Item 1. Financial Statements
Item 1. Financial Statements
INTELLIA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets (unaudited)
(Amounts in thousands except share and per share data)
June 30,
2021
December 31,
2020
ASSETS
Current Assets:
Cash and cash equivalents
$
129,879
$
160,020
Marketable securities
399,140
437,351
Accounts receivable
1,993
2,130
Prepaid expenses and other current assets
18,392
17,016
Total current assets
549,404
616,517
Marketable securities - noncurrent
22,262
-
Property and equipment, net
18,530
15,943
Operating lease right-of-use assets
77,070
39,114
Other assets
4,977
4,748
Total Assets
$
672,243
$
676,322
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$
6,854
$
10,460
Accrued expenses
37,150
25,554
Current portion of operating lease liability
7,415
5,696
Current portion of deferred revenue
22,544
22,544
Total current liabilities
73,963
64,254
Deferred revenue, net of current portion
40,208
51,387
Long-term operating lease liability
63,259
33,609
Commitments and contingencies (Note 6)
Stockholders’ Equity:
Common stock, $ 0.0001 par value; 120,000,000 shares authorized;
68,331,780 and 66,234,056 shares issued and outstanding at
June 30, 2021 and December 31, 2020, respectively
7
7
Additional paid-in capital
1,044,939
962,173
Accumulated other comprehensive (loss) income
( 13
)
1
Accumulated deficit
( 550,120
)
( 435,109
)
Total stockholders’ equity
494,813
527,072
Total Liabilities and Stockholders’ Equity
$
672,243
$
676,322
See notes to condensed consolidated financial statements.
3
INTELLIA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(Amounts in thousands except per share data)
Three Months Ended June 30,
Six Months Ended June 30,
2021
2020
2021
2020
Collaboration revenue
$
6,550
$
16,263
$
12,995
$
29,179
Operating expenses:
Research and development
58,884
37,771
98,160
72,421
General and administrative
16,683
11,526
30,277
22,840
Total operating expenses
75,567
49,297
128,437
95,261
Operating loss
( 69,017
)
( 33,034
)
( 115,442
)
( 66,082
)
Interest income
211
641
431
1,883
Net loss
$
( 68,806
)
$
( 32,393
)
$
( 115,011
)
$
( 64,199
)
Net loss per share, basic and diluted
$
( 1.01
)
$
( 0.61
)
$
( 1.70
)
$
( 1.24
)
Weighted average shares outstanding, basic and
diluted
68,164
53,369
67,675
51,938
Other comprehensive loss:
Unrealized loss on marketable securities
( 1
)
( 218
)
( 14
)
( 106
)
Comprehensive loss
$
( 68,807
)
$
( 32,611
)
$
( 115,025
)
$
( 64,305
)
See notes to condensed consolidated financial statements.
4
INTELLIA THERAPEUTICS, INC.
Condensed Consolidated Statements of Cash Flows (unaudited)
(Amounts in thousands)
Six Months Ended June 30,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 115,011
)
$
( 64,199
)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Depreciation and amortization
3,225
3,107
Equity-based compensation
17,038
8,921
Amortization/(accretion) of investment premiums/(discounts)
2,868
( 268
)
Changes in operating assets and liabilities:
Accounts receivable
137
756
Prepaid expenses and other current assets
( 8,703
)
( 564
)
Operating right-of-use assets
4,018
3,195
Other assets
( 229
)
239
Accounts payable
( 2,606
)
( 3,899
)
Accrued expenses
10,135
2,434
Deferred revenue
( 11,179
)
71,869
Operating lease liabilities
( 5,050
)
( 2,719
)
Net cash (used in) provided by operating activities
( 105,357
)
18,872
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment
( 5,350
)
( 1,881
)
Purchases of marketable securities
( 185,431
)
( 31,208
)
Maturities of marketable securities
198,499
183,500
Net cash provided by investing activities
7,718
150,411
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock through follow-on offerings,
net of issuance costs
-
107,732
Proceeds from issuance of common stock through at-the-market offerings,
net of issuance costs
45,255
14,722
Proceeds from issuance of common stock to Regeneron
-
12,580
Proceeds from options exercised
19,503
1,370
Issuance of shares through employee stock purchase plan
970
685
Net cash provided by financing activities
65,728
137,089
Net (decrease) increase in cash and cash equivalents and restricted cash and cash
equivalents
( 31,911
)
306,372
Cash and cash equivalents and restricted cash and cash equivalents, beginning of
period
164,606
57,226
Cash and cash equivalents and restricted cash and cash equivalents, end of period
$
132,695
$
363,598
Reconciliation of cash and cash equivalents and restricted cash and cash
equivalents to condensed consolidated balance sheet:
Cash and cash equivalents
$
129,879
$
361,687
Restricted cash and cash equivalents, included in prepaids and other current assets
and other assets
2,816
1,911
Total cash and cash equivalents and restricted cash and cash equivalents
$
132,695
$
363,598
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Purchases of property and equipment unpaid at period end
$
1,969
$
432
Right-of-use assets acquired under operating leases
41,974
7,527
Offering costs unpaid at period end
208
-
See notes to condensed consolidated financial statements.
