Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 22, 2023 | Jun. 30, 2022 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 001-36509 | ||
Entity Registrant Name | Amphastar Pharmaceuticals, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 33-0702205 | ||
Entity Address, Address Line One | 11570 6th Street | ||
Entity Address, City or Town | Rancho Cucamonga | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 91730 | ||
City Area Code | 909 | ||
Local Phone Number | 980-9484 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | AMPH | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 885,261,017 | ||
Entity Common Stock, Shares Outstanding | 47,896,820 | ||
Entity Central Index Key | 0001297184 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Irvine, California |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 156,098 | $ 126,353 |
Restricted cash | 235 | 235 |
Short-term investments | 19,664 | 10,320 |
Restricted short-term investments | 2,200 | 2,200 |
Accounts receivable, net | 88,804 | 78,804 |
Inventories | 103,584 | 92,807 |
Income tax refunds and deposits | 171 | 126 |
Prepaid expenses and other assets | 7,563 | 7,274 |
Total current assets | 378,319 | 318,119 |
Property, plant, and equipment, net | 238,266 | 244,244 |
Finance lease right-of-use assets | 753 | 353 |
Operating lease right-of-use assets | 25,554 | 26,894 |
Investment in unconsolidated affiliate | 2,414 | 3,985 |
Goodwill and intangible assets, net | 37,298 | 38,870 |
Other assets | 20,856 | 16,665 |
Deferred tax assets | 38,527 | 22,399 |
Total assets | 741,987 | 671,529 |
Current Liabilities: | ||
Accounts payable and accrued liabilities | 84,242 | 89,545 |
Income taxes payable | 4,571 | 9,081 |
Current portion of long-term debt | 3,046 | 2,202 |
Current portion of operating lease liabilities | 3,003 | 2,982 |
Total current liabilities | 94,862 | 103,810 |
Long-term reserve for income tax liabilities | 7,225 | 6,531 |
Long-term debt, net of current portion and unamortized debt costs | 72,839 | 74,776 |
Long-term operating lease liabilities, net of current portion | 23,694 | 24,703 |
Deferred tax liabilities | 144 | 534 |
Other long-term liabilities | 14,565 | 15,653 |
Total liabilities | 213,329 | 226,007 |
Stockholders' equity: | ||
Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding | ||
Common stock: par value $0.0001; 300,000,000 shares authorized; 58,110,231 and 48,112,069 shares issued and outstanding as of December 31, 2022 and 56,440,202 and 47,714,912 shares issued and outstanding as of December 31, 2021, respectively | 6 | 6 |
Additional paid-in capital | 455,077 | 422,423 |
Retained earnings | 271,723 | 180,337 |
Accumulated other comprehensive loss | (8,624) | (6,765) |
Treasury stock | (189,524) | (150,479) |
Total equity | 528,658 | 445,522 |
Total liabilities and stockholders' equity | $ 741,987 | $ 671,529 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock; shares authorized | 300,000,000 | 300,000,000 |
Common stock; shares issued | 58,110,231 | 56,440,202 |
Common stock; shares outstanding | 48,112,069 | 47,714,912 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
CONSOLIDATED STATEMENTS OF OPERATIONS | |||
Net revenues | $ 498,987 | $ 437,768 | $ 349,846 |
Cost of revenues | 250,127 | 238,029 | 206,506 |
Gross profit | 248,860 | 199,739 | 143,340 |
Operating (income) expenses: | |||
Selling, distribution, and marketing | 21,531 | 17,486 | 14,780 |
General and administrative | 45,061 | 51,434 | 50,377 |
Research and development | 74,771 | 60,932 | 67,229 |
Total operating expenses | 141,363 | 129,852 | 132,386 |
Income (loss) from operations | 107,497 | 69,887 | 10,954 |
Non-operating income (expenses): | |||
Interest income | 1,321 | 601 | 642 |
Interest expense | (1,846) | (885) | (374) |
Other income (expenses), net | 9,068 | 14,536 | (6,585) |
Total non-operating income (expenses), net | 8,543 | 14,252 | (6,317) |
Income (loss) before income taxes | 116,040 | 84,139 | 4,637 |
Income tax provision (benefit) | 23,477 | 20,630 | 3,540 |
Income before equity in losses of unconsolidated affiliate | 92,563 | 63,509 | 1,097 |
Equity in losses of unconsolidated affiliates | (1,177) | (208) | |
Net income (loss) | 91,386 | 63,301 | 1,097 |
Net income (loss) attributable to non-controlling interests | 1,185 | (306) | |
Net income (loss) attributable to Amphastar Pharmaceuticals, Inc. | $ 91,386 | $ 62,116 | $ 1,403 |
Net income (loss) per share attributable to Amphastar Pharmaceuticals, Inc. stockholders: | |||
Basic (in Dollars per share) | $ 1.88 | $ 1.30 | $ 0.03 |
Diluted (in Dollars per share) | $ 1.74 | $ 1.25 | $ 0.03 |
Weighted-average shares used to compute net income (loss) per share attributable to Amphastar Pharmaceuticals, Inc. stockholders: | |||
Basic (in Shares) | 48,551 | 47,777 | 47,038 |
Diluted (in Shares) | 52,427 | 49,784 | 49,124 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | |||
Net income (loss) attributable to Amphastar Pharmaceuticals, Inc. | $ 91,386 | $ 62,116 | $ 1,403 |
Other comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc., net of income taxes | |||
Reclassification of adjustment for amounts included in net income | (362) | ||
Foreign currency translation adjustment | (2,335) | (2,943) | 1,121 |
Change in pension obligations | 476 | 261 | (155) |
Total other comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc. | (1,859) | (3,044) | 966 |
Total comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc. | $ 89,527 | $ 59,072 | $ 2,369 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Treasury Stock [Member] | Total Amphastar Stockholders' Equity [Member] | Non-controlling Interest [Member] | Total |
Balance at Dec. 31, 2019 | $ 5 | $ 367,305 | $ 116,370 | $ (4,687) | $ (97,627) | $ 381,366 | $ 46,162 | |
Balance at Dec. 31, 2019 | $ 427,528 | |||||||
Balance at Dec. 31, 2019 | 52,495,483 | (5,918,515) | ||||||
Changes in Stockholders' Equity | ||||||||
Net income (loss) attributable to Amphastar Pharmaceuticals, Inc. | 1,403 | 1,403 | 1,403 | |||||
Other comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc. | 966 | 966 | 966 | |||||
Proceeds from the private placement of ANP | (106) | (106) | ||||||
Net income (loss) attributable to non-controlling interest | (306) | (306) | ||||||
Treasury stock acquired | $ (24,425) | (24,425) | (24,425) | |||||
Treasury stock acquired (in Shares) | (1,366,915) | |||||||
Issuance of treasury stock in connection with the Company's equity plans | (240) | $ 240 | ||||||
Issuance of treasury stock in connection with the Company's equity plans (in Shares) | 19,947 | |||||||
Issuance of common stock in connection with the Company's equity plans | 23,165 | 23,165 | 23,165 | |||||
Issuance of common stock in connection with the Company's equity plans (in Shares) | 2,265,439 | |||||||
Share-based compensation expense | 19,831 | 19,831 | 667 | 20,498 | ||||
Balance at Dec. 31, 2020 | $ 5 | 410,061 | 117,773 | (3,721) | $ (121,812) | 402,306 | 46,417 | |
Balance at Dec. 31, 2020 | 448,723 | |||||||
Balance at Dec. 31, 2020 | 54,760,922 | (7,265,483) | ||||||
Changes in Stockholders' Equity | ||||||||
Net income (loss) attributable to Amphastar Pharmaceuticals, Inc. | 62,116 | 62,116 | 62,116 | |||||
Other comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc. | (3,044) | |||||||
Other comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc. | (2,682) | (2,682) | (2,682) | |||||
ANP Restructuring | (22,162) | 448 | (362) | (22,076) | (46,641) | (68,717) | ||
Net income (loss) attributable to non-controlling interest | 1,185 | 1,185 | ||||||
Treasury stock acquired | $ (28,873) | (28,873) | (28,873) | |||||
Treasury stock acquired (in Shares) | (1,477,305) | |||||||
Issuance of treasury stock in connection with the Company's equity plans | (206) | $ 206 | ||||||
Issuance of treasury stock in connection with the Company's equity plans (in Shares) | 17,498 | |||||||
Issuance of common stock in connection with the Company's equity plans | $ 1 | 15,924 | 15,925 | 15,925 | ||||
Issuance of common stock in connection with the Company's equity plans (in Shares) | 1,679,280 | |||||||
Share-based compensation expense | 18,806 | 18,806 | $ (961) | 17,845 | ||||
Balance at Dec. 31, 2021 | $ 6 | 422,423 | 180,337 | (6,765) | $ (150,479) | 445,522 | ||
Balance at Dec. 31, 2021 | $ 445,522 | |||||||
Balance at Dec. 31, 2021 | 56,440,202 | (8,725,290) | 47,714,912 | |||||
Changes in Stockholders' Equity | ||||||||
Net income (loss) attributable to Amphastar Pharmaceuticals, Inc. | 91,386 | 91,386 | $ 91,386 | |||||
Other comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc. | (1,859) | (1,859) | (1,859) | |||||
Treasury stock acquired | $ (39,909) | (39,909) | (39,909) | |||||
Treasury stock acquired (in Shares) | (1,335,528) | |||||||
Issuance of treasury stock in connection with the Company's equity plans | (864) | $ 864 | ||||||
Issuance of treasury stock in connection with the Company's equity plans (in Shares) | 62,656 | |||||||
Issuance of common stock in connection with the Company's equity plans | 15,658 | 15,658 | 15,658 | |||||
Issuance of common stock in connection with the Company's equity plans (in Shares) | 1,670,029 | |||||||
Share-based compensation expense | 17,860 | 17,860 | 17,860 | |||||
Balance at Dec. 31, 2022 | $ 6 | $ 455,077 | $ 271,723 | $ (8,624) | $ (189,524) | $ 528,658 | ||
Balance at Dec. 31, 2022 | $ 528,658 | |||||||
Balance at Dec. 31, 2022 | 58,110,231 | (9,998,162) | 48,112,069 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash Flows From Operating Activities: | |||
Net income (loss) | $ 91,386 | $ 63,301 | $ 1,097 |
Reconciliation to net cash provided by operating activities: | |||
Loss (gain) on impairment and disposal of assets | 141 | 348 | 240 |
Gain on deconsolidation of subsidiary | (13,587) | ||
(Gain) loss on interest rate swaps and foreign currency transactions, net | (2,196) | 27 | (2,173) |
Depreciation of property, plant, and equipment | 23,815 | 22,196 | 20,491 |
Amortization of product rights, trademarks, and patents | 1,420 | 1,290 | 1,036 |
Operating lease right-of-use asset amortization | 3,506 | 3,266 | 3,653 |
Equity in losses of unconsolidated affiliate | 1,177 | 208 | |
Share-based compensation | 17,860 | 18,687 | 20,498 |
Changes in reserve for uncertain tax positions | 694 | 1,821 | 1,285 |
Changes in deferred taxes, net | (16,445) | 2,388 | (162) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (10,132) | (14,921) | (20,160) |
Inventories | (11,746) | 1,258 | 15,297 |
Prepaid expenses and other assets | (1,854) | 2,927 | 643 |
Income tax refunds, deposits, and payables, net | (4,555) | 8,349 | (972) |
Operating lease liabilities | (3,154) | (3,198) | (3,597) |
Accounts payable and accrued liabilities | (736) | 3,634 | 20,090 |
Net cash provided by operating activities | 89,181 | 97,994 | 57,266 |
Cash Flows From Investing Activities: | |||
Purchases and construction of property, plant, and equipment | (24,034) | (27,456) | (33,855) |
Proceeds from the sale of property, plant and equipment | 421 | ||
Purchase of investments | (35,761) | (17,375) | (13,557) |
Maturity of investments | 27,969 | 18,771 | 12,411 |
Payment of deposits and other assets | (1,372) | (2,612) | (1,414) |
Net cash used in investing activities | (32,777) | (28,672) | (36,415) |
Cash Flows From Financing Activities: | |||
Acquisition of additional ownership interest in ANP | (106) | ||
ANP restructuring (see Note 3) | (53,592) | ||
Proceeds from equity plans, net of withholding tax payments | 15,658 | 15,925 | 23,165 |
Purchase of treasury stock | (39,909) | (28,873) | (24,425) |
Settlement of ANP equity awards | (839) | ||
Debt issuance costs | (407) | (1,738) | |
Proceeds from borrowing under lines of credit | 1,238 | ||
Repayments under lines of credit | (1,161) | ||
Proceeds from issuance of long-term debt | 70,000 | 6,283 | |
Principal payments on long-term debt | (1,781) | (36,740) | (8,401) |
Net cash provided by (used in) financing activities | (26,439) | (37,018) | (2,246) |
Effect of exchange rate changes on cash | (220) | (223) | 352 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 29,745 | 32,081 | 18,957 |
Cash, cash equivalents, and restricted cash at beginning of period | 126,588 | 94,507 | 75,550 |
Cash, cash equivalents, and restricted cash at end of period | 156,333 | 126,588 | 94,507 |
Noncash Investing and Financing Activities: | |||
Capital expenditure included in accounts payable | 5,256 | 9,488 | 11,136 |
Operating lease right-of-use assets in exchange for operating lease liabilities | 2,166 | 11,041 | 4,819 |
Equipment acquired under finance leases | 642 | 107 | 61 |
Supplemental Disclosures of Cash Flow Information: | |||
Interest paid, net of capitalized interest | 3,023 | 2,109 | 2,199 |
Income taxes paid | $ 44,442 | $ 8,096 | $ 3,411 |
Business
Business | 12 Months Ended |
Dec. 31, 2022 | |
Business | |
Business | Note 1. Business Amphastar Pharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, hereinafter referred to as the “Company”) is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, including products with high technical barriers to market entry. Additionally, the Company sells insulin active pharmaceutical ingredient, or API, products. Most of the Company’s products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company’s insulin API products are sold to other pharmaceutical companies for use in their own products and are being used by the Company in the development of injectable finished pharmaceutical products. The Company’s inhalation product, Primatene MIST ® |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries, and are prepared in accordance with United States generally accepted accounting principles, or GAAP. Certain prior period amounts have been reclassified within the operating activities of the consolidated statements of cash flows to conform to the current period presentation. All intercompany activity has been eliminated in the preparation of the consolidated financial statements. In the opinion of management, the accompanying consolidated financial statements include all adjustments, which are of a normal recurring nature, necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company. The Company’s subsidiaries include: (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Amphastar Nanjing Pharmaceuticals Inc., or ANP, (4) Amphastar France Pharmaceuticals, S.A.S., or AFP, (5) Amphastar UK Ltd., or AUK, and (6) International Medication Systems (UK) Limited, or IMS UK. Investments in Unconsolidated Affiliate The Company applies the equity method of accounting for investments when it has significant influence, but not controlling interest in the investee. Judgment regarding the level of influence over each equity method investment includes key factors such as ownership interest, representation on the board of directors, participation in policy-making decisions and material intercompany transactions. The Company’s proportionate share of the earnings or losses resulting from these investments is reported as “Equity in losses of unconsolidated affiliate” in the accompanying consolidated statements of operations. Investments accounted for using the equity method may be reported on a lag of up to three months if financial statements of the investee are not available in sufficient time for the investor to apply the equity method as of the current reporting date. The determination of whether an investee’s results are recorded on a lag is made on an investment-by-investment basis. The carrying value of equity method investments is reported as “Investment in unconsolidated affiliate” in the accompanying consolidated balance sheets. The Company’s equity method investments are reported at cost and adjusted each period for the Company’s share of the investee’s earnings or losses and dividends paid, if any. The Company assesses equity method investments for impairment whenever events or changes in circumstances indicate that the carrying value of an investment may not be recoverable. If the decline in value is considered to be other than temporary, the investment is written down to its estimated fair value, which establishes a new cost basis in the investment. No such impairment was identified for any of the periods presented. Use of Estimates The preparation of consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: determination of allowances for credit losses, fair value of financial instruments, allowance for discounts, provision for chargebacks and rebates, provision for product returns, adjustment of inventory to its net realizable value, impairment of investments, long-lived and intangible assets and goodwill, accrual for workers’ compensation liabilities, litigation reserves, stock price volatility for share-based compensation expense, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions. Foreign Currency The functional currency of the Company, its domestic subsidiaries, its Chinese subsidiary ANP, and its U.K. subsidiary, AUK, is the U.S. Dollar, or USD. ANP maintains its books of record in Chinese yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s accompanying consolidated statements of operations. The Company’s French subsidiary, AFP, maintains its book of record in euros. AUK’s subsidiary, IMS UK, maintains its book of record in British pounds. These local currencies have been determined to be the subsidiaries’ respective functional currencies. Activities in the statements of operations are translated to USD using average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other accumulated comprehensive income (loss). The unrealized gains or losses of intercompany foreign currency transactions that are of a long-term investment nature are reported in other accumulated comprehensive income (loss). The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature for the years ended December 31, 2022, 2021, and 2020 were a $1.8 million loss, a $2.6 million loss, and a $3.0 million gain, respectively. Comprehensive Income The Company’s comprehensive income includes its foreign currency translation gains and losses as well as its share of other comprehensive income from its equity method investments. There was no material income tax provision allocated to other comprehensive loss for the years ended December 31, 2022 and 2021. Income tax expense of $0.9 million was allocated to other comprehensive income for the year ended December 31, 2020. Shipping and Handling Costs For the years ended December 31, 2022, 2021, and 2020, the Company included shipping and handling costs of approximately $7.4 million, $4.3 million and $4.3 million, respectively, in selling, distribution and marketing expenses in the accompanying consolidated statements of operations. Advertising Expense Advertising expenses, primarily associated with Primatene MIST ® Company’s consolidated statements of operations. For the years ended December 31, 2022, 2021, and 2020, advertising expenses were $8.7 million, $8.1 million, and $5.8 million, respectively. Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities. These include salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, research-related overhead expenses and fees paid to external service providers. The Company may produce or purchase inventories prior to or with the expectation of receiving regulatory approval in the near term, based on operational decisions about the most effective use of existing resources. This inventory is referred to as pre-launch inventory. It is the Company’s accounting policy that the pre-launch inventory is capitalized if it has a probable future economic benefit at the time it is purchased or manufactured. If regulatory approval is received and previously expensed pre-launch inventory is sold, such sales may contribute up to a 100% margin to the Company’s operating results. Pre-launch inventory costs include cost of work in process, materials, and finished drug products. As of December 31, 2022, 2021, and 2020, the Company did not have material capitalized pre-launch inventory. Financial Instruments The carrying amounts of cash and cash equivalents, short-term investments, restricted cash and short-term investments, accounts receivable, accounts payable, accrued expenses, and short-term borrowings approximate fair value due to the short maturity of these items. The majority of the Company’s long-term obligations consist of variable rate debt, and their carrying value approximates fair value as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities. The Company at times enters into interest rate swap contracts to manage its exposure to interest rate changes and its overall cost of long-term debt. The Company’s interest rate swap contracts exchange the variable interest rates for fixed interest rates. The Company from time to time may enter into forward currency contracts to lock in currency exchange rates to manage its foreign currency exchange rate exposure. The Company’s interest rate swaps and forward currency contracts have not been designated as hedging instruments and, therefore are recorded at their fair values at the end of each reporting period with changes in fair value recorded in other income (expenses) on the consolidated statements of operations. As of December 31, 2022, the Company had an unsettled forward currency contract to purchase foreign currency with a fair value of approximately $0.2 million based on Level 2 inputs, which was recorded as a liability in the accounts payable and accrued liabilities line in the accompanying consolidated balance sheets. Cash and Cash Equivalents Cash and cash equivalents consist of cash, money market accounts, certificates of deposit and highly liquid investments with original maturities of three months or less. Investments Investments as of December 31, 2022 and 2021 consisted of certificates of deposit and investment grade corporate and municipal bonds with original maturity dates between three and fifteen months. Restricted Cash Restricted cash is collateral required for the Company to guarantee certain vendor payments in France. As of December 31, 2022 and 2021, the restricted cash balance was $0.2 million. Restricted Short-Term Investments Restricted short-term investments consist of certificates of deposit that are collateral for standby letters of credit to qualify for workers’ compensation self-insurance. The certificates of deposit have original maturities greater than three months, but less than one year. As of December 31, 2022 and 2021, the balance of restricted short-term investments was $2.2 million. Allowance for Credit Losses The Company evaluates the collectability of accounts receivable based on a combination of factors. When the Company is aware of circumstances that may impair a customer’s ability to pay subsequent to the original sale, the Company records a specific allowance to reduce the amounts receivable to the amount that the Company reasonably believes to be collectable. For all other customers, the Company recognizes an allowance for credit losses based on factors that include the length of time the receivables are past due, industry and geographic concentrations, the current economic conditions and historical collection experience. As of December 31, 2022 and 2021, the Company's allowance for credit losses was $2.7 million and $2.3 million, respectively. Inventories Inventories consist of currently marketed products and products manufactured under contract. Inventories are stated using the first-in, first-out method, on a consistent basis. The Company states inventory at the lower of cost or net realizable value. Provisions are made for slow moving, unsellable, or obsolete items. