美国
证券交易委员会
华盛顿特区20549
表格
（标记一）
根据1934年证券交易法第13或15(d)节的季度报告 |
截至季度结束日期的财务报告
或者
根据1934年证券交易法第13或15(d)节的转型报告书 |
过渡期从_____到_____
委托文件编号：001-39866
（依据其宪章指定的注册名称）
（国家或其他管辖区的 公司成立或组织） |
（IRS雇主 |
，（主要行政办公地址） |
(邮政编码) |
公司电话，包括区号：
在法案第12(b)条的规定下注册的证券：
每一类的名称 |
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交易 符号: |
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在其上注册的交易所的名称 |
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请在以下复选框中打勾，指示注册人：(1)在前12个月(或注册人被要求提交这些报告的更短期间内)已经提交了1934年证券交易法第13或15(d)条规定需要提交的所有报告；以及(2)在过去的90天内一直受到了此类文件提交要求的限制。
请在勾选标志处表示注册人是否已经在过去12个月内（或者在注册人要求提交这些文件的较短时期内）按照规则405 of协议S-T（本章节的§232.405）提交了每个交互式数据文件。 ☒ 没有 ☐
请勾选标记以说明注册人是大型快速申报人、加速申报人、非加速申报人、较小的报告公司还是新兴成长型公司。请查看《交易所法》第120亿.2条中“大型快速申报人”、“加速申报人”、“较小的报告公司”和“新兴成长型公司”的定义。
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非加速过滤器 |
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规模较小的申报公司 |
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新兴成长型公司 |
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如果是新兴成长型企业，请勾选复选标记，表明注册者已选择不使用延长过渡期来符合根据证券交易法第13(a)条规定提供的任何新财务会计准则。 ☐
请在检查标记处说明申报人是否为外壳公司 (见交易所法案 Rule 12b-2 定义)。 是☐ 没有
截至2024年11月4日，注册人员已
目录
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页面 |
第一部分 |
4 |
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第 1 项。 |
4 |
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4 |
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第 2 项。 |
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第 3 项。 |
38 |
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第 4 项。 |
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第二部分。 |
39 |
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第 1 项。 |
39 |
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第 1A 项。 |
39 |
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第 2 项。 |
39 |
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第 3 项。 |
39 |
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第 4 项。 |
39 |
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第 5 项。 |
39 |
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第 6 项。 |
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adaptive biotechnologies公司
前瞻性声明
此报告包含基于管理层信念和假设以及目前管理层可获得信息的前瞻性声明。除历史事实声明外，本报告中所有声明均属于前瞻性声明，其中包括但不限于以下声明：
本报告中的前瞻性声明还包括关于我们开发、商业化和市场接受我们现有和计划中的产品和服务的能力，以及我们的研发工作和有关业务战略、资本使用、经营业绩、财务状况、未来经营计划和目标等方面的声明。在某些情况下，您可以从以下词语中辨认出前瞻性声明：“可能”，“将”，“可能”，“应该”，“期望”，“打算”，“计划”，“预期”，“相信”，“估计”，“预测”，“项目”，“潜在”，“继续”，“正在进行”或这些术语的否定形式或其他类似术语，尽管并非所有前瞻性声明都包括这些词语。这些声明涉及风险、不确定性和其他因素，可能导致实际结果、活动水平、业绩或成就与这些前瞻性声明所表达或暗示的信息有实质性不同。这些风险、不确定性和其他因素在本报告中的“风险因素”、“管理层对财务状况和经营业绩的讨论”以及其他地方描述，以及我们不时向证券交易委员会（“SEC”）提交的其他文件中描述。我们警告您，前瞻性声明基于我们目前已知的事实和因素的组合，以及我们对未来的预测，关于这些事我们不能确定。因此，这些前瞻性声明可能不会被证实准确。本报告中的前瞻性声明代表我们截至本报告日期的观点。
我们不承担更新任何前瞻性声明的义务，除非法律要求。
除非另有说明或情境另有指示，“我们”，“我们”，“我们”和类似参照指的是adaptive biotechnologies公司。
3
adaptive biotechnologies公司
第一部分——财务拨号信息
项目1. 财务报表（未经审核的）
汇总的资产负债表（未经审计） 表格
(以千为单位，除每股数据外)
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2024年9月30日 |
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2023年12月31日 |
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(未经审计) |
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资产 |
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流动资产 |
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现金及现金等价物 |
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$ |
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$ |
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短期市场有价证券（摊销成本为$ |
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2,687,823 |
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库存 |
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预付费用和其他流动资产 |
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总流动资产 |
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长期资产 |
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资产和设备，净值 |
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经营租赁权使用资产 |
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长期市场证券（摊销成本为$ |
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— |
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受限现金 |
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无形资产, 净额 |
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商誉 |
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其他 |
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资产总额 |
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$ |
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$ |
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负债和股东权益 |
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流动负债 |
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应付账款 |
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$ |
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$ |
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应计负债 |
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应计的薪酬和福利 |
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经营租赁负债流动部分 |
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递延营收的当前部分 |
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流动负债合计 |
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长期负债 |
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租赁负债，除去当前部分 |
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递延营业收入，减去流动部分 |
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营业收入利息负债净额 |
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其他长期负债 |
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— |
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负债合计 |
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股东权益 |
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4,998,000,000 |
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普通股：$ |
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额外实收资本 |
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累计其他综合收益 |
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累积赤字 |
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( |
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( |
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自适应生物技术公司的股东权益总额 |
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非控股权益 |
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( |
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( |
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股东权益合计 |
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负债和股东权益总计 |
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$ |
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$ |
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附注是这些简明合并财务报表的组成部分。
4
adaptive biotechnologies公司
现金流量简明合并报表操作
(以千为单位，除每股数据外)
(未经审计)
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截至9月30日的三个月 |
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截至9月30日的九个月 |
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2024 |
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2023 |
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2024 |
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2023 |
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收入 |
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$ |
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$ |
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$ |
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$ |
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运营费用 |
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收入成本 |
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研究和开发 |
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销售和营销 |
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一般和行政 |
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无形资产的摊销 |
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长期资产的减值 |
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— |
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— |
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— |
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运营费用总额 |
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运营损失 |
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( |
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( |
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( |
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( |
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利息和其他收入，净额 |
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利息支出 |
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( |
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( |
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( |
) |
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( |
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净亏损 |
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( |
) |
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( |
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( |
) |
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( |
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添加：归因于非控股权益的净亏损 |
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归因于自适应生物技术公司的净亏损 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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归属于适应性生物技术公司普通股股东的每股净亏损（基本亏损和摊薄后） |
|
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
用于计算归属于自适应生物技术公司普通股股东的每股净亏损的加权平均股份，基本和摊薄后 |
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附注是这些简明合并财务报表的组成部分。
5
adaptive biotechnologies公司
压缩综合财务报表综合损益表和综合损失表
（以千为单位）
(未经审计)
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截至9月30日的三个月 |
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截至9月30日的九个月 |
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2024 |
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2023 |
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2024 |
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2023 |
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净损失 |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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$ |
( |
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其他综合收益 |
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投资的未实现收益和损失变动 |
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综合损失 |
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( |
) |
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( |
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( |
) |
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( |
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添加：归属于非控股利益的综合损失 |
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适用生物技术公司的综合损失 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
附注是这些简明合并财务报表的组成部分。
6
adaptive biotechnologies公司
（以千为单位，除股份数量外）
(未经审计)
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普通股 |
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额外 |
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累积其他 |
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累积 |
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非控制性 |
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总计 |
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股票 |
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金额 |
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实收资本 |
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综合（亏损）收益 |
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赤字 |
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利息 |
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股东权益 |
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截至 2023 年 6 月 30 日的余额 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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$ |
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在行使股票期权时以现金发行普通股 |
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— |
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— |
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— |
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— |
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限制性股票单位的归属 |
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— |
