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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

☒

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2022

OR

 

☐

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: 001-38957

 

ADAPTIVE BIOTECHNOLOGIES CORPORATION

(Exact Name of Registrant as Specified in its Charter)

 

 

Washington

27-0907024

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

1165 Eastlake Avenue East

Seattle, Washington

98109

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (206) 659-0067

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common stock, par value $0.0001 per share

 

ADPT

 

The NASDAQ Stock Market LLC

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. Yes ☒ No ☐

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). Yes ☒ No ☐

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.

 

Large accelerated filer

 

☒

 

Accelerated filer

 

☐

 

 

 

 

Non-accelerated filer

 

☐

 

Smaller reporting company

 

☐

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

☐

 

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 ☐ No ☒

As of October 28, 2022, the registrant had 143,012,157 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

4

Item 1.

Financial Statements (Unaudited)

4

 

Condensed Consolidated Balance Sheets

4

 

Condensed Consolidated Statements of Operations

5

 

Condensed Consolidated Statements of Comprehensive Loss

6

 

Condensed Consolidated Statements of Shareholders’ Equity

7

 

Condensed Consolidated Statements of Cash Flows

9

 

Notes to Unaudited Condensed Consolidated Financial Statements

10

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

25

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

39

Item 4.

Controls and Procedures

39

PART II.

OTHER INFORMATION

40

Item 1.

Legal Proceedings

40

Item 1A.

Risk Factors

40

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

40

Item 3.

Defaults Upon Senior Securities

40

Item 4.

Mine Safety Disclosures

41

Item 5.

Other Information

41

Item 6.

Exhibits

41

Signatures

42

 

 

 

 

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:

•
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;
•
our ability to achieve and maintain commercial market acceptance of our current products and services, such as clonoSEQ and immunoSEQ, as well as our ability to achieve market acceptance for any additional products and services beyond our current portfolio, if developed;
•
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;
•
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; and
•
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)

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

217,552

 

 

$

139,065

 

Short-term marketable securities (amortized cost of $295,689 and $214,115, respectively)

 

 

290,527

 

 

 

213,996

 

Accounts receivable, net

 

 

26,549

 

 

 

17,409

 

Inventory

 

 

17,345

 

 

 

19,263

 

Prepaid expenses and other current assets

 

 

12,407

 

 

 

13,015

 

Total current assets

 

 

564,380

 

 

 

402,748

 

Long-term assets

 

 

 

 

 

 

Property and equipment, net

 

 

86,662

 

 

 

85,262

 

Operating lease right-of-use assets

 

 

82,605

 

 

 

87,678

 

Long-term marketable securities (amortized cost of $20,507 and $218,163, respectively)

 

 

19,698

 

 

 

217,145

 

Restricted cash

 

 

2,433

 

 

 

2,138

 

Intangible assets, net

 

 

7,256

 

 

 

8,526

 

Goodwill

 

 

118,972

 

 

 

118,972

 

Other assets

 

 

2,202

 

 

 

875

 

Total assets

 

$

884,208

 

 

$

923,344

 

Liabilities and shareholders’ equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

4,163

 

 

$

3,307

 

Accrued liabilities

 

 

10,702

 

 

 

9,343

 

Accrued compensation and benefits

 

 

12,733

 

 

 

15,642

 

Current portion of operating lease liabilities

 

 

8,528

 

 

 

5,055

 

Current portion of deferred revenue

 

 

67,892

 

 

 

80,460

 

Total current liabilities

 

 

104,018

 

 

 

113,807

 

Long-term liabilities

 

 

 

 

 

 

Operating lease liabilities, less current portion

 

 

100,521

 

 

 

106,685

 

Deferred revenue, less current portion

 

 

67,300

 

 

 

98,750

 

Revenue interest liability, net

 

 

124,555

 

 

 

—

 

Total liabilities

 

 

396,394

 

 

 

319,242

 

Commitments and contingencies (Note 10)

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

 

Preferred stock: $0.0001 par value, 10,000,000 shares authorized at September 30, 2022 and December 31, 2021; no shares issued and outstanding at September 30, 2022 and December 31, 2021

 

 

—

 

 

 

—

 

Common stock: $0.0001 par value, 340,000,000 shares authorized at September 30, 2022 and December 31, 2021; 142,987,127 and 141,393,865 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

 

14

 

 

 

14

 

Additional paid-in capital

 

 

1,372,751

 

 

 

1,324,006

 

Accumulated other comprehensive loss

 

 

(5,971

)

 

 

(1,137

)

Accumulated deficit

 

 

(878,954

)

 

 

(718,891

)

Total Adaptive Biotechnologies Corporation shareholders’ equity

 

 

487,840

 

 

 

603,992

 

Noncontrolling interest

 

 

(26

)

 

 

110

 

Total shareholders’ equity

 

 

487,814

 

 

 

604,102

 

Total liabilities and shareholders’ equity

 

$

884,208

 

 

$

923,344

 

 

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)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue

 

$

47,830

 

 

$

39,467

 

 

$

130,110

 

 

$

116,414

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

14,907

 

 

 

14,189

 

 

 

41,320

 

 

 

34,945

 

Research and development

 

 

35,658

 

 

 

36,072

 

 

 

110,534

 

 

 

107,644

 

Sales and marketing

 

 

21,513

 

 

 

24,949

 

 

 

71,887

 

 

 

68,769

 

General and administrative

 

 

20,755

 

 

 

20,154

 

 

 

66,099

 

 

 

51,156

 

Amortization of intangible assets

 

 

428

 

 

 

428

 

 

 

1,270

 

 

 

1,270

 

Total operating expenses

 

 

93,261

 

 

 

95,792

 

 

 

291,110

 

 

 

263,784

 

Loss from operations

 

 

(45,431

)

 

 

(56,325

)

 

 

(161,000

)

 

 

(147,370

)

Interest and other income, net

 

 

765

 

 

 

327

 

 

 

1,454

 

 

 

1,429

 

Interest expense

 

 

(653

)

 

 

—

 

 

 

(653

)

 

 

—

 

Net loss

 

 

(45,319

)

 

 

(55,998

)

 

 

(160,199

)

 

 

(145,941

)

Add: Net loss attributable to noncontrolling interest

 

 

38

 

 

 

95

 

 

 

136

 

 

 

95

 

Net loss attributable to Adaptive Biotechnologies Corporation

 

$

(45,281

)

 

$

(55,903

)

 

$

(160,063

)

 

$

(145,846

)

Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted

 

$

(0.32

)

 

$

(0.40

)

 

$

(1.12

)

 

$

(1.04

)

Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted

 

 

142,928,654

 

 

 

140,833,564

 

 

 

142,334,342

 

 

 

140,060,379

 

 

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)

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

 

$

(45,319

)

 

$

(55,998

)

 

$

(160,199

)

 

$

(145,941

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized gains and losses on investments

 

 

(171

)

 

 

(209

)

 

 

(4,834

)

 

 

(886

)

Comprehensive loss

 

 

(45,490

)

 

 

(56,207

)

 

 

(165,033

)

 

 

(146,827

)

Add: Comprehensive loss attributable to noncontrolling interest

 

 

38

 

 

 

95

 

 

 

136

 

 

 

95

 

Comprehensive loss attributable to Adaptive Biotechnologies Corporation

 

$

(45,452

)

 

$

(56,112

)

 

$

(164,897

)

 

$

(146,732

)

 

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)

 

 

 

Common Stock

 

 

Additional

 

 

Accumulated Other

 

 

Accumulated

 

 

Noncontrolling

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

Paid-In Capital

 

 

Comprehensive Gain (Loss)

 

 

Deficit

 

 

Interest

 

 

Shareholders’ Equity

 

Balance at June 30, 2021

 

 

140,663,755

 

 

$

14

 

 

$

1,294,506

 

 

$

216

 

 

$

(601,555

)

 

$

129

 

 

$

693,310

 

Issuance of common stock for cash upon exercise of stock options

 

 

360,607

 

 

 

—

 

 

 

2,797

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

2,797

 

Vesting of restricted stock units

 

 

3,125

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Common stock option and restricted stock unit share-based compensation

 

 

—

 

 

 

—

 

 

 

11,643

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

11,643

 

Other comprehensive loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(209

)

 

 

—

 

 

 

—

 

 

 

(209

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(55,903

)

 

 

(95

)

 

 

(55,998

)

Balance at September 30, 2021

 

 

141,027,487

 

 

$

14

 

 

$

1,308,946

 

 

$

7

 

 

$

(657,458

)

 

$

34

 

 

$

651,543

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2022

 

 

142,784,868

 

 

$

14

 

 

$

1,357,763

 

 

$

(5,800

)

 

$

(833,673

)

 

$

12

 

 

$

518,316

 

Issuance of common stock for cash upon exercise of stock options

 

 

131,802

 

 

 

—

 

 

 

846

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

846

 

Vesting of restricted stock units

 

 

70,457

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Common stock option, restricted stock unit and market-based restricted stock unit share-based compensation

 

 

—

 

 

 

—

 

 

 

14,142

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

14,142

 

Other comprehensive loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(171

)

 

 

—

 

 

 

—

 

 

 

(171

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(45,281

)

 

 

(38

)

 

 

(45,319

)

Balance at September 30, 2022

 

 

142,987,127

 

 

$

14

 

 

$

1,372,751

 

 

$

(5,971

)

 

$

(878,954

)

 

$

(26

)

 

$

487,814

 

 

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)

 

 

 

Common Stock

 

 

Additional

 

 

Accumulated Other

 

 

Accumulated

 

 

Noncontrolling

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

Paid-In Capital

 

 

Comprehensive Gain (Loss)

 

 

Deficit

 

 

Interest

 

 

Shareholders’ Equity

 

Balance at December 31, 2020

 

 

137,646,896

 

 

$

14

 

 

$

1,253,971

 

 

$

893

 

 

$

(511,612

)

 

$

—

 

 

$

743,266

 

Issuance of common stock upon exercise of common stock warrant

 

 

54,162

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock for cash upon exercise of stock options

 

 

3,310,804

 

 

 

—

 

 

 

23,299

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

23,299

 

Vesting of restricted stock units

 

 

15,625

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Common stock option and restricted stock unit share-based compensation

 

 

—

 

 

 

—

 

 

 

31,376

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

31,376

 

Capital contributions for Digital Biotechnologies, Inc.

