What changed in Amphastar Pharmaceuticals, Inc.'s 10-K — 2023 vs 2024
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Paragraph-level year-over-year comparison of Amphastar Pharmaceuticals, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.
+370 added−423 removedSource: 10-K (2025-03-03) vs 10-K (2024-02-29)
Top changes in Amphastar Pharmaceuticals, Inc.'s 2024 10-K
370 paragraphs added · 423 removed · 285 edited across 1 sections
- Item 1C. Cybersecurity+370 / −423 · 285 edited
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
285 edited+85 added−138 removed170 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
285 edited+85 added−138 removed170 unchanged
2023 filing
2024 filing
Biggest changeConsolidated Statements of Stockholders’ Equity (in thousands, except share data) Common Stock Accumulated Treasury Stock Total Additional Other Amphastar Non- Paid-in Retained Comprehensive Stockholders' controlling Shares Amount Capital Earnings Income (loss) Shares Amount Equity Interest Total Balance as of December 31, 2020 54,760,922 $ 5 $ 410,061 $ 117,773 $ (3,721) (7,265,483) $ (121,812) $ 402,306 $ 46,417 $ 448,723 Net income attributable to Amphastar Pharmaceuticals, Inc. — — — 62,116 — — — 62,116 — 62,116 Other comprehensive loss attributable to Amphastar Pharmaceuticals, Inc. — — — — (2,682) — — (2,682) — (2,682) ANP restructuring (see Note 3) — — (22,162) 448 (362) — — (22,076) (46,641) (68,717) Net income attributable to non-controlling interest — — — — — — — — 1,185 1,185 Purchase of treasury stock — — — — — (1,477,305) (28,873) (28,873) — (28,873) Issuance of treasury stock in connection with the Company's equity plans — — (206) — — 17,498 206 — — — Issuance of common stock in connection with the Company's equity plans 1,679,280 1 15,924 — — — — 15,925 — 15,925 Share-based compensation expense — — 18,806 — — — — 18,806 (961) 17,845 Balance as of December 31, 2021 56,440,202 $ 6 $ 422,423 $ 180,337 $ (6,765) (8,725,290) $ (150,479) $ 445,522 $ — $ 445,522 Net income attributable to Amphastar Pharmaceuticals, Inc. — — — 91,386 — — — 91,386 — 91,386 Other comprehensive loss attributable to Amphastar Pharmaceuticals, Inc. — — — — (1,859) — — (1,859) — (1,859) Purchase of treasury stock — — — — — (1,335,528) (39,909) (39,909) — (39,909) Issuance of treasury stock in connection with the Company's equity plans — — (864) — — 62,656 864 — — — Issuance of common stock in connection with the Company's equity plans 1,670,029 — 15,658 — — — — 15,658 — 15,658 Share-based compensation expense — — 17,860 — — — — 17,860 — 17,860 Balance as of December 31, 2022 58,110,231 $ 6 $ 455,077 $ 271,723 $ (8,624) (9,998,162) $ (189,524) $ 528,658 $ — $ 528,658 Net income attributable to Amphastar Pharmaceuticals, Inc. — — — 137,545 — — — 137,545 — 137,545 Other comprehensive loss attributable to Amphastar Pharmaceuticals, Inc. — — — — 146 — — 146 — 146 Purchase of treasury stock — — — — — (1,338,757) (58,144) (58,144) — (58,144) Issuance of treasury stock in connection with the Company's equity plans — — (237) — — 15,606 237 — — — Issuance of common stock in connection with the Company's equity plans 1,279,963 — 10,974 — — — — 10,974 — 10,974 Share-based compensation expense — — 20,242 — — — — 20,242 — 20,242 Balance as of December 31, 2023 59,390,194 $ 6 $ 486,056 $ 409,268 $ (8,478) (11,321,313) $ (247,431) $ 639,421 $ — $ 639,421 See accompanying notes to consolidated financial statements. 109 Table of Contents AMPHASTAR PHARMACEUTICALS, INC.
Biggest changeConsolidated Statements of Stockholders’ Equity (in thousands, except share data) Common Stock Accumulated Treasury Stock Additional Other Paid-in Retained Comprehensive Shares Amount Capital Earnings loss Shares Amount Total Balance as of December 31, 2021 56,440,202 $ 6 $ 422,423 $ 180,337 $ (6,765) (8,725,290) $ (150,479) $ 445,522 Net income — — — 91,386 — — — 91,386 Other comprehensive loss — — — — (1,859) — — (1,859) Purchase of treasury stock — — — — — (1,335,528) (39,909) (39,909) Issuance of treasury stock in connection with the Company's equity plans — — (864) — — 62,656 864 — Issuance of common stock in connection with the Company's equity plans 1,670,029 — 15,658 — — — — 15,658 Share-based compensation expense — — 17,860 — — — — 17,860 Balance as of December 31, 2022 58,110,231 $ 6 $ 455,077 $ 271,723 $ (8,624) (9,998,162) $ (189,524) $ 528,658 Net income — — — 137,545 — — — 137,545 Other comprehensive income — — — — 146 — — 146 Purchase of treasury stock — — — — — (1,338,757) (58,144) (58,144) Issuance of treasury stock in connection with the Company's equity plans — — (237) — — 15,606 237 — Issuance of common stock in connection with the Company's equity plans 1,279,963 — 10,974 — — — — 10,974 Share-based compensation expense — — 20,242 — — — — 20,242 Balance as of December 31, 2023 59,390,194 $ 6 $ 486,056 $ 409,268 $ (8,478) (11,321,313) $ (247,431) $ 639,421 Net income — — — 159,519 — — — 159,519 Other comprehensive loss — — — — (703) — — (703) Purchase of treasury stock — — — — — (1,919,670) (85,458) (85,458) Issuance of treasury stock in connection with the Company's equity plans — — (175) — — 11,550 175 — Issuance of common stock in connection with the Company's equity plans 1,456,930 — (4,849) — — — — (4,849) Share-based compensation expense — — 24,368 — — — — 24,368 Balance as of December 31, 2024 60,847,124 $ 6 $ 505,400 $ 568,787 $ (9,181) (13,229,433) $ (332,714) $ 732,298 See accompanying notes to consolidated financial statements. 103 Table of Contents AMPHASTAR PHARMACEUTICALS, INC.
The standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statements.
The standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statements.
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 underlying common stock.
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 the underlying common stock.
Gain or loss due to change in actuarial valuation of the Company’s defined benefit pension plan is recorded in other comprehensive income (loss). Non-qualified Deferred Compensation Plan In December 2019, the Company established a non-qualified deferred compensation plan.
Gain or loss due to change in actuarial valuation of the Company’s defined benefit pension plan is recorded in other comprehensive income. Non-qualified Deferred Compensation Plan In December 2019, the Company established a non-qualified deferred compensation plan.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management overriding of the controls.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management overriding the controls.
The resolution of a matter could be recognized as an adjustment to our provision for income taxes and our effective tax rate in the period of resolution, and may also require a use of cash. Share-Based Compensation Options issued under our 2015 Equity Incentive Award Plan, or the 2015 Plan, and our Amended and Restated 2005 Equity Incentive Award Plan, or 2005 Plan, are granted at exercise prices equal to or greater than the fair value of the underlying common shares on the date of grant and vest based on continuous service.
The resolution of a matter could be recognized as an adjustment to our provision for income taxes and our effective tax rate in the period of resolution, and may also require a use of cash. Share-Based Compensation Options issued under our amended and restated 2015 Equity Incentive Award Plan, or the Amended 2015 Plan, 2015 Equity Incentive Award Plan, or the Original 2015 Plan, and our amended and restated 2005 Equity Incentive Award Plan, or 2005 Plan, are granted at exercise prices equal to or greater than the fair value of the underlying common shares on the date of grant and vest based on continuous service.
Based on the evaluation under that framework and applicable SEC rules, our management concluded that our internal control over financial reporting was effective as of December 31, 2023 . Our internal control over financial reporting as of December 31, 2023 has been audited by Ernst & Young, LLP, an independent registered public accounting firm, as stated in their report appearing below. Changes in Internal Control Over Financial Reporting There have been no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Inherent Limitations of Internal Controls Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls over financial reporting will prevent or detect all errors and all fraud.
Based on the evaluation under that framework and applicable SEC rules, our management concluded that our internal control over financial reporting was effective as of December 31, 2024. Our internal control over financial reporting as of December 31, 2024 has been audited by Ernst & Young, LLP, an independent registered public accounting firm, as stated in their report appearing below. Changes in Internal Control Over Financial Reporting There have been no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Inherent Limitations of Internal Controls Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls over financial reporting will prevent or detect all errors and all fraud.
We require each third-party service provider to certify that it has the ability to implement and maintain appropriate security measures, consistent with all applicable laws, to implement and maintain reasonable security measures in connection with their work with us, and to promptly report any suspected breach of its security measures that may affect our business.” For additional information regarding whether any risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect our company, including our business strategy, results of operations, or financial condition, please refer to Item 1A, “Risk Factors,” in this annual report on Form 10-K, including the risk factors entitled “Our business and operations have been impacted in the past, and may be impacted in the future, in the event of system breach or failure” and “Complying with laws in the U.S., Europe, and other jurisdictions that impose restrictive regulations addressing the collection, use, and other processing of personal information may be expensive, and failure to comply with such laws and regulations could cause substantial harm to our company. Governance One of the key functions of our board of directors is informed oversight of our risk management process, including risks from cybersecurity threats.
We require each third-party service provider to certify that it has the ability to implement and maintain appropriate security measures, consistent with all applicable laws, to implement and maintain reasonable security measures in connection with their work with us, and to promptly report any suspected breach of its security measures that may affect our business. For additional information regarding whether any risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect our company, including our business strategy, results of operations, or financial condition, please refer to Item 1A, “Risk Factors,” in this annual report on Form 10-K, including the risk factors entitled “Our business and operations have been impacted in the past, and may be impacted in the future, in the event of system breach or failure” and “Complying with laws in the U.S., Europe, and other jurisdictions that impose restrictive regulations addressing the collection, use, and other processing of personal information may be expensive, and failure to comply with such laws and regulations could cause substantial harm to our company.” 78 Table of Contents Governance One of the key functions of our board of directors is informed oversight of our risk management process, including risks from cybersecurity threats.
We evaluated the reasonableness of significant assumptions (e.g., estimated wholesale customer mix and related contract pricing) by comparing rates at different time periods, including historical and subsequent periods, obtaining an understanding of the facts supporting the selected rates, and performing sensitivity analyses over those rates.
We evaluated the reasonableness of significant assumptions (e.g., estimated future wholesale customer mix and related contract pricing) by comparing rates at different time periods, including historical and subsequent periods, obtaining an understanding of the facts supporting the selected rates, and performing sensitivity analyses over those rates.
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 4, in June 2023, the Company acquired the BAQSIMI ® product rights.
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 ® product rights.
(incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 10.6+ 2014 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.17 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 10.7+ Employment Agreement, dated May 19, 2014, between Amphastar Pharmaceuticals, Inc. and Jack Zhang (incorporated by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 10.8+ Employment Agreement, dated May 19, 2014, between Amphastar Pharmaceuticals, Inc. and Mary Luo (incorporated by reference to Exhibit 10.22 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 153 Table of Contents 10.9+ Employment Agreement, dated March 11, 2014, between Amphastar Pharmaceuticals, Inc. and William Peters (incorporated by reference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 10.10† Supply Agreement, dated July 31, 2014, between MannKind Corporation and Amphastar France Pharmaceuticals, S.A.S.
(incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 10.6+ 2014 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.17 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 10.7+ Employment Agreement, dated May 19, 2014, between Amphastar Pharmaceuticals, Inc. and Jack Zhang (incorporated by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 10.8+ Employment Agreement, dated May 19, 2014, between Amphastar Pharmaceuticals, Inc. and Mary Luo (incorporated by reference to Exhibit 10.22 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 146 Table of Contents 10.9+ Employment Agreement, dated March 11, 2014, between Amphastar Pharmaceuticals, Inc. and William Peters (incorporated by reference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014) 10.10† Supply Agreement, dated July 31, 2014, between MannKind Corporation and Amphastar France Pharmaceuticals, S.A.S.
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.
Rebates include primarily amounts paid to retailers, payers, and providers in the United States, including those paid to Medicare and state Medicaid programs, and are based on contractual arrangements or statutory requirements.
These risks, uncertainties and other factors include among others, those identified under the “Special Note About Forward-Looking Statements,” above and described in greater detail elsewhere in this Annual Report on Form 10-K, particularly in Item 1A, “Risk Factors.” In this section, we generally discuss the results of our operations for the year ended December 31, 2023, compared to the year ended December 31, 2022.
These risks, uncertainties and other factors include among others, those identified under the “Special Note About Forward-Looking Statements,” above and described in greater detail elsewhere in this Annual Report on Form 10-K, particularly in Item 1A, “Risk Factors.” In this section, we generally discuss the results of our operations for the year ended December 31, 2024, compared to the year ended December 31, 2023.
Compensation cost for all share-based payments granted with service-based graded vesting schedules is recognized using the straight-line method over the requisite service period. Options issued under the Company’s 2015 Plan and 2005 Plan are granted at exercise prices equal to or greater than the fair value of the underlying common shares on the date of grant and vest based on continuous service.
Compensation cost for all share-based payments granted with service-based graded vesting schedules is recognized using the straight-line method over the requisite service period. Options issued under the Company’s Amended 2015 Plan, Original 2015 Plan, and 2005 Plan are granted at exercise prices equal to or greater than the fair value of the underlying common shares on the date of grant and vest based on continuous service.
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).
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.
Controls and Procedures. Evaluation of Disclosure Controls and Procedures Our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, our principal executive and principal financial officers, respectively, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended, as of the end of the period covered by this Annual Report on Form 10-K.
Controls and Procedures. Evaluation of Disclosure Controls and Procedures Our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, our principal executive and principal financial officers, respectively, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under Securities Exchange Act of 1934, as amended, or the Exchange Act, as of the end of the period covered by this Annual Report on Form 10-K.
As of December 31, 2023 and 2022, the restricted cash balance was $0.2 million. Restricted Short-Term Investments Restricted short-term investments consist of certificates of deposit that are collateral for standby letters of credit to qualify for workers’ compensation self-insurance. The certificates of deposit have original maturities greater than three months, but less than one year.
As of December 31, 2024 and 2023, the restricted cash balance was $0.2 million. Restricted Short-Term Investments Restricted short-term investments consist of certificates of deposit that are collateral for standby letters of credit to qualify for workers’ compensation self-insurance. The certificates of deposit have original maturities greater than three months, but less than one year.
Bank Trust Company, National Association, as trustee. The 2029 Convertible Notes will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the 2029 Convertible Notes; equal in right of payment to all of the Company’s unsecured indebtedness that is not so subordinated; effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness, including any amount outstanding under the Company’s credit facilities; and structurally junior to all indebtedness and other liabilities of the Company’s current or future subsidiaries, including trade payables. Interest will be payable semi-annually in arrears on March 15 and September 15 of each year, beginning on March 15, 2024.
Bank Trust Company, National Association, as trustee. The 2029 Convertible Notes will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the 2029 Convertible Notes; equal in right of payment to all of the Company’s unsecured indebtedness that is not so subordinated; effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness, including any amount outstanding under the Company’s credit facilities; and structurally junior to all indebtedness and other liabilities of the Company’s current or future subsidiaries, including trade payables. Interest is payable semi-annually in arrears on March 15 and September 15 of each year.
Investments consist of certificates of deposit as well as investment-grade corporate, agency and municipal bonds with original maturity dates between three and fifteen months. The certificates of deposit are carried at amortized cost in the Company’s consolidated balance sheets, which approximates their fair value determined based on Level 2 inputs.
Investments consist of certificates of deposit as well as investment-grade corporate, agency and municipal bonds with original maturity dates between three and nineteen months. The certificates of deposit are carried at amortized cost in the Company’s consolidated balance sheets, which approximates their fair value determined based on Level 2 inputs.
Information required by this item will be included in our Proxy Statement for our 2024 Annual Meeting of Stockholders to be filed within 120 days after our fiscal year end of December 31, 2023, or 2024 Proxy Statement, and is incorporated by reference into this Annual Report on Form 10-K. Item 11. Executive Compensation.
Information required by this item will be included in our Proxy Statement for our 2025 Annual Meeting of Stockholders to be filed within 120 days after our fiscal year end of December 31, 2024, or 2025 Proxy Statement, and is incorporated by reference into this Annual Report on Form 10-K. Item 11. Executive Compensation.
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.
If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset or asset group, further impairment analysis is performed.
The Company issues new shares of common stock upon exercise of stock options, vesting of restricted stock units, or RSU, and settlement of ESPP, with the exception of the awards granted to employees at AFP, which are settled through re-issuance of the Company’s treasury shares. 137 Table of Contents AMPHASTAR PHARMACEUTICALS, INC.
The Company issues new shares of common stock upon exercise of stock options, vesting of restricted stock units, or RSU, and settlement of ESPP, with the exception of the awards granted to employees at AFP, which are settled through re-issuance of the Company’s treasury shares. 131 Table of Contents AMPHASTAR PHARMACEUTICALS, INC.
