Adaptive Biotechnologies Corp
For the period ended Mar 31, 2024. Filed May 7, 2024.
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Mar 31, 2024 · Filed May 7, 2024
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Notes to Unaudited Condensed Consolidated Financial Statements
- Organization and Description of Business
Adaptive Biotechnologies Corporation (“we,” “us” or “our”) is a commercial-stage company advancing the field of immune medicine by harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our immune medicine platform applies our proprietary technologies to read the diverse genetic code of a patient’s immune system and understand precisely how the immune system detects and treats disease in that patient. We capture these insights in our dynamic clinical immunomics database and related antigen annotations, which are underpinned by computational biology and machine learning, and use them to develop and commercialize clinical products and services that can be tailored to the needs of individual patients. We have commercial products and services and a robust pipeline of clinical products and services that we are designing to diagnose, monitor and enable the treatment of diseases, such as cancer and autoimmune disorders.
We were incorporated in the State of Washington on September 8, 2009 under the name Adaptive TCR Corporation. On December 21, 2011, we changed our name to Adaptive Biotechnologies Corporation. We are headquartered in Seattle, Washington.
- Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The unaudited condensed consolidated financial statements include the accounts of Adaptive Biotechnologies Corporation, Adaptive Biotechnologies B.V., our wholly-owned subsidiary, and Digital Biotechnologies, Inc., a corporate subsidiary we have 70% ownership interest in. The remaining interest in Digital Biotechnologies, Inc., held by certain of our related parties and their related family trusts, are shown in the unaudited condensed consolidated financial statements as noncontrolling interest. All intercompany transactions and balances have been eliminated upon consolidation.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and the related disclosures at the date of the condensed consolidated financial statements, as well as the reported amounts of revenues and expenses during the periods presented. We base our estimates on historical experience and other relevant assumptions that we believe to be reasonable under the circumstances. Estimates are used in several areas including, but not limited to, estimates of progress to date for certain performance obligations and the transaction price for certain contracts with customers, share-based compensation, imputing interest for our revenue interest purchase agreement (the “Purchase Agreement”) that we entered into in September 2022, the provision for income taxes, including related reserves, the analysis of goodwill impairment and the recoverability and impairment of long-lived assets, among others. These estimates generally involve complex issues and require judgments, involve the analysis of historical results and prediction of future trends, can require extended periods of time to resolve and are subject to change from period to period. Actual results may differ materially from management’s estimates.
Unaudited Interim Condensed Consolidated Financial Statements
In our opinion, the accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information. These unaudited condensed consolidated financial statements include all adjustments necessary to fairly state our financial position and the results of our operations and cash flows for interim periods in accordance with GAAP. All such adjustments were of a normal, recurring nature. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period.
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024.
Segment Information
We operate astwo operating and reportable segments: MRD and Immune Medicine. We have determined that our chief executive officer is the chief operating decision maker (“CODM”). The CODM reviews operating results and other financial information presented at the MRD and Immune Medicine segment level, as well as on a consolidated basis, to make resource allocation decisions. The MRD and Immune Medicine segments are also our two reporting units.
Restricted Cash
We had a restricted cash balance of$3.0 million and$2.9 million as of March 31, 2024 and December 31, 2023, respectively. Our restricted cash primarily relates to certain balances we are required to maintain under lease arrangements for some of our property and facility leases.
Goodwill
Goodwill represents the excess of the purchase price over the net amount of attributed identifiable assets acquired and liabilities assumed in a business combination measured at fair value. We assess goodwill for impairment annually on October 1, or more frequently if events or changes in circumstances would more likely than not reduce the fair value of one or both of our reporting units below their respective carrying value. We evaluate goodwill for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value of one or both of our reporting units is less than their respective carrying amount. If we so determine, or if we choose to bypass the qualitative assessment, we perform a quantitative goodwill impairment test. If impairment exists, the carrying value of the allocated goodwill is reduced to its fair value through an impairment charge recorded in the consolidated statements of operations. To date, we have not recognized any impairment of goodwill.
Concentrations of Risk
We are subject to a concentration of risk from a limited number of suppliers, or in certain cases, single suppliers, for some of our laboratory instruments and materials. This risk is managed by targeting a quantity of surplus stock.
Cash, cash equivalents and marketable securities are financial instruments that potentially subject us to concentrations of credit risk. We invest in money market funds, United States (“U.S.”) government treasury and agency securities, corporate bonds and commercial paper with high-quality accredited financial institutions.
Significant customers are those that represent more than ten percent of our total revenue or accounts receivable, net balances for the periods and as of each condensed consolidated balance sheet date presented, respectively.
For each significant customer, revenue as a percentage of total revenue for the periods presented and accounts receivable, net as a percentage of total accounts receivable, net as of the dates presented were as follows:
| Revenue · Accounts Receivable, Net | ||||
|---|---|---|---|---|
| Three Months Ended March 31, · March 31, · December 31, | ||||
| 2024 | 2023 | 2024 | 2023 | |
| Customer A | *% | *% | *% | *% |
| Customer B | * | * | * | * |
| Customer C | 11.7 | * | 11.2 | * |
| Genentech, Inc. and Roche Group | 13.5 | 26.6 | * | * |
| * less than 10% | ||||
Revenue Recognition
For all revenue-generating contracts, we perform the following steps to determine the amount of revenue to be recognized: (1) identify the contract or contracts; (2) determine whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (3) measure the transaction price, including the constraint on variable consideration; (4) allocate the transaction price to the performance obligations based on estimated selling prices; and (5) recognize revenue when (or as) we satisfy each performance obligation.