 

 

—

 

 

 

—

 

 

 

300

 

 

 

—

 

 

 

—

 

 

 

129

 

 

 

429

 

Other comprehensive loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(886

)

 

 

—

 

 

 

—

 

 

 

(886

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(145,846

)

 

 

(95

)

 

 

(145,941

)

Balance at September 30, 2021

 

 

141,027,487

 

 

$

14

 

 

$

1,308,946

 

 

$

7

 

 

$

(657,458

)

 

$

34

 

 

$

651,543

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2021

 

 

141,393,865

 

 

$

14

 

 

$

1,324,006

 

 

$

(1,137

)

 

$

(718,891

)

 

$

110

 

 

$

604,102

 

Issuance of common stock for cash upon exercise of stock options

 

 

1,361,891

 

 

 

—

 

 

 

7,562

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

7,562

 

Vesting of restricted stock units

 

 

231,371

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Common stock option, restricted stock unit and market-based restricted stock unit share-based compensation

 

 

—

 

 

 

—

 

 

 

41,183

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

41,183

 

Other comprehensive loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(4,834

)

 

 

—

 

 

 

—

 

 

 

(4,834

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(160,063

)

 

 

(136

)

 

 

(160,199

)

Balance at September 30, 2022

 

 

142,987,127

 

 

$

14

 

 

$

1,372,751

 

 

$

(5,971

)

 

$

(878,954

)

 

$

(26

)

 

$

487,814

 

 

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)

 

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(160,199

)

 

$

(145,941

)

Adjustments to reconcile net loss to net cash used in operating activities

 

 

 

 

 

 

Depreciation expense

 

 

14,364

 

 

 

7,834

 

Noncash lease expense

 

 

5,423

 

 

 

5,259

 

Share-based compensation expense

 

 

41,183

 

 

 

31,376

 

Intangible assets amortization

 

 

1,270

 

 

 

1,270

 

Investment amortization

 

 

1,825

 

 

 

5,956

 

Research and development inventory reserve

 

 

2,638

 

 

 

—

 

Interest expense

 

 

653

 

 

 

—

 

Other

 

 

(20

)

 

 

(9

)

Changes in operating assets and liabilities

 

 

 

 

 

 

Accounts receivable, net

 

 

(9,139

)

 

 

(7,075

)

Inventory

 

 

(2,212

)

 

 

(4,168

)

Prepaid expenses and other current assets

 

 

601

 

 

 

(2,239

)

Accounts payable and accrued liabilities

 

 

(3,419

)

 

 

5,518

 

Operating lease right-of-use assets and liabilities

 

 

(3,041

)

 

 

9,935

 

Deferred revenue

 

 

(44,018

)

 

 

(46,345

)

Other

 

 

165

 

 

 

(272

)

Net cash used in operating activities

 

 

(153,926

)

 

 

(138,901

)

Investing activities

 

 

 

 

 

 

Purchases of property and equipment

 

 

(13,807

)

 

 

(52,501

)

Purchases of marketable securities

 

 

(113,744

)

 

 

(238,001

)

Proceeds from maturities of marketable securities

 

 

228,000

 

 

 

404,500

 

Net cash provided by investing activities

 

 

100,449

 

 

 

113,998

 

Financing activities

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

7,568

 

 

 

23,439

 

Proceeds from revenue interest purchase agreement, net of issuance costs

 

 

124,691

 

 

 

—

 

Proceeds from initial capital contributions for Digital Biotechnologies, Inc.

 

 

—

 

 

 

429

 

Net cash provided by financing activities

 

 

132,259

 

 

 

23,868

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

78,782

 

 

 

(1,035

)

Cash, cash equivalents and restricted cash at beginning of year

 

 

141,203

 

 

 

125,574

 

Cash, cash equivalents and restricted cash at end of period

 

$

219,985

 

 

$

124,539

 

Noncash investing and financing activities

 

 

 

 

 

 

Purchases of equipment included in accounts payable and accrued liabilities

 

$

2,619

 

 

$

8,133

 

Revenue interest purchase agreement issuance costs included in accounts payable and accrued liabilities

 

$

316

 

 

$

—

 

 

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 70% ownership interest in. The remaining interest in Digital Biotechnologies, Inc., held by certain of our related parties and their related family trusts, are shown in the unaudited condensed consolidated financial statements as noncontrolling interest. All intercompany transactions and balances between Adaptive Biotechnologies Corporation, our wholly-owned subsidiary and Digital Biotechnologies, Inc. have been eliminated upon consolidation.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and the related disclosures at the date of the condensed consolidated financial statements, as well as the reported amounts of revenues and expenses during the periods presented. We base our estimates on historical experience and other relevant assumptions that we believe to be reasonable under the circumstances. Estimates are used in several areas including, but not limited to, estimates of progress to date for certain performance obligations and the transaction price for certain contracts with customers, share-based compensation, including the fair value of stock, imputing interest for our revenue interest purchase agreement (the "Purchase Agreement") that we entered into in September 2022, the provision for income taxes, including related reserves, 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 Securities and Exchange Commission ("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 Minimal Residual Disease ("MRD") market opportunities.

10

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

Restricted Cash

We had a restricted cash balance of $2.4 million and $2.1 million as of September 30, 2022 and December 31, 2021, respectively. Our restricted cash primarily relates to certain balances we are required to maintain under lease arrangements for some of our property and facility leases.

Revenue Interest Liability, Net and Related Imputed Interest

The revenue interest liability balance associated with the Purchase Agreement that we entered into in September 2022 is presented net of issuance costs on our unaudited condensed consolidated balance sheets. We impute our associated interest expense using the effective interest rate method. We calculate an effective interest rate which will amortize our related obligation to zero over the anticipated repayment period. The effective interest rate may vary during the term of the agreement depending on a number of factors, including changes in forecasted GAAP revenues. We evaluate the effective interest rate quarterly based on both achieved and forecasted revenues, utilizing the prospective method. A significant increase or decrease in forecasted revenue will materially impact our interest expense and the time period for repayment.

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 ten percent of our total revenue or accounts receivable, net balances for the periods and as of each condensed consolidated balance sheet date presented, respectively.

For each significant customer, revenue as a percentage of total revenue for the periods presented and accounts receivable, net as a percentage of total accounts receivable, net as of the dates presented were as follows:

 

 

 

Revenue

 

Accounts Receivable, Net

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

September 30,

 

December 31,

 

 

2022

 

2021

 

2022

 

2021

 

2022

 

2021

Customer B

 

*%

 

*%

 

13.0%

 

*%

 

22.5%

 

11.3%

Customer D

 

*

 

*

 

*

 

*

 

11.9

 

*

Genentech, Inc. and Roche Group

 

45.1

 

39.8

 

38.2

 

42.6

 

*

 

*

* 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, Inc. ("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.

11

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

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.

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 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 outstanding and the maximum nonvested market-based restricted stock units outstanding 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. The following table presents our disaggregated revenue for the periods presented (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Immune Medicine revenue

 

 

 

 

 

 

 

 

 

 

 

 

Service revenue

 

$

6,559

 

 

$

8,169

 

 

$

20,968

 

 

$

17,622

 

Collaboration revenue

 

 

21,320

 

 

 

15,446

 

 

 

50,105

 

 

 

49,137

 

Total Immune Medicine revenue

 

 

27,879

 

 

 

23,615

 

 

 

71,073

 

 

 

66,759

 

MRD revenue

 

 

 

 

 

 

 

 

 

 

 

 

Service revenue

 

 

19,951

 

 

 

14,352

 

 

 

55,037

 

 

 

39,655

 

Regulatory milestone revenue

 

 

—

 

 

 

1,500

 

 

 

4,000

 

 

 

10,000

 

Total MRD revenue

 

 

19,951

 

 

 

15,852

 

 

 

59,037

 

 

 

49,655

 

Total revenue

 

$

47,830

 

 

$

39,467

 

 

$

130,110

 

 

$

116,414

 

 

During the three months ended September 30, 2022, we recognized $1.1 million in MRD service revenue related to cancelled customer contracts, Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote and changes in estimates of total samples to be provided under certain of our agreements. During the three months ended September 30, 2021, we recognized $1.5 million in MRD service revenue related to Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote and changes in estimates of total samples to be provided under certain of our agreements.

During the nine months ended September 30, 2022, we recognized $3.7 million in MRD service revenue related to Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote, changes in estimates of total samples to be provided under certain of our agreements and cancelled customer contracts. During the nine months ended September 30, 2021, we recognized $5.4 million in MRD service revenue related to changes in estimates of total samples to be provided under certain of our agreements, Medicare reimbursements resulting from our determination that the likelihood of additional testing for specific patients was remote and cancelled customer contracts.

As of September 30, 2022, we could receive up to an additional $370.5 million in milestone payments in future periods if certain regulatory approvals are obtained by our customers’ therapeutics in connection with MRD data generated from our MRD product.

Genentech Collaboration Agreement

In December 2018, we entered into a worldwide collaboration and license agreement with Genentech (the “Genentech Agreement”) to leverage our capability to develop cellular therapies in oncology. Subsequent to receipt of regulatory approval in January 2019, we received a non-refundable, upfront payment of $300.0 million in February 2019 and may be eligible to receive more than $1.8 billion over time, including payments of up to $75.0 million upon the achievement of specified regulatory milestones, up to $300.0 million upon the achievement of specified development milestones and up to $1,430.0 million upon the achievement of specified commercial milestones. In addition, we are separately able to receive tiered royalties at a rate ranging from the mid-single digits to the mid-teens on aggregate worldwide net sales of products arising from the strategic collaboration, subject to certain reductions, with aggregate minimum floors. Under the agreement, we are pursuing two product development pathways for novel T cell immunotherapies in which Genentech intends to use T cell receptors (“TCRs”) screened by our immune medicine platform to engineer and manufacture cellular medicines:

•
Shared Products. The shared products will use “off-the-shelf” TCRs identified against cancer antigens shared among patients (“Shared Products”).
•
Personalized Product. The personalized product will use patient-specific TCRs identified by real-time screening of TCRs against cancer antigens in each patient (“Personalized Product”).

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.

