Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 02, 2023 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
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 $0.0001 per share | |
Trading Symbol | AMPH | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 48,855,602 | |
Entity Central Index Key | 0001297184 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 148,595 | $ 156,098 |
Restricted cash | 2,685 | 235 |
Short-term investments | 14,541 | 19,664 |
Restricted short-term investments | 2,200 | 2,200 |
Accounts receivable, net | 104,715 | 88,804 |
Inventories | 104,617 | 103,584 |
Income tax refunds and deposits | 1,329 | 171 |
Prepaid expenses and other assets | 5,872 | 7,563 |
Total current assets | 384,554 | 378,319 |
Property, plant, and equipment, net | 278,526 | 238,266 |
Finance lease right-of-use assets | 657 | 753 |
Operating lease right-of-use assets | 26,327 | 25,554 |
Investment in unconsolidated affiliate | 1,462 | 2,414 |
Goodwill and intangible assets, net | 625,603 | 37,298 |
Other assets | 20,269 | 20,856 |
Deferred tax assets | 40,868 | 38,527 |
Total assets | 1,378,266 | 741,987 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 217,536 | 84,242 |
Income taxes payable | 17,696 | 4,571 |
Current portion of long-term debt | 12,920 | 3,046 |
Current portion of operating lease liabilities | 3,133 | 3,003 |
Total current liabilities | 251,285 | 94,862 |
Long-term reserve for income tax liabilities | 7,225 | 7,225 |
Long-term debt, net of current portion and unamortized debt issuance costs | 488,280 | 72,839 |
Long-term operating lease liabilities, net of current portion | 24,407 | 23,694 |
Deferred tax liabilities | 201 | 144 |
Other long-term liabilities | 17,633 | 14,565 |
Total liabilities | 789,031 | 213,329 |
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; 59,068,477 and 48,818,806 shares issued and outstanding as of June 30, 2023 and 58,110,231 and 48,112,069 shares issued and outstanding as of December 31, 2022, respectively | 6 | 6 |
Additional paid-in capital | 471,110 | 455,077 |
Retained earnings | 323,880 | 271,723 |
Accumulated other comprehensive loss | (8,324) | (8,624) |
Treasury stock | (197,437) | (189,524) |
Total equity | 589,235 | 528,658 |
Total liabilities and stockholders' equity | $ 1,378,266 | $ 741,987 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
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 | 59,068,477 | 58,110,231 |
Common stock; shares outstanding | 48,818,806 | 48,112,069 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Net revenues | $ 145,712 | $ 123,467 | $ 285,734 | $ 243,835 |
Cost of revenues | 72,974 | 60,111 | 139,156 | 124,653 |
Gross profit | 72,738 | 63,356 | 146,578 | 119,182 |
Operating expenses: | ||||
Selling, distribution, and marketing | 6,718 | 5,756 | 13,827 | 11,275 |
General and administrative | 12,281 | 9,979 | 25,764 | 22,449 |
Research and development | 16,843 | 22,798 | 36,658 | 39,021 |
Total operating expenses | 35,842 | 38,533 | 76,249 | 72,745 |
Income from operations | 36,896 | 24,823 | 70,329 | 46,437 |
Non-operating income (expenses): | ||||
Interest income | 1,030 | 229 | 1,954 | 410 |
Interest expense | (3,602) | (397) | (4,000) | (752) |
Other income (expenses), net | (1,516) | (1,504) | (1,906) | 6,089 |
Total non-operating income (expenses), net | (4,088) | (1,672) | (3,952) | 5,747 |
Income before income taxes | 32,808 | 23,151 | 66,377 | 52,184 |
Income tax provision | 6,383 | 5,551 | 13,135 | 9,628 |
Income before equity in losses of unconsolidated affiliate | 26,425 | 17,600 | 53,242 | 42,556 |
Equity in losses of unconsolidated affiliates | (301) | (254) | (1,086) | (957) |
Net income (loss) | $ 26,124 | $ 17,346 | $ 52,156 | $ 41,599 |
Net income per share | ||||
Basic (in Dollars per share) | $ 0.54 | $ 0.35 | $ 1.08 | $ 0.86 |
Diluted (in Dollars per share) | $ 0.49 | $ 0.33 | $ 0.99 | $ 0.79 |
Weighted-average shares used to compute net income per shares | ||||
Basic (in Shares) | 48,404 | 48,864 | 48,202 | 48,501 |
Diluted (in Shares) | 53,102 | 53,227 | 52,536 | 52,603 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ||||
Net income | $ 26,124 | $ 17,346 | $ 52,156 | $ 41,599 |
Other comprehensive income (loss), net of income taxes | ||||
Foreign currency translation adjustment | (56) | (1,464) | 300 | (1,944) |
Total other comprehensive income (loss) | (56) | (1,464) | 300 | (1,944) |
Total comprehensive income | $ 26,068 | $ 15,882 | $ 52,456 | $ 39,655 |
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 |
Balance at Dec. 31, 2021 | $ 6 | $ 422,423 | $ 180,337 | $ (6,765) | $ (150,479) | |
Balance at Dec. 31, 2021 | $ 445,522 | |||||
Balance at Dec. 31, 2021 | 56,440,202 | (8,725,290) | ||||
Changes in Stockholders' Equity | ||||||
Net income | 24,253 | 24,253 | ||||
Other comprehensive income | (480) | (480) | ||||
Purchase of treasury stock | $ (1,229) | (1,229) | ||||
Purchase of treasury stock (in Shares) | (51,168) | |||||
Issuance of treasury stock in connection with the Company's equity plans | (428) | $ 428 | ||||
Issuance of treasury stock in connection with the Company's equity plans (in Shares) | 33,231 | |||||
Issuance of common stock in connection with the Company's equity plans | 6,437 | 6,437 | ||||
Issuance of common stock in connection with the Company's equity plans (in Shares) | 1,055,200 | |||||
Share-based compensation expense | 5,022 | 5,022 | ||||
Balance at Mar. 31, 2022 | $ 6 | 433,454 | 204,590 | (7,245) | $ (151,280) | |
Balance at Mar. 31, 2022 | 479,525 | |||||
Balance at Mar. 31, 2022 | 57,495,402 | (8,743,227) | ||||
Balance at Dec. 31, 2021 | $ 6 | 422,423 | 180,337 | (6,765) | $ (150,479) | |
Balance at Dec. 31, 2021 | 445,522 | |||||
Balance at Dec. 31, 2021 | 56,440,202 | (8,725,290) | ||||
Changes in Stockholders' Equity | ||||||
Net income | 41,599 | |||||
Other comprehensive income | (1,944) | |||||
Balance at Jun. 30, 2022 | $ 6 | 443,042 | 221,936 | (8,709) | $ (156,968) | |
Balance at Jun. 30, 2022 | 499,307 | |||||
Balance at Jun. 30, 2022 | 57,896,337 | (8,904,048) | ||||
Balance at Mar. 31, 2022 | $ 6 | 433,454 | 204,590 | (7,245) | $ (151,280) | |
Balance at Mar. 31, 2022 | 479,525 | |||||
Balance at Mar. 31, 2022 | 57,495,402 | (8,743,227) | ||||
Changes in Stockholders' Equity | ||||||
Net income | 17,346 | 17,346 | ||||
Other comprehensive income | (1,464) | (1,464) | ||||
Purchase of treasury stock | $ (6,118) | (6,118) | ||||
Purchase of treasury stock (in Shares) | (189,840) | |||||
Issuance of treasury stock in connection with the Company's equity plans | (430) | $ 430 | ||||
Issuance of treasury stock in connection with the Company's equity plans (in Shares) | 29,019 | |||||
Issuance of common stock in connection with the Company's equity plans | 5,783 | 5,783 | ||||
Issuance of common stock in connection with the Company's equity plans (in Shares) | 400,935 | |||||
Share-based compensation expense | 4,235 | 4,235 | ||||
Balance at Jun. 30, 2022 | $ 6 | 443,042 | 221,936 | (8,709) | $ (156,968) | |
Balance at Jun. 30, 2022 | 499,307 | |||||
Balance at Jun. 30, 2022 | 57,896,337 | (8,904,048) | ||||
Balance at Dec. 31, 2022 | $ 6 | 455,077 | 271,723 | (8,624) | $ (189,524) | |
Balance at Dec. 31, 2022 | $ 528,658 | |||||
Balance at Dec. 31, 2022 | 58,110,231 | (9,998,162) | 48,112,069 | |||
Changes in Stockholders' Equity | ||||||
Net income | 26,032 | $ 26,032 | ||||
Other comprehensive income | 356 | 356 | ||||
Purchase of treasury stock | $ (8,015) | (8,015) | ||||
Purchase of treasury stock (in Shares) | (263,131) | |||||
Issuance of common stock in connection with the Company's equity plans | (4,565) | (4,565) | ||||
Issuance of common stock in connection with the Company's equity plans (in Shares) | 330,300 | |||||
Share-based compensation expense | 6,111 | 6,111 | ||||
Balance at Mar. 31, 2023 | $ 6 | 456,623 | 297,755 | (8,268) | $ (197,539) | |
Balance at Mar. 31, 2023 | 548,577 | |||||
Balance at Mar. 31, 2023 | 58,440,531 | (10,261,293) | ||||
Balance at Dec. 31, 2022 | $ 6 | 455,077 | 271,723 | (8,624) | $ (189,524) | |
Balance at Dec. 31, 2022 | $ 528,658 | |||||
Balance at Dec. 31, 2022 | 58,110,231 | (9,998,162) | 48,112,069 | |||
Changes in Stockholders' Equity | ||||||
Net income | $ 52,156 | |||||
Other comprehensive income | 300 | |||||
Balance at Jun. 30, 2023 | $ 6 | 471,110 | 323,880 | (8,324) | $ (197,437) | |
Balance at Jun. 30, 2023 | $ 589,235 | |||||
Balance at Jun. 30, 2023 | 59,068,477 | (10,249,671) | 48,818,806 | |||
Balance at Mar. 31, 2023 | $ 6 | 456,623 | 297,755 | (8,268) | $ (197,539) | |
Balance at Mar. 31, 2023 | $ 548,577 | |||||
Balance at Mar. 31, 2023 | 58,440,531 | (10,261,293) | ||||
Changes in Stockholders' Equity | ||||||
Net income | 26,124 | 26,124 | ||||
Other comprehensive income | (56) | (56) | ||||
Purchase of treasury stock | $ (129) | (129) | ||||
Purchase of treasury stock (in Shares) | (3,585) | |||||
Issuance of treasury stock in connection with the Company's equity plans | (231) | $ 231 | ||||
Issuance of treasury stock in connection with the Company's equity plans (in Shares) | 15,207 | |||||
Issuance of common stock in connection with the Company's equity plans | 9,853 | 9,853 | ||||
Issuance of common stock in connection with the Company's equity plans (in Shares) | 627,946 | |||||
Share-based compensation expense | 4,865 | 4,865 | ||||
Balance at Jun. 30, 2023 | $ 6 | $ 471,110 | $ 323,880 | $ (8,324) | $ (197,437) | |
Balance at Jun. 30, 2023 | $ 589,235 | |||||
Balance at Jun. 30, 2023 | 59,068,477 | (10,249,671) | 48,818,806 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash Flows From Operating Activities: | ||
Net income | $ 52,156 | $ 41,599 |
Reconciliation to net cash provided by operating activities: | ||
Loss on disposal of assets | 7 | (58) |
(Gain) loss on interest rate swaps and foreign currency transactions, net | 2,434 | (298) |
Impairment of long-lived assets | 2,700 | |
Depreciation of property, plant, and equipment | 12,121 | 11,411 |
Amortization of product rights, trademarks, and patents | 471 | 504 |
Operating lease right-of-use asset amortization | 1,825 | 1,709 |
Amortization of debt issuance costs and debt modification costs | 3,249 | 192 |
Equity in losses of unconsolidated affiliate | 1,086 | 957 |
Share-based compensation | 10,976 | 9,257 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (10,533) | (2,178) |
Inventories | (767) | (7,422) |
Prepaid expenses and other assets | 740 | 468 |
Income tax refunds, deposits, and payable, net | 11,967 | (14,235) |
Operating lease liabilities | (1,750) | (1,468) |
Accounts payable and accrued liabilities | 8,623 | 13,142 |
Net cash provided by operating activities | 95,305 | 53,580 |
Cash Flows From Investing Activities: | ||
BAQSIMI acquisition | (500,829) | |
Purchases and construction of property, plant, and equipment | (18,531) | (12,101) |
Proceeds from the sale of property, plant and equipment | 421 | |
Purchase of investments | (19,774) | (12,004) |
Maturity of investments | 25,151 | 6,391 |
Deposits and Other Assets | 932 | (3) |
Net cash used in investing activities | (514,915) | (17,290) |
Cash Flows From Financing Activities: | ||
Proceeds from equity plans, net of withholding tax payments | 5,288 | 12,220 |
Purchase of treasury stock | (8,143) | (7,346) |
Debt issuance costs | (14,150) | (89) |
Proceeds from issuance of long-term debt | 500,000 | |
Principal payments on long-term debt | (68,432) | (1,131) |
Net cash used in financing activities | 414,563 | 3,654 |
Effect of exchange rate changes on cash | (6) | (140) |
Net increase in cash, cash equivalents, and restricted cash | (5,053) | 39,804 |
Cash, cash equivalents, and restricted cash at beginning of period | 156,333 | 126,588 |
Cash, cash equivalents, and restricted cash at end of period | 151,280 | 166,392 |
Noncash Investing and Financing Activities: | ||
Deferred payment for BAQSIMI acquisition | 127,276 | |
Capital expenditures included in accounts payable | 3,681 | 5,539 |
Operating lease right-of-use assets in exchange for operating lease liabilities | 2,598 | 1,777 |
Supplemental Disclosures of Cash Flow Information: | ||
Interest paid, net of capitalized interest | 2,772 | 1,167 |
Income taxes paid | $ 1,322 | $ 23,964 |
General
General | 6 Months Ended |
Jun. 30, 2023 | |
General | |