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— |
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— |
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— |
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— |
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— |
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基于股份的薪酬支出 |
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— |
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— |
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— |
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— |
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— |
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其他综合收入 |
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— |
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— |
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— |
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— |
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— |
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净亏损 |
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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 2023 年 9 月 30 日的余额 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
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截至 2024 年 6 月 30 日的余额 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
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在行使股票期权时以现金发行普通股 |
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— |
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— |
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— |
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— |
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限制性股票单位的归属 |
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— |
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— |
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— |
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— |
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— |
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— |
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基于股份的薪酬支出 |
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— |
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— |
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— |
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— |
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— |
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其他综合收入 |
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— |
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— |
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— |
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— |
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— |
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净亏损 |
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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 日的余额 |
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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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附注是这些简明合并财务报表的组成部分。
7
adaptive biotechnologies公司
综合股东权益简明合并报表（续）
（以千为单位，除股份数量外）
(未经审计)
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普通股 |
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额外的 |
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其他积累 |
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累积的 |
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非控制权益 |
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总计 |
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股份 |
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金额 |
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实收资本 |
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综合（损失）盈利 |
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赤字 |
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利息 |
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股东权益 |
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2022年12月31日结存余额 |
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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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发行普通股以换取期权现金 |
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— |
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— |
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— |
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— |
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受限制股票单位解除限制 |
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— |
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— |
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— |
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— |
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— |
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— |
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基于股份的报酬支出 |
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— |
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— |
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— |
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— |
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— |
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2023年9月30日结余 |
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$ |
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$ |
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2023年12月31日结余为 |
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发行普通股以换取期权现金 |
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受限制股单位的分配，净值 |
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基于股份的报酬支出 |
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其他综合收益 |
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净损失 |
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— |
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2024年9月30日的余额 |
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$ |
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$ |
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$ |
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$ |
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附注是这些简明合并财务报表的组成部分。
8
adaptive biotechnologies公司
现金流量简明合并报表现金流量表
（以千为单位）
(未经审计)
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截至9月30日的九个月 |
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2024 |
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2023 |
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经营活动 |
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净损失 |
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$ |
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$ |
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调整净亏损为经营活动使用的现金净额 |
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折旧费用 |
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无形资产摊销 |
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投资摊销 |
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长期资产减值 |
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— |
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库存准备 |
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非现金利息支出 |
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其他 |
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营运资产和负债的变化 |
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2,687,823 |
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( |
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库存 |
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( |
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预付费用和其他流动资产 |
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应付账款及应计费用 |
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经营租赁权益资产和负债 |
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( |
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递延收入 |
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( |
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( |
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其他 |
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( |
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经营活动使用的净现金流量 |
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( |
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投资活动 |
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购买固定资产 |
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购买有市场流通的证券 |
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可市场出售证券到期款 |
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投资活动提供的净现金流量 |
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筹资活动 |
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行使股票期权所得 |
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筹资活动产生的现金净额 |
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现金、现金等价物和受限制现金净减少额 |
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( |
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年初现金、现金等价物和受限制的现金余额 |
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期末现金、现金等价物及受限制的现金余额 |
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$ |
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$ |
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非现金投资活动 |
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设备采购已计入应付账款和预提费用 |
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$ |
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$ |
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现金流量补充披露 |
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支付的利息现金 |
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$ |
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附注是这些简明合并财务报表的组成部分。
9
adaptive biotechnologies公司
简明联合财务报表附注(未经审计)
(未经审计)
1. 业务的组织和描述
adaptive biotechnologies公司（“我们”或“我们的”）是一家商业阶段公司，通过利用适应性免疫系统的固有生物学来推动免疫医学领域的发展，从而改变疾病的诊断和治疗。我们相信适应性免疫系统是大自然调谐最精细的用于大多数疾病的诊断和治疗的工具，但是由于无法解码它，医疗界无法充分利用其能力。我们的免疫医学平台应用我们的专有技术来读取患者免疫系统的多样基因密码，并准确了解免疫系统如何检测和治疗该患者的疾病。我们将这些洞察力记录在我们动态临床免疫学数据库和相关抗原注释中，这些信息由计算生物学和机器学习支持，用于开发和商业化可根据个体患者需要定制的临床产品和服务。我们拥有商业产品和服务以及一系列临床产品和服务的强大管道，我们正在设计这些产品和服务以诊断、监测和促进治疗癌症和自身免疫性疾病等疾病。
我们成立于2009年9月8日，是一家总部位于华盛顿州的公司，最初的名字为Adaptive TCR Corporation。在2011年12月21日，我们将公司更名为adaptive biotechnologies 公司，总部位于华盛顿州西雅图。
2。重要会计政策
列报基础和合并原则
未经审计的简明合并财务报表包括自适应生物技术公司、我们的全资子公司Adaptive Biotechnologies B.V. 和我们的公司子公司Digital Biotechnologies, Inc. 的账目
估算值的使用
根据美利坚合众国普遍接受的会计原则（“GAAP”）编制简明合并财务报表要求管理层做出某些估计、判断和假设，这些估计、判断和假设会影响简明合并财务报表之日报告的资产负债金额和相关披露，以及报告期内报告的收入和支出金额。我们的估计基于历史经验和其他我们认为在当时情况下合理的相关假设。估算值用于多个领域，包括但不限于对某些履约义务迄今为止进展的估算以及与客户签订的某些合同的交易价格、基于股份的薪酬、我们的收入利息购买协议（“收购协议”）的估算利息、包括相关储备金在内的所得税准备金、商誉减值分析以及长期资产的可收回性和减值等。这些估计通常涉及复杂的问题，需要作出判断，涉及对历史结果的分析和对未来趋势的预测，可能需要很长时间才能解决，并且可能因时期而异。实际结果可能与管理层的估计存在重大差异。
未经审计的中期简明合并财务报表
我们认为，随附的未经审计的简明合并财务报表是根据中期财务信息的公认会计原则编制的。这些未经审计的简明合并财务报表包括根据公认会计原则公允陈述我们的财务状况以及中期经营业绩和现金流所必需的所有调整。所有这些调整都是正常的、经常性的。中期业绩不一定代表全年或任何后续中期的经营业绩或现金流量。
随附的未经审计的简明合并财务报表应与我们在2024年2月29日向美国证券交易委员会（“SEC”）提交的截至2023年12月31日止年度的10-k表年度报告中包含的经审计的合并财务报表和附注一起阅读。
细分信息
我们的运作方式是
10
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
限制性现金
截至2024年9月30日和2023年12月31日，我们的受限现金余额为 $
商誉
商誉代表收购价格高于以公允价值计量的商业组合中获得的可识别资产和承担的负债的净额的部分。我们每年在10月1日评估商誉的减值情况，或者如果事件或情况的变化更有可能将我们一个或两个报告单位的公允价值降低至它们各自的账面价值以下，则更频繁地进行评估。我们首先评估定性因素来判断我们一个或两个报告单位的公允价值是否很可能低于它们各自的账面价值。如果我们做出这样的判断，或者选择跳过定性评估，我们将进行数量化商誉减值测试。如果存在减值，分配的商誉账面价值将通过在综合损益表中记录的减值损失减少至其公允价值。到目前为止，我们尚未确认任何商誉减值。
风险集中
我们面临来自有限数量供应商的风险集中，或在某些情况下，来自单一供应商的风险，用于一些实验室仪器和材料。通过制定多余库存的数量来管理这种风险。
现金、现金等价物和有市场的证券是潜在使我们面临信用风险集中的金融工具。我们投资于货币市场基金、美国政府国债和机构债券、高素质认可的金融机构的企业债券和商业票据。
收入确认
对于所有产生营业收入的合同，我们执行以下步骤来确定应确认的营业收入金额：(1)确认合同或合同；(2)判断承诺的货物或服务是否履行义务，包括它们在合同背景中是否是独立的；(3)测量交易价格，包括对变量考虑的限制；(4)根据估计的销售价格将交易价格分配给履行义务；以及(5)在满足每项履行义务时（或按照这样的方式）确认营业收入。
我们通过在我们的MRD和免疫医学业务领域提供诊断和研究服务来获得营业收入。我们的MRD营收包括从（1）向临床客户提供我们的clonoSEQ报告；（2）向生物制药客户和某些学术机构提供MRD样品测试服务，包括研究者主导的临床试验；以及（3）通过技术转移向特定国际实验室站点提供我们的clonoSEQ报告或结果所产生的收入。我们的免疫医学收入包括通过向生物制药客户和学术机构提供商业研究产品Adaptive Immunosequencing的样品测试服务以及与Genentech公司（“Genentech”）和其他生物制药客户在药物和靶标发现领域的合作协议所产生的收入。
