Item 1. Financial Statements
Item 1. Financial Statements.
ARCUS BIOSCIENCES, INC.
Condensed Consolida ted Balance Sheets
(unaudited)
(In thousands, except share and per share amounts)
September 30,
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$
179,432
$
173,415
Short-term investments
345,210
555,231
Receivable from collaboration partners ($ 617 and $ 943 from a related party)
871
1,049
Accrued interest receivable
2,201
649
Prepaid expenses and other current assets
17,574
5,471
Total current assets
545,288
735,815
Long-term investments
218,730
6,440
Property and equipment, net
28,818
10,807
Right-of-use assets
35,553
12,781
Restricted cash
3,005
203
Other long-term assets
7,896
6,246
Total assets
$
839,290
$
772,292
LIABILITIES
Current liabilities:
Accounts payable
$
13,219
$
15,682
Accrued research and development
40,470
18,307
Other accrued liabilities
14,625
9,543
Deferred revenue, current ($ 67,571 and $ 67,571 to a related party)
74,343
74,571
Other current liabilities
209
3,566
Total current liabilities
142,866
121,669
Deferred revenue, noncurrent ($ 94,675 and $ 117,808 to a related party)
94,675
122,830
Operating lease liabilities, noncurrent
48,943
15,243
Other long-term liabilities ($ 9,703 and $ 9,703 to a related party)
10,199
10,246
Total liabilities
296,683
269,988
Commitments (Note 11)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized as of September 30, 2021 and December 31, 2020; no shares issued and outstanding as of September 30, 2021 and December 31, 2020
-
-
Common stock, $ 0.0001 par value, 400,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 70,241,590 and 65,114,685 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively. Shares outstanding includes 39,142 and 1,422,784 shares issued but subject to vesting as of September 30, 2021 and December 31, 2020, respectively
7
6
Additional paid-in capital
1,097,414
830,438
Accumulated deficit
( 554,722
)
( 328,184
)
Accumulated other comprehensive (loss) income
( 92
)
44
Total stockholders’ equity
542,607
502,304
Total liabilities and stockholders’ equity
$
839,290
$
772,292
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
ARCUS BIOSCIENCES, INC.
Condensed Consolidated Statements o f Operations and Comprehensive Loss
(unaudited)
(In thousands, except share and per share amounts)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Revenues:
License revenue ($ 0 , $ 55,096 , $ 0 and $ 55,096 from a related party)
$
-
$
55,096
$
-
$
55,096
Collaboration revenue ($ 7,711 , $ 7,684 , $ 23,133 and $ 7,684 from a related party)
9,461
9,434
28,383
12,934
Total revenues
9,461
64,530
28,383
68,030
Operating expenses:
Research and development (($ 756 ), ($ 2,971 ), ($ 6,856 ) and ($ 2,971 ) from a related party)
71,254
51,801
206,412
110,636
General and administrative
16,343
11,177
48,990
29,617
Total operating expenses
87,597
62,978
255,402
140,253
Income (loss) from operations
( 78,136
)
1,552
( 227,019
)
( 72,223
)
Non-operating income (expense):
Interest and other income, net
161
270
481
1,218
Gain on deemed sale from equity method investee
-
-
-
613
Share of loss from equity method investee
-
-
-
( 613
)
Total non-operating income, net
161
270
481
1,218
Net income (loss)
( 77,975
)
1,822
( 226,538
)
( 71,005
)
Other comprehensive income (loss)
( 46
)
( 63
)
( 136
)
17
Comprehensive income (loss)
$
( 78,021
)
$
1,759
$
( 226,674
)
$
( 70,988
)
Net income (loss) per share, basic
$
( 1.11
)
$
0.03
$
( 3.28
)
$
( 1.37
)
Weighted-average number of shares used to
compute basic net income (loss) per share
70,110,138
62,599,193
68,990,290
51,852,247
Net income (loss) per share, diluted
$
( 1.11
)
$
0.03
$
( 3.28
)
$
( 1.37
)
Weighted-average number of shares used to
compute diluted net income (loss) per share
70,110,138
65,145,707
68,990,290
51,852,247
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
ARCUS BIOSCIENCES, INC.
Condensed Consolidated Sta tements of Stockholders’ Equity
(unaudited)
(In thousands, except share amounts)
Common stock
Additional
Paid-In
Accumulated
Accumulated
Other
Comprehensive
Total
Stockholders’
Shares
Amount
Capital
Deficit
Income (Loss)
Equity
Balance at December 31, 2019
44,212,195
$
4
$
369,100
$
( 205,326
)
$
64
$
163,842
Issuance of common stock upon exercise of stock options
59,939
-
643
-
-
643
Vesting of early exercised stock options
77,388
-
220
-
-
220
Stock-based compensation
-
-
3,462
-
-
3,462
Other comprehensive income
-
-
-
-
224
224
Net loss
-
-
-
( 27,753
)
-
( 27,753
)
Balance at March 31, 2020
44,349,522
$
4
$
373,425
$
( 233,079
)
$
288
$
140,638
Issuance of common stock in public offering, net of $ 21,629 offering costs ( 2,200,000 shares and $ 56,738 , net of $ 3,762 offering costs, from a related party)
12,650,000
2
326,244
-
-
326,246
Issuance of common stock upon exercise of stock options
216,286
-
1,751
-
-
1,751
Vesting of early exercised stock options
64,501
-
216
-
-
216
Issuance of common stock under Employee Stock Purchase Plan
91,859
-
607
-
-
607
Stock-based compensation
-
-
4,470
-
-
4,470
Other comprehensive loss
-
-
-
-
( 144
)
( 144
)
Net loss
-
-
-
( 45,074
)
-
( 45,074
)
Balance at June 30, 2020
57,372,168
$
6
$
706,713
$
( 278,153
)
$
144
$
428,710
Issuance of common stock and rights to purchase additional shares to related party in accordance with Gilead Purchase Agreement, net of $ 1,931 offering costs
5,963,029
-
107,468
-
-
107,468
Issuance of common stock upon exercise of stock options
30,039
-
270
-
-
270
Vesting of early exercised stock options
60,209
-
208
-
-
208
Stock-based compensation
-
-
6,002
-
-
6,002
Other comprehensive loss
-
-
-
-
( 63
)
( 63
)
Net income
-
-
-
1,822
-
1,822
Balance at September 30, 2020
63,425,445
$
6
$
820,661
$
( 276,331
)
$
81
$
544,417
Balance at December 31, 2020
63,691,901
$
6
$
830,438
$
( 328,184
)
$
44
$
502,304
Issuance of common stock and rights to purchase additional shares in accordance with Amended and Restated Gilead Purchase Agreement, net of $ 55 offering costs
5,650,000
1
220,295
-
-
220,296
Issuance of common stock upon exercise of stock options
and vesting of restricted stock
200,828
-
1,885
-
-
1,885
Vesting of early exercised stock options
54,039
-
183
-
-
183
Stock-based compensation
-
-
12,761
-
-
12,761
Other comprehensive loss
-
-
-
-
( 46
)
( 46
)
Net loss
-
-
-
( 72,593
)
-
( 72,593
)
Balance at March 31, 2021
69,596,768
$
7
$
1,065,562
$
( 400,777
)
$
( 2
)
$
664,790
Issuance of common stock upon exercise of stock options
and vesting of restricted stock
269,369
-
843
-
-
843
Vesting of early exercised stock options
36,245
-
175
-
-
175
Issuance of common stock under Employee Stock Purchase Plan
140,408
-
1,394
-
-
1,394
Stock-based compensation
-
-
13,367
-
-
13,367
Other comprehensive loss
-
-
-
-
( 44
)
( 44
)
Net loss
-
-
-
( 75,970
)
-
( 75,970
)
Balance at June 30, 2021
70,042,790
$
7
$
1,081,341
$
( 476,747
)
$
( 46
)
$
604,555
Issuance of common stock upon exercise of stock options and vesting of restricted stock
125,182
-
1,318
-
-
1,318
Vesting of early exercised stock options
34,476
-
170
-
-
170
Stock-based compensation
-
-
14,585
-
-
14,585
Other comprehensive loss
-
-
-
-
( 46
)
( 46
)
Net loss
-
-
-
( 77,975
)
-
( 77,975
)
Balance at September 30, 2021
70,202,448
$
7
$
1,097,414
$
( 554,722
)
$
( 92
)
$
542,607
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ARCUS BIOSCIENCES, INC.
