INVITAE CORP – 10-Q – Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes and other financial information included in Part I, Item 1. of this Form 10-Q, and together with our audited consolidated financial statements and the related notes and other information included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 . Historic results are not necessarily indicative of future results. This report contains forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this report other than statements of historical fact, including statements identified by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect" and similar expressions, are forwardlooking statements. Forwardlooking statements include, but are not limited to, statements about:
•our views regarding the future of genetic testing and its role in mainstream
medical practice;
•the impact of the COVID-19 pandemic on our business and the actions we have
taken or may take in response thereto;
•our mission and strategy for our business, products and technology;
•the implementation of our business model and the success of our strategic
realignment efforts;
•the expected costs and benefits of our strategic realignment, and our ability
to achieve positive operating cash flow;
•the expected benefits from and our ability to integrate our acquisitions;
•our ability to obtain regulatory approvals for our tests;
•the rate and degree of market acceptance of our tests and genetic testing
generally;
•our ability to scale our infrastructure and operations in a costeffective
manner;
•our expectations regarding our platform and future offerings;
•the timing and results of studies with respect to our tests;
•developments and expectations relating to our competitors and our industry;
•our competitive strengths;
•the degree to which individuals will share genetic information generally, as
well as share any related potential economic opportunities with us;
•our commercial plans;
•our ability to obtain and maintain adequate reimbursement for our tests;
•regulatory, political and other developments in
countries;
•our ability to attract and retain key scientific, sales, engineering or
management personnel;
•our expectations regarding our ability to obtain and maintain intellectual
property protection and not infringe on the rights of others;
•the effects of litigation or investigations on our business;
•our ability to obtain funding for our operations and to service and repay our
debt;
•our future financial performance;
•our beliefs regarding our future growth and the drivers of such growth;
•our expectations regarding environmental, social and governance matters;
•the impact of accounting pronouncements and our critical accounting policies,
judgments, estimates and assumptions on our financial results;
•our expectations regarding our future revenue, cost of revenue, operating
expenses and capital expenditures, and our future capital requirements;
•the impact of macroeconomic conditions, including inflation and recession, on
our business; and
•the impact of tax laws on our business.
Forwardlooking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expected. These risks and uncertainties include, but are not limited to, those risks discussed in Part II, Item 1A. "Risk Factors" in this Quarterly Report on Form 10-Q. Although we believe that the expectations and assumptions reflected in the forwardlooking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Any forwardlooking statements in this report speak 28
--------------------------------------------------------------------------------
only as of the date of this report. We expressly disclaim any obligation or
undertaking to update any forwardlooking statements.
In this report, all references to "
mean
Invitae and theInvitae logo are trademarks ofInvitae Corporation . AMP™, LiquidPlex™, VariantPlex® and FusionPlex®, are the property ofArcherDX, LLC , a wholly-owned subsidiary ofInvitae Corporation . We also refer to trademarks of other companies and organizations in this report.
Summary of risk factors
Our business is subject to numerous risks and uncertainties that could affect our ability to successfully implement our business strategy and affect our financial results. You should carefully consider all of the information in this Quarterly Report and, in particular, the following principal risks and all of the other specific factors described in Part II, Item 1A. "Risk Factors" in this Quarterly Report on Form 10-Q before deciding whether to invest in our company.
•We expect to continue incurring significant losses, and we may not successfully
execute our plan to achieve or sustain profitability.
•We have a large amount of debt, servicing our debt requires a significant amount of cash, we may not have sufficient cash flow from our business to service our debt, and we may need to refinance all or a significant portion of our debt.
•Our inability to raise additional capital on acceptable terms in the future may
limit our ability to develop and commercialize new tests and expand our
operations.
•Our strategic realignment and the associated headcount reduction have and are expected to significantly change our business, result in significant expense, may not result in anticipated savings, and will disrupt our business. •We rely on highly skilled personnel in a broad array of disciplines and, if we are unable to hire, retain or motivate these individuals, or maintain our corporate culture, we may not be able to maintain the quality of our services or grow effectively. •We have acquired and may continue to acquire businesses or assets, form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders' ownership, or cause us to incur debt or significant expense. •We need to scale our infrastructure in advance of demand for our tests and other products and services, and our failure to generate sufficient demand for our products and services would have a negative impact on our business and our ability to attain profitability.
•We face risks related to health epidemics, including the ongoing COVID-19
pandemic, and macroeconomic conditions, which could have a material adverse
effect on our business and results of operations.
•If third-party payers, including managed care organizations, private health insurers and government health plans, do not provide adequate reimbursement for our tests or we are unable to comply with their requirements for reimbursement, our commercial success could be negatively affected. •We face intense competition, which is likely to intensify further as existing competitors devote additional resources to, and new participants enter, the markets in which we operate. If we cannot compete successfully, we may be unable to increase our revenue or achieve and sustain profitability.
•The market for patient data software is competitive, and our business will be
adversely affected if we are unable to successfully compete.
•Security breaches, privacy issues, loss of data and other incidents could compromise sensitive or personal information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
•If we are not able to continue to generate substantial demand of our tests, our
commercial success will be negatively affected.
•Our success will depend on our ability to use rapidly changing genetic data to interpret test results accurately and consistently, and our failure to do so would have an adverse effect on our operating results and business, harm our reputation and could result in substantial liabilities that exceed our resources. 29 --------------------------------------------------------------------------------
•Impairment in the value of our goodwill or other intangible assets has and may
in the future have a material adverse effect on our operating results and
financial condition.
•If the FDA regulates the tests we currently offer as LDTs as medical devices,
we could incur substantial costs and our business, financial condition and
results of operations could be adversely affected.
•One of our competitors has alleged that our Anchored Multiplex PCR, or AMP, chemistry and products using AMP are infringing on its intellectual property, and we may be required to redesign the technology, obtain a license, cease using the AMP chemistry altogether and/or pay significant damages, among other consequences, any of which would have a material adverse effect on our business as well as our financial condition and results of operations.
Mission and strategy
Invitae's mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Our goal is to aggregate a majority of the world's genetic information into a comprehensive network that enables sharing of data among network participants to improve healthcare and clinical outcomes.
We were founded on four core principles:
•Patients should own and control their own genetic information;
•Healthcare professionals are fundamental in ordering and interpreting genetic
information;
•Driving down the price of genetic information will increase its clinical and
personal utility; and
•Genetic information is more valuable when shared.
Our strategy for long-term growth centers on five key drivers of our business,
which we believe work in conjunction to create a flywheel effect extending our leadership position in the new market we are building: [[Image Removed: nvta-20220930_g2.jpg]] •Refocusing our content offering. We continue to prioritize our core genome sequencing platform and streamline our product portfolio to focus on core testing opportunities among hereditary cancer, precision oncology, women's health, rare disease and pharmacogenomics, ultimately leading to affordable and ongoing access to the molecular information that enables personalized medicine. Sharpening our focus on our content offering is a core and central contribution to an improved user experience and the potential for better health outcomes. •Creating a unique user experience. We are committed to continue our expansion and integration of key digital health-based technologies and services in order to create a differentiated model in genetic health. A state-of-the-art interactive platform will enhance our service offering, leverage the uniquely empowering characteristics of online sharing of genetic information and, we believe, enable a superior economic offering to clients. We intend to continue to expend efforts developing and implementing technology-driven improvements to our customers' experience. We believe that an enhanced user 30 --------------------------------------------------------------------------------
experience and the resulting benefits to our brand and reputation will help draw
customers to us over and above our direct efforts to do so.
