Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
As of December 31, 2021, we had cash and cash equivalents of $417.2 million. A portion of our cash equivalents, which are in money market funds, may be subject to interest rate risk and could fall in value if market interest rates increase. However, because our cash equivalents are primarily short-term in duration, we believe that our exposure to interest rate risk is not significant and a 1% movement in market interest rates would not have a significant impact on the total value of our portfolio.
We are exposed to market risk related to changes in foreign exchange rates. We contract with CROs and contract manufacturers globally and thus we face foreign exchange risk as a result of entering into transactions denominated in currencies other than United States dollars. Due to the uncertain timing of expected payments in foreign currencies, we do not utilize any forward exchange contracts. All foreign transactions settle on the applicable spot exchange basis at the time such payments are made. An adverse movement in foreign exchange rates could have a material effect on payments made to foreign suppliers and for license agreements. A hypothetical 10% change in foreign exchange rates during any of the periods presented would not have had a material impact on our financial statements. We do not enter into investments for trading or speculative purposes and have not used any derivative financial instruments to manage our interest rate risk exposure.
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Item 8. Consolidated Financial Statements and Supplementary Data
COHERUS BIOSCIENCES, INC.
ANNUAL REPORT ON FORM 10-K
INDEX TO AUDITED CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 42 )
92
Audited Consolidated Financial Statements
Consolidated Ba lance Sheets
95
Consolidated Statements of Operations
96
Consolidated Statements of Comprehensive (Loss) Income
97
Consolidated Statements of Stockholders’ Equity (Deficit)
98
Consolidated Statements of Cash Flows
99
Notes to Consolidated Financial Statements
100
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Coherus BioSciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Coherus BioSciences, Inc., (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive (loss) income, stockholders' equity (deficit), and cash flows for each of the three years in the period ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021, in conformity with U.S. generally accepted accounting principles. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 23, 2022 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved especially challenging, subjective or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
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Estimate of Reserves for Chargebacks and Rebates
Description of the Matter
As described in Note 2 to the consolidated financial statements, the Company recognizes revenues from product sales at the net sales price, which includes estimates of reserves for chargebacks and rebates it provides to hospitals, clinics, and payers under commercial and government programs. These reserves are recorded in the period when sales occur and are based on the amounts to be claimed on the related sales which may not be known at the point of sale. Chargebacks and rebates are estimated based on expected channel and payer mix, and contracted discount rates, adjusted for current period assumptions. Estimated chargebacks are recorded as a reduction of trade receivables on the consolidated balance sheet and totaled $29.3 million at December 31, 2021. Estimated rebates are presented within accrued rebates, fees and reserves on the consolidated balance sheets and totaled $54.0 million at December 31, 2021.
Auditing the estimates for chargebacks and rebates was complex due to the judgmental nature of the assumptions used. In particular for product that remains in the distribution channel at December 31, 2021, management is required to estimate the portion of product that is expected to be subject to a chargeback and rebate as well as the applicable discount rate.
How We Addressed the Matter in Our Audit
We obtained an understanding, evaluated the design and tested the operating effectiveness of internal controls over the Company's estimates of chargebacks and rebates, which are accounted for as reductions to revenue. This included controls over management’s review of significant assumptions used in the estimates such as expected channel and payer mix and contractual discount rate.
To test the Company's estimated reserves for chargebacks and rebates, our audit procedures included, among others, testing the accuracy and completeness of the underlying data used in the Company’s analyses and evaluating the significant assumptions stated above. Specifically, for estimated chargebacks and rebates, we obtained third-party channel inventory reports and reviewed the remaining inventory in the distribution channel, tested historical channel and payer mix data, and compared applicable contractual chargeback or rebate percentages applied against executed chargeback and rebate agreements. We also assessed the completeness and accuracy of current and historical channel and payer mix and discount rate data used in management’s estimates and performed sensitivity analyses to determine the effect of changes in assumptions, where appropriate.
Excess and Obsolete Inventory Reserve
Description of the Matter
As of December 31, 2021, the Company had $93.3 million of inventory which included $4.9 million of raw materials, $65.1 million of work in progress and $23.3 million of finished goods. As disclosed in Note 1 to the Company’s consolidated financial statements, inventories are stated at the lower of cost or net realizable value. The Company assesses its inventory levels along with its purchase commitments each reporting period and writes down inventory that is either expected to be at risk of expiration prior to sale or has a cost basis in excess of its expected net realizable value.
Auditing management's estimates for excess inventory involved subjective auditor judgment because the estimates rely on a number of factors that are affected by market and economic conditions outside the Company's control. In particular, the excess inventory calculations are sensitive to significant assumptions, including the expected demand for the Company’s product, the effect on demand of competitive products and the Company's purchase commitments.
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How We Addressed the Matter in Our Audit
We obtained an understanding, evaluated the design, and tested the operating effectiveness of internal controls over the Company's excess and obsolete inventory reserve process including management’s review of the significant assumptions described above and controls over the completeness and accuracy of the information used to develop the estimate.
Our substantive audit procedures included, among others, evaluating methodologies used and data utilized in the analysis for inventory expected to be at risk for expiration or excess. We evaluated purchase commitments or alternative uses, compared forecasted demand to historical trends, compared actual inventory levels to forecasted demand requirements, and evaluated the sensitivity of sales forecast assumptions on the amount of inventory reserves recorded.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2012.
Redwood City, California
February 23, 2022
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Coherus BioSciences, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
417,195
$
541,158
Trade receivables, net
123,022
157,046
Inventory
37,642
44,233
Prepaid manufacturing
13,666
19,429
Other prepaid and other assets
10,798
5,613
Total current assets
602,323
767,479
Property and equipment, net
7,813
10,108
Inventory, non-current
55,610
47,956
Intangible assets
2,620
2,620
Goodwill
943
943
Other assets, non-current
10,025
12,543
Total assets
$
679,334
$
841,649
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
16,159
$
15,201
Accrued rebates, fees and reserves
79,027
81,529
Accrued compensation
22,014
22,244
Accrued and other current liabilities
48,127
26,679
Total current liabilities
165,327
145,653
2022 Convertible Notes
81,359
79,885
2022 Convertible Notes - related parties
27,120
26,628
2026 Convertible Notes
224,288
223,029
2025 Term loan
75,513
74,481
Lease liabilities, non-current
7,251
9,948
Other liabilities, non-current
750
1,051
Total liabilities
581,608
560,675
Commitments and contingencies (Note 8)
Stockholders’ equity:
Common stock ( $ 0.0001 par value; shares authorized: 300,000,000 ; shares issued and outstanding : 76,930,096 and 72,513,348 at December 31, 2021 and 2020, respectively)
7
7
Additional paid-in capital
1,147,843
1,043,991
Accumulated other comprehensive loss
( 270 )
( 270 )
Accumulated deficit
( 1,049,854 )
( 762,754 )
Total stockholders' equity
97,726
280,974
Total liabilities and stockholders’ equity
$
679,334
$
841,649
See accompanying notes.
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Coherus BioSciences, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share data)
Year Ended December 31,
2021
2020
2019
Net revenue
$
326,551
$
475,824
$
356,071
Cost and expenses:
Cost of goods sold
57,591
37,667
17,078
Research and development
363,105
142,759
94,188
Selling, general and administrative
169,713
139,079
137,037
Total cost and expenses
590,409
319,505
248,303
(Loss) income from operations
( 263,858 )
156,319
107,768
Interest expense (includes related party expense of $ 2,541 , $ 2,498 and $ 2,457 for the years ended December 31, 2021, 2020 and 2019, respectively)
( 22,959 )
( 21,166 )
( 17,601 )
Other (expense) income, net
( 283 )
554
2,608
Net (loss) income before income taxes
( 287,100 )
135,707
92,775
Income tax provision
—
3,463
2,942
Net (loss) income
$
( 287,100 )
$
132,244
$
89,833
Net (loss) income per share:
Basic
$
( 3.81 )
$
1.85
$
1.29
Diluted
$
( 3.81 )
$
1.62
$
1.23
Weighted-average number of shares used in computing net (loss) income per share:
Basic
75,449,632
71,411,705
69,679,916
Diluted
75,449,632
83,491,898
73,185,943
See accompanying notes.
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Coherus BioSciences, Inc.
Consolidated Statements of Comprehensive (Loss) Income
(in thousands)
Year Ended December 31,
2021
2020
2019
Net (loss) income
$
( 287,100 )
$
132,244
$
89,833
Other comprehensive (loss) income:
Foreign currency translation adjustments, net of tax
—
288
( 276 )
Comprehensive (loss) income
$
( 287,100 )
$
132,532
$
89,557
See accompanying notes.
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Coherus BioSciences, Inc.
Consolidated Statements of Stockholders’ Equity (Deficit)
(in thousands, except share and per share data)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
Loss
Deficit
Equity (Deficit)
Balances at December 31, 2018
68,302,681
$
7
$
946,515
$
( 282 )
$
( 984,831 )
$
( 38,591 )
Net income
—
—
—
—
89,833
89,833
Cumulative translation adjustment
—
—
—
( 276 )
—
( 276 )
Issuance of common stock in connection with common stock offerings, net of underwriters discounts, commissions and offering costs
761,130
—
8,228
—
—
8,228
Issuance of common stock upon exercise of stock options
863,940
—
5,934
—
—
5,934
Issuance of common stock upon vesting of RSUs
39,765
—
—
—
—
—
Issuance of common stock under the ESPP
289,977
—
3,518
—
—
3,518
Issuance of common stock upon 2018 bonus payout in RSUs
175,054
—
2,165
—
—
2,165
Taxes paid related to net share settlement of bonus payout in RSUs
( 65,886 )
—
( 815 )
—
—
( 815 )
Stock-based compensation expense
—
—
35,218
—
—
35,218
Balances at December 31, 2019
70,366,661
7
1,000,763
( 558 )
( 894,998 )
105,214
Net income
—
—
—
—
132,244
132,244
Cumulative translation adjustment
—
—
—
288
—
288
Issuance of common stock upon exercise of stock options
1,704,764
—
17,061
—
—
17,061
Issuance of common stock upon vesting of RSUs
89,668
—
—
—
—
—
Issuance of common stock under the ESPP
267,772
—
3,801
—
—
3,801
Issuance of common stock upon 2019 bonus payout in RSUs
134,099
—
2,378
—
—
2,378
Taxes paid related to net share settlement of bonus payout in RSUs
( 49,616 )
—
( 880 )
—
—
( 880 )
Purchase of capped call options related to convertible notes due 2026
—
—
( 18,170 )
—
—
( 18,170 )
Stock-based compensation expense
—
—
39,038
—
—
39,038
Balances at December 31, 2020
72,513,348
7
1,043,991
( 270 )
( 762,754 )
280,974
Net loss
—
—
—
—
( 287,100 )
( 287,100 )
Issuance of common stock upon exercise of stock options
1,316,361
—
10,410
—
—
10,410
Issuance of common stock upon vesting of RSUs
465,930
—
—
—
—
—
Issuance of common stock under the ESPP
238,934
—
3,002
—
—
3,002
Issuance of common stock to Junshi Biosciences, net of issuance costs
2,491,988
—
40,903
—
—
40,903
Taxes paid related to net share settlement of RSUs
( 96,465 )
—
( 1,753 )
—
—
( 1,753 )
Stock-based compensation expense
—
—
51,290
—
—
51,290
Balances at December 31, 2021
76,930,096
$
7
$
1,147,843
$
( 270 )
$
( 1,049,854 )
$
97,726
See accompanying notes.
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Coherus BioSciences, Inc.
