美国
证券交易委员会
华盛顿特区20549
形式
(标记一) |
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根据1934年《证券交易法》第13或15(D)条规定的季度报告 |
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截至本季度末
根据1934年证券交易法第13或15（d）条提交的过渡报告 |
由_至_的过渡期
委托文档号
(注册人的确切姓名载于其章程)
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(述明或其他司法管辖权 公司或组织) |
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(税务局雇主 识别号码) |
（主要行政办公室地址、邮政编码）
(
(注册人的电话号码，包括区号)
不适用
(前姓名、前地址和前财政年度，如果自上次报告以来发生变化)
根据该法第12(B)条登记的证券：
每个班级的标题 |
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交易 符号 |
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各交易所名称 在其上注册的 |
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用复选标记表示注册人(1)是否在过去12个月内(或注册人被要求提交此类报告的较短时间内)提交了1934年《证券交易法》第13条或15(D)节要求提交的所有报告，以及(2)在过去90天内是否符合此类提交要求。
用复选标记表示注册人是否在过去12个月内(或在注册人被要求提交此类文件的较短时间内)以电子方式提交了根据S-T规则第405条(本章232.405节)要求提交的每个交互数据文件。
用复选标记表示注册人是大型加速申报公司、加速申报公司、非加速申报公司、较小的报告公司或新兴成长型公司。请参阅《交易法》第12b-2条规则中“大型加速申报公司”、“加速申报公司”、“较小申报公司”和“新兴成长型公司”的定义。
大型加速文件服务器 |
☐ |
加速文件管理器 |
☐ |
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规模较小的报告公司 |
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新兴成长型公司 |
如果是一家新兴的成长型公司，用复选标记表示注册人是否已选择不使用延长的过渡期来遵守根据《交易所法》第13(A)节提供的任何新的或修订的财务会计准则。
通过勾选标记检查注册人是否是空壳公司（定义见《交易法》第120亿.2条）：是'否
截至2024年11月4日，有几个
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第1项。 |
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第1项。 |
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第1A项。 |
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第二项。 |
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第四项。 |
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第五项。 |
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第六项。 |
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Temp美国人工智能公司
浓缩巩固d季度财务报表（未经审计）
2024年9月30日
1
Tempus AI，Inc.
浓缩Consolida泰德资产负债表
(未经审计)
(单位为千，不包括每股和每股金额)
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9月30日， |
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十二月三十一日， |
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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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应收账款，扣除准备金净额#美元 |
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库存 |
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认股权证资产 |
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预付费用和其他流动资产 |
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有价证券 |
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递延发售成本 |
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流动资产总额 |
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$ |
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$ |
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财产和设备，净额 |
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商誉 |
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令状资产，减去流动部分 |
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无形资产，净额 |
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投资和其他资产 |
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对合资企业的投资 |
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令状合同资产，减流动部分 |
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经营性租赁使用权资产 |
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受限现金 |
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总资产 |
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$ |
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负债、可转换可赎回优先股和股东权益（赤字） |
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流动负债 |
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应付帐款 |
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应计费用 |
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递延收入 |
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递延其他收入 |
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其他流动负债 |
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经营租赁负债 |
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应计数据许可费 |
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应计股息 |
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流动负债总额 |
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$ |
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$ |
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经营租赁负债减去流动部分 |
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可转换本票 |
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认股权证法律责任 |
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其他长期负债 |
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应付利息 |
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长期债务，净额 |
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递延其他收入，减流动部分 |
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递延收入，减去当期部分 |
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总负债 |
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$ |
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$ |
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(Note 8） |
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可转换可赎回优先股，美元 |
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附注是这些简明综合财务报表的组成部分。
2
股东权益(亏损) |
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A类投票普通股，美元 |
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$ |
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$ |
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b类投票普通股，美元 |
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无投票权普通股，美元 |
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国库股票， |
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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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累计赤字 |
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股东权益总额（赤字） |
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$ |
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$ |
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总负债，可转换可赎回优先股， |
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$ |
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$ |
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随附的附注是该等简明综合财务报表的组成部分。
3
Tempus AI，Inc.
简明综合损益计算书 运营和综合损失
（未经审计）
(in数千，每股金额除外）
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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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净营收 |
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Genomics |
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$ |
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$ |
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$ |
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$ |
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数据和服务 |
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总净营收 |
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$ |
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$ |
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$ |
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$ |
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成本和运营费用 |
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收入成本、基因组学 |
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收入、数据和服务成本 |
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技术研发 |
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研发 |
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销售，一般和行政 |
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总成本和运营费用 |
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经营亏损 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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利息收入 |
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利息开支 |
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( |
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( |
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( |
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( |
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其他（费用）收入，净 |
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( |
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( |
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所得税拨备前损失 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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所得税拨备 |
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( |
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( |
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( |
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( |
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权益法投资的损失 |
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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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A系列的股息、B 10 2、C、D、E、F、G、G-3和 |
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( |
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( |
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( |
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C系列优先累积未宣派股息 |
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( |
) |
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( |
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( |
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归属于普通股股东的净亏损（基本和稀释） |
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( |
) |
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( |
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( |
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( |
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归属于普通股股东的每股净亏损，基本 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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用于计算净亏损的加权平均流通股 |
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综合损失，扣除税款 |
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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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外币换算调整 |
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( |
) |
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( |
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全面亏损 |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
随附的附注是该等简明综合财务报表的组成部分。
4
Tempus AI，Inc.
凝结凝固S现金流的纹身
（未经审计）
(in千，份额和每股金额除外）
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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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净亏损 |
$ |
( |
) |
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$ |
( |
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调整净亏损与经营活动中使用的净现金 |
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认购证负债公允价值变化 |
$ |
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$ |
( |
) |
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股票补偿 |
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认购权行使收益 |
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( |
) |
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有价股权证券的收益 |
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( |
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权益法投资的损失 |
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原发行折扣摊销 |
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延期融资费用摊销 |
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或有对价公允价值变化 |
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( |
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凭证合同资产摊销 |
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折旧及摊销 |
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坏帐费用拨备 |
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认购证资产公允价值变动 |
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( |
) |
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融资使用权租赁资产摊销 |
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非现金经营租赁成本 |
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最低增长费用 |
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无形资产减值 |
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PIk利息添加到本金中 |
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资产和负债变化 |
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应收帐款 |
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( |
) |
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( |
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库存 |
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( |
) |
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( |
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预付费用和其他易变现资产 |
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( |
) |
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( |
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投资和其他资产 |
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( |
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( |
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应付帐款 |
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( |
) |
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( |
) |
递延收入 |
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( |
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( |
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递延其他收入 |
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应计数据许可费 |
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( |
) |
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( |
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应计费用及其他 |
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应付利息 |
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经营租赁负债 |
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( |
) |
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( |
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经营活动所用现金净额 |
$ |
( |
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$ |
( |
) |
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投资活动 |
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购买财产和设备 |
$ |
( |
) |
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$ |
( |
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出售有价股本证券的收益 |
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业务合并，扣除收购现金（注4） |
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( |
) |
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合营企业投资 |
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( |
) |
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购买有价股本证券 |
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( |
) |
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投资活动所用现金净额 |
$ |
( |
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$ |
( |
) |
随附的附注是该等简明综合财务报表的组成部分。
5
Tempus AI，Inc.
简明综合现金流量表
（未经审计）
(in千，份额和每股金额除外）
融资活动 |
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与首次公开发行相关的普通股发行收益，扣除承销折扣和佣金 |
$ |
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$ |
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与限制性股票单位净份额结算相关的预扣税 |
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( |
) |
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发行G-5系列优先股 |
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融资租赁负债本金付款 |
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( |
) |
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购买库藏股 |
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( |
) |
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支付延期发行成本 |
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( |
) |
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( |
) |
上缴红利 |
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( |
) |
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( |
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长期债务收益，扣除原始发行折扣 |
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支付与收购相关的赔偿扣留 |
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( |
) |
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G-4特殊付款 |
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( |
) |
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融资活动提供的净现金 |
$ |
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$ |
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外汇价位对现金的影响 |
$ |
( |
) |
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$ |
( |
) |
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现金、现金等值物和限制现金净增加（减少） |
$ |
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$ |
( |
) |
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现金、现金等值物和受限制现金，期末 |
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现金、现金等值物和限制现金，期末 |
$ |
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$ |
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现金、现金等值物和限制现金包括： |
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现金及现金等价物 |
$ |
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$ |
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受限制现金和现金等值物 |
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现金、现金等值物和限制现金总额 |
$ |
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$ |
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现金流量信息补充披露 |
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年内支付的利息现金 |
$ |
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|
$ |
|
||
所得税支付的现金 |
$ |
|
|
$ |
|
||
|
|
|
|
|
|
||
非现金投资和融资活动的补充披露 |
|
|
|
|
|
||
应付股利 |
$ |
|
|
$ |
|
||
购置财产和设备，应计但未支付 |
$ |
|
|
$ |
|
||
应计但尚未支付的递延发行成本 |
$ |
|
|
$ |
|
||
赎回可转换商业本票 |
$ |
|
|
$ |
|
||
与企业合并相关发行的无投票权普通股 |
$ |
|
|
$ |
|
||
获得使用权资产产生的经营租赁负债 |
$ |
|
|
$ |
|
||
与首次公开发行相关的可赎回可转换优先股转换为普通股 |
$ |
|
|
$ |
|
||
与尚未缴纳的限制性股票单位净份额结算相关的税款 |
$ |
|
|
$ |
|
||
首次公开发行时将延期发行成本重新分类为额外实缴资本 |
$ |
|
|
$ |
|
||
发行G-3系列优先股 |
$ |
|
|
$ |
|
||
发行G-4系列优先股 |
$ |
|
|
$ |
|
||
随附的附注是该等简明综合财务报表的组成部分。
6
Tempus AI，Inc.
可赎回可转换的浓缩合并报表
斯托克，普通斯托克安D股东股票（赤字）
（未经审计）
(in千，份额和每股金额除外）
|
可赎回可换股 |
|
|
|
投票普通股 |
|
非投票 |
|
财政部 |
|
额外 |
|
|
|
积累 |
|
总 |
|
||||||||||||||||||||||||||
|
股票 |
|
|
|
A类 |
|
B类 |
|
普通股 |
|
股票 |
|
实收 |
|
积累 |
|
全面 |
|
股东 |
|
||||||||||||||||||||||||
|
单位 |
|
量 |
|
|
|
单位 |
|
量 |
|
单位 |
|
量 |
|
单位 |
|
量 |
|
单位 |
|
量 |
|
资本 |
|
赤字 |
|
（损失）收入 |
|
赤字 |
|
||||||||||||||
余额 |
|
|
$ |
|
|
|
|
|
$ |
|
|
— |
|
$ |
— |
|
|
|
$ |
|
|
( |
) |
$ |
( |
) |
|
|
$ |
( |
) |
$ |
|
$ |
( |
) |
||||||||
发行系列G-3 |
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||
发行系列G-4 |
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||
发行系列G-5 |
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||
发行的普通股 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||||
红利 |
|
— |
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
|
发行普通 |
|
— |
|
|
— |
|
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||||
可赎回的转换 |
|
( |
) |
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
( |
) |
|
— |
|
|
|
||||||
无投票权的转换 |
|
— |
|
|
— |
|
|
|
|
|
|
|
|
— |
|
|
— |
|
|
( |
) |
|
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
— |
|
|
|
||||
发行普通 |
|
— |
|
|
— |
|
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
— |
|
|
( |
) |
||
发行普通 |
|
— |
|
|
— |
|
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
— |
|
|
( |
) |
||
股票型 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||
外币 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
||
净亏损 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
2024年9月30日余额 |
|
|
$ |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
( |
) |
$ |
( |
) |
$ |
|
$ |
( |
) |
$ |
|
$ |
|
|||||||||||
随附的附注是该等简明综合财务报表的组成部分。
7
Tempus AI，Inc.
可赎回可转换的浓缩合并报表
国家股票、普通股票和股东股票（赤字）
（未经审计）
(in千，份额和每股金额除外）
|
可赎回可换股 |
|
|
|
投票普通股 |
|
非投票 |
|
财政部 |
|
额外 |
|
|
|
积累 |
|
总 |
|
||||||||||||||||||||||||||
|
股票 |
|
|
|
A类 |
|
B类 |
|
普通股 |
|
股票 |
|
实收 |
|
积累 |
|
全面 |
|
股东 |
|
||||||||||||||||||||||||
|
单位 |
|
量 |
|
|
|
单位 |
|
量 |
|
单位 |
|
量 |
|
单位 |
|
量 |
|
单位 |
|
量 |
|
资本 |
|
赤字 |
|
（损失）收入 |
|
赤字 |
|
||||||||||||||
余额 |
|
|
$ |
|
|
|
|
|
$ |
|
|
— |
|
$ |
— |
|
|
|
$ |
|
|
— |
|
$ |
— |
|
|
|
$ |
( |
) |
$ |
|
$ |
( |
) |
||||||||
发行系列G-3 |
|
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||
外币 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
红利 |
|
— |
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
|
回购无投票权 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
发行的普通股 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||||
净亏损 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
2023年9月30日余额 |
|
|
$ |
|
|
|
|
|
$ |
|
|
— |
|
$ |
— |
|
|
|
$ |
|
|
( |
) |
$ |
( |
) |
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
|||||||
随附的附注是该等简明综合财务报表的组成部分。
8
Tempus AI，Inc.
可赎回可转换的浓缩合并报表
国家股票、普通股票和股东股票（赤字）
（未经审计）
(in千，份额和每股金额除外）
|
可赎回 |
|
|
|
投票普通股 |
|
非投票 |
|
|
|
|
|
额外 |
|
|
|
积累 |
|
总 |
|
||||||||||||||||||||||||
|
股票 |
|
|
|
A类 |
|
B类 |
|
普通股 |
|
库藏股 |
|
实收 |
|
积累 |
|
全面 |
|
股东 |
|
||||||||||||||||||||||||
|
单位 |
|
量 |
|
|
|
单位 |
|
量 |
|
单位 |
|
量 |
|
单位 |
|
量 |
|
单位 |
|
量 |
|
资本 |
|
赤字 |
|
（损失）收入 |
|
赤字 |
|
||||||||||||||
余额 |
|
|
$ |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
( |
) |
$ |
( |
) |
|
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||||||||
发行普通股 |
|
— |
|
|
— |
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
— |
|
|
( |
) |
|
股票补偿 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||
外币 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
||
净亏损 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
2024年9月30日余额 |
|
|
$ |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
( |
) |
$ |
( |
) |
$ |
|
$ |
( |
) |
$ |
|
$ |
|
|||||||||||
|
可赎回 |
|
|
|
投票普通股 |
|
非投票 |
|
|
|
|
|
额外 |
|
|
|
积累 |
|
总 |
|
||||||||||||||||||||||||
|
股票 |
|
|
|
A类 |
|
B类 |
|
普通股 |
|
库藏股 |
|
实收 |
|
积累 |
|
全面 |
|
股东 |
|
||||||||||||||||||||||||
|
单位 |
|
量 |
|
|
|
单位 |
|
量 |
|
单位 |
|
量 |
|
单位 |
|
量 |
|
单位 |
|
量 |
|
资本 |
|
赤字 |
|
（损失）收入 |
|
赤字 |
|
||||||||||||||
余额 |
|
|
$ |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
( |
) |
$ |
( |
) |
|
|
$ |
( |
) |
$ |
|
$ |
( |
) |
||||||||||
外币 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
红利 |
|
— |
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
|
净亏损 |
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
2023年9月30日余额 |
|
|
$ |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
( |
) |
$ |
( |
) |
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
|||||||||
随附的附注是该等简明综合财务报表的组成部分。
9
冷凝注意事项 综合财务报表
（未经审计）
公司资讯
Tempus AI，Inc.及其开展业务的子公司(“本公司”)是一家医疗技术公司，专注于将人工智慧和机器学习引入医疗保健领域，以改善对多种疾病患者的护理。该公司将实验室测试结果与其他多模式数据集相结合，通过支持医疗保健生态系统中的各方，包括医生、研究人员、付款人和制药公司，改善患者护理。该公司的收入主要来自向医生和大型学术研究机构出售全面的基因测试、向第三方许可数据、将患者与临床试验相匹配以及相关服务。
该公司总部设在伊利诺伊州芝加哥，由公司首席执行官兼执行主席埃里克·P·莱夫科夫斯基创立，由莱夫科夫斯基创立的名为Bioin的企业演变而来。Bioin最初是作为一家有限责任公司成立的。自2015年9月21日起，Bioin将其法律形式转变为根据特拉华州公司法组织和存在的公司。Bioin随后于2015年9月更名为Tempus Health，Inc.，2016年10月更名为Tempus Labs，Inc.，2023年12月更名为Tempus AI，Inc.。
首次公开发行
2024年6月13日，公司首次公开发行股票注册书宣布生效，其A类普通股于2024年6月14日在纳斯达克全球精选市场开始交易。2024年6月17日，公司完成首次公开募股
与首次公开招股结束有关，本公司当时已发行的可赎回可转换优先股的所有股份，除本公司的B系列可赎回可转换优先股外，全部转换为
截至2024年6月16日，公司的可赎回可转换优先股应计金额为
无投票权普通股的流通股按一对一的方式转换为
根据本公司2015年计划授予员工的限制性股票单位(“RSU”)受两个归属条件的约束。第一个是基于时间的元件。第二个归属条件是发生流动性事件。与该等奖励有关的流动资金事项条件于首次公开发售时已获满足，因此，本公司确认为美元。
关于首次公开招股，本公司发行了
关于首次公开招股，本公司修订及重述其公司注册证书(“重订证书”)，根据该证书，法定股本包括
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合并原则和列报基础
