0001558370-23-002917 | 10-K | XBRL Viewer

Leases

12 Months Ended

Dec. 31, 2022

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 the Vehicle Lease Agreement, pursuant to which the Company currently leases approximately 100 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, Leases), 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	2022		2021
Operating leases	Other assets, non-current	$	5,690	$	8,193
Finance leases	Property and equipment, net		2,584		1,220
Total leased assets		$	8,274	$	9,413


(in thousands)		December 31,
Liabilities	Balance Sheet Classification	2022		2021
Operating lease liabilities, current	Accrued and other current liabilities	$	3,127	$	2,751
Operating lease liabilities, non-current	Lease liabilities, non-current		3,628		6,753
Total operating lease liabilities		$	6,755	$	9,504

Finance lease liabilities, current	Accrued and other current liabilities	$	1,191	$	741
Finance lease liabilities, non-current	Lease liabilities, non-current		1,418		498
Total finance lease liabilities		$	2,609	$	1,239

Other information related to lease term and discount rate is as follows:


	December 31,
	2022		2021
Weighted-Average Remaining Lease Term
Operating leases		2.2 years		3.2 years
Finance leases		2.2 years		1.7 years
Weighted-Average Discount Rate
Operating leases		8.0%		8.0%
Finance leases		8.4%		5.8%

The components of lease expense were as follows:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Finance lease cost
Amortization of right-of-use assets	$	1,228	$	707	$	368
Interest on lease liabilities		166		82		57
Total finance lease cost		1,394		789		425
Operating lease cost		3,154		3,066		3,126
Total lease cost	$	4,548	$	3,855	$	3,551

Supplemental cash flow information related to leases was as follows:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Cash paid for amounts included in measurement of lease liabilities:
Operating cash flows from operating leases	$	3,401	$	3,435	$	3,217
Operating cash flows from finance leases	$	155	$	81	$	53
Financing cash flows from finance leases	$	1,228	$	672	$	388
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—	$	434	$	1,388
Finance leases	$	2,694	$	477	$	1,817

As of December 31, 2022, the maturities of the lease liabilities were as follows:


Year ending December 31, (in thousands)	Operating leases		Finance leases
2023	$	3,560	$	1,354
2024		3,014		1,026
2025		412		481
2026		292		—
2027 and thereafter		124		—
Total lease payments		7,402		2,861
Less imputed interest		(647)		(252)
Lease liabilities	$	6,755	$	2,609

Revenue (Tables)

12 Months Ended

Dec. 31, 2022

Revenue

Net revenue initiated sales in the United States of total net revenue


	Year Ended December 31,
(in thousands)	2022		2021		2020
Products
UDENYCA	$	203,814	$	326,509	$	475,824
CIMERLI		6,946		—		—
Total net product revenue		210,760		326,509		475,824
Other		282		42		—
Total net revenue	$	211,042	$	326,551	$	475,824

Gross Revenues by Significant Customer as a Percentage of Total Gross Revenues


	Year Ended December 31,
	2022		2021		2020
McKesson Corporation	38	%	39	%	38	%
AmeriSource-Bergen Corporation	44	%	39	%	37	%
Cardinal Health, Inc.	17	%	20	%	23	%

Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances


	Year Ended December 31, 2022
	Chargebacks				Other Fees,
	and Discounts				Co-pay
	for Prompt				Assistance
(in thousands)	Payment		Rebates		and Returns		Total
Balances at December 31, 2021	$	29,665	$	54,004	$	26,054	$	109,723
Provision related to sales made in:
Current period		436,865		68,399		73,435		578,699
Prior period		(2,090)		(1,050)		32		(3,108)
Payments and customer credits issued		(421,763)		(82,640)		(80,408)		(584,811)
Balances at December 31, 2022	$	42,677	$	38,713	$	19,113	$	100,503


	Year Ended December 31, 2021
	Chargebacks				Other Fees,
	and Discounts				Co-pay
	for Prompt				Assistance
(in thousands)	Payment		Rebates		and Returns		Total
Balances 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)
Balances at December 31, 2021	$	29,665	$	54,004	$	26,054	$	109,723

	Year Ended December 31, 2020
Balances 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)
Balances at December 31, 2020	$	40,580	$	54,058	$	28,760	$	123,398

Commitments and Contingencies

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies.

Commitments and Contingencies

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, 2022, the Company’s non-cancelable purchase commitments under the terms of its agreements are as follows:


Year ending December 31, (in thousands)
2023	$	53,652
2024		13,724
2025		1,128
2026		260
Total obligations	$	68,764

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 assesses 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.

Legal Proceedings and Other Claims

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 a material accrual for such matters as of December 31, 2021 and established an accrual of approximately $4.7 million as of December 31, 2022 that was included in accrued rebates, fees and reserves in the consolidated balance sheets.

In late April of 2022, the Company received a demand letter from Zinc Health Services, LLC (“Zinc”) asserting that Zinc was entitled to approximately $14.0 million from the Company for claims related to certain sales of UDENYCA from October 2020 through December 2021. The Company is continuing to evaluate the claims in the letter. No legal proceeding has been filed in connection with the claims in the letter and based on currently available information the final resolution of the matter is uncertain. The Company intends to defend any legal proceeding that may be filed. The Company established an accrual as of December 31, 2022 that represented its estimated liability to resolve the matter. Loss contingencies are inherently unpredictable, the assessment is highly subjective and requires judgments about future events and unfavorable developments or resolutions can occur. The Company regularly reviews litigation matters to determine whether its accrual is adequate. The amount of ultimate loss may differ materially from the amount accrued to date.

Other than the matter in connection with the demand letter described in this Note 8, there are no 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.

Stock-Based Compensation and Employee Benefits - Valuation Assumptions (Details)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected dividend yield	0.00%
2014 Employee Stock Purchase Plan (ESPP)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected term (years)	6 months	6 months	6 months
Expected volatility	70.00%	42.00%	58.00%
Risk-free interest rate	3.77%	0.06%	0.13%
Employee Stock Option
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected term (years)	6 years 1 month 6 days	6 years 1 month 6 days	6 years 1 month 6 days
Expected volatility	62.00%	65.00%	68.00%
Risk-free interest rate	2.37%	0.89%	1.09%

Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Current
State			$ 3,463
Subtotal			3,463
Deferred
Provision for income taxes	$ 0	$ 0	$ 3,463

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Inventory

12 Months Ended

Dec. 31, 2022

Inventory

Inventory

4.Inventory

Inventory consisted of the following:


	December 31,
(in thousands)	2022		2021
Raw materials	$	10,262	$	4,870
Work in process		86,712		65,117
Finished goods		18,077		23,265
Total	$	115,051	$	93,252

The Company began capitalizing YUSIMRY inventory in the second quarter of 2022 and had $23.7 million of such inventory recognized in the consolidated balance sheets at December 31, 2022. Inventory expected to be sold more than twelve months from the balance sheet date is classified as inventory, non-current in the consolidated balance sheets. As of December 31, 2022 and 2021, the non-current portion of inventory consisted of raw materials, work in process and a portion of finished goods. The following table presents the inventory balance sheet classifications:


	December 31,
(in thousands)	2022		2021
Inventory	$	38,791	$	37,642
Inventory, non-current		76,260		55,610
Total	$	115,051	$	93,252

Prepaid manufacturing of $17.9 million as of December 31, 2022 includes prepayments of $13.0 million to CMOs for manufacturing services of the Company’s products, which the Company expects to be converted into inventory during 2023; and prepayments of $4.9 million to various CMOs for research and development pipeline programs. 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; and prepayments of $5.4 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 in 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. No material expense relating to the discontinuation of CHS-2020 was recognized after March 31, 2021.

Debt Obligations - Capped Call Transactions - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions		1 Months Ended
	Apr. 30, 2020	Apr. 30, 2020	Dec. 30, 2022	Apr. 14, 2020
Option Indexed to Issuer's Equity [Line Items]
Closing stock, price per share			$ 7.92	$ 14.82
Capped Call Transactions in connection with the 2026 Convertible Notes
Option Indexed to Issuer's Equity [Line Items]
Payment for capped call transactions		$ 18.2
Initial cap price of capped call transactions.	$ 25.93
Percentage of cap price		75.00%

Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
Income Taxes (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Operating Loss Carryforwards [Line Items]
Income tax provision	$ 0	$ 0	$ 3,463
Increase (decrease) in valuation allowance	64,400	72,400	(22,700)
Unrecognized tax benefits, accrued interest and penalties accrued	0	0	0
Unrecognized Tax Benefits	16,838	$ 15,495	$ 13,243	$ 11,603
Federal
Operating Loss Carryforwards [Line Items]
Net operating loss carryforwards	$ 591,200
Net operating loss carryforwards expiration year	2036
Tax credit carryforwards	$ 57,700
Tax credit carryforwards expiration year	2031
Various states
Operating Loss Carryforwards [Line Items]
Net operating loss carryforwards	$ 113,200
Net operating loss carryforwards expiration year	2031
Tax credit carryforwards	$ 26,400

Stock-Based Compensation and Employee Benefits - Employee Stock Purchase Plan (Details) - USD ($) $ in Thousands		1 Months Ended	12 Months Ended
	Oct. 31, 2014	Feb. 28, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock-based compensation expense		$ 800	$ 50,737	$ 51,364	$ 38,160
Unrecognized stock-based compensation expenses related to stock options			$ 51,500
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition			2 years 8 months 12 days
2014 Employee Stock Purchase Plan (ESPP)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Common stock reserved for future issuance			3,172,117
Percentage of purchase common stock of lesser of fair market value of common stock on first or last day of offering period by eligible employees			85.00%
Employee stock purchase plan offering period one	--05-16
Employee stock purchase plan offering period two	--11-16
Unrecognized stock-based compensation expenses related to stock options			$ 700
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition			4 months 15 days
2014 Employee Stock Purchase Plan (ESPP) \| Minimum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Percentage of shares reserve for issuance	1.00%

Collaborations and Other Arrangements

12 Months Ended

Dec. 31, 2022

Collaborations and Other Arrangements

Collaborations and Other Arrangements

6.	Collaborations and Other Arrangements

Junshi Biosciences

On February 1, 2021, the Company entered into the 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, an option in these territories to Junshi Biosciences’ anti-TIGIT antibody CHS-006, an option in these territories to a 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.

In March 2022, the Company paid $35.0 million for the exercise of its option to license CHS-006. Junshi Biosciences and the Company are jointly developing CHS-006 with each party responsible for the associated development costs as set forth in the Collaboration Agreement. If the Company exercises its remaining option for the IL-2 cytokine, it will be obligated to pay an additional option exercise fee of $35.0 million. Additionally, for each exercised option, the Company will be obligated to pay Junshi Biosciences an 18% royalty on net sales, up to $85.0 million for the achievement of certain regulatory approvals, and up to $170.0 million for the attainment of certain sales thresholds. Under the Collaboration Agreement, the Company retains the right to collaborate in the development of toripalimab and the other licensed compounds, including CHS-006, 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 licensing transaction and the exercise of the option were accounted for as asset acquisitions under the relevant accounting rules. Research and development expenses recognized for obligations to Junshi Biosciences were $68.5 million in 2022, inclusive of the $35.0 million option fee, $175.4 million in 2021, and $5.0 million in 2020 representing the right of first negotiation fee which was fully credited against the total upfront license fee obligation under the Collaboration Agreement. The first quarter of 2021 included $145.0 million for the upfront payment for the exclusive rights to toripalimab and the second quarter of 2021 included a credit of $9.0 million for the DLOM, discussed below. Accrued and other current liabilities in the consolidated balance sheets as of December 31, 2022 and 2021 included $8.4 million and $1.9 million, respectively, related to the co-development, regulatory and technology transfer costs related to these programs.

A $25.0 million milestone payment will be due upon the regulatory approval of toripalimab. Junshi Biosciences and the Company have not received an action letter from the FDA regarding the BLA for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma by the Prescription Drug User Fee Action date of December 23, 2022. The FDA previously communicated that on-site inspections, including Junshi Biosciences’ manufacturing facility for toripalimab, are required before the FDA can approve the original BLA; however, they were unable to conduct the inspection by December 23, 2022 due to the impact of COVID-19 related restrictions on travel in China. The BLA for toripalimab remains under review, and Junshi Biosciences and the Company are engaged in ongoing discussions with the FDA about the pre-approval inspection plans. The Company plans to launch toripalimab in the United States in the third quarter of 2023, if approved by July 1, 2023. As of December 31, 2022, the Company did not have any outstanding milestone or royalty payment obligations to Junshi Biosciences. The additional milestone payments, option fee for the IL-2 cytokine and

royalties are contingent upon future events and, therefore, will be recorded if and when it becomes probable that a milestone will be achieved, or when an option fee or royalties are incurred.

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 amount of approximately $50.0 million in cash. Under the terms of the Stock Purchase Agreement, Junshi Biosciences 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 the bevacizumab Licensed Product in the United States and Canada.

Under the Innovent Agreement, the Company paid Innovent $5.0 million upfront and committed to pay 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. 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 the 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, and during 2022 this research and development expense was immaterial. As of December 31, 2022, the Company did not have any outstanding milestone or royalty payment obligations to Innovent.

On May 3, 2022, the Company provided notice of termination of the Innovent Agreement to Innovent because regulatory approval of the licensed product could not be reasonably obtained within the agreed time period. In connection therewith, the Company has discontinued development of the bevacizumab Licensed Product.

Bioeq

On November 4, 2019, the Company entered into the Bioeq 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.

Bioeq will manufacture and supply the Bioeq Licensed Products to the Company in accordance with terms and conditions specified in the Bioeq Agreement and the Bioeq Manufacturing Agreement and will remain in force until the first to occur of the following: (1) the termination of the Bioeq Agreement; (2) the exercise of a right to termination by the Company or Bioeq for a material breach of the other party that is not cured in accordance with the Bioeq Manufacturing Agreement; and (3) the exercise of a right to termination by Bioeq if invoices are not paid in full in accordance with the Bioeq Manufacturing Agreement.

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 terms of the Bioeq Agreement include 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 including a €2.5 million milestone related to the FDA approval of the CIMERLI Section 351(k) BLA that was paid in 2022. This was recorded as an intangible asset and is being amortized over ten years. The Company shares 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. Royalties due to Bioeq were $2.9 million as of December 31, 2022. The remaining milestone payments are contingent upon future events and, therefore, will be recorded when it becomes probable that a milestone will be achieved.

Balance Sheet Components - Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Balance Sheet Components
Accrued manufacturing and clinical	$ 21,774	$ 30,541
Accrued co-development costs for toripalimab	8,356	1,926
Lease liabilities, current	15,649	12,168
Accrued other	4,318	3,492
Total Accrued and other current liabilities	$ 50,097	$ 48,127

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2022

Fair Value Measurements

Cash and cash equivalents, marketable securities and restricted cash


	December 31, 2022
(in thousands)	Cost		Unrealized Gain		Unrealized (Loss)		Fair Value
Money market funds	$	55,060	$	—	$	—	$	55,060
U.S. government agency securities		19,929		35		—		19,964
U.S. treasury securities		68,431		8		(21)		68,418
Commercial paper and corporate notes		48,203		—		—		48,203
Total	$	191,623	$	43	$	(21)	$	191,645

Revenue - Gross Revenues by Significant Customer as a Percentage of Total Gross Revenues (Details) - Net Product Revenue - Customer Concentration Risk	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
McKesson
Concentration Risk
Percentage of total gross revenue	38.00%	39.00%	38.00%
AmeriSource-Bergen Corp
Concentration Risk
Percentage of total gross revenue	44.00%	39.00%	37.00%
Cardinal
Concentration Risk
Percentage of total gross revenue	17.00%	20.00%	23.00%

Related Party Transactions

12 Months Ended

Dec. 31, 2022

Related Party Transactions

Related Party Transactions

14.	Related Party Transactions

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 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. There have been no subsequent material related party expenses. Total liabilities recognized in the consolidated balance sheets with respect to these services were immaterial as of December 31, 2022 and 2021.

Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands	2019 bonus payout in RSUs Common Stock	2019 bonus payout in RSUs Additional Paid-In Capital	2019 bonus payout in RSUs	Common Stock At The Market Offering.	Common Stock	Additional Paid-In Capital At The Market Offering.	Additional Paid-In Capital	Accumulated Other Comprehensive Loss Cumulative translation adjustment	Accumulated Other Comprehensive Loss	Accumulated Deficit	Cumulative translation adjustment	At The Market Offering.	Total
Beginning Balances at Dec. 31, 2019					$ 7		$ 1,000,763		$ (558)	$ (894,998)			$ 105,214
Beginning Balances (in shares) at Dec. 31, 2019					70,366,661
Net loss										132,244			132,244
Issuance of common stock upon exercise of stock options							17,061						17,061
Issuance of common stock upon exercise of stock options (in shares)					1,704,764
Issuance of common stock upon vesting of RSUs		$ 2,378	$ 2,378
Issuance of common stock upon vesting of RSUs (in shares)	134,099				89,668
Stock-based compensation expense							39,038						39,038
Issuance of common stock under the ESPP							3,801						3,801
Issuance of common stock under the ESPP (in shares)					267,772
Taxes paid related to net share settlement of RSUs							(880)						(880)
Taxes paid related to net share settlement of RSUs (in shares)					(49,616)
Purchase of capped call options related to convertible notes due 2026							18,170						18,170
Cumulative translation adjustment								$ 288			$ 288		288
Ending Balances at Dec. 31, 2020					$ 7		1,043,991		(270)	(762,754)			280,974
Ending Balances (in shares) at Dec. 31, 2020					72,513,348
Net loss										(287,100)			(287,100)
Issuance of common stock upon exercise of stock options							10,410						10,410
Issuance of common stock upon exercise of stock options (in shares)					1,316,361
Issuance of common stock upon vesting of RSUs (in shares)					465,930
Stock-based compensation expense							51,290						51,290
Issuance of common stock to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences"), net of issuance costs							40,903						40,903
Issuance of common stock to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences"), net of issuance costs (in shares)					2,491,988
Issuance of common stock under the ESPP							3,002						3,002
Issuance of common stock under the ESPP (in shares)					238,934
Stock Issued During Period Value New Issues							40,903						40,903
Taxes paid related to net share settlement of RSUs							(1,753)						(1,753)
Taxes paid related to net share settlement of RSUs (in shares)					(96,465)
Ending Balances at Dec. 31, 2021					$ 7		1,147,843		(270)	(1,049,854)			$ 97,726
Ending Balances (in shares) at Dec. 31, 2021					76,930,096								76,930,096
Net loss										(291,754)			$ (291,754)
Issuance of common stock upon exercise of stock options							691						691
Issuance of common stock upon exercise of stock options (in shares)					141,897
Issuance of common stock upon vesting of RSUs (in shares)					806,854
Stock-based compensation expense							51,188						51,188
Issuance of common stock under ATM Offering, net of issuance costs				$ 1		$ 6,133						$ 6,134
Issuance of common stock to Shanghai Junshi Biosciences Ltd. ("Junshi Biosciences"), net of issuance costs (in shares)				916,884								916,884
Issuance of common stock under the ESPP							2,320						2,320
Issuance of common stock under the ESPP (in shares)					347,883
Taxes paid related to net share settlement of RSUs							(3,744)						(3,744)
Taxes paid related to net share settlement of RSUs (in shares)					(292,098)
Other comprehensive gain (loss), net of tax									21				21
Cumulative translation adjustment													(1)
Ending Balances at Dec. 31, 2022					$ 8		$ 1,204,431		$ (249)	$ (1,341,608)			$ (137,418)
Ending Balances (in shares) at Dec. 31, 2022					78,851,516								78,851,516

Leases - Components of lease expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Leases
Amortization of right-of-use assets	$ 1,228	$ 707	$ 368
Interest on lease liabilities	166	82	57
Total finance lease cost	1,394	789	425
Operating lease cost	3,154	3,066	3,126
Total lease cost	$ 4,548	$ 3,855	$ 3,551

Leases - Other information related to lease term and discount rate (Details)	Dec. 31, 2022	Dec. 31, 2021
Leases
Operating lease weighted average remaining term	2 years 2 months 12 days	3 years 2 months 12 days
Finance lease weighted average remaining term	2 years 2 months 12 days	1 year 8 months 12 days
Operating lease Weighted average discount rate	8.00%	8.00%
Finance lease Weighted average discount rate	8.40%	5.80%

Organization and Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2022

Organization and Significant Accounting Policies

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 COVID-19 outbreaks 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, as the chief operating decision maker (“CODM”), manages and allocates resources to the operations of the Company on an entity-wide basis. Managing and allocating resources on an entity-wide basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions. Primarily, all revenue is generated and all long-lived assets are 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.

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:



(in thousands)	January 1,
At beginning of period:	2022		2021		2020
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

	December 31,
At end of period:	2022		2021		2020
Cash and cash equivalents	$	63,547	$	417,195	$	541,158
Restricted cash		440		440		440
Total cash, cash equivalents and restricted cash	$	63,987	$	417,635	$	541,598

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 in 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 U.S. Treasury securities, commercial paper, corporate debt obligations and short-term money market instruments. 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 limits its exposure to any single issuer, except for securities issued by the U.S. government. 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 regularly reviews its investments for declines in fair value below the amortized cost basis to determine whether the impairment, if any, is due to credit-related or other factors. This review includes the credit worthiness of the security issuers, the severity of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of the amortized cost basis. Unrealized gains and losses on available-for-sale debt 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 available-for-sale debt 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. There were no impairments related to credit losses during any of the periods presented. Realized gains and losses, if any, on available-for-sale securities are included in other income (expense), net, in the consolidated statements of operations based on the specific identification method. During 2022, 2021 and 2020, interest income from marketable securities was $1.9 million, $1.4 million and $0.6 million, respectively, and is included in other income (expense), net, in the consolidated statements of operations.

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 and was not material during the periods presented. The Company believes that its allowance for expected credit losses was adequate and immaterial as of December 31, 2022 and 2021.

Concentration of Risk

Concentrations of Risk

The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, investments in marketable securities and trade receivables. The Company attempts to minimize the risks related to cash, cash equivalents and marketable securities by 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. The Company 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.

Substantially all of the Company’s revenues are in the United States to three wholesalers. UDENYCA and CIMERLI were the only products sold by the Company during 2022. UDENYCA was the only product sold and accounted for all of the Company’s revenues in 2021 and 2020.

The Company enters into a strategic commercial supply agreement for each of its products. The Company currently has not engaged back-up suppliers or vendors. If any of the Company’s current vendors are 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.

Foreign Currency

Assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates for monetary assets and liabilities. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Translation gains and losses are included in accumulated other comprehensive loss in stockholders’ equity (deficit). Revenue and expense accounts are translated to U.S. dollars at average exchange rates in effect during the period with resulting transaction gains and losses recognized in other income (expense), net in the consolidated statements of operations. 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. During the third quarter of 2022, the Company recorded a $26.0 million write-down of inventory in cost of goods sold in the consolidated statements of operations due to the competitive environment and lower demand for UDENYCA resulting in certain inventory becoming at risk of expiration. For 2022, this increased the net loss by $26.0 million and basic and diluted net loss per share by $0.33.

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 product candidates, the Company incurred expenses for the manufacture of drug product that could potentially be available to support the commercial launch of the products. Inventory 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. Inventory in the consolidated balance sheets as of December 31, 2022 was related to UDENYCA, YUSIMRY and CIMERLI. The Company began to capitalize inventory costs associated with UDENYCA and CIMERLI after receiving final regulatory approval in November 2018 and August 2022, respectively, and capitalization of YUSIMRY inventory costs began in the second quarter of 2022 when sales were deemed probable.

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 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 fair value of net assets acquired in a business combination. Goodwill is not amortized but is evaluated for impairment on an annual basis, during the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s single reporting unit below its carrying amount. The Company’s goodwill balance was $0.9 million as of December 31, 2022 and 2021, and no goodwill impairment charges were recognized in 2022, 2021 or 2020.

Acquired in-process research and development (“IPR&D”) that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each IPR&D project, the Company will make a determination as to the then-useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. The Company evaluates IPR&D for impairment on an annual basis, during the fourth quarter, or more frequently if impairment indicators exist. The Company’s IPR&D balance was $2.6 million as of December 31, 2022 and 2021, and no IPR&D impairment charges were recognized in 2022, 2021 or 2020.

As of December 31, 2022, the Company had a $2.4 million definite-lived intangible asset, net related to a 2022 capitalized milestone payment under a license agreement. This is amortized on a straight-line basis over its estimated economic life of ten years and is reviewed periodically for impairment. Amortization expense is recorded as a component of cost of goods sold in the consolidated statements of operations and was immaterial in 2022.

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, 2022, 2021 and 2020.

Accrued Research and Development Expenses

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 Product Revenue, Product Sales Discounts and Allowances and Royalty Revenue

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 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 approximately 90 days from date of shipment and may be extended during the launch period of a new product.

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 all periods presented and is included in net revenue.

Cost of Goods Sold

Cost of goods sold consists primarily of third-party manufacturing, distribution, and certain overhead costs. Through March 31, 2021, a portion of the costs of producing UDENYCA sold was expensed as research and development before the FDA approval of UDENYCA and therefore is not reflected in cost of goods sold. All the inventory expensed prior to approval of UDENYCA was fully utilized by March 31, 2021; thus, the costs of producing UDENYCA are fully reflected in cost of goods sold beginning April 1, 2021.

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. Additionally, the Company shares 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.

In 2022, 2021 and 2020, cost of goods sold included inventory write-offs, net of $26.0 million, $5.1 million and $2.2 million, respectively.

Research and Development Expense

Research and development expense represents costs incurred to conduct research, such as the discovery and development of 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 collaborators, 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, analytical activities and pre-launch inventory manufactured prior to regulatory approval being obtained or deemed to be probable; 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.

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.

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 expense comprises 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 $10.5 million, $8.7 million and $3.8 million in 2022, 2021 and 2020, 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 when, 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 from prior years to change significantly in 2023.

Operating and Finance Leases

Operating and Finance Leases

The Company determines at an arrangement’s inception whether it is a lease. 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 accrued and 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 lease term.

The terms of vehicles leased under the Company’s fleet agreement (“Vehicle Lease Agreement”) are 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. Assets under finance leases are depreciated to operating expenses on a straight-line basis over the lease term.

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 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 13. 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 are recorded as an element of stockholders’ equity (deficit), but are excluded from net (loss) income. The Company’s other comprehensive (loss) income includes unrealized gain (loss) on available-for-sale securities and foreign currency translation adjustments in 2022, 2021 and 2020.

Reclassifications

Recent Accounting Pronouncements

The Company has reviewed 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.

Revenue - net revenue (Details) - USD ($) $ in Thousands	12 Months Ended
Revenue - net revenue (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Disaggregation of Revenue [Line Items]
Net revenue	$ 211,042	$ 326,551	$ 475,824
Total net product revenue
Disaggregation of Revenue [Line Items]
Net revenue	210,760	326,509	475,824
UDENYCA
Disaggregation of Revenue [Line Items]
Net revenue	203,814	326,509	$ 475,824
CIMERLI
Disaggregation of Revenue [Line Items]
Net revenue	6,946
Other
Disaggregation of Revenue [Line Items]
Net revenue	$ 282	$ 42

- Definition

Amount, including tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value-added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9038-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130545-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8906-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-Subparagraph (b)
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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-Topic 280
-SubTopic 10
-Section 50
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
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-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI https://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Debt Obligations - 2022 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Debt Instrument
Amortization of debt discount and debt issuance costs	$ 6,431	$ 4,257	$ 3,481
Total interest expense	32,474	22,959	21,166
8.2% Convertible Notes due 2022 \| Convertible Notes
Debt Instrument
Stated coupon interest	2,050	8,200	8,200
Amortization of debt discount and debt issuance costs	521	1,966	1,791
Total Interest expense	$ 2,571	$ 10,166	$ 9,991

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income Taxes

Components of Income (Loss) Before Income Taxes


	Year Ended December 31,
(in thousands)	2022		2021		2020
Domestic	$	(291,746)	$	(287,058)	$	133,615
Foreign		(8)		(42)		2,092
Total	$	(291,754)	$	(287,100)	$	135,707

Schedule of Provision For (Benefit From) Income Taxes


	Year Ended December 31,
(in thousands)	2022		2021		2020
Current:
Federal	$	—	$	—	$	—
State		—		—		3,463
Foreign		—		—		—
Subtotal	$	—	$	—	$	3,463

Deferred:
Federal	$	—	$	—	$	—
State		—		—		—
Foreign		—		—		—
Subtotal	$	—	$	—	$	—

Provision for income taxes	$	—	$	—	$	3,463

Reconciliation of Statutory U.S. Federal Rate


	Year Ended December 31,
	2022		2021		2020
Percent of pre-tax income:
United States federal statutory income tax rate	21.0	%	21.0	%	21.0	%
State taxes, net of federal benefit	1.7		2.6		2.0
Foreign rate differences	—		—		(0.3)
Permanent items	(0.1)		0.2		0.4
Research and development credit	1.8		2.6		(4.8)
Stock-based compensation costs	(2.3)		(1.2)		1.3
Other	—		—		(0.3)
Change in valuation allowance	(22.1)		(25.2)		(16.7)
Effective income tax rate	—	%	—	%	2.6	%

Components of Net Deferred Tax Assets


	December 31,
(in thousands)	2022		2021
Net operating loss carryforwards	$	131,423	$	117,793
Research and development credits		63,164		58,039
Depreciation and amortization		51,877		40,620
Stock-based compensation		32,561		30,565
Sales related accruals		23,864		17,299
Other accruals		19,717		11,798
Capitalized research and development		17,673		—
Gross deferred tax assets		340,279		276,114
Right-of-use asset		(1,903)		(2,167)
In-process research and development		(603)		(603)
Gross deferred tax liabilities		(2,506)		(2,770)
Total net deferred tax asset		337,773		273,344
Less valuation allowance		(337,773)		(273,344)
Net deferred tax assets	$	—	$	—

Reconciliation of Unrecognized Tax Benefits


	Year Ended December 31,
(in thousands)	2022		2021		2020
Balance at beginning of year	$	15,495	$	13,243	$	11,603
Additions based on tax positions related to current year		1,385		2,038		1,749
Additions (reductions) for tax positions of prior years		(42)		214		(109)
Balance at end of year	$	16,838	$	15,495	$	13,243

Organization and Significant Accounting Policies - Investments in Marketable Securities (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Organization and Significant Accounting Policies
Interest income from marketable securities	$ 1,900,000	$ 1,400,000	$ 600,000
Impairments related to credit losses	$ 0	$ 0	$ 0

Stock-Based Compensation and Employee Benefits - Restricted Stock Units narrative (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended	12 Months Ended
	Feb. 28, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock-based compensation expense	$ 800	$ 50,737	$ 51,364	$ 38,160
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition		2 years 8 months 12 days
Restricted Stock Units
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total fair value of RSUs vested		$ 13,600	8,400	4,100
Total estimated grant date fair value		$ 22,500	$ 27,900	$ 21,200
Estimated weighted-average grant-date fair value of RSUs granted		$ 13.34	$ 16.86	$ 17.86
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition		1 year 6 months
Restricted Stock Units \| Minimum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Vesting period		1 year
Restricted Stock Units \| Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Vesting period		3 years

Organization and Significant Accounting Policies - Property and Equipment (Details)	12 Months Ended
	Dec. 31, 2022
Furniture and Fixtures
Property and Equipment, Net
Estimated useful lives	5 years
Machinery and Equipment
Property and Equipment, Net
Estimated useful lives	5 years
Leasehold Improvements
Property and Equipment, Net
Estimated useful lives, description	Shorter of lease term or useful life
Maximum \| Computer Equipment and Software
Property and Equipment, Net
Estimated useful lives	7 years
Minimum \| Computer Equipment and Software
Property and Equipment, Net
Estimated useful lives	3 years

Stock-Based Compensation and Employee Benefits

12 Months Ended

Dec. 31, 2022

Stock-Based Compensation and Employee Benefits

Stock-Based Compensation and Employee Benefits

11.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, 2022. There were 1,252,865 shares of common stock available for future issuance as of December 31, 2022 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, 2022, the Company had 861,312 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 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 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
				Weighted-
				Average	Aggregate
		Weighted-		Remaining	Intrinsic
	Number of	Average		Contractual Terms	Value
	Options	Exercise Price		(Years)	(in thousands)
Outstanding at December 31, 2021	19,959,815	$	15.89
Granted - at fair value	4,685,750	$	12.09
Exercised	(141,897)	$	4.88
Forfeited/Canceled	(2,812,347)	$	16.97
Outstanding at December 31, 2022	21,691,321	$	15.00	6.0	$	10,714
Exercisable at December 31, 2022	15,027,783	$	15.47	4.8	$	9,647

Aggregate intrinsic value represents the value of the Company’s closing stock price on the last trading day of the year in excess of the exercise price multiplied by the number of options outstanding or exercisable.

