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
101
Consolidated Statements of Operations
102
Consolidated Statements of Comprehensive Income
103
Consolidated Statements of Stockholders’ Equity
104
Consolidated Statements of Cash Flows
105
Notes to Consolidated Financial Statements
106
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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, 2022 and 2021, 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, 2022, 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, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022, 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, 2022, 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 1, 2023 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 $20.5 million at December 31, 2022. As described in Note 4 to the consolidated financial statements, a provision for chargebacks is made at the time of sale and is analyzed and adjusted, if necessary, at each balance sheet date.
Auditing the provision for chargebacks estimate, the resulting impact of which is netted on the statement of operations against product sales, was complex, requires significant judgment, and the
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amounts involved are material to the financial statements taken as a whole. The significant judgment primarily relates to the estimation of the future wholesale customer mix and related contract pricing, which determine the rates at which future chargebacks on current sales will be paid. Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon delivery, and is based on an amount that reflects the consideration to which the Company expects to be entitled, which represents an amount that is net of the estimated provision for chargebacks, among other deductions. The estimated provision for chargebacks is based on wholesaler inventory levels, historic chargeback rates, and current contract pricing and wholesaler customer mix.
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 provision for chargebacks estimation process. This included testing controls over management’s review of significant assumptions and inputs used in the provision for chargebacks estimate, including actual sales, historical experience, wholesaler inventory levels, customer mix and contract pricing.
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 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.
Enoxaparin inventory lower of cost or net realizable value estimate
Description of the Matter
The Company's inventories totaled $103.6 million as of December 31, 2022 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 $14.9 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, 2022. As explained in Note 2 to the consolidated financial statements, the Company states inventory at the lower of cost and 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 estimation of the average 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, and expected competition.
How We Addressed the
We obtained an understanding, evaluated the design, and tested the operating effectiveness of internal controls over the Company's lower of cost or net realizable value estimate process. This included controls over management's assessment of assumptions such as future demand, customer
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Matter in Our Audit
mix and expected competition and data underlying the estimate, including but not limited to the completeness of the underlying inventory.
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 value enoxaparin inventory. We compared the cost of on-hand enoxaparin inventory and related purchase commitments to the estimated net realizable value estimated based on selling price forecasts. We also evaluated adjustments to the estimated selling price for specific considerations, such as new significant customers, competitors, or planned price changes. We evaluated the reasonableness of management’s forecasted selling price and whether expected changes in demand, competition, or customer mix were appropriate in comparison with the Company’s experience. We also assessed the historical accuracy of management's estimates by performing retrospective reviews over prior periods' forecasted average selling prices and performed sensitivity analyses over the Company’s significant assumptions.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 1998.
Irvine, California
March 1, 2023
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AMPHASTAR PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
December 31,
December 31,
2022
2021
ASSETS
Current assets:
Cash and cash equivalents
$
156,098
$
126,353
Restricted cash
235
235
Short-term investments
19,664
10,320
Restricted short-term investments
2,200
2,200
Accounts receivable, net
88,804
78,804
Inventories
103,584
92,807
Income tax refunds and deposits
171
126
Prepaid expenses and other assets
7,563
7,274
Total current assets
378,319
318,119
Property, plant, and equipment, net
238,266
244,244
Finance lease right-of-use assets
753
353
Operating lease right-of-use assets
25,554
26,894
Investment in unconsolidated affiliate
2,414
3,985
Goodwill and intangible assets, net
37,298
38,870
Other assets
20,856
16,665
Deferred tax assets
38,527
22,399
Total assets
$
741,987
$
671,529
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$
84,242
$
89,545
Income taxes payable
4,571
9,081
Current portion of long-term debt
3,046
2,202
Current portion of operating lease liabilities
3,003
2,982
Total current liabilities
94,862
103,810
Long-term reserve for income tax liabilities
7,225
6,531
Long-term debt, net of current portion and unamortized debt issuance costs
72,839
74,776
Long-term operating lease liabilities, net of current portion
23,694
24,703
Deferred tax liabilities
144
534
Other long-term liabilities
14,565
15,653
Total liabilities
213,329
226,007
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; 58,110,231 and 48,112,069 shares issued and outstanding as of December 31, 2022 and 56,440,202 and 47,714,912 shares issued and outstanding as of December 31, 2021, respectively
6
6
Additional paid-in capital
455,077
422,423
Retained earnings
271,723
180,337
Accumulated other comprehensive loss
( 8,624 )
( 6,765 )
Treasury stock
( 189,524 )
( 150,479 )
Total equity
528,658
445,522
Total liabilities and stockholders’ equity
$
741,987
$
671,529
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,
2022
2021
2020
Net revenues
$
498,987
$
437,768
$
349,846
Cost of revenues
250,127
238,029
206,506
Gross profit
248,860
199,739
143,340
Operating expenses:
Selling, distribution, and marketing
21,531
17,486
14,780
General and administrative
45,061
51,434
50,377
Research and development
74,771
60,932
67,229
Total operating expenses
141,363
129,852
132,386
Income from operations
107,497
69,887
10,954
Non-operating income (expenses):
Interest income
1,321
601
642
Interest expense
( 1,846 )
( 885 )
( 374 )
Other income (expenses), net
9,068
14,536
( 6,585 )
Total non-operating income (expenses), net
8,543
14,252
( 6,317 )
Income before income taxes
116,040
84,139
4,637
Income tax provision
23,477
20,630
3,540
Income before equity in losses of unconsolidated affiliate
92,563
63,509
1,097
Equity in losses of unconsolidated affiliate
( 1,177 )
( 208 )
—
Net income
$
91,386
$
63,301
$
1,097
Net income (loss) attributable to non-controlling interests
$
—
$
1,185
$
( 306 )
Net income attributable to Amphastar Pharmaceuticals, Inc.