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose. Property, Plant and Equipment Property, plant and equipment are stated at cost or, in the case of assets acquired in a business combination, at fair value on the purchase date. Depreciation and amortization expense is computed using the straight line method over the estimated useful lives of the related assets as follows: Buildings 20 - 31 years Machinery and equipment 3 - 12 years Furniture and fixtures 3 - 7 years Automobiles 4 - 5 years Leasehold improvements Lesser of remaining lease term or useful life Intangible Assets Intangible assets with finite lives are amortized using the straight-line method over the period the asset is expected to contribute directly or indirectly to the future cash flows of the Company as follows: Product rights 10 - 15 years Patents 10 - 20 years Land-use rights 37 - 50 years Impairment of Long-Lived Assets, including Identifiable Definite-Lived Intangible Assets The Company assesses long-term and identifiable definite-lived intangible assets or asset groups for impairment when events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset or an asset group, further impairment analysis is performed. An impairment loss is measured as the amount by which the carrying amount of the asset or asset groups exceeds the fair value (assets to be held and used) or fair value less cost to sell (assets to be disposed of). The Company also assesses the useful lives of its assets periodically to determine whether events and circumstances warrant a revision to the remaining useful life. Changes in the useful life are adjusted prospectively by revising the remaining period over which the asset is amortized. Deferred Income Taxes The Company utilizes the liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized. Impairment of Indefinite-Lived Intangible Asset and Goodwill The Company assesses indefinite lived intangible asset and goodwill for impairment in the fourth quarter of each year or more frequently if indicators of impairment are present. When the Company chooses to perform a qualitative assessment, it evaluates economic, industry and company-specific factors as an initial step. If the Company determines it is more likely than not that the indefinite-lived intangible asset is impaired or the fair value of a reporting unit is less than its carrying amount, further quantitative impairment testing is then performed; otherwise, no further testing is required. An impairment loss is recorded if the asset’s fair value is less than its carrying value. The Company also periodically assesses its indefinite-lived intangible asset to determine if events and circumstances continue to support an indefinite useful life. If the life is no longer indefinite, the asset is tested for impairment. The carrying value, after recognition of any impairment loss, is amortized over its remaining useful life. Self-Insured Claims The Company is primarily self-insured, up to certain limits, for workers’ compensation claims. The Company has purchased stop-loss insurance, which will reimburse the Company for individual claims in excess of $350,000 or aggregate minimum attachment of $4.4 million annually. The cost of claims reported and an estimate of claims incurred but not reported are charged to operating expenses. A liability for unpaid claims and the associated claim expenses, including incurred but not reported losses, is actuarially determined and reflected in accrued liabilities in the accompanying consolidated balance sheets. Total expense under the program was approximately $0.3 million, $0.5 million, and $0.5 million, for the years ended December 31, 2022, 2021 and 2020, respectively. The self-insured claims liability was $3.7 million and $4.1 million at December 31, 2022 and 2021, respectively. The determination of such claims and expenses and the appropriateness of the related liability is reviewed periodically and updated, as necessary. Changes in estimates are recorded in the period identified. Litigation, Commitments and Contingencies Litigation, commitments and contingencies are accrued when management, after considering the facts and circumstances of each matter as then known to management, has determined it is probable a liability will be found to have been incurred and the amount of the loss can be reasonably estimated. When only a range of amounts is reasonably estimable and no amount within the range is more likely than another, the low end of the range is recorded. Legal fees are expensed as incurred. Due to the inherent uncertainties surrounding gain contingencies, the Company generally does not recognize potential gains until they are realized. In the fourth quarter of 2021, the Company settled a legal dispute with an unaffiliated third party and subsequently received a settlement payment, net of contingent legal fees, in the amount of $2.7 million. The net amount of $2.7 million was recorded as other income in the other income (expense), net line in the consolidated statements of operations for the year ended December 31, 2021. Recent Accounting Pronouncements The Company does not believe that any recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements. |
ANP Restructuring
ANP Restructuring | 12 Months Ended |
Dec. 31, 2022 | |
ANP Restructuring | |
ANP Restructuring | Note 3. ANP Restructuring As a result of the ANP restructuring that was completed during the third quarter of 2021, and subsequent investments by other equity holders of Hanxin, the Company has a 14% noncontrolling investment in Hanxin as of December 31, 2022 that is accounted for as an equity method investment. In addition to the retained noncontrolling investment in Hanxin, the Company maintains a seat on Hanxin’s board of directors, and Henry Zhang, a relative of Dr. Jack Zhang and Dr. Mary Luo, is an equity holder, general manager, and chairman of the board of directors of Hanxin. As a result, it was determined that the Company has significant influence over Hanxin and as such the retained noncontrolling investment in Hanxin is accounted for as an equity method investment. Hanxin continues to be a related party after the deconsolidation. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2022 | |
Revenue Recognition | |
Revenue Recognition | Note 4. Revenue Recognition In accordance with Accounting Standard Codification, or ASC, 606 Revenue from Contracts with Customers Generally, revenue is recognized at the time of product delivery to the Company’s customers. In some cases, revenue is recognized at the time of shipment when stipulated by the terms of the sale agreements. The consideration the Company receives in exchange for its goods or services is only recognized when it is probable that a significant reversal will not occur. The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration. The Company makes significant estimates for related variable consideration at the point of sale, including chargebacks, rebates, product returns, other discounts and allowances. The Company’s payment terms vary by types and locations of customers and the products or services offered. Payment terms differ by jurisdiction and customers, but payment is generally required in a term ranging from 30 to 75 days from date of shipment or satisfaction of the performance obligation. For certain products or services and certain customer types, the Company may require payment before products are delivered or services are rendered to customers. Provisions for estimated chargebacks, rebates, discounts, product returns and credit losses are made at the time of sale and are analyzed and adjusted, if necessary, at each balance sheet date. Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers. The Company’s accounting policy is to review each agreement involving contract development and manufacturing services to determine if there are multiple revenue-generating activities that constitute more than one unit of accounting. Revenues are recognized for each unit of accounting based on revenue recognition criteria relevant to that unit. The Company does not have any revenue arrangements with multiple performance obligations. Service revenues derived from research and development contracts is recognized over time based on progress toward completion of the performance obligation. For each performance obligation satisfied over time, the Company assesses the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction of services or an output method of determining the progress of completion of performance obligation. Revenue from research and development services at ANP was $4.3 million and $5.1 million for the years ended December 31, 2022 and 2021, respectively. Provision for Chargebacks and Rebates The provision for chargebacks and rebates is a significant estimate used in the recognition of revenue. Wholesaler chargebacks relate to sales terms under which the Company agrees to reimburse wholesalers for differences between the gross sales prices at which the Company sells its products to wholesalers and the actual prices of such products that wholesalers resell under the Company’s various contractual arrangements with third parties such as hospitals and group purchasing organizations in the United States. Rebates include primarily amounts paid to retailers, payers, and providers in the United States, including those paid to state Medicaid programs, and are based on contractual arrangements or statutory requirements. The Company estimates chargebacks and rebates using the expected value method at the time of sale to wholesalers based on wholesaler inventory stocking levels, historic chargeback and rebate rates, and current contract pricing. The provision for chargebacks and rebates is reflected as a component of net revenues. The following table is an analysis of the chargeback and rebate provision: Year Ended December 31, 2022 2021 (in thousands) Beginning balance $ 20,167 $ 20,380 Provision for chargebacks and rebates 208,081 201,133 Credits and payments issued to third parties (201,642) (201,346) Ending balance $ 26,606 $ 20,167 Changes in the chargeback provision from period to period are primarily dependent on the Company’s sales to its wholesalers, the level of inventory held by wholesalers, and the wholesalers’ customer mix. Changes in the rebate provision from period to period are primarily dependent on retailer’s and other indirect customers’ purchases. The approach that the Company uses to estimate chargebacks has been consistently applied for all periods presented. Variations in estimates have been historically small. The Company continually monitors the provision for chargebacks and rebates and makes adjustments when it believes that the actual chargebacks and rebates may differ from the estimates. The settlement of chargebacks and rebates generally occurs within 20 days to 60 days after the sale to wholesalers. Accounts receivable and/or accounts payable and accrued liabilities are reduced and/or increased by the chargebacks and rebate amounts depending on whether the Company has the right to offset with the customer. Of the provision for chargebacks and rebates as of December 31, 2022 and 2021, $20.5 million and $15.6 million were included as a reduction to accounts receivable, net, on the consolidated balance sheets, respectively. The remaining provision as of December 31, 2022 and 2021 was $6.1 million and $4.6 million, respectively, which were included in accounts payable and accrued liabilities in the accompanying consolidated balance sheets. Accrual for Product Returns The Company offers most customers the right to return qualified excess or expired inventory for partial credit; however, API product sales are generally non-returnable. The Company’s product returns primarily consist of the returns of expired products from sales made in prior periods. Returned products cannot be resold. At the time product revenue is recognized, the Company records an accrual for product returns estimated using the expected value method. The accrual is based, in part, upon the historical relationship of product returns to sales and customer contract terms. The Company also assesses other factors that could affect product returns including market conditions, product obsolescence, and new competition. Although these factors do not normally give the Company’s customers the right to return products outside of the regular return policy, the Company realizes that such factors could ultimately lead to increased returns. The Company analyzes these situations on a case-by-case basis and makes adjustments to the product return reserve as appropriate. The provision for product returns is reflected as a component of net revenues. The following table is an analysis of the product return liability: Year Ended December 31, 2022 2021 (in thousands) Beginning balance $ 21,677 $ 14,204 Provision for product returns 4,405 15,005 Credits issued to third parties (6,631) (7,532) Ending balance $ 19,451 $ 21,677 Of the provision for product returns as of December 31, 2022 and 2021, $14.9 million and $16.0 million were included in accounts payable and accrued liabilities on the accompanying consolidated balance sheets, respectively. The remaining provision as of December 31, 2022 and 2021, of $4.6 million and $5.7 million were included in other long-term liabilities, respectively. For the years ended December 31, 2022 and 2021, the Company’s aggregate product return rate was 1.4% and 1.7% of qualified sales, respectively. |
Income per Share Attributable t
Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders | 12 Months Ended |
Dec. 31, 2022 | |
Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders | |
Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders | Note 5. Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders Basic net income per share attributable to Amphastar Pharmaceuticals Inc. stockholders is calculated based upon the weighted-average number of shares outstanding during the period. Diluted net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders gives effect to all potential dilutive shares outstanding during the period, such as stock options, non-vested restricted stock units, and shares issuable under the Company’s Employee Stock Purchase Plan, or ESPP. For the year ended December 31, 2022, options to purchase 704,483 shares of stock with a weighted-average exercise price of $34.79 per share were excluded from the computation of diluted net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders because their effect would be anti-dilutive. For the year ended December 31, 2021, options to purchase 1,906,029 shares of stock with a weighted-average exercise price of $20.82 per share and the reallocation of net income attributable to non-controlling interest were excluded from the computation of diluted net income per common share attributable to Amphastar Pharmaceuticals, Inc. stockholders because their effect would be anti-dilutive. For the year ended December 31, 2020, options to purchase 1,917,437 shares of stock with a weighted-average exercise price of $20.85 per share and the reallocation of net income attributable to non-controlling interest were excluded from the computation of diluted net income per common share attributable to Amphastar Pharmaceuticals, Inc. stockholders because their effect would be anti-dilutive. The following table provides the calculation of basic and diluted net income per share attributable to Amphastar Pharmaceuticals, Inc. shareholders for each of the periods presented: Year Ended December 31, 2022 2021 2020 (in thousands, except per share data) Basic and dilutive numerator: Net income attributable to Amphastar Pharmaceuticals, Inc. $ 91,386 $ 62,116 $ 1,403 Denominator: Weighted-average shares outstanding — basic 48,551 47,777 47,038 Net effect of dilutive securities: Incremental shares from equity awards 3,876 2,007 2,086 Weighted-average shares outstanding — diluted 52,427 49,784 49,124 Net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders — basic $ 1.88 $ 1.30 $ 0.03 Net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders — diluted $ 1.74 $ 1.25 $ 0.03 |
Segment Reporting
Segment Reporting | 12 Months Ended |
Dec. 31, 2022 | |
Segment Reporting | |
Segment Reporting | Note 6. Segment Reporting The Company’s business is the development, manufacture, and marketing of pharmaceutical products. The Company has identified two reporting segments that each report to the Chief Operating Decision Maker, or CODM, as defined in ASC 280, Segment Reporting. The Company’s performance is assessed and resources are allocated by the CODM based on the following two reportable segments: ● Finished pharmaceutical products ● APIs The finished pharmaceutical products segment manufactures, markets and distributes Primatene MIST ® Selected financial information by reporting segment is presented below: Year Ended December 31, 2022 2021 2020 (in thousands) Net revenues: Finished pharmaceutical products $ 486,505 $ 419,570 $ 331,368 API 12,482 18,198 18,478 Total net revenues 498,987 437,768 349,846 Gross profit (loss): Finished pharmaceutical products 256,710 209,715 151,645 API (7,850) (9,976) (8,305) Total gross profit 248,860 199,739 143,340 Operating expenses 141,363 129,852 132,386 Income from operations 107,497 69,887 10,954 Non-operating income (expenses) 8,543 14,252 (6,317) Income before income taxes $ 116,040 $ 84,139 $ 4,637 The Company manages its business segments to the gross profit level and manages its operating and other costs on a company-wide basis. The Company does not identify total assets by segment for internal purposes, as the Company’s CODM does not assess performance, make strategic decisions, or allocate resources based on assets. The amount of net revenues in the finished pharmaceutical product segment is presented below: Year Ended December 31, 2022 2021 2020 (in thousands) Finished pharmaceutical products net revenues: Primatene MIST ® $ 84,309 $ 73,113 $ 51,725 Epinephrine 74,204 57,530 23,799 Glucagon 55,322 47,639 — Lidocaine 52,539 44,413 41,113 Phytonadione 49,500 45,498 42,646 Enoxaparin 34,950 35,962 48,681 Naloxone 26,269 27,540 33,416 Other finished pharmaceutical products 109,412 87,875 89,988 Total finished pharmaceutical products net revenues $ 486,505 $ 419,570 $ 331,368 The amount of depreciation and amortization expense included in cost of revenues, by reporting segment is presented below: Year Ended December 31, 2022 2021 2020 (in thousands) Depreciation and amortization expense Finished pharmaceutical products $ 8,884 $ 6,003 $ 5,766 API 3,713 4,222 3,264 Total depreciation and amortization expense $ 12,597 $ 10,225 $ 9,030 Net revenues and carrying values of long-lived assets by geographic regions are as follows: Net Revenue Long-Lived Assets Year Ended December 31, December 31, 2022 2021 2020 2022 2021 (in thousands) United States $ 486,833 $ 419,869 $ 333,093 $ 136,328 $ 134,731 China 4,697 6,020 3,161 88,647 91,876 France 7,457 11,879 13,592 39,598 44,884 Total $ 498,987 $ 437,768 $ 349,846 $ 264,573 $ 271,491 |
Customer and Supplier Concentra
Customer and Supplier Concentration | 12 Months Ended |
Dec. 31, 2022 | |
Customer and Supplier Concentration | |