Condensed Consolidated S tatements of Cash Flows
(unaudited)
(In thousands)
Nine Months Ended
September 30,
2021
2020
Cash flow from operating activities
Net loss
$
( 226,538
)
$
( 71,005
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
40,713
13,934
Depreciation and amortization
2,583
2,371
Amortization of right-of-use assets
1,701
552
Amortization of premiums on investments
2,804
( 333
)
Changes in operating assets and liabilities:
Receivable from collaboration partners ($ 326 and ($ 2,504 ) from a related party)
178
( 2,447
)
Prepaid expenses and other current assets
( 5,290
)
( 6,906
)
Other long-term assets
750
( 1,373
)
Accounts payable
( 5,424
)
3,165
Accrued research and development
19,163
23,665
Other accrued liabilities
5,082
2,485
Other current liabilities ($ 0 and $ 1,869 to a related party)
-
1,869
Deferred revenue (($ 23,133 ) and $ 193,140 to a related party)
( 28,383
)
187,890
Operating lease liabilities
( 1,405
)
( 790
)
Other long-term liabilities ($ 0 and $ 7,344 to a related party)
( 2
)
7,973
Net cash used in operating activities
( 194,068
)
161,050
Cash flow from investing activities
Purchases of short-term and long-term investments
( 584,850
)
( 568,903
)
Proceeds from maturities of short-term and long-term investments
572,140
135,300
Sales of short-term and long-term investments
7,500
1,003
Purchases of property and equipment
( 17,572
)
( 1,536
)
Net cash used in investing activities
( 22,782
)
( 434,136
)
Cash flow from financing activities
Proceeds from issuance of common stock ($ 220,235 and $ 164,207 from a related party)
220,235
433,776
Proceeds from issuance of common stock pursuant to equity award plans
5,440
3,271
Repurchase of unvested shares of stock
( 6
)
( 49
)
Net cash provided by financing activities
225,669
436,998
Net increase in cash and cash equivalents
8,819
163,912
Cash, cash equivalents and restricted cash at beginning of period
173,618
58,140
Cash, cash equivalents and restricted cash at end of period
$
182,437
$
222,052
Supplemental disclosures:
Cash paid for amounts included in measurement of lease liabilities
$
3,074
$
1,572
Cash received from tenant improvement allowances
$
792
$
-
Non-cash investing and financing activities:
Right-of-use assets obtained in exchange for new operating lease liabilities
$
24,473
$
13,004
Recognition of tenant improvement allowance receivable included in other current assets
$
10,598
$
979
Unpaid portion of property and equipment purchases included in accounts payable and accrued liabilities
$
4,605
$
245
Unpaid portion of other assets included in accrued research and development
$
3,000
$
-
Vesting of early exercised stock options and restricted stock
$
529
$
643
Unpaid portion of financing costs included in accrued liabilities
$
-
$
61
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ARCUS BIOSCIENCES, INC.
Notes to Condensed Con solidated Financial Statements
Note 1. Organization
Description of Business
Arcus Biosciences, Inc. (the Company) is a clinical-stage biopharmaceutical company focused on creating best-in-class cancer therapies. The Company’s initial focus has been on well-characterized biological pathways with significant scientific data supporting their importance. Since its inception in 2015, the Company has built a robust and highly efficient drug discovery capability to create highly differentiated small molecules, which the Company is developing in combination with its in-licensed monoclonal antibodies through rationally designed, indication-specific clinical trial designs. The Company currently has six investigational products in clinical development: domvanalimab (formerly referred to as AB154), etrumadenant (formerly referred to as AB928), quemliclustat (formerly referred to as AB680), zimberelimab (formerly referred to as AB122), AB308 and AB521.
Liquidity and Capital Resources
As of September 30, 2021, the Company had cash and investments of $ 743.4 m illion, which are cash, cash equivalents, and investments in marketable securities, which the Company believes will be sufficient to fund its planned operations for a period of at least twelve months following the date of filing of this report.
Note 2. Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the Company’s opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the periods presented have been included.
Operating results for the nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021 or for any future period. The balance sheet as of December 31, 2020 has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements.
The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 25, 2021. There have been no significant changes to the Company’s significant accounting policies described in Note 2, Summary of Significant Accounting Policies, in Notes to Consolidated Financial Statements in Item 8 of Part II of the Form 10-K.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Arcus Biosciences, Inc. and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
5
Use of Estimates
The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, as well as related disclosures of contingent assets and liabilities. Estimates were used to determine the standalone selling price of performance obligations and the timing of revenue recognition, the value of stock-based awards and other issuances, accruals for research and development costs, useful lives of long-lived assets, and uncertain tax positions. Actual results could differ materially from the Company’s estimates.
Cash Equivalents and Investments
Cash equivalents include marketable securities having an original maturity of three months or less at the time of purchase. Short-term investments have maturities of greater than three months and up to twelve months at the time of purchase. Long-term investments have maturities greater than 12 months at the time of purchase. Collectively, cash equivalents, short-term and long-term investments are considered available-for-sale and are recorded at fair value. Unrealized gains and losses are recorded in accumulated other comprehensive income (loss). Realized gains and losses are included in interest and other income, net in the condensed consolidated statements of operations and comprehensive income or loss. The basis on which the cost of a security that is sold or an amount that is reclassified out of accumulated other comprehensive income or loss into earnings is determined using the specific identification method.
Reconciliation of Cash, Cash Equivalents, and Restricted Cash as Reported in Condensed Consolidated Statements of Cash Flows
Restricted cash at September 30, 2021 and 2020 represents cash balances held as security in connection with the Company’s facility lease agreements. The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the condensed consolidated balance sheets to the total shown in the condensed consolidated statements of cash flows (in thousands):
September 30,
2021
2020
Cash and cash equivalents
$
179,432
$
221,849
Restricted cash
3,005
203
Cash, cash equivalents and restricted cash
$
182,437
$
222,052
Concentration of Credit Risk
Cash equivalents, short-term and long-term investments are financial instruments that potentially subject the Company to concentrations of credit risk. The Company invests in money market funds, treasury bills and notes, government bonds, commercial paper and corporate notes. The Company limits its credit risk associated with cash equivalents, short-term and long-term investments by placing them with banks and institutions it believes are credit worthy and in highly rated investments.
Leases and Rent Expense
The Company recognizes a lease asset for its right to use the underlying asset and a lease liability for the corresponding lease obligation. The Company determines whether an arrangement is or contains a lease at contract inception. Operating leases and related tenant improvement allowances receivable are included in operating lease right-of-use assets, prepaid expenses and other current assets, and operating lease liabilities, noncurrent in our condensed consolidated balance sheets at September 30, 2021 and December 31, 2020. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its incremental borrowing rate based on information available at the lease commencement date. The incremental borrowing rate represents the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease. The Company considers a lease term to be the noncancelable period that it has the right to use the underlying asset, including any periods where it is reasonably assured the Company will exercise the option to extend the contract. Periods covered by an option to extend are included in the lease term if the lessor controls the exercise of that option.
The Company elected to not apply the recognition requirements of the new leasing standard to short-term leases with terms of 12 months or less which do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. For short-term leases, lease payments are recognized as operating expenses on a straight-line basis over the lease term.
Note 3. Fair Value Measurements
Financial assets and liabilities are recorded at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market
6
participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
During the periods presented, the Company has not changed the manner in which it values assets and liabilities that are measured at fair value. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy as of September 30, 2021 and December 31, 2020. The following tables set forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):
September 30, 2021
Total
Level 1
(Quoted Prices in
Active Markets For
Identical Assets)
Level 2
(Significant Other
Observable
Remaining Inputs)
Level 3
(Significant Other
Unobservable
Remaining Inputs)
Money market funds
$
172,431
$
172,431
$
-
$
-
U.S. treasury securities
109,946
-
109,946
-
Corporate securities and commercial paper
460,995
-
460,995
-
Total assets measured at fair value
$
743,372
$
172,431
$
570,941
$
-
December 31, 2020
Total
Level 1
(Quoted Prices in
Active Markets For
Identical Assets)
Level 2
(Significant Other
Observable
Remaining Inputs)
Level 3
(Significant Other
Unobservable
Remaining Inputs)
Money market funds
$
146,468
$
146,468
$
-
$
-
U.S. treasury securities
301,112
-
301,112
-
U.S. government agency obligations
25,001
-
25,001
-
Corporate securities and commercial paper
262,505
-
262,505
-
Total assets measured at fair value
$
735,086
$
146,468
$
588,618
$
-
Classified as (with contractual maturities):
September 30, 2021
December 31, 2020
Cash and cash equivalents
$
179,432
$
173,415
Short-term investments (due within one year)
345,210
555,231
Long-term investments (due between one and three years)
218,730
6,440
Total cash, cash equivalents and investments in marketable securities
$
743,372
$
735,086
7
Investments in marketable securities are classified as available-for-sale. At September 30, 2021 and December 31, 2020, the balance in the Company’s accumulated other comprehensive income related to the Company’s available-for-sale marketable securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale marketable securities as of September 30, 2021 and December 31, 2020, and as a result, the Company did no t reclassify any amounts out of accumulated other comprehensive income for the periods then ended. The Company has not recognized any allowances for credit losses given the nature of its receivables and investment portfolio and the immaterial amount of unrealized losses on available for sale securities. No credit related losses have been recognized for any of the periods presented. The fair value and amortized cost of investments in marketable securities by major security type as of September 30, 2021 and December 31, 2020 are presented in the tables that follow (in thousands):
Amortized
Cost
Unrealized
Gain
Unrealized
Loss
Fair
Value
As of September 30, 2021:
Money market funds
$
172,431
$
-
$
-
$
172,431
U.S. treasury securities
109,972
9
( 35
)
109,946
Corporate securities and commercial paper
461,061
53
( 119
)
460,995
Total
$
743,464
$
62
$
( 154
)
$
743,372
Amortized
Cost
Unrealized
Gain
Unrealized
Loss
Fair
Value
As of December 31, 2020:
Money market funds
$
146,468
$
-
$
-
$
146,468
U.S. treasury securities
301,075
38
( 1
)
301,112
U.S. government agency obligations
24,997
4
-
25,001
Corporate securities and commercial paper
262,502
15
( 12
)
262,505
Total
$
735,042
$
57
$
( 13
)
$
735,086
Note 4. Other Accrued Liabilities
Other a ccrued liabilities consisted of the following (in thousands):
As of September 30, 2021
As of December 31, 2020
Accrued personnel expenses
$
13,499
$
8,632
Professional fees
523
295
Other
603
616
Total
$
14,625
$
9,543
Note 5. Equity Investment in PACT Pharma
The Company owns approximately 3.6 million shares of common stock, 1.0 million shares of Series A preferred stock, and warrants to purchase additional stock of PACT Pharma, Inc. (PACT Pharma), a privately-held clinical-stage biopharmaceutical company focused on pioneering individualized, non-viral precision genome engineered, tumor-specific T cell therapies for the treatment of patients with solid tumors. This interest in PACT Pharma is accounted for as an equity method investment, and as a result the Company records its share of PACT Pharma’s operating results in interest and other income, net, in its condensed consolidated statements of operations and comprehensive loss. The investment balance was zero at September 30, 2021 and December 31, 2020 and the Company is not required to record losses beyond the carrying amount of the investment as it has no obligation to provide further cash financing to PACT Pharma. The investment had an immaterial impact on the condensed consolidated statements of operations and comprehensive loss, as well as the statement of cash flows, for each of the three and nine months ended September 30, 2021 and 2020.