Consolidated Statements of Cash Flows
(in thousands)
Years Ended December 31,
2021
2020
2019
Operating activities
Net (loss) income
$
( 287,100 )
$
132,244
$
89,833
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:
Depreciation and amortization
3,454
2,888
3,259
Stock-based compensation expense
51,364
38,160
33,591
Write-off of prepaid manufacturing services related to the termination of CHS-2020
3,210
—
—
Write-off of inventory that did not meet acceptance criteria, net
5,133
2,171
395
Non-cash accretion of discount on marketable securities
1,095
( 155 )
( 165 )
Non-cash interest expense from amortization of debt discount
4,257
3,481
2,339
Non-cash operating lease expense
2,207
2,081
1,789
Upfront license fee payment to Junshi Biosciences
136,000
—
—
Upfront and milestone based license fee payments
—
7,500
11,075
Other non-cash adjustments, net
588
426
562
Changes in operating assets and liabilities:
Trade receivables, net
34,062
( 15,218 )
( 141,992 )
Inventory
( 6,253 )
( 38,359 )
( 48,579 )
Prepaid manufacturing
3,828
( 10,851 )
( 672 )
Other prepaid, current and non-current assets
( 5,351 )
( 2,020 )
( 2,474 )
Accounts payable
874
( 9,820 )
9,893
Accrued rebates, fees and reserves
( 2,502 )
30,409
51,120
Accrued compensation
( 230 )
6,212
10,035
Accrued and other current and non-current liabilities
17,932
4,996
8,346
Net cash (used in) provided by operating activities
( 37,432 )
154,145
28,355
Investing activities
Purchases of property and equipment
( 1,289 )
( 7,231 )
( 1,822 )
Proceeds from disposal of property and equipment
—
175
—
Purchases of investments in marketable securities
( 182,485 )
( 273,845 )
( 20,235 )
Proceeds from maturities of investments in marketable securities
99,692
274,000
20,400
Proceeds from sale of investments in marketable securities
81,672
—
—
Upfront license fee payment to Junshi Biosciences
( 136,000 )
—
—
Upfront and milestone based license fee payments
—
( 7,500 )
( 11,075 )
Net cash used in investing activities
( 138,410 )
( 14,401 )
( 12,732 )
Financing activities
Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs
—
—
8,153
Proceeds from issuance of Convertible Notes due 2026, net of issuance costs
—
222,156
—
Purchase of capped call options related to Convertible Notes due 2026
—
( 18,170 )
—
Proceeds from 2025 Term Loan, net of issuance costs
—
—
72,955
Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs
40,903
—
—
Proceeds from issuance of common stock upon exercise of stock options
10,399
17,428
5,558
Proceeds from purchase under the employee stock purchase plan
3,002
3,801
3,519
Taxes paid related to net share settlement of RSUs
( 1,753 )
( 880 )
( 815 )
Principal payments for finance lease obligations
( 672 )
( 389 )
—
Net cash provided by financing activities
51,879
223,946
89,370
Effect of exchange rate changes in cash, cash equivalents and restricted cash
—
—
( 276 )
Net (decrease) increase in cash, cash equivalents and restricted cash
( 123,963 )
363,690
104,717
Cash, cash equivalents and restricted cash at beginning of period
541,598
177,908
73,191
Cash, cash equivalents and restricted cash at end of period
$
417,635
$
541,598
$
177,908
Supplemental disclosure of cash flow information
Cash paid for interest
$
18,684
$
16,959
$
15,263
Cash paid for income taxes
$
1,221
$
3,953
$
1,732
Right-of-use assets obtained in exchange for lease obligations related to operating leases
$
434
$
1,388
$
5,267
Right-of-use assets obtained in exchange for lease obligations related to finance leases
$
477
$
1,817
$
—
Supplemental disclosures of non-cash investing and financing activities
Purchase of property and equipment in accounts payable and accrued liabilities
$
119
$
109
$
999
Non-cash employee bonuses settled in common stock
$
—
$
1,498
$
1,350
See accompanying notes.
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Coherus BioSciences, Inc.
Notes to Consolidated Financial Statements
1. Organization and Significant Accounting Policies
Description of the Business
Coherus BioSciences, Inc. (the “Company” or “Coherus”) is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. The Company’s strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics. The Company’s headquarters and laboratories are located in Redwood City, California and in Camarillo, California, respectively. The Company sells UDENYCA, a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor, in the United States. The FDA-approved YUSIMRY in December 2021, which the Company plans to launch in the United States on or after July 1, 2023, per the terms of an agreement with Humira manufacturer, AbbVie.
The Company’s product pipeline comprises three product candidates, toripalimab, an anti-PD-1 antibody being developed in collaboration with Junshi Biosciences Co., Ltd., CIMERLI, a Lucentis biosimilar candidate in-licensed for commercial rights in the United States and Canada from Bioeq, and a bevacizumab (Avastin) biosimilar in-licensed for commercial rights in the United States from Innovent Biologics (Suzhou) Co., Ltd.
Basis of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with U.S. GAAP and include the accounts of Coherus and its wholly-owned subsidiaries. The Company does not have any significant interests in variable interest entities. All material intercompany transactions and balances have been eliminated upon consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information, such as the economic considerations related to the impact that the recent COVID-19 outbreak could have on the Company’s significant accounting estimates. Accounting estimates and judgements are inherently uncertain and the actual results could differ from these estimates.
Segment Reporting and Revenue by Geographic Region
The Company operates and manages its business as one reportable and operating segment, which is the business of developing and commercializing human pharmaceutical products. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All revenue is generated and all long-lived assets are primarily maintained in the United States.
Cash, Cash Equivalents and Restricted Cash
Cash, cash equivalents and restricted cash comprise cash and highly liquid investments with original maturities of 90 days or less.
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The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets and which, in aggregate, represent the amount reported in the consolidated statements of cash flows:
Year Ended December 31,
(in thousands)
2021
2020
2019
At beginning of period:
Cash and cash equivalents
$
541,158
$
177,668
$
72,356
Restricted cash
440
240
835
Total cash, cash equivalents and restricted cash
$
541,598
$
177,908
$
73,191
At end of period:
Cash and cash equivalents
$
417,195
$
541,158
$
177,668
Restricted cash
440
440
240
Total cash, cash equivalents and restricted cash
$
417,635
$
541,598
$
177,908
Restricted cash consists of deposits for letters of credit that the Company has provided to secure its obligations under certain leases and is included in other assets, non-current on the consolidated balance sheets.
The Company classifies the up-front and milestone payments related to licensing arrangements as cash flows from investing activities in its consolidated statements of cash flows.
Investments in Marketable Securities
Investments in marketable securities primarily consist of corporate debt obligations and commercial paper. Management determines the appropriate classification of investments in marketable securities at the time of purchase based upon management’s intent with regards to such investment and reevaluates such designation as of each balance sheet date. The Company’s investment policy requires that it only invests in highly rated securities and limit its exposure to any single issuer. All investments in marketable debt securities are held as available-for-sale and are carried at the estimated fair value as determined based upon quoted market prices or pricing models for similar securities.
The Company classifies investments in marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date. The Company periodically assesses its marketable securities for impairment and credit losses. Unrealized gains and losses on available-for-sale securities are reported as a component of accumulated comprehensive income (loss), with the exception of unrealized losses believed to be related to credit losses, if any, which are recognized in earnings in the period the impairment occurs. Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is related to a credit loss and, if it is, the portion of the impairment relating to credit loss is recorded as an allowance through net income. Realized gains and losses and declines in value, if any, on available-for-sale securities are included in other (expense) income, net, based on the specific identification method. During 2021, 2020 and 2019, interest income from marketable securities was $ 1.4 million, $ 0.6 million and $ 1.6 million, respectively.
Trade Receivables
Trade receivables are recorded net of allowances for chargebacks, chargeback prepayments, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of December 31, 2021 and 2020.
Concentrations of Risk
The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, investments and accounts receivable. The Company attempts to minimize the risks related to cash, cash equivalents and investments by
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investing in a broad and diverse range of financial instruments. The investment portfolio is maintained in accordance with the Company’s investment policy, which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. There were no material losses from credit risks on such accounts during any of the periods presented. The Company is not exposed to any significant concentrations of credit risk from these financial instruments.
The Company is subject to credit risk from trade receivables related to product sales and monitors the credit worthiness of customers that are granted credit in the normal course of business. In general, there is no requirement for collateral from customers. The Company has not experienced significant losses with respect to the collection of trade receivables. The Company believes that its allowance for expected credit losses was adequate at December 31, 2021.
The Company entered into a strategic commercial supply agreement with KBI Biopharma for the supply of UDENYCA. The Company currently has not engaged back-up suppliers or vendors for this single-sourced service. If KBI Biopharma is not able to manufacture the supply needed in the quantities and timeframe required, the Company may not be able to supply the product in a timely manner.
Substantially all of the Company’s revenues are in the United States to three wholesalers. UDENYCA is currently the only product sold by the Company and accounted for all of the Company’s revenues in 2021, 2020 and 2019.
The Company has no significant monetary assets or liabilities in foreign currencies, and the Company has not had material foreign currency impacts for all years presented.
Inventory
Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory costs include third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. The Company primarily uses actual costs to determine the cost basis for inventory. The determination of excess or obsolete inventory requires judgment including consideration of many factors, such as estimates of future product demand, current and future market conditions, product expiration information, and potential product obsolescence, among others.
Although the Company believes the assumptions used in estimating potential inventory write-downs are reasonable, if actual market conditions are less favorable than projected by management, write-downs of inventory, charges related to firm purchase commitments, or both may be required which would be recorded as cost of goods sold in the consolidated statement of operations. Adverse developments affecting the Company’s assumptions of the level and timing of demand for its products include those that are outside of the Company’s control such as the actions taken by competitors and customers, the direct or indirect effects of the COVID-19 pandemic, and other factors.
Prior to the regulatory approval of our product candidates, the Company incurred expenses for the manufacture of drug product that could potentially be available to support the commercial launch of our products. I nventory costs are capitalized when future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment. A number of factors are considered, including the current status in the regulatory approval process, potential impediments to the approval process such as safety or efficacy, viability of commercialization and marketplace trends. All inventory on the consolidated balance sheet as of December 31, 2021 was related to UDENYCA. The Company began to capitalize inventory costs associated with UDENYCA after receiving regulatory approval in November 2018.
Property and Equipment
Property and equipment is stated at cost less accumulated depreciation and amortization. Maintenance and repairs are charged to expense as incurred. Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for its intended use, at which point the capitalized interest costs are amortized as depreciation or amortization expense over the life of the underlying asset. When the Company disposes of property and equipment, it removes the associated cost and accumulated depreciation from the related accounts in the consolidated balance sheets and include any resulting gain or loss in the consolidated statements of operations. Eligible costs of internal use software and implementation costs of certain hosting arrangements are capitalized
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and amortized over the estimated useful life of the software or associated hosting arrangement, as applicable. Depreciation and amortization are recognized using the straight-line method over the following estimated useful lives:
Computer equipment and software
3 - 7 years
Furniture and fixtures
5 years
Machinery and equipment
5 years
Leasehold improvements
Shorter of lease term or useful life
Goodwill and Intangible Assets
Goodwill represents the excess of the consideration transferred over the estimated fair value of assets acquired and liabilities assumed in a business combination. Intangible assets are measured at their respective fair values as of the acquisition date and may be subject to adjustment within the measurement period, which may be up to one year from the acquisition date. Intangible assets related to acquired in-process research and development (“IPR&D”) projects are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. Goodwill and intangible assets with indefinite useful lives are not amortized and are tested for impairment annually, or more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired. Intangible assets of $ 2.6 million as of December 31, 2021 and 2020 consist of IPR&D. There were no impairments to goodwill or intangible assets during the years ended December 31, 2021, 2020 and 2019.
When development is successfully completed, which generally occurs when regulatory approval is obtained, the associated assets are deemed finite-lived and amortized over their respective estimated useful lives beginning at that point in time. Intangible assets with finite useful lives are amortized over their estimated useful lives, primarily on a straight-line basis, and are reviewed for impairment when facts or circumstances indicate that the carrying value of these assets may not be recoverable.
Impairment of Long-Lived Assets
Long-lived assets, including property and equipment and finite-lived intangible assets, are reviewed for impairment whenever facts or circumstances either internally or externally may indicate that the carrying value of an asset may not be recoverable. If there is an indication of impairment, the Company tests for recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset to the carrying amount of the asset or asset group. If the asset or asset group is determined to be impaired, any excess of the carrying value of the asset or asset group over its estimated fair value is recognized as an impairment loss. There were no material impairments recorded during the years ended December 31, 2021, 2020 and 2019.
Accrued Research and Development Expense
Clinical trial costs are a component of research and development expense. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research and manufacturing organizations and clinical sites. The Company determines the actual costs through monitoring patient enrollment, discussions with internal personnel and external service providers regarding the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.
