |
|
3,473 |
|
|
$ |
|
(1,974 |
) |
|
|
(56.8 |
) |
% |
Personnel and related benefits |
|
|
|
1,456 |
|
|
|
|
1,501 |
|
|
|
|
(45 |
) |
|
|
(3.0 |
) |
% |
Stock-based compensation |
|
|
|
97 |
|
|
|
|
272 |
|
|
|
|
(175 |
) |
|
|
(64.3 |
) |
% |
Materials expense and tree planting |
|
|
|
88 |
|
|
|
|
91 |
|
|
|
|
(3 |
) |
|
|
(3.3 |
) |
% |
Travel and other expenses |
|
|
|
35 |
|
|
|
|
59 |
|
|
|
|
(24 |
) |
|
|
(40.7 |
) |
% |
Other |
|
|
|
868 |
|
|
|
|
685 |
|
|
|
|
183 |
|
|
|
26.7 |
|
% |
Total |
|
$ |
|
4,043 |
|
|
$ |
|
6,081 |
|
|
$ |
|
(2,038 |
) |
|
|
(33.5 |
) |
% |
The change in R&D expense of $2.0 million for the three months ended September 30, 2024, compared to the same period in 2024 was due primarily to:
Sales and Marketing
The following table presents the components of S&M expense for the three months ended September 30, 2024 and 2023, together with the change in such components in dollars and as a percentage:
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
Sales and Marketing: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel and related benefits |
|
$ |
|
830 |
|
|
$ |
|
795 |
|
|
$ |
|
35 |
|
|
|
4.4 |
|
% |
Direct marketing fees and expense |
|
|
|
263 |
|
|
|
|
406 |
|
|
|
|
(143 |
) |
|
|
(35.2 |
) |
% |
Stock-based compensation |
|
|
|
32 |
|
|
|
|
40 |
|
|
|
|
(8 |
) |
|
|
(20.0 |
) |
% |
Other |
|
|
|
885 |
|
|
|
|
231 |
|
|
|
|
654 |
|
|
|
283.1 |
|
% |
Total |
|
$ |
|
2,010 |
|
|
$ |
|
1,472 |
|
|
$ |
|
538 |
|
|
|
36.5 |
|
% |
The change in S&M expense of $538,000 in the three months ended September 30, 2024 compared to the same period in 2023 was due primarily to:
59
General and Administrative
The following table presents the components of G&A expense for the three months ended September 30, 2024 and 2023, together with the change in such components in dollars and as a percentage:
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|||||||||
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|||||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Variance |
|
|
Variance % |
|||||||||
General and Administrative: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel and related benefits |
|
$ |
|
1,046 |
|
|
$ |
|
901 |
|
|
$ |
|
145 |
|
|
|
16.1 |
|
% |
Legal services |
|
|
|
391 |
|
|
|
|
292 |
|
|
|
|
99 |
|
|
|
33.9 |
|
% |
Third-party consulting services |
|
|
|
369 |
|
|
|
|
260 |
|
|
|
|
109 |
|
|
|
41.9 |
|
% |
Public company expense |
|
|
|
361 |
|
|
|
|
542 |
|
|
|
|
(181 |
) |
|
|
(33.4 |
) |
% |
Lease expense |
|
|
|
296 |
|
|
|
|
240 |
|
|
|
|
56 |
|
|
|
23.3 |
|
% |
Stock-based compensation |
|
|
|
181 |
|
|
|
|
225 |
|
|
|
|
(44 |
) |
|
|
(19.6 |
) |
% |
Travel and other expenses |
|
|
|
159 |
|
|
|
|
36 |
|
|
|
|
123 |
|
|
|
341.7 |
|
% |
Audit, tax and accounting services |
|
|
|
85 |
|
|
|
|
494 |
|
|
|
|
(409 |
) |
|
|
(82.8 |
) |
% |
Other |
|
|
|
888 |
|
|
|
|
543 |
|
|
|
|
345 |
|
|
|
63.5 |
|
% |
Total |
|
$ |
|
3,776 |
|
|
$ |
|
3,533 |
|
|
$ |
|
243 |
|
|
|
6.9 |
|
% |
The change in G&A expenses of $243,000 in the three months ended September 30, 2024, compared to the same period in 2023 was due primarily to:
60
Interest Income (Expense)
Interest expense decreased by $662,000, from $500,000 for the three months ended September 30, 2023, to a $162,000 net interest income for the same period in 2024, primarily due to changing the accounting of certain debt instruments to FVO. The lower interest expense was offset by a higher loss in a change in the fair value of financial instruments and hybrid instruments designated at FVO.
