Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data.
Index to Amphastar Pharmaceuticals, Inc. Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 )
98
Consolidated Balance Sheets
100
Consolidated Statements of Operations
101
Consolidated Statements of Comprehensive Income
102
Consolidated Statements of Stockholders’ Equity
103
Consolidated Statements of Cash Flows
104
Notes to Consolidated Financial Statements
105
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Amphastar Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Amphastar Pharmaceuticals, Inc. (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”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company'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), and our report dated March 3, 2025 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Provision for chargebacks estimate
Description of the Matter
The Company’s provision for chargebacks estimate totaled $26.3 million at December 31, 2024. As described in Note 4 to the consolidated financial statements, the Company estimates the provision for chargebacks using the expected value method at the time of sale to wholesalers.
Auditing the provision for chargebacks estimate was especially challenging because of the subjectivity of management assumptions about future wholesale customer mix and related contract pricing, which impact the rates at which future chargebacks on current sales will be paid. The estimated provision for chargebacks is based on wholesaler inventory levels, historic chargeback rates, and current contract pricing and wholesaler customer mix.
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How We Addressed the Matter in Our Audit
We tested the Company’s controls addressing the identified risks of material misstatement related to the valuation of the provision for chargebacks. This included testing controls over management’s review of significant assumptions discussed above. This testing also included management’s control to compare subsequent actual activity to estimated activity and controls to ensure the data used to evaluate the significant assumptions was complete and accurate.
To test the provision for chargebacks estimate, we obtained management’s calculations and performed the following procedures, among others. We evaluated the appropriateness of the Company’s models and methodology, including recalculating the estimate using those models, and testing the completeness and accuracy of the inputs by comparing to internal and external data. 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. We evaluated subsequent events to assess whether there was any new information that would require adjustment to the initial provision.
Estimated selling price impacting the Enoxaparin inventory lower of cost or net realizable value
Description of the Matter
The Company's inventories totaled $153.7 million as of December 31, 2024 which is net of, amongst other things, provisions to reduce the value of Enoxaparin inventory to the lower of its cost and net realizable value. Total charges of $7.4 million related to Enoxaparin inventory and related purchase commitments were included in cost of revenues in the Company’s consolidated statement of operations for the year ended December 31, 2024. As explained in Note 2 to the consolidated financial statements, the Company states inventory at the lower of cost or net realizable value. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose of the inventory.
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. In particular, the estimated selling price forecast is sensitive to changes in significant assumptions, including demand for the Company’s products, customer mix, expected competition, and planned price changes.
How We Addressed the Matter in Our Audit
We obtained an understanding, evaluated the design, and tested the operating effectiveness of internal controls over the Company's estimated selling price impacting the Enoxaparin inventory lower of cost or net realizable value. This included controls over management's assessment of assumptions such as future demand, customer mix, expected competition, and planned price changes.
Our substantive audit procedures included, among others, evaluating the significant assumptions stated above and the accuracy and completeness of the underlying data management used to develop the estimated selling price. We evaluated adjustments to the estimated selling price for specific considerations, such as demand for the Company’s products, new significant customers, competitors, or planned price changes. We evaluated the reasonableness of management’s estimated selling price and whether expected changes in demand, competition, customer mix, or planned price changes were appropriate by comparing with the Company’s historical data and market conditions. We also performed sensitivity analyses over the estimated selling price assumptions and assessed the historical accuracy of management's estimates by performing retrospective reviews over prior periods' estimated selling prices.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 1998.
Irvine, California
March 3, 2025
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AMPHASTAR PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
December 31,
December 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$
151,609
$
144,296
Restricted cash
235
235
Short-term investments
70,036
112,510
Restricted short-term investments
2,200
2,200
Accounts receivable, net
136,289
114,943
Inventories
153,741
105,833
Income tax refunds and deposits
1,747
526
Prepaid expenses and other assets
18,214
9,057
Total current assets
534,071
489,600
Property, plant, and equipment, net
297,345
282,746
Finance lease right-of-use assets
383
564
Operating lease right-of-use assets
46,899
32,333
Investment in unconsolidated affiliate
—
527
Goodwill and intangible assets, net
590,660
613,295
Long-term investments
10,996
14,685
Other assets
25,992
25,910
Deferred tax assets
71,124
53,252
Total assets
$
1,577,470
$
1,512,912
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$
157,057
$
93,366
Accrued payments for BAQSIMI ® (see Note 3)
—
126,090
Income taxes payable
9,664
1,609
Current portion of long-term debt
234
436
Current portion of operating lease liabilities
6,804
3,906
Total current liabilities
173,759
225,407
Long-term reserve for income tax liabilities
6,957
6,066
Long-term debt, net of current portion and unamortized debt issuance costs
601,630
589,579
Long-term operating lease liabilities, net of current portion
41,881
29,721
Other long-term liabilities
20,945
22,718
Total liabilities
845,172
873,491
Commitments and contingencies
Stockholders’ equity:
Preferred stock: par value $ 0.0001 ; 20,000,000 shares authorized; no shares issued and outstanding
—
—
Common stock: par value $ 0.0001 ; 300,000,000 shares authorized; 60,847,124 and 47,617,691 shares issued and outstanding, respectively, as of December 31, 2024 and 59,390,194 and 48,068,881 shares issued and outstanding, respectively, as of December 31, 2023
6
6
Additional paid-in capital
505,400
486,056
Retained earnings
568,787
409,268
Accumulated other comprehensive loss
( 9,181 )
( 8,478 )
Treasury stock
( 332,714 )
( 247,431 )
Total equity
732,298
639,421
Total liabilities and stockholders’ equity
$
1,577,470
$
1,512,912
See accompanying notes to consolidated financial statements.
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AMPHASTAR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Year Ended December 31,
2024
2023
2022
Net revenues:
Product revenues, net
$
712,814
$
593,238
$
498,987
Other revenues
19,153
51,157
—
Total net revenues
731,967
644,395
498,987
Cost of revenues
358,112
293,274
250,127
Gross profit
373,855
351,121
248,860
Operating expenses:
Selling, distribution, and marketing
37,802
28,853
21,531
General and administrative
56,720
51,540
45,061
Research and development
73,914
73,741
74,771
Total operating expenses
168,436
154,134
141,363
Income from operations
205,419
196,987
107,497
Non-operating income (expenses):
Interest income
10,612
5,459
1,321
Interest expense
( 30,343 )
( 27,158 )
( 1,846 )
Other income (expenses), net
4,076
( 3,929 )
9,068
Total non-operating income (expenses), net
( 15,655 )
( 25,628 )
8,543
Income before income taxes
189,764
171,359
116,040
Income tax provision
29,672
31,833
23,477
Income before equity in losses of unconsolidated affiliate
160,092
139,526
92,563
Equity in losses of unconsolidated affiliate
( 573 )
( 1,981 )
( 1,177 )
Net income
$
159,519
$
137,545
$
91,386
Net income per share:
Basic
$
3.29
$
2.85
$
1.88
Diluted
$
3.06
$
2.60
$
1.74
Weighted-average shares used to compute net income per share:
Basic
48,429
48,265
48,551
Diluted
52,058
53,001
52,427
See accompanying notes to consolidated financial statements.
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AMPHASTAR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(in thousands)
Year Ended December 31,
2024
2023
2022
Net income
$
159,519
$
137,545
$
91,386
Other comprehensive income (loss), net of income taxes
Foreign currency translation adjustment
( 695 )
298
( 2,335 )
Change in pension obligations
( 8 )
( 152 )
476
Total other comprehensive income (loss)
( 703 )
146
( 1,859 )
Total comprehensive income
$
158,816
$
137,691
$
89,527
See accompanying notes to consolidated financial statements.
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Amphastar Pharmaceuticals, Inc.
Consolidated 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.
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AMPHASTAR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended December 31,
2024
2023
2022
Cash Flows From Operating Activities:
Net income
$
159,519
$
137,545
$
91,386
Reconciliation to net cash provided by operating activities:
Loss on disposal of assets
9
475
141
Impairment of long-lived assets
—
2,700
—
Loss (gain) on interest rate swaps and foreign currency transactions, net
( 2,792 )
5,330
( 2,196 )
Depreciation of property, plant, and equipment
28,249
25,205
23,815
Amortization of intangible assets
24,718
12,830
954
Operating lease right-of-use asset amortization
4,238
3,742
3,506
Amortization of discounts, premiums, and debt issuance costs
6,032
11,399
466
Equity in losses of unconsolidated affiliate
573
1,981
1,177
Share-based compensation expense
24,368
20,242
17,860
Changes in reserve for uncertain tax positions
891
( 1,159 )
694
Changes in deferred taxes, net
( 17,872 )
( 12,578 )
( 16,445 )
Changes in operating assets and liabilities:
Accounts receivable, net
( 21,671 )
( 26,086 )
( 10,132 )
Inventories
( 48,797 )
( 1,724 )
( 11,746 )
Prepaid expenses and other assets
( 10,726 )
( 2,728 )
( 1,854 )
Income tax refunds, deposits, and payable, net
6,834
( 3,319 )
( 4,555 )
Operating lease liabilities
( 3,750 )
( 3,589 )
( 3,154 )
Accounts payable and accrued liabilities
63,563
13,237
( 736 )
Net cash provided by operating activities
213,386
183,503
89,181
Cash Flows From Investing Activities:
BAQSIMI ® acquisition (see Note 3)
( 129,000 )
( 506,406 )
—
Purchases and construction of property, plant, and equipment
( 41,041 )
( 38,166 )
( 24,034 )
Proceeds from the sale of property, plant and equipment
—
—
421
Purchase of investments
( 76,792 )
( 144,556 )
( 35,761 )
Maturity of investments
126,022
38,622
27,969
Deposits and other assets
( 4,119 )
1,390
( 1,372 )
Net cash used in investing activities
( 124,930 )
( 649,116 )
( 32,777 )
Cash Flows From Financing Activities:
Proceeds from equity plans, net of withholding tax payments
( 4,849 )
10,974
15,658
Purchase of treasury stock
( 85,458 )
( 58,144 )
( 39,909 )
Debt issuance costs
( 816 )
( 25,079 )
( 407 )
Proceeds from borrowing under lines of credit
18,433
—
—
Proceeds from issuance of long-term debt
—
845,000
—
Principal payments on long-term debt
( 8,263 )
( 318,658 )
( 1,781 )
Net cash provided by (used in) financing activities
( 80,953 )
454,093
( 26,439 )
Effect of exchange rate changes on cash
( 190 )
( 282 )
( 220 )
Net increase (decrease) in cash, cash equivalents, and restricted cash
7,313
( 11,802 )
29,745
Cash, cash equivalents, and restricted cash at beginning of period
144,531
156,333
126,588
Cash, cash equivalents, and restricted cash at end of period
$
151,844
$
144,531
$
156,333
Noncash Investing and Financing Activities:
Deferred payment for BAQSIMI ® acquisition
$
—
$
121,699
$
—
Capital expenditures included in accounts payable
$
5,622
$
4,454
$
5,256
Operating lease right-of-use assets in exchange for operating lease liabilities
$
18,804
$
10,521
$
2,166
Equipment acquired under finance leases
$
—
$
—
$
642
Supplemental Disclosures of Cash Flow Information:
Interest paid, net of capitalized interest
$
26,811
$
17,573
$
3,023
Income taxes paid
$
40,104
$
49,001
$
44,442
See accompanying notes to consolidated financial statements
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AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Business
Amphastar Pharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, hereinafter referred to as the “Company”) is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, including products with high technical barriers to market entry. Additionally, the Company sells insulin active pharmaceutical ingredient, or API, products. Most of the Company’s products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company’s insulin API products are sold to other pharmaceutical companies for use in their own products and are being used by the Company in the development of injectable finished pharmaceutical products. The Company’s over-the-counter inhalation product, Primatene MIST ® , is primarily distributed through drug retailers.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries, and are prepared in accordance with United States generally accepted accounting principles, or GAAP. All intercompany activity has been eliminated in the preparation of the consolidated financial statements. In the opinion of management, the accompanying consolidated financial statements include all adjustments, which are of a normal recurring nature, necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company.
