Item 1. Financial Statements (Unaudited)
Notes to Unaudited Condensed Consolidated Financial Statements
(unaudited)
|
1. |
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 aims to understand precisely how the immune system detects and treats disease in that patient. We capture these insights in our dynamic clinical immunomics database, which is underpinned by computational biology and machine learning, and use them to develop and commercialize clinical products and services that we are tailoring to each individual patient. 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, autoimmune disorders and infectious diseases.
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.
|
2. |
Significant Accounting Policies |
Basis of Presentation and Principles of Consolidation
The unaudited condensed consolidated financial statements include the accounts of Adaptive Biotechnologies Corporation, 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 between Adaptive Biotechnologies Corporation, our wholly-owed subsidiary and Digital Biotechnologies, Inc. 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, including the fair value of stock, the provision for income taxes, including related reserves, and goodwill, 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 financial statements and notes included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 15, 2022.
Reclassification
We previously disclosed revenue bifurcated into sequencing and development financial statement captions. Beginning with the reporting period ended March 31, 2022, we changed how we classify revenue and now present total revenue on the unaudited condensed consolidated statements of operations. See Note 3, Revenue for additional disaggregation of revenue under our Immune Medicine and MRD market opportunities.
10
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
Restricted Cash
We had a restricted cash balance of $2.4 million and $2.1 million as of June 30, 2022 and December 31, 2021, 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.
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 debt securities, U.S. government agency securities, commercial paper and corporate bonds with high-quality accredited financial institutions.
Significant customers are those that represent more than 10% 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 June 30, |
|
Six Months Ended June 30, |
|
June 30, |
|
December 31, |
|
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
Customer B |
|
12.3% |
|
*% |
|
14.9% |
|
*% |
|
23.6% |
|
11.3% |
|
Genentech and Roche Group |
|
34.8 |
|
46.0 |
|
34.3 |
|
44.1 |
|
* |
|
* |
|
* less than 10% |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue Recognition
We recognize revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606 (“ASC 606”), Revenue from Contracts with Customers. Under ASC 606, 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 Immune Medicine and MRD market opportunities. Our Immune Medicine revenue consists of revenue generated from (1) providing sample testing services for our commercial research product, immunoSEQ, to biopharmaceutical customers and academic institutions; (2) providing our T-Detect COVID tests to clinical customers; and (3) our collaboration agreements with Genentech and other biopharmaceutical customers in areas of drug and target discovery. 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.
For research customers who utilize either immunoSEQ or our MRD 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 immunoSEQ or MRD data 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 remaining samples expected to be delivered.
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 medical institutions and commercial and government third-party 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.
11
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
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 and assisting in completing a regulatory submission and providing MRD testing services related to customer-provided samples for their 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. 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. 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. 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 recognized 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.
Net Loss Per Share Attributable to Adaptive Biotechnologies Corporation Common Shareholders
We calculate basic net loss per share attributable to our common shareholders by dividing net loss attributable to us by our weighted-average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to our common shareholders is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, outstanding common stock warrants, outstanding stock options, nonvested restricted stock units and the maximum nonvested market-based restricted stock units eligible to be earned are considered common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to our common shareholders, as their effect is anti-dilutive.
12
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
We disaggregate our revenue from contracts with customers by market opportunity 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 June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
7,296 |
|
|
$ |
5,405 |
|
|
$ |
14,409 |
|
|
$ |
9,453 |
|
|
Collaboration revenue |
|
|
15,082 |
|
|
|
17,634 |
|
|
|
28,785 |
|
|
|
33,691 |
|
|
Total Immune Medicine revenue |
|
|
22,378 |
|
|
|
23,039 |
|
|
|
43,194 |
|
|
|
43,144 |
|
|
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
|
20,282 |
|
|
|
13,966 |
|
|
|
35,086 |
|
|
|
25,303 |
|
|
Regulatory milestone revenue |
|
|
1,000 |
|
|
|
1,500 |
|
|
|
4,000 |
|
|
|
8,500 |
|
|
Total MRD revenue |
|
|
21,282 |
|
|
|
15,466 |
|
|
|
39,086 |
|
|
|
33,803 |
|
|
Total revenue |
|
$ |
43,660 |
|
|
$ |
38,505 |
|
|
$ |
82,280 |
|
|
$ |
76,947 |
|
During the three months ended June 30, 2022, we recognized $1.4 million in revenue related to changes in estimates of total samples to be provided under certain of our agreements and Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote, all of which was recognized as MRD service revenue. During the three months ended June 30, 2021, we recognized $3.1 million in revenue related to changes in estimates of total samples to be provided under certain of our agreements, Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote and cancelled customer contracts, all of which was recognized as MRD service revenue.