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. Note 2.
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 over-the-counter inhalation product, Primatene MIST ® , is primarily distributed through drug retailers. Note 2.
However, we are planning to increase capacity at our plant in Rancho Cucamonga, CA which will allow us to eventually quadruple the number of units produced at this facility. We are also increasing the capacity of our inhalation facility in Canton, MA and our insulin API production facility at ANP.
However, we are planning to increase capacity at our plant in Rancho Cucamonga, CA which should allow us to eventually quadruple the number of units produced at this facility. We are also increasing the capacity of our inhalation facility in Canton, MA and our insulin API production facility at ANP.
The corporate, agency and municipal bonds are classified as held-to-maturity and are carried at amortized cost net of allowance for credit losses. The fair value of such bonds is disclosed in Note 10 and was 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. The fair value of such bonds is disclosed in Note 9 and was determined based on Level 2 inputs.
For these and other reasons, actual results may vary significantly from estimated results. Shipping and Handling Costs For the years ended December 31, 2023, 2022, and 2021, the Company included shipping and handling costs of approximately $7.0 million, $7.4 million and $4.3 million, respectively, in selling, distribution and marketing expenses in the accompanying consolidated statements of operations. Advertising Expense Advertising expenses, primarily associated with Primatene MIST ® , are recorded as they are incurred, except for expenses related to the development of a major commercial or media campaign, which are expensed in the period in which the commercial or campaign is first presented, and are reflected as a component of selling, distribution and marketing in the Company’s consolidated statements of operations.
For these and other reasons, actual results may vary significantly from estimated results. Shipping and Handling Costs For the years ended December 31, 2024, 2023, and 2022, the Company included shipping and handling costs of approximately $8.0 million, $7.0 million and $7.4 million, respectively, in selling, distribution and marketing expenses in the accompanying consolidated statements of operations. Advertising Expense Advertising expenses, primarily associated with Primatene MIST ® , are recorded as they are incurred, except for expenses related to the development of a major commercial or media campaign, which are expensed in the period in which the commercial or campaign is first presented, and are reflected as a component of selling, distribution and marketing in the Company’s consolidated statements of operations.
We own or lease a total of 67 buildings at six locations in the U.S., France and China, that comprise 2.4 million square feet of manufacturing, research and development, distribution, packaging, laboratory, office and warehouse space.
We own or lease a total of 68 buildings at six locations in the U.S., France and China, that comprise 2.4 million square feet of manufacturing, research and development, distribution, packaging, laboratory, office and warehouse space.
Information required by this item will be included in our 2024 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Information required by this item will be included in our 2025 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
None. 156 Table of Contents SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. AMPHASTAR PHARMACEUTICALS, INC. (Registrant) By: /s/ JACK Y.
None. 149 Table of Contents SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. AMPHASTAR PHARMACEUTICALS, INC. (Registrant) By: /s/ JACK Y.
For more information regarding our income taxes, see “Part II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 16. – Income Taxes.” Liquidity and Capital Resources Cash Requirements and Sources We need capital resources to maintain and expand our business.
For more information regarding our income taxes, see “Part II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 15. – Income Taxes.” Liquidity and Capital Resources Cash Requirements and Sources We need capital resources to maintain and expand our business.
The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s accompanying consolidated statements of operations. The Company’s French subsidiary, AFP, maintains its book of record in euros. AUK’s subsidiary, IMS UK, maintains its book of record in British pounds.
The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s accompanying consolidated statements of operations. The Company’s French subsidiary, AFP, maintains its books of record in euros. AUK’s subsidiary, IMS UK, maintains its books of record in British pounds.
(the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive income, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”).
(the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”).
Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. 149 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Amphastar Pharmaceuticals, Inc. Opinion on Internal Control Over Financial Reporting We have audited Amphastar Pharmaceuticals, Inc.’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. 142 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Amphastar Pharmaceuticals, Inc. Opinion on Internal Control Over Financial Reporting We have audited Amphastar Pharmaceuticals, Inc.’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
These risk assessments include identification of reasonably foreseeable internal and external risks, the likelihood and 82 Table of Contents potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems, and safeguards in place to manage such risks. Following these risk assessments, we re-design, implement, and maintain reasonable safeguards to minimize identified risks; reasonably address any identified gaps in existing safeguards; and regularly monitor the effectiveness of our safeguards.
These risk assessments include identification of reasonably foreseeable internal and external risks, the likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems, and safeguards in place to manage such risks. Following these risk assessments, we re-design, implement, and maintain reasonable safeguards to minimize identified risks; reasonably address any identified gaps in existing safeguards; and regularly monitor the effectiveness of our safeguards.
The remaining amounts of our cash equivalents as of December 31, 2022, are in non-interest bearing accounts. We maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits.
The remaining amounts of our cash equivalents as of December 31, 2023, are in non-interest bearing accounts. We maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits.
The carrying value of the Company’s long-term obligations, with the exception of the convertible debt (See Note 15) approximates their fair value, as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities.
The carrying value of the Company’s long-term obligations, with the exception of the convertible debt (See Note 14) approximates their fair value, as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 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 ® product rights 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 11 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.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS The total purchase price was allocated to the acquired assets based on their relative fair values, as follows: Fair Value (in thousands) Property, plant, and equipment $ 34,426 BAQSIMI ® product rights 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 was accreted to the full $129.0 million amount over a one-year period through interest expense.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Amended and Restated 2015 Equity Incentive Plan In March 2015, the Board of Directors adopted the Company’s 2015 Equity Incentive Plan, or the 2015 Plan, which was approved by the Company’s stockholders in May 2015 and is set to expire in March 2025.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Amended and Restated 2015 Equity Incentive Plan In March 2015, the Board of Directors adopted the Company’s 2015 Equity Incentive Plan, or the Original 2015 Plan, which was approved by the Company’s stockholders in May 2015 and was set to expire in March 2025.