Change in Fair Value of Freestanding and Hybrid Financial Instruments Designated at FVO
Change in fair value of financial instrument and hybrid instrument designated at FVO decreased $845,000 from a loss of $2.2 million in the three months ended September 30, 2023, to a loss of $3.1 million for the same period in 2024 primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred net losses since our inception. For the nine months ended September 30, 2024 and 2023, we had net losses of $29.0 million and $32.6 million, respectively. We expect to incur additional losses in the near-term future due to significant expenses incurred related to the research and development phase. At September 30, 2024, we had an accumulated deficit of $336.6 million. We continue our efforts to develop our products and continue the development of our pipeline in the near term and to date, we have generated only limited revenues.
As of September 30, 2024, we had cash of $13.3 million. While we are actively exploring various strategies to optimize our cash flows, we recognize that our current capital resources will be sufficient to fund our operating plan for at least one year from the issuance of these unaudited condensed consolidated financial statements.
We have funded our operations primarily through issuing debt and equity securities, in addition to selling our commercial products. Cash provided by financing activities for the nine months ended September 30, 2024, were generated from the issuance of an aggregate of 6,925,606 shares of common stock under the ATM Agreement for total net proceeds of approximately $27.8 million, and issuance of an aggregate 277,778 common in exchange of License Agreement for total net proceeds of $1.2 million.
We expect our expenditures will continue to increase as we continue our efforts to develop our products and continue the development of our pipeline in the near term. We may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. We may also not be successful in entering into partnerships that include payment of upfront licensing fees for our products and product candidates for markets outside the United States, where appropriate. If we do not generate upfront fees from any anticipated arrangements, it would have a negative effect on our operating plan. We still plan to finance our operations and capital funding needs through equity and debt financing as well as revenue from future product sales. However, there can be no assurance that additional funding will be available to us on acceptable terms on a timely basis, if at all, or that we will generate sufficient cash from operations to fund operating needs or ultimately achieve profitability adequately. If we are unable to obtain an adequate level of financing needed for the long-term development and commercialization of our products, we will need to curtail planned activities and reduce costs. Doing so will likely have an adverse effect on our ability to execute on our business plan.
Liquidity Management
As of September 30, 2024, the Company is actively monitoring trends in its capital resources, recognizing favorable and unfavorable developments that may materially impact its financial position. The Company has experienced a slight increase in debt levels due to recent financing activities intended to support operational growth. In contrast, equity levels remain stable, though future fundraising efforts may affect the capital structure.
The Company expects changes in the mix of capital resources, particularly concerning the relative costs of debt versus equity financing. Current market conditions indicate a trend of rising interest rates, which may increase the cost of future debt issuances.
Furthermore, the Company recognizes challenges related to liquidity. It has incurred recurring operating losses and negative cash flows, which raises uncertainties about its future liquidity. The ability to meet current obligations relies on successful ongoing development efforts and securing additional financing.
61
While the Company plans to finance its operations through equity and/or debt financing, collaboration arrangements, and revenue from future product sales, it currently believes that existing cash balances may not be sufficient to fund its operating plan in the next years. There can be no assurance that additional funding will be available on acceptable terms.
To address these liquidity concerns, the Company is committed to pursuing all available avenues for financing and will continuously assess its capital structure and operational needs to ensure financial stability.
Comparison of Operating Income and Cash Flow
For the nine months ended September 30, 2024, the Company’s operating cash flows showed a significant improvement over the prior period, primarily due to reductions in cash outflows associated with operating expenses. Operating income, while still negative at a loss of $29.0 million, improved by $3.6 million, or 11%, over the prior period due to a decrease in total operating expenses. This reflects the Company's efforts in cost containment. However, while operating cash flows benefited from these reductions, the ongoing significant variation between operating income and operating cash flows, highlights challenges in achieving cash flow positivity due to high non-cash charges, such as depreciation and stock-based compensation, alongside increased working capital needs to support expanded operations. This variation highlights the Company’s strategic focus on managing liquidity to maintain operational stability and pursue growth opportunities effectively.