简明合并财务报表包括Tempus AI，Inc.及其全资子公司的账目。在合并中，所有公司间账户和交易都已取消。简明综合财务报表及附注乃根据美国公认会计原则(“公认会计原则”)及美国证券交易委员会(“美国证券交易委员会”)有关中期财务资料的适用规则及规定编制，幷包括所有全资附属公司的资产、负债、收入及开支。本公司并无控股财务权益，但有能力行使重大影响力的未合并实体的投资，按权益会计方法入账。对本公司不能施加重大影响的未合并实体的投资按成本会计方法入账。按照公认会计原则编制的年度综合财务报表中通常包含的某些资讯和披露已被省略。因此，未经审核的中期简明综合财务报表应与经审计的综合财务报表及载于本公司日期为2024年6月13日的最终招股说明书(日期为2024年6月13日)的附注一并阅读，该最终招股说明书于2024年6月17日根据经修订的19证券法(“证券法”)第424(B)条向美国证券交易委员会提交(“招股说明书”)。未经审核的中期简明综合财务报表已按经审核综合财务报表的相同基准编制，管理层认为，该等财务报表反映了为公平反映本公司中期财务状况、经营业绩及现金流量所必需的所有正常、经常性的调整，但并不一定显示全年或任何其他期间的预期结果。
本公司认为，随附的未经审计的简明综合财务报表包含所有调整，仅包括正常的经常性调整，对于公平陈述其截至2024年9月30日的财务状况、截至2024年和2023年9月30日的三个月和九个月的经营业绩以及截至2024年和2023年9月30日的九个月的现金流量是必要的。截至2023年12月31日的简明综合资产负债表来自经审计的年度财务报表，但不包含年度财务报表中的所有注脚披露。
该公司相信，其截至2024年9月30日的现有现金和现金等价物以及可出售的股本证券将足以使公司能够在自发行之日起至少一年的时间内为其当前的运营计划提供资金。由于公司继续亏损，它的盈利转型取决于足以支持公司成本结构的收入水准。未来的资本需求将取决于许多因素，包括用于研发活动和与增长相关的支出的时间和程度。
除下文所述外，于截至2023年12月31日止年度，本公司经审核综合财务报表所载“综合财务报表附注”所载本公司的主要会计政策并无任何变动包括在招股说明书中，对公司的综合财务报表和附注产生重大影响。
改叙
为了与本年度的列报保持一致，对上一年的某些数额进行了重新分类。
新兴成长型公司
本公司是证券法第2(A)节所界定的“新兴成长型公司”，并经2012年的JumpStart Our Business Startups Act(“JOBS法案”)修订，本公司可利用适用于非新兴成长型公司的其他上市公司的各种报告要求的某些豁免，包括但不限于，不被要求遵守萨班斯-奥克斯利法第404条的审计师认证要求，减少定期报告和委托书中关于高管薪酬的披露义务，以及免除就高管薪酬和股东批准之前未获批准的任何黄金降落伞支付进行不具约束力的咨询投票的要求。
此外，《就业法案》第102(B)(1)条免除新兴成长型公司遵守新的或修订后的财务会计准则的要求，直至私营公司(即尚未宣布生效的证券法注册声明或没有根据修订后的1934年《证券交易法》注册的证券类别)被要求遵守新的或修订后的财务会计准则为止。JOBS法案规定，公司可以选择退出延长的过渡期，并遵守适用于非新兴成长型公司的要求，但任何这样的选择退出都是不可撤销的。本公司已选择不选择该延长过渡期，即当一项准则发布或修订，而该准则对上市公司或私人公司有不同的适用日期时，本公司作为新兴成长型公司，可在私人公司采用新准则或经修订准则时采用新准则或经修订准则。这可以比较一下
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的 本公司的简明综合财务报表与另一间既非新兴成长型公司亦非新兴成长型公司的上市公司合并，该等上市公司因所采用的会计准则潜在差异而难以或不可能选择不采用延长的过渡期。
使用估计
根据公认会计原则编制未经审核简明综合财务报表时，管理层须作出估计及假设，以影响简明综合财务报表及附注中资产及负债的呈报金额及分类、收入及开支，以及或有资产及负债的相关披露。最重要的估计与收入、应收账款、基于股票的补偿、经营租赁负债以及财产、设备和无形资产的使用年限有关。实际结果可能与这些估计不同。
归属于普通股股东的每股净亏损
普通股股东应占每股基本净亏损和摊薄净亏损按照参与证券所需的两级法列报。公司将其所有系列的可赎回可转换优先股视为参与证券。在首次公开招股前，根据两类法，普通股股东应占净亏损并未分配给可赎回可转换优先股，因为其可赎回可转换优先股的持有人并无合约义务分担本公司的亏损。首次公开招股时，公司的可赎回可转换优先股转换为A类或B类普通股，因此将计入普通股股东应占净亏损的分配，因为他们将分担公司的亏损。净收入根据普通股股东的参与权归属于普通股股东和参与证券。普通股股东应占每股基本净亏损的计算方法为：普通股股东应占净亏损除以当期已发行普通股的加权平均股数。普通股股东的摊薄每股收益调整基本每股收益，以应对股票期权和可赎回可转换优先股的潜在摊薄影响。由于本公司已公布所有期间的亏损，所有潜在摊薄证券均为反摊薄证券，因此，每股基本净亏损等于每股摊薄净亏损。
延期发行成本
递延发行成本主要包括与IPO相关的会计、法律和其他费用。该公司有$
股本投资
本公司采用权益法对其有能力对被投资方的经营和财务政策施加重大影响的投资进行核算。本公司遵循ASC 323中的指导，投资--权益法和合资企业规定了在本公司具有重大影响力的合资企业中使用权益法进行投资。本公司按成本计入初始投资，并于投资日期后按本公司在被投资人净收益或亏损中所占的百分比进行调整。对于公司的境外权益法投资，被投资人收入的比例份额按该期间的平均汇率换算为美元，投资按报告期末的汇率换算。与投资的外币换算相关的未实现收益和亏损在公司综合资产负债表中的累计其他全面收益中递延。
可变利益实体
可变权益实体(“VIE”)是指(I)股本不足，以致实体在没有额外附属财务支持的情况下为其活动提供资金，(Ii)拥有缺乏控股权特征的股权投资者，或(Iii)实体成立时拥有非实质性投票权(即该实体剥夺了多数经济利益持有人(S)的投票权)。在ASC 810下，巩固，持有VIE可变权益并满足某些要求的实体将被视为VIE的主要受益人，并要求在其合并财务报表中合并VIE。为了被视为VIE的主要受益人，实体必须在VIE中持有可变权益，并同时拥有：
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如果本公司不是VIE的主要受益人，它将根据适用的公认会计原则对VIE的投资或其他可变权益进行核算。本公司定期评估其与该实体的权益或关系的任何变化是否影响其对该实体是否为VIE以及(如果是)其是否为主要受益人的决定。
最近发布的尚未采用的会计公告
2023年11月，FASB发布了ASU编号2023-07，分部报告(主题280)，其中加强了对重大分部费用的披露。该标准还加强了中期披露要求，并为具有单一可报告分部的实体提供了新的分部披露要求。该标准适用于上市公司2023年12月15日之后的财年，以及2024年12月15日之后的财年内的过渡期。以前提交的所有期间都需要追溯采用。允许及早领养。本公司预计采用新准则不会对其综合财务报表产生重大影响。
2023年12月，FASB发布了ASU 2023-09，所得税(专题740)：所得税披露的改进，要求公共实体每年在税率调节中提供特定类别的披露，并披露按司法管辖区分列的已支付所得税。ASU 2023-09在2024年12月15日之后的财年生效，允许提前采用。本公司目前正在评估这一指引对合并财务报表和相关披露的影响。
该公司通过向医生、学术研究机构和其他各方出售实验室服务(“基因组学”)获得收入。该公司还通过将未识别的数据集授权给第三方和提供临床试验支持(例如将患者与其临床试验网路中登记的临床试验相匹配)以及相关服务，从实验室产生的数据(“数据和服务”)商业化中获得收入。该公司的大部分收入来自北美。
公司按照财务会计准则委员会(FASB)ASC 606对收入进行会计处理客户合约收益(“ASC 606”)。当这些产品的控制权转移给客户时，公司开始确认收入，其金额反映了公司预期有权换取此类产品的对价。这一原则是通过应用五步法实现的：(I)当合同得到双方的批准和承诺时，公司对合同进行会计处理；(Ii)确定各方的权利；(Iii)确定付款条件；(Iv)合同具有商业实质；(V)可能可收取对价。收入和任何合同资产只有在满足要求的条件时才能确认。
收入分拆
该公司提供基于基因组学的收入分类，以及简明综合经营报表和全面亏损表上的数据和服务，因为它认为这些最好地描述了收入和现金流的性质、数量、时机和不确定性如何受到经济因素的影响。
Genomics
该公司通常在履行与订单有关的履约义务时确认其提供的基因组产品的收入。本公司已确定其唯一的履行义务是将测试结果交付给订购方。该公司从Medicare、Medicaid和商业保险公司获得临床订单的付款，并直接从研究机构、制药公司或其他第三方获得直接账单订单的付款。该公司确认的基因组学收入为1美元
对于来自联盟医疗保险、医疗补助和商业保险的临床订单，公司通过降低标准费用来确定交易价格，方法是根据任何可变对价的估计影响，例如合同津贴和隐含的价格优惠。该公司根据与既定费率有关的历史收款以及历史数据中没有反映的已知当前或预期的偿还趋势，估计合同津贴和隐含的价格优惠。估计包括本公司将有权获得的对价，其金额很可能不会发生累计对价逆转。本公司根据实际现金收缴情况监测每个报告期应收取的估计金额，以评估是否需要修订估计数。付款通常在付款人处理索赔后到期，通常是自送达之日起30-120天。虽然管理层认为估计是准确的，但实际结果可能不同，对财务报表的潜在影响可能很大。公司认识到
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临床订单的收入为$
对于来自研究机构、制药公司或其他第三方的直接账单订单，公司根据与客户的既定合同费率，扣除任何适用的折扣，确定交易价格。付款一般在发票开具之日起30至60天内支付。该公司确认了基因组学直接账单订单的收入为$
数据和服务
数据和服务收入主要是指该公司向制药和生物技术公司提供的数据许可和临床试验服务。该公司与这些客户的协定条款往往跨越数年。然而，这些合同通常还包括客户在12个月后选择加入或提前终止条款，而不受合同处罚。客户续签的选择权通常不被视为一项实质性权利，因此，公司这些协定的合同期通常被认为不到一年。该公司根据与客户订立的合同费率，扣除任何适用的折扣，确定交易价格。当公司根据与客户的协定条款履行其履约义务时，公司确认其提供的数据和服务产品的收入。该公司提供的两种产品如下：
真知灼见
该公司的Insights产品主要包括许可和分析未识别的记录。每份Insights合同都是独一无二的，可能包括多项承诺，包括提供许可的去身分记录，包括刷新、分析服务或访问公司的增强型镜头应用程式。公司对每份合同进行评估，以确定哪些履约义务能够与合同中的其他承诺区分开来，从而代表不同的履约义务。数据交付的实际时间可能基于各种因素，包括但不限于客户的要求和/或公司的技术、运营和人力资本能力；此外，管理层在与客户的合同中评估相关的合同条款，并在确定和核算某些合同中的所有条款和条件时应用重大判断。交易价格分配给不同的履约义务，并在履行履约义务后确认收入。独立销售价格是基于公司单独销售时的正常定价做法，并考虑了市场状况和其他因素，包括客户人口统计。
该公司已确定，交付非身分记录和分析服务(如果适用)以及访问其增强型Lens应用程式是单独和独特的履约义务。主要的Insights合同类型如下：
该公司确认来自Insights产品的收入为$
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审判
公司的Trials产品包括Time临床试验配对服务和其他临床试验服务。
时间主要包括将患者与潜在配对的临床试验赞助商进行匹配。在合同要求的范围内，公司还可以协助开放临床试验场地并将患者纳入临床试验。该公司已经确定，根据协定的类型，这些合同的履行义务是交付通知或让患者参加临床试验。因此，收入是在以下情况之一确认的：向医生发送通知，提醒他们临床试验匹配，或一旦患者登记参加试验。同时，作为临床试验赞助商的客户也收到来自公司的通知，以确定在结算期内交付或履行的履约义务。
除时间外，该公司还提供进行或支持研究的其他临床试验服务。Tempus Compass LLC是该公司的子公司，是一家合同研究组织，负责管理和执行早期和晚期临床试验，主要是肿瘤学试验。临床试验服务合同可以采取按服务收费或固定价格合同的形式。按服务收费的合同通常根据时间和材料定价，收入根据提供服务时使用的小时和材料确认。固定价格合同通常代表单一的履约义务，并使用基于成本的输入法随著时间推移予以确认。履约义务的进展情况是通过实际发生的费用占完成合同预期总费用的比例来衡量的。这种以成本为基础的收入确认方法要求公司对持续完成其专案的成本进行估计。合同成本主要包括直接人工和可报销的自付成本。
该公司确认来自试验产品的收入为$
对于洞察和试验安排，定价是固定的，公司可能会通过预付款和基于绩效的、在完成所述履约义务时到期的不可退还的付款相结合的方式获得补偿(S)。付款一般在服务日期后60至90天内支付。对于提供的数据和服务产品，公司没有重大的退款、保固或类似义务。本公司选择了切实可行的权宜之计，允许本公司不披露原始条款为12个月或以下的合同的剩余履约义务。可取消的合同收入不被视为剩余的履约义务。该公司确认来自制药公司、非营利组织和研究人员的数据和其他收入为$
多年期合同履行义务
该公司拥有有限的多年期合同，不包含提前终止或客户选择加入条款。这些合同包含明确的、不可撤销的履约义务，这些义务将在未来几年履行。公司与多年期合同有关的剩余履约债务为#美元。
合约资产
收入确认的时间可能与向客户开具发票的时间不同。某些履约义务可能需要在向客户交付服务之前付款。当公司有无条件的支付权，并且合同收入超过账单时，公司确认合同资产。合同资产列在应收账款净额项下。截至2024年9月30日和2023年12月31日的应收账款包括合同资产#美元。
于2021年第四季度，在与客户阿斯利康公司(“阿斯利康”)签署2021年11月的主服务协定(“主服务协定”)的同时，公司根据ASC 606确认了一项合同资产，用于在发行普通股认股权证的同时支付对价。根据FASB ASC 718的权威指引，合同资产最初计量为认股权证负债的初始公允价值补偿-股票补偿。由于收入是在MSA的合同承诺期内确认的，因此相关的合同资产摊销记为收入减少。在每个报告期，权证资产的短期部分根据财务承诺进行调整，并重新分类为预付费用和其他流动资产。
15
以下是截至以下日期的权证合同资产列报摘要2024年9月30日和2023年12月31日(单位：千)：
|
|
9月30日， |
|
|
12月31日， |
|
||
预付费用和其他易变现资产 |
|
$ |
|
|
$ |
|
||
权证合同资产，减去流动部分 |
|
|
|
|
|
|
||
权证合同总资产 |
|
$ |
|
|
$ |
|
||
2023年11月，本公司与Personalis，Inc.(“Personalis”)签订了商业化和参考实验室协定，该协定随后于2024年8月进行了修订。该公司将支付高达$
递延收入
递延收入包括在收入确认之前收到的服务账单或现金，当满足公司的所有收入确认标准时，将被确认为收入。递延收入余额主要受公司提供的数据和服务产品的预付合同付款以及公司未经确认的许可数据和临床测试结果的交付时间的影响。预期将在随后12个月期间确认为收入的递延收入部分计入递延收入当期，其余部分记为递延收入非当期收入。该公司确认了$
SEngine
2023年10月3日，公司收购了特拉华州有限责任公司SEngine Precision Medicine LLC(“SEngine”)的全部已发行和未偿还权益。此次收购使该公司能够使用SEngine有意义的有机物储存库、先进的生物资讯学能力和巴黎测试平台。
这笔收购带来了#美元的商誉。
姆皮里克
2023年3月8日，该公司收购了Mpirik，Inc.(“Mpirik”)的所有已发行和未偿还的权益，Mpirik是一家专注于心脏病学的医疗保健技术公司，专门从事数据驱动的患者筛查、自动化护理协调和临床研究。Mpirik的平台增加了该公司现有的产品组合，以解决心脏病的检测、诊断和治疗方法，进一步扩大了Tempus的心脏病业务。这笔收购带来了#美元的商誉。
现金对价美金
16
12个月截至2023年12月31日的期间。或有对价的购置公允价值日期为#美元。
动脉
2022年10月3日，该公司收购了Arterys，Inc.(简称Arterys)，这是一家提供从放射医学图像中获得洞察力的平台，以改善多个疾病领域的诊断决策、效率和生产力，从而产生了$
17
财产和设备，净值
以下总结了截至2011年的财产和设备净值 2024年9月30日和2023年12月31日(单位：千)：
|
|
9月30日， |
|
|
12月31日， |
|
||
设备 |
|
$ |
|
|
$ |
|
||
租赁物业装修 |
|
|
|
|
|
|
||
家具及固定装置 |
|
|
|
|
|
|
||
财产和设备总额，毛额 |
|
|
|
|
|
|
||
减：累计折旧 |
|
|
( |
) |
|
|
( |
) |
财产和设备，净值 |
|
$ |
|
|
$ |
|
||
物业及设备的折旧费用在随附的简明综合经营报表中分类如下： 截至2024年9月30日和2023年9月30日的三个月和九个月（单位：千）：
|
|
截至9月30日的三个月， |
|
|
截至9月30日的九个月， |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
收入成本、基因组学 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
销售、一般和管理成本 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
总折旧 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
应计费用
截至日期的应计费用 2024年9月30日和2023年12月31日，包括以下内容（以千计）：
|
|
9月30日， |
|
|
12月31日， |
|
||
应计薪酬和员工福利 |
|
$ |
|
|
$ |
|
||
应计费用 |
|
|
|
|
|
|
||
应计云存储成本 |
|
|
|
|
|
|
||
应付利息 |
|
|
|
|
|
|
||
应计费用总额 |
|
$ |
|
|
$ |
|
||
商誉
商誉是指企业合并中的购买价格超过所获得的有形和无形资产净值的公允价值。有几个
无形资产
无形资产最初按购入成本入账，若作为企业合并的一部分购入，则按公允价值计入，并在其预计使用年限内摊销。无形资产包括网站域名、作为业务合并一部分获得的客户关系和商号，以及通过签订研究合作协定获得的许可数据。在每个许可安排中，另一方向公司提供指定的数据，这些数据目前主要用于研究和开发目的，但也可能被许可给第三方。该资产代表该公司使用这些数据集的权利。本公司还确认在应计数据许可费中提出的相关最低付款的负债。
在截至2024年9月30日的三个月和九个月内，公司记录了$
18
2023年1月，该公司修改了一份数据许可协议，减少了该公司所欠的未来数据许可付款，以换取放弃许可数据的排他性权。公司将相关许可数据无形资产重新计量至公允价值，导致亏损美金
下表总结了截至年的无形资产 2024年9月30日和2023年12月31日(单位：千)：
|
|
9月30日， |
|
|
12月31日， |
|
||||||||||||||||||
|
|
毛 |
|
|
累计摊销 |
|
|
净 |
|
|
毛 |
|
|
累计摊销 |
|
|
净 |
|
||||||
客户关系 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
授权数据 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
网站域名 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
商品名 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
无形资产的摊销采用直线法在其估计使用寿命内确认，范围从 到
SB Tempus
对
SB Tempus被视为VIE，因为本公司并无足够的风险股本，并有权透过其股权收取SB Tempus的剩余回报。重大影响SB Tempus经济表现的决定需要得到本公司和软银的同意。因此，本公司的结论是，任何一方均不被视为对SB Tempus拥有主要控制权，本公司也不被视为主要受益人。
本公司对SB Tempus损失的最大风险敞口等于本公司投资的账面价值。截至2024年9月30日，SB Tempus投资的账面价值为$
就订立合营协定而言，本公司订立资料许可协定(“资料许可协定”)，根据该协定，本公司向SB Tempus授予一项有限、非独家、可转让许可，并赋予其有限权利只就若干特定用途于日本再许可若干非识别资料。根据数据许可协定，SB Tempus向本公司支付了人民币
此外，于2024年7月18日，本公司与SB Tempus订立知识产权协定(“知识产权许可协定”)，根据该协定，SB Tempus向本公司额外支付人民币
19
法律事项
在正常业务过程中，公司可能会不时受到各种法律事务的影响，例如威胁或悬而未决的索赔或诉讼。截至2024年9月30日及2023年9月30日止三个月及九个月，不存在重大此类事项。
普通股
在首次公开募股之前，公司已经批准了有投票权和无投票权两类普通股。2021年3月，公司修改了公司注册证书，将有投票权的普通股分为A类普通股和B类普通股。截至2023年12月31日，公司已授权
A类普通股和B类普通股在这些未经审计的中期简明合并财务报表附注中统称为“普通股”，除非另有说明。
除投票权外，A类普通股和B类普通股持有人的权利相同。A类普通股每股享有一票投票权，B类普通股每股享有30票投票权。在首次公开招股之前，该公司还拥有授权发行的无投票权普通股，这些普通股没有任何投票权。首次公开募股后，没有无投票权的普通股被授权或流通股。
根据持有者的选择，每股B类普通股可随时转换为一股A类普通股。
根据重新发行的证书，任何持有B类普通股的持有者股票将在根据某些情况，包括：(1)将此类b类普通股出售或转让给“受控实体”，该“受控实体”是指直接或间接由b类普通股持有人控制或与其共同控制的任何个人或实体；(2)不少于
转让转换为A类普通股后，B类普通股不得再发行。
公司以股票期权、限制性股票单位、绩效股票单位和限制性股票的形式向员工发放股票奖励，所有这些都有可能增加未来普通股的流通股(见附注11，基于股票的薪酬)。
在任何清算、解散或清盘时，A类普通股和B类普通股的持有者将有权平等、相同和按比例分享在任何已发行优先股的任何负债、清算优先股和应计或已申报但未支付的股息(如有)支付后的所有剩余资产，除非该受影响类别的大多数流通股的持有人以赞成票批准不同的待遇，并作为一个类别单独投票。
20
普通股许可证
关于与阿斯利康的MSA，该公司授予阿斯利康认股权证，以购买$
如果阿斯利康拒绝在2024年12月31日之前延长其财务承诺，认股权证将被自动取消和终止，不作任何考虑。如果阿斯利康行使认股权证，阿斯利康将被要求将其在MSA下的最低承诺从1美元增加到1美元。
2023年12月8日，公司向艾伦发出认股权证
库藏股
2023年1月，公司回购
2023年1月，本公司发布
2024年1月，本公司发布
2023年10月，本公司发布
2024年4月，公司发布了
与首次公开招股有关，公司当时所有已发行的可赎回可转换优先股和应计但未支付的股息自动转换为
21
截至2011年发行的可赎回可转换优先股 2023年12月31日包括以下内容（以千计，股份金额除外）：
|
|
|
|
截至12月31日， |
|
|||||||||||||
系列 |
|
年 |
|
股份 |
|
|
清算 |
|
|
帐面 |
|
|||||||
优选 |
|
发布 |
|
授权 |
|
|
优秀 |
|
|
量 |
|
|
值 |
|
||||
A轮 |
|
2015 |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
||||
B轮 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
系列b-1 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
系列b-2 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
C轮 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
D轮 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
E轮 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
系列F |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
系列G |
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
G-2* 系列 |
|
2020/2021 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
G-3系列 ** |
|
2022/2023 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
G-4系列 ** |
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
可转换优先股总额 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
* 不包括与转换可转换票据相关的金额
** 不包括与嵌入式转换功能相关的金额
2015年股票计划
2015年，本公司通过了Tempus AI，Inc.2015股票计划(“2015计划”)，该计划经过多次修订和重述，以增加授权向公司员工、顾问和董事发行的股份总数。截至2023年12月31日，有
2023年1月18日，公司批准将当时的员工的RSU的到期日延长两年，否则他们的RSU将于2023年或2024年到期。本公司将延期计入股票补偿修改，导致未确认补偿费用增加#美元。
IPO后，将不会根据2015年股票计划提供进一步的拨款。
2024年股权激励计划
2024年2月，公司董事会通过了2024年股权激励计划，2024年4月，公司股东批准了2024年股权激励计划(“2024年计划”)，该计划于2024年6月首次公开募股时生效。2024年计划规定授予激励性股票期权、非法定股票期权、股票增值权、RSU、限制性股票单位奖励(RSA)、基于业绩的奖励(PSU)和其他奖励。根据2024年计划可以发行的A类普通股的最大数量为
22
限制性股票单位
大多数RSU在一段时间内归属 到
下表总结了受限制的股票单位活动 截至2024年9月30日的九个月：
|
|
限制性股票单位 |
|
|
加权-平均授予日期 |
|
||
于2023年12月31日未归属 |
|
|
|
|
$ |
|
||
授予 |
|
|
|
|
$ |
|
||
被安置并定居 |
|
|
( |
) |
|
$ |
|
|
已获授权但尚未定居 |
|
|
( |
) |
|
$ |
|
|
没收 |
|
|
( |
) |
|
$ |
|
|
过期 |
|
|
( |
) |
|
$ |
|
|
2024年9月30日未归属 |
|
|
|
|
$ |
|
||
股票薪酬在随附的简明综合经营报表中分类如下 截至2024年9月30日和2023年9月30日的三个月和九个月（单位：千）：
|
|
截至9月30日的三个月， |
|
|
截至9月30日的九个月， |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
收入成本、基因组学 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
收入、数据和服务成本 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
技术研发 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
研发 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
销售，一般和行政 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
股票薪酬总额 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
定期贷款安排
于2022年9月22日，本公司与Ares Capital Corporation(“Ares”)就一笔金额为#美元的优先担保贷款(“定期贷款”)订立信贷协定。
在生效日期后的前三个月，即每个季度，公司可以选择将借款类型转换为基本利率借款，基本利率借款根据基本利率产生利息，基本利率定义为(A)出现在《华尔街日报》或代理商选择的另一国家出版物上的“最优惠利率”部分，(B)联盟基金利率加
23
此外，定期贷款工具包括惯例陈述和担保、财务和其他契约以及违约事件，包括但不限于对套现、里程碑或递延购买义务的限制、优先股和股票回购的股息、现金投资和收购。该公司被要求保持至少#美元的流动资金。
定期贷款融资项下的所有债务均由本公司担保，并以本公司几乎所有资产作抵押。
原来发行的折扣为$
截至2024年9月30日，本公司尚未就定期贷款安排偿还任何本金。截至2024年9月30日的9个月内，公司赚了$
公司确认利息支出为#美元。
可换股承付票据
2020年6月22日，就签订使用谷歌有限责任公司或谷歌的谷歌云平台的协定，公司向谷歌发行了一张可转换本票，原始本金为#美元
经修订及重述的票据，或经修订的票据，本金为$
如经修订票据于到期日仍未偿还，谷歌可选择将根据经修订票据应累算的当时未偿还本金金额及利息转换为若干股公司A类普通股，该等股份的数目相等于(1)于到期日的未偿还金额除以(2)每一交易日的最后交易价的平均数
该公司的结论是，其中一个转换特征符合嵌入式衍生工具的定义，该定义要求作为单独的会计单位进行会计处理。嵌入衍生工具的公允价值并不重要，因此并未被分拆。因此，在发行票据时，公司记录了一张#美元的期票。
24
每股基本净亏损的计算方法是将净亏损除以每期普通股的加权平均流通股数。公司的A类普通股和B类普通股在分配和未分配的收益中所占份额相等；因此，不对参与证券或稀释证券进行分配。稀释每股净亏损是通过考虑所有潜在的稀释性普通股等价物来计算的，包括股票期权、RSU、RSA、PSU和优先股。由于公司每个期间都发生净亏损，所以基本计算和摊薄计算是相同的。该公司使用IF-转换法计算稀释每股收益。由于本公司在截至2024年9月30日和2023年9月30日的三个月和九个月中出现净亏损，所有潜在的稀释普通股等价物都被排除在普通股股东应占稀释每股净亏损的计算之外，因为它们的影响是反稀释的。
下表列出了每股基本净亏损和摊薄净亏损的计算方法(单位为千，不包括每股和每股数据)：
|
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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 |
2023 |
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|
2024 |
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|
2023 |
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||||||
分子： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
净亏损 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
系列A、B亿10亿2、C、D、E、F、G、G-3、 |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
C系列优先累积未宣派股息 |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
归属于普通股股东的净亏损 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
分母： |
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|
|
|
|
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|
|
|
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|
||||
加权平均已发行普通股，基本 |
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||||
普通股股东每股净亏损， |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
下列普通股等价物的流通股不计入每期每股摊薄净亏损的计算，因为计入这些股份的影响将是反摊薄的。如中披露的附注9，公司发行了一份认股权证，认购金额为$
|
|
截至9月30日， |
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|||||
|
|
2024 |
|
|
2023 |
|
||
未行使的股票期权 |
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|
|
|
|
||
可转换优先股 |
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|
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|
||
阿斯利康认股权证 |
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|
||
Mpirik扣留责任 |
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SEngine扣留责任 |
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||
SEngine或有对价 |
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|
|
|
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|
||
未投资的RSU |
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|
||
潜在稀释性股份总数 |
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|
|
|
|
||
如附注11所披露者，于首次公开招股前发行的流动资金单位包括归属前的流动资金事项表现状况。因此，截至2023年9月30日，这些股票被视为或有可发行股票，并被排除在潜在稀释股票之外，因为流动性事件表现条件尚未满足。由于于IPO完成时已满足流动资金事项表现条件，自2024年9月30日起，该等股份计入潜在摊薄股份。
如附注12所披露，视若干融资事件而定，经修订票据将根据到期日的未偿还金额，按持有人的选择权转换为股份，并可根据吾等于到期日前所使用的服务减值。因此，这些股票被视为或有可发行股票，并将被排除在潜在的摊薄影响之外。
如附注10所披露, 该公司的G-3系列优先股、G-4系列优先股和G-5系列优先股包含嵌入式转换功能，导致在首次公开募股完成后增发A类普通股。与这些功能相关的股票发行数量取决于IPO价格。因此，在首次公开募股之前，这些都被视为或有
25
可发行 股2024年6月IPO完成后，A类普通股的额外股份计入加权平均发行普通股。
中期所得税会计处理通常要求通过将整个财政年度的年度有效税率估计值应用于所得税前收入或亏损来确定所得税拨备，并根据报告期的离散项目（如果有）进行调整。公司每季度更新年度有效税率的估计，并在该期间进行累计调整。
截至2024年9月30日和2023年9月30日的三个月和九个月的所得税费用（福利）低于美金
由于公司在美国的亏损历史，公司所有递延所得税资产（包括净营运亏损结转和其他帐簿与税收差异）均保持了全额估值拨备。
公平值计量
金融工具包括现金及现金等价物、应收账款、融资租赁债务、最低特许权使用费、应付账款及应计费用，由于该等工具到期日较短，其账面值接近公允价值。关联方应收账款、融资租赁债务和最低特许权使用费的账面价值接近公允价值，因为所用利率随市场利率浮动，或固定利率基于向本公司提供的类似条款和到期日债务的当前利率。
按公允价值计量的公司资产和负债所使用的估值方法及其在估值层次中的分类摘要如下：
权益性证券-该公司持有有价证券，全部为公开交易的普通股，在活跃的市场中报价，被归类为短期。该等证券在每个报告期均按公允价值计量。本公司按每一报告期的市场报价对有价证券进行估值，将有价证券归类为1级。
或然代价-公司须遵守或有对价安排，以支付总价值为$的现金付款
本公司亦须遵守一项或有代价安排
或有对价负债在每个报告期均按公允价值计量，收购日期公允价值计入相关业务合并中转移的部分对价，随后公允价值变动计入简明综合经营报表营业费用内的收益和全面亏损。该公司使用风险中性类比模型和期权定价框架对或有对价进行估值。于首次公开招股前，本公司将或有对价负债归类为3级，原因是缺乏有关可观察到的市场数据，而非公允价值输入，例如支付结果的概率加权。于二零二四年六月完成首次公开招股后，本公司将最多
权证资产-本公司收到Personalis的认股权证，于2024年8月行使。权证资产在每个报告期内使用Black-Scholes期权定价模型以公允价值计量，该模型考虑了Personalis A类普通股的价格和波动性。公允价值变动记入其他(费用)收入净额。截至2024年9月30日的三个月，公司确认收益为$
26
认股权证法律责任-如附注9所述，该公司发行了一美元
|
|
2024年9月30日 |
|
|
预期期限(以年为单位) |
|
|
|
|
无风险利率 |
|
|
% |
|
预期波幅 |
|
|
% |
|
预期股息收益率 |
|
|
% |
|
由于缺乏关于公允价值投入的相关可观察市场数据，如预期期限，本公司将认股权证负债归类为3级。
定期贷款及票据并未按公允价值入账。定期贷款工具及票据的公允价值与其于2024年9月30日及2023年12月31日的账面价值相若。由于缺乏公允价值投入的相关可观察市场数据，定期贷款融资和票据的公允价值估计被归类为第三级。
下表汇总了截至以下日期按公允价值经常性计量的资产和负债2024年9月30日和2023年12月31日(单位：千)：
|
|
|
|
|
报告日的公允价值计量使用 |
|
||||||||||
|
|
9月30日， |
|
|
报价 |
|
|
意义重大 |
|
|
意义重大 |
|
||||
资产 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
有价证券 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
负债 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
认股权证法律责任 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
或有对价 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
报告日的公允价值计量使用 |
|
||||||||||
|
|
十二月三十一日， |
|
|
报价 |
|
|
意义重大 |
|
|
意义重大 |
|
||||
资产 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
有价证券 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
认股权证资产 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
负债 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
认股权证法律责任 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
或有对价 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
下表提供了使用重大不可观察输入（第3级）按公允价值计量的资产和负债的年初和期末余额对账（以千计）：
|
|
搜查令 |
|
|
或有条件 |
|
||
2023年12月31日的余额 |
|
$ |
|
|
$ |
|
||
认股权证负债的公允价值变动 |
|
|
|
|
|
|
||
或有对价的公允价值变动 |
|
|
|
|
|
|
||
转出3级 |
|
|
|
|
|
( |
) |
|
2024年9月30日余额 |
|
$ |
|
|
$ |
|
||
27
|
|
搜查令 |
|
|
或有条件 |
|
||
2022年12月31日的余额 |
|
$ |
|
|
$ |
|
||
来自Mpirik的或有对价 |
|
|
|
|
|
|
||
认股权证公允价值变动 |
|
|
( |
) |
|
|
|
|
或有对价的公允价值变动 |
|
|
|
|
|
( |
) |
|
2023年9月30日的余额 |
|
$ |
|
|
$ |
|
||
截至2024年9月30日及2023年9月30日止三个月，本公司确认亏损$
有价证券
该公司持有有价证券，这些证券都是Recursion制药公司(“Recursion”)A类普通股和Personalis普通股的公开交易股票。
递归股份作为应收账款的付款收到。在截至2024年9月30日的三个月内，公司没有出售任何递归A类普通股。在截至2024年9月30日的9个月内，公司出售了
作为公司根据2023年11月与Personalis订立的商业化及参考实验室协议对Personalis所负责任的代价，Personalis向本公司发行认股权证，以购买合共
有价证券的公允价值变动计入其他(费用)收入内的收益、简明综合经营报表和全面亏损的净额。
|
|
截至三个月 |
|
|
九个月结束 |
|
||
|
|
9月30日， |
|
|
9月30日， |
|
||
待售期内净收益 |
|
$ |
|
|
$ |
|
||
减：年期间确认的净收益 |
|
|
|
|
|
( |
) |
|
期内确认的未实现损失（收益） |
|
$ |
|
|
$ |
( |
) |
|
28
2018年，该公司获得了
战略投资
于2021年8月19日，本公司与巴索斯AI，Inc.(“巴索斯”)订立关联方安排，并于2024年2月12日作出修订，以进一步推动药物开发的商业化工作。Tempus收到了一份购买授权令
此外，该公司还与帕索斯公司签订了各种协议，包括获得公司的透镜产品、测序、临床研究组织和其他数据服务。公司已经确认了$
截至2024年9月30日，应付关联方的金额不到$
2024年11月4日，公司与特拉华州的Realm IDx，Inc.(“卖方”)和卖方的最终母公司日本公司Konica Minolta，Inc.签订了一项证券购买协定(“购买协定”)，根据该协定，公司同意购买特拉华州的Ambry Genetics Corporation(“Ambry”)的所有流通股，Ambry Genetics Corporation(“Ambry”)是基因测试领域的领先者，旨在通过了解基因和疾病之间的关系来改善健康(“收购”)。根据购买协定的条款，收购的对价为$
关于购买协定，公司于2024年11月4日与阿瑞斯签订了一份债务承诺书(“承诺函”)，根据该承诺书，阿瑞斯承诺提供(I)美元
29
关于前瞻性陈述的注释
这份10-Q表格季度报告包含有关我们和我们行业的前瞻性陈述，涉及重大风险和不确定性。除本季度报告10-Q表格中包含的历史事实陈述之外的所有陈述，包括有关我们未来运营运绩或财务状况、业务战略以及未来运营管理计划和目标的陈述，均为前瞻性陈述。在某些情况下，您可以识别前瞻性陈述，因为它们包含「预期」、「相信」、「设想」、「继续」、「可能」、「估计」、「期望」、「意图」、「可能」、「计划」、「潜力」、「预测」、「项目」、「应该」、「目标」、「将」或「将」等词语或其他类似术语或表达的否定词。本10-Q表格季度报告中包含的这些前瞻性陈述包括但不限于有关以下内容的陈述：
30
你不应该依赖前瞻性陈述作为对未来事件的预测。本季度报告中包含的前瞻性陈述主要基于我们目前对未来事件和趋势的预期和预测，我们认为这些事件和趋势可能会影响我们的业务、财务状况和经营业绩。这些前瞻性陈述中描述的事件的结果受题为“风险因素”一节和本季度报告10-Q表其他部分所描述的风险、不确定因素和其他因素的影响。此外，我们的运营环境竞争激烈，变化迅速。新的风险和不确定因素不时出现，我们无法预测所有可能对本10-Q表格季度报告中的前瞻性表述产生影响的风险和不确定因素。前瞻性陈述中反映的结果、事件和情况可能无法实现或发生，实际结果、事件或情况可能与前瞻性陈述中描述的结果、事件或情况大不相同。
此外，「我们相信」的声明和类似声明反映了我们对相关主题的信念和观点。这些陈述基于截至本季度报告之日我们可用的信息（表格10-Q）。虽然我们相信信息为这些陈述提供了合理的基础，但该信息可能是有限的或不完整的。我们的声明不应被解读为表明我们已对所有相关信息进行了详尽的调查或审查。这些陈述本质上是不确定的，建议投资者不要过度依赖这些陈述。
本季度报告中10-Q表格中的前瞻性陈述仅与截至陈述之日的事件有关。我们没有义务更新本10-Q表格季度报告中的任何前瞻性陈述，以反映本10-Q表格季度报告日期之后的事件或情况，或者反映新信息或非预期事件的发生，法律要求的除外。我们可能无法真正实现前瞻性陈述中披露的计划、意图或预期，您不应过度依赖我们的前瞻性陈述。我们的前瞻性陈述并不反映任何未来收购、合并、处置、合资企业或投资的潜在影响。
31
管理层的讨论和分析
财务状况及经营运绩
项目2.管理层对财务状况和经营成果的讨论和分析
以下对我们财务状况和经营成果的讨论和分析应与本季度报告10-Q表其他部分包含的未经审计的简明财务报表和相关附注以及我们已审计的综合财务报表和相关附注以及在截至2023年12月31日的最终招股说明书或最终招股说明书中以“管理层对财务状况和经营成果的讨论和分析”为标题进行的讨论一并阅读，该说明书的日期为2024年6月13日，并提交给美国证券交易委员会或美国证券交易委员会。根据规则第424(B)(4)条，于2024年6月17日。本讨论和分析中包含的一些资讯，包括与我们在销售和营销、研发以及一般和行政职能方面的计划投资有关的资讯，包括涉及风险和不确定性的前瞻性陈述。您应阅读本季度报告中题为“关于前瞻性陈述的说明”和“风险因素”的章节，讨论前瞻性陈述以及可能导致实际结果与以下讨论和分析中包含的前瞻性陈述所描述或暗示的结果大不相同的重要因素。
概述
天巴斯是一家专注于医疗保健的科技公司，横跨两个融合的世界。我们努力将深厚的医疗专业知识与领先的技术能力结合起来，提供跨多个疾病领域的下一代诊断，利用数据和分析的力量帮助个性化医疗。我们努力通过人工智慧(AI)在医疗保健领域的实际应用来创造智慧诊断，从而释放精准医学的真正力量。智慧诊断使用人工智慧，包括生成式人工智慧，使实验室测试更加准确、量身定做和个性化。与传统的诊断实验室不同，我们可以整合独特的患者资讯，如临床、分子和成像数据，目标是使我们的测试更智慧，结果更有洞察力。与其他科技公司不同，我们深深扎根于临床护理服务领域，是美国最大的癌症患者和其他疾病患者测序公司之一。跨越这两个世界是有利的，因为我们相信智慧诊断代表著精确医学的未来，为更个性化和数据驱动的治疗选择和开发提供资讯。我们相信，它们的采用可以使医生能够提供更好的护理，使研究人员能够开发更精确的治疗方法，有可能拯救数百万人的生命。
为了将人工智慧带入大规模的医疗保健领域，我们认为需要重建整个生态系统中数据流的基础。我们建立了新的数据管道，往返于提供商之间，以允许医生和诊断和生命科学公司之间自由交换数据，医生解释数据，诊断和生命科学公司提供数据，整合相关临床数据，如结果或不良事件，这些数据对许多临床决策至关重要。如果没有这种能力，我们相信数据将继续积累，而不会影响患者护理。为了实现这一点，我们构建了一个技术平台来将医疗数据从孤岛中解放出来，并构建了一个作业系统来使这些数据变得有用，我们将它们的组合称为我们的平台。我们的平台连接了更大的医疗生态系统中的多个利益相关者，通常是即时的，以收集和集成我们收集的数据，从而为医生提供在临床上做出数据驱动的决策的机会，并为研究人员发现和开发疗法提供机会。我们的目标是帮助医生为他们的患者找到最佳的治疗方法，帮助制药和生物技术公司制造尽可能好的药物，并使患者能够在适当的时候获得新兴的治疗方法和临床试验。
我们目前提供三个产品线：基因组学、数据和人工智慧应用。每条产品线都旨在支持和增强其他产品线，从而在我们运营的每个市场产生网路效应。我们能够多次将记录商业化，无论是在测试运行时还是之后。我们的基因组学产品线利用我们最先进的实验室，为医疗保健提供者、制药公司、生物技术公司、研究人员和其他第三方提供下一代测序、NGS诊断、聚合酵素链式反应或聚合酵素链式反应、图谱分析、分子基因分型和其他解剖和分子病理学测试。在商业化之前，在我们的实验室中产生的或作为基因组产品线的一部分被摄取到我们的平台中的数据经过结构化和去识别。然后，这个未识别的资料库将商业化给我们的制药和生物技术合作伙伴，以通过两种主要的数据和服务产品Insights和Trials促进药物发现和开发。我们的第三个产品线，人工智慧应用程式，专注于开发和提供本质上是算法的诊断，将新软体作为医疗设备实施，以及构建和部署临床决策支持工具。
我们主要在美国开展业务，截至2024年9月30日和2023年9月30日的三个月内，总收入分别为180.9美金和13610美金，截至2024年9月30日和2023年9月30日的九个月内，总收入分别为49270美金和38410美金。截至2024年9月30日和2023年9月30日的三个月内，我们还分别出现了75.8美金和5340美金的净亏损，截至2024年9月30日和2023年9月30日的九个月内，我们分别出现了69280美金和16360美金的净亏损。截至2024年9月30日和2023年9月30日的三个月，我们的调整后EBITDA分别为（2，180万）美金和（3，620万）美金，截至2024年和2023年9月30日的九个月，我们的调整后EBITDA分别为（9，700）万美金和（1.191亿）万美金。
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调整后EBITDA是一项非GAAP财务指标。有关调整后EBITDA与净亏损（根据美国公认会计原则（GAAP）规定的最直接可比的财务指标）的对帐，以及有关调整后EBITDA（非GAAP财务指标）的更多信息，请参阅「-非GAAP财务指标。"
收购Ambry Genetics Corporation
2024年11月4日，我们与特拉华州的Realm IDx，Inc.(“卖方”)和卖方的最终母公司日本公司Konica Minolta，Inc.签订了一份证券购买协定(“购买协定”)，根据该协定，我们同意购买特拉华州的Ambry Genetics Corporation(“Ambry”)的所有流通股，Ambry Genetics Corporation(“Ambry”)是基因检测领域的领先者，旨在通过了解基因和疾病之间的关系来改善健康(“收购”)。根据收购协定的条款，收购的代价包括37500美元万现金，经现金、未偿还债务、未支付交易开支及橱柜营运资金净额调整后(“现金代价”)，加上发行合共4,843,136股A类普通股(“股份代价”)，其中2,152,505股股份将于收购完成日期后禁售期一年。此外，现金对价中的500美元万将存入托管账户，以满足完成交易后的任何购买价格调整。收购预计将在2025年第一季度完成，前提是满足购买协定中包含的完成条件，包括收到所有必需的监管批准。