$
91,386
$
62,116
$
1,403
Net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders:
Basic
$
1.88
$
1.30
$
0.03
Diluted
$
1.74
$
1.25
$
0.03
Weighted-average shares used to compute net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders:
Basic
48,551
47,777
47,038
Diluted
52,427
49,784
49,124
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,
2022
2021
2020
Net income attributable to Amphastar Pharmaceuticals, Inc.
$
91,386
$
62,116
$
1,403
Other comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc., net of income taxes
Reclassification of adjustment for amounts included in net income
—
( 362 )
—
Foreign currency translation adjustment
( 2,335 )
( 2,943 )
1,121
Change in pension obligations
476
261
( 155 )
Total other comprehensive income (loss) attributable to Amphastar Pharmaceuticals, Inc.
( 1,859 )
( 3,044 )
966
Total comprehensive income attributable to Amphastar Pharmaceuticals, Inc.
$
89,527
$
59,072
$
2,369
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
Total
Additional
Other
Amphastar
Non-
Paid-in
Retained
Comprehensive
Stockholders'
controlling
Shares
Amount
Capital
Earnings
Income (loss)
Shares
Amount
Equity
Interest
Total
Balance as of December 31, 2019
52,495,483
5
367,305
116,370
( 4,687 )
( 5,918,515 )
( 97,627 )
381,366
46,162
427,528
Net income attributable to Amphastar Pharmaceuticals, Inc.
—
—
—
1,403
—
—
—
1,403
—
1,403
Other comprehensive income attributable to Amphastar Pharmaceuticals, Inc.
—
—
—
—
966
—
—
966
—
966
Acquisition of additional ownership interest in ANP
—
—
—
—
—
—
—
—
( 106 )
( 106 )
Net loss attributable to non-controlling interest
—
—
—
—
—
—
—
—
( 306 )
( 306 )
Purchase of treasury stock
—
—
—
—
—
( 1,366,915 )
( 24,425 )
( 24,425 )
—
( 24,425 )
Issuance of treasury stock in connection with the Company's equity plans
—
—
( 240 )
—
—
19,947
240
—
—
—
Issuance of common stock in connection with the Company's equity plans
2,265,439
—
23,165
—
—
—
—
23,165
—
23,165
Share-based compensation expense
—
—
19,831
—
—
—
—
19,831
667
20,498
Balance as of December 31, 2020
54,760,922
5
410,061
117,773
( 3,721 )
( 7,265,483 )
( 121,812 )
402,306
46,417
448,723
Net income attributable to Amphastar Pharmaceuticals, Inc.
—
—
—
62,116
—
—
—
62,116
—
62,116
Other comprehensive loss attributable to Amphastar Pharmaceuticals, Inc.
—
—
—
—
( 2,682 )
—
—
( 2,682 )
—
( 2,682 )
ANP restructuring (see Note 3)
—
—
( 22,162 )
448
( 362 )
—
—
( 22,076 )
( 46,641 )
( 68,717 )
Net income attributable to non-controlling interest
—
—
—
—
—
—
—
—
1,185
1,185
Purchase of treasury stock
—
—
—
—
—
( 1,477,305 )
( 28,873 )
( 28,873 )
—
( 28,873 )
Issuance of treasury stock in connection with the Company's equity plans
—
—
( 206 )
—
—
17,498
206
—
—
—
Issuance of common stock in connection with the Company's equity plans
1,679,280
1
15,924
—
—
—
—
15,925
—
15,925
Share-based compensation expense
—
—
18,806
—
—
—
—
18,806
( 961 )
17,845
Balance as of December 31, 2021
56,440,202
6
422,423
180,337
( 6,765 )
( 8,725,290 )
( 150,479 )
445,522
—
445,522
Net income attributable to Amphastar Pharmaceuticals, Inc.