The Company’s subsidiaries include: (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Amphastar Nanjing Pharmaceuticals Inc., or ANP, (4) Amphastar France Pharmaceuticals, S.A.S., or AFP, (5) Amphastar UK Ltd., or AUK, (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 consolidated statements of operations. Investments accounted for using the equity method may be reported on a lag of up to three months if financial statements of the investee are not available in sufficient time for the investor to apply the equity method as of the current reporting date.
The carrying value of equity method investments is reported as “Investment in unconsolidated affiliate” in the accompanying consolidated balance sheets. The Company’s equity method investments are reported at cost and adjusted each period for the Company’s share of the investee’s earnings or losses and dividends paid, if any.
Use of Estimates
The preparation of the consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: 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, litigation reserves, stock price volatility for share-based compensation expense, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions.
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AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Foreign Currency
The functional currency of the Company, its domestic subsidiaries, its Chinese subsidiary ANP, and its U.K. subsidiary, AUK, is the U.S. Dollar, or USD. ANP maintains its books of record in Chinese yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s accompanying consolidated statements of operations.
The Company’s French subsidiary, AFP, maintains its books of record in euros. AUK’s subsidiary, IMS UK, maintains its books 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. 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. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and substantive processes that have the ability to create outputs, which would meet the definition of a business.
Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.
For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis, with the exception of non-qualifying assets. Goodwill is not recognized in an asset acquisition. When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration, including assumed contingent considerations, is not recognized until all contingencies are resolved and the consideration is paid or becomes payable (unless contingent considerations meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired), at which point the consideration is allocated to the assets acquired based on their relative
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AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
fair values at the acquisition date, with the exception of non-qualifying assets.
Judgments are used in determining estimates of useful lives of long-lived assets. Useful life estimates are based on, among other factors, estimates of expected future net cash flows, the assessment of each asset’s life cycle, and the impact of competitive trends on each asset’s life cycle and other factors. These judgments can materially impact the estimates used to allocate purchase consideration to assets acquired and liabilities assumed, and the resulting timing and amounts charged to or recognized in current and future operating results. For these and other reasons, actual results may vary significantly from estimated results.
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. 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. These include salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, research-related overhead expenses and fees paid to external service providers.
The Company may produce or purchase inventories prior to or with the expectation of receiving regulatory approval in the near term, based on operational decisions about the most effective use of existing resources. This inventory is referred to as pre-launch inventory. It is the Company’s accounting policy that the pre-launch inventory is capitalized if it has a probable future economic benefit at the time it is purchased or manufactured. If regulatory approval is received and previously expensed pre-launch inventory is sold, such sales may contribute up to a 100% margin to the Company’s operating results. Pre-launch inventory costs include cost of work in process, materials, and finished drug products. For the years ended December 31, 2024, 2023, and 2022, the Company did not have material capitalized pre-launch inventory.
Financial Instruments
The Company’s accompanying consolidated balance sheets include the following financial instruments: cash and cash equivalents, restricted cash, accounts receivable, accounts payable, accrued expenses, short-term borrowings and long-term obligations. The Company considers the carrying amounts of current assets and liabilities on the consolidated balance sheets to approximate the fair value of these financial instruments due to the short maturity of these items. 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. The Company at times enters into interest rate swap contracts to manage its exposure to interest rate changes and its overall cost of long-term debt. The Company’s interest rate swap contracts exchange the variable interest rates for fixed interest rates.
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Cash and Cash Equivalents
Cash and cash equivalents consist of cash, money market accounts, certificates of deposit and highly liquid investments with original maturities of three months or less.
Investments
Investments as of December 31, 2024 and 2023 consisted of certificates of deposit and investment grade corporate, agency, and municipal bonds with original maturity dates between three and nineteen months.
Restricted Cash
Restricted cash is collateral required for the Company to guarantee certain vendor payments in France. 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. 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. When the Company is aware of circumstances that may impair a customer’s ability to pay subsequent to the original sale, the Company records a specific allowance to reduce the amounts receivable to the amount that the Company reasonably believes to be collectable. For all other customers, the Company recognizes an allowance for credit losses based on factors that include the length of time the receivables are past due, industry and geographic concentrations, the current economic conditions and historical collection experience. As of December 31, 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. Provisions are made for slow moving, unsellable, or obsolete items. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose.
Property, Plant and Equipment
Property, plant and equipment are stated at cost or, in the case of assets acquired in a business combination, at fair value on the purchase date. Depreciation and amortization expense is computed using the straight-line method over the estimated useful lives of the related assets as follows:
Buildings
20 - 31 years
Machinery and equipment
3 - 12 years
Furniture and fixtures
3 - 7 years
Automobiles
4 - 5 years
Leasehold improvements
Lesser of remaining lease term or useful life
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Intangible Assets
Intangible assets with finite lives are amortized using the straight-line method over the period the asset is expected to contribute directly or indirectly to the future cash flows of the Company as follows:
Product rights
10 - 24 years
Land-use rights
37 - 50 years
Other intangibles
6 - 20 years
Impairment of Long-Lived Assets, including Identifiable Definite-Lived Intangible Assets
The Company assesses long-term and identifiable definite-lived intangible assets or asset groups for impairment when events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset or asset group, further impairment analysis is performed. An impairment loss is measured as the amount by which the carrying amount of the asset or asset groups exceeds the fair value (assets to be held and used) or fair value less cost to sell (assets to be disposed of). The Company also assesses the useful lives of its assets periodically to determine whether events and circumstances warrant a revision to the remaining useful life. Changes in the useful life are adjusted prospectively by revising the remaining period over which the asset is amortized.
Deferred Income Taxes
The Company utilizes the liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized.
Debt Issuance Costs
Debt issuance costs related to non-revolving debt are recognized as a reduction to the related debt balance in the accompanying consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Debt issuance costs associated with revolving debt are capitalized within other long-term assets on the consolidated balance sheets and are amortized to interest expense over the term of the related revolving debt.
Convertible Debt
The Company accounts for its convertible debt instruments as a single unit of account, a liability, because the Company concluded that the conversion features do not require bifurcation as a derivative under Accounting Standards Codification, or ASC, 815-15, Derivatives and Hedging and the Company did not issue its convertible debt instruments at a substantial premium.
In accordance with Accounting Standards Update, or ASU, 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) : Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , the Company evaluates convertible debt instruments to determine if the conversion feature is freestanding or embedded. If the conversion feature does not require derivative treatment under ASC 815, the instrument is evaluated under ASC 470-20, “ Debt with Conversion and Other Options” for consideration of any beneficial conversion features. If no beneficial conversion features exist that require separate
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recognition, convertible debt instruments are accounted for as a single liability measured at its amortized cost as long as no other features require separation and recognition as derivatives.
Impairment of Indefinite-Lived Intangible Asset and Goodwill
The Company assesses indefinite lived intangible asset and goodwill for impairment in the fourth quarter of each year or more frequently if indicators of impairment are present. When the Company chooses to perform a qualitative assessment, it evaluates economic, industry and company-specific factors as an initial step. If the Company determines it is more likely than not that the indefinite-lived intangible asset is impaired or the fair value of a reporting unit is less than its carrying amount, further quantitative impairment testing is then performed; otherwise, no further testing is required. An impairment loss is recorded if the asset’s fair value is less than its carrying value. The Company also periodically assesses its indefinite-lived intangible asset to determine if events and circumstances continue to support an indefinite useful life. If the life is no longer indefinite, the asset is tested for impairment. The carrying value, after recognition of any impairment loss, is amortized over its remaining useful life.
Self-Insured Claims
The Company is 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. The cost of claims reported and an estimate of claims incurred but not reported are charged to operating expenses. A liability for unpaid claims and the associated claim expenses, including incurred but not reported losses, is actuarially determined and reflected in accrued liabilities in the accompanying consolidated balance sheets. Total expense under the program was approximately $ 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. The determination of such claims and expenses and the appropriateness of the related liability is reviewed periodically and updated, as necessary. Changes in estimates are recorded in the period identified.
Litigation, Commitments and Contingencies
Litigation, commitments and contingencies are accrued when management, after considering the facts and circumstances of each matter as then known to management, has determined it is probable a liability will be found to have been incurred and the amount of the loss can be reasonably estimated. When only a range of amounts is reasonably estimable and no amount within the range is more likely than another, the low end of the range is recorded. Legal fees are expensed as incurred. Due to the inherent uncertainties surrounding gain contingencies, the Company generally does not recognize potential gains until they are realized.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures which is intended to improve reportable segment disclosure requirements, primarily through additional disclosures about significant segment expenses. 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 adoption of this guidance did not have a material impact on the Company’s consolidated financial statements and related disclosures.
In December 2023, the FASB issued Accounting Standard Update 2023-09, Income taxes (Topic 740): Improvements to Income Tax Disclosures which requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the disclosure
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requirements related to the new standard.
In November 2024, the FASB issued ASU 2024-03, Income Statement Reporting-Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income Statement Expenses . The standard update improves the disclosures about a public business entity’s expenses by requiring more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation and amortization) included within income statement expense captions. The guidance will be effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The standard updates are to be applied prospectively with the option for retrospective application. The Company is currently evaluating the impact of disclosure requirements related to the new standard on its financial statements.
Note 3. BAQSIMI ® Acquisition
On June 30, 2023, the Company completed its acquisition of BAQSIMI ® glucagon nasal powder, or BAQSIMI ® pursuant to an asset purchase agreement, or the Purchase Agreement, with Eli Lilly & Company, or Lilly, dated April 21, 2023. In connection with the closing of the transaction, or the Closing, the Company paid Lilly $ 500.0 million in cash. In addition, the Company paid to Lilly a $ 125.0 million guaranteed payment on the first anniversary of the Closing. The Company also paid Lilly $ 4.0 million upon the assignment of certain contracts to the Company. The Company may also be required to pay additional contingent consideration of up to $ 450.0 million to Lilly based on the achievement of certain milestones. The Purchase Agreement provides that the contingent consideration that may become payable to Lilly would be achieved as follows: (i) a one-time payment of $ 100.0 million if the Company achieves annual net sales of $ 175.0 million or more of BAQSIMI ® and certain related products, or the Milestone Products, in any one contract year during the first five years after the Closing; (ii) up to two payments of $ 100.0 million each if the Company achieves annual net sales of $ 200.0 million or more of Milestone Products in any one contract year during the first five years after the Closing; and (iii) a one-time payment of $ 150.0 million if the Company achieves total cumulative net sales of $ 950.0 million or more of the Milestone Products for the first five years after the Closing.