就购买协议而言，我们于2024年11月4日签署了一份债务承诺书（「承诺书」），与战神，根据该规定，Ares承诺提供（i）10000美金的高级有担保循环信贷融资（「循环信贷融资」）和（ii）本金总额为20000加元的额外定期贷款（「额外定期贷款」）。我们预计利用额外定期贷款和循环信贷融资项下的借款为收购的现金对价提供资金并支付相关费用和费用。Ares提供预期融资的义务受承诺书中包含的许多习惯条件的约束，包括签署承诺书中预期的最终文件以及与额外定期贷款和循环信贷融资项下的初始借款基本同时完成收购。
首次公开发行
2024年6月13日，与我们IPO相关的登记声明宣布生效，我们的A类普通股股票于2024年6月14日开始在纳斯达克全球精选市场交易。2024年6月17日，我们完成了首次公开募股，发行并出售了11，100，000股A类普通股，公开发行价为每股37.00美金。扣除承保折扣和佣金2870日元后，我们收到了38200日元的净收益。
随著IPO结束，我们当时已发行的可赎回可转换优先股（我们的b系列可赎回可转换优先股除外）的所有股份均转换为总计66，309，550股A类普通股。b系列可赎回可转换优先股以一对一的方式转换为总计5，374，899股b类普通股。随后，331，110股b类普通股自动转换为A类普通股，因此b类普通股已发行5，043，789股。根据注10中进一步描述的单独协议，我们向G-3系列优先股的投资者额外发行了236，719股A类普通股。
截至2024年6月16日，我们的可赎回可转换优先股已累积18820便士的未付股息，这些股息在IPO结束时以5，098，799股A类普通股的形式支付。
无投票权普通股的流通股以一对一的方式转换为5，069，477股A类普通股。
授予员工的限制性股票单位（RSU）受两个归属条件的约束。第一个是基于时间的组件。第二个归属条件是发生流动性事件。与这些奖励相关的流动性事件条件在IPO生效后得到满足。IPO生效后，我们在截至2024年6月30日的三个月内确认了48830加元的股票薪酬费用。为了满足相关预扣税要求，我们预扣了已发行的4，563，164股A类普通股中的1，911，316股。根据每股37.00美金的IPO公开发行价格，预扣税义务为7080日元。
我们发行了109，459股A类普通股，与行使向艾伦发行的认购权有关，详情请参阅本季度报告中其他地方的未经审计的简明综合财务报表注释9，该报表在IPO后自动净行使。
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与首次公开募股相关，我们修改并重述了我们的公司注册证书，根据该证书，授权股本包括1，000，00，000股A类普通股、5，500，000股B类普通股和20，000，000股优先股。
战略协作
阿斯利康
2021年11月，我们与阿斯利康或阿斯利康签订了主服务协定，或经2022年10月、2023年2月和2023年12月修订的主服务协定，并向阿斯利康或阿斯利康发出了认股权证。根据MSA，我们同意在非独家的基础上向阿斯利康提供我们的某些产品和服务，包括许可数据、测序、临床试验匹配、有机物建模服务、算法开发等。作为某些折扣价格的交换，阿斯利康承诺在万任期内在此类产品和服务上花费至少22000美元。除非提前终止，否则MSA的任期将持续到2028年12月31日。如果发生以下任何事件，最低承诺额可能会从22000美元万增加到2028年12月前的32000美元万：(I)在2024年12月31日或之前阿斯利康当选时，(Ii)阿斯利康行使根据其条款发行的认股权证的日期(如下所述)，或(Iii)如果我们的A类普通股的平均收盘价在首次公开募股一周年后的任何30天交易期内超过IPO价格的两倍。
根据该授权令，阿斯利康有权以相当于每股37.00美金（我们IPO中的公开发行价）的行使价购买价值10000美金的A类普通股。该认购证可在我们IPO定价后180天的日期后随时行使。阿斯利康将有权就该认购证下的股份享有与根据我们日期为2020年11月19日的第九份修订和重述的投资者权利协议授予可登记证券持有人的登记权基本相同的登记权。如果阿斯利康拒绝在2024年12月31日之前延长其财务承诺，如果此前未行使，该授权令将自动取消和无偿终止。如果阿斯利康行使该授权令，阿斯利康将被要求将其在2028年12月之前的MCA下的最低承诺从22000美金增加到32000美金。
葛兰素史克
2022年8月，我们与葛兰素史克（GlaxoSmithKline）或GSk签订了战略合作协议，或经2024年5月修订的GSk协议。根据GSk协议，我们同意在非排他性的基础上向GSk提供我们的某些产品和服务，包括许可数据、测序、临床试验匹配、类器官建模服务、算法开发等。为了换取某些折扣价格，GSk承诺在GSk协议期限内为此类产品和服务花费至少18000美金的发票，其中7000美金的发票已在执行时支付。GSk协议的期限将持续至2027年12月31日，除非提前终止。葛兰素史克在2028年、2029年和2030年选举时可能会触发高达12000美金的额外承诺。
回归主协议
2023年11月，我们与Recursion Pharmaceuticals，Inc.签订了主协议或Recursion协议，或回归。根据Recursion协议，我们同意向Recursion提供某些服务并许可某些数据，包括出于某些治疗产品开发目的访问我们专有的去识别临床和分子资料库的有限权利。作为这些权利的交换，Recursion将支付2200加元的初始许可费和整个协议期限内的年度许可费，加上初始许可费，总计高达16000加元。除非提前终止，否则定期协议的期限将持续到2028年11月3日。除了双方因未解决的违反Recursion协议而终止协议的权利外，Recursion还可以在三年后提前90天通知终止协议，但Recursion须支付提前终止费。
初始许可费和每次年度许可费可由Recursion选择以（x）现金、（y）Recursion A类普通股股份的形式支付，或（z）现金和Recursion A类普通股股份的组合，比例由Recursion自行决定;前提是根据Recursion协议向我们发行的Recursion A类普通股股份总数不得超过19.9% 2023年11月3日，或根据Recursion协议发行任何A类普通股股份之日之前一天，Recursion A类普通股和b类普通股已发行的总股数中，以较小者为准。我们对根据Recursion协议发行的Recursion A类普通股的任何股份拥有习惯登记权。
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影响我们绩效的因素
我们相信有几个重要因素影响了我们的运营运绩和运营结果。虽然这些领域都为我们带来了重大机遇，但也带来了我们必须应对的重大风险和挑战。请参阅「第1A项。-风险因素」了解更多信息。
研发和新产品
随著我们继续开发新的实验室检测、开发算法并将我们的平台扩展到新的疾病领域，我们预计在未来几年内将对产品创新保持高水平的投资。这些投资将包括验证新方法或改进当前检测方法所产生的实验室成本、数据集许可以加速我们在新疾病方面的努力，以及新Algos产品的开发和验证成本。截至2024年9月30日和2023年9月30日的三个月内，我们分别投资了27.3美金和2320美金，截至2024年9月30日和2023年9月30日的九个月内，我们分别投资了11970美金和6630美金用于研发。我们开发新产品、在需要时获得监管机构批准、将其投放市场以及推动客户采用这些产品的能力将继续在我们的业绩中发挥关键作用。
客户获取和扩张
为了发展我们的业务，我们既需要识别新客户，也需要扩大我们与现有客户的合作伙伴关系，覆盖我们的每条产品线。对于基因公司来说，这需要我们的现场销售团队与个别医生和医院系统发展关系，展示我们的平台在使他们能够为他们的患者提供个性化护理方面的力量。对于数据，这需要我们的制药业务开发团队展示我们的平台和资料库在为我们的制药合作伙伴实现药物发现、开发和临床试验匹配方面的力量。对于人工智慧应用程式，这需要展示这些算法在临床环境中的实用性。自我们成立以来，我们的产品已经被超过7000名医生使用，我们已经与200多家生物技术公司以及基于2023年收入的20家最大的上市制药公司中的19家合作，尽管有许多公司我们仍处于采用的早期阶段。我们的财务业绩在很大程度上依赖于我们在平台上增加客户的能力，以及通过采用我们的新产品来扩大与现有客户的关系的能力。
技术投资
技术是我们所做一切的核心。从通过各种提供商集成接收订单和获取数据到交付测试结果和访问我们的分析平台，我们的平台在推动我们的业务方面发挥著关键作用。我们将继续对我们的平台进行大量投资，以不断改善我们的用户体验，并使我们能够在扩大产品范围时更有效地生成、吸收和结构数据。截至2024年9月30日和2023年9月30日的三个月内，我们分别投资了3070美金和2420美金，截至2024年和2023年9月30日的九个月内，我们分别投资了13570美金和7050美金的技术。随著我们继续开发新功能来支持我们当前和未来的业务需求，我们预计将在未来几年保持对技术的高水平投资。我们执行此类技术开发的能力将继续成为我们业绩的关键因素。
付款人承保范围和报销
我们的财务业绩在很大程度上取决于我们从付款人和政府医疗福利计划中获得补偿的能力。我们进行的大部分基因组测试本质上是临床的。我们通常从商业付款人和政府医疗福利计划(如联盟医疗保险和医疗补助)中获得这些测试的报销。我们收到的付款数额差别很大，取决于各种因素，包括付款人、化验结果和患者的其他特征。截至2023年12月31日，我们已收到从2021年1月1日至2022年12月31日期间所有付款人进行的临床肿瘤学NGS测试的约50%的付款。我们根据付款人裁决时间在拖尾的基础上计算了这一指标。然而，我们继续执行我们的NGS测试，直到2023年12月31日。在截至2022年和2023年12月31日的年度内，我们在肿瘤学的NGS测试的平均报销金额分别约为916美元和1,452美元。我们将继续大量投资于旨在提高我们平均报销水准的各种努力，包括进行临床研究以产生临床实用证据，寻求监管机构对我们的测试的批准，以及开设更多的实验室地点。医疗政策的任何变化都会影响我们的测试报销方式，可能会对我们的结果产生重大影响。
运营结果的组成部分
收入
我们目前的收入主要来自两个产品线：（1）基因组学和（2）数据和服务。
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Genomics
基因组学主要包括向医疗保健提供者、制药公司、生物技术公司、研究人员和其他第三方提供的诊断、PCR分析以及其他解剖和分子病理学测试的收入。
数据和服务
数据和服务主要包括通过我们的Genomics产品线产生的去识别数据的收入，这些数据用于我们的制药和生物技术合作伙伴的药物开发工作。这些交易包括数据许可协议、人工智慧支持的临床试验匹配和分析服务。我们的数据收入通常会根据客户的预算周期在下半年进行反向加权。我们目前在此项目中报告我们的人工智慧应用程式收入，因为它并不重要。
成本和运营费用
我们为两个主要产品线中的每一个都产生收入而产生成本。我们Genomics产品线的收入成本占Genomics收入的比例高于数据和服务收入的成本占数据和服务收入的比例。随著收入在这些产品线之间的转移，收入总成本占收入的百分比将受到影响。
收入成本、基因组学
Genomics的收入成本主要包括人员实验室费用，包括薪津、花红、员工福利和股票补偿费用（我们称之为「人员成本」），以及无形资产摊销、实验室用品和消耗品成本、实验室租金费用、与COVID-19检测相关的第三方管理费、实验室设备折旧和运输成本。与执行测试相关的成本在报告交付时处理测试时进行记录。我们预计，随著我们的基因组学收入持续增长，这些成本以绝对美金计算将会增加。
收入、数据和服务成本
数据和服务的收入成本主要包括数据获取和特许权使用费以及与交付数据服务和平台相关的人员成本、云成本以及某些分配的管理费用。与执行数据产品服务相关的成本记录为已发生的成本。我们预计，随著我们的数据和服务收入的持续增长，这些成本以绝对美金计算将会增加。我们目前在此项目中报告人工智慧应用程式的收入成本，因为它并不重要。
研发
研发费用主要包括开发新检测试剂盒和产品所产生的成本，包括验证成本、研发和分配的实验室人员成本、公司科学和实验室研发团队的薪津和福利、无形资产摊销、库存成本、管理费用、合同服务和其他相关成本。研究和开发成本于发生时支销。我们计划继续投资新的检测方法开发并扩展到新的疾病领域。因此，随著我们继续投资支持这些活动，我们预计在可预见的未来，研究和开发费用的绝对值将会增加。
技术研发
技术研发费用主要包括与技术平台和应用的研发以及希望推向市场的新产品的研发相关的人员成本。技术研发成本于发生时支销。我们计划继续投资技术人员来支持我们的平台和新算法开发。我们预计，随著我们继续投资支持这些活动，在可预见的未来，技术研发费用的绝对值将增加。
销售、一般和行政
我们的销售、一般和行政费用主要包括销售、行政、会计和财务的人员成本、法律和人力资源职能、佣金以及其他一般企业费用，包括软体和工具、专业服务、房地产成本和差旅费用。
我们预计，在IPO后，我们的销售、一般和行政费用将继续增加，主要是由于员工数量和与上市公司运营相关的成本增加，包括与法律、法律、
36
会计、监管、遵守交易所上市和SEC要求、董事和高级官员保险费以及投资者关系。尽管这些费用预计将按绝对金额计算增加，但从长远来看，这些费用占收入的百分比预计将小幅下降，尽管由于这些费用的时间和范围，它们的百分比可能会在不同时期波动。由于我们的RSU的基于绩效的归属条件在我们的IPO中得到满足，我们将继续记录与RSU归属相关的基于股票的薪酬费用在此类审查发生的季度。
利息收入
利息收入包括我们的现金和现金等值物赚取的利息。
利息开支
利息费用主要包括我们的修订票据和定期贷款额度（定义见「-流动性和资本资源」）以及融资租赁的利息。与我们的可转换债务相关的利息费用将继续下去，但随著本金额的减少，利息费用应该会随著时间的推移而减少。
其他（未）收入，净
其他(支出)收入，净额包括外币汇兑损益、有价证券的损益、与SB Tempus Corp.或SB Tempus签订的知识产权许可协定的收入(定义见下文)，以及与我们的权证资产和负债相关的任何公允价值变动。外汇汇兑损益涉及以美元以外货币计价的交易以及资产和负债余额。我们预计，由于外币汇率的变化，未来我们的外币损益将继续波动。我们持有Recursion and Personalis，Inc.的普通股，或Personalis的普通股，这些股票记录在可交易的股权证券中。这些股票在每个报告期都按市价计价。我们在2021年11月签署MSA的同时，向我们的客户阿斯利康发出了授权证。我们有一项与2023年11月与Personalis签订的商业化和参考实验室协定相关的权证资产，该协定于2024年8月行使。权证资产和负债的公允价值在每个报告期进行计量。
所得税拨备
所得税拨备包括美国联邦和州所得税以及我们开展业务的某些外国司法管辖区的所得税，并根据不可扣除费用以及我们的递延税资产和负债的估值变化进行调整。我们对美国联邦和州递延所得税资产保持全额估值津贴，因为我们得出的结论是，递延所得税资产更有可能无法实现。
权益法投资的损失
权益法投资的损失包括我们合资企业的收益。
经营运绩
下表列出了我们所列期间经营运绩的重要组成部分（以千计）。
37
|
|
截至9月30日的三个月， |
|
|
截至9月30日的九个月， |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
净营收 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Genomics |
|
$ |
116,422 |
|
|
$ |
96,815 |
|
|
$ |
331,315 |
|
|
$ |
270,797 |
|
数据和服务 |
|
|
64,507 |
|
|
|
39,242 |
|
|
|
161,403 |
|
|
|
113,301 |
|
总净营收 |
|
$ |
180,929 |
|
|
$ |
136,057 |
|
|
$ |
492,718 |
|
|
$ |
384,098 |
|
成本和运营费用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
收入成本、基因组学 |
|
|
60,126 |
|
|
|
46,540 |
|
|
|
181,285 |
|
|
|
138,781 |
|
收入、数据和服务成本 |
|
|
14,964 |
|
|
|
15,490 |
|
|
|
52,384 |
|
|
|
40,690 |
|
技术研发 |
|
|
30,680 |
|
|
|
24,156 |
|
|
|
135,655 |
|
|
|
70,485 |
|
研发 |
|
|
27,348 |
|
|
|
23,234 |
|
|
|
119,713 |
|
|
|
66,268 |
|
销售，一般和行政 |
|
|
101,427 |
|
|
|
71,426 |
|
|
|
644,063 |
|
|
|
211,662 |
|
总成本和运营费用 |
|
|
234,545 |
|
|
|
180,846 |
|
|
|
1,133,100 |
|
|
|
527,886 |
|
经营亏损 |
|
$ |
(53,616 |
) |
|
$ |
(44,789 |
) |
|
$ |
(640,382 |
) |
|
$ |
(143,788 |
) |
利息收入 |
|
|
4,789 |
|
|
|
1,483 |
|
|
|
7,538 |
|
|
|
5,864 |
|
利息开支 |
|
|
(13,761 |
) |
|
|
(12,342 |
) |
|
|
(40,294 |
) |
|
|
(33,245 |
) |
其他（费用）收入，净 |
|
|
(11,522 |
) |
|
|
2,287 |
|
|
|
(17,821 |
) |
|
|
7,909 |
|
所得税拨备前损失 |
|
|
(74,110 |
) |
|
|
(53,361 |
) |
|
|
(690,959 |
) |
|
|
(163,260 |
) |
所得税拨备 |
|
|
(38 |
) |
|
|
(65 |
) |
|
|
(144 |
) |
|
|
(74 |
) |
权益法投资的损失 |
|
|
(1,692 |
) |
|
|
— |
|
|
|
(1,692 |
) |
|
|
(301 |
) |
净亏损 |
|
$ |
(75,840 |
) |
|
$ |
(53,426 |
) |
|
$ |
(692,795 |
) |
|
$ |
(163,635 |
) |
截至2024年9月30日与2023年9月30日的三个月比较
收入
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
Genomics |
|
$ |
116,422 |
|
|
$ |
96,815 |
|
|
$ |
19,607 |
|
|
|
20 |
% |
数据和服务 |
|
|
64,507 |
|
|
|
39,242 |
|
|
|
25,265 |
|
|
|
64 |
% |
总净营收 |
|
$ |
180,929 |
|
|
$ |
136,057 |
|
|
$ |
44,872 |
|
|
|
33 |
% |
与2023年同期相比，截至2024年9月30日的三个月收入增加，是由于Genomics进行的临床肿瘤学测试量增加以及我们的数据和服务产品线的数据交付增加。
Genomics
与2023年同期相比，截至2024年9月30日的三个月，Genomics收入的增加主要是由于肿瘤学NGS检测数量的增加，从截至2023年9月30日的三个月的约55，700次检测增加到截至2024年9月30日的三个月的约69，000次检测。由于准备金覆盖的风险期已开始到期，截至2024年9月30日的三个月内，为与某些政府付款人相关的对价未来逆转风险记录的收入准备金释放了120美金，而截至2023年9月30日的三个月，同一准备金增加了260美金。截至2023年9月30日的三个月。
数据和服务
与2023年同期相比，截至2024年9月30日的三个月数据和服务收入增加主要是由于对我们Insights产品的需求增加而产生的2，330美金的收入。截至2024年9月30日止三个月，所有数据和服务产品收入的增长主要归因于我们现有客户群的持续增长，以及截至2023年9月30日止三个月内未购买服务的新客户采用我们的服务。
38
成本和运营费用
收入成本
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
收入成本、基因组学 |
|
$ |
60,126 |
|
|
$ |
46,540 |
|
|
$ |
13,586 |
|
|
|
29 |
% |
收入、数据和服务成本 |
|
|
14,964 |
|
|
|
15,490 |
|
|
|
(526 |
) |
|
|
-3 |
% |
总 |
|
$ |
75,090 |
|
|
$ |
62,030 |
|
|
$ |
13,060 |
|
|
|
21 |
% |
与2023年同期相比，截至2024年9月30日的三个月收入成本增加，主要是由于与我们的IPO相关的RSU相关的200加元股票薪酬费用（满足基于绩效的归属条件），以及材料和服务成本增加890加元。
收入成本、基因组学
与2023年同期相比，Genomics截至2024年9月30日的三个月收入成本增加，主要是由于与我们的IPO相关的RSU相关的110加元股票补偿费用以及材料和服务成本增加890加元。
收入、数据和服务成本
与2023年同期相比，截至2024年9月30日的三个月的收入、数据和服务成本下降并不重大。
技术研发
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
技术研发 |
|
$ |
30,680 |
|
|
$ |
24,156 |
|
|
$ |
6,524 |
|
|
|
27 |
% |
与2023年同期相比，截至2024年9月30日止三个月的技术研发费用增加，主要是由于与我们的IPO相关的RSU相关的390加元股票补偿费用，满足了基于绩效的归属条件，与云基础设施和新业务线投资相关的人员相关成本增加了240美金。
研发
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
研发 |
|
$ |
27,348 |
|
|
$ |
23,234 |
|
|
$ |
4,114 |
|
|
|
18 |
% |
与2023年同期相比，截至2024年9月30日的三个月的研发费用增加，主要是由于与我们的IPO相关满足基于绩效的归属条件的RSU相关的260加元股票补偿费用，我们研发部门员工的人事相关成本增加了140美金。
销售、一般和行政
39
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
销售，一般和行政 |
|
$ |
101,427 |
|
|
$ |
71,426 |
|
|
$ |
30,001 |
|
|
|
42 |
% |
与2023年同期相比，截至2024年9月30日的三个月销售、一般和行政费用增加，主要是由于与RSU相关的1，260加元的股票补偿费用，这些RSU满足了与我们的IPO有关的基于绩效的归属条件，人员相关成本增加790美金，软体和工具成本增加300美金。
利息收入
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
利息收入 |
|
$ |
4,789 |
|
|
$ |
1,483 |
|
|
$ |
3,306 |
|
|
|
223 |
% |
截至2024年9月30日止三个月的利息收入与2023年同期相比增加，主要是由于截至2024年9月30日的手头现金高于2023年9月30日。
利息开支
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
利息开支 |
|
$ |
(13,761 |
) |
|
$ |
(12,342 |
) |
|
$ |
(1,419 |
) |
|
|
11 |
% |
与2023年同期相比，截至2024年9月30日止三个月的利息费用增加主要是由我们修订后票据的无息推动的。
其他（）收入，净
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
其他（费用）收入，净 |
|
$ |
(11,522 |
) |
|
$ |
2,287 |
|
|
$ |
(13,809 |
) |
|
|
-604 |
% |
与2023年同期相比，截至2024年9月30日止三个月的其他（费用）收入净变化主要是由于与我们的担保凭证负债公允价值变化相关的费用增加了4560美金，但被与有价股权证券未实现收益相关的收入增加260美金所抵消，由于与我们的认股权资产公允价值变化相关的收益，收入增加了2600美金，以及与SB Tempus签订的智慧财产权协议或智慧财产权许可协议带来的4.0美金收入。
所得税拨备
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
所得税拨备 |
|
$ |
(38 |
) |
|
$ |
(65 |
) |
|
$ |
27 |
|
|
|
-42 |
% |
40
截至2024年9月30日止三个月的所得税拨备与2023年同期相比减少并不重大。
权益法投资的损失
|
|
截至9月30日的三个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
权益法投资的损失 |
|
$ |
(1,692 |
) |
|
$ |
— |
|
|
$ |
(1,692 |
) |
|
|
100 |
% |
与2023年同期相比，截至2024年9月30日的三个月权益法投资的损失增加是由于我们于2024年7月成立的合资企业的损失（请参阅本季度报告其他地方包含的未经审计的简明综合财务报表注释7）。表格10-Q季度报告）。
截至2024年9月30日和2023年9月30日的九个月比较
收入
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
Genomics |
|
$ |
331,315 |
|
|
$ |
270,797 |
|
|
$ |
60,518 |
|
|
|
22 |
% |
数据和服务 |
|
|
161,403 |
|
|
|
113,301 |
|
|
|
48,102 |
|
|
|
42 |
% |
总净营收 |
|
$ |
492,718 |
|
|
$ |
384,098 |
|
|
$ |
108,620 |
|
|
|
28 |
% |
与2023年同期相比，截至2024年9月30日的九个月收入增加，是由于Genomics进行的临床肿瘤学测试数量和报销增加以及我们的数据和服务产品线的数据交付增加。
Genomics
与2023年同期相比，截至2024年9月30日的九个月，Genomics收入的增加主要是由于肿瘤学NGS检测数量的增加，从截至2023年9月30日的九个月的约159，400次检测增加到截至9月30日的九个月的约198，200次检测。2024.由于准备金覆盖的风险期已开始到期，截至2024年9月30日的九个月，为与某些政府付款人相关的对价未来逆转风险记录的收入准备金释放了240美金，而截至2023年9月30日的九个月，同一准备金增加了710美金。截至2023年9月30日的九个月。
数据和服务
与2023年同期相比，截至2024年9月30日的九个月数据和服务收入增加主要是由于对我们Insights产品的需求增加而产生的4340美金的收入。在所有数据和服务产品中，截至2024年9月30日的九个月收入的增长主要归因于我们现有客户群的持续增长，以及在截至2023年9月30日的九个月内未购买服务的新客户采用我们的服务。
41
成本和运营费用
收入成本
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
收入成本、基因组学 |
|
$ |
181,285 |
|
|
$ |
138,781 |
|
|
$ |
42,504 |
|
|
|
31 |
% |
收入、数据和服务成本 |
|
|
52,384 |
|
|
|
40,690 |
|
|
|
11,694 |
|
|
|
29 |
% |
总 |
|
$ |
233,669 |
|
|
$ |
179,471 |
|
|
$ |
54,198 |
|
|
|
30 |
% |
与2023年同期相比，截至2024年9月30日止九个月的收入成本增加，主要是由于与我们的IPO相关的RSU相关的股票薪酬费用增加了2050加元，材料和服务成本增加了1640加元，人员成本增加了660加元，以及370美金的云费用。
收入成本、基因组学
与2023年同期相比，Genomics截至2024年9月30日的九个月收入成本增加，主要是由于与RSU相关的1240加元股票补偿费用（其满足了基于绩效的归属条件），材料和服务成本增加了1640加元，人员成本为690美金，云费用为150美金。
收入、数据和服务成本
与2023年同期相比，截至2024年9月30日的九个月收入、数据和服务成本增加，主要是由于与我们的IPO相关的RSU相关的基于股票的薪酬费用810加元，以及云费用增加220加元。
技术研发
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
技术研发 |
|
$ |
135,655 |
|
|
$ |
70,485 |
|
|
$ |
65,170 |
|
|
|
92 |
% |
与2023年同期相比，截至2024年9月30日止九个月的技术研发费用增加，主要是由于与我们的IPO相关的RSU相关的5440加元股票薪酬费用（满足基于绩效的归属条件）、与RSU结算相关的140加元税款，与云基础设施和新业务线投资相关的人员相关成本增加了940美金。
研发
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
研发 |
|
$ |
119,713 |
|
|
$ |
66,268 |
|
|
$ |
53,445 |
|
|
|
81 |
% |
与2023年同期相比，截至2024年9月30日止九个月的研发费用增加，主要是由于与我们的IPO相关满足基于绩效的归属条件的RSU相关的4，480加元股票薪酬费用，我们研发部门员工的验证和监管费用增加了220美金，人员相关费用增加了530美金。
42
销售、一般和行政
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
销售，一般和行政 |
|
$ |
644,063 |
|
|
$ |
211,662 |
|
|
$ |
432,401 |
|
|
|
204 |
% |
与2023年同期相比，截至2024年9月30日止九个月的销售、一般和行政费用增加，主要是由于与我们的IPO相关的基于业绩的归属条件已满足的RSU相关的股票补偿费用38960加元，与RSU结算相关的税款340加元，人员相关成本增加1710美金，软体和工具成本增加620美金，云存储成本增加390美金。
利息收入
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
利息收入 |
|
$ |
7,538 |
|
|
$ |
5,864 |
|
|
$ |
1,674 |
|
|
|
29 |
% |
截至2024年9月30日的九个月利息收入与2023年同期相比增加，主要是由于截至2024年9月30日的手头现金高于2023年9月30日。
利息开支
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
利息开支 |
|
$ |
(40,294 |
) |
|
$ |
(33,245 |
) |
|
$ |
(7,049 |
) |
|
|
21 |
% |
与2023年同期相比，截至2024年9月30日止九个月的利息费用增加主要是由于我们修订后票据的无息以及2023年4月和10月根据定期贷款机制签订的额外债务。
其他（）收入，净
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
其他（费用）收入，净 |
|
$ |
(17,821 |
) |
|
$ |
7,909 |
|
|
$ |
(25,730 |
) |
|
|
-325 |
% |
与2023年同期相比，截至2024年9月30日止九个月的其他（费用）收入净变化主要是由于与我们的担保凭证负债公允价值变化相关的费用增加了5040美金，以及G-4特别付款的230美金费用。费用的增加被与有价股权证券收益相关的510美金收入、由于我们的认股权资产公允价值变化而增加的18.3美金收入以及与SB Tempus的智慧财产权许可协议的4.0美金收入所抵消。
所得税拨备
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
所得税拨备 |
|
$ |
(144 |
) |
|
$ |
(74 |
) |
|
$ |
(70 |
) |
|
|
95 |
% |
43
与2023年同期相比，截至2024年9月30日的九个月所得税拨备增加并不重大。
权益法投资的损失
|
|
截至9月30日的九个月， |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$改变 |
|
|
%变化 |
|
||||
|
|
（未经审计） |
|
|
|
|
|
|
|
|||||||
|
|
(in千人，百分比除外） |
|
|||||||||||||
权益法投资的损失 |
|
$ |
(1,692 |
) |
|
$ |
(301 |
) |
|
$ |
(1,391 |
) |
|
|
462 |
% |
与2023年同期相比，截至2024年9月30日的九个月权益法投资的损失增加是由于我们于2024年7月成立的合资企业的损失（请参阅本季度报告其他地方包含的未经审计的简明综合财务报表注释7）。表格10-Q季度报告）。
非gaap财务指标
为了补充我们根据美国普遍接受的会计原则（GAAP）编制和列报的简明综合财务报表，我们使用调整后的EBITDA来促进我们的财务和业务趋势的分析，并用于内部规划和预测目的。
EBITDA被定义为扣除利息、税项、折旧和摊销前的收益。我们将调整后的EBITDA定义为净收益(亏损)，调整后不包括(I)利息收入，(Ii)利息支出，(Iii)折旧和摊销，(Iv)所得税准备金(收益)，(V)权益法投资损失，(Vi)认股权证负债、认股权证资产、可上市股本证券、或有对价负债和赔偿相关预留负债的公允价值变化，(Vii)基于股票的薪酬支出，(Viii)与基于股票的薪酬支出相关的雇主工资税，(Ix)G-4特别付款，以及(X)摊销我们与SB Tempus达成的知识产权许可协定的递延其他收入。我们将调整后的EBITDA与其相应的GAAP衡量标准--净收益或亏损--结合使用，作为评估我们业务的经营业绩和经营杠杆的业绩衡量标准。上述专案被排除在我们调整后的EBITDA衡量标准之外，因为这些专案本质上是非现金专案，或者因为这些专案的金额和时间不可预测，或者它们不是由运营的核心业绩驱动的，从而使与前几个时期和竞争对手的比较没有那么有意义。我们相信，调整后的EBITDA为投资者和其他人了解和评估我们的经营结果提供了有用的资讯，并为我们的业务业绩的期间比较提供了有用的衡量标准。此外，调整后的EBITDA是我们内部管理层在做出运营决策时使用的关键指标，包括与分析运营费用、评估业绩以及执行战略规划和年度预算有关的决策。
调整后EBITDA作为财务指标存在局限性，应被视为补充性质，并且不意味著替代或优于根据GAAP编制的相关财务信息。其中一些限制是调整后的EBITDA：
由于这些限制，我们认为，而且您也应该考虑，调整EBITDA以及其他财务业绩指标，包括净亏损和我们的其他GAAP业绩。下文提供了我们调整后的EBITDA与净亏损（根据GAAP规定的最直接可比的财务指标）的对帐。鼓励投资者审查相关的GAAP财务指标以及非GAAP财务指标与其最直接可比的GAAP财务指标的对帐。
44
下表总结了我们在下文列出的每个时期的调整后EBITDA以及净亏损（最直接可比的GAAP指标）：
|
|
截至9月30日的三个月， |
|
|
截至9月30日的九个月， |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
（未经审计） |
|
|||||||||||||
|
|
(in数千） |
|
|||||||||||||
净亏损 |
|
$ |
(75,840 |
) |
|
$ |
(53,426 |
) |
|
$ |
(692,795 |
) |
|
$ |
(163,635 |
) |
利息收入 |
|
|
(4,789 |
) |
|
|
(1,483 |
) |
|
|
(7,538 |
) |
|
|
(5,864 |
) |
利息开支 |
|
|
13,761 |
|
|
|
12,342 |
|
|
|
40,294 |
|
|
|
33,245 |
|
折旧 |
|
|
6,788 |
|
|
|
5,404 |
|
|
|
19,472 |
|
|
|
15,658 |
|
摊销 |
|
|
2,652 |
|
|
|
2,920 |
|
|
|
8,316 |
|
|
|
8,851 |
|
所得税拨备 |
|
|
38 |
|
|
|
65 |
|
|
|
144 |
|
|
|
74 |
|
EBITDA |
|
$ |
(57,390 |
) |
|
$ |
(34,178 |
) |
|
$ |
(632,107 |
) |
|
$ |
(111,671 |
) |
权益法投资损失 |
|
|
1,692 |
|
|
|
— |
|
|
|
1,692 |
|
|
|
301 |
|
公允价值变动(1) |
|
|
15,605 |
|
|
|
(2,028 |
) |
|
|
19,885 |
|
|
|
(7,728 |
) |
基于股票的补偿费用 |
|
|
21,038 |
|
|
|
— |
|
|
|
509,351 |
|
|
|
— |
|
与股票相关的雇主薪津税 |
|
|
1,201 |
|
|
|
— |
|
|
|
5,963 |
|
|
|
— |
|
G-4特殊付款 |
|
|
— |
|
|
|
— |
|
|
|
2,250 |
|
|
|
— |
|
技术许可摊销 |
|
|
(3,989 |
) |
|
|
— |
|
|
|
(3,989 |
) |
|
|
— |
|
调整EBITDA |
|
$ |
(21,843 |
) |
|
$ |
(36,206 |
) |
|
$ |
(96,955 |
) |
|
$ |
(119,098 |
) |
流动资金及资本资源
自成立以来，我们的运营已出现重大损失和负现金流，截至2024年9月30日，我们的累计赤字为21日元。
随著我们继续投资和开发新产品、扩大销售组织并加大营销力度以推动市场采用我们的测试，我们预计在不久的将来将出现额外的运营损失，我们的运营费用也将增加。随著医生和生物制药公司对我们测试的需求持续增加，我们预计，如果我们需要额外的实验室容量，我们的资本支出需求也可能增加。
迄今为止，我们的运营资金主要来自出售股票、可转换债务、定期债务和销售我们的产品。截至2024年9月30日，我们拥有现金、现金等值物和限制性现金38890日元。2024年4月，我们以每股57.3069美金的价格出售了总共3，489，981股G-5系列可转换优先股，总购买价格约为20000美金。通过私募向认可投资者。2024年6月，我们完成了IPO，扣除承销折扣和佣金2870日元后，净收益为38200日元。
根据我们当前的业务计划，我们相信我们当前的现金和现金等值物、有价股权证券和预期的运营现金流将足以满足我们自本季度报告之日起十二个多月内的预期现金需求10-Q表格。我们可能会筹集额外资本来扩大业务、寻求战略投资、利用融资机会或出于其他原因。随著我们收入的增长，我们的应收帐款和库存余额将会增加。应收帐款和库存的任何增加可能无法完全被应付帐款和应计费用的增加所抵消，这可能会导致更大的流动资金需求。
如果我们的可用现金和现金等价物以及预期的运营现金流不足以满足我们的流动性需求，原因是我们的客户的偿还率低于当前预期，或本10-Q表格中其他地方描述的其他风险导致对我们产品的需求降低，我们可能会寻求出售额外的普通股或优先股或可转换债务证券，达成信贷安排或其他形式的第三方融资，或寻求其他债务融资。出售股权和可转换债务证券或行使认股权证可能会稀释我们的股东的权益，而就优先股权证券或可转换债务而言，这些证券可能提供优先于我们普通股的权利、优先或特权。根据信贷协定发行或借款的债务证券的条款可能会对我们的业务造成重大限制。如果我们通过合作和许可安排筹集资金，我们可能会被要求放弃对我们的平台技术或产品的重大权利，或者以对我们不利的条款授予许可。额外资本
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我们可能无法以合理的条款或根本无法提供。未能获得任何所需的未来融资可能需要我们减少或取消某些现有业务。
定期贷款安排
2022年9月22日，我们与战神资本公司签订了一项信贷协定，优先担保贷款或定期贷款工具的金额为17500美元万，减去440美元的原始发行折扣和260美元万的递延融资费用。2023年4月25日，我们签署了一项信贷协定修正案，将定期贷款工具的本金总额额外增加5,000美元万，减去原始发行贴现130美元万，并将定期贷款工具的利率提高25个基点。2023年10月11日，我们对信贷协定进行了第二次修订，将定期贷款的本金总额增加了3,500美元万，减去了90美元的原始发行折扣万。第二项修正案的措辞与第一项修正案的措辞一致。定期贷款融资的利息支付如下：(I)对于吾等选择以现金支付利息的任何利息期间，基本利率和定期SOFR借款的现金利率将分别为基本利率加6.25%和定期SOFR加7.25%，以及(Ii)对于吾等选择以实物支付利息的任何利息期间，基本利率和定期SOFR借款的现金利率将分别为基本利率加4%和定期SOFR加5%，而已支付的实物利率将为3.25%。定期贷款融资的收益将用于营运资金和一般企业用途，包括为增长举措提供资金和支付运营费用。定期贷款安排将于2027年9月22日到期，每季度支付一次利息。定期贷款机制下的所有债务均由我们担保，并由我们的几乎所有资产担保。我们有权在任何时间和不时预付全部或部分定期贷款。
定期贷款工具包含习惯陈述和保证、财务和其他契约以及违约事件，包括但不限于对收益的限制、里程碑或延期购买义务、优先股和股票回购的股息、现金投资和收购。我们必须保持至少2500美金的最低流动性，并在截至每个财政季度最后一天的过去十二个月期间保持指定金额的合并收入。最低合并收入每个季度都会增加。截至2024年12月31日和2025年12月31日止年度，我们需要产生的合并收入分别为45910加元和59410加元。截至2024年9月30日，我们遵守了信贷协议的契约。
可换股承付票据
2020年6月22日，就我们签订使用Google LLC或Google Google Cloud Platform的协议而言，我们向Google发行了一张可转换商业本票或票据，原始本金金额为33000日元。2020年11月19日，就我们的G-2系列可转换优先股融资而言，我们向Google发行了8000美金的G-2系列优先股，以该融资每股购买价的10%折扣，以部分偿还票据项下的未偿本金金额，我们修改并重述了票据的条款。
经修订及重述的票据，或经修订的票据，本金金额为25000万，并按其内所载利率计息。本金金额每年根据一个公式自动减少，该公式考虑到我们使用的Google Cloud平台服务的总价值。我们在精简的合并运营报表和全面亏损中将本金削减计入销售、一般和管理费用中的云和计算支出的抵消。经修订票据项下的未偿还本金及应计利息或未偿还金额将于(1)2026年3月22日，即经修订票据的到期日，(2)违约事件发生及持续期间，及(3)加速事件发生时(包括吾等终止吾等的谷歌云平台协定)到期及应付。我们一般不会预付未偿还的金额，除非我们可以选择预付未偿还的金额，以便在偿还后剩余的本金为$15000万。
如果修订后的票据在到期日尚未偿还，Google可以自行选择将修订后的票据下的未偿还本金和应计利息转换为我们A类普通股的股份数量，其数量等于除以（1）到期日的未偿还金额，（2）截至到期日前的二十天期间每个交易日最后交易价格的平均值。
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现金流量
下表总结了我们所列期间的现金流量：
|
|
截至9月30日的九个月里， |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
|
|
（未经审计） |
|
|||||
|
|
(in数千） |
|
|||||
经营活动所用现金净额 |
|
$ |
(149,794 |
) |
|
$ |
(174,072 |
) |
投资活动所用现金净额 |
|
$ |
(122,430 |
) |
|
$ |
(34,768 |
) |
融资活动提供的净现金 |
|
$ |
494,508 |
|
|
$ |
38,661 |
|
经营活动
在截至2024年9月30日的9个月中，经营活动中使用的现金为14980美元万，这是由于净亏损69280美元万和我们的运营资产和负债净变化3,170美元万，被57470美元万的非现金费用所抵消。非现金费用主要包括50940万的股票补偿，4 240万的权证负债公允价值增加，2,780万的折旧和摊销，被1,830万的权证资产公允价值的增加所抵消。本公司经营资产及负债的净变动主要是由于销售及客户付款时间的增加而导致应收账款增加5,170万，应付账款减少2,480万，以及预付开支及其他流动资产增加1,400万，但因与SB Tempus的知识产权许可协定有关的递延其他收入增加4,390万而被抵销，应计开支及其他增加2,340万，主要是由于云开支增加及来自RSU和解的薪俸税，以及由于我们继续就经修订票据收取利息而增加应付利息1,120万。
截至2023年9月30日的九个月内，经营活动中使用的现金为17410加元，这是由于净亏损16360加元以及我们的经营资产和负债净变化4960加元，被3920加元的非现金费用所抵消。非现金费用主要包括2，450加元的折旧和摊销、510加元的非现金经营租赁成本、500加元的认购证合同资产摊销、740加元的无形资产损失以及800加元的认购证负债公允价值减少。我们的经营资产和负债的净变化主要是由于应收帐款增加了2540美金，递延收入减少了1660美金。
投资活动
截至2024年9月30日止九个月内投资活动使用的现金为12240加元，这是由于2024年7月对合资企业的投资9520加元、购买有价股权证券3620加元以及购买1420加元的财产和设备，被出售有价股权证券的收益2310日元所抵消。
截至2023年9月30日的九个月内，投资活动使用的现金为3，480加元，这是购买3，190加元的财产和设备的结果，主要与扩建芝加哥办事处以增加实验室空间有关。
融资活动
截至2024年9月30日的九个月内融资活动提供的现金为49450日元，这是与我们IPO相关的普通股发行收益，扣除承销折扣和佣金38200日元，以及发行G-5系列优先股19980日元，与截至2024年6月1日未偿RSU部分净结算相关的860便士的延期发行成本付款、560便士的股息付款和6990便士的已支付税款相抵消，其中基于服务的归属条件在6月14日之前得到满足，2024年，并且满足了与IPO或RSU净结算相关的基于绩效的归属条件。
截至2023年9月30日的九个月内，融资活动提供的现金为3870日元，主要是长期债务收益，扣除原始发行折扣4880日元，被560日元的股息支付和360日元购买国库券所抵消。
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资产负债表外安排
我们在报告期内没有、目前也没有任何表外融资安排或与未合并实体或金融合作伙伴关系（包括有时被称为结构性融资或特殊目的实体的实体）的任何关系，这些实体是为了促进表外安排或其他合同范围狭窄或有限目的而建立的。
关键会计政策和估计
我们根据美国公认会计原则（GAAP）编制了简明合并财务报表。我们编制该等简明综合财务报表需要我们做出影响简明综合财务报表日期资产、负债、费用和相关披露的报告金额以及报告期内记录的收入和费用的估计、假设和判断。我们持续评估我们的估计和判断。我们的估计基于历史经验和我们认为在当时情况下合理的各种其他因素，其结果构成了对无法从其他来源明显看出的资产和负债的公允价值做出判断的基础。因此，在不同的假设或条件下，实际结果可能与这些估计存在重大差异。
除下文所述外，最终招股说明书中所述，我们的关键会计政策和估计没有发生重大变化。
股票补偿
我们根据授予日期的公允价值，在奖励的剩余必要服务期内以直线法确认股权奖励的补偿费用。对于那些具有市场条件的奖励，我们利用蒙特卡洛模拟模型来估计限制性股票单位的公允价值。
我们向某些员工发放RSU。根据我们的2015年计划发布的RSU的一般条款要求在归属之前满足服务和绩效条件。根据我们的2024年计划发布的RSU仅受服务条件的约束。 当参与者从归属开始日期起完成所需的连续服务期限时，服务条件即得到满足。适用于我们2015年计划的业绩条件在我们于2024年6月完成IPO时发生的流动性事件后得到满足，并导致在截至2024年9月30日的三个月和九个月内分别确认了2100加元和50940加元的股票薪酬费用。
最近的会计声明
有关更多信息，请参阅本季度报告10-Q表格其他地方包含的简明合并财务报表注释2中题为「重要会计政策摘要」的部分。
新兴成长型公司地位
我们是一家「新兴成长型公司」，定义见1933年证券法（经修订）或经2012年《跳板我们的商业初创公司法案》或《JOBS法案》修订的《证券法》，我们可能会利用适用于其他上市公司的各种报告要求的某些豁免，这些要求不是新兴成长型公司，包括，但不限于，不需要遵守《萨班斯-奥克斯利法案》第404条的审计师认证要求，减少我们定期报告和委托书中有关高管薪酬的披露义务，并免除对高管薪酬进行非约束力咨询投票的要求。股东批准之前未批准的任何金降落伞付款。
此外，《就业法案》第102(B)(1)条免除了新兴成长型公司遵守新的或修订后的财务会计准则的要求，直到私营公司(即尚未宣布生效的证券法注册声明或没有根据修订后的1934年《证券交易法》注册的证券类别)被要求遵守新的或修订后的财务会计准则为止。JOBS法案规定，公司可以选择退出延长的过渡期，并遵守适用于非新兴成长型公司的要求，但任何这样的选择退出都是不可撤销的。我们选择不选择延长的过渡期，这意味著当一项标准发布或修订时，如果该标准对上市公司或私人公司有不同的适用日期，我们公司作为一家新兴的成长型公司，可以在私人公司采用新的或修订的标准时采用新的或修订的标准。这可能会将我们的精简合并财务报表与另一家上市公司进行比较，后者既不是新兴成长型公司，也不是
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由于所使用的会计准则的潜在差异，选择不使用延长过渡期的新兴成长型公司很困难或不可能
项目3.关于市场风险的定量和定性披露
我们在正常业务过程中面临市场风险。市场风险指因金融市场价格和利率不利变化而可能影响我们财务状况的损失风险。我们的市场风险主要是利率和外币价位波动的结果。
利率风险
我们面临主要与我们的现金、现金等值物和受限制现金以及我们的债务相关的利率变化的市场风险。截至2024年9月30日，我们主要持有现金存款和货币市场基金中的现金、现金等值物和限制性现金38890美金。
外币风险
我们的大部分收入来自美国。截至2024年9月30日，我们产生的外币收入微不足道。随著我们扩大在国际市场的影响力，我们的经营运绩和现金流预计将越来越受到外币价位变化带来的波动，并且未来可能会因这些相关变化而受到不利影响。截至2024年9月30日，假设外币价位变动10%的影响对我们的财务状况或经营运绩并不重大。迄今为止，我们尚未就外币风险达成任何对冲安排。随著我们国际业务的发展，我们将继续重新评估管理与价位波动相关的风险的方法。
通胀风险