Net Revenues
The Company sells to wholesalers and distributors, (collectively, “Customers”). The Customers then resell to hospitals and clinics (collectively, “Healthcare Providers”) pursuant to contracts with the Company. In addition to distribution agreements with Customers and contracts with Healthcare Providers, the Company enters into arrangements with group purchasing organizations (“GPOs”) that provide for United States government-mandated or privately-negotiated rebates, chargebacks and discounts. The Company also enters into rebate arrangements with payers, which consist primarily of commercial insurance companies and government entities, to cover the reimbursement of our products to Healthcare Providers. The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. Revenue from product sales is recognized at the point when a Customer obtains control of the product and the Company satisfies its performance obligation, which generally occurs at the time product is shipped to the Customer. Payment terms differ by jurisdiction and customer, but payment terms typically range from 30 to 67 days from date of shipment.
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Product Sales Discounts and Allowances
Revenue from product sales is recorded at the net sales price (“transaction price”), which includes estimates of variable consideration for which reserves are established and that result from chargebacks, rebates, co-pay assistance, prompt-payment discounts, returns and other allowances that are offered within contracts between the Company and its Customers, Healthcare Providers, payers and GPOs. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions in trade receivables (if the amounts are payable to a Customer) or current liabilities (if the amounts are payable to a party other than a Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as historical experience, current contractual and statutory requirements, specifically known market events and trends, industry data and forecasted Customer buying and payment patterns. Overall, these reserves reflect the best estimates of the amount of consideration to which the Company is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The actual amount of consideration ultimately received may differ. If actual results in the future vary from the Company’s estimates, the estimates will be adjusted, which will affect net product revenue in the period that such variances become known.
Chargebacks: Chargebacks are discounts that occur when Healthcare Providers purchase directly from a Customer. Healthcare Providers, which belong to Public Health Service institutions, non-profit clinics, government entities, GPOs, and health maintenance organizations, generally purchase the product at a discounted price. The Customer, in turn, charges back to the Company the difference between the price initially paid by the Customer and the discounted price paid by the Healthcare Providers to the Customer. The allowance for chargebacks is based on an estimate of sales through to Healthcare Providers from the Customer.
Discounts for Prompt Payment: The Company provides for prompt payment discounts to its Customers, which are recorded as a reduction in revenue in the same period that the related product revenue is recognized.
Rebates: Rebates include mandated discounts under the Medicaid Drug Rebate Program, other government programs and commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with these public sector benefit providers. The accrual for rebates is based on statutory or contractual discount rates and expected utilization. The estimates for the expected utilization of rebates are based on Customer and commercially available payer data, as well as data collected from the Healthcare Providers, Customers, GPOs, and historical utilization rates. Rebates invoiced by payers, Healthcare Providers and GPOs are paid in arrears. If actual future rebates vary from estimates, the Company may need to adjust its accruals, which would affect net product revenue in the period of adjustment.
Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue.
Product Returns: The Company offers its Customers a limited product return right, which is principally based upon whether the product is damaged or defective, or the product’s expiration date. Product return allowance is estimated and recorded at the time of sale.
Other Allowances: The Company pays fees to Customers and GPOs for account management, data management and other administrative services. To the extent that the services received are distinct from the sale of products to the customer, these payments are classified in selling, general and administrative expense in the Company’s consolidated statements of operations, otherwise they are included as a reduction in product revenue.
Royalty Revenue
Royalty revenue from licensees, which is based on sales to third-parties of licensed products, is recorded when the third-party sale occurs and the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Royalty revenue was insignificant for the periods presented and is included in total revenues.
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Cost of Goods Sold
Cost of goods sold consists primarily of third-party manufacturing, distribution, and certain overhead costs. A portion of the costs of producing UDENYCA sold to date was expensed as research and development prior to the FDA approval of UDENYCA and, therefore, it is not reflected in the cost of goods sold. During the first quarter of 2021, the UDENYCA inventory with no inventory value was fully utilized.
On May 2, 2019, the Company and Amgen settled a trade secret action brought by Amgen. As a result, cost of goods sold reflects a mid-single digit royalty on net product revenue, which began on July 1, 2019. The royalty cost will continue for five years pursuant to the settlement.
In 2021, 2020 and 2019, cost of goods sold included write-offs for inventory of $ 5.1 million, $ 2.2 million and $ 0.4 million, respectively, that did not meet the Company’s acceptance criteria, net of credits received from manufacturers. In 2019, cost of goods sold included write-off of prepaid manufacturing costs of $ 1.3 million due to the cancellation of certain manufacturing reservations.
Research and Development Expense
Research and development expense represents costs incurred to conduct research, such as the discovery and development of our product candidates. The Company recognizes all research and development costs as they are incurred. The Company currently tracks research and development costs incurred on a product candidate basis only for external research and development expenses. The Company’s external research and development expense consists primarily of:
● expense incurred under agreements with consultants, third-party CROs, and investigative sites where a substantial portion of the Company’s preclinical studies and all of its clinical trials are conducted;
● costs of acquiring originator comparator materials and manufacturing preclinical study and clinical trial supplies and other materials from CMOs, and related costs associated with release and stability testing;
● costs associated with manufacturing process development activities; and
● upfront and milestone payments related to licensing and collaboration agreements.
Internal costs are associated with activities performed by the Company’s research and development organization and generally benefit multiple programs. These costs are not separately allocated by product candidate. Unallocated, internal research and development costs consist primarily of:
● personnel-related expense, which include salaries, benefits and stock-based compensation; and
● facilities and other allocated expense, which include direct and allocated expense for rent and maintenance of facilities, depreciation and amortization of leasehold improvements and equipment, laboratory and other supplies.
Products manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred as research and development expense for products that have not been approved until future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment. The Company began to capitalize inventory costs associated with UDENYCA after receiving regulatory approval in November 2018.
License Agreements
The Company has entered and may continue to enter into license agreements to access and utilize certain technology. To determine whether the licensing transactions should be accounted for as a business combination or as an asset acquisition, the Company makes certain judgments, which include assessing whether the acquired set of activities and assets would meet the definition of a business under the relevant accounting rules.
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If the acquired set of activities and assets does not meet the definition of a business, the transaction is recorded as an asset acquisition and therefore, any acquired IPR&D that does not have an alternative future use is charged to expense at the acquisition date. To date none of the Company’s license agreements have been considered to be the acquisition of a business.
Selling, General and Administrative Expense
Selling, general and administrative expenses comprise primarily compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $ 8.7 million, $ 3.8 million and $ 4.5 million in 2021, 2020 and 2019, respectively.
Stock-Based Compensation
The Company’s compensation programs include stock-based awards, and the related grants under these programs are accounted for at fair value. The fair values are recognized as compensation expense on a straight-line basis over the vesting period with the related costs recorded in cost of goods sold, research and development, and selling, general and administrative expense, as appropriate. The Company accounts for forfeitures as they occur.
Income Taxes
The Company utilizes the liability method of accounting for deferred income taxes. Under this method, deferred tax liabilities and assets are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. A valuation allowance is established against deferred tax assets because, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense.
The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. The Company does not expect its unrecognized tax benefits to change significantly in 2022.
Operating and Finance Leases
The Company determines if an arrangement is a lease at inception. The Company does not recognize right-of-use assets and lease liabilities related to short-term leases. The Company also does not separate lease and non-lease components for its facility and vehicle leases. Operating leases are included in other current liabilities, other assets, non-current, and lease liabilities, non-current in the consolidated balance sheets. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. The Company recognizes operating lease expense for these leases on a straight-line basis over the term of the lease.
The term under the Company’s vehicle lease agreement is 36 months . The vehicles leased under this arrangement were classified as finance leases. Finance leases are included in property and equipment, net, accrued and other current liabilities, and lease liabilities, non-current in the consolidated balance sheets and assets under Finance leases are depreciated to operating expenses on a straight-line basis over their estimated useful lives.
The operating and finance lease right-of-use assets and the lease liabilities are recognized based on the present value of lease payments over the lease term at the lease commencement date. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company's leases generally do not provide an implicit rate.
Net (Loss) Income per Share
Basic net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income per share is computed by dividing the net income by the weighted-average number of common shares outstanding for the period plus any potential
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dilutive common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period, without consideration for any potential dilutive common share equivalents as their effect would be antidilutive (see Note 12. Net (Loss) Income Per Share).
Comprehensive (Loss) Income
Comprehensive (loss) income is composed of two components: net (loss) income and other comprehensive (loss) income. Other comprehensive (loss) income refers to gains and losses that under U.S. GAAP are recorded as an element of stockholders’ equity, but are excluded from net (loss) income. The Company’s other comprehensive (loss) income include foreign currency translation adjustments in 2021, 2020 and 2019.
Reclassifications
Certain prior year amounts in the consolidated balance sheets and consolidated statements of cash flows have been reclassified to conform with the current year presentation in 2021. As a result, there was no change to total assets on the consolidated balance sheet or net cash provided by operating activities on the consolidated statements of cash flows for the prior years.
Recent Accounting Pronouncements
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . The new guidance removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation and calculating income taxes in interim periods. It also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. The Company adopted this guidance as of January 1, 2021. The adoption did not have a material impact on the Company’s consolidated financial statements.
In October 2020, the FASB issued ASU 2020-10, Codification Improvements , which updates various codification topics by clarifying or improving disclosure requirements to align with the SEC’s regulations. The Company adopted this guidance as of January 1, 2021. The adoption did not have a material impact on the Company’s consolidated financial statements.
The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption.
2. Revenue
The Company initiated United States sales of UDENYCA on January 3, 2019. The Company recorded net revenue of $ 326.6 million, $ 475.8 million and $ 356.1 million during 2021, 2020 and 2019, respectively.
Revenue by significant Customer was distributed as follows:
Year Ended December 31,
2021
2020
2019
McKesson Corporation
39
%
38
%
42
%
AmeriSource-Bergen Corporation
39
%
37
%
33
%
Cardinal Health, Inc.
20
%
23
%
23
%
Others
2
%
2
%
2
%
Total revenue
100
%
100
%
100
%
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Product Sales Discounts and Allowances
The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows:
Year Ended December 31, 2021
Chargebacks
Other Fees,
and Discounts
Co-pay
for Prompt
Assistance
(in thousands)
Payment
Rebates
and Returns
Total
Balance at December 31, 2020
$
40,580
$
54,058
$
28,760
$
123,398
Provision related to sales made in:
Current period
470,791
113,705
94,703
679,199
Prior period
( 2,876 )
( 4,976 )
( 3,555 )
( 11,407 )
Payments and customer credits issued
( 478,830 )
( 108,783 )
( 93,854 )
( 681,467 )
Balance at December 31, 2021
$
29,665
$
54,004
$
26,054
$
109,723
Year Ended December 31, 2020
Chargebacks
Other Fees,
and Discounts
Co-pay
for Prompt
Assistance
(in thousands)
Payment
Rebates
and Returns
Total
Balance at December 31, 2019
$
35,159
$
27,494
$
24,494
$
87,147
Provision related to sales made in:
Current period
462,328
115,864
114,372
692,564
Prior period
( 1,336 )
( 3,438 )
( 6,288 )
( 11,062 )
Payments and customer credits issued
( 455,571 )
( 85,862 )
( 103,818 )
( 645,251 )
Balance at December 31, 2020
$
40,580
$
54,058
$
28,760
$
123,398
Chargebacks and discounts for prompt payment are recorded as a reduction in trade receivables, and the remaining reserve balances are classified as current liabilities in the accompanying consolidated balance sheets.
3. Fair Value Measurements
The fair value of financial instruments are classified into one of the following categories:
● Level 1 — Quoted prices in active markets for identical assets or liabilities.
● Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
● Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Unrealized gains and losses in the Company’s investments in these money market funds were insignificant in 2021, 2020 and 2019.
There were no transfers between Level 1 , Level 2 and Level 3 during the periods presented. The fair values of cash equivalents approximate their carrying values due to the short-term nature of such financial instruments.