Customer and Supplier Concentration | Note 7. Customer and Supplier Concentration Customer Concentrations Three large wholesale drug distributors, AmerisourceBergen Corporation, or AmerisourceBergen, Cardinal Health, Inc., or Cardinal, and McKesson Corporation, or McKesson, are all distributors of the Company’s products, as well as suppliers of a broad range of health care products. The Company considers these three customers to be its major customers, as each individually and these customers collectively, represented a significant percentage of the Company’s net revenue for the years ended December 31, 2022, 2021, and 2020, and accounts receivable as of December 31, 2022 and 2021, respectively. The following table provides accounts receivable and net revenue information for these major customers: % of Total Accounts % of Net Receivable Revenue December 31, December 31, Year Ended December 31, 2022 2021 2022 2021 2020 AmerisourceBergen 16 % 13 % 23 % 24 % 23 % McKesson 32 % 30 % 22 % 21 % 22 % Cardinal Health 19 % 20 % 17 % 16 % 17 % Supplier Concentrations The Company depends on suppliers for raw materials, APIs, and other components that are subject to stringent FDA requirements. Some of these materials may only be available from one or a limited number of sources. Establishing additional or replacement suppliers for these materials may take a substantial period of time, as suppliers must be approved by the FDA. Furthermore, a significant portion of raw materials may only be available from foreign sources. If the Company is unable to secure, on a timely basis, sufficient quantities of the materials it depends on to manufacture and market its products, it could have a materially adverse effect on the Company’s business, financial condition, and results of operations. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | Note 8. Fair Value Measurements GAAP defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal or most advantageous market for the asset or liability at the measurement date (an exit price). These standards also establish a hierarchy that prioritizes observable and unobservable inputs used in measuring fair value of an asset or liability, as described below: ● Level 1 – Inputs to measure fair value are based on quoted prices (unadjusted) in active markets on identical assets or liabilities; ● Level 2 – Inputs to measure fair value are based on the following: a) quoted prices in active markets on similar assets or liabilities, b) quoted prices for identical or similar instruments in inactive markets, or c) observable (other than quoted prices) or collaborated observable market data used in a pricing model from which the fair value is derived; and ● Level 3 – Inputs to measure fair value are unobservable and the assets or liabilities have little, if any, market activity; these inputs reflect the Company’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities based on best information available in the circumstances. As of December 31, 2022, cash equivalents include money market accounts and corporate and municipal bonds with original maturities of less than three months. Investments consist of certificates of deposit as well as investment-grade corporate and municipal bonds with original maturity dates between three and twelve months. The certificates of deposit are carried at amortized cost in the Company’s consolidated balance sheets, which approximates their fair value determined based on Level 2 inputs. The corporate and municipal bonds are classified as held-to-maturity and are carried at amortized cost net of allowance for credit losses, which approximates their fair value determined based on Level 2 inputs. The restrictions on restricted cash and investments have an immaterial effect on the fair value of these financial assets. The fair value of the Company’s financial assets and liabilities measured on a recurring basis as of December 31, 2022 and 2021, are as follows: Total (Level 1) (Level 2) (Level 3) (in thousands) Cash equivalents $ 130,249 $ 130,249 $ — $ — Restricted cash 235 235 — — Short-term investments 4,600 — 4,600 — Restricted short-term investments 2,200 — 2,200 — Corporate, agency and municipal bonds 23,453 — 23,453 — Interest rate swaps related to variable rate loans 6,048 — 6,048 — Fair value measurement as of December 31, 2022 $ 166,785 $ 130,484 $ 36,301 $ — Cash equivalents $ 102,863 $ 102,863 $ — $ — Restricted cash 235 235 — — Short-term investments 5,103 — 5,103 — Restricted short-term investments 2,200 — 2,200 — Corporate and municipal bonds 6,984 — 6,984 — Interest rate swaps related to variable rate loans 596 — 596 — Fair value measurement as of December 31, 2021 $ 117,981 $ 103,098 $ 14,883 $ — The Company does not hold any Level 3 instruments that are measured at fair value on a recurring basis. Nonfinancial assets and liabilities are not measured at fair value on a recurring basis but are subject to fair value adjustments in certain circumstances. These items primarily include investments in unconsolidated affiliates, long-lived assets, goodwill, and intangible assets for which the fair value is determined as part of the related impairment test. As of December 31, 2022 and 2021, there were no significant adjustments to fair value for nonfinancial assets or liabilities. The deferred compensation plan assets are valued using the cash surrender value of the life insurance policies and are not included in the table above. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2022 | |
Investments | |
Investments | Note 9. Investments A summary of the Company’s investments that are classified as held-to-maturity are as follows: Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value (in thousands) Corporate and agency bonds (due within 1 year) $ 21,612 $ — $ (60) $ 21,552 Municipal bonds (due within 1 year) 1,903 — (2) 1,901 Total investments as of December 31, 2022 $ 23,515 $ — $ (62) $ 23,453 Corporate bonds (due within 1 year) $ 2,481 $ — $ (3) $ 2,478 Corporate bonds (due within 1 to 3 years) 1,248 — (3) 1,245 Municipal bonds (due within 1 year) 3,263 — (2) 3,261 Total investments as of December 31, 2021 $ 6,992 $ — $ (8) $ 6,984 At each reporting period, the Company evaluates securities for impairment when the fair value of the investment is less than its amortized cost. The Company evaluated the underlying credit quality and credit ratings of the issuers, noting neither a significant deterioration since purchase nor any other factors that would indicate a material credit loss. The Company measures expected credit losses on held-to-maturity investments on a collective basis. All the Company’s held-to-maturity investments were considered to be one pool. The estimate for credit losses considers historical loss information that is adjusted for current conditions and reasonable and supportable forecasts. Expected credit losses on held-to-maturity investments were not material to the consolidated financial statements. Investment in unconsolidated affiliate The Company accounts for its share of the earnings or losses of its unconsolidated affiliate (Hanxin) with a reporting lag of three months, as the financial statements of Hanxin are not completed on a basis that is sufficient for the Company to apply the equity method on a current basis. The Company’s share of Hanxin’s losses for the years ended December 31, 2022 and 2021 was $1.2 million and $0.2 million, respectively, which was recorded in the “Equity in losses of unconsolidated affiliate” line on the accompanying consolidated statement of operations. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets | |
Goodwill and Intangible Assets | Note 10. Goodwill and Intangible Assets The table below shows the weighted-average life, original cost, accumulated amortization, and net book value by major intangible asset classification: Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets IMS (UK) international product rights 10 $ 8,462 $ 5,430 $ 3,032 Patents 12 486 362 124 Land-use rights 39 2,540 749 1,791 Subtotal 11 11,488 6,541 4,947 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 3,126 — 3,126 Subtotal * 32,351 — 32,351 As of December 31, 2022 * $ 43,839 $ 6,541 $ 37,298 Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets IMS (UK) international product rights 10 $ 9,445 $ 5,116 $ 4,329 Patents 12 486 340 146 Land-use rights 39 2,540 683 1,857 Subtotal 12 12,471 6,139 6,332 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 3,313 — 3,313 Subtotal * 32,538 — 32,538 As of December 31, 2021 * $ 45,009 $ 6,139 $ 38,870 * Intangible assets with indefinite lives have an indeterminable average life. Goodwill The changes in the carrying amounts of goodwill are as follows: December 31, 2022 2021 (in thousands) Beginning balance $ 3,313 $ 3,940 ANP restructuring — (374) Currency translation (187) (253) Ending balance $ 3,126 $ 3,313 Primatene ® Trademark In January 2009, the Company acquired the exclusive rights to the trademark, domain name, website and domestic marketing, distribution and selling rights related to Primatene MIST ® The trademark was determined to have an indefinite life. In determining its indefinite life, the Company considered the following: the expected use of the intangible; the longevity of the brand; the legal, regulatory and contractual provisions that affect their maximum useful life; the Company’s ability to renew or extend the asset’s legal or contractual life without substantial costs; effects of the regulatory environment; expected changes in distribution channels; maintenance expenditures required to obtain the expected future cash flows from the asset; and considerations for obsolescence, demand, competition and other economic factors. Amortization Included in cost of revenues for the years ended December 31, 2022, 2021 and 2020 is product rights amortization expense of $0.9 million, $1.0 million, and $1.2 million, respectively. As of December 31, 2022, the expected amortization expense for all amortizable intangible assets during the next five fiscal years ended December 31 and thereafter is as follows: (in thousands) 2023 $ 1,035 2024 1,035 2025 1,035 2026 243 2027 79 Thereafter 1,520 Total amortizable intangible assets 4,947 Indefinite-lived intangibles 32,351 Total intangibles (net of accumulated amortization) $ 37,298 |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Inventories | |
Inventories | Note 11. Inventories Inventories consist of the following: December 31, 2022 2021 (in thousands) Raw materials and supplies $ 47,607 $ 41,853 Work in process 37,090 33,298 Finished goods 18,887 17,656 Total inventories $ 103,584 $ 92,807 Charges of $17.2 million, $24.6 million, and $13.9 million were included in the cost of revenues in the Company’s consolidated statements of operations for the years ended December 31, 2022, 2021, and 2020, respectively, to adjust the Company’s inventory and related firm purchase commitments to their net realizable value. For the year ended December 31, 2022, the charge included $14.9 million in the cost of revenues to adjust the Company’s enoxaparin inventory and related firm purchase commitments to their net realizable value. For the year ended December 31, 2021, the charge included $20.7 million as a result of an increase in the price of heparin as well as a decrease in the forecasted average selling price of enoxaparin. For the year ended December 31, 2020, the charge included $9.4 million as a result of an increase in the price of heparin as well as a decrease in the forecasted average selling price of enoxaparin. Losses on firm purchase commitments related to raw materials on order as of December 31, 2022 and 2021 were $2.7 million and $7.1 million, respectively, which are recorded in cost of revenues in the Company’s consolidated statement of operations. |
Property, Plant, and Equipment
Property, Plant, and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant, and Equipment | |
Property, Plant, and Equipment | Note 12. Property, Plant, and Equipment Property, plant, and equipment consist of the following: December 31, 2022 2021 (in thousands) Buildings $ 130,726 $ 130,582 Leasehold improvements 31,535 29,221 Land 7,451 7,615 Machinery and equipment 208,068 207,883 Furniture, fixtures, and automobiles 29,674 27,376 Construction in progress 50,842 41,186 Total property, plant, and equipment 458,296 443,863 Less accumulated depreciation (220,030) (199,619) Total property, plant, and equipment, net $ 238,266 $ 244,244 The Company incurred depreciation expense of $23.8 million, $22.2 million, and $20.5 million for the years ended December 31, 2022, 2021, and 2020, respectively. Interest expense capitalized was approximately $1.4 million, $1.4 million, and $1.8 million, for the years ended December 31, 2022, 2021, and 2020, respectively. |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Accounts Payable and Accrued Liabilities. | |
Accounts Payable and Accrued Liabilities | Note 13. Accounts Payable and Accrued Liabilities Accounts payable and accrued liabilities consisted of the following: December 31, 2022 2021 (in thousands) Accrued customer fees and rebates $ 14,198 $ 12,121 Accrued payroll and related benefits 22,847 23,256 Accrued product returns, current portion 14,867 16,028 Accrued loss on firm purchase commitments 2,686 7,133 Other accrued liabilities 9,143 8,793 Total accrued liabilities 63,741 67,331 Accounts payable 20,501 22,214 Total accounts payable and accrued liabilities $ 84,242 $ 89,545 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt | |
Debt | Note 14. Debt Debt consists of the following: December 31, 2022 2021 (in thousands) Term Loan Term loan with Capital One N.A. due August 2026 $ 68,250 $ 69,563 Mortgage Loans Mortgage payable with East West Bank due June 2027 8,188 8,353 Other Loans and Payment Obligations French government loans due December 2026 204 269 Line of Credit Facilities Line of credit facility with China Merchant Bank — — Revolving line of credit facility with Capital One N.A. due August 2026 — — Equipment under Finance Leases 790 398 Total debt 77,432 78,583 Less current portion of long-term debt 3,046 2,202 Less: Loan issuance costs 1,547 1,605 Long-term debt, net of current portion and unamortized debt issuance costs $ 72,839 $ 74,776 Credit Agreement Credit Agreement with Capital One N.A. - Due August 2026 In August 2021, the Company entered into a $140.0 million credit agreement with Capital One N.A. acting as a lender and as agent for other lenders. Under the terms of the credit agreement, the Company borrowed $70.0 million in the form of a term loan. Proceeds from the loan were used to pay down certain of the Company’s outstanding loans and revolving lines of credit with Cathay Bank and East West Bank. The interest rate on the term loan is based on a variable interest rate, plus an applicable margin rate ranging between 0.5% and 2.5%, determined based on the Company’s net leverage ratio as defined by the terms of the agreement. The loan matures in August 2026. The loan requires principal payments of $1.8 million per year for the first two years, which increases to $3.5 million during the third and fourth year and to $3.9 million in the fifth year, with the remaining balance due at maturity. The loan is secured by substantially all of the Company’s assets, excluding the assets of ANP. The credit agreement provides for a $70.0 million revolving credit facility, which bears a variable interest rate, plus a fixed margin. In conjunction with the new credit agreement, the Company entered into an interest rate swap agreement with Capital One N.A., with a notional amount of $55.0 million to exchange the variable interest rate on the new term loan for a fixed rate of 0.93%. As of December 31, 2022, the Company has incurred approximately $2.1 million in issuance costs in connection with this credit agreement, which are being amortized over the term of the loan. Mortgage Loans Mortgage Payable with East West Bank — Due June 2027 In May 2017, the Company entered into a mortgage term loan with East West Bank in the principal amount of $9.0 million, which matures in June 2027. The loan is payable in monthly installments with a final balloon payment of $7.4 million plus interest. The loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex and two buildings at the Company’s Chino, California, facility. The loan bears a variable interest rate at the one-month LIBOR rate plus 2.5%. As of December 31, 2022, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. The Company entered into a fixed interest rate swap contract on this loan to exchange the variable interest rate for a fixed interest rate of 4.79% until June 2024. Line of Credit Facilities Line of Credit Facility with China Merchant Bank – Due March 2023 In March 2020, the Company entered into a credit agreement with China Merchant Bank. The credit agreement allows the Company to borrow up to $14.6 million secured by buildings and land use rights held by ANP. The interest rate and other terms will be determined at the time of the borrowing, depending on the type of loan requested. The credit period is for 36 months and expires in March 2023. Other Loans and Payment Obligations Loans with Seine-Normandie Water Agency In December 2018, the Company entered into two additional French government loans with the Seine-Normandie water agency in the aggregate amount $0.5 million. The loans have 8 year maturities, and include annual equal payments and bear no As of December 31, 2022, the payment obligation had an aggregate book value of $0.2 million, which approximates fair value. Interest Rate Swap Contracts As of December 31, 2022, the fair value of the loans listed above approximated their carrying amount. The interest rate used in the fair value estimation was determined to be a Level 2 input. For the mortgage loan with East West Bank, as well as the term loan with Capital One N.A., the Company has entered into fixed interest rate swap contracts to exchange the variable interest rates for fixed interest rates. The interest rate swap contracts are recorded at fair value in the other assets line in the condensed consolidated balance sheets. Gains from changes in the fair values of interest rate swaps were $5.5 million and $1.5 million for the years ended December 31, 2022 and 2021, respectively. Covenants At December 31, 2022 and 2021, the Company was in compliance with all of its debt covenants. Long-Term Debt Maturities As of December 31, 2022, the principal amounts of long-term debt maturities during each of the next five fiscal years ending December 31 are as follows: Long-term Debt (in thousands) 2023 $ 2,848 2024 3,733 2025 4,181 2026 58,440 2027 7,440 Thereafter — $ 76,642 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Income Taxes | Note 15. Income Taxes The Company’s income (loss) before income taxes generated from its operations were: Year Ended December 31, 2022 2021 2020 (in thousands) Income (loss) before income taxes: United States $ 127,204 $ 86,236 $ 15,634 Foreign (11,164) (2,097) (10,997) Total income (loss) before taxes $ 116,040 $ 84,139 $ 4,637 The Company’s provision for income taxes consisted of the following: Year Ended December 31, 2022 2021 2020 (in thousands) Current provision: Federal $ 37,626 $ 14,088 $ 1,803 State 732 1,182 541 Foreign 998 1,676 279 Total current provision 39,356 16,946 2,623 Deferred provision (benefit): Federal (16,119) 2,657 1,770 State 816 110 (1,489) Foreign (576) 917 636 Total deferred provision (15,879) 3,684 917 Total provision for income taxes $ 23,477 $ 20,630 $ 3,540 For tax years beginning after December 31, 2021, certain research and development costs are required to be capitalized and amortized over a five or fifteen-year period under the Tax Cuts and Jobs Act of 2017. The Company has reviewed and incorporated this change, which increases the current U.S. federal and state tax expense and cash taxes to be paid for the tax year ending December 31, 2022. A reconciliation of the statutory federal income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2022 2021 2020 Statutory federal income tax 21.0 % 21.0 % 21.0 % State tax expense, net of federal tax benefit 1.1 1.2 (16.2) Foreign tax rate differences (0.3) (2.0) (20.1) Foreign valuation allowance 2.6 5.5 89.5 Research and development credits (3.1) (3.2) (65.1) Share-based compensation (3.5) (0.2) 18.7 Executive compensation 2.3 2.3 48.1 Employee-related expenses 0.2 0.1 1.7 Other (0.1) (0.2) (1.3) Effective tax rate 20.2 % 24.5 % 76.3 % The Company’s effective tax rate for 2022 decreased in comparison to 2021 primarily due to differences in pre-tax income positions and excess tax benefit from share-based compensation. Deferred Tax Assets and Liabilities Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, tax credit carryforwards, and the tax effects of net operating loss carryforwards. The significant components of the Company’s deferred tax assets and liabilities are as follows: December 31, 2022 2021 (in thousands) Deferred tax assets: Research and development credits $ 15,418 $ 17,019 Net operating loss carryforward 20,019 17,568 Inventory capitalization and reserve 9,598 8,489 Share-based compensation 5,208 4,892 Operating leases 6,684 6,555 Accrued expenses 4,956 5,188 Accrued chargebacks 5,125 3,694 Product return allowance 5,464 5,611 Intangibles 2,124 2,124 Research and development capitalization 17,988 — Total deferred tax assets 92,584 71,140 Deferred tax liabilities: Depreciation/amortization 13,272 13,525 Intangibles 8,564 7,893 Operating leases 6,398 6,368 Federal impact of state deferred taxes 3,800 3,966 Other 2,467 642 Total deferred tax liabilities 34,501 32,394 Valuation allowance (19,700) (16,881) Net deferred tax assets $ 38,383 $ 21,865 Net Operating Loss Carryforwards and Tax Credits At December 31, 2022, the Company had no material U.S. federal or state net operating loss carryforwards, or NOL carryforwards. The Company had France and United Kingdom foreign NOL carryforwards of approximately $75.3 million and $2.5 million, respectively. The France and United Kingdom NOL carryforwards can be used annually with certain limitations and have an indefinite carryforward. At December 31, 2022, the Company had California research and development tax credit carryforwards of approximately $21.9 million. The California research and development tax credit has an indefinite carryforward period. The utilization of NOL and credit carryforwards and other tax attributes could be subject to an annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, or the Code, whereby they could be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period as defined in the Code. Valuation Allowance In assessing the need for a valuation allowance, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will be realized. Ultimately, realization depends on the existence of future taxable income. Management considers sources of taxable income such as future reversal of existing deferred taxable temporary differences, tax-planning strategies, and projected future taxable income. The Company continues to record a full valuation allowance on AFP’s net deferred income tax assets and will continue to do so until AFP generates sufficient taxable income to realize its deferred income tax assets. As of December 31, 2022 and 2021, the Company had a full valuation allowance against the net deferred tax assets of AFP, which totaled $18.9 million and $16.9 million, respectively. The Company records a valuation allowance on net deferred income tax assets in states where it files separately and will continue to do so until sufficient taxable income is generated to realize these state deferred income tax assets. Undistributed Earnings from Foreign Operations As of December 31, 2022 and 2021, deferred income taxes have not been provided for any undistributed earnings from foreign operations. The foreign subsidiaries have significant accumulated losses, and as such there are no earnings in which to provide taxes. It is the Company’s plan not to repatriate future foreign earnings to the U.S. and indefinitely reinvest such earnings in the foreign jurisdiction. Uncertain Income Tax Positions A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows: December 31, 2022 2021 2020 (in thousands) Balance at the beginning of the year $ 11,796 $ 10,053 $ 8,331 Deductions based on tax positions related to prior year (41) — — Additions based on tax positions related to the current year 1,643 1,754 1,815 Deductions based on statute of limitations (503) (11) (93) Balance at the end of the year $ 12,895 $ 11,796 $ 10,053 Included in the balance of unrecognized tax benefits as of December 31, 2022 and 2021, was $12.2 million and $11.4 million, respectively that represents the portion that would impact the effective income tax rate if recognized. The Company recognizes interest and penalties related to unrecognized tax benefits in its income tax provision. For the years ended December 31, 2022, 2021 and 2020, the Company accrued interest of approximately $0.8 million, $0.5 million and $0.2 million, respectively, related to its uncertain tax positions. The Company and/or one or more of its subsidiaries files income tax returns in the U.S. federal jurisdiction and various U.S. states and foreign jurisdictions. As of December 31, 2022, the Company does not have a tax examination in progress for federal, state, or foreign jurisdictions. The Company is subject to income tax audit by tax authorities for tax years 2019 to 2021 for federal, 2018 to 2021 for states, and 2012 to 2021 for foreign. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | Note 16. Stockholders' Equity Equity Plans As of December 31, 2022, the Company has two equity plans: the Amended and Restated 2015 Equity Incentive Plan, or 2015 Plan, and the 2014 Employee Stock Purchase Plan or ESPP. Prior to the adoption of these plans, the Company granted options pursuant to the Amended and Restated 2005 Equity Incentive Award Plan. Upon termination of the predecessor plans, the shares available for grant at the time of termination, and shares subsequently returned to the plans upon forfeiture or option termination, were transferred to the successor plan in effect at the time of share return. The Company issues new shares of common stock upon exercise of stock options, vesting of restricted stock units, or RSU, and settlement of ESPP, with the exception of the awards granted to employees at AFP, which are settled through re-issuance of the Company’s treasury shares. Amended and Restated 2015 Equity Incentive Plan In March 2015, the Board of Directors adopted the Company’s 2015 Equity Incentive Plan, or the 2015 Plan, which was approved by the Company’s stockholders in May 2015 and is set to expire in March 2025. The 2015 Plan is designed to meet the needs of a publicly traded company, including the requirements for granting “performance based compensation” under Section 162(m) of the Internal Revenue Code. The 2015 Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units, performance shares, and other stock or cash awards to employees of the Company and its subsidiaries, members of the Board of Directors and consultants. In November 2020, the Board of Directors approved the Amendment and Restated 2015 Equity Incentive Plan to provide that at least 95% of the shares awarded under the plan will be subject to a minimum vesting requirement of at least one year . The Company initially reserved 5,000,000 shares of common stock for issuance under the 2015 Plan. This number will be increased by the number of shares available for issuance under the Company’s prior equity incentive plans or arrangements that are not subject to options or other awards, plus the number of shares of common stock related to options or other awards granted under the Company’s prior equity incentive plans or arrangements that are repurchased, forfeited, expired, or cancelled on or after the effective date of the 2015 Plan. The 2015 Plan also contains an “evergreen provision” that allows for an annual increase in the number of shares available for issuance on January 1 of each year during the 10 year term of the 2015 Plan, beginning January 1, 2016. The annual increase in the number of shares shall be the lesser of (i) 3,000,000 shares, (ii) two and one-half percent ( 2.5% ) of the outstanding shares on the last day of the immediately preceding fiscal year, or (iii) such number of shares as determined by the Board of Directors. As of the effective date of the 2015 Plan, there were 5,300,296 shares available for grant under the 2015 Plan. As of December 31, 2022, the Company reserved an aggregate of 6,499,954 shares of common stock for future issuance under the Amended and Restated 2015 Equity Incentive Plan, or the 2015 Plan, including 1,202,802 shares, which were reserved in January 2023 pursuant to the evergreen provision in the 2015 Plan. Amended and Restated 2005 Equity Incentive Award Plan The Amended and Restated 2005 Equity Incentive Award Plan, or 2005 Plan, provided for the grant of incentive stock options, or ISOs, nonqualified stock options, or NQSOs, restricted stock awards, restricted stock unit awards, stock appreciation rights, or SARs, dividend equivalents and stock payments to the Company’s employees, members of the Board of Directors and consultants. Stock options under the 2005 Plan were granted with a term of up to ten years and at prices no less than the fair market value of the Company’s common stock on the date of grant. To date, stock options granted to existing employees generally vest over three to five years and stock options granted to new employees vest over four years . Stock options granted to Board of Directors and consultants generally vested over one year . As of March 2015, consequent to the 2015 Plan becoming effective, awards were no longer granted under the 2005 Plan. 2014 Employee Stock Purchase Plan In June 2014, the Company adopted the ESPP in connection with its initial public offering. A total of 2,000,000 shares of common stock are reserved for issuance under this plan. The Company’s ESPP permits eligible employees to purchase common stock at a discount through payroll deductions during defined offering periods. Under the ESPP, the Company may specify offerings with durations of not more than 27 months, and may specify shorter purchase periods within each offering. Each offering will have one or more purchase dates on which shares of its common stock will be purchased for employees participating in the offering. An offering may be terminated under certain circumstances. The price at which the stock is purchased is equal to 85% of the lower of the fair market value of the common stock at the beginning of an offering period or on the date of purchase. As of December 31, 2022, the Company has issued 1,089,545 shares of common stock under the ESPP and 910,455 shares of its common stock remains available for issuance under the ESPP. For the years ended December 31, 2022, 2021, and 2020, the Company recorded ESPP expense of $0.9 million, $0.7 million, and $0.8 million, respectively. Share Buyback Program As of December 31, 2022, the Company’s Board of Directors have authorized a total of $235.0 million in the share buyback program. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs. The Company’s share buyback program is expected to continue for an indefinite period of time. Purchases are made through open market and private block transactions pursuant to Rule 10b5-1 plans, privately negotiated transactions or other means as determined by the Company’s management and in accordance with the requirements of the SEC and applicable laws. The timing and actual number of treasury share purchases will depend on a variety of factors including price, corporate and regulatory requirements, and other conditions. These treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s consolidated balance sheets. Pursuant to the Company’s existing share buyback program, the Company purchased 1,335,528 shares, 1,477,305 shares, and 1,366,384, shares of its common stock during the years ended December 31, 2022, 2021 and 2020, for total consideration of $39.9 million, $28.9 million, and $24.4 million, respectively. Share-Based Award Activity and Balances (excluding the ANP Equity Plan) The Company accounts for share-based compensation payments in accordance with ASC 718, which requires measurement and recognition of compensation expense at fair value for all share-based payment awards made to employees and directors. Under these standards, the fair value of option awards and the option components of the ESPP awards are estimated at the grant date using the Black-Scholes option-pricing model. The fair value of RSUs is estimated at the grant date using the Company’s common share price. Compensation cost for all share-based payments granted with service-based graded vesting schedules is recognized using the straight-line method over the requisite service period. Options issued under the Company’s 2015 Plan and 2005 Plan are granted at exercise prices equal to or greater than the fair value of the underlying common shares on the date of grant and vest based on continuous service. There have been no awards with performance conditions and no awards with market conditions. The options have a contractual term of five three five The significant assumptions used in the Black-Scholes option-pricing are as follows: ● Determination of Fair Value of the Underlying Common Stock. For options and ESPP awards granted, the fair value for its underlying common stock is determined using the closing price on the date of grant as reported on the Nasdaq Global Select Market, or Nasdaq with consideration of whether there is material nonpublic information that could impact that estimated fair value when it is released. ● Expected Volatility. The Company estimates its volatility based on the historical volatility of its stock price since IPO. ● Expected Term. The expected term represents the period of time in which the options granted are expected to be outstanding. The Company estimates the expected term of options with consideration of vesting date, contractual term, and historical experience for exercise and post-vesting employment or contractual termination behavior after its common stock has been publicly traded. The expected term of “plain vanilla” options is estimated (using the simplified method as outlined in SAB Topic 14 due to a lack of sufficient historical exercise data) based on the midpoint between the vesting date and the end of the contractual term under the simplified method permitted by the SEC implementation guidance. ● Risk- Free Rate. The risk-free interest rate is selected based upon the implied yields in effect at the time of the option grant on U.S. Treasury zero-coupon issues with a term approximately equal to the expected life of the option being valued. ● Dividends. The Company does not anticipate paying cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield rate of zero. The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual experience differs from those estimates. For the years ended December 31, 2022, 2021 and 2020, the Company estimated an average overall forfeiture rate of approximately 7%, 6%, and 5%, respectively, based on historical experience. Forfeiture rates are separately estimated for its (1) directors and officers, (2) management personnel and (3) other employees. Share-based compensation is recorded net of expected forfeitures. The Company periodically assesses the forfeiture rate and the amount of expense recognized based on estimated historical forfeitures as compared to actual forfeitures. Changes in estimates are recorded in the period they are identified. Tax benefits resulting from tax deductions in excess of the share-based compensation cost recognized (excess tax benefits) are recorded in the statements of cash flows as financing activities. The weighted-averages for key assumptions used in determining the fair value of options granted during the years ended December 31, 2022, 2021, and 2020 are as follows: Year Ended December 31, 2022 2021 2020 Average volatility 41.0 % 42.1 % 43.1 % Average risk-free interest rate 2.3 % 1.2 % 0.8 % Weighted-average expected life in years 6.1 6.1 5.7 Dividend yield rate — % — % — % Stock Options A summary of option activity under all plans for the year ended December 31, 2022, is presented below: Weighted-Average Weighted-Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term (Years) Value (1) (in thousands) Outstanding as of December 31, 2021 8,455,721 $ 15.67 Options granted 792,441 34.35 Options exercised (1,222,147) 14.56 Options cancelled (91,251) 19.56 Options expired (5,614) 13.79 Outstanding as of December 31, 2022 7,929,150 $ 17.66 4.94 87,025 Exercisable as of December 31, 2022 5,550,697 $ 15.69 3.64 68,413 Vested and expected to vest as of December 31, 2022 7,757,291 $ 17.51 4.87 85,920 (1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the estimated fair value of the Company’s stock for those awards that have an exercise price below the estimated fair value at December 31, 2022. During the years ended December 31, 2022, 2021, and 2020, the Company recorded expense of $8.5 million, $8.0 million, and $9.1 million, respectively, related to stock options granted under all plans. Information relating to option grants and exercises is as follows: Year Ended December 31, 2022 2021 2020 (in thousands, except per share data) Weighted-average grant date fair value per option share $ 14.75 $ 7.62 $ 5.51 Intrinsic value of options exercised 21,279 7,906 9,169 Cash received from options exercised 19,202 16,757 24,357 Total fair value of the options vested during the period 8,174 8,177 9,978 A summary of the status of the Company’s non-vested options as of December 31, 2022, and changes during the year ended December 31, 2022, are presented below: Weighted-Average Grant Date Options Fair Value Non-vested as of December 31, 2021 2,848,934 $ 6.95 Options granted 792,441 14.75 Options vested (1,171,671) 6.98 Options forfeited (91,251) 8.41 Non-vested as of December 31, 2022 2,378,453 9.48 As of December 31, 2022, there was $14.5 million of total unrecognized compensation cost, net of forfeitures, related to non-vested stock option based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.5 years and will be adjusted for future changes in estimated forfeitures. In April 2020, Jason Shandell resigned from his position as the Company’s President and General Counsel and as a member of the Company’s board of directors. In connection with his resignation, the Company and Mr. Shandell entered into a separation agreement. As part of the separation agreement, the Company agreed to accelerate 80% of his unvested stock options and extended the expiration date of certain vested stock option awards. As a result of this modification, the Company incurred share-based compensation expense of $0.7 million, which is included within general and administration expenses in the consolidated statement of operations for the year ended December 31, 2020. Restricted Stock Units The Company grants restricted stock units, or RSUs, to certain employees and members of the Board of Directors with a vesting period of up to five years. The grantee receives one share of common stock at a specified future date for each RSU awarded. The RSUs may not be sold or otherwise transferred until vested. The RSUs do not have any voting or dividend rights prior to the issuance of certificates of the underlying common stock. The share-based expense associated with these grants was based on the Company’s common stock fair value at the time of grant and is amortized over the requisite service period, which generally is the vesting period, using the straight-line method. During the years ended December 31, 2022, 2021, and 2020, the Company recorded expenses of $8.4 million, $8.1 million, and $10.0 million, respectively, related to RSU awards granted under all plans. As part of the separation agreement with Mr. Shandell, the Company agreed to accelerate the vesting of 80% of his RSU awards. As a result of this modification, the Company incurred share-based compensation expense of $1.6 million, which is included within general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2020. As of December 31, 2022, there was $15.3 million of total unrecognized compensation cost, net of forfeitures, related to non-vested RSU-based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.5 years and will be adjusted for future changes in estimated forfeitures. Information relating to RSU grants and deliveries is as follows: Total Fair Market Total RSUs Value of RSUs Issued Issued (1) (in thousands) RSUs outstanding at December 31, 2021 1,184,842 RSUs granted 339,397 $ 11,675 RSUs forfeited (39,119) RSUs vested (2) (478,068) RSUs outstanding at December 31, 2022 1,007,052 (1) The total FMV is derived from the number of RSUs granted times the current stock price on the date of grant. (2) Of the vested RSUs, 181,547 shares of common stock were surrendered to fulfil tax withholding obligations. The 2018 ANP Equity Incentive Plan In December 2018, ANP’s board of directors approved the 2018 Plan, which was set to expire in December 2023. The 2018 Plan permitted the grant of stock options and other equity awards in ANP shares to ANP employees. During the second quarter of 2021, in connection with the ANP restructuring, the 2018 Plan was terminated. At the time the 2018 Plan was terminated, the number of stock options outstanding under the 2018 Plan was 5,018,880. As part of the termination, ANP cash settled 4,091,080 stock options, of which 1,944,771 stock options were vested and 2,146,309 stock options were unvested, for $0.8 million which approximated the fair value of these awards at the time of the settlement. The cash settlement of these awards was recorded as a reduction in equity. For the remaining 927,800 stock option awards that were outstanding under the 2018 Plan at the time the 2018 Plan was terminated, of which 56,925 stock options were vested and 870,875 were unvested, the Company cancelled these awards and issued replacement awards under the 2015 Plan. The modified awards vest over periods ranging from 1 to 2 years and have a 10-year contractual term. The cancellation and replacement of the awards was accounted for as a modification in accordance with ASC 718. As a result of the modification, the cost to the Company was $2.3 million, of which $1.8 million was recorded as share-based compensation within general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2021, and the remaining $0.5 million which will be recognized over the vesting period of the modified awards. Prior to the termination of the 2018 Plan, for the years ended December 31, 2021 and 2020, the Company recorded expense of $0.5 million and $0.7 million related to stock options issued by ANP under the 2018 Plan, respectively. Share-based Compensation Expense The Company recorded share-based compensation expense, which is included in the Company’s consolidated statement of operations as follows: Year Ended December 31, 2022 2021 2020 (in thousands) Cost of revenues $ 4,179 $ 3,778 $ 4,248 Operating expenses: Selling, distribution, and marketing 726 596 456 General and administrative 11,180 12,622 14,089 Research and development 1,775 1,691 1,705 Total share-based compensation $ 17,860 $ 18,687 $ 20,498 |
Employee Benefits
Employee Benefits | 12 Months Ended |
Dec. 31, 2022 | |
Employee Benefits | |