对于我们向医生提供clonoSEQ报告的协议，我们确定一个履行义务：交付clonoSEQ报告。我们向商业、政府和医疗机构支付方接收这些交易的账单和款项。由于来自各方付款人的支付可能基于各种报销率和患者责任而有所不同，我们认为交易价格是可变的，并在交付时将交易价格的估计（受变量考虑约束）作为营收记录。交易价格的估计基于与各付款人的历史和预期的报销率，这些报销率在随后的期间进行监测，并根据实际收款经验进行必要的调整。
关于我们在医疗保险下的clonoSEQ覆盖范围，当我们交付首次符合条件的测试报告时，我们会向一个治疗周期内的患者进行一次治疗的账单。这项计费考虑了患者治疗周期内所需的所有必要测试，目前估计每个患者大约需要进行四次测试，包括最初的序列鉴定测试。营业收入的确认从交付首次可计费测试报告的时候开始，并根据至今交付的累积测试来计算。我们根据患者按指标进行历史测试的频率，估计我们预计在患者治疗周期内进行的测试次数。这些估计可能会随着我们随时间获得更多关于利用率的信息而发生变化。来自初始可计费测试的任何未认可的营业收入会被记录为递延收入，或者会在我们交付了患者治疗周期内剩余测试的估计时予以确认，或者在患者不太可能接受额外测试时予以确认。
11
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
我们与生物制药客户签订的合同交易价格，用于进一步开发和商业化其治疗药物的协议，可能由不可退还的预付款、单独定价的MRD测试费以及在我们客户达到特定监管批准时获得的里程碑费用组成。根据合同的不同，这些协议包括单个或多个履约义务。此类履约义务包括提供支持服务，支持客户治疗药物的开发工作，包括在我们的技术将作为客户注册试验的一部分而被使用的情况下提供监管支持，为我们的数据制定分析计划，参与联合委员会，协助完成监管提交，并为客户提交的样本提供MRD测试服务。通常情况下，除MRD测试服务外的支持服务在合同范围内不具备明显区分性，因此被视为单一履约义务。分配给各个履约义务的交易价格是根据调整后的市场评估方法来估计监管支持服务的价格以及估计MRD测试服务的独立销售价格。当MRD样本测试服务作为单独定价的客户期权时，我们将评估是否存在重要权利，如果不存在，则不将购买额外MRD样本测试服务的客户期权视为合同的一部分。我们根据所交付样本结果所占的比例以及预期交付的总样本结果量来随时间确认与MRD测试服务相关的营业收入，以输出法为基础，当能够忠实呈现进展时。我们使用同样的方法来确认监管支持服务。当基于交付的样本结果比例的输出法无法忠实展示进展时，我们会使用基于成本的输入法，根据完成工作量的估计情况。选择衡量进展的方法和估计迄今为止的进展需要进行重大判断。除了任何不可退还的预付款外，其他形式的报酬都代表着变量报酬。在合同初衷时，我们会完全限制与监管里程碑相关的任何考虑，因为此类里程碑的达成取决于第三方监管批准以及客户自身的提交决策。与监管里程碑相关的变量考虑是使用最可能金额法来估计的，在确认之前，变量考虑都会受到限制，以确保不会发生重大累计收入的逆转。监管批准里程碑付款，这取决于不在客户控制范围内的审批，直到获得这些批准后才被视为可能实现。确定监管里程碑付款是否可能实现是一个需要进行重大判断的领域。在进行此评估时，我们评估科学、临床、监管以及其他风险，以及实现各个里程碑所需的努力和投资水平。
对于使用我们的MRD或自适应免疫测序服务的研究客户，合同通常包括预付款项（“预付款”）和随后的账单，随着样本结果交付给客户。收到的预付款项被记录为递延营业收入，我们在履行绩效义务后将其确认为营业收入。我们已确定研究服务合同条款下的两种典型绩效义务：（1）为客户提供样本的MRD数据或自适应免疫测序的交付；和（2）相关数据分析。随着样本结果交付给客户，我们为已确认的两项绩效义务确认营业收入。在样本估算减少或客户项目取消的情况下，且在两种情况下我们仍有相关的递延收入余额时，我们根据已交付样本数量占预期总样本数量的比例采用累计补足方法确认营业收入。
尚未采用新的会计准则
2013年11月，财务会计准则委员会（“FASB”）发布了会计准则更新（“ASU”）2023-07。 黑石矿产有限合伙企业及附属企业（主题280）： 报告业务板块披露的改进，旨在加强关于重大业务部门支出的可报告细分披露。本指引适用于2023年12月15日后开始的财政年度以及2024年12月15日后开始的财政年度内的中期时段。允许提前采用，并且指引要求以追溯方式应用。我们目前正在评估本指引对我们的合并财务报表和相关披露的影响。
2023年12月，FASB发布了ASU No. 2023-09， 所得税 （话题740） 所得税披露改进主要意图是增强利率对账和所得税支付披露。该指南对于从2024年12月15日之后开始的年度期间生效。允许提前采纳，并建议展望式应用；允许追溯应用。我们目前正在评估该指南对我们的合并财务报表和相关披露的影响。
2024年11月，FASB发布了ASU No. 2024-03， 损益表-报告综合收益-费用细分披露 (子课题220-40)损益表开支分项披露旨在通过要求对特定费用类别的额外信息披露来改进财务报告的指导意见。本指导意见适用于2026年12月15日后开始的年度报告期和2027年12月15日后开始的中期报告期。允许提前采纳，指导意见应按照前瞻性应用，并可按照回顾性应用。我们目前正在评估此指导对我们的合并财务报表和相关披露的影响。
12
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
3. 营业收入
我们通过按业务领域和安排类型细分合同与客户的收入，因为我们认为这样最能准确展示我们的营业收入和现金流量在经济因素影响下的性质、金额、时间和不确定性。
以下表格显示了我们所列出时段的细分营业收入（以千为单位）：
|
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截至9月30日的三个月 |
|
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截至9月30日的九个月 |
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||||||||||
|
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2024 |
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2023 |
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2024 |
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2023 |
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||||
MRD 营业收入 |
|
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|
|
|
|
|
|
|
|
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|
||||
服务收入 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
监管里程碑营业收入 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
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||
MRD总营业收入 |
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|
|
|
|
|
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|
||||
免疫药物营业收入 |
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|
||||
服务收入 |
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|
||||
合作收入 |
|
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|
||||
免疫药物总营业收入 |
|
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|
|
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|
||||
总收入 |
|
$ |
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|
$ |
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$ |
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$ |
|
||||
2024年9月30日结束的三个月内，我们确认了$
2024年9月30日结束的九个月里，我们确认了营业收入$
截至2024年9月30日，如果我们的客户在MRD产品产生的MRD数据方面获得某些监管批准，我们将在未来的时期内最多可收到额外的百万美元里程碑付款 $
基因泰克合作协议
2018年12月，我们与干诺德（“干诺德协议”）签署了一项全球合作和许可协议，以利用我们在肿瘤学中开发细胞疗法的能力。在2019年1月获得监管批准后，我们于2019年2月收到了$百万的不可退还的预付款。此外，我们在2023年收到了$百万的里程碑款。我们可能有资格收到$
根据基尼科技协议的条款，我们向基尼科技授予了在肿瘤领域开发和商业化基于TCR的细胞疗法的排他性全球许可，包括对现有共享抗原数据包的许可。此外，基尼科技有权判断要进一步开发哪种产品候选者用于商业化目的。我们判断这一安排符合《会计准则法典》（“ASC”）主题808中规定的标准。 合作安排 《ASC 808》，因为双方都是活跃参与者, 并且根据活动的商业失败或成功承担重大风险和回报。由于ASC 808对如何处理协作安排下的活动没有提供指导，我们应用了ASC话题606中的指导。与客户签订合同的收入 《ASC 606》，以负责与Genentech协议相关的活动。
13
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
在应用ASC 606标准时，我们在协议签订时确定了以下履约义务：
我们确定，在合同范围内，许可证、研发服务或参与各种委员会的义务中，没有一个是独立的，因为这些权利和活动高度相关，并且需要进行大量额外的研发工作来进一步开发这些许可证。我们考虑了诸如各自现有抗原数据包的开发阶段、后续开发将需要确定和提交潜在的靶点以便根据两项产品途径提交新药申请的验收要求，以及在研发途径上的变化性，因为Genentech控制产品商业化。具体来说，在Genentech协议下，Genentech并非必须追求与两个产品途径相关的开发或商业化活动，并且可以选择继续进行其中之一。因此，我们确定所有确定的履约义务都归因于一个总的履约义务，即推动我们的TCR特异性平台的进一步发展，包括数据包，并继续使我们的TCR鉴定流程可供Genentech使用以追求任一产品途径。
另外，我们有责任向Genentech签订供应和制造协议，以生产特定患者的TCR，作为任何个性化产品治疗的一部分。我们确定这是Genentech的一个选择权，如果他们选择商业化个性化产品疗法。由于由于开发初期的不确定性，我们与Genentech合作的新颖方法，以及我们对未来商业里程碑和版税支付的权利，我们确定这个选择权不是一个应在开始阶段计入的重要权利。因此，当双方签订供应和制造协议时，我们将对其进行核算。
我们确定初始交易价格仅由$组成
由于可能需要实质性的发展，Genentech可能能够指导，我们确定我们将应用比例履行模型来识别我们的履约义务的营业收入。我们使用基于已发生成本相对于研究和开发工作的总估计成本的输入法来度量比例履行。继续追求Shared Products和Personalized Product路径的开发活动。当潜在的监管和开发里程碑不再受到完全限制并包含在交易价格中时，将使用累计补偿法基于当时的比例履行时间来确认这些金额。我们目前预计将在约
总共，我们承认了 $
14
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
4。递延收入
基因泰克协议的递延收入是 $
截至2024年9月30日的九个月中，递延收入的变化如下（以千计）：
截至 2023 年 12 月 31 日的递延收入余额 |
|
$ |
|
|
该期间递延收入的增加 |
|
|
|
|
该期间确认的收入 |
|
|
( |
) |
截至 2024 年 9 月 30 日的递延收入余额 |
|
$ |
|
截至 2024 年 9 月 30 日， $
5. 公允价值计量
以下表格列出了截至2024年9月30日和2023年12月31日按照重复计量公允价值的金融资产的公允价值（以千为单位）：
|
|
2024年9月30日 |
|
|||||||||||||
|
|
一级 |
|
|
二级 |
|
|
Level 3 |
|
|
总计 |
|
||||
金融资产 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
货币市场基金 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
商业票据 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
美国政府国库和机构债券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
公司债券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
所有财务资产 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
|
|
2023年12月31日 |
|
|||||||||||||
|
|
一级 |
|
|
二级 |
|
|
Level 3 |
|
|
总计 |
|
||||
金融资产 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
货币市场基金 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
商业票据 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
美国政府国债和机构债券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
公司债券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
所有财务资产 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
一级证券包括高度流动的货币市场基金，其公允价值我们基于相同资产或负债在活跃市场上的报价来衡量。 二级证券包括美国政府国库券、机构证券、公司债券和商业票据，并根据在不活跃市场上证券的最近交易或类似工具的报价市场价格以及其他可从可观察市场数据派生或证实的重要输入进行估值。
15
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
6. 投资
截至2024年9月30日和2023年12月31日，可供出售投资如下（以千计）：
|
|
2024年9月30日 |
|
|||||||||||||
|
|
摊销成本 |
|
|
|
|
|
未实现损失 |
|
|
估算公允价值 |
|
||||
短期市场证券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
商业票据 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
美国政府国债和机构债券 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
公司债券 |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
总的短期市场有价证券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
长期有价证券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美国政府国债 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
总的长期市场有价证券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
2023年12月31日 |
|
|||||||||||||
|
|
摊销成本 |
|
|
|
|
|
未实现损失 |
|
|
估算公允价值 |
|
||||
短期市场证券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
商业票据 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
美国政府国债和机构债券 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
公司债券 |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
总的短期市场有价证券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
所有美国政府国债和机构债券、公司债券和短期可变现证券，其有效到期日等于或少于各自的简明综合资产负债表日期距离一年。那些被指定为长期可变现证券的，其有效到期日则超过了各自的简明综合资产负债表日期一年。
应计利息应收款被排除在我们可变现证券的摊销成本和预估公允价值之外。截至2024年9月30日未经审计的简明综合资产负债表和分别截至2023年12月31日的简明综合资产负债表中，应计利息应收款分别在预付费用和其他流动资产余额内单独呈现。 $
以下表格显示了截至2024年9月30日处于未实现亏损位置的投资的毛未实现持有亏损和公允价值，以及个别证券处于持续亏损位置的时间长度（以千元计）。
|
|
不足12个月 |
|
|
持有12个月或以上 |
|
||||||||||
|
|
公正价值 |
|
|
未实现亏损 |
|
|
公允价值 |
|
|
未实现亏损 |
|
||||
美国政府国债和机构债券 |
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
所有可供出售证券总额 |
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
我们定期审查我们可供出售的证券，以评估信用损失。评估损失的一些考虑因素包括公允价值低于摊销成本基础的程度，与证券相关的不利条件，行业或地理区域，证券评级或行业信用评级的变化以及其他相关市场数据。
截至2024年9月30日，我们并不打算在可摊销成本基础恢复之前出售我们的可供出售投资，这可能是到期。根据我们的评估，截至2024年9月30日的所有损失都是由于除信用损失以外的因素，例如利率变动。未确认信贷准备金，我们可供出售证券的减值已记录在其他综合损失中。
7. 租赁
我们在华盛顿州西雅图、加利福尼亚州南旧金山和华盛顿州Bothell拥有实验室、办公室和仓库设施的经营租赁协议。2024年6月30日结束的三个月内，我们搬离了加利福尼亚州南旧金山的某些租赁空间，并发生了相关的减值损失。详情请参阅第12条注释。 重组 截至2024年9月30日，我们没有参与任何融资租赁。
16
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
以下表格将我们未折现的经营租赁现金流与2024年9月30日的经营租赁负债（以千为单位）进行了调节，减去当前部分余额：
2024年（不包括2024年9月30日结束的九个月） |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
此后 |
|
|
|
|
总未折扣租赁付款 |
|
|
|
|
减：隐含利率 |
|
|
( |
) |
总营业租赁负债 |
|
|
|
|
减：当前部分 |
|
|
( |
) |
租赁负债，除去当前部分 |
|
$ |
|
在2024年和2023年截至九个月的期间，用于计量租赁负债的支付现金为 $
我们有
8. 营业收入利益购买协议
2022年9月，我们与OrbiMed Royalty & Credit Opportunities IV，LP（“OrbiMed”）签订了购买协议，OrbiMed为奥卑梅德顾问有限责任公司的关联公司，担任抵押代理人和购买者方的行政代理人（“购买者”）。根据购买协议，我们在交割时从购买者那里收到$
作为这些付款的对价，购买者有权根据所有GAAP营业收入的一定百分比收取特定的营业收入利益（“营业收入利益”）。有关营业收入利益的支付应在每个财务季度结束后的第X天内进行季度支付（每个，一个“营业收入利益支付”）。
会计处理
我们将这笔交易列为按摊销成本计入的债务，使用有效利率法。
为了判断购买协议义务的摊销，我们需要根据对未来营业收入的时间和金额的估计，计算将该义务摊销至的有效利率。
根据购买协议，我们发生了债务发行成本达
确定债务的预期偿还期限和发行成本的摊销期所使用的假设需要我们进行估计，可能会影响这些成本的短期和长期分类，以及这些成本将摊销的期间。我们定期评估基于内部预测的预期营业收入利息支付的金额和时间。在这些支付额大于或小于我们的初始估计，或者支付时间与我们最初的估计有重大不同的情况下，我们将前瞻性地调整营业收入利息负债和有效利率的摊销。
17
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
以下表格详细列出了2024年9月30日终了的九个月内的营业收入利息负债、净活动（以千为单位）：
2023年12月31日的营业收入利息负债净额 |
|
$ |
|
|
利息支出 |
|
|
|
|
营业收入利息应付 |
|
|
( |
) |
2024年3月31日的营业收入利息负债净额 |
|
|
|
|
利息支出 |
|
|
|
|
营业收入利息应付 |
|
|
( |
) |
2024年6月30日的营业收入利息负债净额 |
|
|
|
|
利息支出 |
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|
|
|
应付利息收入 |
|
|
( |
) |
2024年9月30日应付的利息收入负债净额 |
|
$ |
|
应付的利息收入为$
9. 承诺和或有事项
法律诉讼
我们经常会在业务的正常过程中受到索赔和评估。当可能已经发生责任且金额可以合理估计时，我们将为此类事项计提负债。当只能确定可能损失的区间时，我们会计提区间内最有可能发生的金额。如果在该区间内没有比其他更好的估算金额，则会计提区间内最小的金额。截至2024年9月30日，我们没有参与任何重大法律诉讼。
保护协议
在业务的正常过程中，我们可能会向供应商、出租人、客户和其他方提供各种程度和条款的补偿，涉及某些事项，包括但不限于由他们与我们签订的协议违约或第三方提出的知识产权侵权索赔而产生的损失。此外，我们已与董事会成员和某些高管签订了补偿协议，要求我们对可能因他们作为董事或高管的身份或服务而产生的某些责任进行赔偿。根据这些补偿协议，我们将来可能需要支付的最大潜在金额在许多情况下是无限制的。截至目前，我们尚未因此类赔偿而产生任何重大成本，并且目前也没有意识到任何赔偿要求。
10.股东权益
普通股
我们的普通股没有任何偏好或特权，也不可赎回。
的当时可发行的股份数量增加，增加数量为以下两者中较小者：
此外，我们的员工股票购买计划（“ESPP”）规定，2020年1月1日及以后的每个1月1日，根据以下最小数量的股份数量增加：
自2024年1月1日起，我们2019计划和ESPP储备增加了
18
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
截至2024年9月30日，我们已为以下股份预留了普通股：
行使已发放的在外流通期权后可发行的股份 |
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可发行的在外流通受限股份单元已确定释放和最大未行使的市场为基础的受限股份单元 |
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2019年股权激励计划下用于未来授予的股份 |
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员工股票购买计划下用于未来授予的股份 |
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未来发行的普通股总数 |
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11.股权激励计划
2009股权激励计划
我们于2009年采纳了一项股权激励计划（以下简称“2009计划”），该计划规定发行激励性和非合格普通股期权以及其他股票为公司员工、董事和顾问提供激励。根据2009计划，激励性和非合格股票期权的行权价格不得低于授予日期我公司普通股的公允市场价。根据该计划授予的股票期权在授予之日起不迟于到期，而受限制股权的确立时间是在授予时确定的。根据2019计划的条款，根据2009计划最初授予的未行权、到期或因任何原因终止的股票期权而未向持有人交付股份的股份，将可用于根据2019计划授予的奖励。尽管2009计划下尚有股份用于未来授予，但该计划仍管辖在该计划下已授予的未行权股权奖励。
2019年股权激励计划
2019年计划在2019年7月首次公开招股之前立即生效。2019年计划规定向雇员、董事和顾问发放股票期权和其他以股票为基础的奖励。根据2019年计划，每股股票的行权价格不得低于授予日期当天股票的公允市值，除非在1986年《内部收入法典》的第409A条款或第424(a)条款的规定下明确合格。另外，除非另有规定，根据该计划授予的股票期权应在授予日起","之前到期，授予的时间在授予日确定。除非特定奖励授予给非雇员董事，否则在2019年计划下授予的股票期权和受限制的股票单位通常在一个","期内解锁，视持续服务至每个适用解锁日期而定。截至2024年9月30日，我们在2019年计划授权发行的普通股为","股。
2024年9月30日结束的九个月内，用于授予的股份发生了以下变化：
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可授予的股票 |
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2023年12月31日可以授予的股份 |
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2019年股权激励计划储备增加，自2024年1月1日起生效 |
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授予的股票期权和限制性股票单位，以及最大市场为基础的限制性股票单位的授予资格 |