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INTELLIA THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements (unaudited)
1.
Overview and Basis of Presentation
Intellia Therapeutics, Inc. (“Intellia” or the “Company”) is a leading clinical-stage genome editing company, focused on developing novel, potentially curative therapeutics using CRISPR/Cas9 technology. CRISPR/Cas9, an acronym for C lustered, R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”)/CRISPR associated 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, the Company is pursuing two primary approaches. The Company’s in vivo programs use intravenously administered CRISPR as the therapy, in which its proprietary delivery technology enables highly precise editing of disease-causing genes directly within specific target tissues. The Company’s ex vivo programs use CRISPR to create the therapy by using engineered human cells to treat cancer and autoimmune diseases. The Company’s deep scientific, technical and clinical development experience, along with its robust intellectual property (“IP”) portfolio, enables the Company to unlock broad therapeutic applications of CRISPR/Cas9 to create new classes of genetic medicine.
The condensed consolidated financial statements of the Company included herein have been prepared, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K (“Annual Report”) for the year ended December 31, 2020.
The unaudited condensed 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 unrealized gain/loss on marketable securities.
The preparation of financial statements in conformity with 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 condensed consolidated financial statements have been made in connection with the calculation of revenues, research and development expenses 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.
The effects of material revisions in estimates are reflected in the condensed consolidated financial statements prospectively from the date of the change in estimate.
In the opinion of management, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the results for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.
Liquidity
Since its inception through June 30, 2021, the Company has raised an aggregate of approximately $ 1,166.1 million to fund its operations, of which $ 275.9 million was through its collaboration agreements, $ 170.5 million was from its initial public offering (“IPO”) and concurrent private placements, $ 438.3 million was from follow-on public offerings, $ 196.5 million was from at-the-market offerings and $ 85.0 million was from the sale of convertible preferred stock. In July 2021, the Company closed an underwritten public offering of 4,758,620 shares of common stock at the public offering price of $ 145.00 per share, for aggregate estimated net proceeds of $ 648.1 million after deducting approximately $ 41.9 million in underwriting discounts
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and estimated offering costs (see Note 13 for further details). The Company expect s that its cash, cash equivalents and marketable securities as of June 3 0 , 20 2 1 , a long with the proceeds from the July 2 021 public offering of common stock , 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 condensed consolidated financial statements .
2.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies” to the consolidated financial statements included in the Annual Report for the year ended December 31, 2020. There have been no material changes during the six months ended June 30, 2021, other than as noted below .
Recent Accounting Pronouncements – Adopted
In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify the accounting for income taxes . ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The Company adopted ASU 2019-12 on January 1, 2021. The adoption did not have a material effect on the Company’s condensed consolidated financial statements.
3.