General | Note 1. General 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 ® The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2022 and the notes thereto as filed with the Securities and Exchange Commission, or SEC, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles, or GAAP, have been condensed or omitted from the accompanying condensed consolidated financial statements. The accompanying year-end condensed consolidated balance sheet was derived from the audited financial statements. The accompanying interim financial statements are unaudited, but reflect all adjustments which are, in the opinion of management, necessary for a fair statement of the Company’s consolidated financial position, results of operations, comprehensive income (loss), stockholders’ equity, and cash flows for the periods presented. Unless otherwise noted, all such adjustments are of a normal, recurring nature. The Company’s results of operations, comprehensive income (loss) and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries, and are prepared in accordance with GAAP. Certain prior period amounts have been reclassified within the operating activities of the condensed consolidated statements of cash flows to conform to the current period presentation. All intercompany activity has been eliminated in the preparation of the condensed consolidated financial statements. In the opinion of management, the accompanying unaudited condensed 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, (6) International Medication Systems (UK) Limited, or IMS UK, and (7) Amphastar Medication Co., LLC, or Amphastar Medication. 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 condensed consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: fair value of acquired assets, 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 condensed 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 were a $0.1 million loss and a $0.5 million gain for the three and six months ended June 30, 2023, respectively. For the three and six months ended June 30, 2022, the unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature were a $2.1 million loss and a $2.7 million loss, 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. Acquisition s The Company evaluates acquisitions and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and substantive processes that have the ability to create outputs, which would meet the definition of a business. Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis, with the exception of non-qualifying assets. Goodwill is not recognized in an asset acquisition. When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration, including assumed contingent considerations, is not recognized until all contingencies are resolved and the consideration is paid or becomes payable (unless contingent considerations meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired), at which point the consideration is allocated to the assets acquired based on their relative fair values at the acquisition date, with the exception of non-qualifying assets. Judgments are used in determining estimates of useful lives of long-lived assets. Useful life estimates are based on, among other factors, estimates of expected future net cash flows, the assessment of each asset’s life cycle, and the impact of competitive trends on each asset’s life cycle and other factors. These judgments can materially impact the estimates used to allocate purchase consideration to assets acquired and liabilities assumed, and the resulting timing and amounts charged to or recognized in current and future operating results. For these and other reasons, actual results may vary significantly from estimated results. Advertising Expense Advertising expenses, primarily associated with Primatene MIST ® 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. From time to time, the Company 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 condensed consolidated statements of operations. As of June 30, 2023, the Company did not have any unsettled forward currency contracts to purchase foreign currency. 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 condensed 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 June 30, 2023 and December 31, 2022 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 and China. As of June 30, 2023 and December 31, 2022, the restricted cash balance was $2.7 million and $0.2 million, respectively. 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 June 30, 2023 and December 31, 2022, the balance of restricted short-term investments was $2.2 million. 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. Debt Issuance Costs Debt issuance costs related to non-revolving debt are recognized as a reduction to the related debt balance in the accompanying condensed consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Debt issuance costs associated with revolving debt are capitalized within other long-term assets on the condensed consolidated balance sheets and are amortized to interest expense over the term of the related revolving debt. 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. 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. 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 condensed consolidated financial statements. |
BAQSIMI Acquisition
BAQSIMI Acquisition | 6 Months Ended |
Jun. 30, 2023 | |
BAQSIMI Acquisition | |
BAQSIMI Acquisition | Note 3. BAQSIMI ® Acquisition On June 30, 2023, the Company completed its acquisition of BAQSIMI ® glucagon nasal powder, or BAQSIMI ® pursuant to an asset purchase agreement, or the Purchase Agreement, with Eli Lilly & Company, or Lilly, dated April 21, 2023. In connection with the closing of the transaction, or the Closing, the Company paid Lilly $500.0 million in cash. In addition, the Company is required to pay Lilly a $125.0 million guaranteed payment on the first anniversary of the closing. The Company is also required to pay Lilly $4.0 million upon the assignment of certain contracts to the Company after the first anniversary of the Closing, but no later than 18 months after the Closing. The Company may also be required to pay additional contingent consideration of up to $450.0 million to Lilly based on the achievement of certain milestones. In addition, the Company assumed certain contingent consideration of Lilly, which would require the Company to pay up to an aggregate of $125.0 million based on the achievement of annual net sales milestones of $350.0 million, $400.0 million and $600.0 million. The Purchase Agreement provides that the contingent consideration that may become payable to Lilly would be achieved as follows: (i) a one-time payment of $100.0 million if the Company achieves annual net sales of $175.0 million or more of BAQSIMI ® and certain related products, or the Milestone Products, in any one year during the first five years after the Closing; (ii) up to two payments of $100 million each if the Company achieves annual net sales of $200.0 million or more of Milestone Products in any one year during the first five years after the Closing; and (iii) a one-time payment of $150.0 million if the Company achieves total cumulative net sales of $950.0 million or more of the Milestone Products for the first five years after the Closing. The Company has accounted for the BAQSIMI ® Business Combination ® ® ® The relative fair values of identifiable assets from the acquisition of BAQSIMI ® Manufacturing Services Agreement In connection with the Closing, the Company entered into a Manufacturing Services Agreement, or the MSA, with Lilly, pursuant to which Lilly has agreed, for a period of time not to exceed 18 months , to provide certain manufacturing, packaging, labeling and supply services for BAQSIMI ® directly or through third-party contractors to the Company in connection with its operation of the development, manufacture, and commercialization of BAQSIMI ® . Upon termination of the MSA, the Company will be obligated to purchase all API, components, and finished goods on hand at prices agreed upon in the MSA. Transition Services Agreement In connection with the Closing, the Company entered into a Transition Services Agreement, or the TSA, with Lilly pursuant to which Lilly has agreed, for a period of time not to exceed 18 months , to provide certain services to the Company to support the transition of BAQSIMI ® operations to the Company, including with respect to the conduct of certain clinical, regulatory, medical affairs, and commercial sales channel activities. The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of BAQSIMI ® Fair Value (in thousands) Cash payment $ 500,000 Fair value of deferred cash payment 121,699 Transaction costs 6,406 Total purchase price $ 628,105 The total purchase price was allocated to the acquired assets based on their relative fair values, as follow: Fair Value (in thousands) Property, plant, and equipment $ 34,426 BAQSIMI ® 591,338 Deferred tax assets 2,341 Total assets acquired $ 628,105 The Company is amortizing the acquired intangible asset on a straight line basis over its estimated useful life of 24 years (See Note 10 for additional information). The fair value of the deferred cash payment is being accreted to the full $129.0 million amount over a one-year period through interest expense. Credit Agreement On June 30, 2023, in conjunction with the Company’s acquisition of BAQSIMI ® The Credit Agreement provides for a senior secured term loan in an aggregate principal amount of $500.0 million, or the Term Loan. The Term Loan matures on the June 30, 2028. The Credit Agreement also provides a senior secured revolving credit facility, or the Revolving Credit Facility, in an aggregate principal amount of $200.0 million, with a $15.0 million letter of credit sublimit and a $15.0 million swingline loan sublimit. The Revolving Credit Facility matures on June 30, 2028. As of June 30, 2023, the Company had no borrowings outstanding under the Revolving Credit Facility. Proceeds from the Term Loan were used to finance the acquisition of BAQSIMI ® |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2023 | |
Revenue Recognition | |
Revenue Recognition | Note 4. Revenue Recognition In accordance with 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 are recognized over time based on progress toward satisfaction 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. For the three and six months ended June 30, 2023, revenues from research and development services at ANP were $1.2 million and $1.3 million, respectively. For the three and six months ended June 30, 2022, revenues from research and development services at ANP were $0.7 million and $1.3 million, 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: Six Months Ended June 30, 2023 2022 (in thousands) Beginning balance $ 26,606 $ 20,167 Provision for chargebacks and rebates 143,792 96,593 Credits and payments issued to third parties (141,584) (94,526) Ending balance $ 28,814 $ 22,234 Changes in the provision for chargebacks 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 provision for rebates 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. The provision for chargebacks and rebates is recorded within accounts receivable and/or accounts payable and accrued liabilities depending on whether the Company has the right to offset with the customer. Of the provision for chargebacks and rebates as of June 30, 2023 and December 31, 2022, $21.8 million and $20.5 million were included as a reduction to accounts receivable, net, on the condensed consolidated balance sheets, respectively. The remaining provision as of June 30, 2023 and December 31, 2022 of $7.0 million and $6.1 million, respectively, which were included in accounts payable and accrued liabilities in the condensed 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: Six Months Ended June 30, 2023 2022 (in thousands) Beginning balance $ 19,451 $ 21,677 Provision for product returns 2,160 2,929 Credits issued to third parties (2,825) (3,341) Ending balance $ 18,786 $ 21,265 Of the provision for product returns as of June 30, 2023 and December 31, 2022, $13.8 million and $14.9 million, were included in accounts payable and accrued liabilities on the condensed consolidated balance sheets, respectively. The remaining provision as of June 30, 2023 and December 31, 2022 of $5.0 million and $4.6 million, were included in other long-term liabilities, respectively. For the six months ended June 30, 2023 and 2022, the Company’s aggregate product return rate was 1.2% and 1.6% of qualified sales, respectively. |
Net Income per Share
Net Income per Share | 6 Months Ended |
Jun. 30, 2023 | |
Net Income per Share | |
Net Income per Share | Note 5. Net Income per Share Basic net income per share is calculated based upon the weighted-average number of shares outstanding during the period. Diluted net income per share gives effect to all potentially 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 three and six months ended June 30, 2023, options to purchase 45,464 shares of stock, with a weighted-average exercise price of $46.01 per share, were excluded in the computation of diluted net income per share because the effect would be anti-dilutive. For the three and six months ended June 30, 2022, options to purchase 12,296 and 706,411 shares of stock, respectively, with a weighted-average exercise price of $37.41 per share and $34.79 per share, respectively, were excluded in the computation of diluted net income per share because the effect would be anti-dilutive. The following table provides the calculation of basic and diluted net income per share for each of the periods presented: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands, except per share data) Basic and dilutive numerator: Net income $ 26,124 $ 17,346 $ 52,156 $ 41,599 Denominator: Weighted-average shares outstanding — basic 48,404 48,864 48,202 48,501 Net effect of dilutive securities: Incremental shares from equity awards 4,698 4,363 4,334 4,102 Weighted-average shares outstanding — diluted 53,102 53,227 52,536 52,603 Net income per share — basic $ 0.54 $ 0.35 $ 1.08 $ 0.86 Net income per share — diluted $ 0.49 $ 0.33 $ 0.99 $ 0.79 |
Segment Reporting
Segment Reporting | 6 Months Ended |
Jun. 30, 2023 | |
