0001178879-23-000016 | 10-Q | XBRL Viewer

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Intangible Assets	9 Months Ended
Intangible Assets	Sep. 30, 2023
Goodwill and Intangible Assets Disclosure [Abstract]
Intangible Assets	Intangible AssetsAs of September 30, 2023, the Company's intangible assets consisted of lead enzyme replacement therapy assets acquired with the Callidus Biopharma, Inc. acquisition in 2013, previously accounted for as in-process research and development. In March 2023, as a result of the EC's approval of Pombiliti™, the Company began amortizing the assets over the initial regulatory exclusivity period of 7 years. The Company completed an impairment assessment before changing the classification to definite-lived intangible asset noting no impairment. Amortization expense for the three and nine months ended September 30, 2023 was $0.8 million and $1.7 million, respectively. Total estimated amortization for the finite-lived intangible assets is estimated to be $2.5 million for the year ending December 31, 2023 and $3.3 million for the next four years thereafter.

Assets and Liabilities Measured at Fair Value - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Mar. 31, 2023	Dec. 31, 2022
Business Acquisition [Line Items]
Contingent consideration			$ 21,417
Callidus Biopharma Inc
Business Acquisition [Line Items]
Contingent consideration	$ 15,000	$ 9,000

Debt - Summary of Long Term Debt (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Debt Instrument [Line Items]
Net carrying value of Long-term debt(2)	$ 394,071	$ 391,990
Senior Loans \| Senior Secured Term Loan due 2026
Debt Instrument [Line Items]
Principal	400,000	400,000
Less: debt discount	(3,384)	(4,571)
Less: deferred financing	$ (2,545)	$ (3,439)

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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+ Details

- Definition

Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

Inventories

9 Months Ended

Sep. 30, 2023

Inventory Disclosure [Abstract]

Inventories

Inventories as of September 30, 2023 and December 31, 2022 consisted of the following:


(in thousands)	September 30, 2023		December 31, 2022
Raw materials	$	36,062	$	10,054
Work-in-process	14,316		9,615
Finished goods	6,558		4,147
Total inventories	$	56,936	$	23,816

The Company's reserve for inventory was $0.3 million and $0.4 million as of September 30, 2023 and December 31, 2022, respectively.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Basis of Presentation

The Company has prepared the accompanying unaudited Consolidated Financial Statements in accordance with the U.S. generally accepted accounting principles ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying unaudited Consolidated Financial Statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company's interim financial information.

The accompanying unaudited Consolidated Financial Statements and related notes should be read in conjunction with the Company's financial statements and related notes as contained in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022. For a complete description of the Company's accounting policies, please refer to the Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

Consolidation

The Consolidated Financial Statements include the accounts of the Company and its subsidiaries. Intercompany accounts and transactions are eliminated in consolidation.

Foreign Currency Transactions

The functional currency for most of the Company's foreign subsidiaries is their local currency. For non-U.S. subsidiaries that transact in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign exchange rates for the period. Adjustments resulting from the translation of the financial statements of the Company's foreign operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of stockholders' equity.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.

Cash, Cash Equivalents, Marketable Securities, and Restricted Cash

The Company considers all highly liquid investments purchased with a maturity of three months or less at the date of acquisition to be cash equivalents. Marketable securities consist of fixed income investments with a maturity of greater than three months and other highly liquid investments that can be readily purchased or sold using established markets. These investments are classified as available-for-sale and are reported at fair value on the Company's Consolidated Balance Sheets. Unrealized holding gains and losses are reported within other comprehensive loss in the Company's Consolidated Statements of Comprehensive Loss. Fair value is based on available market information including quoted market prices, broker or dealer quotations, or other observable inputs.

Restricted cash consists primarily of funds held to satisfy the requirements of certain agreements that are restricted in their use and is included in other non-current assets on the Company's Consolidated Balance Sheets.

Concentration of Credit Risk

The Company's financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, and marketable securities. The Company maintains its cash and cash equivalents in bank accounts, which, at times, exceed federally insured limits. The Company invests its marketable securities in high-quality commercial financial instruments. The Company has not recognized any losses from credit risks on such accounts during any of the periods presented. The Company believes it is not exposed to significant credit risk on its cash, cash equivalents, or marketable securities.

The Company is subject to credit risk from its accounts receivable primarily related to its product sales of Galafold®. The Company's accounts receivable at September 30, 2023 have arisen from product sales primarily in Europe, the U.S., and Japan. The Company will periodically assess the financial strength of its customers to establish allowances for anticipated losses, if any. For accounts receivable that have arisen from named patient sales, the payment terms are predetermined, and the Company evaluates the creditworthiness of each customer on a regular basis. As of September 30, 2023, the Company's allowance for doubtful accounts was $0.1 million.

Revenue Recognition

The Company has recorded revenue on sales where its products are available either on a commercial basis or through a reimbursed early access program. Product orders are generally received from distributors and pharmacies, with the ultimate payor often a government authority.

The Company recognizes revenue when its performance obligations to its customers have been satisfied, which occurs at a point in time when the pharmacies or distributors obtain control. The transaction price is determined based on fixed consideration in the Company's customer contracts and is recorded net of estimates for variable consideration, which are third party discounts and rebates. The identified variable consideration is recorded as a reduction of revenue at the time revenue from the sale is recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes.

The following table summarizes the Company's net product sales disaggregated by product:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
Galafold®	$	100,733	$	81,631	$	281,177	$	241,056
Pombiliti™ + Opfolda™	2,768		60		3,097		81
Total net product sales	$	103,501	$	81,691	$	284,274	$	241,137

The following table summarizes the Company's net product sales disaggregated by geographic area:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
U.S.	$	37,801	$	30,222	$	103,760	$	81,940
Ex-U.S.	65,700		51,469		180,514		159,197
Total net product sales	$	103,501	$	81,691	$	284,274	$	241,137

Inventories and Cost of Goods Sold

Until regulatory approval of Pombiliti™ + Opfolda™, the Company expensed all manufacturing costs as research and development expense. Upon regulatory approval, the Company began capitalizing costs related to the purchase and manufacture of Pombiliti™ + Opfolda™.

Inventories are stated at the lower of cost and net realizable value, determined by the first-in, first-out method. Inventories are reviewed periodically to identify slow-moving or obsolete inventory based on projected sales activity as well as product shelf-life. In evaluating the recoverability of inventories produced, the probability that revenue will be obtained from the future sale of the related inventory is considered and inventory value is written down for inventory quantities in excess of expected requirements. Expired inventory is disposed of and the related costs are recognized as cost of goods sold in the Company's Consolidated Statements of Operations.

Cost of goods sold includes the cost of inventory sold, manufacturing and supply chain costs, product shipping and handling costs, provisions for excess and obsolete inventory, as well as royalties payable. A portion of inventory available for sale was expensed as research and development costs prior to regulatory approval and as such, the cost of goods sold and related gross margins are not necessarily indicative of future costs of goods sold and gross margin.

Intangible Assets and Goodwill

The Company records goodwill in a business combination when the total consideration exceeds the fair value of the net tangible and identifiable intangible assets acquired. Goodwill is assessed annually for impairment on October 1 and whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. The Company first assesses the qualitative factors to determine if a quantitative test is necessary. If required, or if the Company elects to bypass the qualitative assessment, a quantitative goodwill impairment test is conducted. If it is determined the Company's single reporting unit's carrying value, including goodwill, exceeds its fair value, an impairment loss is recorded for the difference.

Finite-lived intangible assets are recorded at cost, net of accumulated amortization, and, if applicable, impairment charges. Amortization of finite-lived intangible assets is recorded over the assets’ estimated useful lives on a straight-line basis or based on the pattern in which economic benefits are consumed, if reliably determinable. The Company reviews finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If impairment is determined, the Company writes down the asset to its estimated fair value and records an impairment loss equal to the excess of the carrying value of the asset over its estimated fair value in the period at which such a determination is made.

No indicators of impairment were noted during the nine months ended September 30, 2023.

Recent Accounting Developments

The Company has evaluated recent accounting pronouncements and believes that none of them will have a material effect on the Company's Consolidated Financial Statements or related disclosures.