—
—
—
91,386
—
—
—
91,386
—
91,386
Other comprehensive loss attributable to Amphastar Pharmaceuticals, Inc.
—
—
—
—
( 1,859 )
—
—
( 1,859 )
—
( 1,859 )
Purchase of treasury stock
—
—
—
—
—
( 1,335,528 )
( 39,909 )
( 39,909 )
—
( 39,909 )
Issuance of treasury stock in connection with the Company's equity plans
—
—
( 864 )
—
—
62,656
864
—
—
—
Issuance of common stock in connection with the Company's equity plans
1,670,029
—
15,658
—
—
—
—
15,658
—
15,658
Share-based compensation expense
—
—
17,860
—
—
—
—
17,860
—
17,860
Balance as of December 31, 2022
58,110,231
$
6
$
455,077
$
271,723
$
( 8,624 )
( 9,998,162 )
$
( 189,524 )
$
528,658
$
—
$
528,658
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,
2022
2021
2020
Cash Flows From Operating Activities:
Net income
$
91,386
$
63,301
$
1,097
Reconciliation to net cash provided by operating activities:
Loss on disposal of assets
141
348
240
Gain on deconsolidation of subsidiary
—
( 13,587 )
—
(Gain) loss on interest rate swaps and foreign currency transactions, net
( 2,196 )
27
( 2,173 )
Depreciation of property, plant, and equipment
23,815
22,196
20,491
Amortization of product rights, trademarks, and patents
1,420
1,290
1,036
Operating lease right-of-use asset amortization
3,506
3,266
3,653
Equity in losses of unconsolidated affiliate
1,177
208
—
Share-based compensation expense
17,860
18,687
20,498
Changes in reserve for uncertain tax positions
694
1,821
1,285
Changes in deferred taxes, net
( 16,445 )
2,388
( 162 )
Changes in operating assets and liabilities:
Accounts receivable, net
( 10,132 )
( 14,921 )
( 20,160 )
Inventories
( 11,746 )
1,258
15,297
Prepaid expenses and other assets
( 1,854 )
2,927
643
Income tax refunds, deposits, and payable, net
( 4,555 )
8,349
( 972 )
Operating lease liabilities
( 3,154 )
( 3,198 )
( 3,597 )
Accounts payable and accrued liabilities
( 736 )
3,634
20,090
Net cash provided by operating activities
89,181
97,994
57,266
Cash Flows From Investing Activities:
Purchases and construction of property, plant, and equipment
( 24,034 )
( 27,456 )
( 33,855 )
Proceeds from the sale of property, plant and equipment
421
—
—
Purchase of investments
( 35,761 )
( 17,375 )
( 13,557 )
Maturity of investments
27,969
18,771
12,411
Payment of deposits and other assets
( 1,372 )
( 2,612 )
( 1,414 )
Net cash used in investing activities
( 32,777 )
( 28,672 )
( 36,415 )
Cash Flows From Financing Activities:
Acquisition of additional ownership interest in ANP
—
—
( 106 )
ANP restructuring (see Note 3)
—
( 53,592 )
—
Proceeds from equity plans, net of withholding tax payments
15,658
15,925
23,165
Purchase of treasury stock
( 39,909 )
( 28,873 )
( 24,425 )
Settlement of ANP equity awards
—
( 839 )
—
Debt issuance costs
( 407 )
( 1,738 )
—
Proceeds from borrowing under lines of credit
—
—
1,238
Repayments under lines of credit
—
( 1,161 )
—
Proceeds from issuance of long-term debt
—
70,000
6,283
Principal payments on long-term debt
( 1,781 )
( 36,740 )
( 8,401 )
Net cash used in financing activities
( 26,439 )
( 37,018 )
( 2,246 )
Effect of exchange rate changes on cash
( 220 )
( 223 )
352
Net increase in cash, cash equivalents, and restricted cash
29,745
32,081
18,957
Cash, cash equivalents, and restricted cash at beginning of period
126,588
94,507
75,550
Cash, cash equivalents, and restricted cash at end of period
$
156,333
$
126,588
$
94,507
Noncash Investing and Financing Activities:
Capital expenditure included in accounts payable
$
5,256
$
9,488
$
11,136
Operating lease right-of-use assets in exchange for operating lease liabilities
$
2,166
$
11,041
$
4,819
Equipment acquired under finance leases
$
642
$
107
$
61
Supplemental Disclosures of Cash Flow Information:
Interest paid, net of capitalized interest
$
3,023
$
2,109
$
2,199
Income taxes paid
$
44,442
$
8,096
$
3,411
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 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. Certain prior period amounts have been reclassified within the operating activities of the consolidated statements of cash flows to conform to the current period presentation. All intercompany activity has been eliminated in the preparation of the consolidated financial statements. In the opinion of management, the accompanying consolidated financial statements include all adjustments, which are of a normal recurring nature, necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company.
