Item 1. Financial Statements
Item 1. Financial Statements.
ARCUS BIOSCIENCES, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(unaudited)
September 30,
December 31,
2020
2019*
ASSETS
Current assets:
Cash and cash equivalents
$
221,849
$
57,937
Short-term investments
560,583
130,333
Receivable from collaboration partners
2,579
132
Accrued interest receivable
372
251
Prepaid expenses and other current assets
11,816
4,052
Total current assets
797,199
192,705
Long-term investments
2,700
-
Property and equipment, net
8,728
9,330
Restricted cash
203
203
Other long-term assets
2,245
872
Total assets
$
811,075
$
203,110
LIABILITIES
Current liabilities
Accounts payable
$
8,102
$
4,704
Accrued research and development expenses
28,237
4,572
Other accrued liabilities
7,496
4,950
Deferred revenue, current
115,614
7,000
Other current liabilities
3,422
1,480
Total current liabilities
162,871
22,706
Deferred revenue, noncurrent
91,298
12,022
Deferred rent, noncurrent
4,311
3,734
Other long-term liabilities
8,178
806
Total liabilities
266,658
39,268
Stockholders’ equity:
Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized as of September 30, 2020 and December 31, 2019; no shares issued and outstanding as of September 30, 2020 and December 31, 2019
-
-
Common stock, $ 0.0001 par value, 400,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 64,924,073 and 45,925,004 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively
6
4
Additional paid-in capital
820,661
369,100
Accumulated deficit
( 276,331
)
( 205,326
)
Accumulated other comprehensive income
81
64
Total stockholders’ equity
544,417
163,842
Total liabilities and stockholders’ equity
$
811,075
$
203,110
The accompanying notes are an integral part of these condensed consolidated financial statements.
*
The Condensed Consolidated Balance Sheet as of December 31, 2019 has been derived from the audited financial statements as of that date.
1
ARCUS BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(In thousands, except share and per share amounts)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Collaboration and license revenue
$
64,530
$
1,750
$
68,030
$
5,250
Operating expenses:
Research and development
51,801
17,241
110,636
57,795
General and administrative
11,177
7,758
29,617
18,637
Total operating expenses
62,978
24,999
140,253
76,432
Income (loss) from operations
1,552
( 23,249
)
( 72,223
)
( 71,182
)
Non-operating income (expense):
Interest and other income, net
270
1,254
1,218
4,272
Gain on deemed sale from equity method investee
-
-
613
-
Share of loss from equity method investee
-
( 357
)
( 613
)
( 1,202
)
Total non-operating income, net
270
897
1,218
3,070
Net income (loss)
1,822
( 22,352
)
( 71,005
)
( 68,112
)
Other comprehensive income (loss)
( 63
)
( 59
)
17
160
Comprehensive income (loss)
$
1,759
$
( 22,411
)
$
( 70,988
)
$
( 67,952
)
Net income (loss) per share, basic
$
0.03
$
( 0.51
)
$
( 1.37
)
$
( 1.56
)
Weighted-average number of shares used to
compute basic net income (loss) per share
62,599,193
43,939,281
51,852,247
43,750,154
Net income (loss) per share, diluted
$
0.03
$
( 0.51
)
$
( 1.37
)
$
( 1.56
)
Weighted-average number of shares used to
compute diluted net income (loss) per share
65,145,707
43,939,281
51,852,247
43,750,154
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
ARCUS BIOSCIENCES, INC.
Condensed Consolidated Statements of Stockholders’ Equity
(In thousands, except share amounts)
(unaudited)
Common stock
Additional
Paid-In
Accumulated
Accumulated
Other
Comprehensive
Total
Stockholders’
Shares
Amount
Capital
Deficit
Income (Loss)
Equity
Balance at December 31, 2018 *
43,610,823
$
4
$
357,873
$
( 122,828
)
$
( 107
)
$
234,942
Cumulative effect adjustment upon adoption of ASC 606
-
-
-
2,212
-
2,212
Issuance of common stock upon exercise of stock options
69
-
-
-
-
-
Vesting of early exercised stock options and restricted stock
114,934
-
273
-
-
273
Stock-based compensation
-
-
1,674
-
-
1,674
Other comprehensive income
-
-
-
-
136
136
Net loss
-
-
-
( 17,670
)
( 17,670
)
Balance at March 31, 2019
43,725,826
$
4
$
359,820
$
( 138,286
)
$
29
$
221,567
Issuance of common stock upon exercise of stock options
17,649
-
99
-
-
99
Vesting of early exercised stock options and restricted stock
107,952
-
260
-
-
260
Issuance of common stock under Employee Stock Purchase Plan
82,681
-
596
-
-
596
Stock-based compensation
-
-
2,130
-
-
2,130
Other comprehensive income
-
-
-
-
84
84
Net loss
-
-
-
( 28,090
)
-
( 28,090
)
Balance at June 30, 2019
43,934,108
$
4
$
362,905
$
( 166,376
)
$
113
$
196,646
Issuance of common stock upon exercise of stock options
1,052
-
1
-
-
1
Vesting of early exercised stock options and restricted stock
100,397
-
252
-
-
252
Stock-based compensation
-
-
2,740
-
-
2,740
Other comprehensive income
-
-
-
-
( 60
)
( 60
)
Net loss
-
-
-
( 22,352
)
-
( 22,352
)
Balance at September 30, 2019
44,035,557
$
4
$
365,898
$
( 188,728
)
$
53
$
177,227
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 and restricted stock
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
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 and restricted stock
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 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 and restricted stock
60,209
-
208
-
-
208
Stock-based compensation
-
-
6,002
-
-
6,002
Other comprehensive income
-
-
-
-
( 63
)
( 63
)
Net income
-
-
-
1,822
-
1,822
Balance at September 30, 2020
63,425,445
$
6
$
820,661
$
( 276,331
)
$
81
$
544,417
The accompanying notes are an integral part of these condensed consolidated financial statements.