Information required by this item will be included in our 2024 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K. Item 13. Certain Relationships and Related Transactions, and Director Independence. Information required by this item will be included in our 2024 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K.
Information required by this item will be included in our 2025 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K. Item 13. Certain Relationships and Related Transactions, and Director Independence. Information required by this item will be included in our 2025 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K.
As of December 31, 2023 and 2022, the balance of restricted short-term investments was $2.2 million. Allowance for Credit Losses The Company evaluates the collectability of accounts receivable based on a combination of factors.
As of December 31, 2024 and 2023, the balance of restricted short-term investments was $2.2 million. Accounts receivable and Allowance for Credit Losses The Company evaluates the collectability of accounts receivable based on a combination of factors.
The liability is included in other long-term liabilities in the accompanying consolidated balance sheets. The plan is currently unfunded, and the benefit obligation under the plan was $2.6 million and $2.2 million at December 31, 2023 and 2022, respectively.
The liability is included in other long-term liabilities in the accompanying consolidated balance sheets. The plan is currently unfunded, and the benefit obligation under the plan was $2.6 million and $2.6 million at December 31, 2024 and 2023, respectively.
The unrealized gains or losses of intercompany foreign currency transactions that are of a long-term investment nature are reported in other comprehensive income (loss). The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature for the years ended December 31, 2023, 2022, and 2021 were a $1.1 million gain, a $1.8 million loss, and a $2.6 million loss, respectively. Comprehensive Income (loss) The Company’s comprehensive income (loss) includes its foreign currency translation gains and losses, changes in pension obligations as well as its share of other comprehensive income from its equity method investments. Acquisitions 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.
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. The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature for the years ended December 31, 2024, 2023, and 2022 were a $1.9 million loss, a $1.1 million gain, and a $1.8 million loss, respectively. Comprehensive Income The Company’s comprehensive income includes its foreign currency translation gains and losses, changes in pension obligations as well as its share of other comprehensive income from its equity method investments. Acquisitions 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.
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.
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, group purchasing organizations and pharmacy benefit managers in the United States.
(incorporated by reference to Exhibit 10.39 to the Company’s Annual Report on Form 10-K filed with the SEC on March 16, 2020) 10.18+ Amphastar Pharmaceuticals, Inc. 2015 Equity Incentive Plan, as amended and restated effective as of November 3, 2020 (incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2020) 10.19* Sixth Amendment to the Supply Agreement by and between MannKind Corporation and Amphastar Pharmaceuticals, Inc., dated May 24, 2021 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021) 10.20* Share Purchase Agreement by and between Amphastar Pharmaceuticals, Inc., Nanjing Zhongpan Enterprise Management Consulting Center (LLP), Nanjing Zhanrun Enterprise Management Consulting Center (LLP), and Listening Dragon Investment Company Limited, dated May 6, 2021 (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021) 10.21* Share Repurchase Agreement by and between Amphastar Pharmaceuticals, Inc., Nanjing Qianqia Enterprise Management Consulting (LLP), Nanjing Zhongpan Enterprise Management Consulting Center (LLP), and Nanjing Zhanrun Enterprise Management Consulting Center (LLP), dated May 6, 2021 (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021) 10.22 Credit Agreement dated August 4, 2021, between Amphastar Pharmaceuticals, Inc. and Capital One N.A. in the original sum of $140,000,000 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2021) 154 Table of Contents 10.23* Share Purchase Agreement by and between Amphastar Pharmaceuticals, Inc. and Nanjing Quanqia Enterprise Management Consulting, LLP, dated August 19, 2021 (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2021) 10.24* Contract Manufacturing Agreement by and between Amphastar Nanjing Pharmaceutical, Co.
Employee Deferred Compensation Plan, effective December 1, 2019 (incorporated by reference to Exhibit 10.39 to the Company’s Annual Report on Form 10-K filed with the SEC on March 16, 2020) 10.18+ Amphastar Pharmaceuticals, Inc. 2015 Equity Incentive Plan, as amended and restated effective as of November 3, 2020 (incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2020) 10.19* Sixth Amendment to the Supply Agreement by and between MannKind Corporation and Amphastar Pharmaceuticals, Inc., dated May 24, 2021 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021) 10.20* Share Purchase Agreement by and between Amphastar Pharmaceuticals, Inc., Nanjing Zhongpan Enterprise Management Consulting Center (LLP), Nanjing Zhanrun Enterprise Management Consulting Center (LLP), and Listening Dragon Investment Company Limited, dated May 6, 2021 (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021) 10.21* Share Repurchase Agreement by and between Amphastar Pharmaceuticals, Inc., Nanjing Qianqia Enterprise Management Consulting (LLP), Nanjing Zhongpan Enterprise Management Consulting Center (LLP), and Nanjing Zhanrun Enterprise Management Consulting Center (LLP), dated May 6, 2021 (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021) 10.22 Credit Agreement dated August 4, 2021, between Amphastar Pharmaceuticals, Inc. and Capital One N.A. in the original sum of $140,000,000 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2021) 147 Table of Contents 10.23* Share Purchase Agreement by and between Amphastar Pharmaceuticals, Inc. and Nanjing Quanqia Enterprise Management Consulting, LLP, dated August 19, 2021 (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2021) 10.24* Contract Manufacturing Agreement by and between Amphastar Nanjing Pharmaceutical, Co.
Treasury securities at the time of grant for instruments with maturities commensurate with the expected term of the stock option. Our volatility estimate was based on the weighted average historical volatility of our stock price since IPO. Our dividend yield was assumed to be 0%, because we have no plans to pay dividends.
Treasury securities at the time of grant for instruments with maturities commensurate with the expected term of the stock option. Our volatility estimate was based on the weighted average historical volatility of our stock price since IPO. Our 93 Table of Contents dividend yield was assumed to be 0%, because we have no plans to pay dividends.