We derive revenue by providing diagnostic and research services in our Minimal Residual Disease (“MRD”) and Immune Medicine business areas. Our MRD revenue consists of revenue generated from (1) providing our clonoSEQ report to clinical customers; (2) providing MRD sample testing services to biopharmaceutical customers and certain academic institutions, including investigator-led clinical trials; and (3) providing our clonoSEQ report or results to certain international laboratory sites through technology transfers. Our Immune Medicine revenue consists of revenue generated from (1) providing sample testing services for our commercial research product, Adaptive Immunosequencing, to biopharmaceutical customers and academic institutions; and (2) our collaboration agreements with Genentech, Inc. (“Genentech”) and other biopharmaceutical customers in areas of drug and target discovery.
For agreements where we provide our clonoSEQ report to ordering physicians, we have identified one performance obligation: the delivery of a clonoSEQ report. We bill and receive payments for these transactions from commercial, government and medical institution payors. As payment from the respective payors may vary based on the various reimbursement rates and patient responsibilities, we consider the transaction price to be variable and record an estimate of the transaction price, subject to the constraint for variable consideration, as revenue at the time of delivery. The estimate of transaction price is based on historical and expected reimbursement rates with the various payors, which are monitored in subsequent periods and adjusted, as necessary, based on actual collection experience.
Regarding our clonoSEQ coverage under Medicare, we bill an episode of treatment when we deliver the first eligible test report. This billing contemplates all necessary tests required during a patient’s treatment cycle, which is currently estimated at approximately four tests per patient, including the initial sequence identification test. Revenue recognition commences at the time the initial billable test report is delivered and is based upon cumulative tests delivered to date. We estimate the number of tests we expect to deliver over a patient’s treatment cycle based on historical testing frequencies for patients by indication. These estimates are subject to change as we develop more information about utilization over time. Any unrecognized revenue from the initial billable test is recorded as deferred revenue and is recognized either as we deliver our estimate of the remaining tests in a patient’s treatment cycle or when the likelihood becomes remote that a patient will receive additional testing.
The contract transaction price for agreements we enter into with biopharmaceutical customers to further develop and commercialize their therapeutics may consist of a combination of non-refundable upfront fees, separately priced MRD testing fees and milestone fees earned upon our customers’ achievement of certain regulatory approvals. Depending on the contract, these agreements include single or multiple performance obligations. Such performance obligations include providing services to support our customers’ therapeutic development efforts, including regulatory support for our technology intended to be utilized as part of our customers’ registrational trials, developing analytical plans for our data, participating on joint research committees, assisting in completing a regulatory submission and providing MRD testing services related to customer-provided samples for our customers' regulatory submissions. Generally, the support services, excluding MRD testing services, are not distinct within the context of the contract and thus are accounted for as a single performance obligation. The transaction price allocated to the respective performance obligations is estimated using an adjusted market assessment approach for the regulatory support services and a standalone selling price for the estimated MRD testing services. When MRD sample testing services are separately priced customer options, we assess if a material right exists and, if not, the customer option to purchase additional MRD sample testing services is not considered part of the contract. We recognize revenue related to MRD testing services over time using an output method based on the proportion of sample results delivered relative to the total amount of sample results expected to be delivered, when expected to be a faithful depiction of progress. We use the same method to recognize the regulatory support services. When an output method based on the proportion of sample results delivered is not expected to be a faithful depiction of progress, we utilize an input method using a cost-based model based on estimates of effort completed. Selecting the measure of progress and estimating progress to date requires significant judgment. Except for any non-refundable upfront fees, the other forms of compensation represent variable consideration. At contract inception, we fully constrain any consideration related to regulatory milestones, as the achievement of such milestones is subject to third-party regulatory approval and the customers’ own submission decision-making. Variable consideration related to regulatory milestones is estimated using the most likely amount method, where variable consideration is constrained until it is probable that a significant reversal of cumulative revenue will not occur. Milestone payments for regulatory approvals, which are not within our customers’ control, are not considered probable of being achieved until those approvals are received. Determining whether regulatory milestone payments are probable is an area that requires significant judgment. In making this assessment, we evaluate scientific, clinical, regulatory and other risks, as well as the level of effort and investment required to achieve the respective milestone.
For research customers who utilize either our MRD or Adaptive Immunosequencing services, contracts typically include an amount billed in advance of services (“upfront”) and subsequent billings as sample results are delivered to the customer. Upfront amounts received are recorded as deferred revenue, which we recognize as revenue upon satisfaction of performance obligations. We have identified two typical performance obligations under the terms of our research service contracts: (1) the delivery of our MRD data or Adaptive Immunosequencing for customer provided samples; and (2) related data analysis. We recognize revenue for both identified performance obligations as sample results are delivered to the customer. In periods where our sample estimates are reduced or a customer project is cancelled and, in either case, we have remaining related deferred revenue, we recognize revenue using a cumulative catch-up approach based on the proportion of samples delivered to date relative to the total samples expected to be delivered.
New Accounting Pronouncements Not Yet Adopted
In November 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which intends to enhance reportable segment disclosures about significant segment expenses. This guidance is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the guidance is to be applied retrospectively. We are currently evaluating the impact of this guidance on our consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which primarily intends to enhance the rate reconciliation and income taxes paid disclosures. This guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted and the guidance is to be applied prospectively; retrospective application is permitted. We are currently evaluating the impact of this guidance on our consolidated financial statements.
- Revenue
We disaggregate our revenue from contracts with customers by business area and type of arrangement, as we believe this best depicts how the nature, amount, timing and uncertainty of our revenue and cash flows are affected by economic factors.
