美国
证券和交易委员会
华盛顿特区 20549
表格
（标记一）
截至季度结束日期的财务报告
or
过渡期从___________到_____________
委托文件编号：001-39866
(根据其章程规定的注册人准确名称)
| ||
（国家或其他管辖区的 | （纳税人识别号码） | |
(主要行政办公室地址) | (邮政编码) |
(
公司注册电话号码，包括区号
在法案第12(b)条的规定下注册的证券：
每个类别的标题 | 交易标的 | 在其上注册的交易所的名称 |
请勾选适用的选项：
(1) 在过去的12个月内（或注册人要求提交这些报告的较短期间内），已按照证券交易法第13或第15(d)条的规定提交了所有要求提交的报告；并
(2) 在过去90天内一直履行了这些提交要求。
请按复选标记指示是否在过去的12个月内（或注册人需要提交此类文件的较短期间）每次提交自Rule 405条款和Regulation S-t（本章第232.405条）规定的互动数据文件。
勾选以下选框，指示申报人是大型加速评估提交人、加速评估提交人、非加速评估提交人、小型报告公司或新兴成长型公司。关于“大型加速评估提交人”、“加速评估提交人”、“小型报告公司”和“新兴成长型公司”的定义，请参见《交易所法规》第120亿.2条。
大型加速文件者☐ | 加速器文件☐ |
较小的报告公司 | |
新兴成长公司 |
如果属于新兴成长型企业，请在复选框中标记，以表示公司已选择不使用根据交易所法第13(a)条规定为遵守任何新的或修订的财务会计准则所提供的延长过渡期。
请按复选标记指示是否为壳公司（根据该法规第120亿.2条款定义）。 是
2024年11月11日，登记公司普通股的流通股数：
Akoya Biosciences，Inc。
关于前瞻性声明的特别说明
本报告包含基于管理层信念和假设以及当前管理层可获得信息的前瞻性声明。本报告中除历史事实声明之外的所有声明均为前瞻性声明，包括关于我们开发、商业化以及实现我们当前和计划产品及服务的市场接受能力、我们的研究和开发努力以及有关我们业务战略、资本使用、经营业绩和财务状况以及未来运营计划和目标的其他事项的声明。在某些情况下，您可以通过“可能”、“将”、“可以”、“将会”、“应该”、“期望”、“打算”、“计划”、“预计”、“相信”、“估计”、“预测”、“项目”、“潜在”、“继续”、“进行中”或这些术语的否定形式或其他可比较术语来识别前瞻性声明，尽管并非所有前瞻性声明都包含这些词。这些声明涉及的风险、不确定性和其他因素可能导致实际结果、活动水平、表现或成就与这些前瞻性声明所表达或暗示的信息存在重大差异。这些风险、不确定性和其他因素在“风险因素”、“管理层关于财务状况和经营业绩的讨论与分析”以及本报告中和我们不时提交给证券交易委员会（“SEC”）的其他文件中有所描述。我们提醒您，前瞻性声明基于我们目前已知的事实和因素的组合以及我们对未来的预测，而我们无法确定这些预测。因此，前瞻性声明可能并不准确。本报告中的前瞻性声明代表我们截至本报告日期的观点。我们不承担更新任何前瞻性声明的义务，除非法律要求。
除非另有说明或上下文另有指示，否则提及“Akoya”、“我们”、“我们”、“我们的”以及类似引用是指Akoya Biosciences, Inc.及其合并子公司。
本报告中包含了我们商标以及其他实体商标的引用。为了方便，提及的商标和商号，包括标志、艺术作品和其他视觉苹果-显示屏，可能没有附带®或™符号，但这样的引用并不是目的在于表明其各自的所有者不会在适用法律的最大范围内主张对此的权利。我们并不打算通过使用或展示其他公司的商号或商标来暗示与任何其他公司有关系，或者受到其他公司的认可或赞助。
1
AKOYA BIOSCIENCES，INC.及其子公司
合并资产负债表
(以千计，除分享和每分享数据外)
| 2024年9月30日 |
| 2023年12月31日 | |||
(未经审计) | ||||||
资产 |
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流动资产 |
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现金及现金等价物 | $ | | $ | | ||
可交易证券 | | — | ||||
应收账款，净额 |
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净存货 |
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预付费用及其他流动资产 |
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总流动资产 |
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物业和设备，净值 |
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有市场价值的证券，扣除当前部分 | | — | ||||
受限现金 |
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演示库存净额 |
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无形资产-净额 |
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商誉 |
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租赁权使用资产净额 | | | ||||
租赁权资产的融资租赁净资产 | | | ||||
其他资产 |
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总资产 | $ | | $ | | ||
负债和股东权益 |
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流动负债 |
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应付账款 | $ | | $ | | ||
应计费用和其他流动负债 |
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经营租赁负债流动部分 | | | ||||
融资租赁负债目前部分 | | | ||||
递延收入 |
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总流动负债 |
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递延收入，减去当前部分净额 |
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长期债务，减债务折扣 |
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递延所得税负债，净额 |
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经营租赁负债，净值超过流动资产 | | | ||||
Financing lease liabilities, net of current portion | | | ||||
Contingent consideration liability, net of current portion |
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其他负债 | | — | ||||
总负债 |
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股东权益: |
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优先股，$ | ||||||
普通股票$ |
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股票认购应收款项。 |
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累积赤字 |
| ( |
| ( | ||
累计其他综合收益 | | — | ||||
股东权益总额 |
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总负债和股东权益 | $ | | $ | | ||
有关合并财务报表的附注请参阅。
2
AKOYA BIOSCIENCES公司及其子公司
合并营业收入表（未经审计）
(单位: 千元，除每股数据外)
截至三个月的时间结束 |
| 截至九个月 | ||||||||||
九月30日 | 九月30日 |
| 九月30日 | 九月30日 | ||||||||
| 2024 |
| 2023 | 2024 |
| 2023 | ||||||
收入： |
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产品收入 | $ | | $ | | $ | | $ | | ||||
服务和其他营业收入 |
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总营业收入 |
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营业成本: |
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产品营业成本 | | | | | ||||||||
服务和其他收益成本 | | | | | ||||||||
营业成本合计 | | | | | ||||||||
毛利润 | | | | | ||||||||
运营费用： |
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销售、一般及行政费用 |
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研发 |
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或有对价公允价值变动 |
| ( |
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减值 |
| — |
| — |
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| — | ||||
重组 | | — | | — | ||||||||
总营业费用 |
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营业损失 |
| ( |
| ( |
| ( |
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其他收入（费用）： |
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利息支出 |
| ( |
| ( |
| ( |
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利息收入 | | | | | ||||||||
其他费用，净额 |
| ( |
| ( |
| ( |
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税前亏损 | ( | ( | ( | ( | ||||||||
所得税准备金 |
| ( |
| ( |
| ( |
| ( | ||||
净亏损 | $ | ( | $ | ( | $ | ( | $ | ( | ||||
每股普通股股东净亏损，基本与稀释后 | ( | ( | ( | ( | ||||||||
基本和摊薄加权平均股本 |
| |
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有关合并财务报表的附注请参阅。
3
4
AKOYA BIOSCIENCES，INC.及其子公司
合并报表
股东权益（未经审计）
（以千为单位，除股票数据外）
累计 | |||||||||||||||||
额外的 | 其他 | 总计 | |||||||||||||||
普通股 | 实缴 | 累计 | 综合 | 股东权益 | |||||||||||||
| 股份 |
| 金额 |
| 资本 |
| 亏损 |
| （损失）收益 |
| 股权 | ||||||
2023年12月31日余额 |
| | $ | |
| $ | | $ | ( | $ | — | $ | | ||||
行使股票期权 |
| | — |
|
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| — |
| — |
| | |||||
限制性股票单位的认股权发放 | | — | ( | — | — | ( | |||||||||||
净亏损 | — | — | — | ( | — | ( | |||||||||||
其他综合损失 |
| — | — |
|
| — |
| — |
| ( |
| ( | |||||
基于股票的补偿 |
| — | — |
|
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| — |
| — |
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2024年3月31日结存余额 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
行使股票期权 |
| | — |
|
| |
| — |
| — |
| | |||||
限制性股票单位的认股权发放 | | — | ( | — | — | ( | |||||||||||
净亏损 | — | — | — | ( | — | ( | |||||||||||
其他综合收益 |
| — | — |
|
| — |
| — |
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基于股票的补偿 |
| — | — |
|
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| — |
| — |
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2024年6月30日余额 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
行使股票期权 |
| | — |
|
| |
| — |
| — |
| | |||||
限制性股票单位的认股权发放 | | — | — | — | — | — | |||||||||||
净亏损 | — | — | — | ( | — | ( | |||||||||||
其他综合收益 |
| — | — |
|
| — |
| — |
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基于股票的补偿 |
| — | — |
|
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| — |
| — |
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2024年9月30日的结余 | | $ | | $ | | $ | ( | $ | | $ | | ||||||
累计 | |||||||||||||||||
额外的 | 其他 | 总计 | |||||||||||||||
普通股 | 实缴 | 累计 | 综合 | 股东权益 | |||||||||||||
股份 |
| 金额 |
| 资本 |
| 亏损 |
| （损失）收益 |
| 股权 | |||||||
2022年12月31日余额 |
| | $ | |
| $ | | $ | ( | $ | ( | $ | | ||||
行使股票期权 |
| | — |
|
| |
| — |
| — |
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限制性股票单位的认股权发放 | | — | ( | — | — | ( | |||||||||||
净亏损 |
| — | — |
|
| — |
| ( |
| — |
| ( | |||||
其他综合收益 | — | — | — | — | | | |||||||||||
基于股票的补偿 |
| — | — |
|
| |
| — |
| — |
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2023年3月31日的余额 | | $ | | $ | | $ | ( | $ | — | $ | | ||||||
行使股票期权 |
| | — |
|
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| — |
| — |
| | |||||