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). We are also exposed to the potential earnings effects from intercompany foreign currency assets and liabilities that arise from normal trade receivables and payables and other intercompany loans. As of December 31, 2023, a theoretical 10% unfavorable change in the exchange rate of the U.S. dollar strengthening against the foreign currencies to which we have exposure would result in approximately $2.2 million reduction of foreign currency gains, and approximately $1.6 million reduction in other comprehensive income. As of December 31, 2022, a theoretical 10% unfavorable change in the exchange rate of the U.S. dollar strengthening against the foreign currencies to which we have exposure would result in approximately $2.6 million reduction of foreign currency gains, and approximately $1.6 million reduction in other comprehensive income. As of December 31, 2023 and 2022, our foreign subsidiaries had cash balances denominated in foreign currencies in the amount of $8.9 million and $2.5 million, respectively. 101 Table of Contents Item 8.
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). We are also exposed to the potential earnings effects from intercompany foreign currency assets and liabilities that arise from normal trade receivables and payables and other intercompany loans. As of December 31, 2024, a theoretical 10% unfavorable change in the exchange rate of the U.S. dollar strengthening against the foreign currencies to which we have exposure would result in approximately $1.2 million reduction of foreign currency gains, and approximately $3.1 million reduction in other comprehensive income. As of December 31, 2023, a theoretical 10% unfavorable change in the exchange rate of the U.S. dollar strengthening against the foreign currencies to which we have exposure would result in approximately $2.2 million reduction of foreign currency gains, and approximately $1.6 million reduction in other comprehensive income. As of December 31, 2024 and 2023, our foreign subsidiaries had cash balances denominated in foreign currencies in the amount of $6.6 million and $8.9 million, respectively. 96 Table of Contents Item 8.
The following graph illustrates a comparison of the total cumulative stockholder return on our common stock since December 31, 2018, with the cumulative stockholder return since December 31, 2018, on two indices: the Nasdaq Composite Index and the Nasdaq Biotechnology Index.
The following graph illustrates a comparison of the total cumulative stockholder return on our common stock since December 31, 2019, with the cumulative stockholder return since December 31, 2019, on two indices: the Nasdaq Composite Index and the Nasdaq Biotechnology Index.
These books are remeasured into the functional currency of USD, using the current or historical exchange rates. The resulting currency remeasurement 100 Table of Contents adjustments and other transactional foreign exchange gains and losses are reflected in our statement of operations. Our French subsidiary, AFP, maintains its books of record in euros.
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 exchange gains and losses are reflected in our consolidated statement of operations. 95 Table of Contents Our French subsidiary, AFP, maintains its books of record in euros.
(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and our report dated February 29, 2024 expressed an unqualified opinion thereon. Basis for Opinion The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Internal Reporting.
(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on the COSO criteria. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes and our report dated March 3, 2025 expressed an unqualified opinion thereon. Basis for Opinion The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Financial Reporting.
The graph assumes an initial investment of $100 on December 31, 2018, both in our common stock and each index. It also assumes reinvestment of dividends, if any.
The graph assumes an initial investment of $100 on December 31, 2019, both in our common stock and each index. It also assumes reinvestment of dividends, if any.
If we determine it is more likely than not that the Primatene ® trademark is impaired or the fair value of a reporting unit is less than its carrying amount, further quantitative impairment process is then performed; otherwise, no further testing is 97 Table of Contents required.
If we determine it is more likely than not that the Primatene ® trademark is impaired or the fair value of a reporting unit is less than its carrying amount, further quantitative impairment process is then performed; otherwise, no further testing is required.
Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset groups and its eventual disposition. If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset or asset groups, further impairment analysis is performed.
Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset groups and its eventual disposition. If the sum of the expected future undiscounted cash flows is less than 92 Table of Contents the carrying amount of the asset or asset groups, further impairment analysis is performed.
The carrying value, after recognition of any impairment loss, is amortized over its remaining useful life. Self-Insured Claims The Company is self-insured, up to certain limits, for workers’ compensation claims. The Company has purchased stop-loss insurance, which will reimburse the Company for individual claims in excess of $350,000 or aggregate minimum attachment of $4.8 million annually.
The carrying value, after recognition of any impairment loss, is amortized over its remaining useful life. Self-Insured Claims The Company is self-insured, up to certain limits, for workers’ compensation claims. The Company has purchased stop-loss insurance, which will reimburse the Company for individual claims in excess of $350,000 or aggregate minimum attachment of $5.3 million annually.
For a discussion of the year ended December 31, 2022, to the year ended December 31, 2021, please refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 1, 2023, which discussion is hereby incorporated herein by reference. Overview We are a bio-pharmaceutical company focusing primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin API products.
For a discussion of the year ended December 31, 2023, to the year ended December 31, 2022, please refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 29, 2024, which discussion is hereby incorporated herein by reference. Overview We are a bio-pharmaceutical company focusing primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin API products.
Auditing management's estimate in determining the net realizable value of enoxaparin inventory involved subjective auditor judgment because the estimation of the average selling price relies on a number of factors that are affected by market conditions outside the Company's control.
Auditing management's estimate in determining the net realizable value of Enoxaparin inventory involved subjective auditor judgment because the estimated selling price relies on a number of factors that are affected by market conditions outside the Company's control.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. None. 151 Table of Contents PART III Item 10. Directors, Executive Officers and Corporate Governance.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. None. 144 Table of Contents PART III Item 10. Directors, Executive Officers and Corporate Governance.
We have in the past approached capacity at one of our facilities largely as a result of the FDA’s request that we reintroduce certain previously discontinued products to help cope with a nationwide shortage of these products.
We have in the past approached capacity at one of our facilities largely as a result of the 79 Table of Contents FDA’s request that we reintroduce certain previously discontinued products to help cope with a nationwide shortage of these products.
Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 2. – Summary of Significant Accounting Policies”, we believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our audited consolidated financial statements.
Financial Statements and Supplementary Data – Notes to 90 Table of Contents Consolidated Financial Statements – Note 2. – Summary of Significant Accounting Policies”, we believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our audited consolidated financial statements.
For the years ended December 31, 2023, 2022 and 2021, the Company accrued interest of approximately $1.0 million, $0.8 million and $0.5 million, respectively, related to its uncertain tax positions. The Company and/or one or more of its subsidiaries files income tax returns in the U.S. federal jurisdiction and various U.S. states and foreign jurisdictions.
For the years ended December 31, 2024, 2023 and 2022, the Company accrued interest of approximately $1.3 million, $1.0 million and $0.8 million, respectively, related to its uncertain tax positions. The Company and/or one or more of its subsidiaries files income tax returns in the U.S. federal jurisdiction and various U.S. states and foreign jurisdictions.
As of December 31, 2023, none of our investments experienced any declines in fair value that we believe are other than temporary.
As of December 31, 2024, none of our investments experienced any declines in fair value that we believe are other than temporary.
Stock Performance Graph This graph shall not be deemed “soliciting material” or to be “filed” with the Securities and Exchange Commission for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities under that Section, and shall not be deemed to be incorporated by reference into any filing of Amphastar Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Exchange Act.
Stock Performance Graph This graph shall not be deemed “soliciting material” or to be “filed” with the Securities and Exchange Commission for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that Section, and shall not be deemed to be incorporated by reference into any filing of Amphastar Pharmaceuticals, Inc. under the Securities Act or the Exchange Act.
The cost is expected to be recognized over a weighted-average period of 2.5 years and will be adjusted for future changes in estimated forfeitures. 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 cost is expected to be recognized over a weighted-average period of 2.4 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 four years.
Total expense under the program was approximately $1.7 million, $0.3 million, and $0.5 million, for the years ended December 31, 2023, 2022 and 2021, respectively. The self-insured claims liability was $4.3 million and $3.7 million at December 31, 2023 and 2022, respectively.
Total expense under the program was approximately $2.0 million, $1.7 million, and $0.3 million, for the years ended December 31, 2024, 2023 and 2022, respectively. The self-insured claims liability was $5.2 million and $4.3 million at December 31, 2024 and 2023, respectively.
Item 14. Principal Accountant Fees and Services. Information required by this item will be included in our 2024 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K. 152 Table of Contents PART IV Item 15. Exhibits and Financial Statement Schedules.
Item 14. Principal Accountant Fees and Services. Information required by this item will be included in our 2025 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K. 145 Table of Contents PART IV Item 15. Exhibits and Financial Statement Schedules.
It is the Company’s plan not to repatriate future foreign earnings to the U.S. and indefinitely reinvest such earnings in the foreign jurisdiction. Uncertain Income Tax Positions A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows: December 31, 2023 2022 2021 (in thousands) Balance at the beginning of the year $ 12,895 $ 11,796 $ 10,053 Deductions based on tax positions related to prior year — (41) — Additions based on tax positions related to the current year 2,074 1,643 1,754 Deductions based on statute of limitations (2,476) (503) (11) Balance at the end of the year $ 12,493 $ 12,895 $ 11,796 Included in the balance of unrecognized tax benefits as of December 31, 2023 and 2022, was $11.7 million and $12.2 million, respectively that represents the portion that would impact the effective income tax rate if recognized. The Company recognizes interest and penalties related to unrecognized tax benefits in its income tax provision.
It is the Company’s plan not to repatriate future foreign earnings to the U.S. and indefinitely reinvest such earnings in the foreign jurisdiction. Uncertain Income Tax Positions A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows: December 31, 2024 2023 2022 (in thousands) Balance at the beginning of the year $ 12,493 $ 12,895 $ 11,796 Deductions based on tax positions related to prior year — — (41) Additions based on tax positions related to the current year 2,659 2,074 1,643 Deductions based on statute of limitations (1,414) (2,476) (503) Balance at the end of the year $ 13,738 $ 12,493 $ 12,895 Included in the balance of unrecognized tax benefits as of December 31, 2024 and 2023, was $12.7 million and $11.7 million, respectively that represents the portion that would impact the effective income tax rate if recognized. The Company recognizes interest and penalties related to unrecognized tax benefits in its income tax provision.
As of December 31, 2023 and 2022, the Company's allowance for credit losses was $2.8 million and $2.7 million, respectively. Inventories Inventories consist of currently marketed products and products manufactured under contract. Inventories are stated using the first-in, first-out method, on a consistent basis. The Company states inventory at the lower of cost or net realizable value.
As of December 31, 2024 and 2023, the Company's allowance for credit losses was $3.5 million and $2.8 million, respectively. Inventories Inventories consist of currently marketed products and products manufactured under contract. Inventories are stated using the first-in, first-out method, on a consistent basis. The Company states inventory at the lower of cost or net realizable value.
(incorporated by reference to Exhibit 10.45 to the Company’s Annual Report on Form 10-K filed with the SEC on March 15, 2018) 10.16* Fifth Amendment to the Supply Agreement by and between MannKind Corporation and Amphastar Pharmaceuticals, Inc., dated August 2, 2019.
(incorporated by reference to Exhibit 10.45 to the Company’s Annual Report on Form 10-K filed with the SEC on March 15, 2018) 10.16* Fifth Amendment to the Supply Agreement by and between MannKind Corporation and Amphastar Pharmaceuticals, Inc., dated August 2, 2019 (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2019) 10.17 Amphastar Pharmaceuticals, Inc.
Our cash obligations include the principal and interest payments due on our existing loans and lease payments, as described below and throughout this Annual Report on Form 10-K. As of December 31, 2023, our foreign subsidiaries collectively held $11.2 million in cash and cash equivalents.