•Increasing volume. We intend to increase our brand equity and visibility through a commitment to precision testing results, excellent service and a variety of marketing and promotional techniques, including scientific publications and presentations, sales, marketing, public relations, social media and web technology vehicles. Our ability to increase billable volume will depend in part on our success achieving broad reimbursement coverage and laboratory service contracts for our tests from third-party payers and agreements with institutions and partners. •Attracting partners. As we add more customers to our platform, we believe our business becomes particularly attractive to potential partners that can help the patients in our network further benefit from their genetic information or that provide us access to new customers who may wish to join our network. We believe the cumulative effect of the increased billable volume brought by these strategic components will allow us to lower the cost of our service and expand patient access globally. •Achieving scale. Our goal is to provide customers with a broad menu of genetic content at a reasonable price and rapid turn-around times in order to grow billable volume and, in turn, achieve greater economies of scale. As our customers and our business benefit from further cost savings, we expect that those cost savings will further improve the customer experience, allowing us to reap the cumulative benefits from all of the efforts outlined above.
Business overview
We are focused on making comprehensive, high-quality genetic information more accessible and instrumental to the healthcare ecosystem and stakeholders, including patients, providers and physicians, payers, pharmaceutical partners and more. Our comprehensive and convenient physical and digital platform of risk assessment and the resulting data that is actionable and guided is designed to power healthcare decisions across our stakeholders, importantly providing patients a lifetime partner inInvitae to best guide and manage their personal and familial health decisions. We offer genetic testing across multiple clinical areas, including hereditary cancer, precision oncology, women's health, rare diseases and pharmacogenomics. Medical genetics is central to health outcomes and we are bringing it to the mainstream by lowering the costs and removing barriers to adoption, which is driven by our user-friendly and comprehensive Invitae Digital Health Platform. Ultimately, the utility of the accumulated data will compound, enabling improved individual and population health and advancing the benefits of molecular medicine around the globe. For the years endedDecember 31, 2021 , 2020 and 2019, our revenue was$460.4 million ,$279.6 million , and$216.8 million , respectively, and we incurred net losses of$379.0 million ,$602.2 million , and$242.0 million , respectively. For the nine months endedSeptember 30, 2022 and 2021, our revenue was$393.8 million and$334.3 million , respectively, and we recognized net losses of$3.0 billion and$173.9 million , respectively. AtSeptember 30, 2022 , our accumulated deficit was$4.7 billion . In 2021, 2020 and 2019, we generated 1,169,000, 659,000 and 469,000 billable units, respectively. In the nine months endedSeptember 30, 2022 , we generated 990,000 billable units compared to 842,000 billable units in the same period in 2021. We calculate volume using billable units, which are billable events that include individual test reports released and individual reactions shipped. We refer to the set of reagents needed to perform a next generation sequencing ("NGS") test as a "reaction." Approximately 55% of the billable volume generated in the first nine months of 2022 were billable to patients, biopharmaceutical partners and other business-to-business customers (e.g., hospitals, clinics, medical centers), and the remainder were billable to government and private insurance payers. Many of the gene tests on our assays are reimbursable by health insurance companies. However, when we do not have reimbursement policies or contracts with private insurers, our claims for reimbursement may be denied upon submission, and we must appeal the claims. The appeals process is time consuming and expensive, and may not result in payment. Even if we are successful in achieving reimbursement, we may be paid at lower rates than if we were under contract with the third-party payer. When there is not a contracted rate for reimbursement, there is typically a greater payment requirement from the patient that may result in further delay in payment for these tests. We believe that the keys to long-term profitable growth will be to align our cost structure with our streamlined product portfolio and implement operational discipline, increase billable volume, achieve broad reimbursement coverage for our tests from third-party payers and increase the amount we receive from other types of payers, advance digital health solutions and data services, provide affordable pricing for genetic analysis and interpretation, reduce the costs associated with performing our genetic tests, optimize the amount of genetic content we offer and 31
-------------------------------------------------------------------------------- is used by providers across the range of healthcare platforms, consistently improve the client experience, drive physician and patient utilization of our platform for ordering and delivery of results, and increase the number of strategic partners working with us to add value for our clients. We also believe that providing a unique genetic testing platform that is agnostic to stage of life or disease category will deliver unique benefits to customers, payers and other institutions that are seeking to make genetic information a standard element of healthcare decisions in the future. The accumulation of genetic and patient information will ultimately enable the healthcare ecosystem and stakeholders, including patients, providers and physicians, payers, pharmaceutical partners and more to achieve improved outcomes. OnJuly 18, 2022 , we initiated a strategic realignment of our operations and began implementing cost reduction programs in order to accelerate our path to positive operating cash flow. We are in the process of implementing initiatives to eliminate non-core operations while realigning and sharpening our focus on the portfolio of businesses that we believe can generate sustainable margins and deliver returns to fuel future investment. In the testing business, we are shifting operational and commercial efforts to accelerate positive cash flow by maintaining robust support of the higher-margin, higher-growth testing opportunities among hereditary cancer, precision oncology, women's health, rare disease and pharmacogenomics. We also plan to continue our expansion and integration of key digital health-based technologies and services in order to create a differentiated model in genetic health. Longer-term, we remain committed to our genomic management business. We believe that we hold significant growth potential and intend to continue to prioritize the tools, partnerships and applications that support the development of genome management as the catalyst for the future of healthcare. The realignment plan includes a reduction in workforce of approximately 1,000 positions, lab and office space consolidation, portfolio optimization, decrease in other operating expenses, as well as a reduced international footprint. Our strategic realignment is anticipated to result in approximately$326 million in annualized cash savings, which is expected to be fully realized by 2023. We currently expect that the realignment plan will be completed within the next 12 months and estimate we will incur costs up to$170 million for associated employee severance and benefits, losses on asset disposals, and other restructuring costs related to the realignment plan. This reflects the best estimate of the Company, which may be revised in subsequent periods as the strategic realignment plan progresses. Concurrently, we also announced thatKenneth D. Knight , formerly our Chief Operating Officer since 2020, was appointed as our Chief Executive Officer, replacing Dr.Sean E. George .Dr. George , who co-founded our company and served as our Chief Executive Officer since 2017, will support our company through a transition period as a consultant and continue to serve as a member of the board of directors untilDecember 31, 2022 . Additionally,Randy Scott , Ph.D.,Invitae's co-founder, former CEO from 2012 to 2017, and former executive chairman from 2017 to 2019, returned to the Company as chairman of the board.
We expect to incur operating losses for the near term as we implement the
strategic realignment of our operations. If we are unable to achieve these
objectives and successfully manage our costs, we may not be able to achieve
positive operating cash flow in the near term or at all.