限制性股票单位的认股权发放 | | — | — | — | — | — | |||||||||||
公开发行普通股销售，扣除成本后 | | — | | — | — | | |||||||||||
净亏损 |
| — | — |
|
| — |
| ( |
| — |
| ( | |||||
基于股票的补偿 |
| — | — |
|
| |
| — |
| — |
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2023年6月30日的余额 | | $ | | $ | | $ | ( | $ | — | $ | | ||||||
行使股票期权 |
| | — |
|
| |
| — |
| — |
| | |||||
限制性股票单位的认股权发放 | | — | — | — | — | — | |||||||||||
净亏损 |
| — | — |
|
| — |
| ( |
| — |
| ( | |||||
基于股票的补偿 |
| — | — |
|
| |
| — |
| — |
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2023年9月30日余额 | | $ | | $ | | $ | ( | $ | — | $ | | ||||||
有关合并财务报表的附注请参阅。
5
AKOYA 生物科学公司及其子公司
合并现金流量表（未经审计）
(以千为单位)
截至九个月 | ||||||
2023年9月30日， | 2023年9月30日， | |||||
| 2024 |
| 2023 | |||
运营活动 |
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净损失 | $ | ( | $ | ( | ||
调整净亏损与经营活动使用的现金的折算： |
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折旧和摊销 |
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非现金利息费用 |
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基于股票的补偿费用 |
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递延税项 |
| |
| — | ||
或有对价公允价值变动 |
| ( |
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应收账款的信用损失 | | — | ||||
可交易证券的净增加 | ( | ( | ||||
经营租赁使用权资产 | | | ||||
过剩和过时库存的准备 | | | ||||
减值 | | — | ||||
经营资产和负债的变动： |
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应收账款，净额 |
| |
| ( | ||
预付费用和其他资产 |
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存货，净额 |
| ( |
| ( | ||
应付账款 |
| ( |
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应计费用和其他负债 |
| ( |
| ( | ||
经营租赁负债 | ( | ( | ||||
递延收入 |
| ( |
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净现金流出活动 |
| ( |
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投资活动 |
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购买房产和设备 |
| ( |
| ( | ||
购买可市场证券 | ( | — | ||||
可出售证券销售 | | — | ||||
可交易证券的到期日 | | | ||||
投资活动产生的净现金(使用)提供 |
| ( |
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融资活动 |
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在承销发行中出售普通股票，扣除成本后 | — | | ||||
股票期权行使的收入 |
| |
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限制性股票单位的结算用于税款预扣义务 | ( | ( | ||||
融资租赁的本金偿还 | ( | ( | ||||
债务发行成本的支付 | — | ( | ||||
递延发行费用的支付 |
| ( |
| ( | ||
有条件对价的支付 | ( | ( | ||||
融资活动所使用的净现金（或提供的净现金） |
| ( |
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现金、现金等价物和受限现金的净（减少）增加 |
| ( |
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期初的现金、现金等价物和受限现金 |
| |
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期末的现金、现金等价物和受限现金 | $ | | $ | | ||
现金流信息的补充披露 |
|
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支付的利息 | $ | | $ | | ||
支付的所得税现金 | $ | — | $ | | ||
非现金活动的补充披露 |
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因租赁负债获得的使用权资产 | $ | | $ | | ||
与承销发行的普通股销售相关的未支付发行费用 | $ | — | $ | | ||
包含在应付账款和应计费用中的房地产和设备购买 | $ | | $ | | ||
请参见合并基本报表的附注。
6
AKOYA BIOSCIENCES, INC. 及其子公司
合并基本报表附注
(金额以千计，除分享及每分享数据外)
(1) 公司及其陈述基础
业务描述
Akoya Biosciences, Inc.（“Akoya”或“公司”）是一家生命科学科技公司，成立于2015年11月13日，作为德拉瓦州公司，在马尔伯勒，马萨诸塞州运营，提供专注于转变发现、临床研究和诊断的空间生物学解决方案。空间生物学是指一种快速发展的技术，使学术界和生物制药科学家能够在单细胞分辨率下检测和映射细胞类型和生物标志物在整个组织样本中的分布，从而推动他们对疾病进展和患者对治疗反应的理解的进步。通过Akoya的PhenoCycler（前称CODEX）和PhenoImager（前称Phenoptics）平台、试剂、软件和服务，公司提供端到端解决方案，以实现从发现到转化和临床研究及诊断的组织分析和空间表型分析。
2018年9月28日，公司收购了Perkin Elmer, Inc.（“PKI”）的商业定量病理解决方案（“QPS”）部门，随后更名为Revvity, Inc.（“Revvity”），用于多重免疫荧光，旨在为消费者提供一整套端到端的高参数组织分析解决方案。QPS技术为癌症免疫学和免疫治疗研究提供病理解决方案，包括先进的多重免疫化学染色试剂盒、多光谱成像和完整侧面扫描仪器，以及图像分析软件。公司的互补技术组合旨在推动癌症免疫学、免疫治疗、神经学及其他广泛应用的突破性进展。公司销售至
合并原则
公司的基本报表已经按照美国会计原则（“GAAP”）进行准备。本说明中的任何相关指导均指向美国公认的会计原则，这些原则可以在财务会计标准委员会（“FASB”）的会计标准分类（“ASC”）和会计标准更新（“ASU”）中找到。公司的合并基本报表包括公司及其全资子公司Akoya Biosciences UK Ltd.（“Akoya UK”）的账户。所有的内部公司余额和交易在合并中已被消除。
未经审计的中期财务信息
截至2024年9月30日的合并资产负债表、合并经营报表、合并全面损失报表以及截至2024年和2023年9月30日三个月和九个月的合并股东权益报表，以及截至2024年和2023年9月30日九个月的合并现金流量表均为未经审计。未经审计的中期合并基本报表已按照审计的年度合并基本报表相同的基础准备，并且管理层认为，反映了截至2024年9月30日公司财务状况的所有调整，这些调整仅包括正常的经常性调整，对于截至2024年和2023年9月30日三个月和九个月的经营结果，以及截至2024年和2023年9月30日九个月的现金流量而言，都是必要的。这些与2024年和2023年9月30日三个月和九个月相关的财务数据和其他信息在这些注释中也为未经审计。截至2024年9月30日的三个月和九个月的结果不一定代表预计的截止2024年12月31日的年度结果、任何其他中期，或任何未来年份或时期的结果。此处包含的截至2023年12月31日的合并资产负债表取自该日期的审计合并基本报表。这些未经审计的合并基本报表应当结合在一起阅读。
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连同2024年3月5日向美国证券交易委员会（“SEC”）提交的10-k表年度报告中包含的公司截至2023年12月31日止年度的经审计的合并财务报表及其附注。
流动性和持续经营
该公司面临许多与其他新商业生命科学公司类似的风险，包括但不限于其开发产品和潜在产品并获得市场认可、成功与竞争对手竞争、保护其专有技术以及在需要时筹集额外资金的能力。
截至2024年9月30日，该公司的现金、现金等价物和有价证券为美元
公司通过Midcap Financial Trust（“Midcap Trust Term Lo）” 进行债务an”) 受最低财务契约的约束。根据公司目前的运营计划，公司无法确定在这些财务报告发布后的至少未来十二个月内能够保持对这些财务契约的遵守情况，如果公司的中型股信托定期贷款到期，这可能会导致需要额外的现金资源。公司打算向Midcap Financial Trust或其他贷款机构寻求豁免，为未偿借款再融资或以其他方式缓解这些担忧。无法保证会获得豁免，也无法保证公司能够为未偿金额再融资，在这种情况下，贷款机构可以行使Midcap Trust Termil贷款规定的任何和所有权利和补救措施。
由于这些不确定性，公司是否有能力在这些合并财务报表发布之日后的未来十二个月内继续作为持续经营企业存在很大疑问。所附的合并财务报表是在持续经营的基础上编制的，其中考虑在正常业务过程中变现资产和清偿负债。财务报表不包括因上述不确定性而可能产生的与所记录资产金额的可收回性和分类或负债金额和分类有关的任何调整。
(2) 重要会计政策摘要
重要的会计政策
该公司的重要会计政策已在向美国证券交易委员会提交的截至2023年12月31日的10-k表年度报告中披露，在截至2024年9月30日的九个月中没有重大变化。
重新分类
上期合并财务报表中的某些金额已重新分类，以符合本期的列报方式。
收入确认
该公司遵循ASC 606标准， 与客户签订合同的收入 （“ASC 606”）。
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公司通过销售和安装仪器、相关的保修服务、试剂、软件（包括公司自有和第三方的软件）以及实验室服务产生营业收入。根据ASC 606，当客户获得承诺的商品或服务的控制权时，确认营业收入。确认的营业收入金额反映了公司期望因这些商品和服务应得的对价。
为了判断在606主题范围内确认的适当营业收入金额，公司执行以下五个步骤：（i）识别客户合同；（ii）识别履约义务；（iii）测量交易价格，包括对变量对价的限制；（iv）将交易价格分配给履约义务；（v）当（或在）公司满足每个履约义务时确认营业收入。公司仅在可以合理确定公司将收取其应得的对价以交换其转移给客户的商品或服务的情况下，适用这五步模型。
公司评估客户合同中承诺的所有商品和服务，并判断哪些是独立的履约义务。此评估包括对商品或服务是否具备独特性及其是否可以从合同中的其他承诺中分离的评估。当（i）客户可以单独或与其他现成资源一起从商品或服务中获益，并且（ii）承诺的商品或服务可以从合同中的其他承诺中单独识别时，承诺的商品或服务被视为独特。
公司与客户的大多数合同包含多个履约义务（即，仪器销售和保修服务）。对于这些合同，如果履约义务是独特的（即能够独立及与合同中的其他承诺分离），公司将单独对待每个履约义务。交易价格相对于单独售价基础分配给各个履约义务。销售税和其他类似税费不包括在交易价格中，按净额列示。
为了判断单独销售价格，公司定期分析各种商品或服务是否具有可观察的单独销售价格，并识别当前单独销售价格的显著变化。如果公司没有特定商品或服务的可观察单独销售价格，则通过最大化使用可观察输入的方法来估算该特定商品或服务的单独销售价格。公司判断单独销售价格的过程需要判断，并考虑多个合理可用的因素，最大化使用可能随着时间变化的可观察输入，这些因素可能与每个履约义务相关的独特事实和情况有关。公司认为这种方法可以生成一个估计值，代表公司如果将产品单独出售时的定价。
税费，如销售税、增值税和其他税费，随着营业活动从客户处收取并上缴给政府部门，这些不包含在营业收入中。与外发货物相关的运输和处理费用被视为履行成本，包含在销售成本中。
产品营业收入
产品收入主要通过公司在美国及国外地域的直销团队销售仪器和消耗性试剂而产生。公司通常不向客户提供产品退货或交换权利（除了与缺陷商品保修相关的情况）或价格保护津贴。当客户购买仪器时，公司在相关履约义务被满足时确认收入（即当仪器的控制权转移给客户时）。消耗品的销售收入在发货给客户时确认。公司的永久软件许可证在交付时通常具有显著的独立功能，视为功能性知识产权。公司的永久软件许可证被视为独特的履约义务，分配给软件许可证的收入通常在提供许可证/软件代码给客户时确认（即当软件可供客户访问和下载时）。
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服务和其他营业收入
仪器的产品销售包括通常为期一年的基于服务的保修， 在安装所购买仪器后的服务期内，许多情况下还提供额外一年的延长保修。这些是单独的履约义务，因为它们是基于服务的保修，并在服务交付期间以直线法确认。服务期结束后，客户可以选择续订或延长保修服务，通常需要额外的 服务期以换取额外的报酬。延长保修也是基于服务的保修，代表了独立的购买决策。公司在服务交付期间以直线法确认分配给延长保修履约义务的收入。独立收取的安装服务的收入在安装过程完成时确认。此外，公司提供实验室服务，收入在服务履行时确认。对于实验室服务，公司通常使用产出法来衡量履约义务完成进度的程度。对于伴随诊断开发，公司通常使用成本对成本的方法来衡量履约义务完成进度的程度，因为公司认为这最能反映资产转移给客户的情况。在产出法下，完成进度的程度根据迄今为止转移服务的价值与合同下承诺的剩余服务进行衡量。在成本对成本测量方法中，完成进度的程度根据迄今为止发生的成本与履约义务完成时的总预计成本的比例进行衡量。收入根据成本发生的比例进行记录。公司将向客户收取的运输和处理费用记录为服务和其他营业收入，并在合并经营报表中将相关费用计入服务和其他营业收入的成本中。
在2022年6月，公司与Acrivon Therapeutics, Inc.（以下简称“Acrivon协议”）签订了一个伴随诊断协议，共同开发、验证并商业化Acrivon的OncoSignature®测试。2023年12月4日，公司修订了Acrivon协议，扩大了工作范围并增加了总研发里程碑支付，总金额为$
Acrivon协议属于ASC 606的范围， 来自客户合同的营业收入公司认为Acrivon协议包含一个针对特定开发服务的履约义务，因为其基础要素是一个单一开发服务的输入，并且在合同的背景下并不独立。Acrivon协议中的其他开发服务被视为一个选择，因有某些具有重大不确定性的或有条件情形。公司将在一段时间内按比例确认交易价格的营业收入，金额与发生的费用和满足其履约义务的总预计费用成比例。
公司在该安排下发生的费用被作为研发费用包含在公司的合并损益表中，因为这些费用与公司拥有并提供的新服务和科技的开发相关。
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营业收入的分解
公司根据产品类型将与客户的合同收入进行分解，并在仪器保修与服务和其他收入之间进行区分，因为这最能体现收入和现金流的性质、金额、时机及不确定性如何受到经济因素的影响。下表将公司的收入按主要来源进行分解：
截至三个月 | 截至九个月 | |||||||||||
| 2024年9月30日 |
| 2023年9月30日 |
| 2024年9月30日 |
| 2023年9月30日 | |||||
营业收入 |
|
|
|
|
|
|
| |||||
产品收入 |
|
|
|
|
|
|
| |||||
工具 | $ | | $ | | $ | | $ | | ||||
消耗品 |
| |
| |
| |
| | ||||
独立软件产品 |
| |
| |
| |
| | ||||
总产品收入 | $ | | $ | | $ | | $ | | ||||
