UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____to _____
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of July 29, 2022, the registrant had
Table of Contents
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Page |
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PART I. |
4 |
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Item 1. |
4 |
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4 |
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5 |
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6 |
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7 |
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9 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
10 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
23 |
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Item 3. |
34 |
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Item 4. |
34 |
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PART II. |
35 |
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Item 1. |
35 |
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Item 1A. |
35 |
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Item 2. |
35 |
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Item 3. |
35 |
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Item 4. |
35 |
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Item 5. |
35 |
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Item 6. |
36 |
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37 |
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Adaptive Biotechnologies Corporation
FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this report other than statements of historical fact are forward-looking statements, which include but are not limited to, statements about:
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our ability to leverage and extend our immune medicine platform to discover, develop and commercialize our products and services, including further commercialization and development of products and services related to our Immune Medicine and Minimal Residual Disease (“MRD”) market opportunities, particularly in light of the novelty of immune medicine and our methods; |
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our ability to achieve and maintain commercial market acceptance of our current products and services, such as clonoSEQ, T-Detect and immunoSEQ, as well as our ability to achieve market acceptance for any additional products and services beyond our current portfolio, if developed; |
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our collaboration with Genentech, Inc. (“Genentech”) and our ability to develop and commercialize cellular therapeutics, including our ability to achieve milestones and realize the intended benefits of the collaboration; |
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our ability to develop a map of the interaction between the immune system and disease (“TCR-Antigen Map”) and yield insights from it that are commercially viable, including with respect to the T-Detect product line; and |
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our expected reliance on collaborators and other third parties for development, clinical testing and regulatory approval of current products in new indications and potential product candidates, which may fail at any time due to a number of possible unforeseen events. |
The forward-looking statements in this report also include statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts and other matters regarding our business strategies, use of capital, results of operations and financial position and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under “Risk Factors,” “Management's Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report and in other documents we file with the Securities and Exchange Commission (“SEC”) from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this report represent our views as of the date of this report.
We undertake no obligation to update any forward-looking statements for any reason, except as required by law.
Unless otherwise stated or the context otherwise indicates, references to “we,” “us,” “our” and similar references refer to Adaptive Biotechnologies Corporation.
3
Adaptive Biotechnologies Corporation
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
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June 30, 2022 |
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December 31, 2021 |
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(unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term marketable securities (amortized cost of $ |
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Accounts receivable, net |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Long-term assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Long-term marketable securities (amortized cost of $ |
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Restricted cash |
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Intangible assets, net |
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Goodwill |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and shareholders’ equity |
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Current liabilities |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities |
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Accrued compensation and benefits |
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Current portion of operating lease liabilities |
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Current portion of deferred revenue |
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Total current liabilities |
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Long-term liabilities |
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Operating lease liabilities, less current portion |
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Deferred revenue, less current portion |
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Total liabilities |
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Commitments and contingencies (Note 9) |
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Shareholders’ equity |
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Preferred stock: $ |
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Common stock: $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
) |
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( |
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Accumulated deficit |
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( |
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( |
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Total Adaptive Biotechnologies Corporation shareholders’ equity |
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Noncontrolling interest |
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Total shareholders’ equity |
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Total liabilities and shareholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Adaptive Biotechnologies Corporation
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Operating expenses |
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Cost of revenue |
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Research and development |
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Sales and marketing |
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General and administrative |
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Amortization of intangible assets |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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Interest and other income, net |
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Net loss |
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( |
) |
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( |
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( |
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( |
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Add: Net loss attributable to noncontrolling interest |
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— |
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— |
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Net loss attributable to Adaptive Biotechnologies Corporation |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Adaptive Biotechnologies Corporation
Condensed Consolidated Statements of Comprehensive Loss
(in thousands)
(unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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Other comprehensive loss |
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Change in unrealized gains and losses on investments |
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( |
) |
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( |
) |
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( |
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( |
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Comprehensive loss |
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( |
) |
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( |
) |
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( |
) |
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( |
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Add: Comprehensive loss attributable to noncontrolling interest |
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— |
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— |
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Comprehensive loss attributable to Adaptive Biotechnologies Corporation |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Adaptive Biotechnologies Corporation
Condensed Consolidated Statements of Shareholders’ Equity
(in thousands, except share amounts)
(unaudited)
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Common Stock |
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Additional |
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Accumulated Other |
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Accumulated |
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Noncontrolling |
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Total |
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Shares |
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Amount |
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Paid-In Capital |
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Comprehensive Gain (Loss) |
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Deficit |
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Interest |
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Shareholders’ Equity |
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Balance at March 31, 2021 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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Issuance of common stock for cash upon exercise of stock options |
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— |
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— |
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— |
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— |
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Vesting of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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— |
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Common stock option and restricted stock unit share-based compensation |
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— |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
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— |
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— |
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( |
) |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
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Balance at June 30, 2021 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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Balance at March 31, 2022 |
|
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
|
$ |
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|
$ |
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|
Issuance of common stock for cash upon exercise of stock options |
|
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— |
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— |
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— |
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— |
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Vesting of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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— |
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Common stock option, restricted stock unit and market-based restricted stock unit share-based compensation |
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— |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
|
|
— |
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|
|
— |
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( |
) |
|
Net loss |
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— |
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— |
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— |
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|
|
— |
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|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Balance at June 30, 2022 |
|
|
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|
|
$ |
|
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|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
7
Adaptive Biotechnologies Corporation
Condensed Consolidated Statements of Shareholders’ Equity (Continued)
(in thousands, except share amounts)
(unaudited)
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Common Stock |
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Additional |
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Accumulated Other |
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Accumulated |
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Noncontrolling |
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Total |
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||||||||||
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Shares |
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Amount |
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Paid-In Capital |
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Comprehensive Gain (Loss) |
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Deficit |
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Interest |
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Shareholders’ Equity |
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|||||||
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Balance at December 31, 2020 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
|
|
|
Issuance of common stock upon exercise of common stock warrant |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock for cash upon exercise of stock options |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
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|
Vesting of restricted stock units |
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|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Common stock option and restricted stock unit share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Capital contributions for Digital Biotechnologies, Inc. |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
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|
— |
|
|
|
|
|
|
|
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Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
Balance at June 30, 2021 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2021 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
Issuance of common stock for cash upon exercise of stock options |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Vesting of restricted stock units |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Common stock option, restricted stock unit and market-based restricted stock unit share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Balance at June 30, 2022 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
8
Adaptive Biotechnologies Corporation
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
|
Six Months Ended June 30, |
|
|||||
|
|
|
2022 |
|
|
2021 |
|
||
|
Operating activities |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
|
|
|
|
Depreciation expense |
|
|
|
|
|
|
|
|
|
Noncash lease expense |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
|
|
|
|
|
|
Intangible assets amortization |
|
|
|
|
|
|
|
|
|
Investment amortization |
|
|
|
|
|
|
|
|
|
Research and development inventory reserve |
|
|
|
|
|
|
— |
|
|
Other |
|
|
( |
) |
|
|
( |
) |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
( |
) |
|
|
( |
) |
|
Inventory |
|
|
( |
) |
|
|
( |
) |
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
( |
) |
|
|
( |
) |
|
Operating lease right-of-use assets and liabilities |
|
|
( |
) |
|
|
|
|
|
Deferred revenue |
|
|
( |
) |
|
|
( |
) |
|
Other |
|
|
|
|
|
|
( |
) |
|
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
Investing activities |
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
|
Purchases of marketable securities |
|
|
( |
) |
|
|
( |
) |
|
Proceeds from maturities of marketable securities |
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
|
|
|
|
|
|
|
Proceeds from initial capital contributions for Digital Biotechnologies, Inc. |
|
|
— |
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash, cash equivalents and restricted cash |
|
|
( |
) |
|
|
|
|
|
Cash, cash equivalents and restricted cash at beginning of year |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash at end of period |
|
$ |
|
|
|
$ |
|
|
|
Noncash investing activities |
|
|
|
|
|
|
|
|
|
Purchases of equipment included in accounts payable and accrued liabilities |
|
$ |
|
|
|
$ |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
9
Adaptive Biotechnologies Corporation
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
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 $
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 |
|
|
|
*% |
|
|
|
*% |
|
|
|
|
|
Genentech and Roche Group |
|
|
|
|
|
|
|
|
|
* |
|
* |
|
* 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)
|
3. |
Revenue |
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.