13

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

In applying ASC 606, we identified the following performance obligations at the inception of the agreement:

1.
License to utilize on an exclusive basis all TCR-specific platform intellectual property to develop and commercialize any licensed products in the field of oncology.
2.
License to utilize all data and information within each shared antigen data package and any other know-how disclosed by us to Genentech in oncology.
3.
License to utilize all private antigen TCR product data in connection with research and development activities in the field of use.
4.
License to existing shared antigen data packages.
5.
Research and development services for Shared Products development, including expansion of shared antigen data packages.
6.
Research and development services for private product development.
7.
Obligations to participate on various joint research, development and project committees.

 

We determined that none of the licenses, research and development services or obligations to participate on various committees were distinct within the context of the contract, given such rights and activities were highly interrelated and there was substantial additional research and development to further develop the licenses. We considered factors such as the stage of development of the respective existing antigen data packages, the subsequent development that would be required to both identify and submit a potential target for investigational new drug acceptance under both product pathways and the variability in research and development pathways given Genentech’s control of product commercialization. Specifically, under the agreement, Genentech is not required to pursue development or commercialization activities pertaining to both product pathways and may choose to proceed with one or the other. Accordingly, we determined that all of the identified performance obligations were attributable to one general performance obligation, which is to further the development of our TCR-specific platform, including data packages, and continue to make our TCR identification process available to Genentech to pursue either product pathway.

Separately, we have a responsibility to Genentech to enter into a supply and manufacturing agreement for patient-specific TCRs as it pertains to any Personalized Product therapeutic. We determined this was an option right of Genentech should they pursue commercialization of a Personalized Product therapy. Because of the uncertainty resulting from the early stage of development, the novel approach of our collaboration with Genentech and our rights to future commercial milestones and royalty payments, we determined that this option right was not a material right that should be accounted for at inception. As such, we will account for the supply and manufacturing agreement when entered into between the parties.

We determined the initial transaction price shall be made up of only the $300.0 million upfront, non-refundable payment, as all potential regulatory and development milestone payments were probable of significant revenue reversal given their achievement was highly dependent on factors outside our control. As a result, these payments were fully constrained and were not included in the transaction price as of September 30, 2022. We excluded the commercial milestones and potential royalties from the transaction price, as those items relate predominantly to the license rights granted to Genentech and will be assessed when and if such events occur.

As there are potential substantive developments necessary, which Genentech may be able to direct, we determined that we would apply a proportional performance model to recognize revenue for our performance obligation. We measure proportional performance using an input method based on costs incurred relative to the total estimated costs of research and development efforts to pursue both the Shared Products and Personalized Product pathways. When any of the potential regulatory and development milestones are no longer fully constrained and are included in the transaction price, such amounts will be recognized using the cumulative catch-up method based on proportional performance at such time. We currently expect to recognize the revenue over a period of approximately seven to eight years from the effective date. This estimate of the research and development period considers pursuit options of development activities supporting both the Shared Products and the Personalized Product, but may be reduced or increased based on the various activities as directed by the joint committees, decisions made by Genentech, regulatory feedback or other factors not currently known.

14

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

We recognized $20.4 million and $15.0 million in Immune Medicine collaboration revenue during the three months ended September 30, 2022 and 2021, respectively, and $46.5 million and $47.8 million in Immune Medicine collaboration revenue during the nine months ended September 30, 2022 and 2021, respectively, related to the Genentech Agreement. Costs related to the Genentech Agreement are included in research and development expenses.

4. Deferred Revenue

Deferred revenue from our Genentech Agreement represents $39.6 million and $64.0 million of the current and non-current deferred revenue balances, respectively, as of September 30, 2022 and $56.1 million and $94.0 million of the current and non-current deferred revenue balances, respectively, as of December 31, 2021. We expect our current deferred revenue to be recognized as revenue within 12 months. We expect the majority of our non-current deferred revenue to be recognized as revenue over a period of approximately four to five years from September 30, 2022. This period of time represents an estimate of the research and development period to develop cellular therapies in oncology, which may be reduced or increased based on the various research and development activities.

Changes in deferred revenue during the nine months ended September 30, 2022 were as follows (in thousands):

 

Deferred revenue balance at December 31, 2021

 

$

179,210

 

Additions to deferred revenue during the period

 

 

27,994

 

Revenue recognized during the period

 

 

(72,012

)

Deferred revenue balance at September 30, 2022

 

$

135,192

 

 

As of September 30, 2022, $58.0 million was recognized as revenue that was included in the deferred revenue balance at December 31, 2021.

5. Fair Value Measurements

The following tables set forth the fair value of financial assets as of September 30, 2022 and December 31, 2021 that were measured at fair value on a recurring basis (in thousands):

 

 

 

September 30, 2022

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Financial assets

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

197,188

 

 

$

—

 

 

$

—

 

 

$

197,188

 

U.S. government debt securities

 

 

—

 

 

 

292,940

 

 

 

—

 

 

 

292,940

 

Corporate bonds

 

 

—

 

 

 

17,285

 

 

 

—

 

 

 

17,285

 

Total financial assets

 

$

197,188

 

 

$

310,225

 

 

$

—

 

 

$

507,413

 

 

 

 

December 31, 2021

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Financial assets

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

131,946

 

 

$

—

 

 

$

—

 

 

$

131,946

 

U.S. government debt securities

 

 

—

 

 

 

391,145

 

 

 

—

 

 

 

391,145

 

Corporate bonds

 

 

—

 

 

 

39,996

 

 

 

—

 

 

 

39,996

 

Total financial assets

 

$

131,946

 

 

$

431,141

 

 

$

—

 

 

$

563,087

 

 

 

Level 1 securities include highly liquid money market funds, for which we measure the fair value based on quoted prices in active markets for identical assets or liabilities. Level 2 securities consist of U.S. government debt securities and corporate bonds, and are valued based on recent trades of securities in inactive markets or on quoted market prices of similar instruments and other significant inputs derived from or corroborated by observable market data.

15

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

6. Investments

Available-for-sale investments consisted of the following as of September 30, 2022 and December 31, 2021 (in thousands):

 

 

 

September 30, 2022

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Estimated Fair Value

 

Short-term marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

 

$

278,192

 

 

$

—

 

 

$

(4,950

)

 

$

273,242

 

Corporate bonds

 

 

17,497

 

 

 

—

 

 

 

(212

)

 

 

17,285

 

Total short-term marketable securities

 

$

295,689

 

 

$

—

 

 

$

(5,162

)

 

$

290,527

 

Long-term marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

 

$

20,507

 

 

$

—

 

 

$

(809

)

 

$

19,698

 

Total long-term marketable securities

 

$

20,507

 

 

$

—

 

 

$

(809

)

 

$

19,698

 

 

 

 

December 31, 2021

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Estimated Fair Value

 

Short-term marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

 

$

186,752

 

 

$

4

 

 

$

(109

)

 

$

186,647

 

Corporate bonds

 

 

27,363

 

 

 

—

 

 

 

(14

)

 

 

27,349

 

Total short-term marketable securities

 

$

214,115

 

 

$

4

 

 

$

(123

)

 

$

213,996

 

Long-term marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

 

$

205,472

 

 

$

—

 

 

$

(974

)

 

$

204,498

 

Corporate bonds

 

 

12,691

 

 

 

—

 

 

 

(44

)

 

 

12,647

 

Total long-term marketable securities

 

$

218,163

 

 

$

—

 

 

$

(1,018

)

 

$

217,145

 

 

All the U.S. government debt securities and corporate bonds designated as short-term marketable securities have an effective maturity date that is equal to or less than one year from the respective condensed consolidated balance sheet date. Those that are designated as long-term marketable securities have an effective maturity date that is more than one year from the respective condensed consolidated balance sheet date.

Accrued interest receivable is excluded from the amortized cost and estimated fair value of our marketable securities. Accrued interest receivable of $1.0 million and $1.4 million is presented separately within the prepaid expenses and other current assets balance on the unaudited condensed consolidated balance sheet as of September 30, 2022 and on the condensed consolidated balance sheet as of December 31, 2021, respectively.

 

The following table presents the gross unrealized holding losses and fair value for investments in an unrealized loss position, and the length of time individual securities have been in a continuous loss position, as of September 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

 

$

181,925

 

 

$

(3,240

)

 

$

111,015

 

 

$

(2,519

)

Corporate bonds

 

 

9,349

 

 

 

(95

)

 

 

7,936

 

 

 

(117

)

Total available-for-sale securities

 

$

191,274

 

 

$

(3,335

)

 

$

118,951

 

 

$

(2,636

)

 

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 September 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 September 30, 2022 to be due to factors other than credit loss, such as changes in interest rates. A credit allowance was not recognized and the impairment of our available-for-sale securities was recorded in other comprehensive loss.

16

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

7. Goodwill and Intangible Assets

There have been no changes in the carrying amount of goodwill since its recognition in 2015.

Intangible assets subject to amortization as of September 30, 2022 and December 31, 2021 consisted of the following (in thousands):

 

 

 

September 30, 2022

 

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net Carrying Amount

 

Acquired developed technology

 

$

20,000

 

 

$

(12,884

)

 

$

7,116

 

Purchased intellectual property

 

 

325

 

 

 

(185

)

 

 

140

 

Balance at September 30, 2022

 

$

20,325

 

 

$

(13,069

)

 

$

7,256

 

 

 

 

December 31, 2021

 

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net Carrying Amount

 

Acquired developed technology

 

$

20,000

 

 

$

(11,638

)

 

$

8,362

 

Purchased intellectual property

 

 

325

 

 

 

(161

)

 

 

164

 

Balance at December 31, 2021

 

$

20,325

 

 

$

(11,799

)

 

$

8,526

 

 

The developed technology was acquired in connection with our acquisition of Sequenta, Inc. in 2015. The remaining balance of the acquired developed technology and the purchased intellectual property is expected to be amortized over the next 4.3 years.