*
The balances as of December 31, 2019 and 2018 have been derived from the audited financial statements as of that date.
3
ARCUS BIOSCIENCES, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(unaudited)
Nine Months Ended
September 30,
2020
2019
Cash flow from operating activities
Net loss
$
( 71,005
)
$
( 68,112
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
13,934
6,544
Depreciation and amortization
2,371
2,722
Share of loss from equity method investee
613
1,202
Gain on deemed sale from equity method investee
( 613
)
-
Amortization of premiums on investments
( 333
)
( 2,213
)
Changes in operating assets and liabilities:
Receivable from collaboration partners
( 2,447
)
( 5,276
)
Amounts owed by a related party
83
Prepaid expenses and other current assets
( 7,885
)
( 1,902
)
Other long-term assets
( 1,373
)
21
Accounts payable
3,165
( 94
)
Accrued research and development expenses
23,665
2,989
Accrued liabilities
2,485
650
Other current liabilities
1,869
42
Deferred revenue
187,890
( 250
)
Deferred rent
741
( 397
)
Other long-term liabilities
7,973
-
Net cash (used in) provided by operating activities
161,050
( 63,991
)
Cash flow from investing activities
Purchases of short-term and long-term investments
( 568,903
)
( 180,245
)
Proceeds from maturities of short-term and long-term investments
135,300
253,290
Sales of short-term investments
1,003
-
Purchases of property and equipment
( 1,536
)
( 1,729
)
Net cash (used in) provided by investing activities
( 434,136
)
71,316
Cash flow from financing activities
Proceeds from issuance of common stock and rights to purchase additional shares, net of issuance costs
433,776
-
Proceeds from issuance of common stock pursuant to equity award plans
3,271
697
Repurchase of unvested shares of stock
( 49
)
( 94
)
Net cash provided by financing activities
436,998
603
Net increase in cash and cash equivalents
163,912
7,928
Cash, cash equivalents and restricted cash at beginning of period
58,140
71,267
Cash, cash equivalents and restricted cash at end of period
$
222,052
$
79,195
Non-cash investing and financing activities:
Unpaid portion of financing costs included in accrued liabilities
$
61
$
-
Unpaid portion of property and equipment purchases included in accounts payable and accrued liabilities
$
245
$
33
Vesting of early exercised stock options and restricted stock
$
643
$
784
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ARCUS BIOSCIENCES, INC.
Notes to Condensed Consolidated 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, adaptive clinical trial designs.
Liquidity and Capital Resources
As of September 30, 2020, the Company had cash and investments of $ 785.1 million, 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 filing date 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, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020 or for any future period. The balance sheet as of December 31, 2019 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. Certain reclassifications have been made to prior period amounts to conform to the current year presentation. “Accrued interest receivable,” which was previously reported as “Prepaid expenses and other current assets”, and “Accrued research and development expense”, which was previously reported as “Other accrued liabilities” on the consolidated balance sheets, are now reported as separate line items.
The accompanying 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, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 5, 2020.
The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and will remain an emerging growth company until December 31, 2020. Under the JOBS Act, the Company elected the extended transition period for complying with new or revised accounting standards. At June 30, 2020 the Company determined that it will become a large accelerated filer at December 31, 2020 and in the process will no longer qualify as an emerging growth company. The Company will adopt any accounting pronouncements deferred under the extended transition period election on or before December 31, 2020.
Principles of Consolidation
The Company established a wholly-owned subsidiary in Australia in 2017 and a wholly-owned subsidiary in Ireland in 2019. The condensed consolidated financial statements include the Company’s accounts and those of its wholly-owned subsidiaries. All intercompany accounts, transactions and balances have been eliminated.