At September 30, 2021 and December 31, 2020, the Company determined the fair value of the warrants to be insignificant to the condensed consolidated financial statements.
Note 6. Leases
In April 2021, the Company amended the non-cancelable operating lease for its corporate headquarters, which includes approximately 136,293 square feet of executive offices and research and development and business operations, in an office park in Hayward, California. The amended lease added 14,460 square feet of additional space in a new lease expected to commence in 2022 , and extended the term of the existing leases through at least December 31, 2031 . Once the lease of additional space commences, the
8
Company’s leased space in Hayward will total 150,753 square feet. Any extension periods defined under previous amendments were cancelled under the lease amendment and replaced by two options to extend the lease term for the entire 150,753 square feet then under lease in the Hayward premises for a period of eight years each. The Company also leases space in Brisbane, California under a non-cancelable operating lease that is expected to commence in the fourth quarter of 2021 and extend through December 31, 2031 .
At September 30, 2021 the Company’s lease portfolio had a weighted average remaining term of 10.3 years. T he leases require monthly lease payments that are subject to annual increases throughout the lease term. The optional extension periods have not been considered in the determination of the right-of-use assets or lease liabilities associated with this lease as the Company did not consider it reasonably certain it would exercise the option.
The weighted average discount rate for the Company’s lease portfolio at September 30, 2021 was 5.2 % .
Lease expense is included in operating expenses in the condensed consolidated statements o f operations and comprehensive loss. For the three and nine months ended September 30, 2021, the Company incurred lease expense of $ 1.5 million and $ 4.1 million, respectively, in relation to its operating leases. For the same periods in the prior year, the Company incurred lease expense of $ 0.7 million and $ 1.8 million, respectively. Lease costs include variable rent expense, which consists primarily of the Company’s proportionate share of operating expenses, property taxes, and insurance and is classified as lease expense due to the Company’s election to not separate lease and non-lease components. Short-term lease costs were zero and $ 0.3 mil lion for the three and nine months ended September 30, 2021, respectively. The Company incurred zero and $ 0.1 million in short-term lease costs for the same periods in the prior year.
At September 30, 2021, the Company’s operating lease right-of-use asset totaled $ 35.6 million, and the operating lease liability totaled $ 51.7 million. The difference between the amount of the right-of-use asset and the lease liabilities relates to the incentives the Company received upon signing the original leases and its most recent amendment, of which approximately $ 10.8 million is expected to be received within one year of September 30, 2021 and is recorded in prepaid expenses and other current assets, net of the $ 2.8 million short-term portion of the operating lease liability. The long term portion of the lease liability was $ 48.9 million at September 30, 2021 and is reported on the balance sheet as operating lease liability, noncurrent.
As of September 30, 2021, the Company’s future minimum lease payments were as follows (in thousands):
Operating
Year Ending December 31,
Leases
2021 (from October to December)
$
1,159
2022
5,722
2023
5,908
2024
6,101
2025
6,302
Thereafter
42,489
Total undiscounted future minimum lease payments
67,681
Less: Imputed interest
( 15,905
)
Less: Tenant improvement allowance receivable
( 10,785
)
Total operating lease liabilities
40,991
Tenant improvement allowance expected to be received in
less than one year, net of current portion of lease liability
(included in prepaid expenses and other current assets)
7,952
Operating lease liabilities, noncurrent
$
48,943
Total undiscounted future minimum lease payments do not include approxi mately $ 90.3 million and $ 5.3 million, respectively, related to the Company’s Brisbane lease and its additional space in Hayward, neither of which have yet commenced. The Brisbane lease is expected to commence during the fourth quarter of 2021 and the additional Hayward lease is expected to commence in 2022 , both with terms through at least December 31, 2031 .
The Company has provided deposits for letters of credit totaling $ 3.0 million to secure its obligations under its leases, which have been classified as restricted cash on the Company’s condensed consolidated balance sheet as of September 30, 2021.
9
Note 7. License and Collaboration Agreements
The following table summarizes the revenues for the three and nine months ended September 30, 2021 and 2020 received as a result of the Company’s collaboration agreements with Gilead Sciences, Inc. (Gilead) and Taiho Pharmaceutical Co., Ltd. (Taiho):
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
License revenue
$
-
$
55,096
$
-
$
55,096
Collaboration revenue
9,461
9,434
28,383
12,934
Total revenues
$
9,461
$
64,530
$
28,383
$
68,030
The following table summarizes details of revenues for the three and nine months ended September 30, 2021 and 2020 by collaboration and by category of revenue:
Three Months Ended September 30,
Nine Months Ended September 30,
Revenues recognized:
Over time
Point in time
2021
2020
2021
2020
Gilead license to zimberelimab
*
$
-
$
55,096
$
-
$
55,096
Gilead access rights related to the
Company's research and development pipeline
*
7,711
7,684
23,133
7,684
Taiho collaboration agreement
*
1,750
1,750
5,250
5,250
Total revenues
$
9,461
$
64,530
$
28,383
$
68,030
The Company recognized the following revenue as a result of changes in the deferred revenue balance during the period below (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
Revenue recognized in the period from:
2021
2020
2021
2020
Amounts included in deferred revenue at the beginning of the period
$
9,461
$
1,750
$
28,383
$
5,250
Performance obligations satisfied in previous period
-
-
-
-
Gilead Sciences, Inc.
On May 27, 2020, the Company entered into an Option, License and Collaboration Agreement (Gilead Collaboration Agreement), Common Stock Purchase Agreement (the Stock Purchase Agreement), and Investor Rights Agreement, (collectively, the Gilead Agreements), each with Gilead Sciences, Inc. (Gilead). The transaction closed on July 13, 2020 following expiration of the antitrust waiting period. Upon closing, Gilead made an upfront payment of $ 175 million pursuant to the Gilead Collaboration Agreement, and made an equity investment of approximately $ 200 million in the Company by purchasing 5,963,029 shares of Arcus common stock at a per share price of $ 33.54 pursuant to the Stock Purchase Agreement. Pursuant to the Investor Rights Agreement, the Company appointed two Gilead designees to the Company’s Board of Directors. See Note 12 for further discussion of the agreements with Gilead.
Pursuant to the terms of the Gilead Collaboration Agreement, Gilead has an exclusive license to develop and commercialize zimberelimab in certain markets and obtained exclusive options to acquire an exclusive license to develop and commercialize all of the Company’s current and future clinical programs during the 10-year collaboration term, contingent upon Gilead’s access rights payments of up to $ 400 million and, for those programs that enter clinical development prior to the end of the collaboration term, for up to an additional three years thereafter.
Gilead's option, on a program-by-program basis, will expire after a proscribed period, following the achievement of a development milestone in such program and the Company's delivery to Gilead of the requisite data package. If Gilead exercises its option in a timely manner, after obtaining any applicable anti-trust approvals, Gilead shall pay the Company an option fee that ranges from $ 200 million to $ 275 million per program for the Company’s clinical programs in existence at the date of the agreement, and $ 150 million per program for all other programs that enter clinical development thereafter should Gilead elect to exercise its options. Gilead may exercise its option to any program at any time prior to expiration of the option. The Company may incur consulting fees to a third party if Gilead exercises its option to certain programs on or before December 31, 2022, ranging from $ 2.0 million to $ 4.5 million for those programs.
10
Upon closing of Gilead’s exercise of its option to a program, the two companies will co-develop and equally share global development costs for the joint development program, subject to certain opt-out rights of the Company, and expense caps on the Company’s spending and related subsequent adjustments. For each optioned program, provided the Company has not exercised its opt-out rights, the Company has an option to co-promote in the United States with equal sharing of related profits and losses. Gilead has the right to exclusively commercialize any optioned programs outside of the U.S., subject to the rights of the Company’s existing partners to any territories, and Gilead will pay to the Company tiered royalties as a percentage of revenues ranging from the high teens to the low twenties.
Pursuant to the Stock Purchase Agreement and the Investor Rights Agreement, Gilead has the right, at its option, to purchase additional shares from the Company, up to a maximum of 35 % of the Company’s then-outstanding voting common stock, from time to time over a five-year period from closing of the initial transaction, at a purchase price equal to the greater of a 20 % premium to market (based on a trailing five-day average closing price) at the time Gilead exercises such option, and the $ 33.54 initial purchase price. Based on the value of the Company’s common stock at the contract closing, the right to purchase additional shares had no value. In January 2021, the Company and Gilead entered into an Amended and Restated Common Stock Purchase Agreement, which amended and restated in its entirety the Common Stock Purchase Agreement, pursuant to which Gilead purchased 5,650,000 shares of the Company’s common stock at a purchase price of $ 39.00 per share for total gross proceeds of $ 220.4 million. All other terms of the original Stock Purchase Agreement remain unchanged. The Investor Rights Agreement also includes a three-year standstill and a two-year lockup and provides Gilead with registration rights commencing at the end of the lockup period, pro rata participation rights in certain future financings and the right to designate two individuals to be appointed to the Company’s Board of Directors.