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 ® BAQSIMI ® Selected financial information by reporting segment is presented below: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Net revenues: Finished pharmaceutical products $ 142,866 $ 120,123 $ 278,876 $ 236,669 API 2,846 3,344 6,858 7,166 Total net revenues 145,712 123,467 285,734 243,835 Gross profit (loss): Finished pharmaceutical products 77,067 67,084 153,243 124,023 API (4,329) (3,728) (6,665) (4,841) Total gross profit 72,738 63,356 146,578 119,182 Operating expenses 35,842 38,533 76,249 72,745 Income from operations 36,896 24,823 70,329 46,437 Non-operating income (4,088) (1,672) (3,952) 5,747 Income before income taxes $ 32,808 $ 23,151 $ 66,377 $ 52,184 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: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Finished pharmaceutical products net revenues: Glucagon $ 27,276 $ 11,795 $ 52,972 $ 22,779 Primatene MIST ® 16,520 18,974 40,003 43,671 Epinephrine 16,714 18,119 36,805 33,275 Lidocaine 14,006 16,042 27,652 26,632 Phytonadione 17,855 13,381 25,568 23,856 Enoxaparin 7,872 9,031 17,739 19,155 Naloxone 5,102 7,193 10,059 14,606 Other finished pharmaceutical products 37,521 25,588 68,078 52,695 Total finished pharmaceutical products net revenues $ 142,866 $ 120,123 $ 278,876 $ 236,669 The amount of depreciation and amortization expense included in cost of revenues, by reporting segment, is presented below: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Depreciation and amortization expense Finished pharmaceutical products $ 2,081 $ 2,059 $ 4,527 $ 3,853 API 982 937 1,935 1,885 Total depreciation and amortization expense $ 3,063 $ 2,996 $ 6,462 $ 5,738 Net revenues and carrying values of long-lived assets by geographic regions are as follows: Net Revenue Long-Lived Assets Three Months Ended Six Months Ended June 30, June 30, June 30, December 31, 2023 2022 2023 2022 2023 2022 (in thousands) United States $ 143,895 $ 120,786 $ 281,853 $ 237,900 $ 768,988 $ 136,328 China 1,182 766 1,309 1,699 89,236 88,647 France 635 1,915 2,572 4,236 38,624 39,598 Total $ 145,712 $ 123,467 $ 285,734 $ 243,835 $ 896,848 $ 264,573 |
Customer and Supplier Concentra
Customer and Supplier Concentration | 6 Months Ended |
Jun. 30, 2023 | |
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 three and six months ended June 30, 2023 and 2022, and accounts receivable as of June 30, 2023 and December 31, 2022, respectively. The following table provides accounts receivable and net revenue information for these major customers: % of Total Accounts % of Net Receivable Revenue Three Months Ended Six Months Ended June 30, December 31, June 30, June 30, 2023 2022 2023 2022 2023 2022 McKesson 40 % 32 % 31 % 22 % 27 % 20 % AmerisourceBergen 13 % 16 % 21 % 24 % 22 % 23 % Cardinal Health 17 % 19 % 17 % 17 % 16 % 16 % 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 | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, 2023, 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, agency 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 condensed consolidated balance sheets, which approximates their fair value determined based on Level 2 inputs. The corporate, agency 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 June 30, 2023 and December 31, 2022, are as follows: Total (Level 1) (Level 2) (Level 3) (in thousands) Cash equivalents $ 92,576 $ 92,576 $ — $ — Restricted cash 2,684 2,684 — — Restricted short-term investments 2,200 — 2,200 — Corporate, agency and municipal bonds 14,433 — 14,433 — Interest rate swaps related to variable rate loans (1,526) — (1,526) — Fair value measurement as of June 30, 2023 $ 110,367 $ 95,260 $ 15,107 $ — Cash equivalents $ 130,199 $ 130,199 $ — $ — Restricted cash 235 235 — — Short-term investments 4,600 — 4,600 — Restricted short-term investments 2,200 — 2,200 — Corporate, agency and municipal bonds 14,931 — 14,931 — Interest rate swaps related to variable rate loans 6,048 — 6,048 — Fair value measurement as of December 31, 2022 $ 158,213 $ 130,434 $ 27,779 $ — 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 an impairment test. As of June 30, 2023, and December 31, 2022, there were no significant adjustments to fair value for nonfinancial assets or liabilities. The Company’s 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 | 6 Months Ended |
Jun. 30, 2023 | |
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) $ 14,239 $ — $ (11) $ 14,228 Municipal bonds (due within 1 year) 205 — — 205 Total investments as of June 30, 2023 $ 14,444 $ — $ (11) $ 14,433 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 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, identifying 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 condensed consolidated financial statements. Investment in unconsolidated affiliate The Company accounts for its share of the earnings or losses of its unconsolidated affiliate (Nanjing Hanxin Biomedical Testing Service Co., Ltd., or 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 three and six months ended June 30, 2023 was $0.3 million and $1.1 million, respectively, which was recorded in the “Equity in losses of unconsolidated affiliate” line on the condensed consolidated statement of operations. The Company’s share of Hanxin’s losses for the three and six months ended June 30, 2022, was $0.3 million and $1.0 million, respectively, which was recorded in the “Equity in losses of unconsolidated affiliate” line on the condensed consolidated statement of operations. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 6 Months Ended |
Jun. 30, 2023 | |
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 BAQSIMI ® (1) 24 $ 591,338 $ — $ 591,338 IMS (UK) international product rights (2) 10 8,462 8,462 — Patents 12 486 369 117 Land-use rights 39 2,540 782 1,758 Subtotal 23 602,826 9,613 593,213 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 3,165 — 3,165 Subtotal * 32,390 — 32,390 As of June 30, 2023 * $ 635,216 $ 9,613 $ 625,603 Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets IMS (UK) international product rights (2) 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 * (1) See Note 3. (2) In June 2023, the Company recorded an impairment related to its IMS (UK) international product rights in the amount of $2.7 million. The Company recorded the impairment in the cost of revenue line in its condensed consolidated statement of operations for the three and six months ended June 30, 2023 Goodwill The changes in the carrying amounts of goodwill are as follows: June 30, December 31, 2023 2022 (in thousands) Beginning balance $ 3,126 $ 3,313 Currency translation 39 (187) Ending balance $ 3,165 $ 3,126 Amortization As of June 30, 2023, the expected amortization expense for all intangible assets during the next five fiscal years ended December 31 and thereafter is as follows: (in thousands) 2023 $ 12,359 2024 24,718 2025 24,718 2026 24,718 2027 24,718 Thereafter 481,982 Total amortizable intangible assets 593,213 Indefinite-lived intangibles 32,390 Total intangibles (net of accumulated amortization) $ 625,603 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. BAQSIMI ® Product Rights As discussed in Note 3, in June 2023, the Company acquired the BAQSIMI ® ® ® . In determining the BAQSIMI ® |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2023 | |
Inventories | |
Inventories | Note 11. Inventories Inventories consist of the following: June 30, December 31, 2023 2022 (in thousands) Raw materials and supplies $ 44,630 $ 47,607 Work in process 31,771 37,090 Finished goods 28,216 18,887 Total inventories $ 104,617 $ 103,584 Charges of $8.3 million and $10.2 million were included in the cost of revenues in the Company’s condensed consolidated statements of operations for the three and six months ended June 30, 2023, respectively, to adjust the Company’s inventory and related firm purchase commitments to their net realizable value. For the three and six months ended June 30, 2022, charges of $0.6 million and $8.6 million were included in the cost of revenues, respectively, to adjust the Company’s inventory and related firm purchase commitments to their net realizable value. Losses on firm purchase commitments related to raw materials on order as of June 30, 2023 and December 31, 2022 were $4.5 million and $2.7 million, respectively, which are recorded in cost of revenues in the Company’s condensed consolidated statement of operations. |
Property, Plant, and Equipment
Property, Plant, and Equipment | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant, and Equipment. | |
Property, Plant, and Equipment | Note 12. Property, Plant, and Equipment Property, plant, and equipment consist of the following: June 30, December 31, 2023 2022 (in thousands) Buildings $ 131,438 $ 130,726 Leasehold improvements 31,535 31,535 Land 7,465 7,451 Machinery and equipment 257,722 208,068 Furniture, fixtures, and automobiles 30,693 29,674 Construction in progress 52,024 50,842 Total property, plant, and equipment 510,877 458,296 Less accumulated depreciation (232,351) (220,030) Total property, plant, and equipment, net $ 278,526 $ 238,266 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
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: June 30, December 31, 2023 2022 (in thousands) Accrued customer fees and rebates $ 17,764 $ 14,198 Accrued payroll and related benefits 24,912 22,847 Accrued product returns, current portion 13,845 14,867 Accrued loss on firm purchase commitments 5,187 2,686 Accrued payments for BAQSIMI ® 126,760 — Other accrued liabilities 10,236 9,143 Total accrued liabilities 198,704 63,741 Accounts payable 18,832 20,501 Total accounts payable and accrued liabilities $ 217,536 $ 84,242 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2023 | |
Debt | |
Debt | Note 14. Debt Debt consists of the following: June 30, December 31, 2023 2022 (in thousands) Term Loan Wells Fargo Bank Term Loan due June 2028 $ 500,000 $ — Capital One N.A. Term Loan paid off June 2023 — 68,250 Mortgage Loans Mortgage payable with East West Bank due June 2027 8,104 8,188 Other Loans and Payment Obligations French government loans due December 2026 212 204 Line of Credit Facilities Line of credit facility with China Merchant Bank expired April 2023 — — Wells Fargo Bank Revolving line of credit facility due June 2028 — — Capital One N.A. Revolving line of credit facility closed in June 2023 — — Equipment under Finance Leases 692 790 Total debt 509,008 77,432 Less current portion of long-term debt 12,920 3,046 Less: Loan issuance costs 7,808 1,547 Long-term debt, net of current portion and unamortized debt issuance costs $ 488,280 $ 72,839 Credit Agreements Syndicated Credit Agreement with Wells Fargo Bank, National Association - Due June 2028 In June 2023, in connection with the BAQSIMI ® ® The loan requires principal payments of $12.5 million for the first year, which increases to $25.0 million during the second year, and $37.5 million during the third, fourth and fifth years, with the remaining balance due at maturity. The loan is secured by substantially all of the Company’s U.S. assets. The Credit Agreement provides for a $200.0 million revolving credit facility, or the Wells Fargo Bank Revolving line of credit facility, with a $15.0 million letter of credit sublimit and a $15.0 million swingline loan sublimit, which bears the same interest rate as the term loan. In conjunction with the new credit agreement, the Company entered into an interest rate swap agreement with Wells Fargo, with a notional amount of $250.0 million to exchange the variable interest rate on the new term for a fixed rate of 4.04%. The interest swap agreement had a fair value of $1.8 million loss as of June 30, 2023. For lenders that were part of the previous credit agreement with Capital One N.A. as well as the new Credit Agreement, the transaction was accounted for as a modification under ASC 470-50, Debt Modifications and Extinguishments The Company incurred approximately $14.3 million in issuance costs in connection with this Credit Agreement, of which $3.0 million represented debt modification costs and were charged to interest expense in the Company’s condensed consolidated statement of operations for the three and six months ended June 30, 2023. Debt issuance costs associated with the Credit Agreement (other than its Revolving Credit Facility component) are presented as a reduction to the carrying value of the related debt, while debt issuance costs associated with the Revolving Credit Facility are capitalized within other long-term assets on the condensed consolidated balance sheets. Total unamortized debt issuance costs as of June 30, 2023 were $12.5 million which is being amortized over the term of the Credit Agreement using the effective interest rate method. Syndicated Credit Agreement with Capital One N.A. – Paid off June 2023 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, or the Capital One N.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 was 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. As a result of the credit agreement that the Company entered into with Wells Fargo in June 2023, the Company repaid all outstanding amounts under this loan. Amortization of debt issuance costs totaled $0.1 million and $0.2 million for the three and six months ended June 30, 2023, respectively. Amortization of debt issuance costs totaled $0.1 million and $0.2 million for the three and six months ended June 30, 2022, respectively. Interest Rate Swap Contracts As of June 30, 2023, 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 Wells Fargo Bank, 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. Changes in the fair values of interest rate swaps were $1.2 million loss and $2.2 million loss for the three and six months ended June 30, 2023, respectively. Changes in the fair values of interest rate swaps were $0.9 million gain and $3.9 million gain for the three and six months ended June 30, 2022, respectively. Covenants At June 30, 2023 and December 31, 2022, the Company was in compliance with all of its debt covenants. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Taxes | |