During the first quarter of 2022,Russia commenced a military invasion ofUkraine , and the ensuing conflict has created disruption in the region and around the world. We have suspended operations inRussia , which has not had and is not expected to have a material impact on our operating results. We serve customers globally across a broad geographic base. NeitherRussia norUkraine has comprised or is expected to comprise a material portion of our total revenue, net loss, or net assets. We continue to closely monitor the ongoing conflict and related sanctions, which could impact our financial results in the future. Other impacts due to this evolving situation are currently unknown and could potentially subject our business to adverse consequences should the situation escalate beyond its current scope. See Part II, Item 1A. "Risk Factors" in this Quarterly Report on Form 10-Q for additional information about the conflict betweenRussia andUkraine and its potential effect on our business and results of operations. Impact of COVID-19
We expect the COVID-19 pandemic may continue to impact our business. We have
reviewed and adjusted, when necessary, for the impact of COVID-19 on our
estimates related to revenue recognition and expected credit losses.
In response to the pandemic, we have implemented measures to protect the health of all of our employees during this time with additional measures in place to better protect our on-site lab production and support teams. 32 -------------------------------------------------------------------------------- Our production facilities currently remain fully operational. Substantially all of the Company's offices have re-opened in a hybrid working model, subject to operating restrictions which adhere to healthcare guidelines to protect public health and the health and safety of employees. While we have not experienced significant disruption in our supply chain, we have experienced supply delays and higher logistics costs as a result of the COVID-19 pandemic and have also had to obtain supplies from new suppliers. As a result of government-imposed restrictions, many announced healthcare guidelines resulted in a shift of regular physician visits and healthcare delivery activities to remote/telehealth formats. This was particularly important for patients who, despite the fall-out from COVID-19, continued to be diagnosed with critical diseases, like cancer, and for women who are pregnant or are trying to conceive. We believe our investments in new access platforms and technologies has and will continue to position us well to provide a range of testing to clinicians and patients using a "clinical care from afar" model. An example is our rollout inApril 2020 of our Gia telehealth platform, which expands access to remote interaction between patients and clinicians as well as direct ordering of genetic tests. Although many government-imposed restrictions have been reduced or eliminated, the future impact of the COVID-19 pandemic continues to be highly uncertain. Given the unknown duration and extent of COVID-19's impact on our business, and the healthcare system in general, we continue to monitor evolving market conditions and have pivoted our focus and investments on the commercial execution of workflows that support remote ordering, online support and telehealth. InMarch 2020 , the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act") was signed into law as a stimulus bill intended to bolster the economy, among other things, and provide assistance to qualifying businesses and individuals. The CARES Act included an infusion of funds into the healthcare system and inJanuary 2021 we received$2.3 million as part of this initiative. This payment was recognized as other income, net in our condensed consolidated statement of operations in the period received.
Adverse macroeconomic conditions
Adverse macroeconomic developments, including inflation, slowing growth, rising interest rates, or recession, may adversely affect our business and financial condition. These developments have caused, and could in the future cause, disruptions and volatility in global financial markets and increased rates of default and bankruptcy, and negatively affect business and consumer spending. Adverse economic conditions may also increase the costs of operating our business, including vendor, supplier and workforce expenses. Management continues to evaluate the impact of macroeconomic events, including inflation, on our business and our future plans and intends to take appropriate measures to help alleviate their impact, but there can be no assurance that these efforts will be successful.
Factors affecting our performance
Number of billable units
Our centralized test revenue is tied to the number of tests which we bill third-party payers, biopharmaceutical partners, other business-to-business customers (e.g., hospitals, clinics, medical centers), or patients. Our decentralized product revenue is based upon the number of individual reactions we ship biopharmaceutical partners and other business-to-business customers. We refer to the set of reagents needed to perform an NGS test as a "reaction," and we refer to billable events that include individual test reports released and individual reactions shipped as billable units. We typically bill for our services following delivery of the billable report derived from testing samples and interpreting the results. For units manufactured for use by customers in distributed facilities, we typically bill customers upon shipment of those units. Test orders are placed under signed requisitions or contractual agreements, as we often enter into contracts with biopharmaceutical partners, other business-to-business customers and insurance companies. We incur the expenses associated with a unit in the period in which the unit is processed regardless of when payment is received with respect to that unit. We believe the number of billable units in any period is an important indicator of the growth in our testing business, and with time, this will translate into the number of customers accessing our platform.
Number and size of research and commercial partnerships
Pharma development service revenue, which we recognize within other revenue in our condensed consolidated statements of operations, is generated primarily from services provided to biopharmaceutical companies and other partners and is related to companion diagnostic development, clinical research, and clinical trial services across the research, development and commercialization phases of collaborations. The result of these 33 -------------------------------------------------------------------------------- relationships may include the development of new targeted companion diagnostics, which underscore and expand the need for genetic testing and in some cases may lead to intellectual property and/or revenue sharing opportunities with third-party partners. In addition to research partnerships, we also seek to grow the number of biopharmaceutical partners and other business-to-business customers for whom we provide testing technologies, analysis, supplies and expertise to institutions that provide independent testing services to customers in their respective regions.
Success obtaining and maintaining reimbursement
Our ability to increase volume and revenue will depend in part on our success achieving broad reimbursement coverage and laboratory service contracts for our tests from third-party payers and agreements with institutions and partners. Reimbursement may depend on a number of factors, including a payer's determination that a test is appropriate, medically necessary and cost-effective, as well as whether we are in contract, where we get paid more consistently and at higher rates. Because each payer makes its own decision as to whether to establish a policy or enter into a contract to reimburse for our testing services and specific tests, seeking these approvals is a time-consuming and costly process. In addition, clinicians and patients may decide not to order our tests if the cost of the test is not covered by insurance. Because we require an ordering physician to requisition a test, our revenue growth also depends on our ability to successfully promote the adoption of our testing services and expand our base of ordering clinicians. We believe that establishing coverage and obtaining contracts from third-party payers is an important factor in gaining adoption by ordering clinicians. Our arrangements for laboratory services with payers cover approximately 331 million lives, comprised of Medicare, all national commercial health plans, and Medicaid in most states, includingCalifornia (Medi-Cal ), our home state.
Ability to lower the costs associated with performing our tests
Reducing the costs associated with performing our genetic tests is both a focus and a strategic objective of ours. Over the long term, we will need to reduce the cost of raw materials by improving the output efficiency of our assays and laboratory processes, modifying our platform-agnostic assays and laboratory processes to use materials and technologies that provide equal or greater quality at lower cost, improve how we manage our materials, port some tests onto a next generation sequencing platform and negotiate favorable terms for our materials purchases. We also intend to continue to design and implement hardware and software tools that are designed to reduce personnel-related costs for both laboratory and clinical operations/medical interpretation by increasing personnel efficiency and thus lowering labor costs per test.
Ability to optimize our genetic content in meeting market needs and create new
pathways to test
We intend to continue to reduce the average cost per test, optimize our test menus and content, and offer the tests at affordable prices in order to meet customer and patient needs. In addition, we have and intend to continue to identify new ways to connect our testing services and information to patients. These include direct patient outreach and ordering capacity, the use of automated assistants for physician customers to improve the ease of ordering and processing genetic tests and programs designed to reach underserved patient populations with genetic testing. We also continue to collaborate with strategic partners and identity new market and channel opportunities.