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( |
) |
股票期权、限制性股票单位以及最大市场为基础的限制性股票单位的被放弃或到期情况 |
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2024年9月30日可以授予的股份 |
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19
adaptive biotechnologies公司
未审计的简明综合财务报表附注（续）
(未经审计)
股票期权
2009计划和2019计划在2024年9月30日结束的九个月内的股票期权活动如下：
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发行的受限股份 |
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加权平均行使 |
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总内在价值 |
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2023年12月31日未行使的股票期权 |
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$ |
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期权授予 |
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股票期权被放弃 |
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( |
) |
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股票期权到期 |
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( |
) |
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期权行权 |
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( |
) |
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2024年9月30日未行使的股票期权 |
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$ |
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$ |
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|||
2024年9月30日已授予并可行使的股票期权 |
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$ |
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$ |
|
|||
截至2024年9月30日，未行使股票期权的加权平均剩余合约期限为
受限股票单位
根据2019年计划，截至2024年9月30日结束的九个月内的受限制股份单位活动情况如下:
|
|
受限股票单位 |
|
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加权平均授予日期 |
|
||
2023年12月31日未获授的受限制股单位未归还 |
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$ |
|
||
授予的限制性股票单位数 |
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被取消的限制股单位 |
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( |
) |
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已授予限制性股份单位 |
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( |
) |
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2024年9月30日未获授的受限制股单位未归还 |
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$ |
|
||
市场限制股票单位
除上述受限制股单位外，我们董事会于2024年3月向我们的首席执行官、前首席财务官、总裁/首席运营官和首席科学官授予了基于市场的受限制股单位奖励，并于2024年5月向我们现任首席财务官授予了基于市场的受限制股单位奖励。根据授予给我们的首席执行官、前首席财务官(在其与公司分离前)、总裁/首席运营官、首席科学官和现任首席财务官的奖励，可获得的普通股股份数量在
20
自适应生物技术公司
未经审计的简明合并财务报表附注（续）
（未经审计）
授予日期的期权、限制股票单位和市场限制股票单位的公允价值
2024年和2023年9月30日结束的九个月内授予的期权的估计授予日期公允价值是使用Black-Scholes期权定价模型和以下假设估算的：
|
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截至9月30日的九个月 |
||
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2024 |
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2023 |
普通股的公允价值 |
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$ |
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$ |
预计期限（年） |
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||
无风险利率 |
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预期波动率 |
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||
预期股息收益 |
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— |
|
— |
使用Black-Scholes期权定价模型判断授予的股票期权授予日期公平价值受我们普通股公平价值的影响，以及涉及一系列主观变量的假设，通常需要判断来确定。估值假设如下确定：
普通股的公允价值——每股普通股的公允价值基于我们普通股在授予日期或其他相关确定日期的收盘价，如纳斯达克全球精选市场报告的价格。
预期期限—授予给员工和非雇员董事的股票期权的预期期限是使用ASC 718主题中所示的“简化”方法确定的，因为我们没有足够的行权历史来确定预期期限的更好估计。根据这种方法，预期期限是基于股票期权的认购日期和合同期限结束日期之间的中点。 报酬-股票报酬，因为我们没有足够的行权历史来确定预期期限的更好估计。根据这种方法，预期期限是基于股票期权的认购日期和合同期限结束日期之间的中点。
无风险利率在期权估值模型中，我们使用无风险利率，基于美国国债零息券的问题，剩余期限与股票期权的预期期限类似。
预期波动率直至2024年，由于我们的普通股没有足够的交易历史，预期波动率基于我们公开交易的行业同行的历史波动率，利用与我们预期期限一致的一段时间。自2024年开始，预期波动率是基于我们历史波动率和公开交易的行业同行的历史波动率的加权平均值，利用与我们预期期限一致的一段时间。
预期股息收益我们不预计在可预见的将来支付任何现金分红，因此，在期权估值模型中使用预期股息收益率为
2024年9月30日至2023年9月30日结束的九个月内授予的每股期权授予日期加权平均公允价值为 $
用于计算授予的受限股票单位的授予日期公平价值基于授予日或其他相关判断日期的我们普通股收盘价，如在纳斯达克全球精选市场报告的。截至2024年9月30日和2023年九个月结束时，每股授予的受限股票单位的加权平均授予日期公平价值为 $
截至2024年9月30日和2023年九个月结束时，每股授予的以市场为基础的受限股票单位的加权平均授予日期公平价值为$
21
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
The compensation cost related to stock options, restricted stock units and market-based restricted stock units for the three and nine months ended September 30, 2024 and 2023, respectively, are included on the unaudited condensed consolidated statements of operations as follows (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
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2024 |
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2023 |
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2024 |
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2023 |
|
||||
Cost of revenue |
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$ |
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$ |
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$ |
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$ |
|
||||
Research and development |
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Sales and marketing |
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General and administrative |
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||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
As of September 30, 2024, unrecognized share-based compensation expense and the remaining weighted-average recognition period were as follows:
|
|
Unrecognized Share-Based |
|
|
Remaining Weighted-Average |
|
||
Nonvested stock options |
|
$ |
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||
Nonvested restricted stock units |
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Nonvested market-based restricted stock units |
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||
十二.重组
在截至 2024 年 3 月 31 日止的三个月期间，我们实施了一项重组计划，以更好地将我们的组织与我们的一致性。
截至 2024 年 6 月 30 日止的三个月内，我们实施了额外的重组措施，这些措施影响了某些计划的软体增强功能，并导致某些研究和开发工作流程的整合。受影响的软体增强功能主要与我们的实验室资讯管理系统有关。作为这些重组的一部分，我们拥有长寿的资产不再被利用，并且我们在加利福尼亚州南三藩市的某些租赁空间放置了。因此，我们对相关资产的减值进行评估，方法是先将其帐面值与预计在其余租赁条款或折旧期间产生的未来未经折扣现金流进行比较，视适用情况而产生的未来未经折扣现金流。所有记录价值均被发现无法回收，因此我们评估资产的公平价值。资产的帐面价值超过其公平价值的程度代表要承认的减值成本。根据我们的评估结果，我们认识到 $
此外，我们产生的整体重组成本为 $
总计，我们承认的重组成本为 $
22
adaptive biotechnologies 公司
未经核数的简明综合基本报表附注（续）
(未经审计)
每股损失归属于adaptive biotechnologies股份有限公司普通股股东
以下表格列出了截至2024年9月30日及2023年9月30日的三个月和九个月的基本和稀释的每股净损，以千为单位，股份和每股金额除外：
|
|
截至9月30日三个月结束时， |
|
|
截至9月30日九个月结束时， |
|
||||||||||
|
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2024 |
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2023 |
|
|
2024 |
|
|
2023 |
|
||||
归属于adaptive biotechnologies股份有限公司的净损 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
计算归属于adaptive biotechnologies股份有限公司普通股股东的每股净损的基本和稀释的加权平均股份 |
|
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|
||||
归属于adaptive biotechnologies股份有限公司普通股股东的每股净损，基本和稀释 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
鉴于所有期间的亏损状况，我们的普通股股东应占的基本每股净损与应占的稀释每股净损相同，因为所有潜在的已发行普通股股份的含入将会导致抗稀释。
以下加权平均普通股等效证券未纳入截至2024年和2023年9月30日止三个月和九个月的稀释每股净亏损计算中，因其具有抗稀释效应：
|
|
截至9月30日三个月结束时， |
|
|
截至9月30日九个月结束时， |
|
||||||||||
|
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2024 |
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2023 |
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2024 |
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2023 |
|
||||
尚未行使的股票期权 |
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||||
未投资的受限制股票单位尚未实现 |
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||||
最大非投资型市场限制股票单位，有资格获得 |
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总计 |
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十四.区段资讯
在 2024 年，与组织重新调整有关，我们开始经营我们的业务
MRD 业务专注于使用我们高度敏感的下一代定序测试测量血液恶性肿瘤患者的 MRD。它包括我们向临床医生提供的 ClonoSeq 临床诊断测试，以及我们向生物制药合作伙伴提供的 ClonoSeq 测试组成，以促进药物开发工作。我们的 MRD 收入包括来自 (1) 向临床客户提供 ClonoSeq 报告；(2) 向生物制药客户和某些学术机构提供 MRD 样本测试服务，包括研究人员主导的临床试验；以及 (3) 通过技术转移向某些国际化验室提供我们的 ClonoSeq 报告或结果给某些国际实验场所产生的收入。
免疫医学业务利用我们的专有能力来大规模对 TCR 和 b 细胞受体（「BCR」）进行序列、映射、配对和特征。我们创建了一个强大的数据引擎，以推动新型疗法的开发。我们的免疫医学收入包括（1）为我们的商业研究产品「适应免疫测序」向生物制药客户和学术机构提供样品测试服务的收入；以及 (2) 我们与 Genentech 和其他生物制药客户在药物和目标发现领域的合作协议所得的收入。
23
adaptive biotechnologies 公司
未经核数的简明综合基本报表附注（续）
(未经审计)
有
以下表格列出了我们截至2024年和2023年9月30日三个月和九个月的部门信息（以千为单位）:
|
|
2024年9月30日结束的三个月 |
|
|||||||||||||
|
|
MRD |
|
|
免疫医学 |
|
|
未分配公司 |
|
|
总计 |
|
||||
营收 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
营业费用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
调整后的EBITDA(1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
将净损调整为调整后的EBITDA： |
|
|
|
|
|
|
|
|
|
|
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|
||||
净亏损 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
归属于非控制权益的净亏损 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
归属于adaptive biotechnologies股份有限公司的净损 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
利息收益及其他净收入 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
利息支出(2) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
折旧和摊销费用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
重组费用(3) |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
股份报酬成本(4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
调整后的EBITDA(1) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
2023年9月30日结束的三个月 |
|
|||||||||||||
|
|
MRD |
|
|
Immune Medicine |
|
|
Unallocated Corporate |
|
|
总计 |
|
||||
营收 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
营业费用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
调整后的EBITDA(1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
调解净损盈额至调整后EBITDA: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
净亏损 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
归属于非控制权益的净亏损 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
归属于adaptive biotechnologies股份有限公司的净损 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
利息收益及其他净收入 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
利息支出(2) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
折旧和摊销费用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
股份报酬成本(4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
调整后的EBITDA(1) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
24
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
|
|
Nine Months Ended September 30, 2024 |
|
|||||||||||||
|
|
MRD |
|
|
Immune Medicine |
|
|
Unallocated Corporate |
|
|
Total |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Reconciliation of Net Loss to Adjusted EBITDA: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss attributable to noncontrolling interest |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Net loss attributable to Adaptive Biotechnologies Corporation |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Interest and other income, net |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Interest expense(2) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Depreciation and amortization expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Impairment of long-lived assets(3) |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Restructuring expense(3) |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Share-based compensation expense(4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
Nine Months Ended September 30, 2023 |
|
|||||||||||||
|
|
MRD |
|
|
Immune Medicine |
|
|
Unallocated Corporate |
|
|
Total |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Reconciliation of Net Loss to Adjusted EBITDA: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss attributable to noncontrolling interest |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Net loss attributable to Adaptive Biotechnologies Corporation |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Interest and other income, net |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Interest expense(2) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Depreciation and amortization expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Share-based compensation expense(4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
(1)
(2)
(3)
(4)
Segment information for the three and nine months ended September 30, 2023 is presented on a comparable basis to that of the current periods and is based on judgments and allocation methods from our organizational changes implemented during the three months ended March 31, 2024.
