Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Company has established disclosure controls and procedures designed to ensure that information required to be disclosed in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including the principal executive officer (our Chief Executive Officer) and principal financial officer (our Chief Financial Officer), to allow timely decisions regarding required disclosure.
Our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report on Form 10-K. Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives. Our disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2022.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the company’s principal executive and principal financial officers and effected by the company’s board of directors, management and other personnel, to provide reasonable
103
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
• Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;
• Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
• Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2022. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013 framework) (“COSO”). Based on its assessment, management believes that, as of December 31, 2022, our internal control over financial reporting is effective based on those criteria.
Deloitte & Touche LLP, our independent registered public accounting firm, has issued an attestation report on the effectiveness of our internal control over financial reporting, which is included below.
Changes in Internal Controls over Financial Reporting
No change in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
104
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the Board of Directors of Intellia Therapeutics, Inc.
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of Intellia Therapeutics, Inc. and subsidiary (the “Company”) as of December 31, 2022, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2022, of the Company and our report dated February 23, 2023, expressed an unqualified opinion on those financial statements.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
February 23, 2023
105
Item 9B. Other Information
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
106
PART III
Certain information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated by reference from our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders, pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, which we expect to file with the SEC no later than May 1, 2023.
Item 10. Directors, Executive Of ficers and Corporate Governance
Information regarding our directors, including the audit committee and audit committee financial experts, and executive officers and compliance with Section 16(a) of the Exchange Act will be included in our 2023 Proxy Statement and is incorporated herein by reference.
We have adopted a Code of Business Conduct and Ethics for all of our directors, officers and employees as required by Nasdaq governance rules and as defined by applicable SEC rules. Stockholders may locate a copy of our Code of Business Conduct and Ethics on our website at www.intelliatx.com or request a copy without charge from:
Intellia Therapeutics, Inc.
Attention: Investor Relations
40 Erie Street, Suite 130
Cambridge, MA 02139
We will post to our website any amendments to the Code of Business Conduct and Ethics, and any waivers that are required to be disclosed by the rules of either the SEC or Nasdaq.
Item 11. Executi ve Compensation
The information required by this item regarding executive compensation will be included in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Own ers and Management and Related Stockholder Matters
The information required by this item regarding security ownership of certain beneficial owners and management and securities authorized for issuance under equity compensation plans will be included in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item regarding certain relationships and related transactions and director independence will be included in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 14. Principal Accoun ting Fees and Services
Information about aggregate fees billed to us by our independent principal accountant, Deloitte & Touche LLP (PCAOB ID No. 34), located in Boston, Massachusetts, will be presented in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders under the caption “Audit Committee Matters — Principal Accounting Firm Fees” and is incorporated herein by reference.
107
PART IV
Item 15. Exhibits, Financ ial Statement Schedules
(a) The following documents are included in this Annual Report on Form 10-K:
1. The following Report and Consolidated Financial Statements of the Company are included in this Annual Report:
Report of Independent Registered Public Accounting Firm (PCAOB ID No.34)
Consolidated Balance Sheets
Consolidated Statements of Operations and Comprehensive Loss
Consolidated Statements of Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
2. All financial schedules have been omitted because the required information is either presented in the consolidated financial statements or the notes thereto or is not applicable or required.
3. The exhibits required by Item 601 of Regulation S-K and Item 15(b) of this Annual Report on Form 10-K are listed in the Exhibit Index immediately preceding the signature page of this Annual Report on Form 10-K. The exhibits listed in the Exhibit Index are incorporated by reference herein.
Item 16. Form 10-K Summary
The Company has elected not to include summary information.
108
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34 )
F- 2
Consolidated Balance Sheets
F- 4
Consolidated Statements of Operations and Comprehensive Loss
F- 5
Consolidated Statements of Stockholders’ Equity
F- 6
Consolidated Statements of Cash Flows
F- 7
Notes to Consolidated Financial Statements
F- 8
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the Board of Directors of Intellia Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Intellia Therapeutics, Inc. and subsidiary (the "Company") as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows, for each of the three years in the period ended December 31, 2022, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 23, 2023, expressed an unqualified opinion on the Company's internal control over financial reporting.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Rewrite Asset Acquisition - Contingent Consideration Liability – Refer to Notes 2, 4, and 11 to the financial statements
Critical Audit Matter Description
In February 2022, the Company completed the acquisition of Rewrite Therapeutics, Inc. (“Rewrite”) and the transaction was accounted for as an asset acquisition.
Pursuant to the terms of the agreement to acquire Rewrite (the “Rewrite Merger Agreement”), the Company may be required to make a payment to the previous stockholders and option holders of Rewrite in the form of the Company’s common stock based on the achievement of a research milestone. As this milestone is payable in the
F- 2
Company’s common stock, the contingent consideration qualifies as a liability under ASC 480, Distinguishing Liabilities from Equity . As of the acquisition date and as of December 31, 2022, the Company recorded an estimated liability for the acquisition-related contingent consideration at its fair value. The Company estimated the fair value using unobservable inputs by applying a probability-based valuation model.
The key assumptions management used in the valuation model are the probability and estimated timing of achieving the research milestone. These assumptions are not observable in the market and therefore represent Level 3 measurements within the fair value hierarchy.
Given that the fair value of the Rewrite contingent consideration liability is estimated based on unobservable inputs and is sensitive to changes in the probability and timing of milestone achievement, auditing the key assumptions required a high degree of auditor judgment and additional audit procedures, including the need to involve our fair value specialists.
How the Critical Audit Matter Was Addressed in the Audit
Our principal audit procedures related to the Rewrite contingent consideration liability included the following, among others:
• We read the Rewrite Merger Agreement and other documents related to the acquisition to understand the terms of the contingent consideration obligation and compared the contract terms to the valuation model to evaluate consistency.
• We tested the design, implementation, and effectiveness of controls over management’s review of the inputs and assumptions used in the valuation of the Rewrite contingent consideration liability, including the probability and timing of achievement of the research milestone.
• With the assistance of our fair value specialists, we evaluated the reasonableness of the valuation methodology.
• We also assessed the qualification, competence and objectivity of the external valuation professionals engaged by the Company.
• We inquired of management and the Company’s scientific personnel to understand the milestone and the underlying assumptions, including current progress of development and underlying data associated with development efforts and timing of the related milestone.
• We evaluated the reasonableness of management’s assumptions of the probability and timing of achievement of the research milestone by reviewing internal communications to management and the board of directors.
• We evaluated whether management’s assumptions used for the research milestone were consistent with evidence obtained in other areas of the audit.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
February 23, 2023
We have served as the Company's auditor since 2015.
F- 3
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED BA LANCE SHEETS
(Amounts in thousands except share and per share data)
December 31,
2022
December 31,
2021
ASSETS
Current Assets:
Cash and cash equivalents
$
523,506
$
123,406
Marketable securities
669,116
625,282
Accounts receivable ($ 0.3 million and $ 0.1 million from related party)
3,768
2,031
Prepaid expenses and other current assets
20,407
18,584
Total current assets
1,216,797
769,303
Marketable securities - noncurrent
69,338
337,361
Property and equipment, net
27,921
20,968
Operating lease right-of-use assets
133,076
79,143
Equity method investment
32,455
58,131
Investments and other assets
40,527
29,558
Total Assets
$
1,520,114
$
1,294,464
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$
5,154
$
9,653
Accrued expenses ($ 1.6 million and $ 0 million due to related party)
60,876
43,309
Current portion of operating lease liability
16,685
9,112
Current portion of deferred revenue ($ 19.9 million and $ 34.2 million from related party)
43,839
63,759
Total current liabilities
126,554
125,833
Deferred revenue, net of current portion ($ 0 million and $ 19.9 million from related party)
19,932
63,476
Long-term operating lease liability
114,018
64,911
Contingent consideration liability
24,026
-
Commitments and contingencies (Note 8)
Stockholders’ Equity:
Common stock, $ 0.0001 par value; 120,000,000 shares authorized;
87,103,007 and 74,485,883 shares issued and outstanding at
December 31, 2022 and 2021, respectively
9
7
Additional paid-in capital
2,420,223
1,745,870
Accumulated other comprehensive loss
( 7,461
)
( 2,632
)
Accumulated deficit
( 1,177,187
)
( 703,001
)
Total stockholders’ equity
1,235,584
1,040,244
Total Liabilities and Stockholders’ Equity
$
1,520,114
$
1,294,464
See notes to consolidated financial statements.
F- 4
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OP ERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands except per share data)
Year Ended December 31,
2022
2021
2020
Collaboration revenue (1)
$
52,121
$
33,053
$
57,994
Operating expenses:
Research and development
419,979
229,807
150,408
General and administrative
90,306
71,096
44,169
Total operating expenses
510,285
300,903
194,577
Operating loss
( 458,164
)
( 267,850
)
( 136,583
)
Other (expense) income, net:
Interest income
8,542
1,283
2,352
Loss from equity method investment
( 11,079
)
( 1,325
)
-
Change in fair value of contingent consideration
( 13,485
)
-
-
Total other (expense) income, net
( 16,022
)
( 42
)
2,352
Net loss
$
( 474,186
)
$
( 267,892
)
$
( 134,231
)
Net loss per share, basic and diluted
$
( 6.16
)
$
( 3.78
)
$
( 2.40
)
Weighted average shares outstanding, basic and diluted
76,972
70,894
55,987
Other comprehensive loss:
Unrealized loss on marketable securities
( 1,637
)
( 2,126
)
( 260
)
Other comprehensive loss from equity method investment
( 3,192
)
( 507
)
-
Comprehensive loss
$
( 479,015
)
$
( 270,525
)
$
( 134,491
)
(1) Including the following revenue from related party (see Notes 9 and 16):
$
21,134
$
6,072
$
-
See notes to consolidated financial statements.
F- 5
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Amounts in thousands, except share data)
Additional
Accumulated
Other
Total
Common
Paid-In
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income (Loss)
Deficit
Equity
Balance at December 31, 2019
50,198,044
$
5
$
570,493
$
261
$
( 300,878
)
$
269,881
Issuance of common stock through follow-on offerings,
net of issuance costs of $ 669
11,815,069
2
296,605
-
-
296,607
Issuance of common stock to Regeneron
925,218
-
12,580
-
-
12,580
Issuance of common stock through at-the-market offerings, net
of issuance costs of $ 151
2,270,161
-
49,461
-
-
49,461
Exercise of stock options
840,824
-
11,574
-
-
11,574
Vesting of restricted stock units
82,829
-
-
-
-
-
Issuance of shares under employee stock purchase plan
101,911
-
1,557
-
-
1,557
Equity-based compensation
-
-
19,903
-
-
19,903
Other comprehensive loss - unrealized loss on marketable securities
-
-
-
( 260
)
-
( 260
)
Net loss
-
-
-
-
( 134,231
)
( 134,231
)
Balance at December 31, 2020
66,234,056
7
962,173
1
( 435,109
)
527,072
Issuance of common stock through follow-on offerings,
net of issuance costs of $ 284
4,758,620
-
648,315
-
-
648,315
Issuance of common stock through at-the-market offerings, net
of issuance costs of $ 52
641,709
-
45,255
-
-
45,255
Exercise of stock options
2,700,886
-
41,094
-
-
41,094
Vesting of restricted stock units
119,715
-
-
-
-
-
Issuance of shares under employee stock purchase plan
30,897
-
2,024
-
-
2,024
Equity-based compensation
-
-
47,009
-
-
47,009
Other comprehensive loss - unrealized loss on marketable securities
-
-
-
( 2,126
)
-
( 2,126
)
Other comprehensive loss - equity method investment
-
-
-
( 507
)
-
( 507
)
Net loss
-
-
-
-
( 267,892
)
( 267,892
)
Balance at December 31, 2021
74,485,883
7
1,745,870
( 2,632
)
( 703,001
)
1,040,244
Issuance of common stock through follow-on offerings,
net of issuance costs of $ 253
7,532,751
1
337,891
-
-
337,892
Issuance of common stock through at-the-market offerings, net
of issuance costs of $ 164 - 2019 Sale Agreement
579,788
1
38,885
-
-
38,886
Issuance of common stock through at-the-market offerings, net
of issuance costs of $ 125 - 2022 Sale Agreement
3,395,339
-
189,011
-
-
189,011
Exercise of stock options
883,954
-
14,517
-
-
14,517
Vesting of restricted stock units
147,674
-
-
-
-
-
Issuance of shares under employee stock purchase plan
77,618
-
2,649
-
-
2,649
Equity-based compensation
-
-
91,400
-
-
91,400
Other comprehensive loss - unrealized loss on marketable securities
-
-
-
( 1,637
)
-
( 1,637
)
Other comprehensive loss - equity method investment
-
-
-
( 3,192
)
-
( 3,192
)
Net loss
-
-
-
-
( 474,186
)
( 474,186
)
Balance at December 31, 2022
87,103,007
$
9
$
2,420,223
$
( 7,461
)
$
( 1,177,187
)
$
1,235,584
F- 6
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Year Ended December 31,
2022
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 474,186
)
$
( 267,892
)
$
( 134,231
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
7,572
6,891
6,311
(Gain) loss on disposal of property and equipment
( 162
)
-
35
Equity-based compensation
91,400
47,009
19,903
Amortization of investment premiums
4,003
7,604
538
Loss from equity method investment
11,079
1,325
-
Deferral of equity method investment intra-entity profit on sales
11,405
2,937
-
Change in fair value of contingent consideration
13,485
-
-
In-process research and development charge
55,990
-
-
Changes in operating assets and liabilities:
Accounts receivable
( 1,737
)
99
2,490
Prepaid expenses and other current assets
( 2,160
)
( 9,798
)
( 9,206
)
Operating lease right-of-use assets
13,121
9,349
6,457
Other assets
( 1,091
)
117
83
Accounts payable
( 4,584
)
529
5,060
Accrued expenses
15,924
17,260
13,031
Deferred revenue
( 63,464
)
( 31,355
)
45,121
Operating lease liabilities
( 9,882
)
( 9,105
)
( 5,504
)
Net cash used in operating activities
( 333,287
)
( 225,030
)
( 49,912
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment
( 13,558
)
( 12,756
)
( 3,585
)
Purchases of marketable securities
( 429,032
)
( 1,020,620
)
( 473,702
)
Maturities of marketable securities
647,581
485,598
262,800
Proceeds from sale of property and equipment
150
-
-
Acquired in-process research and development, net of cash acquired of $ 287
( 44,832
)
-
-
Investment in Kyverna Therapeutics, Inc.