服务及其他收入 | ||||||||||||
服务及其他收入 | $ | | $ | | $ | | $ | | ||||
仪器保修 | | | | | ||||||||
总服务与其他营业收入 | $ | | $ | | $ | | $ | | ||||
总营业收入 | $ | | $ | | $ | | $ | | ||||
重大判断
公司与客户的合同通常包括将多种产品和服务转让给客户的承诺。判断产品和服务是否被视为独立的履约义务，应该单独核算还是一起核算，需要重大判断。一旦公司确定了履约义务，公司便确定交易价格，包括估计应包含在交易价格中的变量对价的金额（如果有的话），该金额基于最可能的金额。然后，公司根据相对独立销售价格方法将交易价格分配给合同中的每个履约义务。相关的营业收入在相关履约义务被满足时确认，正如上述营业收入类别所讨论的。
需要判断来确定每个独立履约义务的独立销售价格。公司基于合同中履约义务（即仪器、服务保修、安装）可单独出售的价格来确定独立销售价格。由于每个仪器的第一年保修已嵌入仪器价格中，因此分配给第一年保修的金额是基于公司提供的延长保修产品在续订基础上销售时的可单独识别价格确定的。
如果无法通过过去的交易观察到独立销售价格，公司会考虑可用信息（例如市场条件和与履约义务相关的预计成本和利润）来估计独立销售价格。仅识别出一个履约义务的合同（即消耗品和独立软件产品）不需要分配交易价格。
合同资产和负债
公司的合同资产包括已确认的、但尚未发票给客户的实验室服务、辅助诊断开发和仪器的收入。公司将合同资产归类为应收账款。合同资产根据公司预期何时向客户开具发票的时间分类为流动或非流动。公司记录了$
公司的合同负债包括与仪器销售相关的基于服务的保修的预付款，以及实验室服务。公司将与基于服务的保修相关的合同负债归类为递延收入，将与实验室服务相关的合同负债归类为应付费用。合同负债被分类为
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根据公司预计提供保修服务或完成实验室服务合同的时间来判断是流动还是非流动。
获取和履行合同的成本
根据ASC 606，公司需要资本化某些获取客户合同和履行客户合同的成本。这些成本要求在与资产相关的货物或服务转移给客户时，以系统的方式摊销为费用，而不是以前的即时费用化。作为一种实用的权宜之计，公司在发生时将获取合同的任何增量成本认定为费用，如果资产的摊销期为
基于股票的补偿
公司为授予员工、非员工以及公司董事会（“董事会”）成员的股票激励补偿进行记录，以根据授予日的公允价值进行记录，费用在必需的服务期内按照直线法进行记录，通常是
公司使用布莱克-斯科尔斯-默顿期权定价模型来判断股票期权的公允价值。使用布莱克-斯科尔斯-默顿期权定价模型需要管理层对期权的预期期限、与期权预期生命周期一致的普通股的预期波动性、无风险利率和普通股的预期分红派息收益率做出假设。预期期限是根据简化方法确定的，即归属分期的日期和合同期限的平均值。由于缺乏公司特定的历史和隐含波动率，公司将其预期波动率的估计基于一组公开交易的类似公司的历史波动率，结合公司的历史波动率。对于这些分析，选择具有可比特征的公司，包括企业价值和行业内的位置，以及具有足够的历史价格信息以满足股票奖励的预期生命周期。公司使用其股票奖励的预计期限的等效期间内公司及所选公司的每日收盘价来计算历史波动率数据。公司将继续应用此过程，直到有关其自身股票价格的波动率的足够历史信息可用为止。无风险利率通过参考与期权预期期限相似的美国国债零息票的发行来判断。公司没有支付现金分红的历史，也不预期会支付，因此预期分红派息收益率被假定为
对于公司股票基薪计划下发行的限制性股票单位（"RSUs"），每次授予的公允价值根据授予日期公司股票的价格计算。
公司选择在发生注销时进行会计处理；由于未满足服务或业绩控件的奖励被注销而之前确认的任何补偿费用将在注销期间被冲回。
有关公司股票补偿计划的进一步详情，请参阅注释11。
归属于普通股股东的每股净亏损
基本和稀释后每股普通股净亏损是通过将净亏损除以期间内的加权平均普通股数量来判断的。对于稀释后每股净亏损计算的目的，期权和未归属限制性股票单位被视为潜在的稀释证券，但由于其影响将导致反稀释，因此在稀释后每股净亏损中被排除，因此所有展示期间的基本与稀释后每股净亏损是相同的。
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综合收益（亏损）
全面收入（损失）的组成部分，包括净损失，在被确认的期间报导于基本报表中。其他全面收入（损失）定义为在一段期间因非所有者来源的交易和其他事件及情况而引起的股本变化。净损失和其他全面收入（损失）是在扣除任何相关税收影响后报导的，以计算全面收入（损失）。全面收入（损失）包括净损失以及因与股东无关的交易和经济事件所导致的股东权益的其他变化，对于截至2024年和2023年9月30日的三个月和九个月，由未实现的市场证券收益（损失）组成。
可售证券
可出售市场证券代表根据公司的投资政策持有的可供出售市场债务证券。短期市场证券在资产负债表日一年内到期，而长期市场证券在一年后到期。市场证券的投资按公允价值记录，任何未实现的收益和损失在累计其他全面收入（损失）中作为股东权益的单独元件进行报告，直到实现或做出判断认为已经发生非暂时性的市场价值降低为止。债务证券的摊余成本根据溢价的摊销和折价的增值进行调整，直至到期。这些摊销和增值反映为利息收入的一个组成部分。售出证券的利息基于特定识别法确定，并反映为利息收入。任何已实现的投资售出收益或损失反映为投资的已实现（损失）收益。
最近的会计标准
不时地，FASB或其他标准制定机构会发布新的会计公告，并根据指定的生效日期由公司采纳。公司被认为是《2012年启动我们的商业创业法案》（Jobs Act）修订版中规定的“新兴成长公司”。Jobs Act规定新兴成长公司可以享受延长的过渡期，以遵守新的或修订的会计标准。因此，新兴成长公司可以推迟采用某些会计标准，直到这些标准本应适用于私人公司。公司已选择利用这一延长的过渡期，因此，公司在相关日期将不被要求按照其他公立公司的要求采用新的或修订的会计标准。
最近发布但尚未采用的会计准则
在2023年11月，FASB发布了ASC更新第2023-07号， 分部报告（主题280）：可报告分部披露的改进该更新增强了可报告分部的披露要求，要求公共实体提供重大分部费用和其他分部项目的披露，以及关于可报告分部的利润或亏损和资产的披露，这在中期阶段目前要求每年进行一次。新标准将于2024年1月1日开始的期间适用于公司的年度基本报表。公司目前正在评估该标准对其合并基本报表的影响。
在2023年12月，FASB发布了ASC更新第2023-09号， 所得税（主题740）：所得税披露的改进该更新增强了所得税披露要求，要求公共实体在其税率调解中提供更多信息，并提供有关已支付所得税的额外披露。该更新适用于2024年12月15日之后开始的年度期间。允许早期采用尚未发布或提供发布的年度基本报表，并且本次更新中的修正案应前瞻性施行，但实体可以选择追溯适用。公司目前正在评估该标准对其合并基本报表的影响。
13
(3) Significant risks and uncertainties including business and credit concentrations
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, marketable securities, and receivables. The Company’s cash equivalents are held by large, credit worthy financial institutions. Marketable securities consist of short-term investments. The Company has established guidelines relative to credit ratings, diversification and maturities that seek to maintain safety and liquidity. Deposits in these banks generally exceed federally insured limits. To date, the Company has not experienced any losses on its deposits of cash and cash equivalents.
The Company controls credit risk through credit approvals, credit limits, and monitoring procedures. The Company performs periodic credit evaluations of its customers and generally does not require collateral. Accounts receivable are recorded net of an allowance for credit losses. The allowance for credit losses is developed using historical collection experience, current and future economic and market conditions, and a review of the status of customers’ accounts receivable. The Company had an allowance for credit losses of $
For the three and nine months ended September 30, 2024 and 2023,
14
(4) Fair value of financial instruments
The Company measures the following financial liabilities at fair value on a recurring basis. There were
The following tables set forth the Company’s financial assets and liabilities carried at fair value categorized using the lowest level of input applicable to each financial instrument as of September 30, 2024 and December 31, 2023:
Quoted Prices | ||||||||||||
in Active | Significant | |||||||||||
Markets for | Other | Significant | ||||||||||
Balance at | Identical | Observable | Unobservable | |||||||||
September 30, | Assets | Inputs | Inputs | |||||||||
| 2024 |
| (Level 1) |
| (Level 2) |
| (Level 3) | |||||
Assets: | ||||||||||||
Cash equivalents | $ | | $ | | $ | | $ | — | ||||
U.S Treasury securities | | | | — | ||||||||
U.S. Government agency bonds | | | | — | ||||||||
Commercial paper | | | | — | ||||||||
Total Assets | $ | | $ | | $ | | $ | — | ||||
Liabilities: |
|
|
|
|
|
|
|
| ||||
Contingent consideration – Short term portion | $ | | $ | | $ | | $ | | ||||
Contingent consideration – Long term portion | | | | | ||||||||
Total Liabilities | $ | | $ | | $ | | $ | | ||||
Quoted Prices | ||||||||||||
in Active | Significant | |||||||||||
Markets for | Other | Significant | ||||||||||
Balance at | Identical | Observable | Unobservable | |||||||||
| December 31, |
| Assets |
| Inputs |
| Inputs | |||||
| 2023 |
| (Level 1) |
| (Level 2) |
| (Level 3) | |||||
Assets: | ||||||||||||
Cash equivalents | $ | | $ | | $ | | $ | — | ||||
Total Assets | $ | | $ | | $ | | $ | — | ||||
Liabilities: |
|
|
|
|
|
|
|
| ||||
Contingent consideration – Short term portion | $ | | $ | | $ | | $ | | ||||
Contingent consideration – Long term portion | | | | | ||||||||
Total Liabilities | $ | | $ | | $ | | $ | | ||||
15
The following is a summary of cash equivalents and marketable securities as of September 30, 2024 and December 31, 2023:
September 30, 2024 | ||||||||||||
Gross | Gross | |||||||||||
Unrealized | Unrealized | Estimated | ||||||||||
| Cost |
| Gains |
| Losses |
| Fair Value | |||||
Cash equivalents | $ | | $ | — | $ | — | $ | | ||||
Marketable securities (due in one year or less): | ||||||||||||
U.S Treasury securities | | | ( | | ||||||||
Commercial paper | | — | — | | ||||||||
Total marketable securities due in one year or less | | | ( | | ||||||||
Marketable securities (due in one to two years): | ||||||||||||
U.S. Government agency bonds | | — | ( | | ||||||||
Total marketable securities due in one to two years | | — | ( | | ||||||||
Total cash equivalents and marketable securities | $ | | $ | | $ | ( | $ | | ||||
December 31, 2023 | ||||||||||||
Gross | Gross | |||||||||||
Unrealized | Unrealized | Estimated | ||||||||||
| Cost |
| Gains |
| Losses |
| Fair Value | |||||
Cash equivalents | $ | | $ | — | $ | — | $ | | ||||
Total cash equivalents | $ | | $ | — | $ | — | $ | | ||||
The Company held four debt securities at September 30, 2024 classified as marketable securities with original maturity dates greater than three months that were in an unrealized loss position for less than twelve months. The fair market value of these securities was $
The Company had no material realized gains or losses on its available-for-sale securities for the three and nine months ended September 30, 2024 and 2023.