我们还面临通胀风险和通胀因素，例如原材料和管理费用增加，这可能会损害我们的经营运绩。尽管我们不认为通货膨胀对我们迄今为止的财务状况或运营运绩产生重大影响，但未来的高通胀率可能会对我们维持当前毛利率和运营费用占收入百分比水平的能力产生不利影响。
项目4.控制和程式
披露控制和程式的评估
我们的管理层在执行长和财务长的参与下，评估了截至本季度报告所涵盖的期末我们的披露控制和程式（定义见1934年证券交易法（经修订）的规则13 a-15（e）和15 d-15（e））的有效性。表格10-Q。根据该评估，我们的执行长和财务长得出的结论是，截至2024年9月30日，这些披露控制和程式在合理的保证水平上有效。
财务报告内部控制的变化
在本10-Q表格季度报告涵盖的期间，我们对财务报告的内部控制没有发生与《交易法》第13 a-15（d）条和第15 d-15（d）条要求的评估相关的变化，这些变化对我们对财务报告的内部控制产生了重大影响或合理可能产生重大影响。
控制和程式有效性的限制
我们的管理层，包括我们的首席执行官和首席财务官，相信我们对财务报告的披露控制和程式以及内部控制旨在为实现其目标提供合理的保证，并在合理的保证水准下有效。然而，对财务报告的任何内部控制的有效性都受到内在限制，包括在设计、实施、操作和评估控制和程式时行使判断力，以及无法完全消除不当行为。由于所有控制系统的固有局限性，任何控制评价都不能绝对保证所有控制问题和舞弊事件都已被发现。任何控制系统的设计在一定程度上都是基于对未来事件可能性的某些假设，不能保证任何设计在所有潜在的未来条件下都能成功地实现其所述目标。随著时间的推移，控制措施可能会
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由于条件变化或政策或程式遵守程度恶化而变得不充分。由于具有成本效益的控制系统的固有局限性，可能会发生因错误或欺诈而导致的错误陈述，并且无法被发现。
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第二部分-奥特她的信息
项目1.腿阿尔会议记录
我们可能不时涉及各种法律程序，包括客户和供应商的商业索赔、潜在的寻求损害赔偿和/或禁令救济的诉讼、雇佣纠纷、传票、政府调查、监管或行政程式，以及与正常商业活动有关的其他类型的事项。我们也可以对各种第三方提起这样的诉讼。对此类诉讼进行辩护和起诉代价高昂，并可能给管理层和员工带来巨大负担。任何当前或未来诉讼的结果都不能肯定地预测，无论结果如何，诉讼都可能因为辩护和和解成本、管理资源分流等因素而对我们产生不利影响。除下文所述外，吾等相信，吾等或吾等物业目前并无任何未决法律程序会对吾等的财务状况、经营业绩或现金流产生重大不利影响。
2022年5月19日，我们收到了俄亥俄州总检察长办公室的传票。传票要求提供与2019年至2022年间接受我们临床诊断测试的9名俄亥俄州医疗补助患者相关的某些帐单和患者记录。我们于2022年6月提供了响应文件，此后就没有收到俄亥俄州总检察长办公室的额外询问。
同样，在2024年3月4日，我们收到了来自纽约东区联盟检察官办公室的民事调查要求或CID。CID要求提供与我们遵守《虚假申报法》、《反回扣条例》，特别是《联盟医疗保险条例》第42 C.F.R.第414.510(B)条(通常称为联盟医疗保险14天或服务日期规则)有关的档案和其他资讯。我们在2024年4月4日提供了初步档案，并从那时起滚动制作了更多的回应档案。虽然我们相信其计划和支付符合反回扣法规，但不能保证政府调查的时间或结果，也不能保证不会对我们的业务造成实质性的不利影响。此外，我们还收到了某些统一计划诚信协调员或代表政府工作的其他第三方关于Tempus向参加Medicare和Medicaid计划的患者提供临床诊断服务的医疗记录和账单资讯的请求。我们已经回应了所有这类要求提供资讯的要求。
2024年6月11日，Guardant向美国德拉瓦特区地方法院对我们提出投诉。投诉称，Tempus xF、Tempus xF+、Tempus xm Monitor和Tempus xm MRD产品使用侵犯Guardant五项美国专利的液体活检技术。该投诉寻求禁令救济、未具体说明的金钱损害赔偿（包括增加的损害赔偿）、未来的强制使用费、费用和律师费。
我们评估法律或有事项，以确定财务报表中潜在应计可能损失的可能性程度和范围。在评估法律意外情况时，由于多种因素，我们可能无法提供有意义的估计，包括所讨论事项的程式状态、复杂或新颖的法律理论的存在和/或对事项重要的信息的持续发现和开发。此外，索赔的损失金额可能没有证据支持、夸大或与可能的结果无关，因此并不是潜在责任的有意义的指标。或有损失（包括日常业务过程中产生的索赔和法律诉讼）在可能发生损失且损失金额或范围能够合理估计时记录为负债。
项目1A.危险因素
与我们业务相关的风险和不确定性的描述如下。您应仔细考虑以下描述的风险以及本季度报告中的其他信息，包括我们的简明合并财务报表及其注释，以及「管理层对财务状况和经营运绩的讨论和分析」。下文描述的任何事件或事态发展的发生可能会对我们的业务、运营运绩、财务状况、声誉和前景产生不利影响。在这种情况下，我们A类普通股的市场价格可能会下跌，您可能会损失全部或部分投资。
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风险因素总结
我们的业务面临许多风险和不确定性，包括下文10-Q表格季度报告中更全面描述的风险和不确定性。以下是可能对我们的业务、财务状况和经营运绩产生重大不利影响的主要风险和不确定性总结。本摘要应与第1A项的其余部分一起阅读。风险因素不应依赖于作为我们业务面临的重大风险和不确定性的详尽总结。
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与我们的业务和战略相关的风险
自成立以来，我们已经遭受了重大损失，未来我们可能会继续遭受损失，而且我们可能无法产生足够的收入来实现和维持盈利能力。
自成立以来，我们遭受了重大损失。截至2023年和2022年12月31日的年度，以及截至2024年和2023年9月30日的9个月，我们分别发生了21410美元的万、280美元的万、69280美元的万和16360美元的万。截至2024年9月30日，我们的累计赤字为21美元亿。到目前为止，我们的运营资金主要来自出售股票和可转换证券，以及我们的基因组和数据业务的收入。我们已将几乎所有资源投入我们的平台和当前产品的开发和商业化，以及与平台开发和未来产品相关的研究和开发活动，包括为我们的诊断测试获得营销批准或认证的监管举措，以及我们的基因组和数据业务的销售和营销活动。我们将需要创造可观的收入来实现并维持盈利能力，即使我们实现盈利，我们也不能确定我们在任何时期都能保持盈利。
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我们当前或未来的产品可能无法获得或维持足够的商业市场接受度。
我们相信，我们的商业成功取决于我们继续成功营销和销售当前的基因组诊断产品的能力，通过扩大我们当前的关系和与临床医生、制药和生物技术客户发展新的关系来继续发展我们的数据业务，并开发和商业化基于我们的平台的新产品。包括将我们的基因组学产品线扩展到新的疾病领域，以及推进我们现有和未来的人工智慧应用。我们实现和保持现有和未来产品足够的商业市场接受度的能力将取决于多种因素，包括：
我们无法保证我们将成功解决这些标准中的每一项或可能影响我们产品市场接受度的其他标准。如果我们未能实现和维持市场对我们产品的足够接受，我们的业务、财务状况和运营运绩将受到影响。
我们的经营运绩可能会大幅波动，这使得我们未来的经营运绩难以预测，并可能导致我们的经营运绩低于预期或我们可能提供的任何指导。
我们的季度和年度经营运绩可能会出现大幅波动，这使得我们很难预测未来的经营运绩。由于我们计划以长期为重点运营运务，因此这些波动可能比其他以短期为重点运营的公司所经历的波动更为明显。这些波动可能由于多种因素而发生，其中许多因素超出了我们的控制范围，包括但不限于：
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此外，很难预测我们将能够从商业支付者那里为我们的诊断测试收取多少金额。我们是少数商业付款人的参与网路提供商，我们从这些付款人那里获得诊断测试的报销。付款人决定他们愿意向我们报销测试费用的金额。我们为许多疾病类型和适应症的患者提供检测，大部分时间是作为非参与提供者。即使支付人已经支付了索赔，他们也可以随时选择审查以前支付的针对这些索赔的多付索赔。虽然我们到目前为止还没有经历重大的追溯性调整，但在确定多付款项的情况下，付款人可以将他们确定多付的金额与他们在当前索赔中欠我们的金额相抵销。我们对这些追溯性调整提出异议的筹码有限，也无法预测支付者可能在何时或多久进行这些审查。在任何一个特定季度，一个或多个付款人的这些补偿中的相当大一部分可能会对我们的运营结果产生实质性影响，并导致它们低于我们可能提供的预期或指导。由于报销情况的内在变异性和不可预测性，包括与付款人为我们的任何测试向我们报销的金额有关，以前记录的收入调整并不表明来自实际现金收入的未来收入调整，这可能会有很大波动。
此外，对我们的基因组学以及数据和服务产品的需求将部分取决于制药和生物技术客户的研发和临床预算，这些预算受到我们无法控制的因素的影响，例如：
由于这些客户研发或临床支出的减少和延迟，我们的经营运绩可能会大幅波动。此外，我们的许多数据许可协议允许我们在一段时间内（可能跨越一年或更长时间）向客户提供数据。根据我们的数据许可协议，收入在向客户交付数据时、完成相关服务的履行义务时确认，或者在订阅的情况下，随著时间的推移按比例确认。数据交付的实际时间可能基于多种因素，包括但不限于客户的要求和/或我们的技术、运营和人力资本能力;此外，管理层评估与客户的合同中的相关合同条款，并在识别和核算某些合同中的所有条款和条件时应用重大判断。
上述因素的累积影响可能会导致我们的季度和年度经营运绩出现大幅波动和不可预测性。因此，将我们的经营运绩进行逐期比较可能没有意义。投资者不应依赖我们过去的业绩作为未来业绩的指标。
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这种可变性和不可预测性也可能导致我们无法满足任何时期行业或财务分析师或投资者的期望。如果我们的收入或经营运绩低于分析师或投资者的预期或低于我们可能提供的任何指导，或者如果我们提供的指导低于分析师或投资者的预期，我们普通股的价格可能会大幅下跌。即使我们满足了之前可能提供的任何公开声明的指导，这种股价下跌也可能发生。
我们业务的成功取决于我们持续访问去识别患者数据并将其货币化的能力。
我们的业务依赖于我们以符合适用法律、法规以及合同和技术限制的方式获取、处理、货币化和分发医疗行业高度监管的数据的能力。我们通过提供基因组测试和其他来源收集的数据对于我们提供数据和人工智慧应用产品和服务的能力至关重要。我们的平台还包括专有软体和专用数据管道，创建了一个医疗机构网路，为我们提供复杂的多模式数据。此外，我们依赖某些合作和许可协定来访问重要数据。我们业务的成功依赖于我们继续访问这些内部和外部未识别的患者数据并将其货币化的能力。随著我们寻求将我们的业务扩展到更多的疾病领域和地理位置，我们还需要成功地建立和维护足够大的相关数据集，并获得必要的许可，以消除识别和将这些数据用于商业目的。
我们维护、扩大数据集并将其货币化的能力受到许多因素的影响，其中许多因素是我们无法控制的。对于包括在我们的数据和人工智慧应用产品中的数据，我们依赖于作为HIPAA覆盖实体和作为HIPAA业务伙伴的法定权利的组合。作为HIPAA覆盖的实体，我们使用通过我们提供的基因组测试产生的数据。作为HIPAA的业务伙伴，我们可能依赖医疗保健提供者获得其患者(我们可能与其没有直接接触)的必要同意，以使用我们在向提供者提供我们的其他产品时生成的去身分数据，或者我们从提供者那里获得的受保护健康资讯或PHI生成的数据。更广泛地说，我们或我们的数据供应商和处理器未能以合规的方式获取患者数据可能会对我们使用和披露数据的能力产生有害影响，进而可能损害我们的功能和运营，包括我们与第三方共享数据或将其整合到我们产品中的能力。此外，使用、处理和分发患者数据可能需要我们或我们的数据供应商和处理器获得第三方的同意，或遵守适用于医疗保健行业的其他法律、法规或合同和技术限制。这些要求可能会干扰我们部署产品的能力，阻止创建新产品，或者以其他方式限制对我们有利的数据驱动活动。此外，由于缺乏有效的通知、充分的同意或豁免，我们可能会因使用或披露数据或其他资讯而受到索赔或责任的约束。
我们还依赖于我们网路中的医疗机构继续为我们提供对多模式数据的广泛访问，以支持我们的基因组测试和其他产品的稳健性，并依赖于我们与ASCO、OnCare Alliance和类似组织的合作，以及在未来与其他组织进行类似的合作，特别是在我们试图扩展到其他疾病领域的时候。这些第三方的利益可能与我们的利益背道而驰，包括以不同的方式将他们的数据货币化的愿望，并且不能保证我们将成功地维护和增长我们的数据集。此外，我们与其中一些第三方的安排不是排他性的，这可能允许这些第三方向我们的竞争对手提供数据，从而对我们提供差异化产品和服务的能力产生不利影响。我们向提供商提供来自我们的基因组测试的原始数据以及作为提供测试的一部分而构建的相应临床数据的做法，也可能允许这些提供商以损害我们的商业利益的方式使用数据。
患者数据的使用、处理和分发也是美国和全球复杂、相互关联且频繁变化的法律法规的主题。我们制定了政策和程式来解决数据的正确处理和使用问题，但可能会面临这样的指控：我们的做法不充分，或者以适用法律或我们与数据提供者、患者或其他第三方的协议或义务不允许的方式发生。这些索赔或责任以及其他未遵守适用要求的行为可能会使我们承担意外成本，并对我们的业务、财务状况和运营运绩产生不利影响。此外，任何实际或感知的未遵守适用的隐私和数据安全法的行为都可能会对我们依赖访问数据的第三方继续向我们提供此类数据的意愿产生不利影响。
我们产品和服务的持续采用取决于许多因素，其中许多因素是相互关联的。
我们执行增长战略并实现盈利的能力高度取决于许多因素，其中许多因素是相互关联的。
继续采用和使用我们的Genomics产品线将取决于几个因素，包括我们对测试收取的价格、第三方付款人为我们的测试提供的覆盖范围和报销金额、支持我们测试价值的临床数据的可用性以及将我们的测试纳入行业治疗指南。此外，许多临床医生、医院系统和制药公司与开发分子诊断测试的公司建立了现有关系，
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包括我们的竞争对手，并且可能会继续使用他们的测试而不是我们的测试。尽管我们在业务发展方面做出了努力，但医疗保健提供者为患者更换诊断测试可能会很困难、昂贵和/或耗时，而且我们的测试可能不会被医生广泛接受（如果有的话），这反过来又可能会阻碍我们测试的销售增长。如果我们无法在测试中取得商业成功，我们的业务、财务状况和运营运绩将受到重大不利影响。我们还特别依赖我们的肿瘤学测试，截至2023年12月31日和2022年12月31日止年度，肿瘤学测试分别占我们收入的63%和46%。我们无法保证我们的肿瘤学测试将继续保持或获得市场接受，否则将对我们的业务、财务状况和运营结果造成重大损害。
继续采用和使用我们的数据和服务产品将在一定程度上取决于我们是否有能力与制药和生物技术客户保持关系并建立新的关系，并向这些客户提供相关数据，用于结果研究、配套诊断开发、新目标发现和验证等用途。由于许多因素，这可能很困难，包括所需数据的类型以及我们提供这些数据以满足制药和生物技术客户的满意度的能力。我们的制药和生物技术客户可能会决定减少或停止使用我们的Insights产品，原因可能是他们的研究和产品开发计划发生变化、临床试验失败、资金紧张或其他我们无法控制的情况。此外，制药和生物技术公司可能会因为与我们的任何竞争对手进行战略合作而拒绝与我们做生意，或者减少或停止使用我们的数据。我们投入资源，寻求与制药和生物技术公司就潜在的商业机会不断发展关系。不能保证这些投资中的任何一项都会导致商业协定，不能保证由此产生的关系会成功，也不能保证我们作为合作的一部分提供的数据会产生成功的结果。如果我们不能保持现有的关系，或与制药和生物技术公司建立新的关系，我们的产品开发可能会被推迟，收入和运营结果可能会受到不利影响。
我们可以为客户提供的数据和服务以及人工智慧应用产品的范围和稳健性在很大程度上取决于我们基因组学产品线的持续成功，因为我们通过基因组测试收集的数据是我们数据和服务以及人工智慧应用产品的重要组成部分。此外，我们相信，我们数据和服务产品使用的增长将有助于提高人们对我们基因组学产品线的认识和采用，这反过来又将推动我们数据和服务以及人工智慧应用产品线的进一步增长。然而，不能保证我们会实现这些协同效应。
我们有限的运营历史和快速的增长使得我们很难评估我们的未来前景以及我们可能遇到的风险和挑战。
我们成立于2015年，在收入、产品和服务的采用率、测试量、数据集的大小、临床试验匹配以及我们认为对评估我们的业务至关重要的其他指标方面都经历了快速增长。此外，我们在以快速技术进步为特征的竞争激烈的市场中运营，我们的业务已经发展，我们预计它将继续发展，随著时间的推移保持竞争力。我们有限的经营历史、不断发展的业务、快速增长和雄心勃勃的目标使我们很难评估我们的未来前景以及我们可能遇到的风险和挑战，并可能增加我们无法继续以历史速度或接近历史速度增长的风险。此外，这些因素可能会使我们难以实现既定的里程碑和目标，也难以准确预测我们业务的未来业绩。例如，我们可能永远不会意识到我们的技术的潜在好处，正如这份10-Q表格季度报告中在其他地方所设想的那样。
如果我们未能解决我们面临的风险和困难，包括本「风险因素」部分其他地方描述的风险和困难，我们的业务、财务状况和经营运绩可能会受到不利影响。我们过去遇到过，未来也将遇到在快速变化的行业中运营历史有限的成长型公司经常经历的风险和不确定性。如果我们对这些风险和不确定性（我们用于规划和运营运务）的假设不正确或发生变化，或者如果我们未能成功应对这些风险，我们的经营运绩可能会与我们的预期存在重大差异，并且我们的业务、财务状况和经营运绩可能会受到不利影响。
我们可能需要筹集额外资金来资助我们的现有业务、开发我们的平台、将新产品商业化或扩大我们的业务。
我们未来可能需要筹集额外资本以扩大业务、履行现有义务、寻求收购或战略投资、利用融资机会或出于其他原因，包括：
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我们现在和未来的资金需求将取决于许多因素，包括：
我们没有承诺的资金来源。我们可能寻求出售股权或可转换证券，进入信贷安排或其他形式的第三方融资，或寻求其他债务融资。我们筹集额外资本的各种方式都有潜在的风险。如果我们通过发行股票或可转换证券来筹集资金，可能会对我们的股东造成稀释。任何发行的优先股权证券也可能规定优先于我们普通股持有人的权利、优先或特权。如果我们通过发行债务证券筹集资金，这些债务证券将拥有优先于我们普通股持有者的权利、优先和特权。根据信贷协定发行或借款的债务证券的条款可能会对我们的业务造成重大限制。如果我们通过合作和许可安排筹集资金，我们可能会被要求放弃对我们的平台或产品的重大权利，或者以对我们不利的条款授予许可。我们可能无法以可接受或商业上合理的条件，或以足以满足我们需要的金额，获得这些筹集额外资本的选择。未能获得任何所需的未来融资可能需要我们减少或取消某些现有业务，并可能导致市场对我们或我们的证券的负面看法。
我们的人工智慧应用产品线刚刚起步。
我们的人工智慧应用产品线中的商业化算法有限。人工智慧应用程式产生的收入在我们的数据和服务产品线中报告，截至2023年12月31日和2022年12月31日的年度分别为550万美元万和140万美元万，分别占我们每个时期总收入的1.0%和0.4%。在截至2024年9月30日和2023年9月30日的三个月里，来自人工智慧应用程式的收入分别为430美元万和180美元万，分别占我们每个时期总收入的2.4%和1.3%。截至2024年9月30日和2023年9月30日的9个月，来自人工智慧应用程式的收入分别为750万美元万和300万美元万，分别占我们每个时期总收入的1.5%和0.8%。我们还有一些额外的算法正在开发中，我们可能无法成功地开发这些或未来的算法并将其商业化，或实现我们的其他发展目标。此外，我们可以为客户提供的人工智慧应用程式的范围和稳定性在很大程度上取决于我们的基因组产品线的持续成功和对第三方数据的访问，这一点无法得到保证。我们也无法准确估计我们未来的AI应用程式将如何定价，是否可以获得报销，或者我们是否会从此类AI应用程式中产生任何收入。此外，使用本质上完全是算法的诊断是新颖的，今天只占诊断市场的一小部分。算法诊断的使用也可能受到现有的和全新的法规的约束，这些法规可能会对其采用、使用、报销和持续生存产生重大影响。虽然我们相信人工智慧应用对我们来说是一个重要的长期机会，但不能保证此类诊断会发展成一个强劲和持续的市场，也不能保证我们会在任何这样的市场上成功竞争。
新产品开发和商业化涉及一个漫长而复杂的过程，我们可能无法及时或根本无法开发或商业化新产品。
正在开发的产品需要时间和大量资源来开发，我们可能无法及时或根本无法完成此类产品的开发和商业化。
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在我们将任何新的基因组学或人工智慧应用诊断产品商业化之前，我们需要花费大量资金以：
我们的诊断产品开发过程涉及高度风险，产品开发工作可能会因多种原因失败，包括：
扩大我们数据业务的产品也是一项投机性且有风险的努力，可能需要我们：
我们的平台开发计划涉及使用当前产品产生的数据和分析见解来促进未来产品的研究和开发。然而，如果我们无法生成额外或兼容的数据和见解，那么我们可能无法快速或根本无法推进我们正在开发的产品，或者在没有重大额外投资的情况下。
在我们开发产品时，我们已经并将不得不对平台开发、营销和销售资源进行大量投资，这可能会对我们未来的现金流产生不利影响。我们还可能依赖第三方开发新产品，我们可以获得许可并将其包含在我们的整体产品中，特别是对于我们的人工智慧应用程式业务，并且我们可能会对此类开发工作施加有限或没有控制。
此外，在我们业务线的开发和商业化计划中，我们可能会放弃可能提供更大收入或更有利可图的其他机会。例如，虽然我们希望向制药和生物技术公司提供诊断和数据技术（包括我们的执行长、创始人兼董事长Eric Lefkofsky或我们的其他执行官、董事或重要股东可能拥有重大或控股投票权和经济利益的公司）开发治疗各种疾病的疗法，包括癌症，我们目前不希望自己开发治疗方法。因此，即使我们的开发努力产生了商业上可行的产品，我们的业务和运营运绩也可能会低于我们的客户和竞争对手。
我们可能无法成功更新或以其他方式增强我们的平台和产品。
我们开发了涵盖肿瘤学、传染病和神经精神病学的多种基因组学诊断测试，以及涵盖肿瘤学和心脏病学的算法诊断测试。我们战略的一个主要部分是通过更新我们的平台和现有产品，为客户带来新的高价值增强功能，其中可能包括用额外功能、应用程式和数据模式扩展我们的现有产品。我们预计将进行大量投资来推进这些努力。
增强我们的平台和产品是一项投机性和高风险的努力。最初显示出希望的功能、应用和数据模式可能无法实现预期结果，或者可能无法达到可接受的分析准确度或实用性水准。在确定潜在的成功更新之前，我们可能需要更改正在开发的产品并重复研究。产品开发成本高昂，可能需要数年时间才能完成，而且可能会产生不确定的结果。失败可能发生在开发的任何阶段。即使我们确认我们的产品可以针对其他功能、应用程式和数据模式成功更新，这些功能、应用程式和数据模式的范围可能仅限于某些疾病、疾病部分、患者市场或地理位置。如果在开发后，更新的产品看起来很成功，我们可能需要获得FDA、通知机构和其他监管机构的许可、授权、认证或批准，然后才能将更新的产品推向市场，具体取决于更新的性质。
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FDA和公告机构的许可、授权、批准或认证途径可能需要大量的时间和支出。FDA或其他适用的监管机构或公告机构可能不会明确、授权、认证或批准我们开发的任何产品更新，甚至可能以影响我们现有产品或服务（包括我们的平台）的方式更改适用法规或这些法规的应用。即使我们开发了获得监管许可、认证、授权或批准的产品更新，我们或我们的合作者也需要投入大量资源来商业化、销售和营销更新的产品，而这可能永远不会在各个利益相关者中获得明显的市场接受度并取得商业成功。
此外，我们通常在技术变革迅速、新产品推出频繁和行业标准不断变化的行业销售产品。如果我们不及时开发基于技术创新的平台和产品增强功能，我们的平台和产品可能会随著时间的推移而过时，我们的财务和竞争地位将受到影响。我们的成功将取决于几个因素，包括我们的能力：
与我们的平台扩展不成功相关的费用或损失可能会对我们的业务、财务状况和运营结果产生不利影响。
如果我们不能成功利用我们的平台来识别、开发和商业化额外的基因组和算法测试，我们扩大业务和实现战略目标的能力就会受到损害。
我们战略的一个关键要素是利用我们的平台来识别、开发并可能商业化超出我们当前产品组合的基因组和算法测试，以诊断各种类型的疾病。无论任何基因组或算法测试最终是否被开发和商业化，识别新的基因组和算法测试都需要大量的技术、财政和人力资源。我们可能会追求我们认为有希望的机会来利用我们的平台，但却发现我们的某些风险或资源分配决策不正确或不充分，或者单个基因组或算法测试具有以前未知或未充分认识的局限性。
我们追求平台价值的战略，即在长期范围内针对多种人类疾病开发基因组和算法测试，可能并不有效。如果这些领域中任何一个的重大决策被证明是错误的或次优的，我们可能会对我们的业务和运营资金的能力产生重大不利影响，而且我们可能永远不会意识到我们所认为的平台在开发和商业化基因组和算法测试方面的潜力。
如果我们现有的和新的产品未能达到和维持足够的科学接受度，我们将无法产生预期收入，我们的前景可能会受到损害。
生命科学社区由少数早期采用者和关键意见领袖组成，他们对社区的其他部分产生了重大影响。生命科学产品的成功在很大程度上是由于科学界接受了某些产品，并将其作为适用研究领域的最佳做法。目前的学术和科学研究体系认为，在同行评议的期刊上发表文章是衡量成功与否的标准。在这样的期刊出版物中，研究人员不仅会描述他们的发现，还会描述为这些发现提供动力的方法以及通常使用的产品。在同行评议的期刊出版物中被提及是我们的产品被普遍接受为最佳实践的一个很好的晴雨表。确保早期采用者和主要意见领袖发表涉及使用我们产品的研究，对于确保我们的产品获得广泛接受和市场增长至关重要。继续与这样的关键意见领袖保持良好的关系对于发展我们的市场至关重要。近年来，我们的产品在同行评议的出版物中被提及的次数显著增加。截至2023年12月31日，我们的产品已在主要期刊上发表的117篇同行评议文章中被提及，其中87篇是Tempus撰写的。然而，我们不能向投资者保证，我们的产品将继续以任何频率在同行评议文章中被提及，或者我们未来推出的任何新产品将在同行评议文章中被提及。此外，提及我们产品的自行撰写的期刊出版物可能存在实际的、潜在的或感知到的利益冲突，因此，提及我们产品的出版物数量可能不能代表
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我们产品的接受程度。如果太少的研究人员描述我们产品的使用，太多的研究人员转向竞争产品并发表概述他们对该产品的使用的研究，或者太多的研究人员在出版物中负面描述我们产品的使用或可用性，这可能会导致现有和潜在客户远离我们的产品，这可能会损害我们的运营结果。同行评审期刊中提及我们产品的频率的任何下降，或此类出版物质量的下降，都可能会对我们的前景产生负面影响。
我们的诊断产品或我们竞争对手的诊断产品可能存在缺陷或错误，或者无法满足患者、医生和第三方付款人的期望;在这种情况下，我们的经营运绩、声誉和业务可能会受到影响。
我们基因组学和人工智慧应用产品的成功在一定程度上取决于患者、医生和第三方付款人对我们平台能够提供可靠、高质量智慧诊断的信心，这些诊断将改善临床结果并降低医疗成本，以及我们遵守适用隐私和数据安全要求的能力。我们相信，患者、医生和第三方付款人可能会对我们对数据的使用以及产品使用中的产品缺陷和错误特别敏感，包括如果我们的产品未能从样本中高精度地检测到基因组变化或其他临床相关资讯、如果我们未能在测试报告中列出或错误地列出某些治疗方案和可用的临床试验，或者如果我们未能遵守适用的隐私和数据安全法律，并且不能保证我们在这方面会取得成功。此外，如果我们的竞争对手的诊断产品没有达到预期的性能，或者如果他们没有遵守适用的法律和法规，也可能导致对我们的信心下降。因此，我们的诊断产品或竞争对手的诊断产品未能按预期运行，或我们或我们的竞争对手未能遵守适用的法律和法规，都可能严重损害我们的经营业绩和声誉。此外，我们可能会受到任何此类故障引起的法律索赔，包括我们的诊断产品中的缺陷或错误导致受伤或死亡的索赔。对我们的信心，以及我们的品牌和声誉的实力，也可能被我们或我们的竞争对手感知到的失败所侵蚀，即使没有任何失败或不当行为的证据。
如果我们无法支持对当前和未来Genomics产品线的需求，包括确保我们有足够的能力来满足不断增长的需求，或者我们无法成功管理我们的预期增长，我们的业务可能会受到影响。
随著我们基因组产品线销售量的增长，我们将需要继续增加我们在样本采集、客户服务、账单和一般流程改进方面的工作流程能力，扩大我们的内部品质保证计划，并扩展我们的平台，以在预期的周转时间内支持更大规模的全面基因组分析。我们将需要更多经过认证的实验室科学家和其他科学技术人员来处理更多的基因组测试。我们的部分流程不是自动化的，需要更多的人员来扩展。我们还需要购买更多的设备，其中一些可能需要几个月或更长的时间来采购、设置和验证，并增加我们的软体和计算能力，以满足日益增长的需求。不能保证任何这些规模的增加、人员、设备、软体和计算能力的扩大或流程的改进将被成功实施，或者我们的实验室设施将有足够的空间或能够确保更多的设施空间来容纳所需的扩展。
随著我们将更多基因组学产品商业化，我们将需要整合新设备、实施新技术系统和实验室流程，并雇用具有不同资格的新人员。未能管理好这种增长或转型可能会导致周转时间延迟、产品成本上升、产品质量下降、客户服务恶化以及对竞争挑战的反应较慢。其中任何一个领域的失败都可能使我们难以满足市场对我们产品的期望，并可能损害我们的声誉和业务前景。
我们吸引和保留候选人以支持基因组学和其他产品扩张的能力可能会受到我们无法控制的因素的影响，或者我们可以控制但未能执行的因素。例如，全球劳动力短缺、我们的薪酬和福利待遇、员工组建工会的尝试以及其他因素可能会影响我们招聘、雇用、培训和留住员工的能力，这将进一步影响我们实现增长和扩张目标的能力。
此外，我们正确管理增长的能力将要求我们继续改进我们的运营、财务和管理控制以及我们的报告系统和程式。实施这些新系统和程式所需的时间和资源是不确定的，并且可能要求很高，如果未能及时有效地完成这一点，可能会对我们的业务、财务状况和运营结果产生不利影响。
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如果第三方付款人（包括商业付款人和政府医疗保健计划）不为我们的检测提供保险、充分的报销、或撤销或改变与我们的检测相关的政策，我们的业务、财务状况和运营结果将受到负面影响。
截至2023年12月31日，我们在2021年1月1日至2022年12月31日期间对所有付款人进行的临床肿瘤学下一代测序(NGS)测试已收到约50%的付款。我们根据付款人裁决时间在拖尾的基础上计算了这一指标。然而，我们继续执行我们的NGS测试，直到2023年12月31日。在截至2022年和2023年12月31日的年度内，我们在肿瘤学的NGS测试的平均报销金额分别约为916美元和1,452美元。此外，我们的诊断收入的很大一部分来自数量有限的第三方商业付款人，其中大多数还没有与我们签订合同，成为参与提供者。我们还从Medicare获得与我们的各种诊断测试相关的报销。在截至2023年12月31日和2022年12月31日的年度内，我们的临床测试中分别有大约26%和28%是针对联邦医疗保险受益人的。我们的收入和商业成功取决于从支付者那里获得我们测试的覆盖和补偿，包括商业和政府支付者。如果付款人没有为我们的测试提供保险，或者没有为我们的测试提供足够的补偿，我们可能需要向患者寻求付款，这可能会对我们的测试需求产生不利影响。
此外，由于我们的基因组学和人工智能应用诊断测试代表了诊断疾病的新方法，我们无法准确估计它们将如何定价，是否可以获得补偿或任何潜在的收入。付款人对承保范围的确定可能取决于许多因素，包括但不限于付款人对测试是适当的、医学上必要的或成本效益的确定。如果我们无法向付款人提供足够的证据证明我们测试的临床实用性和有效性，他们可能无法提供保险、可能提供有限的保险或可能终止保险，这将对我们的业务、财务状况和运营结果产生不利影响。如果更多的竞争对手进入我们的市场，我们测试的覆盖范围和报销率可能会因为我们遇到来自竞争对手的定价压力或付款人根据其他因素决定降低我们测试的报销率而减少。
每个付款人自己决定是否为我们的测试提供保险，是否与我们签订合同，以及测试的报销率。与付款人谈判是耗时的，付款人通常坚持他们的标准格式合同，这可能允许付款人在短时间内终止保险，对我们施加重大义务，并为我们制造额外的监管和合规障碍。不能保证付款人将为我们的测试提供足够的保险或补偿，也不能保证我们能在合理的条件下与付款人达成协议，而不会受到额外的监管和合规风险的影响。在没有承保范围的情况下，或者我们与付款人没有约定的报销费率，患者通常要承担更大份额的检测费用，这可能会导致收入延迟、增加收取成本或降低收取的可能性。我们维持着一项财政援助计划，根据该计划，我们评估患者的经济需求，并为满足该计划经济和其他资格标准的某些患者提供折扣或免费测试。这可能会导致我们的经济援助计划的付款人进行审查，并可能导致补偿行动或终止我们的测试覆盖范围。
我们的报销要求在过去被拒绝，未来也可能再次被拒绝，我们需要，而且可能再次需要，对这种拒绝提出上诉，以便获得赔偿。这样的上诉可能不会导致付款。如果支付者认为资金支付错误或确定我们的测试在医学上没有必要，则支付者可以对历史上支付的索赔进行审计，并在资金最初分配数年后尝试追回资金。如果付款人对我们的索赔的审计结果是否定的，而我们无法通过上诉推翻这一发现，那么任何后续的赔偿可能会对我们的收入造成实质性的不利影响。此外，在某些情况下，我们不是参与提供者的商业付款人可以随时选择审查以前支付的索赔，并确定他们支付的金额过高。在这些情况下，付款人通常会将其决定通知我们，然后将其确定多付的金额抵消其在当前索赔中欠我们的金额。我们没有对这些追溯性调整提出异议的机制，我们也无法预测付款人可能在何时或多久进行这些审查，因为历史性的成功和付款并不能预示未来此类上诉的成功和付款。
我们成为众多商业付款人的参与提供商的努力可能不会成功。当我们与作为参与提供商的付款人签订合同时，付款人的报销通常根据协商后的费用表进行，并且仅限于涵盖的适应症或已获得事先批准的情况。
尽管我们是一家拥有多个商业付款人的参与提供商，但一些大型商业付款人已发布非承保政策，将组织和液体全面基因组谱测试（包括我们的某些基因组学测试）视为实验性或研究性。如果我们未能成功从此类付款人获得保险，或者如果其他付款人发布类似的非保险政策，我们的业务、财务状况和运营运绩可能会受到重大不利影响。
覆盖范围和报销不断变化，我们无法控制竞争对手的覆盖范围和定价策略的制定方式。我们的一些竞争对手拥有广泛的品牌知名度以及更高的财务和技术
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资源和开发、生产和营销能力都比我们强。其他人可能会开发价格较低、不太复杂的测试，付款人和医疗保健专业人员可能认为这些测试在功能上与我们的产品相当，这可能迫使我们降低测试的标价，并影响我们的营运利润率以及我们实现和维持盈利能力的能力。付款人可能会将我们的产品与竞争对手进行比较，并将其用作先例，这可能会影响我们的覆盖范围和报销。此外，导致创建比我们更有效的增强型诊断工具的技术创新可能会使其他临床实验室、医院、医务人员或医疗提供者能够以比目前可能的更亲患者、更高效或更具成本效益的方式提供与我们类似的专业诊断测试。
在美国，许多关于新诊断报销的重要决定是由联盟医疗保险和医疗补助服务中心(CMS)做出的，该中心就新诊断是否以及在多大程度上将在联盟医疗保险下覆盖和报销做出全国覆盖确定(NCD)，尽管它经常将这一权力委托给当地的联盟医疗保险行政承包商(MAC)，后者可能会就覆盖和报销做出本地覆盖确定(LCD)。私人付款人倾向于在很大程度上遵循联盟医疗保险。在截至2023年12月31日的一年中，联盟医疗保险索赔占我们临床测试量的26%。鉴于我们在多个Mac中运营实验室，并同时运行LDT和FDA批准的检测，适用的报销决定根据运行的检测和处理地点的不同而有所不同。CMS用来确定我们测试报销率的规则和标准经常变化，可能会对我们的结果产生实质性影响。
例如，Medicare于2018年首次建立并于2020年更新的针对NGS的NCD规定，NGS肿瘤学测试(如我们的Tempus|XT和Tempus|XF测试)将在以下情况下在全国范围内由Medicare覆盖：(1)在临床实验室改进修正案或CLIA认证实验室进行，(2)由治疗医生下令，(3)患者满足某些临床和治疗标准，包括复发、复发、难治、转移或晚期III或IV期癌症，(4)FDA批准或批准该测试作为FDA批准或批准用于该患者癌症的适应症的伴随体外诊断，以及(5)使用指定治疗选项的报告模板将结果提供给治疗医生以管理患者。我们相信，我们于2023年4月获得FDA批准的XT CDX检测将符合NCD下的报销标准。NGS NCD还规定，只有在由治疗医生下令的CLIA认证实验室进行测试，并且患者符合NGS NCD下的全国覆盖的下一代测序测试所要求的相同临床和治疗标准时，每个MAC才可以为癌症患者提供其他下一代测序测试的本地覆盖。当癌症患者在NCD或LCD下没有上述癌症指征时，NGS测试通常不包括在医疗保险范围内。
国家政府服务公司是当地的MAC，为我们芝加哥实验室进行的测试做出本地覆盖确定或LCD。当地MAC已经发布了两份与癌症基因测试相关的LCD，目前每一份都要求根据描述该测试的单一当前程序术语或CPT代码提交索赔。由于没有CPT代码全面描述我们的NGS肿瘤学测试，我们历史上曾根据所描述的癌症亚型使用单独的代码提交索赔。2021年3月25日，当地MAC指示我们使用不同的指定CPT代码提交我们的索赔，并表示将对此类索赔进行单独审查。随后，2021年7月23日，当地MAC发布了修订的CPT编码说明，并于2021年7月29日进一步更新了这些说明。根据2021年3月和2021年7月的指导提交的索赔被立即驳回，我们已对这些否认提出上诉。这一过程通常是缓慢和昂贵的，而且可能需要多个级别的上诉来裁决未决的索赔。
2022年2月10日，本地MAC发布了修订后的LCD（L37810）以及相应的计费和编码更新（A56867）。修订后的LCD中规定的覆盖范围扩大将导致他们指示我们于2021年7月开始计费的CPt代码将按照符合修订后的覆盖标准的测试的现行医疗保险费率进行报销。修改后的LCD将于2022年4月1日生效，适用于实体瘤治疗中的基因组序列分析小组测试，鉴于修改后的LCD中的覆盖范围进行了修改，这主要影响我们的实体瘤检测，ext。我们将继续监控LCD对目前处于上诉过程中的索赔的影响;然而，LCD总体上对2022年4月1日之后提交的索赔的报销产生了有利的影响。
从2023年1月1日开始，新的CPt代码生效，涵盖与DNA测试分开进行的完整转录组测试。从历史上看，我们的ext检测实际上由两个独立且不同的程式组成：DNA和RNA。鉴于RNA没有适用的CPt代码，我们没有对该测试收取费用。随著新代码的引入，我们现在有了两种独立的检测方法，一种分析DNA -文本，一种分析RNA - xR，这两种检测方法分别订购和计费。我们要求本地MAC将新的CPt代码添加到LCD中，他们于2023年1月1日生效。
Palmetto是MAC管辖区，负责确定通过MolDx计划在罗利和亚特兰大实验室进行的测试的报销。MolDx要求实验室完成技术评估流程，以确保其管辖范围内实验室运行的测试获得报销。在技术评估过程中获得批准后，检测试剂盒将被分配一个z代码和一个价格，MolDx将报销索赔。在启动罗利实验室的同时，我们于2022年提交了对ext检测试剂盒和2023年提交了对xF检测试剂盒的技术评估。我们于2023年10月获得了ext assay的批准，并于2024年3月获得了xF assay的批准。
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此外，根据CMS的规定，在某些情况下，我们不能直接向Medicare收取为Medicare受益人提供的测试费用。CMS对其实验室服务日期规定采取了例外情况，如果满足某些条件，像我们这样的分子测试实验室可以依赖该例外情况直接向医疗保险收费，而不是向医院寻求付款。如果CMS废除或削减了该例外情况，或者其实验室服务日期法规发生其他变化，从而对我们直接向医疗保险收费的能力产生不利影响，那么我们的收入可能会大幅减少。
此外，2023年9月27日，联盟医疗保险和医疗补助服务中心(CMS)公布了2024日历年联盟医疗保险临床实验室费用表(CLF)上新的和重新考虑的代码的初步付款决定，包括可能适用于我们通过基因业务提供的测试的新代码。在这样做的过程中，CMS拒绝了临床诊断实验室测试(CDLT)咨询小组专家的建议，并建议对几个描述基因组图谱测试的新程式代码的报销率大大低于我们进行这些测试的成本。在一段评议期后，CMS修改了初步确定，并将每个新代码分配给GapFill-通过这个过程，每个单独的Mac为代码定价，由此产生的Mac中值价格成为Medicare CLF的价格。我们目前正在参与与我们合作的Mac的缺口填补过程。2024年5月1日，CMS发布了特定于MAC的付款建议，其中表示适用于我们测试的代码的报销水准将与之前相同或更高。这些建议目前公开征求公众意见，CMS将在9月份公布最终的MAC具体金额。如果CMS最终以低于之前报销我们测试费用的价格为新代码定价，这种定价决策可能会对我们的业务、运营结果、财务状况和前景产生重大影响。国家政府服务公司于2024年2月5日修订了其编码指南，通知实验室从2024年1月1日起开始使用新的分子诊断CPT代码，尽管这些代码没有定价，因为它们正在经历缺口填充过程。
一些付款人已经实施或正在实施实验室福利管理方案，通常使用第三方福利管理器来管理这些方案。这些计划的既定目标是帮助提高门诊实验室服务的质量，支持以证据为基础的患者护理指南，并降低成本。第三方积极的实验室福利管理对我们等实验室的影响尚不清楚，我们预计这将在短期内对我们的收入产生负面影响。付款人可能会抵制我们的测试报销，转而支持更便宜的测试，要求我们的测试预先授权，或者为我们的测试报销施加额外的定价压力和重大的行政负担。我们预计将继续集中大量资源，以增加我们目前的测试和我们未来可能开发的测试的采用率、覆盖率和报销。我们认为，我们可能需要几年时间才能实现广泛的覆盖范围和足够的合同补偿，并为我们的测试支付大部分费用。然而，我们无法预测付款人是否会在什么情况下或在什么价格水准上承保和报销我们的测试。如果我们未能建立并保持广泛采用我们的测试、覆盖和补偿我们的测试，我们的创收能力可能会受到损害，我们的业务、财务状况和运营结果可能会受到影响。
如果我们无法在美国境外获得或维持足够的Genomics产品线的报销，我们国际扩张的能力将受到损害。
我们基因组产品线的很大一部分收入来自第三方付款人报销。在美国以外的许多国家，报销制度因国家和地区的不同而有很大差异，必须在国家/地区的基础上获得报销批准，并且需要获得各种覆盖范围、定价和报销批准，才能向大量患者提供我们的测试。在欧盟，一些国家要求完成额外的研究，将特定候选医疗器械的成本效益与目前可用的疗法进行比较。这一健康技术评估或HTA程式目前由欧盟个别成员国的国家法律管辖，是对在个别国家的国家医疗保健系统中使用特定医疗设备的公共健康影响、治疗影响以及经济和社会影响进行评估的程式。有关特定医疗器械的HTA结果往往会影响欧盟个别成员国主管当局给予这些产品的定价和报销地位。我们预计，需要几年时间才能在美国以外的国家为我们的测试建立广泛的覆盖范围和报销范围，我们的努力可能不会成功。
即使获得了公共或私人报销，它也可能涵盖竞争性检测，或者报销可能仅限于符合条件的患者群体的一部分，或者取决于当地测试的表现或我们可能难以满足的其他要求。
美国境外的报销水平可能与我们收到的国内报销金额存在很大差异。我们还可能受到欧盟或欧盟和其他地区几个国家的金融不稳定和实施的紧缩措施的负面影响。
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劳资关系问题可能会对我们的业务、声誉、前景、运营运绩和财务状况产生重大不利影响。
2024年2月8日，国际机械师和航空航太工人协会(IAM，第八区)向国家劳资关系委员会(NLRB)提交了一份选举请愿书，作为我们位于伊利诺伊州芝加哥的某些实验室员工的集体谈判代表。2024年3月6日和7日，全国劳资关系委员会举行了一次选举，确定的集体谈判单位投票决定成立工会，并选举IAM担任集体谈判代表。我们已经开始与IAM谈判一项集体谈判协定的进程。我们无法预测我们能否成功达成集体谈判协定，也无法预测这种努力可能带来的额外成本和费用。此外，在我们不成功的程度上，或者如果此类努力花费的时间比预期的要长，受影响的员工可能会威胁和/或参与停工和罢工，因此我们的劳动力成本可能会继续增加。尽管我们目前不知道其他成立工会的努力，但其他员工也可能寻求成立工会。实验室工作人员的缺勤，或我们无法控制与这些问题相关的劳动力成本以及未来成立工会的努力，可能会对我们的业务、声誉、前景、运营结果和财务状况产生实质性的不利影响。
我们在产品和服务中使用人工智慧，这可能会导致运营挑战、法律责任、声誉问题和竞争风险。
人工智慧由我们的平台以及我们的诊断和数据产品启用或集成到其中，因此是我们当前业务和未来战略的重要组成部分。与许多正在开发的技术一样，人工智慧带来的风险和挑战可能会影响其进一步开发、采用和使用，从而影响我们的业务。人工智慧存在许多已知和未知的风险。目前已知的一些风险包括准确性、偏见、毒性、智慧财产权侵犯或挪用、数据隐私和网络安全以及数据来源。例如，我们对人工智慧的开发和使用可能会导致将第三方数据（包括个人、专有或机密数据）纳入我们的人工智慧中。如果我们没有足够的权利使用AI所依赖的数据，我们可能会因违反此类法律、第三方隐私或我们所签署的其他权利或合同而承担责任。
此外，人工智慧领域的监管不断变化，可能会使我们难以继续使用我们的人工智慧方法进行诊断和数据分析。人工智慧是包括美国证券交易委员会和联盟贸易委员会在内的多个美国政府和监管机构不断审查的对象，美国各州和其他外国司法管辖区正在或正在考虑将其网路安全和数据保护法适用于人工智慧，特别是产生型人工智慧，和/或正在考虑针对人工智慧的一般法律框架(如2024年8月1日生效的欧盟人工智慧法案或人工智慧法案)，其中规定的行政罚款最高可达3,500万欧元，相当于上一财年全球总营业额的7%。两者以较高者为准)。此外，人工智慧的使用和部署在遵守适用的法律法规方面带来了复杂性和挑战，特别是因为我们既是一家技术公司，也是一家诊断检测服务的医疗保健提供商。生命科学公司可能会为人工智慧算法的开发提供部分担保或资金，这可能要求我们披露适用的资金来源，因此可能会减缓此类技术的采用。此外，就我们开发或部署的算法的输出直接或间接建议可由联盟医疗计划报销的产品或服务的潜在订购而言，我们可能会遇到执法挑战，即使此类建议是基于客观的临床指南和标准。如果发生任何此类事件，可能会对我们的业务运营和声誉产生重大不利影响。
此外，算法可能存在缺陷或偏见，数据集可能不足、质量差或包含有偏见的信息。克服技术障碍并纠正缺陷或错误可能被证明是不可能或不切实际的，并且产生的成本可能会很大并对我们的运营结果产生不利影响。如果我们平台的人工智慧应用程式协助生成的诊断、确定、建议、预测或分析有缺陷或不准确，我们可能会受到竞争损害、潜在的法律责任以及品牌或声誉损害。此外，人工智慧生成的内容可能具有冒犯性、偏见或有害性，或者违反当前或未来的法律和法规，我们对人工智慧的依赖可能会带来道德问题并导致缺乏人类监督和控制。
数据科学家、工程师和我们或竞争对手产品的最终用户的不适当或有争议的数据实践也可能损害人们对人工智慧产品的接受度。尽管我们的商业实践旨在减轻许多风险，但如果我们启用或提供因对人权、隐私、就业或其他社会问题据称或实际影响而引起争议的人工智慧产品，我们可能会遭受品牌或声誉损害。
我们在部署人工智慧技术方面的投资可能很大，而且可能比预期的更昂贵。如果我们的平台无法可靠地运行、未能满足性能预期，或者由于监管或声誉问题日益严重而无法充分利用，我们可能无法提供此类服务，我们的客户可能会停止使用我们的产品，或者我们的竞争对手可能会将人工智慧技术融入到他们的产品或服务中比我们更成功。所有这些都可能损害我们在市场中有效竞争的能力。
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我们了解到，「人工智慧」、「机器学习」、「生成性人工智慧」、「大型语言模型」和其他类似术语对不同的人可能意味著不同的含义。因此，当我们使用这些术语时，我们赋予它们最广泛、公认的含义。例如，人工智慧是一个允许计算机软体执行类似人类的智能任务的科学领域。从本质上讲，人工智慧只是数学的复杂应用，旨在帮助机器执行与人类类似或更好的任务。人工智慧是一个总括术语，涵盖许多其他子领域和技术，包括上面列出和下面描述的那些：
我们使用生成性人工智慧工具可能会对我们的专有软体和系统构成特定风险，并使我们承担法律责任。
我们在业务中使用生成式人工智慧工具，并希望在未来使用生成式人工智慧工具。使用生成性人工智慧工具来制作与人类生成的内容难以区分的内容是一项相对新颖的发展，但许多好处、风险和责任仍不清楚。美国版权局最近的决定表明，我们将无法对我们通过使用生成性人工智慧工具开发的任何原始码、文本、图像或其他材料主张版权所有权，而且其他国家是否存在此类保护尚不清楚。因此，如果第三方重复使用这些相同的材料或也由人工智慧工具生成的类似材料，我们就无法补救。
我们面临并预计将继续面临指控，我们可能会面临来自第三方的指控，即侵犯他们的知识产权，或强制遵守开源软体或其他许可条款，涉及我们认为可供使用的软体或其他材料或内容，而不受许可条款或其他第三方专有权利的约束。例如，如果我们以与其使用条款不一致的方式使用任何生成的材料，我们也可能受到生成性人工智慧工具提供商的索赔。这些索赔中的任何一项都可能导致法律诉讼，并可能要求我们购买昂贵的许可证，遵守开源软体许可条款的要求，或者限制或停止使用受影响的软体或其他材料或内容，除非我们能够重新设计此类软体、材料或内容以避免侵权或更改或删除受影响的第三方材料，这可能会降低或消除我们的技术和服务的价值。我们使用生成性人工智慧工具还可能带来额外的安全风险，因为生成的源代码可能是从公开可用的代码中建模的，或者不受我们所有标准内部控制的约束，这可能会使黑客和其他第三方更容易确定如何入侵我们依赖代码的网站和系统。这些风险中的任何一个都可能难以消除或管理，如果不加以处理，可能会对我们的业务、运营结果、财务状况和未来前景产生实质性的不利影响。
我们可能会在获取、开发、增强或部署业务所需的技术方面遇到挑战。
我们的平台需要复杂的计算机系统和软体，以便准确有效地捕获、服务和处理越来越多的健康数据，特别是我们的客户通过来自不同制造商的各种NGS检测试剂盒、测序仪和样本材料生成的越来越多的基因组图谱。一些技术正在迅速变化，我们必须继续以可接受的成本及时有效地适应这些变化。无法保证我们能够开发、获取、增强、部署或集成新技术，包括将基因组学数据集成到我们的平台中所需的技术，无法保证这些新技术将有效且高效，将满足我们的需求或实现我们的预期目标，或者我们能够像竞争对手一样快速或具有成本效益地做到这一点。
如果我们无法与竞争对手成功竞争，我们可能无法增加或维持收入，也无法实现并维持盈利能力。
人们对与治疗选择和反应相关的生物标志物重要性的日益了解，导致更多的公司提供基因组测试产品，包括NGS诊断和PCR分析。此外，还有许多医疗保健技术公司提供数据分析产品，包括人工智慧驱动的数据平台和诊断产品。
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我们基因组学产品的竞争对手包括某些诊断公司，例如Foundation Medical，Inc.，该公司被罗氏控股公司收购，Caris生命科学，Guardant Health，Inc.，Negenomics、ResolutionBio（被Agilent收购）和Natera，Inc.，其中包括我们目前上市的精确肿瘤学检测以及Quest和LabCorp等遗留诊断实验室。此外，神经精神病学药物遗传学测试的竞争对手包括Myriad Genetics，Inc.和Genomind，Inc.
