UNITED STATES
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Washington, D.C. 20549
FORM
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AMPHASTAR PHARMACEUTICALS, INC.
TABLE OF CONTENTS
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2024
Special Note About Forward-Looking Statements
SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or Quarterly Report, contains “forward-looking statements” that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements relate to future events or future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by the forward-looking statements. These forward-looking statements include, but are not limited to, statements about:
● | our expectations regarding the sales and marketing of our products; |
● | our expectations regarding our newly acquired product, BAQSIMI®, including with respect to our ability to increase our revenues and derive certain benefits as a result of our acquisition of BAQSIMI®; |
● | our ability to successfully acquire and integrate assets, including our ability to integrate BAQSIMI®; |
● | our expectations regarding our manufacturing and production and the integrity of our supply chain for our products, including the risks associated with our single source suppliers; |
● | our business and operations in general, including: adverse impacts of the Russia-Ukraine and Middle East conflicts and challenging macroeconomic conditions on our business, financial condition, operations, cash flows and liquidity; |
● | our ability to attract, hire, and retain highly skilled personnel; |
● | interruptions to our manufacturing and production as a result of natural catastrophic events or other causes beyond our control such as power disruptions, pandemics, wars, terrorist attacks or other events; |
● | global, national and local economic and market conditions, specifically with respect to geopolitical uncertainty, including the Russia-Ukraine and Middle East conflicts, inflation and high interest rates; |
● | the timing and likelihood of U.S. Food and Drug Administration, or FDA, approvals and regulatory actions on our product candidates, manufacturing activities and product marketing activities; |
● | our ability to advance product candidates in our platforms into successful and completed clinical trials and our subsequent ability to successfully commercialize our product candidates; |
● | cost and delays resulting from the extensive pharmaceutical regulations to which we are subject; |
● | our ability to compete in the development and marketing of our products and product candidates; |
● | our expectations regarding the business of our Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Ltd., or ANP; |
● | the potential for adverse application of environmental, health and safety and other laws and regulations on our operations; |
● | our expectations for market acceptance of our new products and proprietary drug delivery technologies, as well as those of our active pharmaceutical ingredient, or API, customers; |
● | the effects of reforms in healthcare regulations and reductions in pharmaceutical pricing, reimbursement and coverage; |
● | our expectations in obtaining insurance coverage and adequate reimbursement for our products from third-party payers; |
● | the amount of price concessions or exclusion of suppliers adversely affecting our business; |
● | variations in intellectual property laws, our ability to establish and maintain intellectual property protection for our products and our ability to successfully defend our intellectual property in cases of alleged infringement; |
● | the implementation of our business strategies, product development strategies and technology utilization; |
● | the potential for exposure to product liability claims; |
● | our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions, divestitures or investments, including the anticipated benefits of such acquisitions, divestitures or investments; |
● | our ability to expand internationally; |
● | economic and industry trends and trend analysis; |
● | our ability to remain in compliance with laws and regulations that currently apply or become applicable to our business both in the United States and internationally; |
● | the impact of trade tariffs, export or import restrictions, or other trade barriers; |
● | the impact of Patient Protection and Affordable Care Act (as amended) and other legislative and regulatory healthcare reforms in the countries in which we operate including the potential for drug price controls; |
● | the impact of global and domestic tax reforms; |
● | the timing for completion and the validation of the new construction at our ANP and Amphastar facilities; |
● | the timing and extent of share buybacks; and |
● | our financial performance expectations, including our expectations regarding our backlog, revenue, cost of revenue, gross profit or gross margin, operating expenses, including changes in research and development, sales and marketing and general and administrative expenses, and our ability to achieve and maintain future profitability. |
You should read this Quarterly Report and the documents that we reference elsewhere in this Quarterly Report completely and with the understanding that our actual results may differ materially from what we expect as expressed or implied by our forward-looking statements. In light of the significant risks and uncertainties to which our forward-looking statements are subject, you should not place undue reliance on or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. We discuss many of these risks and uncertainties in greater detail in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2023, particularly in Item 1A. “Risk Factors.” These forward-looking statements represent our estimates and assumptions only as of the date of this Quarterly Report regardless of the time of delivery of this Quarterly Report, and such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this Quarterly Report.