Realignment of our business and timing of expenses
As part of the strategic business realignment of our operations announced inJuly 2022 , we initiated a comprehensive plan focused on supporting business lines and geographies that we believe can generate sustainable margins, provide the best return to fuel future investment and accelerate the company's path to positive cash flow. We believe the plan further helps ensure we remain at the forefront of innovation and advancements in genomics by allocating resources towards our core genetic testing and genome management platforms that have the potential to improve healthcare outcomes. We have conducted an assessment of our product portfolio as well as the associated research and development and commercial spending. Our new plan shifts the focus to programs relevant to the core testing business to drive near-term cost of revenue reductions. We have also performed an extensive review of internal and external costs and how those expenses align with the new business structure. Additional savings are expected to be generated through the ongoing digitization of workflows, elimination of duplication and streamlined processes across the core platforms and rationalization of technology and external services. 34 -------------------------------------------------------------------------------- As we refocus our operations on our core genomic testing platform, we also plan to continue to invest in our genetic testing and information management business to drive long-term profitable growth. We deploy state-of-the-art technologies in our genetic testing services, and we intend to continue to scale our infrastructure, including our testing capacity and capabilities as well as our information systems. We also expect to incur software development costs as we seek to further digitize and automate our laboratory processes and our genetic interpretation and report sign-out procedures, scale our customer service capabilities to improve our customers' experience, and expand the functionality of our website. We will continue to incur costs related to marketing and branding as we spread our initiatives beyond our current customer base and focus on providing access to customers through our website. In addition, we will incur ongoing expenses as a result of operating as a public company. The expenses we incur may vary significantly by quarter as we focus on different aspects of our business. How we recognize revenue We generally recognize revenue on an accrual basis, which is when a customer obtains control of the promised goods or services, typically a test report, or upon shipment of our precision oncology products. Accrual amounts recognized are based on estimates of the consideration that we expect to receive, and such estimates are adjusted and subsequently recorded until fully settled. Changes to such estimates may increase or decrease revenue recognized in future periods. Revenue from our tests may not be equal to billed amounts due to a number of factors, including differences in reimbursement rates, the amounts of patient payments, the existence of secondary payers and claim denials. Some test orders are placed under signed requisitions or contractual agreements, and we often enter into contracts with biopharmaceutical partners, other business-to-business customers and insurance companies that include pricing provisions under which such tests are billed. Pharma development service revenue is generated primarily from custom assay design services, sample processing activities and consultative inputs, which is separate from revenue generated by any related or unrelated product component. Revenue is recognized as samples are processed or scope of work is completed based on contracted agreements with those biopharmaceutical customer companies. Under these collaborations, we also generate revenue from achievement of milestones, provision of on-going support, and related pass-through costs and fees. We generally have distinct performance obligations for development milestones related to our development of a companion diagnostic device. We use a cost plus a margin approach to estimate the standalone value of our companion diagnostic development service performance obligations. Revenue is recognized over time using input or output methods based on our assessments of performance completed to date toward each milestone.
Financial overview
Revenue
We primarily generate revenue from testing services and sales of distributed precision oncology products. Customers are typically billed upon delivery of test results or shipment of products. We also generate revenue from development agreements, access to data, data analytics and other related services provided for biopharmaceutical partners and other parties. Our ability to increase our revenue will depend on our ability to increase our market penetration, obtain contracted reimbursement coverage from third-party payers, and grow our relationships with biopharmaceutical customers.
Cost of revenue
Cost of revenue reflects the aggregate costs incurred in delivering our products and services and includes expenses for materials and supplies, personnel-related costs, freight, costs for lab services, genetic interpretation and clinical trial support, equipment and infrastructure expenses and allocated overhead including rent, information technology, equipment depreciation, amortization of acquired intangibles, and utilities. We expect cost of revenue to generally increase in line with the increase in billable volume, however, we expect a future increase in amortization of acquired intangible assets that is not dependent on billed volume. We anticipate our cost per unit for existing tests will generally decrease over time due to the efficiencies we expect to gain as volume increases and from automation and other cost reductions. These reductions in cost per unit will likely be offset by new offerings, which often have a higher costs per unit during the introductory phases before we are able to gain efficiencies. The cost per unit may fluctuate significantly from quarter to quarter. 35 --------------------------------------------------------------------------------
Operating expenses
Our operating expenses are classified into three categories related to our operational activities: research and development, selling and marketing, and general and administrative. For each category, the largest component is generally personnel-related costs, which include salaries, employee benefit costs, bonuses, commissions, as applicable, and stock-based compensation expense. Operating expense categories also include asset impairments, change in fair value of contingent consideration, and restructuring, which are discussed further below. Research and development Research and development expenses represent costs incurred to develop our technology and future offerings. These costs are principally for process development associated with our efforts to expand the number of genes we can evaluate, our efforts to lower the costs per unit and our development of new products to expand our platform. We have and may continue to partner with other companies to develop new technologies and capabilities we expect to invest capital and incur significant operating costs to support these development efforts. In addition, we incur process development costs to further develop the software we use to operate our laboratories, analyze generated data, process customer orders, validate clinical activities, enable ease of customer ordering, deliver reports and automate our business processes. These costs consist of personnel-related costs, laboratory supplies and equipment expenses, consulting costs, amortization of acquired intangible assets, and allocated overhead including rent, information technology, equipment depreciation and utilities. We expense all research and development costs in the periods in which they are incurred. We expect our research and development expenses to decrease as a percentage of revenue as we streamline our product portfolio, shift investments, including exiting certain business lines and commercial geographies, and reduce labor costs through a reduction in workforce. We expect to make investments to reduce costs and streamline our technology to provide patients access to testing aligned to scale with our long-term profitable growth targets.
Selling and marketing
Selling and marketing expenses consist of personnel-related costs, including commissions, client service expenses, advertising and marketing expenses, educational and promotional expenses, market research and analysis, and allocated overhead including rent, information technology, equipment depreciation, amortization of acquired intangibles, and utilities. We expect our selling and marketing expenses to decrease as a percentage of revenue as a result of a reduction in workforce, targeted sales force expansion and lower marketing spending as we implement a more efficient sales and marketing approach to support our core genetic testing platform.
General and administrative
General and administrative expenses include executive, finance and accounting, billing and collections, legal and human resources functions as well as other administrative costs. These expenses include personnel-related costs; audit, accounting and legal expenses; consulting costs; allocated overhead including rent, information technology, equipment depreciation, and utilities; costs incurred in relation to our co-development agreements; and post-combination expenses incurred in relation to companies we acquire. We expect our general and administrative expenses to decrease as a percentage of revenue as a result of our cost reduction plan including a reduction in workforce, consolidation of underutilized facilities, digitization of workflows, elimination of duplication and streamlined processes, and rationalization of technology and external services spending.