Debt - Interest Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Debt - Interest Expense (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Debt Disclosure [Abstract]
Contractual interest expense	$ 12,270	$ 8,945	$ 35,289	$ 24,034
Amortization of debt discount	411	382	1,187	1,121
Amortization of deferred financing	$ 310	$ 286	$ 893	$ 842

Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands	Total	ATM	Common Stock	Common Stock ATM	Additional Paid-In Capital	Additional Paid-In Capital ATM	Warrants	Other Comprehensive Loss	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2021			278,912,800
Beginning balance at Dec. 31, 2021	$ 307,369		$ 2,808		$ 2,595,419		$ 83	$ 4,981	$ (2,295,922)
Increase (Decrease) in Stockholders' Equity
Stock options exercised, net (in shares)			506,823
Stock options exercised, net	3,191		$ 5		3,186
Vesting of restricted stock units, net of taxes (in shares)			1,467,513
Vesting of restricted stock units, net of taxes	(11,119)				(11,119)
Stock-based compensation	57,886				57,886
Unrealized (loss) gain on available-for-sale securities	(84)							(84)
Foreign currency translation adjustment	(43,975)							(43,975)
Net loss	(180,703)								(180,703)
Ending balance (in shares) at Sep. 30, 2022			280,887,136
Ending balance at Sep. 30, 2022	132,565		$ 2,813		2,645,372		83	(39,078)	(2,476,625)
Beginning balance (in shares) at Jun. 30, 2022			280,456,667
Beginning balance at Jun. 30, 2022	173,425		$ 2,811		2,631,110		83	(17,240)	(2,443,339)
Increase (Decrease) in Stockholders' Equity
Stock options exercised, net (in shares)			172,118
Stock options exercised, net	1,333		$ 2		1,331
Vesting of restricted stock units, net of taxes (in shares)			258,351
Vesting of restricted stock units, net of taxes	(1,841)				(1,841)
Stock-based compensation	14,772				14,772
Unrealized (loss) gain on available-for-sale securities	283							283
Foreign currency translation adjustment	(22,121)							(22,121)
Net loss	(33,286)								(33,286)
Ending balance (in shares) at Sep. 30, 2022			280,887,136
Ending balance at Sep. 30, 2022	$ 132,565		$ 2,813		2,645,372		83	(39,078)	(2,476,625)
Beginning balance (in shares) at Dec. 31, 2022	281,108,273		281,108,273
Beginning balance at Dec. 31, 2022	$ 123,047		$ 2,815		2,664,744		83	(12,105)	(2,532,490)
Increase (Decrease) in Stockholders' Equity
Stock options exercised, net (in shares)	1,032,000		1,025,684
Stock options exercised, net	$ 7,847		$ 11		7,836
Vesting of restricted stock units, net of taxes (in shares)			2,068,048
Vesting of restricted stock units, net of taxes	(16,355)				(16,355)
Stock-based compensation	67,982				67,982
Issuance of shares in connection with at-the-market offering, net of issuance costs (in shares)				5,244,936
Issuance of shares in connection with at-the-market offering, net of issuance costs		$ 63,108		$ 52		$ 63,056
Warrants exercised (in shares)			1,220,100
Warrants exercised	12		$ 12		12		(12)
Unrealized (loss) gain on available-for-sale securities	(79)							(79)
Foreign currency translation adjustment	5,416							5,416
Net loss	$ (117,741)								(117,741)
Ending balance (in shares) at Sep. 30, 2023	290,667,041		290,667,041
Ending balance at Sep. 30, 2023	$ 133,237		$ 2,890		2,787,275		71	(6,768)	(2,650,231)
Beginning balance (in shares) at Jun. 30, 2023			286,992,923
Beginning balance at Jun. 30, 2023	111,581		$ 2,856		2,733,148		71	4,160	(2,628,654)
Increase (Decrease) in Stockholders' Equity
Stock options exercised, net (in shares)			372,467
Stock options exercised, net	3,442		$ 4		3,438
Vesting of restricted stock units, net of taxes (in shares)			299,297
Vesting of restricted stock units, net of taxes	(2,347)				(2,347)
Stock-based compensation	16,511				16,511
Issuance of shares in connection with at-the-market offering, net of issuance costs (in shares)				3,002,354
Issuance of shares in connection with at-the-market offering, net of issuance costs		$ 36,555		$ 30		$ 36,525
Unrealized (loss) gain on available-for-sale securities	(18)							(18)
Foreign currency translation adjustment	(10,910)							(10,910)
Net loss	$ (21,577)								(21,577)
Ending balance (in shares) at Sep. 30, 2023	290,667,041		290,667,041
Ending balance at Sep. 30, 2023	$ 133,237		$ 2,890		$ 2,787,275		$ 71	$ (6,768)	$ (2,650,231)

Cash, Cash Equivalents, Marketable Securities, and Restricted Cash

9 Months Ended

Sep. 30, 2023

Cash, Cash Equivalents, and Short-Term Investments [Abstract]

Cash, Cash Equivalents, Marketable Securities, and Restricted Cash

As of September 30, 2023, the Company held $263.3 million in cash and cash equivalents and $17.0 million of marketable securities which are reported at fair value on the Company's Consolidated Balance Sheets. Unrealized holding gains and losses are generally reported within other comprehensive (loss) gain in the Company's Consolidated Statements of Comprehensive Loss. If a decline in the fair value of a marketable security below the Company's cost basis is determined to be other-than-temporary or if an available-for-sale debt security’s fair value is determined to be less than the amortized cost and the Company intends or is more than likely to sell the security before recovery and it is not considered a credit loss such security is written down to its estimated fair value as a new cost basis and the amount of the write-down is included in earnings as an impairment charge. If the unrealized loss of an available-for-sale debt security is determined to be a result of credit loss, the Company would recognize an allowance and the corresponding credit loss would be included in earnings.

The Company regularly invests excess operating cash in deposits with major financial institutions and money market funds, as well as fixed income investments which can be readily purchased and sold using established markets. The Company believes that the market risk arising from its holdings of these financial instruments is mitigated as, in accordance with Company policy, securities are of high credit rating. Investments that have original maturities greater than three months but less than one year are classified as current.

Cash, cash equivalents and marketable securities are classified as current unless mentioned otherwise below and consisted of the following:


	As of September 30, 2023
(in thousands)	Cost		Gross Unrealized Gain		Gross Unrealized Loss		Fair Value
Cash and cash equivalents	$	263,320	$	—	$	—	$	263,320
Commercial paper	16,826		3		—		16,829
Money market	100		—		—		100
Certificates of deposit	51		—		—		51
	$	280,297	$	3	$	—	$	280,300
Included in cash and cash equivalents	$	263,320	$	—	$	—	$	263,320
Included in marketable securities	16,977		3		—		16,980
Total cash, cash equivalents, and marketable securities	$	280,297	$	3	$	—	$	280,300


	As of December 31, 2022
(in thousands)	Cost		Gross Unrealized Gain		Gross Unrealized Loss		Fair Value
Cash and cash equivalents	$	148,813	$	—	$	—	$	148,813
Commercial paper	144,299		82		—		144,381
Money market	350		—		—		350
Certificate of deposit	51		—		—		51
	$	293,513	$	82	$	—	$	293,595
Included in cash and cash equivalents	$	148,813	$	—	$	—	$	148,813
Included in marketable securities	144,700		82		—		144,782
Total cash, cash equivalents, and marketable securities	$	293,513	$	82	$	—	$	293,595

For both the nine months ended September 30, 2023 and the fiscal year ended December 31, 2022, there were no realized gains or losses. The cost of securities sold is based on the specific identification method.

Unrealized loss positions in the marketable securities as of September 30, 2023 reflect temporary impairments and are not a result of credit loss. Additionally, as these positions have been in a loss position for less than twelve months and the Company does not intend to sell these securities before recovery, the losses are recognized in other comprehensive (loss) gain. The Company had no securities in an unrealized loss position as of both September 30, 2023 and December 31, 2022.

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Company's Consolidated Balance Sheets that sum to the total of the same such amounts shown in the Company's Consolidated Statements of Cash Flows.


	As of September 30,
(in thousands)	2023		2022
Cash and cash equivalents	$	263,320	$	277,592
Restricted cash	2,952		3,941
Cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows	$	266,272	$	281,533

Debt

9 Months Ended

Sep. 30, 2023

Debt Disclosure [Abstract]

Debt

The Company's debt consists of the following:


(in thousands)	September 30, 2023		December 31, 2022
Senior Secured Term Loan due 2026:
Principal	$	400,000	$	400,000
Less: debt discount (1)	(3,384)		(4,571)
Less: deferred financing (1)	(2,545)		(3,439)
Net carrying value of Long-term debt(2)	$	394,071	$	391,990

______________________________

(1) Included in the Company's Consolidated Balance Sheets within long-term debt and amortized to interest expense over the remaining life of the Senior Secured Term Loan due 2026 using the effective interest rate method.