Unless expressly indicated or the context requires otherwise, references in this Quarterly Report to “Amphastar,” “the Company,” “we,” “our,” and “us” refer to Amphastar Pharmaceuticals, Inc. and our subsidiaries.
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
| June 30, |
| December 31, | |||
2024 | 2023 | |||||
(unaudited) | ||||||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | | $ | | ||
Restricted cash | | | ||||
Short-term investments | | | ||||
Restricted short-term investments |
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Accounts receivable, net |
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Inventories |
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Income tax refunds and deposits |
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Prepaid expenses and other assets |
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Total current assets |
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Property, plant, and equipment, net |
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Finance lease right-of-use assets | | | ||||
Operating lease right-of-use assets | | | ||||
Investment in unconsolidated affiliate | — | | ||||
Goodwill and intangible assets, net |
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Long-term investments | | | ||||
Other assets |
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Deferred tax assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable and accrued liabilities | $ | | $ | | ||
Accrued payments for BAQSIMI® (see Note 3) | — | | ||||
Income taxes payable |
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Current portion of long-term debt |
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Current portion of operating lease liabilities | | | ||||
Total current liabilities |
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Long-term reserve for income tax liabilities |
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Long-term debt, net of current portion and unamortized debt issuance costs |
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Long-term operating lease liabilities, net of current portion | | | ||||
Other long-term liabilities |
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Total liabilities |
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Commitments and contingencies | ||||||
Stockholders’ equity: | ||||||
Preferred stock: par value $ |
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Common stock: par value $ |
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Additional paid-in capital |
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Retained earnings |
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Accumulated other comprehensive loss |
| ( |
| ( | ||
Treasury stock |
| ( |
| ( | ||
Total equity | | | ||||
Total liabilities and stockholders’ equity | $ | | $ | |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-1-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in thousands, except per share data)
Three Months Ended | Six Months Ended |
| |||||||||||
June 30, | June 30, | ||||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 |
| |||||
Net revenues: | |||||||||||||
Product revenues, net | $ | | $ | | $ | | $ | | |||||
Other revenues | | — | | — | |||||||||
Total net revenues | | | | | |||||||||
Cost of revenues |
| |
| |
| |
| | |||||
Gross profit |
| |
| |
| |
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Operating expenses: | |||||||||||||
Selling, distribution, and marketing |
| |
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| | | ||||||
General and administrative |
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Research and development |
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| | | ||||||
Total operating expenses |
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Income from operations |
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Non-operating income (expenses): | |||||||||||||
Interest income |
| |
| |
| | | ||||||
Interest expense |
| ( |
| ( |
| ( | ( | ||||||
Other income (expenses), net |
| |
| ( |
| | ( | ||||||
Total non-operating income (expenses), net |
| ( |
| ( |
| ( |
| ( | |||||
Income before income taxes |