Marketable Securities
The following table summarizes the Company’s available-for-sale marketable securities as of June 30, 2021 and December 31, 2020 at net book value:
June 30, 2021
Amortized
Cost
Gross Unrealized
Gains
Gross Unrealized
Losses
Estimated Fair
Value
(In thousands)
Marketable securities:
U.S. Treasury and other government securities
$
163,832
$
22
$
( 2
)
$
163,852
Financial institution debt securities
182,076
12
( 47
)
182,041
Corporate debt securities
42,191
2
-
42,193
Other asset-backed securities
33,315
1
-
33,316
Total
$
421,414
$
37
$
( 49
)
$
421,402
December 31, 2020
Amortized
Cost
Gross Unrealized
Gains
Gross Unrealized
Losses
Estimated Fair
Value
(In thousands)
Marketable securities:
U.S. Treasury and other government securities
$
245,666
$
13
$
( 11
)
$
245,668
Financial institution debt securities
138,445
6
( 8
)
138,443
Corporate debt securities
41,765
3
( 2
)
41,766
Other asset-backed securities
11,474
1
( 1
)
11,474
Total
$
437,350
$
23
$
( 22
)
$
437,351
The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. At June 30, 2021 and December 31, 2020, 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. There were no realized gains or losses in the six months ended June 30, 2021 or for the year ended December 31, 2020. The Company did not reclassify any amounts out of accumulated other comprehensive (loss) income during this period. The Company did not have any securities in a material unrealized loss position at June 30, 2021 or December 31, 2020.
The Company's available-for-sale securities that are classified as short-term marketable securities in the condensed 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 condensed 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 June 30,
7
202 1 and December 31, 20 20 , the Company did no t hold any investments that matured beyond five year s 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 (unadjusted) 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 June 30, 2021 and December 31, 2020, the Company’s financial assets recognized at fair value on a recurring basis consisted of the following:
Fair Value as of June 30, 2021
Total
Level 1
Level 2
Level 3
(In thousands)
Cash equivalents and restricted cash equivalents
$
130,005
$
130,005
$
-
$
-
Marketable securities:
U.S. Treasury and other government securities
163,852
140,494
23,358
-
Financial institution debt securities
182,041
-
182,041
-
Corporate debt securities
42,193
-
42,193
-
Other asset-backed securities
33,316
-
33,316
-
Total marketable securities
421,402
140,494
280,908
-
Total
$
551,407
$
270,499
$
280,908
$
-
Fair Value as of December 31, 2020
Total
Level 1
Level 2
Level 3
(In thousands)
Cash equivalents and restricted cash equivalents
$
163,805
$
163,805
$
-
$
-
Marketable securities:
U.S. Treasury and other government securities
245,668
241,664
4,004
-
Financial institution debt securities
138,443
-
138,443
-
Corporate debt securities
41,766
-
41,766
-
Other asset-backed securities
11,474
-
11,474
-
Total marketable securities
437,351
241,664
195,687
-
Total
$
601,156
$
405,469
$
195,687
$
-
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 June 30, 2021 or December 31, 2 020.
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.
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5 .
Accrued Expenses
Accrued expenses consisted of the following:
June 30,
December 31,
2021
2020
(In thousands)
Accrued research and development
$
18,399
$
11,008
Employee compensation and benefits
10,039
10,920
Accrued legal and professional expenses
4,109
1,876
Accrued other
4,603
1,750
Total accrued expenses
$
37,150
$
25,554
6.
Commitments and Contingencies
Litigation
There have been no material changes to any of the outstanding litigation, nor is the Company a party to any new litigation, since December 31, 2020, except as described b elow. For further information please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2020.
Caribou Arbitration
On October 17, 2018, the Company initiated an arbitration proceeding against Caribou Biosciences, Inc. (“Caribou”) asserting that Caribou violated the terms and conditions of a license agreement the Company entered into with them in July 2014 related to certain IP (the “Caribou License”), as well as other contractual and legal obligations to the Company, by using and seeking to license to third parties two patent families relating to specific structural or chemical modifications of guide RNAs (“gRNAs”), that were purportedly invented or controlled by Caribou, in the Company’s exclusive human therapeutic field, before an agreed-upon cutoff date of January 30, 2018.
On September 26, 2019, the Company announced that the arbitration panel issued an interim award concluding that both the structural and chemical gRNA modification technologies were exclusively licensed to the Company by Caribou pursuant to the Caribou License. Nevertheless, the arbitration panel, solely with respect to the clinically modified gRNAs, stated that it will declare that Caribou has an equitable “leaseback”, which it described as exclusive, perpetual and worldwide (the “Caribou Award”). The Caribou Award does not include the structural guide modifications IP also at issue in the arbitration, any other IP exclusively licensed or sublicensed by Caribou to the Company under the Caribou License (including but not limited to the foundational CRISPR/Cas9 IP co-owned by the Regents of the University of California, University of Vienna and Dr. Emmanuelle Charpentier), or any other of the Company’s IP. On February 6, 2020, the panel clarified that the Caribou Award is limited to a particular on-going Caribou program, known as CB-010, which seeks to develop a chimeric antigen receptor T (“CAR-T”) product directed at CD19.