The following table presents our disaggregated revenue for the periods presented (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| MRD revenue | ||
| Service revenue | $28,126 | $21,427 |
| Regulatory milestone revenue | 4,500 | — |
| Total MRD revenue | 32,626 | 21,427 |
| Immune Medicine revenue | ||
| Service revenue | 4,559 | 7,102 |
| Collaboration revenue | 4,688 | 9,118 |
| Total Immune Medicine revenue | 9,247 | 16,220 |
| Total revenue | $41,873 | $37,647 |
During the three months ended March 31, 2024, we recognized $1.5 million in MRD service revenue related to Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote and from cancelled customer contracts. During the three months ended March 31, 2023, we recognized $1.0 million in MRD service revenue related to Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote and from cancelled customer contracts.
As of March 31, 2024, we could receive up to an additional$430.5 million in milestone payments in future periods if certain regulatory approvals are obtained by our customers’ therapeutics in connection with MRD data generated from our MRD product.
Genentech Collaboration Agreement
In December 2018, we entered into a worldwide collaboration and license agreement with Genentech (the “Genentech Agreement”) to leverage our capability to develop cellular therapies in oncology. Subsequent to receipt of regulatory approval in January 2019, we received a non-refundable, upfront payment of $300.0 million in February 2019. Additionally, we received a $10.0 million milestone in 2023. We may be eligible to receive $1.8 billion over time, including payments of up to $65.0 million upon the achievement of specified regulatory milestones, up to $300.0 million upon the achievement of specified development milestones and up to $1,430.0 million upon the achievement of specified commercial milestones. In addition, we are separately able to receive tiered royalties at a rate ranging from the mid-single digits to the mid-teens on aggregate worldwide net sales of products arising from the strategic collaboration, subject to certain reductions, with aggregate minimum floors. Under the Genentech Agreement, we are pursuing two product development pathways for novel T cell therapeutic products in which Genentech intends to use T cell receptors (“TCRs”) screened by our immune medicine platform to engineer and manufacture cellular medicines:
Shared Products. The shared products will use “off-the-shelf” TCRs identified against cancer antigens shared among patients (“Shared Products”).
Personalized Product. The personalized product will use patient-specific TCRs identified by real-time screening of TCRs against cancer antigens in each patient (“Personalized Product”).
Under the terms of the Genentech Agreement, we granted Genentech exclusive worldwide licenses to develop and commercialize TCR-based cellular therapies in the field of oncology, including licenses to existing shared antigen data packages. Additionally, Genentech has the right to determine which product candidates to further develop for commercialization purposes. We determined that this arrangement meets the criteria set forth in Accounting Standards Codification (“ASC”) Topic 808, Collaborative Arrangements (“ASC 808”), because both parties are active participants in the activity and are exposed to significant risks and rewards depending on the activity’s commercial failure or success. Because ASC 808 does not provide guidance on how to account for the activities under a collaborative arrangement, we applied the guidance in ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”) to account for the activities related to the Genentech Agreement.
In applying ASC 606, we identified the following performance obligations at the inception of the agreement:
License to utilize on an exclusive basis all TCR-specific platform intellectual property to develop and commercialize any licensed products in the field of oncology.
License to utilize all data and information within each shared antigen data package and any other know-how disclosed by us to Genentech in oncology.
License to utilize all private antigen TCR product data in connection with research and development activities in the field of use.
License to existing shared antigen data packages.
Research and development services for Shared Products development, including expansion of shared antigen data packages.
Research and development services for private product development.
Obligations to participate on various joint research, development and project committees.
We determined that none of the licenses, research and development services or obligations to participate on various committees were distinct within the context of the contract, given such rights and activities were highly interrelated and there was substantial additional research and development to further develop the licenses. We considered factors such as the stage of development of the respective existing antigen data packages, the subsequent development that would be required to both identify and submit a potential target for investigational new drug acceptance under both product pathways and the variability in research and development pathways given Genentech’s control of product commercialization. Specifically, under the Genentech Agreement, Genentech is not required to pursue development or commercialization activities pertaining to both product pathways and may choose to proceed with one or the other. Accordingly, we determined that all of the identified performance obligations were attributable to one general performance obligation, which is to further the development of our TCR-specific platform, including data packages, and continue to make our TCR identification process available to Genentech to pursue either product pathway.
Separately, we have a responsibility to Genentech to enter into a supply and manufacturing agreement for patient-specific TCRs as it pertains to any Personalized Product therapeutic. We determined this was an option right of Genentech should they pursue commercialization of a Personalized Product therapy. Because of the uncertainty resulting from the early stage of development, the novel approach of our collaboration with Genentech and our rights to future commercial milestones and royalty payments, we determined that this option right was not a material right that should be accounted for at inception. As such, we will account for the supply and manufacturing agreement when entered into between the parties.
We determined the initial transaction price shall be made up of only the $300.0 million upfront, non-refundable payment, as all potential regulatory and development milestone payments were probable of significant revenue reversal given their achievement was highly dependent on factors outside our control. As a result, these payments were fully constrained and were not included in the initial transaction price. In May 2023, one of the regulatory milestones was achieved, resulting in a $10.0 million addition to the transaction price, $7.7 million of which was recognized as revenue in the three months ended June 30, 2023, with the remainder included in deferred revenue to be recognized as revenue over the remaining research and development period. We continue to exclude the commercial milestones and potential royalties from the transaction price, as those items relate predominantly to the license rights granted to Genentech and will be assessed when and if such events occur.