The Company’s assessment of the transaction price included an analysis of amounts it expected to receive, which at contract inception consisted of the upfront cash payment of $ 175.0 million due upon contract closing in July 2020, the $ 100.0 million payment related to the research and development access rights due in 2022, and the $ 90.6 million premium resulting from Gilead’s purchase of common stock. All payments to date have been made by Gilead as they became due and payable. Given this successful collection history, the Company considers the entire $ 365.6 million outlined above to be the initial transaction price.
The Company evaluated the Gilead Agreements under ASC 606 and determined that the performance obligations at the contract inception consisted of the following:
Zimberelimab license
Effective on closing, Gilead obtained an exclusive license to zimberelimab. The standalone selling price of this license was determined using a discounted cash flow method. The Company recognized the full revenues associated with this performance obligation on the date the transaction closed.
Etrumadenant option
Gilead has the right to exercise an option for exclusive rights to etrumadenant, the Company’s adenosine receptor program, in exchange for an option payment of $ 250.0 million, that expires after a proscribed period following the Company’s achievement of certain development milestones. The Company calculated the standalone selling price of this program using a discounted cash flow method and concluded that it exceeded the price of the option, creating a material right and a distinct performance obligation. If the option is exercised, the performance obligations associated with the option will be identified and the Company will determine the accounting for the option’s transaction price. If the exercise occurs on or before December 31, 2022, the Company will also incur $ 4.5 million in consulting fees to a third party. If the option is allowed to lapse, the Company will recognize any deferred revenue allocated to the option at the time of the lapse.
At September 30, 2021, the Company had $ 127.0 million of deferred revenue on its condensed consolidated balance sheets related to this performance obligation. The Company has evaluated the program’s status as of the balance sheet date and believes that some or all of the revenue associated with the opt-in will be recognized within the minimum four-year term of the Gilead Collaboration Agreement.
Domvanalimab option
Gilead has the right to exercise an option for exclusive rights to domvanalimab, the Company’s anti-TIGIT monoclonal antibody, in exchange for an option payment of $ 275.0 million, that expires after a proscribed period following the Company’s achievement of certain development milestones. In addition to the option payment, the Company has the right to receive clinical and regulatory milestones totaling up to $ 500 million. The Company calculated the standalone selling price of this program using a discounted cash flow method and concluded that it exceeded the price of the option, creating a material right and a distinct performance obligation. If the option is exercised, the performance obligations associated with the option will be identified and the Company will determine the accounting for the option’s transaction price. If the exercise occurs on or before December 31, 2022, the Company will also incur $ 4.5 million in consulting fees to a third party. If the option is allowed to lapse, the Company will recognize any deferred revenue allocated to the option at the time of the lapse.
11
At September 30, 2021, the Company had $ 36.7 million of deferred revenue on its condensed consolidated balance sheets related to this performance obligation. The Company has evaluated the program’s status and believes that revenue associated with the opt-in will be recognized within one year . As of September 30, 2021, Gilead's option rights remained outstanding and no clinical or regulatory milestones had been achieved under this agreement.
Access rights related to the Company’s research and development pipeline
Gilead receives exclusive access to the Company’s current programs as well as the future programs for a period of ten years , contingent upon Gilead’s payment of $ 400 million, with the first payment of $ 100 million in 2022 , and an additional $ 100 million payment due at Gilead’s option on each of the fourth, sixth, and eighth anniversaries of the agreement. The standalone selling price of this ongoing research and development pipeline access was determined using an expected cost-plus margin approach. The Company evaluated its rights and obligations in the Gilead Collaboration Agreement and determined that Gilead is contractually obligated to make the $ 100 million payment due in 2022 resulting in a minimum term of four years for this performance obligation. As a result, the amount was included in the transaction price. The Company uses a time-elapsed input method to measure progress toward satisfying this obligation, which is the method the Company believes most faithfully depicts the Company’s performance in transferring the promised services during the time period in which Gilead has access to the Company’s research and development pipeline. Accordingly, the revenue allocated to the performance obligation is being recognized using this input method over the minimum four-year period. The Company further determined that Gilead is not obligated to pay the remaining $ 300 million due over the remainder of the term. Failure to pay the non-obligatory payments will result in Gilead’s loss of certain rights to access and obtain licenses to the programs arising from the Company’s research and development pipeline.
At September 30, 2021, the Company had $ 98.6 million of deferred revenue on its consolidated balance sheets related to this performance obligation, classified between current and noncurrent based on the amortization of the revenue.
Development and commercialization services for zimberelimab monotherapy
In conjunction with the license, the Company determined there existed a separate obligation to perform further development and commercialization services for Gilead related to zimberelimab monotherapy. The standalone selling price of this obligation was determined using an expected cost-plus margin approach. This obligation includes a 50/50 share of the costs associated with all future development and commercialization of zimberelimab as a monotherapy. The portion of the transaction price allocated to this performance obligation has been allocated in accordance with the total costs forecast for the development and commercialization of zimberelimab as a monotherapy. The Company will recognize the amounts allocated to these services as the performance obligation is satisfied. Any additional payments received from or payments made to Gilead for the 50/50 cost share will be recognized as a reduction or an increase to R&D expense, respectively.
At September 30, 2021, the Company had $ 9.7 million of contract liabilities on its consolidated balance sheets related to this performance obligation. The Company has evaluated the program’s status and believes that revenue associated with these services will be recognized over the full term of the contract. As of September 30, 2021, no revenue had been recognized from this performance obligation.
Gilead was also granted option rights to programs not yet in development. These programs were not determined to be performance obligations at contract inception, as there are no identified programs, revenues, or costs to compare against the option price.
Prepaid expenses
The Company incurred $ 7.3 million in expenses to obtain the contract, which consisted of consultant and legal fees that were directly connected to the successful completion of the Gilead Agreements. The Company determined that $ 1.9 million of these expenses were related to the Stock Purchase Agreement and recorded them as offering costs. The Company allocated the remaining expenses between the various performance obligations, to be recognized when the underlying revenue is recognized. The portion allocated to the delivery of zimberelimab was recognized immediately, and the portion allocated to the remaining performance obligations will be recognized with timing consistent with the associated performance obligation. During the three and nine months ended September 30, 2021, the Company recognize d $ 0.1 million and $ 0.3 million, respectively, in expense from the amortization of these assets. At September 30, 2021, the Company had $ 3.9 million in prepaid expenses from costs to obtain the Gilead Agreements, of which $ 1.0 million was recorded in prepaid expenses and other current assets and $ 2.9 million was recorded in other long-term assets.
Taiho Pharmaceutical Co., Ltd
In September 2017, the Company and Taiho entered into an option and license agreement (the Taiho Agreement) to collaborate on the potential development and commercialization of certain investigational products from the Company’s portfolio in Japan and certain other territories in Asia (excluding China) (the Taiho Territory). The Taiho Agreement provides Taiho with exclusive options, over a five-year period ending September 2022 (the Option Period), to obtain an exclusive development and commercialization license to clinical stage investigational products from the Company’s programs (each, an Arcus Program).
12
In consideration for the exclusive options and other rights contained in the Taiho Agreement, Taiho agreed to make non-refundable, non-creditable cash payments to the Company totaling $ 35.0 million, of which the Company received $ 25.0 million during 2017. An additional $ 5.0 million was received in 2018 and the remaining $ 5.0 million was received in 2019.
For each option that Taiho elects to exercise, it will be obligated to make an option exercise payment of between $ 3.0 million to $ 15.0 million, depending on the development stage of the applicable Arcus Program for which the option is exercised. In addition, the Taiho Agreement provides that the Company is eligible to receive additional clinical and regulatory milestones totaling up to $ 130.0 million per Arcus Program, and it will be eligible to receive contingent payments of up to $ 145.0 million per Arcus Program associated with the achievement of specified levels of Taiho net sales in the Taiho Territory.
In addition, the Company will receive royalties ranging from high single-digits to mid-teens on net sales of licensed products in the Taiho Territory. Royalties will be payable on a licensed product-by-licensed product and country-by-country basis during the period of time commencing on the first commercial sale of a licensed product in a country and ending upon the later of: (a) ten (10) years from the date of first commercial sale of such licensed product in such country; and (b) expiration of the last-to-expire valid claim of the Company’s patents covering the manufacture, use or sale or exploitation of such licensed product in such country (the Royalty Term).
The Company determined that the identified performance obligations, which include the combined performance obligation of the research and development services and the obligation to participate on the joint steering committee, are satisfied over time. The Company uses a time-elapsed input method to measure progress toward satisfying its performance obligation, which is the method the Company believes most faithfully depicts the Company’s performance in transferring the promised services during the time period in which Taiho has access to the Company’s research and development activities. Accordingly, the transaction price of $ 35.0 million is being recognized using this input method over the estimated performance period of five years .
Based on the nature of the clinical and regulatory milestones, such as the regulatory approvals which are not within the Company’s control, the Company will not consider achievement of such milestones to be probable until the uncertainty associated with the milestones has been resolved. When it is probable that a significant reversal of revenue will not occur, the milestone payment will be added to the transaction price, which will then be allocated to each performance obligation, on a relative standalone selling price basis, for which the Company recognizes revenue. As of September 30, 202 1, no clinical or regulatory milestones had been achieved under the Taiho Agreement.
The Company also considers the contingent payments due from Taiho upon the achievement of specified sales volumes to be similar to royalty payments. The Company considers the license to be the predominant item to which the royalties relate. The Company will recognize 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). As of September 30, 2021, no sales milestone or royalty revenue has been recognized.
The Taiho Agreement shall remain in effect until expiry of all Royalty Terms for the licensed products, in each case subject to certain exceptions.