On June 16, 2021, the Company executed a Leaseback Agreement (“Leaseback”) with Caribou, which settles the ongoing arbitration. Under the Leaseback negotiated by the parties, in exchange for an upfront payment, potential future regulatory and sales milestones, and single-digit royalties payable by Caribou, the Company has agreed to leaseback or sublicense certain CRISPR/Cas9 IP, including the Company’s chemical gRNA modification technology and foundational CRISPR/Cas9 IP, to Caribou so that it can develop and commercialize CB-010. Caribou also will be responsible for any payments required in respect of the Company’s in-licensed IP. The Company recorded $ 1.0 million within “Collaboration Revenue” on the condensed consolidated statements of operations and comprehensive loss for an upfront payment related to the Leaseback.
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 June 30, 2021, the satisfaction and timing of the contingent payments is uncertain and not reasonably estimable .
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7 .
Collaborations
To accelerate the development and commercialization of CRISPR/Cas9-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/Cas9 therapeutic development. As of June 30, 2021, the Company’s accounts receivable is made up of $ 1.0 million for an upfront payment related to the Leaseback with Caribou (see Note 6) and $ 1.0 million related to the collaboration with Regeneron, and the Company’s contract liabilities were related to its collaboration with Regeneron.
The following table presents changes in the Company’s accounts receivable and contract liabilities during the six months ended June 30, 2021 and 2020 (in thousands):
Balance at
Beginning of
Period
Additions
Deductions
Balance at End
of Period
Six Months Ended June 30, 2021
Accounts receivable
$
2,130
$
3,079
$
( 3,216
)
$
1,993
Contract liabilities - Deferred revenue
$
73,931
$
-
$
( 11,179
)
$
62,752
Balance at
Beginning of
Period
Additions
Deductions
Balance at End
of Period
Six Months Ended June 30, 2020
Accounts receivable
$
4,620
$
101,049
$
( 101,805
)
$
3,864
Contract liabilities - Deferred revenue
$
28,810
$
87,477
$
( 15,608
)
$
100,679
During the six months ended June 30, 2021 and 2020, the Company recognized the following revenues as a result of changes in the contract liability balance (in thousands):
Six Months Ended June 30,
Revenue recognized in the period from:
2021
2020
Amounts included in the contract liability at the beginning of the period
$
11,179
$
5,674
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.
License and Collaboration Agreement
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”).
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On May 30, 2020, the Company entered into (i) amendment no. 1 (the “2020 Regeneron Amendment”) to the 2016 Regeneron Agreemen t , (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 a 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 additiona l i n 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, 2020, 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, 2020.
Revenue Recognition – Collaboration Revenue. Through June 30, 2021, 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 $ 35.6 million for research and development services, primarily under the ATTR Co/Co agreement. Through June 30, 2021 , the Company has recognized $ 135.2 million of collaboration revenue under all arrangements, including $ 5.5 million and $ 12.0 million during the three and six months ended June 30, 2021, respectively, and $ 1 6.3 million and $ 24.2 million during the three and six months ended June 30, 2020, respectively, in the condensed consolidated statements of operations and comprehensive loss. This includes $ 1.0 million and $ 1.8 million during the three and six months ended June 30, 2021, respectively, and $ 3.8 million and $ 8.6 million during the three and six months ended June 30, 2020, respectively, primarily representing payments due 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 $ 1.0 million during the three and six months ended June 30, 2021, respectively.
As of June 30, 2021, there was approximately $ 62.8 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 June 30, 2021 and December 31, 2020, the Company had accounts receivable of $ 1.0 million and $ 2.1 million, respectively, related to the Amended Agreements. The Company had deferred revenue of $ 62.8 million and $ 73.9 million as of June 30, 2021 and December 31, 2020, respectively, related to the Amended Agreements.
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 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 condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2021. Since December 31, 2020, there have been no other material changes to the key terms of the 2014 Novartis Agreement and the Novartis Amendment. 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, 2020.