 

As of September 30, 2022, expected future amortization expense for intangible assets was as follows (in thousands):

 

 

2022 (excluding the nine months ended September 30, 2022)

 

$

429

 

2023

 

 

1,699

 

2024

 

 

1,703

 

2025

 

 

1,699

 

2026

 

 

1,699

 

Thereafter

 

 

27

 

Total future amortization expense

 

$

7,256

 

 

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 September 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 September 30, 2022 (in thousands):

 

2022 (excluding the nine months ended September 30, 2022)

 

$

3,488

 

2023

 

 

13,964

 

2024

 

 

13,692

 

2025

 

 

14,098

 

2026

 

 

12,330

 

Thereafter

 

 

81,188

 

Total undiscounted lease payments

 

 

138,760

 

Less:

 

 

 

   Imputed interest rate

 

 

(28,517

)

   Tenant improvement receivables

 

 

(1,194

)

Total operating lease liabilities

 

 

109,049

 

Less: Current portion

 

 

(8,528

)

Operating lease liabilities, less current portion

 

$

100,521

 

 

During the nine months ended September 30, 2022, cash paid for amounts included in the measurement of lease liabilities was $6.9 million, net of $4.0 million of cash received for tenant improvement allowances. Cash paid for amounts included in the measurement of lease liabilities was $5.6 million and cash received for tenant improvement allowances was $11.5 million during the nine months ended September 30, 2021.

17

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

We previously entered into a $2.1 million letter of credit with one of our financial institutions in connection with one of our leases.

9. Revenue Interest Purchase Agreement

Revenue Interest Purchase Agreement

In September 2022, we entered into the Purchase Agreement with OrbiMed Royalty & Credit Opportunities IV, LP ("OrbiMed"), an affiliate of OrbiMed Advisors LLC, as collateral agent and administrative agent for the purchasers party thereto (the “Purchasers”). Pursuant to the Purchase Agreement, we received $125 million from the Purchasers at closing (the "First Payment"), less certain transaction expenses. We will also be entitled to receive up to $125 million in subsequent installments as follows: (i) $75 million upon our request occurring no later than September 12, 2025 (the “Second Payment”) and (ii) $50 million upon our request in connection with certain permitted acquisitions occurring no later than September 12, 2025 (the “Third Payment”), in each case subject to certain funding conditions. To secure our obligations under the Purchase Agreement, we and our subsidiaries have granted OrbiMed a security interest in our core platform technology assets, subject to certain customary exclusions, as defined in the Purchase Agreement.

Revenue Interest Payments

As consideration for such payments, the Purchasers will have a right to receive certain revenue interests (the “Revenue Interests”) from us based on a percentage (the “Applicable Payment Percentage”) of all GAAP revenue (the “Revenue Base”). If only the First Payment has been made, the Applicable Payment Percentage shall be five percent of the quarterly Revenue Base. If both the First Payment and Second Payment have been made, the Applicable Payment Percentage shall be eight percent of the quarterly Revenue Base. If each of the First, Second and Third Payments have been made, the applicable payment percentage applied to the Revenue Interest shall be ten percent of the quarterly Revenue Base.

Payments in respect of the Revenue Interests shall be made quarterly within 45 days following the end of each fiscal quarter (each, a “Revenue Interest Payment”). If OrbiMed has not received Revenue Interest Payments in the aggregate equal to or greater than the sum of its invested capital (the “Cumulative Purchaser Payments”) on or prior to September 12, 2028, the revenue interest rate shall be increased to a rate which, if applied retroactively to our cumulative Revenue Base, would have resulted in Revenue Interest Payments equal to the sum of all Cumulative Purchaser Payments.

Return Cap

OrbiMed will be entitled to 100% of the Revenue Interest Payments until it has received a total cumulative value of 165% of the Cumulative Purchaser Payments (the “Return Cap”), unless full repayment of the amount of the Return Cap has not been made by September 12, 2032, in which case the Return Cap shall be increased to 175% of the Cumulative Purchaser Payments.

Put/Call Options

Upon the occurrence of a Put Option Event (as defined in the Purchase Agreement), including material divestitures by us, a change in control, material judgments, or bankruptcy events, Purchasers representing at least a majority of the purchase commitments under the Purchase Agreement shall have the right but not the obligation ("the Put Option") to require us to repurchase all of the outstanding Revenue Interests at the applicable price (the “Put/Call Price”). Additionally, at any time following receipt of the First Payment, we may exercise a call option to repurchase all Revenue Interests at the applicable Put/Call Price.

For all Put Option Events other than a change of control or a material divestiture, the Put/Call Price shall be an amount equal to the applicable Return Cap. For a change of control or a material divestiture, prior to March 12, 2024, the Put/Call Price shall be an amount equal to 120% of the Cumulative Purchaser Payments less the sum of all Revenue Interest Payments made by us to the Purchasers prior to such date, between March 12, 2024 and September 12, 2024, the Put/Call Price shall be an amount equal to 125% of the Cumulative Purchaser Payments less the sum of all Revenue Interest Payments made by us to the Purchasers prior to such date, and after September 12, 2024, the Put/Call Price shall be equal to the applicable Return Cap.

18

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

Accounting Treatment

We evaluated the terms of the Purchase Agreement and concluded that the features of the Cumulative Purchaser Payments are similar to those of a debt instrument. Accordingly, we accounted for the transaction as long-term debt recorded at amortized cost using the effective interest rate method. We further evaluated the terms of the debt and determined that the Put Option that is exercisable by the Purchasers upon certain contingent events requires bifurcation as a derivative. However, the value of the Put Option was determined to be immaterial due to the remote possibility of exercise. We assess the value of the Put Option periodically.

To determine the amortization of the Purchase Agreement obligation, we are required to estimate the amount and timing of future Revenue Interest Payments based on our estimate of the timing and amount of future revenues and calculate an effective interest rate which will amortize the obligation to zero over the amortization period, taking into account the forecasted Revenue Interest Payments. The calculated effective interest rate as of September 30, 2022 was 11.5%.

In connection with the Purchase Agreement, we incurred debt issuance costs of $0.6 million. Debt issuance costs have been recorded to long-term debt and are being amortized over the estimated term of the debt using the effective interest method, adjusted on a prospective basis for changes in the underlying assumptions and inputs.

The assumptions used in determining the expected repayment term of the obligation and amortization period of the issuance costs requires that we make estimates that could impact the short- and long-term classification of these costs, as well as the period over which these costs will be amortized. We periodically assess the amount and timing of expected Revenue Interest Payments based on internal forecasts.

To the extent such payments are greater or less than our initial estimates or the timing of such payments is materially different than our original estimates, we will prospectively adjust the amortization of the revenue interest liability and the effective interest rate. Noncash interest expense recognized for the three and nine months ended September 30, 2022 was $0.7 million.

The following table sets forth the revenue interest liability, net activity during the nine months ended September 30, 2022 (in thousands):

 

Revenue interest liability at inception

 

$

125,000

 

Capitalized issuance costs

 

 

(625

)

Interest expense

 

 

653

 

Revenue interest payable

 

 

(473

)

Total revenue interest liability, net at September 30, 2022

 

$

124,555

 

 

10. 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 September 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.

19

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

11. Shareholders’ Equity

Common Stock

Our common stock has no preferences or privileges and is not redeemable. Holders of our common stock are entitled to one vote for each share of common stock held. The holders of record of outstanding shares of common stock shall be entitled to receive, when, as and if declared, out of funds legally available, such cash and other dividends as may be declared from time to time.

As of September 30, 2022, we had reserved shares of common stock for the following:

 

Shares issuable upon the exercise of outstanding stock options granted

 

 

13,789,307

 

Shares issuable upon the vesting of outstanding restricted stock units granted and the maximum outstanding market-based restricted stock units eligible to be earned

 

 

5,960,617

 

Shares available for future grant under the 2019 Equity Incentive Plan

 

 

14,946,912

 

Shares available for future grant under the Employee Stock Purchase Plan

 

 

2,804,298

 

Total shares of common stock reserved for future issuance

 

 

37,501,134

 

Our 2019 Equity Incentive Plan (“2019 Plan”) provides for annual increases in the number of shares that may be issued under the 2019 Plan on January 1, 2020 and on each subsequent January 1, thereafter, by a number of shares equal to the lesser of (a) 5% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or (b) an amount determined by our board of directors.

Furthermore, our Employee Stock Purchase Plan (“ESPP”) provides for annual increases in the number of shares available for issuance under our ESPP on January 1, 2020 and on each January 1, thereafter, by a number of shares equal to the smallest of (a) 1% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or (b) an amount determined by our board of directors.

Our board of directors determined not to increase the 2019 Plan and ESPP reserves in 2022.

12. Equity Incentive Plans

2009 Equity Incentive Plan

We adopted an equity incentive plan in 2009 (“2009 Plan”) that provided for the issuance of incentive and nonqualified common stock options and other share-based awards for employees, directors and consultants. Under the 2009 Plan, the exercise price for incentive and nonqualified stock options were not to be less than the fair market value of our common stock at the date of grant. Stock options granted under this plan expire no later than ten years from the grant date and vesting was established at the time of grant. Pursuant to the terms of the 2019 Plan, any shares subject to outstanding stock options originally granted under the 2009 Plan that terminate, expire or lapse for any reason without the delivery of shares to the holder thereof shall become available for issuance pursuant to awards granted under the 2019 Plan. While no shares are available for future issuance under the 2009 Plan, it continues to govern outstanding equity awards granted thereunder.

2019 Equity Incentive Plan

The 2019 Plan became effective immediately prior to the closing of our initial public offering in July 2019. The 2019 Plan provides for the issuance of awards in the form of stock options and other share-based awards for employees, directors and consultants. Under the 2019 Plan, the stock option exercise price per share shall not be less than the fair market value of a share of stock on the effective date of grant, as defined by the 2019 Plan, unless explicitly qualified under the provisions of Section 409A or Section 424(a) of the Internal Revenue Code of 1986. Additionally, unless otherwise specified, stock options granted under this plan expire no later than ten years from the grant date and vesting is established at the time of grant. Except for certain stock option and restricted stock unit grants made to non-employee directors, stock options and restricted stock units granted under the 2019 Plan generally vest over a four-year period, subject to continuous service through each applicable vesting date. As of September 30, 2022, we had 29,217,365 shares of common stock authorized for issuance under the 2019 Plan.