Asset impairments
Asset impairments includes the impairment loss recognized on goodwill, the IPR&D indefinite-lived intangible asset initially recognized as part of the acquisition of Singular Bio and specific equipment that is no longer being utilized on this project and has no alternative future use.Goodwill and indefinite-lived intangible assets are assessed for impairment on an annual basis and whenever events and circumstances indicate that these assets may be impaired. We compare the fair value of our reporting unit to its carrying value, including goodwill. If the carrying value, including goodwill, exceeds the reporting unit's fair value, we will recognize an impairment loss for the amount by which the carrying amount exceeds the reporting unit's fair value. Asset impairments also includes the impairment of right-of-use assets and related leasehold improvements associated with our decision to cease use of certain facilities as part of our strategic realignment to consolidate lab and office space and reduce our international footprint. 36 --------------------------------------------------------------------------------
Change in fair value of contingent consideration
Changes in fair value of contingent consideration are adjustments related to contingent consideration related to business combinations. We expect these expenses to fluctuate significantly period to period due to fair value adjustments that are dependent on many factors, including the value of our common stock and our assessment of the probability of meeting certain acquisition-related milestones within the terms of the respective acquisition agreements, including certain prescribed deadlines for achievement. With respect to the ArcherDX Final Milestone, the liability was reduced to nil as ofJune 30, 2021 , with the offsetting change recorded as changes in fair value of contingent consideration in our condensed consolidated statements of operations. The removal of the liability balance and the associated change in fair value of contingent consideration was a result of our reassessment of the steps necessary to achieve clearance or approval based on FDA feedback received principally in the three months endedJune 30, 2021 . InApril 2022 , an agreement was entered into with previousArcherDX stockholders to extend the date of achievement of the ArcherDX Final Milestone toMarch 31, 2023 . We currently do not believe that this milestone will be achieved within this timeframe. As such, no liability was recorded as ofSeptember 30, 2022 .
Restructuring
Restructuring includes employee separation costs, losses on asset disposals and other costs. Employee separation costs are comprised of severance, other termination benefit costs, and stock-based compensation expense for the acceleration of RSUs related to workforce reductions. Employee separation costs include one-time termination benefits that are recognized as a liability at estimated fair value, at the time of communication to employees, unless future service is required, in which case the costs are recognized ratably over the future service period. Ongoing termination benefits are recognized as a liability at estimated fair value when the amount of such benefits are probable and reasonably estimable. Losses on asset disposals include losses on disposals of property and equipment, leasehold improvements, and other asset write-downs associated with exiting lines of business, consolidating lab and office space, and reducing our international footprint. Other restructuring costs include the write-off of prepaid assets related to the exit of certain product offerings, legal and professional fees, and contract exit costs.
Other income, net
Other income, net, primarily consists of adjustments to the fair value of our stock payable liabilities arising from business combinations, and we expect it to fluctuate significantly from period to period due to the volatility of our common stock. Other income, net also includes income generated from our cash equivalents and marketable securities and amounts received under the CARES Act.
Interest expense
Interest expense is primarily attributable to interest incurred related to our debt and finance leases. See Note 8, "Commitments and contingencies" in Notes to Consolidated Financial Statements in Part I, Item 1. of this Quarterly Report on Form 10-Q for additional information.
Income tax benefit
Since we generally establish a full valuation allowance against our deferred tax assets, our income tax benefit primarily consists of changes in our deferred tax realization assessments as a result of taxable temporary differences assumed in connection with our acquisitions and changes in the expected timing of the reversal of taxable temporary differences.
Critical accounting policies and estimates
Management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance withU.S. generally accepted accounting principles, orU.S. GAAP. The preparation of these financial statements requires us to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. We evaluate our estimates on an ongoing basis. Our estimates are based on current facts, our 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 liabilities that are not readily apparent from other sources. Actual results may differ from these estimates 37 -------------------------------------------------------------------------------- under different assumptions or conditions and any such differences may be material. We believe that our accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management's judgments and estimates. The following updates our discussion of impairment testing as ofJune 30, 2022 , and should be read in conjunction with our critical accounting policies and estimates disclosed in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2021 . Except as presented below, there have been no material changes from the critical accounting policies and estimates described in our Annual Report on Form 10-K. See Note 2, "Summary of significant accounting policies" in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1. of this Quarterly Report on Form 10-Q for information regarding recent accounting pronouncements.
In accordance with ASC 350, Intangibles -Goodwill and Other we do not amortize goodwill or other intangible assets with indefinite lives, including IPR&D, but rather test them for impairment. ASC 350 requires us to perform an impairment review of our goodwill and indefinite-lived intangible balances at least annually, which we do in the fourth quarter of each year for our single consolidated reporting unit, and whenever events or changes in circumstances indicate that the carrying amount of these assets may not be recoverable. Factors that may indicate potential impairment and trigger an interim impairment test include, but are not limited to, current economic, market and geopolitical conditions, including a significant, sustained decline in our stock price and market capitalization compared to the net book value, an adverse change in legal factors, business climate or operational performance of the business, or significant changes in the ability of a particular asset (or group of assets) to generate positive cash flows for our strategic business objectives. During the three months endedJune 30, 2022 , as a result of significant, sustained decline in our stock price and related market capitalization and lower than expected financial performance, we performed an impairment assessment of goodwill, IPR&D intangibles, and long-lived assets, including definite-lived intangibles. During the three months endedJune 30, 2022 , the Company completed a quantitative impairment test for goodwill. In performing the goodwill impairment test, we estimated the fair value of the reporting unit by utilizing the discounted cash flow method under the income approach. The determination of the fair value of the reporting unit requires significant estimates and assumptions, including significant unobservable inputs. The key inputs to this valuation approach include, but were not limited to, management's forecast of projected revenues associated with future cash flows, discount rates, and control premiums. When performing our income approach for the reporting unit, we incorporate the use of projected financial information and a discount rate that is developed using market participant-based assumptions. The cash flow projections are based on an 11 year financial forecast developed by management that includes projections of billable units, revenue by test type and mix, rate changes, capital spending trends, investments in working capital to support future revenue and projected cash flow sources and needs, among others. The selected discount rate then considers the risk and nature of the reporting unit's cash flows and rates of return market participants would require to invest capital in the reporting unit. Based on this analysis, we recognized a goodwill impairment charge of$2.3 billion during the three months endedJune 30, 2022 , which was included in asset impairments in the condensed consolidated statements of operations. The goodwill was fully impaired as ofJune 30, 2022 . We also identified indicators of impairment related to the IPR&D intangible asset initially recognized as part of the acquisition of Singular Bio that is more likely than not that the asset is impaired. The Company identified conditions during the period endedJune 30, 2022 such as alternative technologies and uncertainties around the desired outcome of our in-development asset and other economic factors that raised issues with the realizability of our asset. As a result of our evaluation, we also recognized a non-cash, pre-tax impairment loss of$30.0 million during the three months endedJune 30, 2022 . The indefinite-lived intangible asset was fully impaired as ofJune 30, 2022 . Additionally, we recognized an impairment loss of$4.8 million during the three months endedJune 30, 2022 related to specific equipment that is also no longer being utilized on this project and has no alternative future use. The impairment is recorded in asset impairments in the condensed consolidated statements of operations. During the three months endedSeptember 30, 2022 , we did not record any further impairments of intangible assets.
Impairment assessment of long-lived assets
A recoverability test was performed for the long-lived assets, including definite-lived intangibles, using the undiscounted cash flows approach, which included significant unobservable inputs including management's forecasts of projected revenue associated with future cash flows and residual value. The cash flow estimates 38
-------------------------------------------------------------------------------- reflected the Company's assumptions about its use of the long-lived assets and eventual disposition of the asset group. We determined that our long-lived assets held and used, including intangible assets that are subject to amortization, did not have identifiable cash flows that are largely independent of the cash flows of other assets and liabilities and of other asset groups, because the assets are highly interrelated and interdependent. Therefore, the Company evaluated its long-lived assets for impairment on an entity-wide level. The long-lived assets passed the recoverability test as ofJune 30, 2022 . As a result of the strategic realignment, we evaluated the recoverability of the carrying amount of long-lived assets for impairment. We concluded that the fair value of long-lived assets was in excess of their carrying value atSeptember 30, 2022 and no impairment was recorded except for operating lease impairments, which are discussed in the "Leases" section of Note 8 "Commitments and contingencies" in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1. of this Quarterly Report on Form 10-Q. We also recorded losses on disposal of assets pursuant to the strategic realignment, which are discussed in Note 11, "Restructuring" in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1. of this Quarterly Report on Form 10-Q.