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Financial assets and liabilities measured at fair value on a recurring basis are summarized as follows:
Fair Value Measurements
December 31, 2021
(in thousands)
Level 1
Level 2
Level 3
Total
Financial Assets:
Cash and cash equivalents (money market funds)
$
417,165
$
—
$
—
$
417,165
Restricted cash (money market funds)
440
—
—
440
Total financial assets
$
417,605
$
—
$
—
$
417,605
Financial Liabilities:
Contingent consideration
$
—
$
—
$
102
$
102
Fair Value Measurements
December 31, 2020
(in thousands)
Level 1
Level 2
Level 3
Total
Financial Assets:
Cash and cash equivalents (money market funds)
$
538,673
$
—
$
—
$
538,673
Restricted cash (money market funds)
440
—
—
440
Total financial assets
$
539,113
$
—
$
—
$
539,113
Financial Liabilities:
Contingent consideration
$
—
$
—
$
102
$
102
As part of the InteKrin acquisition in February 2014, the Company recognized contingent consideration associated with potential payments, which would be payable to the former InteKrin stockholders if the Company enters into a compound transaction agreement as defined in the InteKrin purchase agreement. In February 2020, the Company announced that it is seeking strategic alternatives to finance this program externally. As of December 31, 2021 and 2020, the $ 0.1 million fair value of the contingent consideration was recorded in other liabilities, non-current on the consolidated balance sheets.
1.5 % Convertible Notes due 2026
The estimated fair value of the 1.5 % Convertible Notes due 2026, which the Company issued in April 2020 (see Note 7. Debt Obligations) is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. The market for trading of the Convertible Notes due 2026 is not considered to be an active market and therefore the estimate of fair value is based on Level 2 inputs. The estimated fair value of the Convertible Notes due 2026 was $ 271.9 million and $ 269.1 million (par value $ 230.0 million) as of December 31, 2021 and 2020, respectively.
8.2 % Convertible Notes due 2022
The estimated fair value of the 8.2 % Convertible Senior Notes Due 2022, which the Company issued on February 29, 2016 (see Note 7. Debt Obligations) is based on an income approach. When determining the estimated fair value of the Company’s 8.2 % Convertible Notes due 2022, the Company used a single factor binomial lattice model which incorporates the terms and conditions of the convertible notes and market-based risk measurement that are indirectly observable, such as credit risk and therefore the estimate of fair value is based on Level 3 inputs. The lattice model produces an estimated fair value based on changes in the price of the underlying common shares price over successive periods of time. An estimated yield based on market data is used to discount straight debt cash flows. The estimated fair value was $ 108.4 million and $ 113.7 million (par value $ 100.0 million plus premium of $ 9.0 million) as of December 31, 2021 and 2020, respectively.
2025 Term Loan
The principal amount outstanding under the Company’s 2025 Term Loan (see Note 7. Debt Obligations) as of December 31, 2021 of $ 75 .0 million is subject to a variable interest rate, which is based on three month LIBOR (“LIBOR”) plus a fixed percentage, and as such, the Company believes the carrying amount of these obligations approximates fair value.
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4. Inventory
Inventory consisted of the following:
December 31,
(in thousands)
2021
2020
Raw Materials
$
4,870
$
5,205
Work in process
65,117
43,952
Finished goods
23,265
43,032
Total
$
93,252
$
92,189
Inventory expected to be sold more than twelve months from the balance sheet date is classified as inventory, non-current on the consolidated balance sheets. As of December 31, 2021 and 2020, t he non-current portion of inventory consisted of raw materials and work in process, as well as a portion of finished goods at December 31, 2020. The following table presents the inventory b alance sheet classifications:
December 31,
(in thousands)
2021
2020
Inventory
$
37,642
$
44,233
Inventory, non-current
55,610
47,956
Total
$
93,252
$
92,189
Prepaid manufacturing of $ 13.7 million as of December 31, 2021 includes prepayments of $ 8.3 million to a CMO for manufacturing services for UDENYCA, which the Company expects to be converted into inventory during 2022; and prepayments of $ 5.4 million to various CMOs for research and development pipeline programs. Prepaid manufacturing of $ 19.4 million as of December 31, 2020 includes prepayments of $ 8.9 million to a CMO for manufacturing services for UDENYCA; and prepayments of $ 10.5 million to various CMOs for other research and development pipeline programs.
In February 2021, the Company announced the discontinuation of the development of CHS-2020, a biosimilar of Eylea as part of a realignment of research and development resources toward other development programs. As a result, the Company recognized $ 11.2 million within research and development expense on the consolidated statement of operations in 2021, which included an impairment charge of $ 3.2 million for the write-off of prepaid manufacturing services no longer deemed to have future benefits.
5. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consisted of the following:
December 31,
(in thousands)
2021
2020
Machinery and equipment
$
11,876
$
13,301
Computer equipment and software
3,033
3,996
Furniture and fixtures
1,129
1,268
Leasehold improvements
5,942
5,830
Finance lease right of use assets
2,294
1,451
Construction in progress
388
312
Total property and equipment
24,662
26,158
Accumulated depreciation and amortization
( 16,849 )
( 16,050 )
Property and equipment, net
$
7,813
$
10,108
Depreciation and amortization expense was $ 3.5 million, $ 2.9 million and $ 3.3 million in 2021, 2020 and 2019, respectively. There were no material impairments of property and equipment in 2021, 2020 and 2019.
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Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following:
December 31,
(in thousands)
2021
2020
Accrued manufacturing and clinical
$
30,541
$
11,365
Accrued co-development costs for toripalimab
1,926
—
Accrued other
12,168
12,182
Lease liabilities, current
3,492
3,132
Total Accrued and other current liabilities
$
48,127
$
26,679
6.
6. Collaborations and Other Arrangements
Junshi Biosciences
On February 1, 2021, the Company entered into Collaboration Agreement with Junshi Biosciences for the co-development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 antibody, in the United States and Canada.
Under the terms of the Collaboration Agreement, the Company paid $ 150.0 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. The Company will have the right to conduct all commercial activities of toripalimab in the United States and Canada. The Company will be obligated to pay Junshi Biosciences a 20 % royalty on net sales of toripalimab and up to an aggregate $ 380.0 million in one-time payments for the achievement of various regulatory and sales milestones. If the Company exercises its options, it will be obligated to pay an option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine of $ 35.0 million per program. Additionally, for each exercised option, the Company will be obligated to pay Junshi Biosciences an 18 % royalty on net sales and up to an aggregate $ 255.0 million for the achievement of various regulatory and sales milestones. Under the Collaboration Agreement, the Company retains the right to collaborate in the development of toripalimab and the other licensed compounds and will pay for a portion of these co-development activities up to a maximum of $ 25.0 million per licensed compound per year. Additionally, the Company is responsible for certain associated regulatory and technology transfer costs for toripalimab and other licensed compounds and will reimburse Junshi Biosciences for such costs. The Company recognized research and development expense of $ 39.4 million in the consolidated statement of operations for the year ended December 31, 2021, and had $ 1.9 million recorded in accrued and other current liabilities on the consolidated balance sheets as of December 31, 2021 related to the co-development, regulatory and technology transfer costs. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. In addition, the Company recorded research and development expense of $ 145.0 million during the first quarter of 2021, related to the upfront payment for exclusive rights to toripalimab in the United States and Canada. The Company had entered into a Right of First Negotiation agreement with Junshi Biosciences and paid a fee of $ 5.0 million which was fully expensed as research and development expense in the fourth quarter of 2020. The Right of First Negotiation fee was fully credited against the total upfront license fee obligation under the Collaboration Agreement. As of December 31, 2021, the Company did not have any outstanding milestone or royalty payment obligations to Junshi Biosciences.
In January 2022, the Company took steps that it expects will result in the payment to Junshi Biosciences of an additional $ 35.0 million upon the closing of the exercise of our option to license JS006, a TIGIT-targeted antibody, in the United States and Canada. The $ 35.0 million payment for the option to license JS006 will be reflected in our first quarter 2022 financial statements (see Note 14. Subsequent Events). The additional milestone payments, option fees and royalties are contingent upon future events and, therefore, will be recorded when it is probable that a milestone will be achieved, option fees will be incurred or when royalties are due.
In connection with the Collaboration Agreement, the Company entered into the Stock Purchase Agreement with Junshi Biosciences agreeing, subject to customary conditions, to acquire certain equity interests in the Company. Pursuant to the Stock Purchase Agreement, on April 16, 2021, the Company issued 2,491,988 unregistered shares of its common stock to Junshi Biosciences, at a price per share of $ 20.06 , for an aggregate value of approximately $ 50.0 million cash. Under the terms of the Stock Purchase Agreement, Junshi Biosciences
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is not permitted to sell, transfer, make any short sale of, or grant any option for the sale of the common stock for the two-year period following its effective date. The Collaboration Agreement and the Stock Purchase Agreement were negotiated concurrently and were therefore evaluated as a single agreement. The Company used the “Finnerty” and “Asian put” valuation models and determined the fair value for the discount for lack of marketability was $ 9.0 million at the date the shares were issued. The fair value of the DLOM was attributable to the Collaboration Agreement and was included as an offset against the research and development expense in the consolidated statement of operations for the year ended December 31, 2021.
Innovent Biologics (Suzhou) Co., Ltd.
On January 13, 2020, the Company entered into a license agreement with Innovent for the development and commercialization of a biosimilar version of bevacizumab (Avastin) in any dosage form and presentations in the United States and Canada. Under the License Agreement, Innovent granted to the Company an exclusive, royalty-bearing license to develop and commercialize the bevacizumab Licensed Product in the field of treatment, prevention or amelioration of any human diseases and conditions as included in the label of Avastin. Under the License Agreement, the Company also acquired an option to develop and commercialize Innovent’s biosimilar version of rituximab (Rituxan) in any dosage form and presentations in the Territory. Subject to the terms of the License Agreement, the Company may exercise its option within 12 months of its receipt of certain regulatory materials from Innovent. Following the Company’s option exercise, Innovent’s biosimilar version of rituximab would be deemed an Innovent Licensed Product for all purposes of the License Agreement and Innovent would grant to the Company an exclusive, royalty-bearing license to develop and commercialize Innovent’s biosimilar version of rituximab in the field of treatment, prevention or amelioration of any human diseases and conditions as included in the label of Rituxan.
Innovent will supply the Innovent Licensed Products to the Company in accordance with a manufacturing and supply agreement to be executed by the parties. Under the License Agreement, the Company acquired the right to require Innovent to perform technology transfer for the manufacturing of the Innovent Licensed Products in the Territory and, upon completion of such technology transfer, the Company will have the exclusive right to manufacture the Innovent Licensed Products in the Territory.
Under the License Agreement, the Company committed to pay Innovent a $ 5.0 million upfront payment and an aggregate of up to $ 40.0 million in milestone payments in connection with the achievement of certain development, regulatory and sales milestones with respect to the bevacizumab Licensed Product and, if the Company’s option is exercised, an aggregate of up to $ 40.0 million in milestone payments in connection with the achievement of certain development, regulatory and sales milestones with respect to the rituximab Licensed Product. The Company will share a percentage of net sales of Innovent Licensed Products with Innovent in the mid-teens to low twenty percent range. If the Company exercises its option to acquire Innovent’s biosimilar version of rituximab (Rituxan), it would be required to pay a fee of $ 5.0 million. Subject to the terms of the License Agreement, if the Company requests Innovent to perform technology transfer for the manufacturing of the Innovent Licensed Products, it would be required to pay up to $ 10.0 million for fees related thereto. The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. The Company recorded research and development expense of $ 7.5 million during the year ended December 31, 2020 related to an upfront payment and a milestone payment for the bevacizumab Licensed Product. During the year ended December 31, 2021, the Company recognized research and development expense of $ 1.1 million related to bevacizumab Licensed Product development activities directly with Innovent. As of December 31, 2021, the Company did not have any outstanding milestone or royalty payment obligations to Innovent.
The additional milestone payments, option fee for licensing of rituximab (Rituxan), manufacturing technology transfer fee and royalties are contingent upon future events and, therefore, will be recorded when such payments become probable.