20

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

Changes in shares available for grant during the nine months ended September 30, 2022 were as follows:

 

 

 

Shares Available for Grant

 

Shares available for grant at December 31, 2021

 

 

22,299,923

 

Stock options and restricted stock units granted and the maximum market-based restricted stock units granted eligible to be earned

 

 

(10,823,237

)

Stock options and restricted stock units forfeited, cancelled or expired

 

 

3,470,226

 

Shares available for grant at September 30, 2022

 

 

14,946,912

 

Stock Options

Stock option activity under the 2009 Plan and 2019 Plan during the nine months ended September 30, 2022 was as follows:

 

 

 

Shares Subject to
Outstanding Stock Options

 

 

Weighted-Average Exercise
Price per Share

 

 

Aggregate Intrinsic Value
(in thousands)

 

Stock options outstanding at December 31, 2021

 

 

12,778,984

 

 

$

19.72

 

 

 

 

Stock options granted

 

4,423,644

 

 

 

11.67

 

 

 

 

Stock options forfeited or cancelled

 

 

(1,554,973

)

 

 

28.64

 

 

 

 

Stock options expired

 

 

(496,457

)

 

 

33.05

 

 

 

 

Stock options exercised

 

 

(1,361,891

)

 

 

5.55

 

 

 

 

Stock options outstanding at September 30, 2022

 

 

13,789,307

 

 

$

17.05

 

 

$

4,183

 

Stock options vested and exercisable at September 30, 2022

 

7,226,163

 

 

$

14.42

 

 

$

4,178

 

 

The weighted-average remaining contractual life for stock options outstanding as of September 30, 2022 was 7.2 years. The weighted-average remaining contractual life for vested and exercisable stock options as of September 30, 2022 was 5.6 years.

Of the $23.4 million proceeds from the exercise of stock options included on the unaudited condensed consolidated statements of cash flows for the nine months ended September 30, 2021, $0.3 million related to options exercised prior to but settled during the nine months ended September 30, 2021. As of September 30, 2021, there was $0.1 million in unsettled cash proceeds related to options exercised during the nine months ended September 30, 2021.

Restricted Stock Units

Restricted stock unit activity under the 2019 Plan during the nine months ended September 30, 2022 was as follows:

 

 

 

Restricted Stock Units
Outstanding

 

 

Weighted-Average Grant Date
Fair Value per Share

 

Nonvested restricted stock units outstanding at December 31, 2021

 

 

1,211,191

 

 

$

37.41

 

Restricted stock units granted

 

 

5,905,359

 

 

 

11.72

 

Restricted stock units forfeited or cancelled

 

 

(1,418,796

)

 

 

16.44

 

Restricted stock units vested

 

 

(231,371

)

 

 

39.40

 

Nonvested restricted stock units outstanding at September 30, 2022

 

 

5,466,383

 

 

$

15.01

 

 

21

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

Market-Based Restricted Stock Units

In addition to the restricted stock units described above, our board of directors approved an award of market-based restricted stock units to our chief executive officer in March 2022. The shares of common stock that may be earned under the award, ranging from zero shares to 494,234 shares, are calculated based upon our total shareholder return during a three-year performance period as measured against that of the group of companies comprising the S&P Biotechnology Select Industry Index as of the grant date, subject to certain adjustments to such index group. Except as expressly provided in the terms of the award agreement, vesting is subject to our chief executive officer's continuous service through the end of the three-year performance period.

Grant Date Fair Value of Stock Options, Restricted Stock Units and Market-Based Restricted Stock Units Granted

The estimated grant date fair values of stock options granted during the nine months ended September 30, 2022 and 2021 were estimated using the Black-Scholes option-pricing model with the following assumptions:

 

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

Fair value of common stock

 

$7.30 - $14.95

 

 

$30.86 - $66.50

 

Expected term (in years)

 

5.27 - 6.08

 

 

5.27 - 6.08

 

Risk-free interest rate

 

1.7% - 3.0%

 

 

0.5% - 1.1%

 

Expected volatility

 

68.2% - 71.0%

 

 

67.1% - 70.0%

 

Expected dividend yield

 

 

—

 

 

 

—

 

 

The determination of the grant date fair value of stock options granted using a Black-Scholes option-pricing model is affected by the fair value of our common stock, as well as assumptions regarding a number of variables that are complex, subjective and generally require significant judgment to determine. The valuation assumptions were determined as follows:

 

Fair value of common stock—The fair value of each share of common stock is based on the closing price of our common stock on the date of grant, or other relevant determination date, as reported on The Nasdaq Global Select Market.

 

Expected term—The expected term of stock options granted to employees and non-employee directors is determined using the “simplified” method, as illustrated in ASC Topic 718, Compensation—Stock Compensation, as we do not have sufficient exercise history to determine a better estimate of expected term. Under this approach, the expected term is based on the midpoint between the vesting date and the end of the contractual term of the stock option.

 

Risk-free interest rate—We utilize a risk-free interest rate in the option valuation model based on U.S. Treasury zero-coupon issues with remaining terms similar to the expected terms of the stock options.

 

Expected volatility—As we do not have sufficient trading history for our common stock, expected volatility is based on the historical volatility of our publicly traded industry peers utilizing a period of time consistent with our estimate of expected term.

 

Expected dividend yield—We do not anticipate paying any cash dividends in the foreseeable future and, therefore, use an expected dividend yield of zero in the option valuation model.

 

The weighted-average grant date fair value per share of stock options granted during the nine months ended September 30, 2022 and 2021 was $7.36 and $25.25, respectively.

The grant date fair value of restricted stock units granted is based on the closing price of our common stock on the date of grant, or other relevant determination date, as reported on The Nasdaq Global Select Market. The weighted-average grant date fair value per share of restricted stock units granted during the nine months ended September 30, 2022 and 2021 was $11.72 and $40.21, respectively.

The grant date fair value of the market-based restricted stock units granted in March 2022 is $18.89 and was determined using a Monte Carlo valuation model, which uses assumptions such as volatility, risk-free interest rate and dividend estimated for the performance period. The related share-based compensation expense of $4.7 million is recognized on a straight-line basis over the three-year performance period, which is also the requisite service period. Attainment of the market condition and the number of shares earned and vested does not impact the related share-based compensation expense recognized. Share-based compensation expense will be reversed only if our chief executive officer does not provide continuous service through the performance period for reasons other than those expressly provided in the terms of the award.

22

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

The compensation cost related to stock options, restricted stock units and market-based restricted stock units for the three and nine months ended September 30, 2022 and 2021, respectively, are included on the unaudited condensed consolidated statements of operations as follows (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Cost of revenue

 

$

1,058

 

 

$

650

 

 

$

2,807

 

 

$

1,386

 

Research and development

 

 

4,382

 

 

 

3,637

 

 

 

13,370

 

 

 

10,311

 

Sales and marketing

 

 

3,357

 

 

 

3,369

 

 

 

10,170

 

 

 

9,166

 

General and administrative

 

 

5,345

 

 

 

3,987

 

 

 

14,836

 

 

 

10,513

 

Total share-based compensation expense

 

$

14,142

 

 

$

11,643

 

 

$

41,183

 

 

$

31,376

 

 

As of September 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

 

$

74,954

 

 

 

2.65

 

Nonvested restricted stock units

 

 

69,624

 

 

 

3.22

 

Nonvested market-based restricted stock units

 

 

3,774

 

 

 

2.43

 

 

13. 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 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.

23

Adaptive Biotechnologies Corporation

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

(unaudited)

 

14. 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 nine months ended September 30, 2022 and 2021, respectively (in thousands, except share and per share amounts):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss attributable to Adaptive Biotechnologies Corporation

 

$

(45,281

)

 

$

(55,903

)

 

$

(160,063

)

 

$

(145,846

)

Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted

 

 

142,928,654

 

 

 

140,833,564

 

 

 

142,334,342

 

 

 

140,060,379

 

Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted

 

$

(0.32

)

 

$

(0.40

)

 

$

(1.12

)

 

$

(1.04

)

Given the loss position for all periods presented, basic net loss per share attributable to our common shareholders is the same as diluted net loss per share attributable to our common shareholders, as the inclusion of all potential shares of common stock outstanding would have been anti-dilutive. The following weighted-average common stock equivalents were excluded from the calculation of diluted net loss per share attributable to our common shareholders for the three and nine months ended September 30, 2022 and 2021, respectively, as they had an anti-dilutive effect:

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Stock options outstanding

 

 

13,996,403

 

 

 

12,901,028

 

 

 

13,984,427

 

 

 

13,205,328

 

Nonvested restricted stock units outstanding

 

 

5,486,711

 

 

 

795,469

 

 

 

4,490,170

 

 

 

572,194

 

Maximum nonvested market-based restricted stock units outstanding eligible to be earned

 

 

494,234

 

 

 

—

 

 

 

381,990

 

 

 

—

 

Common stock warrant outstanding

 

 

—

 

 

 

—

 

 

 

—

 

 

 

11,458

 

Total

 

 

19,977,348

 

 

 

13,696,497

 

 

 

18,856,587

 

 

 

13,788,980

 

 

24

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, for which we have launched two indications: T-Detect COVID, which is designed to confirm past SARS-CoV-2 infection, and T-Detect Lyme, which is designed to help diagnose early Lyme disease.

Our therapeutic product candidates, being developed under our worldwide collaboration and license agreement with Genentech (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.

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.

25

Adaptive Biotechnologies Corporation

 

We recognized revenue of $47.8 million and $39.5 million for the three months ended September 30, 2022 and 2021, respectively, and $130.1 million and $116.4 million for the nine months ended September 30, 2022 and 2021, respectively. Net loss attributable to Adaptive Biotechnologies Corporation was $45.3 million and $55.9 million for the three months ended September 30, 2022 and 2021, respectively, and $160.1 million and $145.8 million for the nine months ended September 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 and proceeds from the revenue interest purchase agreement. As of September 30, 2022 and December 31, 2021, we had cash, cash equivalents and marketable securities of $527.8 million and $570.2 million, respectively.

Revenue Interest Purchase Agreement

In September 2022, we entered into a revenue interest purchase agreement (the "Purchase Agreement") with OrbiMed Royalty & Credit Opportunities IV, LP ("OrbiMed"), an affiliate of OrbiMed Advisors LLC, as collateral agent and administrative agent for the purchasers party thereto (the “Purchasers”). Pursuant to the Purchase Agreement, we received $125 million from the Purchasers at closing (the "First Payment"), less certain transaction expenses. We will also be entitled to receive up to $125 million in subsequent installments as follows: (i) $75 million upon our request occurring no later than September 12, 2025 (the “Second Payment”) and (ii) $50 million upon our request in connection with certain permitted acquisitions occurring no later than September 12, 2025 (the “Third Payment”), in each case subject to certain funding conditions.