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Revenue Recognition – Milestone . 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 condensed consolidated statement of operations and comprehensive loss. No other milestones under the 2014 Novartis Agreement and the Novartis Amendment were achieved during the three or six months ended June 30, 2021 or 2020. The Company is eligible to receive additional downstream success-based milestones and royalties.
As of June 30, 2021 and December 31, 2020, the Company had no accounts receivable or deferred revenue related to the 2014 Novartis Agreement and the Novartis Amendment.
8 .
Leases
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 Company’s obligation to pay rent will start on the date that is six months after the commencement date or the date on which the Company occupies the premises, whichever occurs earlier (the “Rent Commencement Date”). The initial term of the 281 Albany Lease is ten years following the Rent Commencement Date. In March 2021 the Company determined, in accordance with Accounting Standards Codification 842, “Leases (Topic 842)” , that the commencement date of the lease had been met as the facility was substantially complete and available for use and, accordingly, the Company recognized a right-of-use asset and a lease liability of approximately $ 40.4 million and $ 34.8 million, respectively, in the first quarter of 2021 related to the 281 Albany Lease. In determining the lease liability, the Company used an incremental borrowing rate of 5.52 % based on a number of factors including the total lease payments, the Company’s credit rating, and the lease term. Included in the recognized right-of-use asset at the inception of the lease was approximately $ 5.6 million in lease payments that were prepaid under the terms of the lease. The base rent under the 281 Albany Lease is $ 99.00 per square foot per year during the first year of the term, which is subject to scheduled annual increases up to $ 128.87 per square foot per year during the last year of the initial term, plus certain operating expenses and taxes. In addition, the landlord agreed to contribute an aggregate of $ 4.4 million toward the cost of construction and tenant improvements for the premises. In accordance with the 281 Albany Lease, the Company is required to maintain a letter of credit in the amount of $ 1.9 million that is restricted for the term of the lease. These restricted cash equivalents are reported in “Other Assets” in the Company’s condensed consolidated balance sheets. The Company has the option to extend the 281 Albany Lease for two successive five-year terms. The option for this extension is not included as part of the lease liability and right-of-use asset at June 30, 2021, as it is not reasonably certain that it will be exercised.
9.
Equity-Based Compensation
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, 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. 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 .
As of June 30, 2021, there were 3,938,391 shares available for future issuance under the 2015 Plan and the 2016 Employee Stock Purchase 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 common stock issued and outstanding on the immediately preceding December 31 or such lesser number of shares of common stock as determined by the board of directors. The number of shares reserved for issuance under the 2016 Employee Stock Purchase 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 sha res of common stock as determined by the board of directors.
12
Equity-based compensation expense is classified in the condensed consolidated statements of operations and comprehensive loss as follows:
Three Months Ended June 30,
Six Months Ended June 30,
2021
2020
2021
2020
(In thousands)
Research and development
$
6,135
$
2,390
$
9,626
$
4,550
General and administrative
4,479
2,374
7,412
4,371
Total
$
10,614
$
4,764
$
17,038
$
8,921
Restricted Stock Units
Restricted stock units are measured at fair value based on the quoted price of the Company’s common stock.
The following table summarizes the Company’s restricted stock activity for the six months ended June 30, 2021:
Number of
Shares
Weighted
Average Grant
Date Fair Value
per Share
Unvested restricted stock units as of December 31, 2020
193,936
$
23.98
Granted
353,072
62.82
Vested
( 26,235
)
15.05
Cancelled
( 23,588
)
38.90
Unvested restricted stock units as of June 30, 2021
497,185
$
51.33
In March 2021, the Company granted 259,839 RSUs with a service condition to executive and non-executive employees as part of their annual grant, which vest over a period of four years . The weighted average grant date fair value of these RSUs was $ 57.71 . The vesting start date for these RSUs is January 1, 2021.
Included in the unvested restricted stock as of June 30, 2021 are 78,705 RSUs that include a performance condition in addition to a service condition. These RSUs will vest over a period of 1.5 years and are subject to accelerated vesting based on the Company’s programs achieving certain development milestones before December 1, 2022. The fair value of the RSUs at date of grant was $ 15.05 . An additional 26,235 shares from this grant vested in the six months ended June 30, 2021, as a service condition had been reached.