Bioeq
On November 4, 2019, the Company entered into a license agreement with Bioeq for the commercialization of a biosimilar version of ranibizumab (Lucentis) in certain dosage forms in both a vial and pre-filled syringe presentation. Under this agreement, Bioeq granted to the Company an exclusive, royalty-bearing license to commercialize the Bioeq Licensed Products in the field of ophthalmology (and any other approved labelled indication) in the United States. Bioeq will supply to the Company the Bioeq Licensed Products in accordance with terms and conditions specified in the agreement and a manufacturing and supply agreement to be executed by the parties in accordance therewith. The agreement’s initial term continues in effect for ten years after the first commercial sale of a Bioeq Licensed Product in the United States, and thereafter renews for an unlimited period of time unless otherwise terminated in accordance with its terms.
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Under the agreement, Bioeq must use commercially reasonable efforts to develop and obtain regulatory approval of the Bioeq Licensed Products in the United States in accordance with a development and manufacturing plan, and the Company must use commercially reasonable efforts to commercialize the Bioeq Licensed Products in accordance with a commercialization plan. Additionally, the Company must commit certain pre-launch and post-launch resources to the commercialization of the Bioeq Licensed Products for a limited time as specified in the agreement.
The Company accounted for the licensing transaction as an asset acquisition under the relevant accounting rules. The Company paid Bioeq an upfront and a milestone payment aggregating to € 10 million ($ 11.1 million), which was recorded as research and development expense in the Company’s consolidated statement of operations in 2019. The Company is obligated to pay Bioeq an aggregate of up to € 12.5 million in additional milestone payments in connection with the achievement of certain development and regulatory milestones with respect to the Bioeq Licensed Products in the United States. The Company will share a percentage of gross profits on sales of Bioeq Licensed Products in the United States with Bioeq in the low to mid fifty percent range. The additional milestone payments and royalties are contingent upon future events and, therefore, will be recorded when it is probable that a milestone will be achieved or when royalties are due. As of December 31, 2021 and 2020, the Company did not have any outstanding obligations for milestones and royalties to Bioeq.
7. Debt Obligations
1.5% Convertible Senior Subordinated Notes due 2026
In April 2020, the Company issued and sold $ 230.0 million aggregate principal amount of its 1.5 % Convertible Senior Subordinated notes due 2026 (the “2026 Convertible Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The net proceeds from the offering were $ 222.2 million after deducting initial purchasers’ fees and offering expenses. The 2026 Convertible Notes are general unsecured obligations and will be subordinated to the Company’s designated senior indebtedness (as defined in the indenture for the 2026 Convertible Notes) and structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables. The 2026 Convertible Notes accrue interest at a rate of 1.5 % per annum, payable semi-annually in arrears on April 15 and October 15 of each year, since October 15, 2020, and will mature on April 15, 2026 , unless earlier repurchased or converted.
At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their 2026 Convertible Notes at their option into shares of the Company’s common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. The initial conversion rate is 51.9224 shares of common stock per $ 1,000 principal amount of the 2026 Convertible Notes, which represents an initial conversion price of approximately $ 19.26 per share of common stock. The initial conversion price represents a premium of approximately 30.0 % over the last reported sale of $ 14.815 per share of the Company’s common stock on the Nasdaq Global Market on April 14, 2020, the date the 2026 Convertible Notes were issued. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events. If a “make-whole fundamental change” (as defined in the indenture for the 2026 Convertible Notes) occurs, the Company will, in certain circumstances, increase the conversion rate for a specified period of time for noteholders who convert their 2026 Convertible Notes in connection with that make-whole fundamental change. The 2026 Convertible Notes are not redeemable at the Company’s election before maturity. If a “fundamental change” (as defined in the indenture for the 2026 Convertible Notes) occurs, then, subject to a limited exception, noteholders may require the Company to repurchase their 2026 Convertible Notes for cash. The repurchase price will be equal to the principal amount of the 2026 Convertible Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.
The 2026 Convertible Notes have customary provisions relating to the occurrence of “events of default” (as defined in the Indenture for the 2026 Convertible Notes). The occurrence of such events of default could result in the acceleration of all amounts due under the 2026 Convertible Notes.
As of December 31, 2021, the Company was in full compliance with these covenants and there were no events of default under the 2026 Convertible Notes.
The Company evaluated the features embedded in the 2026 Convertible Notes under the relevant accounting rules and concluded that the embedded features do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as
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an equity component. The proceeds received from the issuance of the convertible debt were recorded as a liability on the consolidated balance sheets.
Capped Call Transactions
In connection with the pricing of the 2026 Convertible Notes, the Company also paid $ 18.2 million to enter into privately negotiated capped call transactions with one or a combination of the initial purchasers, their respective affiliates and other financial institutions (the “option counterparties”). The capped call transactions are generally expected to reduce the potential dilution upon conversion of the 2026 Convertible Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the 2026 Convertible Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the 2026 Convertible Notes. The cap price of the capped call transactions will initially be $ 25.9263 per share, which represents a premium of approximately 75.0 % over the last reported sale price of the Company’s common stock of $ 14.815 per share on April 14, 2020, and is subject to certain adjustments under the terms of the capped call transactions.
The capped call transactions are accounted for as separate transactions from the 2026 Convertible Notes and classified as equity instruments. Therefore, the total $ 18.2 million capped call premium paid was recorded as a reduction to additional paid-in capital on the consolidated balance sheets. The capped calls will not be subsequently re-measured as long as the conditions for equity classification continue to be met.
The Company incurred $ 0.9 million of debt issuance costs relating to the issuance of the 2026 Convertible Notes, which were recorded as a reduction to the notes on the consolidated balance sheet. The debt issuance costs are being amortized and recognized as additional interest expense over the six-year contractual term of the notes using the effective interest rate method.
The following table summarizes components of the 2026 Convertible Notes:
December 31,
(in thousands)
2021
2020
Principal amount of the 2026 Convertible Notes
$
230,000
$
230,000
Unamortized debt discount and debt issuance costs
( 5,712 )
( 6,971 )
Total 2026 Convertible Notes
$
224,288
$
223,029
If the 2026 Convertible Notes were converted on December 31, 2021, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $ 190.6 million based on the Company’s closing stock price of $ 15.96 as of December 31, 2021.
The following table presents the components of interest expense related to 2026 Convertible Notes:
Year Ended December 31,
(in thousands)
2021
2020
Stated coupon interest
$
3,450
$
2,434
Accretion of debt discount and debt issuance costs
1,259
873
Total interest expense
$
4,709
$
3,307
The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of $ 5.7 million as of December 31, 2021, will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes of 4.3 years. The annual effective interest rate is 2.1 % for the 2026 Convertible Notes.
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Future payments on the 2026 Convertible Notes as of December 31, 2021 are as follows:
Year ending December 31, (in thousands)
2022
$
3,450
2023
3,450
2024
3,450
2025
3,450
2026 and beyond
231,725
Total minimum payments
245,525
Less amount representing interest
( 15,525 )
2026 Convertible Notes, principal amount
230,000
Less debt discount and debt issuance costs on 2026 Convertible Notes
( 5,712 )
Net carrying amount of 2026 Convertible Notes
$
224,288
8.2% Convertible Notes due 2022
On February 29, 2016, the Company issued and sold $ 100.0 million aggregate principal amount, which excludes a 9.0 % premium due at maturity or redemption, of its 2022 Convertible Notes and received total net proceeds of approximately $ 99.2 million, after deducting issuance costs of $ 0.8 million . The 2022 Convertible Notes constitute general, senior unsubordinated obligations of the Company and are guaranteed by certain subsidiaries of the Company. The 2022 Convertible Notes bear interest at a fixed coupon rate of 8.2 % per annum payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year, since March 31, 2016 , and will mature on March 31, 2022 , unless earlier converted, redeemed or repurchased. If the Company fails to satisfy certain registration or reporting requirements, then additional interest will accrue on the 2022 Convertible Notes at a rate of up to 0.50 % per annum in the aggregate. The 2022 Convertible Notes also bear a premium of 9.0 % of their principal amount, which is payable when the 2022 Convertible Notes mature or are repurchased or redeemed by the Company.
The 2022 Convertible Notes were issued to Healthcare Royalty Partners III, L.P., for $ 75.0 million in aggregate principal amount, and to three related party investors, KKR Biosimilar L.P., MX II Associates LLC, and KMG Capital Partners, LLC, for $ 20.0 million, $ 4.0 million, and $ 1.0 million, respectively, in aggregate principal amount.
At any time before the close of business on the business day immediately preceding March 31, 2022, the 2022 Convertible Note noteholders may convert their 2022 Convertible Notes at their option into shares of the Company’s common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. The initial conversion rate is 44.7387 shares of common stock per $ 1,000 principal amount of the 2022 Convertible Notes, which represents an initial conversion price of approximately $ 22.35 per share of common stock. The initial conversion price represents a 60 % premium over the average last reported sale price of our common stock over the 15 trading days preceding the date the 2022 Convertible Notes were issued. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events. The 2022 Convertible Notes are redeemable in whole, and not in part, at the Company’s option with effect from March 31, 2020, if the last reported sale price per share of common stock exceeds 160 % of the conversion price on 20 or more trading days during the 30 consecutive trading days preceding the date on which the Company sends notice of such redemption to the holders of the 2022 Convertible Notes. At maturity or redemption, if not earlier converted, the Company will pay 109 % of the principal amount of the 2022 Convertible Notes maturing or being redeemed, together with accrued and unpaid interest, in cash.
The 2022 Convertible Notes contain customary negative covenants and events of default, the occurrence of which could result in the acceleration of all amounts due under the 2022 Convertible Notes. The 2022 Convertible Notes also contain covenants restricting the Company’s ability to incur additional indebtedness for borrowed money or convertible preferred stock and to pay dividends or make distributions on the Company’s equity interests, subject to certain exceptions. As of December 31, 2021, the Company was in full compliance with these covenants and there were no events of default under the 2022 Convertible Notes.
The Company evaluated the features embedded in the 2022 Convertible Notes under the relevant accounting rules and concluded that the embedded features do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as an equity component.
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The Company granted the holders of the 2022 Convertible Notes certain registration rights requiring the Company to register, under the Securities Act of 1933, as amended, the resale of the shares of common stock issuable upon conversion or settlement of the 2022 Convertible Notes.
The following table summarizes components of the 2022 Convertible Notes:
December 31,
(in thousands)
2021
2020
Principal amount of the 2022 Convertible Notes
$
81,750
$
81,750
Unamortized debt discount and debt issuance costs
( 391 )
( 1,865 )
2022 Convertible Notes
$
81,359
$
79,885
Principal amount of the 2022 Convertible Notes - related parties
$
27,250
$
27,250
Unamortized debt discount and debt issuance costs - related parties
( 130 )
( 622 )
2022 Convertible Notes - related parties
$
27,120
$
26,628
Total 2022 Convertible Notes, net carrying amount
$
108,479
$
106,513
In January 2022, the Company entered into the 2027 Term Loans (see Note 14. Subsequent Events). Since the Company expects to refinance the 2022 Convertible Notes with proceeds from the 2027 Term Loans which will be funded no later than April 1, 2022, subject to the delivery certain customary deliverables and which mature in 2027, the 2022 Convertible Notes were classified as non-current on the December 31, 2021 consolidated balance sheets. The contractual future payments on the 2022 Convertible Notes as of December 31, 2021, without consideration of the expected refinancing, is $ 111.1 million due in 2022, inclusive of $ 2.1 million of interest.
If the 2022 Convertible Notes were converted on December 31, 2021, the holders of the 2022 Convertible Notes would receive common shares with an aggregate value of $ 71.4 million based on the Company’s closing stock price of $ 15.96 .
The following table presents the components of interest expense of the 2022 Convertible Notes:
Year Ended December 31,
(in thousands)
2021
2020
2019
Stated coupon interest
$
6,150
$
6,150
$
6,150
Accretion of debt discount and debt issuance costs
1,475
1,343
1,223
Interest expense
$
7,625
$
7,493
$
7,373
Stated coupon interest - related parties
$
2,050
$
2,050
$
2,050
Accretion of debt discount and debt issuance costs - related parties
491
448
407
Interest expense - related parties
$
2,541
$
2,498
$
2,457
Total interest expense
$
10,166
$
9,991
$
9,830
The remaining total unamortized debt discount and debt offering costs related to the Company’s 2022 Convertible Notes and 2022 Convertible Notes – related parties of $ 0.5 million as of December 31, 2021, will be amortized using the effective interest rate over the remaining term of three months from the balance sheet date. The annual effective interest rate is 9.5 % for the 2022 Convertible Notes and 2022 Convertible Notes – related parties.