我们的数据和服务产品的竞争对手包括Flatiron Health，Inc.，艾昆纬控股公司，和ConcertAI等。此外，我们的数据和服务产品还面临著Fortrea、ICON、Syneos、DPD等CROs的竞争，这些公司为制药和生物技术公司提供数据和临床试验匹配服务。
我们在人工智慧应用产品方面的竞争对手包括罗氏控股公司、Caris生命科学，Guardant Health，Inc.，Illumina，Inc.以及其他人，关于我们的TO测试，以及Myriad Genetics，Inc.，Caris生命科学公司和其他公司就我们的HRD测试进行了讨论。我们还可能与使用各种不同数据模式开发或商业化基于算法的诊断的公司竞争，包括PathAI，Inc.等数字病理公司。还有PaigeAI。在心脏病学领域，我们相信我们的竞争对手可能包括HeartFlow Inc.，Anumana，Inc.和Eko设备公司此外，我们意识到学术医疗中心可能正在开发自己的人工智慧应用程式，并可能决定进入这个市场。
我们的一些竞争对手和潜在竞争对手可能拥有更长的运营历史；更大的客户基础；更高的品牌认知度和市场渗透率；更多的财务、技术和研发资源以及销售和营销能力；以及与第三方支付方打交道的更多经验。因此，他们可能会对客户需求的变化做出更快的反应，投入比我们更多的资源来开发、推广和销售他们的产品，或者以旨在赢得显著市场份额的价格销售他们的产品。我们可能无法有效地与这些组织竞争。政府实体和其他第三方付款人的竞争加剧和成本节约举措可能会导致定价压力，这可能会损害我们的销售或获得市场份额的能力。此外，竞争对手可能被规模更大、历史悠久、资金雄厚的公司收购、接受投资或与之建立其他商业关系。与我们相比，我们的某些竞争对手可能能够以更优惠的条件从供应商那里获得关键投入，将更多的资源投入到营销和促销活动中，采用更积极的定价政策，并投入更多的资源用于产品开发。此外，通过伞式合同或地区优惠来控制基因检测的公司或政府可能会宣传我们的竞争对手或阻止我们销售某些产品。如果我们不能成功地与当前和未来的竞争对手竞争，我们可能无法提高市场对我们测试的接受度和销售量，这可能会阻止我们增加收入或实现盈利，并可能导致我们的股价下跌。
我们当前和未来产品的市场规模尚未精确确定，并且可能比我们估计的要小。
我们对当前产品和正在开发的产品的年度潜在市场总量的估计基于许多内部和第三方估计，包括但不限于我们测试的疾病中具有基因组诊断特征的患者数量、基因组和算法测试产品的假设价格、我们能够成功开发和商业化的基因组和算法测试的数量、以及多模式患者数据和临床试验匹配服务的现有市场。虽然我们相信我们的假设和支持我们估计的数据是合理的，但这些假设和估计可能不正确，支持我们的假设或估计的条件可能随时发生变化，从而降低这些潜在因素的预测准确性。因此，我们对当前或未来产品的年度潜在市场总量的估计可能被证明是不正确的。如果将从我们的产品中受益的实际患者数量、我们可以销售产品的价格、我们能够成功开发和商业化的基因组或算法测试的数量，或者我们产品的年度潜在市场总量比我们估计的要少，这可能会削弱我们的销售增长，并对我们的业务、财务状况和运营结果产生不利影响。
我们运营的行业会发生快速变化，这可能会使我们的平台、我们当前的产品以及我们可能开发的任何未来产品过时。
医疗诊断和数据行业的特点是快速变化，包括技术和科学突破，频繁推出和增强新产品，以及不断发展的行业标准，任何这些都可能使我们当前和未来的产品过时。我们未来的成功将取决于我们能否及时和具有成本效益地跟上客户不断变化的需求，并寻求随著科学和技术进步而发展的新市场机会。近年来，与基因组诊断测试相关的技术取得了许多进展，人工智慧在医疗诊断和决策中的应用也取得了进展。我们必须不断增强我们的平台和我们现有的诊断、数据和分析产品，并开发新产品，以跟上不断发展的护理标准。如果我们不更新我们的产品，以反映关于疾病生物学的新科学知识、关于新疗法或相关临床试验的资讯，或者关于当前治疗环境的适用适应症和计算技术进展的见解
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生物学、软体开发和人工智慧、我们的平台和产品可能会过时，我们当前产品和我们可能开发的任何新产品的销售可能会下降或无法按预期增长。此外，如果制药或生物技术公司能够开发出根除或大幅限制我们销售诊断方法的疾病发病率的疗法或技术，那么我们适用产品的市场可能会完全消失。
我们的研发战略强调快速创新和可能没有行业专业知识的成功员工的晋升，我们经常将患者护理和客户满意度置于短期财务业绩之上。如果我们无法在成长过程中维持或正确管理我们的文化，我们的业务可能会受到损害。
我们有一个研发战略，鼓励员工快速开发和推出旨在解决客户最重要问题的技术，并将平台和产品开发、技术和工程员工的晋升优先考虑到基于功绩的重大责任职位，尽管在某些情况下，以前的工作或行业经验有限。成功的入门级招聘通常会很快获得晋升，并获得重大责任的奖励，包括担任重要的面向客户的角色，如专案经理、开发主管和产品经理。随著我们的业务增长和变得更加复杂，我们的文化强调快速行动，并为研发人员(包括某些面向客户的员工)配备人员，而这些人员缺乏重要的行业经验，可能会导致意外的结果或客户或其他利益相关者不太接受的决定。例如，在许多情况下，我们在没有签订长期合同的情况下，自费启动与客户的试点部署，其中一些部署并未导致客户采用或扩大其对我们产品的使用，或产生大量或任何收入或付款。此外，随著我们继续增长，包括在地理上，随著我们发展上市公司基础设施，我们可能会发现很难保持我们的文化。
Our culture also prioritizes patient care and customer satisfaction over short-term financial results, and we frequently make product decisions that may reduce our short-term revenue or cash flow if we believe that the decisions are consistent with our mission and thereby have the potential to improve our financial performance over the long term. These decisions may not produce the long-term benefits and results that we expect or may be poorly received in the short term by the public markets, in which case our customer growth and our business, financial condition and results of operations may be harmed.
We may not be able to successfully market, sell or distribute our products, and if we are unable to expand our sales organization to adequately address our customers’ needs, our business, financial condition and results of operations may be adversely affected.
We may not be able to market, sell or distribute our data products and diagnostic tests, and other products we may develop effectively enough to support our planned growth. We currently sell our Genomics and AI Applications tests to clinicians and hospital systems in the United States through our own sales organization and may leverage distributors to help sell our Genomics diagnostic tests in international markets, and we sell our Data and Services products to pharmaceutical and biotechnology companies through our business development team.
Each of our target markets is large, distinct and diverse. As a result, we believe it is necessary for many of our sales representatives and business development managers to have established diagnostic- or healthcare data- focused expertise. Competition for such employees within the precision diagnostics and healthcare data analytics industries is intense. We may not be able to attract and retain personnel or be able to build an efficient and effective sales organization or business development team, which could negatively impact sales and market acceptance of our products and limit our revenue growth and potential profitability.
Our expected future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees. Our future financial performance and our ability to commercialize our products, to increase our sales and to compete effectively will depend, in part, on our ability to manage this potential future growth effectively, without compromising quality.
If we are not successful in executing our strategy to increase sales of our Data and Services products to large pharmaceutical and biotechnology customers, our results of operations may suffer.
An important part of our growth strategy is to increase sales of Data and Services products, and in particular our Insights product, to large pharmaceutical and biotechnology companies. Sales to large companies involve risks that may not be present (or that are present to a lesser extent) with sales to small-to-mid-sized entities. These risks include:
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Selling to large pharmaceutical and biotechnology companies is often a lengthy process, generally taking several months and sometimes longer. Following the establishment of the relationship, the negotiation of purchase terms can be time-consuming, and a potential customer may require an extended evaluation and testing period. Due to the length, size, scope, and requirements of these evaluations, we frequently provide short-term pilot deployments of our Data and Services products at no or low cost. We sometimes spend substantial time, effort and money in our sales efforts without producing any sales. The success of the investments that we make to acquire customers depends on factors such as our ability to identify potential customers for which our data products have an opportunity to add significant value to the customer’s business, our ability to identify and agree with the potential customer on an appropriate pilot deployment to demonstrate the value of our products, and whether we successfully execute on such pilot deployment. Even if the pilot deployment is successful, we or the customer could choose not to enter into a larger contract for a variety of reasons. For example, product purchases by large companies are frequently subject to budget constraints, leadership changes, multiple approvals, and unplanned administrative, processing, and other delays, any of which could significantly delay or entirely prevent our realization of sales. As a result, in the event a sale is not completed or is canceled or delayed, we may have incurred substantial expenses, making it more difficult for us to become profitable or otherwise negatively impacting our financial results.
Finally, large companies typically (i) have longer implementation cycles, (ii) require greater product functionality and scalability and a broader range of services, including design services, (iii) demand that vendors take on a larger share of risks, (iv) sometimes require acceptance provisions that can lead to a delay in revenue recognition and (v) expect greater payment flexibility from vendors.
All of these factors can add further risk to business conducted with these customers. If sales expected from a large customer for a particular quarter are not realized in that quarter or at all, our business, financial condition and results of operations could be materially and adversely affected.
If our existing customers do not renew their licenses, do not buy additional products from us, or renew at lower prices, our business and operating results will suffer.
For the year ended December 31, 2023, we derived $67.9 million, or approximately 40% and 13%, of our Data and Services product line revenue and total revenue, respectively, from three customers. We expect to continue to derive a significant portion of our Data and Services product line revenue from renewal of existing agreements. As a result, maintaining the renewal rate of our existing customers and selling additional products to them is critical to our future operating results. Factors that may affect the renewal rate for our customers and our ability to sell additional products to them include:
We deliver our Insights product through license agreements that allow our customers to use de-identified datasets for a specified term or for specified uses. Our customers have no obligation to renew their licenses for our Data and Services products after the license ends, and many of our contracts may be terminated or reduced in scope either immediately or upon notice. In addition, our
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customers may negotiate terms less advantageous to us upon renewal, which may reduce our revenue from these customers. Factors that are not within our control may contribute to a reduction in our Data and Services product line revenue. For instance, our customers may change the indications in which they are conducting research and development, which could result in a reduced demand for our products and thus a lower aggregate renewal fee. The loss, reduction in scope, or delay of a large contract, or the loss or delay of multiple contracts, could materially adversely affect our business, financial condition and results of operations.
Our future operating results also depend, in part, on our ability to sell expanded products to our existing customers. For example, the willingness of existing customers to expand their use of our Insights product will depend on our ability to deliver meaningful information and insights relevant to our customers’ research and development endeavors, which we may not do successfully. If our customers fail to renew their agreements, renew their agreements upon less favorable terms or at lower fee levels, or fail to purchase expanded licenses from us, our revenue may decline and our future revenue may be constrained.
A significant portion of our Data and Services product line revenue are generated by sales to life sciences industry customers, and factors that adversely affect this industry could also adversely affect our Data business sales.
A significant portion of our current Data and Services products sales are to customers in the life sciences industry, in particular the pharmaceutical and biotechnology industry. Demand for our Data and Services products could be affected by factors that adversely affect the life sciences industry, including macroeconomic and market conditions that may adversely impact earlier stage biotechnology companies. The life sciences industry is highly regulated and competitive and has experienced periods of considerable consolidation. Consolidation among our customers could cause us to lose customers, decrease the available market for our products, and adversely affect our business, financial condition and results of operations. In addition, changes in regulations that make investment in the life sciences industry less attractive or drug development more expensive could adversely impact the demand for our data analytics products. For these reasons and others, selling data analytics products to life sciences companies can be competitive, expensive, and time consuming, often requiring significant upfront time and expense without any assurance that we will successfully complete a sale. Accordingly, our operating results and our ability to efficiently provide our products to life sciences companies and to grow or maintain our customer base could be adversely affected as a result of factors that affect the life sciences industry generally.
We have invested and expect to continue to invest in research and development efforts that further enhance our data analytics. Such investments may affect our operating results, and, if the return on these investments is lower or develops more slowly than we expect, our revenue and operating results may suffer.
We have invested and expect to continue to invest in research and development efforts that further enhance our data analytics, often in response to our customers’ requirements. These investments may involve significant time, risks, and uncertainties, including the risk that the expenses associated with these investments may affect our margins and operating results and that such investments may not generate sufficient revenue to offset liabilities assumed and expenses associated with these new investments. The healthcare data analytics industry changes rapidly as a result of technological and product developments, which may render our Platform and products less desirable. We believe that we must continue to invest a significant amount of time and resources in our Platform and products to maintain and improve our competitive position. If we do not achieve the benefits anticipated from these investments, if the achievement of these benefits is delayed, or if a slowdown in general computing power impacts the rate at which we expect our physics-based simulations to increase in power and domain applicability, our revenue and operating results may be adversely affected.
If we are unable to collect receivables from our customers, our operating results may be adversely affected.
While the majority of our current customers are well-established large companies and hospital systems, we also provide our Data and Services products to smaller institutions and companies and our Genomics product line to individuals. Our financial success depends upon the creditworthiness and ultimate collection of amounts due from our customers, including our smaller customers with fewer financial resources. If we are not able to collect amounts due from our customers, we may be required to write-off significant accounts receivable and recognize bad debt expenses, which could materially and adversely affect our operating results.
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Our existing and any future debt may affect our flexibility in operating and developing our business and our ability to satisfy our obligations.
As of September 30, 2024, we had indebtedness of $444.7 million, comprised of $174.5 million under the convertible promissory note, as amended, or the Amended Note, that we issued to Google LLC, or Google, and $270.2 million pursuant to a credit agreement with Ares Capital Corporation, or Ares, as amended, for a senior secured loan, or the Term Loan Facility. Our current and future indebtedness, including the Amended Note and the Term Loan Facility may have significant negative effects on our operations, including:
We intend to satisfy our current and future debt service obligations with our then existing cash and cash equivalents. However, we may not have sufficient funds, and may be unable to arrange for additional financing, to pay the amounts due under the Term Loan Facility, the Amended Note or any other debt instruments. In addition, the Term Loan Facility and Amended Note contain, and the agreements governing our future indebtedness may contain, restrictive covenants that may limit our ability to engage in activities that may be in our long-term best interest. These restrictive covenants include, among others, financial reporting requirements, limitations on indebtedness, liens, mergers, consolidations, liquidations and dissolutions, sales of assets, investments (including acquisitions), dividends and other restricted payments and transactions with affiliates. Our failure to make payments under or comply with other covenants contained in the documents governing our indebtedness could result in an event of default which, if not cured or waived, could result in the acceleration of substantially all of our debt and potentially the foreclosure on our assets in the event we are unable to repay all amounts owed.
We rely on a limited number of suppliers or, in some cases, sole suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or promptly transition to alternative suppliers.
We rely on a limited number of suppliers or, in some cases, sole suppliers, including Illumina Inc., or Illumina, for certain sequencers, reagents, blood tubes and other equipment, instruments and materials that we use in our laboratory operations. Purchases from this supplier accounted for approximately 33% and 35% of total vendor payments for the years ended December 31, 2023 and 2022, respectively. Amounts due to this supplier were approximately $11.8 million at December 31, 2023. An interruption in our laboratory operations could occur if we encounter delays or difficulties in securing these laboratory equipment, instruments or materials, and if we cannot then obtain an acceptable substitute. Any such interruption could significantly and adversely affect our business, financial condition and results of operations. We rely on Illumina as the sole supplier of the sequencers and as the sole provider of maintenance and repair services for these sequencers. Any disruption in operations of Illumina or other sole or limited suppliers or termination or suspension of our relationships with them could materially and adversely impact our supply chain and laboratory operations of our diagnostic testing business and thus our ability to conduct our business and generate revenue. These limited or sole suppliers could engage in diverse types of businesses, including selling products in competition with us, and there can be no assurance that we can continue to receive required equipment, instruments or materials from them.
We believe that there are only a limited number of manufacturers that are capable of supplying and servicing the equipment and materials necessary for our laboratory operations, including sequencers and various associated reagents, and potentially replacing our current suppliers. The use of equipment or materials furnished by replacement suppliers would require us to alter our laboratory operations. Transitioning to a new supplier would be time-consuming and expensive, may result in interruptions in our laboratory
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operations, could affect the performance specifications of our laboratory operations or could require that we revalidate our tests. There can be no assurance that we will be able to secure alternative equipment, reagents and other materials, bring such equipment, reagents and materials online, and revalidate our tests without experiencing interruptions in our workflow. In the case of an alternative supplier for Illumina, for example, there can be no assurance that replacement sequencers and various associated reagents will be available or will meet our quality control and performance requirements for our laboratory operations. If we should encounter delays or difficulties in securing, reconfiguring or integrating the equipment and reagents we require for our products or in revalidating our products, our business, financial condition and results of operations could be materially and adversely affected.
Certain disruptions in supply of, and changes in the competitive environment for, raw materials and components integral to the manufacturing of our products may adversely affect our ability to achieve and maintain profitability.
We use a broad range of materials and supplies, including chemicals and other electronic components, in our Genomics product line. A significant disruption in the supply of these materials, including disruptions like those stemming from the COVID-19 pandemic, could decrease production and shipping levels, materially increase our operating costs and materially adversely affect our profit margins. Shortages of materials or interruptions in transportation systems, labor strikes, work stoppages, infectious disease, epidemics or pandemics including COVID-19, outbreaks, conflicts (including the armed conflicts between Russia and Ukraine and the hostilities in the Middle East), civil unrest, acts of terrorism or other interruptions to or difficulties in the employment of labor (such as strikes by unionized workforces) or transportation in the markets in which we purchase materials, components and supplies for the production of our diagnostic tests, in each case may adversely affect our ability to maintain our testing capacity. Unforeseen end-of-life or unavailability for certain components, such as enzymes, could cause backorders as we modify our product specifications to accommodate replacement components. If we were to experience a significant disruption in the supply of, or prolonged shortage of, critical components from any of our suppliers and could not procure the components from other sources, we would be unable to sustain our testing capacity, which would adversely affect our sales, margins and customer relations.
If our existing laboratory and storage facilities become damaged or inoperable or we are required to vacate our existing facilities, our ability to perform our tests and pursue our research and development efforts may be jeopardized.
We currently derive nearly all of our diagnostic revenue from tests performed at laboratory facilities located in Chicago, Illinois, Atlanta, Georgia, and Raleigh, North Carolina, and these facilities generally do not have completely redundant capabilities. Further, while we are currently in the process of expanding the number and type of diagnostic tests within our laboratory facility in Raleigh, North Carolina, there is no assurance that we will successfully transition in a timely manner or at all, and we may not be able to fully operationalize this facility to its capacity. Our facilities and equipment could be harmed or rendered inoperable by natural or man-made disasters, including war, fire, earthquake, power loss, communications failure or terrorism, which may render it difficult or impossible for us to operate our Genomics product line for some period of time and which may also cause us to lose valuable stored tissue samples, including organoids. The inability to perform our tests or to reduce the backlog that could develop if a facility is inoperable for even a short period of time, may result in the loss of customers or harm to our reputation, and we may be unable to regain those customers or repair our reputation. Furthermore, our facilities and the equipment we use to perform our research and development work could be unavailable or costly and time-consuming to repair or replace. It would be difficult, time-consuming and expensive to rebuild a facility, to locate and qualify a new facility or enable a third party to practice our proprietary technology, particularly in light of licensure and accreditation requirements. Even if we are able to find a third party with such qualifications to perform our tests, the parties may be unable to agree on commercially reasonable terms. Our physical laboratory facilities are also subject to regulatory oversight, such by the federal Occupational Safety and Health Administration, or OSHA, and certain state analogs. On occasion, certain safety issues are reported directly to OSHA. While we have been successful in promptly remediating any such issues, there is no guarantee we will be able to do so in the future, and these regulatory bodies could intervene and suspend our operations, which could have a material impact on our business.
We carry insurance for damage to our property and disruption of our business, but this insurance may not cover all of the risks associated with damage or disruption to our facilities and business, may not provide coverage in amounts sufficient to cover our potential losses and may not continue to be available to us on acceptable terms, if at all.
We rely on commercial courier delivery services to transport samples to our laboratory facility in a timely and cost-efficient manner and if these delivery services are disrupted, our business will be harmed.
Our business depends on our ability to deliver test results quickly and reliably to our customers. Blood and tissue samples sent from the United States by patients, physicians or hospital pathology departments are typically received within days for analysis at our Chicago, Atlanta, or Raleigh facilities. Disruptions in delivery services to transport samples to that facility, whether due to labor disruptions, bad weather, natural disaster, terrorist acts or threats or for other reasons could adversely affect specimen integrity and our ability to process samples in a timely manner, delay our provision of test results to our customers, and ultimately our reputation and
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our business. In addition, if we are unable to continue to obtain expedited delivery services to transport samples to us on commercially reasonable terms, our business, financial condition and results of operations may be adversely affected.
If we cannot provide quality technical support and services for our Data and Services products, we could lose customers and our business and prospects will suffer.
Our ability to provide relevant information to customers of our Data business, and in particular of our Insights product, depends substantially on our ability to provide quality technical support and services during the term of their license. Accordingly, we need highly trained technical support and services personnel. Hiring support and services personnel is very competitive in our industry due to the limited number of people available with the necessary scientific and technical backgrounds and ability to understand our products and the needs of our customers. To effectively support new customers and the expanding needs of current customers, we will need to substantially expand our support and services staff and develop our support infrastructure and processes. If we are unable to attract, train or retain the number of highly qualified technical services personnel that our business needs, our business and prospects will suffer.
Seasonality may cause fluctuations in our revenue and results of operations.
We believe that there are significant seasonal factors which may cause sales of our products, such as our Insights product and our infectious disease tests, to vary on a quarterly or yearly basis and increase the magnitude of quarterly or annual fluctuations in our operating results. We believe that this seasonality results from a number of factors, including the procurement and budgeting cycles of many of our customers, especially pharmaceutical and biotechnology customers. These customers typically have calendar year fiscal years, which result in a disproportionate amount of their purchasing activity occurring during our fourth quarter. These factors have contributed, and may contribute in the future, to substantial fluctuations in our quarterly operating results. Because of these fluctuations, it is possible that in some quarters our operating results will fall below the expectations of securities analysts or investors. If that happens, the market price of our common stock would likely decrease. These fluctuations, among other factors, also mean that our operating results in any particular period may not be relied upon as an indication of future performance. Seasonal or cyclical variations in our sales have in the past, and may in the future, become more or less pronounced over time, and have in the past materially affected, and may in the future materially affect, our business, financial condition and results of operations.
International expansion of our business exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States.
We currently have limited international operations, but our business strategy incorporates potentially significant international expansion. We plan to conduct physician and patient association outreach activities, to extend laboratory capabilities, to expand payer relationships and to market our Data business to pharmaceutical and biotechnology customers outside of the United States. Doing business internationally involves a number of risks, including:
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In late February 2022, Russian military forces launched a significant military action against Ukraine. In October 2023, following a series of coordinated attacks in Israel conducted by the Palestinian Islamist militant group Hamas, Israel began air strikes and a subsequent ground war against Hamas, which has since expanded. The Israel/Hamas conflict is threatening to spread further, and may in the future spread, into other Middle Eastern countries. While our business and operations are currently not impacted, including in Israel where we sell certain molecular tests through a third party and perform certain testing services, it is not possible to predict consequences of these crises, or any other conflicts that may arise, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, security conditions, currency exchange rates and financial markets, any of which could have a material adverse impact on our future operations and results.
Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenue and results of operations.
Risks Related to Our Highly Regulated Industry
Our collection, processing, use and disclosure of personally identifiable information, including patient and employee information, is subject to privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information in our possession could result in significant liability or reputational harm.
The privacy and security of personally identifiable information and/or protected health information stored, maintained, received or transmitted, including electronically, is a major issue in the United States and abroad. We collect, process, maintain, retain, evaluate, utilize and distribute large amounts of personal health and financial information and other confidential and sensitive data about our customers, employees and others in the ordinary course of our business. Concerns about and claims challenging our practices with regard to the collection, use, retention, disclosure or security of personally identifiable information, protected health information, or other privacy-related matters, even if unfounded and even if we are in compliance with applicable laws, could damage our reputation and harm our business, financial condition and results of operations.
许多联邦、州和外国法律法规规范个人身份信息和受保护的健康信息的收集、传播、使用和保密，包括HIPAA;州隐私和保密法（包括要求披露违规行为的州法律）;联邦和州消费者保护和就业法;以及欧洲和其他外国数据保护法。州和联邦层面都有一系列执法机构可以执行这些法律和法规。新的隐私立法可能会为消费者创造额外的权利，并对企业提出额外的要求。随著这些法律和法规的复杂性和数量的增加，它们可能会频繁变化，有时会发生冲突，并增加我们的合规工作、成本和风险。
经2009年《经济和临床健康资讯技术法案》(HITECH)修订的HIPAA建立了一套国家隐私和安全标准，用于通过健康计划、医疗资讯交换所和某些以电子方式提交某些承保交易的医疗保健提供者或其“业务伙伴”，即为或代表承保实体执行涉及创建、接收、维护或传输PHI及其承保分包商的特定服务的个人或实体，来保护PHI。我们是HIPAA下的承保实体，作为HIPAA下的商业伙伴，我们也经常收到大量的PHI，因此必须遵守其保护健康资讯隐私和安全的要求，并必须为个人提供关于其健康资讯的某些权利。如果我们聘请业务伙伴帮助我们进行医疗保健活动和职能，我们必须与该业务伙伴签订书面的业务伙伴合同或其他安排，明确规定该业务伙伴所从事的工作，并要求该业务伙伴遵守同样的要求。
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对违反这些法律的处罚各不相同。例如，单一违约事件可能导致违反HIPAA多项规定的调查结果。对不遵守HIPAA和HITECH要求的处罚差别很大，包括对违反HIPAA各项规定的民事罚款，以及在某些情况下的刑事处罚，包括监禁和/或额外罚款。违反HIPAA，故意获取或披露个人可识别的健康资讯的人可能面临额外罚款和最高一年的监禁。如果不法行为涉及虚假借口或意图为商业利益、个人利益或恶意伤害出售、转让或使用可识别的健康资讯，则增加刑事处罚。此外，任何关于我们违反HIPAA的指控，无论其是非曲直，都可能损害我们的声誉，并消耗大量内部资源。对涉嫌违反这些和其他法律法规的政府调查做出回应，即使最终得出的结论是没有发现违规行为或没有施加惩罚，也可能会消耗公司资源并影响我们的业务，如果公开，也会损害我们的声誉。
随著新法规的生效，数据隐私在国内和国际层面上仍然是一个不断发展的格局。例如，加利福尼亚州、马萨诸塞州等州也实施了类似的隐私法律法规，如加州医疗资讯保密法，对健康资讯和其他个人身分资讯的使用和披露施加了限制性要求，以及2020年1月1日生效的加州消费者隐私法，为用户创造了新的数据隐私权。CCPA要求处理加州居民个人资讯的覆盖企业披露他们的数据收集、使用和共享做法。此外，CCPA为加州居民提供了新的数据隐私权(包括选择不披露某些个人数据的能力)，对涵盖的企业施加了新的运营要求，规定了对违规行为的民事处罚，以及针对数据泄露和法定损害赔偿的私人诉讼权(这预计将增加数据泄露的集体诉讼，并导致大量面临代价高昂的法律判决和和解)。《全面和平协定》及其解释和执行的各个方面仍然不确定。此外，CCPA于2023年1月1日扩大，当时加州2020年隐私权法案(CPRA)生效。CPRA赋予加州居民限制使用某些敏感个人资讯的能力，进一步限制跨语境广告的使用，建立对保留个人资讯的限制，扩大受CCPA私人诉讼权利约束的数据泄露类型，规定对涉及16岁以下加州居民的CPRA违规行为加重处罚，并设立新的加州隐私保护局来实施和执行CPRA。尽管CCPA对临床试验数据的豁免有限，但CCPA和其他类似法律可能会影响我们的商业活动，具体取决于对它们的解释。近年来，美国其他许多州-包括弗吉尼亚州、科罗拉多州、康涅狄格州和犹他州-都颁布了全面的隐私法，对覆盖的企业施加了某些义务，包括在隐私通知中提供具体披露，并向居民提供有关其个人数据的某些权利。如果适用，此类权利可能包括访问、更正或删除某些个人数据的权利，以及选择退出某些数据处理活动的权利，例如定向广告、分析和自动决策。其他几个州以及联盟和地方各级也在考虑类似的法律，我们预计未来会有更多的州通过类似的法律。
此外，美国所有50个州和哥伦比亚特区都颁布了违规通知法，可能要求我们在未经授权访问或披露我们或我们的服务提供商经历的个人或机密资讯时通知患者、客户、员工或监管机构。这些法律并不一致，在发生大范围数据泄露的情况下遵守是困难的，而且可能代价高昂。此外，各州一直在频繁修改现有法律，要求关注不断变化的监管要求。我们也可能被合同要求或可能选择自愿通知患者或其他交易对手安全漏洞。尽管我们与我们的服务提供商可能有合同保护，但任何实际或感知的安全漏洞都可能损害我们的声誉和品牌，使我们承担潜在的责任，或要求我们在数据安全和应对任何此类实际或感知的违规行为方面花费大量资源。我们可能从我们的服务提供商那里获得的任何合同保护可能不足以充分保护我们免受任何此类责任和损失，并且我们可能无法执行任何此类合同保护。除了政府监管外，隐私倡导者和行业团体已经并可能在未来不时提出自我监管标准。这些标准和其他行业标准可能在法律上或合同上适用于我们，或者我们可能选择遵守这些标准。
HIPAA不一定先发制人，特别是当一个国家为个人提供比HIPAA更大的保护时。如果州法律与HIPAA不同，我们可能必须遵守这些规定。除了对违规者施加罚款和惩罚外，其中一些州法律还向认为自己的个人资讯被滥用的个人提供了私人诉讼权利。联盟和州法律的相互作用可能会受到法院和政府机构的不同解释，给我们和我们的客户带来复杂的合规问题，并可能使我们面临额外的费用、不利的宣传和责任。此外，随著监管机构对隐私问题的关注不断增加，以及有关保护个人资讯的法律法规不断扩大和变得更加复杂，这些对我们业务的潜在风险可能会加剧。与加强对某些类型的敏感数据(如PHI或其他类型的敏感个人身分资讯或PII)的保护相关的法律或法规的变化，或对应用于个人身分资讯的增强数据安全基础设施的需求增加，可能会极大地增加我们提供产品的成本，减少对我们产品的需求，减少我们的收入和/或使我们面临额外的风险。
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此外，在美国、欧盟(包括欧洲经济区的所有国家)和其他地方，消费者、健康和数据保护法的解释和适用，特别是在基因样本和数据方面，往往是不确定的、相互矛盾的和不断变化的。我们可能在美国以外的一些国家开展业务，这些国家的法律在某些情况下可能比美国的要求更严格。例如，欧盟成员国对将个人数据跨境转移到某些司法管辖区，包括我们的实验室所在的美国，都有具体的要求。此外，一些国家对个人数据的收集、使用或共享有更严格的消费者通知和/或同意要求，对组织的隐私计划有更严格的要求，并提供了更强的个人权利。此外，国际隐私和数据安全法规继续变得更加复杂，产生更大的后果。例如，《一般数据保护条例》(GDPR)于2018年5月生效，对欧盟内个人数据的控制器和处理器提出了严格的数据保护要求。GDPR适用于在欧盟设立的任何公司以及欧盟以外的公司，如果他们收集和使用与向欧盟内个人提供商品或服务或监测他们的行为有关的个人数据。GDPR加强了个人数据处理者和控制人的数据保护义务，例如，包括获得个人同意以处理其个人数据的更高标准，更有力地向个人披露资讯和加强个人数据权利制度，数据泄露通知通知监管当局的最短72小时的时限，对资讯保留的限制，关于健康数据、其他特殊类别的个人测序和假名(即关键编码)数据的更多要求，以及当我们与第三方处理器就个人数据的处理签订合同时的额外义务。GDPR规定，欧盟成员国可以制定自己的进一步法律和法规，限制对个人数据的处理，包括基因、生物识别或健康数据，这可能会限制我们使用和共享个人数据的能力，或者可能导致我们的成本增加，并损害我们的业务、财务状况和运营结果。不遵守GDPR的要求可能会导致高达20,000,000欧元的巨额罚款或上一财政年度全球年营业额的4%(以较高者为准)，以及其他行政处罚。欧洲数据保护当局已经对违反GDPR的行为处以罚款，在某些情况下，罚款高达数亿欧元。GDPR还赋予数据主体和消费者协会一项私人诉讼权利，可以向监管当局提出投诉，寻求司法补救，并就违反GDPR造成的损害获得赔偿。不遵守GDPR和其他适用的隐私或数据安全相关法律、规则或法规可能会导致监管机构施加重大处罚，影响我们对客户合同的遵守，并对我们的业务、财务状况和运营结果产生不利影响。
包括GDPR在内的欧洲数据保护法也对从欧洲向美国和其他国家转移个人数据施加了严格的规则，除非转移的各方已经实施了保护转移的个人数据的具体保障措施。这些义务的解释和适用可能在不同的司法管辖区之间不一致，并可能与其他要求或我们的做法相冲突。此外，欧盟标准合同条款是欧洲法院法律挑战的对象，标准合同条款以及这些条款的任何后续版本(S)可能在未来面临额外的挑战，并被发现同样无效，如果缺乏针对持续数据传输的后续保障措施，可能需要我们在欧洲创建重复的、可能昂贵的资讯技术基础设施和业务运营，或者限制我们收集和使用在欧洲收集的个人资讯的能力。尽管存在上述挑战，欧盟标准合同条款的使用也受到了欧洲法院的质疑。现在必须逐案评估标准合同条款的使用情况，同时考虑到目的地国适用的法律制度，特别是适用的监督法和个人对所转移数据的相关权利。2023年7月11日，欧盟委员会对欧盟-美国数据隐私框架(EU-US Data Privacy Framework，简称EU-US DPF)(将个人资讯从欧洲经济区转移到美国的新框架)的充分性决定生效，确定这种框架确保对从欧洲经济区转移到美国的个人资讯的保护将与欧盟提供的保护相当。然而，这一决定可能会面临法律挑战，最终可能会像欧盟-美国隐私盾牌一样被CJEU宣布无效。2023年10月12日，英美数据桥生效，作为欧盟-美国DPF的延伸，以促进英国和美国认证实体之间的个人数据传输。这种数据桥不仅可能受到挑战，而且可能会受到对欧盟-美国DPF的任何挑战的影响。如果我们不能为跨境个人数据传输实施有效的合规机制，我们可能面临更多的监管行动、巨额罚款和禁令，禁止在欧洲经济区和英国以外处理或传输个人数据，包括向美国。
由于这些法律的广度及其例外和安全港的狭窄性，我们当前的做法可能会受到一项或多项此类法律的挑战，或者我们将不得不大幅修改我们的业务实践才能开始在这些领域运营。这些法律中每项的范围和执行都不确定，并且会在当前医疗改革环境中发生迅速变化。联邦、州和外国执法机构加强了对医疗保健公司和医疗保健提供者之间互动的审查，这导致了医疗保健行业的一系列调查、起诉、定罪和和解。
GDPR、CCPA和其他与隐私和数据保护相关的法律、法规和其他义务强加了新的且相对繁重的义务，并且这些义务和其他义务的解释和适用存在很大的不确定性
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义务，我们可能会在满足他们的要求并对我们的政策和实践做出必要的改变方面面临挑战，并且可能会为此付出大量的成本和费用。此外，如果与我们合作的第三方（例如供应商或服务提供商）违反适用的法律或法规或我们的政策，此类违规行为也可能使我们或我们客户的数据面临风险，并可能反过来对我们的业务、财务状况和运营结果产生不利影响。我们或我们的服务提供商如果未能或被认为未能遵守我们与隐私或数据保护相关的适用政策或通知、我们对第三方的合同或其他义务，或我们与隐私或数据保护相关的任何其他法律义务，可能会导致政府调查或执法行动、诉讼、索赔和其他程式，损害我们的声誉，并可能导致重大责任。
我们在一个监管严格的行业开展业务，法规的变化或违反法规可能会直接或间接减少我们的收入，对我们的业务、财务状况和经营运绩产生不利影响。
诊断测试行业受到严格监管，无法保证我们运营的监管环境未来不会发生重大变化和不利变化。可能影响我们开展业务能力的监管环境领域包括但不限于：
特别是，管理诊断检测营销的法律法规复杂，往往没有足够的监管或司法解释。例如，根据联盟食品、药物和化妆品法案(FDCA)的医疗器械条款，我们的一些诊断测试受到FDA的积极监管。FDA将医疗器械定义为包括任何仪器、仪器、器具、机器、装置、植入物、体外试剂或其他类似或相关物品，包括用于诊断疾病或其他疾病，或用于治疗、缓解、治疗或预防人类或其他动物疾病的元件、部件或附件。我们的许多基因组和算法诊断测试很可能被FDA视为医疗设备。除其他事项外，根据FDCA及其实施条例，FDA对美国医疗器械的研究、设计、测试、制造、安全、标签、储存、记录保存、上市前批准或批准、营销和推广以及销售和分销进行监管，以确保国内分销的医疗器械对于其预期用途是安全和有效的。此外，FDA还对医疗器械的进出口进行监管。在欧洲经济区，为了放置一个体外如果诊断医疗器械(“IVD”)或IVD附件在市场上销售，或在欧洲经济区投入使用，则该设备的设计、开发、制造和销售必须符合相关的法律框架。2022年5月26日，《关于体外培养《诊断性医疗器械(欧盟)2017/746号条例》(IVDR)开始适用，废除和取代了关于体外培养诊断医疗器械(98/79/EC)，或“IVDD。IVDR及其相关的指导档案和协调标准，除其他外，管理设备设计和开发、临床前和临床或性能测试、上市前合格评估、注册和上市、制造、标签、储存、索赔、销售和分销、进出口和上市后监督、警戒和市场监督。IVDR还建立了过渡性条款，允许某些已按照CE标记的设备
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IVD将继续在严格的条件下和特定的时间内投放在欧洲经济区市场，具体取决于设备的风险分类。医疗器械受《医疗器械法规》（法规（EU）2017/745）（「MDR」）管辖，该法规于2021年5月26日生效，废除并取代了《医疗器械指令》（93/42/EC）（「MDB」）。MDR就医疗器械制定了与IDR类似的条款。如果我们不遵守这些要求或未能充分遵守，我们的业务、财务状况和运营运绩可能会受到损害。
当前算法诊断产品和服务监管框架的变化可能会给我们带来额外的监管负担。FDA目前还在考虑为人工智慧技术和其他软体开发新型监管途径。随著监管框架的发展，我们可能会承担高昂的成本来确保遵守新的或修订的法律和法规。不遵守任何这些法律和法规可能会导致我们受到执法行动、损害我们的声誉和损失信誉，其中任何情况都可能对我们的业务、财务状况和经营运绩产生重大不利影响。
我们的某些测试目前以LDT形式销售，FDA对LDT执法自由裁量权的未来变化可能会使我们的运营面临更重要的监管要求。
FDA历来在对LDT的执行自由裁量权政策下运作，因此FDA没有积极执行其对此类测试的监管要求。2024年5月6日，FDA公布了于2024年7月5日生效的最终法规，该法规将在四年内逐步取消执法自由裁量权，并要求遵守设备注册和上市要求、医疗设备报告要求、510(K)许可、重新授权或上市前批准以及FDA质量体系法规的要求。如果我们未能逐步遵守这些规定，我们可能会被要求停止销售我们现有的测试或推出我们可能开发的任何其他测试，并在继续销售我们的测试之前进行额外的临床试验或采取其他行动。这可能会显著增加进行或以其他方式损害我们的业务、财务状况和运营结果的成本和费用。即使这样的测试被FDA授权上市，该机构也可以限制测试的适应症使用，这可能会极大地限制该产品的市场，并可能对我们的业务和财务状况产生不利影响。此外，由于我们提供的平台和其他软体应用程式包括与我们运行的LDTS结果报告相关的功能，FDA可以尝试监管我们用来向客户提供LDTS结果的软体应用程式，包括我们平台的一部分，这可能需要进行昂贵的修改、额外的开发或减少我们产品中的功能，这反过来可能会降低它们对我们客户的吸引力。
无法保证FDA将授予510（k）许可或上市前批准，或者类似的外国监管机构将对我们的产品授予必要的许可、批准或认证，并且未能为我们的产品获得必要的许可、批准或认证将对我们发展业务的能力产生不利影响。
在我们开始在美国标记和销售我们的某些产品以用作临床诊断（包括作为伴随诊断）之前，我们可能需要获得510（k）许可或上市前批准，或补充上市前批准，或分别获得FDA的PMA或sPMA，除非适用豁免或FDA行使其执法自由裁量权并避免执行其医疗器械要求。
获得监管批准或批准的过程可能是一个严格、昂贵、漫长和不确定的过程。在PMA过程中，FDA必须部分基于大量数据，包括但不限于技术、临床前、临床试验、制造和标签数据，确定拟议的设备对于其预期用途是安全和有效的。在510(K)批准过程中，FDA必须确定建议的设备与市场上合法销售的设备“基本上等同”，即所谓的“谓词”设备，以便批准建议的设备上市。要达到“实质等同”，所提议的装置必须与述语装置具有相同的预期用途，并且要么具有与述语装置相同的技术特征，要么具有不同的技术特征，并且不会引起与述语装置不同的安全或有效性问题。有时需要临床数据来支持实质上的等效性判定。
FDA可以出于多种原因推迟、限制或拒绝设备的许可或批准，包括：
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在国外司法管辖区，我们可能被要求在营销我们的诊断产品之前获得类似的监管批准、许可或认证。例如，在欧盟，我们需要遵守新的MDR和IVDR。静脉注射用药必须符合IVDR附件一所列的一般安全和性能要求(“GSPR”)，医疗器械必须符合MDR附件I所列的GSPR。遵守这些要求是能够将CE标志贴在静脉注射用药或医疗器械上的先决条件，如果没有这些要求，它们就不能在EEA中销售或销售。为了证明符合IVDR或MDR中规定的GSPR，并获得贴CE标志的权利，医疗器械制造商必须接受合格评估程式。根据IVD或医疗器械的类型及其分类，合格评估程式可能需要通知机构的干预。在成功完成对IVD或医疗器械及其制造商进行的合格评定程式并使其符合GSPR之后，被通知机构颁发CE合格证书。该证书和相关的符合性评估程式使制造商在准备并签署了相关的欧盟符合性声明后，有权在其静脉注射器或医疗器械上贴上CE标志。在外国司法管辖区获得必要的监管批准、许可或认证可能代价高昂，并可能涉及相当大的延误。
任何延迟或未能获得必要的监管批准、许可或认证都会对我们的业务、财务状况和运营运绩产生重大不利影响。
对我们获得FDA批准、批准或CE标志的产品的修改可能需要新的510（k）许可或上市前批准或认证，或者可能要求我们停止营销或召回修改后的产品，直到获得许可。
对于根据PMA批准的任何产品，我们需要为批准的产品的许多类型的更改寻求补充批准，对于这些更改，我们需要确定是否需要PMA补充或其他监管申报，或者更改是否可以通过PMA年度报告进行报告。同样，对获得510(K)许可的设备进行的任何修改，如果可能严重影响其安全性或有效性，或将对其预期用途、设计或制造构成重大变化，都需要新的510(K)许可，或者可能需要批准新的PMA。如果FDA要求我们为修改以前批准或批准的产品寻求批准或许可，而我们得出结论认为没有必要进行新的批准或许可，我们可能会被要求停止营销或分销我们的产品，或者召回修改后的产品，直到我们获得批准或许可，我们可能会受到巨额的监管罚款或处罚。同样，在欧盟，对于我们有CE标志的任何产品，未来对我们产品的更改或更新，如果影响其安全性或有效性，可能需要新的通知机构认证，然后我们才能销售修订后的产品。
我们的产品未来可能会被产品召回。自愿或在FDA或其他政府当局或监管当局的指示下召回我们的产品，或者发现我们的产品存在严重的安全问题，可能会对我们产生重大不利影响。
在设计或制造中存在重大缺陷或缺陷的情况下，FDA和国际监管机构有权要求召回受FDA或外国适用法规约束的商业化产品。我们也可以主动召回一种产品。例如，FDA要求某些类别的召回在召回开始后十个工作日内报告给FDA。在欧盟的FDA批准的测试或CE标志测试的情况下，我们或我们的某个分销商可能会因不可接受的健康风险、部件故障、故障、制造错误、设计或标签缺陷或其他缺陷和问题而发生政府强制或自愿召回。召回我们的任何产品都可能损害我们以经济高效和及时的方式生产产品的能力，这将对我们的声誉、业务、财务状况和运营结果产生不利影响。我们可能受到责任索赔，可能被要求承担成本，或可能采取其他行动，可能会对我们未来的销售和我们创造利润的能力产生负面影响。我们可以发起
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我们确定未来涉及我们产品的自愿召回不需要通知FDA或外国监管机构。如果FDA或外国监管机构不同意我们的决定，FDA或外国监管机构可以要求我们报告这些行动，并对在召回时未能报告的情况采取执法行动。未来的召回公告可能会损害我们在客户中的声誉，并对我们的业务、财务状况和运营结果产生负面影响。
如果我们对我们的一项测试启动更正或删除、发布安全警报或采取现场行动或召回以减少测试对健康造成的风险，这可能会导致FDA和外国监管机构以及我们的客户对我们测试的质量和安全性加强审查，并引发负面宣传，包括FDA或外国监管机构警报，新闻稿或行政或司法行为。此外，任何此类负面宣传的传播都可能损害我们的声誉，被竞争对手在竞争情况下用来对抗我们，并导致客户推迟购买决策或取消订单。
Arterys，Inc.，我们于2022年收购的一家公司开发了多种受FDA和欧盟医疗器械立法监管的医疗器械。Arterys还分销第三方开发的设备。如果我们发现其中一种设备存在问题或提议对其进行更改，从而影响患者安全或导致我们采取现场行动或实施召回，那么我们的业务运营和声誉可能会受到有意义的损害。
Our “research use only” and any potential “investigational use only” products could become subject to more onerous regulation by the FDA or other regulatory authorities in the future, which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business, financial condition and results of operations.