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, 2020 and December 31, 2019 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,
2020
December 31,
2019
Cash and cash equivalents
$
221,849
$
57,937
Restricted cash
203
203
Cash, cash equivalents and restricted cash
222,052
$
58,140
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.
Collaborative Arrangements and Contracts with Customers
The Company assesses whether its collaboration agreements are subject to Accounting Standards Codification (ASC) Topic 808, Collaborative Arrangements (ASC 808) based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, the Company applies the unit of account guidance under ASC Topic 606, Revenue from Contracts with Customers (ASC 606) to identify distinct performance obligations, and then determine whether a customer relationship exists for each distinct performance obligation. If the Company determines a performance obligation within the arrangement is with a customer, it applies the guidance in ASC 606. If a portion of a distinct bundle of goods or services within an arrangement is not with a customer, then the unit of account is not within the scope of ASC 606, and the recognition and measurement of that unit of account shall be based on analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election.
The Company enters into collaborative arrangements that typically include one of more of the following: (i) license fees; (ii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; (iii) royalties on net sales of licensed products; (iv) fees attributable to options to intellectual property; and (v) cost-sharing or research and development (R&D) funding arrangements. When a portion of non‑refundable upfront fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied. Fees attributable to options are deferred until the option expires or is exercised. When an option is exercised, the performance obligations associated with the option are identified, which will determine the accounting for the transaction price attributable to the option.
6
As part of the accounting for these arrangements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation. To determine t he stand-alone selling price , the Company may consider items such as forecasted revenues, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluate s each performance obligation to determine if it can be satisfied at a point in time or over time. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.
License Fees
If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments and Variable Consideration
At the inception of each arrangement that includes milestone payments or variable consideration, the Company evaluates whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated value is included in the transaction price. Milestone payments that are not within the control of the Company or the Company’s collaboration partner, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration or other revenues and earnings in the period of adjustment.
Cost-Sharing or R&D Funding Arrangements
Under certain collaborative arrangements, the Company has been reimbursed for a portion of its research and development expenses, including costs of drug supplies. When these R&D services are performed under a reimbursement or cost sharing model with a collaboration partner, the Company records these reimbursements as a reduction of R&D expense in its condensed consolidated statements of operations.
Royalties
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its collaborative arrangements.
Research and Development Expenses
Research and development costs are expensed as incurred. Research and development expenses consist primarily of personnel costs for the Company’s research and development employees, costs incurred to third-party service providers for the conduct of research, preclinical and clinical studies, laboratory supplies and equipment maintenance costs, product license fees, consulting and other related expenses.
The Company estimates research, preclinical and clinical study expenses based on services performed, pursuant to contracts with third-party research and development organizations that conduct and manage research, preclinical and clinical activities on its behalf. The Company estimates these expenses based on discussions with internal management personnel and external service providers as to the progress or stage of completion of services and the contracted fees to be paid for such services. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments associated with licensing agreements to acquire licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternative future use are expensed as incurred. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered.
7
Stock-Based Compensation
Stock-based awards granted include stock options and restricted stock awards with time-based vesting. Accounting standards require the recognition of compensation expense, using a fair value-based method, for costs related to all stock-based payments. The Company’s determination of the fair value of stock options with time-based vesting on the date of grant utilizes the Black-Scholes option-pricing model, and is impacted by the Company’s common stock price as well as other variables including, but not limited to, expected term that options will remain outstanding, expected common stock price volatility over the term of the option awards, risk-free interest rates and expected dividends. Compensation expense associated with restricted stock awards is based on the fair value of common stock on the date of grant.
Income Taxes
On March 18, 2020, the Families First Coronavirus Response act (FFCR Act), and on March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) were each enacted in response to the COVID-19 pandemic. The FFCR Act and the CARES Act contain numerous tax-related provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. On June 29, 2020 California State Assembly Bill 85 (the Trailer Bill) was enacted which suspends the use of California net operating loss (NOL) deductions and certain tax credits, including research and development tax credits, for the 2020, 2021, and 2022 tax years.
The FFCR Act, CARES Act and Trailer Bill did not have a material impact on the Company’s condensed consolidated financial statements as of September 30, 2020; however, the Company continues to examine the impacts the FFCR Act, CARES Act and Trailer Bill may have on its business, results of operations, financial condition and liquidity.
Recently Adopted Accounting Standards
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . ASU 2019-12 reduces costs and complexity of applying accounting standards while maintaining the usefulness of the information provided to users of financial statements. While not required to be adopted until 2021 for most calendar year public business entities, early adoption is permitted for any financial statements not yet issued. The Company early adopted this ASU as of January 1, 2020, with an immaterial impact on its financial statements.