25
Adaptive Biotechnologies Corporation
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited condensed consolidated financial statements and related notes and the other financial information appearing elsewhere in this report, as well as the other financial information we file with the SEC from time to time. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties relating to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements.
As a result of many factors, including those factors set forth in the “Risk Factors” section of this report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are advancing the field of immune medicine by harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our immune medicine platform applies our proprietary technologies to read the diverse genetic code of a patient’s immune system and understand precisely how the immune system detects and treats disease in that patient. We capture these insights in our dynamic clinical immunomics database and related antigen annotations, which are underpinned by computational biology and machine learning, and use them to develop and commercialize clinical products and services that can be tailored to the needs of individual patients. Our existing and future commercial products and services are aligned to two business areas which we refer to as MRD and Immune Medicine.
Our current product and service offerings in MRD related to the MRD market are our clonoSEQ clinical diagnostic test, offered to clinicians, and our clonoSEQ or MRD assay, offered to biopharmaceutical partners to advance drug development efforts (“MRD Pharma”). Our first clinical diagnostic product, clonoSEQ, is the first test authorized by the Food and Drug Administration for the detection and monitoring of MRD in patients with multiple myeloma, B cell acute lymphoblastic leukemia and chronic lymphocytic leukemia, and is also available as a CLIA-validated laboratory developed test for patients with other lymphoid cancers, including diffuse large B-cell lymphoma. With the use of clonoSEQ, we are transforming how lymphoid cancers are treated by working with providers, pharmaceutical partners and payors.
Immune Medicine leverages our proprietary ability to sequence, map, pair and characterize T cell receptors (“TCRs”) and B cell receptors (“BCRs”) at scale to drive opportunities in cancer, autoimmune disorders, infectious diseases and neurodegenerative disorders. Our core research product, Adaptive Immunosequencing, serves as our underlying research and development engine and generates revenue from biopharmaceutical and academic customers. Leveraging our collaboration with Microsoft Corporation, we are creating the TCR-Antigen Map. We are using the TCR-Antigen Map to identify and validate disease signatures to improve the diagnosis and treatment of many diseases. In Drug Discovery, we use our proprietary capabilities to discover new drug targets and leverage our validated TCR and BCR discovery approaches to discover and develop TCR or antibody therapeutic assets. Drug Discovery includes our worldwide collaboration and license agreement with Genentech (the “Genentech Agreement”).
We recognized revenue of $46.4 million and $37.9 million for the three months ended September 30, 2024 and 2023, respectively, and $131.5 million and $124.5 million for the nine months ended September 30, 2024 and 2023, respectively. Net loss attributable to Adaptive Biotechnologies Corporation was $32.1 million and $50.3 million for the three months ended September 30, 2024 and 2023, respectively, and $125.8 million and $155.8 million for the nine months ended September 30, 2024 and 2023, respectively. We have funded our operations to date principally from the sale of convertible preferred stock and common stock and, to a lesser extent, revenue and proceeds from the revenue interest purchase agreement we entered into in September 2022 with OrbiMed Royalty & Credit Opportunities IV, LP, an affiliate of OrbiMed Advisors LLC, as collateral agent and administrative agent for the purchasers party thereto (the “Purchase Agreement”). As of September 30, 2024 and December 31, 2023, we had cash, cash equivalents and marketable securities of $267.2 million and $346.4 million, respectively.
Restructurings
During the nine months ended September 30, 2024, we implemented various restructuring plans which better aligned our organization to our two operating segments, impacted certain planned software enhancements and resulted in the consolidation of certain research and development workflows, among other things. The software enhancements were primarily associated with our laboratory information management systems. As part of these restructurings, we reduced our workforce, had long-lived assets that were no longer being utilized and vacated certain leased space in South San Francisco, California. As such, we recognized restructuring costs of $0.2 million and $9.1 million during the three and nine months ended September 30, 2024, respectively. Of the $9.1 million restructuring costs recognized, $7.2 million related to impairment charges. The activities related to these restructurings were primarily completed as of September 30, 2024 and are expected to be fully complete as of December 31, 2024.
26
Adaptive Biotechnologies Corporation
Segment Information
In 2024, in connection with an organizational realignment, we began operating our business as two reporting segments: MRD and Immune Medicine. These segments are organized by market opportunity in commercial diagnostics and drug discovery, respectively. See Note 14, Segment Information of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information regarding our segments and the assumptions used to allocate shared expenses. See “Management's Discussion and Analysis of Financial Condition and Results of Operations—2023 Quarterly Segment Information” included in our Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 7, 2024 for quarterly 2023 segment information.
Components of Results of Operations
Revenue
We derive revenue by providing diagnostic and research services in our MRD and Immune Medicine business areas. Our MRD revenue consists of revenue generated from (1) providing our clonoSEQ report to clinical customers; (2) providing MRD sample testing services to biopharmaceutical customers and certain academic institutions, including investigator-led clinical trials; and (3) providing our clonoSEQ report or results to certain international laboratory sites through technology transfers. We disclose our clonoSEQ test volume, which includes the number of clonoSEQ reports and results we have provided to ordering physicians in the United States (“U.S.”) and international technology transfer sites. These volumes do not include sample results from our biopharmaceutical customers or academic institutions utilizing our MRD services. Our Immune Medicine revenue consists of revenue generated from (1) providing sample testing services for our commercial research product, Adaptive Immunosequencing, to biopharmaceutical customers and academic institutions; and (2) our collaboration agreements with Genentech and other biopharmaceutical customers in areas of drug and target discovery.
For our clinical customers, we primarily derive revenue from providing our clonoSEQ report to ordering physicians. We bill commercial, government and medical institution payors based on reports delivered to ordering physicians. Amounts paid for clonoSEQ by commercial, government and medical institution payors vary based on respective reimbursement rates and patient responsibilities, which may differ from our targeted list price. We recognize clinical revenue by evaluating customer payment history, contracted reimbursement rates, if applicable, and other adjustments to estimate the amount of revenue that is collectible.
For our clonoSEQ coverage under Medicare, we bill an episode of treatment when we deliver the first eligible test report. This billing contemplates all necessary tests required during a patient’s treatment cycle, which is currently estimated at approximately four tests per patient, including the initial sequence identification test. Revenue recognition commences at the time the initial billable test report is delivered and is based upon cumulative tests delivered to date. Any unrecognized revenue from the initial billable test is recorded as deferred revenue and recognized either as we deliver our estimate of the remaining tests in a patient’s treatment cycle or when the likelihood becomes remote that a patient will receive additional testing.
For our research customers, which include biopharmaceutical customers and academic institutions for both our MRD and Adaptive Immunosequencing services, delivery of the respective test results may include some level of professional support and analysis. Terms with biopharmaceutical customers generally include non-refundable payments made in advance of services (“upfront payments”), which we record as deferred revenue. For all research customers, we recognize revenue as we deliver sequencing results. From time to time, we offer discounts in order to gain rights and access to certain datasets. Revenue is recognized net of these discounts and costs associated with these services are reflected in cost of revenue. In periods where our sample estimates are reduced or a customer project is cancelled and, in either case, we have remaining related deferred revenue, we recognize revenue using a cumulative catch-up approach based on the proportion of samples delivered to date relative to the total samples expected to be delivered. Certain of our MRD revenue arrangements with biopharmaceutical customers include cash consideration from the achievement of regulatory milestones of the respective biopharmaceutical customers’ therapeutics. Such revenue is constrained from recognition until it becomes probable that such milestone will be achieved.
Under certain agreements with our biopharmaceutical customers who seek access to our platform to support their therapeutic development activities, revenues are generated from research and development support services that we provide. These agreements may include substantial non-refundable upfront payments, which we recognize over time as we perform the respective services. Revenue recognized from these activities relate primarily to the Genentech Agreement.
We expect our MRD revenue to increase in the long term as we continue to increase our MRD clinical testing volume through increased penetration in our existing covered patient populations, expand into new patient populations and optimize payor coverage. Our MRD revenue may fluctuate period to period due to the uncertain timing of receipt of our biopharmaceutical customer samples, which may cause uncertainty in the delivery of our products and services, the recognition of milestones related to regulatory approvals of our biopharmaceutical customers’ therapeutics and changes in estimates of our clinical revenue reimbursement rates.
27
Adaptive Biotechnologies Corporation
We expect our Immune Medicine revenue to increase in the long term as we or our collaborators advance therapies to commercialization. Our Immune Medicine revenue may fluctuate from period to period due to the timing of expenses incurred, changes in estimates of total anticipated costs related to the Genentech Agreement and other events not within our control, including the recognition of milestones under the Genentech Agreement and the timing of receipt of customer samples from our biopharmaceutical customers.
Cost of Revenue
Cost of revenue includes the cost of materials, personnel-related expenses (including salaries, benefits and share-based compensation), shipping and handling expenses, equipment costs, allocated facility costs associated with processing samples and professional support costs related to our service revenue activities. Allocated facility costs include depreciation of laboratory equipment, as well as allocated facility occupancy and information technology costs. Costs associated with processing samples are recorded as expense, regardless of the timing of revenue recognition. As such, cost of revenue and related volume does not always trend in the same direction as revenue recognition and related volume. Additionally, costs to support the Genentech Agreement are a component of our research and development expenses.
We expect cost of revenue to increase in absolute dollars in the long term as we grow our sample testing volume, but the cost per sample to decrease over the long term due to the efficiencies we may gain as assay volume increases from improved utilization of our laboratory capacity, automation and other value engineering initiatives. If our sample volume throughput is reduced, cost of revenue as a percentage of total revenue may be adversely impacted due to fixed overhead costs.
Research and Development Expenses
Research and development expenses consist of laboratory materials costs, personnel-related expenses (including salaries, benefits and share-based compensation), equipment costs, allocated facility and information technology costs and contract service expenses. Research and development activities support further development and refinement of existing assays and products, discovery of new technologies and investments in our immune medicine platform. We also include in research and development expenses the costs associated with software development of applications to support future commercial opportunities, as well as development activities to support laboratory scaling and workflow. We are currently conducting research and development activities for several products and services and we typically use our laboratory materials, personnel, facilities, information technology and other development resources across multiple development programs. Additionally, certain of these research and development activities benefit more than one of our product opportunities. We have not historically tracked research and development expenses by specific product candidates.
The costs to support the Genentech Agreement are a component of our research and development expenses. Additionally, a component of our research and development expenses are costs supporting clinical and analytical validations to obtain regulatory approval for future clinical products and services. Some of these activities have generated and may in the future generate revenue.