In the United States, some of our products are currently available, or may become available, for research use only, or RUO, or for investigational use only, or IUO, depending on the proposed application. We make our RUO and IUO products available to a variety of parties, including pharmaceutical and biotechnology companies and research institutes. Because RUO and IUO products are not intended for use in clinical practice and cannot be advertised or promoted for clinical or diagnostic claims, they are exempt from many regulatory requirements otherwise applicable to medical devices. In particular, while the FDA regulations require that RUO products be labeled “For Research Use Only. Not for use in diagnostic procedures,” and that IUO products be labeled “For Investigational Use Only. The performance characteristics of this product have not been established,” such products are not subject to the FDA’s pre- and post-market controls for medical devices.
A significant change in the laws governing RUO or IUO products or how they are enforced may require us to change our business model in order to maintain compliance. For instance, in November 2013 the FDA issued a guidance document entitled “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only,” or the RUO/IUO Guidance, which highlights the FDA’s interpretation that distribution of RUO or IUO products with any labeling, advertising or promotion that suggests that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as an LDT is in conflict with the RUO or IUO status. The RUO/IUO Guidance further articulates the FDA’s position that any assistance offered in performing clinical validation or verification, or similar specialized technical support, to clinical laboratories, is in conflict with RUO or IUO status. If we engage in any activities that the FDA deems to be in conflict with the RUO or IUO status held by any of our products so labeled, we may be subject to immediate, severe and broad FDA enforcement action that would adversely affect our ability to continue operations. Accordingly, if the FDA finds that we are distributing our RUO or IUO products in a manner that is inconsistent with its RUO/IUO Guidance, we may be forced to stop distribution of our RUO/IUO tests until we are in compliance, which would reduce our revenue, increase our costs and adversely affect our business, financial condition and results of operations.
Even if we receive regulatory approval or certification of our products, we will continue to be subject to extensive regulatory oversight.
Medical devices are subject to extensive regulation by the FDA in the United States, European Union legislation in the European Economic Area, or EEA, enforced by the Competent Authorities of EEA countries, and comparable regulatory authorities in other territories where we do or may do business. If any of our products are approved by the FDA, or other comparable foreign regulatory authorities, or CE marked in accordance with EU legislation governing medical devices or IVDs, we will be required to timely file various reports. If these reports are not filed timely, regulators may impose sanctions and sales of our products may suffer, and we may be subject to product liability or regulatory enforcement actions, all of which could harm our business, financial condition and results of operations. In addition, as a condition of approving a PMA application, the FDA may also require some form of post-approval study or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional safety and effectiveness data for the device. The product labeling must be updated and submitted in a PMA supplement as results, including any adverse event data from the post-approval study, become available. Failure to conduct or
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timely complete post-approval studies in compliance with applicable regulations, update the product labeling, or comply with other post-approval requirements could result in withdrawal of approval of the PMA, which would harm our business, financial condition and results of operations Similar considerations and requirements apply in relation to those products we have CE marked in the EEA, or for any products we may CE mark in the future in accordance with the IVDR or the MDR.
The FDA the FTC and comparable foreign regulatory authorities also regulate the advertising and promotion of medical devices to ensure that their promotional claims made are consistent with the applicable marketing authorizations or certification, that there are adequate and reasonable data to substantiate the claims, and that the promotional labeling and advertising is neither false nor misleading in any respect. If the FDA, FTC or a comparable foreign regulatory authority determines that any of our promotional claims are false, misleading, not substantiated or not permissible, we may be subject to enforcement actions and we may be required to revise our promotional claims and make other corrections or restitutions.
The FDA, state and foreign authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, state or foreign regulatory authorities, or actions by Notified Bodies in the EEA in relation to the CE Certificate of Conformity they have issued in accordance with EU legislation governing medical devices or IVDs, which may include any of the following sanctions:
Any of these sanctions could also result in higher than anticipated costs or lower than anticipated sales of our products and have a material adverse effect on our business, financial condition and results of operations.
In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval or clearance of our current or future products under development. For example, in November 2018, FDA officials announced forthcoming steps that the FDA intends to take to modernize the premarket notification pathway under Section 510(k) of the FDCA. Similar considerations apply in foreign countries.
Among other things, the FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates. These proposals included plans to potentially sunset certain older devices that were used as predicates under the 510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old. In May 2019, the FDA solicited public feedback on these proposals. The FDA requested public feedback on whether it should consider certain actions that might require new authority, such as whether to sunset certain older devices that were used as predicates under the 510(k) clearance pathway. These proposals have not yet been finalized or adopted, and the FDA may work with Congress to implement such proposals through legislation. Accordingly, it is unclear the extent to which any proposals, if adopted, could impose additional regulatory requirements on us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict our ability to maintain our current clearances, or otherwise create competition that may negatively affect our business, financial condition and results of operations.
The FDA may establish performance criteria for classes of devices for which we or our competitors seek or currently have received clearance, and it is unclear the extent to which such performance standards, if established, could impact our ability to obtain new 510(k) clearances or otherwise create competition that may negatively affect our business, financial condition and results of operations.
The changes to the regulatory system implemented in the EU by the IVDR and the MDR include stricter requirements for clinical evidence and pre-market assessment of safety and performance, new classifications to indicate risk levels, requirements for third party testing by Notified Bodies, tightened and streamlined quality management system assessment procedures and additional
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requirements for the quality management system, additional requirements for traceability of products and transparency as well a refined responsibility of economic operators. We would also be required to provide clinical data in the form of a clinical evaluation or performance report. Fulfillment of the obligations imposed by these Regulations may cause us to incur substantial costs. We may be unable to fulfill these obligations, or our Notified Body may consider that we have not adequately demonstrated compliance with our related obligations to merit the issuance of a CE Certificate of Conformity under the IVDR or the MDR for any of our products, or the continued use of any CE Certificate of Conformity issued under the IVDR or MDR.
Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our current or future products or make it more difficult to obtain clearance or approval for, manufacture, market or distribute our products.
The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay regulatory clearance, approval or certification of our diagnostic tests.
We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad, including the potential impact of the U.S. Supreme Court’s decision in Loper Bright Enterprises vs. Raimondo, which curtails the power of federal agencies to interpret the laws they administer.
We may never obtain approval or certification in foreign jurisdictions for any of our products and, even if we do, we may never be able to commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential.
In order to eventually market any of our current or future products in any particular foreign jurisdiction, we must comply with numerous and varying regulatory requirements on a jurisdiction-by-jurisdiction basis regarding quality, safety, data privacy, performance and efficacy. In addition, products offered in one country may not be accepted by regulatory authorities in other countries. Approval and certification processes vary among countries and can involve additional product testing and validation and additional administrative review periods.
Seeking foreign regulatory clearance, authorization, approval or certification could result in difficulties and costs for us and require additional studies, trials or investigations which could be costly and time-consuming. Regulatory requirements and ethical approval obligations can vary widely from country to country and could delay or prevent the introduction of our products in those countries. If we or our collaborators fail to comply with regulatory requirements in international markets or to obtain and maintain required regulatory clearances, authorizations, approvals or certification in international markets, or if those approvals or certification are delayed, our target market will be reduced and our ability to realize the full market potential of our products will be unrealized.
Failure to comply with federal, state and foreign laboratory licensing requirements and the applicable requirements of the FDA or any other regulatory authority, could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial sanctions.
We are subject to CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. CLIA regulations establish specific standards with respect to personnel qualifications, facility administration, proficiency testing, quality control, quality assurance and inspections. Any testing subject to CLIA regulation must be performed in a CLIA certified laboratory. CLIA certification is also required in order for us to be eligible to bill state and federal healthcare programs, as well as commercial payers, for our tests. We have a current CLIA certificate to perform our tests at our laboratories in Chicago, Illinois, Atlanta, Georgia and Raleigh, North Carolina. To maintain this certificate, we are subject to survey and inspection every two years. Moreover, CLIA inspectors may make random inspections of our laboratory from time to time. Similar considerations may apply in foreign countries.
We are also required to maintain clinical laboratory licenses to perform testing in Illinois, Georgia, and North Carolina. State laboratory laws establish standards for day-to-day operation of our clinical laboratories, including the training and skills required of personnel and quality control. In addition, some other states require our laboratories to be licensed in the state in order to test specimens from those states. In addition to Illinois, North Carolina and Georgia, our laboratories are licensed in California, Rhode Island, Pennsylvania, New York and Maryland. Although we have obtained licenses from states where we believe we are required to be licensed, it is possible that other states we are not aware of currently require out-of-state laboratories to obtain licensure in order to test specimens from the state, and that other states may adopt similar requirements in the future.
We may also be subject to regulations in foreign jurisdictions as we seek to expand international utilization of our tests or as such jurisdictions adopt new licensure requirements, which may require review of our tests in order to offer them or may have other
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limitations such as restrictions on the transport of specimens necessary for us to perform our tests that may limit our ability to make our tests available outside of the United States. Complying with licensure requirements in new jurisdictions may be expensive, time-consuming and subject us to significant and unanticipated delays.
Failure to comply with applicable clinical laboratory licensure requirements may result in a range of enforcement actions, including suspension, limitation or revocation of our CLIA certificate and/or state licenses, imposition of a directed plan of action, on-site monitoring, civil monetary penalties, criminal sanctions, inability to receive reimbursement from Medicare, Medicaid and commercial payers, as well as significant adverse publicity. Any sanction imposed under CLIA, its implementing regulations, or state or foreign laws or regulations governing clinical laboratory licensure or our failure to renew our CLIA certificate, a state or foreign license or accreditation, could have a material adverse effect on our business, financial condition and results of operations. Even if we were able to bring our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing so.
In order to test specimens from New York, LDTs must be approved by the New York State Department of Health, or NYSDOH, on a product-by-product basis before they are offered, and versions of our xT and xF tests have been approved by NYSDOH. We will need to seek NYSDOH approval of any future LDTs we develop, or for modifications to our existing LDTs, and want to offer for clinical testing to New York residents, and there can be no assurance that we will be able to obtain such approval. As a result, we are subject to periodic inspection by the NYSDOH and are required to demonstrate ongoing compliance with NYSDOH regulations and standards. To the extent NYSDOH identifies any non-compliance and we are unable to implement satisfactory corrective actions to remedy such non-compliance, the State of New York could withdraw approval for our tests.
The College of American Pathologists, or CAP, maintains a clinical laboratory accreditation program. While not required to operate a CLIA-certified laboratory, many private insurers require CAP accreditation as a condition to contracting with clinical laboratories to cover their tests. In addition, some countries outside the United States require CAP accreditation as a condition to permitting clinical laboratories to test samples taken from their citizens. We have obtained CAP accreditation for our Chicago, Atlanta and Raleigh, North Carolina laboratories. In order to maintain CAP accreditation, we are subject to survey for compliance with CAP standards every two years. Failure to maintain CAP accreditation could have a material adverse effect on the sales of our tests and the results of our operations.
We are subject to numerous federal, state and foreign healthcare statutes and regulations; complying with such laws pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties and a material adverse effect to our business, financial condition and results of operations.
Our operations are subject to other extensive federal, state, local and foreign laws and regulations, all of which are subject to change. These laws and regulations may include, among others:
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As a clinical laboratory, our business practices may face additional scrutiny from various government agencies such as the Department of Justice, the U.S. Department of Health and Human Services Office of Inspector General, or OIG, and CMS. Certain arrangements between clinical laboratories and referring physicians have been identified in fraud alerts issued by the OIG as implicating the AKS. The OIG has stated that it is particularly concerned about these types of arrangements because the choice of laboratory and the decision to order laboratory tests typically are made or strongly influenced by the physician, with little or no patient input. Moreover, the provision of payments or other items of value by a clinical laboratory to a referral source could be prohibited under the Stark Law unless the arrangement meets all criteria of an exception. The government has been active in enforcement of these laws against clinical laboratories.
Numerous states have enacted laws prohibiting business corporations, such as us, from practicing medicine and from employing or engaging physicians and other medical professionals (generally referred to as the prohibition against the corporate practice of medicine), which could include physician laboratory directors. These laws are designed to prevent interference in the medical decision-making process by anyone who is not a licensed medical professional. For example, the medical boards of certain states have indicated that determining the appropriate diagnostic tests for a particular condition and taking responsibility for the ultimate overall care of a patient, including making treatment options available to the patient, would constitute the unlicensed practice of medicine if performed by an unlicensed person. Violation of these laws may result in sanctions and civil or criminal penalties. It is possible that governmental authorities may conclude that our business practices, including our consulting and advisory board arrangements with physicians and other healthcare providers, a small number of whom may receive stock or stock options as compensation for services provided, do not comply with current or future corporate practice of medicine statutes, regulations, agency guidance or case law.
The growth and international expansion of our business may increase the potential of violating applicable laws and regulations. The risk is further increased by the fact that many such laws and regulations have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Efforts to ensure that our internal operations and business arrangements with third parties comply with applicable laws and regulations will involve substantial costs. Any action brought against us for violation of these or other laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Any of the foregoing consequences could seriously harm our business, financial condition and results of operations. To the extent our business operations are found to be in violation of any of these laws or regulations, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, individual imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and pursue our strategy. If any of the healthcare providers or other parties with whom we interact or may interact in the future, are found not to be in compliance with applicable laws and regulations, they may be subject to criminal, civil or administrative sanctions, including exclusions from participation in various healthcare programs, which could also negatively affect our business, financial condition and results of operations.
We have received requests for medical records and billing information from certain Unified Program Integrity Contractors, or UPICs, regarding clinical diagnostic services provided by Tempus to patients enrolled in the Medicare and Medicaid programs. Federal and state governments continue to pursue enforcement policies resulting in a significant number of investigations, inspections, audits, citations of regulatory deficiencies, and other regulatory sanctions including demands for refund of overpayments, terminations
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from the Medicare and Medicaid programs, bans on Medicare and Medicaid payments for new admissions, and civil monetary penalties or criminal penalties. These policies may impact our business. For example, on May 19, 2022, we received a subpoena from the Office of the Ohio Attorney General. The subpoena required production of certain billing and patient records associated with nine Ohio Medicaid patients who received our clinical diagnostic tests between 2019 and 2022. We provided responsive documents in June 2022 and have not received any additional inquiry since that time. Similarly, on March 4, 2024, we received a Civil Investigative Demand, or CID, from the U.S. Attorney’s Office for the Eastern District of New York. The CID requested documents and other information related to our compliance with the False Claims Act, the Anti-Kickback statute, and in particular 42 C.F.R. § 414.510(b), which is commonly referred to as the Medicare 14-Day Rule. We provided an initial production on April 4, 2024, and have continued to produce responsive documents on a rolling basis since that time. While we believe our programs and payments comply with the Anti-Kickback statute, no assurance can be given as to the timing or outcome of the government’s investigation, or that it will not result in a material adverse effect on our business.
In addition, we expect audits under the CMS Recovery Audit Contractor, or RAC, program, the CMS Targeted Probe and Educate, or TPE, program, the UPIC program and other federal and state audits evaluating the medical necessity of services to further intensify the regulatory environment surrounding the healthcare industry as third-party firms engaged by CMS and others conduct extensive reviews of Tempus’ claims data and medical and other records to identify improper payments to healthcare providers under the Medicare and Medicaid programs. If we fail to comply with the extensive laws, regulations and prohibitions applicable to our businesses, we could become ineligible to receive government program reimbursement, suffer civil or criminal penalties, or be required to make significant changes to our operations and refund certain payments we have received. In addition, we could be forced to expend considerable resources responding to investigations, audits or other enforcement actions related to these laws, regulations or prohibitions.
Our status as both a healthcare company and a technology company presents unique complexities when attempting to comply with these myriad laws and regulations. For example, certain data services we provide as a technology company may result in compensating other healthcare providers for access to data or the right to commercialize de-identified data. While such services, standing alone, appear routine, the compliance issues become more complex when considering our status as a healthcare provider that performs clinical diagnostic testing on behalf of healthcare providers. We have implemented programs to ensure we comply with all applicable laws and regulations notwithstanding these complexities; however, we cannot guarantee we will be successful in doing so, or that government enforcement agencies will agree that our efforts have been sufficient. Accordingly, we may be subject to enforcement actions that could materially impact our reputation, operations, and results.
If the validity of an informed consent from patients regarding our tests was challenged, we could be forced to stop offering our products or using our resources, and our business, financial condition and results of operations could be negatively affected.
We seek to ensure that all data and biological samples that we receive have been collected from patients, subjects or participants who have provided the necessary informed consent for purposes that extend to our development activities. In many instances, our ability to obtain these consents requires the physician or hospital system ordering the diagnostic system to obtain the consent of the patient and to attest that they have done so on our requisition forms. We also have certain relationships where data and samples, and certain data licensed to us by third parties, are provided to us in a de-identified manner. The collection and analysis of data and samples in many different jurisdictions results in complex legal questions regarding the adequacy of informed consent and the status of genetic material. Therefore, with respect to data and samples received from our customers, we rely on physicians and hospital systems to comply, and with regard to data received from our suppliers, we rely on these third parties to comply, with the informed consent requirements and with applicable local law regarding informed consent. The subject’s informed consent obtained in any particular jurisdiction could be challenged in the future, and that consent could prove invalid, unlawful or otherwise inadequate for our purposes. Any findings against us, or our customers or suppliers, could deny us access to or force us to stop using some of our data and clinical samples, which would hinder our product development efforts, potentially involve us in costly and prolonged litigation, result in reputational harm and adversely affect our business, financial condition and results of operations.
We may be subject to fines, penalties, licensure requirements, or legal liability, if it is determined that through our test reports we are practicing medicine without a license.
Many of our test reports delivered to physicians provide information regarding therapies and clinical trials that physicians may use in making treatment decisions for their patients and certain other reports provide pharmacogenomic information. We make members of our organization available to discuss the information provided in the reports. Certain state laws prohibit the practice of medicine without a license. Our customer service representatives and medical affairs team provide support to our customers, including assistance in interpreting the test report results. A governmental authority or other parties could allege that the identification of available therapies and clinical trials in our reports and the related customer service we provide constitute the practice of medicine. A state may seek to have us discontinue the inclusion of certain aspects of our test reports or the related services we provide, or subject
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us to fines, penalties, or licensure requirements. Any determination that we are practicing medicine without a license may result in significant liability to us, and our business, financial condition and results of operations would be harmed.
Our billing and claim processing are complex and time-consuming, and any delay in submitting claims or failure to comply with applicable billing requirements could hinder collection and have an adverse effect on our revenue.
Billing for our diagnostic tests is complex, time-consuming and expensive. Depending on the billing arrangement and applicable law, we bill various payers, such as Medicare, Medicaid, health plans, insurance companies, hospital systems, providers, and patients, all of which may have different billing requirements. Several factors make the billing process complex, including:
These billing complexities and the related uncertainty in obtaining payment for our tests could negatively affect our revenue and cash flow, our ability to achieve profitability and the consistency and comparability of our results of operations. In addition, if claims for our tests are not submitted to payers on a timely basis, or if we fail to comply with applicable billing requirements, it could have an adverse effect on our business, financial condition and results of operations.
In addition, the coding procedure used by third-party payers to identify various procedures, including our tests, during the billing process is complex, does not adapt well to our tests and may not enable coverage and adequate reimbursement rates. Third-party payers usually require us to identify the test for which we are seeking reimbursement using a CPT code. CPT coding plays a significant role in how our diagnostic tests are reimbursed both from commercial and governmental payers. For example, historically, no CPT code comprehensively describes our NGS oncology tests. In the past, we submitted claims using individual codes or combinations of codes based on the cancer subtype profiled. Over time, in response to guidance from payers and our local MAC, we transitioned from using individual gene codes, or combinations of individual gene codes, to using “panel” CPT codes. With the introduction of new codes that are potentially applicable to comprehensive genomic profiling tests like the ones we offer, we are in the process of updating our approach again. Despite our diligence in developing a comprehensive billing strategy that accurately describes the tests we provide, payers, such as the Local MACs, have in the past and may in the future disagree with our CPT code selection and instruct us to submit our claims using a different designated CPT code. Any disputes over appropriate coding, or requirements that we submit claims under codes with lower reimbursement rates, may materially adversely affect our business financial condition and results of operations,Use of coding for billing our products that does not describe a specific test, requires the claim to be examined to determine what test was provided, whether the test was appropriate and medically necessary, and whether payment should be rendered, which may require a letter of medical necessity from the ordering physician. This process has in the past and may in the future result in a delay in processing the claim, a lower reimbursement amount or denial of the claim. For example, we continue to appeal the denials of certain of our NGS oncology tests by the Local MAC. Because billing third-party payers for our tests is an unpredictable, challenging, time-consuming and costly process, we may face long collection cycles and the risk that we may never collect at all, either of which could adversely affect our business, financial condition and results of operations, and we may have to increase collection efforts and incur additional costs.
Because next generation genomic sequencing is a rapidly evolving area of medicine, and because clinical treatment guidelines continue to develop, any changes to, or interpretations of, applicable billing and coding guidance, rules, policies, and procedures may impact our business. Tempus offers multiple diagnostic tests, which enable ordering healthcare providers to sequence both a cancer patient’s tissue and blood. Healthcare providers may order multiple tests, either concurrently or longitudinally, even when those distinct tests cover similar genes. Similarly, when a treating healthcare provider orders our tissue-based test, we can provide, and historically have provided when available, distinct test results for DNA and RNA. Effective January 1, 2023, we began billing these tests under separate codes based on American Medical Association guidance and the National Correct Coding Initiative Manual Provider instructions. As of December 31, 2023, approximately 50% of the liquid biopsy tests we provide are ordered in proximity to a solid tissue-based test, and over 85% of our solid tissue-based tests include both RNA and DNA results. In each case, while the ordering physician attests to each distinct test’s medical necessity, there is no guarantee that our retrospective or prospective billing
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practices will not be challenged or reversed, such as by a demand for repayment, recoupment, or prospective billing policies. Any such attempts could adversely affect our results and operations.
Changes in healthcare laws, regulations and policies could increase our costs, decrease our sales and revenue and negatively impact reimbursement for our tests.
In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or the ACA, became law. This law substantially changed the way health care is financed by both commercial payers and government payers, and significantly impacted our industry. The ACA contains a number of provisions that impacted existing state and federal healthcare programs or result in the development of new programs, including those governing enrollments in state and federal healthcare programs, reimbursement changes and fraud and abuse. Our business, financial condition and results of operations have been and will continue to be affected by the ACA, including in ways we cannot currently predict.
Since its enactment, there have been efforts to repeal all or part of the ACA. For example, on June 17, 2021 the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Further, prior to the U.S. Supreme Court ruling on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021 and remained open through August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is possible that other challenges to the ACA will be made in the future. Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other things extends enhanced subsidies for individuals purchasing health insurance coverage in the ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and establishing a new manufacturer discount program. It is unclear how any additional healthcare reform measures of the Biden administration will impact the ACA and our business.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, reduced Medicare payments to providers by 2% per fiscal year, effective on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2032.
We anticipate there will continue to be proposals by legislators at both the federal and state levels, regulators and commercial and government payers to reduce healthcare costs while expanding individual healthcare benefits. Certain of these changes could impose additional limitations on the prices we will be able to charge for our tests, the coverage of, or the amounts of reimbursement available for our tests from commercial and government payers.
We face risks related to handling of hazardous materials and other regulations governing environmental safety.
Our operations are subject to complex and stringent environmental, health, safety and other governmental laws and regulations that both public officials and private individuals may seek to enforce. Our activities that are subject to these regulations include, among other things, our use of hazardous materials in manufacturing and in our products, and the generation, transportation and storage of waste. We could discover that we or our suppliers are not in material compliance with these regulations. Existing laws and regulations may also be revised or reinterpreted, or new laws and regulations may become applicable to us, whether retroactively or prospectively, that may have a negative effect on our business, financial condition and results of operations. It is also impossible to eliminate completely the risk of accidental environmental contamination or injury to individuals. In such an event, we could be liable for any damages that result, which could adversely affect our business, financial condition and results of operations.
We could be adversely affected by violations of the FCPA and other anti-bribery laws.
We are subject to the FCPA, which prohibits companies and their intermediaries from making payments in violation of law to non-U.S. government officials for the purpose of obtaining or retaining business or securing any other improper advantage, as a result of our international operations. We are also subject to similar anti-bribery laws in the jurisdictions in which we operate, including the United Kingdom’s Bribery Act of 2010, which also prohibits commercial bribery and makes it a crime for companies to fail to prevent bribery. These laws are complex and far-reaching in nature, and, as a result, we cannot assure that we would not be required in the future to alter one or more of our practices to be in compliance with these laws or any changes in these laws or the interpretation thereof. Any violations of these laws, or allegations of such violations, could disrupt our operations, involve significant management distraction, cause us to incur significant costs and expenses, including legal fees, and result in a material adverse effect on our
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business, financial condition and results of operations. We could also suffer severe penalties, including criminal and civil penalties, disgorgement and other remedial measures.
Risks Related to Our Intellectual Property
If we are unable to obtain, maintain and enforce sufficient intellectual property protection for our Platform and products, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired.
We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights protection and contractual restrictions to protect our Platform, products and other proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage. If we fail to protect our intellectual property, third parties may be able to compete more effectively against us. In addition, we have incurred and may continue to incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property.
To the extent our intellectual property offers inadequate protection, or is found to be invalid or unenforceable, we would be exposed to a greater risk of direct competition. If our intellectual property does not provide adequate coverage of our competitors’ products, our competitive position could be adversely affected, as could our business, financial condition and results of operations. Both the patent application process and the process of managing patent disputes can be time-consuming and expensive. Our pending and future owned and licensed patent applications may not result in patents being issued which protect our technology, effectively prevent others from commercializing competitive technologies or otherwise provide any competitive advantage. In fact, patent applications may not issue as patents at all. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance.
As is the case with other biotechnology companies, our success depends in part on our ability to obtain and maintain protection of the intellectual property we own solely and may own jointly with others or we have licensed and may continue to license from others, particularly patents, in the United States and other countries with respect to our products and technologies. We apply for patents covering our products and technologies and uses thereof, as we deem appropriate. However, obtaining and enforcing patents, and specifically biotechnology patents, is costly, time-consuming and complex, and we may fail to apply for patents on important products, services and technologies in a timely fashion or at all, or we may fail to apply for patents in potentially relevant jurisdictions. We may not be able to obtain or maintain patent applications and patents due to the subject matter claimed in such patent applications and patents being in disclosures in the public domain. In some cases, the inventions we attempt to patent may have been previously discovered by others and entered the public domain, which may preclude our ability to obtain patent protection for such inventions. We may not be able to file and prosecute all necessary or desirable patent applications, or maintain, enforce and license any patents that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Although we enter into nondisclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach these agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. Moreover, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to patents licensed to us. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.
We own or license numerous U.S. patents and pending U.S. patent applications, with international counterparts in certain countries. It is possible that our or our licensors’ pending patent applications will not result in issued patents in a timely fashion or at all, and even if patents are granted, they may not provide a basis for intellectual property protection of commercially viable products or services, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties. It is possible that others will design around our current or future patented technologies to circumvent our owned or licensed patents by developing similar or alternative technologies or therapeutics in a non-infringing manner. If the patent protection provided by the patents and patent applications we own or license is not sufficiently broad to impede such competition, our ability to successfully commercialize our products could be negatively affected, which could have a material adverse effect on our business, financial condition and results of operations. Some of our patent rights may be challenged in the future, including at the United States Patent and Trademark Office, or USPTO, in post-grant proceedings, at the European Patent Office, or EPO, in opposition proceedings. We may not be successful in defending any such challenges made against our owned or licensed patents or patent applications. Any successful third-party challenge to such patent rights could result in their unenforceability or invalidity and increased competition to our business. We have challenged and may choose to challenge the patents or patent applications of third parties. The outcome of patent litigation or other proceeding can be uncertain, and any attempt by us to enforce our patent rights against others or to challenge the patent rights of others may not
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be successful, or, if successful, may take substantial time and result in substantial cost, and may divert our efforts and attention from other aspects of our business.
The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. As a result, the issuance, scope, validity, enforceability and commercial value of any patent rights are highly uncertain. No consistent policy regarding the breadth of claims allowed in such companies’ patents has emerged to date in the United States or elsewhere. Courts frequently render opinions in the biotechnology field that may affect the patentability of certain inventions or discoveries, including opinions that may affect the patentability of methods for analyzing or comparing DNA sequences.
In particular, the patent positions of companies engaged in the development and commercialization of genomic and algorithmic diagnostic tests, like our current products and services, and our future products, are particularly uncertain. Various courts, including the U.S. Supreme Court, have rendered decisions that affect the scope of patentability of certain inventions or discoveries relating to certain diagnostic tests and related methods. These decisions state, among other things, that a patent claim that recites an abstract idea, natural phenomenon or law of nature (for example, the relationship between particular genetic variants and cancer) are not themselves patentable. Precisely what constitutes an abstract idea, natural phenomenon or law of nature is uncertain, and it is possible that certain aspects of genetic or algorithmic diagnostics tests would be found not patentable. Accordingly, the evolving legal and administrative standards around the world, including in the United States may adversely affect our ability to obtain patents and may facilitate third-party challenges to any owned or licensed patents. The laws of some foreign jurisdictions do not protect intellectual property rights to the same extent as the laws of the United States, and we may encounter difficulties in protecting and defending such rights in foreign jurisdictions. The legal systems of many foreign jurisdictions do not favor the enforcement of patent rights and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the infringement of our patent rights and other violations of our intellectual property rights thereunder. Proceedings to enforce our patent rights and other intellectual property protection in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.
Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our Platform and products.
Changes in either the patent laws or in interpretations of patent laws in the United States or other countries or regions may diminish the value of our intellectual property. We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. We may not develop additional proprietary products, methods and technologies that are patentable.
Assuming that other requirements for patentability are met, prior to March 16, 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. On or after March 16, 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, enacted in September 16, 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO on or after March 16, 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our products or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications.
The America Invents Act also includes a number of significant changes that affect the way patent applications are prosecuted and also affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings, to attack the validity of a patent. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence might not be sufficient to invalidate the claim if presented in a district court action. Accordingly, third parties have used and may continue to use the USPTO proceedings to invalidate our patent claims that would not have been invalidated if first challenged by the third party in a district court action. Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding our or our licensors’ prosecution of patent applications and enforcement or defense of issued patents, all of which could have a material adverse effect on our business, financial condition and results of operations.
The patent positions of companies engaged in the development and commercialization of biotechnology and software are particularly uncertain. Court rulings may narrow the scope of patent protection available in certain circumstances and weaken the
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rights of patent owners in certain situations. We cannot predict how decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents. Any similar adverse changes in the patent laws of other jurisdictions could also have a material adverse effect on our business, financial condition and results of operations. Depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Issued patents covering our Platform or products could be found invalid or unenforceable if challenged.
Our owned and licensed patents and patent applications may be subject to priority, validity, inventorship and enforceability disputes. If we or our licensors are unsuccessful in any of these proceedings, such patents and patent applications may be narrowed, invalidated or held unenforceable and we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms or at all, or we may be required to cease the development, manufacture and commercialization the products we may develop. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability and our owned and licensed patents may be challenged in courts or patent offices in the United States and abroad. Some of our owned or licensed patent rights may be challenged at a future point in time in opposition, derivation, re-examination, inter partes review, post-grant review or interference proceedings and other similar proceedings in foreign jurisdictions. Any successful third-party challenge to our patent rights in this or any other proceeding could result in the narrowing, unenforceability or invalidity, in whole or in part, of such patent rights, which may lead to increased competition to our business, which could harm our business, financial condition and results of operations. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize our current or future products.
We may not be aware of all third-party intellectual property rights potentially relating to our Platform and products. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until approximately 18 months after filing or, in some cases, not until such patent applications issue as patents. We might not have been the first to make the inventions covered by each of our pending patent applications and we might not have been the first to file patent applications for these inventions. To determine the priority of these inventions, we may participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO that could result in substantial cost to us. The outcome of such proceedings is uncertain. No assurance can be given that other patent applications will not have priority over our patent applications. In addition, changes to the patent laws of the United States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome is therefore uncertain. Our licensors may also license patent rights to others, and we may not be aware of such licenses before they are granted or such licenses may be subject to disputes or uncertainties that affect patent rights licensed by us or could limit our ability to enforce such patent rights. If third parties bring actions against our owned or licensed patent rights, we could experience significant costs and management distraction.