Employee Benefits | Note 17. Employee Benefits 401(k) Plan The Company has a defined contribution 401(k) plan, or the Plan, whereby eligible employees voluntarily contribute up to a defined percentage of their annual compensation. The Company matches contributions at a rate of 50% on the first 6% of employee contributions, and pays the administrative costs of the Plan. Total employer contributions for the years ended December 31, 2022, 2021, and 2020 were approximately $2.2 million, $2.0 million, and $1.9 million, respectively. Defined Benefit Pension Plan The Company’s subsidiary, AFP, has an obligation associated with a defined-benefit plan for its eligible employees. This plan provides benefits to the employees from the date of retirement and is based on the employee’s length of time employed by the Company. The calculation is based on a statistical calculation combining a number of factors that include the employee’s age, length of service, and AFP employee turnover rate. The liability under the plan is based on a discount rate of 3.75% and 1.00% as of December 31, 2022 and 2021, respectively. The liability is included in other long-term liabilities in the accompanying consolidated balance sheets. The plan is currently unfunded, and the benefit obligation under the plan was $2.2 million and $2.7 million at December 31, 2022 and 2021, respectively. The Company recorded an immaterial amount of expense under the plan for each of the years ended December 31, 2022, 2021 and 2020. Gain or loss due to change in actuarial valuation of the Company’s defined benefit pension plan is recorded in other comprehensive income (loss). Non-qualified Deferred Compensation Plan In December 2019, the Company established a non-qualified deferred compensation plan. The plan allows certain eligible participants to defer a portion of their cash compensation and provides a matching contribution at the discretion of the Company. The plan obligations are payable upon retirement, termination of employment and/or certain other times in a lump-sum distribution or in installments, as elected by the participant in accordance with the plan. Participants can allocate their deferred compensation amongst various investment options with earnings accruing to the participant. The Company has established a Rabbi Trust to fund the plan obligations and to hold the plan assets. Eligible participants began contributing to the plan in January 2020. The plan assets were valued at approximately $4.5 million and $3.4 million as of December 31, 2022 and December 31, 2021, respectively. The plan liabilities were valued at approximately $4.6 million and $3.5 million as of December 31, 2022 and December 31, 2021, respectively. The plan assets and liabilities are included in other long-term assets and other long-term liabilities, respectively, on the Company’s consolidated balance sheets. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 18. Commitments and Contingencies Lease Liabilities Right-of-Use, or ROU, assets represent the Company’s right to control an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Lease terms are generally based on their initial non-cancelable terms, unless there is a renewal option that is reasonably certain to be exercised. Various factors, including economic incentives, intent, past history, and business needs are considered to determine if a renewal option is reasonably certain to be exercised. As most of its leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the discount rate used to present value the lease payments. The Company has lease agreements with both lease and non-lease components, which are accounted for as a single component for all asset classes. The Company leases real and personal property, in the normal course of business, under various non-cancelable operating leases. The Company, at its option, can renew a substantial portion of its leases, at the market rate, for various renewal periods ranging from one to six years . The components of lease costs for the years ended December 31, 2022, 2021 and 2020 were as follows: Year Ended December 31, 2022 2021 2020 (in thousands) Operating lease costs $ 4,709 $ 4,328 $ 4,462 Short-term lease costs 300 518 649 Finance lease costs Amortization of right-of-use assets 237 384 351 Interest on lease liabilities 26 26 33 Total finance lease costs $ 263 $ 410 $ 384 Total lease costs $ 5,272 $ 5,256 $ 5,495 Other information pertaining to leases is as follows: Year Ended December 31, 2022 2021 2020 (in thousands, except lease term and discount rate) Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 4,329 $ 4,446 $ 4,491 Operating cash flows from finance leases 18 25 33 Financing cash flows from finance leases 233 310 369 Right-of use assets obtained in exchange for lease liabilities Operating leases 2,166 11,041 4,819 Finance leases 642 110 61 Weighted-average remaining lease term (years) Operating leases 8.7 9.5 8.7 Finance leases 4.3 2.4 2.3 Weighted-average discount rate Operating leases 4.4 % 4.5 % 5.2 % Finance leases 6.7 % 5.2 % 5.0 % Future minimum rental payments under leases that have initial or remaining non-cancelable lease terms in excess of 12 months as of December 31, 2022, are as follows: Operating Finance Leases Leases Total (in thousands) 2023 $ 4,078 $ 243 $ 4,321 2024 3,742 212 3,954 2025 3,635 189 3,824 2026 3,534 159 3,693 2027 3,364 104 3,468 Thereafter 14,080 — 14,080 Total lease payments $ 32,433 $ 907 $ 33,340 Less: interest 5,736 117 5,853 Total $ 26,697 $ 790 $ 27,487 Purchase Commitments As of December 31, 2022, the Company has entered into commitments to purchase equipment and raw materials for an aggregate amount of approximately $58.2 million. |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related-Party Transactions | |
Related-Party Transactions | Note 19. Related-Party Transactions ANP Restructuring Subsequent to the ANP restructuring discussed in Note 3, which involved various related parties, Hanxin is no longer a wholly-owned subsidiary of the Company and was deconsolidated in the third quarter of 2021. The Company determined that it has significant influence over Hanxin as a result of its 14% ownership interest, its seat on Hanxin’s board of directors, and Henry Zhang’s position as an equity holder, general manager, and chairman of the board of directors of Hanxin, given he is the son of Dr. Jack Zhang. Additionally, Dr. Mary Luo and Dr. Jack Zhang, through an affiliated entity, have an ownership interest in Hanxin and as such Hanxin continues to be a related party after the restructuring. Contract manufacturing agreement with Hanxin In April 2022, the Company’s Chinese subsidiary, ANP, entered into a contract manufacturing agreement with Hanxin, a related party, whereby Hanxin will develop several active pharmaceutical ingredients and finished products for the Chinese market and will engage ANP to manufacture the products on a cost-plus basis. Hanxin will commit to purchase certain quantities from ANP subject to the terms and conditions set forth in the agreement, including Hanxin filing for and obtaining any required marketing authorizations. During the year ended December 31, 2022, the Company recognized $0.4 million of revenue from manufacturing services provided to Hanxin. As of December 31, 2022, the Company did not have any Receivables from Hanxin. Contract Research Agreement with Hanxin In July 2022, the Company entered into a three-year contract research agreement with Hanxin, a related party, whereby Hanxin will develop Recombinant Human Insulin Research Cell Banks, or RCBs, for the Company and license the RCBs to the Company subject to a fully paid, exclusive, perpetual, transferable, sub-licensable worldwide license. The RCBs will be used by the Company to make Master Cell Banks for one of its product candidates. Per the terms of the agreement with Hanxin, all title to the RCBs developed, prepared and produced by Hanxin in conducting research and development will belong to the Company. The Company will also own any confidential and proprietary information, technology regarding development and manufacturing of the RCBs, which shall include engineering, scientific and practical information and formula, research data, design, and procedures and others to develop and manufacture the RCBs, in use or developed by Hanxin. The total cost of the agreement to the Company shall not exceed approximately $2.2 million, with payments adjusted based on the then current exchange rates. Any additional work or changes to the scope of work requested by the Company will be charged by Hanxin to the Company on a cost-plus basis, plus any applicable taxes. During the year ended December 31, 2022, the Company paid $0.6 million under this agreement and has accrued an additional $0.4 million payable to Hanxin as of December 31, 2022. Supply Agreement with Letop In November 2022, the Company’s Chinese subsidiary, ANP, entered in to a supply agreement with Nanjing Letop Biotechnology Co., Ltd., or Letop, a related party, whereby Letop would manufacture and deliver chemical intermediates for ANP on a cost-plus basis. The agreement is effective for three years and the total cost of the agreement shall not exceed approximately $1.5 million, with payments adjusted based on the then current exchange rates. During the year ended December 31, 2022, ANP paid $0.2 million under this agreement. As of December 31, 2022, the Company did not have any additional accruals payable to Letop. Retirement of James Luo In December 2020, James Luo retired from his position as the Company’s Senior Vice President of Engineering and President of AFP. Mr. Luo is a relative of the Company’s Chief Operating Officer, Dr. Mary Luo. In connection with his retirement, the Company and Mr. Luo entered into a retirement agreement where the Company agreed to pay Mr. Luo approximately $1.0 million in cash compensation over a period of three years as well as provide health insurance coverage for a six year period beginning in 2021. As a result, the Company recorded a total of $1.1 million in general and administrative expense in the fourth quarter of 2020 related to this agreement. |
Litigation
Litigation | 12 Months Ended |
Dec. 31, 2022 | |
Litigation | |
Litigation | Note 20. Litigation Amphastar Pharmaceuticals, Inc. v Aventis Pharma, SA In January 2009, the Company filed a qui tam ® On November 13, 2020, the Court issued an Order (“November Order”) awarding Aventis $12.1 million in attorneys’ fees and $0.7 million in costs and expenses. The Company recorded $12.8 million in other income (expenses) in the consolidated statement of operations for the year ended December 31, 2020. On May 3, 2021, the Court issued a further Order based upon supplemental application to the Court seeking fees, expenses, and interest for the period after, and not covered by, the November Order. The Court awarded Aventis an additional $4.4 million bringing the total amount awarded to Aventis to $17.2 million. On June 30, 2021, the Company and Aventis entered into a settlement agreement to settle the attorney fees’ and expenses claim for $14.5 million. The additional $1.7 million was recorded in other income (expenses), in the consolidated statement of operations. The settlement was paid in full in the third quarter of 2021. Hatch-Waxman Litigation Regadenoson (0.4 mg/5 mL, 0.08 mg/mL) Patent Litigation On February 25, 2020, Astellas US LLC, Astellas Pharma US, Inc., and Gilead Sciences, Inc. (collectively, “Astellas-Gilead”) filed a Complaint in the United States District Court for the District of Delaware against IMS for infringement of U.S. Patent Nos. 8,106,183 (the “‘183 patent”), RE47,301 (the “‘301 patent”), and 8,524,883 (the “‘883 patent”) (collectively, “Astellas-Gilead Patents”) with regard to IMS’s ANDA No. 214,252 for approval to manufacture and sell 0.4 mg/5 mL (0.08 mg/mL) intravenous solution of Regadenoson. On March 4, 2020, IMS filed its Answer and Counterclaims. On March 30, 2020, the Court issued an Order allowing the Company to join pending consolidated litigation with five other generic Regadenoson ANDA filers involving similar claims. The Company’s 30-month FDA stay expired August 10, 2022. On January 26, 2022, the Company and Astellas-Gilead reached an agreement to resolve the lawsuit. The parties submitted, and the Court granted on January 27, 2022, a Motion to Dismiss Without Prejudice for Astellas-Gilead’s complaint of infringement against IMS. Under the terms of the agreement, the Company received $5.4 million from Astellas constituting saved litigation expenses. The Company recorded the settlement amount in the other income (expenses) line in its consolidated statement of operations for the year ended December 31, 2022. Employee Litigations In 2021 and 2020, the Company settled employee litigations relating to alleged violations of various California labor laws pertaining to wage and hour against the Company. For each of the years ended December 31, 2021 and 2020, the Company recorded $1.0 million, related to the settlement of employment litigation, in general and administrative expense in the Company’s consolidated statements of operations. Other Litigation The Company is also subject to various other claims, arbitrations, investigations, and lawsuits from time to time arising in the ordinary course of business. In addition, third parties may, from time to time, assert claims against the Company in the forms of letters and other communications. The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a material adverse effect on its financial position, results of operations, or cash flows; however, the results of litigation and claims are inherently unpredictable and the Company’s view of these matters may change in the future. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries, and are prepared in accordance with United States generally accepted accounting principles, or GAAP. Certain prior period amounts have been reclassified within the operating activities of the consolidated statements of cash flows to conform to the current period presentation. All intercompany activity has been eliminated in the preparation of the consolidated financial statements. In the opinion of management, the accompanying consolidated financial statements include all adjustments, which are of a normal recurring nature, necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company. The Company’s subsidiaries include: (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Amphastar Nanjing Pharmaceuticals Inc., or ANP, (4) Amphastar France Pharmaceuticals, S.A.S., or AFP, (5) Amphastar UK Ltd., or AUK, and (6) International Medication Systems (UK) Limited, or IMS UK. |
Investments in Unconsolidated Affiliates | Investments in Unconsolidated Affiliate The Company applies the equity method of accounting for investments when it has significant influence, but not controlling interest in the investee. Judgment regarding the level of influence over each equity method investment includes key factors such as ownership interest, representation on the board of directors, participation in policy-making decisions and material intercompany transactions. The Company’s proportionate share of the earnings or losses resulting from these investments is reported as “Equity in losses of unconsolidated affiliate” in the accompanying consolidated statements of operations. Investments accounted for using the equity method may be reported on a lag of up to three months if financial statements of the investee are not available in sufficient time for the investor to apply the equity method as of the current reporting date. The determination of whether an investee’s results are recorded on a lag is made on an investment-by-investment basis. The carrying value of equity method investments is reported as “Investment in unconsolidated affiliate” in the accompanying consolidated balance sheets. The Company’s equity method investments are reported at cost and adjusted each period for the Company’s share of the investee’s earnings or losses and dividends paid, if any. The Company assesses equity method investments for impairment whenever events or changes in circumstances indicate that the carrying value of an investment may not be recoverable. If the decline in value is considered to be other than temporary, the investment is written down to its estimated fair value, which establishes a new cost basis in the investment. No such impairment was identified for any of the periods presented. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: determination of allowances for credit losses, fair value of financial instruments, allowance for discounts, provision for chargebacks and rebates, provision for product returns, adjustment of inventory to its net realizable value, impairment of investments, long-lived and intangible assets and goodwill, accrual for workers’ compensation liabilities, litigation reserves, stock price volatility for share-based compensation expense, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions. |
Foreign Currency | Foreign Currency The functional currency of the Company, its domestic subsidiaries, its Chinese subsidiary ANP, and its U.K. subsidiary, AUK, is the U.S. Dollar, or USD. ANP maintains its books of record in Chinese yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s accompanying consolidated statements of operations. The Company’s French subsidiary, AFP, maintains its book of record in euros. AUK’s subsidiary, IMS UK, maintains its book of record in British pounds. These local currencies have been determined to be the subsidiaries’ respective functional currencies. Activities in the statements of operations are translated to USD using average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other accumulated comprehensive income (loss). The unrealized gains or losses of intercompany foreign currency transactions that are of a long-term investment nature are reported in other accumulated comprehensive income (loss). The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature for the years ended December 31, 2022, 2021, and 2020 were a $1.8 million loss, a $2.6 million loss, and a $3.0 million gain, respectively. |
Comprehensive Income (Loss) | Comprehensive Income The Company’s comprehensive income includes its foreign currency translation gains and losses as well as its share of other comprehensive income from its equity method investments. There was no material income tax provision allocated to other comprehensive loss for the years ended December 31, 2022 and 2021. Income tax expense of $0.9 million was allocated to other comprehensive income for the year ended December 31, 2020. |
Shipping and Handling Costs | Shipping and Handling Costs For the years ended December 31, 2022, 2021, and 2020, the Company included shipping and handling costs of approximately $7.4 million, $4.3 million and $4.3 million, respectively, in selling, distribution and marketing expenses in the accompanying consolidated statements of operations. |
Advertising Expense | Advertising Expense Advertising expenses, primarily associated with Primatene MIST ® Company’s consolidated statements of operations. For the years ended December 31, 2022, 2021, and 2020, advertising expenses were $8.7 million, $8.1 million, and $5.8 million, respectively. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities. These include salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, research-related overhead expenses and fees paid to external service providers. The Company may produce or purchase inventories prior to or with the expectation of receiving regulatory approval in the near term, based on operational decisions about the most effective use of existing resources. This inventory is referred to as pre-launch inventory. It is the Company’s accounting policy that the pre-launch inventory is capitalized if it has a probable future economic benefit at the time it is purchased or manufactured. If regulatory approval is received and previously expensed pre-launch inventory is sold, such sales may contribute up to a 100% margin to the Company’s operating results. Pre-launch inventory costs include cost of work in process, materials, and finished drug products. As of December 31, 2022, 2021, and 2020, the Company did not have material capitalized pre-launch inventory. |
Financial Instruments | Financial Instruments The carrying amounts of cash and cash equivalents, short-term investments, restricted cash and short-term investments, accounts receivable, accounts payable, accrued expenses, and short-term borrowings approximate fair value due to the short maturity of these items. The majority of the Company’s long-term obligations consist of variable rate debt, and their carrying value approximates fair value as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities. The Company at times enters into interest rate swap contracts to manage its exposure to interest rate changes and its overall cost of long-term debt. The Company’s interest rate swap contracts exchange the variable interest rates for fixed interest rates. The Company from time to time may enter into forward currency contracts to lock in currency exchange rates to manage its foreign currency exchange rate exposure. The Company’s interest rate swaps and forward currency contracts have not been designated as hedging instruments and, therefore are recorded at their fair values at the end of each reporting period with changes in fair value recorded in other income (expenses) on the consolidated statements of operations. As of December 31, 2022, the Company had an unsettled forward currency contract to purchase foreign currency with a fair value of approximately $0.2 million based on Level 2 inputs, which was recorded as a liability in the accounts payable and accrued liabilities line in the accompanying consolidated balance sheets. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash, money market accounts, certificates of deposit and highly liquid investments with original maturities of three months or less. |
Investments | Investments Investments as of December 31, 2022 and 2021 consisted of certificates of deposit and investment grade corporate and municipal bonds with original maturity dates between three and fifteen months. |
Restricted Cash | Restricted Cash Restricted cash is collateral required for the Company to guarantee certain vendor payments in France. As of December 31, 2022 and 2021, the restricted cash balance was $0.2 million. |
Restricted Short-Term Investments | Restricted Short-Term Investments Restricted short-term investments consist of certificates of deposit that are collateral for standby letters of credit to qualify for workers’ compensation self-insurance. The certificates of deposit have original maturities greater than three months, but less than one year. As of December 31, 2022 and 2021, the balance of restricted short-term investments was $2.2 million. |
Allowance for Credit Losses | Allowance for Credit Losses The Company evaluates the collectability of accounts receivable based on a combination of factors. When the Company is aware of circumstances that may impair a customer’s ability to pay subsequent to the original sale, the Company records a specific allowance to reduce the amounts receivable to the amount that the Company reasonably believes to be collectable. For all other customers, the Company recognizes an allowance for credit losses based on factors that include the length of time the receivables are past due, industry and geographic concentrations, the current economic conditions and historical collection experience. As of December 31, 2022 and 2021, the Company's allowance for credit losses was $2.7 million and $2.3 million, respectively. |
Inventories | Inventories Inventories consist of currently marketed products and products manufactured under contract. Inventories are stated using the first-in, first-out method, on a consistent basis. The Company states inventory at the lower of cost or net realizable value. Provisions are made for slow moving, unsellable, or obsolete items. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose. |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are stated at cost or, in the case of assets acquired in a business combination, at fair value on the purchase date. Depreciation and amortization expense is computed using the straight line method over the estimated useful lives of the related assets as follows: |