As of June 30, 2021, there was $ 22.8 million of unrecognized equity-based compensation expense related to restricted stock that is expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 3.1 years.
13
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 $ 48.44 and $ 38.70 per option for those options granted during the three and six months ended June 30, 2021 and $ 9.04 and $ 8.16 per option for those options granted during the three and six months ended June 30, 2020, respectively. The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised during the three and six months ended June 30, 2021 was $ 29.7 million and $ 84.5 million, respectively, and during the three and six months ended June 30, 2020 was $ 0.5 million and $ 0.8 million, respectively. Weighted average assumptions used to apply this pricing model were as follows:
Three Months Ended June 30,
Six Months Ended June 30,
2021
2020
2021
2020
Risk-free interest rate
1.1 %
0.4 %
0.9 %
0.9 %
Expected life of options
6.0 years
5.5-6.0 years
6.0 years
5.5-6.0 years
Expected volatility of underlying stock
73.0 %
70.2 %
72.2 %
67.3 %
Expected dividend yield
0.0 %
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.
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.
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 six months ended June 30, 2021:
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, 2020
6,977,440
$
15.43
Granted
1,993,802
61.07
Exercised
( 1,409,370
)
13.84
Forfeited
( 298,214
)
27.85
Outstanding at June 30, 2021
7,263,658
$
27.75
8.14
$
974,470
Exercisable at June 30, 2021
2,815,568
As of June 30, 2021, there was $ 91.6 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 3.1 years.
14
10 .
Loss Per Share
The Company calculates basic loss per share by dividing net loss for each respective period by the weighted average number of common shares outstanding for each respective period. The Company computes diluted loss 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.
Basic and diluted loss per share was calculated as follows:
Three Months Ended June 30,
Six Months Ended June 30,
2021
2020
2021
2020
(In thousands)
Net loss
$
( 68,806
)
$
( 32,393
)
$
( 115,011
)
$
( 64,199
)
Weighted average shares outstanding, basic
and diluted
68,164
53,369
67,675
51,938
Net loss per share, basic and diluted
$
( 1.01
)
$
( 0.61
)
$
( 1.70
)
$
( 1.24
)
The following common stock equivalents were excluded from the calculation of diluted loss per share because their inclusion would have been anti-dilutive:
Three and Six Months Ended June 30,
2021
2020
(In thousands)
Unvested restricted stock units
497
248
Stock options
7,264
7,581
7,761
7,829
15
11 .
Stockholders’ Equity
The following tables present changes in stockholders’ equity for the six-month periods ended June 30, 2021 and 2020 (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, 2020
66,234,056
$
7
$
962,173
$
1
$
( 435,109
)
$
527,072
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
1,014,569
-
13,340
-
-
13,340
Equity-based compensation
-
-
6,424
-
-
6,424
Other comprehensive loss
-
-
-
( 13
)
-
( 13
)
Net loss
-
-
-
-
( 46,205
)
( 46,205
)
Balance at March 31, 2021
67,890,334
7
1,027,192
( 12
)
( 481,314
)
545,873
Exercise of stock options
394,801
-
6,163
-
-
6,163
Vesting of restricted units
26,235
-
-
-
-
-
Issuance of shares under employee stock
purchase plan
20,410
-
970
-
-
970
Equity-based compensation
-
-
10,614
-
-
10,614
Other comprehensive loss
-
-
-
( 1
)
-
( 1
)
Net loss
-
-
-
-
( 68,806
)
( 68,806
)
Balance at June 30, 2021
68,331,780
$
7
$
1,044,939
$
( 13
)
$
( 550,120
)
$
494,813
Additional
Accumulated
Other
Total
Common
Paid-In
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income
Deficit
Equity
Balance at December 31, 2019
50,198,044
$
5
$
570,493
$
261
$
( 300,878
)
$
269,881
Issuance of common stock through at-the-market
offerings, net of issuance costs of $ 48
351,252
-
5,079
-
-
5,079
Exercise of stock options
53,579
-
336
-
-
336
Equity-based compensation
-
-
4,157
-
-
4,157
Other comprehensive income
-
-
-
112
-
112
Net loss
-
-
-
-
( 31,806
)
( 31,806
)
Balance at March 31, 2020
50,602,875
5
580,065
373
( 332,684
)
247,759
Issuance of common stock through follow-on
offering, net of issuance costs of $ 369
6,301,370
1
107,731
-
-
107,732
Issuance of common stock in private placement
with Regeneron
925,218
-
12,580
-
-
12,580
Issuance of common stock through at-the-market
offerings, net of issuance costs of $ 23
755,848
-
9,643
-
-
9,643
Exercise of stock options
83,631
-
1,035
-
-
1,035
Issuance of shares under employee stock
purchase plan
55,296
-
685
-
-
685
Equity-based compensation
-
-
4,764
-
-
4,764
Other comprehensive loss
-
-
-
( 218
)
-
( 218
)
Net loss
-
-
-
-
( 32,393
)
( 32,393
)
Balance at June 30, 2020
58,724,238
$
6
$
716,503
$
155
$
( 365,077
)
$
351,587
At-the-Market Offering Programs
I n August 2019, the Company entered into an Open Market Sale Agreement (the “2019 Sales Agreement”) with 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
16
proceeds of sales of common stock under the 2019 Sales Agreement. Please refer to the Company’s Annual Report for the year ended December 31, 2020 for additional information regarding these offerings.