-
( 3,000
)
-
Net cash provided by (used in) investing activities
160,309
( 550,778
)
( 214,487
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock through follow-on
offerings, net of issuance costs
337,892
648,315
296,607
Proceeds from issuance of common stock through at-the-market
offerings, net of issuance costs
227,897
45,255
49,461
Proceeds from issuance of common stock to Regeneron Pharmaceuticals, Inc.
-
-
12,580
Proceeds from options exercised
14,517
41,094
11,574
Issuance of shares through employee stock purchase plan
2,649
2,024
1,557
Net cash provided by financing activities
582,955
736,688
371,779
Net increase (decrease) in cash and cash equivalents and restricted cash
equivalents
409,977
( 39,120
)
107,380
Cash and cash equivalents and restricted cash equivalents, beginning of period
125,486
164,606
57,226
Cash and cash equivalents and restricted cash equivalents, end of period
$
535,463
$
125,486
$
164,606
Reconciliation of cash and cash equivalents and restricted cash equivalents to consolidated balance sheet:
Cash and cash equivalents
$
523,506
$
123,406
$
160,020
Restricted cash equivalents, included in investments and other assets
11,957
2,080
4,586
Total cash and cash equivalents and restricted cash equivalents
$
535,463
$
125,486
$
164,606
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Purchases of property and equipment unpaid at period end
$
1,623
$
667
$
1,508
Right-of-use assets acquired under operating leases
67,053
49,378
26,432
Contingent consideration liability assumed in asset acquisition
10,541
-
-
Non-cash trade-in of property and equipment
200
-
-
Non-cash contribution of intellectual property to AvenCell Therapeutics, Inc.
-
62,900
-
Non-cash contribution of intellectual property to SparingVision SAS
-
14,759
-
Non-cash contribution of intellectual property to Kyverna Therapeutics, Inc.
-
7,000
-
See notes to consolidated financial statements.
F- 7
INTELLIA THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. The Company
Intellia Therapeutics, Inc. (“Intellia” or the “Company”) is a leading clinical-stage genome editing company focused on developing potentially curative therapies using CRISPR/Cas9-based technologies. CRISPR/Cas9, an acronym for C lustered, R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”)/ C RISPR a ssociated 9 (“Cas9”), is a technology for genome editing, the process of altering selected sequences of genomic deoxyribonucleic acid (“DNA”). To fully realize the transformative potential of CRISPR/Cas9-based technologies, Intellia is building a full-spectrum genome editing company, by leveraging its modular platform, to advance in vivo and ex vivo therapies for diseases with high unmet need by pursuing two primary approaches. For in vivo applications to address genetic diseases, the Company deploys CRISPR/Cas9 as the therapy that targets cells within the body. In parallel, the Company is developing ex vivo applications to address immuno-oncology and autoimmune diseases, where we use CRISPR/Cas9 as the tool to create the engineered cell therapy. The Company's deep scientific, technical and clinical development experience, along with its robust intellectual property (“IP”) portfolio, have enabled it to unlock broad therapeutic applications of CRISPR/Cas9 and related technologies to create new classes of genetic medicine.
The Company was founded and commenced active operations in mid-2014. The Company will require substantial additional capital to fund its research and development. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of more advanced or effective therapies, dependence on key executives, protection of and dependence on proprietary technology, compliance with government regulations and ability to secure additional capital to fund operations. Programs currently in development or moving into development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Liquidity
Since its inception through December 31, 2022, the Company has raised an aggregate of $ 2,395.2 million to fund its operations through its initial public offering (“IPO”) and concurrent private placements, follow-on public offerings, at-the-market offerings and the sale of convertible preferred stock, as well as through its collaboration agreements. The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2022 will enable the Company to fund its ongoing operating expenses and capital expenditure requirements for at least the twelve-month period following the issuance of these consolidated financial statements.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements include the accounts of Intellia Therapeutics, Inc. and its wholly owned, controlled subsidiary, Intellia Securities Corp. All intercompany balances and transactions have been eliminated in consolidation. Comprehensive loss is comprised of net loss and gain/loss on marketable securities and equity method investments.
On February 2, 2022, the Company entered into an agreement to acquire Rewrite Therapeutics, Inc., a Delaware corporation (“Rewrite”). On the effective date of the agreement, Rewrite became a wholly-owned subsidiary of the Company. In September 2022, Rewrite merged into Intellia, with Intellia the surviving entity.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant estimates in these consolidated financial statements have been made in connection with the calculation of revenues, research and development expenses, valuation of equity and fair value method investments, contingent consideration and equity-based compensation expense. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances at the time such estimates are made. Actual results could differ from those estimates. The Company periodically reviews its estimates in light of changes in circumstances, facts and experience. The extent of the impact of the coronavirus disease 19 (“COVID-19”) pandemic on the Company’s operational and financial performance will depend on certain developments, including the length and severity of this pandemic, as well as its effect on the Company's employees, collaborators and vendors, all of which are uncertain and cannot be predicted. The Company cannot reasonably estimate the extent to which the disruption may materially impact its consolidated results of operations or financial position.
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The effects of material revisions in estimates are reflected in the consolidated financial statements prospectively from the date of the change in estimate.
Fair Value Measurements
The Company’s financial instruments include cash equivalents, marketable securities, accounts receivable, non-marketable securities, accounts payable, accrued expenses and a contingent consideration liability. Certain of the Company’s financial assets, including cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services or other observable market data. The pricing services utilize industry standard valuation models and observable market inputs to determine value.
Refer to Note 4 for further information regarding the Company’s fair value measurements.
Other financial instruments, including accounts receivable, accounts payable and accrued expenses, are carried at cost, which approximate fair value due to the short duration and term to maturity.
Cash Equivalents
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. As of December 31, 2022, cash equivalents consisted of interest-bearing money market accounts and reverse repurchase agreements. As of December 31, 2021, cash equivalents consisted of interest-bearing money market accounts.
Restricted Cash Equivalents
The Company has restricted cash equivalents made up of money market funds held in collateral accounts that are restricted to secure letters of credit in accordance with certain of its leases. As of December 31, 2022, these restricted cash equivalents amounted to $ 12.0 million. As of December 31, 2021, these restricted cash equivalents amounted to $ 2.1 million. The letters of credit are required to be maintained throughout the term of the leases; in some cases, the Company is able to reduce the amounts held over time. These restricted cash equivalents are long-term in nature and are included in “Investments and other assets” in the Company’s consolidated balance sheets.
Marketable Securities
The Company’s marketable securities are accounted for as available-for-sale and recorded at fair value with the related unrealized gains and losses included in accumulated other comprehensive (loss)/income, a component of stockholders’ equity.
The Company reviews its investment portfolio to identify and evaluate investments that have an indication of possible other-than-temporary impairment. Factors considered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than the cost basis, the financial condition and near-term prospects of the investee, and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value.
Refer to Note 3 for further information regarding the Company’s marketable securities.
Asset Acquisitions
At the time of acquisition, the Company determines if a transaction should be accounted for as a business combination or acquisition of assets. The Company measures and recognizes asset acquisitions that are not deemed to be business combinations based on the cost to acquire the assets, which includes transaction costs, and the consideration is allocated to the items acquired based on a relative fair value methodology. Goodwill is not recognized in asset acquisitions. In an asset acquisition, the cost allocated to acquire in-process research and development with no alternative future use is charged to research and development expense at the acquisition date.
Non-Marketable Equity Securities
The Company also invests in equity securities of companies whose securities are not publicly traded and where fair value is not readily available. These investments are accounted for using the measurement alternative at cost minus impairment adjusted for changes in observable prices. The Company monitors these investments to evaluate whether any increase or decline in their value has occurred, based on the implied value of recent company financings and general market conditions, or if the investment has a readily determinable fair value. These investments are included in “Investments and other assets” in the Company’s consolidated balance sheets. Refer to Note 10 for further information regarding the Company’s investments in non-marketable equity securities.
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Concentrations of Credit Risk
The Company’s cash, cash equivalents and marketable securities may potentially be subject to concentrations of credit risk. The Company generally maintains balances in various accounts in excess of federally insured limits with financial institutions that management believes to be of high credit quality.
Accounts receivable represents amounts due from collaboration partners and joint ventures. The Company monitors economic conditions to identify facts or circumstances that may indicate that any of its accounts receivable are at risk of collection. As of December 31, 2022, the Company’s accounts receivable were related to its collaborations with Regeneron Pharmaceuticals, Inc. (“Regeneron”), AvenCell Therapeutics, Inc. (“AvenCell”), SparingVision SAS (“SparingVision”) and ONK Therapeutics, Ltd. (“ONK”). As of December 31, 2021, the Company’s accounts receivable were related to its collaborations with Regeneron and AvenCell.
Property and Equipment
The Company records property and equipment at cost and recognizes depreciation and amortization using the straight-line method over the following estimated useful lives of the respective assets:
Asset Category
Useful Life
Laboratory equipment
5 years
Office furniture and equipment
5 years
Computer software
3 years
Computer equipment
3 years
Leasehold improvements
5 years or term of respective lease, if shorter
Expenditures for repairs and maintenance of assets are expensed as incurred. Upon retirement or sale, the cost of assets disposed and the corresponding accumulated depreciation are removed from the related accounts and any resulting gain or loss is reflected in the results of operations.
Impairment of Long-Lived Assets
The Company tests long-lived assets to be held and used, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of assets or asset groups may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets.
Evaluation of recoverability of the asset or asset group is based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the assets are written down to their estimated fair values. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. To date, the Company has not recorded any material impairment losses on long-lived assets.
Contingent Consideration
The Company accounts for contingent consideration identified in an asset acquisition, that is payable in cash and does not meet the definition of a derivative under Accounting Standard Codification (“ASC”) 815, Derivatives and Hedging , when the contingency is resolved and the consideration is paid or becomes payable.
The Company accounts for contingent consideration identified in an asset acquisition that is settled in shares of common stock under ASC 480, Distinguishing Liabilities from Equity (“ASC 480”). The contingent consideration liability will be recorded at fair value at the end of each reporting period with changes in estimated fair values recorded in other (expense) income in the consolidated statements of operations and comprehensive loss.
The estimated fair value of the contingent consideration liability related to the acquisition of Rewrite (see Notes 4 and 11) is determined based on a probability adjusted discounted cash flow model that includes significant estimates and assumptions pertaining to research and development. Significant changes in any of the probabilities of success or in the probabilities as to the periods in which the milestone would be achieved would result in a significantly higher or lower fair value measurement. The Company will continue to adjust the liability for changes in fair value until the obligation is settled or the research is abandoned.