Income Taxes | Note 15. Income Taxes The following table sets forth the Company’s income tax provision for the periods indicated: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Income before taxes $ 32,808 $ 23,151 $ 66,377 $ 52,184 Income tax provision 6,383 5,551 13,135 9,628 Income before equity in losses of unconsolidated affiliate $ 26,425 $ 17,600 $ 53,242 $ 42,556 Income tax provision as a percentage of income before income taxes 19.5 % 24.0 % 19.8 % 18.5 % The change in the Company’s effective tax rate for the three and six months ended June 30, 2023, was primarily due to differences in pre-tax income positions and timing of discrete tax items. In connection with the purchase accounting for its acquisition of BAQSIMI ® 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 income in prior carryback periods, future reversal of existing deferred taxable temporary differences, tax-planning strategies, and projected future taxable income. During the three months ended June 30, 2023, the Company determined its U.K. subsidiaries, AUK and IMS UK, more likely than not would not realize the benefits of their deferred tax assets. Therefore, the Company recorded a valuation allowance expense of an immaterial amount and will discontinue recognizing income tax benefits until sufficient taxable income is generated to realize their deferred tax assets. 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. 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. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | Note 16. Stockholders' Equity Share Buyback Program Pursuant to the Company’s existing share buyback program, the Company purchased 3,585 and 266,716 shares of its common stock during the three and six months ended June 30, 2023, for total consideration of $0.1 million and $8.1 million, respectively. The Company purchased 189,840 and 241,008 shares of its common stock during the three and six months ended June 30, 2022, for total consideration of $6.1 million and $7.3 million, respectively. In November 2022, the Company’s Board of Directors authorized a $50.0 million increase to the Company’s share buyback program, which is expected to continue for an indefinite period of time. Since the inception of the program, 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. 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 condensed consolidated balance sheets. Amended and Restated 2015 Equity Incentive Plan As of June 30, 2023, the Company reserved an aggregate of 6,774,598 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. 2014 Employee Stock Purchase Plan As of June 30, 2023, the Company has issued 1,155,478 shares of common stock under the ESPP and 844,522 shares of its common stock remain available for issuance under the ESPP. In May 2023, the Company issued 65,933 shares at a purchase price of $25.52 per share under the ESPP. For the three and six months ended June 30, 2023, the Company recorded ESPP expense of $0.3 million and $0.6 million, respectively. For the three and six months ended June 30, 2022, the Company recorded ESPP expense of $0.2 million and $0.4 million, respectively. Share-Based Award Activity and Balances 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. The weighted-averages for key assumptions used in determining the fair value of options granted during the three and six months ended June 30, 2023 and 2022, are as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Average volatility 40.2 % 40.5 % 41.4 % 41.0 % Average risk-free interest rate 3.8 % 3.0 % 4.1 % 2.3 % Weighted-average expected life in years 4.9 4.8 6.2 6.1 Dividend yield rate — % — % — % — % A summary of option activity under all plans for the six months ended June 30, 2023, 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, 2022 7,929,150 $ 17.66 Options granted 759,350 35.83 Options exercised (642,019) 15.22 Options forfeited (4,526) 29.60 Options expired (500) 14.66 Outstanding as of June 30, 2023 8,041,455 $ 19.57 5.02 304,777 Exercisable as of June 30, 2023 5,945,056 $ 16.51 3.78 243,537 Vested and expected to vest as of June 30, 2023 7,814,400 $ 19.27 4.91 298,513 (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 June 30, 2023. For the three and six months ended June 30, 2023, the Company recorded expense of $2.3 million and $5.3 million, respectively, related to stock options granted under all plans. For the three and six months ended June 30, 2022, the Company recorded expense of $2.0 million and $4.5 million, respectively, related to stock options granted under all plans. Information relating to option grants and exercises is as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands, except per share data) Weighted-average grant date fair value per option share $ 17.77 $ 12.13 $ 16.76 $ 14.75 Intrinsic value of options exercised 16,575 6,510 18,916 18,710 Cash received from options exercised 8,350 4,469 9,738 16,919 Total fair value of the options vested during the period 1,136 1,004 8,720 7,990 A summary of the status of the Company’s non-vested options as of June 30, 2023, and changes during the six months ended June 30, 2023, are presented below: Weighted-Average Grant Date Options Fair Value Non-vested as of December 31, 2022 2,378,453 $ 9.48 Options granted 759,350 16.76 Options vested (1,036,878) 8.41 Options forfeited (4,526) 13.40 Non-vested as of June 30, 2023 2,096,399 12.64 As of June 30, 2023, there was $20.6 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 2.9 years and will be adjusted for future changes in estimated forfeitures. 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. For the three and six months ended June 30, 2023, the Company recorded total expenses of $2.2 million and $5.1 million, respectively, related to RSU awards granted under all plans. For the three and six months ended June 30, 2022, the Company recorded expenses of $2.0 million and $4.4 million, respectively, related to RSU awards granted under all plans. As of June 30, 2023, there was $21.8 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 2.8 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, 2022 1,007,052 RSUs granted 355,959 $ 12,715 RSUs forfeited (2,017) RSUs vested (2) (432,216) RSUs outstanding at June 30, 2023 928,778 (1) The total fair market value is derived from the number of RSUs granted times the current stock price on the date of grant. (2) Of the vested RSUs, 165,215 shares of common stock were surrendered to fulfill tax withholding obligations. Share-based Compensation Expense The Company recorded share-based compensation expense, which is included in the Company’s condensed consolidated statement of operations as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Cost of revenues $ 1,158 $ 938 $ 2,864 $ 2,323 Operating expenses: Selling, distribution, and marketing 227 194 436 362 General and administrative 2,991 2,718 6,348 5,579 Research and development 489 385 1,328 993 Total share-based compensation $ 4,865 $ 4,235 $ 10,976 $ 9,257 |
Employee Benefits
Employee Benefits | 6 Months Ended |
Jun. 30, 2023 | |
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 three and six months ended June 30, 2023 were approximately $0.6 million and $1.2 million, respectively, compared to the prior year expense of $0.5 million and $1.1 million for the three and six months ended June 30, 2022, 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 3.8% as of June 30, 2023 and December 31, 2022. The liability is included in other long-term liabilities in the accompanying condensed consolidated balance sheets. The plan is currently unfunded, and the benefit obligation under the plan was $2.3 million and $2.2 million at June 30, 2023 and December 31, 2022, respectively. The Company recorded an immaterial amount of expense under the plan for each of the three and six months ended June 30, 2023 and 2022. 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 $5.4 million and $4.5 million as of June 30, 2023 and December 31, 2022, respectively. The plan liabilities were valued at approximately $5.6 million and $4.6 million as of June 30, 2023, and December 31, 2022, respectively. The plan assets and liabilities are included in other long-term assets and other long-term liabilities, respectively, on the Company’s condensed consolidated balance sheets. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 18. Commitments and Contingencies Purchase Commitments As of June 30, 2023, the Company has entered into commitments to purchase equipment and raw materials for an aggregate amount of approximately $75.2 million. |
Related-Party Transactions
Related-Party Transactions | 6 Months Ended |
Jun. 30, 2023 | |
Related-Party Transactions | |
Related-Party Transactions | Note 19. Related Party Transactions Investment in Hanxin The Company has a 14% ownership in Hanxin that is accounted for as an equity method investment. The Company maintains a seat on Hanxin’s board of directors, and Henry Zhang, the son of Dr. Jack Zhang is an equity holder, the general manager, and the chairman of the board of directors of Hanxin. Additionally, Dr. Mary Luo and Dr. Jack Zhang, have an ownership interest in Hanxin through an affiliated entity. As a result, Hanxin is a related party. Contract manufacturing agreement with Hanxin In April 2022, ANP, entered into a contract manufacturing agreement with Hanxin, 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 three and six months ended June 30, 2023, the Company recognized an immaterial amount of revenue from manufacturing services provided to Hanxin. As of June 30, 2023, the Company had an immaterial 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. In March 2023, the Company amended the agreement with Hanxin, whereby Hanxin will perform scale-up manufacturing process development using the RCBs for the Company. Per the terms of the amended agreement the Company will own any confidential and proprietary information and technology produced during the scale-up manufacturing, which shall include engineering, scientific and practical information and formula, research data design and procedures and others to develop and manufacture the RCBs. The amendment agreement will remain in full force and effect until July 5, 2025. The total cost of the amended agreement to the Company shall not exceed approximately $0.5 million in additional payments beyond the $2.2 million in payments under the contract research agreement, with payments adjusted based on actual currency 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 three and six months ended June 30, 2023, the Company paid $0.4 million and $1.0 million, respectively, under this agreement and has accrued an additional $0.2 million payable to Hanxin as of June 30, 2023. Supply Agreement with Letop In November 2022, ANP, entered in to a supply agreement with Nanjing Letop Biotechnology Co., Ltd., or Letop, a subsidiary of Hanxin, whereby Letop will 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 three months ended June 30, 2023, ANP paid an immaterial not |
Litigation
Litigation | 6 Months Ended |
Jun. 30, 2023 | |
Litigation | |
Litigation | Note 20. Litigation 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 January 26, 2022, the Company and Astellas-Gilead reached an agreement to resolve the lawsuit. 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 condensed consolidated statement of operations for the six months ended June 30, 2022. 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) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries, and are prepared in accordance with GAAP. Certain prior period amounts have been reclassified within the operating activities of the condensed consolidated statements of cash flows to conform to the current period presentation. All intercompany activity has been eliminated in the preparation of the condensed consolidated financial statements. In the opinion of management, the accompanying unaudited condensed 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, (6) International Medication Systems (UK) Limited, or IMS UK, and (7) Amphastar Medication Co., LLC, or Amphastar Medication. |
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 condensed consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: fair value of acquired assets, 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 condensed 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 were a $0.1 million loss and a $0.5 million gain for the three and six months ended June 30, 2023, respectively. For the three and six months ended June 30, 2022, the unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature were a $2.1 million loss and a $2.7 million loss, 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. |