During the six months ended June 30, 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 Sales 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 six months ended June 30, 2020, the Company issued 1,107,100 shares of its common stock in a series of sales at an average price of $ 13.78 per share in accordance with the 2019 Sales Agreement, for aggregate net proceeds of $ 14.7 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 June 30, 2021, $ 47.4 million in shares of common stock remain eligible for sale under the 2019 Sales Agreement.
1 2 .
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 condensed consolidated financial statements.
13.
Subsequent Events
New CAR-T Cell Therapy Company
On June 22, 2021, the Company announced that it has entered into an agreement with Cellex Cell Professionals GmbH (“Cellex”) and funds managed by Blackstone Life Sciences Advisors L.L.C. (“BXLS”) to establish a new CAR-T cell therapy company (“NewCo”) that will be focused on the development of allogeneic universal CAR-T cell therapies for immuno-oncology and autoimmune diseases. The new company will be headquartered in Cambridge, Massachusetts and will acquire Cellex’s subsidiary GEMoaB GmbH (“GEMoaB”), with established offices and labs in Dresden, Germany. The new company will have an exclusive license to Intellia’s CRISPR/Cas9 allogeneic cell engineering platform limited to its use with GEMoaB’s switchable, universal CAR-T cell platforms (UniCAR and RevCAR). As a subsidiary of the new company, GEMoaB will continue to advance its clinical-stage, autologous CAR-T cell therapy programs. Funds managed by Blackstone Life Sciences have committed up to $ 250 million to the transaction and with Intellia and Cellex (and certain related entities) have equal ownership of the new company at the time of the initial closing. The transaction closed in the third quarter of 2021.
In July 2021, the new company and Intellia entered into a license and collaboration agreement with NewCo, under which the Company will collaborate to develop allogeneic universal CAR-T cell therapies, as well as a co-development and co-funding (“Co/Co”) agreement to co-develop an allogeneic universal CAR-T cell product for an immuno-oncology indication, which the parties will co-commercialize in the U.S. and key European countries. The Company will have one additional option to enter into a second Co/Co agreement from selected allogeneic universal CAR-T cell therapy products that the parties will develop under the collaboration.
July 2021 Offering
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 (inclusive of shares sold pursuant to the exercise of the underwriters’ option to purchase additional shares) at a public offering price of $ 145.00 per share. The offering closed on July 2, 2021, for aggregated estimated net proceeds of $ 648.1 million after deducting $ 41.9 million in underwriting discounts and estimated offering costs.
New Lease Agreement
In July 2021, the Company entered into an agreement to lease approximately 13,662 square feet of space at 17 Tudor Street in Cambridge, Massachusetts under an operating lease agreement (the “17 Tudor Lease”). The Company’s obligation to pay rent will start on November 1, 2021. The initial term of the 17 Tudor Lease is five years . The Company has an option to extend the 17 Tudor Lease for one three-year term. The base rent under the 17 Tudor Lease is $ 74.00 per square foot during the first year of the term, which is subject to scheduled annual increases throughout the term, resulting in a base rent of $ 83.29 per square foot during the last year of the initial term, plus certain operating expenses and taxes.
17
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.