2025 Term Loan
On January 7, 2019 (the “2025 Term Loan Closing Date”), the Company entered into a credit agreement (the “2025 Term Loan”) with affiliates of Healthcare Royalty Partners (together, the “Lender”). The 2025 Term Loan consists of a six-year term loan facility for an aggregate principal amount of $ 75.0 million (the “Borrowings”). The obligations of the Company under the loan documents are guaranteed by the Company’s material domestic United States subsidiaries.
The Borrowings under the 2025 Term Loan bear interest through maturity at 7.00 % per annum plus three month LIBOR. Pursuant to the terms of the 2025 Term Loan, the interest rate was reduced to 6.75 % per annum plus LIBOR as of January 1, 2020 as the consolidated net sales for UDENYCA for the fiscal year ending December 31, 2019 were in excess of $ 250.0 million. Interest is payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate is not
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constant, and any change in the expected cash flows is recognized prospectively as an adjustment to the effective yield. As of December 31, 2021, the effective interest rate was 10.7 %.
Pursuant to the terms of the 2025 Term Loan, the Company was required to begin paying principal on the Borrowings in equal quarterly installments beginning on the third anniversary of the 2025 Term Loan Closing Date, with the outstanding balance to be repaid on January 7, 2025, the maturity date. However, in January 2022, the Company entered into the 2027 Term Loans (see Note 14. Subsequent Events) and voluntarily prepaid all amounts outstanding under the 2025 Term Loan, pursuant to which a payoff amount of $ 81.9 million was outstanding. Since the Company expected to refinance the 2025 Term Loan with proceeds from Tranche A of the 2027 Term Loans which was funded on January 5, 2022 and will mature in 2027, the 2025 Term Loan was classified as non-current on the December 31, 2021 consolidated balance sheets.
If all or any of the Borrowings are prepaid or required to be prepaid under the 2025 Term Loan, then the Company shall pay, in addition to such prepayment, a prepayment premium equal to (i) with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Credit Agreement Closing Date, 5.00 % of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the 2025 Term Loan Closing Date , (ii) with respect to any prepayment paid or required to be paid after the three year anniversary of the 2025 Term Loan Closing Date but on or prior to the four year anniversary of the 2025 Term Loan Closing Date, 5.00 % of the Borrowings prepaid or required to be prepaid , (iii) with respect to any prepayment paid or required to be paid after the four year anniversary of the 2025 Term Loan Closing Date but on or prior to the five year anniversary of the 2025 Term Loan Closing Date, 2.50 % of the Borrowings prepaid or required to be prepaid , and (iv) with respect to any prepayment paid or required to be prepaid thereafter, 1.25 % of the Borrowings prepaid or required to be prepaid .
In connection with the 2025 Term Loan, the Company paid a fee to the Lender of approximately $ 1.1 million at closing in the form of an original issue discount. Upon the prepayment or maturity of the Borrowings (or upon the date such prepayment or repayment is required to be paid), it is required to pay an additional exit fee in an amount equal to 4.00 % of the total principal amount of the Borrowings.
The obligations under the 2025 Term Loan are secured by a lien on substantially all of the Company’s tangible and intangible property, including intellectual property. The 2025 Term Loan contains certain affirmative covenants, negative covenants and events of default, including, covenants and restrictions that among other things, restrict the ability of the Company and its subsidiaries to, incur liens, incur additional indebtedness, make loans and investments, engage in mergers and acquisitions, in asset sales, and declare dividends or redeem or repurchase capital stock. Additionally, the consolidated net sales for UDENYCA must not be lower than $ 70.0 million for the fiscal year ending December 31, 2019, (b) $ 125.0 million for the fiscal year ending December 31, 2020, and (c) $ 150.0 million for each fiscal year thereafter. A failure to comply with these covenants could permit the Lender under the 2025 Term Loan to declare the Borrowings, together with accrued interest and fees, to be immediately due and payable.
As of December 31, 2021, the Company was in full compliance with these covenants and there were no events of default under the 2025 Term Loan.
The following table summarizes components of the 2025 Term Loan:
December 31,
(in thousands)
2021
2020
Principal amount of the 2025 Term Loan
$
75,000
$
75,000
Exit fee due on payment of 2025 Term Loan
3,000
3,000
2025 Term Loan, gross
78,000
78,000
Unamortized exit fee, debt discount and debt issuance costs, net
( 2,487 )
( 3,519 )
Net carrying amount of 2025 Term Loan
$
75,513
$
74,481
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The following table presents the components of interest expense of the 2025 Term Loan:
Year Ended December 31,
(in thousands)
2021
2020
2019
Stated coupon interest
$
7,034
$
7,053
$
7,063
Accretion of debt discount and debt issuance costs
1,032
818
709
Interest expense
$
8,066
$
7,871
$
7,772
In January 2022 , the 2025 Term Loan was refinanced with proceeds from the 2027 Term Loans which mature in 2027 (see Note 14. Subsequent Events). Therefore, the 2025 Term Loan was classified as non-current on the consolidated balance sheets at December 31, 2021. If the refinancing had not occurred, the future payments on the 2025 Term Loan as of December 31, 2021 would be as follows:
Year ending December 31, (in thousands)
2022
$
29,294
2023
27,130
2024
24,972
2025
8,780
Total minimum payments
90,176
Less amount representing interest
( 12,176 )
2025 Term Loan, gross
78,000
Less unamortized exit fee, debt discount and debt issuance costs, net
( 2,487 )
Net carrying amount of 2025 Term Loan
$
75,513
8.
8. Commitments and Contingencies
Purchase Commitments
The Company entered into agreements with certain vendors to secure raw materials and certain CMOs to manufacture its supply of products. As of December 31, 2021, the Company’s non-cancelable contractual obligations under the terms of its agreements are as follows:
Years ending December 31, (in thousands)
2022
$
27,052
2023
16,300
2024
10,108
2025
268
2026
179
Total obligations
$
53,907
The Company enters into contracts in the normal course of business with contract research organizations for preclinical studies and clinical trials and CMOs for the manufacture of clinical trial materials. The contracts are cancellable, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would generally only be obligated for products or services that the Company had received as of the effective date of the termination and any applicable cancellation fees.
Guarantees and Indemnifications
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company would assess the likelihood of any adverse judgments or related claims, as well as ranges of probable losses. In the cases where the Company believes that a reasonably possible or probable loss exists, it will disclose the facts and circumstances of the claims, including an estimate range, if possible.
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Legal Proceedings
The Company is a party to various legal proceedings and claims that arise in the ordinary, routine course of business and that have not been fully resolved. The outcome of such legal proceedings and claims is inherently uncertain. Accruals are recognized for such legal proceedings and claims to the extent that a loss is both probable and reasonably estimable. The best estimate of a loss within a range is accrued; however, if no estimate in the range is better than any other, then the minimum amount in the range is accrued. If its determined that a material loss is reasonably possible and the loss or range of loss can be estimated, the possible loss is disclosed. Sometimes it is not possible to determine the outcome of these matters or, unless otherwise noted, the outcome (including in excess of any accrual) is not expected to be material, and the maximum potential exposure or the range of possible loss cannot be reasonably estimated. The Company did not have any material accruals in the consolidated balance sheets as of December 31, 2021 and 2020.
There are no material pending legal proceedings, other than ordinary routine litigation incidental to the business, to which the Company or any of its subsidiaries is a party, or that any of the Company or its subsidiaries' property is subject.
9. Leases
The Company leases approximately 47,789 square feet of office space for its corporate headquarters in Redwood City, California. This lease terminates in September 2024 and contains a one -time option to extend the lease term for five years . The Company also leases approximately 25,017 square feet for its laboratory facilities in Camarillo, California which commenced in January 2020. This lease terminates in May 2027 and contains a one -time option to extend the lease term for five years . Both facility leases provide for certain limited rent abatement and annual scheduled rent increases over their respective lease terms.
The Company determined that the above facility leases were operating leases. The options to extend the lease terms for these leases were not included as part of the right-of-use asset or lease liability as it was not reasonably certain the Company would exercise those options.
In 2019, the Company entered into a vehicle lease agreement, pursuant to which the Company currently leases approximately 50 vehicles. Delivery of the vehicles commenced during the first quarter of 2020. The term of each leased vehicle is 36 months and commences upon the delivery of the vehicle. The vehicles leased under this arrangement were classified as finance leases.
For the leases that commenced prior to January 1, 2019 (adoption date of ASC 842), the Company determined the present value of the lease payments using the incremental borrowing rate on that date. For all other leases, the Company used the incremental borrowing rate on the lease commencement or the lease modification date, as applicable.
Supplemental information related to the Company’s leases is as follows:
(in thousands)
December 31,
Assets
Balance Sheet Classification
2021
2020
Operating lease
Other assets, non-current
$
8,193
$
9,956
Finance lease
Property and equipment, net
1,220
1,451
Total leased assets
$
9,413
$
11,407
(in thousands)
December 31,
Liabilities
Balance Sheet Classification
2021
2020
Operating lease liabilities, current
Accrued and other current liabilities
$
2,751
$
2,573
Operating lease liabilities, non-current
Lease liabilities, non-current
6,753
9,073
Total operating lease liabilities
$
9,504
$
11,646
Finance lease liabilities, current
Accrued and other current liabilities
$
741
$
560
Finance lease liabilities, non-current
Lease liabilities, non-current
498
875
Total finance lease liabilities
$
1,239
$
1,435
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Operating lease costs were $ 3.1 million, $ 3.1 million and $ 2.4 million in 2021, 2020 and 2019, respectively. Cash paid for amounts included in the measurement of the operating lease liabilities in 2021 and 2020 was $ 3.4 million and $ 3.2 million, respectively, and was included in net cash used in operating activities in the consolidated statements of cash flows. Finance lease costs and cash paid for amounts included in the measurement of finance lease liabilities were immaterial during 2021, 2020 and 2019.
As of December 31, 2021, the maturities of the lease liabilities were as follows:
Years ending December 31, (in thousands)
Operating leases
Finance leases
2022
$
3,401
$
790
2023
3,560
449
2024
3,014
61
2025
412
—
2026 and thereafter
416
—
Total lease payments
10,803
1,300
Less imputed interest
( 1,299 )
( 61 )
Lease liabilities
$
9,504
$
1,239
As of December 31, 2021 and 2020, the weighted average remaining lease term for operating leases was 3.2 years and 4.1 years, respectively. The weighted average discount rate used to determine the operating lease liabilities was 8.0 % and 8.1 % as of December 31, 2021 and 2020, respectively. The weighted average remaining lease term for finance leases was 1.7 years and 2.4 years as of December 31, 2021 and 2020, respectively. The weighted average discount rate used to determine the finance lease liabilities was 5.8 % as of December 31, 2021 and 2020, respectively.
10. Stock-Based Compensation and Employee Benefits
Equity Incentive Plans
In October 2014, the Company’s board of directors and its stockholders adopted the 2014 Equity Incentive Plan, which became effective upon the closing of the Company’s IPO on November 6, 2014. The 2014 Plan is subject to automatic annual increases in the number of shares available for issuance on the first business day of each fiscal year equal to four percent ( 4 %) of the number of shares of the Company’s common stock outstanding as of such date or a lesser number of shares as determined by the Company’s board of directors. All remaining shares under the Company’s 2010 Stock Plan (the “2010 Plan”) were transferred to the 2014 Plan upon adoption and any additional shares that would otherwise return to the 2010 Plan as a result of forfeiture, termination or expiration of the awards will return to the 2014 Plan. The 2014 Plan provided for the Company to grant shares and/or options to purchase shares of common stock to employees, directors, consultants and other service providers. While the 2014 Plan allows for non-qualified or incentive stock options, all option grants made since June 2016 have been for non-qualified stock options. Under the 2010 Plan, no awards have been issued since 2014, and there were no shares of common stock available for future issuance as of December 31, 2021. There were 468,671 shares of common stock available for future issuance as of December 31, 2021 under the 2014 Plan.