We expect research and development expenses to decrease in the short term and to decrease as a percentage of revenue in the long term, although the percentage may fluctuate from period to period due to the timing and extent of our development and commercialization efforts.
Sales and Marketing Expenses
Sales and marketing expenses include personnel-related expenses (including salaries, benefits and share-based compensation) for commercial sales, product and account management, marketing, reimbursement, medical education and business development personnel that support commercialization of our platform products. In addition, these expenses include external costs such as advertising expenses, customer education and promotional expenses, market analysis expenses, conference fees, travel expenses and allocated facility and information technology costs.
We expect sales and marketing expenses to experience moderate increases in the short term. In the long term, we expect sales and marketing expenses to increase in absolute dollars as we increase marketing activities to drive awareness and adoption of our products and services. However, we expect sales and marketing expenses to decrease as a percentage of revenue in the long term, subject to fluctuations from period to period due to the timing and magnitude of these expenses.
General and Administrative Expenses
General and administrative expenses include personnel-related expenses (including salaries, benefits and share-based compensation) for our personnel in executive, legal, finance and accounting, human resources and other administrative functions, including third-party clinical billing services. In addition, these expenses include insurance costs, external legal costs, accounting and tax service expenses, consulting fees and allocated facility and information technology costs.
28
Adaptive Biotechnologies Corporation
We expect general and administrative expenses to remain relatively consistent in the short term and to decrease as a percentage of revenue in the long term.
Interest Expense
Interest expense includes costs associated with our revenue interest liability related to the Purchase Agreement and noncash interest costs associated with the amortization of the related deferred issuance costs. We impute interest expense using the effective interest rate method. We calculate an effective interest rate which will amortize our related obligation to zero over the anticipated repayment period. A significant increase or decrease in or changes in timing of forecasted revenue will prospectively impact our interest expense.
Statements of Operations Data and Other Financial and Operating Data
The following table sets forth our statements of operations data and other financial and operating data for the periods presented (in thousands, except share and per share amounts):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue |
|
$ |
46,435 |
|
|
$ |
37,919 |
|
|
$ |
131,498 |
|
|
$ |
124,492 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of revenue |
|
|
16,667 |
|
|
|
19,346 |
|
|
|
54,035 |
|
|
|
55,937 |
|
Research and development |
|
|
24,163 |
|
|
|
28,533 |
|
|
|
79,761 |
|
|
|
93,371 |
|
Sales and marketing |
|
|
20,551 |
|
|
|
20,493 |
|
|
|
63,184 |
|
|
|
66,673 |
|
General and administrative |
|
|
17,258 |
|
|
|
20,075 |
|
|
|
54,750 |
|
|
|
63,208 |
|
Amortization of intangible assets |
|
|
428 |
|
|
|
428 |
|
|
|
1,275 |
|
|
|
1,270 |
|
Impairment of long-lived assets |
|
|
— |
|
|
|
— |
|
|
|
7,205 |
|
|
|
— |
|
Total operating expenses |
|
|
79,067 |
|
|
|
88,875 |
|
|
|
260,210 |
|
|
|
280,459 |
|
Loss from operations |
|
|
(32,632 |
) |
|
|
(50,956 |
) |
|
|
(128,712 |
) |
|
|
(155,967 |
) |
Interest and other income, net |
|
|
3,474 |
|
|
|
4,282 |
|
|
|
11,462 |
|
|
|
10,918 |
|
Interest expense |
|
|
(2,939 |
) |
|
|
(3,652 |
) |
|
|
(8,628 |
) |
|
|
(10,788 |
) |
Net loss |
|
|
(32,097 |
) |
|
|
(50,326 |
) |
|
|
(125,878 |
) |
|
|
(155,837 |
) |
Add: Net loss attributable to noncontrolling interest |
|
|
26 |
|
|
|
26 |
|
|
|
78 |
|
|
|
28 |
|
Net loss attributable to Adaptive Biotechnologies Corporation |
|
$ |
(32,071 |
) |
|
$ |
(50,300 |
) |
|
$ |
(125,800 |
) |
|
$ |
(155,809 |
) |
Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.86 |
) |
|
$ |
(1.08 |
) |
Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
|
147,516,398 |
|
|
|
144,704,868 |
|
|
|
146,908,234 |
|
|
|
144,208,940 |
|
Other Financial and Operating Data: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjusted EBITDA(1) |
|
$ |
(14,300 |
) |
|
$ |
(29,831 |
) |
|
$ |
(63,926 |
) |
|
$ |
(91,748 |
) |
(1) Adjusted EBITDA is a non-GAAP financial measure that we define as net loss attributable to Adaptive Biotechnologies Corporation adjusted for interest and other income, net, interest expense, income tax (expense) benefit, depreciation and amortization expense, impairment costs for long-lived assets, restructuring expense and share-based compensation expense. See “Adjusted EBITDA” below for a reconciliation between Adjusted EBITDA and net loss attributable to Adaptive Biotechnologies Corporation, the most directly comparable GAAP financial measure, and a discussion about the limitations of Adjusted EBITDA.
29
Adaptive Biotechnologies Corporation
Comparison of the Three Months Ended September 30, 2024 and 2023
Revenue
|
|
Three Months Ended September 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
|
2024 |
|
|
2023 |
|
||||||
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Service revenue |
|
$ |
32,470 |
|
|
$ |
24,668 |
|
|
$ |
7,802 |
|
|
|
32 |
% |
|
|
|
|
|
|
||
Regulatory milestone revenue |
|
|
5,000 |
|
|
|
— |
|
|
|
5,000 |
|
|
* |
|
|
|
|
|
|
|
|||
Total MRD revenue |
|
|
37,470 |
|
|
|
24,668 |
|
|
|
12,802 |
|
|
|
52 |
|
|
|
81 |
% |
|
|
65 |
% |
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Service revenue |
|
|
5,453 |
|
|
|
5,238 |
|
|
|
215 |
|
|
|
4 |
|
|
|
|
|
|
|
||
Collaboration revenue |
|
|
3,512 |
|
|
|
8,013 |
|
|
|
(4,501 |
) |
|
|
(56 |
) |
|
|
|
|
|
|
||
Total Immune Medicine revenue |
|
|
8,965 |
|
|
|
13,251 |
|
|
|
(4,286 |
) |
|
|
(32 |
) |
|
|
19 |
% |
|
|
35 |
% |
Total revenue |
|
$ |
46,435 |
|
|
$ |
37,919 |
|
|
$ |
8,516 |
|
|
|
22 |
|
|
|
100 |
% |
|
|
100 |
% |
* Not applicable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
The $12.8 million increase in MRD revenue was primarily due to a $5.6 million increase in revenue generated from providing clonoSEQ to clinical customers, a $5.0 million increase in revenue recognized upon the achievement of certain regulatory milestones by one of our biopharmaceutical customers, a $2.0 million increase in revenue generated from providing MRD sample testing services to biopharmaceutical customers and a $0.4 million increase in revenue generated from providing MRD sample testing services to investigator-led clinical trials. Our clonoSEQ test volume increased by 30% to 19,600 tests delivered in the three months ended September 30, 2024 from 15,072 tests delivered in the three months ended September 30, 2023.
The $4.3 million decrease in Immune Medicine revenue was primarily due to a $4.5 million decrease in revenue generated from the Genentech Agreement, which resulted from decreased collaboration expenses, partially offset by a $0.2 million increase in revenue generated from our biopharmaceutical and academic customers.
Cost of Revenue
|
|
Three Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Cost of revenue |
|
$ |
16,667 |
|
|
$ |
19,346 |
|
|
$ |
(2,679 |
) |
|
(14)% |
|
|
36 |
% |
|
|
51 |
% |
The $2.7 million decrease in cost of revenue was primarily attributable to a $4.0 million decrease in labor and overhead costs, which was largely driven by laboratory relocation and consolidation activities, a $0.3 million decrease in cost of materials primarily due to a reduction in inventory reserve expense and a $0.2 million decrease in shipping and handling expenses. These decreases were partially offset by a $1.3 million increase related to higher usage of our production laboratory to process revenue samples versus research and development samples and a $0.7 million increase in materials cost resulting from increased revenue sample volume.
Research and Development
|
|
Three Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Research and development |
|
$ |
24,163 |
|
|
$ |
28,533 |
|
|
$ |
(4,370 |
) |
|
(15)% |
|
|
52 |
% |
|
|
75 |
% |
The following table presents disaggregated research and development expenses by cost classification for the periods presented:
|
|
Three Months Ended September 30, |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Research and development materials and allocated production laboratory expenses |
|
$ |
3,976 |
|
|
$ |
4,063 |
|
|
$ |
(87 |
) |
Personnel expenses |
|
|
14,305 |
|
|
|
17,979 |
|
|
|
(3,674 |
) |
Allocable facilities and information technology expenses |
|
|
2,609 |
|
|
|
2,931 |
|
|
|
(322 |
) |
Software and cloud services expenses |
|
|
1,242 |
|
|
|
697 |
|
|
|
545 |
|
Depreciation and other expenses |
|
|
2,031 |
|
|
|
2,863 |
|
|
|
(832 |
) |
Total |
|
$ |
24,163 |
|
|
$ |
28,533 |
|
|
$ |
(4,370 |
) |
30
Adaptive Biotechnologies Corporation
The $4.4 million decrease in research and development expenses was primarily attributable to a $3.7 million decrease in personnel costs and a $0.8 million decrease in depreciation and other expenses.
Sales and Marketing
|
|
Three Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Sales and marketing |
|
$ |
20,551 |
|
|
$ |
20,493 |
|
|
$ |
58 |
|
|
* |
|
|
44 |
% |
|
|
54 |
% |
* Increase is less than 1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
The $0.1 million increase in sales and marketing expenses was primarily attributable to a $0.6 million increase in computer and software expenses and a $0.4 million increase in allocated overhead expenses. These increases were partially offset by a $0.5 million decrease in personnel costs and a $0.4 million decrease in marketing expenses, which was largely driven by reduced clonoSEQ and research marketing activities.
General and Administrative
|
|
Three Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
General and administrative |
|
$ |
17,258 |
|
|
$ |
20,075 |
|
|
$ |
(2,817 |
) |
|
(14)% |
|
|
37 |
% |
|
|
53 |
% |
The $2.8 million decrease in general and administrative expenses was primarily attributable to a $1.2 million decrease in personnel costs, a $0.6 million decrease in building, facility, overhead and depreciation related expenses largely driven by office space transitions made to support laboratory consolidation activities and a $0.4 million decrease in legal fees. These decreases were partially offset by a $0.3 million increase in third-party billing service fees.
Interest and Other Income, Net
|
|
Three Months Ended September 30, |
|
|
Change |
|||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|||
Interest and other income, net |
|
$ |
3,474 |
|
|
$ |
4,282 |
|
|
$ |
(808 |
) |
|
(19)% |
The $0.8 million decrease in interest and other income, net was primarily attributable to a decrease in net interest income and investment amortization driven by decreased interest rates and related yields of our invested cash and cash equivalents and marketable securities.
Interest Expense
|
|
Three Months Ended September 30, |
|
|
Change |
|||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|||
Interest expense |
|
$ |
(2,939 |
) |
|
$ |
(3,652 |
) |
|
$ |
713 |
|
|
(20)% |
The $0.7 million decrease in interest expense was attributable to a change in our assumptions regarding the timeframe in which our Purchase Agreement will be fully repaid.
Segment Adjusted EBITDA
|
|
Three Months Ended September 30, |
|
|
Change |
|
||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||
MRD Adjusted EBITDA(1) |
|
$ |
(6,120 |
) |
|
$ |
(21,616 |
) |
|
$ |
15,496 |
|
|
(72)% |
|
|
Immune Medicine Adjusted EBITDA(1) |
|
|
(5,212 |
) |
|
|
(4,986 |
) |
|
|
(226 |
) |
|
|
5 |
|
(1)Adjusted EBITDA is a non-GAAP financial measure. See “Adjusted EBITDA” below for an explanation of how it is calculated and used by management.