In November 2018, the FASB issued ASU No. 2018-18 (Topic 808), Collaborative Arrangements . ASU 2018-18 clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606, Revenue from Contracts with Customers , (Topic 606) when the collaborative arrangement participant is a customer in the context of a unit of account and precludes recognizing as revenue consideration received from a collaborative arrangement participant if the participant is not a customer. The Company adopted this ASU as of January 1, 2020, with an immaterial impact on its financial statements.
Recently Issued Accounting Standards or Updates Not Yet Effective
In February 2016, the FASB issued ASU No. 2016-02 (Topic 842), Leases (ASU 2016-02). ASU 2016-02 requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. The ASU will also require new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. In July 2018, the FASB issued ASU No. 2018-10 , Codification Improvements to Topic 842, Leases and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements , which offers a practical expedient for transitioning at the adoption date. The Company is required to adopt these ASUs for its year ended December 31, 2020, with an effective date of January 1, 2020. The Company expects to adopt the standard using the modified retrospective approach which requires a cumulative-effect adjustment to retained earnings for adjustments prior to January 1, 2020. The Company also expects to adopt certain practical expedients provided by ASU 2018-11. The Company is in the process of implementing its plan, which includes the identification of its lease population and implementing changes to existing process that will be required to meet the requirements of the new standard. The adoption of Topic 842 is expected to impact the Company’s condensed consolidated financial statements as the Company has certain operating lease arrangements for which it is the lessee. The Company is currently evaluating the impact the adoption of Topic 842 will have on its financial position and results of operations but anticipates the recognition of additional material assets and corresponding material liabilities on its condensed consolidated balance sheet related to leases. The adoption of this accounting standard update is also expected to impact the Company’s condensed consolidated financial statement disclosures. While the Company is finalizing its evaluation of adopting this accounting standard update on its financial statements and related disclosures, the Company expects to recognize on its balance sheet for associated leases new ROU assets and corresponding liabilities as of January 1, 2020, approximately $ 6 million and $ 10 million, respectively.
In June 2016, the FASB issued ASU No. 2016 -13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which modifies the measurement and recognition of credit losses for most financial assets and certain other
8
instruments. The ASU updates the guidance for measuring and recording of current expected credit losses on financial assets measured at amortized cost by replacing the “incurred loss” model with an “expected loss” model. Accordingly, these financial assets will be presented at the net amount expected to be collected. The ASU also requires that credit losses related to available-for-sale debt securities be recorded as an allowance through net income rather than reducing the carrying amount under the current, other-than-temporary-impairment model. The Company is required to adopt ASU 2016-13 for its year ended December 31, 2020, with an effective date of January 1, 2020. The Company expects to adopt the standard using the modified retrospective approach which requires a cumulative-effect adjustment to accumulated deficit for adjustments prior to January 1, 2020. The adoption of this standard is not expected to have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued ASU No.2018-13 (Topic 820), Fair Value Measurement. ASU 2018-13 modifies the disclosure requirements on fair value measurement in Topic 820. The Company is required to adopt ASU 2018-13 by December 31, 2020, with an effective date of January 1, 2020. The Company expects to adopt the standard on December 31, 2020. The adoption of this standard is not expected to have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued ASU No.2018-15 (Subtopic 350-40), Intangibles – Goodwill and Other – Internal-Use Software. ASU 2018-15 requires an entity in a hosting arrangement that is a service contract to follow the guidance in Subtopic 350-40 to determine which implementation costs to capitalize as an asset related to internal-use software. The Company is required to adopt ASU 2018-15 by December 31, 2020, with an effective date of January 1, 2020. The Company expects to adopt the standard on December 31, 2020. The adoption of this standard is not expected to have a material impact on the Company’s condensed consolidated financial statements.