Information on options outstanding and exercisable as of December 31, 2022 is summarized as follows:


					Options Outstanding				Options Exercisable
						Weighted-
						Average	Weighted-			Weighted-
						Remaining	Average			Average
					Number	Contractual Terms	Exercise		Number	Exercise
Range of Exercise Prices					Outstanding	(Years)	Price		Exercisable	Price
$	1.42	-	$	10.05	4,801,972	5.2	$	6.64	3,223,663	$	5.99
$	10.78	-	$	14.13	4,598,418	6.4	$	12.72	3,381,021	$	12.67
$	14.30	-	$	17.17	4,857,557	7.2	$	15.91	2,530,714	$	16.08
$	17.30	-	$	19.07	4,406,311	6.9	$	17.93	3,000,465	$	17.94
$	19.19	-	$	36.85	3,027,063	3.4	$	25.98	2,891,920	$	26.22
					21,691,321	6.0	$	15.00	15,027,783	$	15.47

The intrinsic value is defined as the difference between the current market value and the exercise price. Additional information on options is summarized as follows:


	Year Ended December 31,
(in thousands, except weighted-average grant date fair values)	2022		2021		2020
Total intrinsic value of options exercised	$	914	$	9,726	$	14,572
Total grant date fair value of options vested	$	34,916	$	40,365	$	34,090
Weighted-average grant date fair value of options granted	$	7.04	$	9.80	$	10.94

As of December 31, 2022, total unrecognized stock-based compensation expense related to unvested stock options was $51.5 million, which is expected to be recognized over a weighted-average period of 2.7 years.

Restricted Stock Units

The Company grants RSUs primarily to its employees. RSUs are share awards that entitle the holder to receive freely tradable shares of the Company’s 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 the Company’s common stock on the grant date.

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, 2021	1,843,732	$	17.00
RSUs granted	1,686,875	$	13.34
RSUs vested	(806,854)	$	16.85
RSUs canceled	(390,446)	$	15.43
Balances at December 31, 2022	2,333,307	$	14.66

The total grant-date fair value of RSUs that vested during 2022, 2021 and 2020 was $13.6 million, $8.4 million and $4.1 million, respectively. The total grant-date fair value of RSUs granted was $22.5 million, $27.9 million and $21.2 million during 2022, 2021 and 2020, respectively. The estimated weighted-average grant-date fair value per share of RSUs granted during 2022, 2021 and 2020 was $13.34, $16.86 and $17.86, respectively.

As of December 31, 2022, total unrecognized stock-based compensation expense related to unvested RSUs was $20.3 million, which is expected to be recognized over a weighted-average period of 1.5 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 3,172,117 shares of common stock available for future issuance as of December 31, 2022. 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. As of December 31, 2022, there was $0.7 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

The following table summarizes the classification of stock-based compensation expense in the Company’s consolidated financial statements related to options and RSUs granted to employees and nonemployees:



	Year Ended December 31,
(in thousands)	2022		2021		2020
Cost of goods sold ⁽¹⁾	$	736	$	1,099	$	583
Research and development		18,999		18,688		13,837
Selling, general and administrative		31,002		31,577		23,740
Stock-based compensation expense	$	50,737	$	51,364	$	38,160

Stock-based compensation expense capitalized into inventory	$	1,187	$	1,025	$	1,460

(1)	Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold.

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, 2022, 2021 and 2020:


	Year Ended December 31,
	2022		2021		2020
Expected term (years)
Stock options	6.1		6.1		6.1
ESPP	0.5		0.5		0.5
Expected volatility
Stock options	62	%	65	%	68	%
ESPP	70	%	42	%	58	%
Risk-free interest rate
Stock options	2.37	%	0.89	%	1.09	%
ESPP	3.77	%	0.06	%	0.13	%
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 had limited historical information to develop expectations about future exercise patterns and post-vesting employment termination behavior. Since January 1, 2021, the Company has used historical data to calculate the expected term.

Expected Volatility: The expected volatility is calculated based on the Company’s daily stock closing prices for a period equal to the expected life of the award.

Risk-Free Interest Rate: The risk-free interest rate is based on the United States Treasury constant maturity rate at the time of grant using a term equal to the expected life.

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, 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 $2.1 million, $1.7 million and $0.8 million in 2022, 2021 and 2020, respectively.

Fair Value Measurements

12 Months Ended

Dec. 31, 2022

Fair Value Measurements

Fair Value Measurements

3.Fair Value Measurements

The fair value of financial instruments are classified into one of the following categories based upon the lowest level of input that is significant to the fair value measurement:

●

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.

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.

Financial assets measured at fair value on a recurring basis are summarized as follows:


	Fair Value Measurements
	December 31, 2022
(in thousands)	Level 1		Level 2		Level 3		Total
Financial Assets:
Money market funds	$	55,060	$	—	$	—	$	55,060
Marketable debt securities:
U.S. government agency securities		19,964		—		—		19,964
U.S. treasury securities		68,418		—		—		68,418
Commercial paper and corporate notes		—		48,203		—		48,203
Total	$	143,442	$	48,203	$	—	$	191,645

The financial assets at December 31, 2021 consisted of money market funds and were classified as Level 1.

The cost, unrealized gains or losses, and fair value by investment type are summarized as follows:


	December 31, 2022
(in thousands)	Cost		Unrealized Gain		Unrealized (Loss)		Fair Value
Money market funds	$	55,060	$	—	$	—	$	55,060
U.S. government agency securities		19,929		35		—		19,964
U.S. treasury securities		68,431		8		(21)		68,418
Commercial paper and corporate notes		48,203		—		—		48,203
Total	$	191,623	$	43	$	(21)	$	191,645

The Company held 13 positions that were in unrealized loss positions as of December 31, 2022, and aggregated gross unrealized losses on available-for-sale debt securities were not material. No impairment was recognized in 2022. Excluding restricted cash and as of December 31, 2022, the remaining contractual maturities of available-for-sale securities were less than one year, and the average maturity of investments upon acquisition was approximately 7 months. The accrued interest receivable on available-for-sale marketable securities was immaterial at December 31, 2022, and is included in other prepaids and current assets.

There were no investments in marketable securities as of December 31, 2021; thus, no unrealized gain (loss) was recognized as of December 31, 2021.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Net (Loss) Income Per Share - Computation of Basic and Diluted Net Income Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Numerator:
Net (loss) income	$ (291,754)	$ (287,100)	$ 132,244
Denominator:
Weighted-average common shares outstanding - Basic	77,630,020	75,449,632	71,411,705
Weighted-average common shares outstanding - Diluted	77,630,020	75,449,632	83,491,898
Basic net (loss) income per share	$ (3.76)	$ (3.81)	$ 1.85
Diluted net (loss) income per share	$ (3.76)	$ (3.81)	$ 1.62
Numerator:
Add interest expense on 2026 Convertible Notes, net of tax			$ 3,307
Numerator for diluted net (loss) income per share	$ (291,754)	$ (287,100)	$ 135,551
Add effect of potential dilutive securities:
Stock options, including shares subject to ESPP			3,455,646
Restricted stock units			167,597
Shares issuable upon conversion of convertible notes			8,456,950
Denominator for diluted net (loss) income per share	77,630,020	75,449,632	83,491,898

At The Market Offering

12 Months Ended

Dec. 31, 2022

At-The-Market Offering

At The Market Offering

10.At-The-Market Offering

On November 8, 2022, the Company filed a Registration Statement on Form S-3, which was declared effective on November 17, 2022. Under the Registration Statement, the Company may offer and sell up to $150.0 million in the aggregate of its common stock, preferred stock, debt securities, warrants and units from time to time in one or more offerings. Also on November 8, 2022, the Company entered into a Sales Agreement with Cowen, pursuant to which the Company may issue and sell from time to time up to $150.0 million of its common stock through or to Cowen as the Company’s sales agent or principal in the ATM Offering. As of December 31, 2022, the Company sold 916,884 shares of common stock at a weighted-average price per share of $7.30 for gross proceeds of $6.7 million pursuant to the ATM Offering and received net proceeds of $6.5 million, net of $0.2 million of commissions and fees. In January 2023, the Company settled an additional 295,200 shares at a weighted-average price per share of $7.41 for gross proceeds of $2.2 million pursuant to the ATM Offering and received net proceeds of $2.1 million, net of $0.1 million of commissions and fees.

Income Taxes - Components of Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Components of income (loss) before income taxes
Domestic	$ (291,746)	$ (287,058)	$ 133,615
Foreign	(8)	(42)	2,092
(Loss) income before income taxes	$ (291,754)	$ (287,100)	$ 135,707

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8906-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 940
-SubTopic 20
-Section 25
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=126941158&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI https://asc.fasb.org/extlink&oid=126953954&loc=SL114868664-224227

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-Name Accounting Standards Codification
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-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
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Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
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-Section 50
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Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-URI https://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

Debt Obligations - 2027 Term Loan - Narrative (Details) $ in Thousands	1 Months Ended		3 Months Ended	12 Months Ended
	Mar. 31, 2022 USD ($)	Jan. 31, 2022 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2022 USD ($)	Sep. 14, 2022 USD ($)	Jan. 05, 2022 USD ($) tranche	Apr. 30, 2020 USD ($)	Feb. 29, 2016 USD ($)
Debt Instrument [Line Items]
Outstanding amount paid off				$ 81,750
Outstanding amount payoff				$ 109,000
2027 Term Loans
Debt Instrument [Line Items]
Debt Instrument, Interest Rate During Period			12.00%
2027 Term Loans \| Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member]
Debt Instrument [Line Items]
Spread on variable rate				1.00%
Debt Instrument, Interest Rate During Period				0.26161%
2027 Term Loans \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Principal amount						$ 300,000
Number of tranches \| tranche						4
Net carrying value			$ 245,483	$ 245,483
Loan agreement covenants, minimum trailing twelve month net sales for current quarter		$ 200,000
Loan agreement covenants, minimum trailing twelve month net sales for the quarter ended March 30, 2024		210,000
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended June 30, 2024		230,000
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended September 30, 2024		270,000
Loan agreement covenants, minimum trailing twelve-month net sales for the quarter ended December 31, 2024 and thereafter		$ 300,000
Mandatory prepayment term		10 days
Debt discounts and issuance costs		$ 6,800
Remaining unamortized debt discount and debt offering costs			$ 4,517	$ 4,517
2027 Term Loans \| BioPharma Credit Investments V GP LLC \| Three-month LIBOR
Debt Instrument [Line Items]
Spread on variable rate		1.00%
2027 Term Loans \| Additional facility amount \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Uncommitted additional facility		$ 100,000
2027 Term Loans \| Through March 31, 2023 \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Stated interest rate		8.25%
2027 Term Loans \| Starting April 1, 2023
Debt Instrument [Line Items]
Stated interest rate			8.25%	8.25%
Tranche A Loan, funded January 5, 2022 \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Principal amount						$ 100,000
Debt discounts and issuance costs		$ 7,800
Tranche B Loan, funded no later than April 1, 2022 \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Principal amount	$ 100,000
Debt discounts and issuance costs	2,300
Convertible notes, Issuance Cost	1,000
Tranche C Loan, funded between April 1, 2022 and March 17, 2023 \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Amount not funded		50,000
Tranche D Loan, funded on September 14, 2022 \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Principal amount					$ 50,000
Convertible notes, Issuance Cost					$ 500
1.5% Convertible Senior Subordinated Notes due 2026 \| Convertible Notes
Debt Instrument [Line Items]
Principal amount							$ 230,000
Net carrying value			$ 225,575	$ 225,575
Stated interest rate							1.50%
Remaining unamortized debt discount and debt offering costs			$ 4,425	$ 4,425
Total term of the loan				3 years 3 months 18 days
Effective interest rate			2.10%	2.10%
1.5% Convertible Senior Subordinated Notes due 2026 \| BioPharma Credit Investments V GP LLC \| Scenario, Plan \| Maximum
Debt Instrument [Line Items]
Principal amount		50,000
8.2% Convertible Notes due 2022 \| Convertible Notes
Debt Instrument [Line Items]
Principal amount								$ 100,000
Stated interest rate								8.20%
Outstanding amount payoff	$ 111,100
Convertible notes, Issuance Cost								$ 800
2025 Term Loan
Debt Instrument [Line Items]
Net carrying value			$ 0	$ 0
2025 Term Loan \| Convertible Notes
Debt Instrument [Line Items]
Outstanding amount paid off		$ 81,900
Tranche A and B Loans \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Remaining unamortized debt discount and debt offering costs			$ 4,500	$ 4,500
Tranches A, B and D \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Remaining term				4 years

Net (Loss) Income Per Share (Tables)

12 Months Ended

Dec. 31, 2022

Net (Loss) Income Per Share

Computation of Basic and Diluted Net (loss) Income Per Share


	Year Ended December 31,
(in thousands, except share and per share data)	2022		2021		2020
Basic net (loss) income per share
Numerator:
Net (loss) income	$	(291,754)	$	(287,100)	$	132,244
Denominator:
Weighted-average common shares outstanding		77,630,020		75,449,632		71,411,705
Basic net (loss) income per share	$	(3.76)	$	(3.81)	$	1.85

Diluted net (loss) income per share
Numerator:
Net (loss) income	$	(291,754)	$	(287,100)	$	132,244
Add interest expense on 2026 Convertible Notes, net of tax		—		—		3,307
Numerator for diluted net (loss) income per share		(291,754)		(287,100)		135,551
Denominator:
Denominator for basic net (loss) income per share		77,630,020		75,449,632		71,411,705
Add effect of potential dilutive securities:
Stock options, including shares subject to ESPP		—		—		3,455,646
Restricted stock units		—		—		167,597
Shares issuable upon conversion of convertible notes		—		—		8,456,950
Denominator for diluted net (loss) income per share		77,630,020		75,449,632		83,491,898
Diluted net (loss) income per share	$	(3.76)	$	(3.81)	$	1.62

Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net (loss) Income Per Share

The 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,
	2022	2021	2020
Stock options, including shares subject to ESPP	22,214,875	19,895,097	9,521,403
Restricted stock units	2,399,465	1,811,607	7,689
Shares issuable upon conversion of 2022 Convertible Notes	1,078,632	4,473,871	4,473,871
Shares issuable upon conversion of 2026 Convertible Notes	11,942,152	11,942,152	—
Total	37,635,124	38,122,727	14,002,963

Stock-Based Compensation and Employee Benefits - Stock Options Narrative (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
	Feb. 28, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock-based compensation expense	$ 800	$ 50,737	$ 51,364	$ 38,160
Unrecognized stock-based compensation expenses related to stock options		$ 51,500
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition		2 years 8 months 12 days
Employee Stock Option
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Vesting period		4 years
Options, expiration period		10 years
Restricted Stock Units
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Unrecognized stock-based compensation expenses related to stock options		$ 20,300
Unrecognized share-based compensation related to stock options, RSUs and ESPP, period for recognition		1 year 6 months

Stock-Based Compensation and Employee Benefits - Additional Information Related to Status of Options (Details) - 2016 plan and 2014 plan - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total intrinsic value of options exercised	$ 914	$ 9,726	$ 14,572
Total grant date fair value of options vested	$ 34,916	$ 40,365	$ 34,090
Weighted-average grant date fair value of options granted	$ 7.04	$ 9.80	$ 10.94