Results of operations
Three Months Ended
The following sets forth our condensed consolidated statements of operations data for each of the periods indicated (in thousands, except percentage changes). Our historical results are not necessarily indicative of our results of operations to be expected for any future period. Three Months Ended September 30, Dollar % 2022 2021 Change Change Revenue: Test revenue $ 128,839$ 111,676 $ 17,163 15% Other revenue 4,697 2,719 1,978 73% Total revenue 133,536 114,395 19,141 17% Cost of revenue 116,956 87,741 29,215 33% Research and development 87,177 97,511 (10,334) (11)% Selling and marketing 49,193 55,501 (6,308) (11)% General and administrative 44,939 86,820 (41,881) (48)% Asset impairments 6,708 - 6,708 100% Change in fair value of contingent consideration - (19,866) 19,866 100% Restructuring 118,514 - 118,514 100% Total cost and operating expenses 423,487 307,707 115,780 38% Loss from operations (289,951) (193,312) (96,639) (50)% Other income, net 1,872 3,357 (1,485) (44)% Interest expense (14,145) (14,069) (76) (1)% Net loss before taxes (302,224) (204,024) (98,200) (48)% Income tax benefit (1,068) (5,848) 4,780 82% Net loss$ (301,156) $ (198,176) $ (102,980) (52)% NM - Not Meaningful Revenue The increase in total revenue of$19.1 million for the three months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to an increase in billable volume due to growth in our business and higher average revenue per billable unit. Billable volume increased to approximately 324,000 in the three months endedSeptember 30, 2022 compared to 296,000 in the same period of 2021, an increase of 9 percent. Average revenue per billable unit was$398 per unit in the three months endedSeptember 30, 2022 compared to$377 per unit in the comparable prior period primarily due to changes in payer and product mix. Cost of revenue The increase in the cost of revenue of$29.2 million for the three months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to an increase in billable volume and a higher cost per 39 -------------------------------------------------------------------------------- billable unit. Cost per unit was$361 in the three months endedSeptember 30, 2022 compared to$296 for the same period in 2021. The cost per unit increased primarily due to the write down of inventory and prepaid items of$16.4 million related to the exit of certain product offerings, and amortization of acquired intangible assets of$14.3 million . These increases were partially offset by a decrease in lab materials of$2.5 million .
Research and development
The decrease in research and development expense of$10.3 million for the three months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to a decreases in outside labor of$6.2 million , lab-related expenses for supplies and materials of$6.1 million and other expenses of$1.3 million . These decreases were partially offset by higher depreciation and amortization of$3.3 million due to accelerated depreciation for lab equipment related to the exit of certain product offerings.
Selling and marketing
The decrease in selling and marketing expense of
months ended
primarily due to a decrease in marketing costs of
spending on brand initiatives, and a decrease in information technology costs
and other corporate expenses of
General and administrative
The decrease in general and administrative expense of$41.9 million for the three months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to a decrease in acquisition-related stock-based compensation expense of$31.7 million , a decrease in legal fees of$6.1 million for litigation-related expenses included in the prior period, a decrease in professional and outside services of$4.8 million , and a decrease in personnel-related expenses of$4.0 million due to lower headcount as a result of the reduction in workforce. These decreases were offset by increases in other corporate expenses of$4.7 million .
Asset impairments
Under our strategic realignment plan, we decided to cease use of certain facilities and actively began looking to sublease the locations, including the related leasehold improvements. During the three months endedSeptember 30, 2022 , we recognized an impairment charge of$4.4 million related to right-of-use assets and$2.3 million for the related leasehold improvements.
Change in fair value of contingent consideration
The change in fair value of contingent consideration decreased$19.9 million for the three months endedSeptember 30, 2022 compared to the same period in 2021. The prior year period includes fair value adjustments to reduce our contingent consideration liability primarily related to our acquisition ofArcherDX and the remaining development milestones resulting from a decrease in the value of our common stock and the removal of our contingent consideration liability relating to the outstanding milestone for FDA clearance or approval of a therapy selection IVD. The prior year adjustments to decrease our contingent consideration were due to our determination that this milestone will not be achieved in the timeframe prescribed in the acquisition agreement.
Restructuring
InJuly 2022 , we began implementing a strategic realignment of our operations to reduce operating costs and drive future growth aligned with our core genetic testing and genome management platforms. The realignment plan includes a reduction in workforce, lab and office space consolidation, portfolio optimization, decrease in other operating expenses, as well as a reduced international footprint. Under this strategic realignment, we reduced our workforce by approximately 1,000 employees. During the three months endedSeptember 30, 2022 , we incurred restructuring expenses of$118.5 million . Restructuring expense was comprised of$57.9 million in employee severance and benefits,$48.8 million in losses on asset disposals, and$11.8 million in other restructuring expenses. We did not have similar expenses for the three months endedSeptember 30, 2021 .
Other income, net
The decrease in other income, net of$1.5 million for the three months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to a decrease in fair value adjustments of$3.9 million related to our 40 -------------------------------------------------------------------------------- stock payable liabilities. InSeptember 2022 , the amounts held back to satisfy indemnification obligations for an acquisition were partially released to the former stockholders. This was partially offset by an increase in interest income of$2.4 million associated with marketable securities investments in the current year. Interest expense
The increase in interest expense of
outstanding as compared to the prior year period.
Income tax benefit
The decrease in income tax benefit of$4.8 million for the three months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to a$6.0 million reduction in the valuation allowance on our legacy deferred tax assets primarily as a result of net deferred tax liabilities of$6.9 million assumed in connection with an acquisition inSeptember 2021 . There was no similar income tax benefit in the current period for the three months endedSeptember 30, 2022 .
Nine Months Ended
The following sets forth our condensed consolidated statements of operations data for each of the periods indicated (in thousands, except percentage changes). Our historical results are not necessarily indicative of our results of operations to be expected for any future period. Nine Months Ended September 30, Dollar % 2022 2021 Change Change Revenue: Test revenue $ 381,518$ 322,448 $ 59,070 18% Other revenue 12,331 11,880 451 4% Total revenue 393,849 334,328 59,521 18% Cost of revenue 324,412 252,563 71,849 28% Research and development 330,559 284,323 46,236 16% Selling and marketing 172,086 163,705 8,381 5% General and administrative 149,071 197,640 (48,569) (25)% Asset impairments 2,324,572 - 2,324,572 100% Change in fair value of contingent consideration (1,850) (386,836) 384,986 100% Restructuring 118,514 - 118,514 100% Total cost and operating expenses 3,417,364 511,395 2,905,969 NM Loss from operations (3,023,515) (177,067) (2,846,448) NM Other income, net 19,637 9,846 9,791 99% Interest expense (42,149) (35,869) (6,280) (18)% Net loss before taxes (3,046,027)
(203,090) (2,842,937) NM Income tax benefit (39,551) (29,208) (10,343) (35)% Net loss$ (3,006,476) $ (173,882) $ (2,832,594) NM NM - Not Meaningful Revenue The increase in total revenue of$59.5 million for the nine months endedSeptember 30, 2022 compared to the same period in 2021 was due primarily to increased billable volume and slightly higher average revenue per billable unit. Billable volume increased to 990,000 in the nine months endedSeptember 30, 2022 compared to 842,000 in the same period of 2021, an increase of 18 percent, due to growth in the business. Average revenue per billable unit increased to$385 per unit in the nine months endedSeptember 30, 2022 compared to$383 per unit in the comparable prior period primarily due to changes in payer and product mix. 41
--------------------------------------------------------------------------------
Cost of revenue
The increase in the cost of revenue of$71.8 million for the nine months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to increased billable volume and higher cost per billable unit. Cost per billable unit was$328 in the nine months endedSeptember 30, 2022 compared to$300 for the same period in 2021. The increase in cost per unit in the nine months endedSeptember 30, 2022 was primarily attributable to an increase in amortization of acquired intangible assets of$39.0 million , an increase in write downs of inventory and prepaid items of$19.6 million related to the exit of certain product offerings, an increase in shipping costs of$6.5 million , higher sales and use taxes of$4.0 million due to an increase in inventory purchases, and an increase in other costs of$2.7 million , as well as changes in product mix.