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 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 as follows:
Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
Level 3—Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
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, 2020 and December 31, 2019. 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, 2020
Total
Level 1
Level 2
Level 3
Money market funds
$
181,303
$
181,303
$
-
$
-
U.S. treasury securities
373,476
-
373,476
-
U.S. government agency securities
34,992
-
34,992
-
Corporate securities and commercial paper
195,361
-
195,361
-
Total assets measured at fair value
$
785,132
$
181,303
$
603,829
$
-
9
December 31, 2019
Total
Level 1
Level 2
Level 3
Money market funds
$
45,498
$
45,498
$
-
$
-
U.S. treasury securities
74,854
-
74,854
-
Corporate securities and commercial paper
67,918
-
67,918
-
Total assets measured at fair value
$
188,270
$
45,498
$
142,772
$
-
Classified as (with contractual maturities):
September 30, 2020
December 31, 2019
Cash and cash equivalents
$
221,849
$
57,937
Short-term investments (due within one year)
560,583
130,333
Long-term investments (due between one and two years)
2,700
-
Total cash, cash equivalents and investments in marketable securities
$
785,132
$
188,270
Investments in marketable securities are classified as available-for-sale. At September 30, 2020 and December 31, 2019, the balance in the Company’s accumulated other comprehensive income comprised activity related to the Company’s available-for-sale marketable securities. There were immaterial and no realized gains or losses recognized on the sale or maturity of available-for-sale marketable securities as of September 30, 2020 and December 31, 2019, respectively, 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 a limited number of available-for-sale marketable securities in loss positions as of September 30, 2020, which the Company does not intend to sell and has concluded it will not be required to sell before recovery of the amortized cost for the investment at maturity . The fair value and amortized cost of investments in marketable securities by major security type as of September 30, 2020 and December 31, 2019 are presented in the tables that follow (in thousands):
Amortized
Cost
Unrealized
Gain
Unrealized
Loss
Fair
Value
As of September 30, 2020:
Money market funds
$
181,303
$
-
$
-
$
181,303
U.S. treasury securities
373,423
54
( 1
)
373,476
U.S. government agency securities
34,986
6
-
34,992
Corporate securities and commercial paper
195,339
27
( 5
)
195,361
Total
$
785,051
$
87
$
( 6
)
$
785,132
Amortized
Cost
Unrealized
Gain
Unrealized
Loss
Fair
Value
As of December 31, 2019:
Money market funds
$
45,498
$
-
$
-
$
45,498
U.S. treasury securities
74,801
12
( 1
)
74,812
Corporate securities and commercial paper
67,907
55
( 2
)
67,960
Total
$
188,206
$
67
$
( 3
)
$
188,270
Note 4. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
As of September 30, 2020
As of December 31, 2019
Personnel expenses
$
6,247
$
4,571
Professional fees
632
183
Other
617
196
Total
$
7,496
$
4,950
10
Note 5. Equity Investment
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 funded, early-stage biopharmaceutical company focused on adoptive cell therapy. 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 income (loss). The investment balance was zero at September 30, 2020 and December 31, 2019. Since the Company has no obligation to provide cash financing to PACT Pharma, the Company is not required to record losses beyond the carrying amount of the investment.
In January and June 2020, PACT Pharma issued shares in its Series C and Series C-1 preferred stock financings. The Company did not participate in these financings. The decrease in the Company’s equity ownership percentage and an increase in PACT Pharma’s estimated fair value per share resulted in gains on dilution totaling an immaterial amount and $ 1.5 million during the three and nine months ended September 30, 2020. After applying an immaterial amount and $ 0.9 million in losses accumulated in prior periods when the equity investment balance was zero , the Company recorded a gain of zero and $ 0.6 million for the three and nine months ended September 30, 2020, respectively.
The Company’s share of PACT Pharma’s losses for the for the three and nine months ended September 30, 2020 exceeded gains for the same period. The Company recorded zero and $ 0.6 million for its share of PACT Pharma’s operating losses for the three and nine months ended September 30, 2020, respectively. The unrecognized equity method losses in excess of the Company’s investment was $ 1.2 million as of September 30, 2020.
At September 30, 2020 and December 31, 2019, the Company determined the fair value of the warrants to be insignificant to the condensed consolidated financial statements.
Note 6. License and Collaboration Agreements
The following table summarizes the revenues for the three and nine months ended September 30, 2020 and 2019 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,
2020
2019
2020
2019
License revenue
$
55,096
$
-
$
55,096
$
-
Collaboration revenue
9,434
1,750
12,934
5,250
Collaboration and license revenue
$
64,530
$
1,750
$
68,030
$
5,250
The following table summarizes details of revenues for the three and nine months ended September 30, 2020 and 2019 by collaboration and by category of revenue:
Three Months Ended September 30,
Nine Months Ended September 30,
Revenues recognized:
Over time
Point in time
2020
2019
2020
2019
Gilead license to zimberelimab
*
$
55,096
$
-
$
55,096
$
-
Gilead access rights related to the Company's research and development pipeline
*
7,684
-
7,684
-
Taiho collaboration agreement
*
1,750
1,750
5,250
5,250
Total collaboration and license revenue
$
64,530
$
1,750
$
68,030
$
5,250
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In addition to revenues, the Company recognized $ 0.5 million as a reduction to R&D expense for the three months ended September 30, 2020 due to the development services performed during the period for zimberelimab . 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:
2020
2019
2020
2019
Amounts included in deferred revenue at the beginning of the period
$
1,750
$
1,750
$
5,250
$
5,250
Performance obligations satisfied in previous period
-
-
-
-
The Company received $ 175 million in upfront payments from Gilead in connection with the Option, License and Collaboration Agreement and identified $ 100 million in unconstrained consideration to be received in 2022. In addition, 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 in July 2020 with the remaining premium of $ 90.6 million allocated to the transaction price. The Company determined the present value of the unconstrained variable consideration to be $ 99.1 million at the contract closing date. These payments were allocated to the performance obligations identified as follows:
September 30, 2020
Allocation of transaction price
Upfront cash consideration
$
175,000
Payment for access rights related to the Company's research and development pipeline
99,126
Premium from Stock Purchase Agreement
90,600
Total transaction price allocated to revenue
$
364,726
Allocation to performance obligations
Zimberelimab license
$
55,096
Etrumadenant option
126,657
Domvanalimab option
36,640
Access rights related to the Company's research and development pipeline
136,653
Development and commercialization services for zimberelimab
9,680
Total
$
364,726
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, and the Company appointed Gilead’s designee, Merdad Parsey, M.D., Ph.D., to the Company’s Board of Directors pursuant to the Investor Rights Agreement.