In addition, the Company assumed certain contingent consideration of Lilly, which would require the Company to pay up to an aggregate of $ 125.0 million based on the achievement of annual net sales milestones of $ 350.0 million, $ 400.0 million and $ 600.0 million. Through December 31, 2024, the Company has not triggered any milestones and therefore no amounts have been recognized or paid.
The Company has accounted for the BAQSIMI ® acquisition as an asset acquisition in accordance with ASC 805, Business Combination s, as substantially all the fair value of the assets acquired is concentrated in a single identifiable asset, BAQSIMI ® product rights. The BAQSIMI ® product rights include the license for the BAQSIMI ® intellectual property, regulatory documentation, marketing authorizations, and domain names, which are considered a single asset as they are inextricably linked. As an asset acquisition, the cost to acquire the group of assets, including transaction costs, is allocated to the individual assets acquired based on their relative fair values, with the exception of non-qualifying assets.
The relative fair values of identifiable assets from the acquisition of BAQSIMI ® are based on estimates of fair value using assumptions that the Company believes are reasonable.
The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of BAQSIMI ® :
Fair Value
(in thousands)
Cash payment
$
500,000
Fair value of deferred cash payments
121,699
Transaction costs
6,406
Total purchase price
$
628,105
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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. During the years ended December 31, 2024 and 2023, $ 3.6 million and $ 3.7 million of interest expense was recognized related to accretion of the deferred cash payments, respectively. The Company made the $129.0 million deferred cash payment in June 2024.
Manufacturing Services Agreement
In connection with the Closing, the Company entered into a Manufacturing Services Agreement, or the MSA, with Lilly, pursuant to which Lilly agreed, for a period of time not to exceed 18 months , to provide certain manufacturing, packaging, labeling and supply services for BAQSIMI ® directly or through third-party contractors to the Company in connection with its operation of the development, manufacture, and commercialization of BAQSIMI ® . Upon termination of the MSA, the Company was obligated to purchase all API, components, and finished goods on hand at prices agreed upon in the MSA.
In December 2024, as the MSA expired, the Company entered into a commercial supply agreement with a third party contract manufacturing organization, or CMO, pursuant to which the CMO will provide manufacturing services for BAQSIMI ® .
Transition Services Agreement
In connection with the Closing, the Company entered into a Transition Services Agreement, or the TSA, with Lilly pursuant to which Lilly agreed, for a period of time not to exceed 18 months , to provide certain services to the Company to support the transition of BAQSIMI ® operations to the Company, including with respect to the conduct of certain clinical, regulatory, medical affairs, and commercial sales channel activities.
Throughout 2024, the Company assumed distribution responsibilities, from Lilly, to its customers in the United States, and certain other countries. As a result, the Company has recorded the sales and related cost of BAQSIMI ® to its customers in these countries as product revenue, net and cost of revenues, respectively. The assumption of distribution of BAQSIMI ® for the final two countries occurred on January 1, 2025.
Credit Agreement
On June 30, 2023, in conjunction with the Company’s acquisition of BAQSIMI ® , the Company entered into a $ 700.0 million syndicated credit agreement, or the Credit Agreement, by and among the Company, certain subsidiaries of the Company, as guarantors, certain lenders, and Wells Fargo Bank, National Association, or Wells Fargo, as Administrative Agent (in such capacity, Agent), Swing line Lender and L/C Issuer.
The Credit Agreement provides for a senior secured term loan, or the Wells Fargo Term Loan, in an aggregate principal amount of $ 500.0 million. The Wells Fargo Term Loan matures on June 30, 2028. In 2023, the Company repaid $ 250.0 million of the Wells Fargo Term Loan. Proceeds from the Term Loan were used to finance the acquisition of
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BAQSIMI ® .
The Credit Agreement also provides a senior secured revolving credit facility, or the Revolving Credit Facility, in an aggregate principal amount of $ 200.0 million. The Revolving Credit Facility matures on June 30, 2028. As of December 31, 2024, the Company had no borrowings outstanding under the Revolving Credit Facility.
Note 4. Revenue Recognition
Product revenues, net
In accordance with ASC 606 Revenue from Contracts with Customers , revenue is recognized at the time that the Company’s customers obtain control of the promised goods and we satisfy our performance obligations, which is generally at the time of product delivery to the Company’s customers. In some cases, our performance obligation is satisfied, and revenue is recognized at the time of shipment when stipulated by the terms of the sale agreements.
The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration including provision for chargebacks and rebates, accrual for product returns, prompt pay discounts, distributor fees, patient co-pay assistance, and other related deductions. These deductions to product sales are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product sales occur. Payment terms offered to customers generally range from 30 to 75 days ; however, payment terms differ by jurisdiction, by customer and, in some instances, by type of product. Revenues from product sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable of occurring when the uncertainty associated with gross-to-net deductions is subsequently resolved. Taxes assessed by governmental authorities and collected from customers are excluded from product sales. If the Company expects, at contract inception, that the period between the transfer of control and corresponding payment from the customer will be one year or less, the amount of consideration is not adjusted for the effects of a financing component. Shipping and handling activities are considered to be fulfillment activities rather than a separate performance obligation and are recorded within selling, distribution and marketing expenses in the accompanying consolidated statements of operations.
Provision for Chargebacks and Rebates: The provision for chargebacks and rebates is a significant estimate used in the recognition of revenue. Wholesaler chargebacks relate to sales terms under which the Company agrees to reimburse wholesalers for differences between the gross sales prices at which the Company sells its products to wholesalers and the actual prices of such products that wholesalers resell under the Company’s various contractual arrangements with third parties such as hospitals, group purchasing organizations and pharmacy benefit managers in the United States. 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. The Company estimates chargebacks and rebates using the expected value method at the time of sale to customers based on inventory stocking levels, historical chargeback and rebate rates, and current contract pricing.
The provision for chargebacks and rebates is reflected as a component of product revenues, net. The following table is an analysis of the chargeback and rebate provision:
Year Ended December 31,
2024
2023
(in thousands)
Beginning balance
$
27,920
$
26,606
Provision for chargebacks and rebates
289,332
257,219
Credits and payments issued to third parties
( 256,921 )
( 255,905 )
Ending balance
$
60,331
$
27,920
Changes in the chargeback provision from period to period are primarily dependent on the Company’s sales to its wholesalers, the level of inventory held by wholesalers, and the wholesalers’ customer mix. Changes in the rebate
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provision from period to period are primarily dependent on retailers’ and other indirect customers’ purchases. The approach that the Company uses to estimate chargebacks and rebates has been consistently applied for all periods presented. Variations in estimates have been historically small. The Company continually monitors the provision for chargebacks and rebates and makes adjustments when it believes that the actual chargebacks and rebates may differ from the estimates. Accounts receivable and/or accounts payable and accrued liabilities are reduced and/or increased by the chargebacks and rebate amounts depending on whether the Company has the right to offset with the customer.
The provision for chargebacks and rebates is included in the following balance sheet accounts:
December 31,
2024
2023
(in thousands)
Reduction to accounts receivable, net
$
26,258
$
21,861
Accounts payable and accrued liabilities
34,073
6,059
Total
$
60,331
$
27,920
Accrual for Product Returns: The Company offers certain customers the right to return qualified excess or expired inventory for full or partial credit. The Company’s product returns primarily consist of the returns of expired products from sales made in prior periods. Returned products cannot be resold. At the time product revenue is recognized, the Company records an accrual for product returns estimated using the expected value method. The accrual is based, in part, upon the historical relationship of product returns to sales and customer contract terms. The Company also assesses other factors that could affect product returns including market conditions, product obsolescence, and new competition.
The provision for product returns is reflected as a component of net revenues. The following table is an analysis of the product return liability:
Year Ended December 31,
2024
2023
(in thousands)
Beginning balance
$
17,179
$
19,451
Provision for product returns
9,597
4,275
Credits issued to third parties
( 6,917 )
( 6,547 )
Ending balance
$
19,859
$
17,179
The provision for product returns is included in the following balance sheet accounts:
December 31,
2024
2023
(in thousands)
Accounts payable and accrued liabilities
$
14,559
$
12,263
Other long-term liabilities
5,300
4,916
Total
$
19,859
$
17,179
Prompt Pay Discounts: The Company provides its customers with a percentage discount on their invoice if the customers pay within the agreed upon timeframe. The Company generally expects that its customers will earn such prompt pay discounts. The Company estimates the probability of customers paying promptly based on the percentage of discount outlined in the purchase agreement between the two parties, and deducts the full amount of these discounts from gross product sales and accounts receivable at the time revenue is recognized.
Distributor Fees: The Company engages with wholesalers to distribute its products to end customers. The Company pays the wholesalers a fee for services such as: inventory management, chargeback administration, and service level commitments. The Company estimates the amount of distribution services fees to be paid and adjusts the transaction
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price with the amount of such estimate at the time of sale to the customer. An accrued liability is recorded for unpaid distribution service fees.
Patient Co-Pay Assistance: Co-pay assistance represents financial assistance to qualified patients, assisting them with prescription drug co-payments required by insurance. The accrual for co-pay is based on an estimate of claims and the cost per claim that the Company expects to receive associated with inventory that exists in the distribution channel at period end.
Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers. The Company’s accounting policy is to review each agreement involving contract development and manufacturing services to determine if there are multiple revenue-generating activities that constitute more than one unit of account. Revenues are recognized for each unit of account based on revenue recognition criteria relevant to that unit.
Service revenues derived from research and development contracts are recognized over time based on progress toward satisfaction of the performance obligation. For each performance obligation satisfied over time, the Company assesses the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction of services or an output method of determining the progress of completion of performance obligation. Revenue from research and development services at ANP was $ 4.2 million, $ 4.5 million, and $ 4.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
Other revenues
Revenues related to BAQSIMI ® sales made by Lilly under the TSA during the years ended December 31, 2024 and 2023, were recorded on a net basis, similar to a royalty arrangement.
Note 5. Income per Share
Basic net income per share is calculated based upon the weighted-average number of shares outstanding during the period. Diluted net income per share gives effect to all potentially dilutive shares outstanding during the period, such as stock options, non-vested restricted stock units, and shares issuable under the Company’s Employee Stock Purchase Plan, or ESPP, and potential shares of common stock issuable upon conversion of Convertible Notes of the Company, due March 2029, or the 2029 Convertible Notes.