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Collaboration revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Regulatory milestone revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
During the three months ended June 30, 2022, we recognized $
During the six months ended June 30, 2022, we recognized $
As of June 30, 2022, we could receive up to an additional $
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 $
|
|
• |
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 $
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
14
Adaptive Biotechnologies Corporation
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
(unaudited)
We recognized $
|
4. |
Deferred Revenue |
Deferred revenue from our Genentech Agreement represents $
Changes in deferred revenue during the six months ended June 30, 2022 were as follows (in thousands):
|
Deferred revenue balance at December 31, 2021 |
|
$ |
|
|
|
Additions to deferred revenue during the period |
|
|
|
|
|
Revenue recognized during the period |
|
|
( |
) |
|
Deferred revenue balance at June 30, 2022 |
|
$ |
|
|
As of June 30, 2022, $
|
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 |
|
$ |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
|
U.S. government debt securities |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
Corporate bonds |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
Total financial assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
|
December 31, 2021 |
|
|||||||||||||
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
|
U.S. government debt securities |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
Corporate bonds |
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
Total financial assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
— |
|
|
$ |
|
|
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)
|
6. |
Investments |
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 |
|
$ |
|
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
|
Corporate bonds |
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
Total short-term marketable securities |
|
$ |
|
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
|
Long-term marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government debt securities |
|
$ |
|
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
|
Total long-term marketable securities |
|
$ |
|
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
|
|
|
December 31, 2021 |
|
|||||||||||||
|
|
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Estimated Fair Value |
|
||||
|
Short-term marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government debt securities |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
Corporate bonds |
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
Total short-term marketable securities |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
Long-term marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government debt securities |
|
$ |
|
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
|
Corporate bonds |
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
Total long-term marketable securities |
|
$ |
|
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
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 $
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 |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
Corporate bonds |
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
Total available-for-sale securities |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
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
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 |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
Purchased intellectual property |
|
|
|
|
|
|
( |
) |
|
|
|
|
|
Balance at June 30, 2022 |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
|
|
December 31, 2021 |
|
|||||||||
|
|
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net Carrying Amount |
|
|||
|
Acquired developed technology |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
Purchased intellectual property |
|
|
|
|
|
|
( |
) |
|
|
|
|
|
Balance at December 31, 2021 |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
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
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) |
|
$ |
|
|
|
2023 |
|
|
|
|
|
2024 |
|
|
|
|
|
2025 |
|
|
|
|
|
2026 |
|
|
|
|
|
Thereafter |
|
|
|
|
|
Total future amortization expense |
|
$ |
|
|
|
8. |
Leases |
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) |
|
$ |
|
|
|
2023 |
|
|
|
|
|
2024 |
|
|
|
|
|
2025 |
|
|
|
|
|
2026 |
|
|
|
|
|
Thereafter |
|
|
|
|
|
Total undiscounted lease payments |
|
|
|
|
|
Less: |
|
|
|
|
|
Imputed interest rate |
|
|
( |
) |
|
Tenant improvement receivables |
|
|
( |
) |
|
Total operating lease liabilities |
|
|
|
|
|
Less: Current portion |
|
|
( |
) |
|
Operating lease liabilities, less current portion |
|
$ |
|
|
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 $
We previously entered into a $
|
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.
|
10. |
Shareholders’ Equity |
Common Stock
Our common stock has no preferences or privileges and is not redeemable.
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 |
|
|
|
|
|
Shares issuable upon the vesting of outstanding restricted stock units granted and the maximum outstanding market-based restricted stock units eligible to be earned |
|
|
|
|
|
Shares available for future grant under the 2019 Equity Incentive Plan |
|
|
|
|
|
Shares available for future grant under the Employee Stock Purchase Plan |
|
|
|
|
|
Total shares of common stock reserved for future issuance |
|
|
|
|
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)
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)
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
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
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 |
|
|
|
|
|
Stock options and restricted stock units granted and the maximum market-based restricted stock units granted eligible to be earned |
|
|
( |
) |
|
Stock options and restricted stock units forfeited, cancelled or expired |
|
|
|
|
|
Shares available for grant at June 30, 2022 |
|
|
|
|
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 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
Stock options granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options forfeited or cancelled |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
Stock options expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
Stock options exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
Stock options outstanding at June 30, 2022 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
Stock options vested and exercisable at June 30, 2022 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
The weighted-average remaining contractual life for stock options outstanding as of June 30, 2022 was
Of the $
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 |
|
|
|
|
|
$ |
|
|
|
Restricted stock units granted |
|
|
|
|
|
|
|
|
|
Restricted stock units forfeited or cancelled |
|
|
( |
) |
|
|
|
|
|
Restricted stock units vested |
|
|
( |
) |
|
|
|
|
|
Nonvested restricted stock units outstanding at June 30, 2022 |
|
|
|
|
|
$ |
|
|
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
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 |
|
|
|
|
|
|
||
|
Expected term (in years) |
|
|
|
|
|
|
||
|
Risk-free interest rate |
|
|
|
|
|
|
||
|
Expected volatility |
|
|
|
|
|
|
||
|
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
The weighted-average grant date fair value per share of stock options granted during the six months ended June 30, 2022 and 2021 was $
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 $
The grant date fair value of the market-based restricted stock units granted in March 2022 is $
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
Cost of revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
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 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
Nonvested restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested market-based restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
12. |
Restructuring |
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
We incurred aggregate restructuring costs of $
The activities related to our reduction in workforce were primarily completed in March 2022 and the $
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 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
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.