WuXi Biologics License Agreements
The Company entered into a license agreement (the WuXi PD-1 Agreement) with WuXi Biologics in August 2017, as subsequently amended, in which it obtained an exclusive license to develop, use, manufacture, and commercialize products including an anti-PD-1 antibody worldwide except for Greater China. From the inception of the WuXi PD-1 Agreement through September 30, 2021, the Company has made upfront and milestone payments of $ 41.0 million and incurred sub-license fees of $ 11.3 million. These payments were recorded as research and development expense, as the products had not reached technological feasibility and did not have an alternative future use. The WuXi PD-1 Agreement also provides for clinical and regulatory milestone payments, commercialization milestone payments of up to $ 375.0 million, and tiered royalty payments to be made to WuXi Biologics that range from the high single-digits to low teens of net sales by the Company of licensed products.
The Company incurred zero and $ 10.0 m illion, respectively, in development milestone expense under the WuXi PD-1 Agreement during the three and nine months ended September 30, 2021.
In December 2020, the Company entered into a separate license agreement (the WuXi CD-39 Agreement) with WuXi Biologics to develop anti-CD39 antibodies. Under the agreement, the Company was granted exclusive worldwide rights to anti-CD39 antibodies discovered under the collaboration and will be responsible for the further development and commercialization of those antibodies. From the inception of the WuXi CD-39 Agreement through September 30, 2021, the Company has paid $ 0.5 million in upfront payments which was recorded in research and development expense, as the products are still in research stage. The WuXi CD-39 Agreement provides for clinical and regulatory milestone payments totaling $ 16.5 million, and royalty payments in the low single digits of net sales by the Company of licensed products.
The Company incurred no development milestone expense under the WuXi CD-39 Agreement during the three and nine months ended September 30, 2021.
13
Abmuno License Agreement
In December 2016, the Company entered into a license agreement (the Abmuno Agreement) with Abmuno Therapeutics LLC (Abmuno) in which it obtained a worldwide exclusive license to develop, use, manufacture, and commercialize products that include an anti-TIGIT antibody, including domvanalimab (formerly referred to as AB154). Under the Abmuno Agreement, the Company has made upfront and milestone payments totaling $ 14.6 m illion as of September 30, 2021. The Abmuno Agreement also provides for additional clinical, regulatory and commercialization milestone remaining payments of up to $ 93.0 million as of September 30, 2021.
The Company incurred zero and $ 5.0 million in development milestone expense under the Abmuno Agreement during the three and nine months ended September 30, 2021. The Company incurr ed $ 3.0 million in development milestone expense under the Abmuno Agreement during the three and nine months ended September 30, 2020.
Strata Collaboration Agreement
On April 30, 2019, the Company and Strata Oncology, Inc. (Strata) entered into a Co-Development and Collaboration Agreement (the Strata Agreement) to pursue a clinical development collaboration utilizing Strata’s precision drug development platform and proprietary biomarkers to evaluate zimberelimab, the Company’s clinical-stage anti-PD-1 antibody, in patients in a tumor-agnostic fashion. Under the terms of the Strata Agreement, the parties share a portion of development costs for the clinical collaboration. From the inception of the Agreement through September 30, 2021, the Company has made a milestone payment of $ 2.5 million and has incurred expenses of $ 4.5 million, of which $ 0.9 million had b een reimbursed by Strata as development cost sharing. Net expenses related to this co-development agreement were recorded within research and development expenses.
As further consideration in connection with the Strata Agreement, the Company issued to Strata 1,257,651 restricted shares of its common stock in April 2019 with an initial measured fair value of $ 15.0 million, which were subject to vesting based upon the achievement of specified regulatory milestones within certain timelines. In September 2021, the Company and Strata agreed to cancel the full amount of the restricted shares upon final determination that the biomarker indications were unlikely to be successful given the evolution of the competitive landscape.
For the three and nine months ended September 30, 2021, the Company incurred expenses p ursuant to the Strata Agreement of $ 0.7 million and $ 1.8 million, respectively. Of these expenses, $ 0.1 million and $ 0.3 mi llion, respectively, were reimbursed by Strata. For the three and nine months ended September 30, 2020, the Company incurred expenses pursuant to the Strata Agreement of $ 0.3 million and $ 1.2 million, respectively. Of these expenses, $ 0.1 and $ 0.2 million, respectively, were reimbursed by Strata.
AstraZeneca Agreement
On October 29, 2020 the Company announced a collaboration with AstraZeneca to evaluate domvanalimab, the Company’s investigational anti-TIGIT antibody, in combination with AstraZeneca’s Imfinzi (durvalumab) in a registrational Phase 3 clinical trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC). Under the terms of the agreement, each company will retain existing rights to their respective molecules and any future commercial economics. AstraZeneca will conduct the trial, and each company will supply its respective anti-cancer agent to support the trial. Under the terms of the agreement and subject to the parties’ approval of a final budget for the clinical trial, the Company may be obligated to reimburse AstraZeneca for a portion of the costs incurred.
Consistent with the terms of the Gilead Collaboration Agreement, Gilead maintains an option to co-develop and co-commercialize domvanalimab. If Gilead exercises its option to domvanalimab, the trial from this AstraZeneca collaboration is expected to form part of the Arcus and Gilead joint development program and Arcus’s portion of the trial costs would be shared with Gilead.
For the three and nine months ended September 30, 2021, the Company incurred $ 0.3 million and $ 0.6 million, respectively, of expenses pursuant to the AstraZeneca Agreement. Expenses from this co-development agreement are recorded within research and development expenses.
14
Genentech Collaboration Agreement
In December 2019, the Company and Genentech, through F. Hoffmann-La Roche Ltd (collectively, Genentech) entered into a Master Clinical Collaboration Agreement (the Genentech Agreement) pursuant to which the parties may conduct combination clinical studies involving Genentech’s monoclonal antibody, atezolizumab, and the Company’s investigational products. Pursuant to the Genentech Agreement, the parties entered into Trial Supplements for the evaluation of etrumadenant and atezolizumab utilizing the MORPHEUS platform in two separate study indications: second and third line metastatic colorectal cancer and first line metastatic pancreatic cancer. The Company and Genentech each supply their respective investigational products for use in the collaboration studies and share a portion of the development costs under specific terms as set forth in the agreement. For each of the three and nine months ended September 30, 2021 and 2020, the Company recorded immaterial n et expenses related to this co-development agreement within research and development expenses.
Note 8. Stockholders’ Equity
In June 2020, pursuant to a shelf registration statement on Form S-3 that was filed in May 2020, the Company issued 12,650,000 shares of its common stock at $ 27.50 per share in an underwritten public offering (the May 2020 Public Offering). The total number of shares sold consisted of 11,000,000 base shares and an additional 1,650,000 shares sold pursuant to the underwriters’ option exercise. Net proceeds from the May 2020 Public Offering were approximately $ 326.2 million after deducting underwriting discounts, commissions and other offering expenses.
In July 2020, the Company closed the Gilead Collaboration Agreement, Common Stock Purchase Agreement, and the Investor Rights Agreement, each signed with Gilead in May 2020. The transaction closed on July 13, 2020 following expiration of the antitrust waiting period. Upon closing, Gilead made an equity investment of approximately $ 200 million in the Company by purchasing 5,963,029 shares of Arcus common stock at a per share price of $ 33.54 pursuant to the Stock Purchase Agreement. Of the $ 200 million equity investment, approximately $ 90.6 million was determined to be a premium on the purchase of common stock and allocated to the performance obligations created by the Gilead Collaboration Agreement. See Note 7 in this Form 10-Q for further discussion of the agreements with Gilead. Net proceeds from Gilead’s equity investment were approximately $ 107.5 million after allocating the premium and deducting direct offering expenses of $ 1.9 million.
In February 2021, the Company closed the Amended and Restated Common Stock Purchase Agreement with Gilead, pursuant to which Gilead made an equity investment of approximately $ 220.4 million in the Company by purchasing 5,650,000 shares of the Company’s common stock at a per share price of $ 39.00 .
Note 9. Stock-Based Compensation
The Company grants awards under its 2018 Equity Incentive Plan and the 2020 Inducement Plan. Total stock-based compensation expense was recognized in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Research and development
$
7,949
$
3,075
$
21,087
$
7,179
General and administrative
6,636
2,927
19,626
6,755
Total stock-based compensation
$
14,585
$
6,002
$
40,713
$
13,934
15
Note 10. Net Income (Loss) per Share
Basic net income (loss) per share is calculated based on the weighted-average number of shares of the Company’s common stock during the period. Diluted net income (loss) per share is calculated based on the weighted-average number of shares of the Company’s common stock and other dilutive securities outstanding during the period. Potentially dilutive securities are excluded from the calculation if their inclusion would have been antidilutive. The potentially dilutive shares of the Company's common stock resulting from the assumed exercise of outstanding stock options and equivalents were determined under the treasury stock method.
The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data):
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Numerator:
Net loss
$
( 77,975
)
$
1,822
$
( 226,538
)
$
( 71,005
)
Denominator:
Weighted-average common shares outstanding
71,286,685
64,132,283
70,296,187
53,452,007
Less: weighted-average common shares subject to vesting
( 1,176,547
)
( 1,533,090
)
( 1,305,897
)
( 1,599,760
)
Weighted-average common shares used to compute basic net income (loss) per share
70,110,138
62,599,193
68,990,290
51,852,247
Dilutive effect of stock options
-
2,538,926
-
-
Dilutive effect of ESPP
-
7,588
-
-
Weighted-average common shares used to compute diluted net income (loss) per share
70,110,138
65,145,707
68,990,290
51,852,247
Net income (loss) per share: basic
$
( 1.11
)
$
0.03
$
( 3.28
)
$
( 1.37
)
Net income (loss) per share: diluted
$
( 1.11
)
$
0.03
$
( 3.28
)
$
( 1.37
)
The following outstanding potentially dilutive securities were excluded from the computation of diluted net loss per share because including them would have been antidilutive:
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Common stock options issued and outstanding
12,625,226
1,518,386
12,625,226
7,841,220
Unvested restricted stock units
1,361,008
653,950
1,361,008
653,950
Employee Stock Purchase Plan shares
166,461
12,966
166,461
79,848
Unvested early exercised common stock options
39,142
-
39,142
240,977
Unvested restricted common stock issued as
part of collaboration agreement
-
1,257,651
-
1,257,651
Total
14,191,837
3,442,953
14,191,837
10,073,646
The Company also excluded the effect of Gilead’s right to purchase additional shares of the Company’s common stock from its calculation as these rights had no intrinsic value at September 30, 2021.