During the six months ended June 30, 2022, we recognized $2.8 million in revenue related to Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote, changes in estimates of total samples to be provided under certain of our agreements and cancelled customer contracts, $0.2 million of which was recognized as Immune Medicine service revenue and $2.6 million of which was recognized as MRD service revenue. During the six months ended June 30, 2021, we recognized $4.1 million in revenue related to changes in estimates of total samples to be provided under certain of our agreements, Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote and cancelled customer contracts, $0.1 million of which was recognized as Immune Medicine service revenue and $4.0 million of which was recognized as MRD service revenue.
As of June 30, 2022, we could receive up to an additional $355.5 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 and may be eligible to receive more than $1.8 billion over time, including payments of up to $75.0 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 agreement, we are pursuing two product development pathways for novel T cell immunotherapies 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”). |
13
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
Under the terms of the 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 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 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:
|
|
1. |
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. |
|
|
2. |
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. |
|
|
3. |
License to utilize all private antigen TCR product data in connection with research and development activities in the field of use. |
|
|
4. |
License to existing shared antigen data packages. |
|
|
5. |
Research and development services for Shared Products development, including expansion of shared antigen data packages. |
|
|
6. |
Research and development services for private product development. |
|
|
7. |
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 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 transaction price as of June 30, 2022. We excluded 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 the revenue over a period of approximately seven to eight 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 the 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.
14
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
We recognized $13.8 million and $17.2 million in Immune Medicine collaboration revenue during the three months ended June 30, 2022 and 2021, respectively, and $26.0 million and $32.8 million in Immune Medicine collaboration revenue during the six months ended June 30, 2022 and 2021, respectively, related to the Genentech Agreement. Costs related to the Genentech Agreement are included in research and development expenses.
Deferred revenue from our Genentech Agreement represents $53.9 million and $70.1 million of the current and non-current deferred revenue balances, respectively, as of June 30, 2022 and $56.1 million and $94.0 million of the current and non-current deferred revenue balances, respectively, as of December 31, 2021. 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 to five years from June 30, 2022. 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 the various research and development activities.
Changes in deferred revenue during the six months ended June 30, 2022 were as follows (in thousands):
|
Deferred revenue balance at December 31, 2021 |
|
$ |
179,210 |
|
|
Additions to deferred revenue during the period |
|
|
19,379 |
|
|
Revenue recognized during the period |
|
|
(43,553 |
) |
|
Deferred revenue balance at June 30, 2022 |
|
$ |
155,036 |
|
As of June 30, 2022, $34.5 million was recognized as revenue that was included in the deferred revenue balance at December 31, 2021.
|
5. |
Fair Value Measurements |
The following tables set forth the fair value of financial assets as of June 30, 2022 and December 31, 2021 that were measured at fair value on a recurring basis (in thousands):
|
|
|
June 30, 2022 |
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
70,358 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
70,358 |
|
|
U.S. government debt securities |
|
|
— |
|
|
|
334,857 |
|
|
|
— |
|
|
|
334,857 |
|
|
Corporate bonds |
|
|
— |
|
|
|
39,397 |
|
|
|
— |
|
|
|
39,397 |
|
|
Total financial assets |
|
$ |
70,358 |
|
|
$ |
374,254 |
|
|
$ |
— |
|
|
$ |
444,612 |
|
|
|
|
December 31, 2021 |
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
131,946 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
131,946 |
|
|
U.S. government debt securities |
|
|
— |
|
|
|
391,145 |
|
|
|
— |
|
|
|
391,145 |
|
|
Corporate bonds |
|
|
— |
|
|
|
39,996 |
|
|
|
— |
|
|
|
39,996 |
|
|
Total financial assets |
|
$ |
131,946 |
|
|
$ |
431,141 |
|
|
$ |
— |
|
|
$ |
563,087 |
|
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 debt securities 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.