In patent litigation in the United States or abroad, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, written description, non-enablement or failure to claim patent-eligible subject matter. Grounds for an unenforceability assertion could include an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution. Similar claims may also be raised before administrative bodies in the United States or abroad, even outside the context of litigation, through mechanisms including re-examination, post-grant review and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to our patent rights in such a way that they no longer cover our Platform and products. The outcome of patent litigation or patent office proceedings following assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and our licensing partners and the patent examiner were unaware during prosecution. If a third party were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our Platform and products. Such a loss of patent protection could have a material adverse impact on our business, financial condition and results of operations.
We and our licensors may initiate or become involved in legal proceedings against a third party to enforce a patent covering our Platform or one of our products. Defendants in such proceedings could counterclaim that the patents covering our Platform or product are invalid or unenforceable and could institute legal proceedings to challenge such patents both in court and before patent offices.
The intellectual property landscape in the next generation sequencing, generative AI, and other fields in which we operate continues to evolve in ways that may impact our business. For example, we are aware of patent litigation involving certain disciplines in which we operate, such as liquid biopsy sequencing methods and minimal residual disease testing methods. Many of our
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competitors are or have been party to these suits, including Guardant Health, Inc., or Guardant, Haystack Oncology, Inc., Invitae Corp., Illumina, Inc., Natera, Inc., NeoGenomics Laboratories, Inc., Personalis, Inc., TwinStrand Biosciences, Inc., and others, and, as a result, we have monitored and continue to monitor their developments and their potential impact on us. In addition, on June 11, 2024, Guardant filed a complaint for patent infringement against us alleging that the Tempus xF, Tempus xF+, Tempus xM Monitor and Tempus xM MRD products use liquid biopsy technology that infringes five Guardant U.S. patents. The complaint seeks injunctive relief, unspecified monetary damages (including enhanced damages), a future mandatory royalty, costs and attorneys’ fees. Given the uncertainty of outcomes of patent litigation disputes, we have not determined whether our products and services could be subject to potential additional claims of patent infringement based on the patents at issue in these or other cases, whether we may need to modify or change any existing or planned sequencing procedures, or whether any of the patents at issue are valid or enforceable against us. However, it is possible that we will be subject to additional claims of patent infringement and that we may need to either modify our existing or future sequencing methods or license intellectual property from third parties, both of which could be time consuming and expensive.
From time to time we may receive notifications from third parties purportedly asserting certain intellectual property rights with respect to our products and services. For example, on September 21, 2023, SEngine Precision Medicine LLC (including its predecessor corporation SEngine Precision Medicine, Inc.), or SEngine, a company we acquired on October 3, 2023, received a letter from an attorney representing HUB Organoids IP B.V., or HUB Organoids, which states that SEngine’s PARIS® test methodologies “appear to share similarities with methods that the HUB has used in its own organoid work.” Similarly, on January 30, 2024, we received a letter from an attorney representing Molecular Loop Biosciences, Inc., which states that “[a]fter reviewing specific products made, used or sold by Tempus, Molecular Loop believes that Tempus requires a license to several of the patents in Molecular Loop’s patent portfolio.” While the letter received on behalf of HUB Organoids contains no specific allegations that SEngine infringes certain patents controlled by HUB Organoids referenced in the letter, and while the letter received on behalf of Molecular Loop contains only generalized allegations that Tempus may infringe certain patents controlled by Molecular Loop referenced in the letter, and while we have received and may in the future receive letters alleging patent infringement from other third parties, if any claims against us were made by these parties, including any claim that any portion of our products and services infringes any of the referenced patents, or any other patents held by a third party, we would defend against such claims, however, there can be no assurances that any such defense would be successful. Moreover, if we are subject to claims of patent infringement, we may need to modify existing methods governing use of our products and services, or license third party intellectual property, at some point in the future, which may be time consuming and expensive or may not be technically feasible.
We rely on licenses from third parties to provide certain products, and if we lose these licenses or if our rights under these licenses are limited, then our business will be adversely impacted.
We are, and we may acquire companies that are, party to various license agreements that grant us rights to use certain intellectual property, including de-identified patient data, AI software, and certain patents and patent applications, typically in certain specified fields of use. Such license agreements impose, and future agreements may impose, various obligations, such as diligence, development, payment, royalty, sublicensing and other obligations on us in order to maintain the licenses. We may need to obtain additional licenses from others to advance our research, development and commercialization activities. Our future licenses may not provide us with exclusive rights to use the licensed intellectual property and technology, or may not provide us with exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology in the future. As a result, we may not be able to prevent competitors or other third parties from developing and commercializing competitive products, including in territories covered by our licenses.
If these licenses are terminated, or if the underlying intellectual property rights fail to provide the intended rights and protections, our ability to develop and commercialize products and technology covered by these license agreements would be limited or lost, and our competitors or other third parties might have the freedom to develop, produce, seek regulatory approval or certification of, or to market, products identical or similar to ours and we may be required to cease our development and commercialization activities. Our actual or potential licensors could also take action with respect to our licensed intellectual property that may decrease the value of such licensed intellectual property. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Moreover, disputes could arise with respect to any aspect of our license agreements, including:
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If we do not prevail in such disputes, we may lose any of such license agreements, the license agreements may not be meaningful for our business and operations, and we may be subject to unnecessary or additional payment obligations.
In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements could be susceptible to multiple interpretations. The resolution of any such contract interpretation disagreement could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition and results of operations. Moreover, if disputes over licensed intellectual property impair our ability to enforce licensed intellectual property against third parties or use it to defend ourselves in litigation, the value of such licensed intellectual property may be diminished.
Additionally, our licenses may be subject to certain rights of third parties, and, as a result, our current and future licenses may not provide us with exclusive rights to use the licensed intellectual property and technology. Such licenses may be subject to reservations of rights including certain non-commercial rights reserved by universities and certain rights retained by the U.S. government, including march-in rights. Patents licensed to us could be put at risk of being invalidated or interpreted narrowly in litigation filed by or against our licensors or another licensee or in administrative proceedings brought by or against our licensors or another licensee in response to such litigation or for other reasons. As a result, we may not be able to prevent competitors or other third parties from developing and commercializing competitive products, including in territories covered by our licenses.
If we fail to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product, which could have a material adverse effect on our business, financial condition and results of operations. If any of these license agreements is terminated, if the licensor fails to abide by the terms of the license agreement, if the licensor fails to prevent infringement, misappropriation, or other violations by third parties, or if the licensed patent or other rights are found to be invalid or unenforceable, we may lose our rights to develop and market our technology, may be unable to achieve our business goals and our results of operations and financial condition could be adversely affected. In addition, we may seek to obtain additional licenses from our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors, including by agreeing to terms that could enable third parties, including our competitors, to receive licenses to a portion of the intellectual property that is subject to our existing licenses and to compete with our products. Absent the license agreements, we could infringe, misappropriate or otherwise violate patents or other intellectual property rights subject to those agreements, and if the license agreements are terminated, we may be subject to litigation by the licensor. Litigation could result in substantial costs and be a distraction to management. If we do not prevail, we may be required to pay damages, including treble damages, attorneys’ fees, costs and expenses, royalties or, be enjoined from selling our products and services, including our tests, which could adversely affect our ability to offer products and our business, financial condition and results of operations.
If we cannot license and maintain rights to use third-party intellectual property on reasonable terms, we may not be able to successfully commercialize our products. Our licensed or acquired technology may lose value or utility over time.
From time to time, we may identify third-party intellectual property we may need, including to develop or commercialize new products. We may also need to negotiate licenses before or after introducing a commercial product, and we may not be able to obtain necessary licenses to such intellectual property. The licensing or acquisition of third party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to enter into the necessary licenses on acceptable terms or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or fail to prevent infringement, misappropriation, or other violations by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable, our business, financial condition and results of operations may suffer. In addition, any technology licensed or acquired by us may lose value or utility, including as a result of a change in the industry, in our
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business objectives, others’ technology, our dispute with the licensor, and other circumstances outside our control. In return for the use of a third party’s technology, we may agree to pay the licensor royalties based on sales of our products or services. Royalties are a component of the cost of products and affect the margins on our products. If we are unable to negotiate reasonable royalties or if we have to pay royalties on technology that becomes less useful for us or ceases to provide value to us, our profit margin will be reduced and we may suffer losses.
We may not be able to protect or enforce our intellectual property rights adequately throughout the world.
Filing, prosecuting and defending patents and trademarks on our Platform and products in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some territories outside the United States are less extensive than those in the United States. In some cases, we or our licensors may not be able to obtain patent or trademark protection for certain technology outside of the United States. In addition, the laws of some foreign countries and regions do not protect intellectual property rights to the same extent as the federal and state laws in the United States, and we may encounter difficulties in protecting and defending such rights in foreign jurisdictions where we do pursue patent or trademark protection. Consequently, we may not be able to prevent third parties from practicing our inventions in all jurisdictions, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our inventions in jurisdictions where we have not pursued and obtained patent protection to develop their own products and may also export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products. Our patents or other intellectual property rights existing outside the United States may not be effective or sufficient to prevent them from competing. Similarly, intellectual property rights may be exhausted in certain situations, and others could import our products sold abroad and compete with us domestically.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries and regions, and particularly developing countries, do not favor the enforcement of patents, trademarks, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement, misappropriation or other violations of our patents, trademarks or other intellectual property, or marketing of competing products in violation of our intellectual property rights generally in such jurisdictions. Proceedings to enforce our patent or other intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents or other intellectual property at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded to us, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage.
Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our business, financial condition and results of operations could be materially and adversely affected.
If we are unable to protect the confidentiality of our trade secrets, the value of our Platform and other technology could be materially adversely affected and our business could be harmed.
In addition to pursuing patents on our Platform and other technology, we take steps to protect our intellectual property and proprietary know-how and technology that is not patentable or that we elect not to patent, including certain of our algorithms and software. We seek to protect our trade secrets and proprietary know-how and technology by entering into agreements, including confidentiality agreements, non-disclosure agreements and intellectual property assignment agreements, with our employees, consultants, academic institutions, corporate partners and, when needed, our advisers. However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain that our trade secrets and other proprietary information will not be disclosed or that competitors or other third parties will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. For example, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Such agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements, and we may not be able to prevent such unauthorized use or disclosure. If we are required to assert our rights against such party, it could result in significant cost and distraction.
Monitoring unauthorized use or disclosure is difficult, and we do not know whether the steps we have taken to prevent such use or disclosure are, or will be, adequate. If we were to enforce a claim that a third party had illegally obtained and was using our trade
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secrets, it would be expensive and time-consuming, and the outcome would be unpredictable. In addition, trade secrets can be difficult to protect and some courts inside and outside the United States are less willing or unwilling to protect trade secrets.
We also seek to preserve the integrity and confidentiality of our proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached and we may not have adequate remedies for any breach. If any of our confidential proprietary information were to be lawfully obtained or independently developed by a competitor, absent patent protection, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed trade secrets of their former employers.
We have employed or engaged and expect to employ or engage individuals who were previously employed at or associated with universities or other companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, we have in the past been, and may again in the future be, subject to claims that our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers or other third parties, or to claims that we have improperly used or obtained such trade secrets. Litigation may be necessary to defend against these claims. If we lose, in addition to paying monetary damages, we may be deprived of valuable intellectual property and face increased competition. A loss of key research personnel or work product could hamper or prevent our ability to commercialize potential products, which could harm our business. Even if we are successful in defending against these claims, litigation could result in damage to our reputation and substantial costs and be a distraction to management and affected individuals.
We may not be able to protect and enforce our trademarks and we could infringe or otherwise violate others’ trademarks and if our trademarks are not adequately protected, then we may not be able to build name recognition in our markets of interest.
We have not yet registered trademarks in all of our potential markets, although we have registered Tempus and certain diagnostic test names for certain classes of goods and services in the United States. If we apply to register additional trademarks in the United States and other countries, our applications may not be allowed for registration in a timely fashion or at all, and our registered trademarks may not be maintained or enforced and our trademarks may be challenged, infringed, circumvented or declared generic or determined to be infringing on or otherwise violating another mark. For example, opposition or cancellation proceedings may be filed against our trademark applications and registrations, and our trademarks may not survive such proceedings. Such proceedings can be expensive and time-consuming, particularly for a company of our size. If we do not timely register and enforce marks used in connection with our Platform or products, we may encounter difficulty in enforcing them against third parties, and if these marks are registered by others, we could infringe or otherwise violate such trademarks.
We may not be able to protect our rights to these trademarks, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trademark infringement or other violation claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks. Over the long term, if we are unable to establish name recognition based on our trademarks, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks may be ineffective and could result in substantial costs and diversion of resources. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
We may be subject to claims challenging the inventorship or ownership of our owned or licensed intellectual property or claims asserting ownership of what we regard as our own intellectual property.
While it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. Moreover, even when we obtain agreements assigning intellectual property to us, the assignment of intellectual property rights may not be self-executing or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Furthermore, individuals executing agreements with us may have preexisting or competing obligations to a third party, such as an academic institution, and thus an agreement with us may be ineffective in perfecting ownership of inventions developed by that individual. Disputes about the ownership of intellectual property that we may own may have a material adverse effect on our business, financial condition and results of operations. In addition, former employees may refuse to assign certain intellectual property rights to us, even though we have
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agreements requiring them to do so. Our ability to enforce our contractual rights may require us to seek legal action, which could be costly and time-intensive.
We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in or right to our owned or licensed patents, trade secrets or other intellectual property. For example, we or our licensors may have inventorship disputes arise from conflicting obligations of employees, consultants or others who are involved in developing such intellectual property. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership of our owned or licensed patents, trade secrets or other intellectual property. If we or our licensors fail in defending against any such claims, in addition to paying monetary damages, we may lose exclusive ownership of, or right to use, valuable intellectual property. An inability to incorporate such technologies or features would harm our business and may prevent us from successfully commercializing our products or at all. In addition, we may lose personnel as a result of such claims and any such litigation or the threat thereof may adversely affect our ability to hire employees or contract with independent contractors. A loss of key personnel or their work product could hamper or prevent our ability to commercialize our products. Even if we are successful in defending against such claims, litigation could result in damage to our reputation and substantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
We are and may in the future become involved in litigation and other legal proceedings alleging that we are infringing, misappropriating or otherwise violating third-party intellectual property rights, or asserting our intellectual property rights, which could be time-intensive and costly and may adversely affect our business, financial condition and results of operations.
We are and may become involved with litigation or USPTO actions with various third parties. For example, on June 11, 2024, Guardant filed a complaint for patent infringement against us alleging that the Tempus xF, Tempus xF+, Tempus xM Monitor and Tempus xM MRD products use liquid biopsy technology that infringes five Guardant U.S. patents. The complaint seeks injunctive relief, unspecified monetary damages (including enhanced damages), a future mandatory royalty, costs and attorneys’ fees. We expect that the number of such types of claims may increase as the number of our products grows, and the level of competition in our industry segments increases. Given the vast number of patents in our field of technology, we cannot be certain or guarantee that we do not infringe existing patents or that we will not infringe patents that may be granted in the future. Many companies and institutions have filed, and continue to file, patent applications related to the development and commercialization of genomic and algorithmic diagnostic tests. Some of these patent applications have already been allowed or issued and others may issue in the future. Since this area is competitive and of strong interest to biotechnology companies, there will likely be additional patent applications filed and additional patents granted in the future, as well as additional research and development programs expected in the future. If a patent holder believes the manufacture, use, sale or importation of our products infringe its patent, the patent holder may sue us even if we own or have licensed other patent protection for our technology. The biotechnology industry is characterized by extensive and complex litigation regarding patents and other intellectual property rights. Moreover, we face and expect to continue to face allegations of patent infringement, and we may face claims regarding such allegations, from nonpracticing entities that have no relevant product revenue and against whom our owned or licensed patent portfolio may therefore have no deterrent effect. Any infringement claim, regardless of its validity, could harm our business by, among other things, resulting in time-consuming and costly litigation, diverting management’s time and attention from the development of our business, or requiring the payment of monetary damages (including treble damages, attorneys’ fees, costs and expenses if we are found to have willfully infringed) and ongoing royalties.
Litigation may be necessary for us to enforce our intellectual property and proprietary rights or to determine the scope, coverage and validity of the intellectual property and proprietary rights of others. The outcome of such lawsuits, as well as any other litigation or proceeding, is inherently uncertain and might not be favorable to us. Further, we could encounter delays in product introductions, or interruptions in the sale of products, as we develop alternative products. In addition, if we resort to legal proceedings to enforce our intellectual property rights or to determine the validity, scope and coverage of the intellectual property or other proprietary rights of others, the proceedings could be burdensome and expensive, even if we were to prevail. If we do not prevail in such legal proceedings, we may be required to pay damages, and we may lose significant intellectual property protection for our products, such that competitors could copy our products. Any litigation that may be necessary in the future could result in substantial costs and diversion of resources and could have a material adverse effect on our business, financial condition and results of operations.
As we move into new markets and applications for our Platform or products, incumbent participants in such markets may assert their patents and other intellectual property or proprietary rights against us as a means of slowing our entry into such markets or as a means to extract substantial license and royalty payments from us. As our business matures and our public profile grows, we may also be subject to an increased number of allegations of patent infringement, whether by our competitors or other patent owners, both in the United States and throughout the world wherever we seek to commercialize our products. Our competitors and others may have significantly larger and more mature patent portfolios than we have. In addition, while we can assert our own patents or other rights during litigation, our own patents may provide little or no deterrence or protection against patent holding companies or other patent
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owners who have no relevant product or service revenue. Therefore, our commercial success may depend in part on our non-infringement of the patents or other rights of third parties and on our success in defending ourselves in litigation.
However, our research, development and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other intellectual property rights owned or controlled by third parties. There is a substantial amount of litigation and other patent challenges, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology industry, including patent infringement lawsuits, interferences, oppositions and inter partes review proceedings before the USPTO, and corresponding proceedings before foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing products. As the intelligent medicine and healthcare data analytics industries expand and more patents are issued, the risk increases that our Platform or products may be subject to claims of infringement of the patent rights of third parties. Numerous significant intellectual property issues have been litigated, are being litigated and will likely continue to be litigated, between existing and new participants in our existing and targeted markets, and our competitors have asserted and may in the future assert that our Platform or products infringe, misappropriate or otherwise violate their intellectual property rights as part of a business strategy to impede our successful entry into or growth in those markets, and we may enforce our owned or licensed intellectual property rights against our competitors and other parties.
Third parties may assert that we are employing their patents, proprietary technology or trade secrets without authorization. By interacting with us, our licensors may learn more about our business or technology and could assert additional patent rights against us, such as patent rights that are not currently licensed to us or patent rights that may be obtained by any such licensors in the future, which may occur if such patent rights are not available for licensing or if they are not offered on acceptable or commercially reasonable terms. Because patent applications can take many years to issue and are not publicly available until a certain period of time passes from filing, there may be currently pending patent applications which may later result in issued patents that our current or future products and services may infringe. In addition, similar to what other companies in our industry have experienced, we expect our competitors and others may develop or obtain patents with our Platform or products in mind and claim that making, having made, using, selling, offering to sell or importing our products infringes these patents.
Patent and other types of intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could adversely affect our ability to commercialize our technology. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there can be no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent or find that our technology did not infringe any such claims. Further, even if we were successful in defending against any such claims, such claims could require us to incur substantial costs and divert financial resources and the attention of our management and technical personnel in defending against any of these claims. Parties making claims against us may be able to sustain the costs of complex patent litigation more effectively than we can, for example, because they have substantially greater resources.
If any third-party patent were to be asserted against us, there can be no assurance that any defenses will be successful. If our defenses to such assertion were unsuccessful, the third-party making claims against us may be able to obtain injunctive or other relief, including by court order, which could block our ability to develop, commercialize and sell certain products, and could result in the award of substantial damages against us, including treble damages, attorney’s fees, costs and expenses if we are found to have willfully infringed. In the event of a successful claim of infringement against us, we may be required to pay damages and ongoing royalties, and obtain one or more licenses from third parties, or be prohibited from selling certain products. Further, we may be required to redesign our technology in a non-infringing manner which may not be commercially feasible. We could also be required or may choose to obtain a license from such third party to continue developing, manufacturing and marketing our technology. However, we may not be able to obtain these licenses on acceptable or commercially reasonable terms, if at all, or these licenses may be non-exclusive, which could result in our competitors gaining access to the same intellectual property. In addition, we could encounter delays in product introductions while we attempt to develop alternative products to avoid infringing third-party patents or otherwise violating proprietary rights. Defense of any lawsuit or failure to obtain any of these licenses could prevent us from commercializing products, and the prohibition of sale of any of our products could materially affect our business and our ability to gain market acceptance for our products. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our scientific and management personnel from their normal responsibilities. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the
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price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.
In addition, our agreements with some of our customers, suppliers or other entities with whom we do business require us to defend or indemnify these parties to the extent they become involved in infringement claims, including the types of claims described above. We could also voluntarily agree to defend or indemnify third parties in instances where we are not obligated to do so if we determine it would be important to our business relationships. If we are required or agree to defend or indemnify third parties in connection with any infringement claims, we could incur significant costs and expenses that could adversely affect our business, financial condition and results of operations.
Obtaining and maintaining our patent and trademark protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications and trademarks and trademark applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States at several stages over the lifetime of the patents and/or applications and trademarks and trademark applications. We have systems in place to remind us to pay these fees, and we rely on our outside counsel to pay these fees due to U.S. and non-U.S. patent and trademark agencies. The USPTO and various foreign governmental patent and trademark agencies require compliance with a number of procedural, documentary, fee payment and other similar requirements during the patent and trademark application processes. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which non-compliance can result in abandonment or forfeiture of the patent or patent application or trademark or trademark application and thus the partial or complete loss of patent or trademark rights in the relevant jurisdiction. Such an event would allow our competitors to enter the unprotected market and have a material adverse effect on our business, financial condition and results of operations.
Patent terms may be inadequate to protect our competitive position for an adequate amount of time.
Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our Platform or products are obtained, once the patent life has expired, we may be open to competition. Given the amount of time required for the development, testing and regulatory review of our new products, patents protecting them might expire before or shortly after they are commercialized. As a result, our owned and licensed patent portfolio may not provide us with a sufficient exclusivity period to exclude others from commercializing products similar or identical to ours.
Intellectual property rights do not necessarily address all potential threats.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business or permit us to maintain our competitive advantage. For example:
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Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Our products contain third-party open source software components and failure to comply with the terms of the underlying open source software licenses could restrict our ability to sell our products or may require us to publicly disclose our proprietary software.
Our products contain software tools licensed by third parties under open source software licenses. Use and distribution of open source software may entail greater risks than use of third-party commercial software, as open source software licensors generally do not provide warranties or other contractual protections regarding infringement or other violation claims or the quality of the code. Some open source software licenses contain requirements that the licensee make its source code publicly available if the licensee creates modifications or derivative works using the open source software or provide software services at no cost to the user, depending on the type of open source software the licensee uses and how the licensee uses it. If we combine our proprietary software with open source software in a certain manner, we could, under certain open source software licenses, be required to release the source code of our proprietary software to the public for free. This would allow our competitors to create similar products with less development effort and time and ultimately could result in a loss of product sales and revenue. In addition, some companies that use third-party open source software have faced claims challenging their use of such open source software, seeking enforcement of open source license provisions, asserting ownership of open source software incorporated in products and demanding compliance with the terms of the applicable open source license. We may be subject to suits by third parties claiming ownership of what we believe to be open source software, or claiming non-compliance with the applicable open source licensing terms. Use of open source software may also present additional security risks because the public availability of such software may make it easier for hackers and other third parties to compromise or attempt to compromise our Platform and systems. If an author or other third party that distributes such open source software were to allege that we had not complied with the conditions of an open source license, we could incur significant legal costs defending ourselves against such allegations. In the event such claims were successful, we could be subject to significant damages or be enjoined from the distribution of our products.
There is little legal precedent and the terms of many open source software licenses have not been interpreted by United States courts, and there is a risk that these licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to commercialize our products. Moreover, we cannot assure investors that our processes for monitoring and controlling our use of open source software in our products will be effective. If we are held to have breached the terms of an open source software license, we could be required to seek licenses from third parties to continue offering our products on terms that are not economically feasible, to re-engineer our product, to discontinue the sale of our products if re-engineering could not be accomplished on a timely basis, or to make generally available, in source code form, our proprietary code, any of which could adversely affect our business, financial condition and results of operations.
In addition, to the extent we use open source technologies or licensed third-party technologies in our AI Applications product line, those products may be subject to similar concerns or even unanticipated or unknown risks given the nascency of the industry and the types of products we intend to develop and deploy. For example, developers of open source technologies and third-party licensors may not adhere to the same or similar standards that we adhere to in the development, validation, training and maintenance of AI models. To the extent such third parties’ standards fall below a certain level and go undetected during our diligence and evaluation of such technologies, our business could suffer unintended consequences, including a detrimental impact on the patients we serve or the introduction of malware or other information security vulnerabilities into our network architecture.
The legislative, judicial and regulatory landscapes relating to AI are evolving and may impact our ability to use AI, and could limit our ability to operate and expand our business, cause revenue to decline and adversely affect our business.
Uncertainty in the legal regulatory regime relating to AI may require significant resources to modify and maintain business practices to comply with U.S. and non-U.S. laws, the nature of which cannot be determined at this time. Several jurisdictions around the globe, including Europe and certain U.S. states, have already proposed or enacted laws governing AI. For example, on May 17, 2024, Colorado became the first state in the United States to pass a law that requires developers of high-risk AI systems to avoid
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algorithmic discrimination involving certain AI decisions and to extensively document how the high-risk AI system was evaluated for performance and mitigation of algorithmic discrimination. The law also requires documentation of data governance measures used with the training data sets, the intended outputs of the high-risk AI system, how the AI system should and should not be used, and other aspects of the system. The law could require us to significantly alter our use of AI or how we train our algorithms, which could lead to increased costs. The law does not go into effect until February 1, 2026.
Further, on July 12, 2024, the AI Act was published in the Official Journal of the European Union and will follow a phased implementation process with the bulk of its requirements becoming applicable from August 2, 2026 (including the core of the requirements relevant to the “high-risk” systems referred to below). The AI Act will establish, among other things, a risk-based governance framework for regulating AI systems in the EU. This framework would categorize AI systems, based largely on the risks associated with such AI systems’ intended purposes or their capabilities, for example, prohibiting certain “unacceptable” AI practices, classifying certain AI systems as “high-risk” systems that must meet stringent compliance requirements (including various transparency, conformity and risk assessment, monitoring, and human oversight requirements), introducing specific compliance obligations for certain “general-purpose AI systems” (more commonly known as foundation models) with all other AI systems being considered either limited risk (requiring primarily adherence to certain transparency requirements) or low risk. There is a risk that our use of AI may obligate us to comply with the applicable requirements of the AI Act, which may impose additional costs on us, increase our risk of liability or adversely affect our business.
Other jurisdictions may decide to adopt similar or more restrictive legislation that may render the use of such technologies challenging. We may not be able to adequately anticipate or respond to these evolving laws and regulations, and we may need to expend additional resources to adjust our offerings in certain jurisdictions if applicable legal frameworks are inconsistent across jurisdictions.
Risks Related to Ownership of Our Class A Common Stock
The dual class structure of our common stock will have the effect of concentrating voting control with our Chief Executive Officer, Founder and Chairman, which will limit your ability to influence the outcome of important decisions.
Our Class B common stock has 30 votes per share and our Class A common stock, has one vote per share. Our Chief Executive Officer, Founder, and Chairman, Eric Lefkofsky, who, collectively with his controlled entities, holds all our outstanding shares of Class B common stock, beneficially owned shares representing approximately 64.3% of the voting power of our outstanding capital stock immediately following the completion of the IPO. As a result, Mr. Lefkofsky has the ability to control the outcome of matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions, such as a merger, other sale of our company or our assets or significant acquisitions, even if his stock ownership represents less than 50% of the outstanding aggregate number of shares of our capital stock. This concentration of voting control limits the ability of other stockholders to influence corporate matters and may cause us to make strategic decisions that could involve risks to you or that may not be aligned with your interests. In addition, Mr. Lefkofsky serves as an observer on our nominating and corporate governance committee, and accordingly, may have substantial influence over the individuals nominated to serve as directors. As a board member, Mr. Lefkofsky owes a fiduciary duty to our stockholders and is legally obligated to act in good faith and in a manner he reasonably believes to be in the best interests of our stockholders. As a stockholder, Mr. Lefkofsky is entitled to vote his shares in his own interests, which may not always be in the interests of our stockholders generally. Mr. Lefkofsky’s control may adversely affect the market price of our Class A common stock.
We have not elected to take advantage of the “controlled company” exemption to the corporate governance rules for publicly listed companies but may do so in the future.
Because our Chief Executive Officer, Founder, and Chairman, Eric Lefkofsky, who, collectively with his controlled entities, holds all our outstanding shares of Class B common stock, beneficially owns shares representing in excess of 50% of the voting power of our outstanding capital stock, we are eligible to elect the “controlled company” exemption to the corporate governance rules for publicly listed companies. We have not elected to do so. If we decide to become a “controlled company” under the corporate governance rules for publicly listed companies, we would not be required to have a majority of our board of directors be independent, nor would we be required to have a compensation committee or an independent nominating function. If we choose controlled company status in the future, our status as a controlled company could cause our Class A common stock to be less attractive to certain investors or otherwise harm our trading price.
We cannot predict the impact our dual class structure may have on the market price of our Class A common stock.
We cannot predict whether our dual class structure, combined with the concentrated control of our Chief Executive Officer, Founder and Chairman, who beneficially owns all of the outstanding shares of our Class B common stock, will result in a lower or
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more volatile market price of our Class A common stock or in adverse publicity or other adverse consequences. Certain index providers have announced restrictions on including companies with multiple-class share structures in certain of their indexes. For example, in July 2017, FTSE Russell and Standard & Poor’s announced that they would cease to allow most newly public companies utilizing dual or multi-class capital structures to be included in their indices. Under the announced policies, our dual class capital structure would make us ineligible for inclusion in any of these indices. Given the sustained flow of investment funds into passive strategies that seek to track certain indexes, exclusion from stock indexes would likely preclude investment by many of these funds and could make our Class A common stock less attractive to other investors. As a result, the market price of our Class A common stock could be adversely affected.
An active public trading market for our Class A common stock may not continue to develop or be sustained.
Prior to the IPO, there was no public market for our Class A common stock. An active public trading market for our Class A common stock may not continue to develop or be sustained. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an active market may also reduce the fair value of your shares. An inactive market may also impair our ability to raise capital to continue to fund operations by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration.
We have incurred, and expect to further incur, substantial federal and state tax withholding and remittance obligations in connection with the settlement of RSUs that vested in connection with the IPO. The manner in which we fund these tax liabilities may have an adverse effect on our financial condition.
We have incurred, and expect to further incur, substantial federal and state tax obligations in light of the large number of RSUs that vested in connection with the IPO. The RSUs granted prior to the date of the IPO vest upon satisfaction of service-based and performance-based vesting conditions. We used approximately $69.9 million of the net proceeds from the IPO to satisfy federal and state tax withholding and remittance obligations in connection with the net settlement of a portion of the RSUs outstanding as of June 1, 2024 for which the service-based vesting condition was satisfied before June 14, 2024 and for which the performance-based vesting condition was satisfied in connection with the IPO, or the RSU Net Settlement. In connection with the RSU Net Settlement, we withheld certain shares underlying the applicable RSUs and remitted federal and state taxes on behalf of the holders of such RSUs at applicable statutory tax withholding rates based on the IPO per share price. For vested RSUs that were not settled in connection with the IPO (other than those held by our Chief Executive Officer), we have been satisfying, and will continue to satisfy, related federal and state tax withholding and remittance obligations by requiring such RSU holders to sell a portion of such shares into the market during the 180-day period after the date of the final prospectus filed in connection with the IPO, or the restricted period, utilizing sell-to-cover, through brokers on certain settlement dates, with the proceeds of such sales to be delivered to us for remittance to the relevant taxing authorities, or the Additional RSU Settlement. The Compensation Committee of our board of directors elected to defer the settlement of approximately 4,469,400 RSUs held by our Chief Executive Officer until the period of time commencing on January 15, 2025 and ending on or before March 15, 2025, or the CEO Deferred Settlement Period. We expect to satisfy the tax withholding and remittance obligations related to the settlements of the RSUs described above that are held by our Chief Executive Officer through the sale of approximately 1,915,988 shares of our Class A common stock (assuming a 42% tax rate) in one or more mandatory sell-to-cover transactions during the CEO Deferred Settlement Period. Shares sold by our Chief Executive Officer or other employees in sell-to-cover transactions may have an adverse effect on the market price of our Class A common stock. See “Future sales of our Class A common stock in the public market could cause the market price of our Class A common stock to decline.”
Settlement and sell-to-cover transaction during the restricted period may extend over a multi-day period based on trading volumes. Because the purpose of sell-to-cover transactions is to generate proceeds sufficient to satisfy federal and state tax withholding obligations, the exact number of shares sold will depend on the sale prices of the Class A common stock in such transactions and our stockholders’ personal tax rates. However, with respect to employees that are not executive officers, if sell-to-cover proceeds are not available at the time taxes must be remitted to state and federal tax authorities, we would need to remit taxes to the relevant tax authorities using cash on hand, which may include cash proceeds generated from the IPO, pending the receipt of such sell-to-cover proceeds. If we are required to remit tax obligations on behalf of our employees without having first received proceeds from their sell-to-cover transactions, we could have significant cash outlays that could have an adverse effect on our financial condition.
Future sales of our Class A common stock in the public market could cause the market price of our Class A common stock to decline.
Sales of a substantial number of shares of our Class A common stock in the public market, or the perception that these sales might occur, could depress the market price of our Class A common stock and could impair our ability to raise capital through the sale of additional equity securities. Many of our existing equity holders have substantial unrecognized gains on the value of the equity they hold based upon the price of our IPO, and therefore they may take steps to sell their shares or otherwise secure the unrecognized gains
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on those shares. We are unable to predict the timing of or the effect that such sales may have on the prevailing market price of our Class A common stock.
All of the Class A common stock sold in our IPO is freely tradable without restrictions or further registration under the Securities Act, except for any shares held by our affiliates as defined in Rule 144 under the Securities Act, or Rule 144, and shares subject to lock-up and market standoff agreements described below.
We, all of our directors, executive officers, and the holders of substantially all of our common stock and securities exercisable for or convertible into our common stock outstanding immediately prior to the closing of the IPO (except for the RSUs previously issued to our employees other than our executive officers, including the RSUs that settled or will settle in connection with the RSU Net Settlement or the Additional RSU Settlement, as applicable, and the warrants issued to Allen and AstraZeneca), have agreed with the underwriters that, during the restricted period, we and they will not, without the prior written consent of Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC, offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise dispose of any of our shares of common stock, any options or warrants to purchase any of our shares of common stock or any securities convertible into or exchangeable for or that represent the right to receive shares of our common stock. In addition, the restricted period may be shortened with respect to a portion of the locked-up securities under certain circumstances and the lock-up agreements are subject to a number of important exceptions. Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC may release any of the securities subject to these lock-up agreements at any time, subject to applicable notice requirements. In addition to the restrictions contained in the lock-up agreements, we have entered into market standoff agreements with substantially all of our RSU holders, including holders of the RSUs that settled or will settle in connection with the RSU Net Settlement and the Additional RSU Settlement, imposing restrictions on the ability of such security holders to offer, sell, contract to sell, pledge, hypothecate, grant any option to purchase or make any short sale of, or otherwise dispose of any shares of our common stock or any rights to acquire our common stock during the restricted period, subject to earlier release at any time by us. If not earlier released, all of the shares of Class A common stock not sold in the IPO will become eligible for sale upon the expiration of the restricted period, except for any shares held by our affiliates as defined in Rule 144.
In addition, pursuant to certain exceptions in the lock-up agreements and because of our ability to release RSU holders early under the market standoff agreements, approximately 3,200,000 shares of our Class A common stock have been or will be sold in the open market by our employees during the restricted period in order to satisfy tax withholding obligations in connection with the settlement of an aggregate of approximately 7,700,000 RSUs for shares of our Class A common stock (assuming an estimated 42% tax rate). The vested RSUs held by our Chief Executive Officer that were not settled at the time of the IPO will settle during the CEO Deferred Settlement Period. Such settlement and sell-to-cover transactions may extend over a multi-day period based on trading volumes. Because the purpose of sell-to-cover transactions is to generate proceeds sufficient to satisfy tax withholding obligations, the exact number of shares sold will depend on the sale prices of the Class A common stock in such transactions and our stockholders' personal tax rates.
In addition, there were 210,000 shares of Class A common stock issuable upon the exercise of a stock option outstanding as of September 30, 2024. We have registered all of the shares of Class A common stock issuable upon the exercise of the outstanding option, settlement of outstanding RSUs and other equity incentives we may grant in the future for public resale under the Securities Act.
AstraZeneca holds an outstanding warrant, pursuant to which AstraZeneca has the right to purchase $100 million in shares of our Class A common stock at an exercise price equal to the public offering price in our IPO. The shares of Class A common stock will become eligible for sale in the public market to the extent such warrant is exercised, subject to the market standoff provision included in such agreement and compliance with applicable securities laws. In addition, pursuant to the Warrant Net Exercise, Allen, an underwriter in our offering, received 109,459 shares of Class A common stock following our IPO. The shares of Class A common stock issued pursuant to the Warrant Net Exercise will become eligible for sale in the public market, subject to the market standoff provision contained in the Allen warrant agreement and compliance with applicable securities laws.
Further, based on shares outstanding as of June 17, 2024, the closing date of our IPO, holders of approximately 130,107,420 shares of Class A common stock and 5,043,789 shares of Class B common stock, or approximately 87.7% of our capital stock, have rights, subject to some conditions, to require us to file registration statements covering the sale of their shares or to include their shares in registration statements that we may file for ourselves or other stockholders.
Sales, short sales, or hedging transactions involving our equity securities, whether before or after our IPO and whether or not we believe them to be prohibited, could adversely affect the price of our Class A common stock.
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The lock-up agreements relating to the IPO are subject to a number of important exceptions and the restricted period pursuant to such lock-up agreements or the market standoff agreements with our RSU holders may be shortened. In addition, a significant number of shares may be sold in sell-to-cover transactions and we may issue a significant number of shares as consideration in certain transactions, including during the restricted period. As a result, a large number of shares of Class A common stock may become available for resale in the immediate future, including within 180 days after the date of the final prospectus filed in connection with the IPO, which could materially depress the market price of our Class A common stock.
Although we, all of our directors, executive officers, and the holders of substantially all of our common stock and securities exercisable for or convertible into our common stock outstanding immediately prior to the closing of the IPO (except for the RSUs previously issued to our employees other than our executive officers, and the warrants issued to Allen and AstraZeneca) have agreed with the underwriters that, until December 11, 2024, which is the 181st day after the date of the final prospectus filed in connection with the IPO, we and they will not offer, sell, make any short sale or otherwise dispose of any of our shares of common stock, any options or warrants to purchase any of our shares of common stock or any securities convertible into or exchangeable for or that represent the right to receive shares of our common stock, such lock-up agreements are subject to a number of important exceptions. For example, at any time during such period, we may agree to issue or issue up to 15.0% of the total number of shares of our common stock outstanding immediately following the issuance of our Class A common stock in the IPO, or 24,724,891 shares, in connection with an acquisition, merger, joint venture, strategic alliance, commercial or other collaborative relationship or certain other transactions. In addition, under the market standoff agreements that we have entered into with substantially all of our RSU holders, we have the right to release early some or all shares of our Class A common stock issuable pursuant to such RSUs, subject to the consent of Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC.
Moreover, Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC may release any of the securities subject to these lock-up agreements at any time. In the event that any officer, director or other holder holding in excess of 1% of our outstanding shares of common stock is granted an early release from the lock-up restrictions with respect to our securities in an aggregate amount in excess of 1% of our outstanding shares of common stock (whether in one or multiple releases), then every other person subject to lock-up automatically will be granted an equivalent early release from its obligations under the lock-up agreement on a pro rata basis.
Each of the events described above may occur independently of the other events. As a result of any such event or any combination thereof, a large number of shares of our Class A common stock may become available for resale in the immediate future, including before December 11, 2024, which is the first day following the restricted period, which may materially depress the market price of our Class A common stock. In addition, some or all of these events may occur in close proximity or simultaneously, which may exacerbate their impact on the market price of our Class A common stock.
We do not intend to pay dividends for the foreseeable future and, as a result, your ability to achieve a return on your investment will depend on appreciation in the price of our Class A common stock.
While we have in the past paid dividends to holders of our convertible preferred stock, we do not intend to pay any cash dividends in the foreseeable future. Any determination to pay dividends in the future will be at the discretion of our board of directors. Accordingly, you may need to rely on sales of our Class A common stock after price appreciation, which may never occur, as the only way to realize any future gains on your investment.