Intangible Assets | Intangible Assets Intangible assets with finite lives are amortized using the straight-line method over the period the asset is expected to contribute directly or indirectly to the future cash flows of the Company as follows: |
Impairment of Long Lived Assets, including Identifiable Definite-Lived Intangible Assets | Impairment of Long-Lived Assets, including Identifiable Definite-Lived Intangible Assets The Company assesses long-term and identifiable definite-lived intangible assets or asset groups for impairment when events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset or an asset group, further impairment analysis is performed. An impairment loss is measured as the amount by which the carrying amount of the asset or asset groups exceeds the fair value (assets to be held and used) or fair value less cost to sell (assets to be disposed of). The Company also assesses the useful lives of its assets periodically to determine whether events and circumstances warrant a revision to the remaining useful life. Changes in the useful life are adjusted prospectively by revising the remaining period over which the asset is amortized. |
Deferred Income Taxes | Deferred Income Taxes The Company utilizes the liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized. |
Impairment of Indefinite-Lived Intangible Asset and Goodwill | Impairment of Indefinite-Lived Intangible Asset and Goodwill The Company assesses indefinite lived intangible asset and goodwill for impairment in the fourth quarter of each year or more frequently if indicators of impairment are present. When the Company chooses to perform a qualitative assessment, it evaluates economic, industry and company-specific factors as an initial step. If the Company determines it is more likely than not that the indefinite-lived intangible asset is impaired or the fair value of a reporting unit is less than its carrying amount, further quantitative impairment testing is then performed; otherwise, no further testing is required. An impairment loss is recorded if the asset’s fair value is less than its carrying value. The Company also periodically assesses its indefinite-lived intangible asset to determine if events and circumstances continue to support an indefinite useful life. If the life is no longer indefinite, the asset is tested for impairment. The carrying value, after recognition of any impairment loss, is amortized over its remaining useful life. |
Self-Insured Claims | Self-Insured Claims The Company is primarily self-insured, up to certain limits, for workers’ compensation claims. The Company has purchased stop-loss insurance, which will reimburse the Company for individual claims in excess of $350,000 or aggregate minimum attachment of $4.4 million annually. The cost of claims reported and an estimate of claims incurred but not reported are charged to operating expenses. A liability for unpaid claims and the associated claim expenses, including incurred but not reported losses, is actuarially determined and reflected in accrued liabilities in the accompanying consolidated balance sheets. Total expense under the program was approximately $0.3 million, $0.5 million, and $0.5 million, for the years ended December 31, 2022, 2021 and 2020, respectively. The self-insured claims liability was $3.7 million and $4.1 million at December 31, 2022 and 2021, respectively. The determination of such claims and expenses and the appropriateness of the related liability is reviewed periodically and updated, as necessary. Changes in estimates are recorded in the period identified. |
Litigation, Commitments and Contingencies | Litigation, Commitments and Contingencies Litigation, commitments and contingencies are accrued when management, after considering the facts and circumstances of each matter as then known to management, has determined it is probable a liability will be found to have been incurred and the amount of the loss can be reasonably estimated. When only a range of amounts is reasonably estimable and no amount within the range is more likely than another, the low end of the range is recorded. Legal fees are expensed as incurred. Due to the inherent uncertainties surrounding gain contingencies, the Company generally does not recognize potential gains until they are realized. In the fourth quarter of 2021, the Company settled a legal dispute with an unaffiliated third party and subsequently received a settlement payment, net of contingent legal fees, in the amount of $2.7 million. The net amount of $2.7 million was recorded as other income in the other income (expense), net line in the consolidated statements of operations for the year ended December 31, 2021. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The Company does not believe that any recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Schedule of estimated useful life of property, plant and equipment | Buildings 20 - 31 years Machinery and equipment 3 - 12 years Furniture and fixtures 3 - 7 years Automobiles 4 - 5 years Leasehold improvements Lesser of remaining lease term or useful life |
Schedule of estimated useful life of intangible assets | Product rights 10 - 15 years Patents 10 - 20 years Land-use rights 37 - 50 years |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenue Recognition | |
Schedule of chargeback and rebates provision analysis | Year Ended December 31, 2022 2021 (in thousands) Beginning balance $ 20,167 $ 20,380 Provision for chargebacks and rebates 208,081 201,133 Credits and payments issued to third parties (201,642) (201,346) Ending balance $ 26,606 $ 20,167 |
Schedule of product return liability analysis | Year Ended December 31, 2022 2021 (in thousands) Beginning balance $ 21,677 $ 14,204 Provision for product returns 4,405 15,005 Credits issued to third parties (6,631) (7,532) Ending balance $ 19,451 $ 21,677 |
Income per Share Attributable_2
Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders | |
Schedule of basic and diluted net income (loss) per share calculation | Year Ended December 31, 2022 2021 2020 (in thousands, except per share data) Basic and dilutive numerator: Net income attributable to Amphastar Pharmaceuticals, Inc. $ 91,386 $ 62,116 $ 1,403 Denominator: Weighted-average shares outstanding — basic 48,551 47,777 47,038 Net effect of dilutive securities: Incremental shares from equity awards 3,876 2,007 2,086 Weighted-average shares outstanding — diluted 52,427 49,784 49,124 Net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders — basic $ 1.88 $ 1.30 $ 0.03 Net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders — diluted $ 1.74 $ 1.25 $ 0.03 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Segment Reporting | |
Schedule of financial information by reporting segment | Year Ended December 31, 2022 2021 2020 (in thousands) Net revenues: Finished pharmaceutical products $ 486,505 $ 419,570 $ 331,368 API 12,482 18,198 18,478 Total net revenues 498,987 437,768 349,846 Gross profit (loss): Finished pharmaceutical products 256,710 209,715 151,645 API (7,850) (9,976) (8,305) Total gross profit 248,860 199,739 143,340 Operating expenses 141,363 129,852 132,386 Income from operations 107,497 69,887 10,954 Non-operating income (expenses) 8,543 14,252 (6,317) Income before income taxes $ 116,040 $ 84,139 $ 4,637 |
Schedule of net revenues in the finished pharmaceutical products segment | Year Ended December 31, 2022 2021 2020 (in thousands) Finished pharmaceutical products net revenues: Primatene MIST ® $ 84,309 $ 73,113 $ 51,725 Epinephrine 74,204 57,530 23,799 Glucagon 55,322 47,639 — Lidocaine 52,539 44,413 41,113 Phytonadione 49,500 45,498 42,646 Enoxaparin 34,950 35,962 48,681 Naloxone 26,269 27,540 33,416 Other finished pharmaceutical products 109,412 87,875 89,988 Total finished pharmaceutical products net revenues $ 486,505 $ 419,570 $ 331,368 |
Schedule of depreciation and amortization expense by reporting segment | Year Ended December 31, 2022 2021 2020 (in thousands) Depreciation and amortization expense Finished pharmaceutical products $ 8,884 $ 6,003 $ 5,766 API 3,713 4,222 3,264 Total depreciation and amortization expense $ 12,597 $ 10,225 $ 9,030 |
Schedule of net revenues and carrying values of long-lived assets by geographic region | Net Revenue Long-Lived Assets Year Ended December 31, December 31, 2022 2021 2020 2022 2021 (in thousands) United States $ 486,833 $ 419,869 $ 333,093 $ 136,328 $ 134,731 China 4,697 6,020 3,161 88,647 91,876 France 7,457 11,879 13,592 39,598 44,884 Total $ 498,987 $ 437,768 $ 349,846 $ 264,573 $ 271,491 |
Customer and Supplier Concent_2
Customer and Supplier Concentration (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Customer and Supplier Concentration | |
Schedule of accounts receivable and net revenues by major customer | % of Total Accounts % of Net Receivable Revenue December 31, December 31, Year Ended December 31, 2022 2021 2022 2021 2020 AmerisourceBergen 16 % 13 % 23 % 24 % 23 % McKesson 32 % 30 % 22 % 21 % 22 % Cardinal Health 19 % 20 % 17 % 16 % 17 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities measured on a recurring basis | Total (Level 1) (Level 2) (Level 3) (in thousands) Cash equivalents $ 130,249 $ 130,249 $ — $ — Restricted cash 235 235 — — Short-term investments 4,600 — 4,600 — Restricted short-term investments 2,200 — 2,200 — Corporate, agency and municipal bonds 23,453 — 23,453 — Interest rate swaps related to variable rate loans 6,048 — 6,048 — Fair value measurement as of December 31, 2022 $ 166,785 $ 130,484 $ 36,301 $ — Cash equivalents $ 102,863 $ 102,863 $ — $ — Restricted cash 235 235 — — Short-term investments 5,103 — 5,103 — Restricted short-term investments 2,200 — 2,200 — Corporate and municipal bonds 6,984 — 6,984 — Interest rate swaps related to variable rate loans 596 — 596 — Fair value measurement as of December 31, 2021 $ 117,981 $ 103,098 $ 14,883 $ — |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments | |
Schedule of securities classified as held-to-maturity | Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value (in thousands) Corporate and agency bonds (due within 1 year) $ 21,612 $ — $ (60) $ 21,552 Municipal bonds (due within 1 year) 1,903 — (2) 1,901 Total investments as of December 31, 2022 $ 23,515 $ — $ (62) $ 23,453 Corporate bonds (due within 1 year) $ 2,481 $ — $ (3) $ 2,478 Corporate bonds (due within 1 to 3 years) 1,248 — (3) 1,245 Municipal bonds (due within 1 year) 3,263 — (2) 3,261 Total investments as of December 31, 2021 $ 6,992 $ — $ (8) $ 6,984 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets | |
Schedule of weighted-average life, original cost, accumulated amortization and net book value by major class | Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets IMS (UK) international product rights 10 $ 8,462 $ 5,430 $ 3,032 Patents 12 486 362 124 Land-use rights 39 2,540 749 1,791 Subtotal 11 11,488 6,541 4,947 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 3,126 — 3,126 Subtotal * 32,351 — 32,351 As of December 31, 2022 * $ 43,839 $ 6,541 $ 37,298 Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets IMS (UK) international product rights 10 $ 9,445 $ 5,116 $ 4,329 Patents 12 486 340 146 Land-use rights 39 2,540 683 1,857 Subtotal 12 12,471 6,139 6,332 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 3,313 — 3,313 Subtotal * 32,538 — 32,538 As of December 31, 2021 * $ 45,009 $ 6,139 $ 38,870 * Intangible assets with indefinite lives have an indeterminable average life. |
Schedule of changes in carrying amounts of goodwill | December 31, 2022 2021 (in thousands) Beginning balance $ 3,313 $ 3,940 ANP restructuring — (374) Currency translation (187) (253) Ending balance $ 3,126 $ 3,313 |
Schedule of finite-lived intangible assets, future amortization expense | (in thousands) 2023 $ 1,035 2024 1,035 2025 1,035 2026 243 2027 79 Thereafter 1,520 Total amortizable intangible assets 4,947 Indefinite-lived intangibles 32,351 Total intangibles (net of accumulated amortization) $ 37,298 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventories | |
Schedule of inventories | December 31, 2022 2021 (in thousands) Raw materials and supplies $ 47,607 $ 41,853 Work in process 37,090 33,298 Finished goods 18,887 17,656 Total inventories $ 103,584 $ 92,807 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant, and Equipment | |
Schedule of property, plant, and equipment | December 31, 2022 2021 (in thousands) Buildings $ 130,726 $ 130,582 Leasehold improvements 31,535 29,221 Land 7,451 7,615 Machinery and equipment 208,068 207,883 Furniture, fixtures, and automobiles 29,674 27,376 Construction in progress 50,842 41,186 Total property, plant, and equipment 458,296 443,863 Less accumulated depreciation (220,030) (199,619) Total property, plant, and equipment, net $ 238,266 $ 244,244 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounts Payable and Accrued Liabilities. | |
Schedule of accounts payable and accrued liabilities | December 31, 2022 2021 (in thousands) Accrued customer fees and rebates $ 14,198 $ 12,121 Accrued payroll and related benefits 22,847 23,256 Accrued product returns, current portion 14,867 16,028 Accrued loss on firm purchase commitments 2,686 7,133 Other accrued liabilities 9,143 8,793 Total accrued liabilities 63,741 67,331 Accounts payable 20,501 22,214 Total accounts payable and accrued liabilities $ 84,242 $ 89,545 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt | |
Schedule of debt | December 31, 2022 2021 (in thousands) Term Loan Term loan with Capital One N.A. due August 2026 $ 68,250 $ 69,563 Mortgage Loans Mortgage payable with East West Bank due June 2027 8,188 8,353 Other Loans and Payment Obligations French government loans due December 2026 204 269 Line of Credit Facilities Line of credit facility with China Merchant Bank — — Revolving line of credit facility with Capital One N.A. due August 2026 — — Equipment under Finance Leases 790 398 Total debt 77,432 78,583 Less current portion of long-term debt 3,046 2,202 Less: Loan issuance costs 1,547 1,605 Long-term debt, net of current portion and unamortized debt issuance costs $ 72,839 $ 74,776 |
Schedule of Maturities of Long-term Debt | Long-term Debt (in thousands) 2023 $ 2,848 2024 3,733 2025 4,181 2026 58,440 2027 7,440 Thereafter — $ 76,642 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Schedule of income (loss) before income taxes | Year Ended December 31, 2022 2021 2020 (in thousands) Income (loss) before income taxes: United States $ 127,204 $ 86,236 $ 15,634 Foreign (11,164) (2,097) (10,997) Total income (loss) before taxes $ 116,040 $ 84,139 $ 4,637 |
Summary of provision (benefit) for income taxes | Year Ended December 31, 2022 2021 2020 (in thousands) Current provision: Federal $ 37,626 $ 14,088 $ 1,803 State 732 1,182 541 Foreign 998 1,676 279 Total current provision 39,356 16,946 2,623 Deferred provision (benefit): Federal (16,119) 2,657 1,770 State 816 110 (1,489) Foreign (576) 917 636 Total deferred provision (15,879) 3,684 917 Total provision for income taxes $ 23,477 $ 20,630 $ 3,540 |
Schedule of reconciliation of the statutory federal income tax rate | Year Ended December 31, 2022 2021 2020 Statutory federal income tax 21.0 % 21.0 % 21.0 % State tax expense, net of federal tax benefit 1.1 1.2 (16.2) Foreign tax rate differences (0.3) (2.0) (20.1) Foreign valuation allowance 2.6 5.5 89.5 Research and development credits (3.1) (3.2) (65.1) Share-based compensation (3.5) (0.2) 18.7 Executive compensation 2.3 2.3 48.1 Employee-related expenses 0.2 0.1 1.7 Other (0.1) (0.2) (1.3) Effective tax rate 20.2 % 24.5 % 76.3 % |
Summary of deferred tax assets and liabilities | December 31, 2022 2021 (in thousands) Deferred tax assets: Research and development credits $ 15,418 $ 17,019 Net operating loss carryforward 20,019 17,568 Inventory capitalization and reserve 9,598 8,489 Share-based compensation 5,208 4,892 Operating leases 6,684 6,555 Accrued expenses 4,956 5,188 Accrued chargebacks 5,125 3,694 Product return allowance 5,464 5,611 Intangibles 2,124 2,124 Research and development capitalization 17,988 — Total deferred tax assets 92,584 71,140 Deferred tax liabilities: Depreciation/amortization 13,272 13,525 Intangibles 8,564 7,893 Operating leases 6,398 6,368 Federal impact of state deferred taxes 3,800 3,966 Other 2,467 642 Total deferred tax liabilities 34,501 32,394 Valuation allowance (19,700) (16,881) Net deferred tax assets $ 38,383 $ 21,865 |
Schedule of unrecognized tax benefits | December 31, 2022 2021 2020 (in thousands) Balance at the beginning of the year $ 11,796 $ 10,053 $ 8,331 Deductions based on tax positions related to prior year (41) — — Additions based on tax positions related to the current year 1,643 1,754 1,815 Deductions based on statute of limitations (503) (11) (93) Balance at the end of the year $ 12,895 $ 11,796 $ 10,053 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity | |
Schedule of key assumptions to determine fair value of options | Year Ended December 31, 2022 2021 2020 Average volatility 41.0 % 42.1 % 43.1 % Average risk-free interest rate 2.3 % 1.2 % 0.8 % Weighted-average expected life in years 6.1 6.1 5.7 Dividend yield rate — % — % — % |
Schedule of the summary of option activity under all plans | Weighted-Average Weighted-Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term (Years) Value (1) (in thousands) Outstanding as of December 31, 2021 8,455,721 $ 15.67 Options granted 792,441 34.35 Options exercised (1,222,147) 14.56 Options cancelled (91,251) 19.56 Options expired (5,614) 13.79 Outstanding as of December 31, 2022 7,929,150 $ 17.66 4.94 87,025 Exercisable as of December 31, 2022 5,550,697 $ 15.69 3.64 68,413 Vested and expected to vest as of December 31, 2022 7,757,291 $ 17.51 4.87 85,920 |
Schedule of information relating to options grants | Year Ended December 31, 2022 2021 2020 (in thousands, except per share data) Weighted-average grant date fair value per option share $ 14.75 $ 7.62 $ 5.51 Intrinsic value of options exercised 21,279 7,906 9,169 Cash received from options exercised 19,202 16,757 24,357 Total fair value of the options vested during the period 8,174 8,177 9,978 |
Schedule of the summary of nonvested options status | Weighted-Average Grant Date Options Fair Value Non-vested as of December 31, 2021 2,848,934 $ 6.95 Options granted 792,441 14.75 Options vested (1,171,671) 6.98 Options forfeited (91,251) 8.41 Non-vested as of December 31, 2022 2,378,453 9.48 |
Schedule of information relating to RSU grants and deliveries | Total Fair Market Total RSUs Value of RSUs Issued Issued (1) (in thousands) RSUs outstanding at December 31, 2021 1,184,842 RSUs granted 339,397 $ 11,675 RSUs forfeited (39,119) RSUs vested (2) (478,068) RSUs outstanding at December 31, 2022 1,007,052 (1) The total FMV is derived from the number of RSUs granted times the current stock price on the date of grant. (2) Of the vested RSUs, 181,547 shares of common stock were surrendered to fulfil tax withholding obligations. |
Schedule of recorded share-based compensation expense under all plans | Year Ended December 31, 2022 2021 2020 (in thousands) Cost of revenues $ 4,179 $ 3,778 $ 4,248 Operating expenses: Selling, distribution, and marketing 726 596 456 General and administrative 11,180 12,622 14,089 Research and development 1,775 1,691 1,705 Total share-based compensation $ 17,860 $ 18,687 $ 20,498 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies | |
Schedule of lease information | The components of lease costs for the years ended December 31, 2022, 2021 and 2020 were as follows: Year Ended December 31, 2022 2021 2020 (in thousands) Operating lease costs $ 4,709 $ 4,328 $ 4,462 Short-term lease costs 300 518 649 Finance lease costs Amortization of right-of-use assets 237 384 351 Interest on lease liabilities 26 26 33 Total finance lease costs $ 263 $ 410 $ 384 Total lease costs $ 5,272 $ 5,256 $ 5,495 Other information pertaining to leases is as follows: Year Ended December 31, 2022 2021 2020 (in thousands, except lease term and discount rate) Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 4,329 $ 4,446 $ 4,491 Operating cash flows from finance leases 18 25 33 Financing cash flows from finance leases 233 310 369 Right-of use assets obtained in exchange for lease liabilities Operating leases 2,166 11,041 4,819 Finance leases 642 110 61 Weighted-average remaining lease term (years) Operating leases 8.7 9.5 8.7 Finance leases 4.3 2.4 2.3 Weighted-average discount rate Operating leases 4.4 % 4.5 % 5.2 % Finance leases 6.7 % 5.2 % 5.0 % |
Schedule of future minimum rental payments for operating leases | Operating Finance Leases Leases Total (in thousands) 2023 $ 4,078 $ 243 $ 4,321 2024 3,742 212 3,954 2025 3,635 189 3,824 2026 3,534 159 3,693 2027 3,364 104 3,468 Thereafter 14,080 — 14,080 Total lease payments $ 32,433 $ 907 $ 33,340 Less: interest 5,736 117 5,853 Total $ 26,697 $ 790 $ 27,487 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Gains and (losses) of intercompany foreign currency transactions | $ (1,800,000) | $ (2,600,000) | $ 3,000,000 | |
Income tax expense allocated to other comprehensive income | 0 | 0 | 900,000 | |
Selling, distribution, and marketing | 21,531,000 | 17,486,000 | 14,780,000 | |
Allowance for Credit Losses | $ 2,300,000 | 2,700,000 | 2,300,000 | |
Forward Currency Contracts Liabilities | 200,000 | |||
Restricted cash | 235,000 | 235,000 | 235,000 | |
Certificates of deposit | 2,200,000 | 2,200,000 | 2,200,000 | |
Amount retained, individual claims | 350,000 | |||
Amount retained, aggregate claims | 4,400,000 | |||
Actuarially Determined Self-insurance Expense | 300,000 | 500,000 | 500,000 | |
Self-insurance Claims Liability | 4,100,000 | 3,700,000 | 4,100,000 | |
Settled Litigation [Member] | ||||
Litigation Settlement, Amount Awarded from Other Party | $ 2,700,000 | |||
Finished Pharmaceutical Products Segment [Member] | Primatene Mist | ||||
Advertising expense | 8,700,000 | 8,100,000 | 5,800,000 | |