Note 11. Commitments
Standby Letters of Credit
The Company has standby letters of credit up to an aggregate of $ 3.0 million provided as collateral for its leases. The letters of credit are secured by $ 3.0 million in deposits classified as restricted cash on the Company’s condensed consolidated balance sheets. At September 30, 2021 the standby letters of credit were not drawn down.
16
Note 12. Related parties
Relationship and transactions with Gilead Sciences, Inc. (Gilead)
As of September 30, 2021, Gilead held approximate ly 19.7 % o f the Company’s outstanding common stock. These holdings resulted from Gilead’s participation in the May 2020 Public Offering as well as purchases of stock under the stock purchase agreements. In the May 2020 public offering, Gilead purchased 2,200,000 shares of common stock for an amount of $ 56.7 million, net of offering costs. Under the stock purchase agreements, Gilead purchased 5,963,029 and 5,650,000 shares in July 2020 and February 2021, respectively, for a total investment of $ 327.8 million, net of offering costs and amounts allocated to the performance obligations created by the Gilead Collaboration Agreement. Gilead has the right, at its option, to purchase up to a maximum of 35 % of the Company’s then-outstanding voting common stock, from time to time over a five-year period from the closing of the initial transaction in July 2020. Gilead also has the right under the Investor Rights Agreement to designate two individuals to be appointed to the Company’s Board of Directors. Pursuant to the Investor Rights Agreement, the Company appointed the Gilead designees, Merdad Parsey, M.D., Ph.D. and Michael Quigley, Ph.D., to its Board of Directors, in July 2020 and January 2021, respectively. In August 2021, in connection with his departure from Gilead, Dr. Quigley resigned from the Company’s Board of Directors. In his place and pursuant to the Investor Rights Agreement, the Company appointed Linda Higgins, Ph.D., Senior Vice President of Research, External Innovation at Gilead, to its board. See Note 7 for further discussion of the agreements with Gilead.
At September 30, 2021, the Company had a $ 0.6 million cost sharing receivable recorded on the condensed consolidated balance sheets under receivable from collaboration partners, to be invoiced the following quarter. The Company also had $ 162.2 million in deferred revenue at September 30, 2021, of which $ 94.7 million represented the long-term portion of revenue allocated to performance obligations not expected to be completed within one year of the balance sheet date, which was recorded in deferred revenue, noncurrent on the condensed consolidated balance sheets. The Company also had $ 9.7 mil lion in contract liabilities for future development and commercialization services for zimberelimab as a monotherapy which Gilead prepaid, all of which was recorded in other long-term liabilities on the consolidated balance sheets.
For the three and nine months ended September 30, 2021, the C ompany recognized $ 7.7 million and $ 23.1 million, respectively, in revenue under the Gilead Collaboration Agreement. For each of these periods, the Company also recognized reductions of $ 0.8 million and $ 6.9 million, respectively, in research and development expense, including $ 4.0 million of cost sharing reimbursement related to milestone expense, under the cost-sharing provision s of the agreement.
The Company received a $ 175 million upfront payment from Gilead in connection with the Gilead Collaboration Agreement in July 2020 and identified $ 100 million in unconstrained consideration to be received in 2022. In addition, in July 2020 the Company received $ 200 million from Gilead in connection with the Stock Purchase Agreement, of which approximately $ 109.4 million represented the fair value of stock purchased at the transaction closing date with the remaining premium of $ 90.6 million allocated to the transaction price. In February 2021, the Company received $ 220.4 million from Gilead in connection with the purchase by Gilead of 5,650,000 shares of the Company’s common stock at a per share price of $ 39.00 pursuant to the amended and restated Stock Purchase Agreement.
Note 13. Subsequent event
BVF Agreement
In the fourth quarter of 2021, the Company and BVF Partners L.P. (BVF) entered into an agreement (the BVF Agreement) under which BVF will pay up to $ 15 million to the Company for the discovery and development of compounds for the treatment of inflammatory diseases (the Program). The Company received $ 5 million from BVF in the fourth quarter of 2021. In return, the Company is obligated to make milestone payments upon the achievement of certain clinical and regulatory milestones and will pay royalties based on net sales of products generated by the Program. The agreement also provides BVF with the option to provide an additional $ 10 million in funding for the Program in exchange for an increase in the royalty rate. Consistent with the terms of the Gilead Collaboration Agreement, Gilead has an option to the Program.
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and notes thereto in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and notes thereto for the year ended December 31, 2020, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2021. This discussion and other parts of this report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations, and intentions. Further, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Our actual results could differ materially from those discussed in these forward-looking and other statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report entitled “Risk Factors.”
Overview
We are a clinical-stage biopharmaceutical company focused on creating best-in-class cancer therapies. Our initial focus has been on well-characterized biological pathways with significant scientific data supporting their importance. We have built a robust and highly efficient drug discovery capability to create highly differentiated small molecules, which we have the ability to develop in combinations with our monoclonal antibodies through rationally designed, indication-specific clinical trial designs. Our vision is to create, develop and commercialize highly differentiated combination cancer therapies.
In 2020, we entered into an Option, License and Collaboration Agreement (Gilead Collaboration Agreement) with Gilead Sciences, Inc. (Gilead), whereby Gilead obtained rights to zimberelimab and a time-limited exclusive option to all of our current and future programs during the 10-year collaboration term. For each program to which Gilead exercises their option, the parties will co-develop globally and co-commercialize in the U.S., subject to certain exceptions, and Gilead will have the right to commercialize the program outside of the United States, subject to the rights of our existing partners to certain territories. In connection with the Gilead Collaboration Agreement, we also entered into a Common Stock Purchase Agreement (as amended and restated in January 2021), pursuant to which Gilead purchased an aggregate of 11,613,029 shares of our common stock for aggregate gross proceeds of $420.4 million and has the right, at its option from time to time over a five-year period, to purchase up to a maximum ownership of 35% of our then-outstanding voting common stock, and an Investor Rights Agreement that provides for a three-year standstill, two-year lockup and the right to designate two individuals to be appointed to our Board of Directors.
In 2017, we entered into an Option and License Agreement (Taiho Agreement) with Taiho Pharmaceutical Co., Ltd. (Taiho) pursuant to which Taiho has a time-limited option to exclusively license the development and commercialization rights to each of our programs for Japan and certain other territories in Asia (excluding China). To date, Taiho has exercised their option rights to our adenosine receptor antagonist program (including etrumadenant) and our anti-PD-1 program (including zimberelimab).
We currently have six investigational products in clinical development:
Domvanalimab (formerly referred to as AB154), our anti-TIGIT monoclonal antibody, is being evaluated in combination with zimberelimab with or without etrumadenant vs. zimberelimab monotherapy in ARC-7, our randomized Phase 2 trial in first-line metastatic PD-L1 ≥ 50% non-small cell lung cancer. In February 2021, we initiated ARC-10, our first registrational trial evaluating domvanalimab in combination with zimberelimab and zimberelimab monotherapy vs. chemotherapy in this same setting.
Etrumadenant (formerly referred to as AB928), our small molecule dual A 2a /A 2b adenosine receptor antagonist, is being evaluated by us in several randomized or Phase 2 trials across major tumor types, including in our ARC-4, ARC-6, ARC-7, and ARC-9 studies, as well as in two randomized Phase 1b/2 trials being conducted by Genentech (the Morpheus trials).
Quemliclustat (formerly referred to as AB680), our small-molecule CD73 inhibitor, is being evaluated in a Phase 1/1b study for the treatment of first-line metastatic pancreatic cancer (ARC-8) as well as late-line metastatic prostate cancer (ARC-6).
Zimberelimab (formerly referred to as AB122), our anti-PD-1 monoclonal antibody, is the cornerstone of our combination strategy. We are currently evaluating zimberelimab, either alone or in combination with other agents across several tumor types, including non-small cell lung cancer in ARC-7, our Phase 2 trial, and ARC-10, our recently initiated registrational trial which is designed to support the approval of zimberelimab.
AB308, our Fc-enabled anti-TIGIT monoclonal antibody, is being evaluated in a Phase 1/1b study. The dose escalation portion was designed to expeditiously establish the safety, pharmacokinetics and pharmacodynamics of AB308 in combination with zimberelimab. The dose expansion portion is evaluating AB308 in combination with zimberelimab in multiple tumor types, including hematological malignancies.
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AB521, our HIF-2α inhibitor, is being evaluated in a healthy volunteer study to expeditiously characterize the pharmacokinetic and safety profile of AB521 and to identify the starting dose for a Phase 1/1b study in oncology indications.
COVID-19 Pandemic
The degree to which COVID-19 impacts our business operations, research and development programs and financial condition remains highly uncertain and will depend on future developments, including the ultimate duration and/or severity of the pandemic, the impact of any resurgences and new variants that emerge, actions by government authorities to contain the spread of the virus, the availability, adoption and effectiveness of any vaccines, and when and to what extent normal economic and operating conditions can resume. Our management continues to actively monitor this health crisis and its effects on our operations, key vendors and workforce.