Acquisitions | Acquisition s The Company evaluates acquisitions and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and substantive processes that have the ability to create outputs, which would meet the definition of a business. Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis, with the exception of non-qualifying assets. Goodwill is not recognized in an asset acquisition. When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration, including assumed contingent considerations, is not recognized until all contingencies are resolved and the consideration is paid or becomes payable (unless contingent considerations meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired), at which point the consideration is allocated to the assets acquired based on their relative fair values at the acquisition date, with the exception of non-qualifying assets. Judgments are used in determining estimates of useful lives of long-lived assets. Useful life estimates are based on, among other factors, estimates of expected future net cash flows, the assessment of each asset’s life cycle, and the impact of competitive trends on each asset’s life cycle and other factors. These judgments can materially impact the estimates used to allocate purchase consideration to assets acquired and liabilities assumed, and the resulting timing and amounts charged to or recognized in current and future operating results. For these and other reasons, actual results may vary significantly from estimated results. |
Advertising Expense | Advertising Expense Advertising expenses, primarily associated with Primatene MIST ® |
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. From time to time, the Company 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 condensed consolidated statements of operations. As of June 30, 2023, the Company did not have any unsettled forward currency contracts to purchase foreign currency. 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 condensed 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 June 30, 2023 and December 31, 2022 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 and China. As of June 30, 2023 and December 31, 2022, the restricted cash balance was $2.7 million and $0.2 million, respectively. |
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 June 30, 2023 and December 31, 2022, the balance of restricted short-term investments was $2.2 million. |
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. |
Debt Issuance Costs | Debt Issuance Costs Debt issuance costs related to non-revolving debt are recognized as a reduction to the related debt balance in the accompanying condensed consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Debt issuance costs associated with revolving debt are capitalized within other long-term assets on the condensed consolidated balance sheets and are amortized to interest expense over the term of the related revolving debt. |
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. |
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 condensed consolidated financial statements. |
BAQSIMI Acquisition (Tables)
BAQSIMI Acquisition (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
BAQSIMI Acquisition | |
Summary of aggregate amount paid for assets acquired | Fair Value (in thousands) Cash payment $ 500,000 Fair value of deferred cash payment 121,699 Transaction costs 6,406 Total purchase price $ 628,105 |
Schedule of purchase price allocated to acquired assets | Fair Value (in thousands) Property, plant, and equipment $ 34,426 BAQSIMI ® 591,338 Deferred tax assets 2,341 Total assets acquired $ 628,105 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Revenue Recognition | |
Schedule of chargeback and rebates provision analysis | Six Months Ended June 30, 2023 2022 (in thousands) Beginning balance $ 26,606 $ 20,167 Provision for chargebacks and rebates 143,792 96,593 Credits and payments issued to third parties (141,584) (94,526) Ending balance $ 28,814 $ 22,234 |
Schedule of product return liability analysis | Six Months Ended June 30, 2023 2022 (in thousands) Beginning balance $ 19,451 $ 21,677 Provision for product returns 2,160 2,929 Credits issued to third parties (2,825) (3,341) Ending balance $ 18,786 $ 21,265 |
Net Income per Share (Tables)
Net Income per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Net Income per Share | |
Schedule of basic and diluted net income (loss) per share calculation | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands, except per share data) Basic and dilutive numerator: Net income $ 26,124 $ 17,346 $ 52,156 $ 41,599 Denominator: Weighted-average shares outstanding — basic 48,404 48,864 48,202 48,501 Net effect of dilutive securities: Incremental shares from equity awards 4,698 4,363 4,334 4,102 Weighted-average shares outstanding — diluted 53,102 53,227 52,536 52,603 Net income per share — basic $ 0.54 $ 0.35 $ 1.08 $ 0.86 Net income per share — diluted $ 0.49 $ 0.33 $ 0.99 $ 0.79 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Segment Reporting | |
Schedule of financial information by reporting segment | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Net revenues: Finished pharmaceutical products $ 142,866 $ 120,123 $ 278,876 $ 236,669 API 2,846 3,344 6,858 7,166 Total net revenues 145,712 123,467 285,734 243,835 Gross profit (loss): Finished pharmaceutical products 77,067 67,084 153,243 124,023 API (4,329) (3,728) (6,665) (4,841) Total gross profit 72,738 63,356 146,578 119,182 Operating expenses 35,842 38,533 76,249 72,745 Income from operations 36,896 24,823 70,329 46,437 Non-operating income (4,088) (1,672) (3,952) 5,747 Income before income taxes $ 32,808 $ 23,151 $ 66,377 $ 52,184 |
Schedule of net revenues in the finished pharmaceutical products segment | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Finished pharmaceutical products net revenues: Glucagon $ 27,276 $ 11,795 $ 52,972 $ 22,779 Primatene MIST ® 16,520 18,974 40,003 43,671 Epinephrine 16,714 18,119 36,805 33,275 Lidocaine 14,006 16,042 27,652 26,632 Phytonadione 17,855 13,381 25,568 23,856 Enoxaparin 7,872 9,031 17,739 19,155 Naloxone 5,102 7,193 10,059 14,606 Other finished pharmaceutical products 37,521 25,588 68,078 52,695 Total finished pharmaceutical products net revenues $ 142,866 $ 120,123 $ 278,876 $ 236,669 |
Schedule of depreciation and amortization expense by reporting segment | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Depreciation and amortization expense Finished pharmaceutical products $ 2,081 $ 2,059 $ 4,527 $ 3,853 API 982 937 1,935 1,885 Total depreciation and amortization expense $ 3,063 $ 2,996 $ 6,462 $ 5,738 |
Schedule of net revenues and carrying values of long-lived assets by geographic region | Net Revenue Long-Lived Assets Three Months Ended Six Months Ended June 30, June 30, June 30, December 31, 2023 2022 2023 2022 2023 2022 (in thousands) United States $ 143,895 $ 120,786 $ 281,853 $ 237,900 $ 768,988 $ 136,328 China 1,182 766 1,309 1,699 89,236 88,647 France 635 1,915 2,572 4,236 38,624 39,598 Total $ 145,712 $ 123,467 $ 285,734 $ 243,835 $ 896,848 $ 264,573 |
Customer and Supplier Concent_2
Customer and Supplier Concentration (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Customer and Supplier Concentration | |
Schedule of accounts receivable and net revenues by major customer | % of Total Accounts % of Net Receivable Revenue Three Months Ended Six Months Ended June 30, December 31, June 30, June 30, 2023 2022 2023 2022 2023 2022 McKesson 40 % 32 % 31 % 22 % 27 % 20 % AmerisourceBergen 13 % 16 % 21 % 24 % 22 % 23 % Cardinal Health 17 % 19 % 17 % 17 % 16 % 16 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 $ 92,576 $ 92,576 $ — $ — Restricted cash 2,684 2,684 — — Restricted short-term investments 2,200 — 2,200 — Corporate, agency and municipal bonds 14,433 — 14,433 — Interest rate swaps related to variable rate loans (1,526) — (1,526) — Fair value measurement as of June 30, 2023 $ 110,367 $ 95,260 $ 15,107 $ — Cash equivalents $ 130,199 $ 130,199 $ — $ — Restricted cash 235 235 — — Short-term investments 4,600 — 4,600 — Restricted short-term investments 2,200 — 2,200 — Corporate, agency and municipal bonds 14,931 — 14,931 — Interest rate swaps related to variable rate loans 6,048 — 6,048 — Fair value measurement as of December 31, 2022 $ 158,213 $ 130,434 $ 27,779 $ — |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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) $ 14,239 $ — $ (11) $ 14,228 Municipal bonds (due within 1 year) 205 — — 205 Total investments as of June 30, 2023 $ 14,444 $ — $ (11) $ 14,433 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 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 BAQSIMI ® (1) 24 $ 591,338 $ — $ 591,338 IMS (UK) international product rights (2) 10 8,462 8,462 — Patents 12 486 369 117 Land-use rights 39 2,540 782 1,758 Subtotal 23 602,826 9,613 593,213 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 3,165 — 3,165 Subtotal * 32,390 — 32,390 As of June 30, 2023 * $ 635,216 $ 9,613 $ 625,603 Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets IMS (UK) international product rights (2) 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 * (1) See Note 3. (2) In June 2023, the Company recorded an impairment related to its IMS (UK) international product rights in the amount of $2.7 million. The Company recorded the impairment in the cost of revenue line in its condensed consolidated statement of operations for the three and six months ended June 30, 2023 |
Schedule of changes in carrying amounts of goodwill | June 30, December 31, 2023 2022 (in thousands) Beginning balance $ 3,126 $ 3,313 Currency translation 39 (187) Ending balance $ 3,165 $ 3,126 |
Schedule of finite-lived intangible assets, future amortization expense | (in thousands) 2023 $ 12,359 2024 24,718 2025 24,718 2026 24,718 2027 24,718 Thereafter 481,982 Total amortizable intangible assets 593,213 Indefinite-lived intangibles 32,390 Total intangibles (net of accumulated amortization) $ 625,603 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventories | |
Schedule of inventories | June 30, December 31, 2023 2022 (in thousands) Raw materials and supplies $ 44,630 $ 47,607 Work in process 31,771 37,090 Finished goods 28,216 18,887 Total inventories $ 104,617 $ 103,584 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant, and Equipment. | |
Schedule of property, plant, and equipment | June 30, December 31, 2023 2022 (in thousands) Buildings $ 131,438 $ 130,726 Leasehold improvements 31,535 31,535 Land 7,465 7,451 Machinery and equipment 257,722 208,068 Furniture, fixtures, and automobiles 30,693 29,674 Construction in progress 52,024 50,842 Total property, plant, and equipment 510,877 458,296 Less accumulated depreciation (232,351) (220,030) Total property, plant, and equipment, net $ 278,526 $ 238,266 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounts Payable and Accrued Liabilities. | |
Schedule of accounts payable and accrued liabilities | June 30, December 31, 2023 2022 (in thousands) Accrued customer fees and rebates $ 17,764 $ 14,198 Accrued payroll and related benefits 24,912 22,847 Accrued product returns, current portion 13,845 14,867 Accrued loss on firm purchase commitments 5,187 2,686 Accrued payments for BAQSIMI ® 126,760 — Other accrued liabilities 10,236 9,143 Total accrued liabilities 198,704 63,741 Accounts payable 18,832 20,501 Total accounts payable and accrued liabilities $ 217,536 $ 84,242 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt | |
Schedule of debt | June 30, December 31, 2023 2022 (in thousands) Term Loan Wells Fargo Bank Term Loan due June 2028 $ 500,000 $ — Capital One N.A. Term Loan paid off June 2023 — 68,250 Mortgage Loans Mortgage payable with East West Bank due June 2027 8,104 8,188 Other Loans and Payment Obligations French government loans due December 2026 212 204 Line of Credit Facilities Line of credit facility with China Merchant Bank expired April 2023 — — Wells Fargo Bank Revolving line of credit facility due June 2028 — — Capital One N.A. Revolving line of credit facility closed in June 2023 — — Equipment under Finance Leases 692 790 Total debt 509,008 77,432 Less current portion of long-term debt 12,920 3,046 Less: Loan issuance costs 7,808 1,547 Long-term debt, net of current portion and unamortized debt issuance costs $ 488,280 $ 72,839 |
Income Taxes (Tables)
Income Taxes (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Income Taxes | |
Summary of provision (benefit) for income taxes | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Income before taxes $ 32,808 $ 23,151 $ 66,377 $ 52,184 Income tax provision 6,383 5,551 13,135 9,628 Income before equity in losses of unconsolidated affiliate $ 26,425 $ 17,600 $ 53,242 $ 42,556 Income tax provision as a percentage of income before income taxes 19.5 % 24.0 % 19.8 % 18.5 % |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity | |
Schedule of key assumptions to determine fair value of options | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Average volatility 40.2 % 40.5 % 41.4 % 41.0 % Average risk-free interest rate 3.8 % 3.0 % 4.1 % 2.3 % Weighted-average expected life in years 4.9 4.8 6.2 6.1 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, 2022 7,929,150 $ 17.66 Options granted 759,350 35.83 Options exercised (642,019) 15.22 Options forfeited (4,526) 29.60 Options expired (500) 14.66 Outstanding as of June 30, 2023 8,041,455 $ 19.57 5.02 304,777 Exercisable as of June 30, 2023 5,945,056 $ 16.51 3.78 243,537 Vested and expected to vest as of June 30, 2023 7,814,400 $ 19.27 4.91 298,513 (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 June 30, 2023. |
Schedule of information relating to options grants | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands, except per share data) Weighted-average grant date fair value per option share $ 17.77 $ 12.13 $ 16.76 $ 14.75 Intrinsic value of options exercised 16,575 6,510 18,916 18,710 Cash received from options exercised 8,350 4,469 9,738 16,919 Total fair value of the options vested during the period 1,136 1,004 8,720 7,990 |