The Company’s recurring fair value measurements using Level 3 inputs relate to the Company’s contingent consideration liability. In those circumstances where an acquisition involves a contingent consideration arrangement, the Company recognizes a liability equal to the fair value of the contingent payments the Company expects to make as of the acquisition date. The Company re-measures this liability each reporting period and records changes in the fair value through changes in fair value of contingent consideration on the Company’s consolidated statements of operations. Increases or decreases in the fair value of the contingent consideration liability can result from changes in discount rates, periods, timing and amount of projected revenue.
16
The recurring Level 3 fair value measurements of the Company’s contingent consideration liability include the following significant unobservable inputs:
Fair Value | Fair Value |
|
| ||||||
as of | as of | ||||||||
September 30, | December 31, | Valuation | Unobservable | ||||||
Contingent Consideration Liability |
| 2024 |
| 2023 | Technique |
| Inputs | ||
Revenue-based Payments | $ | |
| $ | | Discounted Cash Flow Analysis under the Income Approach |
| Revenue discount factor, discount rate | |
(5) Property and equipment, net
Property and equipment consists of the following:
Estimated Useful | September 30, | December 31, | ||||||
| Life (Years) |
| 2024 |
| 2023 | |||
Furniture and fixtures |
| $ | | $ | | |||
Computers, laptop and peripherals |
|
| |
| | |||
Laboratory equipment |
|
| |
| | |||
Leasehold improvements |
| Shorter of the lease life or |
| |
| | ||
Total property and equipment |
|
|
| |
| | ||
Less: Accumulated depreciation |
|
|
| ( |
| ( | ||
Property and equipment, net |
|
| $ | | $ | | ||
For the three months ended March 31, 2024, the Company recorded $
Depreciation expense relating to property and equipment charged to operations was $
Demo inventory consists of the following:
Estimated | September 30, | December 31, | ||||||
| Life (Years) |
| 2024 |
| 2023 | |||
Demo inventory – gross |
| $ | | $ | | |||
Less: Accumulated depreciation |
|
|
| ( |
| ( | ||
Demo inventory, net |
|
| $ | | $ | | ||
Depreciation expense relating to demo equipment charged to operations was $
17
(6) Allowance for credit losses
The Company is exposed to credit losses primarily through sales of products and services. The Company’s expected loss allowance methodology for accounts receivable is developed using historical collection experience, current and future economic and market conditions, and a review of the current status of customers’ trade accounts receivable. Due to the short-term nature of such receivables, the estimated accounts receivable that may not be collected is based on aging of the accounts receivable balances.
The Company evaluates contract terms and conditions, country, and political risk, and may require prepayment to mitigate risk of loss. Specific allowance amounts are established to record the appropriate provision for customers that have a higher probability of default. The Company monitors changes to the receivables balance on a timely basis, and balances are written off as they are determined to be uncollectable after all collection efforts have been exhausted.
As of September 30, 2024, the Company’s accounts receivable balance was $
Balance at January 1, 2024 | $ | | |
Change in provision | | ||
Balance at September 30, 2024 | $ | |
(7) Intangible assets
Intangible assets as of September 30, 2024 are summarized as follows:
Accumulated | Useful Life | ||||||||
| Cost |
| Amortization |
| Net |
| (in years) | ||
Customer relationships | $ | | $ | ( | $ | |
| ||
Developed technology | |
| ( |
| |
| |||
Licenses | |
| ( |
| |
| |||
Trade names and trademarks | |
| ( |
| |
| |||
Capitalized software | |
| ( |
| |
| |||
Total intangible assets | $ | | $ | ( | $ | |
|
| |
Intangible assets as of December 31, 2023 are summarized as follows:
Accumulated | Useful Life | ||||||||
| Cost |
| Amortization |
| Net |
| (in years) | ||
Customer relationships | $ | | $ | ( | $ | |
| ||
Developed technology | |
| ( |
| |
| |||
Licenses | |
| ( |
| |
| |||
Trade names and trademarks | |
| ( |
| |
| |||
Capitalized software | |
| ( |
| |
| |||
Total intangible assets | $ | | $ | ( | $ | |
|
| |
Total amortization expense was $
18
As of September 30, 2024 the amortization expense related to identifiable intangible assets in future periods is expected to be as follows:
2024 remaining |
| $ | |
2025 |
| | |
2026 |
| | |
2027 |
| | |
2028 | | ||
Thereafter |
| | |
Total | $ | |
(8) Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following:
September 30, | December 31, | |||||
| 2024 |
| 2023 | |||
Payroll and compensation | $ | | $ | | ||
Current portion of contingent consideration |
| |
| | ||
Inventory purchases |
| |
| | ||
Customer deposits | | | ||||
Accrued interest | | | ||||
Other accrued expenses |
| |
| | ||
Total accrued expenses and other current liabilities | $ | | $ | | ||
(9) Debt
Term Loan Agreements
In October 2020, the Company entered into the Midcap Trust Term Loan with Midcap Financial Trust, for a $
The Midcap Trust Term Loan initially provided for an interest only term for
On March 21, 2022, the Company entered into Amendment No. 1 to the Midcap Trust Term Loan, which amended certain provisions to permit certain additional debt and capital leases.
On June 1, 2022, the Company entered into Amendment No. 2 (“Amendment No. 2”) to the Midcap Trust Term Loan, which permitted the draw of a second tranche of $
19
commitment fee as well as a
On November 7, 2022, the Company entered into Amendment No. 3 (“Amendment No. 3”) to the Midcap Trust Term Loan, which permitted the draw of two additional tranches, each totaling $
In July 2024, the Company entered into Amendment No. 4 (“Amendment No. 4”) to the Midcap Trust Term Loan, which amended certain affirmative financial covenants.
In November 2024, the Company entered into Amendment No. 5 (“Amendment No. 5”) to the Midcap Trust Term Loan, effective as of September 30, 2024, which amended certain affirmative financial covenants. Amendment No. 5 also extends the interest only period from December 1, 2025 until March 1, 2026 (subject to further extension upon certain conditions), at which point the Company must repay the principal amounts in equal monthly installments until the maturity date of November 1, 2027. Finally, Amendment No. 5 increases the exit fee from
The interest rate was
Debt consists of the following:
September 30, | December 31, | |||||
| 2024 |
| 2023 | |||
Midcap Trust Term Loan |
| $ | |
| $ | |
Unamortized debt discount |
| ( |
| ( | ||
Accretion of final fee |
| |
| | ||
Total long-term debt, net | $ | | $ | | ||
As of September 30, 2024, future principal payments due under the Midcap Trust Term Loan, excluding the $
Midcap Trust | |||
Year ended: |
| Term Loan | |
December 31, 2024 | $ | — | |
December 31, 2025 | | ||
December 31, 2026 | | ||
December 31, 2027 | | ||
Total minimum principal payments | $ | | |
20
(10) Stockholder’s equity
The Company’s Amended and Restated Certificate of Incorporation authorizes it to issue
On November 7, 2022, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler”) with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $
Issuance costs incurred related to the Equity Distribution Agreement are classified as long-term assets on the balance sheet at September 30, 2024 and December 31, 2023.
On June 7, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Morgan Stanley & Co. LLC and Piper Sandler (collectively, the “Underwriters”), pursuant to which the Company agreed to issue and sell up to
On June 8, 2023, the Underwriters exercised their option to purchase the Optional Shares in full.
The Company received approximately $
(11) Stock compensation plans
2021 Equity Incentive Plan
On March 24, 2021, the Board, and on April 8, 2021, the Company’s stockholders, approved and adopted the 2021 Equity Incentive Award Plan (the “2021 Plan”). The 2021 Plan became effective immediately prior to the closing of the IPO. Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock or cash-based awards to individuals who are then employees, officers, directors or consultants of the Company. A total of
21
repurchased by the Company were added to the shares reserved under the 2021 Plan. In addition, the number of shares of common stock available for issuance under the 2021 Plan will be automatically increased on the first day of each calendar year during the term of the 2021 Plan, beginning with January 1, 2022 and ending with January 1, 2030, by an amount equal to
2015 Equity Incentive Plan
The 2015 Plan was established for granting stock incentive awards to directors, officers, employees and consultants to the Company. The 2015 Plan provided for the grant of incentive and non-qualified stock options, stock appreciation rights, restricted stock and restricted stock units as determined by the Board. Under the 2015 Plan, stock options were generally granted with exercise prices equal to or greater than the fair value of the common stock as determined by the Board, expired no later than
Stock Options
During the nine months ended September 30, 2024 and 2023, the Company granted options with an aggregate fair value of $
During the nine months ended September 30, 2024, the Company granted options to purchase
Three months ended | Three months ended | Nine months ended | Nine months ended | |||||||
September 30, | September 30, | September 30, | September 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | ||||||
Weighted-average risk-free interest rate | | % | | % | | % | | % | ||
Expected dividend yield | % | % | % | % | ||||||
Expected volatility | | % | | % | | % | | % | ||
Expected term |
|
|
|
|
Restricted Stock Units
During the nine months ended September 30, 2024 and 2023, the Company granted RSUs with an aggregate fair value of $
22
Stock-Based Compensation
Stock-based compensation related to the Company’s stock-based awards was recorded as an expense and allocated as follows:
Three months ended | Nine months ended | |||||||||||
September 30, | September 30, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Cost of goods sold | $ | | $ | | $ | | $ | | ||||
Selling, general and administrative |
| |
| |
| |
| | ||||
Research and development |
| |
| |
| |
| | ||||
Total stock-based compensation | $ | | $ | | $ | | $ | | ||||
As of September 30, 2024, there was $
As of September 30, 2024, there was $
(12) Employee stock purchase plan
On March 24, 2021, the Board and on April 8, 2021, the Company’s stockholders approved and adopted the 2021 Employee Stock Purchase Plan (the “ESPP”). The ESPP became effective in connection with the closing of the Company’s IPO. The ESPP permits participants to purchase common stock through payroll deductions of up to
(13) Income taxes
During the three months ended September 30, 2024 and 2023, the Company recorded a tax provision of $
(14) Commitments and contingencies
License Agreements
In September 2018, in connection with the acquisition of the QPS division of PKI (subsequently known as Revvity), the Company entered into a License Agreement with PKI, pursuant to which PKI granted the Company an exclusive, nontransferable, sublicensable license under certain patent rights to make, use, import and commercialize QPS products and services. The Company is required to pay royalties on net sales of products and services that are covered by patent rights under the agreement at a rate ranging from
23
2024, and actual net sales in 2023, as of September 30, 2024 and December 31, 2023, respectively. Such amounts are payable in the first quarter of 2025 and 2024, respectively.
Changes in the fair value of the Company’s long-term portion of the contingent consideration liability During the nine months ended September 30, 2024 and 2023 were as follows:
Balance as of December 31, 2023 |
| $ | |
Reclassification of FY 2024 payment to accrued expenses |
| ( | |
| ( | ||
Balance as of September 30, 2024 | $ | |
Balance as of December 31, 2022 |
| $ | |
Reclassification of FY 2023 payment to accrued expenses |
| ( | |
| | ||
Balance as of September 30, 2023 | $ | |
(15) Net loss per share attributable to common stockholders
Potentially issuable shares of common stock include shares issuable upon the exercise of outstanding employee stock option awards. Awards granted with performance conditions are excluded from the shares used to compute diluted earnings per share until the performance conditions associated with the awards are met.