As there are potential substantive developments necessary, which Genentech may be able to direct, we determined that we would apply a proportional performance model to recognize revenue for our performance obligation. We measure proportional performance using an input method based on costs incurred relative to the total estimated costs of research and development efforts to pursue both the Shared Products and Personalized Product pathways. When any of the potential regulatory and development milestones are no longer fully constrained and are included in the transaction price, such amounts will be recognized using the cumulative catch-up method based on proportional performance at such time. We currently expect to recognize revenue generated from the Genentech Agreement over a period of approximately nine years from the effective date. This estimate of the research and development period considers pursuit options of development activities supporting both the Shared Products and Personalized Product, but may be reduced or increased based on the various activities as directed by the joint committees, decisions made by Genentech, regulatory feedback or other factors not currently known.
In total, we recognized $4.7 million and $9.1 million in Immune Medicine collaboration revenue during the three months ended March 31, 2024 and 2023, respectively, related to the Genentech Agreement. Costs related to the Genentech Agreement are included in research and development expenses.
- Deferred Revenue
Deferred revenue from the Genentech Agreement represents$8.4 million and$41.6 million of the current and non-current deferred revenue balances, respectively, as of March 31, 2024 and$13.6 million and$41.1 million of the current and non-current deferred revenue balances, respectively, as of December 31, 2023. We expect our current deferred revenue to be recognized as revenue within 12 months. We expect the majority of our non-current deferred revenue to be recognized as revenue over a period of approximately four years from March 31, 2024. This period of time represents an estimate of the research and development period to develop cellular therapies in oncology, which may be reduced or increased based on various research and development activities.
Changes in deferred revenue during the three months ended March 31, 2024 were as follows (in thousands):
| Deferred revenue balance at December 31, 2023 | $93,423 |
|---|---|
| Additions to deferred revenue during the period | 10,802 |
| Revenue recognized during the period | (13,195) |
| Deferred revenue balance at March 31, 2024 | $91,030 |
As of March 31, 2024,$10.5 million was recognized as revenue that was included in the deferred revenue balance at December 31, 2023.
- Fair Value Measurements
The following tables set forth the fair values of financial assets as of March 31, 2024 and December 31, 2023 that were measured at fair value on a recurring basis (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Financial assets | ||||
| Money market funds | $44,303 | $— | $— | $44,303 |
| Commercial paper | — | 10,777 | — | 10,777 |
| U.S. government treasury securities | — | 217,701 | — | 217,701 |
| Corporate bonds | — | 9,161 | — | 9,161 |
| Total financial assets | $44,303 | $237,639 | $— | $281,942 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Financial assets | ||||
| Money market funds | $45,123 | $— | $— | $45,123 |
| Commercial paper | — | 10,630 | — | 10,630 |
| U.S. government treasury and agency securities | — | 264,426 | — | 264,426 |
| Corporate bonds | — | 6,281 | — | 6,281 |
| Total financial assets | $45,123 | $281,337 | $— | $326,460 |
Level 1 securities include highly liquid money market funds, for which we measure the fair value based on quoted prices in active markets for identical assets or liabilities. Level 2 securities consist of U.S. government treasury and agency securities, commercial paper and corporate bonds, and are valued based on recent trades of securities in inactive markets or on quoted market prices of similar instruments and other significant inputs derived from or corroborated by observable market data.
- Investments
Available-for-sale investments consisted of the following as of March 31, 2024 and December 31, 2023 (in thousands):
| Amortized Cost | Unrealized Gain | Unrealized Loss | Estimated Fair Value | |
|---|---|---|---|---|
| Short-term marketable securities | ||||
| Commercial paper | $10,777 | $— | $— | $10,777 |
| U.S. government treasury securities | 217,805 | 25 | (129) | 217,701 |
| Corporate bonds | 9,163 | — | (2) | 9,161 |
| Total short-term marketable securities | $237,745 | $25 | $(131) | $237,639 |
| Amortized Cost | Unrealized Gain | Unrealized Loss | Estimated Fair Value | |
|---|---|---|---|---|
| Short-term marketable securities | ||||
| Commercial paper | $10,630 | $— | $— | $10,630 |
| U.S. government treasury and agency securities | 264,214 | 232 | (20) | 264,426 |
| Corporate bonds | 6,278 | 3 | — | 6,281 |
| Total short-term marketable securities | $281,122 | $235 | $(20) | $281,337 |
All the U.S. government treasury and agency securities, commercial paper and corporate bonds designated as short-term marketable securities have an effective maturity date that is equal to or less than one year from the respective condensed consolidated balance sheet date. Those that are designated as long-term marketable securities have an effective maturity date that is more than one year from the respective condensed consolidated balance sheet date.
Accrued interest receivable is excluded from the amortized cost and estimated fair value of our marketable securities. Accrued interest receivable of$1.1 million and$1.0 million was presented separately within the prepaid expenses and other current assets balance on the unaudited condensed consolidated balance sheet as of March 31, 2024 and on the condensed consolidated balance sheet as of December 31, 2023, respectively.
The following table presents the gross unrealized holding losses and fair values for investments in an unrealized loss position, and the length of time individual securities have been in a continuous loss position, as of March 31, 2024 (in thousands):
| Less Than 12 Months | 12 Months Or Greater | |||
|---|---|---|---|---|
| Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | |
| U.S. government treasury securities | $134,826 | $(129) | $— | $— |
| Corporate bonds | 6,514 | (2) | — | — |
| Total available-for-sale securities | $141,340 | $(131) | $— | $— |
We periodically review our available-for-sale securities to assess for credit impairment. Some of the factors considered in assessing impairment include the extent to which the fair value is less than the amortized cost basis, adverse conditions related to the security, an industry or geographic area, changes to security ratings or sector credit ratings and other relevant market data.
As of March 31, 2024, we did not intend, nor were we more likely than not to be required, to sell our available-for-sale investments before the recovery of their amortized cost basis, which may be maturity. Based on our assessment, we concluded all impairment as of March 31, 2024 to be due to factors other than credit loss, such as changes in interest rates. A credit allowance was not recognized and the impairment of our available-for-sale securities was recorded in other comprehensive loss.