Stock Based Compensation and Employee Benefits - Options outstanding and exercisable (Details) - 2016 plan and 2014 plan - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Options outstanding, Number of Options	21,691,321	19,959,815
Options outstanding, Weighted-Average Remaining Contractual Terms	6 years
Options outstanding, Weighted-Average Exercise Price	$ 15.00	$ 15.89
Number of Options, Exercisable	15,027,783
Weighted Average Exercise Price, Exercisable	$ 15.47
1.42 - 10.05
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Exercise price range, Lower	1.42
Exercise price range, Upper	$ 10.05
Options outstanding, Number of Options	4,801,972
Options outstanding, Weighted-Average Remaining Contractual Terms	5 years 2 months 12 days
Options outstanding, Weighted-Average Exercise Price	$ 6.64
Number of Options, Exercisable	3,223,663
Weighted Average Exercise Price, Exercisable	$ 5.99
10.78 - 14.13
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Exercise price range, Lower	10.78
Exercise price range, Upper	$ 14.13
Options outstanding, Number of Options	4,598,418
Options outstanding, Weighted-Average Remaining Contractual Terms	6 years 4 months 24 days
Options outstanding, Weighted-Average Exercise Price	$ 12.72
Number of Options, Exercisable	3,381,021
Weighted Average Exercise Price, Exercisable	$ 12.67
14.30 - 17.17
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Exercise price range, Lower	14.30
Exercise price range, Upper	$ 17.17
Options outstanding, Number of Options	4,857,557
Options outstanding, Weighted-Average Remaining Contractual Terms	7 years 2 months 12 days
Options outstanding, Weighted-Average Exercise Price	$ 15.91
Number of Options, Exercisable	2,530,714
Weighted Average Exercise Price, Exercisable	$ 16.08
17.30 - 19.07
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Exercise price range, Lower	17.30
Exercise price range, Upper	$ 19.07
Options outstanding, Number of Options	4,406,311
Options outstanding, Weighted-Average Remaining Contractual Terms	6 years 10 months 24 days
Options outstanding, Weighted-Average Exercise Price	$ 17.93
Number of Options, Exercisable	3,000,465
Weighted Average Exercise Price, Exercisable	$ 17.94
19.19 to 36.85
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Exercise price range, Lower	19.19
Exercise price range, Upper	$ 36.85
Options outstanding, Number of Options	3,027,063
Options outstanding, Weighted-Average Remaining Contractual Terms	3 years 4 months 24 days
Options outstanding, Weighted-Average Exercise Price	$ 25.98
Number of Options, Exercisable	2,891,920
Weighted Average Exercise Price, Exercisable	$ 26.22

Organization and Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Organization and Significant Accounting Policies
Cash and cash equivalents	$ 63,547	$ 417,195	$ 541,158	$ 177,668
Restricted cash, non-current	440	440	440	240
Total cash, cash equivalents and restricted cash	$ 63,987	$ 417,635	$ 541,598	$ 177,908

Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions		1 Months Ended
	Jul. 01, 2019	Apr. 30, 2022	Dec. 31, 2022
Contractual Obligation Fiscal Year Maturity [Abstract]
Royalty payment term	5 years
Claims related to certain sales of UDENYCA from October 2020 through December 2021		$ 14.0
Established a litigation accrual			$ 4.7

Leases - Additional Information (Details) $ in Thousands	12 Months Ended
Leases - Additional Information (Details) $ in Thousands	Dec. 31, 2022 USD ($) ft²	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)	Dec. 31, 2019 item
Lessee Lease Description
Term of leases	36 months
Operating lease costs \| $	$ 4,548	$ 3,855	$ 3,551
Cash paid for amounts included in measurement of lease liabilities \| $	$ 3,401	$ 3,435	$ 3,217
Operating lease weighted average remaining term	2 years 2 months 12 days	3 years 2 months 12 days
Operating lease Weighted average discount rate	8.00%	8.00%
Finance lease weighted average remaining term	2 years 2 months 12 days	1 year 8 months 12 days
Finance lease Weighted average discount rate	8.40%	5.80%
Corporate Headquarters Lease
Lessee Lease Description
Area of office space leased \| ft²	47,789
Lease Expiration Date	Sep. 01, 2024
Option to extend lease	true
Term of optional lease renewal	5 years
Laboratory Facilities Lease
Lessee Lease Description
Area of office space leased \| ft²	25,017
Term of optional lease renewal	5 years
New Camarillo Lease
Lessee Lease Description
Lease Expiration Date	May 01, 2027
Option to extend lease	true
Vehicle Lease
Lessee Lease Description
Number of vehicles leased \| item				100
Term of leases				36 months

Commitments and Contingencies (Tables)

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies.

Schedule of Non-cancelable Contractual Obligations


Year ending December 31, (in thousands)
2023	$	53,652
2024		13,724
2025		1,128
2026		260
Total obligations	$	68,764

Leases - Schedule of Maturities of Operating and Finance Lease Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Operating leases
2023	$ 3,560
2024	3,014
2025	412
2026	292
2027 and thereafter	124
Total lease payments	7,402
Less imputed interest	(647)
Total operating lease liabilities	6,755	$ 9,504
Finance leases
2023	1,354
2024	1,026
2025	481
Total lease payments	2,861
Less imputed interest	(252)
Total finance lease liabilities	$ 2,609	$ 1,239

Inventory - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Inventory [Line Items]
Inventory write-offs, net	$ 26,000	$ 26,000	$ 5,133	$ 2,171
Estimate increased the net loss, amount		$ 26,000
Estimated net loss per share (basic and diluted)		$ 0.33
Prepayment made for manufacturing services		$ 17,880	13,666
Inventory		38,791	37,642
Impairment charge within research and development expenses			3,210
Impairment charge for the write-off of prepaid manufacturing services no longer deemed to have future benefits			3,200
Research and development		199,358	363,105	$ 142,759
Prepayments made to a CMO for manufacturing services for UDENYCA		13,000	8,300
Prepayments made to a CMO For Other Research And Development Pipeline Program		4,900	5,400
Yusimry Product [Member]
Inventory [Line Items]
Inventory		$ 23,700
CHS-2020
Inventory [Line Items]
Research and development			$ 11,200

Balance Sheet Components

12 Months Ended

Dec. 31, 2022

Balance Sheet Components

Balance Sheet Components

5.Balance Sheet Components

Property and Equipment, Net

Property and equipment, net consisted of the following:


	December 31,
(in thousands)	2022		2021
Machinery and equipment	$	12,944	$	11,876
Computer equipment and software		3,183		3,033
Furniture and fixtures		1,258		1,129
Leasehold improvements		6,198		5,942
Finance lease right of use assets		4,632		2,294
Construction in progress		696		388
Total property and equipment		28,911		24,662
Accumulated depreciation and amortization		(20,157)		(16,849)
Property and equipment, net	$	8,754	$	7,813

Depreciation and amortization expense related to property and equipment, net was $3.6 million, $3.5 million, and $2.9 million in 2022, 2021 and 2020, respectively. There were no material impairments of property and equipment in 2022, 2021 and 2020.

As of December 31, 2022 and 2021, the net book value of software implementation costs related to hosting arrangements was $3.5 million and $1.3 million, respectively, and the amortization expense was immaterial for all periods presented.

Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following:


	December 31,
(in thousands)	2022		2021
Accrued commercial and research and development manufacturing	$	21,774	$	30,541
Accrued co-development costs payable to Junshi Biosciences		8,356		1,926
Lease liabilities, current		4,318		3,492
Accrued other		15,649		12,168
Total Accrued and other current liabilities	$	50,097	$	48,127

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Operating activities
Net (loss) income	$ (291,754)	$ (287,100)	$ 132,244
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:
Depreciation and amortization	3,699	3,454	2,888
Stock-based compensation expense	50,737	51,364	38,160
Write-off of prepaid manufacturing services related to the termination of CHS-2020		3,210
Inventory write-offs, net	26,000	5,133	2,171
Non-cash interest expense from amortization of debt discount & issuance costs	6,431	4,257	3,481
Upfront and option payments to Junshi Biosciences	35,000	136,000
Other upfront and milestone based license fee payments			7,500
Loss on debt extinguishment	6,222
Other non-cash adjustments, net	1,798	3,890	2,352
Changes in operating assets and liabilities:
Trade receivables, net	13,052	34,062	(15,218)
Inventory	(47,348)	(6,253)	(38,359)
Prepaid manufacturing	(4,214)	3,828	(10,851)
Other prepaid, current and non-current assets	(13,424)	(5,351)	(2,020)
Accounts payable	(4,548)	874	(9,820)
Accrued rebates, fees and reserves	(24,566)	(2,502)	30,409
Accrued compensation	596	(230)	6,212
Accrued and other current and non-current liabilities	1,195	17,932	4,996
Net cash (used in) provided by operating activities	(241,124)	(37,432)	154,145
Investing activities
Purchases of property and equipment	(2,039)	(1,289)	(7,231)
Proceeds from disposal of property and equipment			175
Purchases of investments in marketable securities	(127,382)	(182,485)	(273,845)
Proceeds from maturities of investments in marketable securities		99,692	274,000
Proceeds from sale of investments in marketable securities		81,672
Upfront and option payments to Junshi Biosciences	(35,000)	(136,000)
Other upfront and milestone based license fee payments	(2,429)		(7,500)
Net cash used in investing activities	(166,850)	(138,410)	(14,401)
Financing activities
Proceeds from issuance of 2026 Convertible Notes, net of issuance costs			222,156
Proceeds from 2027 Term Loans, net of debt discount & issuance costs	240,679
Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs		40,903
Proceeds from issuance of common stock under ATM Offering, net of issuance costs	6,358
Proceeds from issuance of common stock upon exercise of stock options	691	10,399	17,428
Proceeds from purchase under the employee stock purchase plan	2,320	3,002	3,801
Purchase of capped call options related to 2026 Convertible Notes			(18,170)
Taxes paid related to net share settlement of RSUs	(3,744)	(1,753)	(880)
Repayment of 2022 Convertible Notes and premiums	(109,000)
Repayment of 2025 Term Loan, premiums and exit fees	(81,750)
Other financing activities	(1,228)	(672)	(389)
Net cash provided by financing activities	54,326	51,879	223,946
Net (decrease) increase in cash, cash equivalents and restricted cash	(353,648)	(123,963)	363,690
Cash, cash equivalents and restricted cash at beginning of period	417,635	541,598	177,908
Cash, cash equivalents and restricted cash at end of period	63,987	417,635	541,598
Supplemental disclosure of cash flow information
Cash paid for interest	34,878	18,684	16,959
Cash paid for income taxes	40	1,221	3,953
Right-of-use assets obtained in exchange for lease obligations related to operating leases		434	1,388
Right-of-use assets obtained in exchange for lease obligations related to finance leases	2,694	477	1,817
Supplemental disclosures of non-cash investing and financing activities
Purchase of property and equipment in accounts payable and accrued liabilities	$ 32	$ 119	109
Non-cash employee bonuses settled in common stock			$ 1,498

Organization and Significant Accounting Policies - Inventory (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Organization and Significant Accounting Policies
Inventory write-offs, net	$ 26,000	$ 26,000	$ 5,133	$ 2,171
Estimate increased the net loss, amount		$ 26,000
Estimated net loss per share (basic and diluted)		$ 0.33

Consolidated Balance Sheets (Parentheticals) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Consolidated Balance Sheets
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	300,000,000	300,000,000
Common stock, shares issued	78,851,516	76,930,096
Common stock, shares outstanding	78,851,516	76,930,096

Net (Loss) Income Per Share - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net (loss) Income Per Share (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Antidilutive securities excluded from computation of EPS
Antidilutive securities excluded from the calculation of diluted net (loss) income per share	37,635,124	38,122,727	14,002,963
Stock options, including shares subject to ESPP
Antidilutive securities excluded from computation of EPS
Antidilutive securities excluded from the calculation of diluted net (loss) income per share	22,214,875	19,895,097	9,521,403
Restricted Stock Units
Antidilutive securities excluded from computation of EPS
Antidilutive securities excluded from the calculation of diluted net (loss) income per share	2,399,465	1,811,607	7,689
8.2% Convertible Notes due 2022 \| Shares Issuable Upon Conversion of Convertible Notes
Antidilutive securities excluded from computation of EPS
Antidilutive securities excluded from the calculation of diluted net (loss) income per share	1,078,632	4,473,871	4,473,871
1.5% Convertible Senior Subordinated Notes due 2026 \| Shares Issuable Upon Conversion of Convertible Notes
Antidilutive securities excluded from computation of EPS
Antidilutive securities excluded from the calculation of diluted net (loss) income per share	11,942,152	11,942,152

Subsequent Events

12 Months Ended

Dec. 31, 2022

Subsequent Events

Subsequent Events

15.	Subsequent Events

On January 9, 2023, the Company announced that it entered into the Term Sheet with Klinge Biopharma for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States. The parties to the Term Sheet expect to execute the Definitive Agreements contemplated by the Term Sheet and complete the transaction in the first half of 2023. Under the Term Sheet, the Company will make a total upfront payment of approximately €30 million, comprised of cash and the Company’s common stock, thirty days after the execution of the Definitive Agreements. The Company has also agreed to make other regulatory and launch milestone payments and to make royalty payments based on approximately equal sharing of profits from the sale of FYB203 in consideration for the commercialization rights to FYB203 in the United States.

The material terms of the transaction with Klinge Biopharma will be set forth in the Definitive Agreements, which will be included in a subsequent filing by the Company when such Definitive Agreements are executed.

Organization and Significant Accounting Policies - Cost of Goods Sold (Details) - USD ($) $ in Thousands				3 Months Ended	12 Months Ended
	Nov. 04, 2019	Jul. 01, 2019	May 02, 2019	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Cost of Goods Sold
Royalty payment term		5 years
Inventory write-offs, net				$ 26,000	$ 26,000	$ 5,133	$ 2,171
Bioeq IP AG
Cost of Goods Sold
Percentage of gross profits shared	50.00%		50.00%

Revenue

12 Months Ended

Dec. 31, 2022

Revenue

Revenue

2.Revenue

The Company initiated sales in the United States of CIMERLI on October 3, 2022. The Company’s net revenue was as follows:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Products
UDENYCA	$	203,814	$	326,509	$	475,824
CIMERLI		6,946		—		—
Total net product revenue		210,760		326,509		475,824
Other		282		42		—
Total net revenue	$	211,042	$	326,551	$	475,824

Revenue by significant Customer was as follows:


	Year Ended December 31,
	2022		2021		2020
McKesson Corporation	38	%	39	%	38	%
AmeriSource-Bergen Corporation	44	%	39	%	37	%
Cardinal Health, Inc.	17	%	20	%	23	%

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, 2022
	Chargebacks				Other Fees,
	and Discounts				Co-pay
	for Prompt				Assistance
(in thousands)	Payment		Rebates		and Returns		Total
Balances at December 31, 2021	$	29,665	$	54,004	$	26,054	$	109,723
Provision related to sales made in:
Current period		436,865		68,399		73,435		578,699
Prior period		(2,090)		(1,050)		32		(3,108)
Payments and customer credits issued		(421,763)		(82,640)		(80,408)		(584,811)
Balances at December 31, 2022	$	42,677	$	38,713	$	19,113	$	100,503


	Year Ended December 31, 2021
	Chargebacks				Other Fees,
	and Discounts				Co-pay
	for Prompt				Assistance
(in thousands)	Payment		Rebates		and Returns		Total
Balances 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)
Balances at December 31, 2021	$	29,665	$	54,004	$	26,054	$	109,723

	Year Ended December 31, 2020
Balances 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)
Balances 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 and other liabilities, non-current in the accompanying consolidated balance sheets.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/topic&trid=49130388

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+ Details

Fair Value Measurements - Additional Information (Details)	12 Months Ended
	Dec. 31, 2022 USD ($) position	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)
Fair Value Measurements
Long lived assets, material impairments	$ 0	$ 0	$ 0
Positions that were in unrealized loss positions \| position	13
Remaining contractual maturities of available-for-sale securities	1 year
Average maturity of investments upon acquisition	7 months
Investments in marketable securities		0
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount	$ 0
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount	0
Fair Value, Liabilities, Level 1 to Level 2 Transfers, Amount	0
Fair Value, Liabilities, Level 2 to Level 1 Transfers, Amount	0
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Asset, Transfers, Net	0
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Transfers, Net	$ 0
Unrealized Gain (Loss) on Securities		$ 0

Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2022	Feb. 28, 2023	Jun. 30, 2022
Cover [Abstract]
Document Type	10-K
Document Annual Report	true
Document Transition Report	false
Document Period End Date	Dec. 31, 2022
Documents Incorporated by Reference	Part III incorporates by reference certain information from the registrant’s definitive proxy statement for the 2023 Annual Meeting of Stockholders.
Entity File Number	001-36721
Entity Registrant Name	Coherus BioSciences, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	27-3615821
Entity Address, Address Line One	333 Twin Dolphin Drive
Entity Address, Address Line Two	Suite 600
Entity Address, City or Town	Redwood City
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94065
City Area Code	650
Local Phone Number	649 - 3530
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	CHRS
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Accelerated Filer
ICFR Auditor Attestation Flag	true
Auditor Name	Ernst & Young LLP
Auditor Firm ID	42
Auditor Location	San Mateo, California
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		79,609,789
Entity Public Float			$ 443,562,973
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	FY
Entity Central Index Key	0001512762
Amendment Flag	false

Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Balance Sheet Components
Depreciation and amortization expense related to property and equipment	$ 3,600	$ 3,500	$ 2,900
Material impairments of property and equipment	0	0	$ 0
Software implementation costs	$ 3,500	$ 1,300

Related Party Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended	12 Months Ended
	Feb. 28, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Related Party Transaction
Stock-based compensation expense	$ 800	$ 50,737	$ 51,364	$ 38,160
Consulting Agreement With Lanfear Advisors
Related Party Transaction
Number of options, granted	65,000
Exercise price	$ 17.60
Consulting expense			$ 200	$ 300

Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Consolidated Statements of Comprehensive (Loss) Income
Net (loss) income	$ (291,754)	$ (287,100)	$ 132,244
Other comprehensive (loss) income:
Unrealized gain on available-for-sale securities, net of tax	22
Foreign currency translation adjustments, net of tax	(1)		288
Comprehensive (loss) income	$ (291,733)	$ (287,100)	$ 132,532

- Definition

Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income. Excludes changes in equity resulting from investments by owners and distributions to owners.