We are an “emerging growth company,” and we cannot be certain if the reduced reporting and disclosure requirements applicable to emerging growth companies will make our Class A common stock less attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,” including the auditor attestation requirements of Section 404, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Pursuant to Section 107 of the JOBS Act, as an emerging growth company, we have elected to use the extended transition period for complying with new or revised accounting standards until those standards would otherwise apply to private companies. As a result, our condensed consolidated financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make our Class A common stock less attractive to investors. In addition, if we cease to be an emerging growth company, we will no longer be able to use the extended transition period for complying with new or revised accounting standards.
We will remain an emerging growth company until the earliest of: (1) the last day of the fiscal year following the fifth anniversary of our IPO; (2) the last day of the first fiscal year in which our annual gross revenue is $1.235 billion or more; (3) the date
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on which we have, during the previous rolling three-year period, issued more than $1.0 billion in non-convertible debt securities; and (4) the last day of the fiscal year in which the market value of our Class A common stock held by non-affiliates exceeded $700 million as of June 30 of such fiscal year.
We cannot predict if investors will find our Class A common stock less attractive if we choose to rely on these exemptions. If some investors find our Class A common stock less attractive, there may be a less active trading market for our Class A common stock and our stock price may be more volatile.
Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of our company more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our Class A common stock.
In addition to the effects of our dual class structure, provisions in our amended and restated certificate of incorporation and amended and restated bylaws, as they are in effect as of the completion of our IPO, may have the effect of delaying or preventing a change in control or changes in our management. Our amended and restated certificate of incorporation and amended and restated bylaws will include provisions that may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.
In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which generally, subject to certain exceptions, prohibits a Delaware corporation from engaging in any of a broad range of business combinations with any “interested” stockholder for a period of three years following the date on which the stockholder became an “interested” stockholder. Any of the foregoing provisions could limit the price that investors might be willing to pay in the future for shares of our Class A common stock, and they could deter potential acquirers of our company, thereby reducing the likelihood that you would receive a premium for your shares of our Class A common stock in an acquisition.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America are the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:
The provisions would not apply to suits brought to enforce a duty or liability created by the Securities Exchange Act of 1934, or the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation will further provide that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause or causes of action arising under the Securities Act, including all causes of action asserted against any defendant to such complaint. For the avoidance of doubt, this provision is intended to benefit and may be enforced by us, our officers and directors, the underwriters to any offering giving rise to such complaint, and any other professional entity whose profession gives authority to a statement made by that person or entity and who has prepared or certified any part of the documents underlying the offering.
While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such an instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.
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These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers, and other employees. If a court were to find either exclusive-forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business, financial condition and results of operations.
Our stock price may be volatile, and the value of our Class A common stock may decline.
The market price of our Class A common stock has been highly volatile, ranging from $22.89 to $77.00 per share since our IPO. The price of our Class A common stock may fluctuate or decline substantially as a result of a variety of factors, some of which are beyond our control, including:
Broad market and industry fluctuations, as well as general economic, political, regulatory, and market conditions, may also negatively impact the market price of our Class A common stock. In addition, technology stocks have historically experienced high levels of volatility. In the past, companies that have experienced volatility in the market price of their securities have been subject to securities class action litigation. We may be the target of this type of litigation in the future, which could result in substantial expenses and divert our management’s attention.
If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the market price and trading volume of our Class A common stock could decline.
The market price and trading volume of our Class A common stock following the completion of our IPO is heavily influenced by the way analysts interpret our financial information and other disclosures. We do not have control over these analysts. If few securities analysts commence coverage of us, or if industry analysts cease coverage of us, our stock price would be negatively affected. If securities or industry analysts do not publish research or reports about our business, downgrade our Class A common stock, or publish negative reports about our business, our stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our Class A common stock could decrease, which might cause our stock price to decline and could decrease the trading volume of our Class A common stock.
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We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance with our public company responsibilities and corporate governance practices.
As a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company, which we expect to further increase after we are no longer an “emerging growth company.” The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Exchange Act, the listing requirements of the Nasdaq Stock Market and other applicable securities rules and regulations impose various requirements on public companies. Our management and other personnel devote a substantial amount of time to compliance with these requirements. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly, such as maintaining directors’ and officers’ liability insurance. We cannot predict or estimate the amount of additional costs we will incur as a public company or the specific timing of such costs, and any such costs may adversely affect our business, financial condition and results of operations.
General Risk Factors
Our business could be adversely affected by the effects of health pandemics or epidemics, including the COVID-19 global pandemic.
Our business could be adversely affected by the effects of health pandemics or epidemics, including the COVID-19 global pandemic. For example, the COVID-19 global pandemic and the various attempts throughout the world to contain it created significant volatility, uncertainty and disruption.
We experienced significant reduction in access to our customers, including restrictions on our ability to market and distribute our tests and to collect samples. Our partners, vendors and customers similarly had their operations altered or temporarily suspended. Due to impacts and measures resulting from the COVID-19 pandemic, we experienced and could again experience unpredictable reductions in the demand for our tests as healthcare customers divert medical resources and priorities toward the treatment of the virus. To the extent the COVID-19 pandemic causes severe disruption again in the future, vendors of equipment and reagents for our operations could also reduce production or even go out of business, resulting in supply constraints for us. The COVID-19 pandemic resulted in, and could continue to cause, increased costs or delays to production and development of our products.
The COVID-19 pandemic has also led to uncertainties related to our growth, forecast and trends. Our historic results such as revenue, operating margins, cash flows, tests performed, and other financial and operating metrics, may not be indicative of our results for future periods. For example, following a reduced demand for COVID-19 testing, we stopped offering COVID-19 PCR diagnostic tests in the first quarter of 2023. Increases in the number of diagnostic tests performed by us prior to the COVID-19 pandemic may reflect an acceleration of growth that we may not see during or after the COVID-19 pandemic.
While these effects have subsided and continue to subside, the full extent to which the COVID-19 pandemic may continue to impact our performance, financial condition, volume of business, results of operations and cash flows will depend on future developments that are uncertain and cannot be accurately predicted. We cannot assure you that these effects will remain reduced in the future, including due to potential new public health outbreaks. To the extent future public health outbreaks adversely affect our business and financial results, they may also have the effect of heightening many of the other risks described in this “Risk Factors” section.
We may acquire businesses, form joint ventures or make investments in companies or technologies that could negatively affect our operating results, distract management’s attention from other business concerns, dilute our stockholders’ ownership, and significantly increase our debt, costs, expenses, liabilities and risks.
We have made acquisitions of businesses, technologies and assets and may pursue additional acquisitions in the future, one or more of which may be substantial. We also may pursue strategic alliances and additional joint ventures that leverage our Platform and industry experience to expand our product offerings or distribution. We have limited experience with acquisitions, joint ventures and forming strategic partnerships. We compete for those opportunities with others including our competitors, some of which have greater financial or operational resources than we do. We may not be able to identify suitable acquisition candidates or strategic partners, we may have inadequate access to information or insufficient time to complete due diligence, and we may not be able to complete such transactions on favorable terms, if at all. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities. Difficulties in assimilating acquired businesses include redeployment or loss of key employees and their severance, combination of teams and processes in various functional areas, reorganization or closures of facilities, relocation or disposition of excess equipment, and increased litigation, regulatory and compliance risks, any of which could be expensive and time consuming and adversely affect us. Integration of an acquired business also may disrupt our ongoing operations and require management resources that we would otherwise focus on developing our existing business. In addition, any acquisition could result in the incurrence of debt, contingent liabilities or future write-offs of intangible assets or goodwill, any of which could have a material adverse effect on our financial condition, results of operations and cash flows.
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We may also experience losses related to investments in other companies, which could have a material negative effect on our business, financial condition and results of operations. We may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.
We evaluate opportunities for transactions of these types from time to time. For example, on May 18, 2024, we entered into the Joint Venture Agreement (the “Joint Venture Agreement”) with SoftBank Group Corporation (“SoftBank”) to form SB Tempus Corp. (the “Joint Venture” or "SB Tempus"). The Joint Venture closed on July 18, 2024, at which time we and SoftBank each contributed ¥15 billion ($95.2 million). Each party received 50% of SB Tempus' outstanding capital stock and board seats. SB Tempus will engage in certain business activities in Japan similar to those conducted by us in the United States, including performing clinical sequencing, organizing patient data, and building a real world data business in Japan. We have limited experience forming joint ventures and we may not realize the anticipated benefits of the Joint Venture. We may also realize losses related to our investment in the Joint Venture, which could have a material negative effect on our business, financial condition and results of operations.
In addition, on November 4, 2024 we entered into the Purchase Agreement to acquire all of the outstanding shares of capital stock of Ambry. Pursuant to the terms of the Purchase Agreement, consideration for the Acquisition consists of $375.0 million in Cash Consideration, plus the issuance of an aggregate of 4,483,136 shares of our Class A common stock as Stock Consideration, 2,152,505 of which shares will be subject to a lock-up for a period of one year following the closing date of the Acquisition. The Acquisition is expected to close in the first quarter of 2025, subject to the satisfaction of closing conditions contained in the Purchase Agreement, including receipt of all required regulatory approvals. If the Acquisition is consummated, our stockholders will experience immediate dilution as a result of the issuance of the Stock Consideration. In addition, we intend to utilize borrowings under the Additional Term Loan and the Revolving Credit Facility to fund the Cash Consideration for the Acquisition and to pay fees and expenses related thereto. Ares’ obligation to provide the contemplated financings is subject to a number of customary conditions contained in the Commitment Letter, including the execution of definitive documentation contemplated by the Commitment Letter and the closing of the Acquisition substantially simultaneously with the initial borrowings under the Additional Term Loan and Revolving Credit Facility. There can be no assurance that the Acquisition will be consummated on the terms set forth herein or at all and, if consummated, that we will achieve the expected benefits of the Acquisition. Moreover, pursuant to the Purchase Agreement, we are obligated to consummate the Acquisition irrespective of whether or not we obtain the requisite financing. There can be no assurance that definitive documentation related to the Additional Term Loan and the Revolving Credit Facility will be entered into, or that funding thereunder will be received, on the terms set forth herein or at all, and we may be required to utilize cash on hand to fund the Cash Consideration, which could have an adverse effect on our financial condition.
To finance any acquisitions, joint ventures or investments, we may choose to issue shares of our common stock as consideration, which would dilute the ownership of our stockholders. During the period through and including December 10, 2024, which is 180 days after the date of the Final Prospectus filed in connection with the IPO, we are permitted to issue up to 15.0% of the total number of shares of our common stock outstanding immediately following this offering in connection with acquisitions, joint ventures, commercial agreements or other similar arrangements. Additional funds may not be available on terms that are favorable to us, or at all. If the price of our common stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project using our stock as consideration.
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
We have incurred net losses since our inception and we may never achieve or sustain profitability. Generally, losses incurred will carry forward until such losses expire (for losses generated prior to January 1, 2018) or are used to offset future taxable income, if any. Under current law, U.S. federal net operating losses, or NOLs, incurred in taxable years beginning after December 31, 2017, can be carried forward indefinitely to offset future taxable income, but the deductibility of such U.S. federal NOL carryforwards in a taxable year is limited to 80% of taxable income in such year. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the IRC, if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period, the corporation’s ability to use its pre-change net operating loss, carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income or taxes may be limited. We have not completed a study to assess whether one or more ownership change for purposes of Section 382 or 383 have occurred since our inception. For purposes of Section 382 or 383, we may have experienced ownership changes in the past and may experience ownership changes in the future as a result of shifts in our stock ownership (some of which shifts are outside our control). As a result, if we earn net taxable income, our ability to use our pre-change NOL carryforwards to offset such taxable income will be subject to limitations. Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes. Therefore, if we attain profitability, we may be unable to use a material portion of our NOL carryforwards and other tax attributes, which could adversely affect our future cash flows. These changes may adversely affect our future cash flow.
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Taxing authorities may successfully assert that we should have collected or in the future should collect sales and use, value added, or similar taxes, and we could be subject to tax liabilities with respect to past or future sales, which could adversely affect our results of operations.
We do not collect sales and use, value added, and similar taxes in all jurisdictions in which we have sales, based on our belief that such taxes are not applicable or that we are not required to collect such taxes with respect to the jurisdiction. Sales and use, value added, and similar tax laws and rates vary greatly by jurisdiction. Certain jurisdictions in which we do not collect such taxes may assert that such taxes are applicable, which could result in tax assessments, penalties, and interest, and we may be required to collect such taxes in the future. Such tax assessments, penalties, and interest or future requirements may adversely affect our results of operations.
If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America, or GAAP, requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent from other sources. Actual results could therefore differ materially from these estimates under different assumptions or conditions. It is possible that interpretation, industry practice and guidance may evolve as we work toward implementing these new accounting standards. If our assumptions change or if actual circumstances differ from our assumptions, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of analysts and investors, resulting in a decline in the market price of our common stock.
We are highly dependent on the services of Eric Lefkofksy and other members of our senior management team and the loss of any member of our senior management team or our inability to attract and retain highly skilled scientists, clinicians, sales representatives and business development managers could adversely affect our business, financial condition and results of operations.
Our success depends on the skills, experience and performance of key members of our senior management team. In particular, we are highly dependent on the services of Eric Lefkofsky, our Founder, Chief Executive Officer, and Chairman of our board of directors. Mr. Lefkofsky spends substantially all of his professional time with us, and he is highly active in our management; however, he does devote some of his time and attention to other endeavors. Mr. Lefkofsky is also a co-founder and serves as Executive Chairman of the board of Pathos AI, Inc., an AI-enabled drug development company that has entered into an agreement with us, is the managing partner and co-founder of Lightbank LLC, a private venture capital firm specializing in investments in technology companies that has invested in us, and is a trustee of the Lefkofsky Family Foundation. Mr. Lefkofsky’s participation in and attention to these other endeavors may impact our business. In October 2022, for example, Lightbank and the Lefkofsky Family Foundation experienced a cybersecurity incident in which third party hackers gained access to Lightbank’s internal computer services and were able to exfiltrate data regarding Lightbank’s historical business practices and Mr. Lefkofsky’s personal financial information. While the incident did not involve or impact Tempus’ systems, this security breach or others like it could indirectly impact Tempus.
In addition, we depend on the services of our Chief Operating Officer, Ryan Fukushima. Mr. Fukushima is a co-Founder of Pathos AI, Inc. and currently serves as its interim Chief Executive Officer. Under the terms of his employment agreement with Tempus, Mr. Fukushima devotes no less than 50% of his professional activities to Tempus.
The individual and collective efforts of Mr. Lefkofsky, Mr. Fukushima and our other employees will be important as we continue to develop our Platform and additional products, and as we expand our commercial activities. The loss or incapacity of existing members of our executive management team, or the inability of such individuals to devote sufficient time to our endeavors, could adversely affect our operations if we experience difficulties in hiring qualified successors. While our executive officers have entered into employment agreements with us, they are at-will employees and we cannot guarantee their retention for any period of time. We do not maintain “key person” insurance on any of our employees, including Mr. Lefkofsky. Additionally, we have a number of key employees whose equity ownership in our company gives them a substantial amount of personal wealth. As a result, it may be difficult for us to continue to retain and motivate these employees, and this wealth could affect their decisions about whether or not they continue to work for us or at all.
Our research and development programs and laboratory operations depend on our ability to attract and retain highly skilled scientists and technicians. We may not be able to attract or retain qualified scientists and technicians in the future due to the competition for qualified personnel among life science businesses, particularly near our laboratories in Chicago, Atlanta and Raleigh.
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We also face competition from universities and public and private research institutions in recruiting and retaining highly qualified scientific personnel. In addition, we may have difficulties locating, recruiting or retaining qualified sales representatives and business development managers, as well as software engineers. Recruiting and retention difficulties can limit our ability to support our research and development and sales programs. All of our employees are at-will, which means that either we or the employee may terminate their employment at any time. Our employees also are subject to certain post-employment noncompete obligations; however, on April 23, 2024, the FTC voted to finalize a rule banning almost all post-employment noncompetes, subject to narrow exceptions, including existing non-compete agreements with “senior executives” (as defined under the rule). If the FTC ban becomes effective, as expected, and is implemented and these noncompete obligations are therefore deemed to be unenforceable, our competitors may be more successful in recruiting our employees.
Further, certain macroeconomic conditions, which have been referred to as the Great Resignation, may result in higher than normal attrition in the sectors in which we operate, and in our business in particular. Our ability to manage human capital, and attract and retain the resources necessary to operate our business successfully, may suffer as a result.
我们之前发现我们对财务报告的内部控制存在重大缺陷。如果我们未能对财务报告保持有效的内部控制系统，我们可能无法准确报告我们的财务业绩或防止欺诈。
IPO完成后，我们必须根据2002年萨班斯-奥克斯利法案第404条或第404条记录和测试我们对财务报告的内部控制，以便我们的管理层能够认证我们对财务报告的内部控制的有效性。同样，当我们不再是「新兴成长型公司」（如2012年《创业创业法案》或《JOBS法案》中所定义）时，我们的独立特许会计师事务所必须提供一份关于我们对财务报告内部控制有效性的证明报告。此时，如果发现重大缺陷，我们的独立特许会计师事务所可能会发布不利报告。
在编制合并财务报表方面，我们发现截至2021年12月31日财务报告内部控制存在重大缺陷，如下所述。重大缺陷是指财务报告内部控制的缺陷或缺陷组合，导致我们合并财务报表的重大错误陈述有合理的可能性无法及时预防或发现。
由于缺乏与我们的财务报告要求相称的适当技术会计和财务报告知识和经验水平的人员补充，我们没有设计或维持有效的控制环境。
我们确定，截至2022年12月31日，上述重大弱点已得到纠正，因为管理层已完成对技术会计和财务报告控制的设计和实施，包括聘请首席会计官和其他关键技术会计和财务报告角色，以进一步制定和记录我们的会计政策和财务报告程式，包括正在进行的高级管理层审查。
参见第4项。管理层就截至本10-Q表格季度报告所涵盖期间结束时有效披露控制和程式的主张的控制和程式。
尽管纠正了上述重大弱点，但我们无法保证未来不会因未能实施和维持对财务报告的充分内部控制或规避这些控制而出现任何额外的重大弱点或财务业绩重述。如果我们的管理层无法得出结论认为我们对财务报告拥有有效的内部控制，或无法证明此类控制的有效性，或者如果我们的独立特许会计师事务所无法对管理层的评估和我们对财务报告的内部控制的有效性提出无保留意见，或者如果未来发现我们内部控制中的重大弱点，我们可能会受到监管审查并失去公众信心，这可能会对我们的业务和股价产生重大不利影响。
我们的披露控制和程式可能无法防止或检测所有错误或欺诈行为。
我们须遵守《交易法》的定期报告要求。我们设计了披露控制和程式，以提供合理的保证，即我们必须在根据《交易法》提交或提交的报告中披露的信息是在SEC规则和表格规定的时间内积累、传达给管理层、记录、处理、总结和报告的。我们相信，任何披露控制和程式，无论构思和操作如何完善，只能提供合理而非绝对的保证，以实现控制系统的目标。
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这些固有的局限性包括决策中的判断可能是错误的，并且可能由于简单的错误或错误而发生故障。此外，某些人的个人行为、两个或多个人的勾结或未经授权的超控可以规避控制。因此，由于我们的控制系统固有的局限性，可能会发生因错误或欺诈而导致的错误陈述，并且无法被发现。
我们的员工、主要调查人员、顾问和商业合作伙伴可能从事不当行为或其他不当活动，包括不遵守监管标准和要求以及内幕交易。
我们面临著员工、主要调查人员、顾问和商业合作伙伴的欺诈或其他不当行为的风险。这些当事人的不当行为可能包括故意不遵守FDA、CMS和非美国监管机构的规定，不遵守美国和国外的医疗欺诈和滥用法律法规，不准确地报告财务资讯或数据，或向我们披露未经授权的活动。特别是，医疗保健行业的销售、营销和商业安排受到旨在防止欺诈、不当行为、回扣、自我交易和其他滥用行为的广泛法律法规的约束。这些法律法规可能会限制或禁止广泛的定价、折扣、营销和促销、销售佣金、客户激励计划和其他商业安排。此类不当行为还可能涉及不当使用在临床研究过程中获得的资讯，这可能会导致监管制裁，并对我们的声誉造成严重损害。我们目前有适用于所有员工的行为准则，但并不总是能够识别和阻止员工的不当行为，我们为发现和防止此类行为而采取的行为准则和其他预防措施可能无法有效控制未知或未管理的风险或损失，或保护我们免受因未能遵守这些法律或法规而引起的政府调查、诉讼或其他行动。如果对我们提起任何此类诉讼，而我们未能成功地为自己辩护或维护我们的权利，这些行动可能会导致施加重大的民事、刑事和行政处罚，包括但不限于损害赔偿、罚款、个人监禁、返还利润、可能被排除在参与Medicare、Medicaid和其他联盟医疗保健计划或类似的外国计划之外、或被排除在商业支付者的保险范围之外、合同损害、声誉损害、利润减少和未来收益、额外的报告或监督义务，如果我们受到公司诚信协定或其他协定的约束，以解决有关违反法律的指控，并削减或重组我们的业务，这可能会对我们的业务、财务状况和运营结果产生重大不利影响。无论我们能否成功应对此类诉讼，我们都可能产生包括法律费用在内的巨额成本和支出，并将管理层的注意力从我们的业务运营中转移出去。
法律索赔和诉讼可能会对我们的业务产生不利影响。
我们已经并可能在未来受到威胁或实际的法律索赔和监管程式。我们认为我们在此类索赔和诉讼方面的历史经验是我们业务的正常过程，或者是我们行业的典型；然而，很难评估这些事件的结果，我们可能不会在当前或未来的任何诉讼或诉讼中获胜。例如，我们收到了一位重要股东的要求，要求根据特拉华州公司法第220条提供我们的某些账簿和记录，未来任何与此请求相关的诉讼都可能对我们产生实质性的不利影响。无论案情如何，任何威胁或实际的索赔或诉讼程式都可能需要大量的时间和费用来进行调查和辩护。由于诉讼本身是不确定的，因此不能保证我们会成功地为自己辩护，或者我们对这些事项的重要性的评估，包括与此相关的任何储备，将与这些事项的最终结果保持一致。
我们的某些高级官员、董事和主要股东可能会寻求独立于我们的企业机会，这可能与我们和我们的股东利益产生冲突。
我们的某些高级管理人员、董事和主要股东从事对公司进行投资或提供建议的业务，并持有(并可能在未来不时获得)可能直接或间接与我们的业务竞争或成为我们的供应商或客户的业务的权益，或向这些业务提供建议或服务。这些人还可能寻求与我们的业务相辅相成的收购，或者进入我们原本处于有利地位的行业，因此，我们可能无法获得这些收购机会。例如，我们的首席执行官、创始人兼董事长埃里克·莱夫科夫斯基是Paos AI，Inc.和Lightbank LLC的联合创始人和执行主席，Paos AI，Inc.是一家从事疗法发现和开发的公司，我们与该公司有商业关系，Lightbank LLC是一家专门投资科技公司的私人风险投资公司。我们的章程规定，同时也是我们主要股东的高级管理人员、董事员工、合作伙伴、董事管理人员、主要股东、独立承包商或其他联营公司的高级管理人员或董事不会因为以下事实而对我们或我们的股东违反任何受信责任：任何此等个人为其自身或联属公司的账户(视情况而定)而不是我们将公司机会转给任何其他人或不向我们传达有关公司机会的资讯而违反公司机会的责任。
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如果我们因产品责任或专业责任而被起诉，我们可能会面临超出我们资源范围的巨额责任。
如果有人声称我们的产品识别出有关样本或分析信息的不准确或不完整的信息、报告了有关疾病可用疗法的不准确或不完整的信息或以其他方式未能按设计执行，则我们产品的营销、销售和使用可能会导致提出产品责任索赔。我们还可能因我们在正常业务活动过程中提供的信息的错误、误解或不当依赖而承担专业责任。产品责任或专业责任索赔可能会导致重大损害赔偿，并且我们的辩护成本高昂且耗时。
我们保留产品和专业责任保险，但该保险可能无法完全保护我们免受产品责任或专业责任索赔的财务影响。针对我们提出的任何产品责任或专业责任索赔，无论是否有根据，都可能增加我们的保险费率或阻止我们在未来获得保险。此外，任何产品责任或专业责任诉讼都可能损害我们的声誉，或导致当前临床客户终止与我们和潜在临床客户的现有协议以寻求其他合作伙伴，其中任何一项都可能对我们的运营运绩产生不利影响。
我们依赖信息技术系统，包括本地、同地和第三方数据中心和平台，任何服务中断或故障都可能损害和损害我们的业务、财务状况和运营结果。
我们的运营依赖于资讯技术和电信系统，包括我们的实验室资讯管理系统、我们的计算生物学系统、我们的人工智慧算法、我们的知识管理系统和我们的客户报告。我们已经安装并预计将扩大一些企业软体系统，这些系统影响广泛的业务流程和职能领域，例如，包括处理人力资源、财务控制和报告、合同管理、合规和其他基础设施业务的系统。除了上述业务系统外，我们还打算通过增强我们技术系统的监控和警报功能、网路设计和自动对抗操作来扩展我们的预防和检测安全控制的能力。这些资讯技术和电信系统支持各种职能，包括实验室业务、检测验证、样品跟踪、质量控制、客户服务支持、账单和报销、研究和开发活动、科学和医疗管理以及一般行政活动。此外，我们在美国为晚期临床试验提供计费和收款服务的第三方供应商依赖于其外部供应商提供的技术和电信系统。
我们还依赖美国各地的内部、主机托管和第三方基础设施，为我们的算法诊断产品和数据业务执行计算要求苛刻的分析任务，以及我们的研发计划和其他业务目的。资讯技术和电信系统容易受到各种来源的损害，包括电信或网路故障、恶意人为行为和自然灾害。此外，尽管采取了网路安全和备份措施，但我们所依赖的一些服务器可能容易受到物理或电子入侵、电脑病毒和类似的破坏问题的影响。尽管我们已采取预防措施来防止可能影响我们的资讯技术和电信系统的问题，但我们的资讯技术或电信系统或我们的第三方服务提供商使用的系统发生故障或严重停机可能会阻止我们准备和向医生提供报告、向付款人付款、处理报销上诉、处理患者或医生查询、进行研发活动和管理我们业务的行政方面。
如果我们的本地、主机托管或第三方数据中心出现任何技术问题，我们向客户提供人工智慧产品的能力或我们依赖此类服务的内部职能(包括研发)或运营我们业务的其他管理方面可能会中断。中断或故障可能由各种因素引起，包括基础设施更改、人为或软体错误、病毒、蠕虫、勒索软体、安全攻击、欺诈、客户使用量激增和拒绝服务问题。我们数据分析业务的中断或故障可能会减少我们的收入，导致客户流失，对我们吸引新客户的能力产生不利影响，或损害我们的声誉。我们研发计划的重大中断可能会导致我们推迟推出新产品或改进现有产品，这可能会对我们的业务、财务状况、运营结果和我们产品的竞争力产生不利影响。在这种情况下，我们的保险单可能无法充分赔偿我们可能遭受的损失，但此类事件可能会使我们承担责任，并导致我们开具信用或导致客户放弃我们的产品。
此外，我们目前使用Google Cloud平台或Google Cloud来进行大部分计算、存储、数据处理、网络和其他服务。对我们使用Google Cloud的任何重大干扰或干扰都可能对我们的业务、财务状况和运营运绩产生不利影响。谷歌拥有广泛的自由裁量权来更改和解释
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有关我们的服务条款和其他政策，这些行为可能不利于我们的业务运营。谷歌还可能采取超出我们控制范围的可能严重损害我们业务的行动，包括停止或限制我们对一项或多项服务的访问、提高定价条款、终止或寻求完全终止我们的合同关系或改变我们处理数据的方式对我们不利或成本高昂。如果我们与Google Cloud的安排被终止，或者我们被迫过渡到新的云提供商，我们进行诊断测试或向客户提供数据产品的能力可能会中断，以及安排替代云基础设施服务的延迟和额外费用。任何向新云提供商的过渡都将难以实施，并会导致我们产生重大延误和费用。
此外，我们很容易受到Google Cloud和其他提供商经历的服务中断的影响，并且我们预计未来服务可用性将因多种因素而出现中断、延迟或中断，包括基础设施变更、人为、硬体或软体错误、托管中断和容量限制。这些提供商提供的服务水平，或该服务的定期或长期中断，也可能影响我们产品的使用和客户对我们产品的满意度，并可能损害我们的业务和声誉。此外，随著我们客户群的增长，托管成本也会增加，如果我们的收入增长速度无法快于使用这些服务或其他提供商服务的成本，这可能会损害我们的业务。任何这些因素都可能进一步减少我们的收入或使我们承担责任，其中任何因素都可能对我们的业务、财务状况和经营运绩产生不利影响。
与我们的信息系统和计算机网络相关的网络攻击、安全漏洞、数据丢失和其他中断可能会损害与我们业务相关的敏感信息，阻止我们访问这些信息并使我们承担重大责任，这可能会对我们的业务和声誉产生不利影响。
网路攻击、安全漏洞、电脑病毒感染、恶意软体执行和其他事件可能会导致机密数据、个人资讯、材料或资讯的挪用、暴露、丢失或其他未经授权的泄露，包括与我们客户和员工有关的资讯。网路攻击中使用了越来越复杂的方法，包括勒索软体、网路钓鱼、供应链攻击、结构化查询语言注入和分布式拒绝服务攻击。网路攻击也可以是未经授权访问我们的网路资源(或阻止授权访问)的形式。勒索软体攻击正变得越来越普遍和严重，可能导致我们的运营严重中断、延迟或中断，临床试验中断，数据(包括与临床试验相关的数据)丢失，收入损失，恢复数据或系统的巨额额外费用，声誉损失和资金转移。为了减轻勒索软体攻击对财务、运营和声誉的影响，勒索软体攻击受害者可能更愿意提出付款要求，但如果我们成为此类攻击的受害者，我们可能不愿意或无法这样做(例如，包括适用的法律或法规禁止此类付款)。同样，供应链攻击的频率和严重性也在增加，我们不能保证我们供应链中的第三方和基础设施没有受到危害，或者它们不包含可能导致我们的系统和网路或支持我们的第三方的系统或网路遭到破坏或中断的可利用的缺陷或错误。这样的攻击很难避免。虽然我们不知道我们或我们的第三方供应商的系统或资讯发生了任何此类入侵或事件，但我们不能保证我们或我们的供应商将来能够检测、防止或控制此类攻击或其他资讯安全风险、漏洞或威胁的影响。试图防范上述风险的成本以及应对和补救系统免受网路攻击的成本是巨大的。检测、调查、缓解、遏制和补救网路攻击或其他安全事件可能很困难和/或代价高昂，我们这样做的努力可能不会成功。我们或与我们合作的第三方为检测、调查、缓解、控制和补救安全事件而采取的行动可能会导致停机、数据丢失和业务中断。其他实体的大规模数据泄露增加了我们和我们的供应商在维护我们的资讯技术系统和客户的敏感资讯安全方面面临的挑战。发生网路攻击后，我们和/或我们供应商的补救努力可能不会成功，网路攻击可能会导致服务中断、延迟或停止，并失去现有或潜在客户。此外，违反我们和/或我们供应商的安全措施，以及未经授权传播或提供关于我们、我们的客户或其他第三方的敏感个人资讯或专有资讯或机密资讯，可能会使我们客户和我们客户的私人资讯面临财务或医疗身分被盗的风险，或使我们或其他第三方面临该资讯丢失或滥用的风险，并导致调查、监管执法行动、重大罚款和处罚、客户损失、诉讼或其他可能对我们的业务、财务状况和运营结果产生重大不利影响的行动。此外，如果我们未能遵守我们的隐私政策和关于我们的隐私或网路安全做法的其他已公布声明，或关于我们处理、使用、传输和披露受保护资讯的适用法律，或者如果我们的声明或做法被发现具有欺骗性或失实陈述，我们可能面临监管行动、罚款和其他责任。见“风险因素--与我们高度监管的行业相关的风险”。我们收集、处理、使用和披露个人身分资讯，包括患者和员工资讯，都受到隐私和安全法规的约束，我们如果不遵守这些法规或未能充分保护我们拥有的资讯，可能会导致重大责任或声誉损害。“
在我们的正常业务过程中，我们收集和存储敏感数据，包括PHI、个人身份信息、信用卡和其他财务信息、智慧财产权和我们拥有或控制的专有业务信息或
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其他当事人，如客户和付款人。我们结合使用现场系统和基于云的数据中心来管理和维护我们的应用程式和数据。我们利用外部安全和基础设施供应商来管理我们的部分数据中心。我们还通过电话、互联网、传真、多个第三方供应商及其分包商或与第三方电子医疗记录的集成来传递敏感数据，包括患者数据。这些应用程式和数据包含对我们的业务至关重要的各种资讯，包括研发资讯、患者数据、商业资讯以及商业和财务资讯。我们面临许多与保护这些关键资讯相关的风险，包括无法访问、故意或意外地不当使用或披露、未经授权的访问、不适当的修改，以及我们无法充分监控、审计或修改我们对此类关键资讯的控制。此风险延伸至第三方供应商和分包商，我们使用这些供应商和分包商来管理这些敏感数据或以其他方式代表我们处理这些数据。
这些关键资讯的安全处理、存储、维护和传输对我们的运营和业务战略至关重要，我们投入大量资源建立各种机制，包括行政、物理和技术措施，旨在保护这些资讯。尽管我们采取措施保护敏感数据免受未经授权的访问、使用、修改或泄露，但任何安全措施都不可能是完美的，也不可能针对所有威胁或漏洞提供保护，我们的资讯技术基础设施可能容易受到黑客、网路钓鱼诈骗、恶意软体、病毒、安全漏洞、员工或其他授权访问我们网路的人的错误以及其他不当行为或无意中断的影响。对我们的安全措施或资讯技术基础设施的任何破坏或中断都可能危及我们的网路，存储在那里的资讯可能被未经授权的各方访问，公开披露、丢失或被盗。任何此类资讯的访问、泄露或其他丢失都可能导致法律索赔或诉讼，以及根据保护个人资讯隐私的联盟、州或外国法律(如HIPAA或HITECH)承担的责任，以及监管处罚。
必须向受影响的个人、卫生与公众服务部部长或其他州、联盟或外国监管机构(包括州总检察长)发出违反HIPAA的通知，对于广泛违反的情况，可能需要向媒体发出通知。这样的通知可能会损害我们的声誉和竞争能力。患者数据目前可能可以通过多个渠道访问，并且不能保证我们可以保护所有数据不会被泄露或暴露。未经授权的访问、丢失或传播可能会扰乱我们的运营(包括我们执行分析、提供测试结果、向付款人或患者付款、处理索赔和上诉、提供客户帮助、进行研究和开发、开发知识产权、收集、处理和准备财务资讯、提供有关我们的测试的资讯以及继续其他患者和医生教育和外展工作以及管理我们的业务的能力)，并损害我们的声誉，任何这些能力都可能对我们的业务、财务状况和运营结果产生不利影响。例如，已完成或未来临床试验中的临床试验数据丢失可能会导致我们的监管审批或认证工作的延迟或取消，并显著增加我们恢复或复制丢失数据的成本。我们也可能依赖第三方提供我们所依赖的产品或服务，与他们的电脑系统相关的类似事件也可能对我们的业务、财务状况和运营结果产生重大不利影响。如果任何中断或安全事件导致代表我们处理或维护的我们的数据或其他资讯的任何丢失、销毁或更改，或损坏或未经授权访问，或不适当地披露或传播任何此类资讯，我们候选产品的进一步开发和商业化可能会被推迟。我们继续优先考虑安全以及制定实践和控制措施，以保护我们的系统。随著网路威胁的发展，我们可能需要花费大量额外资源来继续修改或增强我们的保护措施，或者调查和补救任何资讯安全漏洞，而这些努力可能不会成功。
我们为我们的业务或运营中可能出现的某些潜在索赔、债务和成本制定了应急计划和保险；但是，保险范围可能不足以涵盖所有索赔、债务和事故引起的成本，包括罚款和罚款。此外，我们不能确定网路安全事故的保险将继续以经济合理的条款向我们提供，或者根本不能确定任何保险公司不会拒绝为未来的任何索赔提供保险。我们的合同可能不包含责任限制，即使有，也不能保证我们的合同中的责任限制足以保护我们免受与我们的数据隐私和安全义务相关的责任、损害或索赔。可能很难预测任何此类事件的最终解决办法，也很难估计由此可能造成的潜在损失的数额或范围。如果我们不能成功解决安全事件或控制任何潜在损失，可能会对我们的业务、财务状况和运营结果造成实质性影响。
项目2. U股权证券的未登记销售和收益的使用
所得款项用途
2024年6月17日，我们完成了首次公开募股，发行并出售了11，100，000股A类普通股，公开发行价为每股37.00美金。扣除承保折扣和佣金2870日元后，我们收到了38200日元的净收益。随著IPO结束，我们当时已发行的可转换优先股的所有股份自动转换为总计66，640，660股A类普通股。所有出售的股份均根据
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经修订的S-1表格（文件号333-279558）注册声明（「注册声明」），由SEC于2024年6月13日宣布生效。摩根史坦利有限责任公司、摩根大通证券有限责任公司和艾伦担任IPO承销商的代表。在出售根据登记声明登记的所有证券后，发行终止。没有直接或间接向（i）我们的任何高级职员或董事或其联系人，（ii）拥有我们任何类别股票证券10%或以上的任何人士，或（iii）我们的任何附属公司支付该等费用。
我们使用IPO的一部分净收益来满足截至2024年9月30日期间与RSU净结算相关的预扣税和汇款义务以及流动资金。如日期为2024年6月13日并于2024年6月17日根据第424（b）（4）条向SEC提交的最终招股说明书中所述，我们IPO所得款项净额的预期用途没有重大变化。
项目3. De高级证券的缺陷
没有。
项目4.矿井安全y披露
不适用因
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项目5. Oth呃信息
交易安排的披露
在截至2024年9月30日的财政季度内，我们的董事或高级职员（定义见《交易法》第16 a-1（f）条）均未采用或终止「规则10 b5 -1交易安排」或「非规则10 b5 -1交易安排」，每个术语均在S-k法规第408项中定义，下表规定的除外。以下每项计划下的销售最早要到与我们IPO相关的禁售限制到期时才会开始。
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类型的交易 |
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姓名和职位 |
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行动 |
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日期 |
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规则 |
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非规则 |
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股份总数 |
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失效日期 |
行政和法律官员和 助理秘书 |
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X |
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总法律顾问和秘书 |
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X |
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是 (2) |
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X |
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是 (3) |
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X |
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X |
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X |
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X |
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*
**
股权奖励
2024年11月1日，公司董事会薪酬委员会批准向公司财务长吉姆·罗杰斯（Jim Rogers）授予30，000个限制性股票单位（「RSU」），其中四分之一于2025年1月15日一周年归属，此后每季度归属一次。
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项目6. Exhibits
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通过引用并入 |
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表现出 |
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展品描述 |
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形式 |
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文件编号 |
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表现出 |
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申请日 |
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3.1 |
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8-K |
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001-42130 |
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3.1 |
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2024年6月17日 |
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3.2 |
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8-K |
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001-42130 |
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3.2 |
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2024年6月17日 |
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10.11* |
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31.1* |
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31.2* |
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32.1*+ |
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101.IN * |
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Inline DatabRL实例文档-实例文档不会出现在交互式数据文件中，因为其BEP标签嵌入Inline DatabRL文档中。 |
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101.SCH* |
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具有嵌入Linkbase文档的内联MBE分类扩展模式。 |
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104* |
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封面页面格式为内联BEP，包含在附件101中。 |
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* 一起提交
+ 特此提供，不应被视为根据1934年证券交易法（经修订）第18条的目的「提交」，并且不应被视为通过引用纳入根据1933年证券法（经修订）或1934年证券交易法（经修订）下的任何提交。
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SIG性质
根据1934年证券交易法的要求，登记人已正式促使以下正式授权的签署人代表其签署本报告。
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TEMPUS AI，Inc. |
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日期：2024年11月4日 |
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作者： |
/s/埃里克·莱夫科夫斯基 |
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埃里克·莱夫科夫斯基 |
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执行长、创始人兼董事长 |
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（执行长） |
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日期：2024年11月4日 |
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作者： |
/s/詹姆斯·罗杰斯 |
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詹姆斯·罗杰斯 |
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财务长 |
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（财务长） |
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