Pursuant to the terms of the Gilead Collaboration Agreement, Gilead has an exclusive license to develop and commercialize zimberelimab (formerly referred to as AB122) 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 payment of up to $ 400.0 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 may exercise its option, on a program-by-program basis, upon payment of an option fee that ranges from $ 200 million to $ 275 million per program for the Company’s current clinical programs, and $ 150 million per program for all other programs should Gilead elect to exercise its options.
Upon Gilead’s exercise of its option to a program, the two companies will co-develop and equally share global development costs, 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. Gilead will further provide
12
ongoing research and development support in the form of research and development pipeline access rights payments of up to $ 400 million over the collaboration term.
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 the next five years , 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. 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 present value of 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 so given this successful collection history, the Company considers the entire $ 364.7 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 (formerly AB122) 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 (formerly AB928) 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. The Company will recognize revenue allocated to the material right either upon the option’s exercise or expiration.
Domvanalimab (formerly AB154) 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. 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. The Company will recognize revenue allocated to the material right either upon the option’s exercise or expiration.
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 $ 400.0 million, with the first payment of $ 100.0 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 $ 100.0 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 determined that the revenue allocated to the performance obligation should be recognized over the four-year period. The Company further determined that Gilead is not obligated to pay the remaining $ 300.0 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.
Development and commercialization services for zimberelimab
In conjunction with the license, the Company determined there existed a separate obligation to perform further development and commercialization services for Gilead. 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. 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. The Company will recognize the amounts allocated to development services throughout the initial 4 year period of the contract. The Company will defer the portion allocated to
13
commercialization services until future periods when the actual costs are incurred . Any 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.
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 and contract liabilities
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 Collaboration Agreement, the Stock Purchase Agreement and the Investor Rights Agreement. 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 over the initial noncancelable four-year term of the Gilead Collaboration Agreement. During the three and nine months ended September 30, 2020, the Company recognized $ 1.1 million in expense from the amortization of these assets. At September 30, 2020, the Company had $ 4.3 million in prepaid expenses from costs to obtain the Gilead Agreements, of which $ 2.9 million was recorded in prepaid expenses and other current assets and $ 1.4 million was recorded in other long-term assets. The Company also recognized $ 9.2 million in contract liabilities for future development and promotion costs which Gilead prepaid, of which $ 1.9 million and $ 7.3 million represented the short and long-term portions of the liability, recorded in other current liabilities and other non-current liabilities on the condensed consolidated balance sheets, respectively.
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 in the Taiho Territory, over a five-year period (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).
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.
In the event that the Company has not initiated IND enabling studies for at least five Arcus Programs prior to the expiration of the Option Period, Taiho may elect to extend the Option Period, up to a maximum of seven years , subject to an extension fee. For each option that Taiho elects to exercise, Taiho 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 evaluated the Taiho Agreement under ASC 606 and determined that the current performance obligations consist of (1) the research and development services, in which the Company will use commercially reasonable efforts to initiate IND enabling studies for at least five Arcus Programs, as well as further develop such Arcus Programs during the term of the Agreement, and (2) the obligation to participate on the joint steering committee. These deliverables are non-contingent in nature. The Company determined that the obligation to participate in the joint steering committee does not have stand-alone value to Taiho because the committee’s primary purpose is to monitor and govern the research and development activities and, hence, it is inseparable from the research and development services.
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 $ 20.0 million due upon contract execution in September 2017, a $ 5.0 million payment due within 30 days of contract execution, an anniversary payment of $ 5.0 million due in 2018, and a final anniversary payment of $ 5.0 million due in 2019. All payments were made by Taiho as they became due and payable so given this successful collection history, the Company considers the entire $ 35.0 million in non-refundable fees to be the initial transaction price.
The Company determined that 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
14
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 .