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
Stock options outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum nonvested market-based restricted stock units eligible to be earned |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
Common stock warrant outstanding |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22
Adaptive Biotechnologies Corporation
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited condensed consolidated financial statements and related notes and the other financial information appearing elsewhere in this report, as well as the other financial information we file with the SEC from time to time. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties relating to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements.
As a result of many factors, including those factors set forth in the “Risk Factors” section of this report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are 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.
Our immune medicine platform is the foundation for our expanding suite of products and services. The cornerstone of our platform and core immunosequencing product, immunoSEQ, serves as our underlying research and development engine and generates revenue from biopharmaceutical and academic customers.
Leveraging our collaboration with Microsoft, we are creating the TCR-Antigen Map. We are using this map to develop research solutions by disease, called immunoSEQ T-MAP, and a diagnostic product for many diseases from a single blood test, called T-Detect.
Regarding our specific products and pipeline, T-Detect COVID, for which we have received Emergency Use Authorization, is designed to confirm past SARS-CoV-2 infection, the virus that causes COVID-19. It is the first indication for the T-Detect product line. In June 2022, we launched a second indication, T-Detect Lyme, which is designed to help diagnose early Lyme disease. In addition, we have confirmed signals in Crohn’s disease, celiac disease and multiple sclerosis, and we have identified signals in ulcerative colitis and rheumatoid arthritis. In the future, we intend to sell other diagnostic products and services, including other indications for T-Detect.
Our therapeutic product candidates, being developed under the Genentech Agreement, leverage our platform to identify specific receptors on immune cells to develop into cellular therapies in oncology. We also extended our platform to identify highly potent neutralizing antibodies against SARS-CoV-2 and we believe this differentiated approach may be leveraged across multiple disease states.
Our first clinical diagnostic product, clonoSEQ, is the first test authorized by the Food and Drug Administration for the detection and monitoring of MRD in patients with multiple myeloma, B cell acute lymphoblastic leukemia and chronic lymphocytic leukemia, and is also available as a CLIA-validated laboratory developed test for patients with other lymphoid cancers. We disclose our clonoSEQ test volume, which includes the number of clonoSEQ reports and results we have provided to ordering physicians in the United States and international technology transfer sites. These volumes do not include sample results from our biopharmaceutical customers or academic institutions utilizing our MRD services.
Historically, we have sold immunoSEQ as a fee-for-service offering. These research offerings have comprised the majority of our revenue to date, although our business is pursuing broader opportunities. As we continue to expand the use of our clonoSEQ diagnostic tests, develop T-Detect and develop and commercialize therapeutic product candidates with our drug discovery collaborator, we expect our mix of revenue to shift to clinical products and services, which we believe will become our largest sources of revenue.
23
Adaptive Biotechnologies Corporation
We are actively pursuing opportunities to deepen our relationships with current customers and initiate relationships with new customers. We have an experienced, specialty salesforce that is targeting department heads, laboratory directors, principal investigators, core facility directors, clinicians, payors, research scientists and pathologists at leading academic and research institutions, biopharmaceutical companies and contract research organizations. As MRD assessment becomes standard practice for patient management across a range of blood cancers, we believe it will be essential for clinicians and patients to have access to a highly accurate, sensitive and standardized MRD assessment tool. We are focused on establishing and maintaining collaborative relationships with payors, developing health economic evidence and building billing and patient access infrastructure to expand reimbursement coverage for our clinical diagnostics. We continue to seek expanded coverage of our clonoSEQ diagnostic test and have successfully expanded coverage through contractual agreements or positive medical policies with Medicare and several of the largest national private health insurers in the United States.
We recognized revenue of $43.7 million and $38.5 million for the three months ended June 30, 2022 and 2021, respectively, and $82.3 million and $76.9 million for the six months ended June 30, 2022 and 2021, respectively. Net loss attributable to Adaptive Biotechnologies Corporation was $52.0 million and $49.3 million for the three months ended June 30, 2022 and 2021, respectively, and $114.8 million and $89.9 million for the six months ended June 30, 2022 and 2021, respectively. We have funded our operations to date principally from the sale of convertible preferred stock and common stock and, to a lesser extent, revenue. As of June 30, 2022 and December 31, 2021, we had cash, cash equivalents and marketable securities of $450.7 million and $570.2 million, respectively.
Reduction in Workforce
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.
Revenue Reclassification and clonoSEQ Test Volume
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 included elsewhere in this report. We disaggregate revenue under our Immune Medicine and MRD market opportunities in Note 3 of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report.