+ References + Details

- Definition

The consolidated profit or loss for the period, net of income taxes, including the portion attributable to the noncontrolling interest.

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+ Details

Revenue - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Concentration of Revenue [Line Items]
Net revenue	$ 211,042	$ 326,551	$ 475,824
Total net product revenue
Concentration of Revenue [Line Items]
Net revenue	$ 210,760	$ 326,509	$ 475,824

- Definition

+ References

+ Details

Organization and Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2022

Organization and Significant Accounting Policies

Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash



(in thousands)	January 1,
At beginning of period:	2022		2021		2020
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

	December 31,
At end of period:	2022		2021		2020
Cash and cash equivalents	$	63,547	$	417,195	$	541,158
Restricted cash		440		440		440
Total cash, cash equivalents and restricted cash	$	63,987	$	417,635	$	541,598

Schedule of Estimated Useful Lives of Property Plant and Equipment


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

Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Property and Equipment, Net
Total property and equipment	$ 28,911	$ 24,662
Accumulated depreciation and amortization	(20,157)	(16,849)
Property and equipment, net	8,754	7,813
Machinery and Equipment
Property and Equipment, Net
Total property and equipment	12,944	11,876
Computer Equipment and Software
Property and Equipment, Net
Total property and equipment	3,183	3,033
Furniture and Fixtures
Property and Equipment, Net
Total property and equipment	1,258	1,129
Leasehold Improvements
Property and Equipment, Net
Total property and equipment	6,198	5,942
Finance lease right of use assets
Property and Equipment, Net
Total property and equipment	4,632	2,294
Construction in Progress
Property and Equipment, Net
Total property and equipment	$ 696	$ 388

Debt Obligations - 2025 Term Loan Interest Expense Components (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Debt Instrument
Amortization of debt discount and debt issuance costs	$ 6,431	$ 4,257	$ 3,481
Lender \| 2025 Term Loan
Debt Instrument
Amortization of debt discount and debt issuance costs	16	1,032	818
Total Interest expense	$ 170	$ 8,066	$ 7,871

Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward
Balance at beginning of year	$ 15,495	$ 13,243	$ 11,603
Additions based on tax positions related to current year	1,385	2,038	1,749
Additions (reductions) for tax positions of prior years	(42)	214	(109)
Balance at end of year	$ 16,838	$ 15,495	$ 13,243

Debt Obligations - Summary of Debt Obligations (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
2027 Term Loans \| Level 2
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Principal amount	$ 250,000
Unamortized debt discount and debt issuance costs	(4,517)
Net carrying value	245,483
Estimated fair value	245,483
1.5% Convertible Senior Subordinated Notes due 2026 \| Level 2
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Principal amount	230,000	$ 230,000
Unamortized debt discount and debt issuance costs	(4,425)	(5,712)
Net carrying value	225,575	224,288
Estimated fair value	157,205	271,860
8.2% Convertible Notes due 2022 \| Level 2
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Principal amount		109,000
Unamortized debt discount and debt issuance costs		(521)
Net carrying value		108,479
Estimated fair value		108,361
2025 Term Loan
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Net carrying value	$ 0
2025 Term Loan \| Level 2
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Principal amount		75,000
Unamortized debt discount and debt issuance costs		513
Net carrying value		75,513
Estimated fair value		$ 75,513

Stock-Based Compensation and Employee Benefits - 401(k) Retirement Plan (Details) - 401(k) Plan - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Percentage of maximum contribution of annual compensation		100.00%	50.00%
First amount of each participant's contributions		$ 7,500	$ 6,000
Compensation expense related to match plan	$ 2,100,000	$ 1,700,000	$ 800,000
Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Percentage of maximum contribution of annual compensation				90.00%
Percentage of employer matching contributions		4.00%

Stock-Based Compensation and Employee Benefits - Equity Incentive Plans Narrative (Details)	12 Months Ended	108 Months Ended
	Dec. 31, 2022 shares	Dec. 31, 2022 shares
2014 Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Percentage of shares available for issuance	4.00%
Common stock reserved for future issuance	1,252,865	1,252,865
2010 Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Awards issued		0
Common stock reserved for future issuance	0	0
2016 Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Common stock reserved for future issuance	861,312	861,312

Debt Obligations - 2027 Term Loan Future Payments (Details) - 2027 Term Loans - BioPharma Credit Investments V GP LLC $ in Thousands	Dec. 31, 2022 USD ($)
Debt Instrument [Line Items]
2023 - interest only	$ 30,412
2024 - interest only	30,496
2025 - interest only	30,412
2026 - principal and interest	221,231
2027 - principal and interest	50,083
Total minimum payments	362,634
Less amount representing interest	(112,634)
Term Loan, gross	250,000
Less unamortized debt discount and debt issuance costs, net	(4,517)
Net carrying amount of Term Loans	$ 245,483

Collaborations and Other Arrangements (Details) $ / shares in Units, $ in Thousands, € in Millions						1 Months Ended	3 Months Ended	12 Months Ended
	Apr. 16, 2021 USD ($) $ / shares shares	Feb. 01, 2021 USD ($)	Jan. 13, 2020 USD ($)	Nov. 04, 2019 EUR (€)	May 02, 2019	Mar. 31, 2022 USD ($)	Mar. 31, 2021 USD ($)	Dec. 31, 2022 USD ($) $ / shares	Dec. 31, 2022 EUR (€)	Dec. 31, 2021 USD ($) $ / shares	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)	Dec. 31, 2019 EUR (€)	Dec. 30, 2022 $ / shares	Jun. 30, 2021 USD ($)	Apr. 14, 2020 $ / shares
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Additional milestone payments related to FDA approval								$ 25,000
Research and development								199,358		$ 363,105	$ 142,759
Accounts payable								11,526		16,159
Accrued and other current liabilities								50,097		$ 48,127
Collaboration agreement, threshold royalty payments								$ 2,900
License Agreement Fee						$ 35,000
Common Stock Par Or Stated Value Per Share \| $ / shares								$ 0.0001		$ 0.0001
Share Price \| $ / shares														$ 7.92		$ 14.82
Finite-Lived Intangible Asset, Useful Life								10 years	10 years
Bioeq IP AG
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Initial term of agreement				10 years
Percentage of gross profits shared				50.00%	50.00%
Bioeq IP AG \| Licensed Products
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Maximum aggregate milestone payments \| €				€ 12.5
Additional milestone payments related to FDA approval \| €									€ 2.5
Bioeq IP AG \| Research and Development Expense [Member]
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Upfront and milestone payment												$ 11,100	€ 10.0
Innovent Biologics (Suzhou) Co., Ltd. \| Bevacizumab Licensed Product
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Collaboration Agreement, upfront amount paid			$ 5,000
Maximum aggregate milestone payments			$ 40,000
Innovent Biologics (Suzhou) Co., Ltd. \| Research and Development Expense [Member] \| Bevacizumab Licensed Product
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Research and development										$ 1,100	7,500
Collaboration Agreement
Collaborative Arrangements And Noncollaborative Arrangement Transactions
License Agreement Fee		$ 35,000
Collaboration Agreement \| Anti-TIGIT Antibody and IL-2 cytokine
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Collaboration Agreement , Maximum Payments On Attainment Of Certain Sales Thresholds For Each Option Program							$ 170,000
Junshi Biosciences
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Maximum paid amount for co-development activities (per licensed compound)		$ 25,000
License Agreement Fee						$ 35,000
Collaboration agreement, royalty on net sales for each exercised option, percentage		18.00%
Collaboration agreement, Maximum aggregate one-time payment for achievement of milestones, for each option program		$ 85,000
Share Price \| $ / shares	$ 20.06
Unregistered shares \| shares	2,491,988
Aggregate value	$ 50,000
Period before the company can sell, transfer or make any short sale of common stock (in years)	2 years
Fair value for the discount for lack of marketability (DLOM)								$ 9,000
Junshi Biosciences \| Accrued and other current liabilities
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Co-development, regulatory and technology transfer costs								8,400		1,900
Junshi Biosciences \| Toripalimab
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Collaboration Agreement, upfront amount paid		$ 150,000
Collaboration agreement, royalty on net sales, percentage		20.00%
Collaboration agreement, threshold royalty payments		$ 380,000
Fair value for the discount for lack of marketability (DLOM)															$ 9,000
Junshi Biosciences \| Research and Development Expense [Member]
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Research and development								$ 68,500		$ 175,400	$ 5,000
Junshi Biosciences \| Research and Development Expense [Member] \| Toripalimab
Collaborative Arrangements And Noncollaborative Arrangement Transactions
Upfront payment for the exclusive rights							$ 145,000

Organization and Significant Accounting Policies - Operating and Finance Leases (Details)	Dec. 31, 2022
Organization and Significant Accounting Policies
Term of leases	36 months

Organization and Significant Accounting Policies - Organization (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2022 item product	Dec. 31, 2021 USD ($)
Organization and Significant Accounting Policies
Product pipeline, number of product candidates \| product	3
Number of reportable and operating segments \| item	1
Investments in marketable securities \| $		$ 0

Debt Obligations

12 Months Ended

Dec. 31, 2022

Debt Obligations

Debt Obligations

7.Debt Obligations

A summary of the Company’s debt obligations, including level within the fair value hierarchy (see Note 3), is as follows:


	At December 31, 2022
(in thousands)	Principal Amount			Unamortized Debt Discount and Debt Issuance Costs	Net Carrying Value		Estimated Fair Value		Level
Financial Liabilities:
2027 Term Loans	$	250,000	$	(4,517)	$	245,483	$	245,483	Level 2*
2026 Convertible Notes	$	230,000	$	(4,425)	$	225,575	$	157,205	Level 2**

	At December 31, 2021
(in thousands)	Principal Amount		Unamortized Exit Fee, Debt Discount and Debt Issuance Costs		Net Carrying Value		Estimated Fair Value		Level
Financial Liabilities:
2026 Convertible Notes	$	230,000	$	(5,712)	$	224,288	$	271,860	Level 2**
2022 Convertible Notes	$	109,000	$	(521)	$	108,479	$	108,361	Level 3***
2025 Term Loan	$	75,000	$	513	$	75,513	$	75,513	Level 2*


*	The principal amounts outstanding are subject to variable interest rates, which are based on three-month LIBOR plus fixed percentages through March 31, 2023. Therefore, the Company believes the carrying amount of these obligations approximates fair value.
**	The fair value is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. Since the market for trading of the 2026 Convertible Notes is not considered to be an active market, the estimated fair value is based on Level 2 inputs.
***	The fair value was based on an income approach using 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 were Level 3 inputs. The lattice model produced 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 was used to discount straight debt cash flows.

2027 Term Loans

The Company entered into the Loan Agreement with BioPharma Credit, PLC, BPCR Limited Partnership, and Biopharma Credit Investments V (Master) LP, acting by its general partner, BioPharma Credit Investments V GP LLC that provides for a senior secured term loan facility of up to $300.0 million to be funded in four committed tranches: (i) the Tranche A Loan in an aggregate principal amount of $100.0 million that was funded on January 5, 2022; (ii) the Tranche B Loan in an aggregate principal amount of $100.0 million that was funded on March 31, 2022; (iii) the Tranche C Loan in an aggregate principal amount of $50.0 million that was not funded; and (iv) the Tranche D Loan in an aggregate principal amount of $50.0 million that was funded on September 14, 2022. The Company has the right to request an uncommitted additional facility amount of up to $100.0 million that is 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 the Company’s 2026 Convertible Notes is greater than $50.0 million on October 1, 2025. The 2027 Term Loans accrue interest from inception through March 31, 2023 at 8.25% plus three-month LIBOR per annum with a LIBOR floor of 1.0%; and, starting April 1, 2023, accrue interest at 8.25% plus the Adjusted Term SOFR which is the sum of three-month SOFR and 0.26161% per annum, with a floor on Adjusted Term SOFR of 1.0%. The interest rate for the fourth quarter of 2022 was 12.00%. Interest

is payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year. Repayment of outstanding principal of the 2027 Term Loans will be made in five equal quarterly payments of principal commencing March 31, 2026.

The Company adopted the prospective method to account for future cash payments. Under the prospective method, the effective interest rate is not constant, and any change in the expected cash flows is recognized prospectively as an adjustment to the effective yield.

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 the Company’s 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; in March 2022, proceeds of the Tranche B Loan were drawn in connection with the full repayment of all amounts outstanding under the 2022 Convertible Notes, as well as all associated costs and expenses pursuant to which a payoff amount of $111.1 million was outstanding.

The Loan Agreement contains certain customary representations and warranties. In addition, the Loan Agreement includes covenants, such as the requirement to maintain minimum trailing twelve-month net sales in an amount that begins at $200.0 million for the quarter ending March 31, 2022, increases to $210.0 million for the quarter ended March 31, 2024, increases to $230.0 million for the quarter ending June 30, 2024, increases to $270.0 million for the quarter ending September 30, 2024, and increases to $300.0 million for the quarter ended December 31, 2024 and thereafter. Further, the Loan Agreement includes certain other affirmative covenants and negative covenants, including, covenants and restrictions that among other things, restrict the Company’s ability to incur liens, incur additional indebtedness, 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, the Company’s failure to make any principal or interest payments when due, the occurrence of certain bankruptcy or insolvency events or its breach of the covenants under the Loan Agreement. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate the Company’s obligations under the Loan Agreement. A change of control of the Company triggers a mandatory prepayment of the 2027 Term Loans within ten business days.

As of December 31, 2022, the Company was in full compliance with these covenants and there were no events of default under the 2027 Term Loans.

In connection with the closing of Tranche A, the Company incurred $7.8 million in debt discounts and issuance costs of which $6.8 million related to all the tranches of the 2027 Term Loans and was thus allocated pro rata between the tranches. The unamortized debt discount and issuance costs allocated to funded tranches are presented as deductions to the 2027 Term Loan balance and are amortized into interest expense using the effective interest method. The $2.3 million allocated to Tranche B was fully amortized over the commitment period prior to funding and recognized as interest expense in the first quarter of 2022. Until unfunded tranches are drawn, the associated debt discounts and issuance costs are deferred as assets and amortized into interest expense using the straight-line method over the commitment period of the respective tranches. At the closing dates of Tranche B on March 31, 2022 and Tranche D on September 14, 2022, the Company incurred an additional $1.0 million and $0.5 million, respectively, in debt issuance costs. As of December 31, 2022, the total remaining unamortized debt discount and debt offering costs related to Tranches A, B and D of $4.5 million will be amortized using the effective interest rate over the remaining term of 4.0 years.