- Leases
We have operating lease agreements for laboratory, office and warehouse facilities in Seattle, Washington, South San Francisco, California and Bothell, Washington. As of March 31, 2024, we were not party to any finance leases.
The following table reconciles our undiscounted operating lease cash flows to our operating lease liabilities, less current portion balance as of March 31, 2024 (in thousands):
| 2024 (excluding the three months ended March 31, 2024) | $10,297 |
| 2025 | 14,098 |
| 2026 | 12,330 |
| 2027 | 11,944 |
| 2028 | 12,282 |
| Thereafter | 56,962 |
| Total undiscounted lease payments | 117,913 |
| Less: Imputed interest rate | (21,419) |
| Total operating lease liabilities | 96,494 |
| Less: Current portion | (9,594) |
| Operating lease liabilities, less current portion | $86,900 |
During the three months ended March 31, 2024 and 2023, cash paid for amounts included in the measurement of lease liabilities was $3.7 million and $3.4 million, respectively.
We have $2.1 million in letters of credit with one of our financial institutions in connection with certain of our leases.
- Revenue Interest Purchase Agreement
In September 2022, we entered into the Purchase Agreement with OrbiMed Royalty & Credit Opportunities IV, LP (“OrbiMed”), an affiliate of OrbiMed Advisors LLC, as collateral agent and administrative agent for the purchasers party thereto (the “Purchasers”). Pursuant to the Purchase Agreement, we received $125.0 million from the Purchasers at closing, less certain transaction expenses. We are also entitled to receive up to $125.0 million in subsequent installments as follows: (i) $75.0 million upon our request occurring no later than September 12, 2025 and (ii) $50.0 million upon our request in connection with certain permitted acquisitions occurring no later than September 12, 2025, in each case subject to certain funding conditions.
As consideration for such payments, the Purchasers have a right to receive certain revenue interests (the “Revenue Interests”) from us based on a percentage of all GAAP revenue. Payments in respect of the Revenue Interests shall be made quarterly within 45 days following the end of each fiscal quarter (each, a “Revenue Interest Payment”).
Accounting Treatment
We accounted for the transaction as debt recorded at amortized cost using the effective interest rate method.
To determine the amortization of the Purchase Agreement obligation, we are required to estimate the amount and timing of future Revenue Interest Payments based on our estimate of the timing and amount of future revenues and calculate an effective interest rate which will amortize the obligation tozero over the amortization period. The calculated effective interest rate as of March 31, 2024 was 9.2%.
In connection with the Purchase Agreement, we incurred debt issuance costs of $0.6 million. Debt issuance costs have been recorded to debt and are being amortized over the estimated term of the debt using the effective interest method, adjusted on a prospective basis for changes in the underlying assumptions and inputs.
The assumptions used in determining the expected repayment term of the obligation and amortization period of the issuance costs requires that we make estimates that could impact the short- and long-term classification of these costs, as well as the period over which these costs will be amortized. We periodically assess the amount and timing of expected Revenue Interest Payments based on internal forecasts. To the extent such payments are greater or less than our initial estimates or the timing of such payments is materially different than our original estimates, we will prospectively adjust the amortization of the revenue interest liability and the effective interest rate.
The following table sets forth the revenue interest liability, net activity during the three months ended March 31, 2024 (in thousands):
| Revenue interest liability, net at December 31, 2023 | $130,660 |
|---|---|
| Interest expense | 2,993 |
| Revenue interest payable | (2,108) |
| Revenue interest liability, net at March 31, 2024 | $131,545 |
Revenue interest payable of $2.1 million and $2.3 million was included within the accounts payable balance on the unaudited condensed consolidated balance sheet as of March 31, 2024 and on the condensed consolidated balance sheet as of December 31, 2023, respectively.
- Commitments and Contingencies
Legal Proceedings
We are subject to claims and assessments from time to time in the ordinary course of business. We will accrue a liability for such matters when it is probable that a liability has been incurred and the amount can be reasonably estimated. When only a range of possible loss can be established, the most probable amount in the range is accrued. If no amount within this range is a better estimate than any other amount within the range, the minimum amount in the range is accrued. We were not party to any material legal proceedings as of March 31, 2024.
Indemnification Agreements
In the ordinary course of business, we may provide indemnification of varying scope and terms to vendors, lessors, customers and other parties with respect to certain matters including, but not limited to, losses arising out of breach of our agreements with them or from intellectual property infringement claims made by third parties. In addition, we have entered into indemnification agreements with members of our board of directors and certain of our executive officers that will require us to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments that we could be required to make under these indemnification agreements is, in many cases, unlimited. We have not incurred any material costs as a result of such indemnifications and are not currently aware of any indemnification claims.
- Shareholders’ Equity
Common Stock
Our common stock has no preferences or privileges and is not redeemable. Holders of our common stock are entitled toone vote for each share of common stock held. The holders of record of outstanding shares of common stock shall be entitled to receive, when, as and if declared, out of funds legally available, such cash and other dividends as may be declared from time to time.
Our 2019 Equity Incentive Plan (the “2019 Plan”) provides for annual increases in the number of shares that may be issued under the 2019 Plan on January 1, 2020 and on each subsequent January 1, thereafter, by a number of shares equal to the lesser of (a)5% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or (b) an amount determined by our board of directors.
Furthermore, our Employee Stock Purchase Plan (the “ESPP”) provides for annual increases in the number of shares available for issuance under our ESPP on January 1, 2020 and on each January 1, thereafter, by a number of shares equal to the smallest of (a)1% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or (b) an amount determined by our board of directors.