Shipping and Handling [Member] | ||||
Selling, distribution, and marketing | $ 7,400,000 | $ 4,300,000 | $ 4,300,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Schedule of PP&E Useful Lives) (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Building [Member] | Minimum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 20 years |
Building [Member] | Maximum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 31 years |
Machinery and Equipment [Member] | Minimum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 3 years |
Machinery and Equipment [Member] | Maximum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 12 years |
Furniture and Fixtures [Member] | Minimum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 3 years |
Furniture and Fixtures [Member] | Maximum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 7 years |
Automobiles [Member] | Minimum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 4 years |
Automobiles [Member] | Maximum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 5 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Schedule of Intangible Useful Lives) (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Useful life of intangibles | 11 years | 12 years |
Product Rights [Member] | Minimum | ||
Useful life of intangibles | 10 years | |
Product Rights [Member] | Maximum | ||
Useful life of intangibles | 15 years | |
Patents | ||
Useful life of intangibles | 12 years | 12 years |
Patents | Minimum | ||
Useful life of intangibles | 10 years | |
Patents | Maximum | ||
Useful life of intangibles | 20 years | |
Land-Use Rights [Member] | ||
Useful life of intangibles | 39 years | 39 years |
Land-Use Rights [Member] | Minimum | ||
Useful life of intangibles | 37 years | |
Land-Use Rights [Member] | Maximum | ||
Useful life of intangibles | 50 years |
ANP Restructuring (Details)
ANP Restructuring (Details) | Dec. 31, 2022 |
Hanxin | Hanxin | |
Restructuring and Related Cost [Line Items] | |
Ownership after transaction | 14% |
Revenue Recognition (Analysis o
Revenue Recognition (Analysis of the Chargeback Provision) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue | $ 498,987 | $ 437,768 | $ 349,846 |
Beginning balance | 20,167 | 20,380 | |
Provision for chargebacks and rebates | 208,081 | 201,133 | |
Credits and payments issued to third parties | (201,642) | (201,346) | |
Ending balance | 26,606 | 20,167 | $ 20,380 |
Research and development services | ANP | |||
Revenue | $ 4,300 | 5,100 | |
Minimum | |||
Payment terms | 30 days | ||
Settlement of chargebacks and rebates terms | 20 days | ||
Maximum | |||
Payment terms | 75 days | ||
Settlement of chargebacks and rebates terms | 60 days | ||
Accounts Receivable, Net | |||
Provision for chargebacks and rebates | $ 20,500 | 15,600 | |
Accounts Payable and Accrued Liabilities | |||
Provision for chargebacks and rebates | $ 6,100 | $ 4,600 |
Revenue Recognition (Analysis_2
Revenue Recognition (Analysis of Product Return Liability) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Aggregate product return rate | 1.40% | 1.70% |
Return accrual included in accounts payable and accrued liabilities | $ 14,867 | $ 16,028 |
Return accrual included in other long-term liabilities | 4,600 | 5,700 |
Product returns | ||
Beginning balance | 21,677 | 14,204 |
Provision for product returns | 4,405 | 15,005 |
Credits issued to third parties | (6,631) | (7,532) |
Ending balance | $ 19,451 | $ 21,677 |
Income per Share Attributable_3
Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders (Narrative) (Details) - Employee and Non-Employee Stock Options [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Shares | 704,483 | 1,906,029 | 1,917,437 |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Exercise Price of Excluded Securities | $ 34.79 | $ 20.82 | $ 20.85 |
Income per Share Attributable_4
Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders (Calculation of Basic and Diluted Net Income (Loss) Per Share) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Basic and dilutive numerator: | |||
Net Income (Loss) Attributable to Parent | $ 91,386 | $ 62,116 | $ 1,403 |
Denominator: | |||
Weighted-average shares outstanding-basic | 48,551 | 47,777 | 47,038 |
Net effect of dilutive securities: | |||
Incremental shares from equity awards | 3,876 | 2,007 | 2,086 |
Weighted-average shares outstanding - diluted | 52,427 | 49,784 | 49,124 |
Net income (loss) per share - basic | $ 1.88 | $ 1.30 | $ 0.03 |
Net income (loss) per share - diluted | $ 1.74 | $ 1.25 | $ 0.03 |
Segment Reporting (Selected Fin
Segment Reporting (Selected Financial Information by Reporting Segment) (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Segment Reporting Information [Line Items] | |||
Number of Reportable Segments | segment | 2 | ||
Net revenues: | |||
Net revenues | $ 498,987 | $ 437,768 | $ 349,846 |
Gross profit (loss): | |||
Gross Profit | 248,860 | 199,739 | 143,340 |
Operating expenses | 141,363 | 129,852 | 132,386 |
Income (loss) from operations | 107,497 | 69,887 | 10,954 |
Non-operating income (expenses) | 8,543 | 14,252 | (6,317) |
Income (loss) before income taxes | 116,040 | 84,139 | 4,637 |
Finished Pharmaceutical Products Segment [Member] | |||
Net revenues: | |||
Net revenues | 486,505 | 419,570 | 331,368 |
Gross profit (loss): | |||
Gross Profit | 256,710 | 209,715 | 151,645 |
Active Pharmaceutical Ingredient Segment [Member] | |||
Net revenues: | |||
Net revenues | 12,482 | 18,198 | 18,478 |
Gross profit (loss): | |||
Gross Profit | $ (7,850) | $ (9,976) | $ (8,305) |
Segment Reporting (Summary of N
Segment Reporting (Summary of Net Revenues by Product Segment) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | $ 498,987 | $ 437,768 | $ 349,846 |
Finished Pharmaceutical Products Segment [Member] | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | 486,505 | 419,570 | 331,368 |
Finished Pharmaceutical Products Segment [Member] | Enoxaparin [Member] | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | 34,950 | 35,962 | 48,681 |
Finished Pharmaceutical Products Segment [Member] | Lidocaine | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | 52,539 | 44,413 | 41,113 |
Finished Pharmaceutical Products Segment [Member] | Phytonadione | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | 49,500 | 45,498 | 42,646 |
Finished Pharmaceutical Products Segment [Member] | Naloxone | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | 26,269 | 27,540 | 33,416 |
Finished Pharmaceutical Products Segment [Member] | Epinephrine | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | 74,204 | 57,530 | 23,799 |
Finished Pharmaceutical Products Segment [Member] | Primatene Mist | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | 84,309 | 73,113 | 51,725 |
Finished Pharmaceutical Products Segment [Member] | Glucagon | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | 55,322 | 47,639 | |
Finished Pharmaceutical Products Segment [Member] | Other Finished Pharmaceutical Products | |||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |||
Net revenues | $ 109,412 | $ 87,875 | $ 89,988 |
Segment Reporting (Depreciation
Segment Reporting (Depreciation and Amortization Expense by Reporting Segment) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Segment Reporting Information [Line Items] | |||
Depreciation and amortization expense | $ 12,597 | $ 10,225 | $ 9,030 |
Finished Pharmaceutical Products Segment [Member] | |||
Segment Reporting Information [Line Items] | |||
Depreciation and amortization expense | 8,884 | 6,003 | 5,766 |
Active Pharmaceutical Ingredient Segment [Member] | |||
Segment Reporting Information [Line Items] | |||
Depreciation and amortization expense | $ 3,713 | $ 4,222 | $ 3,264 |
Segment Reporting (Summary of R
Segment Reporting (Summary of Revenues and Long-Lived Assets by Geographic Region) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Net revenues | $ 498,987 | $ 437,768 | $ 349,846 |
Long-Lived Assets | 264,573 | 271,491 | |
UNITED STATES | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Net revenues | 486,833 | 419,869 | 333,093 |
Long-Lived Assets | 136,328 | 134,731 | |
CHINA | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Net revenues | 4,697 | 6,020 | 3,161 |
Long-Lived Assets | 88,647 | 91,876 | |
FRANCE | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Net revenues | 7,457 | 11,879 | $ 13,592 |
Long-Lived Assets | $ 39,598 | $ 44,884 |
Customer and Supplier Concent_3
Customer and Supplier Concentration (Details) - Customer Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2022 item customer | Dec. 31, 2021 item customer | Dec. 31, 2020 item | |
Revenue, Major Customer [Line Items] | |||
Number of major customers that are wholesale distributors | 3 | ||
Accounts Receivable, Net | |||
Revenue, Major Customer [Line Items] | |||
Number of major customers | customer | 3 | 3 | |
Net Revenue | |||
Revenue, Major Customer [Line Items] | |||
Number of major customers | 3 | 3 | 3 |
AmerisourceBergen [Member] | Accounts Receivable, Net | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 16% | 13% | |
AmerisourceBergen [Member] | Net Revenue | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 23% | 24% | 23% |
Cardinal Health [Member] | Accounts Receivable, Net | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 19% | 20% | |
Cardinal Health [Member] | Net Revenue | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 17% | 16% | 17% |
McKesson [Member] | Accounts Receivable, Net | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 32% | 30% | |
McKesson [Member] | Net Revenue | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 22% | 21% | 22% |
Fair Value Measurements (Fair V
Fair Value Measurements (Fair Values of the Company's Financial Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Forward Currency Contracts Liabilities | $ 200 | |
Recurring Basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Restricted cash | 235 | $ 235 |
Short-term investments | 4,600 | 5,103 |
Restricted short-term investments | 2,200 | 2,200 |
Fair value measurement | 166,785 | 117,981 |
Recurring Basis | Interest rate swaps | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Interest rate swaps related to variable rate loans | 6,048 | 596 |
Recurring Basis | Corporate bonds (due within 1 to 3 years) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate, agency and municipal bonds | 23,453 | 6,984 |
Recurring Basis | Money market | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 130,249 | 102,863 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Restricted cash | 235 | 235 |
Fair value measurement | 130,484 | 103,098 |
Level 1 | Money market | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 130,249 | 102,863 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 4,600 | 5,103 |
Restricted short-term investments | 2,200 | 2,200 |
Fair value measurement | 36,301 | 14,883 |
Level 2 | Interest rate swaps | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Interest rate swaps related to variable rate loans | 6,048 | 596 |
Level 2 | Corporate bonds (due within 1 to 3 years) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate, agency and municipal bonds | $ 23,453 | $ 6,984 |
Investments (Held-to_Maturity)
Investments (Held-to_Maturity) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost | $ 23,515 | $ 6,992 |
Gross Unrealized Losses | (62) | (8) |
Fair Value | 23,453 | 6,984 |
Corporate and Agency Bonds (due within 1 year) | ||
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost | 21,612 | 2,481 |
Gross Unrealized Losses | (60) | (3) |
Fair Value | 21,552 | 2,478 |
Corporate bonds (due within 1 to 3 years) | ||
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost | 1,248 | |
Gross Unrealized Losses | (3) | |
Fair Value | 1,245 | |
Municipal Bonds [Member] | ||
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost | 1,903 | 3,263 |
Gross Unrealized Losses | (2) | (2) |
Fair Value | $ 1,901 | $ 3,261 |
Investments (Equity Method Inve
Investments (Equity Method Investment) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restructuring and Related Cost | ||
Equity in losses of unconsolidated affiliates | $ (1,177) | $ (208) |
Hanxin | ||
Restructuring and Related Cost | ||
Equity in losses of unconsolidated affiliates | $ 1,200 | $ 200 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets (Summary of Intangible Assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 11 years | 12 years | |
Finite-Lived Intangible Assets, Gross | $ 11,488 | $ 12,471 | |
Accumulated Amortization | 6,541 | 6,139 | |
Finite-Lived Intangible Assets, Net | 4,947 | 6,332 | |
Indefinite-lived intangible assets | |||
Indefinite-lived intangible assets | 29,200 | ||
Goodwill recognized | 3,126 | 3,313 | $ 3,940 |
Subtotal, Original Cost | 32,351 | 32,538 | |
Subtotal, Net Book Value | 32,351 | 32,538 | |
Balance, Original Cost | 43,839 | 45,009 | |
Balance, Net Book Value | 37,298 | 38,870 | |
Finished Pharmaceutical Products Segment [Member] | |||
Indefinite-lived intangible assets | |||
Goodwill recognized | 3,126 | 3,313 | |
Trademarks | |||
Indefinite-lived intangible assets | |||
Indefinite-lived intangible assets | $ 29,225 | $ 29,225 | |
Patents | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 12 years | 12 years | |
Finite-Lived Intangible Assets, Gross | $ 486 | $ 486 | |
Accumulated Amortization | 362 | 340 | |
Finite-Lived Intangible Assets, Net | $ 124 | $ 146 | |
Land-Use Rights [Member] | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 39 years | 39 years | |
Finite-Lived Intangible Assets, Gross | $ 2,540 | $ 2,540 | |
Accumulated Amortization | 749 | 683 | |
Finite-Lived Intangible Assets, Net | $ 1,791 | $ 1,857 | |
International Medication Systems (UK) Limited | Acquired international product rights | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 10 years | 10 years | |
Finite-Lived Intangible Assets, Gross | $ 8,462 | $ 9,445 | |
Accumulated Amortization | 5,430 | 5,116 | |
Finite-Lived Intangible Assets, Net | $ 3,032 | $ 4,329 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets (Summary of Changes in the Carrying Amount of Goodwill) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill and Intangible Assets | ||
Beginning balance | $ 3,313 | $ 3,940 |
Disposal Group, Not Discontinued Operation, Loss (Gain) on Write-down | (374) | |
Currency translation and other adjustments | (187) | (253) |
Ending balance | $ 3,126 | $ 3,313 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets (Summary of Expected Amortization Expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
2023 | $ 1,035 | ||
2024 | 1,035 | ||
2025 | 1,035 | ||
2026 | 243 | ||
2027 | 79 | ||
Thereafter | 1,520 | ||
Finite-Lived Intangible Assets, Net | 4,947 | $ 6,332 | |
Indefinite-lived intangibles | 32,351 | ||
Balance, Net Book Value | 37,298 | 38,870 | |
Amortization expense | 1,420 | 1,290 | $ 1,036 |
Product Rights [Member] | |||
Amortization expense | $ 900 | $ 1,000 | $ 1,200 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Raw materials and supplies | $ 47,607 | $ 41,853 | |
Work in process | 37,090 | 33,298 | |
Finished goods | 18,887 | 17,656 | |
Total inventory, net | 103,584 | 92,807 | |
Inventory adjustment to reflect net realizable value | 17,200 | 24,600 | $ 13,900 |
Enoxaparin [Member] | |||
Inventory adjustment to reflect net realizable value | 14,900 | 20,700 | $ 9,400 |
Inventory, Firm Purchase Commitment, Loss | $ 2,700 | $ 7,100 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment (Summary of Property, Plant, and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 458,296 | $ 443,863 |
Less accumulated depreciation and amortization | (220,030) | (199,619) |
Total property, plant, and equipment, net | 238,266 | 244,244 |
Building [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 130,726 | 130,582 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 31,535 | 29,221 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 7,451 | 7,615 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 208,068 | 207,883 |
Furniture, fixtures, and automobiles | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 29,674 | 27,376 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 50,842 | $ 41,186 |
Property, Plant, and Equipmen_3
Property, Plant, and Equipment (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant, and Equipment | |||
Depreciation expense | $ 23,815 | $ 22,196 | $ 20,491 |
Interest Costs Capitalized | $ 1,400 | $ 1,400 | $ 1,800 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accounts Payable and Accrued Liabilities. | ||
Accrued customer fees and rebates | $ 14,198 | $ 12,121 |
Accrued payroll and related benefits | 22,847 | 23,256 |
Accrued product returns, current portion | 14,867 | 16,028 |
Accrued loss on firm purchase commitments | 2,686 | 7,133 |
Other accrued liabilities | 9,143 | 8,793 |
Total accrued liabilities | 63,741 | 67,331 |
Accounts payable | 20,501 | 22,214 |
Total accounts payable and accrued liabilities | $ 84,242 | $ 89,545 |
Debt (Schedule of Debt) (Detail
Debt (Schedule of Debt) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Instrument | ||
Unamortized Debt Issuance Expense | $ 1,547 | $ 1,605 |
Equipment under Finance Leases | $ 790 | $ 398 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Long-term debt, net of current portion and unamortized debt costs | Long-term debt, net of current portion and unamortized debt costs |
Total debt | $ 77,432 | $ 78,583 |
Less current portion of long-term debt and finance leases | 3,046 | 2,202 |
Long-term debt, net of current portion and unamortized debt costs | 72,839 | 74,776 |
Term Loan - Due August 2026 | Capital One, N.A. | ||
Debt Instrument | ||
Long Term Debt | 68,250 | 69,563 |
Mortgage Payable - Due June 2027 | East West Bank [Member] | ||
Debt Instrument | ||
Long Term Debt | 8,188 | 8,353 |
French Government Loan 5 - Due December 2026 | Seine-Normandie Water Agency [Member] | ||
Debt Instrument | ||
Long Term Debt | $ 204 | $ 269 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | 1 Months Ended | 12 Months Ended | |||||||
Aug. 04, 2021 USD ($) | May 18, 2017 USD ($) building | Mar. 31, 2020 USD ($) | Dec. 31, 2018 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Aug. 05, 2021 USD ($) | Dec. 31, 2018 loan | |
Debt | |||||||||
Proceeds from borrowing under lines of credit | $ 1,238,000 | ||||||||
Interest rate swaps | |||||||||
Debt | |||||||||
Gains (losses) from changes in fair values of interest rate swaps | $ 5,500,000 | $ 1,500,000 | |||||||
Seine-Normandie Water Agency [Member] | |||||||||
Debt | |||||||||
Debt Instrument, Term | 8 years | ||||||||
Number of Loans with Government Agency | 500,000 | 2 | |||||||
Debt Instrument, Periodic Payment, Interest | $ 0 | ||||||||
Notes Payable | 200,000 | ||||||||
Mortgage Payable - Due June 2027 | East West Bank [Member] | |||||||||
Debt | |||||||||
Principal amount | $ 9,000,000 | ||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 7,400,000 | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.79% | ||||||||
Mortgage Payable - Due June 2027 | East West Bank [Member] | Rancho Cucamonga, California | |||||||||
Debt | |||||||||
Number of Buildings Securing Loan | building | 1 | ||||||||
Mortgage Payable - Due June 2027 | East West Bank [Member] | Chino, California | |||||||||
Debt | |||||||||
Number of Buildings Securing Loan | building | 2 | ||||||||
Mortgage Payable - Due June 2027 | East West Bank [Member] | LIBOR | |||||||||
Debt | |||||||||
Debt Instrument, Basis Spread on Variable Rate | 2.50% | ||||||||
Credit Agreement - Expires March 2023 | China Merchant Bank | |||||||||
Debt | |||||||||
Draw down period | 36 months | ||||||||
Maximum borrowing capacity | $ 14,600,000 | ||||||||
Line of Credit [Member] | Capital One, N.A. | |||||||||
Debt | |||||||||
Maximum borrowing capacity | $ 140,000,000 | ||||||||
Secured Debt [Member] | Capital One, N.A. | |||||||||
Debt | |||||||||
Borrowings | 70,000,000 | ||||||||
Loan issuance costs | $ 2,100,000 | ||||||||
Secured Debt [Member] | Capital One, N.A. | In the first two years | |||||||||
Debt | |||||||||
Debt Instrument, Annual Principal Payment | 1,800,000 | ||||||||
Secured Debt [Member] | Capital One, N.A. | Starting in the third year | |||||||||
Debt | |||||||||
Debt Instrument, Annual Principal Payment | 3,500,000 | ||||||||
Secured Debt [Member] | Capital One, N.A. | Starting in the fifth year | |||||||||
Debt | |||||||||
Debt Instrument, Annual Principal Payment | 3,900,000 | ||||||||
Secured Debt [Member] | Capital One, N.A. | Interest rate swaps | |||||||||
Debt | |||||||||
Notional Amount | $ 55,000,000 | ||||||||
Interest rate swap, fair value | $ 0.93 | ||||||||
Revolving Credit Facility | Capital One, N.A. | |||||||||
Debt | |||||||||
Maximum borrowing capacity | $ 70,000,000 | ||||||||
Minimum | Secured Debt [Member] | Capital One, N.A. | LIBOR | |||||||||
Debt | |||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.50% | ||||||||
Maximum | Secured Debt [Member] | Capital One, N.A. | LIBOR | |||||||||
Debt | |||||||||
Debt Instrument, Basis Spread on Variable Rate | 2.50% |
Debt (Long-Term Debt Maturities
Debt (Long-Term Debt Maturities) (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt | |
2023 | $ 2,848 |
2024 | 3,733 |
2025 | 4,181 |
2026 | 58,440 |
2027 | 7,440 |
Total long-term Debt | $ 76,642 |
Income Taxes (Summary of Income
Income Taxes (Summary of Income (Loss) Before Income Taxes) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income (loss) before income taxes: | |||
United States | $ 127,204 | $ 86,236 | $ 15,634 |
Foreign | (11,164) | (2,097) | (10,997) |
Income (loss) before income taxes | 116,040 | 84,139 | 4,637 |
Income tax provision (benefit) | 23,477 | 20,630 | 3,540 |
Income before equity in losses of unconsolidated affiliate | $ 92,563 | $ 63,509 | $ 1,097 |
Income tax provision as a percentage of income before income taxes | 20.20% | 24.50% | 76.30% |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Tax Credit Carryforward [Line Items] | |||
Federal income tax rate | 21% | 21% | 21% |
Deferred tax assets | $ 38,527 | $ 22,399 | |
Cumulative excess benefits of stock compensation established | 5,208 | 4,892 | |