The following table sets forth the computation of basic and diluted earnings per common share:
Three months ended | Nine months ended | |||||||||||
September 30, | September 30, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted |
| |
| |
| |
| | ||||
Basic and diluted net loss per common share outstanding | $ | ( | $ | ( | $ | ( | $ | ( | ||||
The Company’s potential dilutive securities, which include stock options, and unvested restricted stock units, have been excluded from the computation of diluted net loss per share attributable to common stockholders whenever the effect of including them would be to reduce the net loss per share. In periods where there is a net loss, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The following potential common shares, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
September 30, | ||||
| 2024 |
| 2023 | |
Outstanding stock options |
| |
| |
Unvested restricted stock units | | | ||
Total |
| |
| |
(16) Segments
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company’s chief operating decision-maker, the Company’s chief executive officer, views the Company’s operations and manages its business as a single operating segment. Accordingly, the Company has a single
24
reportable segment structure. The Company’s principal operations and decision-making functions are located in the United States.
The following table provides the Company’s revenues by geographical market based on the location where the services were provided or to which product was shipped:
Three months ended | Nine months ended | |||||||||||
September 30, | September 30, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
North America | $ | | $ | | $ | | $ | | ||||
APAC |
| |
| | |
| | |||||
EMEA |
| |
| | |
| | |||||
Total Revenue | $ | | $ | | $ | | $ | | ||||
Three months ended |
| Nine months ended |
| |||||||
September 30, |
| September 30, |
| |||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||
North America |
| | % | | % | | % | | % | |
APAC |
| | % | | % | | % | | % | |
EMEA |
| | % | | % | | % | | % | |
Total Revenue |
| | % | | % | | % | | % | |
North America includes the United States and related territories, as well as Canada. APAC also includes Australia. For the three and nine months ended September 30, 2024, the Company had
As of September 30, 2024 and December 31, 2023, substantially all of the Company’s long-lived assets are located in the United States.
(17) Related party transactions
Argonaut Manufacturing Services Inc. (“AMS”) is a portfolio company of Telegraph Hill Partners, which holds greater than
One of the Company’s officers is a member of the board of directors of a software-as-a-service provider, who provides software development services to the Company, which are utilized for research purposes. During the three months ended September 30, 2024 and 2023, the Company incurred research and development expenses of approximately $
(18) Leases
In the first quarter of 2024, the Company ceased use of its leased facility in Menlo Park, California with the intention to either sublease or exit the vacant space to recover a portion of the total lease costs. The Company’s cease use of its leased facilities required an impairment assessment and the related right-of-use (“ROU”) assets and property and
25
equipment became their own asset group. The impairment analysis evaluated the present value of net cash flows under the original lease and the estimated cash flows under estimated subleases to identify any potential impairment amount. The impairment assessment considered all industry and economic factors such as rental rates, interest rates, and recent real estate activities to estimate the net cash flows analysis and impairment amount.
The above assessments resulted in the Company recording an impairment charge of $
In June 2024, the Company signed a thirty-five month sublease agreement for a portion of its leased facility in Menlo Park, California. In connection with this agreement, the Company received a security deposit totaling $
There were
The Company is a lessee under operating leases of offices, warehouse space, laboratory space, and auto leases, and financing leases of computer equipment, staining equipment, and furniture.
Some leases include an option to renew, with renewal terms that can extend the lease term by five years. The exercise of lease renewal options is at the Company’s sole discretion. None of these options to renew are recognized as part of the Company’s right-of-use asset or lease liability as of September 30, 2024, as renewal was determined to not be reasonably assured.
The table below summarizes the Company’s lease costs for the three and nine months ended September 30, 2024 and 2023:
Three months ended September 30, | Nine months ended September 30, | |||||||||||||
Lease Costs |
| Classification |
| 2024 |
| 2023 |
| 2024 |
| 2023 | ||||
Finance lease cost: | ||||||||||||||
Amortization of right-of-use assets | Cost of service and other revenue | $ | $ | $ | $ | |||||||||
Amortization of right-of-use assets | Selling, general and administrative | |||||||||||||
Amortization of right-of-use assets | Research and development | — | ||||||||||||
Interest on lease liabilities | Interest expense, net | |||||||||||||
Operating lease cost: | ||||||||||||||
Sublease income | Selling, general and administrative | ( | — | ( | — | |||||||||
Rent expense | Cost of product revenue | | | |||||||||||
Rent expense | Selling, general and administrative | | | |||||||||||
Total lease cost | $ | | $ | $ | | $ | ||||||||
26
As of September 30, 2024, future minimum commitments under ASC 842 under the Company’s operating leases were as follows:
Maturity of operating lease liabilities |
| As of September 30, 2024 | |
2024 remaining | $ | ||
2025 | |||
2026 | |||
2027 | |||
2028 | |||
Thereafter | |||
Total lease payments | $ | | |
Less: discount to lease payments | ( | ||
Total operating lease liabilities | $ | | |
As of September 30, 2024, future minimum commitments under ASC 842 under the Company’s financing leases were as follows:
Maturity of financing lease liabilities |
| As of September 30, 2024 | |
2024 remaining | $ | | |
2025 | | ||
2026 | | ||
2027 | | ||
2028 | | ||
Total lease payments | $ | | |
Less: discount to lease payments | ( | ||
Total financing lease liabilities | $ | | |
The table below summarizes the weighted-average remaining lease term (in years), the weighted-average incremental borrowing rate (in percentages), as well as supplemental cash flow information related to leases for the nine months ended September 30, 2024 and 2023:
Nine months ended September 30, | ||||||||
Lease Term, Discount Rates, and Other |
| 2024 |
| 2023 | ||||
Weighted average remaining lease term | ||||||||
Operating leases | years | years | ||||||
Financing leases | years | years | ||||||
Weighted average incremental borrowing rate | ||||||||
Operating leases | % | % | ||||||
Financing leases | | % | | % | ||||
Cash payments of amounts included in lease liabilities | ||||||||
Operating cash flows from operating leases | $ | | $ | | ||||
Operating cash flows from finance leases | | | ||||||
Financing cash flows from finance leases | | | ||||||
(19) Reductions in force
In January of 2024, the Company initiated a workforce reduction in connection with certain operating expense cost savings initiatives implemented by the Company, including the consolidation of its facilities and the exit of its Menlo Park, California leased facility as discussed in Note 18 – Leases. This workforce reduction was substantially completed by the end of the first quarter of 2024.
During the three months ended March 31, 2024, the Company recorded $
27
respectively, which were recorded in restructuring on the consolidated statements of operations. As of September 30, 2024, none of these workforce reduction charges remain unpaid.
In July 2024, the Company initiated a workforce reduction in connection with certain operating expense cost savings initiatives. This workforce reduction was substantially completed by the end of the third quarter of 2024.
During the three months ended September 30, 2024, the Company recorded $
(20) Subsequent events
The Company has evaluated subsequent events from the consolidated balance sheet date through November 14, 2024, which is the date the consolidated financial statements were issued.
On October 25, 2024, the Company entered into the Fourth Amendment to the Acrivon Agreement with Acrivon Therapeutics, Inc., which added additional milestone payments totaling $
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of financial condition and results of operations together with our consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the fiscal year ended December 31, 2023 included in the Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2024. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those described in our Annual Report on Form 10-K for the year ended December 31, 2023, as referred to in the section titled “Risk Factors” under Part II, Item 1A below. Please also see the section titled “Special note regarding forward looking statements.”
Overview
We are an innovative life sciences technology company delivering spatial biology solutions focused on transforming discovery, clinical research and diagnostics. Our mission is to bring context to the world of biology and human health through the power of spatial phenotyping. Spatial phenotyping refers to a rapidly evolving technology that enables academic and biopharma scientists to detect and map the distribution of cell types and biomarkers across whole tissue samples at single-cell resolution, enabling advancements in their understanding of disease progression and patient response to therapy. Through our PhenoCycler and PhenoImager platforms, reagents, software and services, we offer end-to-end solutions to perform tissue analysis and spatial phenotyping across the full continuum from discovery through translational and clinical research and diagnostics.
Our spatial biology solutions measure cells and proteins by providing biomarker data in its spatial context while preserving tissue integrity. Biomarkers are objective measures that capture what is happening in a cell or tissue at a given moment. Current genomic and proteomic methods, such as next-generation sequencing (“NGS”), single-cell analysis, flow cytometry and mass spectrometry, are providing meaningful data but require the destruction of the tissue sample for analysis. While valuable and broadly adopted, these approaches allow scientists to analyze the biomarkers and cells that comprise the tissue but do not provide the fundamental information about tissue structure, cellular interactions and the localized measurements of key biomarkers. Furthermore, current non-destructive tissue analysis and histological methods provide some limited spatial information, but they only measure a minimal number of biomarkers at a time and require expert pathologist interpretation. Our platforms address these limitations by providing end-to-end solutions that enable researchers to quantitatively interrogate a large number of biomarkers and cell types across a tissue section at single-cell resolution. The result is a detailed and computable map of the tissue sample that thoroughly captures the underlying tissue dynamics and interactions between key cell types and biomarkers, a process now referred to as spatial phenotyping. We believe that we are the only business with the breadth of platform capabilities that enable
28
researchers to do a deep exploratory and discovery study, and then further advance and scale their research through the translational and clinical phases, leading to a better understanding of human biology, disease progression and response to therapy. We also believe that we are the only spatial biology business that is capable of delivering a menu of clinical in vitro diagnostics (“IVD”) tests on our platform for routine diagnostic testing.
We offer complete end-to-end solutions for spatial phenotyping, designed to serve the unique needs of our customers in the discovery, translational and clinical markets. The PhenoCycler is an ultra-high parameter and cost-effective platform ideally suited for discovery high-plex research. The PhenoImager platforms, which includes the Fusion instrument and HT instrument, provide high-throughput scalable solutions with the automation and robustness needed for translational and clinical applications. Furthermore, the PhenoCycler and the PhenoImager Fusion can be integrated into a combined system, the PhenoCycler-Fusion, to enable spatial discovery at scale by providing significant improvements in the speed of the workflow. Our portfolio of products offer seamless and integrated workflow solutions for our customers, including important benefits such as flexible sample types, automated sample processing, scalability, comprehensive data analysis and software solutions and dedicated field and applications support. With these platforms, our customers are performing spatial phenotyping to further advance their understanding of diseases such as cancer, neurological and autoimmune disorders, and many other therapeutic areas.
For the three months ended September 30, 2024 and 2023, revenue from North America accounted for approximately 56% and 65% of our revenue, respectively. For the nine months ended September 30, 2024 and 2023, revenue from North America accounted for approximately 58% and 60% of our revenue, respectively.
We generally outsource our production manufacturing and distribution of our instruments and some of our reagents. Design work and prototyping are performed in-house before pilot manufacturing and production are outsourced to third-party contract manufacturers. We use one contract manufacturer to produce our PhenoImager and PhenoCycler instruments, and a second to produce some of our reagent kits. Additionally, we have made investments in our infrastructure and manufacturing facilities to support strategic in-house manufacturing as it relates to our critical and high-complexity proprietary reagents. The contract manufacturers of our systems and reagent kits are located in the United States and Asia. Certain of our suppliers of components and materials are single source suppliers.