The following table presents the amount of sequencing revenue and development revenue recognized under our Immune Medicine and MRD market opportunities for the periods presented (in thousands):
|
|
|
Three Months Ended |
|
|||||||||||||
|
|
|
December 31, 2021 |
|
|
September 30, 2021 |
|
|
June 30, 2021 |
|
|
March 31, 2021 |
|
||||
|
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sequencing revenue |
|
$ |
6,860 |
|
|
$ |
8,170 |
|
|
$ |
5,404 |
|
|
$ |
4,048 |
|
|
Development revenue |
|
|
14,514 |
|
|
|
15,445 |
|
|
|
17,635 |
|
|
|
16,057 |
|
|
Total Immune Medicine revenue |
|
|
21,374 |
|
|
|
23,615 |
|
|
|
23,039 |
|
|
|
20,105 |
|
|
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sequencing revenue |
|
|
16,201 |
|
|
|
13,936 |
|
|
|
13,151 |
|
|
|
11,126 |
|
|
Development revenue |
|
|
355 |
|
|
|
1,916 |
|
|
|
2,315 |
|
|
|
7,211 |
|
|
Total MRD revenue |
|
|
16,556 |
|
|
|
15,852 |
|
|
|
15,466 |
|
|
|
18,337 |
|
|
Total revenue |
|
$ |
37,930 |
|
|
$ |
39,467 |
|
|
$ |
38,505 |
|
|
$ |
38,442 |
|
24
Adaptive Biotechnologies Corporation
|
|
|
Three Months Ended |
|
|||||||||||||
|
|
|
December 31, 2020 |
|
|
September 30, 2020 |
|
|
June 30, 2020 |
|
|
March 31, 2020 |
|
||||
|
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sequencing revenue |
|
$ |
3,310 |
|
|
$ |
3,691 |
|
|
$ |
2,036 |
|
|
$ |
3,170 |
|
|
Development revenue |
|
|
17,155 |
|
|
|
12,438 |
|
|
|
12,856 |
|
|
|
11,077 |
|
|
Total Immune Medicine revenue |
|
|
20,465 |
|
|
|
16,129 |
|
|
|
14,892 |
|
|
|
14,247 |
|
|
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sequencing revenue |
|
|
9,399 |
|
|
|
7,585 |
|
|
|
5,949 |
|
|
|
6,299 |
|
|
Development revenue |
|
|
321 |
|
|
|
2,585 |
|
|
|
147 |
|
|
|
364 |
|
|
Total MRD revenue |
|
|
9,720 |
|
|
|
10,170 |
|
|
|
6,096 |
|
|
|
6,663 |
|
|
Total revenue |
|
$ |
30,185 |
|
|
$ |
26,299 |
|
|
$ |
20,988 |
|
|
$ |
20,910 |
|
We also previously disclosed the number of clonoSEQ reports provided to ordering physicians in the United States, referred to as “clinical sequencing volume” or “clinical sequencing volume, excluding T-Detect COVID volume” in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of certain of our SEC filings. Beginning with the reporting period ended March 31, 2022, we changed our disclosures related to volume metrics and now present the number of clonoSEQ reports and results we have provided to ordering physicians in the United States and international technology transfer sites, collectively referred to as “clonoSEQ test volume.” Our clonoSEQ test volume does not include sample results from our biopharmaceutical customers or academic institutions utilizing our MRD services.
The following table presents our clonoSEQ test volume for the periods presented:
|
|
|
Three Months Ended |
|
|||||||||||||
|
|
|
December 31, 2021 |
|
|
September 30, 2021 |
|
|
June 30, 2021 |
|
|
March 31, 2021 |
|
||||
|
Clinical sequencing volume, excluding T-Detect COVID volume |
|
|
6,356 |
|
|
|
5,928 |
|
|
|
5,475 |
|
|
|
4,757 |
|
|
clonoSEQ reports or results provided to international technology transfer sites |
|
|
494 |
|
|
|
413 |
|
|
|
422 |
|
|
|
543 |
|
|
clonoSEQ test volume |
|
|
6,850 |
|
|
|
6,341 |
|
|
|
5,897 |
|
|
|
5,300 |
|
|
|
|
Three Months Ended |
|
|||||||||||||
|
|
|
December 31, 2020 |
|
|
September 30, 2020 |
|
|
June 30, 2020 |
|
|
March 31, 2020 |
|
||||
|
Clinical sequencing volume |
|
|
4,509 |
|
|
|
4,023 |
|
|
|
3,136 |
|
|
|
3,518 |
|
|
clonoSEQ reports or results provided to international technology transfer sites |
|
|
704 |
|
|
|
375 |
|
|
|
310 |
|
|
|
238 |
|
|
clonoSEQ test volume |
|
|
5,213 |
|
|
|
4,398 |
|
|
|
3,446 |
|
|
|
3,756 |
|
25
Adaptive Biotechnologies Corporation
Components of Results of Operations
Revenue
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 our research customers, which include biopharmaceutical customers and academic institutions for both our immunoSEQ and MRD services, delivery of the respective test results may include some level of professional support and analysis. Terms with biopharmaceutical customers generally include non-refundable upfront payments, which we record as deferred revenue. For all research customers, we recognize revenue as we deliver sequencing results. From time to time, we offer discounts in order to gain rights and access to certain datasets. Revenue is recognized net of these discounts and costs associated with these services are reflected in cost of revenue. 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. Certain of our MRD revenue arrangements with biopharmaceutical customers include consideration in the form of regulatory milestones upon regulatory approval of the respective biopharmaceutical partners’ therapeutics. Such revenue is constrained from recognition until it becomes probable that such milestone will be achieved.
Under certain agreements with our biopharmaceutical customers who seek access to our platform to support their therapeutic development activities, revenues are generated from research and development support services that we provide. These agreements may include substantial non-refundable upfront payments, which we recognize over time as we perform the respective services. Revenue recognized from these activities relate primarily to our Genentech Agreement.
For our clinical customers, we primarily derive revenue from providing our clonoSEQ report to ordering physicians. We bill medical institutions and commercial and government payors based on reports delivered to ordering physicians. Amounts paid for clonoSEQ by medical institutions and commercial and government payors vary based on respective reimbursement rates and patient responsibilities, which may differ from our targeted list price. We recognize clinical revenue by evaluating customer payment history, contracted reimbursement rates, if applicable, and other adjustments to estimate the amount of revenue that is collectible.
For 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. Any unrecognized revenue from the initial billable test is recorded as deferred revenue and 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.
We expect revenue to increase over the long term, particularly as the mix of revenue migrates to clinical diagnostics and drug discovery. The pace by which this mix migrates will be determined by the level of customer adoption and frequency of use of our products and services. Our revenue may fluctuate from period to period due to the uncertain nature of delivery of our products and services, the achievement of milestones by our customers, timing of expenses incurred, changes in estimates of total anticipated costs related to our Genentech Agreement and other events not within our control, such as the delivery of customer samples or customer decisions to no longer pursue their development initiatives.
Due to the ongoing uncertainties related to the COVID-19 pandemic, we may experience variability in revenue in the near term as our customers’ abilities to procure samples for their research initiatives change, as customer initiatives evolve and as clinical testing is impacted by the pandemic.
Cost of Revenue
Cost of revenue includes the cost of materials, personnel-related expenses (including salaries, benefits and share-based compensation), shipping and handling expenses, equipment costs and allocated facility costs associated with processing samples and professional support for our service revenue activities. Allocated facility costs include depreciation of laboratory equipment, as well as allocated facility occupancy and information technology costs. Costs associated with processing samples are recorded as expense, regardless of the timing of revenue recognition. As such, cost of revenue and related volume does not always trend in the same direction as revenue recognition and related volume. Additionally, costs to support our Genentech Agreement are a component of our research and development expenses.
26
Adaptive Biotechnologies Corporation
We expect cost of revenue to increase in absolute dollars as we grow our sample testing volume and make investments in laboratory automation and facilities, but the cost per sample to decrease over the long term due to the efficiencies we may gain as assay volume increases from improved utilization of our laboratory capacity, automation and other value engineering initiatives. If our sample volume throughput is reduced as a result of the COVID-19 pandemic or otherwise, cost of revenue as a percentage of total revenue may be adversely impacted due to fixed overhead costs.