Effective January 1, 2024, our 2019 Plan and ESPP reserves increased by 7,254,113 shares and 1,450,822 shares, respectively.
As of March 31, 2024, we had reserved shares of common stock for the following:
| Shares issuable upon the exercise of outstanding stock options granted | 13,588,812 |
|---|---|
| Shares issuable upon the vesting of outstanding restricted stock units granted and the maximum outstanding market-based restricted stock units eligible to be earned | 15,986,199 |
| Shares available for future grant under the 2019 Equity Incentive Plan | 15,149,986 |
| Shares available for future grant under the Employee Stock Purchase Plan | 5,686,170 |
| Total shares of common stock reserved for future issuance | 50,411,167 |
- Equity Incentive Plans
2009 Equity Incentive Plan
We adopted an equity incentive plan in 2009 (the “2009 Plan”) that provided for the issuance of incentive and nonqualified common stock options and other share-based awards for employees, directors and consultants. Under the 2009 Plan, the exercise price for incentive and nonqualified stock options were not to be less than the fair market value of our common stock at the date of grant. Stock options granted under this plan expire no later thanten years from the grant date and vesting was established at the time of grant. Pursuant to the terms of the 2019 Plan, any shares subject to outstanding stock options originally granted under the 2009 Plan that terminate, expire or lapse for any reason without the delivery of shares to the holder thereof shall become available for issuance pursuant to awards granted under the 2019 Plan. Whileno shares are available for future grant under the 2009 Plan, it continues to govern outstanding equity awards granted thereunder.
2019 Equity Incentive Plan
The 2019 Plan became effective immediately prior to the closing of our initial public offering in July 2019. The 2019 Plan provides for the issuance of awards in the form of stock options and other share-based awards for employees, directors and consultants. Under the 2019 Plan, the stock option exercise price per share shall not be less than the fair market value of a share of stock on the effective date of grant, as defined by the 2019 Plan, unless explicitly qualified under the provisions of Section 409A or Section 424(a) of the Internal Revenue Code of 1986. Additionally, unless otherwise specified, stock options granted under this plan expire no later thanten years from the grant date and vesting is established at the time of grant. Except for certain stock option and restricted stock unit grants made to non-employee directors, stock options and restricted stock units granted under the 2019 Plan generally vest over afour-year period, subject to continuous service through each applicable vesting date. As of March 31, 2024, we had 39,881,924 shares of common stock authorized for issuance under the 2019 Plan.
Changes in shares available for grant during the three months ended March 31, 2024 were as follows:
| Shares Available for Grant | |
|---|---|
| Shares available for grant at December 31, 2023 | 15,299,763 |
| 2019 Equity Incentive Plan reserve increase effective January 1, 2024 | 7,254,113 |
| Stock options and restricted stock units granted and the maximum market-based restricted stock units granted eligible to be earned | (8,399,478) |
| Stock options and restricted stock units forfeited or expired | 995,588 |
| Shares available for grant at March 31, 2024 | 15,149,986 |
Stock Options
Stock option activity under the 2009 Plan and 2019 Plan during the three months ended March 31, 2024 was as follows:
| Shares Subject toOutstanding Stock Options | Weighted-Average ExercisePrice per Share | Aggregate Intrinsic Value(in thousands) | |
|---|---|---|---|
| Stock options outstanding at December 31, 2023 | 12,875,045 | $15.90 | |
| Stock options granted | 1,008,364 | 3.99 | |
| Stock options forfeited | (195,745) | 17.55 | |
| Stock options expired | (67,952) | 17.31 | |
| Stock options exercised | (30,900) | 1.43 | |
| Stock options outstanding at March 31, 2024 | 13,588,812 | $15.02 | $108 |
| Stock options vested and exercisable at March 31, 2024 | 9,662,208 | $16.25 | $108 |
The weighted-average remaining contractual life for stock options outstanding as of March 31, 2024 was 6.2 years. The weighted-average remaining contractual life for vested and exercisable stock options as of March 31, 2024 was 5.2 years.
Restricted Stock Units
Restricted stock unit activity under the 2019 Plan during the three months ended March 31, 2024 was as follows:
| Restricted Stock UnitsOutstanding | Weighted-Average Grant DateFair Value per Share | |
|---|---|---|
| Nonvested restricted stock units outstanding at December 31, 2023 | 9,669,460 | $10.32 |
| Restricted stock units granted | 5,327,094 | 3.99 |
| Restricted stock units forfeited | (731,891) | 10.05 |
| Restricted stock units vested | (2,255,158) | 11.04 |
| Nonvested restricted stock units outstanding at March 31, 2024 | 12,009,505 | $7.39 |
Market-Based Restricted Stock Units
In addition to the restricted stock units described above, our board of directors approved awards of market-based restricted stock units to our chief executive officer, former chief financial officer, president/chief operating officer and chief scientific officer in March 2024. The shares of common stock that may be earned under the awards granted to our chief executive officer, former chief financial officer, president/chief operating officer and chief scientific officer, which range from zero shares to 709,220 shares,295,580 shares,350,000 shares and 709,220 shares, respectively, are calculated based on our total shareholder return during athree-year performance period as measured against that of the group of companies comprising the S&P Biotechnology Select Industry Index as of the grant date, subject to certain adjustments to such index group. Except as expressly provided in the terms of each award's agreement, vesting is subject to the respective grantee's continuous service through the end of the three-year performance period. These market-based restricted stock units, along with those granted in March 2022 and March 2023, which had a weighted-average grant date fair value per share of $15.13 and under which zero shares to 1,912,674 shares may be earned, remained outstanding as of March 31, 2024.