For the year ended December 31, 2024, options to purchase 618,973 shares of stock with a weighted-average exercise price of $ 46.63 per share were excluded in the computation of diluted net income per share because their effect would be anti-dilutive. The 2029 Convertible Notes had no impact on the computation of diluted net income per share as the average stock price during the period was less than the conversion price.
For the year ended December 31, 2023, the Company did not have any options that were excluded in the computation of diluted net income per share because the effect would be anti-dilutive. The 2029 Convertible Notes had no impact on the computation of diluted net income per share as the average stock price during the period was less than the conversion price.
For the year ended December 31, 2022, options to purchase 704,483 shares of stock with a weighted-average exercise price of $ 34.79 per share were excluded from the computation of diluted net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders because their effect would be anti-dilutive.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The following table provides the calculation of basic and diluted net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders for each of the periods presented:
Year Ended December 31,
2024
2023
2022
(in thousands, except per share data)
Basic and dilutive numerator:
Net income
$
159,519
$
137,545
$
91,386
Denominator:
Weighted-average shares outstanding — basic
48,429
48,265
48,551
Net effect of dilutive securities:
Incremental shares from equity awards
3,629
4,736
3,876
Weighted-average shares outstanding — diluted
52,058
53,001
52,427
Net income per share — basic
$
3.29
$
2.85
$
1.88
Net income per share — diluted
$
3.06
$
2.60
$
1.74
Note 6. Segment Reporting
The Company’s business is the development, manufacture, and marketing of pharmaceutical products (See note 1). The Company’s Chief Executive Officer, is the Chief Operating Decision Maker, or CODM.
The Company has previously disclosed two reporting segments: Finished pharmaceutical products and APIs.; however, the BAQSIMI ® acquisition that was completed in 2023 as well as the decline in API revenues resulted in a change to information provided to and used regularly by the CODM to assess the Company’s performance. The CODM currently uses consolidated information to assess the Company’s performance. As a result, in the fourth quarter of 2024, the Company combined both of its reportable segments into one segment, pharmaceutical products.
The measure of segment assets is reported on the consolidated balance sheets as total assets.
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Selected segment financial information is presented below. The Company has recast the corresponding items of segment information for the periods presented:
Year Ended December 31,
2024
2023
2022
(in thousands)
Net revenues:
$
731,967
$
644,395
$
498,987
Less:
Payroll expense
191,274
173,818
155,784
Materials and supplies
46,111
46,134
50,129
Clinical trials expense
594
5,216
5,689
Depreciation and amortization expense
52,967
38,035
24,769
Stock-based compensation expense
24,368
20,242
17,860
Consulting and outside services expense
27,772
17,698
12,011
Advertising and promotional expense
11,559
11,123
8,698
Other segment items (1)
167,827
139,071
107,482
Interest income
( 10,612 )
( 5,459 )
( 1,321 )
Interest expense
30,343
27,158
1,846
Income tax provision
29,672
31,833
23,477
Equity in losses of unconsolidated affiliate
573
1,981
1,177
Net income
$
159,519
$
137,545
$
91,386
(1) Other segment items includes maintenance and repairs expense, travel expense, professional services expense, legal expense, rent expense, manufacturing amounts capitalized on the balance sheet, certain overhead expenses, miscellaneous expenses, and foreign currency exchange gains and losses .
Net revenues by product are presented below:
Year Ended December 31,
2024
2023
2022
(in thousands)
Product revenues, net:
BAQSIMI ®
$
126,898
$
—
$
—
Glucagon
108,319
113,684
55,322
Primatene MIST ®
102,012
89,321
84,309
Epinephrine
94,090
81,650
74,204
Lidocaine
55,854
58,162
52,539
Phytonadione
43,169
44,939
49,500
Enoxaparin
21,715
31,533
34,950
Naloxone
15,728
19,004
26,269
Other products
145,029
154,945
121,894
Total product revenues, net
712,814
593,238
498,987
Other revenues
19,153
51,157
—
Total net revenues
$
731,967
$
644,395
$
498,987
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Net revenues and carrying values of long-lived assets, which includes property, plant and equipment, as well as finance and operating lease right-of-use assets, by geographic regions, based on where the Company conducts its operations, are as follows:
Net Revenue
Long-Lived Assets
Year Ended December 31,
December 31,
2024
2023
2022
2024
2023
(in thousands)
United States (1)
$
707,681
$
635,192
$
486,833
$
202,328
$
186,083
China
4,339
4,505
4,697
107,887
91,913
France (1)
19,947
4,698
7,457
34,412
37,647
Total
$
731,967
$
644,395
$
498,987
$
344,627
$
315,643
(1) Includes revenue from the sales of BAQSIMI ® .
Note 7. Customer and Supplier Concentration
Customer Concentrations
The following table provides accounts receivable and net revenue information for the Company’s four major customers:
% of Total Accounts
% of Net
Receivable
Revenue
December 31,
December 31,
Year Ended December 31,
2024
2023
2024
2023
2022
McKesson
34
%
26
%
25
%
25
%
22
%
Cencora
23
%
16
%
20
%
20
%
23
%
Cardinal Health
16
%
13
%
19
%
15
%
17
%
Lilly (1)
1
%
20
%
3
%
8
%
—
(1) Net revenues from BAQSIMI ® sales made under the TSA agreement.
Supplier Concentrations
The Company depends on suppliers for raw materials, APIs, and other components that are subject to stringent FDA requirements. Some of these materials may only be available from one or a limited number of sources. Establishing additional or replacement suppliers for these materials may take a substantial period of time, as suppliers must be approved by the FDA. Furthermore, a significant portion of raw materials may only be available from foreign sources. If the Company is unable to secure, on a timely basis, sufficient quantities of the materials it depends on to manufacture and market its products, it could have a materially adverse effect on the Company’s business, financial condition, and results of operations.
Note 8. Fair Value Measurements
GAAP defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal or most advantageous market for the asset or liability at the measurement date (an exit price). These standards also establish a hierarchy that prioritizes observable and unobservable inputs used in measuring fair value of an asset or liability, as described below:
● Level 1 – Inputs to measure fair value are based on quoted prices (unadjusted) in active markets on identical assets or liabilities;
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● Level 2 – Inputs to measure fair value are based on the following: (a) quoted prices in active markets on similar assets or liabilities, (b) quoted prices for identical or similar instruments in inactive markets, or (c) observable (other than quoted prices) or collaborated observable market data used in a pricing model from which the fair value is derived; and
● Level 3 – Inputs to measure fair value are unobservable and the assets or liabilities have little, if any, market activity; these inputs reflect the Company’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities based on best information available in the circumstances.
As of December 31, 2024 and 2023, cash equivalents include money market accounts and corporate and municipal bonds with original maturities of less than three months. Investments consist of certificates of deposit as well as investment-grade corporate, agency and municipal bonds with original maturity dates between three and 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. 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. The restrictions on restricted cash and investments have an immaterial effect on the fair value of these financial assets.
The fair values of the Company’s financial assets and liabilities measured on a recurring basis as of December 31, 2024 and 2023, are as follows:
Total
Level 1
Level 2
Level 3
(in thousands)
Cash equivalents
$
102,059
$
102,059
$
—
$
—
Restricted cash
235
235
—
—
Short-term investments
26,629
—
26,629
—
Restricted short-term investments
2,200
—
2,200
—
Interest rate swaps related to variable rate loans
( 234 )
—
( 234 )
—
Total assets and liabilities measured at fair value as of December 31, 2024
$
130,889
$
102,294
$
28,595
$
—
Total
Level 1
Level 2
Level 3
(in thousands)
Cash equivalents
$
116,441
$
116,441
$
—
$
—
Restricted cash
235
235
—
—
Short-term investments
37,142
—
37,142
—
Restricted short-term investments
2,200
—
2,200
—
Interest rate swaps related to variable rate loans
( 5,243 )
—
( 5,243 )
—
Total assets and liabilities measured at fair value as of December 31, 2023
$
150,775
$
116,676
$
34,099
$
—
The Company does not hold any Level 3 instruments that are measured at fair value on a recurring basis.
Nonfinancial assets and liabilities are not measured at fair value on a recurring basis but are subject to fair value adjustments in certain circumstances. These items primarily include investments in unconsolidated affiliates, long-lived assets, goodwill, and intangible assets for which the fair value is determined as part of an impairment test. As of December 31, 2024 and 2023, there were no significant adjustments to fair value for nonfinancial assets or liabilities.
The Company’s deferred compensation plan assets are valued using the cash surrender value of the life insurance policies and are not included in the table above.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 9. Investments
The following is a summary of the Company’s investments that are classified as held-to-maturity:
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
(in thousands)
Corporate and agency bonds (due within 1 year)
$
42,907
$
34
$
( 25 )
$
42,916
Corporate and agency bonds (due within 1 to 3 years)
10,867
—
( 6 )
10,861
Municipal bonds (due within 1 year)
199
—
( 1 )
198
Total investments as of December 31, 2024
$
53,973
$
34
$
( 32 )
$
53,975
Corporate and agency bonds (due within 1 year)
$
73,815
$
7
$
( 21 )
$
73,801
Corporate and agency bonds (due within 1 to 3 years)
14,621
56
( 1 )
14,676
Municipal bonds (due within 1 year)
1,081
1
—
1,082
Total investments as of December 31, 2023
$
89,517
$
64
$
( 22 )
$
89,559
At each reporting period, the Company evaluates securities for impairment when the fair value of the investment is less than its amortized cost. The Company evaluated the underlying credit quality and credit ratings of the issuers, identifying neither a significant deterioration since purchase nor any other factors that would indicate a material credit loss.
The Company measures expected credit losses on held-to-maturity investments on a collective basis. All the Company’s held-to-maturity investments were considered to be one pool. The estimate for credit losses considers historical loss information that is adjusted for current conditions and reasonable and supportable forecasts. Expected credit losses on held-to-maturity investments were not material to the consolidated financial statements.
Note 10. Goodwill and Intangible Assets
The table below shows the weighted-average life, original cost, accumulated amortization, and net book value by major intangible asset classification:
Weighted-Average
Accumulated
Life (Years)
Original Cost
Amortization
Net Book Value
(in thousands)
Definite-lived intangible assets
BAQSIMI ® product rights (1)
24
$
591,338
$
36,958
$
554,380
Land-use rights
39
2,540
881
1,659
Other intangibles
7
2,443
96
2,347
Subtotal
24
596,321
37,935
558,386
Indefinite-lived intangible assets
Trademark
*
29,225
—
29,225
Goodwill
*
3,049
—
3,049
Subtotal
*
32,274
—
32,274
As of December 31, 2024
*
$
628,595
$
37,935
$
590,660
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Weighted-Average
Accumulated
Life (Years)
Original Cost
Amortization
Net Book Value
(in thousands)
Definite-lived intangible assets
BAQSIMI ® product rights (1)
24
$
591,338
$
12,319
$
579,019
Land-use rights
39
2,540
815
1,725
Other intangibles
12
486
376
110
Subtotal
24
594,364
13,510
580,854
Indefinite-lived intangible assets
Trademark
*
29,225
—
29,225
Goodwill
*
3,216
—
3,216
Subtotal
*
32,441
—
32,441
As of December 31, 2023
*
$
626,805
$
13,510
$
613,295
*
Intangible assets with indefinite lives have an indeterminable average life.