In June 2016, the Company adopted the 2016 Employment Commencement Incentive Plan. The 2016 Plan is designed to comply with the inducement exemption contained in Nasdaq’s Rule 5635(c)(4), which provides for the grant of non-qualified stock options, restricted stock units, restricted stock awards, performance awards, dividend equivalents, deferred stock awards, deferred stock units, stock payment and stock appreciation rights to a person not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to the individual’s entering into employment with the Company. As of December 31, 2021, the Company had 446,037 shares of common stock available for future issuance for new employees. The 2016 Plan does not provide for any annual increases in the number of shares available.
Stock option exercises are settled with common stock from the plans’ previously authorized and available pool of shares. If any shares subject to an award granted under the 2014 Plan or the 2016 Plan expire or become forfeited, terminated or canceled without the issuance of shares, the shares subject to such awards are added back into the authorized pool on the same basis that they were removed. In addition, shares withheld to pay for minimum statutory tax obligations with respect to full-value awards are added back into the
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authorized pool. The annual grant to eligible employees can vary on the type of award, and the award size is determined by the employee’s grade level.
Stock Options
Incentive stock options and non-statutory stock options may be granted with exercise prices of not less than the fair value of the common stock on the date of grant. These stock options generally vest over four years , expire in ten years from the date of grant and are generally exercisable after vesting.
The following table sets forth the summary of option activities under the 2016 Plan and the 2014 Plan:
Options Outstanding
Weighted-
Number of
Average
Options
Exercise Price
Balances at December 31, 2020
19,014,835
$
15.41
Granted - at fair value
4,559,125
$
16.62
Exercised
( 1,316,361 )
$
7.91
Forfeited/Canceled
( 2,297,784 )
$
17.96
Balances at December 31, 2021
19,959,815
$
15.89
Additional information related to the status of options as of December 31, 2021 is summarized as follows:
Weighted-
Weighted-
Average
Aggregate
Average
Remaining
Intrinsic
Number of
Exercise
Contractual Terms
Value (in
Options
Price
(Years)
thousands)
Options outstanding
19,959,815
$
15.89
6.4
$
47,892
Options vested and exercisable
13,453,683
$
15.56
5.4
$
43,291
During the years ended December 31, 2021, 2020 and 2019, the estimated weighted-average grant-date fair value of options granted was $ 9.80 , $ 10.94 and $ 9.52 per share, respectively, and the aggregate intrinsic value of options exercised was $ 9.7 million, $ 14.6 million and $ 10.3 million, respectively. The intrinsic value is defined as the difference between the current market value and the exercise price.
The Company recognized stock-based compensation expense of $ 36.7 million, $ 30.3 million and $ 31.4 million in 2021, 2020 and 2019, respectively, related to stock options. As of December 31, 2021, total unrecognized stock-based compensation expenses related to unvested stock options was $ 61.4 million, which is expected to be recognized on a straight-line basis over a weighted-average period of 2.6 years.
Restricted Stock Units
The Company grants restricted stock units (“RSUs”) primarily to its employees. RSUs are share awards that entitle the holder to receive freely tradable shares of our common stock upon vesting. The RSUs cannot be transferred and are subject to forfeiture if the holder’s employment terminates prior to the release of the vesting restrictions. The Company’s RSUs generally vest over one to three years from the applicable grant date, provided the employee remains continuously employed with the Company. The estimated fair value of RSUs is based on the closing price of our common stock on the grant date.
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The following table sets forth the summary of RSUs activity, under the 2014 Plan:
RSUs Outstanding
Weighted-Average
Number of
Grant Date Fair
RSUs
Value
Balances at December 31, 2020
1,009,657
$
17.91
RSUs granted
1,652,512
$
16.86
RSUs vested
( 465,930 )
$
18.10
RSUs canceled
( 352,507 )
$
17.54
Balances at December 31, 2021
1,843,732
$
17.00
The total fair value of RSUs vested was $ 8.4 million, $ 4.1 million and $ 2.7 million during the years ended December 31, 2021, 2020 and 2019, respectively. The total estimated grant date fair value of RSUs was $ 27.9 million, $ 21.2 million and $ 4.3 million granted during the years ended December 31, 2021, 2020 and 2019, respectively. The estimated weighted-average grant-date fair value per share of RSUs granted during the years ended December 31, 2021, 2020 and 2019 was $ 16.86 , $ 17.86 and $ 15.11 , respectively.
The Company recognized stock-based compensation expense related to RSUs of $ 13.5 million, $ 6.5 million and $ 0.8 million in 2021, 2020 and 2019, respectively. As of December 31, 2021, total unrecognized stock-based compensation expenses related to unvested RSUs was $ 20.7 million, which is expected to be recognized on a straight-line basis over a weighted-average period of 1.8 years.
Employee Stock Purchase Plan
In October 2014, the Company’s board of directors and its stockholders approved the establishment of the ESPP. The ESPP provides for annual increases in the number of shares available for issuance on the first business day of each fiscal year equal to the lesser of one percent ( 1 %) of the number of shares of the Company’s common stock outstanding as of such date or a number of shares as determined by the Company’s board of directors. The ESPP had 3,238,648 shares of common stock available for future issuance as of December 31, 2021. Eligible employees may purchase common stock at 85 % of the lesser of the fair market value of the Company’s common stock on the first or last day of the offering period. The offering periods of the ESPP are on May 16 and November 16 . The Company recognized stock-based compensation expense related to the ESPP of $ 1.2 million, $ 1.4 million and $ 1.3 million in 2021, 2020 and 2019, respectively. As of December 31, 2021, there was $ 0.6 million of unrecognized compensation expense associated with the ESPP, which is expected to be recognized over an estimated weighted-average period of 4.5 months.
Stock-Based Compensation
Stock-based compensation expense is reflected in the consolidated statements of operations as follows:
Year Ended December 31,
(in thousands)
2021
2020
2019
Cost of goods sold (1)
$
1,099
$
583
$
108
Research and development
18,688
13,837
12,912
Selling, general and administrative
31,577
23,740
20,571
Stock-based compensation expense
$
51,364
$
38,160
$
33,591
Capitalized stock-based compensation expense into inventory
$
1,025
$
1,460
$
1,735
(1) Stock-based compensation capitalized into inventory is recognized as cost of sales when the related product is sold.
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Valuation Assumptions of Awards Granted to Employees
The Company estimated the fair value of each stock option and awards granted under the ESPP on the date of grant using the Black-Scholes option-pricing model. The following table illustrates the weighted average assumptions for the Black-Scholes option-pricing model used in determining the fair value of the awards during the years ended December 31, 2021, 2020 and 2019:
Year Ended December 31,
2021
2020
2019
Expected term (years)
Stock options
6.08
6.10
6.00
ESPP
0.50
0.50
0.50
Expected volatility
Stock options
65
%
68
%
69
%
ESPP
42
%
58
%
61
%
Risk-free interest rate
Stock options
0.89
%
1.09
%
2.29
%
ESPP
0.06
%
0.13
%
1.89
%
Expected dividend yield
Stock options
—
%
—
%
—
%
ESPP
—
%
—
%
—
%
Expected Term: The expected term represents the period for which the stock-based awards are expected to be outstanding and is based on the options’ vesting term and contractual term. Through December 31, 2020, the Company elected to use the “simplified method” for estimating the expected term, which is calculated as the mid-point between the vesting period and the contractual term of the options, as it has limited historical information to develop expectations about future exercise patterns and post-vesting employment termination behavior. Beginning January 1, 2021, the expected term is calculated using historical exercise data.
Expected Volatility: The expected volatility in 2021, 2020 and 2019 is based on the Company’s historical stock price volatility.
Risk-Free Interest Rate: The Company based the risk-free interest rate by using an equivalent to the expected term based on the United States Treasury constant maturity rate as of the date of grant.
Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future, and therefore used an expected dividend yield of zero in the valuation model.
401(k) Retirement Plan
In 2019, the Company’s Compensation Committee approved the Company’s matching of the employees 401(k) Plan (the “401(k) Plan”) whereby eligible employees may elect to contribute up to the lesser of 90 % of their annual compensation or the statutorily prescribed annual limit allowable under Internal Revenue Service regulations. Beginning January 1, 2021, the Company made matching contributions of 100 % of the first 4 % of eligible compensation, up to a maximum of $ 7,500 . In 2020 and 2019, the Company made matching contributions of 50 % of the first $ 6,000 of each participant’s contributions. The Company recorded compensation expense related to the match of $ 1.7 million, $ 0.8 million and $ 0.8 million in 2021, 2020 and 2019, respectively.
11. Income Taxes
The components of (loss) income before income taxes are as follows:
Year Ended December 31,
(in thousands)
2021
2020
2019
Domestic
$
( 287,058 )
$
133,615
$
92,585
Foreign
( 42 )
2,092
190
Total
$
( 287,100 )
$
135,707
$
92,775
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Provision for income taxes:
Year Ended December 31,
(in thousands)
2021
2020
2019
Current:
Federal
$
—
$
—
$
—
State
—
3,463
2,942
Foreign
—
—
—
Subtotal
$
—
$
3,463
$
2,942
Deferred:
Federal
$
—
$
—
$
—
State
—
—
—
Foreign
—
—
—
Subtotal
$
—
$
—
$
—
Provision for income taxes
$
—
$
3,463
$
2,942
There was no income tax provision in 2021 due to the Company’s history of losses and valuation of allowances against the deferred tax assets. The income tax provisions in 2020 and 2019 of $ 3.5 million and $ 2.9 million, respectively, primarily relate to state taxes in jurisdictions outside of California, for which the Company has a limited operating history.
A reconciliation of the statutory United States federal rate to the Company’s effective tax rate is as follows:
Year Ended December 31,
2021
2020
2019
Percent of pre-tax income:
United States federal statutory income tax rate
21.0
%
21.0
%
21.0
%
State taxes, net of federal benefit
2.6
2.0
1.5
Foreign rate differences
( 0.0 )
( 0.3 )
( 0.1 )
Permanent items
0.2
0.4
( 0.6 )
Research and development credit
2.6
( 4.8 )
( 4.8 )
Stock based compensation costs
( 1.2 )
1.3
1.3
Other
( 0.0 )
( 0.3 )
( 0.7 )
Change in valuation allowance
( 25.2 )
( 16.7 )
( 14.4 )
Effective income tax rate
( 0.0 )
%
2.6
%
3.2
%
The components of the Company’s net deferred tax assets as of December 31, 2021 and 2020 consist of the following:
December 31,
(in thousands)
2021
2020
Net operating loss carryforwards
$
117,793
$
94,043
Research and development credits
58,039
49,965
Depreciation and amortization
40,620
9,672
Stock-based compensation
30,565
25,983
Sales related accruals
17,299
16,404
Other accruals
11,798
8,013
Gross deferred tax assets
276,114
204,080
Right-of-use asset
( 2,167 )
( 2,566 )
In-process research and development
( 603 )
( 589 )
Gross deferred tax liabilities
( 2,770 )
( 3,155 )
Total net deferred tax asset
273,344
200,925
Less valuation allowance
( 273,344 )
( 200,925 )
Net deferred tax assets
$
—
$
—
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The tax benefit of net operating losses, temporary differences and credit carry forwards is recorded as an asset to the extent that management assesses that realization is “more likely than not.” The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible. Due to the Company’s history of losses, and lack of other positive evidence, the Company has determined that it is more likely than not that its Federal net deferred tax assets and certain state net deferred tax assets will not be realized, and therefore, the Company has fully offset the Federal and certain state net deferred tax assets by a valuation allowance as of December 31, 2021 and 2020.
The valuation allowance increased by $ 72.4 million during the year ended December 31, 2021 and decreased by $ 22.7 million and $ 13.4 million during the years ended December 31, 2020 and 2019, respectively.
As of December 31, 2021, the Company had operating loss carryforwards for federal income of $ 533.5 million, which will start to expire in the year 2036 , and various states net operating loss carryforwards of $ 83.7 million, which have various expiration dates beginning in 2031 .