We conduct our clinical trials in the U.S. and internationally in geographic regions that are impacted by COVID-19 to varying degrees. While we have seen relatively robust enrollment in most of our ongoing Arcus-sponsored studies, disruptions caused by the COVID-19 pandemic may impact our ability to initiate, enroll, conduct or complete our ongoing or planned clinical trials. The American Cancer Society has also reported that the pandemic has led to declines in screening, diagnosis and treatment for cancer patients, which will impact the enrollment of patients in clinical trials targeting early stage cancers and retention of patients overall in our trials. Patient safety remains our paramount concern and we continue to collaborate with our existing and with new investigational sites to implement measures to minimize disruptions to patients and ensure continued access to treatment, in accordance with health authority guidance. We are unable to predict the ultimate impact of this pandemic on our ongoing and planned clinical programs.
With respect to manufacturing and supply, our third-party contract manufacturers continue to operate at or near normal levels. At this time and subject to further COVID-19 implications, we believe we have manufactured sufficient drug supply for our ongoing clinical studies and we do not anticipate any disruptions to our ability to manufacture our investigational products. Global shipping has been severely challenged by the evolving pandemic, which has led to delays in our receipt of materials and supplies used in our clinical and laboratory operations. We actively manage our supply chain needs to minimize the impact of any disruptions to our clinical and laboratory operations.
Our discovery programs were impacted by reduced operating capacity in our laboratories; however, our laboratory operations are operating at or near normal levels following the availability of vaccines and our mandatory vaccine policy. Our office-based employees continue to work remotely; however, we are beginning to resume periodic in-person meetings. The safety, health and well-being of our employees remains a primary concern, and we may restrict our business activities or modify our employee work arrangements in order to reduce the risk of exposure to COVID-19 among our employees.
The COVID-19 pandemic continues to evolve and future developments, which are unpredictable, may result in a material, negative impact to our operations and financial condition.
Components of Operating Results
Collaboration and License Revenue
Our collaboration and license revenue consists of revenue recognized from the upfront and periodic payments received from Taiho and Gilead, for research and development services performed by us to develop our investigational products under the terms of our collaboration agreements, and from any option exercise payments.
Operating Expenses
Research and Development Expenses
Our research and development expenses consist of expenses incurred in connection with the research and development of our pipeline programs. These expenses include pre-clinical and clinical expenses, payroll and personnel expenses, including stock-based compensation for our employees, laboratory supplies, product licenses, consulting costs, contract research, and depreciation. Shared facility expenses are allocated to functional groups proportionally based on usage. Under certain collaboration agreements we agree to share research and development expenses with our partners or to reimburse our partners for qualified expenses. We expense both internal and external research and development costs as they are incurred. We record advance payments for services that will be used or rendered for future research and development activities as prepaid expenses and recognize them as an expense as the related services are performed.
We do not allocate our costs by investigational product, as a significant amount of research and development expenses include internal costs, such as payroll and other personnel expenses, and certain external costs that are not recorded at the investigational product level. In particular, with respect to internal costs, several of our departments support multiple research and development programs, and we do not allocate those costs by investigational product.
We expect our research and development expenses to increase substantially during the next few years due to our Gilead collaboration and as we seek to complete existing clinical trials and advance our programs into later-stage clinical trials, pursue regulatory approval
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for our investigational products, and advance other programs into the clinic. Later-stage clinical trials typically include a larger number of subjects, are of a longer duration and include more geographic regions. As we advance our clinical-stage programs and prepare to seek regulatory approval, we will also need to conduct certain validation activities with respect to our manufacturing processes for the investigational products in each program. Moreover, in order to maximize the potential of our collaboration with Gilead, we believe it will be important to grow our discovery capabilities and pipeline. As a result, we expect our preclinical, clinical, and contract manufacturing expenses to increase significantly relative to what we have incurred to date. The level of our future research and development investment will depend on a number of factors and uncertainties, including clinical outcomes from our ongoing clinical trials, whether our collaborators opt into any of our programs, the amount of opt-in and milestone payments we receive from our collaborators, and the breadth of any joint development program agreed to with Gilead for programs they opt into. In addition, under our license agreements with WuXi Biologics and Abmuno, and our co-development and collaboration agreement with AstraZeneca, we may be required to pay additional clinical and regulatory milestone payments based on the development progress of our investigational products. Therefore, we are unable to predict the timing or the final cost to complete our clinical programs or validation of our manufacturing and supply processes and delays may occur due to numerous factors. Factors that could cause or contribute to delays or additional costs include, but are not limited to, those discussed in “Item 1A. Risk Factors.”
General and Administrative Expenses
General and administrative expenses consist principally of personnel-related costs including payroll and stock-based compensation for personnel in executive, finance, human resources, information technology, business and corporate development, and other administrative functions. Shared facility expenses are allocated to functional groups proportionally based on usage. Our general and administrative expenses also include professional fees for legal, consulting, and accounting services, rent and other facilities costs, fixed asset depreciation, and other general operating expenses not otherwise classified as research and development expenses.
We anticipate that our general and administrative expenses will increase substantially during the next few years as we support our growing research and development activities, including staff expansion, additional occupancy costs, and other costs associated with increased infrastructure needs.
Other Non-Operating Income, net
Other non-operating income, net consists primarily of interest earned on our investments in fixed-income marketable securities as well as activity related to our equity method investment in PACT Pharma, Inc (PACT Pharma). To date, gains have consisted of gains on dilution of our investment in PACT Pharma, typically occurring upon PACT Pharma’s new issuances of equity securities. Losses associated with the investment consist of our share of PACT Pharma’s net losses.
Critical Accounting Policies, Significant Judgments and Use of Estimates
Our condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenue and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies relating to revenue recognition, clinical trial accruals and stock-based compensation reflect the more significant estimates and assumptions used in the preparation of our condensed consolidated financial statements.
There have been no significant changes to our critical accounting policies and estimates in the nine months ended September 30, 2021, compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on February 25, 2021. For a description of our critical accounting policies and estimates, please refer to our Annual Report on Form 10-K.
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Results of Operations
Three Months Ended September 30, 2021 and 2020
The following table summarizes our results of operations for the three months ended September 30, 2021 and 2020 (in thousands):
Three Months Ended September 30,
Change
2021
2020
$
%
Revenues:
License revenue
$
-
$
55,096
$
(55,096
)
-100
%
Collaboration revenue
9,461
9,434
27
0
%
Total revenues
9,461
64,530
(55,069
)
-85
%
Operating expenses:
Research and development
71,254
51,801
19,453
38
%
General and administrative
16,343
11,177
5,166
46
%
Total operating expenses
87,597
62,978
24,619
39
%
Income (loss) from operations
(78,136
)
1,552
(79,688
)
*
Non-operating income, net
161
270
(109
)
-40
%
Net income (loss)
$
(77,975
)
$
1,822
$
(79,797
)
*
* Not meaningful
Collaboration and License Revenue
Collaboration and license revenue decreased $55.0 million, from $64.5 million for the three months ended September 30, 2020 to $9.5 million for the three months ended September 30, 2021. In the three months ended September 30, 2021, we recognized $7.7 million in collaboration revenues related to Gilead’s ongoing rights to access our intellectual property in accordance with the Gilead Collaboration Agreement, as well as $1.8 million under the Taiho Agreement. In the three months ended September 30, 2020, we recognized $55.1 million in revenue for the license to zimberelimab and $7.7 million in collaboration revenues in accordance with the Gilead Collaboration Agreement, as well as $1.8 million under the Taiho Agreement.
Research and Development Expenses
Research and development expenses increased $19.5 million, or 38%, from $51.8 million for the three months ended September 30, 2020 to $71.3 million for the three months ended September 30, 2021. The increase in research and development expenses was driven by costs incurred to support our expanded clinical and development activities. Our growing headcount and our 2021 stock awards drove a $12.9 million increase in employee compensation costs, including approximately $4.9 million of increased non-cash stock-based compensation. Clinical costs for our ongoing studies increased $12.7 million as a result of the increased number of programs and clinical trials compared to the same quarter in the prior year. We incurred an additional $2.9 million increase in office facilities and technology expense, $2.2 million increase in clinical consulting costs, and $1.0 million increase in lab supplies and equipment as we expanded our development efforts. There was also a net $1.7 million increase in research and development expense due to a decrease in reimbursement from collaboration partners for shared expenses. In the current quarter we recognized reimbursement of approximately $0.8 million from Gilead for certain applicable costs of developing zimberelimab in accordance with the Gilead Collaboration Agreement, compared to approximately $2.5 million from our collaboration partners in the same quarter in the prior year. The overall increase in research and development expense is partially offset by a decrease of $13.1 million in milestone expense incurred and a $1.3 million decrease in expense from manufacturing and development. We did not incur milestone expense in the three months ended September 30, 2021, compared to $13.1 million in the same quarter in the prior year.
General and Administrative Expenses
General and administrative expenses increased $5.1 million, or 46%, from $11.2 million for the three months ended September 30, 2020 to $16.3 million for the three months ended September 30, 2021. The increase in general and administrative expenses was driven by the increased complexity of supporting our expanding clinical pipeline and partnership obligations, as well as costs associated with being a public company. Our growing headcount as well as our 2021 stock awards drove a $5.7 million increase in employee compensation costs, including approximately $3.7 million in increased non-cash stock-based compensation. The overall increase in general and administrative expense is partially offset by a $1.0 million decrease in outside legal, accounting, and other consulting expenses due to costs related to our transaction with Gilead and other corporate development activities incurred in 2020.