Research and Development Expenses
Research and development expenses consist of laboratory materials costs, personnel-related expenses, equipment costs, allocated facility costs, information technology expenses and contract service expenses. Research and development activities support further development and refinement of existing assays and products, discovery of new technologies and investments in our immune medicine platform. We also include in research and development expenses the costs associated with software development of applications to support future commercial opportunities, as well as development activities to support laboratory scaling and workflow. We are currently conducting research and development activities for several products and services and we typically use our laboratory materials, personnel, facilities, information technology and other development resources across multiple development programs. Additionally, certain of these research and development activities benefit more than one of our product opportunities. We do not track research and development expenses by specific product candidates.
A component of our research and development expenses are costs supporting clinical and analytical validations to obtain regulatory approval for future clinical products and services. Additionally, the costs to support our Genentech Agreement are a component of our research and development expenses. Some of these activities have generated and may in the future generate Immune Medicine collaboration revenue.
We expect research and development expenses to experience modest increases in the short term. However, we expect research and development expenses to decrease as a percentage of revenue in the long term, although the percentage may fluctuate from period to period due to the timing and extent of our development and commercialization efforts.
Sales and Marketing Expenses
Sales and marketing expenses include personnel-related expenses for commercial sales, product and account management, marketing, reimbursement, medical education and business development personnel that support commercialization of our platform products. In addition, these expenses include external costs, such as advertising expenses, customer education and promotional expenses, market analysis expenses, conference fees, travel expenses and allocated facility costs.
We expect our sales and marketing expenses to experience modest increases in the short term. In the long term, we expect sales and marketing expenses to increase in absolute dollars as we increase marketing activities to drive awareness and adoption of our products and services. However, we expect sales and marketing expenses to decrease as a percentage of revenue in the long term, subject to fluctuations from period to period due to the timing and magnitude of these expenses.
General and Administrative Expenses
General and administrative expenses include personnel-related expenses (including salaries, benefits and share-based compensation) for our personnel in executive, legal, finance and accounting, human resources and other administrative functions, including third-party billing services. In addition, these expenses include insurance costs, external legal costs, accounting and tax service expenses, consulting fees and allocated facility costs.
We expect minimal growth in our general and administrative expenses in the short term. In the long term, we expect these expenses to decrease as a percentage of revenue as revenue increases.
27
Adaptive Biotechnologies Corporation
Statements of Operations Data
The following table sets forth our statements of operations data for the periods presented (in thousands, except share and per share amounts):
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
Revenue |
|
$ |
43,660 |
|
|
$ |
38,505 |
|
|
$ |
82,280 |
|
|
$ |
76,947 |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
13,221 |
|
|
|
10,765 |
|
|
|
26,413 |
|
|
|
20,756 |
|
|
Research and development |
|
|
37,037 |
|
|
|
37,800 |
|
|
|
74,876 |
|
|
|
71,572 |
|
|
Sales and marketing |
|
|
24,281 |
|
|
|
23,216 |
|
|
|
50,374 |
|
|
|
43,820 |
|
|
General and administrative |
|
|
21,200 |
|
|
|
16,066 |
|
|
|
45,344 |
|
|
|
31,002 |
|
|
Amortization of intangible assets |
|
|
423 |
|
|
|
423 |
|
|
|
842 |
|
|
|
842 |
|
|
Total operating expenses |
|
|
96,162 |
|
|
|
88,270 |
|
|
|
197,849 |
|
|
|
167,992 |
|
|
Loss from operations |
|
|
(52,502 |
) |
|
|
(49,765 |
) |
|
|
(115,569 |
) |
|
|
(91,045 |
) |
|
Interest and other income, net |
|
|
418 |
|
|
|
464 |
|
|
|
689 |
|
|
|
1,102 |
|
|
Net loss |
|
|
(52,084 |
) |
|
|
(49,301 |
) |
|
|
(114,880 |
) |
|
|
(89,943 |
) |
|
Add: Net loss attributable to noncontrolling interest |
|
|
38 |
|
|
|
— |
|
|
|
98 |
|
|
|
— |
|
|
Net loss attributable to Adaptive Biotechnologies Corporation |
|
$ |
(52,046 |
) |
|
$ |
(49,301 |
) |
|
$ |
(114,782 |
) |
|
$ |
(89,943 |
) |
|
Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.81 |
) |
|
$ |
(0.64 |
) |
|
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 |
|
Comparison of the Three Months Ended June 30, 2022 and 2021
Revenue
|
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
7,296 |
|
|
$ |
5,405 |
|
|
$ |
1,891 |
|
|
|
35 |
% |
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
|
15,082 |
|
|
|
17,634 |
|
|
|
(2,552 |
) |
|
|
(14 |
) |
|
|
|
|
|
|
|
|
|
Total Immune Medicine revenue |
|
|
22,378 |
|
|
|
23,039 |
|
|
|
(661 |
) |
|
|
(3 |
) |
|
|
51 |
% |
|
|
60 |
% |
|
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
|
20,282 |
|
|
|
13,966 |
|
|
|
6,316 |
|
|
|
45 |
|
|
|
|
|
|
|
|
|
|
Regulatory milestone revenue |
|
|
1,000 |
|
|
|
1,500 |
|
|
|
(500 |
) |
|
|
(33 |
) |
|
|
|
|
|
|
|
|
|
Total MRD revenue |
|
|
21,282 |
|
|
|
15,466 |
|
|
|
5,816 |
|
|
|
38 |
|
|
|
49 |
% |
|
|
40 |
% |
|
Total revenue |
|
$ |
43,660 |
|
|
$ |
38,505 |
|
|
$ |
5,155 |
|
|
|
13 |
|
|
|
100 |
% |
|
|
100 |
% |
The $0.7 million decrease in Immune Medicine revenue was primarily due to a $3.4 million decrease in revenue generated from the Genentech Agreement due to reduced collaboration expenses and a $1.0 million decrease in revenue generated from our T-Detect COVID clinical customers, which were partially offset by a $3.7 million increase in revenue generated from our biopharmaceutical and academic customers.
The $5.8 million increase in MRD revenue was primarily due to a $3.8 million increase in revenue generated from providing our clonoSEQ report to clinical customers and a $2.7 million increase in revenue generated from providing MRD sample testing services to biopharmaceutical customers. These increases were partially offset by a $0.5 million decrease in revenue recognized upon the achievement of certain regulatory milestones by our biopharmaceutical customers’ therapeutics and a $0.3 million decrease in revenue generated from providing MRD sample testing services to investigator-led clinical trials. Our clonoSEQ test volume increased by 53% to 8,998 tests delivered in the three months ended June 30, 2022 from 5,897 tests delivered in the three months ended June 30, 2021.