(2) The Company classifies the current portion of long-term debt as non-current liabilities on the Consolidated Balance Sheets when it has the intent and ability to refinance the obligations on a long-term basis, in accordance with ASC 470-50 “Debt.” Accordingly, as of September 30, 2023, the debt was recorded as a long-term liability in the Company’s Consolidated Balance Sheet.

In October 2023, the Company entered into a $400 million loan agreement (the “Senior Secured Term Loan due 2029”) with Blackstone with an interest rate equal to 3-month Term SOFR, subject to a 2.5% floor, plus a Term SOFR adjustment of 0.26161% and a margin of 6.25% that requires interest-only payments until early-2027 and matures in six years in 2029. This transaction resulted in net proceeds of $387.4 million, after deducting fees and estimated expenses. There were no warrants or equity conversion features associated with the Senior Secured Term Loan due 2029.

The Company used proceeds from the Senior Secured Term Loan due 2029 and the private placement to prepay the Senior Secured Term Loan due 2026, inclusive of the outstanding principal amount, accrued interest and prepayment premium. In connection with the prepayment, the Company expects to record a loss from early extinguishment of debt of approximately $13.9 million in the fourth quarter of 2023, primarily related to the prepayment premium and write-off of unamortized debt discount and deferred financing costs.

Interest Expense

The following table sets forth interest expense recognized related to the Company's debt for the three and nine months ended September 30, 2023 and 2022, respectively:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
Contractual interest expense	$	12,270	$	8,945	$	35,289	$	24,034
Amortization of debt discount	$	411	$	382	$	1,187	$	1,121
Amortization of deferred financing	$	310	$	286	$	893	$	842

- 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://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Section S99
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+ Details

Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Accumulated depreciation of property and equipment	$ 25,018	$ 22,281
Accumulated amortization of intangible assets	$ 1,682	$ 0
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	500,000,000	500,000,000
Common stock, shares issued (in shares)	290,667,041	281,108,273
Common stock, shares outstanding (in shares)	290,667,041	281,108,273

Summary of Significant Accounting Policies - Revenue by Product and Geographical Area (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Net product sales	$ 103,501	$ 81,691	$ 284,274	$ 241,137
Galafold
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Net product sales	100,733	81,631	281,177	241,056
Pombiliti + Opfolda
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Net product sales	2,768	60	3,097	81
U.S.
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Net product sales	37,801	30,222	103,760	81,940
Ex-U.S.
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Net product sales	$ 65,700	$ 51,469	$ 180,514	$ 159,197

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

- Definition

Amount, excluding 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
-Topic 924
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Paragraph 30
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-30

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147482810/280-10-50-42

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Cash, Cash Equivalents, Marketable Securities, and Restricted Cash - Components (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 2022
Cash, Money Market Funds, and Marketable Securities
Cash and cash equivalents	$ 263,320	$ 148,813	$ 277,592
Fair value, cash balances	263,320	148,813
Cost, available-for-sale securities	16,977	144,700
Gross unrealized gain, available-for-sale securities	3	82
Gross unrealized loss, available-for-sale securities	0	0
Fair value, available-for-sale debt securities	16,980	144,782
Cost, cash balances and available-for-sale securities	280,297	293,513
Gross unrealized gain, cash balances and available-for-sale securities	3	82
Gross unrealized loss, cash balances and available-for-sale securities	0	0
Fair value, cash balances and available-for-sale securities	280,300	293,595
Commercial paper
Cash, Money Market Funds, and Marketable Securities
Cost, available-for-sale securities	16,826	144,299
Gross unrealized gain, available-for-sale securities	3	82
Gross unrealized loss, available-for-sale securities	0	0
Fair value, available-for-sale debt securities	16,829	144,381
Money market
Cash, Money Market Funds, and Marketable Securities
Cost, available-for-sale securities	100	350
Gross unrealized gain, available-for-sale securities	0	0
Fair value, available-for-sale debt securities	100	350
Gross unrealized loss, cash balances and available-for-sale securities	0	0
Certificates of deposit
Cash, Money Market Funds, and Marketable Securities
Cost, available-for-sale securities	51	51
Gross unrealized gain, available-for-sale securities	0	0
Fair value, available-for-sale debt securities	51	51
Gross unrealized loss, cash balances and available-for-sale securities	$ 0	$ 0

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Operating activities
Net loss	$ (117,741)	$ (180,703)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of debt discount and deferred financing	2,080	1,963
Depreciation and amortization	5,691	4,031
Stock-based compensation	67,982	57,886
Non-cash changes in the fair value of contingent consideration payable	2,583	(506)
Foreign currency remeasurement loss	18,121	2,828
Deferred taxes	(4,939)	0
Asset impairment charges and other asset write-offs	2,360	17,271
Changes in operating assets and liabilities:
Accounts receivable	(8,614)	(7,426)
Inventories	(42,233)	4,913
Prepaid expenses and other current assets	(26,010)	(5,583)
Accounts payable, accrued expenses, and other current liabilities	41,101	25,465
Other non-current assets and liabilities	(4,993)	(5,942)
Payment of contingent consideration	(7,937)	0
Net cash used in operating activities	(72,549)	(85,803)
Investing activities
Sale and redemption of marketable securities	180,828	259,920
Purchases of marketable securities	(53,098)	(99,811)
Capital expenditures	(5,709)	(1,089)
Net cash provided by investing activities	122,021	159,020
Financing activities
Payment of finance leases	(82)	(92)
Withholding taxes paid on vested restricted stock units	(16,355)	(11,119)
Proceeds from stock options exercised, net	7,847	3,191
Proceeds from warrants exercised, net	12	0
Proceeds from the issuance of shares in connection with at-the-market offering, net of issuance costs	63,108	0
Payment of contingent consideration	(1,063)	0
Net cash provided by (used in) financing activities	53,467	(8,020)
Effect of exchange rate changes on cash, cash equivalents, and restricted cash	10,218	(33,120)
Net increase in cash, cash equivalents, and restricted cash at the end of the period	113,157	32,077
Cash, cash equivalents, and restricted cash at the beginning of period	153,115	249,456
Cash, cash equivalents, and restricted cash at the end of period	266,272	281,533
Supplemental disclosures of cash flow information
Cash paid during the period for interest	35,448	24,058
Cash paid for taxes	6,473	935
Capital expenditures unpaid at the end of period	$ 877	$ 53

Assets and Liabilities Measured at Fair Value

9 Months Ended

Sep. 30, 2023

Fair Value Disclosures [Abstract]

Assets and Liabilities Measured at Fair Value

The Company's financial assets and liabilities are measured at fair value and classified within the fair value hierarchy, which is defined as follows:

Level 1 — Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2 — Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly.

Level 3 — Inputs that are unobservable for the asset or liability.

A summary of the fair value of the Company's recurring assets and liabilities aggregated by the level in the fair value hierarchy within which those measurements fall as of September 30, 2023 are identified in the following tables:


(in thousands)	Level 2		Total
Assets:
Commercial paper	$	16,829	$	16,829
Money market	6,818		6,818
	$	23,647	$	23,647


(in thousands)	Level 2		Total
Liabilities:
Deferred compensation plan liability	$	6,718	$	6,718
	$	6,718	$	6,718

A summary of the fair value of the Company's recurring assets and liabilities aggregated by the level in the fair value hierarchy within which those measurements fall as of December 31, 2022 are identified in the following tables:


(in thousands)	Level 2		Total
Assets:
Commercial paper	$	144,381	$	144,381
Money market	5,808		5,808
	$	150,189	$	150,189


(in thousands)	Level 2		Level 3		Total
Liabilities:
Contingent consideration payable	$	—	$	21,417	$	21,417
Deferred compensation plan liability	5,458		—		5,458
	$	5,458	$	21,417	$	26,875

The Company's Senior Secured Term Loan due 2026 falls into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals. The carrying value of the Senior Secured Term Loan due 2026 approximates the fair value. Deferred compensation plan liability is recorded as a component of other non-current liabilities on the Company's Consolidated Balance Sheets.

The Company did not have any Level 3 assets as of September 30, 2023 or December 31, 2022. Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration.

Cash, Money Market Funds, and Marketable Securities

The Company classifies its cash within the fair value hierarchy as Level 1 as these assets are valued using quoted prices in an active market for identical assets at the measurement date. The Company considers its investments in marketable securities as available-for-sale and classifies these assets and the money market funds within the fair value hierarchy as Level 2 primarily utilizing broker quotes in a non-active market for valuation of these securities.