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Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences attributable to differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax reporting purposes and for operating loss and tax credit carryforwards. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes.
The Company’s deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which these temporary differences are expected to be recovered or settled. A valuation allowance is recorded to reduce deferred tax assets if it is determined that it is more likely than not that all or a portion of the deferred tax asset will not be realized. The Company considers many factors when assessing the likelihood of future realization of deferred tax assets, including recent earnings results, expectations of future taxable income, carryforward periods available and other relevant factors. The Company records changes in the required valuation allowance in the period that the determination is made.
The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available as of the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50 % likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, the Company does not recognize a tax benefit in the financial statements. The Company records interest and penalties related to uncertain tax positions, if applicable, as a component of income tax expense.
Revenue Recognition
The Company recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) and its related amendments (collectively known as “ASC 606”).
At inception, the Company determines whether contracts are within the scope of ASC 606 or other topics. For contracts that are determined to be within the scope of ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these goods and services. To achieve this core principle, the Company applies the following five steps: (i) identify the contract with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when the Company determines that collection of substantially all consideration for goods and services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration.
Performance obligations promised in a contract are identified based on the goods and services that will be transferred to the customer that are both capable of being distinct and are distinct in the context of the contract. To the extent a contract includes multiple promised goods and services, the Company applies judgment to determine whether promised goods and services are both capable of being distinct and distinct in the context of the contract. If these criteria are not met, the promised goods and services are accounted for as a combined performance obligation.
The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method, depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes. Determining the transaction price requires significant judgment, which is discussed in further detail for each of the Company’s collaboration agreements in Note 9. In addition, none of the Company’s contracts as of December 31, 2022 or 2021 contained a significant financing component.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation on a relative standalone selling price basis unless the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct service that forms part of a single performance obligation. The consideration to be received is allocated among the separate performance obligations based on relative standalone selling prices. The Company typically determines standalone selling prices using an adjusted market assessment approach model.
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The Company satisfies performance obligations either over time or at a point in time. Revenue is recognized over time if either (i) the customer simultaneously receives and consumes the benefits provided by the entity’s performance, (ii) the entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced, or (iii) the entity’s performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for performance completed to date. If the entity does not satisfy a performance obligation over time, the related performance obligation is satisfied at a point in time by transferring the control of a promised good or service to a customer. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
As of December 31, 2022, the Company’s only revenue recognized is related to collaboration agreements with third parties which are either within the scope of ASC 606, under which the Company licenses certain rights to its product candidates to third parties, or within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) if it involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards with respect to the arrangement. For the collaboration arrangements under the scope of ASC 606, as discussed in further detail in Note 9, the terms of these arrangements typically include payment to the Company of one or more of the following: nonrefundable, upfront fees; development, regulatory, and commercial milestone payments; research and development funding payments; and royalties on the net sales of licensed products. Additionally, the terms of certain arrangements may include an equity interest in the other company. Each of these payments results in collaboration revenues, except for revenues from royalties on the net sales of licensed products, which are classified as royalty revenues. For arrangements within the scope of ASC 808, the terms of these arrangements typically include payments received or made under the cost sharing provisions which are recognized as a component of revenues in the consolidated statements of operations and comprehensive loss.
Licenses of intellectual property: If the license to the Company’s IP is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from consideration allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the licenses. For licenses that are combined with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue.
Milestone payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates the probability of reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management is unable to assert that a reversal of revenue would not be probable. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on levels of sales, if the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its collaboration agreements.
The Company receives payments from its customers based on billing schedules or upon the achievement of milestones established in each contract. The Company’s contract liabilities consist of deferred revenue. Upfront payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company satisfies its obligations under these arrangements.
The Company also considers the nature and contractual terms of an arrangement and assesses whether the arrangement involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards with respect to the arrangement. If the Company is an active participant and is exposed to the significant risks and rewards with respect to the arrangement, the Company accounts for the arrangement under ASC 808 . Based on this consideration, the Company accounts for its co-development and co-promotion (“Co/Co”) agreements with Regeneron and AvenCell under ASC 808. Because ASC 808 does not
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provide recognition and measurement guidance for collaborative arrangements, the Company has analogized to ASC 606. Refer to Note 9 for additional information regarding the Company’s collaboration agreements.
Research and Development Expenses
Research and development costs are expensed as incurred. Research and development costs consist of expenses incurred in performing research and development activities, such as salaries, equity-based compensation and benefits of employees, allocated facility-related expenses, overhead expenses, license, sublicense and milestone fees, contract research, clinical trial costs, development and manufacturing services, and other related costs.
The Company records payments made for research and development services prior to the services being rendered as prepaid expenses on the consolidated balance sheet and expenses them as the services are provided. Contracts for multi-year research and development services are recorded on a straight-line basis over each annual contractual period based on the total contractual fee when the services rendered are expected to be substantially equivalent over the term of the arrangement. The cost of obtaining licenses for certain technology or IP is recorded to research and development expense when incurred if the licensed technology or IP has not yet reached technological feasibility and has no alternative future use.
Equity-Based Compensation
The Company measures employee equity-based compensation based on the grant date fair value of the equity awards using the Black-Scholes option pricing model. Equity-based compensation expense is recognized on a straight-line basis over the requisite service period of the awards and is adjusted for pre-vesting forfeitures in the period in which the forfeitures occur. For equity awards that have a performance condition, the Company recognizes stock-based compensation expense using the accelerated attribution method, based on its assessment of the probability that the performance condition will be achieved.
The Company classifies equity-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified.
(Loss) Earnings per Share
The Company calculates basic (loss) earnings per share by dividing net (loss) income for each respective period by the weighted average number of common shares outstanding for each respective period. The Company computes diluted (loss) earnings per share after giving consideration to the dilutive effect of stock options and unvested restricted stock that are outstanding during the period, except where such securities would be anti-dilutive.
Segment Information
The Company's chief executive officer, its chief operating decision maker, manages the Company's operations as a single segment for the purpose of assessing performance and making operating decisions. The Company’s one business segment is the development of genome editing-based therapies. All of the Company’s assets are held in the U.S. and all of the Company’s revenue has been generated in the U.S.
Variable Interest Entity
The Company evaluates at the inception of each arrangement, and whenever a reconsideration event occurs, whether an entity in which the Company holds an investment or in which the Company has other variable interests is considered a variable interest entity (“VIE”) in accordance with FASB ASC Topic 810, Consolidation (“ASC 810”). If the entity meets the criteria to qualify as a VIE, the Company assesses whether or not the Company is the primary beneficiary of that VIE based on a number of factors, including (i) which party has the power to direct the activities that most significantly affect the VIE’s economic performance, (ii) the parties’ contractual rights and responsibilities pursuant to any contractual agreements and (iii) which party has the obligation to absorb losses or the right to receive benefits from the VIE. If the Company is deemed the primary beneficiary of a VIE, the Company consolidates such entity and reflects the non-controlling interest of other beneficiaries of that entity. If the Company is not the primary beneficiary, no consolidation is necessary, and the Company accounts for the investment or other variable interest in accordance with applicable U.S. GAAP.
Equity Method of Accounting
In circumstances where the Company has the ability to exercise significant influence, but not control, over the operating and financial policies of an entity in which the Company has a common stock or in-substance common stock investment, the Company utilizes the equity method of accounting for recording related investment activity. In assessing whether the Company exercises significant influence, the Company considers the nature and magnitude of the investment, the voting and protective rights the Company holds, any
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participation in the governance of the other entity and other relevant factors such as the presence of a collaborative or other business relationship.
Under the equity method of accounting, the Company’s investments are initially recorded at cost on the consolidated balance sheets. Upon recording an equity method investment, the Company evaluates whether there are basis differences between the carrying value and fair value of the Company’s proportionate share of the investee’s underlying net assets. Typically, the Company amortizes basis differences identified on a straight-line basis over the underlying assets’ estimated useful lives when calculating the attributable earnings or losses, excluding the basis differences attributable to in-process research and development (“IPR&D”) that has no alternative future use. If the Company is unable to attribute all of the basis difference to specific assets or liabilities of the investee, the residual excess of the cost of the investment over the proportional fair value of the investee’s assets and liabilities is considered to be Equity Method Goodwill and is recognized within the equity investment balance, which is tracked separately within the Company’s memo accounts. The Company subsequently records in the consolidated statements of operations and comprehensive loss its share of income or loss of the other entity within other income/expense. If the share of losses exceeds the carrying value of the Company’s investment, the Company will suspend recognizing additional losses and will continue to do so unless it commits to providing additional funding; however, if there are intra-entity profits this can cause the investment balance to go negative.
The Company evaluates its equity method investments for impairment whenever events or changes in circumstance indicate that the carrying amounts of such investments may be impaired and considers qualitative and quantitative factors including the investee's financial metrics, product and commercial outlook and cash usage. If a decline in the value of an equity method investment is determined to be other than temporary, a loss is recorded in earnings in the current period and the investment is written down to fair value.
At December 31, 2022 and 2021, the Company accounted for its investment in AvenCell under the equity method of accounting and no impairment charges were recognized during the years ended December 31, 2022 or 2021. Refer to Note 10 for further details.
Recent Accounting Pronouncements
There were no accounting pronouncements adopted by the Company in 2022 other than as noted above.
3. Marketable Securities
The following table summarizes the Company’s available-for-sale marketable securities as of December 31, 2022 and 2021 at net book value:
December 31, 2022
Amortized
Cost
Gross Unrealized
Gains
Gross Unrealized
Losses
Estimated Fair
Value
(In thousands)
Marketable securities:
U.S. Treasury and other government securities
$
244,562
$
62
$
( 1,938
)
$
242,686
Financial institution debt securities
380,891
-
( 1,030
)
379,861
Corporate debt securities
102,059
-
( 509
)
101,550
Other asset-backed securities
14,703
-
( 346
)
14,357
Total
$
742,215
$
62
$
( 3,823
)
$
738,454
December 31, 2021
Amortized
Cost
Gross Unrealized
Gains
Gross Unrealized
Losses
Estimated Fair
Value
(In thousands)
Marketable securities:
U.S. Treasury and other government securities
$
301,493
$
-
$
( 1,016
)
$
300,477
Financial institution debt securities
441,068
-
( 652
)
440,416
Corporate debt securities
62,500
-
( 151
)
62,349
Other asset-backed securities
159,707
-
( 306
)
159,401
Total
$
964,768
$
-
$
( 2,125
)
$
962,643
The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. At December 31, 2022 and 2021, the balance in the Company’s accumulated other comprehensive (loss)/income was composed of activity related to the Company’s available-for-sale marketable securities and equity method investment. There were no material realized gains or losses in the years ended December 31, 2022, 2021 or 2020. The Company did not reclassify any amounts out of accumulated other comprehensive income (loss) during these periods. T he Company generally does not intend to sell any investments prior to recovery of their amortized cost basis for any investment in an unrealized loss position. As such, the Company has classified these losses as temporary in nature.
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The Company's available-for-sale securities that are classified as short-term marketable securities in the consolidated balance sheet mature within one year or less as of the balance sheet date. Available-for-sale securities that are classified as noncurrent in the consolidated balance sheet are those that mature after one year but within five years from the balance sheet date and that the Company does not intend to dispose of within the next twelve months. At December 31, 2022 and 2021, the Company did no t hold any investments that matured beyond five years of the balance sheet date.
4. Fair Value Measurements
The Company classifies fair value-based measurements using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1, quoted market prices in active markets for identical assets or liabilities; Level 2, observable inputs other than quoted market prices included in Level 1, such as quoted market prices for markets that are not active or other inputs that are observable or can be corroborated by observable market data; and Level 3, unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
As of December 31, 2022 and 2021, the Company’s financial assets recognized at fair value on a recurring basis consisted of the following:
Fair Value as of December 31, 2022
Total
Level 1
Level 2
Level 3
(In thousands)
Cash equivalents and restricted cash equivalents
$
534,581
$
534,581
$
-
$
-
Marketable securities:
U.S. Treasury and other government securities
242,686
172,939
69,747
-
Financial institution debt securities
379,861
-
379,861
-
Corporate debt securities
101,550
-
101,550
-
Other asset-backed securities
14,357
-
14,357
-
Total marketable securities
738,454
172,939
565,515
-
Total
$
1,273,035
$
707,520
$
565,515
$
-
Fair Value as of December 31, 2021
Total
Level 1
Level 2
Level 3
(In thousands)
Cash equivalents and restricted cash equivalents
$
124,636
$
124,636
$
-
$
-
Marketable securities:
U.S. Treasury and other government securities
300,477
280,085
20,392
-
Financial institution debt securities
440,416
-
440,416
-
Corporate debt securities
62,349
-
62,349
-
Other asset-backed securities
159,401
-
159,401
-
Total marketable securities
962,643
280,085
682,558
-
Total
$
1,087,279
$
404,721
$
682,558
$
-
Certain of the Company’s financial assets, including cash equivalents, restricted cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services or other observable market data. The pricing services utilize industry standard valuation models and observable market inputs to determine value. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by the pricing services as of December 31, 2022 or 2021.