Grant Date Fair Value of Stock Options, Restricted Stock Units and Market-Based Restricted Stock Units Granted
The estimated grant date fair values of stock options granted during the three months ended March 31, 2024 and 2023 were estimated using the Black-Scholes option-pricing model with the following assumptions:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Fair value of common stock | $3.99 | $8.46 |
| Expected term (in years) | 5.27 - 6.08 | 5.27 - 6.08 |
| Risk-free interest rate | 4.2% | 4.2% - 4.3% |
| Expected volatility | 74.5% - 75.0% | 71.2% - 71.6% |
| Expected dividend yield | — | — |
The determination of the grant date fair value of stock options granted using a Black-Scholes option-pricing model is affected by the fair value of our common stock, as well as assumptions regarding a number of variables that are subjective and generally require judgment to determine. The valuation assumptions were determined as follows:
Fair value of common stock—The fair value of each share of common stock is based on the closing price of our common stock on the date of grant, or other relevant determination date, as reported on The Nasdaq Global Select Market.
Expected term—The expected term of stock options granted to employees and non-employee directors is determined using the “simplified” method, as illustrated in ASC Topic 718, Compensation—Stock Compensation, as we do not have sufficient exercise history to determine a better estimate of expected term. Under this approach, the expected term is based on the midpoint between the vesting date and the end of the contractual term of the stock option.
Risk-free interest rate—We utilize a risk-free interest rate in the option valuation model based on U.S. Treasury zero-coupon issues with remaining terms similar to the expected terms of the stock options.
Expected volatility—As we do not have sufficient trading history for our common stock, expected volatility has been based on the historical volatility of our publicly traded industry peers utilizing a period of time consistent with our estimate of expected term. Beginning in 2024, expected volatility was based on a weighted average of our historical volatility and the historical volatility of our publicly traded industry peers utilizing a period of time consistent with our estimate of expected term.
Expected dividend yield—We do not anticipate paying any cash dividends in the foreseeable future and, therefore, use an expected dividend yield ofzero in the option valuation model.
The weighted-average grant date fair value per share of stock options granted during the three months ended March 31, 2024 and 2023 was$2.70 and $5.61, respectively.
The grant date fair value of restricted stock units granted is based on the closing price of our common stock on the date of grant, or other relevant determination date, as reported on The Nasdaq Global Select Market. The weighted-average grant date fair value per share of restricted stock units granted during the three months ended March 31, 2024 and 2023 was$3.99 and $8.46, respectively.
The weighted-average grant date fair value per share of the market-based restricted stock units granted during the three months ended March 31, 2024 and 2023 was $6.49 and $13.82, respectively, and was determined using a Monte Carlo valuation model, which uses assumptions such as volatility, risk-free interest rate and dividend estimated for the respective performance periods. The weighted-average grant date fair value per share of the target payout level of the market-based restricted stock units outstanding as of March 31, 2024,1,988,347 shares, was $10.65. The aggregate share-based compensation expense of the market-based restricted stock units granted during the three months ended March 31, 2024 and 2023 was $6.7 million and $9.8 million, respectively, and is recognized on a straight-line basis over the respective grants'three-year performance periods, which are also the requisite service periods. Attainment of each grant's respective market condition and the number of shares earned and vested does not impact the related share-based compensation expense recognized. Share-based compensation expense will be reversed only if the respective grantee does not provide continuous service through the respective performance period for reasons other than those expressly provided in the terms of the respective award.
The compensation cost related to stock options, restricted stock units and market-based restricted stock units for the three months ended March 31, 2024 and 2023 are included on the unaudited condensed consolidated statements of operations as follows (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Cost of revenue | $906 | $1,294 |
| Research and development | 4,684 | 4,549 |
| Sales and marketing | 3,013 | 3,431 |
| General and administrative | 5,695 | 5,397 |
| Total share-based compensation expense | $14,298 | $14,671 |
As of March 31, 2024, unrecognized share-based compensation expense and the remaining weighted-average recognition period were as follows:
| Unrecognized Share-BasedCompensation Expense(in thousands) | Remaining Weighted-AverageRecognition Period(in years) | |
|---|---|---|
| Nonvested stock options | $28,766 | 1.92 |
| Nonvested restricted stock units | 83,591 | 2.79 |
| Nonvested market-based restricted stock units | 14,271 | 2.28 |
- Net Loss Per Share Attributable to Adaptive Biotechnologies Corporation Common Shareholders
The following table sets forth the computation of basic and diluted net loss per share attributable to our common shareholders for the three months ended March 31, 2024 and 2023 (in thousands, except share and per share amounts):
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Net loss attributable to Adaptive Biotechnologies Corporation | $(47,507) | $(57,699) |
| Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted | 145,787,527 | 143,511,142 |
| Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted | $(0.33) | $(0.40) |
Given the loss position for all periods presented, basic net loss per share attributable to our common shareholders is the same as diluted net loss per share attributable to our common shareholders, as the inclusion of all potential shares of common stock outstanding would have been anti-dilutive.
The following weighted-average common stock equivalents were excluded from the calculation of diluted net loss per share attributable to our common shareholders for the three months ended March 31, 2024 and 2023, as they had an anti-dilutive effect:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options outstanding | 13,085,872 | 13,800,485 |
| Nonvested restricted stock units outstanding | 10,341,199 | 7,386,862 |
| Maximum nonvested market-based restricted stock units outstanding eligible to be earned | 2,547,757 | 904,006 |
| Total | 25,974,828 | 22,091,353 |
- Segment Information
In 2024, in connection with an organizational realignment, we began operating our business astwo reporting segments: MRD and Immune Medicine. These segments are organized by market opportunity in commercial diagnostics and drug discovery, respectively.