Contingent Consideration Payable

The contingent consideration payable resulted from the acquisition of Callidus Biopharma, Inc. ("Callidus") in November 2013. The Company reached regulatory milestones of $9.0 million in March 2023 and $15.0 million in September 2023 associated with the approval of Pombiliti™ by the EC and FDA, respectively. The $9.0 million milestone payment was paid in the second quarter of 2023 and the $15.0 million milestone payment, which is payable in cash, is recorded as a component of accounts payable on the Company's Consolidated Balance Sheets as of September 30, 2023.

The following table shows the change in the balance of contingent consideration payable for the three and nine months ended September 30, 2023 and 2022, respectively:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
Balance, beginning of the period	$	13,005	$	19,266	$	21,417	$	20,339
Changes in fair value during the period, included in the Consolidated Statements of Operations	1,995		567		2,583		(506)
Milestone paid or payable in cash	(15,000)		—		(24,000)		—
Balance, end of the period	$	—	$	19,833	$	—	$	19,833

- 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

Intangible Assets (Details) $ in Millions	3 Months Ended	9 Months Ended
Intangible Assets (Details) $ in Millions	Sep. 30, 2023 USD ($)	Sep. 30, 2023 USD ($)
Goodwill and Intangible Assets Disclosure [Abstract]
Initial regulatory exclusivity period		7 years
Amortization expenses of intangible assets	$ 0.8	$ 1.7
Remainder of fiscal year 2023	2.5	2.5
2024	$ 3.3	$ 3.3

Cash, Cash Equivalents, Marketable Securities, and Restricted Cash - Cash, Cash Equivalents, And Restricted Cash (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
Cash, Cash Equivalents, and Short-Term Investments [Abstract]
Cash and cash equivalents	$ 263,320	$ 148,813	$ 277,592
Restricted cash	2,952		3,941
Cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows	$ 266,272	$ 153,115	$ 281,533	$ 249,456

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2023	Oct. 25, 2023
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Document Transition Report	false
Entity File Number	001-33497
Entity Registrant Name	Amicus Therapeutics, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	71-0869350
Entity Address, Address Line One	47 Hulfish Street
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08542
City Area Code	(609)
Local Phone Number	662-2000
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	FOLD
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		293,245,738
Entity Central Index Key	0001178879
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3

Inventories (Tables)

9 Months Ended

Sep. 30, 2023

Inventory Disclosure [Abstract]

Schedule of Inventories for the Period

Inventories as of September 30, 2023 and December 31, 2022 consisted of the following:


(in thousands)	September 30, 2023		December 31, 2022
Raw materials	$	36,062	$	10,054
Work-in-process	14,316		9,615
Finished goods	6,558		4,147
Total inventories	$	56,936	$	23,816

Debt - Narrative (Details) - Secured Debt - USD ($) $ in Millions	1 Months Ended	3 Months Ended
	Oct. 31, 2023	Dec. 31, 2023
Senior Loans \| Subsequent Event
Debt Instrument [Line Items]
Maximum borrowing capacity	$ 400.0
Basis spread on variable rate	6.25%
Maturity term	6 years
Proceeds from secured lines of credit	$ 387.4
Senior Loans \| Subsequent Event \| Secured Overnight Financing Rate Floor
Debt Instrument [Line Items]
Basis spread on variable rate	2.50%
Senior Loans \| Subsequent Event \| Secured Overnight Financing Rate Adjustment
Debt Instrument [Line Items]
Basis spread on variable rate	0.26161%
2029 Senior Secured Term Loan \| Forecast
Debt Instrument [Line Items]
Loss on extinguishment of debt		$ 13.9

Basic and Diluted Net Loss per Common Share

9 Months Ended

Sep. 30, 2023

Earnings Per Share [Abstract]

Basic and Diluted Net Loss per Common Share

The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss attributable to common stockholders per common share:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands, except per share amounts)	2023		2022		2023		2022
Numerator:
Net loss attributable to common stockholders	$	(21,577)	$	(33,286)	$	(117,741)	$	(180,703)
Denominator:
Weighted average common shares outstanding — basic and diluted	295,759,435		289,223,709		293,314,167		288,841,092

Dilutive common stock equivalents would include the dilutive effect of outstanding common stock options and unvested RSUs. Potentially dilutive common stock equivalents were excluded from the diluted earnings per share denominator for all periods because of their anti-dilutive effect. Weighted average common shares outstanding includes outstanding pre-funded warrants with an exercise price of $0.01.

The table below presents potential shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method:


	As of September 30,
(in thousands)	2023	2022
Options to purchase common stock	23,256	19,236
Unvested restricted stock units	10,331	9,839
Total number of potentially issuable shares	33,587	29,075

Insider Trading Arrangements

3 Months Ended

9 Months Ended

Sep. 30, 2023

Trading Arrangements, by Individual

Material Terms of Trading Arrangement

The following table describes, for the quarterly period covered by this report, each director and officer (as defined in Rule 16a-1(f) under the Exchange Act who has adopted, modified, or terminated a trading plan intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act (each plan, a “Rule 10b5-1 Trading Plan”). Each Rule 10b5-1 Trading Plan described below was adopted during an open insider trading window and in accordance with the Company’s policies regarding both insider trading and transactions relating to Company securities.

Name
(Title)

Action Taken
(Date of Action)

Rule 10b5-1 Trading Plan Provides for Purchase/Sale

Duration of the Trading Plan(1)

Aggregate Number of Securities

Bradley Campbell

(President and Chief Executive Officer)

Adoption

(August 23, 2023)

Sale

December 31, 2024

Indeterminable (2)

Jeffrey Castelli

(Chief Development Officer)

Adoption

(August 25, 2023)

Sale

May 15, 2024

52,264

David Clark

(Chief People Officer)

Adoption

(August 25, 2023)

Sale

August 15, 2024

Indeterminable (3)

John F. Crowley

(Executive Chairman)

Adoption

(September 6, 2023)

Sale

April 15, 2024

Indeterminable (3)

Ellen Rosenberg

(Chief Legal Officer and Corporate Secretary)

Adoption

(September 8, 2023)

Sale

December 7, 2024

95,000

____________________________

(1) The dates in this column represent the scheduled expiration date of each director or officer’s Rule 10b5-1 Trading Plan. Each Rule 10b5-1 Trading Plan may terminate earlier than the date provided should all transactions contemplated thereunder occur prior to such date.

(2) Mr. Campbell’s Rule 10b5-1 Trading Plan provides for the (i) exercise of up to 190,000 stock options and the sale of up to 190,000 underlying shares of common stock and (ii) sale of an indeterminable number of shares of common stock. The shares of common stock in clause (ii) will be obtained from the settlement of Mr. Campbell’s 2021 performance restricted stock unit (“PRSU”) awards. The number of shares of common stock obtained and available for sale will be subject to the (a) level of achievement of each performance goal contained within the 2021 PRSU awards and (b) shares of common stock withheld to satisfy applicable tax withholding obligations.

(3) The shares of common stock to be sold under this Rule 10b5-1 Trading Plan will be obtained from the settlement of the 2021 PRSU awards and the respective vesting of the 2020, 2021, 2022 and 2023 annual restricted stock unit awards. The number of shares of common stock obtained and available for sale will be subject to the (i) level of achievement of each performance goal contained within the 2021 PRSU awards and (ii) shares of common stock withheld to satisfy applicable tax withholding obligations.

Non-Rule 10b5-1 Arrangement Adopted

false

Rule 10b5-1 Arrangement Terminated

false

Non-Rule 10b5-1 Arrangement Terminated

false

Bradley Campbell [Member]

Trading Arrangements, by Individual

Name

Bradley Campbell

Title

President and Chief Executive Officer

Rule 10b5-1 Arrangement Adopted

true

Adoption Date

August 23, 2023

Arrangement Duration

135 days

Jeffrey Castelli [Member]

Trading Arrangements, by Individual

Name

Jeffrey Castelli

Title

Chief Development Officer

Rule 10b5-1 Arrangement Adopted

true

August 25, 2023

264 days

52,264

Trading Arrangements, by Individual

Name

David Clark

Title

Chief People Officer

Rule 10b5-1 Arrangement Adopted

true

Adoption Date

August 25, 2023

Arrangement Duration

356 days

John F. Crowley [Member]

Trading Arrangements, by Individual

Name

John F. Crowley

Title

Executive Chairman

Rule 10b5-1 Arrangement Adopted

true

Adoption Date

September 6, 2023

Arrangement Duration

222 days

Ellen Rosenberg [Member]