Schedule of the summary of nonvested options status | Weighted-Average Grant Date Options Fair Value Non-vested as of December 31, 2022 2,378,453 $ 9.48 Options granted 759,350 16.76 Options vested (1,036,878) 8.41 Options forfeited (4,526) 13.40 Non-vested as of June 30, 2023 2,096,399 12.64 |
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, 2022 1,007,052 RSUs granted 355,959 $ 12,715 RSUs forfeited (2,017) RSUs vested (2) (432,216) RSUs outstanding at June 30, 2023 928,778 (1) The total fair market value is derived from the number of RSUs granted times the current stock price on the date of grant. (2) Of the vested RSUs, 165,215 shares of common stock were surrendered to fulfill tax withholding obligations. |
Schedule of recorded share-based compensation expense under all plans | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) Cost of revenues $ 1,158 $ 938 $ 2,864 $ 2,323 Operating expenses: Selling, distribution, and marketing 227 194 436 362 General and administrative 2,991 2,718 6,348 5,579 Research and development 489 385 1,328 993 Total share-based compensation $ 4,865 $ 4,235 $ 10,976 $ 9,257 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Gains and (losses) of intercompany foreign currency transactions | $ (100) | $ (2,100) | $ 500 | $ (2,700) | |
Selling, distribution, and marketing | 6,718 | 5,756 | 13,827 | 11,275 | |
Forward Currency Contracts Liabilities | 0 | 0 | $ 200 | ||
Restricted cash | 2,685 | 2,685 | 235 | ||
Certificates of deposit | 2,200 | 2,200 | $ 2,200 | ||
Finished Pharmaceutical Products Segment [Member] | Primatene Mist | |||||
Advertising expense | $ 2,900 | $ 2,500 | $ 6,200 | $ 4,900 |
BAQSIMI Acquisition (Narrative)
BAQSIMI Acquisition (Narrative) (Details) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2023 USD ($) | Apr. 21, 2023 USD ($) payment | Jun. 30, 2023 USD ($) | Dec. 31, 2022 | |
Asset Acquisition [Line Items] | ||||
Useful life of intangibles | 23 years | 23 years | 11 years | |
Wells Fargo Bank | Letter of Credit | ||||
Asset Acquisition [Line Items] | ||||
Maximum borrowing capacity | $ 15,000 | $ 15,000 | ||
Wells Fargo Bank | Swingline Loan | ||||
Asset Acquisition [Line Items] | ||||
Maximum borrowing capacity | 15,000 | 15,000 | ||
Wells Fargo Bank | Secured Debt [Member] | ||||
Asset Acquisition [Line Items] | ||||
Proceeds from borrowing under lines of credit | 500,000 | |||
Wells Fargo Bank | Secured Debt [Member] | Senior secured revolving credit facility | ||||
Asset Acquisition [Line Items] | ||||
Maximum borrowing capacity | 200,000 | 200,000 | ||
Wells Fargo Bank | Secured Debt [Member] | Letter of Credit | ||||
Asset Acquisition [Line Items] | ||||
Maximum borrowing capacity | 15,000 | 15,000 | ||
Wells Fargo Bank | Secured Debt [Member] | Swingline Loan | ||||
Asset Acquisition [Line Items] | ||||
Maximum borrowing capacity | 15,000 | $ 15,000 | ||
BAQSIMI product rights | ||||
Asset Acquisition [Line Items] | ||||
Estimated useful life of acquired intangible asset | 24 years | |||
Cash payment | $ 500,000 | |||
Contingent consideration | 450,000 | |||
Earnout obligations | 125,000 | |||
Deferred payment including accrued interest | $ 129,000 | |||
Interest expense accretion period | 1 year | |||
Asset Acquisition Transaction Cost | 6,406 | |||
BAQSIMI product rights | Maximum | ||||
Asset Acquisition [Line Items] | ||||
Payment period following transaction closing | 18 months | |||
BAQSIMI product rights | Maximum | Manufacturing Services Agreement | ||||
Asset Acquisition [Line Items] | ||||
Agreement term | 18 months | |||
BAQSIMI product rights | Maximum | Transition Services Agreement | ||||
Asset Acquisition [Line Items] | ||||
Agreement term | 18 months | |||
BAQSIMI product rights | Wells Fargo Bank | Secured Debt [Member] | ||||
Asset Acquisition [Line Items] | ||||
Principal amount | 700,000 | $ 700,000 | ||
Aggregate principal amount | $ 700,000 | $ 700,000 | ||
BAQSIMI product rights | Payment on the first anniversary of the closing | ||||
Asset Acquisition [Line Items] | ||||
Guaranteed payment payable | 125,000 | |||
BAQSIMI product rights | Payment after the first anniversary of the closing, but no later than 18 months after the closing | ||||
Asset Acquisition [Line Items] | ||||
Guaranteed payment payable | 4,000 | |||
BAQSIMI product rights | Asset Acquisition, Contingent Consideration, Sales Milestone Achievement One [Member] | ||||
Asset Acquisition [Line Items] | ||||
Threshold of annual sales milestone | $ 175,000 | |||
Period after closing considered for achievement of sales milestone | 5 years | |||
Asset Acquisition Transaction Cost | $ 100,000 | |||
BAQSIMI product rights | Asset Acquisition, Contingent Consideration, Sales Milestone Achievement Two [Member] | ||||
Asset Acquisition [Line Items] | ||||
Contingent consideration | $ 100,000 | |||
Period after closing considered for achievement of sales milestone | 5 years | |||
Number of potential contingent consideration payments | payment | 2 | |||
Threshold annual net sales milestone achievement for payment of earnout liability | $ 200,000 | |||
BAQSIMI product rights | Asset Acquisition, Contingent Consideration, Sales Milestone Achievement Three [Member] | ||||
Asset Acquisition [Line Items] | ||||
Contingent consideration | 150,000 | |||
Threshold of annual sales milestone | $ 950,000 | |||
Period after closing considered for achievement of sales milestone | 5 years | |||
BAQSIMI product rights | Asset Acquisition, Earnout Liability, Sales Milestone Achievement One [Member] | ||||
Asset Acquisition [Line Items] | ||||
Threshold annual net sales milestone achievement for payment of earnout liability | $ 350,000 | |||
BAQSIMI product rights | Asset Acquisition, Earnout Liability, Sales Milestone Achievement Two [Member] | ||||
Asset Acquisition [Line Items] | ||||
Threshold annual net sales milestone achievement for payment of earnout liability | 400,000 | |||
BAQSIMI product rights | Asset Acquisition, Earnout Liability, Sales Milestone Achievement Three [Member] | ||||
Asset Acquisition [Line Items] | ||||
Threshold annual net sales milestone achievement for payment of earnout liability | $ 600,000 |
BAQSIMI Acquisition (Aggregate
BAQSIMI Acquisition (Aggregate Amount Paid for Assets Acquired) (Details) - BAQSIMI product rights $ in Thousands | Apr. 21, 2023 USD ($) |
Asset Acquisition [Line Items] | |
Cash payment | $ 500,000 |
Fair value of deferred cash payment | 121,699 |
Transaction costs | 6,406 |
Total purchase price | $ 628,105 |
Disclosure - BAQSIMI Acquisitio
Disclosure - BAQSIMI Acquisition (Purchase Price Allocated to Acquired Assets) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Apr. 21, 2023 | Dec. 31, 2022 |
Asset Acquisition [Line Items] | |||
Property, plant, and equipment | $ 278,526 | $ 238,266 | |
BAQSIMI product rights | |||
Asset Acquisition [Line Items] | |||
Property, plant, and equipment | $ 34,426 | ||
BAQSIMI product rights | 591,338 | ||
Deferred tax assets | 2,341 | ||
Total assets acquired | $ 628,105 |
Revenue Recognition (Analysis o
Revenue Recognition (Analysis of the Chargeback Provision) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Revenue | $ 145,712 | $ 123,467 | $ 285,734 | $ 243,835 | |
Beginning balance | 26,606 | 20,167 | $ 20,167 | ||
Provision for chargebacks and rebates | 143,792 | 96,593 | |||
Credits and payments issued to third parties | (141,584) | (94,526) | |||
Ending balance | 28,814 | 22,234 | 28,814 | 22,234 | 26,606 |
Research and development services | ANP | |||||
Revenue | $ 1,200 | $ 700 | 1,300 | $ 1,300 | |
Accounts Receivable, Net | |||||
Provision for chargebacks and rebates | 21,800 | 20,500 | |||
Accounts Payable and Accrued Liabilities | |||||
Provision for chargebacks and rebates | $ 7,000 | $ 6,100 |
Revenue Recognition (Analysis_2
Revenue Recognition (Analysis of Product Return Liability) (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Aggregate product return rate | 1.20% | 1.60% | |
Return accrual included in accounts payable and accrued liabilities | $ 13,845 | $ 14,867 | |
Return accrual included in other long-term liabilities | 5,000 | $ 4,600 | |
Product returns | |||
Beginning balance | 19,451 | $ 21,677 | |
Provision for product returns | 2,160 | 2,929 | |
Credits issued to third parties | (2,825) | (3,341) | |
Ending balance | $ 18,786 | $ 21,265 |
Net Income per Share (Narrative
Net Income per Share (Narrative) (Details) - Employee and Non-Employee Stock Options [Member] - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Shares | 45,464 | 12,296 | 45,464 | 706,411 |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Exercise Price of Excluded Securities | $ 46.01 | $ 37.41 | $ 46.01 | $ 34.79 |
Net Income per Share (Calculati
Net Income per Share (Calculation of Basic and Diluted Net Income (Loss) Per Share) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Basic and dilutive numerator: | ||||||
Net Income (Loss) | $ 26,124 | $ 26,032 | $ 17,346 | $ 24,253 | $ 52,156 | $ 41,599 |
Denominator: | ||||||
Weighted-average shares outstanding-basic | 48,404 | 48,864 | 48,202 | 48,501 | ||
Net effect of dilutive securities: | ||||||
Incremental shares from equity awards | 4,698 | 4,363 | 4,334 | 4,102 | ||
Weighted-average shares outstanding - diluted | 53,102 | 53,227 | 52,536 | 52,603 | ||
Net income (loss) per share - basic | $ 0.54 | $ 0.35 | $ 1.08 | $ 0.86 | ||
Net income (loss) per share - diluted | $ 0.49 | $ 0.33 | $ 0.99 | $ 0.79 |
Segment Reporting (Selected Fin
Segment Reporting (Selected Financial Information by Reporting Segment) (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) segment | Jun. 30, 2022 USD ($) | |
Segment Reporting Information [Line Items] | ||||
Number of Reportable Segments | segment | 2 | |||
Net revenues: | ||||
Net revenues | $ 145,712 | $ 123,467 | $ 285,734 | $ 243,835 |
Gross profit (loss): | ||||
Gross Profit | 72,738 | 63,356 | 146,578 | 119,182 |
Operating expenses | 35,842 | 38,533 | 76,249 | 72,745 |
Income from operations | 36,896 | 24,823 | 70,329 | 46,437 |
Non-operating income (expenses) | (4,088) | (1,672) | (3,952) | 5,747 |
Income (loss) before income taxes | 32,808 | 23,151 | 66,377 | 52,184 |
Finished Pharmaceutical Products Segment [Member] | ||||
Net revenues: | ||||
Net revenues | 142,866 | 120,123 | 278,876 | 236,669 |
Gross profit (loss): | ||||
Gross Profit | 77,067 | 67,084 | 153,243 | 124,023 |
Active Pharmaceutical Ingredient Segment [Member] | ||||
Net revenues: | ||||
Net revenues | 2,846 | 3,344 | 6,858 | 7,166 |
Gross profit (loss): | ||||
Gross Profit | $ (4,329) | $ (3,728) | $ (6,665) | $ (4,841) |
Segment Reporting (Summary of N
Segment Reporting (Summary of Net Revenues by Product Segment) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | $ 145,712 | $ 123,467 | $ 285,734 | $ 243,835 |
Finished Pharmaceutical Products Segment [Member] | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | 142,866 | 120,123 | 278,876 | 236,669 |
Finished Pharmaceutical Products Segment [Member] | Enoxaparin [Member] | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | 7,872 | 9,031 | 17,739 | 19,155 |
Finished Pharmaceutical Products Segment [Member] | Lidocaine | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | 14,006 | 16,042 | 27,652 | 26,632 |
Finished Pharmaceutical Products Segment [Member] | Phytonadione | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | 17,855 | 13,381 | 25,568 | 23,856 |
Finished Pharmaceutical Products Segment [Member] | Naloxone | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | 5,102 | 7,193 | 10,059 | 14,606 |
Finished Pharmaceutical Products Segment [Member] | Epinephrine | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | 16,714 | 18,119 | 36,805 | 33,275 |
Finished Pharmaceutical Products Segment [Member] | Primatene Mist | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | 16,520 | 18,974 | 40,003 | 43,671 |
Finished Pharmaceutical Products Segment [Member] | Glucagon | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | 27,276 | 11,795 | 52,972 | 22,779 |
Finished Pharmaceutical Products Segment [Member] | Other Finished Pharmaceutical Products | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net revenues | $ 37,521 | $ 25,588 | $ 68,078 | $ 52,695 |
Segment Reporting (Depreciation
Segment Reporting (Depreciation and Amortization Expense by Reporting Segment) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Segment Reporting Information [Line Items] | ||||
Depreciation and amortization expense | $ 3,063 | $ 2,996 | $ 6,462 | $ 5,738 |
Finished Pharmaceutical Products Segment [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Depreciation and amortization expense | 2,081 | 2,059 | 4,527 | 3,853 |
Active Pharmaceutical Ingredient Segment [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Depreciation and amortization expense | $ 982 | $ 937 | $ 1,935 | $ 1,885 |
Segment Reporting (Summary of R
Segment Reporting (Summary of Revenues and Long-Lived Assets by Geographic Region) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net revenues | $ 145,712 | $ 123,467 | $ 285,734 | $ 243,835 | |
Long-Lived Assets | 896,848 | 896,848 | $ 264,573 | ||
UNITED STATES | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net revenues | 143,895 | 120,786 | 281,853 | 237,900 | |
Long-Lived Assets | 768,988 | 768,988 | 136,328 | ||