Other financial instruments, including accounts receivable, accounts payable and accrued expense, are carried at cost, which approximates fair value due to the short duration and term to maturity.
The Company's investment in AvenCell was initially recorded at fair value, determined according to Level 3 inputs in the fair value hierarchy described above. Refer to Note 10 for further details.
The Company's investment in SparingVision was initially recorded at fair value, determined according to Level 3 inputs in the fair value hierarchy described above. The Company's investment in Kyverna Therapeutics, Inc. (“Kyverna”) was initially recorded at cost, which is representative of fair value. Refer to Note 10 for further details. The SparingVision and Kyverna investments (the “investments”) are included in “Investments and other assets” on the consolidated balance sheets. These investments are accounted for using the measurement alternative at cost minus impairment adjusted for changes in observable prices. There were no changes in observable prices of these investments as of December 31, 2022 or 2021.
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As discussed further in Note 11, under the Rewrite Merger Agreement, the Rewrite Holders are eligible to receive a $ 25.0 million research milestone payment, payable in a combination of cash and the Company’s common stock valued using the volume-weighted average price of the Company’s stock over the ten-day trading period ending two trading days prior to the date on which the applicable milestone is achieved. The milestone payable in the Company’s common stock results in liability classification under ASC 480. This contingent consideration liability is carried at fair value which was estimated by applying a probability-based model, which utilized inputs based on timing of achievement that were unobservable in the market. The contingent consideration liability is classified within Level 3 of the fair value hierarchy.
The following table reconciles the change in fair value of the contingent consideration liability based on the level 3 inputs listed below (in thousands):
For the year ended December 31, 2022
Balance at February 2, 2022 (at inception)
$
10,541
Change in fair value
13,485
Balance at December 31, 2022
$
24,026
As of inception (February 2, 2022)
As of December 31, 2022
Discount rate
7 %
10.1 %
Probability of achievement
50 %
100 %
Projected year of achievement
2024
2023
5. Property and Equipment, Net
Property and equipment, net consisted of the following:
December 31,
2022
2021
(In thousands)
Laboratory equipment
$
51,911
$
39,840
Office furniture and equipment
2,633
2,186
Computer equipment
1,785
1,318
Leasehold improvements
3,066
2,188
Computer software
1,725
1,550
Total property and equipment
61,120
47,082
Less: accumulated depreciation and amortization
( 33,199
)
( 26,114
)
Property and equipment, net
$
27,921
$
20,968
Depreciation and amortization expense was $ 7.6 million, $ 6.9 million and $ 6.3 million for the years ended December 31, 2022, 2021 and 2020, respectively.
6. Accrued Expenses
Accrued expenses consisted of the following:
December 31,
2022
2021
(In thousands)
Accrued research and development
$
32,684
$
16,979
Employee compensation and benefits
21,778
20,359
Accrued legal and professional expenses
1,457
3,100
Accrued other
4,957
2,871
Total accrued expenses
$
60,876
$
43,309
7. Income Taxes
The Company did not record net income tax benefits for the operating losses incurred during the periods presented due to the uncertainty of realizing a tax benefit from those losses. Accordingly, any benefit recorded related to these deferred tax assets was offset by a valuation allowance reflecting management’s conclusion that realization of those assets was not more likely than not.
F- 16
A reconciliation of the federal statutory income tax rate and the Company’s effective income tax rate is as follows:
Year Ended December 31,
2022
2021
2020
Federal statutory income tax rate
( 21.0
)%
( 21.0
)%
( 21.0
)%
State income taxes
( 8.3
)
( 16.6
)
( 7.4
)
Research and development tax credits
( 5.3
)
( 8.7
)
( 1.8
)
Stock-based compensation
( 0.1
)
( 16.8
)
( 1.3
)
162m
0.1
0.2
-
In-process research and development
2.5
-
-
Change in valuation allowance
32.1
62.9
31.5
Effective income tax rate
—
%
—
%
—
%
The Company’s net deferred tax assets (liabilities) consisted of the following:
December 31,
2022
2021
(in thousands)
Deferred tax assets:
Intangibles, including acquired in-process
research and development
$
79,803
$
1,010
Capitalized start-up costs
296
334
Net operating loss carryforwards
229,375
216,629
Research and development credit carryforwards
101,326
61,698
Operating lease liability
35,386
20,055
Deferred revenue
13,189
13,922
Equity-based compensation
22,512
7,774
Accruals and allowances
4,968
3,718
Prepaid rent
1,367
1,393
Equity investment adjustments
3,358
359
Gross deferred tax assets
491,580
326,892
Deferred tax asset valuation allowance
( 454,793
)
( 304,781
)
Total deferred tax assets
36,787
22,111
Deferred tax liabilities:
Fixed assets
( 759
)
( 669
)
Operating lease right-of-use assets
( 36,028
)
( 21,442
)
Total deferred tax liabilities
( 36,787
)
( 22,111
)
Net deferred tax asset (liability)
$
-
$
-
As of December 31, 2022 and 2021, the Company had federal net operating loss carryforwards of $ 852.1 million and $ 800.5 million, respectively, which may be available to offset future income tax liabilities.
Approximately $ 36.9 million of the federal net operating losses generated prior to 2018 will begin to expire in 2034 , unless previously utilized. Losses incurred prior to 2018 will generally be deductible to the extent of the lesser of a corporation’s net operating loss carryover or 100 % of a corporation’s taxable income and be available for twenty years from the period the loss was generated. The federal net operating losses generated after 2017 of approximately $ 815.2 million will be carried over indefinitely, but will generally limit the net operating loss deduction to the lesser of the net operating loss carryforward or 80 % of a corporation’s taxable income (subject to Section 382 of the Internal Revenue Code of 1986, as amended). Also, there will be no carryback for losses incurred after 2017.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, (the “CARES Act”) was enacted in the U.S. The CARES Act temporarily removes the 80 % limit for taxable years beginning before 2021 to allow a net operating loss carryforward to fully offset an organization’s income. The CARES Act allows a five-year carryback of any net operating loss generated in a taxable year beginning after December 31, 2017, and before January 1, 2021. The impact of the CARES Act was not material to the Company.
As of December 31, 2022 and 2021, the Company also had state net operating loss carryforwards of $797. 8 million and $ 767.8 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2034 .
F- 17
As of December 31, 2022 and 2021, the Company had federal tax credit carryforwards of approximately $ 63.4 million and $ 37.9 million, respectively, which begin to expire in 2034 . As of December 31, 2022 and 2021, the Company had state research and development and other credit carryforwards of approximately $ 48.0 million and $ 30.2 million, which begin to expire in 2029 .
The Company evaluated the expected realizability of its net deferred tax assets and determined that there was significant negative evidence due to its net operating loss position and insufficient positive evidence to support the realizability of these net deferred tax assets. The Company concluded it is more likely than not that its net deferred tax assets would not be realized in the future; therefore, the Company has provided a full valuation allowance against its net deferred tax asset balance as of December 31, 2022 and 2021. The valuation allowance increased by $ 150.0 million in 2022, $ 163.9 million in 2021, and $ 42.4 million in 2020.
Ownership changes may limit the amount of net operating loss carryforwards or research and development tax credit carryforwards that can be utilized to offset future taxable income or tax liability. In general, an ownership change, as defined by Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. If the Company has experienced a change of control, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382 and 383 of the Code. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. During 2022, the Company completed an assessment of the available net operating loss carryforwards and other tax attributes under Section 382. The analysis is not expected to result in a material limitation to the Company’s tax attributes and the results of this analysis are reflected herein.
As of December 31, 2022 , the Company had no t identified any unrecognized tax benefits. The Company files income tax returns in the U.S. federal tax jurisdiction and Massachusetts and various other state tax jurisdictions. The Company is subject to examination by the Internal Revenue Service, Massachusetts taxing authorities and state taxing authorities for tax year 2018 through present. The returns in these jurisdictions since inception remain open for examination; however, there are currently no pending tax examinations. The Company will recognize interest and/or penalties related to uncertain tax benefits in income tax expense if they arise.
8. Commitments and Contingencies
Litigation
During the year ended December 31, 2022, there have been no material changes to any outstanding litigation, nor is the Company a party to any new litigation.
License Agreements
The Company is party to license agreements, which include contingent payments. These payments will become payable if and when certain development, regulatory and commercial milestones are achieved. As of December 31, 2022, the satisfaction and timing of the contingent payments is uncertain and not reasonably estimable.
9. Collaborations and Other Arrangements
To accelerate the development and commercialization of CRISPR-based products in multiple therapeutic areas, the Company has formed, and intends to seek other opportunities to form, strategic alliances with collaborators who can augment its leadership in CRISPR therapeutic development. As of December 31, 2022, the Company’s accounts receivable were related to its collaborations with Regeneron, AvenCell, SparingVision and ONK and the Company's contract liabilities were related to its collaborations with Regeneron, AvenCell, SparingVision and Kyverna. As of December 31, 2021, the Company’s accounts receivable were related to its collaborations with Regeneron and AvenCell and the Company's contract liabilities were related to its collaborations with Regeneron, AvenCell, SparingVision and Kyverna.
F- 18
The following table presents changes in the Company’s accounts receivable and contract liabilities during the years ended December 31, 2022 and 2021 (in thousands):
Balance at
Beginning of
Period
Additions
Deductions
Balance at End
of Period
Year Ended December 31, 2022
Accounts receivable
$
2,031
$
12,453
$
( 10,716
)
$
3,768
Contract liabilities - deferred revenue
$
127,235
$
-
$
( 63,464
)
$
63,771
Balance at
Beginning of
Period
Additions
Deductions
Balance at End
of Period
Year Ended December 31, 2021
Accounts receivable
$
2,130
$
7,559
$
( 7,658
)
$
2,031
Contract liabilities - deferred revenue
$
73,931
$
84,659
$
( 31,355
)
$
127,235
During the years ended December 31, 2022, 2021 and 2020, the Company recognized the following revenues as a result of changes in the contract liability balance (in thousands):
Revenue recognized in the period from:
Year Ended
December 31, 2022
Year Ended
December 31, 2021
Year Ended
December 31, 2020
Amounts included in the contract liability at the beginning of the period
$
52,060
$
22,544
$
11,571
Costs to obtain and fulfill a contract
The Company did not incur any expenses to obtain collaboration agreements and costs to fulfill those contracts do not generate or enhance resources of the Company. As such, no costs to obtain or fulfill a contract have been capitalized in any period.
Regeneron Pharmaceuticals, Inc.
In April 2016, the Company entered into a license and collaboration agreement with Regeneron (the “2016 Regeneron Agreement”). The 2016 Regeneron Agreement has two principal components: i) a product development component under which the parties will research, develop and commercialize CRISPR/Cas-based therapeutic products primarily focused on genome editing in the liver, and ii) a technology collaboration component, pursuant to which the Company and Regeneron will engage in research-related activities aimed at discovering and developing novel technologies and improvements to CRISPR/Cas technology to enhance the Company’s genome editing platform. Under this agreement, the Company also may access the Regeneron Genetics Center and proprietary mouse models to be provided by Regeneron for a limited number of the Company’s liver programs. At the inception of the 2016 Regeneron Agreement, Regeneron selected the first of its 10 targets, transthyretin (“ATTR”) amyloidosis, which is subject to a co-development and co-promotion agreement between the Company and Regeneron (the “ATTR Co/Co”).
On May 30, 2020, the Company entered into (i) amendment no. 1 (the “2020 Regeneron Amendment”) to the 2016 Regeneron Agreement, (ii) co-development and co-funding agreements for the treatment of hemophilia A and hemophilia B (the “Hemophilia Co/Co”) agreements and (iii) a stock purchase agreement. The collaboration expansion builds upon the jointly developed targeted transgene insertion capabilities designed to durably restore missing therapeutic protein, and to overcome the limitations of traditional gene therapy. The collaboration was extended until April 2024, at which point Regeneron has an option to renew for an additional two years. The 2020 Regeneron Amendment also grants Regeneron exclusive rights to develop products for five additional in vivo CRISPR/Cas-based therapeutic liver targets and non-exclusive rights to independently develop and commercialize up to 10 ex vivo gene edited products made using certain defined cell types.