As of the date of this Quarterly Report on Form 10-Q, we have financed our operations primarily from the issuance and sale of our equity securities, borrowings under our long-term debt agreement, and revenue from our commercial operations. We have incurred net losses in each period since our inception in 2015. Our net losses were $10.5 million and $12.9 million for the three months ended September 30, 2024 and 2023, respectively. Our net losses were $47.2 million and $52.5 million for the nine months ended September 30, 2024 and 2023, respectively. We expect to continue to incur operating losses for the foreseeable future. However, we plan to continue to grow our business while improving results of operations in an effort to achieve cash flow positivity, as we:
| ● | attract, hire and retain qualified personnel, including in connection with our investments in our infrastructure to support in-house manufacturing; |
| ● | market and sell new and existing solutions and services; |
| ● | invest in processes and infrastructure to scale our business; |
| ● | support research and development to introduce new solutions; |
| ● | expand, protect and defend our intellectual property; and |
| ● | acquire complementary businesses or technologies to support the growth of our business. |
29
Key factors affecting our results of operations and future performance
There are a number of factors that have impacted, and we believe will continue to impact, our business, results of operations and growth. Our ability to successfully address these factors is subject to various risks and uncertainties, including those described under the heading “Risk Factors.”
Our ability to expand our installed base
We are focused on increasing sales of our PhenoCycler and PhenoImager platforms (Fusion and HT) to new and existing customers. Our financial performance has historically been driven by, and will continue to be impacted by, the volume of instrument sales. Additionally, instrument sales are a leading indicator of future recurring revenue from consumables and services. Our operating results and growth prospects will be dependent in part on our ability to increase our instrument installed base as we further penetrate existing markets and expand into, or offer new features and solutions that appeal to, new markets.
We believe our market is still evolving and relatively underpenetrated. As spatial biology is further validated through rapid acceleration of peer-reviewed publications and growing adoption by the life sciences research market, we believe we have an opportunity to significantly increase our installed base. We regularly solicit feedback from our customers in order to enhance our solutions and their applications for life sciences research, which we believe will drive increased adoption of our platforms as they better serve our customers’ needs.
Our ability to drive incremental pull through
We believe that expansion of our installed base to new and existing customers will drive an increase in our recurring reagent and instrument service revenue. In addition, as our research and development team identifies and launches new applications and biomarker targets, we expect to increase incremental pull through on our existing and new instrument installed base. Recurring revenue was 48% and 33% of total revenue for the three months ended September 30, 2024 and 2023, respectively. Recurring revenue was 48% and 35% of total revenue for the nine months ended September 30, 2024 and 2023, respectively. Our recurring revenue as a percentage of total product and service revenue will vary based upon new device placements in the period. As our installed base expands, we expect recurring revenue on an absolute basis to increase and become an increasingly important contributor to our revenue.
Our ability to improve revenue mix and gross margin
Our revenue is primarily derived from sales of our platforms, consumables, software, and services. Our revenue mix will fluctuate from period-to-period, particularly revenue generated from instrument sales. As our installed base grows, we expect consumables and instrument service revenue to constitute a larger percentage of total revenue.
Our margins are higher for those instruments and consumables that we sell directly to customers compared to those sold through distributors.
Future instrument and consumable selling prices and gross margins may fluctuate due to a variety of factors, including the introduction by others of competing products and solutions. We aim to mitigate downward pressure on our average selling prices by increasing the value proposition offered by our instruments and consumables, primarily by expanding the applications for our devices, optimizing the performance of our products, introducing feature enhancements and increasing the quantity and quality of data that can be obtained using our consumables.
Key Business Metrics
We regularly review the number of instrument placements and cumulative instrument placement as key metrics to evaluate our business, measure our performance, identify trends affecting our business, develop financial projections, and make strategic decisions. We believe that these metrics are representative of our current business; however, we anticipate these will change or may be substituted for additional or different metrics as our business grows.
30
During the three and nine months ended September 30, 2024 and 2023, our instrument placements were as follows:
Three months ended | Nine months ended | |||||||
September 30, | September 30, | |||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |
Instrument Placements: |
| 35 |
| 69 | 116 |
| 198 | |
Our instruments are sold globally to leading biopharma companies and top research institutions and medical centers. Our quarterly instrument placements fluctuate from period-to-period due to the type and size of our customers and their procurement and budgeting cycles. We expect continued fluctuations in our quarterly period-to-period number of instrument placements.
We believe our instrument placements is an important metric to measure our business because the number of new placements is driven by our ability to secure new customers and to increase adoption of our PhenoCycler and PhenoImager platforms and because it provides insights into anticipated recurring revenue for consumables and instrument services.
Components of results of operations
Revenue
Product Revenue
We generate product revenue from the sale of our instruments, consumables and software products. Instrument sales accounted for 47% and 67% of product revenue for the three months ended September 30, 2024 and 2023, respectively. Instrument sales accounted for 47% and 65% of product revenue for the nine months ended September 30, 2024 and 2023, respectively. Consumables revenue accounted for 51% and 32% of our product revenue for the three months ended September 30, 2024 and 2023, respectively. Consumables revenue accounted for 51% and 34% of our product revenue for the nine months ended September 30, 2024 and 2023, respectively.
Our current instrument offerings include our PhenoCycler and PhenoImager platforms. Our sales process with customers is often long and involves multiple levels of approvals. As a result, the revenue for our platforms can vary significantly from period-to-period and has been, and may continue to be, concentrated in a small number of customers in any given period.
We sell our instruments directly to customers and through distributors. Each of our instrument sales drives various streams of recurring revenue comprised of consumable product sales and instrument services.
Service and Other Revenue
We primarily generate service and other revenue from instrument service, which generally consists of sales of extended service contracts, in addition to installation and training, as well as from our laboratory services operations, where we provide sample testing services to customers utilizing our in-house lab operation, and revenue generated from companion diagnostic development.
We offer our customers extended warranty and service plans for our platforms. Our extended warranty and service plans are offered for periods beyond the standard one-year warranty that all customers receive. These extended warranty and service plans generally have fixed fees and terms ranging from one to four additional years. We recognize revenue from the sale of extended warranty and service plans over the respective coverage period, which approximates the service effort provided by us.
We record shipping and handling billed to customers as service and other revenue and the related costs in cost of service and other revenue in the consolidated statement of operations.
31
We sell our products globally. We sell directly to end customers in North America and we sell through third party distributors and dealers in the APAC region. We sell both directly and through third party distributors in EMEA.
Cost of Goods Sold, Gross Profit and Gross Margin
Product cost of revenue primarily consists of costs for finished goods (both instruments and reagents) produced by our contract manufacturers or in-house, and associated freight, shipping and handling costs for products shipped to customers, salaries and other personnel costs, and other direct costs related to those sales recognized as product revenue in the period. Cost of goods sold for services and other revenue primarily consists of salaries and other personnel costs, travel related to services provided, costs of servicing equipment at customer sites, and all personnel and related costs for our laboratory services operation.
We expect that our cost of goods sold will increase or decrease to the extent that our revenue increases and decreases and depending on the mix of revenue in any specific period.
Gross profit is calculated as revenue less cost of goods sold. Gross margin is gross profit expressed as a percentage of revenue. Our gross profit in future periods will depend on a variety of factors, including market conditions that may impact our pricing, sales mix among instruments, sales mix changes among consumables, excess and obsolete inventories, costs we pay our contract manufacturers for their services, our cost structure for lab service operations relative to volume, product warranty obligations, and inflationary cost pressures. Our gross profit in future periods will also vary based upon our channel mix and may decrease based upon our distribution channels.
Gross profit was $11.7 million compared to $15.3 million for the three months ended September 30, 2024 and 2023, respectively. Gross profit was $33.5 million compared to $39.7 million for the nine months ended September 30, 2024 and 2023, respectively.
Operating expenses
Research and development. Research and development costs primarily consist of salaries, benefits, engineering/design costs, laboratory supplies, materials expenses for employees and third parties engaged in research and product development, and depreciation of property and equipment and amortization of intangibles. We expense all research and development costs in the period in which they are incurred.
We plan to continue to invest in our research and development efforts to enhance existing products and develop new products. We expect these expenses to vary from period to period as a percentage of revenue.
Selling, general and administrative. Our selling, general and administrative expenses primarily consist of salaries and benefits for employees in our executive, accounting and finance, sales and marketing, operations, legal and human resource functions, professional services fees, such as consulting, audit, tax and legal fees, legal expenses related to intellectual property, general corporate costs, commercial sales functions, marketing, travel expenses, facilities, and IT, as well as depreciation of property and equipment and amortization of intangibles. We expect these expenses to vary from period to period as a percentage of revenue.
Change in fair value of contingent consideration. On September 28, 2018, we acquired substantially all the assets of the QPS division of PKI (subsequently known as Revvity). As part of the acquisition, on September 28, 2018, we entered into a License Agreement with PKI. Under the terms of the License Agreement, we agreed to pay PKI certain royalties as a percentage of future net sales of products and services that are covered by patent rights under the agreement, in exchange for a perpetual license of the right to produce and sell QPS products. As of the acquisition date, we accounted for the future potential royalty payments as contingent consideration. This contingent consideration is subject to remeasurement.
Impairment. Impairment expense primarily consists of charges recorded as a result of exiting the Menlo Park, California facilities. As a result of exiting the facilities, we performed an impairment assessment of our long-lived assets, including operating lease right-of-use assets and property and equipment. A portion of our operating lease right-of-use
32
assets (including related property and equipment) were determined to be impaired as their carrying values exceeded their fair values, and corresponding impairment charges were recorded in the nine months ended September 30, 2024.
Restructuring. Restructuring expense primarily consists of charges recorded in connection with our workforce reductions executed in January and July of 2024.
Other income (expense)
Interest expense. Interest expense consists primarily of interest related to borrowings under our debt obligations.
Interest income. Interest income consists of interest earned on cash, cash equivalents, and marketable securities, and the accretion of discounts from the purchase of marketable securities.
Other expense, net. Other expense, net consists primarily of franchise tax and foreign currency exchange gains and losses.
Provision for income taxes
Our provision for income taxes consists primarily of foreign taxes and minimal state taxes in the United States. As we expand the scale and scope of our international business activities, any changes in the United States and foreign taxation of such activities may increase our overall provision for income taxes in the future.
33
Results of operations
The results of operations presented below should be reviewed in conjunction with the consolidated financial statements and notes included elsewhere in the Quarterly Report on Form 10-Q. The following tables set forth our results of operations for the periods presented:
Three months ended | Nine months ended | |||||||||||
September 30, | September 30, | |||||||||||
($ in thousands) |
| 2024 |
| 2023 |
| 2024 |
| 2023 | ||||
Product revenue | $ | 12,298 | $ | 18,048 | $ | 40,364 | $ | 50,719 | ||||
Service and other revenue |
| 6,516 |
| 7,167 |
| 19,964 |
| 19,427 | ||||
Total revenue |
| 18,814 |
| 25,215 |
| 60,328 |
| 70,146 | ||||
Cost of goods sold: |
|
|
|
|
|
|
|
| ||||
Cost of product revenue | 4,430 | 6,208 | 17,620 | 19,747 | ||||||||
Cost of service and other revenue |
| 2,660 |
| 3,731 |
| 9,219 |
| 10,714 | ||||
Total cost of goods sold |
| 7,090 |
| 9,939 |
| 26,839 |
| 30,461 | ||||
Gross profit |
| 11,724 |
| 15,276 |
| 33,489 |
| 39,685 | ||||
Operating expenses: |
|
|
|
|
|
|
|
| ||||
Selling, general and administrative |
| 14,672 |
| 20,251 |
| 53,629 |
| 67,281 | ||||
Research and development |
| 4,474 |
| 6,314 |
| 15,316 |
| 19,614 | ||||
Change in fair value of contingent consideration |
| (763) |
| 262 |
| (496) |
| 1,019 | ||||
Impairment |
| — |
| — |
| 2,971 |
| — | ||||
Restructuring | 1,690 | — | 3,087 | — | ||||||||
Total operating expenses |
| 20,073 |
| 26,827 |
| 74,507 |
| 87,914 | ||||
Loss from operations |
| (8,349) |
| (11,551) |
| (41,018) |
| (48,229) | ||||
Other income (expense): |
|
|
|
|
|
|
|
| ||||
Interest expense |
| (2,625) |
| (2,239) |
| (7,843) |
| (6,468) | ||||
Interest income | 521 | 1,074 | 2,126 | 2,576 | ||||||||
Other expense, net |
| (36) |
| (185) |
| (277) |
| (338) | ||||
Loss before provision for income taxes |
| (10,489) |
| (12,901) |
| (47,012) |
| (52,459) | ||||
Provision for income taxes |
| (44) |
| (15) |
| (154) |
| (62) | ||||
Net loss | $ | (10,533) | $ | (12,916) | $ | (47,166) | $ | (52,521) | ||||
Comparison of the three months ended September 30, 2024 and 2023
Revenue
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Product revenue | $ | 12,298 | $ | 18,048 |
| $ | (5,750) |
| (32) | % | ||
Service and other revenue |
| 6,516 |
| 7,167 |
|
| (651) |
| (9) | % | ||
Total revenue | $ | 18,814 | $ | 25,215 |
| $ | (6,401) |
| (25) | % | ||
Product revenue decreased by $5.8 million, or 32%, for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The decrease was primarily driven by a $6.3 million decrease in instrument revenue resulting from 35 new system placements during the three months ended September 30, 2024, compared to 69 new system placements for the three months ended September 30, 2023, offset by a $0.6 million increase in consumable revenue resulting from a larger installed base of 1,299 systems as of September 30, 2024, as compared to 1,132 systems as of September 30, 2023.