| |
| |
| |
| | |||||
Income tax provision |
| |
| |
| | | ||||||
Income before equity in losses of unconsolidated affiliate | | | | | |||||||||
Equity in losses of unconsolidated affiliate | — | ( | ( | ( | |||||||||
Net income | $ | | $ | | $ | | $ | | |||||
Net income per share: | |||||||||||||
Basic | $ | | $ | | $ | | $ | | |||||
Diluted | $ | | $ | | $ | | $ | | |||||
Weighted-average shares used to compute net income per share: | |||||||||||||
Basic |
| |
| |
| | | ||||||
Diluted |
| |
| |
| | |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-2-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited; in thousands)
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 |
| |||||
Net income | $ | | $ | | $ | | $ | | |||||
Other comprehensive income (loss), net of income taxes | |||||||||||||
Foreign currency translation adjustment |
| ( | ( |
| ( | | |||||||
Total other comprehensive income (loss) |
| ( |
| ( |
| ( |
| | |||||
Total comprehensive income | $ | | $ | | $ | | $ | |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-3-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited; in thousands, except share data)
Common Stock | Accumulated | Treasury Stock | ||||||||||||||||||||
Additional | Other | |||||||||||||||||||||
Paid-in | Retained | Comprehensive | ||||||||||||||||||||
Shares | Amount | Capital | Earnings | Income (loss) | Shares | Amount | Total | |||||||||||||||
Balance as of December 31, 2023 |
| | $ | | $ | | $ | | $ | ( |
| ( | $ | ( | $ | | ||||||
Net income |
| — |
| — |
| — |
| |
| — |
| — |
| — |
| | ||||||
Other comprehensive loss |
| — |
| — |
| — |
| — |
| ( |
| — |
| — |
| ( | ||||||
Issuance of treasury stock in connection with the Company's equity plans | — | — | ( | — | — | | | — | ||||||||||||||
Issuance of common stock in connection with the Company's equity plans |
| |
| — |
| ( |
| — |
| — |
| — |
| — |
| ( | ||||||
Share-based compensation expense |
| — |
| — |
| |
| — |
| — |
| — |
| — |
| | ||||||
Balance as of March 31, 2024 |
| | $ | | $ | | $ | | $ | ( |
| ( | $ | ( | $ | | ||||||
Net income |
| — |
| — |
| — |
| |
| — |
| — |
| — |
| | ||||||
Other comprehensive loss |
| — |
| — |
| — |
| — |
| ( |
| — |
| — |
| ( | ||||||
Purchase of treasury stock |
| — |
| — |
| — |
| — |
| — |
| ( | ( |
| ( | |||||||
Issuance of treasury stock in connection with the Company's equity plans | — |
| — |
| ( |
| — |
| — |
| | |
| — | ||||||||
Issuance of common stock in connection with the Company's equity plans |
| |
| — |
| |
| — |
| — |
| — |
| — |
| | ||||||
Share-based compensation expense |
| — |
| — |
| |
| — |
| — |
| — |
| — |
| | ||||||
Balance as of June 30, 2024 |
| | $ | | $ | | $ | | $ | ( |
| ( | $ | ( | $ | |
Common Stock | Accumulated | Treasury Stock | ||||||||||||||||||||
Additional | Other | |||||||||||||||||||||
Paid-in | Retained | Comprehensive | ||||||||||||||||||||
Shares | Amount | Capital | Earnings | Income (loss) | Shares | Amount | Total | |||||||||||||||
Balance as of December 31, 2022 |
| | $ | | $ | | $ | | $ | ( |
| ( | $ | ( | $ | | ||||||
Net income |
| — |
| — |
| — |
| |
| — |
| — |
| — |
| | ||||||
Other comprehensive income |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
Purchase of treasury stock |
| — |
| — |
| — |
| — |
| — |
| ( | ( |
| ( | |||||||
Issuance of common stock in connection with the Company's equity plans |
| |
| — |
| ( |
| — |
| — |
| — |
| — |
| ( | ||||||
Share-based compensation expense |
| — |
| — |
| |
| — |
| — |
| — |
| — |
| | ||||||
Balance as of March 31, 2023 |
| | $ | | $ | | $ | | $ | ( |
| ( | $ | ( | $ | | ||||||
Net income |
| — |
| — |
| — |
| |
| — |
| — |
| — |
| | ||||||
Other comprehensive loss |
| — |
| — |
| — |
| — |
| ( |
| — |
| — |
| ( | ||||||
Purchase of treasury stock |
| — |
| — |
| — |
| — |
| — |
| ( | ( |
| ( | |||||||
Issuance of treasury stock in connection with the Company's equity plans | — |
| — |
| ( |
| — |
| — |
| | |
| — | ||||||||
Issuance of common stock in connection with the Company's equity plans |
| |
| — |
| |
| — |
| — |
| — |
| — |
| | ||||||
Share-based compensation expense |
| — |
| — |
| |
| — |
| — |
| — |
| — |
| | ||||||
Balance as of June 30, 2023 |