28
Adaptive Biotechnologies Corporation
Cost of Revenue
|
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
Cost of revenue |
|
$ |
13,221 |
|
|
$ |
10,765 |
|
|
$ |
2,456 |
|
|
|
23 |
% |
|
|
30 |
% |
|
|
28 |
% |
The $2.5 million increase in cost of revenue was primarily attributable to a $0.8 million increase in cost of materials related to mix to higher cost assays, a $0.8 million increase related to higher usage of our production laboratory to process revenue samples versus research and development samples, a $0.8 million increase in labor, overhead and facility costs and a $0.2 million increase in materials cost resulting from increased revenue sample volume. These increases were partially offset by a $0.2 million decrease in certain sample collection costs.
Research and Development
|
|
|
Three Months Ended June 30, |
|
|
Change |
|
Percent of Revenue |
|
||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
2022 |
|
|
2021 |
|
|||||
|
Research and development |
|
$ |
37,037 |
|
|
$ |
37,800 |
|
|
$ |
(763 |
) |
|
(2)% |
|
|
85 |
% |
|
|
98 |
% |
The following table presents disaggregated research and development expenses by cost classification for the periods presented:
|
|
|
Three Months Ended June 30, |
|
|
|
|
|
|||||
|
(in thousands) |
|
2022 |
|
|
2021 |
|
|
Change |
|
|||
|
Research and development materials and allocated production laboratory expenses |
|
$ |
13,330 |
|
|
$ |
15,066 |
|
|
$ |
(1,736 |
) |
|
Personnel expenses |
|
|
16,654 |
|
|
|
15,248 |
|
|
|
1,406 |
|
|
Allocable facilities and information technology expenses |
|
|
2,014 |
|
|
|
1,664 |
|
|
|
350 |
|
|
Software and cloud services expenses |
|
|
762 |
|
|
|
1,023 |
|
|
|
(261 |
) |
|
Depreciation and other expenses |
|
|
4,277 |
|
|
|
4,799 |
|
|
|
(522 |
) |
|
Total |
|
$ |
37,037 |
|
|
$ |
37,800 |
|
|
$ |
(763 |
) |
The $0.8 million decrease in research and development expenses was primarily attributable to a $1.7 million decrease in cost of materials and allocated production laboratory expenses, partially offset by a $1.4 million increase in personnel costs. The $1.7 million decrease in cost of materials and allocated production laboratory expenses was driven primarily by decreased investments in drug discovery and T-Detect and TCR-Antigen Map development activities, partially offset by a $2.8 million inventory reserve charge recognized in the three months ended June 30, 2022. There was also a $0.5 million decrease in depreciation and other expenses, driven primarily by a $1.0 million decrease in collaboration and medical advisory costs, which was partially offset by a $0.5 million increase in depreciation expense.
Sales and Marketing
|
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
Sales and marketing |
|
$ |
24,281 |
|
|
$ |
23,216 |
|
|
$ |
1,065 |
|
|
|
5 |
% |
|
|
56 |
% |
|
|
60 |
% |
The $1.1 million increase in sales and marketing expenses was primarily attributable to a $2.0 million increase in travel and customer event related expenses and a $1.6 million increase in personnel costs, which were partially offset by a $2.5 million decrease in marketing expenses driven primarily by reduced clonoSEQ, T-Detect and corporate marketing efforts.
General and Administrative
|
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
General and administrative |
|
$ |
21,200 |
|
|
$ |
16,066 |
|
|
$ |
5,134 |
|
|
|
32 |
% |
|
|
49 |
% |
|
|
42 |
% |
The $5.1 million increase in general and administrative expenses was primarily attributable to a $3.5 million increase in building, facility and depreciation related expenses, as well as a $1.3 million increase in personnel costs and a $0.7 million increase in computer and software expenses. These increases were partially offset by a $0.7 million decrease in legal and accounting fees.
29
Adaptive Biotechnologies Corporation
Interest and Other Income, Net
|
|
|
Three Months Ended June 30, |
|
|
Change |
|||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|||
|
Interest and other income, net |
|
$ |
418 |
|
|
$ |
464 |
|
|
$ |
(46 |
) |
|
(10)% |
The modest decrease in interest and other income, net was primarily attributable to a slight decrease in net interest income and investment amortization resulting from a smaller portfolio.
Comparison of the Six Months Ended June 30, 2022 and 2021
Revenue
|
|
|
Six Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
Immune Medicine revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
14,409 |
|
|
$ |
9,453 |
|
|
$ |
4,956 |
|
|
|
52 |
% |
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
|
28,785 |
|
|
|
33,691 |
|
|
|
(4,906 |
) |
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
Total Immune Medicine revenue |
|
|
43,194 |
|
|
|
43,144 |
|
|
|
50 |
|
|
* |
|
|
|
52 |
% |
|
|
56 |
% |
|
|
MRD revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
|
35,086 |
|
|
|
25,303 |
|
|
|
9,783 |
|
|
|
39 |
|
|
|
|
|
|
|
|
|
|
Regulatory milestone revenue |
|
|
4,000 |
|
|
|
8,500 |
|
|
|
(4,500 |
) |
|
|
(53 |
) |
|
|
|
|
|
|
|
|
|
Total MRD revenue |
|
|
39,086 |
|
|
|
33,803 |
|
|
|
5,283 |
|
|
|
16 |
|
|
|
48 |
% |
|
|
44 |
% |
|
Total revenue |
|
$ |
82,280 |
|
|
$ |
76,947 |
|
|
$ |
5,333 |
|
|
|
7 |
|
|
|
100 |
% |
|
|
100 |
% |
|
* Less than 0% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The $0.1 million increase in Immune Medicine revenue was primarily due to a $7.1 million increase in revenue generated from our biopharmaceutical and academic customers, which was mostly offset by a $6.8 million decrease in revenue generated from the Genentech Agreement resulting from reduced collaboration expenses and a $0.3 million decrease in revenue generated from our T-Detect COVID clinical customers.
The $5.3 million increase in MRD revenue was primarily due to a $7.4 million increase in revenue generated from providing our clonoSEQ report to clinical customers and a $2.8 million increase in revenue generated from providing MRD sample testing services to biopharmaceutical customers. These increases were partially offset by a $4.5 million decrease in revenue recognized upon the achievement of certain regulatory milestones by our biopharmaceutical customers’ therapeutics and a $0.6 million decrease in revenue generated from providing MRD sample testing services to investigator-led clinical trials. Our clonoSEQ test volume increased by 47% to 16,471 tests delivered in the six months ended June 30, 2022 from 11,197 tests delivered in the six months ended June 30, 2021.