(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. The Company recorded the impairment in the cost of revenues in its consolidated statement of operations for the year ended December 31, 2023.
Goodwill
The changes in the carrying amounts of goodwill are as follows:
December 31,
2024
2023
(in thousands)
Beginning balance
$
3,216
$
3,126
Currency translation
( 167 )
90
Ending balance
$
3,049
$
3,216
Primatene ® Trademark
In January 2009, the Company acquired the exclusive rights to the trademark, domain name, website and domestic marketing, distribution and selling rights related to Primatene MIST ® , an over-the-counter bronchodilator product, recorded at the allocated fair value of $ 29.2 million, which is its carrying value as of December 31, 2024.
The trademark was determined to have an indefinite life. In determining its indefinite life, the Company considered the following: the expected use of the intangible; the longevity of the brand; the legal, regulatory and contractual provisions that affect their maximum useful life; the Company’s ability to renew or extend the asset’s legal or contractual life without substantial costs; effects of the regulatory environment; expected changes in distribution channels; maintenance expenditures required to obtain the expected future cash flows from the asset; and considerations for obsolescence, demand, competition and other economic factors.
BAQSIMI ® Product Rights
As discussed in Note 3, in June 2023, the Company acquired the BAQSIMI ® product rights. The BAQSIMI ® product rights intangible asset is amortized over its estimated useful life of 24 years . In determining the BAQSIMI ® product rights’ useful life, the Company considered the following: the expected use of the intangible asset; 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;
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expected changes in distribution channels; maintenance expenditures required to obtain the expected future cash flows from the asset; and considerations for obsolescence, demand, competition and other economic factors.
Amortization
Included in cost of revenues for the years ended December 31, 2024, 2023 and 2022 is product rights amortization expense of $ 24.7 million, $ 15.5 million, and $ 0.9 million, respectively.
As of December 31, 2024, the expected amortization expense for all amortizable intangible assets during the next five fiscal years ending December 31 and thereafter is as follows:
(in thousands)
2025
$
25,078
2026
25,078
2027
25,078
2028
25,078
2029
25,078
Thereafter
432,996
Total amortizable intangible assets
558,386
Indefinite-lived intangibles
32,274
Total intangibles (net of accumulated amortization)
$
590,660
Note 11. Inventories
Inventories consist of the following:
December 31,
2024
2023
(in thousands)
Raw materials and supplies
$
81,511
$
50,082
Work in process
32,807
30,822
Finished goods
39,423
24,929
Total inventories
$
153,741
$
105,833
Charges of $ 14.0 million, $ 18.8 million, and $ 17.2 million were included in the cost of revenues in the Company’s consolidated statements of operations for the years ended December 31, 2024, 2023, and 2022, respectively, to adjust the Company’s inventory and related firm purchase commitments to their net realizable value. For the year ended December 31, 2024, these charges included $ 7.4 million in the cost of revenues to adjust the Company’s enoxaparin inventory and related firm purchase commitments to their net realizable value. For the year ended December 31, 2023, these charges included $ 9.1 million in the cost of revenues to adjust the Company’s enoxaparin inventory and related firm purchase commitments to their net realizable value. Additionally, as a result of amending the MannKind RHI Supply Agreement in December 2023, the Company booked a $ 3.6 million adjustment to reduce RHI inventory to its net realizable value. For the year ended December 31, 2022, the charge included $ 14.9 million in the cost of revenues to adjust the Company’s enoxaparin inventory and related firm purchase commitments to their net realizable value.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 12. Property, Plant, and Equipment
Property, plant, and equipment consist of the following:
December 31,
2024
2023
(in thousands)
Buildings
$
169,429
$
168,771
Leasehold improvements
42,012
41,686
Land
7,422
7,484
Machinery and equipment
277,408
259,484
Furniture, fixtures, and automobiles
35,976
31,943
Construction in progress
36,685
18,676
Total property, plant, and equipment
568,932
528,044
Less accumulated depreciation
( 271,587 )
( 245,298 )
Total property, plant, and equipment, net
$
297,345
$
282,746
The Company incurred depreciation expense of $ 28.2 million, $ 25.2 million, and $ 23.8 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Interest expense capitalized was approximately $ 0.8 million, $ 2.0 million, and $ 1.4 million, for the years ended December 31, 2024, 2023, and 2022, respectively.
Note 13. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consisted of the following:
December 31,
2024
2023
(in thousands)
Accrued customer fees and rebates
$
53,993
$
16,702
Accrued payroll and related benefits
26,010
25,203
Accrued product returns, current portion
14,559
12,263
Accrued loss on firm purchase commitments
413
918
Other accrued liabilities
31,568
12,842
Total accrued liabilities
126,543
67,928
Accounts payable
30,514
25,438
Total accounts payable and accrued liabilities
$
157,057
$
93,366
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 14. Debt
Debt consists of the following:
December 31,
2024
2023
(in thousands)
Convertible Debt
2029 Convertible Notes
$
345,000
$
345,000
Term Loan
Wells Fargo Term Loan due June 2028
250,000
250,000
Mortgage Loans
Mortgage payable with East West Bank paid off June 2024
—
8,016
Other Loans and Payment Obligations
French government loans due December 2026
99
158
Line of Credit Facilities
Line of credit facility with China Merchant Bank due October 2026
—
—
Wells Fargo Revolving line of credit facility due June 2028
—
—
Line of credit facility with ICBC Bank due November 2033
18,433
—
Equipment under Finance Leases
432
616
Total debt
613,964
603,790
Less current portion of long-term debt
234
436
Less: Loan issuance costs
12,100
13,775
Long-term debt, net of current portion and unamortized debt issuance costs
$
601,630
$
589,579
Credit Agreement
2029 Convertible Notes
In September 2023, the Company issued the 2029 Convertible Notes, in the aggregate principal amount of $ 345.0 million in a private offering pursuant to Section 4(a)(2) and Rule 144A under the Securities Act of 1933, as amended. The Company used portions of the net proceeds from the 2029 Convertible Notes to (i) repay approximately $ 200.0 million of the Company’s borrowings under the Wells Fargo Term Loan and (ii) repurchase $ 50.0 million of the Company’s common stock.
In connection with the issuance of the 2029 Convertible Notes, the Company incurred approximately $ 10.8 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. Unamortized debt issuance costs related to the 2029 Convertible Notes were $ 8.3 million and $ 10.3 million as of December 31, 2024 and 2023, respectively. The fair value of the 2029 convertible notes was approximately $ 320.9 million as of December 31, 2024 based on level 2 inputs.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 2024 and 2023, the total interest expense related to the 2029 Convertible Notes was $ 8.9 million and $ 2.6 million, with coupon interest expense of $ 6.9 million and $ 2.0 million, and the amortization of debt issuance cost of $ 2.0 million and $ 0.6 million, respectively.
The 2029 Convertible Notes are general senior, unsecured obligations and bear an interest rate of 2.0 % per year. The 2029 Convertible Notes were issued pursuant to an indenture, dated September 15, 2023, or the Indenture, between the Company and U.S. 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. The 2029 Convertible Notes may bear additional interest under specified circumstances relating to the Company’s failure to comply with its reporting obligations under the Indenture or if the 2029 Convertible Notes are not freely tradeable as required by the Indenture.
The 2029 Convertible Notes will mature on March 15, 2029, unless earlier converted, repurchased or redeemed.
Conversions of the 2029 Convertible Notes will be settled in cash up to the aggregate principal amount of the 2029 Convertible Notes to be converted, and cash, shares of common stock or a combination of cash and shares of common stock, at the Company’s election, with respect to the remainder, if any, of the Company’s conversion obligation in excess of the aggregate principal amount.
Holders may convert their 2029 Convertible Notes at their option prior to the close of business on the business day immediately preceding December 15, 2028, in multiples of $ 1,000 principal amount, only under the following circumstances; (i) during any calendar quarter commencing after the calendar quarter ending on December 31, 2023 (and only during such calendar quarter), if the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price for the 2029 Convertible Notes on each applicable trading day, (ii) during the five business day period after any five consecutive trading day period in which the trading price, as defined in the Indenture, per $ 1,000 principal amount of the 2029 Convertible Notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day, (iii) if the Company calls the 2029 Convertible Notes for redemption, at any time prior to the close of business on the second scheduled trading day immediately preceding the redemption date, and (iv) upon the occurrence of specified corporate events defined in the Indenture.
On or after December 15, 2028, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their 2029 Convertible Notes, in multiples of $ 1,000 principal amount, at the option of the holder regardless of the foregoing circumstances.
The Company may redeem the 2029 Convertible Notes, at its option, in whole or in part (subject to certain limitations), on or after September 20, 2026 and prior to the 41 st scheduled trading day preceding the maturity date, if the last reported sale price of the Company’s common stock has been at least 130 % of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on and including the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100 % of the principal amount of the 2029 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The initial conversion rate is 15.8821 shares of the Company’s common stock per $ 1,000 principal amount of the 2029 Convertible Notes, which represents an initial conversion price of approximately $ 62.96 per share of common stock. The initial conversion price of $ 62.96 represents a premium of approximately 35.0 % over the last reported sale price of the Company’s common stock on Nasdaq Global Select Market on September 12, 2023. The conversion rate is subject to adjustment under certain circumstances in accordance with the terms of the Indenture.
If a fundamental change, as defined in the Indenture, occurs at any time prior to the maturity date, then, subject to certain conditions, holders of the 2029 Convertible Notes may require the Company to repurchase for cash all or any portion of their 2029 Convertible Notes at a repurchase price equal to 100 % of the principal amount of the 2029 Convertible Notes to be repurchased, plus any accrued and unpaid interest. In addition, following certain specified corporate events or if the Company issues a notice of redemption, the Company will, under certain circumstances, increase the conversion rate for holders who convert their 2029 Convertible Notes in connection with such corporate event or during a redemption period.
Syndicated Credit Agreement with Wells Fargo Bank, National Association - Due June 2028
In June 2023, in connection with the BAQSIMI ® acquisition, the Company entered into a syndicated credit agreement with Wells Fargo, or the Credit Agreement. Under the terms of the Credit Agreement, the Company borrowed $ 500.0 million in the form of a term loan, or the Wells Fargo Term Loan. Proceeds from the Wells Fargo Term Loan were used to finance the acquisition of BAQSIMI ® , repay certain of the Company’s and its subsidiaries’ existing third-party indebtedness, and pay fees and expenses incurred in connection with each of the foregoing. Outstanding borrowings with respect to the Wells Fargo Term Loan initially accrue interest, at the Company’s option, at a per annum rate equal to either (i) a base rate equal to the highest of (x) the federal funds rate, plus 0.50 %, (y) the prime rate then in effect and (z) an adjusted daily one-month Secured Overnight Financing Rate, or SOFR, rate determined on the basis of a one-month interest period plus 1.00 %, in each case, plus an applicable margin of 1.25 %, or (ii) an adjusted Term SOFR rate, subject to a floor of 0.00 %, plus an applicable margin of 2.25 %. Following delivery of financial statements for the Company’s first fiscal quarter following payment in full of a $ 125.0 million guaranteed payment owed to Lilly on June 30, 2024, the applicable margin for outstanding borrowings with respect to the Wells Fargo Term Loan will range from 0.50 % to 1.50 % in the case of base rate loans and 1.50 % to 2.50 % in the case of Term SOFR rate loans, in each case, depending on the Company’s consolidated net leverage ratio as of the most recently ended fiscal quarter. The Wells Fargo Term Loan matures in June 2028.