Since December 31, 2021, there have been no material changes to the key terms of the 2016 Regeneron Agreement and the 2020 Regeneron Amendment (the “Amended Agreements”). For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2021.
Revenue Recognition: Collaboration Revenue. Through December 31, 2022, excluding amounts allocated to Regeneron’s purchase of the Company’s common stock, the Company recorded $ 145.0 million in upfront payments under the Amended Agreements and $ 39.5 million for research and development services, primarily under the ATTR Co/Co agreement. Through December 31, 2022 , the Company has recognized $ 173.1 million of collaboration revenue under all arrangements, including $ 24.1 million, $ 25.7 million and $ 53.0 million of collaboration revenue in the years ended December 31, 2022, 2021 and 2020, respectively, in the consolidated statements of operations and comprehensive loss. This includes $ 11.9 million, $ 5.9 million, and $ 10.7 million, respectively, primarily representing payments due
F- 19
from Regeneron pursuant to the ATTR Co/Co agreement. These revenues are offset in part by contra-revenue related to the Hemophilia Co/Co agreements amounting to $ 10.4 million in the year ended December 31, 2022, $ 2.7 million in the year ended December 31, 2021 and $ 0 million in the year ended December 31, 2020.
As of December 31, 2022, there was approximately $ 28.8 million of the aggregate transaction price of the Amended Agreements remaining to be recognized, which the Company expects to be recognized during the research term through April 2024.
As of December 31, 2022 and 2021, the Company had accounts receivable of $ 3.2 million and $ 2.0 million, respectively, and deferred revenue of $ 28.8 million and $ 51.4 million, respectively, related to the Amended Agreements.
AvenCell Therapeutics, Inc.
On July 30, 2021 (the “Effective Date”), the Company entered into two agreements with AvenCell, a privately held chimeric antigen receptor T (“CAR-T”) cell therapy company formed on that date in a joint venture between the Company, Cellex Cell Professionals GmbH (“Cellex”) and funds managed by Blackstone Life Sciences Advisors L.L.C. (“BXLS”): (i) a license and collaboration agreement (the “AvenCell LCA”), under which the Company will collaborate to develop allogeneic universal CAR-T cell therapies and which granted AvenCell a license to develop and commercialize genome edited universal CAR-T cell therapies (limited to its use with their switchable, universal CAR-T cell UniCAR and RevCAR platforms); and (ii) a co-development and co-funding agreement (the “AvenCell Co/Co”), under which the Company will co-develop and co-commercialize allogeneic universal CAR-T cell products for an immuno-oncology indication.
Since December 31, 2021, there have been no material changes to the key terms of the AvenCell LCA and AvenCell Co/Co agreements. In November 2022, the Company decided to re-prioritize its ex vivo programs and terminated the AvenCell Co/Co, effectively turning over control of the program to AvenCell. The Company will also have one option to enter into an additional co-development and co-funding agreement for a payment of $ 30.0 million to AvenCell. For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company's Annual Report for the year ended December 31, 2021.
Revenue Recognition – Collaboration Revenue. The Company recognized $ 22.8 million and $ 5.9 million in revenue related to the AvenCell LCA for the years ended December 31, 2022 and 2021, respectively, after eliminating $ 11.4 million and $ 2.9 million in intra-entity profits during those respective periods. The elimination of intra-entity profits results in the deferral of revenue that will be recognized if and when AvenCell commercializes a product with the Company's license or abandons the related project. Until such time, this revenue is indefinitely deferred and excluded from the results of operations of the Company. The Company also recognized $ 0.3 million related to materials shipped in accordance with the AvenCell LCA in the year ended December 31, 2022. The Company recognized $ 2.0 million in contra-revenue in the year ended December 31, 2022 related to the AvenCell Co/Co agreement. The Company recognized $ 0.2 million in revenues related to the AvenCell Co/Co agreement for the year ended December 31, 2021.
As of December 31, 2022, there was approximately $ 19.9 million of the aggregate transaction price of the AvenCell LCA remaining to be recognized, which the Company expects to recognize through July 2023.
As of December 31, 2022 and 2021, the Company had $ 0.3 million and $ 0.1 million in accounts receivable, respectively, related to the AvenCell agreements. The Company had deferred revenue of $ 19.9 million and $ 54.1 million as of December 31, 2022 and 2021, respectively, related to the AvenCell LCA.
SparingVision SAS
In October 2021, the Company and SparingVision, a genomic medicine company developing vision saving treatments for ocular diseases, entered into a license and collaboration agreement (the “SparingVision LCA”) to develop novel genomic medicines utilizing CRISPR/Cas9 technology for the treatment of ocular diseases.
Since December 31, 2021, there have been no material changes to the key terms of the SparingVision LCA agreement. For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company's Annual Report for the year ended December 31, 2021.
Revenue Recognition: Collaboration Revenue. The Company recognized $ 0.2 million in revenue related to the SparingVision LCA for the year ended December 31, 2022. The Company did no t recognize collaboration revenue in the year ended December 31, 2021 related to the SparingVision LCA. As of December 31, 2022, the Company had $ 0.1 million in accounts receivable related to the SparingVision LCA. The Company did no t have accounts receivable related to the SparingVision LCA as of December 31, 2021. As of December 31, 2022 and 2021, the Company had deferred revenue of $ 14.7 million and $ 14.8 million related to the SparingVision LCA, respectively, which is expected to be recognized over a six to nine year period from the signing of the agreement.
F- 20
Kyverna Therapeutics, Inc.
In December 2021, the Company and Kyverna, a cell therapy company engineering a new class of therapies for autoimmune and inflammatory diseases, entered into a licensing and collaboration agreement (the “Kyverna LCA”), for the development of an allogeneic CD19 CAR-T cell therapy for the treatment of a variety of B cell-mediated autoimmune diseases.
Since December 31, 2021, there have been no material changes to the key terms of the Kyverna LCA agreement. For further information on the terms and conditions of this agreement, please see the notes to the consolidated financial statements included in the Company's Annual Report for the year ended December 31, 2021.
Revenue Recognition: Collaboration Revenue. The Company recognized $ 6.6 million in revenue for the year ended December 31, 2022 re lated to the Kyverna LCA. The Company did no t recognize any revenue for the year ended December 31, 2021 re lated to the Kyverna LCA. As of December 31, 2022 and 2021, the Company did no t have accounts receivable related to the Kyverna LCA. As of December 31, 2022 and 2021 the Company had deferred revenue of $ 0.4 million and $ 7.0 million, respectively, related to the Kyverna LCA, which is expected to be recognized through January 2023.
ONK Therapeutics, Ltd.
On February 12, 2022 the Company entered into a license, collaboration and option agreement with ONK (the “ONK LCA”), an innovative company dedicated to developing optimally engineered natural killer (“NK”) cell therapies to cure patients with cancer.
Scope: The agreement grants ONK a non-exclusive license to the Company's proprietary ex vivo CRISPR/Cas9-based genome editing platform and its Lipid Nanoparticle (“LNP”)-based delivery technologies for development of up to five allogeneic NK cell therapy products, which license is exclusive with respect to certain guide ribonucleic acids (“gRNAs”).
Responsibilities in the earlier stage of the license and collaboration agreement (the “evaluation program”) will be shared between the two parties, with each party bearing their own cost burden. Upon completion of the evaluation program, ONK will identify up to five allogeneic targets for further development under a development program. Once these allogeneic targets have been selected by ONK, any further development costs incurred by the Company are eligible for reimbursement. ONK will be responsible for preclinical and clinical development for the engineered NK cell therapies enabled by the agreement.
Financial Terms: The Company will be eligible to receive up to $ 184 million per product in future development and commercial milestone payments as achieved, as well as up to mid-single-digit royalties on potential future sales. In addition, the agreement grants the Company options to co-develop and co-commercialize up to two products developed through the collaboration worldwide with rights to lead commercialization in the U.S. There is no fee related to the exercise of these co-development and co-commercialization options.
Governance: The parties formed a joint steering committee, which is responsible for monitoring and managing the collaboration prior to program completion.
ONK LCA – Accounting Analysis: The Company determined that the accounting for the ONK LCA is within the scope of ASC 606. The Company identified one combined performance obligation related to the license, evaluation and development programs. The LCA did not include an exchange of upfront consideration between the parties. As the ONK LCA progresses, the Company will incur certain expenses. Expenses incurred under the evaluation program will be accounted for under ASC 730, Research and Development . Reimbursements under the development programs represent variable constrained consideration, whereas the Company is acting as the principal, and revenue will be recognized as expenses are incurred. Milestone payments and royalties are constrained consideration and will be recorded as revenue upon achievement.
Revenue Recognition: Collaboration Revenue. The Company recognized $ 0.1 million in revenue for the year ended December 31, 2022 related to materials shipped in accordance with the ONK LCA.
Novartis Institutes for BioMedical Research, Inc.
In December 2014, the Company entered into a strategic collaboration agreement with Novartis Institutes for BioMedical Research, Inc. (“Novartis”) (the “2014 Novartis Agreement”), primarily focused on the research of new ex vivo CRISPR/Cas9-edited therapies using CAR-T cells and hematopoietic stem cells (“HSCs”). The agreement was amended in December 2018 (the “Novartis Amendment”) to also include research on ocular stem cells (“OSCs”). In December 2019, per the terms of the 2014 Novartis Agreement, the research term ended, although the 2014 Novartis Agreement remains in effect, for which the Company will be eligible to receive milestone and royalty payments in the future. In June 2021, the Company entered into Amendment No. 3 (the “Amendment”) to the 2014 Novartis Agreement. The Amendment amends Novartis’ rights with respect to all of the CAR-T Therapeutic Targets (as defined in the 2014
F- 21
Novartis Agreement) that Novartis selected under the 2014 Novartis Agreement, including (a) making Novartis’ license non-exclusive for such CAR-T Therapeutic Targets, (b) removing Novartis’ diligence and related reporting obligations for such CAR-T Therapeutic Targets, and (c) refining the scope of Novartis’ sublicense rights for such CAR-T Therapeutic Targets. The Company made a one-time payment to Novartis of $10.0 million within 30 days after the effective date of the Amendment, which was recorded as research and development expense in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2021. Since December 31, 2021, there have been no material changes to the key terms of the 2014 Novartis Agreement and the Novartis Amendments. For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2021.
Revenue Recognition – Milestone: No milestones under the 2014 Novartis Agreement and the Novartis Amendments were achieved during the year ended December 31, 2022. In September 2021, a milestone related to a CRISPR/Cas9-based engineered cell therapy for the treatment of sickle cell disease was reached and, as a result, the Company recognized $ 0.3 million as collaboration revenue within the consolidated statement of operations and comprehensive loss. In March 2020, the U.S. Food and Drug Administration (“FDA”) accepted the Investigational New Drug (“IND”) application submitted by Novartis for a CRISPR/Cas9-based engineered cell therapy for the treatment of sickle cell disease. As a result of meeting this milestone, the Company recognized $ 5.0 million as collaboration revenue within the consolidated statement of operations and comprehensive loss. The Company is eligible to receive additional downstream success-based milestones and royalties.
As of December 31, 2022 and 2021, the Company had no accounts receivable or deferred revenue related to the 2014 Novartis Agreement and the Novartis Amendments .
10. Equity-Method Investment and Other Investments
AvenCell Therapeutics, Inc.
On July 30, 2021, the Company finalized a transaction in which the Company, Cellex and BXLS established AvenCell, a joint venture and privately held company. In exchange for contributing an exclusive license to the joint venture, the Company entered into a Preferred Stock Purchase Agreement with AvenCell for a 33.33 % equity interest in AvenCell at the time of the initial closing. Cellex and BXLS each equally owned the remaining 66.67 % at that time.
The Company has significant influence over, but does not control, AvenCell through its noncontrolling representation on AvenCell’s Board of Directors and the Company’s equity interest in AvenCell. The Company has determined that the preferred stock it owns is in-substance common stock. The Company is not the primary beneficiary as it does not have the power to direct the activities of AvenCell that most significantly impact AvenCell’s economic performance. Accordingly, the Company does not consolidate the financial statements of AvenCell and accounts for its investment using the equity method of accounting.