Trading Arrangements, by Individual

Name

Ellen Rosenberg

Title

Chief Legal Officer and Corporate Secretary

Rule 10b5-1 Arrangement Adopted

true

Adoption Date

September 8, 2023

Arrangement Duration

456 days

Aggregate Available

95,000

Cash, Cash Equivalents, Marketable Securities, and Restricted Cash - Narrative (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 2022
Cash, Cash Equivalents, and Short-Term Investments [Abstract]
Cash and cash equivalents	$ 263,320,000	$ 148,813,000	$ 277,592,000
Available-for-sale debt securities	16,980,000	144,782,000
Debt securities, realized gain (loss)	$ 0	0
Fair value of available-for-sale debt securities in unrealized loss positions		$ 0

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2023

Share-Based Payment Arrangement [Abstract]

Schedule of Fair Value of Options

The fair value of the stock options granted is estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:


	Three Months Ended September 30,						Nine Months Ended September 30,
	2023			2022			2023			2022
Expected stock price volatility	58.4		%	61.0		%	59.2		%	62.2		%
Risk free interest rate	4.3		%	3.1		%	3.9		%	1.7		%
Expected life of options (years)	5.5			5.3			5.5			5.3
Expected annual dividend per share	$	—		$	—		$	—		$	—

Schedule of Stock Options Activity

A summary of the Company's stock options for the nine months ended September 30, 2023 were as follows:


	Number of Shares	Weighted Average Exercise Price		Weighted Average Remaining Years	Aggregate Intrinsic Value
	(in thousands)				(in millions)
Options outstanding, December 31, 2022	19,064	$	11.31
Granted	5,522	$	12.03
Exercised	(1,032)	$	7.61
Forfeited	(248)	$	11.51
Expired	(50)	$	14.39
Options outstanding, September 30, 2023	23,256	$	11.64	6.7	$	32.1
Vested and unvested expected to vest, September 30, 2023	21,389	$	11.58	6.5	$	31.1
Exercisable at September 30, 2023	13,246	$	11.12	5.1	$	27.9

Schedule of Non-Vested RSU Activity under the Plan

A summary of non-vested RSU activity under the Plan for the nine months ended September 30, 2023 is as follows:


	Number of Shares	Weighted Average Grant Date Fair Value		Weighted Average Remaining Years	Aggregate Intrinsic Value
	(in thousands)				(in millions)
Non-vested units as of December 31, 2022	9,717	$	13.07
Granted	4,514	$	13.08
Vested	(3,252)	$	12.25
Forfeited	(648)	$	10.07
Non-vested units as of September 30, 2023	10,331	$	13.56	2.2	$	125.6

Schedule of Equity Compensation Expenses

The following table summarizes information related to compensation expense recognized in the Company's Consolidated Statements of Operations related to the equity awards:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
Research and development expense	$	4,380	$	5,428	$	16,987	$	19,172
Selling, general, and administrative expense	12,131		9,344		50,995		38,714
Total equity compensation expense	$	16,511	$	14,772	$	67,982	$	57,886

Assets and Liabilities Measured at Fair Value (Tables)

9 Months Ended

Sep. 30, 2023

Fair Value Disclosures [Abstract]

Summary of Assets and Liabilities Subject to Fair Value Measurements


(in thousands)	Level 2		Total
Assets:
Commercial paper	$	16,829	$	16,829
Money market	6,818		6,818
	$	23,647	$	23,647


(in thousands)	Level 2		Total
Liabilities:
Deferred compensation plan liability	$	6,718	$	6,718
	$	6,718	$	6,718


(in thousands)	Level 2		Total
Assets:
Commercial paper	$	144,381	$	144,381
Money market	5,808		5,808
	$	150,189	$	150,189


(in thousands)	Level 2		Level 3		Total
Liabilities:
Contingent consideration payable	$	—	$	21,417	$	21,417
Deferred compensation plan liability	5,458		—		5,458
	$	5,458	$	21,417	$	26,875

Schedule of Changes in Continent Consideration Payable

The following table shows the change in the balance of contingent consideration payable for the three and nine months ended September 30, 2023 and 2022, respectively:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
Balance, beginning of the period	$	13,005	$	19,266	$	21,417	$	20,339
Changes in fair value during the period, included in the Consolidated Statements of Operations	1,995		567		2,583		(506)
Milestone paid or payable in cash	(15,000)		—		(24,000)		—
Balance, end of the period	$	—	$	19,833	$	—	$	19,833

Stock-Based Compensation

9 Months Ended

Sep. 30, 2023

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

The Company's Amended and Restated 2007 Equity Incentive Plan (the "Plan") provides for the granting of restricted stock units and options to purchase common stock in the Company to employees, directors, advisors, and consultants at a price to be determined by the Company's Board of Directors. The Plan is intended to encourage ownership of stock by employees and consultants of the Company and to provide additional incentives for them to promote the success of the Company's business. The Board of Directors, or its committee, is responsible for determining the individuals to be granted options, the number of options each individual will receive, the option price per share, and the exercise period of each option.

Stock Option Grants

The fair value of the stock options granted is estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:


	Three Months Ended September 30,						Nine Months Ended September 30,
	2023			2022			2023			2022
Expected stock price volatility	58.4		%	61.0		%	59.2		%	62.2		%
Risk free interest rate	4.3		%	3.1		%	3.9		%	1.7		%
Expected life of options (years)	5.5			5.3			5.5			5.3
Expected annual dividend per share	$	—		$	—		$	—		$	—

A summary of the Company's stock options for the nine months ended September 30, 2023 were as follows:


	Number of Shares	Weighted Average Exercise Price		Weighted Average Remaining Years	Aggregate Intrinsic Value
	(in thousands)				(in millions)
Options outstanding, December 31, 2022	19,064	$	11.31
Granted	5,522	$	12.03
Exercised	(1,032)	$	7.61
Forfeited	(248)	$	11.51
Expired	(50)	$	14.39
Options outstanding, September 30, 2023	23,256	$	11.64	6.7	$	32.1
Vested and unvested expected to vest, September 30, 2023	21,389	$	11.58	6.5	$	31.1
Exercisable at September 30, 2023	13,246	$	11.12	5.1	$	27.9

As of September 30, 2023, the total unrecognized compensation cost related to non-vested stock options granted was $39.8 million and is expected to be recognized over a weighted average period of three years.

Restricted Stock Units and Performance-Based Restricted Stock Units (collectively "RSUs")

RSUs awarded under the Plan are generally subject to graded vesting and are contingent on an employee's continued service. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. A summary of non-vested RSU activity under the Plan for the nine months ended September 30, 2023 is as follows:


	Number of Shares	Weighted Average Grant Date Fair Value		Weighted Average Remaining Years	Aggregate Intrinsic Value
	(in thousands)				(in millions)
Non-vested units as of December 31, 2022	9,717	$	13.07
Granted	4,514	$	13.08
Vested	(3,252)	$	12.25
Forfeited	(648)	$	10.07
Non-vested units as of September 30, 2023	10,331	$	13.56	2.2	$	125.6

As of September 30, 2023, there was $63.1 million of total unrecognized compensation cost related to unvested RSUs with service-based vesting conditions. These costs are expected to be recognized over a weighted average period of two years.

Compensation Expense Related to Equity Awards

The following table summarizes information related to compensation expense recognized in the Company's Consolidated Statements of Operations related to the equity awards:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
Research and development expense	$	4,380	$	5,428	$	16,987	$	19,172
Selling, general, and administrative expense	12,131		9,344		50,995		38,714
Total equity compensation expense	$	16,511	$	14,772	$	67,982	$	57,886