The Wells Fargo Term Loan requires principal payments of $ 12.5 million for the first year, which increases to $ 25.0 million during the second year, and $ 37.5 million during the third, fourth and fifth years, with the remaining balance due at maturity. The loan is secured by substantially all of the Company’s and certain of its subsidiaries’ assets, subject to certain exceptions and limitations. In the third quarter of 2023, the Company repaid approximately $ 200.0 million of the borrowings under the Wells Fargo term Loan with the proceeds from the 2029 Convertible Notes, thereby satisfying all of the current and future loan amortization payments required by the Wells Fargo Term Loan until maturity. In the fourth quarter of 2023, the Company made a principal payment of $ 50.0 million, reducing the balance to $ 250.0 million.
The Credit Agreement also provides for a $ 200.0 million Revolving Credit Facility and bears the same interest rate as the Wells Fargo Term Loan.
In conjunction with the Credit Agreement, the Company entered into an interest rate swap agreement with Wells Fargo, with a notional amount of $ 250.0 million to exchange the variable rate on the Wells Fargo Term Loan for a fixed rate of 4.04 %. The interest swap agreement had a fair value of $ 0.2 million liability as of December 31, 2024.
For lenders that were part of the previous credit agreement with Capital One N.A. as well as the new Credit Agreement, the transaction was accounted for as a modification under ASC 470-50, Debt Modifications and Extinguishments , based on a comparison of the present value of the cash flows for each lender under the terms of the debt immediately before and after the transaction, which resulted in a change of less than 10%.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company incurred approximately $ 14.3 million in issuance costs in connection with the Credit Agreement, of which $ 3.0 million represented debt modification costs and were charged to interest expense in the Company’s consolidated statement of operations for year ended December 31, 2023.
Debt issuance costs associated with the Credit Agreement (other than its Revolving Credit Facility component) are presented as a reduction to the carrying value of the related debt, while debt issuance costs associated with the Revolving Credit Facility are capitalized within other long-term assets on the consolidated balance sheets. Unamortized debt issuance costs related to the Credit Agreement as of December 31, 2024 and 2023 were $ 6.0 million and $ 7.8 million, respectively, which are being amortized over the term of the Credit Agreement using the effective interest rate method.
As a result of the $ 250.0 million repayment of the principal balance of the Wells Fargo Term Loan, approximately $ 3.8 million of unamortized debt issuance costs were written off during the year ended December 31, 2023.
Mortgage Loans
Mortgage Payable with East West Bank — Paid off June 2024
In May 2017, the Company entered into a mortgage term loan with East West Bank in the principal amount of $ 9.0 million, which would have matured in June 2027. The loan was payable in monthly installments with a final balloon payment of $ 7.4 million plus interest. The loan was secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex and two buildings at the Company’s Chino, California, facility. The loan had a variable interest rate at the one-month SOFR rate plus 2.6 %. The Company entered into a fixed interest rate swap contract on this loan to exchange the variable interest rate for a fixed interest rate of 4.79 % until June 2024. In June 2024, the Company repaid all outstanding amounts due under this loan.
Line of Credit Facilities
Line of Credit Facility with China Merchant Bank – Due October 2026
In March 2020, the Company entered into a credit agreement with China Merchant Bank. The credit agreement allows the Company to borrow up to $ 14.6 million secured by buildings and land use rights held by ANP. The interest rate and other terms will be determined at the time of the borrowing, depending on the type of loan requested. The credit period was for 36 months and expired in March 2023.
In October 2023, the Company renewed the credit agreement with China Merchant Bank, and allows the Company to borrow up to $ 4.1 million. The credit period is for 36 months and expires in October 2026.
Syndicated Line of Credit Facility with ICBC Bank – Due November 2033
In January 2024, the Company entered into a credit agreement with Industrial and Commercial Bank of China Limited, or ICBC Bank, acting as a lender and as agent for other lenders. The credit agreement allows the Company to borrow up to $ 40.0 million secured by equipment and buildings at ANP. The interest rate and other terms will be determined at the time of the borrowing, depending on the type of loan requested. The credit agreement expires in November 2033.
As of December 31, 2024, the Company borrowed approximately $ 18.4 million under the credit agreement. The loan bears interest at the prime rate as published by The People’s Bank of China minus 0.2 %. Interest payments are due quarterly and repayment of the principal amount is biannual and begins in May 2026. As of December 31, 2024, the Company had $ 18.4 million of principal outstanding under this loan, which is recorded net of loan issuance costs of $ 1.1 million.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Interest Rate Swap Contract
As of December 31, 2024, the fair value of the loans listed above approximated their carrying amount based on Level 2 inputs, with the exception of the 2029 Convertible Notes. For the Wells Fargo Term Loan, the Company has entered into a fixed interest rate swap contract to exchange the variable interest rates for fixed interest rates. The interest rate swap contract is recorded at fair value in the other assets line in the consolidated balance sheets. Changes in the fair values of interest rate swaps were $ 5.0 million and $ 5.9 million for the years ended December 31, 2024 and 2023, respectively.
Covenants
At December 31, 2024 and 2023, the Company was in compliance with all of its debt covenants.
Long-Term Debt Maturities
As of December 31, 2024, the principal amounts of long-term debt maturities during each of the next five fiscal years ending December 31 are as follows:
Long-term
Debt
(in thousands)
2025
$
50
2026
1,438
2027
5,553
2028
255,553
2029
350,938
$
613,532
Note 15. Income Taxes
The Company’s income (loss) before income taxes generated from its operations were:
Year Ended December 31,
2024
2023
2022
(in thousands)
Income (loss) before income taxes:
United States
$
195,178
$
181,922
$
127,204
Foreign
( 5,414 )
( 10,563 )
( 11,164 )
Total income before income taxes
$
189,764
$
171,359
$
116,040
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The Company’s provision for income taxes consisted of the following:
Year Ended December 31,
2024
2023
2022
(in thousands)
Current provision:
Federal
$
44,251
$
42,689
$
37,626
State
589
1,912
732
Foreign
1,974
1,089
998
Total current provision
46,814
45,690
39,356
Deferred provision (benefit):
Federal
( 17,126 )
( 13,134 )
( 16,119 )
State
363
1,537
816
Foreign
( 379 )
( 2,260 )
( 576 )
Total deferred provision
( 17,142 )
( 13,857 )
( 15,879 )
Total provision for income taxes
$
29,672
$
31,833
$
23,477
For tax years beginning after December 31, 2021, certain research and development costs are required to be capitalized and amortized over a five or fifteen-year period under the Tax Cuts and Jobs Act of 2017. The Company has reviewed and incorporated this change, which increases the current U.S. federal and state tax expense and cash taxes to be paid for the tax year ending December 31, 2024.
A reconciliation of the statutory federal income tax rate to the Company’s effective tax rate is as follows:
Year Ended December 31,
2024
2023
2022
Statutory federal income tax
21.0
%
21.0
%
21.0
%
State tax expense, net of federal tax benefit
0.4
1.6
1.1
Foreign tax rate differences
—
( 0.1 )
( 0.3 )
Foreign valuation allowance
1.4
0.1
2.6
Research and development credits
( 3.7 )
( 4.2 )
( 3.1 )
Share-based compensation
( 5.1 )
( 3.2 )
( 3.5 )
Executive compensation
1.7
2.4
2.3
Employee-related expenses
—
—
0.2
Intercompany transfer of assets other than inventory
—
0.6
—
Other
( 0.1 )
0.4
( 0.1 )
Effective tax rate
15.6
%
18.6
%
20.2
%
The Company’s effective tax rate for 2024 decreased in comparison to 2023 primarily due to excess tax benefit from share-based compensation and lower state income tax expense.
Deferred Tax Assets and Liabilities
Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, tax credit carryforwards, and the tax effects of net operating loss carryforwards.
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The significant components of the Company’s deferred tax assets and liabilities are as follows:
December 31,
2024
2023
(in thousands)
Deferred tax assets:
Research and development credits
$
12,300
$
12,759
Net operating loss carryforward
22,047
20,156
Inventory capitalization and reserve
16,523
12,381
Share-based compensation
5,067
5,464
Operating leases
11,996
8,360
Accrued expenses
6,969
5,970
Accrued chargebacks and rebates
9,080
5,441
Product return allowance
5,749
4,927
Intangibles
2,124
2,124
Research and development capitalization
48,411
34,036
Total deferred tax assets
140,266
111,618
Deferred tax liabilities:
Depreciation/amortization
22,771
21,630
Intangibles
7,849
4,367
Operating leases
11,622
8,037
Federal impact of state deferred taxes
3,522
3,577
Other
984
260
Total deferred tax liabilities
46,748
37,871
Valuation allowance
( 22,394 )
( 20,495 )
Net deferred tax assets
$
71,124
$
53,252
Net Operating Loss Carryforwards and Tax Credits
At December 31, 2024, the Company had no material U.S. federal or state net operating loss carryforwards, or NOL carryforwards. The Company had France and United Kingdom foreign NOL carryforwards of approximately $ 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. The California research and development tax credit has an indefinite carryforward period.
Valuation Allowance
In assessing the need for a valuation allowance, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will be realized. Ultimately, realization depends on the existence of future taxable income. Management considers sources of taxable income such as income in prior carryback periods, future reversal of existing deferred taxable temporary differences, tax-planning strategies, and projected future taxable income.
The Company continues to record a full valuation allowance on the net deferred income tax assets of its French subsidiary, AFP, and its U.K. subsidiaries, AUK and IMS UK and will continue to do so until the subsidiaries generate sufficient taxable income to realize their respective deferred income tax assets. As of December 31, 2024 and 2023, the Company had a full valuation allowance against the net deferred tax assets of AFP, which totaled $ 20.7 million and $ 19.0 million, respectively, and a full valuation allowance against the net deferred tax assets of its UK subsidiaries of immaterial amounts.
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The Company also records a valuation allowance on net deferred income tax assets in states where it files separately and will continue to do so until sufficient taxable income is generated to realize these state deferred income tax assets.
Undistributed Earnings from Foreign Operations
As of December 31, 2024 and 2023, deferred income taxes have not been provided for any undistributed earnings from foreign operations. The foreign subsidiaries have significant accumulated losses, and as such there are no earnings in which to provide taxes. It is the Company’s plan not to repatriate future foreign earnings to the U.S. and indefinitely reinvest such earnings in the foreign jurisdiction.