15
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
Available-for-sale investments consisted of the following as of June 30, 2022 and December 31, 2021 (in thousands):
|
|
|
June 30, 2022 |
|
|
|
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Estimated Fair Value |
|
|
Short-term marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government debt securities |
|
$ |
271,337 |
|
|
$ |
— |
|
|
$ |
(3,408 |
) |
|
$ |
267,929 |
|
|
Corporate bonds |
|
|
39,662 |
|
|
|
— |
|
|
|
(265 |
) |
|
|
39,397 |
|
|
Total short-term marketable securities |
|
$ |
310,999 |
|
|
$ |
— |
|
|
$ |
(3,673 |
) |
|
$ |
307,326 |
|
|
Long-term marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government debt securities |
|
$ |
69,055 |
|
|
$ |
— |
|
|
$ |
(2,127 |
) |
|
$ |
66,928 |
|
|
Total long-term marketable securities |
|
$ |
69,055 |
|
|
$ |
— |
|
|
$ |
(2,127 |
) |
|
$ |
66,928 |
|
|
|
|
December 31, 2021 |
|
|
|
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Estimated Fair Value |
|
|
Short-term marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government debt securities |
|
$ |
186,752 |
|
|
$ |
4 |
|
|
$ |
(109 |
) |
|
$ |
186,647 |
|
|
Corporate bonds |
|
|
27,363 |
|
|
|
— |
|
|
|
(14 |
) |
|
|
27,349 |
|
|
Total short-term marketable securities |
|
$ |
214,115 |
|
|
$ |
4 |
|
|
$ |
(123 |
) |
|
$ |
213,996 |
|
|
Long-term marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government debt securities |
|
$ |
205,472 |
|
|
$ |
— |
|
|
$ |
(974 |
) |
|
$ |
204,498 |
|
|
Corporate bonds |
|
|
12,691 |
|
|
|
— |
|
|
|
(44 |
) |
|
|
12,647 |
|
|
Total long-term marketable securities |
|
$ |
218,163 |
|
|
$ |
— |
|
|
$ |
(1,018 |
) |
|
$ |
217,145 |
|
All the U.S. government debt securities 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 $0.8 million and $1.4 million is presented separately within the prepaid expenses and other current assets balance on the unaudited condensed consolidated balance sheet as of June 30, 2022 and on the condensed consolidated balance sheet as of December 31, 2021, respectively.
The following table presents the gross unrealized holding losses and fair value for investments in an unrealized loss position, and the length of time individual securities have been in a continuous loss position, as of June 30, 2022 (in thousands):
|
|
|
Less Than 12 Months |
|
|
12 Months Or Greater |
|
|
|
|
Fair Value |
|
|
Unrealized Loss |
|
|
Fair Value |
|
|
Unrealized Loss |
|
|
U.S. government debt securities |
|
$ |
334,857 |
|
|
$ |
(5,535 |
) |
|
$ |
— |
|
|
$ |
— |
|
|
Corporate bonds |
|
|
39,397 |
|
|
|
(265 |
) |
|
|
— |
|
|
|
— |
|
|
Total available-for-sale securities |
|
$ |
374,254 |
|
|
$ |
(5,800 |
) |
|
$ |
— |
|
|
$ |
— |
|
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 June 30, 2022, 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 June 30, 2022 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.
16
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
|
7. |
Goodwill and Intangible Assets |
There have been no changes in the carrying amount of goodwill since its recognition in 2015.
Intangible assets subject to amortization as of June 30, 2022 and December 31, 2021 consisted of the following (in thousands):
|
|
|
June 30, 2022 |
|
|
|
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net Carrying Amount |
|
|
Acquired developed technology |
|
$ |
20,000 |
|
|
$ |
(12,464 |
) |
|
$ |
7,536 |
|
|
Purchased intellectual property |
|
|
325 |
|
|
|
(177 |
) |
|
|
148 |
|
|
Balance at June 30, 2022 |
|
$ |
20,325 |
|
|
$ |
(12,641 |
) |
|
$ |
7,684 |
|
|
|
|
December 31, 2021 |
|
|
|
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net Carrying Amount |
|
|
Acquired developed technology |
|
$ |
20,000 |
|
|
$ |
(11,638 |
) |
|
$ |
8,362 |
|
|
Purchased intellectual property |
|
|
325 |
|
|
|
(161 |
) |
|
|
164 |
|
|
Balance at December 31, 2021 |
|
$ |
20,325 |
|
|
$ |
(11,799 |
) |
|
$ |
8,526 |
|
The developed technology was acquired in connection with our acquisition of Sequenta, Inc. in 2015. The remaining balance of the acquired developed technology and the purchased intellectual property is expected to be amortized over the next 4.5 years.