Cost of Revenue
|
|
|
Six Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
Cost of revenue |
|
$ |
26,413 |
|
|
$ |
20,756 |
|
|
$ |
5,657 |
|
|
|
27 |
% |
|
|
32 |
% |
|
|
27 |
% |
The $5.7 million increase in cost of revenue was primarily attributable to a $2.0 million increase in labor, overhead and facility costs and a $1.8 million increase in materials cost resulting from increased revenue sample volume. Additionally, there was a $0.9 million increase related to higher usage of our production laboratory to process revenue samples versus research and development samples, a $0.5 million increase in cost of materials related to mix to higher cost assays and a $0.2 million increase in shipping costs.
Research and Development
|
|
|
Six Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
Research and development |
|
$ |
74,876 |
|
|
$ |
71,572 |
|
|
$ |
3,304 |
|
|
|
5 |
% |
|
|
91 |
% |
|
|
93 |
% |
30
Adaptive Biotechnologies Corporation
The following table presents disaggregated research and development expenses by cost classification for the periods presented:
|
|
|
Six Months Ended June 30, |
|
|
|
|
|
|||||
|
(in thousands) |
|
2022 |
|
|
2021 |
|
|
Change |
|
|||
|
Research and development materials and allocated production laboratory expenses |
|
$ |
25,485 |
|
|
$ |
27,833 |
|
|
$ |
(2,348 |
) |
|
Personnel expenses |
|
|
35,292 |
|
|
|
29,923 |
|
|
|
5,369 |
|
|
Allocable facilities and information technology expenses |
|
|
3,879 |
|
|
|
3,190 |
|
|
|
689 |
|
|
Software and cloud services expenses |
|
|
1,403 |
|
|
|
1,857 |
|
|
|
(454 |
) |
|
Depreciation and other expenses |
|
|
8,817 |
|
|
|
8,769 |
|
|
|
48 |
|
|
Total |
|
$ |
74,876 |
|
|
$ |
71,572 |
|
|
$ |
3,304 |
|
The $3.3 million increase in research and development expenses was primarily attributable to a $5.4 million increase in personnel costs, of which $0.7 million related to our restructuring activities, partially offset by a $2.3 million decrease in cost of materials and allocated production laboratory expenses, which was driven primarily by decreased investments in drug discovery and clonoSEQ efforts, partially offset by a $2.8 million inventory reserve charge recognized in the three months ended June 30, 2022. There was also a $1.2 million decrease in collaboration and medical advisory costs, which was largely offset by a $1.1 million increase in depreciation expense.
Sales and Marketing
|
|
|
Six Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
Sales and marketing |
|
$ |
50,374 |
|
|
$ |
43,820 |
|
|
$ |
6,554 |
|
|
|
15 |
% |
|
|
61 |
% |
|
|
57 |
% |
The $6.6 million increase in sales and marketing expenses was primarily attributable to $7.1 million in additional personnel costs, of which $0.9 million related to our restructuring activities, as well as a $2.4 million increase in travel and customer event related expenses. These increases were partially offset by a $3.2 million decrease in marketing expenses driven primarily by reduced clonoSEQ, T-Detect and corporate marketing efforts.
General and Administrative
|
|
|
Six Months Ended June 30, |
|
|
Change |
|
|
Percent of Revenue |
|
|||||||||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|
|
2022 |
|
|
2021 |
|
||||||
|
General and administrative |
|
$ |
45,344 |
|
|
$ |
31,002 |
|
|
$ |
14,342 |
|
|
|
46 |
% |
|
|
55 |
% |
|
|
40 |
% |
The $14.3 million increase in general and administrative expenses was primarily attributable to a $7.8 million increase in building, facility and depreciation related expenses, as well as a $4.0 million increase in personnel costs, a $1.4 million increase in computer and software expenses and a $1.2 million increase in consultant costs. These increases were partially offset by a $1.0 million decrease in legal and accounting fees.
Interest and Other Income, Net
|
|
|
Six Months Ended June 30, |
|
|
Change |
|||||||||
|
(in thousands, except percentages) |
|
2022 |
|
|
2021 |
|
|
$ |
|
|
% |
|||
|
Interest and other income, net |
|
$ |
689 |
|
|
$ |
1,102 |
|
|
$ |
(413 |
) |
|
(37)% |
The $0.4 million decrease in interest and other income, net was primarily attributable to a decrease in net interest income and investment amortization resulting from a smaller portfolio.
Liquidity and Capital Resources
We have incurred losses since inception and have incurred negative cash flows from operations since inception through June 30, 2022, with the exception of certain 2019 periods for which we had positive cash flows from operations. As of June 30, 2022, we had an accumulated deficit of $833.7 million.
We have funded our operations to date principally from the sale of convertible preferred stock and common stock and, to a lesser extent, revenue. As of June 30, 2022, we had cash, cash equivalents and marketable securities of $450.7 million.
31
Adaptive Biotechnologies Corporation
We believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months. We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons.
If our available cash, cash equivalents and marketable securities balances and anticipated cash flows from operations are insufficient to satisfy our liquidity requirements, we may seek to sell additional equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to our shareholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. This additional capital may not be available on reasonable terms, or at all.
We plan to utilize the existing cash, cash equivalents and marketable securities on hand primarily to fund our continued research and development initiatives for our pipeline candidates and drug discovery initiatives, our ongoing investments in our immune medicine platform and our commercial and marketing activities associated with our clinical products and services. We also expect to make capital expenditures in the near term related to our laboratory space and expect to continue investing in laboratory equipment and operations to support our anticipated growth. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to capital preservation and liquidity. Currently, our funds are held in money market funds and marketable securities consisting of U.S. government debt securities and corporate bonds.
There have been no material changes outside the ordinary course of business to our contractual obligations and commitments as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 15, 2022. See Note 8 of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information regarding our contractual obligations relating to lease agreements.
While we may experience variability in revenue in the near term, as long-term revenue from sales of our current and future products and services is expected to grow, we expect our accounts receivable and inventory balances to increase. Any increase in accounts receivable and inventory may not be completely offset by increases in accounts payable and accrued expenses, which could result in greater working capital requirements.