As consideration for such payments, the Purchasers will have a right to receive certain revenue interests (the “Revenue Interests”) from us based on a percentage (the “Applicable Payment Percentage”) of all revenue as measured in accordance with accounting principles generally accepted in the Unites States of America ("GAAP") (the "Revenue Base"). If only the First Payment has been made, the Applicable Payment Percentage shall be five percent of the quarterly Revenue Base. If both the First Payment and Second Payment have been made, the Applicable Payment Percentage shall be eight percent of the quarterly Revenue Base. If each of the First, Second and Third Payments have been made, the applicable payment percentage applied to the Revenue Interest shall be ten percent of the quarterly Revenue Base.

Payments in respect of the Revenue Interests shall be made quarterly within 45 days following the end of each fiscal quarter (each, a “Revenue Interest Payment”). If OrbiMed has not received Revenue Interest Payments in the aggregate equal to or greater than the sum of its invested capital (the “Cumulative Purchaser Payments”) on or prior to September 12, 2028, the revenue interest rate shall be increased to a rate which, if applied retroactively to our cumulative Revenue Base, would have resulted in Revenue Interest Payments equal to the sum of all Cumulative Purchaser Payments.

OrbiMed will be entitled to 100% of the Revenue Interest Payments until it has received a total cumulative value of 165% of the Cumulative Purchaser Payments (the “Return Cap”), unless full repayment of the amount of the Return Cap has not been made by September 12, 2032, in which case the Return Cap shall be increased to 175% of the Cumulative Purchaser Payments.

In addition, the Purchase Agreement contains various representations and warranties, information rights, non-financial covenants, indemnification obligations and other provisions that are customary for a transaction of this nature.

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.

26

Adaptive Biotechnologies Corporation

 

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

 

 

 

 

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

 

 

27

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 payments made in advance of services ("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. 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, 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.

28

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, 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 decreases in the short term and 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 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 general and administrative expenses to experience nominal fluctuations in the short term and to decrease as a percentage of revenue in the long term.

Interest Expense

Interest expense includes costs associated with our revenue interest liability and noncash interest costs associated with the amortization of the related deferred issuance costs. We impute the related interest expense using the effective interest rate method. We calculate an effective interest rate which will amortize our related obligation to zero over the anticipated repayment period. A significant increase or decrease in forecasted revenue will materially impact our interest expense.

 

29

Adaptive Biotechnologies Corporation

 

Statements of Operations Data and Other Financial and Operating Data

The following table sets forth our statements of operations data and other financial and operating data for the periods presented (in thousands, except share and per share amounts):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Statements of Operations Data:

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

47,830

 

 

$

39,467

 

 

$

130,110

 

 

$

116,414

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

14,907

 

 

 

14,189

 

 

 

41,320

 

 

 

34,945

 

Research and development

 

 

35,658

 

 

 

36,072

 

 

 

110,534

 

 

 

107,644

 

Sales and marketing

 

 

21,513

 

 

 

24,949

 

 

 

71,887

 

 

 

68,769

 

General and administrative

 

 

20,755

 

 

 

20,154

 

 

 

66,099

 

 

 

51,156

 

Amortization of intangible assets

 

 

428

 

 

 

428

 

 

 

1,270

 

 

 

1,270

 

Total operating expenses

 

 

93,261

 

 

 

95,792

 

 

 

291,110

 

 

 

263,784

 

Loss from operations

 

 

(45,431

)

 

 

(56,325

)

 

 

(161,000

)

 

 

(147,370

)

Interest and other income, net

 

 

765

 

 

 

327

 

 

 

1,454

 

 

 

1,429

 

Interest expense

 

 

(653

)

 

 

—

 

 

 

(653

)

 

 

—

 

Net loss

 

 

(45,319

)

 

 

(55,998

)

 

 

(160,199

)

 

 

(145,941

)

Add: Net loss attributable to noncontrolling interest

 

 

38

 

 

 

95

 

 

 

136

 

 

 

95

 

Net loss attributable to Adaptive Biotechnologies Corporation

 

$

(45,281

)

 

$

(55,903

)

 

$

(160,063

)

 

$

(145,846

)

Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted

 

$

(0.32

)

 

$

(0.40

)

 

$

(1.12

)

 

$

(1.04

)

Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted

 

 

142,928,654

 

 

 

140,833,564

 

 

 

142,334,342

 

 

 

140,060,379

 

Other Financial and Operating Data:

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted EBITDA(1)

 

$

(25,868

)

 

$

(41,059

)

 

$

(102,024

)

 

$

(106,795

)

(1) Adjusted EBITDA is a non-GAAP financial measure that we define as net loss attributable to Adaptive Biotechnologies Corporation adjusted for interest and other income, net, interest expense, income tax (expense) benefit, depreciation and amortization expense, restructuring expense and share-based compensation expense. Please refer to “Adjusted EBITDA” below for a reconciliation between Adjusted EBITDA and net loss attributable to Adaptive Biotechnologies Corporation, the most directly comparable GAAP financial measure, and a discussion about the limitations of Adjusted EBITDA.

 

30

Adaptive Biotechnologies Corporation

 

Comparison of the Three Months Ended September 30, 2022 and 2021

Revenue

 

 

 

Three Months Ended September 30,

 

 

Change

 

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

 

2022

 

 

2021

 

Immune Medicine revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Service revenue

 

$

6,559

 

 

$

8,169

 

 

$

(1,610

)

 

(20)%

 

 

 

 

 

 

 

Collaboration revenue

 

 

21,320

 

 

 

15,446

 

 

 

5,874

 

 

 

38

 

 

 

 

 

 

 

Total Immune Medicine revenue

 

 

27,879

 

 

 

23,615

 

 

 

4,264

 

 

 

18

 

 

 

58

%

 

 

60

%

MRD revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Service revenue

 

 

19,951

 

 

 

14,352

 

 

 

5,599

 

 

 

39

 

 

 

 

 

 

 

Regulatory milestone revenue

 

 

—

 

 

 

1,500

 

 

 

(1,500

)

 

 

(100

)

 

 

 

 

 

 

Total MRD revenue

 

 

19,951

 

 

 

15,852

 

 

 

4,099

 

 

 

26

 

 

 

42

%

 

 

40

%

Total revenue

 

$

47,830

 

 

$

39,467

 

 

$

8,363

 

 

 

21

 

 

 

100

%

 

 

100

%

The $4.3 million increase in Immune Medicine revenue was primarily due to a $5.4 million increase in revenue generated from the Genentech Agreement due to increased collaboration expenses and a $1.3 million increase in revenue generated from our biopharmaceutical and academic customers, which were partially offset by a $2.5 million decrease in revenue generated from our T-Detect COVID clinical customers.

The $4.1 million increase in MRD revenue was primarily due to a $3.3 million increase in revenue generated from providing our clonoSEQ report to clinical customers and a $2.5 million increase in revenue generated from providing MRD sample testing services to biopharmaceutical customers. These increases were partially offset by a $1.5 million decrease in revenue recognized upon the achievement of certain regulatory milestones by our biopharmaceutical customers' therapeutics. Our clonoSEQ test volume increased by 52% to 9,649 tests delivered in the three months ended September 30, 2022 from 6,341 tests delivered in the three months ended September 30, 2021.

Cost of Revenue

 

 

 

Three Months Ended September 30,

 

 

Change

 

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

 

2022

 

 

2021

 

Cost of revenue

 

$

14,907

 

 

$

14,189

 

 

$

718

 

 

 

5

%

 

 

31

%

 

 

36

%

The $0.7 million increase in cost of revenue was primarily attributable to a $2.2 million increase in labor and overhead costs, a $0.9 million increase in cost of materials related to mix to higher cost assays and a $0.3 million increase related to higher usage of our production laboratory to process revenue samples versus research and development samples. These increases were partially offset by a $1.7 million decrease in materials cost resulting from decreased revenue sample volume and a $0.8 million decrease in certain sample collection costs.

31

Adaptive Biotechnologies Corporation

 

Research and Development

 

 

 

Three Months Ended September 30,

 

 

Change

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

2022

 

 

2021

 

Research and development

 

$

35,658

 

 

$

36,072

 

 

$

(414

)

 

(1)%

 

 

75

%

 

 

91

%

The following table presents disaggregated research and development expenses by cost classification for the periods presented:

 

 

 

Three Months Ended September 30,

 

 

 

 

(in thousands)

 

2022

 

 

2021

 

 

Change

 

Research and development materials and allocated production laboratory expenses

 

$

10,138

 

 

$

12,620

 

 

$

(2,482

)

Personnel expenses

 

 

16,534

 

 

 

16,184

 

 

 

350

 

Allocable facilities and information technology expenses

 

 

2,616

 

 

 

1,560

 

 

 

1,056

 

Software and cloud services expenses

 

 

729

 

 

 

825

 

 

 

(96

)

Depreciation and other expenses

 

 

5,641

 

 

 

4,883

 

 

 

758

 

Total

 

$

35,658

 

 

$

36,072

 

 

$

(414

)

The $0.4 million decrease in research and development expenses was primarily attributable to a $2.5 million decrease in cost of materials and allocated production laboratory expenses driven primarily by decreased investments in T-Detect and TCR-Antigen Map development activities, which were partially offset by an increase in drug discovery expenditures primarily related to the Genentech Agreement. This decrease was partially offset by a $1.1 million increase in allocable facility expenses and a $0.8 million increase in depreciation and other expenses, which was driven primarily by a $0.5 million increase in depreciation expense and a $0.5 million increase in consultant costs.

Sales and Marketing

 

 

 

Three Months Ended September 30,

 

 

Change

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

2022

 

 

2021

 

Sales and marketing

 

$

21,513

 

 

$

24,949

 

 

$

(3,436

)

 

(14)%

 

 

45

%

 

 

63

%

The $3.4 million decrease in sales and marketing expenses was primarily attributable to a $3.1 million decrease in marketing expenses driven primarily by reduced clonoSEQ marketing efforts, as well as reduced corporate and T-Detect marketing activities. There was also a $0.4 million decrease in consultant costs and a $0.3 million decrease in travel and customer event related expenses, which were partially offset by a $0.4 million increase in people costs.