The following table represents the components of interest expense related to the 2027 Term Loans:


	Year Ended December 31,
(in thousands)	2022
Stated coupon interest	$	20,243
Amortization of debt discount and debt issuance costs		4,550
Total interest expense	$	24,793

Future payments on the 2027 Term Loans as of December 31, 2022 are as follows:


Year ending December 31, (in thousands)
2023 - interest only	$	30,412
2024 - interest only		30,496
2025 - interest only		30,412
2026 - principal and interest		221,231
2027 - principal and interest		50,083
Total minimum payments		362,634
Less amount representing interest		(112,634)
2027 Term Loans, gross		250,000
Less unamortized debt discount and debt issuance costs, net		(4,517)
Net carrying amount of 2027 Term Loans	$	245,483

1.5% Convertible Senior Subordinated Notes due 2026

In April 2020, the Company issued and sold $230.0 million aggregate principal amount of its 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 $14.82 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, 2022, 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 an equity component. The proceeds received from the issuance of the convertible debt were recorded as a liability in 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 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 $25.93 per share, which represents a premium of approximately 75.0% over the last reported sale price of the Company’s common stock of $14.82 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 in 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 in 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.

If the 2026 Convertible Notes were converted on December 31, 2022, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $94.6 million based on the Company’s closing stock price of $7.92 as of December 30, 2022.

The following table presents the components of interest expense related to 2026 Convertible Notes:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Stated coupon interest	$	3,450	$	3,450	$	2,434
Amortization of debt discount and debt issuance costs		1,286		1,259		873
Total interest expense	$	4,736	$	4,709	$	3,307

The remaining unamortized debt discount and debt offering costs related to the Company’s 2026 Convertible Notes of $4.4 million as of December 31, 2022, will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes of 3.3 years. The annual effective interest rate is 2.1% for the 2026 Convertible Notes.

Future payments on the 2026 Convertible Notes as of December 31, 2022 are as follows:


Year ending December 31, (in thousands)
2023 - interest only	$	3,450
2024 - interest only		3,450
2025 - interest only		3,450
2026		231,725
Total minimum payments		242,075
Less amount representing interest		(12,075)
2026 Convertible Notes, principal amount		230,000
Less unamortized debt discount and debt issuance costs		(4,425)
Net carrying amount of 2026 Convertible Notes	$	225,575

8.2% Convertible Notes due 2022

On February 29, 2016, the Company issued and sold $100.0 million aggregate principal amount, which excluded 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 constituted general, senior unsubordinated obligations of the Company and were guaranteed by certain subsidiaries of the Company. The 2022 Convertible Notes bore 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 matured on March 31, 2022. The 2022 Convertible Notes also had a premium of 9.0% of the principal amount which was payable when the 2022 Convertible Notes matured or were 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 could have converted 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 was 44.7387 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which represented an initial conversion price of approximately $22.35 per share of common stock. The initial conversion price represented a 60% premium over the average last reported sale price of the Company’s common stock over the 15 trading days preceding the date the 2022 Convertible Notes were issued. The conversion rate and conversion price were subject to customary adjustments upon the occurrence of certain events. The 2022 Convertible Notes were 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 exceeded 160% of the conversion price on 20 or more trading days during the 30 consecutive trading days preceding the date on which the Company sent notice of such redemption to the holders of the 2022 Convertible Notes. At maturity or redemption, if not earlier converted, the Company would pay 109% of the principal amount of the 2022 Convertible Notes maturing or being redeemed, together with accrued and unpaid interest, in cash.

In March 2022, the Company fully repaid the 2022 Convertible Notes, and as a result had no continuing obligations associated with them thereafter. The payoff amount of $111.1 million included the repayment of the entire outstanding principal amount, the 9.0% premium of the outstanding principal amount and accrued and unpaid interest.

The following table presents the components of interest expense of the 2022 Convertible Notes:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Stated coupon interest	$	2,050	$	8,200	$	8,200
Amortization of debt discount and debt issuance costs		521		1,966		1,791
Total interest expense	$	2,571	$	10,166	$	9,991

2025 Term Loan

On January 7, 2019 (the “2025 Term Loan Closing Date”), the Company entered into the 2025 Term Loan with affiliates of Healthcare Royalty Partners (together, the “Lender”). The 2025 Term Loan consisted 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 were guaranteed by the Company’s material domestic United States subsidiaries and were secured by a lien on substantially all of the Company’s tangible and intangible property, including intellectual property.

Starting January 1, 2020, the Borrowings under the 2025 Term Loan bore interest at 6.75% per annum plus three month LIBOR. Interest was payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate was not constant, and any change in the expected cash flows was recognized prospectively as an adjustment to the effective yield.

If all or any of the Borrowings were prepaid or required to be prepaid under the 2025 Term Loan, then the Company was required to 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, the Company was required to pay an additional exit fee in an amount equal to 4.0% of the total principal amount of the Borrowings.

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. In January 2022, pursuant to the Company entering into the 2027 Term Loans, the Company voluntarily prepaid all amounts outstanding under the 2025 Term Loan. The payoff amount of $81.9 million included principal repayment in full, accrued interest, a 5.0% prepayment premium fee of the Borrowings principal amount, and an exit fee of 4.0% of the Borrowings principal amount. The prepayment premium fee and unamortized exit fee, debt discount and debt issuance costs, net from the 2025 Term Loan totaled $6.2 million and was recorded in loss on debt extinguishment in the consolidated statement of operations for 2022. As of December 31, 2022, the Company had no continuing obligations associated with the 2025 Term Loan.

The following table presents the components of interest expense of the 2025 Term Loan:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Stated coupon interest	$	154	$	7,034	$	7,053
Amortization of debt discount and debt issuance costs		16		1,032		818
Total interest expense	$	170	$	8,066	$	7,871

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-URI https://asc.fasb.org/topic&trid=2208564

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (g)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1E
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495348-112611

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (i)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

+ Details

Debt Obligations - 2027 Term Loans Interest Expense Components (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Debt Instrument [Line Items]
Amortization of debt discount and debt issuance costs	$ 6,431	$ 4,257	$ 3,481
2027 Term Loans \| BioPharma Credit Investments V GP LLC
Debt Instrument [Line Items]
Amortization of debt discount and debt issuance costs	4,550
Total Interest expense	$ 24,793

Stock Based Compensation and Employee Benefits - Summary of Option Activities Under 2016 and 2014 Plans (Details) - 2016 plan and 2014 plan $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($) $ / shares shares
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of Options, Beginning balance \| shares	19,959,815
Number of Options, Granted - at fair value \| shares	4,685,750
Number of Options, Exercised \| shares	(141,897)
Number of Options, Forfeited/Canceled \| shares	(2,812,347)
Number of Options, Ending balance \| shares	21,691,321
Number of Options, Exercisable \| shares	15,027,783
Weighted-Average Exercise Price, Beginning balance \| $ / shares	$ 15.89
Weighted-Average Exercise Price, Granted - at fair value \| $ / shares	12.09
Weighted Average Exercise Price, Exercised \| $ / shares	4.88
Weighted Average Exercise Price, Forfeited/Canceled \| $ / shares	16.97
Weighted-Average Exercise Price, Ending balance \| $ / shares	15.00
Weighted Average Exercise Price, Exercisable \| $ / shares	$ 15.47
Options outstanding, Weighted-Average Remaining Contractual Terms	6 years
Options outstanding, Weighted-Average Remaining Contractual Terms, Exercisable	4 years 9 months 18 days
Options outstanding, Aggregate Intrinsic Value \| $	$ 10,714
Options outstanding, Aggregate Intrinsic Value, Exercisable \| $	$ 9,647

Income Taxes - Reconciliation of Statutory U.S. Federal Rate (Details)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Percent of pre-tax income:
United States federal statutory income tax rate	21.00%	21.00%	21.00%
State taxes, net of federal benefit	1.70%	2.60%	2.00%
Foreign rate differences			(0.30%)
Permanent items	(0.10%)	0.20%	0.40%
Research and development credit	1.80%	2.60%	(4.80%)
Stock based compensation costs	(2.30%)	(1.20%)	1.30%
Other			(0.30%)
Change in valuation allowance	(22.10%)	(25.20%)	(16.70%)
Effective income tax rate			2.60%

Commitments and Contingencies - Schedule of Non-Cancelable Contractual Obligations (Details) $ in Thousands	Dec. 31, 2022 USD ($)
Commitments and Contingencies.
2023	$ 53,652
2024	13,724
2025	1,128
2026	260
Total obligations	$ 68,764

Stock-Based Compensation and Employee Benefits - Summary of RSUs Activity, under 2014 Plan (Details) - Restricted Stock Units - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of RSUs, beginning balances	1,843,732
Number of RSUs granted	1,686,875
Number of RSUs vested	(806,854)
Number of RSUs canceled	(390,446)
Number of RSUs, ending balance	2,333,307	1,843,732
Weighted-Average Grant Date Fair Value, beginning balances	$ 17.00
Weighted-Average Grant Date Fair Value, RSUs granted	13.34	$ 16.86	$ 17.86
Weighted-Average Grant Date Fair Value, RSUs Vested	16.85
Weighted-Average Grant Date Fair Value, RSUs canceled	15.43
Weighted-Average Grant Date Fair Value, ending balances	$ 14.66	$ 17.00

Debt Obligations (Tables)

12 Months Ended

Dec. 31, 2022

Debt Instrument

Summary of the Company's Debt Obligations


	At December 31, 2022
(in thousands)	Principal Amount			Unamortized Debt Discount and Debt Issuance Costs	Net Carrying Value		Estimated Fair Value		Level
Financial Liabilities:
2027 Term Loans	$	250,000	$	(4,517)	$	245,483	$	245,483	Level 2*
2026 Convertible Notes	$	230,000	$	(4,425)	$	225,575	$	157,205	Level 2**

	At December 31, 2021
(in thousands)	Principal Amount		Unamortized Exit Fee, Debt Discount and Debt Issuance Costs		Net Carrying Value		Estimated Fair Value		Level
Financial Liabilities:
2026 Convertible Notes	$	230,000	$	(5,712)	$	224,288	$	271,860	Level 2**
2022 Convertible Notes	$	109,000	$	(521)	$	108,479	$	108,361	Level 3***
2025 Term Loan	$	75,000	$	513	$	75,513	$	75,513	Level 2*


*	The principal amounts outstanding are subject to variable interest rates, which are based on three-month LIBOR plus fixed percentages through March 31, 2023. Therefore, the Company believes the carrying amount of these obligations approximates fair value.
**	The fair value is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. Since the market for trading of the 2026 Convertible Notes is not considered to be an active market, the estimated fair value is based on Level 2 inputs.
***	The fair value was based on an income approach using 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 were Level 3 inputs. The lattice model produced 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 was used to discount straight debt cash flows.

2027 Term Loans

Debt Instrument

Components of Interest Expense


	Year Ended December 31,
(in thousands)	2022
Stated coupon interest	$	20,243
Amortization of debt discount and debt issuance costs		4,550
Total interest expense	$	24,793

Schedule of Future Payments on Debt


Year ending December 31, (in thousands)
2023 - interest only	$	30,412
2024 - interest only		30,496
2025 - interest only		30,412
2026 - principal and interest		221,231
2027 - principal and interest		50,083
Total minimum payments		362,634
Less amount representing interest		(112,634)
2027 Term Loans, gross		250,000
Less unamortized debt discount and debt issuance costs, net		(4,517)
Net carrying amount of 2027 Term Loans	$	245,483

1.5% Convertible Senior Subordinated Notes due 2026

Debt Instrument

Components of Interest Expense


	Year Ended December 31,
(in thousands)	2022		2021		2020
Stated coupon interest	$	3,450	$	3,450	$	2,434
Amortization of debt discount and debt issuance costs		1,286		1,259		873
Total interest expense	$	4,736	$	4,709	$	3,307

Schedule of Future Payments on Debt

Future payments on the 2026 Convertible Notes as of December 31, 2022 are as follows:


Year ending December 31, (in thousands)
2023 - interest only	$	3,450
2024 - interest only		3,450
2025 - interest only		3,450
2026		231,725
Total minimum payments		242,075
Less amount representing interest		(12,075)
2026 Convertible Notes, principal amount		230,000
Less unamortized debt discount and debt issuance costs		(4,425)
Net carrying amount of 2026 Convertible Notes	$	225,575

8.2% Convertible Notes due 2022

Debt Instrument

Components of Interest Expense


	Year Ended December 31,
(in thousands)	2022		2021		2020
Stated coupon interest	$	2,050	$	8,200	$	8,200
Amortization of debt discount and debt issuance costs		521		1,966		1,791
Total interest expense	$	2,571	$	10,166	$	9,991

2025 Term Loan

Debt Instrument

Components of Interest Expense


	Year Ended December 31,
(in thousands)	2022		2021		2020
Stated coupon interest	$	154	$	7,034	$	7,053
Amortization of debt discount and debt issuance costs		16		1,032		818
Total interest expense	$	170	$	8,066	$	7,871

Organization and Significant Accounting Policies - Goodwill, Intangible Assets and Impairment of Long-lived Assets (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Acquired Finite-Lived Intangible Assets [Line Items]
Goodwill and intangible assets	$ 5,931,000	$ 3,563,000
Goodwill	900,000	900,000
Impairment of goodwill	0	0	$ 0
Finite-Lived Intangible Assets, Net	$ 2,400,000
Finite-Lived Intangible Asset, Useful Life	10 years
Long lived assets, material impairments	$ 0	0	0
In-process research and development
Acquired Finite-Lived Intangible Assets [Line Items]
Goodwill and intangible assets	2,600,000	2,600,000
Impairment of intangible assets excluding goodwill	$ 0	$ 0	$ 0

- Definition

Amount after accumulated impairment loss of an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized.

+ References + Details

Inventory - Balance Sheet Classifications (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Inventory
Inventory	$ 38,791	$ 37,642
Inventory, non-current	76,260	55,610
Total	$ 115,051	$ 93,252

Organization and Significant Accounting Policies

12 Months Ended

Dec. 31, 2022

Organization and Significant Accounting Policies

Organization and Significant Accounting Policies

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 cancer treatments and commercialization of its portfolio of FDA-approved biosimilars. 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 (pegfilgrastim-cbqv), a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor, in the United States. The FDA approved YUSIMRY (adalimumab-aqvh), a biosimilar to Humira, in December 2021, which the Company plans to launch in the United States on or after July 1, 2023, pursuant to the terms of an agreement with Humira’s manufacturer, AbbVie. On August 2, 2022, the FDA approved CIMERLI (ranibizumab-eqrn), a biosimilar to Lucentis, and commercial launch commenced on October 3, 2022 in the United States.

The Company’s product pipeline comprises the following three product candidates: toripalimab, an anti-PD-1 antibody being developed in collaboration with Junshi Biosciences; CHS-006, an antibody targeting TIGIT being developed in collaboration with Junshi Biosciences; and one wholly-owned preclinical immuno-oncology program, CHS-1000, an antibody targeting ILT4. In May 2022, the Company discontinued development of its bevacizumab (Avastin) biosimilar product candidate in-licensed from Innovent. In October 2022, the Company discontinued development of its preclinical immuno-oncology program, CHS-3318, an antibody targeting CCR8. On January 9, 2023, the Company announced that it entered into the Term Sheet with Klinge Biopharma for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States. The parties to the Term Sheet expect to execute the Definitive Agreements contemplated by the Term Sheet and complete the transaction in the first half of 2023.

Basis of Consolidation

Use of Estimates

Segment Reporting and Revenue by Geographic Region

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.



(in thousands)	January 1,
At beginning of period:	2022		2021		2020
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

	December 31,
At end of period:	2022		2021		2020
Cash and cash equivalents	$	63,547	$	417,195	$	541,158
Restricted cash		440		440		440
Total cash, cash equivalents and restricted cash	$	63,987	$	417,635	$	541,598

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

Trade Receivables

Concentrations of Risk

Foreign Currency

Inventory

Property and Equipment


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

Impairment of Long-Lived Assets

Accrued Research and Development Expense

Net Revenues

Product Sales Discounts and Allowances

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

Cost of Goods Sold

In 2022, 2021 and 2020, cost of goods sold included inventory write-offs, net of $26.0 million, $5.1 million and $2.2 million, respectively.