Uncertain Income Tax Positions
A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows:
December 31,
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. 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, 2024, the Company is under U.S. federal examination for the 2022 tax year and in California for the 2019-2021 tax years. The Company does not have a tax examination in progress for Massachusetts, other states, or foreign jurisdictions. The Company is subject to income tax audit by tax authorities for tax years 2021 to 2023 for federal, 2019 to 2023 for states, and 2014 to 2023 for foreign.
Note 16. Stockholders' Equity
Equity Plans
As of December 31, 2024, the Company has two equity plans: the Amended and Restated 2015 Equity Incentive Plan, or the Amended 2015 Plan, and the 2014 Employee Stock Purchase Plan or ESPP. Prior to the adoption of these plans, the Company granted options pursuant to the Amended and Restated 2005 Equity Incentive Award Plan. Upon termination of the predecessor plans, the shares available for grant at the time of termination, and shares subsequently returned to the plans upon forfeiture or option termination, were transferred to the successor plan in effect at the time of share return. The Company issues new shares of common stock upon exercise of stock options, vesting of restricted stock units, or RSU, and settlement of ESPP, with the exception of the awards granted to employees at AFP, which are settled through re-issuance of the Company’s treasury shares.
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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. 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. The Original 2015 Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units, performance shares, and other stock or cash awards to employees of the Company and its subsidiaries, members of the Board of Directors and consultants.
In November 2020, the Board of Directors approved the Amendment and Restated 2015 Equity Incentive Plan to provide that at least 95 % of the shares awarded under the plan will be subject to a minimum vesting requirement of at least one year .
The Company initially reserved 5,000,000 shares of common stock for issuance under the Original 2015 Plan and also contained an “evergreen provision” that allowed for an annual increase in the number of shares available for issuance on January 1 of each year during the 10 year term of the 2015 Plan.
In February 2024, the Board of Directors approved the Company’s Amended 2015 Plan, which was subsequently approved by the Company’s stockholders, and accordingly, adopted by the Company in June 2024. The Amended 2015 Plan, among other things, extended the term of the Original 2015 Plan, increased the number of shares available for issuance under the Original 2015 Plan, and removed the evergreen provision. The term of the Amended 2015 Plan will be extended indefinitely, however, the Company’s ability to grant incentive stock options thereunder will continue through February 2034.
As of December 31, 2024, the Company reserved an aggregate of 7,818,314 shares of common stock for future issuance under the Amended 2015 Plan.
Amended and Restated 2005 Equity Incentive Award Plan
The Amended and Restated 2005 Equity Incentive Award Plan, or 2005 Plan, provided for the grant of incentive stock options, or ISOs, nonqualified stock options, or NQSOs, restricted stock awards, restricted stock unit awards, stock appreciation rights, or SARs, dividend equivalents and stock payments to the Company’s employees, members of the Board of Directors and consultants. Stock options under the 2005 Plan were granted with a term of up to ten years and at prices no less than the fair market value of the Company’s common stock on the date of grant. To date, stock options granted to existing employees generally vest over three to five years and stock options granted to new employees vest over four years . Stock options granted to Board of Directors and consultants generally vested over one year .
2014 Employee Stock Purchase Plan
In June 2014, the Company adopted the ESPP in connection with its initial public offering. A total of 2,000,000 shares of common stock are reserved for issuance under this plan. The Company’s ESPP permits eligible employees to purchase common stock at a discount through payroll deductions during defined offering periods. Under the ESPP, the Company may specify offerings with durations of not more than 27 months, and may specify shorter purchase periods within each offering. Each offering will have one or more purchase dates on which shares of its common stock will be purchased for employees participating in the offering. An offering may be terminated under certain circumstances. The price at which the stock is purchased is equal to 85 % of the lower of the fair market value of the common stock at the beginning of an offering period or on the date of purchase.
As of December 31, 2024, the Company has issued 1,289,452 shares of common stock under the ESPP and 710,548 shares of its common stock remains available for issuance under the ESPP.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 2024, 2023, and 2022, the Company recorded ESPP expense of $ 1.2 million, $ 1.1 million, and $ 0.9 million, respectively.
Share Buyback Program
As of December 31, 2024, the Company’s Board of Directors have authorized a total of $ 385.0 million in the share buyback program. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs. The Company’s share buyback program is expected to continue for an indefinite period of time.
Purchases are made through open market and private block transactions pursuant to Rule 10b5-1 plans, privately negotiated transactions or other means as determined by the Company’s management and in accordance with the requirements of the SEC and applicable laws. The timing and actual number of treasury share purchases will depend on a variety of factors including price, corporate and regulatory requirements, and other conditions. These treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s consolidated balance sheets.
Pursuant to the Company’s existing share buyback program, the Company purchased 1,919,670 shares, 1,338,757 shares, and 1,335,528 shares of its common stock during the years ended December 31, 2024, 2023 and 2022, for total consideration of $ 85.5 million, $ 58.1 million, and $ 39.9 million, respectively.
Share-Based Award Activity and Balances
The Company accounts for share-based compensation payments in accordance with ASC 718, which requires measurement and recognition of compensation expense at fair value for all share-based payment awards made to employees and directors. Under these standards, the fair value of option awards and the option components of the ESPP awards are estimated at the grant date using the Black-Scholes option-pricing model. The fair value of RSUs is estimated at the grant date using the Company’s common share price. Compensation cost for all share-based payments granted with service-based graded vesting schedules is recognized using the straight-line method over the requisite service period.
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. There have been no awards with performance conditions and no awards with market conditions. The options have a contractual term of five to ten years and generally vest over a three - to five -year period. The Black-Scholes option pricing model has various inputs such as the common share price on the date of grant, exercise price, the risk-free interest rate, volatility, expected term and dividend yield, all of which are estimates. The Company records share-based compensation expense net of expected forfeitures. The change of any of these inputs could significantly impact the determination of the fair value of the Company’s options as well as significantly impact its results of operations.
The significant assumptions used in the Black-Scholes option-pricing are as follows:
● Determination of Fair Value of the Underlying Common Stock. For options and ESPP awards granted, the fair value for its underlying common stock is determined using the closing price on the date of grant as reported on the Nasdaq Global Select Market, or Nasdaq, with consideration of whether there is material nonpublic information that could impact that estimated fair value when it is released.
● Expected Volatility. The Company estimates its volatility based on the historical volatility of its stock price.
● Expected Term. The expected term represents the period of time in which the options granted are expected to be outstanding. The Company estimates the expected term of options with consideration of
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vesting date, contractual term, and historical experience for exercise and post-vesting employment or contractual termination behavior after its common stock has been publicly traded. The expected term of “plain vanilla” options is estimated (using the simplified method as outlined in SAB Topic 14 due to a lack of sufficient historical exercise data) based on the midpoint between the vesting date and the end of the contractual term under the simplified method permitted by the SEC implementation guidance.
● Risk- Free Rate. The risk-free interest rate is selected based upon the implied yields in effect at the time of the option grant on U.S. Treasury zero-coupon issues with a term approximately equal to the expected life of the option being valued.
● Dividends. The Company does not anticipate paying cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield rate of zero.
The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual experience differs from those estimates. For 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. The Company periodically assesses the forfeiture rate and the amount of expense recognized based on estimated historical forfeitures as compared to actual forfeitures. Changes in estimates are recorded in the period they are identified.
Tax benefits resulting from tax deductions in excess of the share-based compensation cost recognized (excess tax benefits) are recorded in the statements of cash flows as financing activities.
The weighted-averages for key assumptions used in determining the fair value of options granted are as follows:
Year Ended December 31,
2024
2023
2022
Average volatility
41.3
%
41.4
%
41.0
%
Average risk-free interest rate
4.2
%
4.1
%
2.3
%
Weighted-average expected life in years
6.2
6.2
6.1
Dividend yield rate
—
%
—
%
—
%
Stock Options
A summary of option activity under all plans for the year ended December 31, 2024, is presented below:
Weighted-Average
Weighted-Average
Remaining
Aggregate
Exercise
Contractual
Intrinsic
Options
Price
Term (Years)
Value (1)
(in thousands)
Outstanding as of December 31, 2023
7,762,298
$
19.70
Options granted
644,034
46.27
Options exercised
( 1,728,293 )
13.81
Options forfeited
( 22,814 )
35.72
Options expired
—
—
Outstanding as of December 31, 2024
6,655,225
$
23.75
4.90
$
95,286
Exercisable as of December 31, 2024
4,851,541
19.10
3.73
$
87,869
Vested and expected to vest as of December 31, 2024
6,527,332
23.43
4.83
$
95,069
(1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the estimated fair value of the Company’s stock for those awards that have an exercise price below the estimated fair value at December 31, 2024.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
During the years ended December 31, 2024, 2023, and 2022, the Company recorded expense of $ 11.6 million, $ 9.6 million, and $ 8.5 million, respectively, related to stock options granted under all plans.
Information relating to option grants and exercises is as follows:
Year Ended December 31,
2024
2023
2022
(in thousands, except per share data)
Weighted-average grant date fair value per share
$
21.89
$
16.76
$
14.75
Intrinsic value of options exercised
52,068
29,918
21,279
Cash received from options exercised
12,239
14,172
19,202
Total fair value of the options vested during the period
9,818
8,890
8,174
A summary of the status of the Company’s non-vested options as of December 31, 2024, and changes during the year ended December 31, 2024, are presented below:
Weighted-Average
Grant Date
Options
Fair Value
Non-vested as of December 31, 2023
2,076,355
$
12.68
Options granted
644,034
21.89
Options vested
( 893,891 )
10.98
Options forfeited
( 22,814 )
16.52
Non-vested as of December 31, 2024
1,803,684
16.76
As of December 31, 2024, there was $ 19.1 million of total unrecognized compensation cost, net of forfeitures, related to non-vested stock option based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.4 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 . 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. The share-based expense associated with these grants was based on the Company’s common stock fair value at the time of grant and is amortized over the requisite service period, which generally is the vesting period, using the straight-line method. During the years ended December 31, 2024, 2023, and 2022, the Company recorded expenses of $ 11.5 million, $ 9.5 million, and $ 8.4 million, respectively, related to RSU awards granted under all plans.
As of December 31, 2024, there was $ 20.3 million of total unrecognized compensation cost, net of forfeitures, related to non-vested RSU-based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.4 years and will be adjusted for future changes in estimated forfeitures.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Information relating to RSU grants and deliveries is as follows:
Total Fair Market
Total RSUs
Value of RSUs
Issued
Issued (1)
(in thousands)
RSUs outstanding at December 31, 2023
920,376
RSUs granted
304,271
$
14,082
RSUs forfeited
( 10,410 )
RSUs vested (2)
( 388,816 )
RSUs outstanding at December 31, 2024
825,421
(1) The total FMV is derived from the number of RSUs granted times the current stock price on the date of grant.
(2) Of the vested RSUs, 148,020 shares of common stock were surrendered to fulfill tax withholding obligations.