General and Administrative

 

 

 

Three Months Ended September 30,

 

 

Change

 

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

 

2022

 

 

2021

 

General and administrative

 

$

20,755

 

 

$

20,154

 

 

$

601

 

 

 

3

%

 

 

43

%

 

 

51

%

The $0.6 million increase in general and administrative expenses was primarily attributable to a $0.7 million increase in computer and software expenses, a $0.5 million increase in personnel costs and a $0.5 million increase in building, facility and depreciation related expenses, which were partially offset by a $0.6 million decrease in insurance costs and a $0.3 million decrease in consultant costs.

Interest and Other Income, Net

 

 

 

Three Months Ended September 30,

 

 

Change

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

Interest and other income, net

 

$

765

 

 

$

327

 

 

$

438

 

 

134%

The $0.4 million increase in interest and other income, net was primarily attributable to an increase in net interest income and investment amortization resulting from a larger portfolio.

32

Adaptive Biotechnologies Corporation

 

Interest Expense

 

 

Three Months Ended September 30,

 

 

Change

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

Interest expense

 

$

(653

)

 

$

—

 

 

$

(653

)

 

(100)%

The $0.7 million increase in interest expense was attributable to the Purchase Agreement entered into during the three months ended September 30, 2022.

Comparison of the Nine Months Ended September 30, 2022 and 2021

Revenue

 

 

 

Nine Months Ended September 30,

 

 

Change

 

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

 

2022

 

 

2021

 

Immune Medicine revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Service revenue

 

$

20,968

 

 

$

17,622

 

 

$

3,346

 

 

 

19

%

 

 

 

 

 

 

Collaboration revenue

 

 

50,105

 

 

 

49,137

 

 

 

968

 

 

 

2

 

 

 

 

 

 

 

Total Immune Medicine revenue

 

 

71,073

 

 

 

66,759

 

 

 

4,314

 

 

 

6

 

 

 

55

%

 

 

57

%

MRD revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Service revenue

 

 

55,037

 

 

 

39,655

 

 

 

15,382

 

 

 

39

 

 

 

 

 

 

 

Regulatory milestone revenue

 

 

4,000

 

 

 

10,000

 

 

 

(6,000

)

 

 

(60

)

 

 

 

 

 

 

Total MRD revenue

 

 

59,037

 

 

 

49,655

 

 

 

9,382

 

 

 

19

 

 

 

45

%

 

 

43

%

Total revenue

 

$

130,110

 

 

$

116,414

 

 

$

13,696

 

 

 

12

 

 

 

100

%

 

 

100

%

The $4.3 million increase in Immune Medicine revenue was primarily due to an $8.5 million increase in revenue generated from our biopharmaceutical and academic customers, which was partially offset by a $2.8 million decrease in revenue generated from our T-Detect COVID clinical customers and a $1.3 million decrease in revenue generated from the Genentech Agreement due to reduced collaboration expenses.

The $9.4 million increase in MRD revenue was primarily due to a $10.7 million increase in revenue generated from providing our clonoSEQ report to clinical customers and a $5.3 million increase in revenue generated from providing MRD sample testing services to biopharmaceutical customers. These increases were partially offset by a $6.0 million decrease in revenue recognized upon the achievement of certain regulatory milestones by our biopharmaceutical customers' therapeutics and a $0.8 million decrease in revenue generated from providing MRD sample testing services to investigator-led clinical trials. Our clonoSEQ test volume increased by 50% to 26,345 tests delivered in the nine months ended September 30, 2022 from 17,538 tests delivered in the nine months ended September 30, 2021.

Cost of Revenue

 

 

 

Nine Months Ended September 30,

 

 

Change

 

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

 

2022

 

 

2021

 

Cost of revenue

 

$

41,320

 

 

$

34,945

 

 

$

6,375

 

 

 

18

%

 

 

32

%

 

 

30

%

The $6.4 million increase in cost of revenue was primarily attributable to a $4.1 million increase in labor, overhead and facility costs, a $2.4 million increase in cost of materials related to mix to higher cost assays and a $0.5 million increase related to higher usage of our production laboratory to process revenue samples versus research and development samples. These increases were partially offset by a $0.9 million decrease in certain sample collection costs.

Research and Development

 

 

 

Nine Months Ended September 30,

 

 

Change

 

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

 

2022

 

 

2021

 

Research and development

 

$

110,534

 

 

$

107,644

 

 

$

2,890

 

 

 

3

%

 

 

85

%

 

 

92

%

 

33

Adaptive Biotechnologies Corporation

 

The following table presents disaggregated research and development expenses by cost classification for the periods presented:

 

 

 

Nine Months Ended September 30,

 

 

 

 

(in thousands)

 

2022

 

 

2021

 

 

Change

 

Research and development materials and allocated production laboratory expenses

 

$

35,623

 

 

$

40,453

 

 

$

(4,830

)

Personnel expenses

 

 

51,826

 

 

 

46,107

 

 

 

5,719

 

Allocable facilities and information technology expenses

 

 

6,495

 

 

 

4,750

 

 

 

1,745

 

Software and cloud services expenses

 

 

2,132

 

 

 

2,682

 

 

 

(550

)

Depreciation and other expenses

 

 

14,458

 

 

 

13,652

 

 

 

806

 

Total

 

$

110,534

 

 

$

107,644

 

 

$

2,890

 

The $2.9 million increase in research and development expenses was primarily attributable to a $5.7 million increase in personnel costs, of which $0.7 million related to our restructuring activities, a $1.7 million increase in allocable facility expenses and a $0.8 million increase in depreciation and other expenses, which was driven primarily by a $1.6 million increase in depreciation expense and a $0.9 million increase in consultant costs, which were partially offset by a $1.3 million decrease in collaboration and medical advisory costs. These increases were partially offset by a $4.8 million decrease in cost of materials and allocated production laboratory expenses, which was driven primarily by decreased investments in drug discovery, clonoSEQ and T-Detect and TCR-Antigen Map development activities.

Sales and Marketing

 

 

 

Nine Months Ended September 30,

 

 

Change

 

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

 

2022

 

 

2021

 

Sales and marketing

 

$

71,887

 

 

$

68,769

 

 

$

3,118

 

 

 

5

%

 

 

55

%

 

 

59

%

The $3.1 million increase in sales and marketing expenses was primarily attributable to $7.5 million in additional personnel costs, of which $0.9 million related to our restructuring activities, as well as a $2.1 million increase in travel and customer event related expenses. These increases were partially offset by a $6.3 million decrease in marketing expenses driven primarily by reduced clonoSEQ, corporate and T-Detect marketing activities.

General and Administrative

 

 

 

Nine Months Ended September 30,

 

 

Change

 

 

Percent of Revenue

 

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

 

 

2022

 

 

2021

 

General and administrative

 

$

66,099

 

 

$

51,156

 

 

$

14,943

 

 

 

29

%

 

 

51

%

 

 

44

%

The $14.9 million increase in general and administrative expenses was primarily attributable to an $8.3 million increase in building, facility and depreciation related expenses, as well as a $4.5 million increase in personnel costs, a $2.1 million increase in computer and software expenses and a $0.9 million increase in consultant costs. These increases were partially offset by a $1.1 million decrease in legal and accounting fees.

Interest and Other Income, Net

 

 

 

Nine Months Ended September 30,

 

 

Change

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

Interest and other income, net

 

$

1,454

 

 

$

1,429

 

 

$

25

 

 

2%

Interest and other income, net did not significantly change period over period.

 

34

Adaptive Biotechnologies Corporation

 

Interest Expense

 

 

Nine Months Ended September 30,

 

 

Change

(in thousands, except percentages)

 

2022

 

 

2021

 

 

$

 

 

%

Interest expense

 

$

(653

)

 

$

—

 

 

$

(653

)

 

(100)%

The $0.7 million increase in interest expense was attributable to the Purchase Agreement entered into during the three months ended September 30, 2022.

Adjusted EBITDA

Adjusted EBITDA is a non-GAAP financial measure that we define as net loss attributable to Adaptive Biotechnologies Corporation adjusted for interest and other income, net, interest expense, income tax (expense) benefit, depreciation and amortization expense, restructuring expense and share-based compensation expense.

Management uses Adjusted EBITDA to evaluate the financial performance of our business and the effectiveness of our business strategies. We present Adjusted EBITDA because we believe it is frequently used by analysts, investors and other interested parties to evaluate companies in our industry and it facilitates comparisons on a consistent basis across reporting periods. Further, we believe it is helpful in highlighting trends in our operating results because it excludes items that are not indicative of our core operating performance.

Adjusted EBITDA has limitations as an analytical tool and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. We may in the future incur expenses similar to the adjustments in the presentation of Adjusted EBITDA. In particular, we expect to incur meaningful share-based compensation expense in the future. Other limitations include that Adjusted EBITDA does not reflect:

•
all expenditures or future requirements for capital expenditures or contractual commitments;
•
changes in our working capital needs;
•
interest expense, which may be a necessary and ongoing element of our costs and ability to operate;
•
income tax (expense) benefit, which may be a necessary element of our costs and ability to operate;
•
the costs of replacing the assets being depreciated and amortized, which will often have to be replaced in the future;
•
the noncash component of employee compensation expense; and
•
the impact of earnings or charges resulting from matters we consider not to be reflective, on a recurring basis, of our ongoing operations, such as our March 2022 restructuring and reduction in workforce.

In addition, Adjusted EBITDA may not be comparable to similarly titled measures used by other companies in our industry or across different industries.

The following is a reconciliation of net loss attributable to Adaptive Biotechnologies Corporation to Adjusted EBITDA for the periods presented (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss attributable to Adaptive Biotechnologies Corporation

 

$

(45,281

)

 

$

(55,903

)

 

$

(160,063

)

 

$

(145,846

)

Interest and other income, net

 

 

(765

)

 

 

(327

)

 

 

(1,454

)

 

 

(1,429

)

Interest expense

 

 

653

 

 

 

—

 

 

 

653

 

 

 

—

 

Depreciation and amortization expense

 

 

5,383

 

 

 

3,528

 

 

 

15,634

 

 

 

9,104

 

Restructuring expense (1)

 

 

—

 

 

 

—

 

 

 

2,023

 

 

 

—

 

Share-based compensation expense (2)

 

 

14,142

 

 

 

11,643

 

 

 

41,183

 

 

 

31,376

 

Adjusted EBITDA

 

$

(25,868

)

 

$

(41,059

)

 

$

(102,024

)

 

$

(106,795

)

 

(1) Represents expenses recognized in conjunction with restructuring activities. See Note 13 of the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this report for details on our restructuring expense.