The Company also concluded that, at the inception of the agreement, Taiho’s exclusive options are not considered material rights as the options do not contain a significant and incremental discount. The Company therefore excludes the exclusive options from the initial transaction price and accounts for them as separate contracts. In 2018, Taiho exercised its option to the Company’s adenosine receptor antagonist program, including etrumadenant (formerly referred to as AB928), for a fee of $ 3.0 million, which was recognized by the Company as revenue during the year ended December 31, 2018 under ASC 605. The adoption of ASC 606 in 2019 had no effect on the revenue recognized for this fee. In 2019, Taiho exercised its option to the Company’s anti-PD-1 antibody program, including zimberelimab (formerly referred to as AB122) for a fee of $ 8.0 million. The Company identified one performance obligation, the delivery of the license, which was completed in 2019. The transaction price was determined to be the payment of $ 8.0 million, which was recognized by the Company as licensing revenue during the year ended December 31, 2019 under ASC 606. Upon the option exercises, Taiho gained sole responsibility for the development and commercialization of the licensed products from within the programs in the Taiho Territory.
The Company also determined that the clinical and regulatory milestone payments under the Taiho Agreement are variable consideration under ASC 606 which need to be added to the transaction price when it is probable that a significant revenue reversal will not occur. 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, 2020, 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, 2020, 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 Agreement
The Company entered into a license agreement (the WuXi Agreement) with WuXi Biologics (Cayman) Inc. (WuXi Biologics) in August 2017, as subsequently amended in June 2019 and March 2020, in which the Company obtained an exclusive license to develop, use, manufacture, and commercialize products including an anti-PD-1 antibody worldwide except for Greater China and Thailand. From the inception of the WuXi Agreement through September 30, 2020, the Company has made upfront and milestone payments of $ 31.0 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 do not have an alternative future use. The WuXi Agreement also provides for additional 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 $ 10.1 million and $ 15.1 million in expense under the WuXi Agreement during the three and nine months ended September 30, 2020, which includes a sub-license fee of $ 10.1 million due in connection with the grant of a sublicense to Gilead for zimberelimab under the Gilead Collaboration Agreement in July 2020, and a $ 5.0 million development milestone expense.
Abmuno License Agreement
In December 2016, the Company entered into a license agreement (the Abmuno Agreement) with Abmuno Therapeutics LLC (Abmuno) for 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 $ 9.6 million as of September 30, 2020. The Abmuno Agreement also provides for additional clinical, regulatory and commercialization milestone remaining payments of up to $ 98.0 million as of September 30, 2020.
The Company incurred $ 3.0 million in development milestone expense during the three and nine months ended September 30, 2020.
15
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 (TECENTRIQ®) and the Company’s investigational products. Pursuant to the Genentech Agreement, the parties entered into Trial Supplements for the evaluation of etrumadenant (formerly referred to as AB928) 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 will each supply their respective investigational products for use in the collaboration studies and will share a portion of the development costs under specific terms as set forth in the agreement.
For the three and nine months ended September 30, 2020, the Company incurred expenses pursuant to the Genentech Agreement of $ 0.1 million. Net expenses related to this co-development agreement are recorded within research and development expenses.
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 will share a portion of development costs for the clinical collaboration under specified terms. Strata is eligible to receive $ 2.5 million upon the achievement of a development milestone, as well as regulatory and commercial milestones of up to $ 125.0 million and up to double-digit royalties on U.S. net sales of zimberelimab in the biomarker-identified indication. From the inception of the Agreement through September 30, 2020, the Company has made a milestone payment of $ 2.5 million and has incurred expenses of $ 2.2 million, of which $ 0.4 million had been reimbursed by Strata as development cost sharing. These amounts were recorded within research and development expense.
As further consideration in connection with the Strata Agreement, the Company issued to Strata 1,257,651 restricted shares of its common stock with an initial measured fair value of $ 15.0 million, which are subject to vesting based upon the achievement of specified regulatory milestones within certain timelines. Expense relating to the restricted shares subject to these milestones is recognized if it is considered probable that the associated shares will vest. The probability of achievement is assessed at the end of each quarterly period. As of September 30, 2020, the Company determined that no ne of the restricted shares were probable of vesting and, as a result, no compensation expense related to the restricted shares has been recognized to date.
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 million and $ 0.2 million have been reimbursed by Strata as development cost sharing for the three and nine months ended September 30, 2020, respectively. Net expenses related to this co-development agreement are recorded within research and development expenses.
Note 7. 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 6 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.
Note 8. Stock-Based Compensation
In March 2018, the Company adopted the 2018 Equity Incentive Plan (2018 Plan). The 2018 Plan replaced the Company’s 2015 Stock Plan (2015 Plan) and 3,570,000 shares were reserved under the 2018 Plan, along with any shares remaining available for issuance under the Company’s 2015 Plan or outstanding awards under its 2015 Plan that subsequently expire, lapse unexercised or are forfeited to or repurchased by the Company.
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In January 2020, the Company adopted the 2020 Inducement Plan (2020 Plan). Under the 2020 Plan, 3,000,000 shares were reserved for issuance.