Description of Business	9 Months Ended
Description of Business	Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Description of Business	Description of Business Amicus Therapeutics, Inc. (the "Company") is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases. The Company has developed and commercialized the first oral monotherapy for Fabry disease that has achieved widespread global approval and the first two-component therapy for late-onset Pompe disease that has been approved in the European Union (“E.U.”), the United Kingdom (“U.K.”), and in the United States (“U.S.”). The Company is committed to discovering and developing next generation therapies in Fabry and Pompe diseases. The cornerstone of the Company's portfolio is Galafold® (also referred to as "migalastat"), the first and only approved oral precision medicine for people living with Fabry disease who have amenable genetic variants. Migalastat is currently approved under the trade name Galafold® in the U.S., E.U., U.K., and Japan, with multiple additional approvals granted and applications pending in several geographies around the world. Pombiliti™ + Opfolda™ (also referred to as AT-GAA, ATB200/AT2221, or cipaglucosidase alfa-atga/miglustat), is a novel, two-component treatment for late-onset Pompe disease that was approved by the European Commission ("EC") in June 2023, the U.K. Medicines and Healthcare products Regulatory Agency ("MHRA") in August 2023, and the U.S. Food and Drug Administration ("FDA") in September 2023. The Company began launch activities for Pombiliti™ + Opfolda™ in these markets and have commenced the reimbursement processes with healthcare authorities in additional European countries. The Company had an accumulated deficit of $2.7 billion as of September 30, 2023 and anticipates incurring losses through the fiscal year ending December 31, 2023. The Company has historically funded its operations through stock offerings, Galafold® revenues, debt issuances, collaborations, and other financing arrangements. In October 2023, the Company entered into a $400 million loan agreement (the “Senior Secured Term Loan due 2029”) with Blackstone Alternative Credit Advisors LP and Blackstone Life Sciences Advisors L.L.C. (collectively, “Blackstone”) with an interest rate equal to 3-month Term SOFR, subject to a 2.5% floor, plus a Term SOFR adjustment of 0.26161% and a margin of 6.25% that requires interest-only payments until early-2027 and matures in six years in 2029. This transaction resulted in net proceeds of $387.4 million, after deducting fees and estimated expenses. There were no warrants or equity conversion features associated with the Senior Secured Term Loan due 2029. Simultaneously, the Company also entered into a securities purchase agreement with funds managed by Blackstone, for the private placement of an aggregate of 2,467,104 shares of the Company’s common stock, at a purchase price of $12.16 per share. Proceeds from the private placement, net of offering costs, were $29.8 million. The Company used proceeds from the Senior Secured Term Loan due 2029 and the private placement to prepay the Senior Secured Term Loan due 2026, inclusive of the outstanding principal amount, accrued interest and prepayment premium. The remaining proceeds will be used to fund ongoing operations. Based on its current operating model, the Company believes that the current cash position, which includes expected revenues, is sufficient to fund the Company's operations and ongoing research programs for at least the next 12 months. Potential business development collaborations, pipeline expansion, and investment in manufacturing capabilities could impact the Company's future capital requirements.

Stock-Based Compensation - Narrative (Details) $ in Millions	9 Months Ended
	Sep. 30, 2023 USD ($)
Options to purchase common stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total unrecognized compensation costs	$ 39.8
Unrecognized compensation costs, period for recognition (in years)	3 years
Unvested restricted stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total unrecognized compensation costs	$ 63.1
Unrecognized compensation costs, period for recognition (in years)	2 years

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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-Subparagraph (e)(2)
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
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Reference 26: http://www.xbrl.org/2003/role/disclosureRef
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Reference 27: http://www.xbrl.org/2003/role/disclosureRef
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Reference 28: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	3 Months Ended	9 Months Ended
	Oct. 31, 2023	Sep. 30, 2023	Sep. 30, 2023
Subsidiary, Sale of Stock [Line Items]
Offering price per share (in dollars per share)			$ 12.50
Subsequent Event
Subsidiary, Sale of Stock [Line Items]
Private placement net of offering cost	$ 29.8
Common Stock \| Subsequent Event
Subsidiary, Sale of Stock [Line Items]
Stock issued from equity financing (in shares)	2,467,104
ATM
Subsidiary, Sale of Stock [Line Items]
Number of shares issued, private placement (in shares)		3,002,354	5,244,936
Offering price per share (in dollars per share)		$ 12.68
Aggregate net proceeds from stock offering		$ 36.6	$ 63.1
Common stock, capital share reserved for future issuance		184,400,000	184,400,000
ATM \| Common Stock
Subsidiary, Sale of Stock [Line Items]
Stock issued from equity financing (in shares)		3,002,354	5,244,936
Private Placement \| Subsequent Event
Subsidiary, Sale of Stock [Line Items]
Purchase price (in dollars per share)	$ 12.16

Assets and Liabilities Measured at Fair Value - Level 3 Roll Forward (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance, beginning of the period	$ 13,005	$ 19,266	$ 21,417	$ 20,339
Changes in fair value during the period, included in the Consolidated Statements of Operations	(1,995)	(567)	(2,583)	506
Milestone paid or payable in cash	(15,000)	0	(24,000)	0
Balance, end of the period	$ 0	$ 19,833	$ 0	$ 19,833

Basic and Diluted Net Loss per Common Share (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Numerator:
Net loss attributable to common stockholders	$ (21,577)	$ (33,286)	$ (117,741)	$ (180,703)
Denominator:
Weighted average common shares outstanding - basic (in shares)	295,759,435	289,223,709	293,314,167	288,841,092
Weighted average common shares outstanding - diluted (in shares)	295,759,435	289,223,709	293,314,167	288,841,092
Antidilutive securities
Antidilutive securities excluded from computation of diluted earnings per share (in shares)			33,587,000	29,075,000
Options to purchase common stock
Antidilutive securities
Antidilutive securities excluded from computation of diluted earnings per share (in shares)			23,256,000	19,236,000
Unvested restricted stock units
Antidilutive securities
Antidilutive securities excluded from computation of diluted earnings per share (in shares)			10,331,000	9,839,000

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Name Accounting Standards Codification
-Section S99
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 263,320	$ 148,813
Investments in marketable securities	16,980	144,782
Accounts receivable	73,331	66,196
Inventories	56,936	23,816
Prepaid expenses and other current assets	52,689	40,209
Total current assets	463,256	423,816
Operating lease right-of-use assets, net	29,511	29,534
Property and equipment, less accumulated depreciation of $25,018 and $22,281 at September 30, 2023 and December 31, 2022, respectively	31,072	30,778
Intangible assets, less accumulated amortization of $1,682 and $0 at September 30, 2023 and December 31, 2022, respectively	21,318	23,000
Goodwill	197,797	197,797
Other non-current assets	21,130	19,242
Total Assets	764,084	724,167
Current liabilities:
Accounts payable	23,154	15,413
Accrued expenses and other current liabilities	138,535	93,636
Contingent consideration payable	0	21,417
Operating lease liabilities	7,765	8,552
Total current liabilities	169,454	139,018
Long-term debt	394,071	391,990
Operating lease liabilities	52,454	51,578
Deferred reimbursements	5,906	4,656
Deferred income taxes	0	4,939
Other non-current liabilities	8,962	8,939
Total liabilities	630,847	601,120
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.01 par value, 500,000,000 shares authorized, 290,667,041 and 281,108,273 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively	2,890	2,815
Additional paid-in capital	2,787,275	2,664,744
Accumulated other comprehensive loss:
Foreign currency translation adjustment	(6,573)	(11,989)
Unrealized loss on available-for-sale securities	(195)	(116)
Warrants	71	83
Accumulated deficit	(2,650,231)	(2,532,490)
Total stockholders’ equity	133,237	123,047
Total Liabilities and Stockholders’ Equity	$ 764,084	$ 724,167

Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Millions	9 Months Ended
	Sep. 30, 2023
Number of Shares
Balance at the beginning of the period (in shares)	19,064
Options, granted (in shares)	5,522
Options, exercised (in shares)	(1,032)
Options, forfeited (in shares)	(248)
Options, expired (in shares)	(50)
Balance at the end of the period (in shares)	23,256
Vested and unvested expected to vest as of the end of the period (in shares)	21,389
Exercisable at the end of the period (in shares)	13,246
Weighted Average Exercise Price
Balance at the beginning of the period (in dollars per share)	$ 11.31
Options, granted (in dollars per share)	12.03
Options, exercised (in dollars per share)	7.61
Options, forfeited (in dollars per share)	11.51
Options, expired (in dollars per share)	14.39
Balance at the end of the period (in dollars per share)	11.64
Vested and unvested expected to vest as of the end of the period (in dollars per share)	11.58
Exercisable at the end of the period (in dollars per share)	$ 11.12
Weighted Average Remaining Years and Aggregate Intrinsic Value
Balance at the end of the period	6 years 8 months 12 days
Vested and unvested expected to vest at the end of the period	6 years 6 months
Exercisable at the end of the period	5 years 1 month 6 days
Aggregate intrinsic value, options outstanding	$ 32.1
Aggregate intrinsic value, vested and unvested expected to vest	31.1
Aggregate intrinsic value of options exercisable	$ 27.9

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Schedule of Revenue Disaggregated by Geographical Area

The following table summarizes the Company's net product sales disaggregated by product:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
Galafold®	$	100,733	$	81,631	$	281,177	$	241,056
Pombiliti™ + Opfolda™	2,768		60		3,097		81
Total net product sales	$	103,501	$	81,691	$	284,274	$	241,137

The following table summarizes the Company's net product sales disaggregated by geographic area:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
U.S.	$	37,801	$	30,222	$	103,760	$	81,940
Ex-U.S.	65,700		51,469		180,514		159,197
Total net product sales	$	103,501	$	81,691	$	284,274	$	241,137

Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Statement of Comprehensive Income [Abstract]
Net loss	$ (21,577)	$ (33,286)	$ (117,741)	$ (180,703)
Other comprehensive (loss) gain:
Foreign currency translation adjustment (loss) gain	(10,910)	(22,121)	5,416	(43,975)
Unrealized (loss) gain on available-for-sale securities	(18)	283	(79)	(84)
Other comprehensive (loss) gain	(10,928)	(21,838)	5,337	(44,059)
Comprehensive loss	$ (32,505)	$ (55,124)	$ (112,404)	$ (224,762)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2023
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The Company has prepared the accompanying unaudited Consolidated Financial Statements in accordance with the U.S. generally accepted accounting principles ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying unaudited Consolidated Financial Statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company's interim financial information. The accompanying unaudited Consolidated Financial Statements and related notes should be read in conjunction with the Company's financial statements and related notes as contained in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022. For a complete description of the Company's accounting policies, please refer to the Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
Consolidation	Consolidation The Consolidated Financial Statements include the accounts of the Company and its subsidiaries. Intercompany accounts and transactions are eliminated in consolidation.
Foreign Currency Transactions	Foreign Currency Transactions The functional currency for most of the Company's foreign subsidiaries is their local currency. For non-U.S. subsidiaries that transact in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign exchange rates for the period. Adjustments resulting from the translation of the financial statements of the Company's foreign operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of stockholders' equity.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Cash, Cash Equivalents, Marketable Securities and Restricted Cash	Cash, Cash Equivalents, Marketable Securities, and Restricted Cash The Company considers all highly liquid investments purchased with a maturity of three months or less at the date of acquisition to be cash equivalents. Marketable securities consist of fixed income investments with a maturity of greater than three months and other highly liquid investments that can be readily purchased or sold using established markets. These investments are classified as available-for-sale and are reported at fair value on the Company's Consolidated Balance Sheets. Unrealized holding gains and losses are reported within other comprehensive loss in the Company's Consolidated Statements of Comprehensive Loss. Fair value is based on available market information including quoted market prices, broker or dealer quotations, or other observable inputs. Restricted cash consists primarily of funds held to satisfy the requirements of certain agreements that are restricted in their use and is included in other non-current assets on the Company's Consolidated Balance Sheets.
Concentration of Credit Risk	Concentration of Credit Risk The Company's financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, and marketable securities. The Company maintains its cash and cash equivalents in bank accounts, which, at times, exceed federally insured limits. The Company invests its marketable securities in high-quality commercial financial instruments. The Company has not recognized any losses from credit risks on such accounts during any of the periods presented. The Company believes it is not exposed to significant credit risk on its cash, cash equivalents, or marketable securities. The Company is subject to credit risk from its accounts receivable primarily related to its product sales of Galafold®. The Company's accounts receivable at September 30, 2023 have arisen from product sales primarily in Europe, the U.S., and Japan. The Company will periodically assess the financial strength of its customers to establish allowances for anticipated losses, if any. For accounts receivable that have arisen from named patient sales, the payment terms are predetermined, and the Company evaluates the creditworthiness of each customer on a regular basis.
Revenue Recognition	Revenue Recognition The Company has recorded revenue on sales where its products are available either on a commercial basis or through a reimbursed early access program. Product orders are generally received from distributors and pharmacies, with the ultimate payor often a government authority. The Company recognizes revenue when its performance obligations to its customers have been satisfied, which occurs at a point in time when the pharmacies or distributors obtain control. The transaction price is determined based on fixed consideration in the Company's customer contracts and is recorded net of estimates for variable consideration, which are third party discounts and rebates. The identified variable consideration is recorded as a reduction of revenue at the time revenue from the sale is recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes.
Inventories and Cost of Goods Sold	Inventories and Cost of Goods Sold Until regulatory approval of Pombiliti™ + Opfolda™, the Company expensed all manufacturing costs as research and development expense. Upon regulatory approval, the Company began capitalizing costs related to the purchase and manufacture of Pombiliti™ + Opfolda™. Inventories are stated at the lower of cost and net realizable value, determined by the first-in, first-out method. Inventories are reviewed periodically to identify slow-moving or obsolete inventory based on projected sales activity as well as product shelf-life. In evaluating the recoverability of inventories produced, the probability that revenue will be obtained from the future sale of the related inventory is considered and inventory value is written down for inventory quantities in excess of expected requirements. Expired inventory is disposed of and the related costs are recognized as cost of goods sold in the Company's Consolidated Statements of Operations.Cost of goods sold includes the cost of inventory sold, manufacturing and supply chain costs, product shipping and handling costs, provisions for excess and obsolete inventory, as well as royalties payable.
Intangible Assets and Goodwill	Intangible Assets and Goodwill The Company records goodwill in a business combination when the total consideration exceeds the fair value of the net tangible and identifiable intangible assets acquired. Goodwill is assessed annually for impairment on October 1 and whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. The Company first assesses the qualitative factors to determine if a quantitative test is necessary. If required, or if the Company elects to bypass the qualitative assessment, a quantitative goodwill impairment test is conducted. If it is determined the Company's single reporting unit's carrying value, including goodwill, exceeds its fair value, an impairment loss is recorded for the difference. Finite-lived intangible assets are recorded at cost, net of accumulated amortization, and, if applicable, impairment charges. Amortization of finite-lived intangible assets is recorded over the assets’ estimated useful lives on a straight-line basis or based on the pattern in which economic benefits are consumed, if reliably determinable. The Company reviews finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If impairment is determined, the Company writes down the asset to its estimated fair value and records an impairment loss equal to the excess of the carrying value of the asset over its estimated fair value in the period at which such a determination is made. No indicators of impairment were noted during the nine months ended September 30, 2023.
Recent Accounting Developments	Recent Accounting Developments The Company has evaluated recent accounting pronouncements and believes that none of them will have a material effect on the Company's Consolidated Financial Statements or related disclosures.

Basic and Diluted Net Loss per Common Share - Narrative (Details)	Sep. 30, 2023 $ / shares
Private Placement
Antidilutive securities
Warrants exercise price (in dollars per share)	$ 0.01

Cash, Cash Equivalents, Marketable Securities, and Restricted Cash (Tables)

9 Months Ended

Sep. 30, 2023

Cash, Cash Equivalents, and Short-Term Investments [Abstract]

Schedule of Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities are classified as current unless mentioned otherwise below and consisted of the following:


	As of September 30, 2023
(in thousands)	Cost		Gross Unrealized Gain		Gross Unrealized Loss		Fair Value
Cash and cash equivalents	$	263,320	$	—	$	—	$	263,320
Commercial paper	16,826		3		—		16,829
Money market	100		—		—		100
Certificates of deposit	51		—		—		51
	$	280,297	$	3	$	—	$	280,300
Included in cash and cash equivalents	$	263,320	$	—	$	—	$	263,320
Included in marketable securities	16,977		3		—		16,980
Total cash, cash equivalents, and marketable securities	$	280,297	$	3	$	—	$	280,300


	As of December 31, 2022
(in thousands)	Cost		Gross Unrealized Gain		Gross Unrealized Loss		Fair Value
Cash and cash equivalents	$	148,813	$	—	$	—	$	148,813
Commercial paper	144,299		82		—		144,381
Money market	350		—		—		350
Certificate of deposit	51		—		—		51
	$	293,513	$	82	$	—	$	293,595
Included in cash and cash equivalents	$	148,813	$	—	$	—	$	148,813
Included in marketable securities	144,700		82		—		144,782
Total cash, cash equivalents, and marketable securities	$	293,513	$	82	$	—	$	293,595

Schedule of Cash, Cash Equivalents, and Restricted Cash


	As of September 30,
(in thousands)	2023		2022
Cash and cash equivalents	$	263,320	$	277,592
Restricted cash	2,952		3,941
Cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows	$	266,272	$	281,533

Summary of Significant Accounting Policies - Narrative (Details) $ in Millions	Sep. 30, 2023 USD ($)
Accounting Policies [Abstract]
Allowance for doubtful accounts receivable	$ 0.1

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Pay vs Performance Disclosure
Net loss	$ (21,577)	$ (33,286)	$ (117,741)	$ (180,703)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Basic and Diluted Net Loss per Common Share (Tables)

9 Months Ended

Sep. 30, 2023

Earnings Per Share [Abstract]

Schedule of Reconciliation of the Numerator and Denominator Used in Computing Basic and Diluted Net Loss per Common Share