Research and development
The increase in research and development expense of$46.2 million for the nine months endedSeptember 30, 2022 compared to the same period in 2021 principally consisted of the following elements: personnel-related costs increased$57.6 million primarily driven by acquisition-related stock-based compensation expenses related to an acquisition inSeptember 2021 ; professional fees increased$7.6 million due to higher contract labor; depreciation and amortization increased$3.3 million due to accelerated depreciation for lab equipment related to the exit of certain product offerings; and other expenses increased$1.3 million . These increases were partially offset by decreases in lab-related expenses of$23.6 million primarily due lower costs related to external development projects and lab supplies and services.
Selling and marketing
The increase in selling and marketing expense of$8.4 million for the nine months endedSeptember 30, 2022 compared to the same period in 2021 principally consisted of the following elements: personnel-related costs increased by$12.7 million ; travel-related expenses increased$3.0 million resulting from more in-person travel due to reduced COVID-19 restrictions; and information technology costs increased$1.3 million due to higher spending on software licenses. These increases were offset by decreases in brand initiatives and advertising costs of$6.2 million and professional and other expenses of$2.4 million . General and administrative The decrease in general and administrative expense of$48.6 million for the nine months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to decreases in acquisition-related stock-based compensation expense of$35.5 million , personnel-related costs of$15.2 million due to lower stock-based compensation partially offset by higher employee-related costs, and a decrease in legal fees of$9.3 million for litigation-related expenses included in the prior period. These decreases were offset by increases in other corporate expenses of$5.6 million , facilities-related expenses of$4.3 million due to lease expenses and higher security and building support costs, and information technology costs increased$1.5 million due to higher spending on software licenses. Asset impairments Under our strategic realignment plan, we decided to cease use of certain facilities and actively began looking to sublease the locations, including the related leasehold improvements. During the three and nine months endedSeptember 30, 2022 , we recognized an impairment charge of$4.4 million related to right-of-use assets and$2.3 million for the related leasehold improvements. We completed an interim impairment test for goodwill and the IPR&D indefinite-lived intangible asset as ofJune 30, 2022 , and as a result recorded a non-cash impairment charge of$2.3 billion . Additionally, we recognized an impairment loss of$4.8 million related to specific equipment that is no longer being utilized on this project. See Critical accounting policies and estimates above and Note 5, "Goodwill and intangible assets" in Notes to the Condensed Consolidated Financial Statements in "Part 1, Item 1. Condensed Consolidated Financial Statements" of this Quarterly Report on Form 10-Q for further information.
Change in fair value of contingent consideration
The change in fair value of contingent consideration represented income of$1.9 million and$386.8 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The prior year period includes fair value adjustments to reduce our contingent consideration liability primarily related to our acquisition ofArcherDX and the remaining development milestones resulting from a decrease in the value of our common stock and the removal of 42 -------------------------------------------------------------------------------- our contingent consideration liability relating to the outstanding milestone for FDA clearance or approval of a therapy selection IVD. The prior year adjustments to decrease our contingent consideration were due to our determination that this milestone will not be achieved in the timeframe prescribed in the acquisition agreement. Restructuring During the nine months endedSeptember 30, 2022 , we incurred restructuring expenses of$118.5 million . Restructuring expense was comprised of$57.9 million in employee severance and benefits,$48.8 million in losses on asset disposals, and$11.8 million in other restructuring expenses. We did not have similar expenses for the nine months endedSeptember 30, 2021 .
Other income, net
The increase in other income, net of$9.8 million for the nine months endedSeptember 30, 2022 compared to the same period in 2021 was primarily due to increases in fair value adjustments of$6.5 million related to our stock payable liabilities due to the decrease in the price of our common stock as well as higher interest income associated with marketable securities investments in the current year. Interest expense
The increase in interest expense of
outstanding as compared to the prior year period.
Income tax benefit
The increase in income tax benefit of$10.3 million for the nine months endedSeptember 30, 2022 was primarily due to a$34.6 million release of federal and state valuation allowances as a result of the reclassification ofArcherDX's STRATAFIDE and PCM in-process research and development intangibles from indefinite-lived intangibles to developed technology, which enabled the associated deferred tax liability to serve as a source of income to existing finite-lived deferred tax assets for which a valuation allowance had previously been established. There was no similar income tax benefit in the prior year period. The income tax benefit of$29.2 million for the nine months endedSeptember 30, 2021 was primarily due to a reduction in the valuation allowance on our legacy deferred tax assets as a result of net deferred tax liabilities assumed in connection with acquisitions in 2021.
Liquidity and capital resources
Liquidity and capital expenditures
We have generally incurred net losses since our inception. For the nine months endedSeptember 30, 2022 and 2021, we had net losses of$3.0 billion and$173.9 million , respectively, and we expect to incur additional losses in the future. AtSeptember 30, 2022 , we had an accumulated deficit of$4.7 billion . While our revenue has increased over time, we may never achieve revenue sufficient to offset our expenses.
Since inception, our operations have been financed primarily by fees collected
from our customers, net proceeds from sales of our capital stock as well as
borrowing from debt facilities and the issuance of convertible senior notes.
InJanuary 2021 , we issued, in an underwritten public offering, an aggregate of 8.9 million shares of our common stock at a price of$51.50 per share, for gross proceeds of$460.0 million and net proceeds of$434.3 million . InSeptember 2019 , we issued$350.0 million of aggregate principal amount of convertible senior notes due 2024, which bear cash interest at a rate of 2.0% per year. Also inSeptember 2019 , we used the funds received through the issuance of our convertible senior notes due 2024 to settle our Note Purchase Agreement we entered into inNovember 2018 . InApril 2021 , we issued$1,150.0 million of aggregate principal amount of convertible senior notes due 2028, which bear cash interest at a rate of 1.5% per year. Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to service our debt, including paying off the principal when due, and make necessary capital expenditures. Holders of our convertible senior notes have the right to require us to repurchase all or any portion of their notes upon the occurrence of a fundamental change at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any. In addition, upon conversion of the notes, unless we elect to deliver solely shares of our common stock to settle 43 -------------------------------------------------------------------------------- such conversion (other than paying cash in lieu of delivering any fractional share), we will be required to make cash payments, which could adversely affect our liquidity. However, we only have limited ability to make those cash payments under our credit agreement and, even if the credit agreement limitations are no longer in effect, we may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of notes surrendered or notes being converted. InOctober 2020 , in connection with our acquisition ofArcherDX , we entered into a credit facility to borrow$135.0 million which closed concurrently with the merger. The terms of this credit facility restrict our ability to incur certain indebtedness, pay dividends, make acquisitions and take other actions.