31
Adaptive Biotechnologies Corporation
The $15.5 million reduction in MRD Adjusted EBITDA deficit was primarily attributable to a $12.8 million increase in MRD revenue and a reduction in operating expenses, excluding those identified as reconciling items between net loss and adjusted EBITDA. The primary drivers of the operating expense reduction relate to general and administrative activities and cost of revenue activities.
The $0.2 million increase in Immune Medicine Adjusted EBITDA deficit was primarily attributable to a $4.3 million reduction in Immune Medicine revenue, which was largely offset by a reduction in operating expenses, excluding those identified as reconciling items between net loss and adjusted EBITDA. The primary drivers of the operating expense reduction relate to research and development activities and cost of revenue activities.
Comparison of the Nine Months Ended September 30, 2024 and 2023
Revenue
|
|
Nine Months Ended September 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
|
2024 |
|
|
2023 |
|
||||||
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Service revenue |
|
$ |
92,880 |
|
|
$ |
71,977 |
|
|
$ |
20,903 |
|
|
|
29 |
% |
|
|
|
|
|
|
||
Regulatory milestone revenue |
|
|
12,500 |
|
|
|
— |
|
|
|
12,500 |
|
|
* |
|
|
|
|
|
|
|
|||
Total MRD revenue |
|
|
105,380 |
|
|
|
71,977 |
|
|
|
33,403 |
|
|
|
46 |
|
|
|
80 |
% |
|
|
58 |
% |
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Service revenue |
|
|
16,160 |
|
|
|
17,848 |
|
|
|
(1,688 |
) |
|
|
(9 |
) |
|
|
|
|
|
|
||
Collaboration revenue |
|
|
9,958 |
|
|
|
34,667 |
|
|
|
(24,709 |
) |
|
|
(71 |
) |
|
|
|
|
|
|
||
Total Immune Medicine revenue |
|
|
26,118 |
|
|
|
52,515 |
|
|
|
(26,397 |
) |
|
|
(50 |
) |
|
|
20 |
% |
|
|
42 |
% |
Total revenue |
|
$ |
131,498 |
|
|
$ |
124,492 |
|
|
$ |
7,006 |
|
|
|
6 |
|
|
|
100 |
% |
|
|
100 |
% |
* Not applicable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
The $33.4 million increase in MRD revenue was primarily due to a $18.7 million increase in revenue generated from providing clonoSEQ to clinical customers, a $12.5 million increase in revenue recognized upon the achievement of regulatory milestones by our biopharmaceutical customers and a $3.5 million increase in revenue generated from providing MRD sample testing services to biopharmaceutical customers. These increases were partially offset by a $1.1 million decrease in revenue generated from providing MRD sample testing services to investigator-led clinical trials. Our clonoSEQ test volume increased by 35% to 55,160 tests delivered in the nine months ended September 30, 2024 from 40,816 tests delivered in the nine months ended September 30, 2023.
The $26.4 million decrease in Immune Medicine revenue was primarily due to a $24.7 million decrease in revenue generated from the Genentech Agreement, which resulted from decreased collaboration expenses and decreased revenue recognized from the $10.0 million regulatory milestone achieved in May 2023, and a $1.7 million decrease in revenue generated from our biopharmaceutical and academic customers.
Cost of Revenue
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Cost of revenue |
|
$ |
54,035 |
|
|
$ |
55,937 |
|
|
$ |
(1,902 |
) |
|
(3)% |
|
|
41 |
% |
|
|
45 |
% |
The $1.9 million decrease in cost of revenue was primarily attributable to a $7.9 million decrease in overhead costs, which was largely driven by laboratory relocation and consolidation activities. This decrease was partially offset by a $2.8 million increase in cost of materials, $2.4 million of which resulted from increased revenue sample volume and $0.4 million of which was primarily related to an increase in inventory reserve expense, a $2.4 million increase related to higher usage of our production laboratory to process revenue samples versus research and development samples and a $0.4 million increase in shipping and handling expenses.
Research and Development
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Research and development |
|
$ |
79,761 |
|
|
$ |
93,371 |
|
|
$ |
(13,610 |
) |
|
(15)% |
|
|
61 |
% |
|
|
75 |
% |
32
Adaptive Biotechnologies Corporation
The following table presents disaggregated research and development expenses by cost classification for the periods presented:
|
|
Nine Months Ended September 30, |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Research and development materials and allocated production laboratory expenses |
|
$ |
12,381 |
|
|
$ |
16,130 |
|
|
$ |
(3,749 |
) |
Personnel expenses |
|
|
48,834 |
|
|
|
56,598 |
|
|
|
(7,764 |
) |
Allocable facilities and information technology expenses |
|
|
8,156 |
|
|
|
8,817 |
|
|
|
(661 |
) |
Software and cloud services expenses |
|
|
3,684 |
|
|
|
2,424 |
|
|
|
1,260 |
|
Depreciation and other expenses |
|
|
6,706 |
|
|
|
9,402 |
|
|
|
(2,696 |
) |
Total |
|
$ |
79,761 |
|
|
$ |
93,371 |
|
|
$ |
(13,610 |
) |
The $13.6 million decrease in research and development expenses was primarily attributable to a $7.8 million decrease in personnel costs and a $3.7 million decrease in cost of materials and allocated production laboratory expenses, which was driven primarily by decreased investments in drug discovery efforts, including collaboration efforts with Genentech, and TCR-Antigen Map development activities, partially offset by an increase in investments related to clonoSEQ. There was also a $2.7 million decrease in depreciation and other expenses, inclusive of a $1.9 million decrease in costs related to collaboration studies primarily related to Immune Medicine, and a $0.7 million decrease in allocable facilities expenses. These decreases were partially offset by a $1.3 million increase in software and cloud services expenses.
Sales and Marketing
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Sales and marketing |
|
$ |
63,184 |
|
|
$ |
66,673 |
|
|
$ |
(3,489 |
) |
|
(5)% |
|
|
48 |
% |
|
|
54 |
% |
The $3.5 million decrease in sales and marketing expenses was primarily attributable to a $3.8 million decrease in personnel costs. There was also a $1.2 million decrease in marketing expenses, which was largely driven by reduced clonoSEQ marketing activities, followed by reduced research and corporate marketing activities, and a $0.7 million decrease in travel and customer event related expenses. These decreases were partially offset by a $2.1 million increase in computer and software expenses and a $0.4 million increase in allocated facility and overhead expenses.
General and Administrative
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
General and administrative |
|
$ |
54,750 |
|
|
$ |
63,208 |
|
|
$ |
(8,458 |
) |
|
(13)% |
|
|
42 |
% |
|
|
51 |
% |
The $8.5 million decrease in general and administrative expenses was primarily attributable to a $4.2 million decrease in personnel costs, a $2.6 million decrease in building, facility, overhead and depreciation related expenses largely driven by office space transitions made to support laboratory consolidation activities, a $1.1 million decrease in legal fees, a $0.8 million decrease in insurance costs and a $0.6 million decrease in consultant costs. These decreases were partially offset by a $1.4 million increase in third-party billing service fees.
Impairment of Long-Lived Assets
|
|
Nine Months Ended September 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
2024 |
|
|
2023 |
|
|||||
Impairment of long-lived assets |
|
$ |
7,205 |
|
|
$ |
— |
|
|
$ |
7,205 |
|
|
* |
|
|
5 |
% |
|
|
0 |
% |
* Not applicable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
The $7.2 million increase in impairment of long-lived assets expenses was attributable to us impairing certain long-lived assets and us vacating certain leased space as a result of various restructuring activities in 2024.
33
Adaptive Biotechnologies Corporation
Interest and Other Income, Net
|
|
Nine Months Ended September 30, |
|
|
Change |
|
||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||
Interest and other income, net |
|
$ |
11,462 |
|
|
$ |
10,918 |
|
|
$ |
544 |
|
|
|
5 |
% |
The $0.5 million increase in interest and other income, net was primarily attributable to an increase in investment amortization driven by increased related yields of our invested cash and cash equivalents and marketable securities.
Interest Expense
|
|
Nine Months Ended September 30, |
|
|
Change |
|||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|||
Interest expense |
|
$ |
(8,628 |
) |
|
$ |
(10,788 |
) |
|
$ |
2,160 |
|
|
(20)% |
The $2.2 million decrease in interest expense was attributable to a change in our assumptions regarding the timeframe in which our Purchase Agreement will be fully repaid.
Segment Adjusted EBITDA
|
|
Nine Months Ended September 30, |
|
|
Change |
|
||||||||||
(in thousands, except percentages) |
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||
MRD Adjusted EBITDA(1) |
|
$ |
(34,668 |
) |
|
$ |
(71,081 |
) |
|
$ |
36,413 |
|
|
(51)% |
|
|
Immune Medicine Adjusted EBITDA(1) |
|
|
(19,172 |
) |
|
|
(11,149 |
) |
|
|
(8,023 |
) |
|
|
72 |
|
(1)Adjusted EBITDA is a non-GAAP financial measure. See “Adjusted EBITDA” below for an explanation of how it is calculated and used by management.
The $36.4 million reduction in MRD Adjusted EBITDA deficit was primarily attributable to a $33.4 million increase in MRD revenue and a reduction in operating expenses, excluding those identified as reconciling items between net loss and adjusted EBITDA. The primary driver of the operating expense reduction relates to general and administrative activities.
The $8.0 million increase in Immune Medicine Adjusted EBITDA deficit was primarily attributable to a $26.4 million reduction in Immune Medicine revenue, which was partially offset by a reduction in operating expenses, excluding those identified as reconciling items between net loss and adjusted EBITDA. The primary driver of the operating expense reduction relates to research and development activities.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that we define as net loss attributable to Adaptive Biotechnologies Corporation adjusted for interest and other income, net, interest expense, income tax (expense) benefit, depreciation and amortization expense, impairment costs for long-lived assets, restructuring expense and share-based compensation expense. We define our segment Adjusted EBITDA in the same way to the extent the net loss attributable to Adaptive Biotechnologies Corporation and adjustments are allocable to each segment. See Note 14, Segment Information of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information regarding segment Adjusted EBITDA.
Management uses Adjusted EBITDA, including segment Adjusted EBITDA, to evaluate the financial performance of our business and segments and to evaluate the effectiveness of our strategies. We present these figures because we believe it is frequently used by analysts, investors and other interested parties to evaluate companies in our industry and it facilitates comparisons on a consistent basis across reporting periods. Further, we believe it is helpful in highlighting trends in our operating results because it excludes items that are not indicative of our core operating performance.
Adjusted EBITDA, including segment Adjusted EBITDA, has limitations as an analytical tool and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. We may in the future incur expenses similar to the adjustments we make. In particular, we expect to incur meaningful share-based compensation expense in the future. Other limitations include that Adjusted EBITDA, including segment Adjusted EBITDA, does not reflect:
34
Adaptive Biotechnologies Corporation
In addition, Adjusted EBITDA may not be comparable to similarly titled measures used by other companies in our industry or across different industries.