As of the closing date, the fair value of the Company’s investment in AvenCell was $ 62.9 million which represents the fair value of the preferred stock received in exchange for the exclusive license to the Company’s CRISPR/Cas9 allogeneic platform (See Note 9). In determining the fair value of the Company’s investment, the Company used an option pricing model which requires the input of certain subjective assumptions. The key assumptions used in the option pricing model, which are level 3 inputs, include the anticipated holding period to an exit and liquidity event, the volatility of market participants ( 76 %), the probability of AvenCell achieving certain milestones to obtain subsequent financings ( 75 %) and the discount for lack of marketability ( 11 %).
The Company recorded the initial investment in AvenCell of $ 62.9 million in “Equity method investments” on its consolidated balance sheet. Due to the timing and availability of AvenCell's financial information, the Company is recording its share of losses from AvenCell on a quarterly basis on a one-quarter lag. Therefore, the Company recorded its share of twelve months of AvenCell ’s losses generated in the fourth quarter of 2021 and the first three quarters of 2022 in the Company's operating results and other comprehensive loss for the year ended December 31, 2022, resulting in a reduction of the Company's investment by $ 14.3 million. The Company recorded its share of two months of AvenCell's losses generated in the third quarter of 2021 in the Company's operating results and other comprehensive loss in the fourth quarter of 2021, resulting in a reduction of the Company's investment by $ 1.8 million. The elimination of the intra-entity profit component of $ 11.4 million and $ 2.9 million for the years ended December 31, 2022 and 2021, respectively (See Note 9) resulted in a further reduction in the balance of the investment in AvenCell , bringing the carrying value of the investment to $ 32.5 million and $ 58.1 million as of December 31, 2022 and 2021, respectively. The Company is not aware of any material events or transactions during this period that would warrant additional disclosure or recognition in the financial statements.
At December 31, 2022, the maximum exposure to loss is limited to the Company’s equity investment in the joint venture.
F- 22
SparingVision SAS
In connection with the SparingVision LCA (See Note 9), the Company received 83,316 shares of Series A2 Preferred Stock (“Series A2”). Attached to each share of Series A2, the Company received three warrants for the right to purchase additional Series A2 shares at designated prices that are subject to certain vesting conditions (collectively referred to as the “SparingVision investments”). The Company accounts for the SparingVision investments using the measurement alternative as SparingVision is a private company and there is no readily observable transaction price. In determining the fair value of the SparingVision investments, the Company used an option pricing model which requires the input of certain subjective assumptions. The key assumptions used in the option pricing model, which are level 3 inputs, include the anticipated holding period to an exit and liquidity event, the volatility of market participants ( 90 %), and the rate of return ( 65 %). The Company recorded the initial investment in SparingVision of $ 14.8 million in “Investments and other assets” on its consolidated balance sheet. There was no change in the observable price or impairment of the SparingVision investment as of December 31, 2022 or 2021.
Kyverna Therapeutics, Inc.
In connection with the Kyverna LCA (See Note 9), the Company received 3,739,515 shares of Series B Preferred Stock with a fair value of $ 7.0 million. The Company separately made an additional investment in Kyverna, purchasing 1,602,649 shares of Series B Preferred Stock in exchange for $ 3.0 million in cash (collectively referred to as the “Kyverna investment”). The Company accounts for the Kyverna investment using the measurement alternative as Kyverna is a private company and there is no readily observable transaction price. The Company recorded the initial investment in Kyverna of $ 10.0 million in “Investments and other assets” on its consolidated balance sheet. There was no change in the observable price or impairment of the Kyverna investment as of December 31, 2022 or 2021.
11. Rewrite Acquisition
On February 2, 2022, the Company entered into an agreement to acquire Rewrite (the “Rewrite Merger Agreement”). Under the Rewrite Merger Agreement, the Company paid Rewrite’s former stockholders and optionholders (the “Rewrite Holders”) upfront consideration in an aggregate amount of $ 45.0 million, excluding customary purchase price adjustments and closing costs, payable in cash. Pursuant to the Rewrite Merger Agreement, the Company acquired all of the issued and outstanding shares of Rewrite. The Rewrite transaction resulted in the acquisition of certain know-how and IP assets related to Rewrite’s proprietary DNA writing technology. The Company's management determined that the acquired assets did not meet the definition of a business pursuant to ASC 805, Business Combinations , as substantially all of the fair value of the acquired assets is concentrated into one identifiable asset, the DNA writing technology. As of the date of closing of the transactions contemplated by the Rewrite Merger Agreement (the “Rewrite Merger Agreement Date”), the asset acquired had no alternative future use and had not reached a stage of technological feasibility. As a result, all payment obligations have been recorded as research and development expense in the Company's consolidated statements of operations and other comprehensive loss in the amount of $ 56.0 million (see table below for details). The total transaction price was allocated to the assets acquired and liabilities assumed on a relative fair value basis.
In addition, the Rewrite Holders are eligible to receive up to an additional $ 155.0 million in milestone payments, including $ 55.0 million upon the achievement of certain pre-specified research milestones and $ 100.0 million upon the achievement of a certain regulatory approval milestone, payable through a mixture of $ 130.0 million in cash and $ 25.0 million in a combination of cash and the Company’s common stock, which will be valued using the volume-weighted average price of the Company’s Common Stock over the ten consecutive trading day period ending on and including the trading day that is two trading days immediately prior to the issuance of the consideration issued in connection with the applicable milestone. In September 2022, Rewrite Therapeutics, Inc. merged into Intellia, with Intellia the surviving entity.
The Company determined that the research milestone settled in the Company’s common stock is classified as a contingent consideration liability under ASC 480 and, therefore, the Company recorded a liability for this milestone payment as of the Rewrite Merger Agreement Date at its fair value of $ 10.5 million. The contingent consideration liability is remeasured at fair value each financial reporting period, with the resulting impact reflected in the Company’s consolidated statements of operations and other comprehensive loss, presented within other (expense) income. The milestones that will be settled in cash will be recorded when the contingency is resolved and the consideration is paid or becomes payable. As of December 31, 2022, none of the milestones that will be settled in cash were resolved. In January 2023, the $ 25.0 million research milestone noted above was achieved and, in February 2023, the Company paid the Rewrite Holders a mixture of cash and 567,045 shares of common stock in order to fulfill this obligation.
F- 23
The transaction price was determined and allocated as follows (in thousands):
Transaction Price
Upfront cash consideration
$
43,730
Research contingent consideration liabilities
10,541
Transaction costs
1,838
Total transaction price
$
56,109
Transaction Price Allocated
In-process research and development
$
55,990
Cash acquired
287
Other current assets acquired
153
Other liabilities assumed
( 321
)
Total transaction price
$
56,109
12. Leases
In October 2014, the Company entered into an agreement to lease office and laboratory space at 130 Brookline Street in Cambridge, Massachusetts under an operating lease agreement with a term through January 2020 . In April 2019, the lease was amended to extend the term for an additional five-year period, through January 2025 . In March 2020, the Company entered into a second amendment to this lease which extended the term by approximately six years through January 31, 2031 . There is an option to extend the lease for two consecutive five-year terms . The option for these further extensions is not included as part of the lease liability and right-of-use asset at December 31, 2022, as it is not reasonably certain that it will be exercised.
In January 2016, the Company entered into a ten-year agreement to lease office and laboratory space at 40 Erie Street (the “40 Erie Lease”) in Cambridge, Massachusetts under an operating lease agreement, with an option to terminate the lease at the end of the sixth year and an option to extend the term of the lease for an additional three years . In November 2020, the Company entered into a second amendment to the 40 Erie Lease which provides the Company with a right of first offer with respect to any space that becomes available at the 40 Erie Street building, and in consideration for this right the Company agreed to nullify the option to terminate the lease at the end of the sixth year that was included in the 40 Erie Lease . The option to extend the term of the lease for an additional three years is not included as part of the lease liability and right-of-use asset at December 31, 2022, as it is not reasonably certain that it will be exercised.
In March 2020, the Company entered into an agreement to lease approximately 39,000 square feet of office and laboratory space at 281 Albany Street in Cambridge, Massachusetts under an operating lease agreement (the “281 Albany Lease”). The initial term of the 281 Albany Lease is ten years following the rent commencement date which was determined to be March 2021. The Company has the option to extend the 281 Albany Lease for two successive five-year terms ; this option is not included as part of the lease liability and right-of-use asset at December 31, 2022, as it is not reasonably certain that it will be exercised.
In July 2021, the Company entered into an agreement to lease 13,662 square feet of office space at 17 Tudor Street in Cambridge, Massachusetts under an operating lease agreement (the “17 Tudor Lease”). The initial term of the 17 Tudor Lease is five years , and the Company has an option to extend the 17 Tudor Lease for one three-year term. The option is not included as part of the lease liability and right-of-use asset at December 31, 2022, as it is not reasonably certain that it will be exercised.
In January 2022, the Company entered into an agreement to lease approximately 38,000 square feet of office and laboratory space at 730 Main Street, Cambridge, Massachusetts under an operating lease agreement (the “730 Main Lease”). The initial term of the 730 Main Lease is for ten years following the Rent Commencement Date and the Company has the option to extend the 730 Main Lease for one five-year term. The base rent under the 730 Main Lease is $ 130.00 per square foot per year during the first year of the term, which is subject to scheduled 3 % annual increases, plus certain operating expenses and taxes. In October 2022, the Company determined that in accordance with ASC 842, Leases (Topic 842) ( “ ASC 842 ” ), the commencement date of the lease had been met as the lessor had made the space available for the Company's use. Therefore, the Company recognized a right-of-use asset and a lease liability of approximately $ 36.4 million in the fourth quarter of 2022 related to the 730 Main Lease. In determining the lease liability, the Company used an incremental borrowing rate of 9.33 % based on a number of factors including the Company’s credit rating and the lease term. In January 2023, the Company executed a sublease for a portion of the 730 Main Lease.
F- 24
In February 2022, the Company entered into an agreement to lease approximately 140,000 square feet of office, general laboratory and manufacturing space located at 840 Winter Street, Waltham, Massachusetts (the “840 Winter Lease”), which will provide the Company with the ability to manufacture its own products in a good manufacturing practice (“GMP”) compliant facility as well as to supplement the Company’s current leased premises in Cambridge, Massachusetts. The 840 Winter Lease, including the obligation to pay rent, is expected to commence in 2024 for an initial term of twelve years . The base rent under the 840 Winter Lease is $ 73.50 per square foot per year during the first year of the term, which is subject to scheduled 3 % annual increases, plus certain operating expenses and taxes. The Company has the option to extend the 840 Winter Lease for two five-year terms. The Company did not record a right of use asset or liability related to the 840 Winter Lease under ASC 842 during the twelve months ended December 31, 2022, as the Company had not taken control of the premises.
In June 2022, the Company entered into an agreement to lease approximately 62,000 square feet of office and laboratory space located at 640 Memorial Drive, Cambridge, Massachusetts under an operating lease agreement (the “640 Memorial Drive Lease”). The term of the lease is five years , ending in August 2027. The Company does not have an option to extend the 640 Memorial Drive Lease . The base rent under the 640 Memorial Drive Lease is approximately $ 97 per square foot per year during the first year of the term, which is subject to scheduled 4 % annual increases, plus certain operating expenses and taxes. In September 2022 the Company determined, in accordance with ASC 842, that the commencement date for the lease had been met as the lessor had made the space available for the Company's use. The Company recorded a right of use asset of $ 30.7 million and a lease liability of $ 30.2 million related to the 640 Memorial Drive Lease under ASC 842. The difference between the right of use asset and the lease liability of $ 0.5 million relates to prepaid rent. In determining the lease liability, the Company used an incremental borrowing rate of 7.99 % based on a number of factors including the Company's credit rating and the lease term.
Throughout the term of its leases, the Company is responsible for paying certain costs and expenses, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities. The variable portion of these costs are expensed as incurred and are disclosed as variable lease costs.