| | $ | | $ | | $ | | $ | ( |
| ( | $ | ( | $ | |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-4-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in thousands)
Six Months Ended | ||||||
June 30, | ||||||
| 2024 |
| 2023 | |||
Cash Flows From Operating Activities: | ||||||
Net income | $ | | $ | | ||
Reconciliation to net cash provided by operating activities: | ||||||
Loss on disposal of assets |
| |
| | ||
Impairment of long-lived assets | — | | ||||
Loss (gain) on interest rate swaps and foreign currency transactions, net | ( | | ||||
Depreciation of property, plant, and equipment |
| |
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Amortization of product rights, trademarks, and patents |
| |
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Operating lease right-of-use asset amortization | | | ||||
Amortization of discounts, premiums, and debt issuance costs | | | ||||
Equity in losses of unconsolidated affiliate | | | ||||
Share-based compensation expense |
| |
| | ||
Changes in operating assets and liabilities: | ||||||
Accounts receivable, net |
| ( |
| ( | ||
Inventories |
| ( |
| ( | ||
Prepaid expenses and other assets |
| |
| | ||
Income tax refunds, deposits, and payable, net |
| ( |
| | ||
Operating lease liabilities | ( | ( | ||||
Accounts payable and accrued liabilities |
| |
| | ||
Net cash provided by operating activities |
| |
| | ||
Cash Flows From Investing Activities: | ||||||
BAQSIMI® acquisition (See Note 3) |
| ( |
| ( | ||
Purchases and construction of property, plant, and equipment |
| ( |
| ( | ||
Purchase of investments | ( | ( | ||||
Maturity of investments | | | ||||
Deposits and other assets |
| ( |
| ( | ||
Net cash used in investing activities |
| ( |
| ( | ||
Cash Flows From Financing Activities: | ||||||
Proceeds from equity plans, net of withholding tax payments |
| ( |
| | ||
Purchase of treasury stock |
| ( |
| ( | ||
Debt issuance costs | ( | ( | ||||
Proceeds from borrowing under lines of credit |
| |
| — | ||
Proceeds from issuance of long-term debt |
| — |
| | ||
Principal payments on long-term debt |
| ( |
| ( | ||
Net cash provided by (used in) financing activities |
| ( |
| | ||
Effect of exchange rate changes on cash |
| ( | ( | |||
Net increase (decrease) in cash, cash equivalents, and restricted cash |
| |
| ( | ||
Cash, cash equivalents, and restricted cash at beginning of period |
| | | |||
Cash, cash equivalents, and restricted cash at end of period | $ | | $ | | ||
Noncash Investing and Financing Activities: | ||||||
Deferred payment for BAQSIMI® acquisition | $ | — | $ | | ||
Capital expenditures included in accounts payable | $ | | $ | | ||
Operating lease right-of-use assets in exchange for operating lease liabilities | $ | | $ | | ||
Supplemental Disclosures of Cash Flow Information: | ||||||
Interest paid, net of capitalized interest | $ | | $ | | ||
Income taxes paid | $ | | $ | |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-5-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
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®, is primarily distributed through drug retailers.
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, 2023 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, 2023. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America, 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 presentation of the Company’s consolidated financial position, results of operations, comprehensive income, 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 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.
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. 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.
Investment 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. 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 condensed 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.
-6-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The carrying value of equity method investments is reported as “Investment in unconsolidated affiliate” in the accompanying condensed 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.
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 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).