Analysis of Cost of Capital Resources
Changes in market conditions may impact our cost of capital resources. Rising interest rates could increase our cost of debt, while seeking equity financing may lead to higher required returns on equity due to potential dilution. We will actively monitor these factors as part of our financial strategy.
Cash Flows for the Nine Months Ended September 30, 2024 Compared to the Nine Months Ended September 30, 2023
The following table shows a summary of cash flows for the nine months ended September 30, 2024 and 2023:
|
|
Nine Months Ended September 30, |
|
|||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
||||
Total cash used in operating activities |
|
$ |
|
(21,558 |
) |
|
$ |
|
(25,791 |
) |
Total cash used in investing activities |
|
|
|
(16 |
) |
|
|
|
— |
|
Total cash provided by financing activities |
|
|
|
28,372 |
|
|
|
|
23,577 |
|
Effects of foreign exchange rate changes on assets and liabilities |
|
|
|
2 |
|
|
|
|
(29 |
) |
Net increase in cash |
|
$ |
|
6,800 |
|
|
$ |
|
(2,243 |
) |
Cash Used in Operating Activities
During the nine months ended September 30, 2024, net cash used in operating activities of $21.6 million resulted from our net comprehensive loss of $29.1 million, adjusted by the change in fair value of financial instrument and hybrid instrument designated at FVO of $6.9 million, depreciation and amortization expenses of $1.4 million, stock-based compensation of $1.3 million, amortization of operating lease right-of-use asset of $343,000, amortization of debt discounts and debt issuance costs of $274,000, equity in a net loss in the joint venture of $78,000, shares issued in exchange of services $9,000 and partly offset by changes in operating assets and liabilities of $2.2 million and gain on extinguishment of debt of $1.2 million.
Net cash used in operating activities decreased by $4.2 million from the prior year, indicating improved efficiency. However, cash flows remain insufficient to meet ongoing requirements, underscoring the Company's reliance on alternative funding sources.
During the nine months ended September 30, 2023, net cash used in operating activities of $25.8 million resulted from our net comprehensive loss of $32.7 million adjusted by the change in fair value of financial instrument and hybrid instrument designated at FVO of $3.4 million, amortization of debt discounts and debt issuance costs of $11.5 million, stock-based compensation of $1.5 million, depreciation and amortization expenses of $1.5 million, amortization of operating lease right-of-use asset of $286,000, shares issued in exchange of services of $166,000, equity in a net loss in the joint venture of $42,000, gain on extinguishment of debt of $3.7 million and changes in operating assets and liabilities of $7.8 million.
62
Cash Used in Investing Activities
During the nine months ended September 30, 2024, net cash used in investing activities of $16,000 consisted of a $16,000 purchase of equipment.
Cash outflows for investing activities were minimal at $16,000 in 2024, dedicated solely to equipment purchases. This reflects management's commitment to maintaining liquidity, as there were no cash outflows for investing activities in the prior year.
No cash is used in investing activities during the nine months ended September 30, 2023.
Cash Provided by Financing Activities
During the nine months ended September 30, 2024, net cash provided by financing activities of $28.4 million consisted of $27.8 million in net proceeds from shares issued in an At the Market offering, $1.2 million proceeds from the issuance of common shares in exchange of License Agreement, offset by $437,000 repayment of insurance financing, and $100,000 in principal payments of the notes payable.
Net cash provided by financing activities increased to $28.4 million in 2024, primarily from an ATM offering and share issuance related to licensing agreement. This trend underscores the Company's ongoing necessity to leverage external financing to address cash flow shortfalls from operations.
During the nine months ended September 30, 2023, net cash provided by financing activities of $23.6 million consisted of $20.8 million in net proceeds from shares issued in an At the Market offering, $1.2 million net proceeds from issuance of warrants in PIPE financing, $611,000 net proceeds from issuance of preferred shares in PIPE financing and noncontrolling interest of $1.2 million, offset by $293,000 repayment of insurance financing, and $50,000 in principal payments of the notes payable.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Our management, Chief Executive Officer, and Principal Financial and Accounting Officer evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2024. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms.
Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial and Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our Chief Executive Officer and Principal Financial and Accounting Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2024.
Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(c) under the Exchange Act. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of the effectiveness of internal control in future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate. Under the supervision and with the participation of our management, including our Chief Executive Officer and Principal Financial and Accounting Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of September 30, 2024, using the criteria established in Internal Control-Integrated Framework (“2013 Framework”) issued by the Committee of Sponsoring Organization of the Treadway Commission (“COSO”). Based on our evaluation using those criteria, our management has concluded that, as of September 30, 2024, our internal control over financial
63
reporting was effective in providing reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP for the reasons discussed above.
This Quarterly Report on Form 10-Q does not include an attestation report of our registered public accounting firm on our internal control over financial reporting because we are a smaller reporting company and are not subject to auditor attestation requirements under applicable SEC rules.
There were no changes in our internal control over financial reporting that have materially affected or are reasonably likely to materially affect, our internal control over financial reporting.
64
PART II. — OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us due to defense and settlement costs, diversion of our management resources, and other factors. We are not currently subject to any material legal proceedings.
Item 1A. Risk Factors
The following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other statements in this Quarterly Report on Form 10-Q, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed consolidated financial statements and related notes, before making a decision to invest in our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations. If any of the events or circumstances described in the following risk factors actually occur, our business, operating results, financial condition, cash flows, and prospects could be materially and adversely affected. In that event, the market price of our common stock could decline, and you could lose part or all of your investment.
The business, financial condition, and operating results of the Company can be affected by a number of factors, whether currently known or unknown, including but not limited to those described below, any one or more of which could, directly or indirectly, cause the Company’s actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect the Company’s business, financial condition, operating results, and stock price.
Because of the following factors and other factors affecting the Company’s financial condition and operating results, past financial performance should not be considered a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.
Our royalty interests require us to make minimum royalty payments, even if we do not sell sufficient products to cover such.
Since March 2020, we have sold royalty interests to certain lenders that entitle such lenders to receive future royalties on sales of our products. These royalty interests require us to make minimum royalty payments beginning in 2021, even if we do not sell a sufficient amount of product to cover such payments, which may strain our cash resources. Total minimum royalty payments, approximately totaling $36.0 million, will commence in 2026.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On July 15, 2024, the Company entered into a privately negotiated exchange agreement with a holder of royalty interest in the Company pursuant to which the Company issued 455,000 shares of the Company’s common stock, par value $0.0001 to such holder in exchange for a $1,851,850 reduction in the outstanding balance of the royalty interest held by such holder.
On July 18, 2024, the Company entered into a privately negotiated exchange agreement with Iliad pursuant to which the Company issued 200,000 shares of the Company’s common stock, par value $0.0001 to Iliad in exchange for a $819,600 reduction in the outstanding balance of the royalty interest dated October 8, 2020.
The shares of common stock that were issued in the exchange transactions described above were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act.
Other than equity securities issued in transactions disclosed above and on our Current Reports on Form 8-K filed with the SEC on June 10, 2024, and July 16, 2024, there were no unregistered sales of equity securities during the period.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
65
Item 5. Other Information
66
Item 6. Exhibits
Exhibit No. |
|
Description |
3.1 |
|
|
10.1 |
|
|
10.2 |
|
|
31.1* |
|
|
31.2* |
|
|
32.1** |
|
Certification Pursuant to 18 U.S.C. § 1350 (Section 906 of Sarbanes-Oxley Act of 2002). |
32.2** |
|
Certification Pursuant to 18 U.S.C. § 1350 (Section 906 of Sarbanes-Oxley Act of 2002). |
101.INS |
|
Inline XBRL Instance Document– the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104 |
|
The cover page for the Company’s Quarterly Report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101 |
|
|
|
|
|
|
|
|
|
|
|
|
* Filed herewith.
** In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 34 47986, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10 Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933 except to the extent that the registrant specifically incorporates it by reference.
67
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.
November 13, 2024 |
|
|
|
JAGUAR HEALTH, INC. |
|
|
|
|
|
By: |
/s/ Carol R. Lizak |
|
|
Principal Financial and Accounting Officer |
68