The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases for the years ended December 31, 2022 and 2021:
Year Ended December 31,
2022
2021
(In thousands)
Lease cost
Operating lease cost
$
18,031
$
12,871
Short-term lease cost
-
31
Variable lease cost
4,443
3,339
Total lease cost
$
22,474
$
16,241
Year Ended December 31,
2022
2021
(In thousands)
Other information
Operating cash flows used for operating leases
$
14,656
$
12,641
Operating lease liabilities arising from obtaining right-of-use
assets
67,053
49,378
As Of December 31,
2022
2021
Lease term and discount rate
Weighted average remaining lease term
6.9 years
7.2 years
Weighted average discount rate
7.20 %
5.50 %
F- 25
The table below reconciles the undiscounted cash flows for each of the next five years and total of the remaining years to the operating lease liabilities recorded in the consolidated balance sheet as of December 31, 2022:
Future Operating Lease Payments
Year Ending December 31,
(in thousands)
2023
$
25,431
2024
24,930
2025
25,902
2026
25,078
2027
17,530
Thereafter
51,557
Total lease payments
$
170,428
Less: imputed interest
( 39,725
)
Total operating lease liabilities at December 31, 2022
$
130,703
13. Equity-Based Compensation
Equity-based compensation expense is classified in the consolidated statements of operations and comprehensive loss as follows:
Year Ended December 31,
2022
2021
2020
(In thousands)
Research and development
$
56,279
$
26,712
$
10,202
General and administrative
35,121
20,297
9,701
Total
$
91,400
$
47,009
$
19,903
Amended and Restated 2015 Stock Option and Incentive Plan
In April 2016, the Company adopted the Amended and Restated 2015 Stock Option and Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards (“RSAs”), restricted stock units (“RSUs”) and other stock-based awards. Recipients of incentive stock options and non-qualified stock options are eligible to purchase shares of the Company’s common stock at an exercise price equal to the fair value of such stock on the grant date.
Effective July 1, 2022, the Company adopted a retirement policy for equity awards granted to all employees other than the Company’s CEO (the “Policy”) and in December 2022, the Policy was amended to include the Company's CEO (the “Amended Policy”) upon approval by the Company's board of directors. No other changes were made to the Policy in the amendment. The Amended Policy applies to all equity awards granted after the date of adoption to employees who meet certain retirement eligibility criteria set forth in the Amended Policy (the “Retirees”). Pursuant to the terms of the Amended Policy, upon a Retiree’s eligible retirement: (i) all stock options held by the Retiree will continue to vest following the Retiree’s retirement date according to the original vesting schedule of the option until fully vested and all vested stock options held by such Retiree will remain exercisable until the earlier of the five-year anniversary of the Retiree’s retirement date or the original expiration date of the option, (ii) all unvested time-based RSUs held by the Retiree will vest in full on the Retiree’s retirement date and (iii) all unvested performance-based awards held by the Retiree will remain outstanding following the Retiree’s retirement date and the Retiree will remain eligible to earn a pro-rated portion of such performance-based awards at the end of the performance period based on actual performance during the performance period.
As of December 31, 2022, there were 3,541,302 shares available for future issuance under the 2015 Plan. The number of shares reserved for issuance under the 2015 Plan shall be cumulatively increased by four percent of the number of shares of stock issued and outstanding on the immediately preceding December 31 or such lesser number of shares of stock as determined by the board of directors .
F- 26
Restricted Stock Units
RSUs are measured at fair value based on the quoted price of the Company’s common stock.
The following table summarizes the Company’s RSU activity for the year ended December 31, 2022:
Number of
Shares
Weighted
Average Grant
Date Fair Value
per Share
Unvested restricted stock units as of December 31, 2021
453,026
$
71.03
Granted
1,736,844
70.90
Vested
( 147,674
)
70.87
Cancelled
( 100,817
)
75.42
Unvested restricted stock units as of December 31, 2022
1,941,379
$
70.70
In March 2022, the Company granted 794,424 RSUs with a service condition to employees as part of their annual grant, which vest over a period of three years . The weighted average grant date fair value of these RSUs was $ 79.85 and the vesting start date for these RSUs was January 1, 2022.
Also in March 2022, 55,144 RSUs were granted to senior executives as part of their annual grant. These RSUs have the potential to vest after a period of 3 years, with a vesting start date of January 1, 2022, and the number of shares to be delivered will depend on the Company's Total Shareholder Return (“TSR”), a market condition, over that period relative to a defined group of biotechnology companies. The grant date fair value for these RSUs, calculated using a Monte Carlo valuation model, was $ 126.49 . The following assumptions were used to determine the grant date fair value: risk free interest rate: 1.44 %; expected dividend yield: 0.0 %; expected volatility: 82.53 %; expected term (in years): 2.84 .
The Company also granted 66,296 performance-based RSUs in March 2022 to certain non-executive employees that would vest upon obtaining certain scientific milestones. There were two separate tranches, each attached to a different set of milestones. The milestone related to the first tranche, made up of 21,878 RSUs, is deemed to be probable of achievement as of December 31, 2022; the Company recorded $ 1.7 million in expense related to this tranche in 2022 and these RSUs vested in the first quarter of 2023 upon achievement of the milestone. The remaining performance milestones were considered not probable of achievement as of December 31, 2022 and, therefore, no related stock-based compensation was recorded during the period then ending.
The weighted-average grant date fair value of RSUs granted for the years ended December 31, 2022, 2021 and 2020 was $ 70.90 , $ 73.81 and $ 21.70 , respectively. The total fair value of RSUs vested (measured on the date of vesting) for the years ended December 31, 2022, 2021 and 2020 was $ 10.4 million, $ 14.1 million and $ 2.8 million, respectively.
As of December 31, 2022, there was $ 99.3 million of unrecognized equity-based compensation expense related to RSUs that are expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 2.1 years.
Stock Options
The weighted average grant date fair value of options, estimated as of the grant date using the Black-Scholes option pricing model, was $ 57.23 , $ 54.09 and $ 9.07 per option for options granted during the years ended December 31, 2022, 2021 and 2020, respectively. The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised during the years ended December 31, 2022, 2021 and 2020 was $ 42.8 million, $ 262.0 million, and $ 20.3 million, respectively. Weighted average assumptions used to apply this pricing model were as follows:
Year Ended December 31,
2022
2021
2020
Risk-free interest rate
1.9
%
1.0
%
0.8
%
Expected life of options
5.9 years
6.0 years
6.0 years
Expected volatility of underlying stock
76.2
%
72.9
%
67.8
%
Expected dividend yield
0.0
%
0.0
%
0.0
%
Risk-free Interest Rate. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant with maturities approximately equal to the option’s expected term.
Expected Dividend Yield. The expected dividend yield assumption is based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends.
F- 27
Expected Volatility. The expected volatility was derived from a blend of the Company’s historical volatility and an average of the historical stock volatilities of several peer companies within the Company’s industry, both over a period equivalent to the expected term of the stock option grants.
Expected Term. The expected term represents the period that stock option awards are expected to be outstanding. For option grants that are considered to be “plain vanilla,” the Company determines the expected term using the simplified method. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the options. The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate the expected term.
Stock options granted under the 2015 Plan generally vest 25% on the first anniversary of the original vesting date, with the balance vesting monthly over the remaining three years, unless they contain specific performance-based vesting provisions. The maximum term of stock options granted under the 2015 Plan is ten years.
The Company uses the market closing price of its common stock as reported on the Nasdaq Global Select Market to determine the fair value of the shares of common stock underlying stock options. The following is a summary of stock option activity for the year ended December 31, 2022:
Number of
Options
Weighted
Average
Exercise
Price per
Share
Weighted
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
(In years)
(In thousands)
Outstanding at December 31, 2021
6,305,156
$
43.57
Granted
391,910
86.08
Exercised
( 883,954
)
16.42
Forfeited
( 341,437
)
61.72
Outstanding at December 31, 2022
5,471,675
$
49.86
7.37
$
53,736
Exercisable at December 31, 2022
3,216,725
$
36.90
6.81
$
40,938
As of December 31, 2022, there was $ 93.1 million of unrecognized compensation cost related to stock options that have not yet vested. These costs are expected to be recognized over a weighted average remaining vesting period of 2.3 years.
2016 Employee Stock Purchase Plan
In May 2016, the Company adopted the 2016 Employee Stock Purchase Plan (the “2016 Plan”). The 2016 Plan allows eligible employees to purchase shares of the Company’s common stock on the last day of each predetermined six-month offering period at 85 % of the lower of the fair market value per share at the beginning or end of the applicable offering period . The 2016 Plan provides for six-month offering periods beginning in January and July of each year.
As of December 31, 2022, there were 1,219,584 shares available for future issuance under the 2016 Plan. The number of shares reserved for issuance under the 2016 Plan shall be cumulatively increased by the lesser of a) one percent of the number of shares of common stock issued and outstanding on the immediately preceding December 31, b) 500,000 shares of common stock, or c) such lesser number of shares of common stock as determined by the board of directors.
During the years ended December 31, 2022, 2021, and 2020, the Company issued 77,618 , 30,897 , and 101,911 shares of common stock under the 2016 Plan, respectively. The weighted-average purchase prices of shares issued under the 2016 Plan were $ 34.15 , $ 65.51 and $ 15.28 per share for the years ended December 31, 2022, 2021, and 2020, respectively.
The fair value of the awards issued under the 2016 Plan to employees was estimated at the beginning of the offering period using a Black-Scholes option-pricing model with the following assumptions:
Year Ended December 31,
2022
2021
2020
Risk-free interest rate
0.22 %- 2.52 %
0.05 %- 0.09 %
0.17 %- 1.6 %
Expected term (in years)
0.5 years
0.5 years
0.5 years
Expected volatility of underlying stock
63.6 %- 95.3 %
77.5 %- 109.2 %
53.4 %- 98.3 %
Expected dividend yield
0.0
%
0.0
%
0.0
%
F- 28
14. Loss Per Share
Basic and diluted loss per share was calculated as follows:
Year Ended December 31,
2022
2021
2020
(In thousands)
Net loss
$
( 474,186
)
$
( 267,892
)
$
( 134,231
)
Weighted average shares outstanding, basic
and diluted
76,972
70,894
55,987
Net loss per share, basic and diluted
$
( 6.16
)
$
( 3.78
)
$
( 2.40
)
The following common stock equivalents were excluded from the calculation of diluted loss per share in 2022, 2021 and 2020 because their inclusion would have been anti-dilutive:
Year Ended December 31,
2022
2021
2020
(In thousands)
Unvested restricted stock
1,941
453
194
Stock options
5,472
6,305
6,977
7,413
6,758
7,171
15. Stockholders’ Equity
Follow-on Offerings
On June 1, 2020, the Company entered into an underwriting agreement related to a public offering of 6,301,370 shares of its common stock, par value $ 0.0001 per share, including the exercise in full by the underwriters of their option to purchase an additional 821,917 shares, at the public offering price of $ 18.25 per share. The offering closed on June 5, 2020 and the Company received net proceeds of $ 107.7 million, after deducting the underwriting discount, commissions and offering expenses.
On December 1, 2020, the Company entered into an underwriting agreement related to a public offering of 5,513,699 shares of its common stock, par value $ 0.0001 per share, including the exercise in full by the underwriters of their option to purchase an additional 719,178 shares, at the public offering price of $ 36.50 per share. The offering closed on December 4, 2020 and the Company received net proceeds of $ 188.9 million, after deducting the underwriting discount, commissions and offering expenses.
On June 29, 2021, the Company entered into an underwriting agreement related to a public offering of 4,758,620 shares of its common stock , par value $ 0.0001 per share, including the exercise in full by the underwriters of their option to purchase an additional 620,689 shares at a public offering price of $ 145.00 per share. The offering closed on July 2, 2021 and the Company received net proceeds of $ 648.3 million, after deducting the underwriting discount, commissions and offering expenses.
In November 2022, the Company entered into an underwriting agreement related to a public offering of 6,550,219 shares of its common stock, par value $ 0.0001 per share, at a public offering price of $ 45.80 per share. In addition, the Company granted the underwriter an option exercisable for 30 days from the date of the agreement to purchase, at the public offering price less any underwriting discounts and commissions, up to an additional 982,532 shares. The offering closed on December 2, 2022 and the Company received net proceeds of $ 337.9 million, including the exercise in full of the underwriters' option to purchase additional shares, after deducting the underwriting discount, commissions and offering expenses.
At-the-Market Offering Programs
In August 2019, the Company entered into an Open Market Sale Agreement (the “2019 Sale Agreement”) with Jefferies LLC (“Jefferies”) , under which Jefferies was able to offer and sell, from time to time in “at-the-market” offerings, common stock having aggregate gross proceeds of up to $ 150.0 million. The Company agreed to pay Jefferies cash commissions of 3.0 % of the gross proceeds of sales of common stock under the 2019 Sale Agreement.