In June 2020, the Company issued a total of 658,950 shares of common stock under restricted stock agreements to its employees and directors under the 2018 Plan. At the date of grant, the shares had an estimated weighted average fair value of $ 29.41 per share. Under the terms of the restricted stock agreements, shares vest annually over four years for employees and over 12 months for directors. During the three and nine months ended September 30, 2020, 5,000 shares were forfeited. There were 653,950 shares of restricted stock outstanding at September 30, 2020.
Total stock-based compensation expense was recognized in the condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2020
2019
2020
2019
Research and development
$
3,075
$
978
$
7,179
$
2,693
General and administrative
2,927
1,762
6,755
3,851
Total stock-based compensation
$
6,002
$
2,740
$
13,934
$
6,544
Note 9. 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. 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 income (loss) per share (in thousands, except share and per share data):
Three Months Ended September 30,
Nine Months Ended September 30,
2020
2019
2020
2019
Numerator:
Net income (loss)
$
1,822
$
( 22,352
)
$
( 71,005
)
$
( 68,112
)
Denominator:
Weighted-average common shares outstanding
64,132,283
45,787,137
53,452,007
45,253,176
Less: weighted-average common shares subject to vesting
( 1,533,090
)
( 1,847,856
)
( 1,599,760
)
( 1,503,022
)
Weighted-average common shares used to compute basic net income (loss) per share
62,599,193
43,939,281
51,852,247
43,750,154
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
65,145,707
43,939,281
51,852,247
43,750,154
Net income (loss) per share: basic
$
0.03
$
( 0.51
)
$
( 1.37
)
$
( 1.56
)
Net income (loss) per share: diluted
$
0.03
$
( 0.51
)
$
( 1.37
)
$
( 1.56
)
The following outstanding potentially dilutive securities were excluded from the computation of diluted net income (loss) per share because including them would have been antidilutive:
Three Months Ended September 30,
Nine Months Ended September 30,
2020
2019
2020
2019
Common stock options issued and outstanding
1,518,386
4,274,163
7,841,220
4,274,163
Unvested restricted common stock issued as part of
collaboration agreement
1,257,651
1,257,651
1,257,651
1,257,651
Unvested early exercised common stock options
-
552,364
240,977
552,364
Restricted stock units issued
653,950
-
653,950
-
Employee Stock Purchase Plan shares
12,966
-
79,848
-
Total
3,442,953
6,084,178
10,073,646
6,084,178
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The Company also excluded the effect of Gilead ’s right to purchase additional shares of the Company’s common stock from its calculation as the se rights had no intrinsic value at September 30, 2020.
Note 10. Commitments
Leases
The Company leases laboratory and office space in Hayward, California under non-cancelable operating leases that expire in 2025 , subject to an option by the Company to extend the lease term. In June 2020, the Company entered into a lease amendment for 36,303 square feet of additional space in Hayward, California, that is expected to commence January 2021 for an eight-year term with minimum lease payments of $ 10.1 million. The lease amendment provides for one eight-year extension period.
Note 11. Related parties
Relationship and transactions with Gilead Sciences, Inc. (Gilead)
As of September 30, 2020, Gilead held approximately 13 % of the Company’s outstanding common stock, and 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 the next five years. Gilead also has the right under the Investor Rights Agreement to designate two individuals to be appointed to the Company’s board of directors. In July 2020, in accordance with Gilead’s right, the Company appointed the first Gilead designee, Merdad Parsey, M.D., Ph.D., to its board of directors.
At September 30, 2020, the Company had a $ 2.5 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 $ 193.1 million in deferred revenue at September 30, 2020, of which $ 84.5 million represented the long-term portion of revenue allocated to Gilead’s access rights to the Company’s research and development pipeline and was recorded in deferred revenue, noncurrent on the condensed consolidated balance sheets. The Company also recognized $ 9.2 million in contract liabilities for future development and promotion costs which Gilead prepaid , of which $ 1.9 million and $ 7.3 million represented the short and long-term portions of the liability, recorded in other current liabilities and other long-term liabilities on the condensed consolidated balance sheets, respectively.
For the three and nine months ended September 30, 2020, the Company recognized $ 62.8 million in revenue under the Gilead Collaboration Agreement. The Company also recognized a $ 3.0 million reduction in research and development expense related to its cost-sharing provisions of the agreement, of which $ 2.5 million relates to the ongoing collaboration over zimberelimab and $ 0.5 million relates to the development and commercialization activities performance obligation.
The Company received $ 175 million in upfront payments from Gilead in connection with the Option, License and Collaboration Agreement and identified $ 100 million in unconstrained consideration to be received in 2022. In addition, 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 in July 2020 with the remaining premium of $ 90.6 million allocated to the transaction price.
Note 12. Subsequent event
On October 29, 2020 the Company announced a collaboration with AstraZeneca to evaluate domvanalimab (AB154), 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. Pursuant to the terms of the agreement, the parties will share costs for the trial.
Consistent with the terms of the recently completed Arcus-Gilead partnership, 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.
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