Share-based Compensation Expense
The Company recorded share-based compensation expense, which is included in the Company’s consolidated statement of operations as follows:
Year Ended December 31,
2024
2023
2022
(in thousands)
Cost of revenues
$
5,742
$
4,891
$
4,179
Operating expenses:
Selling, distribution, and marketing
1,063
870
726
General and administrative
14,921
12,269
11,180
Research and development
2,642
2,212
1,775
Total share-based compensation
$
24,368
$
20,242
$
17,860
Note 17. Employee Benefits
401(k) Plan
The Company has a defined contribution 401(k) plan, or the Plan, whereby eligible employees voluntarily contribute up to a defined percentage of their annual compensation. The Company matches contributions at a rate of 50 % on the first 6 % of employee contributions, and pays the administrative costs of the Plan. Total employer contributions for the years ended December 31, 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. This plan provides benefits to the employees from the date of retirement and is based on the employee’s length of time employed by the Company. The calculation is based on a statistical calculation combining a number of factors that include the employee’s age, length of service, and AFP employee turnover rate.
The liability under the plan is based on a discount rate of 3.40 % and 3.25 % as of December 31, 2024 and 2023, 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 Company recorded an immaterial amount of expense under the plan for each of the
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
years ended December 31, 2024, 2023 and 2022. 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. The plan allows certain eligible participants to defer a portion of their cash compensation and provides a matching contribution at the discretion of the Company. The plan obligations are payable upon retirement, termination of employment and/or certain other times in a lump-sum distribution or in installments, as elected by the participant in accordance with the plan. Participants can allocate their deferred compensation amongst various investment options with earnings accruing to the participant. The Company has established a Rabbi Trust to fund the plan obligations and to hold the plan assets. Eligible participants began contributing to the plan in January 2020. The plan assets were valued at approximately $ 10.3 million and $ 6.8 million as of December 31, 2024 and 2023, respectively. The plan liabilities were valued at approximately $ 10.7 million and $ 7.1 million as of December 31, 2024 and 2023, respectively. The plan assets and liabilities are included in other long-term assets and other long-term liabilities, respectively, on the Company’s consolidated balance sheets.
Note 18. Commitments and Contingencies
Lease Liabilities
Right-of-Use, or ROU, assets represent the Company’s right to control an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Lease terms are generally based on their initial non-cancelable terms, unless there is a renewal option that is reasonably certain to be exercised. Various factors, including economic incentives, intent, past history, and business needs are considered to determine if a renewal option is reasonably certain to be exercised. As most of its leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the discount rate used to present value the lease payments. The Company has lease agreements with both lease and non-lease components, which are accounted for as a single component for all asset classes. The Company leases real and personal property, in the normal course of business, under various non-cancelable operating leases. The Company, at its option, can renew a substantial portion of its leases, at the market rate, for various renewal periods ranging from one to six years .
In connection with entry into one of the agreements with our CMOs, the Company identified an embedded lease and as a result recorded a ROU asset and a related operating lease liability of approximately $ 16.4 million in December 2024.
The components of lease costs were as follows:
Year Ended December 31,
2024
2023
2022
(in thousands)
Operating lease costs
$
6,135
$
5,267
$
4,709
Short-term lease costs
400
332
300
Finance lease costs
Amortization of right-of-use assets
181
189
237
Interest on lease liabilities
34
45
26
Total finance lease costs
$
215
$
234
$
263
Total lease costs
$
6,750
$
5,833
$
5,272
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Other information pertaining to leases is as follows:
Year Ended December 31,
2024
2023
2022
(in thousands, except lease term and discount rate)
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows paid for operating leases
$
5,647
$
5,106
$
4,329
Operating cash flows paid for finance leases
32
40
18
Financing cash flows paid for finance leases
161
154
233
Right-of use assets obtained in exchange for lease liabilities
Operating leases
18,804
10,521
2,166
Finance leases
—
—
642
Weighted-average remaining lease term (years)
Operating leases
6.6
7.7
8.7
Finance leases
2.5
3.4
4.3
Weighted-average discount rate
Operating leases
6.3
%
5.5
%
4.4
%
Finance leases
6.7
%
6.7
%
6.7
%
Future minimum rental payments under leases that have initial or remaining non-cancelable lease terms in excess of 12 months as of December 31, 2024, are as follows:
Operating
Finance
Leases
Leases
Total
(in thousands)
2025
$
9,583
$
207
$
9,790
2026
9,402
158
9,560
2027
9,218
104
9,322
2028
8,481
—
8,481
2029
8,206
—
8,206
Thereafter
14,425
—
14,425
Total lease payments
$
59,315
$
469
$
59,784
Less: interest
10,630
37
10,667
Total
$
48,685
$
432
$
49,117
Purchase Commitments
As of December 31, 2024, the Company has entered into commitments to purchase equipment and raw materials for an aggregate amount of approximately $ 135.5 million.
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Note 19. Related-Party Transactions
Hanxin Pharmaceutical Technology, Co., Ltd.
The Company has an 11.5 % ownership in Hanxin that is accounted for as an equity method investment. The Company maintains a seat on Hanxin’s board of directors, and Henry Zhang, the son of Dr. Jack Zhang, is an equity holder, the general manager, and the chairman of the board of directors of Hanxin. Additionally, Dr. Mary Luo and Dr. Jack Zhang, have an ownership interest in Hanxin through an affiliated entity. As a result, Hanxin is a related party.
Contract Manufacturing Agreements with Hanxin
The Company has various contract manufacturing agreements with Hanxin and its subsidiaries, whereby Hanxin will develop several active pharmaceutical ingredients and finished products for the Chinese market and will engage the Company to manufacture the products on a cost-plus basis.
During the years ended December 31, 2024, 2023 and 2022, the Company recognized $ 0.5 million, $ 0.1 million and $ 0.4 million of revenue from manufacturing services provided to Hanxin, respectively. As of December 31, 2024, the Company had an immaterial amount of receivables from Hanxin under these agreements.
Contract Research Agreement with Hanxin
In July 2022, the Company entered into a three-year contract research agreement with Hanxin, a related party, whereby Hanxin will develop Recombinant Human Insulin Research Cell Banks, or RCBs, for the Company and license the RCBs to the Company subject to a fully paid, exclusive, perpetual, transferable, sub-licensable worldwide license. Hanxin will also perform scale-up manufacturing process development using the RCBs for the Company.
During the years ended December 31, 2024, 2023 and 2022, the Company paid $ 0.2 million, $ 1.6 million and $ 0.6 million, respectively, under this agreement. As of December 31, 2024, the Company had an immaterial amount of payable to Hanxin under this agreement.
Supply Agreement with Letop
In November 2022, the Company entered into a supply agreement with Nanjing Letop Biotechnology Co., Ltd., or Letop, which is considered a related-party due to an ownership stake of Henry Zhang. Under the terms of the supply agreement, Letop will manufacture and deliver chemical intermediates to the Company on a cost-plus basis. The agreement is effective for three years and the total cost of the agreement shall not exceed $ 1.5 million, with payments adjusted based on the then current exchange rates.
During the year ended December 31, 2024, the Company paid an immaterial amount under this agreement. During the years ended December 31, 2023 and 2022, the Company paid $ 0.7 million and $ 0.2 million, respectively, under this agreement. As of December 31, 2024, the Company did not have any additional accruals payable to Letop.
Primatene MIST ® Distribution Agreement with Hong Kong Genreach Limited
In August 2024, the Company entered into a distribution agreement with Hong Kong Genreach Limited, or Genreach, a wholly owned subsidiary of Hanxin, a related party. Per the terms of the agreement, the Company has appointed Genrearch as the exclusive distributor to market and sell Primatene MIST ® in Mainland China, Taiwan, Hong Kong, and Macau in the Greater China region. Genreach will be responsible for obtaining any and all regulatory approvals in the region for Primatene MIST ® .
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The term of the agreement is ten years, with both parties having termination rights without cause after the completion of the second contract year.
During the year ended December 31, 2024, the Company recognized $ 1.1 million of revenue from the distribution agreement with Genreach. As of December 31, 2024, the Company did not have any receivables from Genreach.
Note 20. Litigation
Albuterol sulfate Inhalation Aerosol Patent Litigation
On July 25, 2024, Teva Branded Pharmaceutical Products R&D, Inc. (“Teva Branded”), Norton (Waterford) Ltd. (“Norton”), and Teva Pharmaceuticals USA, Inc. (“Teva USA”), collectively referred to as (“Plaintiff”) filed a Complaint in the United States District Court for the District of Delaware (“Delaware Court”) against the Company for infringement of U.S. Patent No. 9,463,289, with regard to Amphastar’s ANDA No. 212447, for approval to manufacture and sell generic version of ProAir ® HFA (albuterol sulfate) Inhalation Aerosol. On October 21, 2024, Plaintiff amended its complaint against the Company to include additional claims for infringement of U.S. Patent No. 9,808,587 and 10,561,808, with regard to Amphastar’s ANDA No. 212447, for approval to manufacture and sell generic version of ProAir ® HFA (albuterol sulfate) Inhalation Aerosol. This lawsuit was subsequently settled in January 2025. As part of the settlement, the Company agreed to pay the Plaintiff $ 2.0 million in exchange for a license to use their Patent. The settlement amount was recorded as an intangible asset and is being amortized over its useful life of six years .
Employee Litigations
On April 15, 2024, a former employee initiated an employment litigation against Amphastar and IMS by filing a complaint, as amended, having individual and class action claims for alleged violations of the California Labor Code pertaining to California’s Private Attorneys General Act, or PAGA, wage and hour, and other state laws. This complaint was filed in the Superior Court of California for the County of Los Angeles. In the complaint, the plaintiff is seeking damages and related remedies under California Law, as well as various penalty payments under the California Labor Code. In November 2024, the court ordered the plaintiff to dismiss the individual and class claims, with only the PAGA claim remaining. The Company intends to vigorously defend itself against the complaint.
On June 20, 2024, a former employee initiated an employment litigation against Amphastar, IMS and Roth Staffing Companies L.P. by filing a complaint having individual and class action claims for alleged violations of the California Labor Code pertaining to wage and hour, and other state laws. This complaint was filed in the Superior Court of California for the County of Los Angeles. In the complaint, the plaintiff is seeking damages and related remedies under California Law, as well as various penalty payments under the California Labor Code. The Company intends to vigorously defend itself against the complaint.
Other Litigation
The Company is also subject to various other claims, arbitrations, investigations, and lawsuits from time to time arising in the ordinary course of business. In addition, third parties may, from time to time, assert claims against the Company in the forms of letters and other communications. Currently, the Company is subject to a lawsuit for a property and casualty claim, for which it has recorded an estimated liability of $ 6.0 million within accounts payable and other accrued liabilities on the balance sheet as of December 31, 2024. This estimated liability is fully covered by the Company’s insurance policies. The $ 6.0 million insurance recovery related to this claim is recorded within prepaid expenses and other current assets on the consolidated balance sheet as of December 31, 2024.
The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a material adverse effect on its financial position, results of operations, or cash flows; however, the results of litigation and claims are inherently unpredictable and the Company’s view of these matters may
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change in the future. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.