During the year ended December 31, 2020, the Company issued 2,270,161 shares of its common stock in a series of sales at an average price of $ 22.53 per share in accordance with the 2019 Sale Agreement, for aggregate net proceeds of $ 49.5 million after payment of cash commissions to Jefferies and approximately $ 0.2 million related to legal, accounting and other fees in connection with the sales. During the year ended December 31, 2021, the Company issued 641,709 shares of its common stock in a series of sales at an average price of $ 72.79 per share in accordance with the 2019 Sale Agreement, for aggregate net proceeds of $ 45.3 million after payment of cash commissions to Jefferies and approximately $ 0.1 million related to legal, accounting and other fees in connection with the sales. During the first quarter of 2022, the Company issued 579,788 shares of its common stock, in a series of sales, at an average price of $ 69.43 per share, in accordance with the 2019 Sale Agreement for aggregate net proceeds of $ 38.9 million, after payment of cash
F- 29
commissions to Jefferies and approximately $ 0.2 million related to legal, accounting and other fees in connection with the sales. The 2019 Sale Agreement expired during the third quarter of 2022.
In March 2022, the Company entered into an Open Market Sale Agreement (the “2022 Sale Agreement”) with Jefferies, under which Jefferies will be able to offer and sell, from time to time in “at-the-market” offerings, common stock having aggregate gross proceeds of up to $ 400.0 million. The Company agreed to pay Jefferies cash commissions of 3.0 % of the gross proceeds of sales of common stock under the 2022 Sale Agreement.
During the year ended December 31, 2022, the Company issued 3,395,339 shares of its common stock, in a series of sales, at an average price of $ 57.43 per share, in accordance with the 2022 Sale Agreement for aggregate net proceeds of $ 189.0 million, after payment of cash commissions to Jefferies and approximately $ 0.1 million related to legal, accounting and other fees in connection with the sales. As of December 31, 2022, $ 205.0 million in shares of common stock remain eligible for sale under the 2022 Sale Agreement.
Shares Issued in Private Placement to Regeneron
As described in Note 9 above, in May 2020 the Company entered into an amendment to its collaboration agreement with Regeneron that was entered into in April 2016. Simultaneously, the Company and Regeneron entered into the 2020 Stock Purchase Agreement , under which the Company sold to Regeneron 925,218 shares of its common stock, par value $ 0.0001 per share, for aggregate cash consideration of $ 30.0 million, or $ 32.42 per share, representing a 100 % premium over the volume-weighted average trading price of the Company’s common stock during the 30-day period prior to the closing. Under the 2020 Stock Purchase Agreement, Regeneron will not dispose of any shares of common stock it beneficially owns in the Company until the termination of the Technology Collaboration Term (see Note 9). After applying equity accounting guidance to measure the issuance of the shares, $ 12.6 million was recorded as fair value in the consolidated statement of stockholders’ equity for the shares.
16. Related Party Transactions
In the ordinary course of business, the Company may purchase materials or supplies from entities that are associated with a party that meets the criteria of a related party of the Company. These transactions are reviewed quarterly and to date have not been material to the Company’s consolidated financial statements.
The Company and AvenCell are parties to the AvenCell LCA and AvenCell Co/Co, as described in Note 9. The Company’s relationship with AvenCell is considered to be as a related party due to the Company’s 33.33 % investment in AvenCell being accounted for under the equity method. The Company recognized $ 22.8 million and $ 5.9 million in revenue related to the AvenCell LCA for the years ended December 31, 2022 and 2021, respectively, after eliminating $ 11.4 million and $ 2.9 million in intra-entity profits during those respective periods. The elimination of intra-entity profits results in the deferral of revenue that will be recognized if and when AvenCell commercializes a product with the Company's license or abandons the related project. Until such time, this revenue is indefinitely deferred and excluded from the results of operations of the Company. The Company also recognized $ 0.3 million related to materials shipped in accordance with the AvenCell LCA in the year ended December 31, 2022. The Company recognized $ 2.0 million in contra-revenue in the year ended December 31, 2022 related to the AvenCell Co/Co agreement. The Company recognized $ 0.2 million in revenues related to the AvenCell Co/Co agreement for the year ended December 31, 2021. As of December 31, 2022 the Company had $ 19.9 million in current deferred revenue related to the AvenCell LCA.
17. 401(k) Plan
In 2015, the Company established the Intellia Therapeutics, Inc. 401(k) Plan (the “401(k) Plan”) for its employees, which is designed to be qualified under Section 401(k) of the Internal Revenue Code. Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits. The Company makes matching contributions of 50 % of the first 6 % of employee contributions. The Company made matching contributions of $ 2.7 million, $ 1.6 million and $ 1.1 million for the years ended December 31, 2022, 2021 and 2020, respectively.
F- 30
EXHIBIT INDEX
Exhibit
No.
Exhibit Index
3.1
Second Amended and Restated Certificate of Incorporation of the Registrant (1)
3.2
Second Amended and Restated By-laws of the Registrant (1)
3.3
Amendment to the Second Amended and Restated By-laws of the Registrant (11)
4.1
Description of Certain Registrant’s Securities (15)
10.1#
2015 Amended and Restated Stock Option and Incentive Plan and forms of award agreements thereunder (3)
10.2#
Senior Executive Cash Incentive Bonus Plan (5)
10.3
License Agreement dated as of July 16, 2014 by and between the Registrant (as successor in interest of Intellia Therapeutics, LLC) and Caribou Biosciences, Inc. (4)
10.4
Services Agreement dated as of July 16, 2014 by and between the Registrant (as successor in interest of Intellia Therapeutics, LLC) and Caribou Biosciences, Inc. (4)
10.5
License and Collaborative Research Agreement dated as of December 18, 2014 by and between the Registrant and Novartis Institutes for BioMedical Research, Inc. (2)
10.6#
Form of Indemnification Agreement (3)
10.7
Lease Agreement, by and between the Registrant and MIT 130 Brookline LLC, dated as of October 21, 2014 (5)
10.8
Lease Agreement, by and between the Registrant and BMR-Sidney Research Campus LLC, dated as of January 6, 2016 (5)
10.9#
2016 Employee Stock Purchase Plan (3)
10.10
Amendment No. 1 to License Agreement dated as of February 2, 2016 by and between the Registrant and Caribou Biosciences, Inc. (5)
10.11
Addendum to License Agreement dated as of February 2, 2016 by and between the Registrant and Caribou Biosciences, Inc. (5)
10.12
License and Collaboration Agreement dated as of April 11, 2016 by and between the Registrant and Regeneron Pharmaceuticals, Inc. (2)
10.13
Common Stock Purchase Agreement dated as of April 26, 2016 between the Registrant and Regeneron Pharmaceuticals, Inc. (3)
10.14
Common Stock Purchase Agreement dated as of April 26, 2016 between the Registrant and Novartis Institutes for BioMedical Research, Inc. (3)
10.15#
Form of Employment Agreement for Executive Officers (3)
10.16
Consent to Assignments, Licensing and Common Ownership and Invention Management Agreement dated December 15, 2016 by and between the Registrant, CRISPR Therapeutics AG, The Regents of the University of California, University of Vienna, ERS Genomics Ltd., TRACR Hematology Ltd., Caribou Biosciences, Inc., and Dr. Emmanuelle Charpentier (17)
10.17#
Form of Amended and Restated Employment Agreement (7)
10.18
Letter Agreement, dated as of July 20, 2018, by and between the Company and Regeneron Pharmaceuticals, Inc. and the corresponding Form of Co-Development and Co-Promotion Agreement, by and between the Company and Regeneron Pharmaceuticals, Inc. (8)
10.19
Agreement and Amendment to License and Collaborative Research Agreement, dated as of December 3, 2018, by and between Novartis and the Company (9)
10.20
First Amendment to Lease, dated as of April 5, 2019, by and between the Company and MIT 130 Brookline Leasehold LLC. (10)
F- 31
10.21#
Fifth Amended and Restated Non-Employee Director Compensation Policy (4)
10.22
Lease Agreement, by and between the Registrant and 281-295 Albany Street Leasehold LLC, dated as of March 12, 2020 (12)
10.23
Second Amendment to Lease, dated as of March 12, 2020, by and between the Company and MIT 130 Brookline Leasehold LLC. (12)
10.24
Amendment No. 1 to the License and Collaboration Agreement, dated as of May 30, 2020 by and between the Company and Regeneron Pharmaceuticals, Inc. (13)
10.25
Stock Purchase Agreement, dated as of May 30, 2020 by and between the Company and Regeneron Pharmaceuticals, Inc. (13)
10.26
Corporate Bonus Plan, effective April 3, 2020 (14)
10.27
Amendment #3 to License and Collaborative Research Agreement, dated as of June 14, 2021, by and between the Registrant and Novartis (16)
10.28
Agreement and Plan of Merger, by and among Intellia Therapeutics, Inc., Rewrite Therapeutics, Inc., RW Acquisition Corp., and Shareholder Representative Services, LLC, as securityholder representative, dated as of February 2, 2022 (17)
10.29
Lease Agreement by and between the Registrant and Are-Winter Street Property, LLC, dated as of February 22, 2022 (17)
10.30#*
Amended and Restated Retirement Policy for Equity Awards, effective December 6, 2022
21.1*
Subsidiaries of the Registrant
23.1*
Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm
31.1*
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certifications pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of The Sarbanes-Oxley Act of 2002, by John M. Leonard, M.D., President and Chief Executive Officer of the Company, and Glenn Goddard, Executive Vice President, Chief Financial Officer of the Company (18)
101.INS*
Inline XBRL Instance Document.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104*
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101*)
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10) of Regulation S-K.
* Filed herewith.
# Indicates a management contract or any compensatory plan, contract or arrangement
(1) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No. 001-37766) filed with the Securities and Exchange Commission on May 17, 2016
(2) Incorporated by reference to the Registration Statement on Form S-1 (File No. 333-210689) filed with the Securities and Exchange Commission on May 5, 2016
(3) Incorporated by reference to the Registration Statement on Form S-1 (File No. 333-210689) filed with the Securities and Exchange Commission on April 27, 2016
(4) Incorporated by reference to the Registration Statement on Registrant’s Quarterly Report on Form 10-Q (File No. 001-37766) filed with the Securities and Exchange Commission on May 5, 2022
F- 32
(5) Incorporated by reference to the Registration Statement on Form S-1 (File No. 333-210689) filed with the Securities and Exchange Commission on April 11, 2016
(6) Incorporated by reference to the Registration Statement on Form S-1 (File No. 333-210689) filed with the Securities and Exchange Commission on April 12, 2016
(7) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No. 001-37766) filed with the Securities and Exchange Commission on April 17, 2018
(8) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37766) filed with the Securities and Exchange Commission on October 31, 2018
(9) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No. 001-37766) filed with the Securities and Exchange Commission on February 27, 2019
(10) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37766) filed with the Securities and Exchange Commission on May 2, 2019
(11) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No. 001-37766) filed with the Securities and Exchange Commission on April 9, 2020
(12) Incorporated by reference to the Registrant’s Current Report on Form 10-Q (File No. 001-37766) filed with the Securities and Exchange Commission on May 7, 2020
(13) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No. 001-37766) filed with the Securities and Exchange Commission on June 1, 2020
(14) Incorporated by reference to the Registrant’s Current Report on Form 10-Q (File No. 001-37766) filed with the Securities and Exchange Commission on August 6, 2020
(15) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No. 001-37766) filed with the Securities and Exchange Commission on February 27, 2020
(16) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No. 001-37766) filed with the Securities and Exchange Commission on June 17, 2021
(17) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No. 001-37766) filed with the Securities and Exchange Commission on February 24, 2022
(18) The certifications furnished in Exhibit 32.1 hereto are deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certifications will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
F- 33
SIGNA TURES
Pursuant to the requirements of Section 13 or 15(d) 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.
INTELLIA THERAPEUTICS, INC.
By:
/s/ John M. Leonard
John M. Leonard, M.D.
President and Chief Executive Officer
Dated: February 23, 2023
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/ John M. Leonard
President, Chief Executive Officer and Director
February 23, 2023
John M. Leonard, M.D.
(Principal Executive Officer)
/s/ Glenn Goddard
Executive Vice President, Chief Financial Officer
February 23, 2023
Glenn Goddard
(Principal Financial and Accounting Officer)
/s/ Muna Bhanji
Director
February 23, 2023
Muna Bhanji
/s/ Fred Cohen
Director
February 23, 2023
Fred Cohen, M.D.
/s/ John Crowley
Director
February 23, 2023
John Crowley
/s/ Caroline Dorsa
Director
February 23, 2023
Caroline Dorsa
/s/ Jean François Formela
Director
February 23, 2023
Jean François Formela, M.D.
/s/ Jesse Goodman
Director
February 23, 2023
Jesse Goodman, M.D.
/s/ Georgia Keresty
Director
February 23, 2023
Georgia Keresty
/s/ Frank Verwiel
Director
February 23, 2023
Frank Verwiel, M.D.
F- 34
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.