Research and Development Expense

●

upfront and milestone payments related to licensing and collaboration agreements.

●

personnel-related expense, which include salaries, benefits and stock-based compensation; and

●

License Agreements

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.

Selling, General and Administrative Expense

Stock-Based Compensation

Income Taxes

Operating and Finance Leases

Net (Loss) Income per Share

Comprehensive (Loss) Income

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 2022. As a result, there was no change to total assets in the consolidated balance sheets or net cash (used in) provided by operating activities in the consolidated statements of cash flows for the prior years.

Recent Accounting Pronouncements

Stock-Based Compensation and Employee Benefits - Stock-Based Compensation (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
	Feb. 28, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Employee Service Share Based Compensation Allocation Of Recognized Period Costs
Stock-based compensation expense	$ 800	$ 50,737	$ 51,364	$ 38,160
Stock-based compensation expense capitalized into inventory		1,187	1,025	1,460
Cost of Goods Sold
Employee Service Share Based Compensation Allocation Of Recognized Period Costs
Stock-based compensation expense		736	1,099	583
Research and Development Expense [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs
Stock-based compensation expense		18,999	18,688	13,837
Selling, General and Administrative Expenses
Employee Service Share Based Compensation Allocation Of Recognized Period Costs
Stock-based compensation expense		$ 31,002	$ 31,577	$ 23,740

Income Taxes - Components of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Components Of Deferred Tax Assets [Abstract]
Net operating loss carryforwards	$ 131,423	$ 117,793
Research and development credits	63,164	58,039
Depreciation and amortization	51,877	40,620
Stock-based compensation	32,561	30,565
Sales related accruals	23,864	17,299
Other accruals	19,717	11,798
Capitalized research and development	17,673
Gross deferred tax assets	340,279	276,114
Right-of-use asset	(1,903)	(2,167)
In-process research and development	(603)	(603)
Gross deferred tax liabilities	(2,506)	(2,770)
Total net deferred tax asset	337,773	273,344
Less valuation allowance	$ (337,773)	$ (273,344)

Debt Obligations - 2025 Term Loan - Narrative (Details) - USD ($)		1 Months Ended	12 Months Ended
	Jan. 07, 2019	Jan. 31, 2022	Dec. 31, 2022	Jan. 01, 2020
Debt Instrument
Outstanding amount paid off			$ 81,750,000
Loss on debt extinguishment			$ (6,222,000)
2025 Term Loan
Debt Instrument
Interest rate description	Starting January 1, 2020, the Borrowings under the 2025 Term Loan bore interest at 6.75% per annum plus three month LIBOR. Interest was payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate was not constant, and any change in the expected cash flows was recognized prospectively as an adjustment to the effective yield.
2025 Term Loan \| Paid on or Prior to the Three Year Anniversary of Closing Date
Debt Instrument
Effective interest rate			5.00%
Prepayment premium, description			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
2025 Term Loan \| Paid after the Three Year but on or Prior to the Four Year Anniversary of Closing Date
Debt Instrument
Effective interest rate			5.00%
Prepayment premium, description			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
2025 Term Loan \| Paid after the Four Year but on or Prior to the Five Year Anniversary of Closing Date
Debt Instrument
Effective interest rate			2.50%
Prepayment premium, description			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
2025 Term Loan \| Paid Thereafter
Debt Instrument
Effective interest rate			1.25%
Prepayment premium, description			with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid
Lender \| 2025 Term Loan
Debt Instrument
Total term of the loan	6 years
Principal amount	$ 75,000,000.0
Outstanding amount paid off		$ 81,900,000
Stated interest rate				6.75%
Prepayment premium percentage		5.00%
Payment of closing fee to the lenders in form of origination issue discount	$ 1,100,000
Percentage required to pay an additional exit fee on principal amount	4.00%	4.00%
Loss on debt extinguishment		$ 6.2

Subsequent Events (Details) € in Millions	Jan. 09, 2023 EUR (€)
Term Sheet Agreement \| Klinge Biopharma \| Subsequent Event
Subsequent Event [Line Items]
Collaboration Agreement, upfront amount paid	€ 30

Balance Sheet Components (Tables)

12 Months Ended

Dec. 31, 2022

Organization and Operations

Schedule of Property and Equipment, Net


	December 31,
(in thousands)	2022		2021
Machinery and equipment	$	12,944	$	11,876
Computer equipment and software		3,183		3,033
Furniture and fixtures		1,258		1,129
Leasehold improvements		6,198		5,942
Finance lease right of use assets		4,632		2,294
Construction in progress		696		388
Total property and equipment		28,911		24,662
Accumulated depreciation and amortization		(20,157)		(16,849)
Property and equipment, net	$	8,754	$	7,813

Schedule of Accrued Liabilities


	December 31,
(in thousands)	2022		2021
Accrued commercial and research and development manufacturing	$	21,774	$	30,541
Accrued co-development costs payable to Junshi Biosciences		8,356		1,926
Lease liabilities, current		4,318		3,492
Accrued other		15,649		12,168
Total Accrued and other current liabilities	$	50,097	$	48,127

Leases - Supplemental cash flow information related to leases (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Leases
Operating cash flows from operating leases	$ 3,401	$ 3,435	$ 3,217
Operating cash flows from finance leases	155	81	53
Financing cash flows from finance leases	1,228	672	388
Operating leases		434	1,388
Finance leases	$ 2,694	$ 477	$ 1,817

Fair Value Measurements - Financial Assets Measured on a Recurring Basis (Details) - Fair Value Measurements Recurring Basis $ in Thousands	Dec. 31, 2022 USD ($)
Financial assets measured at fair value on a recurring basis
Total financial assets	$ 191,645
Level 1
Financial assets measured at fair value on a recurring basis
Total financial assets	143,442
Level 2
Financial assets measured at fair value on a recurring basis
Total financial assets	48,203
U.S. government agency securities
Financial assets measured at fair value on a recurring basis
Total financial assets	19,964
U.S. government agency securities \| Level 1
Financial assets measured at fair value on a recurring basis
Total financial assets	19,964
US Treasury Securities
Financial assets measured at fair value on a recurring basis
Total financial assets	68,418
US Treasury Securities \| Level 1
Financial assets measured at fair value on a recurring basis
Total financial assets	68,418
Commercial paper and corporate notes
Financial assets measured at fair value on a recurring basis
Total financial assets	48,203
Commercial paper and corporate notes \| Level 2
Financial assets measured at fair value on a recurring basis
Total financial assets	48,203
Money market funds
Financial assets measured at fair value on a recurring basis
Total financial assets	55,060
Money market funds \| Level 1
Financial assets measured at fair value on a recurring basis
Total financial assets	$ 55,060

Stock-Based Compensation and Employee Benefits (Tables)

12 Months Ended

Dec. 31, 2022

Stock-Based Compensation and Employee Benefits

Summary of Option Activities under 2016 and 2014 Plans


	Options
				Weighted-
				Average	Aggregate
		Weighted-		Remaining	Intrinsic
	Number of	Average		Contractual Terms	Value
	Options	Exercise Price		(Years)	(in thousands)
Outstanding at December 31, 2021	19,959,815	$	15.89
Granted - at fair value	4,685,750	$	12.09
Exercised	(141,897)	$	4.88
Forfeited/Canceled	(2,812,347)	$	16.97
Outstanding at December 31, 2022	21,691,321	$	15.00	6.0	$	10,714
Exercisable at December 31, 2022	15,027,783	$	15.47	4.8	$	9,647

Schedule of options outstanding and exercisable

Information on options outstanding and exercisable as of December 31, 2022 is summarized as follows:


					Options Outstanding				Options Exercisable
						Weighted-
						Average	Weighted-			Weighted-
						Remaining	Average			Average
					Number	Contractual Terms	Exercise		Number	Exercise
Range of Exercise Prices					Outstanding	(Years)	Price		Exercisable	Price
$	1.42	-	$	10.05	4,801,972	5.2	$	6.64	3,223,663	$	5.99
$	10.78	-	$	14.13	4,598,418	6.4	$	12.72	3,381,021	$	12.67
$	14.30	-	$	17.17	4,857,557	7.2	$	15.91	2,530,714	$	16.08
$	17.30	-	$	19.07	4,406,311	6.9	$	17.93	3,000,465	$	17.94
$	19.19	-	$	36.85	3,027,063	3.4	$	25.98	2,891,920	$	26.22
					21,691,321	6.0	$	15.00	15,027,783	$	15.47

Schedule of additional information on options


	Year Ended December 31,
(in thousands, except weighted-average grant date fair values)	2022		2021		2020
Total intrinsic value of options exercised	$	914	$	9,726	$	14,572
Total grant date fair value of options vested	$	34,916	$	40,365	$	34,090
Weighted-average grant date fair value of options granted	$	7.04	$	9.80	$	10.94

Summary of RSU Activity, under 2014 Plan


	RSUs Outstanding
		Weighted-Average
	Number of	Grant Date Fair
	RSUs	Value
Balances at December 31, 2021	1,843,732	$	17.00
RSUs granted	1,686,875	$	13.34
RSUs vested	(806,854)	$	16.85
RSUs canceled	(390,446)	$	15.43
Balances at December 31, 2022	2,333,307	$	14.66

Schedule of Stock-Based Compensation Expense



	Year Ended December 31,
(in thousands)	2022		2021		2020
Cost of goods sold ⁽¹⁾	$	736	$	1,099	$	583
Research and development		18,999		18,688		13,837
Selling, general and administrative		31,002		31,577		23,740
Stock-based compensation expense	$	50,737	$	51,364	$	38,160

Stock-based compensation expense capitalized into inventory	$	1,187	$	1,025	$	1,460

(1)	Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold.

Schedule of Weighted Average Assumptions for Black-Scholes Option-Pricing Model Used in Determining Fair Value of Awards


	Year Ended December 31,
	2022		2021		2020
Expected term (years)
Stock options	6.1		6.1		6.1
ESPP	0.5		0.5		0.5
Expected volatility
Stock options	62	%	65	%	68	%
ESPP	70	%	42	%	58	%
Risk-free interest rate
Stock options	2.37	%	0.89	%	1.09	%
ESPP	3.77	%	0.06	%	0.13	%
Expected dividend yield
Stock options	—	%	—	%	—	%
ESPP	—	%	—	%	—	%

Debt Obligations - Convertible Notes due 2022 Narrative (Details)			1 Months Ended	12 Months Ended
	Jan. 07, 2019 USD ($)	Feb. 29, 2016 USD ($) item $ / shares shares	Mar. 31, 2022 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)	Dec. 30, 2022 $ / shares	Apr. 14, 2020 $ / shares	Jan. 01, 2020
Debt Instrument
Proceeds from issuance of 2026 Convertible Notes, net of issuance costs						$ 222,156,000
Outstanding amount payoff				$ 109,000,000
Convertible trading days \| item		15
Closing stock, price per share \| $ / shares							$ 7.92	$ 14.82
8.2% Convertible Notes due 2022
Debt Instrument
Interest rate description		The 2022 Convertible Notes bore 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
Convertible notes, premium percentage		9.00%
2025 Term Loan
Debt Instrument
Net carrying value				0
Interest rate description	Starting January 1, 2020, the Borrowings under the 2025 Term Loan bore interest at 6.75% per annum plus three month LIBOR. Interest was payable quarterly in arrears. Under the prospective method to account for future cash payments adopted by the Company, the effective interest rate was not constant, and any change in the expected cash flows was recognized prospectively as an adjustment to the effective yield.
2025 Term Loan \| Lender
Debt Instrument
Principal amount	$ 75,000,000.0
Stated interest rate									6.75%
Interest expense				170,000	$ 8,066,000	7,871,000
Debt Instrument Term	6 years
Convertible Notes \| KKR Member
Debt Instrument
Principal amount		$ 20,000,000.0
Convertible Notes \| MX II Member
Debt Instrument
Principal amount		4,000,000.0
Convertible Notes \| KMGCP Member
Debt Instrument
Principal amount		1,000,000.0
Convertible Notes \| Lender \| KKR Member
Debt Instrument
Principal amount		75,000,000.0
Convertible Notes \| 8.2% Convertible Notes due 2022
Debt Instrument
Principal amount		$ 100,000,000.0
Stated interest rate		8.20%
Proceeds from issuance of 2026 Convertible Notes, net of issuance costs		$ 99,200,000
Convertible notes, Issuance Cost		$ 800,000
Interest expense				$ 2,571,000	$ 10,166,000	$ 9,991,000
Debt instrument maturity date		Mar. 31, 2022
Outstanding amount payoff			$ 111,100,000
Convertible Notes Payable			$ 0
Convertible notes, premium percentage		9.00%	9.00%
Initial conversion rate, shares of common stock \| shares		44.7387
Principal amount of notes converted into shares		$ 1,000
Initial conversion price per common share \| $ / shares		$ 22.35
Initial conversion price, percentage premium over average last reported sale price of common stock		60
Percentage of applicable conversion price, threshold		160.00%
Consecutive trading days \| item		30
Percentage to pay in cash of the par value of notes		109.00%
Convertible Notes \| 8.2% Convertible Notes due 2022 \| Minimum
Debt Instrument
Convertible trading days \| item		20

Income Taxes

12 Months Ended

Dec. 31, 2022

Income Taxes

Income Taxes

12.Income Taxes

The components of (loss) income before income taxes are as follows:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Domestic	$	(291,746)	$	(287,058)	$	133,615
Foreign		(8)		(42)		2,092
Total	$	(291,754)	$	(287,100)	$	135,707

Provision for income taxes:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Current:
Federal	$	—	$	—	$	—
State		—		—		3,463
Foreign		—		—		—
Subtotal	$	—	$	—	$	3,463

Deferred:
Federal	$	—	$	—	$	—
State		—		—		—
Foreign		—		—		—
Subtotal	$	—	$	—	$	—

Provision for income taxes	$	—	$	—	$	3,463

There was no income tax provision in 2022 and 2021 due to the Company’s history of losses and valuation of allowances against the deferred tax assets. The income tax provision in 2020 of $3.5 million is primarily related 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,
	2022		2021		2020
Percent of pre-tax income:
United States federal statutory income tax rate	21.0	%	21.0	%	21.0	%
State taxes, net of federal benefit	1.7		2.6		2.0
Foreign rate differences	—		—		(0.3)
Permanent items	(0.1)		0.2		0.4
Research and development credit	1.8		2.6		(4.8)
Stock-based compensation costs	(2.3)		(1.2)		1.3
Other	—		—		(0.3)
Change in valuation allowance	(22.1)		(25.2)		(16.7)
Effective income tax rate	—	%	—	%	2.6	%

The components of the Company’s net deferred tax assets as of December 31, 2022 and 2021 consist of the following:


	December 31,
(in thousands)	2022		2021
Net operating loss carryforwards	$	131,423	$	117,793
Research and development credits		63,164		58,039
Depreciation and amortization		51,877		40,620
Stock-based compensation		32,561		30,565
Sales related accruals		23,864		17,299
Other accruals		19,717		11,798
Capitalized research and development		17,673		—
Gross deferred tax assets		340,279		276,114
Right-of-use asset		(1,903)		(2,167)
In-process research and development		(603)		(603)
Gross deferred tax liabilities		(2,506)		(2,770)
Total net deferred tax asset		337,773		273,344
Less valuation allowance		(337,773)		(273,344)
Net deferred tax assets	$	—	$	—

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, 2022 and 2021.

The valuation allowance increased by $64.4 million and $72.4 million during the years ended December 31, 2022 and 2021, respectively, and decreased by $22.7 million during the year ended December 31, 2020.

As of December 31, 2022, the Company had operating loss carryforwards for federal income of $591.2 million, which will start to expire in the year 2036, and various states net operating loss carryforwards of $113.2 million, which have various expiration dates beginning in 2031.