Service and other revenue decreased by $0.7 million, or 9%, for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The decrease was primarily due to a decrease relating to lab
34
services revenue, partially offset by increases in revenue generated from companion diagnostic development, and other immaterial changes.
Cost of Goods Sold, Gross Profit and Gross Margin
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Cost of product revenue | $ | 4,430 | $ | 6,208 | $ | (1,778) |
| (29) | % | |||
Cost of service and other revenue |
| 2,660 |
| 3,731 |
| (1,071) |
| (29) | % | |||
Total cost of goods sold | $ | 7,090 | $ | 9,939 | $ | (2,849) |
| (29) | % | |||
Gross profit | $ | 11,724 | $ | 15,276 | $ | (3,552) |
| (23) | % | |||
Gross margin |
| 62 | % |
| 61 | % |
|
|
|
| ||
Cost of product revenue decreased by $1.8 million, or 29%, for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The decrease in cost of product revenue was primarily due to a decrease in costs associated with decreased instrument sales during the third quarter of 2024, partially offset by an increase in costs associated with increased reagents sales. Cost of service and other revenue decreased by $1.1 million, or 29%, for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The decrease in cost of service and other revenue was primarily driven by the workforce reductions that we executed in January and July of 2024.
Gross profit decreased by $3.6 million, or 23%, and gross margin increased by 1% for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. The decrease in gross profit was primarily due to decreased instrument sales during the third quarter of 2024, offset by increased reagents sales during the third quarter of 2024. The increase in gross margin was primarily due to a higher mix of consumables driven by a higher installed base as well as decreased instrument sales in the current quarter.
Operating Expenses
Selling, General and Administrative
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Selling, general and administrative | $ | 14,672 | $ | 20,251 | $ | (5,579) |
| (28) | % | |||
Selling, general and administrative expense decreased by $5.6 million, or 28%, for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The decrease was primarily due to a $3.7 million decrease in personnel-related expenses, primarily due to the workforce reductions in January and July of 2024, a $0.2 million decrease in professional fees, and other related fees such as legal, consulting, and IT, and a $0.1 million decrease in recruiting, training, conferences, and travel and expenses.
Research and development
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Research and development | $ | 4,474 | $ | 6,314 | $ | (1,840) |
| (29) | % | |||
Research and development expense decreased by $1.8 million, or 29% for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The decrease was primarily due to a $1.4 million decrease in personnel-related expenses, primarily due to the workforce reductions in January and July of 2024, a $0.1 million decrease in lab supply consumption, and other immaterial changes.
35
Change in fair value of contingent consideration
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Change in fair value of contingent consideration | $ | (763) | $ | 262 | $ | (1,025) |
| (391) | % | |||
Change in fair value of contingent consideration was a $0.8 million gain for the three months ended September 30, 2024, compared to a $0.3 loss for the three months ended September 30, 2023. The decrease of $1.0 million, or 391%, was due to current period remeasurement.
Restructuring
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Restructuring | $ | 1,690 | $ | — | $ | 1,690 |
| 100 | % | |||
Restructuring increased by $1.7 million, or 100% for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, due to the workforce reduction that we executed in July of 2024.
Interest expense
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Interest expense | $ | 2,625 | $ | 2,239 | $ | 386 |
| 17 | % | |||
Interest expense increased by $0.4 million, or 17% for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The increase was primarily due to increased debt levels as of September 30, 2024 as compared to September 30, 2023, as well as an increase in interest rates.
Interest income
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Interest income | $ | 521 | $ | 1,074 | $ | (553) |
| (51) | % | |||
Interest income decreased by $0.6 million, or 51% for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 due to decreased levels of cash, cash equivalents, and marketable securities as of September 30, 2024 as compared to September 30, 2023.
Other expense, net
Three months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Other expense, net | $ | 36 | $ | 185 | $ | (149) |
| (81) | % | |||
Other expense, net decreased by $0.1 million, or 81%, for the three months ended September 30, 2024, compared to the three months ended September 30, 2024.
36
Comparison of the nine months ended September 30, 2024 and 2023
Revenue
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Product revenue | $ | 40,364 | $ | 50,719 |
| $ | (10,355) |
| (20) | % | ||
Service and other revenue |
| 19,964 |
| 19,427 |
|
| 537 |
| 3 | % | ||
Total revenue | $ | 60,328 | $ | 70,146 |
| $ | (9,818) |
| (14) | % | ||
Product revenue decreased by $10.4 million, or 20%, for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The decrease was primarily driven by a $14.0 million decrease in instrument revenue resulting from 116 new system placements during the nine months ended September 30, 2024, compared to 198 new system placements for the nine months ended September 30, 2023, offset by a $3.4 million increase in consumable revenue resulting from a larger installed base of 1,299 systems as of September 30, 2024, as compared to 1,132 systems as of September 30, 2023.
Service and other revenue increased by $0.5 million, or 3%, for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The increase was primarily due increases in revenue generated from companion diagnostic development, offset by decreases relating to lab services revenue, and other immaterial changes.
Cost of Goods Sold, Gross Profit and Gross Margin
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Cost of product revenue | $ | 17,620 | $ | 19,747 | $ | (2,127) |
| (11) | % | |||
Cost of service and other revenue |
| 9,219 |
| 10,714 |
| (1,495) |
| (14) | % | |||
Total cost of goods sold | $ | 26,839 | $ | 30,461 | $ | (3,622) |
| (12) | % | |||
Gross profit | $ | 33,489 | $ | 39,685 | $ | (6,196) |
| (16) | % | |||
Gross margin |
| 56 | % |
| 57 | % |
|
|
|
| ||
Cost of product revenue decreased by $2.1 million, or 11%, for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The decrease in cost of product revenue was primarily driven by a decrease in costs associated with decreased instrument sales, offset by costs associated with increased reagents sales. Cost of service and other revenue decreased by $1.5 million, or 14%, for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The decrease in cost of service and other revenue was primarily driven by the workforce reductions that we executed in January and July of 2024.
Gross profit decreased by $6.2 million, or 16%, and gross margin decreased by 1% for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023. The decrease in gross profit was primarily due to a decrease in instrument sales, offset by increased reagents sales. The decrease in gross margin was primarily driven by a $2.0 million charge related to obsolete inventory associated with the Mantra 2 Quantitative Pathology Workstation and the Vectra 3 Automated Quantitative Pathology Imaging System, a legacy product line which was discontinued in the first quarter of 2024, offset by the $2.0 million charge in the second quarter of 2023 for expired inventory and inventory expected to expire, as well as other immaterial changes.
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Operating Expenses
Selling, General and Administrative
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Selling, general and administrative | $ | 53,629 | $ | 67,281 | $ | (13,652) |
| (20) | % | |||
Selling, general and administrative expense decreased by $13.7 million, or 20%, for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The decrease was primarily due to a $9.5 million decrease in personnel-related expenses, primarily due to the workforce reductions in June of 2023, January of 2024, and July of 2024, a $2.0 million decrease in professional fees, and other related fees such as legal, consulting, and IT, and a $1.0 million decrease in recruiting, training, conferences, and travel and expenses, offset by a $0.9 million charge to our allowance for credit losses, and other immaterial changes.
Research and development
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Research and development | $ | 15,316 | $ | 19,614 | $ | (4,298) |
| (22) | % | |||
Research and development expense decreased by $4.3 million, or 22% for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The decrease was primarily due to a $3.7 million decrease in personnel-related expenses, primarily due to the workforce reductions in June of 2023, January of 2024, and July of 2024, and other immaterial changes.
Change in fair value of contingent consideration
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Change in fair value of contingent consideration | $ | (496) | $ | 1,019 | $ | (1,515) |
| (149) | % | |||
Change in fair value of contingent consideration was a $0.5 million gain for the nine months ended September 30, 2024, compared to a $1.0 million loss for the nine months ended September 30, 2023. The decrease of $1.5 million, or 149%, was due to current period remeasurement.
Impairment
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Impairment | $ | 2,971 | $ | — | $ | 2,971 |
| 100 | % | |||
Impairment increased by $3.0 million, or 100% for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, due to impairment charges to our right-of-use assets and property and equipment associated with exiting our Menlo Park, California facilities in the first quarter of 2024.
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Restructuring
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Restructuring | $ | 3,087 | $ | — | $ | 3,087 |
| 100 | % | |||
Restructuring increased by $3.1 million, or 100% for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, primarily associated with our workforce reductions that we executed in January and July of 2024.
Interest expense
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Interest expense | $ | 7,843 | $ | 6,468 | $ | 1,375 |
| 21 | % | |||
Interest expense increased by $1.4 million, or 21% for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The increase was primarily due to increased debt levels as of September 30, 2024 as compared to September 30, 2023, as well as an increase in interest rates.
Interest income
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Interest income | $ | 2,126 | $ | 2,576 | $ | (450) |
| (17) | % | |||
Interest income decreased by $0.5 million, or 17% for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 due to decreased levels of cash, cash equivalents, and marketable securities as of September 30, 2024 as compared to September 30, 2023.
Other expense, net
Nine months ended |
| |||||||||||
September 30, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2024 |
| 2023 |
| Amount |
| % | ||||
Other expense, net | $ | 277 | $ | 338 | $ | (61) |
| (18) | % | |||
Other expense, net decreased by $0.1 million, or 18% for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023.
Liquidity and Capital Resources
As of September 30, 2024, we had approximately $39.3 million in cash, cash equivalents, and marketable securities.
Since our inception, we have experienced losses and negative cash flows from operations, and we incurred a consolidated net loss of $47.2 million for the nine months ended September 30, 2024 and had an accumulated deficit of $277.2 million as of September 30, 2024. We have historically relied on equity financings and borrowings under our credit facility to fund our operations to date. We may in the future sell shares of our common stock, including pursuant
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to the Equity Distribution Agreement to help fund our operations. We expect to continue to incur operating losses in the foreseeable future. However, we plan to focus on improving results of operations in an effort to achieve cash flow positivity. There can be no assurance that additional financings will be available to us or that we will become profitable.
Our Midcap Trust Term Loan is subject to certain financial covenants. Based on our current operating plan, we cannot be certain that we will be able to maintain compliance with these financial covenants for at least the next twelve months from the issuance of these financials. We intend to seek a waiver, refinance the outstanding borrowings or otherwise mitigate these concerns with Midcap Financial Trust or another lender. However, we can provide no assurance that a waiver will be granted, or that we will be able to refinance the amounts outstanding and in such an event, the lender may exercise any and all of its rights and remedies provided for under the Midcap Trust Term Loan.