The following is a reconciliation of net loss attributable to Adaptive Biotechnologies Corporation, the most directly comparable GAAP financial measure, to Adjusted EBITDA for the periods presented (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Net loss attributable to Adaptive Biotechnologies Corporation |
|
$ |
(32,071 |
) |
|
$ |
(50,300 |
) |
|
$ |
(125,800 |
) |
|
$ |
(155,809 |
) |
Interest and other income, net |
|
|
(3,474 |
) |
|
|
(4,282 |
) |
|
|
(11,462 |
) |
|
|
(10,918 |
) |
Interest expense(1) |
|
|
2,939 |
|
|
|
3,652 |
|
|
|
8,628 |
|
|
|
10,788 |
|
Depreciation and amortization expense |
|
|
4,591 |
|
|
|
5,763 |
|
|
|
14,808 |
|
|
|
16,839 |
|
Impairment of long-lived assets(2) |
|
|
— |
|
|
|
— |
|
|
|
7,205 |
|
|
|
— |
|
Restructuring expense(2) |
|
|
193 |
|
|
|
— |
|
|
|
1,917 |
|
|
|
— |
|
Share-based compensation expense(3) |
|
|
13,522 |
|
|
|
15,336 |
|
|
|
40,778 |
|
|
|
47,352 |
|
Adjusted EBITDA |
|
$ |
(14,300 |
) |
|
$ |
(29,831 |
) |
|
$ |
(63,926 |
) |
|
$ |
(91,748 |
) |
(1) Represents costs associated with our revenue interest liability and noncash interest costs associated with the amortization of the related deferred issuance costs. See Note 8, Revenue Interest Purchase Agreement of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for details on the Purchase Agreement.
(2) Represents expenses recognized in conjunction with restructuring activities. See Note 12, Restructurings of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for details on our restructuring expenses.
(3) Represents share-based compensation expense related to stock option, restricted stock unit and market-based restricted stock unit awards. See Note 11, Equity Incentive Plans of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for details on our share-based compensation expense.
Liquidity and Capital Resources
We have incurred losses since inception and have incurred negative cash flows from operations since inception through September 30, 2024, with the exception of certain 2019 periods for which we had positive cash flows from operations. As of September 30, 2024, we had an accumulated deficit of $1.3 billion.
We have funded our operations to date principally from the sale of convertible preferred stock and common stock, and, to a lesser extent, revenue and proceeds from the Purchase Agreement. Pursuant to the Purchase Agreement entered into in September 2022, we received net cash proceeds of $124.4 million, after deducting issuance costs. We are also entitled to receive up to $125.0 million in subsequent installments as follows: (i) $75.0 million upon our request occurring no later than September 12, 2025 and (ii) $50.0 million upon our request in connection with certain permitted acquisitions occurring no later than September 12, 2025, in each case subject to certain funding conditions. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $267.2 million.
We believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months. We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons.
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Adaptive Biotechnologies Corporation
If our available cash, cash equivalents and marketable securities balances and anticipated cash flows are insufficient to satisfy our liquidity requirements, we may request an additional installment under the Purchase Agreement, seek to sell additional equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to our shareholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. This additional capital may not be available on reasonable terms, or at all.
We plan to utilize the existing cash, cash equivalents and marketable securities on hand primarily to fund our commercial and marketing activities associated with clonoSEQ, our continued investments in streamlining our laboratory operations and our continued research and development initiatives related to drug discovery. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to capital preservation and liquidity. Currently, our funds are held in money market funds and marketable securities consisting of U.S. government treasury and agency securities, corporate bonds and commercial paper.
While we may experience variability in revenue in the near term, over the long-term we expect revenue from our current and future products and services to grow. Accordingly, we expect our accounts receivable and inventory balances to increase. Our levels of accounts receivable may fluctuate relative to our revenue for a number of reasons, including the timing of milestone triggers and related payment of those milestones, as well as reductions in revenue derived from the upfront payment received under the Genentech Agreement and an increase in revenue generated from clinical customers, which may result in more billings in arrears as opposed to upfront payments. Any increase in accounts receivable and inventory may not be completely offset by increases in accounts payable and accrued expenses, which could result in greater working capital requirements.
Contractual Obligations
There have been no material changes outside the ordinary course of business to our contractual obligations and commitments as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024.
See Note 7, Leases and Note 8, Revenue Interest Purchase Agreement of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information regarding our contractual obligations relating to lease agreements and the Purchase Agreement, respectively.
Cash Flows
The following table summarizes our uses and sources of cash for the nine months ended September 30, 2024 and 2023 (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Net cash used in operating activities |
|
$ |
(82,721 |
) |
|
$ |
(129,392 |
) |
Net cash provided by investing activities |
|
|
55,673 |
|
|
|
126,440 |
|
Net cash provided by financing activities |
|
|
114 |
|
|
|
2,158 |
|
Operating Activities
Cash used in operating activities during the nine months ended September 30, 2024 was $82.7 million, which was primarily attributable to a net loss of $125.9 million and a net change in operating assets and liabilities of $20.5 million, partially offset by noncash share-based compensation of $40.8 million, noncash depreciation and amortization of $8.1 million, noncash impairment of long-lived assets of $7.2 million related to our restructuring activities, noncash lease expense of $4.0 million, noncash interest expense related to the Purchase Agreement of $2.0 million and inventory reserve expense of $1.4 million. The net change in operating assets and liabilities was primarily driven by an $8.8 million reduction in deferred revenue largely driven by revenue recognized for Genentech, a $6.4 million decrease in operating lease right-of-use assets and liabilities, a $3.6 million reduction in accounts payable and accrued liabilities, a $2.8 million increase in accounts receivable, net and a $0.9 million increase in prepaid expenses and other current assets. These changes were partially offset by a $2.0 million decrease in inventory.
36
Adaptive Biotechnologies Corporation
Cash used in operating activities during the nine months ended September 30, 2023 was $129.4 million, which was primarily attributable to a net loss of $155.8 million and a net change in operating assets and liabilities of $42.7 million, partially offset by noncash share-based compensation of $47.4 million, noncash depreciation and amortization of $10.6 million, noncash lease expense of $5.5 million, noncash interest expense related to the Purchase Agreement of $4.6 million and inventory reserve expense of $0.9 million. The net change in operating assets and liabilities was primarily driven by a $23.2 million reduction in deferred revenue related primarily to revenue recognized from the Genentech Agreement, a $10.7 million reduction in accounts payable and accrued liabilities largely driven by the payout of our corporate bonus during the three months ended March 31, 2023, a $6.8 million increase in inventory, a $6.7 million decrease in operating lease right-of-use assets and liabilities and a $4.0 million increase in prepaid expenses and other current assets largely driven by an increase in prepaid software charges. These changes were partially offset by an $8.8 million decrease in accounts receivable, net primarily related to collections from our biopharmaceutical customers.
Investing Activities
Cash provided by investing activities during the nine months ended September 30, 2024 was $55.7 million, which was primarily attributable to proceeds from maturities of marketable securities of $258.7 million, partially offset by purchases of marketable securities of $199.5 million and purchases of property and equipment of $3.6 million.
Cash provided by investing activities during the nine months ended September 30, 2023 was $126.4 million, which was primarily attributable to proceeds from maturities of marketable securities of $443.4 million, partially offset by purchases of marketable securities of $307.6 million and purchases of property and equipment of $9.4 million.
Financing Activities
Cash provided by financing activities during the nine months ended September 30, 2024 was $0.1 million, which was attributable to proceeds from the exercise of stock options.
Cash provided by financing activities during the nine months ended September 30, 2023 was $2.2 million, which was attributable to proceeds from the exercise of stock options.
Net Operating Loss Carryforwards
Utilization of our net operating loss (“NOL”) carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986 (“Section 382”) and similar state provisions. The annual limitation may result in the expiration of NOL carryforwards and credits before utilization. If there should be an ownership change, our ability to utilize our NOL carryforwards and credits could be limited. We have completed a Section 382 analysis for changes in ownership through December 31, 2023 and continue to monitor for changes that could trigger a limitation. Based on this analysis, we do not expect to have any permanent limitations on the utilization of our federal NOLs. Under the Tax Cuts and Jobs Act of 2017, federal NOLs incurred in 2018 and future years may be carried forward indefinitely, but the deductibility of such federal NOLs is subject to an annual limitation. NOLs generated prior to 2018 are eligible to be carried forward up to 20 years. Based on the available objective evidence, management determined that it was more likely than not that the net deferred tax assets would not be realizable as of December 31, 2023. Accordingly, management applied a full valuation allowance against net deferred tax assets as of December 31, 2023.
Critical Accounting Policies and Estimates
We have prepared the unaudited condensed consolidated financial statements in accordance with GAAP. Our preparation of these unaudited condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities and related disclosures at the date of the unaudited condensed consolidated financial statements, as well as revenue and expense recorded during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and other relevant assumptions that we believe to be reasonable under the circumstances. Estimates are used in several areas, including, but not limited to, estimates of progress to date for certain performance obligations and the transaction price for certain contracts with customers, imputing interest for the Purchase Agreement, the provision for income taxes, including related reserves, the analysis of goodwill impairment and the recoverability and impairment of long-lived assets, among others. These estimates generally involve complex issues and require judgments, involve the analysis of historical results and prediction of future trends, can require extended periods of time to resolve and are subject to change from period to period. Actual results may differ materially from management’s estimates.
37
Adaptive Biotechnologies Corporation
While our significant accounting policies are described in more detail in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024, as well as in Note 2, Significant Accounting Policies of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report, we believe the following accounting policies are critical to the judgments and estimates used in the preparation of the unaudited condensed consolidated financial statements:
There have been no material changes to our critical accounting policies and estimates as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024.
Recent Accounting Pronouncements
See Note 2, Significant Accounting Policies of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
We are exposed to market risk for changes in interest rates related primarily to our cash and cash equivalents and marketable securities. As of September 30, 2024, there have been no material changes to our market risks as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024. We do not enter into investments for trading purposes and have not used any derivative financial instruments to manage our interest rate risk exposure.
Item 4. Controls and Procedures
Under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) as of the end of the period covered by this report. Based on that evaluation, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures were effective as of September 30, 2024. There was not any change in our internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act) during the three months ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
38
Adaptive Biotechnologies Corporation
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control. In addition to the other information set forth in this report, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I, Item 1A under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024. The risk factors may be important to understanding other statements in this report and should be read in conjunction with the unaudited condensed consolidated financial statements and related notes in this report. The occurrence of any single risk or any combination of risks could materially and adversely affect our business, operations, product pipeline, operating results, financial condition or liquidity, and consequently, the value of our securities. Further, additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business, financial condition, operating results and prospects. There have been no material changes to the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 29, 2024.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
On
Additionally, on
39
Adaptive Biotechnologies Corporation
Item 6. Exhibits
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|
|
Incorporated by Reference |
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Exhibit Number |
|
Exhibit Title |
Form |
File No. |
Exhibit |
Filing Date |
Filed/ Furnished with This Report |
3.1 |
|
8-K |
001-38957 |
3.1 |
7/1/2019 |
|
|
3.2 |
|
8-K |
001-38957 |
3.2 |
7/1/2019 |
|
|
4.1 |
|
S-1 |
333-231838 |
4.1 |
5/30/2019 |
|
|
31.1 |
|
|
|
|
|
X |
|
31.2 |
|
|
|
|
|
X |
|
32.1 |
|
|
|
|
|
X |
|
32.2 |
|
|
|
|
|
X |
|
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 |
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|
|
|
X |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbases Document |
|
|
|
|
X |
104 |
|
Cover Page Interactive Data File (formatted in Inline XBRL and included in Exhibit 101) |
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
|
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|
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40
Adaptive Biotechnologies Corporation
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
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Adaptive Biotechnologies Corporation |
||
|
|
|
||
Date: November 7, 2024 |
|
By: |
|
/s/ Chad Robins |
|
|
|
|
Chad Robins |
|
|
|
|
Chief Executive Officer and Director (Principal Executive Officer) |
|
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Date: November 7, 2024 |
|
By: |
|
/s/ Kyle Piskel |
|
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|
|
Kyle Piskel |
|
|
|
|
Chief Financial Officer (Principal Financial Officer) |
41