As of December 31, 2022, the Company had federal research and development credit carryforwards for federal income tax purposes of $57.7 million, which will start to expire in the year 2031, and state research and development credit carryforwards of $26.4 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 income tax returns in the United States federal jurisdiction, various United States state jurisdictions, and a foreign jurisdiction 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 2022, 2021 and 2020 is as follows:


	Year Ended December 31,
(in thousands)	2022		2021		2020
Balance at beginning of year	$	15,495	$	13,243	$	11,603
Additions based on tax positions related to current year		1,385		2,038		1,749
Additions (reductions) for tax positions of prior years		(42)		214		(109)
Balance at end of year	$	16,838	$	15,495	$	13,243

As of December 31, 2022, 2021 and 2020, the Company had $16.8 million, $15.5 million and $13.2 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 2022, 2021 and 2020, 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.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 63,547	$ 417,195
Investments in marketable securities	128,134
Trade receivables, net	109,964	123,022
Inventory	38,791	37,642
Prepaid manufacturing	17,880	13,666
Other prepaids and current assets	22,918	10,798
Total current assets	381,234	602,323
Property and equipment, net	8,754	7,813
Inventory, non-current	76,260	55,610
Goodwill and intangible assets	5,931	3,563
Other assets, non-current	8,668	10,025
Total assets	480,847	679,334
Current liabilities:
Accounts payable	11,526	16,159
Accrued rebates, fees and reserves	54,461	79,027
Accrued compensation	22,610	22,014
Accrued and other current liabilities	50,097	48,127
Total current liabilities	138,694	165,327
Term loans	245,483	75,513
Convertible notes	225,575	332,767
Lease liabilities, non-current	5,046	7,251
Other liabilities, non-current	3,467	750
Total liabilities	618,265	581,608
Commitments and contingencies (Note 8)
Stockholders' equity (deficit):
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 78,851,516 and 76,930,096 at December 31, 2022 and 2021, respectively)	8	7
Additional paid-in capital	1,204,431	1,147,843
Accumulated other comprehensive loss	(249)	(270)
Accumulated deficit	(1,341,608)	(1,049,854)
Total stockholders' equity (deficit)	(137,418)	97,726
Total liabilities and stockholders' equity (deficit)	$ 480,847	$ 679,334

Debt Obligations - 2026 Convertible Notes Interest Expense Components (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Debt Instrument
Amortization of debt discount and debt issuance costs	$ 6,431	$ 4,257	$ 3,481
1.5% Convertible Senior Subordinated Notes due 2026 \| Convertible Notes
Debt Instrument
Stated coupon interest	3,450	3,450	2,434
Amortization of debt discount and debt issuance costs	1,286	1,259	873
Total Interest expense	$ 4,736	$ 4,709	$ 3,307

Leases - Schedule of Balance Sheet Classification of Lease Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Assets:
Operating lease right-of-use assets	$ 5,690	$ 8,193
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List]	Other Assets Noncurrent	Other Assets Noncurrent
Finance lease	$ 2,584	$ 1,220
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List]	Property, Plant and Equipment, Net	Property, Plant and Equipment, Net
Total leased assets	$ 8,274	$ 9,413
Liabilities:
Lease liabilities, current	$ 3,127	$ 2,751
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Accrued Liabilities Current	Accrued Liabilities Current
Operating lease liability noncurrent	$ 3,628	$ 6,753
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List]	Operating and Finance Lease, Liability, Noncurrent	Operating and Finance Lease, Liability, Noncurrent
Total operating lease liabilities	$ 6,755	$ 9,504
Finance lease liabilities, current	$ 1,191	$ 741
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List]	Accrued Liabilities Current	Accrued Liabilities Current
Finance lease liabilities, non-current	$ 1,418	$ 498
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List]	Other Liabilities Noncurrent	Other Liabilities Noncurrent
Total finance lease liabilities	$ 2,609	$ 1,239

Leases (Tables)

12 Months Ended

Dec. 31, 2022

Leases

Schedule of Balance Sheet Classification of Lease Assets and Liabilities


(in thousands)		December 31,
Assets	Balance Sheet Classification	2022		2021
Operating leases	Other assets, non-current	$	5,690	$	8,193
Finance leases	Property and equipment, net		2,584		1,220
Total leased assets		$	8,274	$	9,413


(in thousands)		December 31,
Liabilities	Balance Sheet Classification	2022		2021
Operating lease liabilities, current	Accrued and other current liabilities	$	3,127	$	2,751
Operating lease liabilities, non-current	Lease liabilities, non-current		3,628		6,753
Total operating lease liabilities		$	6,755	$	9,504

Finance lease liabilities, current	Accrued and other current liabilities	$	1,191	$	741
Finance lease liabilities, non-current	Lease liabilities, non-current		1,418		498
Total finance lease liabilities		$	2,609	$	1,239

Schedule of maturities of the operating and finance lease liabilities


	Year Ended December 31,
(in thousands)	2022		2021		2020
Cash paid for amounts included in measurement of lease liabilities:
Operating cash flows from operating leases	$	3,401	$	3,435	$	3,217
Operating cash flows from finance leases	$	155	$	81	$	53
Financing cash flows from finance leases	$	1,228	$	672	$	388
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—	$	434	$	1,388
Finance leases	$	2,694	$	477	$	1,817

As of December 31, 2022, the maturities of the lease liabilities were as follows:


Year ending December 31, (in thousands)	Operating leases		Finance leases
2023	$	3,560	$	1,354
2024		3,014		1,026
2025		412		481
2026		292		—
2027 and thereafter		124		—
Total lease payments		7,402		2,861
Less imputed interest		(647)		(252)
Lease liabilities	$	6,755	$	2,609

Other information related to lease term and discount rate


	December 31,
	2022		2021
Weighted-Average Remaining Lease Term
Operating leases		2.2 years		3.2 years
Finance leases		2.2 years		1.7 years
Weighted-Average Discount Rate
Operating leases		8.0%		8.0%
Finance leases		8.4%		5.8%

Components of lease expense


	Year Ended December 31,
(in thousands)	2022		2021		2020
Finance lease cost
Amortization of right-of-use assets	$	1,228	$	707	$	368
Interest on lease liabilities		166		82		57
Total finance lease cost		1,394		789		425
Operating lease cost		3,154		3,066		3,126
Total lease cost	$	4,548	$	3,855	$	3,551

Supplemental cash flow information related to leases


	Year Ended December 31,
(in thousands)	2022		2021		2020
Cash paid for amounts included in measurement of lease liabilities:
Operating cash flows from operating leases	$	3,401	$	3,435	$	3,217
Operating cash flows from finance leases	$	155	$	81	$	53
Financing cash flows from finance leases	$	1,228	$	672	$	388
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—	$	434	$	1,388
Finance leases	$	2,694	$	477	$	1,817

Schedule of Maturities of Operating Lease Liabilities


Year ending December 31, (in thousands)	Operating leases		Finance leases
2023	$	3,560	$	1,354
2024		3,014		1,026
2025		412		481
2026		292		—
2027 and thereafter		124		—
Total lease payments		7,402		2,861
Less imputed interest		(647)		(252)
Lease liabilities	$	6,755	$	2,609

Debt Obligations - Convertible Senior Subordinated Notes due 2026 - Narrative (Details)	1 Months Ended	12 Months Ended
	Apr. 30, 2020 USD ($) $ / shares shares	Dec. 31, 2022 USD ($) item	Dec. 31, 2020 USD ($)	Dec. 30, 2022 $ / shares	Apr. 14, 2020 $ / shares
Debt Instrument
Net proceeds from offering			$ 222,156,000
Closing stock, price per share \| $ / shares				$ 7.92	$ 14.82
1.5% Convertible Senior Subordinated Notes due 2026
Debt Instrument
Number of events in default \| item		0
Contractual term		6 years
Convertible Notes \| 1.5% Convertible Senior Subordinated Notes due 2026
Debt Instrument
Principal amount	$ 230,000,000.0
Stated interest rate	1.50%
Net proceeds from offering	$ 222,200,000
Initial conversion rate, shares of common stock \| shares	51.9224
Principal amount of notes converted into shares	$ 1,000
Initial conversion price per common share \| $ / shares	$ 19.26
Interest rate description	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
Debt instrument maturity date	Apr. 15, 2026
Convertible notes, premium percentage	30.00%
Convertible notes, covenant compliance		As of December 31, 2022, the Company was in full compliance with these covenants, and there were no events of default under the 2026 Convertible Notes.
Debt issuance costs		$ 900,000
Remaining unamortized debt discount and debt offering costs		$ 4,425,000
Effective interest rate		2.10%
Debt Instrument Term		3 years 3 months 18 days
Convertible Notes \| 1.5% Convertible Senior Subordinated Notes due 2026 \| Scenario, Plan
Debt Instrument
Convertible notes, converted amount		$ 94,600,000

Revenue - Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Accounts Notes And Loans Receivable
Activities and reserve balance, beginning balance	$ 109,723	$ 123,398	$ 87,147
Provision related to sales made in:
Current period	578,699	679,199	692,564
Prior period	(3,108)	(11,407)	(11,062)
Payments and customer credits issued	(584,811)	(681,467)	(645,251)
Activities and reserve balance, ending balance	100,503	109,723	123,398
Chargebacks and Discounts for Prompt Payment
Accounts Notes And Loans Receivable
Activities and reserve balance, beginning balance	29,665	40,580	35,159
Provision related to sales made in:
Current period	436,865	470,791	462,328
Prior period	(2,090)	(2,876)	(1,336)
Payments and customer credits issued	(421,763)	(478,830)	(455,571)
Activities and reserve balance, ending balance	42,677	29,665	40,580
Rebates
Accounts Notes And Loans Receivable
Activities and reserve balance, beginning balance	54,004	54,058	27,494
Provision related to sales made in:
Current period	68,399	113,705	115,864
Prior period	(1,050)	(4,976)	(3,438)
Payments and customer credits issued	(82,640)	(108,783)	(85,862)
Activities and reserve balance, ending balance	38,713	54,004	54,058
Other Fees, Co-pay Assistance and Returns
Accounts Notes And Loans Receivable
Activities and reserve balance, beginning balance	26,054	28,760	24,494
Provision related to sales made in:
Current period	73,435	94,703	114,372
Prior period	32	(3,555)	(6,288)
Payments and customer credits issued	(80,408)	(93,854)	(103,818)
Activities and reserve balance, ending balance	$ 19,113	$ 26,054	$ 28,760

Net (Loss) Income Per Share

12 Months Ended

Dec. 31, 2022

Net (Loss) Income Per Share

Net (Loss) Income Per Share

13.Net (Loss) Income Per Share

The following table sets forth the computation of the basic and diluted net (loss) income per share:


	Year Ended December 31,
(in thousands, except share and per share data)	2022		2021		2020
Basic net (loss) income per share
Numerator:
Net (loss) income	$	(291,754)	$	(287,100)	$	132,244
Denominator:
Weighted-average common shares outstanding		77,630,020		75,449,632		71,411,705
Basic net (loss) income per share	$	(3.76)	$	(3.81)	$	1.85

Diluted net (loss) income per share
Numerator:
Net (loss) income	$	(291,754)	$	(287,100)	$	132,244
Add interest expense on 2026 Convertible Notes, net of tax		—		—		3,307
Numerator for diluted net (loss) income per share		(291,754)		(287,100)		135,551
Denominator:
Denominator for basic net (loss) income per share		77,630,020		75,449,632		71,411,705
Add effect of potential dilutive securities:
Stock options, including shares subject to ESPP		—		—		3,455,646
Restricted stock units		—		—		167,597
Shares issuable upon conversion of convertible notes		—		—		8,456,950
Denominator for diluted net (loss) income per share		77,630,020		75,449,632		83,491,898
Diluted net (loss) income per share	$	(3.76)	$	(3.81)	$	1.62

The 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,
	2022	2021	2020
Stock options, including shares subject to ESPP	22,214,875	19,895,097	9,521,403
Restricted stock units	2,399,465	1,811,607	7,689
Shares issuable upon conversion of 2022 Convertible Notes	1,078,632	4,473,871	4,473,871
Shares issuable upon conversion of 2026 Convertible Notes	11,942,152	11,942,152	—
Total	37,635,124	38,122,727	14,002,963

Organization and Significant Accounting Policies - Selling, General and Administrative Expense (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Organization and Significant Accounting Policies
Advertising expenses	$ 10.5	$ 8.7	$ 3.8

At-The-Market Offering (Details) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended	12 Months Ended
	Nov. 08, 2022	Jan. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
At-The-Market Offering
Aggregate offering price				$ 40,903
Gross proceeds from issuance of common stock			$ 6,700
At The Market Offering.
At-The-Market Offering
Aggregate offering price	$ 150,000
Common stock, shares issued and sold		295,200	916,884
Share price		$ 7.41	$ 7.30
Gross proceeds from issuance of common stock		$ 2,200
Common stock, net proceeds		2,100	$ 6,500
Commissions and fees		$ 100	$ 200

Inventory (Tables)

12 Months Ended

Dec. 31, 2022

Inventory

Schedule of Inventory

Inventory consisted of the following:


	December 31,
(in thousands)	2022		2021
Raw materials	$	10,262	$	4,870
Work in process		86,712		65,117
Finished goods		18,077		23,265
Total	$	115,051	$	93,252

Schedule of Balance Sheet Classification


	December 31,
(in thousands)	2022		2021
Inventory	$	38,791	$	37,642
Inventory, non-current		76,260		55,610
Total	$	115,051	$	93,252

Consolidated Statements of Operations - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Revenue:
Net revenue	$ 211,042	$ 326,551	$ 475,824
Costs and expenses:
Cost of goods sold	70,083	57,591	37,667
Research and development	199,358	363,105	142,759
Selling, general and administrative	198,481	169,713	139,079
Total costs and expenses	467,922	590,409	319,505
(Loss) income from operations	(256,880)	(263,858)	156,319
Interest expense	(32,474)	(22,959)	(21,166)
Loss on debt extinguishment	(6,222)
Other income (expense), net	3,822	(283)	554
(Loss) income before income taxes	(291,754)	(287,100)	135,707
Income tax provision	0	0	3,463
Net (loss) income	$ (291,754)	$ (287,100)	$ 132,244
Net (loss) income per share:
Basic (In dollar per share)	$ (3.76)	$ (3.81)	$ 1.85
Diluted (In dollar per share)	$ (3.76)	$ (3.81)	$ 1.62
Weighted-average number of shares used in computing basic and diluted net (loss) income per share:
Basic (In shares)	77,630,020	75,449,632	71,411,705
Diluted (In shares)	77,630,020	75,449,632	83,491,898

Debt Obligations - 2026 Convertible Notes Future Payments (Details) - Convertible Notes - 1.5% Convertible Senior Subordinated Notes due 2026 $ in Thousands	Dec. 31, 2022 USD ($)
Debt Instrument
2023 - interest only	$ 3,450
2024 - interest only	3,450
2025 - interest only	3,450
2026 and thereafter	231,725
Total minimum payments	242,075
Less amount representing interest	(12,075)
2026 Convertible Notes, principal amount	230,000
Less unamortized debt discount and debt issuance costs	(4,425)
Net carrying amount of Term Loans	$ 225,575

Fair Value Measurements - Cost, Unrealized Gains or Losses, and Fair Value by Investment Type (Details) $ in Thousands	Dec. 31, 2022 USD ($)
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cost	$ 191,623
Unrealized Gain	43
Unrealized (Loss)	(21)
Fair Value	191,645
Money Market Funds [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cost	55,060
Fair Value	55,060
U.S. government agency securities
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cost	19,929
Unrealized Gain	35
Fair Value	19,964
US Treasury Securities
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cost	68,431
Unrealized Gain	8
Unrealized (Loss)	(21)
Fair Value	68,418
Commercial paper and corporate notes
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cost	48,203
Fair Value	$ 48,203

Organization and Significant Accounting Policies - Net Revenues (Details)	12 Months Ended
	Dec. 31, 2022
Revenue, Performance Obligation, Description of Payment Terms	Payment terms differ by jurisdiction and customer, but payment terms typically range from 30 to approximately 90 days from date of shipment and may be extended during the launch period of a new product.
Maximum
Payment terms from date of shipment, period	90 days
Minimum
Payment terms from date of shipment, period	30 days

Inventory (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Inventory
Raw materials	$ 10,262	$ 4,870
Work in process	86,712	65,117
Finished goods	18,077	23,265
Total	$ 115,051	$ 93,252