Our cash obligations include the principal and interest payments due on our existing loans and lease payments, as described below and throughout this Annual Report on Form 10-K. As of December 31, 2024, our foreign subsidiaries collectively held $9.2 million in cash and cash equivalents.
The 2015 Plan is designed to meet the needs of a publicly traded company, including the requirements for granting “performance based compensation” under Section 162(m) of the Internal Revenue Code.
The Original 2015 Plan was designed to meet the needs of a publicly traded company, including the requirements for granting “performance based compensation” under Section 162(m) of the Internal Revenue Code.
For the years ended December 31, 2023, 2022 and 2021, the Company estimated an average overall forfeiture rate of approximately 7%, 7%, and 6%, respectively, based on historical experience. Forfeiture rates are separately estimated for its (1) directors and officers, (2) management personnel and (3) other employees. Share-based compensation is recorded net of expected forfeitures.
For each of the years ended December 31, 2024, 2023 and 2022, the Company estimated an average overall forfeiture rate of approximately 7% based on historical experience. Forfeiture rates are separately estimated for its (1) directors and officers, (2) management personnel and (3) other employees. Share-based compensation is recorded net of expected forfeitures.
Total employer contributions for the years ended December 31, 2023, 2022, and 2021 were approximately $2.3 million, $2.2 million, and $2.0 million, respectively. Defined Benefit Pension Plan The Company’s subsidiary, AFP, has an obligation associated with a defined-benefit plan for its eligible employees.
Total employer contributions for the years ended December 31, 2024, 2023, and 2022 were approximately $2.6 million, $2.3 million, and $2.2 million, respectively. Defined Benefit Pension Plan The Company’s subsidiary, AFP, has an obligation associated with a defined-benefit plan for its eligible employees.
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.
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.
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 3.25% and 3.75% as of December 31, 2023 and 2022, respectively.
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 3.40% and 3.25% as of December 31, 2024 and 2023, respectively.
For the years ended December 31, 2023, 2022, and 2021, advertising expenses were $10.4 million, $8.7 million, and $8.1 million, respectively. Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities.
For the years ended December 31, 2024, 2023, and 2022, advertising expenses were $10.5 million, $10.4 million, and $8.7 million, respectively. Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities.
(1) See Note 4. (2) In June 2023, the Company recorded an impairment related to its IMS (UK) international product rights in the amount of $2.7 million.
(1) See Note 3. In 2023, the Company recorded an impairment related to its IMS (UK) international product rights in the amount of $2.7 million.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 97.1 Compensation Recovery Policy of the Company 101.INS XBRL Instance Document –The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document 101.SCH Inline XBRL Taxonomy Extension Schema Document 155 Table of Contents 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document 101.DEF Inline XBRL Taxonomy Extension Definitions Linkbase Document 104 Cover Page Interactive File (formatted as Inline XBRL and contained in Exhibit 101) # The information in Exhibits 32.1 and 32.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act (including this Report), unless the registrant specifically incorporates the foregoing information into those documents by reference. * Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10). + Indicates a management contract or compensatory plan or arrangement. ◊ English translation of original Chinese document. † Confidential treatment requested as to portions of the exhibit.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 97.1 Compensation Recovery Policy of the Company (incorporated by reference to Exhibit 97.1 to the Company’s Annual Report on Form 10-K filed with the SEC on February 29, 2024) 101.INS XBRL Instance Document –The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document 101.SCH Inline XBRL Taxonomy Extension Schema Document 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document 101.DEF Inline XBRL Taxonomy Extension Definitions Linkbase Document 104 Cover Page Interactive File (formatted as Inline XBRL and contained in Exhibit 101) # The information in Exhibits 32.1 and 32.2 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act (including this Report), unless the registrant specifically incorporates the foregoing information into those documents by reference. * Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10). + Indicates a management contract or compensatory plan or arrangement. ◊ English translation of original Chinese document. † Confidential treatment requested as to portions of the exhibit.
The cost is expected to be recognized over a weighted-average period of 2.5 years and will be adjusted for future changes in estimated forfeitures. 141 Table of Contents AMPHASTAR PHARMACEUTICALS, INC.
The cost is expected to be recognized over a weighted-average period of 2.4 years and will be adjusted for future changes in estimated forfeitures. 135 Table of Contents AMPHASTAR PHARMACEUTICALS, INC.
Four of the ANDAs and one of the biosimilar insulin candidates are currently on file with the FDA. To complement our internal growth and expertise, we have made several strategic acquisitions of companies, products and technologies.
Four of the ANDAs are currently on file with the FDA. To complement our internal growth and expertise, we have made several strategic acquisitions of companies, products and technologies.
The duration of the trading arrangement is until May 17, 2024, or earlier if all transactions under the trading arrangement are completed. No other officers or directors, as defined in Rule 16a-1(f), adopted or terminated a Rule 10b5-1 trading arrangement, or a non-Rule 10b5-1 trading arrangement, each as defined in Regulation S-K Item 408. Item 9C.
The duration of the trading arrangement is until January 3, 2026, or earlier if all transactions under the trading arrangement are completed. No other officers or directors, as defined in Rule 16a-1(f), adopted or terminated a Rule 10b5-1 trading arrangement, or a non-Rule 10b5-1 trading arrangement, each as defined in Regulation S-K Item 408. Item 9C.
The Company had France and United Kingdom foreign NOL carryforwards of approximately $76.2 million and $2.8 million, respectively. The France and United Kingdom NOL carryforwards can be used annually with certain limitations and have an indefinite carryforward. At December 31, 2023, the Company had California research and development tax credit carryforwards of approximately $20.2 million.
The Company had France and United Kingdom foreign NOL carryforwards of approximately $83.6 million and $2.8 million, respectively. The France and United Kingdom NOL carryforwards can be used annually with certain limitations and have an indefinite carryforward. At December 31, 2024, the Company had California research and development tax credit carryforwards of approximately $20.3 million.
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