Deferred Tax Assets, Valuation Allowance | 19,700 | 16,881 | |
AFP | |||
Tax Credit Carryforward [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | 18,900 | $ 16,900 | |
California Franchise Tax Board [Member] | Research and Development Tax Credit | |||
Tax Credit Carryforward [Line Items] | |||
Tax Credit Carryforward, Amount | 21,900 | ||
Foreign Tax Authority | FRANCE | |||
Tax Credit Carryforward [Line Items] | |||
Operating Loss Carryforwards | 75,300 | ||
Foreign Tax Authority | UNITED KINGDOM | |||
Tax Credit Carryforward [Line Items] | |||
Operating Loss Carryforwards | $ 2,500 |
Income Taxes (Summary of Provis
Income Taxes (Summary of Provision (Benefit) for Income Taxes) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Current provision (benefit): | |||
Federal | $ 37,626 | $ 14,088 | $ 1,803 |
State | 732 | 1,182 | 541 |
Foreign | 998 | 1,676 | 279 |
Total current provision (benefit) | 39,356 | 16,946 | 2,623 |
Deferred provision (benefit): | |||
Federal | (16,119) | 2,657 | 1,770 |
State | 816 | 110 | (1,489) |
Foreign | (576) | 917 | 636 |
Total deferred provision (benefit) | (15,879) | 3,684 | 917 |
Total provision (benefit) for income taxes | $ 23,477 | $ 20,630 | $ 3,540 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of the Statutory Federal Income Tax Rate to the Effective Tax Rate) (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of the statutory federal income tax rate to the Companys effective rate: | |||
Statutory federal income tax (benefit) | 21% | 21% | 21% |
State tax expense, net of federal tax benefit | 1.10% | 1.20% | (16.20%) |
Foreign tax rate differences | (0.30%) | (2.00%) | (20.10%) |
Foreign valuation allowance | 2.60% | 5.50% | 89.50% |
Research and development credits | (3.10%) | (3.20%) | (65.10%) |
Share-based compensation | (3.50%) | (0.20%) | 18.70% |
Executive compensation | 2.30% | 2.30% | 48.10% |
Employee-related expenses | 0.20% | 0.10% | 1.70% |
Other | (0.10%) | (0.20%) | (1.30%) |
Effective tax rate (benefit) | 20.20% | 24.50% | 76.30% |
Income Taxes (Schedule of Defer
Income Taxes (Schedule of Deferred Tax Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Research and development credits | $ 15,418 | $ 17,019 |
Net operating loss carryforward | 20,019 | 17,568 |
Inventory capitalization and reserve | 9,598 | 8,489 |
Share-based compensation | 5,208 | 4,892 |
Operating leases | 6,684 | 6,555 |
Accrued expenses | 4,956 | 5,188 |
Accrued chargebacks | 5,125 | 3,694 |
Product return allowance | 5,464 | 5,611 |
Intangibles | 2,124 | 2,124 |
Research and development capitalization | 17,988 | |
Total deferred tax assets | 92,584 | 71,140 |
Deferred tax liabilities: | ||
Depreciation/amortization | 13,272 | 13,525 |
Intangibles | 8,564 | 7,893 |
Operating leases | 6,398 | 6,368 |
Federal impact of state deferred taxes | 3,800 | 3,966 |
Other | 2,467 | 642 |
Total deferred tax liabilities | 34,501 | 32,394 |
Valuation allowance | (19,700) | (16,881) |
Net deferred tax assets | $ 38,383 | $ 21,865 |
Income Taxes (Reconciliation _2
Income Taxes (Reconciliation of Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Balance at the beginning of the year | $ 11,796 | $ 10,053 | $ 8,331 |
Deductions based on tax positions related to prior years | (41) | ||
Additions based on tax positions related to the current year | 1,643 | 1,754 | 1,815 |
Deductions based on statute of limitations | (503) | (11) | (93) |
Balance at the end of the year | $ 12,895 | $ 11,796 | $ 10,053 |
Income Taxes (Uncertain Income
Income Taxes (Uncertain Income Tax Positions - Narrative) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Contingency [Line Items] | |||
Unrecognized Tax Benefits that Would Impact Effective Tax Rate | $ 12.2 | $ 11.4 | |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued | $ 0.8 | $ 0.5 | $ 0.2 |
Domestic Tax Authority [Member] | Earliest Tax Year [Member] | Internal Revenue Service (IRS) [Member] | |||
Income Tax Contingency [Line Items] | |||
Open Tax Year | 2019 | ||
Domestic Tax Authority [Member] | Latest Tax Year [Member] | Internal Revenue Service (IRS) [Member] | |||
Income Tax Contingency [Line Items] | |||
Open Tax Year | 2021 | ||
State and Local Jurisdiction [Member] | Earliest Tax Year [Member] | |||
Income Tax Contingency [Line Items] | |||
Open Tax Year | 2018 | ||
State and Local Jurisdiction [Member] | Latest Tax Year [Member] | |||
Income Tax Contingency [Line Items] | |||
Open Tax Year | 2021 | ||
Foreign Tax Authority | Earliest Tax Year [Member] | |||
Income Tax Contingency [Line Items] | |||
Open Tax Year | 2012 | ||
Foreign Tax Authority | Latest Tax Year [Member] | |||
Income Tax Contingency [Line Items] | |||
Open Tax Year | 2021 |
Stockholders' Equity (Share Buy
Stockholders' Equity (Share Buyback Program) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Equity, Class of Treasury Stock [Line Items] | |||
Stock buyback program, authorized amount | $ 235,000 | ||
Treasury Stock, Value, Acquired, Cost Method | $ 39,909 | $ 28,873 | $ 24,425 |
November 2014 Share Repurchase Plan | |||
Equity, Class of Treasury Stock [Line Items] | |||
Treasury Stock, Shares, Acquired (in Shares) | 1,335,528 | 1,477,305 | 1,366,384 |
Treasury Stock, Value, Acquired, Cost Method | $ 39,900 | $ 28,900 | $ 24,400 |
Stockholders' Equity (The 2015
Stockholders' Equity (The 2015 Equity Incentive Plan) (Details) - shares | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2023 | Dec. 31, 2022 | Mar. 18, 2015 | |
The 2015 Equity Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in Shares) | 6,499,954 | 5,300,296 | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) | 5,000,000 | ||
Equity Incentive Plan, Term | 10 years | ||
Share Based Compensation Arrangement By Share Based Payment Award Potential Number of Additional Shares Authorized (in Shares) | 3,000,000 | ||
Share Based Compensation Arrangement by Share Based Payment Award Potential Annual Increase in Shares, Percentage | 2.50% | ||
The 2015 Equity Incentive Plan [Member] | Minimum | Shares subject to a minimum vesting requirement | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Percentage of shares awarded subject to a minimum vesting requirement | 95% | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 1 year | ||
The 2015 Equity Incentive Plan [Member] | Subsequent Event [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,202,802 | ||
Amended and Restated 2005 Equity Plan | Existing Employees [Member] | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | ||
Amended and Restated 2005 Equity Plan | Existing Employees [Member] | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 5 years | ||
Amended and Restated 2005 Equity Plan | New Employees [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | ||
Amended and Restated 2005 Equity Plan | Board of Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 1 year |
Stockholders' Equity (2014 Empl
Stockholders' Equity (2014 Employee Stock Purchase Plan) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2014 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 17,860 | $ 18,687 | $ 20,498 | |
2014 Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Employee Stock Purchase Plan, Offering Duration, Maximum | 27 months | |||
Share-based Compensation Arrangement by Share-based Payment Award, Discount from Market Price, Offering Date | 85% | |||
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in Shares) | 1,089,545 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in Shares) | 910,455 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) | 2,000,000 | |||
Allocated share based compensation | $ 900 | $ 700 | $ 800 |
Stockholders' Equity (Key Assum
Stockholders' Equity (Key Assumptions Used in Determining Fair Value of Options Granted) (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stockholders' Equity | |||
Average overall forfeiture rate | 7% | 6% | 5% |
Average volatility | 41% | 42.10% | 43.10% |
Average risk-free interest rate | 2.30% | 1.20% | 0.80% |
Weighted-average expected life in years | 6 years 1 month 6 days | 6 years 1 month 6 days | 5 years 8 months 12 days |
Stockholders' Equity (Summary o
Stockholders' Equity (Summary of Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Options | ||||
Outstanding Options, Beginning of period | 8,455,721 | |||
Options granted | 792,441 | |||
Options exercised | (1,222,147) | |||
Options cancelled | (91,251) | |||
Options expired | (5,614) | |||
Outstanding Options, End of period | 7,929,150 | 8,455,721 | ||
Exercisable at the end of period | 5,550,697 | |||
Vested and expected to vest, at the end of period | 7,757,291 | |||
Weighted-Average Exercise Price | ||||
Outstanding Exercise Price (in dollars per share) | $ 15.67 | |||
Options granted (in dollars per share) | 34.35 | |||
Options exercised (in dollars per share) | 14.56 | |||
Options cancelled (in dollars per share) | 19.56 | |||
Options expired (in dollars per share) | 13.79 | |||
Outstanding Exercise Price (in dollars per share) | 17.66 | $ 15.67 | ||
Exercisable at the end of period (in dollars per share) | 15.69 | |||
Vested and expected to vest at end of period (in dollars per share) | $ 17.51 | |||
Additional Disclosures | ||||
Contractual term | 4 years 11 months 8 days | |||
Outstanding Intrinsic Value | $ 87,025 | |||
Exercisable remaining contractual term (in Years) | 3 years 7 months 20 days | |||
Exercisable aggregate intrinsic value | $ 68,413 | |||
Allocated share based compensation | 17,860 | $ 18,687 | $ 20,498 | |
Vested and expected to vest aggregate intrinsic value | $ 85,920 | |||
Vested and expected to vest weighted average remaining contractual term | 4 years 10 months 13 days | |||
The 2015 Plan and 2005 Plan [Member] | Minimum | ||||
Additional Disclosures | ||||
Contractual term | 5 years | |||
Vesting term | 3 years | |||
The 2015 Plan and 2005 Plan [Member] | Maximum | ||||
Additional Disclosures | ||||
Contractual term | 10 years | |||
Vesting term | 5 years | |||
Employee Stock Options [Member] | ||||
Additional Disclosures | ||||
Allocated share based compensation | $ 8,500 | $ 8,000 | $ 9,100 | |
Employee Stock Options [Member] | President, General Counsel and member of board of directors | ||||
Additional Disclosures | ||||
Allocated share based compensation | $ 700 | |||
Vesting (percent) | 80% |
Stockholders' Equity (Informati
Stockholders' Equity (Information Relating to Option Grants and Exercises) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stockholders' Equity | |||
Weighted-average grant date fair value (in Dollars per share) | $ 14.75 | $ 7.62 | $ 5.51 |
Intrinsic value of options exercised | $ 21,279 | $ 7,906 | $ 9,169 |
Cash received from options exercised | 19,202 | 16,757 | 24,357 |
Total fair value of the options vested during the period | $ 8,174 | $ 8,177 | $ 9,978 |
Stockholders' Equity (Summary_2
Stockholders' Equity (Summary of Nonvested Options) (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Options | |||
Nonvested at beginning of period | 2,848,934 | ||
Options granted | 792,441 | ||
Options vested | (1,171,671) | ||
Options forfeited | (91,251) | ||
Nonvested at end of period | 2,378,453 | 2,848,934 | |
Weighted-Average Grant Date Fair Value | |||
Nonvested at beginning of period (in dollars per share) | $ 6.95 | ||
Options granted (in dollars per share) | 14.75 | $ 7.62 | $ 5.51 |
Options vested (in dollars per share) | 6.98 | ||
Options forfeited (in dollars per share) | 8.41 | ||
Nonvested at end of period (in dollars per share) | $ 9.48 | $ 6.95 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 14.5 | ||
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 6 months |
Stockholders' Equity (Restricte
Stockholders' Equity (Restricted Stock Units) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Contractual term | 4 years 11 months 8 days | |||
Allocated share based compensation | $ 17,860 | $ 18,687 | $ 20,498 | |
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 6 months | |||
Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 5 years | |||
Allocated share based compensation | $ 8,400 | $ 8,100 | $ 10,000 | |
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 6 months | |||
Share-based Compensation Arrangement by Share-based Payment Award, Restricted Stock Units, Number of Shares of Common Stock Per Award (in Shares) | 1 | |||
Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | $ 15,300 | |||
Maximum | Amended and Restated 2005 Equity Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||
Board of Directors | Amended and Restated 2005 Equity Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 1 year | |||
President, General Counsel and member of board of directors | Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 1,600 | |||
Vesting (percent) | 80% |
Stockholders' Equity (Informa_2
Stockholders' Equity (Information Relating to RSU Grants and Deliveries) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) shares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Total RSUs outstanding at the beginning of the period | 1,184,842 |
RSUs granted | 339,397 |
RSUs forfeited | (39,119) |
RSUs vested | (478,068) |
Total RSUs outstanding at the end of the period | 1,007,052 |
Total Fair Market Value of RSUs Issued | |
RSUs granted (in Dollars) | $ | $ 11,675 |
Restricted Stock Units (RSUs) | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Stock surrendered to fulfill tax withholding obligations | 181,547 |
Stockholders' Equity (The 2018
Stockholders' Equity (The 2018 ANP Equity Incentive Plan) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Jul. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options outstanding | 7,929,150 | 8,455,721 | ||||
Number of vested options | 1,171,671 | |||||
Number of unvested options | 2,378,453 | 2,848,934 | ||||
Vested options cancelled | 91,251 | |||||
Unvested options cancelled | 91,251 | |||||
Contractual term | 4 years 11 months 8 days | |||||
Compensation cost not yet recognized | $ 14,500 | |||||
Allocated share based compensation | 17,860 | $ 18,687 | $ 20,498 | |||
General and administrative expenses | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Allocated share based compensation | $ 11,180 | 12,622 | 14,089 | |||
The 2018 ANP Equity Incentive Plan Termination | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Plan modification, share-based compensation expense | 2,300 | |||||
Compensation cost not yet recognized | 500 | |||||
The 2018 ANP Equity Incentive Plan Termination | General and administrative expenses | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Plan modification, share-based compensation expense | 1,800 | |||||
Employee [Member] | The 2018 ANP Equity Incentive Plan Termination | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options outstanding | 4,091,080 | |||||
Number of vested options | 1,944,771 | |||||
Number of unvested options | 2,146,309 | |||||
Options fair value | $ 800 | |||||
Options cancelled | 927,800 | |||||
Vested options cancelled | 56,925 | |||||
Unvested options cancelled | 870,875 | |||||
The 2018 ANP Equity Incentive Plan | Employee [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Contractual term | 10 years | |||||
Allocated share based compensation | $ 500 | $ 700 | ||||
The 2018 ANP Equity Incentive Plan | Employee [Member] | The 2018 ANP Equity Incentive Plan Termination | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options outstanding | 5,018,880 | |||||
The 2015 Equity Incentive Plan [Member] | Employee [Member] | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 1 year | |||||
The 2015 Equity Incentive Plan [Member] | Employee [Member] | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 2 years |
Stockholders' Equity (Share-Bas
Stockholders' Equity (Share-Based Compensation Expense Included in the Statement of Operations) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share based compensation | $ 17,860 | $ 18,687 | $ 20,498 |
Cost Of Revenues [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share based compensation | 4,179 | 3,778 | 4,248 |
Selling, Distribution And Marketing [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share based compensation | 726 | 596 | 456 |
General and administrative expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share based compensation | 11,180 | 12,622 | 14,089 |
Research and Development Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share based compensation | $ 1,775 | $ 1,691 | $ 1,705 |
Employee Benefits (Details)
Employee Benefits (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Benefits | |||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 50% | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 6% | ||
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 2.2 | $ 2 | $ 1.9 |
Defined Benefit Plan, Assumptions Used Calculating Benefit Obligation, Discount Rate | 3.75% | 1% | |
Defined Benefit Plan, Benefit Obligation | $ 2.2 | $ 2.7 | |
Deferred compensation plan assets | 4.5 | 3.4 | |
Deferred compensation plan liabilities | $ 4.6 | $ 3.5 |
Commitments and Contingencies_2
Commitments and Contingencies (Lease Expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | |||
Right-of-use assets | $ 25,554 | $ 26,894 | |
Lease obligations | 26,697 | ||
Operating lease cost | 4,709 | 4,328 | $ 4,462 |
Short-term lease costs | 300 | 518 | 649 |
Amortization of right-of-use assets | 237 | 384 | 351 |
Interest on lease liabilities | 26 | 26 | 33 |
Total financed lease cost | 263 | 410 | 384 |
Total lease costs | $ 5,272 | $ 5,256 | $ 5,495 |
Minimum | |||
Lessee, Lease, Description [Line Items] | |||
Lease renewal term | 1 year | ||
Maximum | |||
Lessee, Lease, Description [Line Items] | |||
Lease renewal term | 6 years |
Commitments and Contingencies_3
Commitments and Contingencies (Lease Cash Flow Information) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies | |||
Operating cash flows from operating Leases | $ 4,329 | $ 4,446 | $ 4,491 |
Operating cash flows from finance leases | 18 | 25 | 33 |
Financing cash flows from finance leases | 233 | 310 | 369 |
Right-of use assets obtained in exchange for lease obligations: Operating leases | 2,166 | 11,041 | 4,819 |
Right-of use assets obtained in exchange for lease obligations: Finance leases | $ 642 | $ 110 | $ 61 |
Weighted-average remaining lease term (years), Operating leases | 8 years 8 months 12 days | 9 years 6 months | 8 years 8 months 12 days |
Weighted-average remaining lease term (years), Finance leases | 4 years 3 months 18 days | 2 years 4 months 24 days | 2 years 3 months 18 days |
Weighted-average discount rate, Operating leases | 4.40% | 4.50% | 5.20% |
Weighted-average discount rate, Finance leases | 6.70% | 5.20% | 5% |
Commitments and Contingencies_4
Commitments and Contingencies (Future Minimum Rental Payments) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Operating Leases | ||
2022 | $ 4,078 | |
2023 | 3,742 | |
2024 | 3,635 | |
2025 | 3,534 | |
2026 | 3,364 | |
Thereafter | 14,080 | |
Total lease payments | 32,433 | |
Less: interest | 5,736 | |
Total | 26,697 | |
Finance Leases | ||
2022 | 243 | |
2023 | 212 | |
2024 | 189 | |
2025 | 159 | |
2026 | 104 | |
Total lease payments | 907 | |
Less: interest | 117 | |
Total | 790 | $ 398 |
Total | ||
2022 | 4,321 | |
2023 | 3,954 | |
2024 | 3,824 | |
2025 | 3,693 | |
2026 | 3,468 | |
Thereafter | 14,080 | |
Total lease payments | 33,340 | |
Less: interest | 5,853 | |
Total | $ 27,487 |
Commitments and Contingencies_5
Commitments and Contingencies (Purchase Commitments) (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Commitments to Purchase Equipment and Raw Materials [Member] | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |
Long-term Purchase Commitment, Amount | $ 58.2 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2022 | Jul. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2020 | |
Retirement agreement | Senior Vice President of Engineering and President of AFP | ||||
Related Party Transaction [Line Items] | ||||
Retirement Compensation Expense | $ 1.1 | |||
Retirement agreement | Senior Vice President of Engineering and President of AFP | Cash compensation | ||||
Related Party Transaction [Line Items] | ||||
Cash compensation | $ 1 | |||
Compensation period | 3 years | |||
Retirement agreement | Senior Vice President of Engineering and President of AFP | Health insurance coverage | ||||
Related Party Transaction [Line Items] | ||||
Compensation period | 6 years | |||
Hanxin | ||||
Related Party Transaction [Line Items] | ||||
Payment to related party | $ 0.6 | |||
Related Party Transaction, Due from (to) Related Party, Current | $ 0.4 | |||
Ownership after transaction | 14% | |||
Related Party Transaction, Amounts of Transaction | $ 2.2 | |||
Letop | ||||
Related Party Transaction [Line Items] | ||||
Related Party Transaction, Due from (to) Related Party, Current | $ 0 | |||
ANP | Hanxin | ||||
Related Party Transaction [Line Items] | ||||
Revenue from Related Parties | 0.4 | |||
ANP | Letop | ||||
Related Party Transaction [Line Items] | ||||
Payment to related party | 0.2 | |||
Related Party Transaction, Due from (to) Related Party, Current | $ 0 | |||
Related Party Transaction, Amounts of Transaction | $ 1.5 |
Litigation (Details)
Litigation (Details) - Settled Litigation [Member] - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2021 | May 03, 2021 | Nov. 13, 2020 | May 31, 2021 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Loss Contingencies [Line Items] | |||||||||
Litigation Settlement, amount paid to the Company | $ 2.7 | ||||||||
Amphastar Pharmaceuticals, Inc. Vs Aventis Pharma, SA | |||||||||
Loss Contingencies [Line Items] | |||||||||
Litigation Settlement, Amount | $ 14.5 | $ 4.4 | $ 12.1 | $ 17.2 | |||||
Costs and expenses | $ 0.7 | ||||||||
Estimated Litigation Liability | $ 12.8 | ||||||||
Litigation settlement accrual amount increase | $ 1.7 | ||||||||
Employee Litigation | |||||||||
Loss Contingencies [Line Items] | |||||||||
Litigation Settlement, Amount | $ 1 | $ 1 | |||||||
Amphastar Pharmaceuticals vs Astellas-Gilead | Astellas-Gilead | |||||||||
Loss Contingencies [Line Items] | |||||||||
Litigation Settlement, amount paid to the Company | $ 5.4 |