(2) Represents share-based compensation expense related to stock option, restricted stock unit and market-based restricted stock unit awards. See Note 12 of the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this report for details on our share-based compensation expense.

35

Adaptive Biotechnologies Corporation

 

Liquidity and Capital Resources

We have incurred losses since inception and have incurred negative cash flows from operations since inception through September 30, 2022, with the exception of certain 2019 periods for which we had positive cash flows from operations. As of September 30, 2022, we had an accumulated deficit of $879.0 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 and proceeds from our Purchase Agreement. Pursuant to the Purchase Agreement entered into with OrbiMed in September 2022, we received net cash proceeds of $124.7 million, after deducting certain issuance costs. As of September 30, 2022, we had cash, cash equivalents and marketable securities of $527.8 million.

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 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 United States government debt securities and corporate bonds.

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.

Contractual Obligations

Other than the contractual obligations set forth below, 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.

Pursuant to the Purchase Agreement entered into during September 2022, the Purchasers will have a right to receive Revenue Interests from us based on the Applicable Payment Percentage of the Revenue Base. If only the First Payment has been made, the Applicable Payment Percentage shall be five percent of the quarterly Revenue Base. If both the First Payment and Second Payment have been made, the Applicable Payment Percentage shall be eight percent of the quarterly Revenue Base. If each of the First, Second and Third Payments have been made, the applicable payment percentage applied to the Revenue Interest shall be ten percent of the quarterly Revenue Base.

Revenue Interest Payments shall be made quarterly within 45 days following the end of each fiscal quarter. If OrbiMed has not received Revenue Interest Payments in the aggregate equal to or greater than the Cumulative Purchaser Payments on or prior to September 12, 2028, the revenue interest rate shall be increased to a rate which, if applied retroactively to our cumulative Revenue Base, would have resulted in Revenue Interest Payments equal to the sum of all Cumulative Purchaser Payments.

OrbiMed will be entitled to 100% of the Revenue Interest Payments until it has received the Return Cap, unless full repayment of the amount of the Return Cap has not been made by September 12, 2032, in which case the Return Cap shall be increased to 175% of the Cumulative Purchaser Payments.

As projected revenues change from our initial estimates, the amount of the obligation and timing of payment is likely to change.

36

Adaptive Biotechnologies Corporation

 

See Note 8 and Note 9 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 and our Purchase Agreement, respectively.

Cash Flows

The following table summarizes our uses and sources of cash for the nine months ended September 30, 2022 and 2021 (in thousands):

 

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

Net cash used in operating activities

 

$

(153,926

)

 

$

(138,901

)

Net cash provided by investing activities

 

 

100,449

 

 

 

113,998

 

Net cash provided by financing activities

 

 

132,259

 

 

 

23,868

 

 

Operating Activities

Cash used in operating activities during the nine months ended September 30, 2022 was $153.9 million, which was primarily attributable to a net loss of $160.2 million and a net change in our operating assets and liabilities of $61.1 million, partially offset by noncash share-based compensation of $41.2 million, noncash depreciation and amortization of $17.5 million, noncash lease expense of $5.4 million, research and development inventory reserve charge of $2.6 million and noncash interest expense related to our Purchase Agreement of $0.7 million. The net change in our operating assets and liabilities was primarily due to a $44.0 million reduction in deferred revenue primarily related to revenue recognized from the Genentech Agreement, an increase in accounts receivable, net of $9.1 million, a reduction in accounts payable and accrued liabilities of $3.4 million driven largely by the payout of our corporate bonus during the three months ended March 31, 2022, a $3.0 million decrease in operating lease right-of-use assets and liabilities and an increase in inventory of $2.2 million.

Cash used in operating activities during the nine months ended September 30, 2021 was $138.9 million, which was primarily attributable to a net loss of $145.9 million and a net change in operating assets and liabilities of $44.6 million, partially offset by noncash share-based compensation of $31.4 million, noncash depreciation and amortization of $15.1 million and noncash lease expense of $5.3 million. The net change in operating assets and liabilities was primarily due to a $46.3 million reduction in deferred revenue primarily related to revenue recognized from the Genentech Agreement, an increase in accounts receivable, net of $7.1 million, an increase in inventory of $4.2 million and increases in prepaid expenses and other current assets of $2.2 million, all of which were partially offset by an increase in operating lease right-of-use assets and liabilities of $9.9 million and an increase in accounts payable and accrued liabilities of $5.5 million.

Investing Activities

Cash provided by investing activities during the nine months ended September 30, 2022 was $100.4 million, which was primarily attributable to proceeds from maturities of marketable securities of $228.0 million, partially offset by purchases of marketable securities of $113.7 million and purchases of property and equipment of $13.8 million.

Cash provided by investing activities during the nine months ended September 30, 2021 was $114.0 million, which was primarily attributable to proceeds from maturities of marketable securities of $404.5 million, partially offset by purchases of marketable securities of $238.0 million and purchases of property and equipment of $52.5 million.

Financing Activities

Cash provided by financing activities during the nine months ended September 30, 2022 was $132.3 million, which was attributable to $124.7 million in proceeds from our Purchase Agreement entered into during September 2022, net of settled issuance costs, as well as $7.6 million in proceeds from the exercise of stock options.

Cash provided by financing activities during the nine months ended September 30, 2021 was $23.9 million, which was primarily attributable to proceeds from the exercise of stock options of $23.4 million.

37

Adaptive Biotechnologies Corporation

 

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, imputing interest for our Purchase Agreement, 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;
•
imputing interest for our Purchase Agreement; and
•
goodwill.

Revenue Interest Liability, Net and Related Imputed Interest

The revenue interest liability balance associated with the Purchase Agreement that we entered into in September 2022 with OrbiMed is presented net of issuance costs on our unaudited condensed consolidated balance sheets. We impute our associated interest expense using the effective interest rate method. We calculate an effective interest rate which will amortize our related obligation to zero over the anticipated repayment period. The effective interest rate may vary during the term of the agreement depending on a number of factors, including changes in forecasted GAAP revenues. We evaluate the effective interest rate quarterly based on both achieved and forecasted revenues, utilizing the prospective method. The estimates of future revenues and resulting revenue interest payments are based on key assumptions including population, penetration, probability of success, and sales price, among others. A significant increase or decrease in forecasted revenue will materially impact our interest expense and the time period for repayment.

Other than that detailed above, 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.

38

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 September 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 September 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 September 30, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

39

Adaptive Biotechnologies Corporation

 

PART II—OTHER INFORMATION

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. Other than the risk factor set forth below, 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.

Our Purchase Agreement with OrbiMed could limit cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations.

Our obligations under the Purchase Agreement, entered into with OrbiMed in September 2022, could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things,:

•
requiring the dedication of a portion of our cash flow from operations to service the Purchase Agreement obligations, which will reduce the amount of cash available for other purposes, and if our cash inflows and capital resources are insufficient to allow us to make required payments, we may have to reduce or delay additional investments in our operations or seek additional capital;
•
increasing our vulnerability to adverse economic and industry conditions;
•
limiting our ability to obtain additional financing;
•
placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital; and
•
if we fail to comply with the terms of the Purchase Agreement, resulting in an event of default that is not cured or waived, the Purchasers could seek to enforce their security interest.

In addition, the Purchase Agreement contains customary affirmative and negative non-financial covenants and events of default, including covenants and restrictions that, among other things, grant a first-position security interest in our core assets and restrict our ability to incur liens, incur additional indebtedness, make loans and investments, make certain restricted payments or transfer core assets. Additionally, the Purchasers under the Purchase Agreement have an option (the "Put Option") to terminate the Purchase Agreement and to require us to repurchase future Revenue Interests at a price of 120% to 175% of Cumulative Purchaser Payments, less the sum of all Revenue Interest Payments made by us to the Purchasers prior to such date, upon enumerated events such as a bankruptcy event, a material judgment against us, a material divestiture or a change of control. The triggering of the Put Option, including by our failure to comply with these covenants, could permit the Purchasers to declare certain amounts to be immediately due and payable.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Not applicable.

Item 3. Defaults Upon Senior Securities

Not applicable.

40

Adaptive Biotechnologies Corporation

 

Item 4. Mine Safety Disclosures

Not applicable.

 

Item 5. Other Information

Not applicable.

Item 6. Exhibits

 

 

 

 

Incorporated by Reference

 

Exhibit

Number

 

Exhibit Title

Form

File No.

Exhibit

Filing Date

Filed/

Furnished with This Report

3.1

 

Amended and Restated Articles of Incorporation

8-K

001-38957

3.1

7/1/2019

 

3.2

 

Amended and Restated Bylaws

8-K

001-38957

3.2

7/1/2019

 

4.1

 

Seventh Amended and Restated Investors' Rights Agreement among the Registrant and certain of its shareholders, dated May 30, 2019

S-1

333-231838

4.1

5/30/2019

 

10.1

 

Revenue Interest Purchase Agreement, made and entered into as of September 12, 2022, by and among Adaptive Biotechnologies Corporation, the Purchasers from time to time party hereto, and OrbiMed Royalty & Credit Opportunities IV, LP

8-K

001-38957

10.1

9/12/2022

 

31.1

 

Certification of Principal Executive Officer pursuant to Rule 13a‑14(a) or Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

X

31.2

 

Certification of Principal Financial Officer pursuant to Rule 13a‑14(a) or Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

X

32.1

 

Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

X

32.2

 

Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

X

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

 

 

 

X

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

 

 

 

X

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

X

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

X

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

X

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

 

X

104

 

Cover Page Interactive Data File (formatted in Inline XBRL and included in Exhibit 101)

 

 

 

 

X

 

 

 

 

 

 

 

 

 

41

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.

 

 

Adaptive Biotechnologies Corporation

 

 

 

Date: November 3, 2022

 

By:

 

/s/ Chad Robins

 

 

 

 

Chad Robins

 

 

 

 

Chief Executive Officer and Director (Principal Executive Officer)

 

 

 

 

 

Date: November 3, 2022

 

By:

 

/s/ Tycho Peterson

 

 

 

 

Tycho Peterson

 

 

 

 

Chief Financial Officer (Principal Financial Officer)

 

42
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