As of June 30, 2022, expected future amortization expense for intangible assets was as follows (in thousands):
|
2022 (excluding the six months ended June 30, 2022) |
|
$ |
857 |
|
|
2023 |
|
|
1,699 |
|
|
2024 |
|
|
1,703 |
|
|
2025 |
|
|
1,699 |
|
|
2026 |
|
|
1,699 |
|
|
Thereafter |
|
|
27 |
|
|
Total future amortization expense |
|
$ |
7,684 |
|
We have operating lease agreements for laboratory, office and warehouse facilities in Seattle, Washington, Bothell, Washington, South San Francisco, California and New York City, New York. As of June 30, 2022, 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 June 30, 2022 (in thousands):
|
2022 (excluding the six months ended June 30, 2022) |
|
$ |
7,053 |
|
|
2023 |
|
|
13,964 |
|
|
2024 |
|
|
13,692 |
|
|
2025 |
|
|
14,098 |
|
|
2026 |
|
|
12,330 |
|
|
Thereafter |
|
|
81,188 |
|
|
Total undiscounted lease payments |
|
|
142,325 |
|
|
Less: |
|
|
|
|
|
Imputed interest rate |
|
|
(29,789 |
) |
|
Tenant improvement receivables |
|
|
(1,194 |
) |
|
Total operating lease liabilities |
|
|
111,342 |
|
|
Less: Current portion |
|
|
(8,615 |
) |
|
Operating lease liabilities, less current portion |
|
$ |
102,727 |
|
17
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
During the six months ended June 30, 2022, cash paid for amounts included in the measurement of lease liabilities was $3.3 million, net of $4.0 million of cash received for tenant improvement allowances. Cash paid for amounts included in the measurement of lease liabilities was $3.5 million and cash received for tenant improvement allowances was $5.4 million during the six months ended June 30, 2021.
We previously entered into a $2.1 million letter of credit with one of our financial institutions in connection with one of our leases.
|
9. |
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 June 30, 2022.
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.
Common Stock
Our common stock has no preferences or privileges and is not redeemable. Holders of our common stock are entitled to one 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.
As of June 30, 2022, we had reserved shares of common stock for the following:
|
Shares issuable upon the exercise of outstanding stock options granted |
|
|
14,338,119 |
|
|
Shares issuable upon the vesting of outstanding restricted stock units granted and the maximum outstanding market-based restricted stock units eligible to be earned |
|
|
6,044,821 |
|
|
Shares available for future grant under the 2019 Equity Incentive Plan |
|
|
14,516,155 |
|
|
Shares available for future grant under the Employee Stock Purchase Plan |
|
|
2,804,298 |
|
|
Total shares of common stock reserved for future issuance |
|
|
37,703,393 |
|
Our 2019 Equity Incentive Plan (“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 (“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.
Our board of directors determined not to increase the 2019 Plan and ESPP reserves in 2022.
18
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
|
11. |
Equity Incentive Plans |
2009 Equity Incentive Plan
We adopted an equity incentive plan in 2009 (“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 than ten 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. While no shares are available for future issuance 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 than ten 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 a four-year period, subject to continuous service through each applicable vesting date. As of June 30, 2022, we had 29,279,180 shares of common stock authorized for issuance under the 2019 Plan.