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Non-Operating Income, Net
Non-operating income, net decreased $0.1 million or 40%, from $0.3 million for the three months ended September 30, 2020 to $0.2 million for the three months ended September 30, 2021. The decrease was primarily due to lower interest income resulting from lower investment yields on our portfolio of marketable fixed-income securities during the quarter ended September 30, 2021 as compared to the same period in the prior year.
Nine Months Ended September 30, 2021 and 2020
The following table summarizes our results of operations for the nine months ended September 30, 2021 and 2020 (in thousands):
Nine Months Ended September 30,
Change
2021
2020
$
%
Revenues:
License revenue
$
-
$
55,096
$
(55,096
)
-100
%
Collaboration revenue
28,383
12,934
15,449
119
%
Total revenues
28,383
68,030
(39,647
)
-58
%
Operating expenses:
Research and development
206,412
110,636
95,776
87
%
General and administrative
48,990
29,617
19,373
65
%
Total operating expenses
255,402
140,253
115,149
82
%
Loss from operations
(227,019
)
(72,223
)
(154,796
)
*
Non-operating income, net
481
1,218
(737
)
-61
%
Net loss
$
(226,538
)
$
(71,005
)
$
(155,533
)
*
* Not meaningful
Collaboration and License Revenue
Collaboration and license revenue decreased $39.6 million, from $68.0 million for the nine months ended September 30, 2020 to $28.4 million for the nine months ended September 30, 2021. In the nine months ended September 30, 2021, we recognized $23.1 million in collaboration revenues related to Gilead’s ongoing rights to access our intellectual property in accordance with the Gilead Collaboration Agreement, as well as $5.3 million under the Taiho Agreement. In the nine months ended September 30, 2020, we recognized $55.1 million in revenue for the license to zimberelimab and $7.7 million in collaboration revenues in accordance with the Gilead Collaboration Agreement, as well as $5.3 million under the Taiho Agreement
Research and Development Expenses
Research and development expenses increased $95.8 million, or 87%, from $110.6 million for the nine months ended September 30, 2020 to $206.4 million for the nine months ended September 30, 2021. The increase in research and development expenses was driven by costs incurred to support our expanded clinical and development activities. Our growing headcount and our 2021 stock awards drove a $36.4 million increase in employee compensation costs, including approximately $13.9 million of increased non-cash stock-based compensation. Clinical costs for our ongoing studies and manufacturing costs increased $34.6 million and $17.5 million, respectively, as a result of the increased number of programs and clinical trials compared to the same period in the prior year. We incurred an additional $5.4 million increase in office facilities and technology expense, $4.4 million increase in lab supplies and equipment, and $4.3 million increase in consulting services as we expanded our development efforts. The overall increase in research and development expense is partially offset by a $3.0 million decrease in development milestone expenses incurred. In the nine months ended September 30, 2021, the Company incurred a $10.0 million milestone payment due to WuXi Biologics pertaining to zimberelimab and $5.0 million incurred for a milestone payment due to Abmuno pertaining to domvanalimab. In the same period in the prior year, we incurred $10.1 million sublicense fee and a $5.0 million development milestone payment, both to WuXi, as well as a $3.0 million development milestone payment to Abmuno. There was also a net $4.0 million decrease in research and development expense due to an increase in reimbursement from collaboration partners for shared expenses. In the nine months ended September 30, 2021, we recognized reimbursement of approximately $6.9 million from Gilead for certain applicable costs of developing zimberelimab, including $4.0 million of cost sharing reimbursement related to milestone expense incurred, in accordance with the Gilead Collaboration Agreement. Reimbursement from our collaboration partners was approximately $2.9 million in the same period in the prior year.
General and Administrative Expenses
General and administrative expenses increased $19.4 million, or 65%, from $29.6 million for the nine months ended September 30, 2020 to $49.0 million for the nine months ended September 30, 2021. The increase in general and administrative expenses was primarily driven by the increased complexity of supporting our expanding clinical pipeline and partnership obligations, as well as
22
costs associated with being a public company. Our growing headcount and our 2021 stock awards drove an $18.7 million increase in employee compensation costs, including approximately $12.9 million in increased non-cash stock-based compensation. We also incurred an approximately $1.5 million increase in office facilities expense due to our expanding headcount and office space. Recruiting expense and taxes increased in connection with our growth, as well as costs associated with ongoing compliance with public company requirements. The overall increase in general and administrative expense is partially offset by a decrease of $2.2 million in outside legal and other consulting expenses compared to the same quarter in the prior year, due to significant costs incurred in 2020 related to our transaction with Gilead and other corporate development activities.
Non-Operating Income, Net
Non-operating income, net decreased $0.7 million or 61%, from $1.2 million for the nine months ended September 30, 2020 to $0.5 million for the nine months ended September 30, 2021. The decrease was primarily due to lower interest income resulting from lower investment yields on our portfolio of marketable fixed-income securities during the nine months ended September 30, 2021 as compared to the same period in the prior year.
Liquidity and Capital Resources
To date, we have financed our operations primarily through net proceeds of approximately $677.1 million from equity offerings and proceeds of approximately $641.4 million from our collaboration and stock purchase agreements, including $220.4 million gross proceeds raised in February 2021 from the sale to Gilead of 5,650,000 shares of our common stock. As of September 30, 2021, we had $743.4 million of cash, cash equivalents, and investments in marketable securities, compared to $735.1 million as of December 31, 2020. Our cash and investments are held in a variety of interest-bearing instruments, including money market funds, U.S. government treasury obligations, U.S. government agency securities, and investments in corporate securities.
Based on our existing business plan, we believe that our existing cash, cash equivalents, and investments will be sufficient to fund our planned level of operations at least through 2023.
We may require additional capital to complete the development and any commercialization of our investigational products. Our future capital requirements will depend on many factors, including:
the scope, rate of progress and costs of clinical trials for our investigational products as well as drug discovery, preclinical development activities, and laboratory testing;
the number and scope of clinical programs we decide to pursue;
the scope and costs of manufacturing development and commercial manufacturing activities;
the timing and amount of expense related to our current and future clinical programs, subject to the rights of our existing partners, and the costs associated with our share of the global development plan for such programs;
the timing and amount of milestone payments we receive under the Taiho Agreement and Gilead Collaboration Agreement, and option fees under the Gilead Collaboration Agreement;
the extent to which we acquire or in-license other investigational products and technologies;
the cost, timing and outcome of regulatory review of our investigational products;
the cost and timing of establishing sales and marketing capabilities, if any of our investigational products receive marketing approval;
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
our ability to establish and maintain collaborations on favorable terms, if at all;
our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our investigational products;
the costs associated with being a public company; and
the cost associated with commercializing our investigational products, if they receive marketing approval.
If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate
23
some or all of our development programs and clinical trials. We may also be required to sell or license to others rights to our investigational products in certain territories or indications that we would prefer to develop and commercialize ourselves.
See “Risk Factors” for additional risks associated with our substantial capital requirements.
Summary Condensed Consolidated Statement of Cash Flows
The following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods presented below (in thousands):
Nine Months Ended September 30,
Net cash (used in) provided by:
2021
2020
Operating activities
$
(194,068
)
$
161,050
Investing activities
(22,782
)
(434,136
)
Financing activities
225,669
436,998
Net increase in cash, cash equivalents and restricted cash
$
8,819
$
163,912
Cash Used in Operating Activities
Net cash used in operating activities was $194.1 million for the nine months ended September 30, 2021, as compared to $161.1 million provided by operating activities for the same period in the prior year. The change in cash flow from operating activities is primarily due to the $155.5 million increase in our net loss to $226.5 million. The change in our net loss is primarily a result of our expanded clinical development activities and general and administrative costs incurred to support our operations, partially offset by the $55.1 million payment received in the prior year from Gilead for the license to zimberelimab. The overall increase in cash used is partially offset by year-over-year changes in non-cash items, including $26.8 million increased expense from stock-based compensation, and changes in our asset and liability balances due to the timing of payments to or from our vendors and collaborators.
Cash Used in Investing Activities
Cash used in investing activities was $22.8 million for the nine months ended September 30, 2021 compared to $434.1 million used in investing activities for the same period in the prior year. The change in cash flow from investing activities was primarily due to higher maturities of our investments in fixed-income marketable securities, partially offset by an increase in purchases of property and equipment as we invested in our expansion of office and laboratory facilities.
Cash Provided by Financing Activities
Cash provided by financing activities was $225.7 million for the nine months ended September 30, 2021 compared to $437.0 million in the same period in the prior year. In February 2021 we received $220.4 million from Gilead pursuant to the terms of the Amended and Restated Stock Purchase Agreement. In 2020, we received $326.2 million, net of direct offering costs, from our May 2020 public offering, as well as $107.5 million, net of direct offering costs, from the Gilead Stock Purchase Agreement.
Contractual Obligations and Commitments
In April 2021, we entered into a lease amendment for our existing operating leases in Hayward, California, that, among other things, extends the terms of those leases. The lease amendment includes approximately $43 million in additional undiscounted future minimum lease payments throughout the expected term and provides additional tenant improvement allowances totaling $5.8 million with options to increase the allowance by $10.9 million.
Other than the additional contractual obligations under the lease amendment, there have been no material changes to our contractual obligations outside the ordinary course of business during the nine months ended September 30, 2021, as compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2020.
Off-Balance Sheet Arrangements
Since our inception, we have not engaged in any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
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Item 3. Quantitative and Qualitati ve Disclosures About Market Risk.
The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates, exchange rates, or general market and economic conditions. Our market risks have not changed materially from those discussed in our Annual Report on Form 10-K filed with the SEC on February 25, 2021. We do not believe that inflation, interest rate changes, exchange rate fluctuations, or general market and economic conditions had a significant impact on our results of operations for any periods presented herein.
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