The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss attributable to common stockholders per common share:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands, except per share amounts)	2023		2022		2023		2022
Numerator:
Net loss attributable to common stockholders	$	(21,577)	$	(33,286)	$	(117,741)	$	(180,703)
Denominator:
Weighted average common shares outstanding — basic and diluted	295,759,435		289,223,709		293,314,167		288,841,092

Schedule of Potential Shares of Common Stock that were Excluded from the Computation as they were Anti-Dilutive Using the Treasury Stock Method

The table below presents potential shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method:


	As of September 30,
(in thousands)	2023	2022
Options to purchase common stock	23,256	19,236
Unvested restricted stock units	10,331	9,839
Total number of potentially issuable shares	33,587	29,075

Stock-Based Compensation - Expense Summary (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total equity compensation expense	$ 16,511	$ 14,772	$ 67,982	$ 57,886
Research and development expense
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total equity compensation expense	4,380	5,428	16,987	19,172
Selling, general, and administrative expense
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total equity compensation expense	$ 12,131	$ 9,344	$ 50,995	$ 38,714

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Description of Business (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended
	Oct. 31, 2023	Sep. 30, 2023	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Accumulated deficit		$ 2,650,231	$ 2,532,490
Subsequent Event
Debt Instrument [Line Items]
Private placement net of offering cost	$ 29,800
Subsequent Event \| Private Placement
Debt Instrument [Line Items]
Purchase price (in dollars per share)	$ 12.16
Subsequent Event \| Common Stock
Debt Instrument [Line Items]
Stock issued during period, shares, new issues (in shares)	2,467,104
Stock issued from equity financing (in shares)	2,467,104
Secured Debt \| Senior Loans \| Subsequent Event
Debt Instrument [Line Items]
Maximum borrowing capacity	$ 400,000
Basis spread on variable rate	6.25%
Maturity term	6 years
Proceeds from secured lines of credit	$ 387,400
Secured Debt \| Senior Loans \| Subsequent Event \| Secured Overnight Financing Rate Floor
Debt Instrument [Line Items]
Basis spread on variable rate	2.50%
Secured Debt \| Senior Loans \| Subsequent Event \| Secured Overnight Financing Rate Adjustment
Debt Instrument [Line Items]
Basis spread on variable rate	0.26161%

Inventories - Narrative (Details) - USD ($) $ in Millions	Sep. 30, 2023	Dec. 31, 2022
Inventory Disclosure [Abstract]
Reserve for inventory	$ 0.3	$ 0.4

Stock-Based Compensation - RSUs and PBRSUs Summary (Details) - Unvested restricted stock units $ / shares in Units, shares in Thousands, $ in Millions	9 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares
Number of Shares
Non-vested units as of the beginning of the period (in shares) \| shares	9,717
Granted (in shares) \| shares	4,514
Vested (in shares) \| shares	(3,252)
Forfeited (in shares) \| shares	(648)
Non-vested units as of the end of the period (in shares) \| shares	10,331
Weighted Average Grant Date Fair Value
Non-vested units as of the beginning of the period (in dollars per share) \| $ / shares	$ 13.07
Granted (in dollars per share) \| $ / shares	13.08
Vested (in dollars per share) \| $ / shares	12.25
Forfeited (in dollars per share) \| $ / shares	10.07
Non-vested units as of the end of the period (in dollars per share) \| $ / shares	$ 13.56
Weighted Average Remaining Years and Aggregate Intrinsic Value
Non-vested units, weighted average remaining years	2 years 2 months 12 days
Non-vested units, aggregate intrinsic value \| $	$ 125.6

Debt (Tables)

9 Months Ended

Sep. 30, 2023

Debt Disclosure [Abstract]

Schedule of Liability Components of Long-Term Debt

The Company's debt consists of the following:


(in thousands)	September 30, 2023		December 31, 2022
Senior Secured Term Loan due 2026:
Principal	$	400,000	$	400,000
Less: debt discount (1)	(3,384)		(4,571)
Less: deferred financing (1)	(2,545)		(3,439)
Net carrying value of Long-term debt(2)	$	394,071	$	391,990

______________________________

Schedule of Components of Total Interest Expense

The following table sets forth interest expense recognized related to the Company's debt for the three and nine months ended September 30, 2023 and 2022, respectively:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2023		2022		2023		2022
Contractual interest expense	$	12,270	$	8,945	$	35,289	$	24,034
Amortization of debt discount	$	411	$	382	$	1,187	$	1,121
Amortization of deferred financing	$	310	$	286	$	893	$	842

Assets and Liabilities Measured at Fair Value - Summary of Fair Value of Assets and Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Assets:
Fair value of assets	$ 23,647	$ 150,189
Liabilities:
Contingent consideration payable		21,417
Deferred compensation plan liability	6,718	5,458
Fair value of liabilities	6,718	26,875
Commercial paper
Assets:
Fair value of assets	16,829	144,381
Money market
Assets:
Fair value of assets	6,818	5,808
Level 2
Assets:
Fair value of assets	23,647	150,189
Liabilities:
Contingent consideration payable		0
Deferred compensation plan liability	6,718	5,458
Fair value of liabilities	6,718	5,458
Level 2 \| Commercial paper
Assets:
Fair value of assets	16,829
Level 2 \| Money market
Assets:
Fair value of assets	$ 6,818	5,808
Level 3
Liabilities:
Contingent consideration payable		21,417
Deferred compensation plan liability		0
Fair value of liabilities		$ 21,417

Consolidated Statements of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Revenue:
Net product sales	$ 103,501	$ 81,691	$ 284,274	$ 241,137
Cost of goods sold	9,946	13,436	26,002	29,215
Gross profit	93,555	68,255	258,272	211,922
Operating expenses:
Research and development	40,704	52,970	117,352	212,806
Selling, general, and administrative	65,651	47,272	205,031	158,767
Changes in fair value of contingent consideration payable	1,995	567	2,583	(506)
Loss on impairment of assets	0	0	1,134	6,616
Depreciation and amortization	2,228	1,286	5,691	4,031
Total operating expenses	110,578	102,095	331,791	381,714
Loss from operations	(17,023)	(33,840)	(73,519)	(169,792)
Other income (expense):
Interest income	1,471	563	5,407	1,052
Interest expense	(12,986)	(9,620)	(37,322)	(26,024)
Other income (expense)	3,833	13,634	(13,007)	22,804
Loss before income tax	(24,705)	(29,263)	(118,441)	(171,960)
Income tax benefit (expense)	3,128	(4,023)	700	(8,743)
Net loss attributable to common stockholders	$ (21,577)	$ (33,286)	$ (117,741)	$ (180,703)
Net loss attributable to common stockholders per common share - basic (in dollars per share)	$ (0.07)	$ (0.12)	$ (0.40)	$ (0.63)
Net loss attributable to common stockholders per common share — diluted (in dollars per share)	$ (0.07)	$ (0.12)	$ (0.40)	$ (0.63)
Weighted average common shares outstanding - basic (in shares)	295,759,435	289,223,709	293,314,167	288,841,092
Weighted average common shares outstanding - diluted (in shares)	295,759,435	289,223,709	293,314,167	288,841,092

Stock-Based Compensation - Weighted-average Assumptions (Details) - Options to purchase common stock - $ / shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected stock price volatility	58.40%	61.00%	59.20%	62.20%
Risk free interest rate	4.30%	3.10%	3.90%	1.70%
Expected life of options (years)	5 years 6 months	5 years 3 months 18 days	5 years 6 months	5 years 3 months 18 days
Expected annual dividend per share (in dollars per share)	$ 0	$ 0	$ 0	$ 0

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Stockholders' Equity	9 Months Ended
Stockholders' Equity	Sep. 30, 2023
Equity [Abstract]
Stockholders' Equity	Stockholder's Equity During the three and nine months ended September 30, 2023, the Company issued and sold an aggregate of 3,002,354 and 5,244,936 shares, respectively, through its at-the-market equity program ("ATM program") at weighted-average public offering prices of $12.68 and $12.50 per share, resulting in net proceeds of $36.6 million and $63.1 million, respectively. As of September 30, 2023, an aggregate of $184.4 million worth of shares remain available to be issued and sold under the ATM program. In October 2023, in connection with the Senior Secured Term Loan due 2029, the Company entered into a securities purchase agreement with funds managed by Blackstone, for the private placement of an aggregate of 2,467,104 shares of the Company’s common stock, at a purchase price of $12.16 per share. Proceeds from the private placement, net of offering costs, were $29.8 million.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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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
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Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Inventories (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Inventory Disclosure [Abstract]
Raw materials	$ 36,062	$ 10,054
Work-in-process	14,316	9,615
Finished goods	6,558	4,147
Total inventories	$ 56,936	$ 23,816