Changes in shares available for grant during the six months ended June 30, 2022 were as follows:
|
|
|
Shares Available for Grant |
|
|
Shares available for grant at December 31, 2021 |
|
|
22,299,923 |
|
|
Stock options and restricted stock units granted and the maximum market-based restricted stock units granted eligible to be earned |
|
|
(10,460,587 |
) |
|
Stock options and restricted stock units forfeited, cancelled or expired |
|
|
2,676,819 |
|
|
Shares available for grant at June 30, 2022 |
|
|
14,516,155 |
|
Stock Options
Stock option activity under the 2009 Plan and 2019 Plan during the six months ended June 30, 2022 was as follows:
|
|
|
Shares Subject to
Outstanding Stock Options |
|
|
Weighted-Average Exercise
Price per Share |
|
|
Aggregate Intrinsic Value
(in thousands) |
|
|
Stock options outstanding at December 31, 2021 |
|
|
12,778,984 |
|
|
$ |
19.72 |
|
|
|
|
|
|
Stock options granted |
|
|
4,397,538 |
|
|
|
11.66 |
|
|
|
|
|
|
Stock options forfeited or cancelled |
|
|
(1,240,578 |
) |
|
|
29.13 |
|
|
|
|
|
|
Stock options expired |
|
|
(367,736 |
) |
|
|
32.41 |
|
|
|
|
|
|
Stock options exercised |
|
|
(1,230,089 |
) |
|
|
5.46 |
|
|
|
|
|
|
Stock options outstanding at June 30, 2022 |
|
|
14,338,119 |
|
|
$ |
17.33 |
|
|
$ |
9,550 |
|
|
Stock options vested and exercisable at June 30, 2022 |
|
|
6,985,837 |
|
|
$ |
13.90 |
|
|
$ |
8,807 |
|
The weighted-average remaining contractual life for stock options outstanding as of June 30, 2022 was 7.4 years. The weighted-average remaining contractual life for vested and exercisable stock options as of June 30, 2022 was 5.7 years.
Of the $20.5 million proceeds from the exercise of stock options included on the unaudited condensed consolidated statements of cash flows for the six months ended June 30, 2021, $0.3 million related to options exercised prior to but settled during the six months ended June 30, 2021. As of June 30, 2021, there was $0.2 million in unsettled cash proceeds related to options exercised during the six months ended June 30, 2021.
19
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
Restricted Stock Units
Restricted stock unit activity under the 2019 Plan during the six months ended June 30, 2022 was as follows:
|
|
|
Restricted Stock Units
Outstanding |
|
|
Weighted-Average Grant Date
Fair Value per Share |
|
|
Nonvested restricted stock units outstanding at December 31, 2021 |
|
|
1,211,191 |
|
|
$ |
37.41 |
|
|
Restricted stock units granted |
|
|
5,568,815 |
|
|
|
11.66 |
|
|
Restricted stock units forfeited or cancelled |
|
|
(1,068,505 |
) |
|
|
16.80 |
|
|
Restricted stock units vested |
|
|
(160,914 |
) |
|
|
43.19 |
|
|
Nonvested restricted stock units outstanding at June 30, 2022 |
|
|
5,550,587 |
|
|
$ |
15.38 |
|
Market-Based Restricted Stock Units
In addition to the restricted stock units described above, our board of directors approved an award of market-based restricted stock units to our chief executive officer in March 2022. The shares of common stock that may be earned under the award, ranging from zero shares to 494,234 shares, are calculated based upon our total shareholder return during a three-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 the award agreement, vesting is subject to our chief executive officer's continuous service through the end of the three-year performance period.
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 six months ended June 30, 2022 and 2021 were estimated using the Black-Scholes option-pricing model with the following assumptions:
|
|
|
Six Months Ended June 30, |
|
|
|
|
2022 |
|
|
2021 |
|
|
Fair value of common stock |
|
$7.30 - $14.95 |
|
|
$34.41 - $66.50 |
|
|
Expected term (in years) |
|
5.27 - 6.08 |
|
|
5.27 - 6.08 |
|
|
Risk-free interest rate |
|
1.7% - 3.0% |
|
|
0.5% - 1.1% |
|
|
Expected volatility |
|
68.2% - 71.0% |
|
|
67.1% - 68.7% |
|
|
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 complex, subjective and generally require significant 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 is based on 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 of zero in the option valuation model.
The weighted-average grant date fair value per share of stock options granted during the six months ended June 30, 2022 and 2021 was $7.36 and $26.52, respectively.
20
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
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 six months ended June 30, 2022 and 2021 was $11.66 and $42.93, respectively.