CHINA | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net revenues | 1,182 | 766 | 1,309 | 1,699 | |
Long-Lived Assets | 89,236 | 89,236 | 88,647 | ||
FRANCE | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net revenues | 635 | $ 1,915 | 2,572 | $ 4,236 | |
Long-Lived Assets | $ 38,624 | $ 38,624 | $ 39,598 |
Customer and Supplier Concent_3
Customer and Supplier Concentration (Details) - Customer Concentration Risk [Member] - item | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
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 | 3 | 3 | |||
Net Revenue | |||||
Revenue, Major Customer [Line Items] | |||||
Number of major customers | 3 | 3 | 3 | 3 | |
AmerisourceBergen [Member] | Accounts Receivable, Net | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 13% | 16% | |||
AmerisourceBergen [Member] | Net Revenue | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 21% | 24% | 22% | 23% | |
Cardinal Health [Member] | Accounts Receivable, Net | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 17% | 19% | |||
Cardinal Health [Member] | Net Revenue | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 17% | 17% | 16% | 16% | |
McKesson [Member] | Accounts Receivable, Net | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 40% | 32% | |||
McKesson [Member] | Net Revenue | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 31% | 22% | 27% | 20% |
Fair Value Measurements (Fair V
Fair Value Measurements (Fair Values of the Company's Financial Assets and Liabilities) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Forward Currency Contracts Liabilities | $ 0 | $ 200 |
Recurring Basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate, agency and municipal bonds | 14,433 | 14,931 |
Fair value measurement | 110,367 | 158,213 |
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 | (1,526) | 6,048 |
Recurring Basis | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 4,600 | |
Restricted short-term investments | 2,200 | 2,200 |
Recurring Basis | Money market | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 92,576 | 130,199 |
Restricted cash | 2,684 | 235 |
Level 1 | Recurring Basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value measurement | 95,260 | 130,434 |
Level 1 | Recurring Basis | Money market | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 92,576 | 130,199 |
Restricted cash | 2,684 | 235 |
Level 2 | Recurring Basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate, agency and municipal bonds | 14,433 | 14,931 |
Fair value measurement | 15,107 | 27,779 |
Level 2 | 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 | (1,526) | 6,048 |
Level 2 | Recurring Basis | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 4,600 | |
Restricted short-term investments | $ 2,200 | $ 2,200 |
Investments (Held-to-Maturity)
Investments (Held-to-Maturity) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost | $ 14,444 | $ 23,515 |
Gross Unrealized Losses | (11) | (62) |
Fair Value | 14,433 | 23,453 |
Corporate and Agency Bonds (due within 1 year) | ||
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost | 14,239 | 21,612 |
Gross Unrealized Losses | (11) | (60) |
Fair Value | 14,228 | 21,552 |
Municipal Bonds [Member] | ||
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost | 205 | 1,903 |
Gross Unrealized Losses | (2) | |
Fair Value | $ 205 | $ 1,901 |
Investments (Equity Method Inve
Investments (Equity Method Investment) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Restructuring and Related Cost | ||||
Equity in losses of unconsolidated affiliates | $ (301) | $ (254) | $ (1,086) | $ (957) |
Hanxin | ||||
Restructuring and Related Cost | ||||
Equity in losses of unconsolidated affiliates | $ 300 | $ 300 | $ 1,100 | $ 1,000 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets (Summary of Intangible Assets) (Details) - USD ($) $ in Thousands | 6 Months Ended | |||
Apr. 21, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Definite-lived intangible assets | ||||
Weighted-Average Life (Years) | 23 years | 11 years | ||
Finite-Lived Intangible Assets, Gross | $ 602,826 | $ 11,488 | ||
Accumulated Amortization | 9,613 | 6,541 | ||
Finite-Lived Intangible Assets, Net | 593,213 | 4,947 | ||
Indefinite-lived intangible assets | ||||
Goodwill recognized | 3,165 | 3,126 | $ 3,313 | |
Subtotal, Original Cost | 32,390 | 32,351 | ||
Subtotal, Net Book Value | 32,390 | 32,351 | ||
Balance, Original Cost | 635,216 | 43,839 | ||
Balance, Net Book Value | 625,603 | 37,298 | ||
Impairment of Long-Lived Assets to be Disposed of | 2,700 | |||
Finished Pharmaceutical Products Segment [Member] | ||||
Indefinite-lived intangible assets | ||||
Goodwill recognized | 3,165 | 3,126 | ||
Trademarks | ||||
Indefinite-lived intangible assets | ||||
Indefinite-lived intangible assets | $ 29,225 | $ 29,225 | ||
BAQSIMI product rights | ||||
Definite-lived intangible assets | ||||
Weighted-Average Life (Years) | 24 years | |||
Finite-Lived Intangible Assets, Gross | $ 591,338 | |||
Finite-Lived Intangible Assets, Net | $ 591,338 | |||
Indefinite-lived intangible assets | ||||
Estimated useful life of acquired intangible asset | 24 years | |||
Patents | ||||
Definite-lived intangible assets | ||||
Weighted-Average Life (Years) | 12 years | 12 years | ||
Finite-Lived Intangible Assets, Gross | $ 486 | $ 486 | ||
Accumulated Amortization | 369 | 362 | ||
Finite-Lived Intangible Assets, Net | $ 117 | $ 124 | ||
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 | 782 | 749 | ||
Finite-Lived Intangible Assets, Net | 1,758 | $ 1,791 | ||
International Medication Systems (UK) Limited | Acquired international product rights | ||||
Indefinite-lived intangible assets | ||||
Impairment of Long-Lived Assets to be Disposed of | $ 2,700 | |||
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 | $ 8,462 | ||
Accumulated Amortization | $ 8,462 | 5,430 | ||
Finite-Lived Intangible Assets, Net | $ 3,032 | |||
BAQSIMI product rights | ||||
Indefinite-lived intangible assets | ||||
Payment to acquire assets | $ 500,000 | |||
Estimated useful life of acquired intangible asset | 24 years |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets (Summary of Changes in the Carrying Amount of Goodwill) (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Goodwill and Intangible Assets | ||
Beginning balance | $ 3,126 | $ 3,313 |
Currency translation and other adjustments | 39 | (187) |
Ending balance | $ 3,165 | $ 3,126 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets (Summary of Expected Amortization Expense) (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Goodwill and Intangible Assets | |||
2023 | $ 12,359 | ||
2024 | 24,718 | ||
2025 | 24,718 | ||
2026 | 24,718 | ||
2027 | 24,718 | ||
Thereafter | 481,982 | ||
Finite-Lived Intangible Assets, Net | 593,213 | $ 4,947 | |
Indefinite-lived intangibles | 32,390 | ||
Balance, Net Book Value | 625,603 | $ 37,298 | |
Amortization expense | $ 471 | $ 504 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Raw materials and supplies | $ 44,630 | $ 44,630 | $ 47,607 | ||
Work in process | 31,771 | 31,771 | 37,090 | ||
Finished goods | 28,216 | 28,216 | 18,887 | ||
Total inventory, net | 104,617 | 104,617 | 103,584 | ||
Inventory adjustment to reflect net realizable value | $ 8,300 | $ 600 | $ 10,200 | $ 8,600 | |
Enoxaparin [Member] | |||||
Inventory, Firm Purchase Commitment, Loss | $ 4,500 | $ 2,700 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment (Summary of Property, Plant, and Equipment) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 510,877 | $ 458,296 |
Less accumulated depreciation and amortization | (232,351) | (220,030) |
Total property, plant, and equipment, net | 278,526 | 238,266 |
Building [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 131,438 | 130,726 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 31,535 | 31,535 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 7,465 | 7,451 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 257,722 | 208,068 |
Furniture, fixtures, and automobiles | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 30,693 | 29,674 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 52,024 | $ 50,842 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accounts Payable and Accrued Liabilities. | ||
Accrued customer fees and rebates | $ 17,764 | $ 14,198 |
Accrued payroll and related benefits | 24,912 | 22,847 |
Accrued product returns, current portion | 13,845 | 14,867 |
Accrued loss on firm purchase commitments | 5,187 | 2,686 |
Accrued payments for BAQSIMI | 126,760 | |
Other accrued liabilities | 10,236 | 9,143 |
Total accrued liabilities | 198,704 | 63,741 |
Accounts payable | 18,832 | 20,501 |
Total accounts payable and accrued liabilities | $ 217,536 | $ 84,242 |
Debt (Schedule of Debt) (Detail
Debt (Schedule of Debt) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Instrument | ||||
Unamortized Debt Issuance Expense | $ 7,808 | $ 1,547 | ||
Equipment under Finance Leases | 692 | 790 | ||
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Long-term debt, net of current portion and unamortized debt issuance costs | Long-term debt, net of current portion and unamortized debt issuance costs | ||
Total debt | 509,008 | 77,432 | ||
Less current portion of long-term debt and finance leases | 12,920 | 3,046 | ||
Long-term debt, net of current portion and unamortized debt issuance costs | 488,280 | 72,839 | ||
Wells Fargo Bank | Secured Debt [Member] | ||||
Debt Instrument | ||||
Unamortized Debt Issuance Expense | 12,500 | |||
Line of Credit - Due March 2023 | China Merchant Bank | Line of Credit [Member] | ||||
Debt Instrument | ||||
Long Term Debt | 0 | 0 | ||
Term Loan - paid off June 2023 | Capital One, N.A. | ||||
Debt Instrument | ||||
Long Term Debt | 68,250 | |||
Term Loan - Due June 2028 | Wells Fargo Bank | ||||
Debt Instrument | ||||
Long Term Debt | 500,000 | |||
Mortgage Payable - Due June 2027 | East West Bank [Member] | ||||
Debt Instrument | ||||
Long Term Debt | 8,104 | 8,188 | ||
French Government Loan 4 - Due December 2026 | Seine-Normandie Water Agency [Member] | ||||
Debt Instrument | ||||
Long Term Debt | 212 | 204 | ||
Revolving line of credit - closed in June 2023 | Capital One, N.A. | Revolving Credit Facility | ||||
Debt Instrument | ||||
Long Term Debt | $ 0 | $ 0 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 | Aug. 04, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Debt | |||||||
Unamortized debt issuance costs | $ 7,808,000 | $ 7,808,000 | $ 7,808,000 | $ 1,547,000 | |||
Amortization of debt issuance costs and debt modification costs | 3,249,000 | $ 192,000 | |||||
Interest rate swaps | |||||||
Debt | |||||||
Gains (losses) from changes in fair values of interest rate swaps | (1,200,000) | $ 900,000 | (2,200,000) | 3,900,000 | |||
Secured Debt [Member] | Wells Fargo Bank | |||||||
Debt | |||||||
Proceeds from borrowing under lines of credit | 500,000,000 | ||||||
Amortization of debt issuance costs and debt modification costs | 3,000,000 | 3,000,000 | |||||
Line of Credit [Member] | Capital One, N.A. | |||||||
Debt | |||||||
Maximum borrowing capacity | $ 140,000,000 | ||||||
Borrowings | $ 70,000,000 | ||||||
Secured Debt [Member] | Capital One, N.A. | |||||||
Debt | |||||||
Amortization of debt issuance costs and debt modification costs | $ 100,000 | $ 200,000 | |||||
Secured Debt [Member] | Wells Fargo Bank | |||||||
Debt | |||||||
Principal amount | 700,000,000 | 700,000,000 | 700,000,000 | ||||
Proceeds from borrowing under lines of credit | 500,000,000 | ||||||
Notional Amount | 250,000,000 | 250,000,000 | 250,000,000 | ||||
Interest rate swap, fair value | 4.04 | 4.04 | 4.04 | ||||
Loan issuance costs | 14,300,000 | 14,300,000 | 14,300,000 | ||||
Unamortized debt issuance costs | 12,500,000 | 12,500,000 | 12,500,000 | ||||
Amortization of debt issuance costs and debt modification costs | 100,000 | 200,000 | |||||
Secured Debt [Member] | Wells Fargo Bank | In the first year | |||||||
Debt | |||||||
Debt Instrument, Annual Principal Payment | 12,500,000 | 12,500,000 | 12,500,000 | ||||
Secured Debt [Member] | Wells Fargo Bank | Starting in the Second year | |||||||
Debt | |||||||
Debt Instrument, Annual Principal Payment | 25,000,000 | 25,000,000 | 25,000,000 | ||||
Secured Debt [Member] | Wells Fargo Bank | Starting in the third year | |||||||
Debt | |||||||
Debt Instrument, Annual Principal Payment | 37,500,000 | 37,500,000 | 37,500,000 | ||||
Secured Debt [Member] | Wells Fargo Bank | Interest rate swaps | |||||||
Debt | |||||||
Gains (losses) from changes in fair values of interest rate swaps | (1,800,000) | ||||||
Secured Debt [Member] | Revolving Credit Facility | Wells Fargo Bank | |||||||
Debt | |||||||
Maximum borrowing capacity | 200,000,000 | 200,000,000 | 200,000,000 | ||||
Letter of Credit | Wells Fargo Bank | |||||||
Debt | |||||||
Maximum borrowing capacity | 15,000,000 | 15,000,000 | 15,000,000 | ||||
Letter of Credit | Secured Debt [Member] | Wells Fargo Bank | |||||||
Debt | |||||||
Maximum borrowing capacity | 15,000,000 | 15,000,000 | 15,000,000 | ||||
Swingline Loan | Wells Fargo Bank | |||||||
Debt | |||||||
Maximum borrowing capacity | 15,000,000 | 15,000,000 | 15,000,000 | ||||
Swingline Loan | Secured Debt [Member] | Wells Fargo Bank | |||||||
Debt | |||||||
Maximum borrowing capacity | $ 15,000,000 | $ 15,000,000 | $ 15,000,000 | ||||
Minimum | Line of Credit [Member] | Secured Debt [Member] | Capital One, N.A. | |||||||
Debt | |||||||
Debt Instrument, Basis Spread on Variable Rate | 0.50% | ||||||