At
billion
securities.
Our primary use of cash is to fund our operations. Cash used to fund operating expenses is affected by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. We have incurred substantial losses since inception, and we expect to continue to incur losses in the near future. We believe our existing cash, cash equivalents and marketable securities as ofSeptember 30, 2022 and fees collected from the sale of our products and services will be sufficient to meet our anticipated cash requirements for at least the next 12 months. We may need or choose to raise additional funding to finance operations and service debt obligations prior to achieving profitability or should we make additional acquisitions. We regularly consider fundraising opportunities and expect to determine the timing, nature and size of future financings based upon various factors, including market conditions, debt maturities and our operating plans. We may in the future elect to finance operations by selling equity or debt securities or borrowing money. If we issue equity securities, dilution to stockholders may result. Any equity securities issued may also provide for rights, preferences or privileges senior to those of holders of our common stock. If we raise funds by issuing additional debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of our common stock. In addition, the terms of additional debt securities or borrowings could impose significant restrictions on our operations. If additional funding is required, there can be no assurance that additional funds will be available to us on acceptable terms on a timely basis, if at all. If we are unable to obtain additional funding when needed, we may need to curtail planned activities to reduce costs. Doing so will likely have an unfavorable effect on our ability to execute on our business plan and have an adverse effect on our business, results of operations and future prospects. OnJuly 18, 2022 , we initiated a strategic realignment of our operations and began implementing cost reduction programs in order to accelerate our path to positive operating cash flow. We are in the process of implementing initiatives to eliminate non-core operations while realigning and sharpening our focus on the portfolio of businesses that we believe can generate sustainable margins and deliver returns to fuel future investment. In the testing business, we are shifting operational and commercial efforts to accelerate positive cash flow by maintaining robust support of the higher-margin, higher-growth testing opportunities among hereditary cancer, precision oncology, women's health, rare disease and pharmacogenomics. The realignment plan also includes a shift in investments as we exit certain business lines and commercial geographies, portfolio optimization, reduction in workforce, lab and office space consolidation, decrease in other operating expenses including lower sales and marketing spending as we implement a more efficient go-to market strategy, and optimize and reassess external spending on professional services and technology. We anticipate the cost savings associated with the realignment plan will extend our cash runway. We expect to incur total restructuring expenses up to$170 million over the next 12 months. This reflects the best estimate of the Company, which may be revised in subsequent periods as the strategic realignment plan progresses.
The following table summarizes our cash flows (in thousands):
Nine
Months Ended
2022 2021 Net cash used in operating activities$ (410,934) $ (383,897) Net cash used in investing activities (296,694) (374,583) Net cash provided by financing activities 1,159 1,558,909 Net (decrease) increase in cash, cash equivalents and restricted cash$ (706,469) $ 800,429 44
--------------------------------------------------------------------------------
Cash flows from operating activities
For the nine months endedSeptember 30, 2022 , cash used in operating activities of$410.9 million principally resulted from our net loss of$3.0 billion , a$39.6 million income tax benefit, and non-cash charges for remeasurements of liabilities in connection with business combinations of$17.5 million . These were partially offset by non-cash charges of$2.3 billion for asset impairments,$164.3 million for stock-based compensation,$104.7 million for depreciation and amortization,$48.8 million related to losses on asset disposals,$11.7 million for amortization of debt discount and issuance costs related to our outstanding debt,$6.8 million of non-cash lease expense, and$5.0 million of post-combination share-based compensation expense. The net effect on cash for changes in net operating assets was a decrease of cash of$14.4 million . For the nine months endedSeptember 30, 2021 , cash used in operating activities of$383.9 million principally resulted from our net loss of$173.9 million , non-cash charges of remeasurements of liabilities in connection with business combinations of$396.0 million , primarily relating to development milestones and a$29.2 million income tax benefit primarily generated from acquisitions. These were partially offset by non-cash charges of$131.8 million for stock-based compensation,$56.8 million for depreciation and amortization,$10.4 million for amortization of debt discount and issuance costs related to our outstanding debt and$7.9 million of post-combination expense primarily comprised of holdback cash consideration and the acceleration of unvested equity from acquisitions. The net effect on cash of changes in net operating assets was an increase of cash of$1.0 million .
Cash flows from investing activities
For the nine months endedSeptember 30, 2022 , cash used in investing activities of$296.7 million was primarily due to net purchases and maturities of marketable securities of$248.3 million and cash used for purchases of property and equipment of$48.4 million . For the nine months endedSeptember 30, 2021 , cash used in investing activities of$374.6 million was due primarily to net cash used to acquire three companies of$239.8 million , net purchases of marketable securities of$97.9 million and cash used for purchases of property and equipment of$35.5 million .
Cash flows from financing activities
For the nine months endedSeptember 30, 2022 , cash provided by financing activities of$1.2 million primarily consisted of cash received from net proceeds from the sale of common stock of$9.7 million and issuances of common stock of$6.3 million . These were partially offset by cash to settle acquisition obligations of$10.6 million and finance lease principal payments of$4.2 million . For the nine months endedSeptember 30, 2021 , cash provided by financing activities of$1.6 billion primarily consisted of net proceeds from the issuance of our 2028 Notes of$1.1 billion and the sale of common stock of$434.3 million as well as cash received from issuances of common stock of$15.8 million .
Contractual obligations
The following table summarizes our contractual obligations, including interest,
as of
Remainder of Contractual obligations: 2022 2023 and 2024 2025 and 2026 2027 and beyond Total Operating leases$ 5,205 $ 52,450 $ 33,789 $ 114,993$ 206,437 Finance leases 1,570 8,939 495 - 11,004 Convertible senior notes - 349,996 - 1,150,000 1,499,996 2020 Term Loan - 135,000 - - 135,000 Purchase commitments 10,022 36,785 2,594 - 49,401 Total$ 16,797 $ 583,170 $ 36,878 $ 1,264,993$ 1,901,838 See Note 8, "Commitments and contingencies" in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1. of this Quarterly Report on Form 10-Q for additional details regarding our leases, convertible senior notes, 2020 Term Loan and purchase commitments.
Off-balance sheet arrangements
We have not entered into any off-balance sheet arrangements.
45 --------------------------------------------------------------------------------
Recent accounting pronouncements
See "Recent accounting pronouncements" in Note 2, "Summary of significant accounting policies" in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1. of this Quarterly Report on Form 10-Q for a discussion of recently adopted accounting pronouncements and accounting pronouncements not yet adopted, and their expected effect on our financial position and results of operations.
Porch Group Reports Third Quarter 2022 Results
FATHOM HOLDINGS INC. – 10-Q – Management's Discussion and Analysis of Financial Condition and Results of Operations.
Advisor News
Annuity News
Health/Employee Benefits News
Life Insurance News