The grant date fair value of the market-based restricted stock units granted in March 2022 is $18.89 and was determined using a Monte Carlo valuation model, which uses assumptions such as volatility, risk-free interest rate and dividend estimated for the performance period. The related share-based compensation expense of $4.7 million is recognized on a straight-line basis over the three-year performance period, which is also the requisite service period. Attainment of the 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 our chief executive officer does not provide continuous service through the performance period for reasons other than those expressly provided in the terms of the award.
The compensation cost related to stock options, restricted stock units and market-based restricted stock units for the three and six months ended June 30, 2022 and 2021, respectively, are included on the unaudited condensed consolidated statements of operations as follows (in thousands):
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Cost of revenue |
|
$ |
954 |
|
|
$ |
408 |
|
|
$ |
1,749 |
|
|
$ |
736 |
|
|
Research and development |
|
|
4,643 |
|
|
|
3,791 |
|
|
|
8,988 |
|
|
|
6,674 |
|
|
Sales and marketing |
|
|
3,584 |
|
|
|
3,302 |
|
|
|
6,813 |
|
|
|
5,797 |
|
|
General and administrative |
|
|
4,999 |
|
|
|
3,748 |
|
|
|
9,491 |
|
|
|
6,526 |
|
|
Total share-based compensation expense |
|
$ |
14,180 |
|
|
$ |
11,249 |
|
|
$ |
27,041 |
|
|
$ |
19,733 |
|
As of June 30, 2022, unrecognized share-based compensation expense and the remaining weighted-average recognition period were as follows:
|
|
|
|
|
|
|
Unrecognized Share-Based
Compensation Expense
(in thousands) |
|
|
Remaining Weighted-Average
Recognition Period
(in years) |
|
|
Nonvested stock options |
|
|
|
|
|
$ |
88,549 |
|
|
|
2.85 |
|
|
Nonvested restricted stock units |
|
|
|
|
|
|
75,935 |
|
|
|
3.42 |
|
|
Nonvested market-based restricted stock units |
|
|
|
|
|
|
4,165 |
|
|
|
2.68 |
|
In March 2022, we began implementing a restructuring plan to reduce operating costs and drive future growth aligned with the strategic reorganization of our business around our MRD and Immune Medicine market opportunities. Under this restructuring plan, we reduced our workforce by approximately 100 employees.
We incurred aggregate restructuring costs of $2.0 million, all of which was recognized in the six months ended June 30, 2022. These costs primarily related to one-time termination benefits and ongoing benefit arrangements, both of which included severance payments and extended benefits coverage support and were contingent upon the impacted employees’ execution and non-revocation of separation agreements. Our aggregate restructuring costs also included certain contract termination costs.
The activities related to our reduction in workforce were primarily completed in March 2022 and the $2.0 million aggregate restructuring costs were paid as of June 30, 2022.
21
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
|
13. |
Net Loss Per Share Attributable to Adaptive Biotechnologies Corporation Common Shareholders |
The following table sets forth the computation of the basic and diluted net loss per share attributable to our common shareholders for the three and six months ended June 30, 2022 and 2021, respectively (in thousands, except share and per share amounts):
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Net loss attributable to Adaptive Biotechnologies Corporation |
|
$ |
(52,046 |
) |
|
$ |
(49,301 |
) |
|
$ |
(114,782 |
) |
|
$ |
(89,943 |
) |
|
Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
|
142,363,589 |
|
|
|
140,359,317 |
|
|
|
142,032,261 |
|
|
|
139,667,380 |
|
|
Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.81 |
) |
|
$ |
(0.64 |
) |
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 and six months ended June 30, 2022 and 2021, respectively, as they had an anti-dilutive effect:
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Stock options outstanding |
|
|
14,693,276 |
|
|
|
13,204,775 |
|
|
|
13,978,339 |
|
|
|
13,360,000 |
|
|
Nonvested restricted stock units |
|
|
5,364,447 |
|
|
|
676,411 |
|
|
|
3,983,640 |
|
|
|
458,707 |
|
|
Maximum nonvested market-based restricted stock units eligible to be earned |
|
|
494,234 |
|
|
|
— |
|
|
|
324,938 |
|
|
|
— |
|
|
Common stock warrant outstanding |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
17,282 |
|
|
Total |
|
|
20,551,957 |
|
|
|
13,881,186 |
|
|
|
18,286,917 |
|
|
|
13,835,989 |
|
22
Adaptive Biotechnologies Corporation