Minimum | Secured Debt [Member] | Wells Fargo Bank | |||||||
Debt | |||||||
Debt Instrument, Basis Spread on Variable Rate | 0.50% | ||||||
Maximum | Line of Credit [Member] | Secured Debt [Member] | Capital One, N.A. | |||||||
Debt | |||||||
Debt Instrument, Basis Spread on Variable Rate | 2.50% | ||||||
Maximum | Secured Debt [Member] | Wells Fargo Bank | |||||||
Debt | |||||||
Debt Instrument, Basis Spread on Variable Rate | 2.50% |
Income Taxes (Summary of Income
Income Taxes (Summary of Income (Loss) Before Income Taxes) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income (loss) before income taxes: | ||||
Income (loss) before income taxes | $ 32,808 | $ 23,151 | $ 66,377 | $ 52,184 |
Income tax provision | 6,383 | 5,551 | 13,135 | 9,628 |
Income before equity in losses of unconsolidated affiliate | $ 26,425 | $ 17,600 | $ 53,242 | $ 42,556 |
Income tax provision as a percentage of income before income taxes | 19.50% | 24% | 19.80% | 18.50% |
BAQSIMI product rights | ||||
Income (loss) before income taxes: | ||||
Deferred tax asset | $ 2,300 | $ 2,300 |
Stockholders' Equity (Share Buy
Stockholders' Equity (Share Buyback Program) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Nov. 03, 2022 | |
Equity, Class of Treasury Stock [Line Items] | |||||||
Treasury Stock, Value, Acquired, Cost Method | $ 129 | $ 8,015 | $ 6,118 | $ 1,229 | |||
November 2014 Share Repurchase Plan | |||||||
Equity, Class of Treasury Stock [Line Items] | |||||||
Stock buyback program, authorized amount | $ 235,000 | $ 235,000 | |||||
Increase authorized for share buyback program | $ 50,000 | ||||||
Treasury Stock, Shares, Acquired (in Shares) | 3,585 | 189,840 | 266,716 | 241,008 | |||
Treasury Stock, Value, Acquired, Cost Method | $ 100 | $ 6,100 | $ 8,100 | $ 7,300 |
Stockholders' Equity (The 2015
Stockholders' Equity (The 2015 Equity Incentive Plan) (Details) - The 2015 Equity Incentive Plan [Member] - shares | Jan. 01, 2023 | Jun. 30, 2023 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) | 6,774,598 | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,202,802 |
Stockholders' Equity (2014 Empl
Stockholders' Equity (2014 Employee Stock Purchase Plan) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
May 31, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Allocated share based compensation | $ 4,865 | $ 4,235 | $ 10,976 | $ 9,257 | |
2014 Employee Stock Purchase Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in Shares) | 65,933 | 1,155,478 | |||
Weighted-Average Purchase Price (In Dollars per Share) | $ 25.52 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in Shares) | 844,522 | 844,522 | |||
Allocated share based compensation | $ 300 | $ 200 | $ 600 | $ 400 |
Stockholders' Equity (Key Assum
Stockholders' Equity (Key Assumptions Used in Determining Fair Value of Options Granted) (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stockholders' Equity | ||||
Average volatility | 40.20% | 40.50% | 41.40% | 41% |
Average risk-free interest rate | 3.80% | 3% | 4.10% | 2.30% |
Weighted-average expected life in years | 4 years 10 months 24 days | 4 years 9 months 18 days | 6 years 2 months 12 days | 6 years 1 month 6 days |
Dividend yield rate | 0% | 0% | 0% | 0% |
Stockholders' Equity (Summary o
Stockholders' Equity (Summary of Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Options | ||||
Outstanding Options, Beginning of period | 7,929,150 | |||
Options granted | 759,350 | |||
Options exercised | (642,019) | |||
Options forfeited | (4,526) | |||
Options expired | (500) | |||
Outstanding Options, End of period | 8,041,455 | 8,041,455 | ||
Exercisable at the end of period | 5,945,056 | 5,945,056 | ||
Vested and expected to vest, at the end of period | 7,814,400 | 7,814,400 | ||
Weighted-Average Exercise Price | ||||
Outstanding Exercise Price (in dollars per share) | $ 17.66 | |||
Options granted (in dollars per share) | 35.83 | |||
Options exercised (in dollars per share) | 15.22 | |||
Options forfeited (in dollars per share) | 29.60 | |||
Options expired (in dollars per share) | 14.66 | |||
Outstanding Exercise Price (in dollars per share) | $ 19.57 | 19.57 | ||
Exercisable at the end of period (in dollars per share) | 16.51 | 16.51 | ||
Vested and expected to vest at end of period (in dollars per share) | $ 19.27 | $ 19.27 | ||
Additional Disclosures | ||||
Contractual term | 5 years 7 days | |||
Outstanding Intrinsic Value | $ 304,777 | $ 304,777 | ||
Exercisable remaining contractual term (in Years) | 3 years 9 months 10 days | |||
Exercisable aggregate intrinsic value | 243,537 | $ 243,537 | ||
Allocated share based compensation | 4,865 | $ 4,235 | 10,976 | $ 9,257 |
Vested and expected to vest aggregate intrinsic value | 298,513 | $ 298,513 | ||
Vested and expected to vest weighted average remaining contractual term | 4 years 10 months 28 days | |||
Employee Stock Option [Member] | ||||
Additional Disclosures | ||||
Allocated share based compensation | $ 2,300 | $ 2,000 | $ 5,300 | $ 4,500 |
Stockholders' Equity (Informati
Stockholders' Equity (Information Relating to Option Grants and Exercises) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stockholders' Equity | ||||
Weighted-average grant date fair value (in Dollars per share) | $ 17.77 | $ 12.13 | $ 16.76 | $ 14.75 |
Intrinsic value of options exercised | $ 16,575 | $ 6,510 | $ 18,916 | $ 18,710 |
Cash received from options exercised | 8,350 | 4,469 | 9,738 | 16,919 |
Total fair value of the options vested during the period | $ 1,136 | $ 1,004 | $ 8,720 | $ 7,990 |
Stockholders' Equity (Summary_2
Stockholders' Equity (Summary of Nonvested Options) (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Options | ||||
Nonvested at beginning of period | 2,378,453 | |||
Options granted | 759,350 | |||
Options vested | (1,036,878) | |||
Options forfeited | (4,526) | |||
Nonvested at end of period | 2,096,399 | 2,096,399 | ||
Weighted-Average Grant Date Fair Value | ||||
Nonvested at beginning of period (in dollars per share) | $ 9.48 | |||
Options granted (in dollars per share) | $ 17.77 | $ 12.13 | 16.76 | $ 14.75 |
Options vested (in dollars per share) | 8.41 | |||
Options forfeited (in dollars per share) | 13.40 | |||
Nonvested at end of period (in dollars per share) | $ 12.64 | $ 12.64 | ||
Employee Stock Options [Member] | ||||
Weighted-Average Grant Date Fair Value | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 20.6 | $ 20.6 | ||
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 10 months 24 days |
Stockholders' Equity (Restricte
Stockholders' Equity (Restricted Stock Units) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 4,865 | $ 4,235 | $ 10,976 | $ 9,257 |
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 | $ 2,200 | $ 2,000 | $ 5,100 | $ 4,400 |
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 9 months 18 days | |||
Share-based Compensation Arrangement by Share-based Payment Award, Restricted Stock Units, Number of Shares of Common Stock Per Award (in Shares) | 1 | 1 | ||
Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | $ 21,800 | $ 21,800 |
Stockholders' Equity (Informa_2
Stockholders' Equity (Information Relating to RSU Grants and Deliveries) (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) shares | |
Restricted Stock Units (RSUs) | |
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 | 1,007,052 |
RSUs granted | 355,959 |
RSUs forfeited | (2,017) |
RSUs vested | (432,216) |
Total RSUs outstanding at the end of the period | 928,778 |
Stock surrendered to fulfill tax withholding obligations | 165,215 |
Restricted Stock Units Issued as Compensation [Member] | |
Total Fair Market Value of RSUs Issued | |
RSUs granted (in Dollars) | $ | $ 12,715 |
Stockholders' Equity (Share-Bas
Stockholders' Equity (Share-Based Compensation Expense Included in the Statement of Operations) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 4,865 | $ 4,235 | $ 10,976 | $ 9,257 |
Cost Of Revenues [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | 1,158 | 938 | 2,864 | 2,323 |
Selling, Distribution And Marketing [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | 227 | 194 | 436 | 362 |
General and administrative expenses | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | 2,991 | 2,718 | 6,348 | 5,579 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 489 | $ 385 | $ 1,328 | $ 993 |
Employee Benefits (Details)
Employee Benefits (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
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 | $ 0.6 | $ 0.5 | $ 1.2 | $ 1.1 | |
Defined Benefit Plan, Assumptions Used Calculating Benefit Obligation, Discount Rate | 3.80% | 3.80% | 3.80% | ||
Defined Benefit Plan, Benefit Obligation | $ 2.3 | $ 2.3 | $ 2.2 | ||
Pension Cost | 0 | $ 0 | 0 | $ 0 | |
Deferred compensation plan assets | 5.4 | 5.4 | 4.5 | ||
Deferred compensation plan liabilities | $ 5.6 | $ 5.6 | $ 4.6 |
Commitments and Contingencies (
Commitments and Contingencies (Purchase Commitments) (Details) $ in Millions | 3 Months Ended |
Jun. 30, 2023 USD ($) | |
Commitments to Purchase Equipment and Raw Materials [Member] | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |
Long-term Purchase Commitment, Amount | $ 75.2 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Mar. 31, 2023 | Nov. 30, 2022 | Jul. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Related Party Transaction [Line Items] | |||||||
Net revenues | $ 145,712 | $ 123,467 | $ 285,734 | $ 243,835 | |||
Hanxin | |||||||
Related Party Transaction [Line Items] | |||||||
Payment to related party | 400 | 1,000 | |||||
Related Party Transaction, Due from (to) Related Party, Current | 200 | $ 200 | |||||
Ownership after transaction | 14% | ||||||
Related Party Transaction, Amounts of Transaction | $ 500 | $ 2,200 | |||||
Letop | |||||||
Related Party Transaction [Line Items] | |||||||
Payment to related party | 0 | $ 700 | |||||
Related Party Transaction, Due from (to) Related Party, Current | 0 | 0 | |||||
Related Party Transaction, Amounts of Transaction | $ 1,500 | ||||||
ANP | Hanxin | |||||||
Related Party Transaction [Line Items] | |||||||
Net revenues | 0 | 0 | |||||
Receivables from Hanxin | $ 0 | $ 0 |
Litigation (Details)
Litigation (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Settled Litigation [Member] | Amphastar Pharmaceuticals vs Astellas-Gilead | Other income (expenses) | Astellas-Gilead | |
Loss Contingencies [Line Items] | |
Litigation Settlement, amount paid to the Company | $ 5.4 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ 26,124 | $ 26,032 | $ 17,346 | $ 24,253 | $ 52,156 | $ 41,599 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2023 shares | |
Jacob Liawatidewi | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | On May 19, 2023, Jacob Liawatidewi, our Executive Vice President of Sales and Marketing and Corporate Administration Center, President of Amphastar France Pharmaceuticals, S.A.S., Corporate Secretary, and Director, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 28,816 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until August 29, 2024, or earlier if all transactions under the trading arrangement are completed. |
Name | Jacob Liawatidewi |
Title | Executive Vice President of Sales and Marketing and Corporate Administration Center, President of Amphastar France Pharmaceuticals, S.A.S., Corporate Secretary, and Director |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | May 19, 2023 |
Aggregate Available | 28,816 |
Expiration Date | August 29, 2024 |
William J. Peters | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | On June 5, 2023, William J. Peters, our Chief Financial Officer, Executive Vice President of Finance, and Treasurer, President of International Medication Systems, Limited, and Director, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 138,129 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until August 15, 2024, or earlier if all transactions under the trading arrangement are completed. |
Name | William J. Peters |
Title | Chief Financial Officer, Executive Vice President of Finance, and Treasurer, President of International Medication Systems, Limited, and Director |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | June 5, 2023 |
Aggregate Available | 138,129 |
Expiration Date | August 15, 2024 |
Mary Z. Luo | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | On June 9, 2023, Mary Z. Luo, our Chief Operating Officer, Chief Scientist and Chairman of the Board of Directors, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 351,186 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until June 9, 2024, or earlier if all transactions under the trading arrangement are completed. |
Name | Mary Z. Luo |
Title | Chief Operating Officer, Chief Scientist and Chairman of the Board of Directors |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | June 9, 2023 |
Aggregate Available | 351,186 |
Expiration Date | June 9, 2024 |
Floyd F. Petersen | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | On June 13, 2023, Floyd F. Petersen, a member of our Board of Directors, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 4,500 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until June 4, 2024, or earlier if all transactions under the trading arrangement are completed. |
Name | Floyd F. Petersen |
Title | a member of our Board of Directors |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | June 13, 2023 |
Aggregate Available | 4,500 |
Expiration Date | June 4, 2024 |