The MRD business focuses on the use of our highly sensitive, next-generation sequencing assay to measure MRD in patients with hematologic malignancies. It is comprised of our clonoSEQ clinical diagnostic test, offered to clinicians, and our clonoSEQ assay, offered to biopharmaceutical partners, to advance drug development efforts. Our MRD revenue consists of revenue generated from (1) providing our clonoSEQ report to clinical customers; (2) providing MRD sample testing services to biopharmaceutical customers and certain academic institutions, including investigator-led clinical trials; and (3) providing our clonoSEQ report or results to certain international laboratory sites through technology transfers.
The Immune Medicine business leverages our proprietary ability to sequence, map, pair and characterize TCRs and B cell receptors (“BCRs”) at scale. We have created a powerful data engine to drive the development of novel therapies. Our Immune Medicine revenue consists of revenue generated from (1) providing sample testing services for our commercial research product, Adaptive Immunosequencing, to biopharmaceutical customers and academic institutions; and (2) our collaboration agreements with Genentech and other biopharmaceutical customers in areas of drug and target discovery.
There areno inter-segment revenues. See Note 3, Revenuefor more information about each segment's revenue. Our CODM evaluates performance of the MRD segment based on both revenue and Adjusted EBITDA and evaluates performance of the Immune Medicine segment based on Adjusted EBITDA. Adjusted EBITDA for each of our segments includes costs that are directly aligned to each segment, as well as certain allocated shared expenses. These shared expenses primarily relate to our general and administrative functions, our non-laboratory facility space in our corporate headquarters and our production laboratory. We use the relative direct headcount assigned to each of the respective segments and our production laboratory sample volume to allocate these expenses. We do not allocate certain expenses, such as our corporate insurance costs, external legal and audit costs and expenses related to our investor relations, chief executive officer and other related support functions. Additionally, we do not allocate costs related to our idle facility in Seattle, Washington, interest expense related to our Purchase Agreement nor interest and other income, net. Given these unallocated costs and income are not included in the measurements reviewed by the CODM to assess each segment's performance, they are included in "Unallocated Corporate" below. Our allocation methodology will be periodically evaluated and may change. Our CODM is not regularly provided nor reviews assets when assessing each segment's performance and to allocate resources. As such, assets for reportable segments are not disclosed.
The following tables set forth our segment information for the three months ended March 31, 2024 and 2023 (in thousands):
| MRD | Immune Medicine | Unallocated Corporate | Total | |
|---|---|---|---|---|
| Revenue | $32,626 | $9,247 | $— | $41,873 |
| Operating expenses | 59,886 | 23,841 | 6,908 | 90,635 |
| Adjusted EBITDA(1) | (17,259) | (6,927) | (3,994) | (28,180) |
| Reconciliation of Net Loss to Adjusted EBITDA: | ||||
| Net loss | $(27,260) | $(14,593) | $(5,680) | $(47,533) |
| Net loss attributable to noncontrolling interest | — | — | 26 | 26 |
| Net loss attributable to Adaptive Biotechnologies Corporation | (27,260) | (14,593) | (5,654) | (47,507) |
| Interest and other income, net | — | — | (4,222) | (4,222) |
| Interest expense(2) | — | — | 2,993 | 2,993 |
| Depreciation and amortization expense | 2,701 | 2,082 | 431 | 5,214 |
| Restructuring expense(3) | 467 | 577 | — | 1,044 |
| Share-based compensation expense(4) | 6,833 | 5,007 | 2,458 | 14,298 |
| Adjusted EBITDA(1) | $(17,259) | $(6,927) | $(3,994) | $(28,180) |
| MRD | Immune Medicine | Unallocated Corporate | Total | |
|---|---|---|---|---|
| Revenue | $21,427 | $16,220 | $— | $37,647 |
| Operating expenses | 56,025 | 31,672 | 7,143 | 94,840 |
| Adjusted EBITDA(1) | (26,386) | (7,427) | (3,285) | (37,098) |
| Reconciliation of Net Loss to Adjusted EBITDA: | ||||
| Net loss | $(34,597) | $(15,452) | $(7,651) | $(57,700) |
| Net loss attributable to noncontrolling interest | — | — | 1 | 1 |
| Net loss attributable to Adaptive Biotechnologies Corporation | (34,597) | (15,452) | (7,650) | (57,699) |
| Interest and other income, net | — | — | (3,024) | (3,024) |
| Interest expense(2) | — | — | 3,531 | 3,531 |
| Depreciation and amortization expense | 2,056 | 2,753 | 614 | 5,423 |
| Share-based compensation expense(4) | 6,155 | 5,272 | 3,244 | 14,671 |
| Adjusted EBITDA(1) | $(26,386) | $(7,427) | $(3,285) | $(37,098) |
(1)Adjusted EBITDA is a non-GAAP financial measure. See “Management's Discussion and Analysis of Financial Condition and Results of Operations—Adjusted EBITDA” for an explanation for how it is calculated and used by management.
(2)Represents costs associated with our revenue interest liability and noncash interest costs associated with the amortization of the related deferred issuance costs. See Note 8, Revenue Interest Purchase Agreementfor details on the Purchase Agreement.
(3)Represents costs associated with our organizational realignment to our two segments initiated in the three months ended March 31, 2024. These costs primarily related to one-time termination benefits and ongoing benefit arrangements.
(4) Represents share-based compensation expense related to stock option, restricted stock unit and market-based restricted stock unit awards. See Note 11, Equity Incentive Plans for details on our share-based compensation expense.
Segment information for the three months ended March 31, 2023 is presented on a comparable basis to that of the current period and is based on judgments and allocation methods from our recent organizational changes.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.