Cash Flows
The following table summarizes our uses and sources of cash for the six months ended June 30, 2022 and 2021 (in thousands):
|
|
|
Six Months Ended June 30, |
|
|||||
|
|
|
2022 |
|
|
2021 |
|
||
|
Net cash used in operating activities |
|
$ |
(111,518 |
) |
|
$ |
(95,458 |
) |
|
Net cash provided by investing activities |
|
|
42,434 |
|
|
|
135,266 |
|
|
Net cash provided by financing activities |
|
|
6,739 |
|
|
|
20,942 |
|
Operating Activities
Cash used in operating activities during the six months ended June 30, 2022 was $111.5 million, which was primarily attributable to a net loss of $114.9 million and a net change in our operating assets and liabilities of $41.7 million, partially offset by noncash share-based compensation of $27.0 million, noncash depreciation and amortization of $11.7 million, noncash lease expense of $3.6 million and a research and development inventory reserve charge of $2.8 million. The net change in our operating assets and liabilities was primarily due to a $24.2 million reduction in deferred revenue primarily related to revenue recognized from the Genentech Agreement, a reduction in accounts payable and accrued liabilities of $9.0 million driven largely by the payout of our corporate bonus during the three months ended March 31, 2022, an increase in accounts receivable of $6.3 million, which includes the $1.0 million regulatory milestone recognized during the three months ended June 30, 2022, and an increase in inventory of $2.3 million.
Cash used in operating activities during the six months ended June 30, 2021 was $95.5 million, which was primarily attributable to a net loss of $89.9 million and a net change in our operating assets and liabilities of $38.5 million, partially offset by noncash share-based compensation of $19.7 million, noncash depreciation and amortization of $9.8 million and noncash lease expense of $3.5 million. The net change in our operating assets and liabilities was primarily due to a $33.7 million reduction in deferred revenue primarily related to revenue recognized from the Genentech Agreement, an increase in inventory of $4.5 million, an increase in accounts receivable of $4.1 million and a reduction in accounts payable and accrued liabilities of $2.5 million, all of which were partially offset by an increase in operating lease liabilities of $4.5 million and reductions in prepaid expenses and other assets of $2.0 million.
32
Adaptive Biotechnologies Corporation
Investing Activities
Cash provided by investing activities during the six months ended June 30, 2022 was $42.4 million, which was primarily attributable to proceeds from maturities of marketable securities of $136.0 million, partially offset by purchases of marketable securities of $85.2 million and purchases of property and equipment of $8.4 million.
Cash provided by investing activities during the six months ended June 30, 2021 was $135.3 million, which was primarily attributable to proceeds from maturities of marketable securities of $269.5 million, partially offset by purchases of marketable securities of $96.4 million and purchases of property and equipment of $37.9 million.
Financing Activities
Cash provided by financing activities during the six months ended June 30, 2022 was $6.7 million, which was attributable to proceeds from the exercise of stock options.
Cash provided by financing activities during the six months ended June 30, 2021 was $20.9 million, which was primarily attributable to proceeds from the exercise of stock options of $20.5 million.
Net Operating Loss Carryforwards
Utilization of our net operating loss (“NOL”) carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986 (“Section 382”) and similar state provisions. The annual limitation may result in the expiration of NOL carryforwards and credits before utilization. If there should be an ownership change, our ability to utilize our NOL carryforwards and credits could be limited. We have completed a Section 382 analysis for changes in ownership through December 31, 2020 and continue to monitor for changes that could trigger a limitation. Based on this analysis, we do not expect to have any permanent limitations on the utilization of our federal NOLs. Under the Tax Cuts and Jobs Act of 2017, federal NOLs incurred in 2018 and future years may be carried forward indefinitely, but the deductibility of such federal NOLs is subject to an annual limitation. NOLs generated prior to 2018 are eligible to be carried forward up to 20 years. Based on the available objective evidence, management determined that it was more likely than not that the net deferred tax assets would not be realizable as of December 31, 2021. Accordingly, management applied a full valuation allowance against net deferred tax assets as of December 31, 2021.
Critical Accounting Policies and Estimates
We have prepared the unaudited condensed consolidated financial statements in accordance with GAAP. Our preparation of these unaudited condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities and related disclosures at the date of the unaudited condensed consolidated financial statements, as well as revenue and expense recorded during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and or 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, 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.
While our significant accounting policies are described in more detail in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 15, 2022, as well as in Note 2 of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report, we believe the following accounting policies are critical to the judgments and estimates used in the preparation of the unaudited condensed consolidated financial statements:
|
|
• |
revenue recognition; and |
|
|
• |
goodwill. |
There have been no material changes to our critical accounting policies and estimates as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 15, 2022.
33
Adaptive Biotechnologies Corporation
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
We are exposed to market risk for changes in interest rates related primarily to our cash, cash equivalents and marketable securities. As of June 30, 2022, there have been no material changes to our market risks as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 15, 2022. We do not enter into investments for trading purposes and have not used any derivative financial instruments to manage our interest rate risk exposure.
Item 4. Controls and Procedures
Under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) as of the end of the period covered by this report. Based on that evaluation, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures were effective as of June 30, 2022. There was not any change in our internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act) during the three months ended June 30, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
34
Adaptive Biotechnologies Corporation
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control. In addition to the other information set forth in this report, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I, Item 1A under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 15, 2022. The risk factors may be important to understanding other statements in this report and should be read in conjunction with the unaudited condensed consolidated financial statements and related notes in this report. The occurrence of any single risk or any combination of risks could materially and adversely affect our business, operations, product pipeline, operating results, financial condition or liquidity, and consequently, the value of our securities. Further, additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business, financial condition, operating results and prospects.
There have been no material changes to the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 15, 2022.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Not applicable.
35
Adaptive Biotechnologies Corporation
Item 6. Exhibits
|
|
|
|
Incorporated by Reference |
|
|||
|
Exhibit Number |
|
Exhibit Title |
Form |
File No. |
Exhibit |
Filing Date |
Filed/ Furnished with This Report |
|
3.1 |
|
8-K |
001-38957 |
3.1 |
7/1/2019 |
|
|
|
3.2 |
|
8-K |
001-38957 |
3.2 |
7/1/2019 |
|
|
|
4.1 |
|
S-1 |
333-231838 |
4.1 |
5/30/2019 |
|
|
|
31.1 |
|
|
|
|
|
X |
|
|
31.2 |
|
|
|
|
|
X |
|
|
32.1 |
|
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X |
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32.2 |
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X |
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
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X |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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X |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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X |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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X |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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X |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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X |
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104 |
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Cover Page Interactive Data File (formatted in Inline XBRL and included in Exhibit 101) |
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X |
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36
Adaptive Biotechnologies Corporation
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Adaptive Biotechnologies Corporation |
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Date: August 3, 2022 |
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By: |
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/s/ Chad Robins |
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Chad Robins |
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Chief Executive Officer and Director (Principal Executive Officer) |
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Date: August 3, 2022 |
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By: |
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/s/ Tycho Peterson |
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Tycho Peterson |
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Chief Financial Officer (Principal Financial Officer) |
37