As of December 31, 2021, the Company had federal research and development credit carryforwards for federal income tax purposes of $ 54.0 million, which will start to expire in the year 2031 , and state research and development credit carryforwards of $ 23.5 million, which have no expiration date.
Utilization of the net operating loss and tax credit carryforwards may be subject to an annual limitation due to historical or future ownership percentage change rules provided by the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitation may result in the expiration of certain net operating loss and tax credit carryforwards before their utilization. Under the new enacted tax law, the carry forward period of net operating losses generated from 2018 forward is indefinite. However, the carryforward period for net operating losses generated prior to 2018 remains the same. Therefore, the annual limitation may result in the expiration of certain net operating losses and tax credit carryforwards before their utilization. The Company files United States, California and other state income tax returns with varying statutes of limitations. The tax years from 2011 forward remain open to examination due to the carryover of unused net operating losses and tax credits.
A reconciliation of the Company’s unrecognized tax benefits during 2021, 2020 and 2019 is as follows:
Year Ended December 31,
(in thousands)
2021
2020
2019
Balance at beginning of year
$
13,243
$
11,603
$
18,115
Additions based on tax positions related to current year
2,038
1,749
1,206
Additions (reductions) for tax positions of prior years
214
( 109 )
( 7,718 )
Balance at end of year
$
15,495
$
13,243
$
11,603
As of December 31, 2021, 2020 and 2019, the Company had $ 15.5 million, $ 13.2 million and $ 11.6 million, respectively, of unrecognized benefits, none of which would currently affect the Company’s effective tax rate if recognized due to the Company’s deferred tax assets being fully offset by a valuation allowance. During 2021, 2020 and 2019, the Company did not recognize accrued interest and penalties related to unrecognized tax benefits. The Company does not anticipate a material adjustment of unrecognized tax benefits during the next twelve months from the balance sheet date as reductions for tax positions of prior years.
The Company files United States, state and foreign income tax returns with varying statutes of limitations. The tax years from inception in 2011 forward remain open to examination due to the carryover of unused net operating losses and tax credits.
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12. Net (Loss) Income Per Share
The following table sets forth the computation of the basic and diluted net (loss) income per share:
Years Ended December 31,
(in thousands, except share and per share data)
2021
2020
2019
Basic net (loss) income per share
Numerator:
Net (loss) income
$
( 287,100 )
$
132,244
$
89,833
Denominator:
Weighted-average common shares outstanding
75,449,632
71,411,705
69,679,916
Basic net (loss) income per share
$
( 3.81 )
$
1.85
$
1.29
Diluted net (loss) income per share
Numerator:
Net (loss) income
$
( 287,100 )
$
132,244
$
89,833
Add interest expense on 2026 Convertible Notes, net of tax
—
3,307
—
Numerator for diluted net (loss) income per share
( 287,100 )
135,551
89,833
Denominator:
Denominator for basic net (loss) income per share
75,449,632
71,411,705
69,679,916
Add effect of potential dilutive securities:
Stock options, including shares subject to ESPP
—
3,455,646
3,491,272
Restricted stock units
—
167,597
14,755
Shares issuable upon conversion of convertible notes
—
8,456,950
—
Denominator for diluted net (loss) income per share
75,449,632
83,491,898
73,185,943
Diluted net (loss) income per share
$
( 3.81 )
$
1.62
$
1.23
The following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect:
The following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect:he following outstanding dilutive potential shares were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect:
Year Ended December 31,
2021
2020
2019
Stock options, including shares subject to ESPP
19,895,097
9,521,403
10,412,471
Restricted stock units
1,811,607
7,689
22,068
Shares issuable upon conversion of 2022 Convertible Notes
4,473,871
4,473,871
4,473,871
Shares issuable upon conversion of 2026 Convertible Notes
11,942,152
—
—
Total
38,122,727
14,002,963
14,908,410
13. Related Party Transactions
Convertible Notes — Related Parties
In February 2016, the Company issued the 2022 Convertible Notes to certain related parties (certain companies affiliated with members of the Company’s board of directors), for an aggregate principal amount of $ 25.0 million (see Note 7. Debt Obligations).
Consulting services
In October 2020, the Company entered into a consulting agreement with Lanfear Advisors owned by Mr. Jonathan Lanfear who is the brother of Dennis Lanfear, the Company’s President, Chief Executive Officer and Chairman of the Board of Directors. Mr. Jonathan Lanfear provided consulting services with respect to the Collaboration Agreement executed with Junshi Biosciences in February 2021 and the Letter Agreement with Junshi Biosciences related to the Collaboration Agreement dated January 9, 2022 (See Note 6. Collaborations and Other Arrangements). In addition to the hourly consulting fee paid to Lanfear Advisors under the consulting agreement, the Company granted fully vested stock options to purchase 65,000 shares of common stock with an exercise price of $ 17.60 per share to Mr. Jonathan
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Lanfear in February 2021 upon the execution of the Collaboration Agreement with Junshi Biosciences and recognized stock-based compensation expense of $ 0.8 million. The Company recorded cash consulting expense of $ 0.2 million and $ 0.3 million in 2021 and 2020, respectively, with respect to these consulting services. Total liabilities recognized in accounts payable and accrued and other current liabilities on the consolidated balance sheets with respect to these services were $ 0.0 million and $ 0.3 million as of December 31, 2021 and 2020, respectively.
14. Subsequent Events
2027 Term Loans
In January 2022, the Company entered into the Loan Agreement with the Collateral Agent and the Lenders that provides for a senior secured term loan facility of up to $ 400.0 million (inclusive of a $ 100.0 million uncommitted additional facility amount) to be funded in four committed tranches: (i) a Tranche A Loan in an aggregate principal amount of $ 100.0 million that was funded on January 5, 2022; (ii) a Tranche B Loan in an aggregate principal amount of $ 100.0 million to be funded no later than April 1, 2022, subject to the delivery of evidence of repayment, repurchase or redemption of indebtedness outstanding under our 8.2 % Convertible Notes due 2022 and certain customary deliverables; (iii) a Tranche C Loan in an aggregate principal amount of $ 50.0 million to be funded at our option between April 1, 2022 and March 17, 2023, subject to certain conditions including the first FDA approval of a BLA for our product candidate toripalimab in the United States; and (iv) a Tranche D Loan in an aggregate principal amount of $ 50.0 million to be funded at our option between April 1, 2022 and March 17, 2023, subject to certain conditions including the first FDA approval of a BLA for our product candidate CHS-201 (ranibizumab biosimilar) in the United States. The Company has the right to request an uncommitted additional facility amount of up to $ 100.0 million after the Tranche A Closing Date that will be subject to new terms and conditions.
The 2027 Term Loans mature on either (i) the fifth anniversary of the Tranche A Closing Date; or (ii) October 15, 2025, if the outstanding aggregate principal amount of our 2026 Convertible Notes is greater than $ 50.0 million on October 1, 2025. The 2027 Term Loans bear interest at 8.25 % plus three-month LIBOR per annum with a LIBOR floor of 1.00 %. In the event of the cessation of LIBOR, the benchmark governing the interest rate will be replaced with a rate based on the secured overnight financing rate published by the Federal Reserve Bank of New York as described in the Loan Agreement. Interest is payable quarterly in arrears. Repayment of outstanding principal of the 2027 Term Loans will be made in five equal quarterly payments of principal commencing after January 5, 2026.
In January 2022, the Company paid to the Lenders a funding fee equal to 2.00 % of the Lenders’ total committed amount to fund the Tranche A Loan, Tranche B Loan, Tranche C Loan and Tranche D Loan, payable on the Tranche A Closing Date. In addition, in the event any of the 2027 Term Loans is prepaid in whole or in part prior to the Maturity Date or is accelerated, it will be subject to a prepayment fee. Prior to the third anniversary of the Tranche A Closing Date, the prepayment fee is 3.00 % of the principal amount prepaid. After the third anniversary but prior to the fourth anniversary of the Tranche A Closing Date, the prepayment fee is 2.00 % of the principal amount prepaid; thereafter and prior to the Maturity Date, the prepayment fee is 1.00 % of the principal amount prepaid. In addition to the prepayment fees, in connection with a full or partial prepayment of a tranche prior to the second anniversary of the applicable funding, a “make-whole” amount will be payable equal to the foregone interest from the date of prepayment through the second anniversary of the Tranche A Closing Date.
The obligations under the Loan Agreement are secured pursuant to customary security documentation, including a guaranty and security agreement among the Credit Parties and the Collateral Agent which provides for a lien on substantially all of the Company’s tangible and intangible assets and property, including intellectual property.
Pursuant to the Loan Agreement, and subject to certain restrictions, proceeds of the 2027 Term Loans were and will be used to fund our general corporate and working capital requirements except for the following: in January 2022, proceeds of the Tranche A Loan were used to repay in full all amounts outstanding under the 2025 Term Loan, as well as all associated costs and expenses pursuant to which a payoff amount of $ 81.9 million was outstanding; and proceeds of the Tranche B Loan will be used at our option to repay, repurchase or redeem in cash, in full, our existing 8.2 % Convertible Notes due 2022 as well as all associated costs and expenses.
The Loan Agreement contains certain customary representations and warranties. In addition, the Loan Agreement includes affirmative covenants, such as the requirement to maintain minimum trailing twelve month net sales in an amount that begins at $ 200 million in the current quarter and increases to $ 210 million for the quarter ended March 30, 2024 and increases to be as much as $ 300 million for the quarter ended December 31, 2024. Further, the Loan Agreement includes certain other affirmative covenants and negative covenants, including, covenants and restrictions that among other things, restrict our ability to, incur liens, incur additional indebtedness,
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make investments, engage in certain mergers and acquisitions or asset sales, and declare dividends or redeem or repurchase capital stock. The Loan Agreement also contains customary events of default, including among other things, our failure to make any principal or interest payments when due, the occurrence of certain bankruptcy or insolvency events or our breach of the covenants under the Loan Agreement. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate our obligations under the Loan Agreement. A change of control of Coherus triggers a mandatory prepayment of the 2027 Term Loans within ten business days.
Junshi Biosciences – TIGIT Option Exercises
On January 9, 2022, the Company entered into a Letter Agreement with Junshi Biosciences related to the Collaboration Agreement (the “TIGIT Exercise Letter Agreement”). Under the TIGIT Exercise Letter Agreement, the Company notified Junshi Biosciences of its election to exercise the license option for the TIGIT program described in the Collaboration Agreement (the “TIGIT Program”), with the TIGIT Exercise Letter Agreement effective on the date that all applicable waiting periods and approvals required under antitrust laws with respect to such exercise by the Company of the license option for the TIGIT Program have expired or have been terminated (in the case of waiting periods) or been received (in the case of approvals), in each case, without the imposition of any conditions (the “TIGIT Exercise Letter Agreement Effective Date”). The Company will pay the option exercise payment of $ 35.0 million to Junshi Biosciences no later than 10 days following the TIGIT Exercise Letter Agreement Effective Date and, if applicable, will pay up to $ 255 million in development regulatory and sales milestones and an 18 % royalty on net product revenue as set forth under the Collaboration Agreement. Pursuant to the TIGIT Exercise Letter Agreement, Coherus will lead further development of the TIGIT antibodies included in the TIGIT Program, including JS006, in the United States and Canada, after the date it makes the option exercise payment and will be responsible for the associated development costs as set forth in the Collaboration Agreement.
In January 2022, the Company initiated the process for the exercise of our option to license JS006, a TIGIT-targeted antibody, in the United States and Canada from Junshi Biosciences, expanding the companies’ 2021 immuno-oncology collaboration agreement . Antibodies blocking TIGIT (T cell immunoglobulin and ITIM domain) have shown potential for synergistic anti-tumor activity in combination with PD-1/PD-L1 inhibitors. In pre-clinical studies, JS006 has demonstrated strong binding affinity and inhibition of the TIGIT pathway. IND applications allowing clinical development of JS006 have been approved in China and in the United States. A dose escalation, dose expansion clinical trial (NCT05061628) evaluating the safety, tolerability and pharmacokinetic properties of JS006 as monotherapy and in combination with PD-1 inhibitor toripalimab in patients with advanced solid tumors is ongoing in China. The Company plans to advance toripalimab in combination with JS006 in a clinical trial in North America later in 2022.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
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