As a result of these uncertainties, there is substantial doubt about our ability to continue as a going concern for the next twelve months following the date that these consolidated financial statements are issued.
Our future capital requirements will depend on many factors, including, but not limited to our ability to successfully commercialize and launch products, and to achieve a level of sales adequate to support our cost structure. If we are unable to execute on our business plan and adequately fund operations, or if the business plan requires a level of spending in excess of cash resources, we will have to seek additional equity or debt financing. If additional financings are required from outside sources, we may not be able to raise capital on terms acceptable to us or at all. If we are unable to raise additional capital when desired, our business, financial condition, results of operations and prospects could be materially adversely affected.
Sources of Liquidity
Since our inception, we have financed our operations primarily from the issuance and sale of our equity securities, borrowings under long-term debt agreements, and revenue from our commercial operations. In April 2021, we raised $138.6 million in net proceeds through the sale of common stock from our IPO, after deducting the underwriter discounts and commissions and offering expenses of $12.8 million. As described further in Note 10 to our consolidated financial statements in this Quarterly Report on Form 10-Q, in June 2023, we completed a follow-on public offering of our common stock pursuant to which we raised approximately $47.8 million in net proceeds, after deducting the underwriting discounts and commissions and offering expenses.
Midcap Trust Term Loan
In October 2020, we entered into the Midcap Trust Term Loan for a $37.5 million credit facility, consisting of a senior, secured term loan. We received $32.5 million in aggregate proceeds as a result of the debt financing. On March 21, 2022, we entered into Amendment No. 1 to the Midcap Trust Term Loan, which amended certain provisions to permit certain additional debt and capital leases.
On June 1, 2022, we entered into Amendment No. 2, which permitted the draw of a second and third tranche of $10.0 million each, which were drawn on June 1, 2022, and September 30, 2022, respectively. Amendment No. 2 also delayed the amortization start dates for the outstanding loan amounts from November 1, 2023 until April 1, 2025, at which point we would be required to repay the principal amounts in seven equal monthly installments until the maturity date. Finally, Amendment No. 2 amended the interest rate payable on the term loan to apply an interest rate equal to the SOFR rate (with a floor of 1.61448%) plus 6.35%.
On November 7, 2022, we entered into Amendment No. 3 to the Midcap Trust Term Loan, which permitted the draw of two additional tranches, each totaling $11,250, which were drawn on November 7, 2022, and December 22, 2023, respectively. Amendment No. 3 also delayed the amortization start dates for the outstanding loan amounts from April 1, 2025 until December 1, 2025 (subject to further extension upon certain conditions), at which point we would be required to repay the principal amounts in equal monthly installments until the new maturity date of November 1, 2027. In addition, Amendment No. 3 amended the interest rate payable on the term loan to apply an interest rate equal to the SOFR rate (with a floor of 2.50%) plus 6.80%, and reset the call protection to begin as of November 7, 2025. Finally, Amendment No. 3 provided for a commitment fee of $74 that was paid on November 7, 2022 on the new tranche
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amounts and an exit fee of 4.75%. Substantially all other terms and conditions, and covenants of the credit agreement remained unchanged.
In July 2024, we entered into Amendment No. 4 to the Midcap Trust Term Loan, which amended certain affirmative financial covenants.
In November 2024, we entered into Amendment No. 5 to the Midcap Trust Term Loan, effective as of September 30, 2024, which amended certain affirmative financial covenants. Amendment No. 5 also extends the interest only period from December 1, 2025 until March 1, 2026 (subject to further extension upon certain conditions), at which point we must repay the principal amounts in equal monthly installments until the maturity date of November 1, 2027. Finally, Amendment No. 5 increases the exit fee from 4.75% to 6.25%.
The Midcap Trust Term Loan is collateralized by substantially all of our assets. The agreement contains customary negative covenants that limit our ability to, among other things, incur additional indebtedness, grant liens, make investments, repurchase stock, pay dividends, transfer assets and merge or consolidate with any other entity or to acquire all or substantially all the capital stock or property of another entity. The agreement also contains customary affirmative covenants, including requirements to, among other things, deliver audited financial statements. If we default under the Midcap Trust Term Loan and if the default is not cured or waived, the lender could cause any amounts outstanding to be payable immediately. Under certain circumstances, the lender could also exercise its rights with respect to the collateral securing such loans. Moreover, any such default would limit our ability to obtain additional financing, which may have an adverse effect on our cash flow and liquidity.
We were in compliance with all covenants under the Midcap Trust Term Loan, as amended through Amendment No. 5, as of September 30, 2024.
At-the-Market Offering
On November 7, 2022, we entered into the Equity Distribution Agreement with Piper Sandler with respect to an ATM offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million through Piper Sandler as our sales agent. As of September 30, 2024, we have not sold any shares of common stock under the ATM program.
Cash flows
The following table summarizes our cash flows for the periods presented:
Nine months ended | ||||||
September 30, | ||||||
($ in thousands) |
| 2024 |
| 2023 | ||
Net cash (used in) provided by: |
|
|
|
| ||
Operating activities | $ | (41,121) | $ | (45,315) | ||
Investing activities |
| (26,744) |
| 3,941 | ||
Financing activities |
| (2,719) |
| 45,767 | ||
Net (decrease) increase in cash, cash equivalents, and restricted cash | $ | (70,584) | $ | 4,393 | ||
Operating activities
Net cash used in operating activities decreased by $4.2 million to $41.1 million in the nine months ended September 30, 2024 compared to $45.3 million in the nine months ended September 30, 2023.
Net cash used in operating activities during the nine months ended September 30, 2024 consisted of a net loss of $47.2 million and a change in our net operating assets and liabilities of $14.4 million, offset by non-cash charges of $20.4 million. The change in our net operating assets and liabilities was primarily due to increased inventory levels of $10.4 million, decreases in accounts payable, accrued expenses and other liabilities of $5.8 million, decreases in
41
operating lease liabilities of $1.7 million, and decreases in deferred revenue of $0.6 million, offset by decreases in accounts receivable of $3.3 million, and a $0.8 million decrease in prepaid expenses and other assets. Non-cash charges primarily consisted of $7.2 million of stock-based compensation expense, $5.8 million of depreciation and amortization, a $3.1 million provision for excess and obsolete inventories, $3.0 million of impairment expense, decreases in operating lease right of use assets of $1.6 million, $0.9 million in credit losses for accounts receivable, and $0.6 million of non-cash interest expense, offset by $1.4 million in accretion of marketable securities and a $0.5 million change in fair value of contingent consideration.
Net cash used in operating activities during the nine months ended September 30, 2023 consisted of a net loss of $52.5 million and a change in our net operating assets and liabilities of $13.4 million, offset by non-cash charges of $20.6 million. The change in our net operating assets and liabilities was due to increases in accounts receivable of $6.4 million, increased inventory levels of $7.0 million, decreases in operating lease liabilities of $1.7 million, and decreases in accounts payable, accrued expenses and other liabilities of $2.1 million, offset by decreases in prepaid expenses and other assets of $2.5 million, and increases in deferred revenue of $1.2 million. Non-cash charges primarily consisted of $7.9 million of stock-based compensation expense, $6.8 million of depreciation and amortization, a $2.6 million adjustment for excess and obsolete inventories, decreases in operating lease right of use assets of $1.8 million, a $1.0 million change in fair value of contingent consideration, and $0.5 million of non-cash interest expense.
Investing activities
Net cash used in investing activities was $26.7 million for the nine months ended September 30, 2024 compared to net cash provided by investing activities of $3.9 million during the nine months ended September 30, 2023.
Net cash used in investing activities for the nine months ended September 30, 2024 was driven by purchases of marketable securities of $87.3 million and purchases of property and equipment of $1.4 million, offset by $53.5 million in maturities of marketable securities and $8.5 million in sales of marketable securities.
Net cash provided by investing activities for the nine months ended September 30, 2023 was driven by maturities of marketable securities of $7.0 million, offset by purchases of property and equipment of $3.1 million.
Financing activities
Net cash used in financing activities was $2.7 million for the nine months ended September 30, 2024 compared to net cash provided by financing activities of $45.8 million for the nine months ended September 30, 2023.
Net cash used in financing activities for the nine months ended September 30, 2024 was primarily driven by $1.9 million in payments of contingent consideration, $0.5 million in principal payments on financing leases, $0.2 million in payments of deferred offering costs, and $0.2 million in settlement of restricted stock units for tax withholding obligations.
Net cash provided by financing activities for the nine months ended September 30, 2023 was primarily driven by $48.0 million in net proceeds received from our Offering, after deducting the underwriting discounts and commissions and offering expenses paid by the Company, and $0.3 million in proceeds from stock option exercises, offset by $1.7 million in payments of contingent consideration, $0.5 million in principal payments on financing leases, $0.2 million in payments of deferred offering costs, and $0.1 million in settlement of restricted stock units for tax withholding obligations.
Critical accounting policies and estimates
We have prepared our consolidated financial statements in accordance with GAAP. Our preparation of these consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue, expenses and related disclosures. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and
42
liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from these estimates under different assumptions or conditions.
There have been no significant changes in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in the section titled “Management’s Discussion and Analysis of Financial Condition and Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 5, 2024.
Recent accounting pronouncements
For information on recently issued accounting pronouncements, see Note 2 to our consolidated financial statements in this Quarterly Report on Form 10-Q.
JOBS Act accounting election
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to avail ourselves of this extended transition period, and, as a result, we will not be required to adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. We intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002.
Smaller reporting company status
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million as of the last trading day of our second quarter and our annual revenue is less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million as of the last trading day of our second quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million as of the last trading day of our second quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. For example, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company, as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, for this reporting period and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 under the Exchange Act as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2024. There was not any change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) under the Exchange Act) during the quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control. In addition to the other information set forth in this report, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I, Item 1A under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 5, 2024. The risk factors may be important to understanding other statements in this report and should be read in conjunction with the unaudited financial statements and related notes in this report. The occurrence of any single risk or any combination of risks could materially and adversely affect our business, operations, product pipeline, operating results, financial condition or liquidity, and consequently, the value of our securities. Further, additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business, financial condition, operating results and prospects.
Other than as set forth below, there have been no material changes to the risk factors described in the Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 5, 2024.
We have limited capital resources and will likely need additional funding before we are able to achieve profitability which raise substantial doubt regarding our ability to continue as a going concern. If we do not continue as a going concern, investors could lose their entire investment.
Our recurring operating losses, in addition to our accumulated deficit, has raised substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our becoming profitable in the future or to obtain the necessary capital to meet our obligations and repay our liabilities when they become due. If we are unable to execute on our business plan and adequately fund operations, or if the business plan requires a level of spending in excess of cash resources, we will have to seek additional equity or debt financing. If additional financings are required from outside sources, we may not be able to raise capital on terms acceptable to us or at all. Our determination of substantial doubt as going concern could materially limit our ability to raise additional funds through the issuance of equity securities or otherwise. There can be no assurance that we will ever become profitable or continue as a going concern.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the third quarter of 2024, no directors or officers
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Item 6. Exhibits
Incorporated by Reference | ||||||||||||
Exhibit |
| Exhibit Title |
| Form |
| File No. |
| Exhibit |
| Filing Date |
| Filed |
101.INS | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) | X | ||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents | X | ||||||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | X | ||||||||||
*This certification is deemed not filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
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Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Akoya Biosciences, Inc. | ||
|---|---|---|
Date: November 14, 2024 | By: | /s/ Brian McKelligon |
Brian McKelligon | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: November 14, 2024 | By: | /s/ Johnny Ek |
Johnny Ek | ||
Chief Financial Officer | ||
(Principal Financial and Accounting Officer) | ||
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