The Company’s subsidiaries include: (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Amphastar Nanjing Pharmaceuticals Inc., or ANP, (4) Amphastar France Pharmaceuticals, S.A.S., or AFP, (5) Amphastar UK Ltd., or AUK, and (6) International Medication Systems (UK) Limited, or IMS UK.
Investments in Unconsolidated Affiliate
The Company applies the equity method of accounting for investments when it has significant influence, but not controlling interest in the investee. Judgment regarding the level of influence over each equity method investment includes key factors such as ownership interest, representation on the board of directors, participation in policy-making decisions and material intercompany transactions. The Company’s proportionate share of the earnings or losses resulting from these investments is reported as “Equity in losses of unconsolidated affiliate” in the accompanying consolidated statements of operations. Investments accounted for using the equity method may be reported on a lag of up to three months if financial statements of the investee are not available in sufficient time for the investor to apply the equity method as of the current reporting date. The determination of whether an investee’s results are recorded on a lag is made on an investment-by-investment basis.
The carrying value of equity method investments is reported as “Investment in unconsolidated affiliate” in the accompanying consolidated balance sheets. The Company’s equity method investments are reported at cost and adjusted each period for the Company’s share of the investee’s earnings or losses and dividends paid, if any.
The Company assesses equity method investments for impairment whenever events or changes in circumstances indicate that the carrying value of an investment may not be recoverable. If the decline in value is considered to be other than temporary, the investment is written down to its estimated fair value, which establishes a new cost basis in the investment. No such impairment was identified for any of the periods presented.
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AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Use of Estimates
The preparation of consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: determination of allowances for credit losses, fair value of financial instruments, allowance for discounts, provision for chargebacks and rebates, provision for product returns, adjustment of inventory to its net realizable value, impairment of investments, long-lived and intangible assets and goodwill, accrual for workers’ compensation liabilities, litigation reserves, stock price volatility for share-based compensation expense, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions.
Foreign Currency
The functional currency of the Company, its domestic subsidiaries, its Chinese subsidiary ANP, and its U.K. subsidiary, AUK, is the U.S. Dollar, or USD. ANP maintains its books of record in Chinese yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s accompanying consolidated statements of operations.
The Company’s French subsidiary, AFP, maintains its book of record in euros. AUK’s subsidiary, IMS UK, maintains its book of record in British pounds. These local currencies have been determined to be the subsidiaries’ respective functional currencies. Activities in the statements of operations are translated to USD using average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other accumulated comprehensive income (loss). The unrealized gains or losses of intercompany foreign currency transactions that are of a long-term investment nature are reported in other accumulated comprehensive income (loss).
The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature for the years ended December 31, 2022, 2021, and 2020 were a $ 1.8 million loss, a $ 2.6 million loss, and a $ 3.0 million gain, respectively.
Comprehensive Income
The Company’s comprehensive income includes its foreign currency translation gains and losses as well as its share of other comprehensive income from its equity method investments. There was no material income tax provision allocated to other comprehensive loss for the years ended December 31, 2022 and 2021. Income tax expense of $ 0.9 million was allocated to other comprehensive income for the year ended December 31, 2020.
Shipping and Handling Costs
For the years ended December 31, 2022, 2021, and 2020, the Company included shipping and handling costs of approximately $ 7.4 million, $ 4.3 million and $ 4.3 million, respectively, in selling, distribution and marketing expenses in the accompanying consolidated statements of operations.
Advertising Expense
Advertising expenses, primarily associated with Primatene MIST ® , 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
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AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Company’s consolidated statements of operations. For the years ended December 31, 2022, 2021, and 2020, advertising expenses were $ 8.7 million, $ 8.1 million, and $ 5.8 million, respectively.
Research and Development Costs
Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities. These include salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, research-related overhead expenses and fees paid to external service providers.
The Company may produce or purchase inventories prior to or with the expectation of receiving regulatory approval in the near term, based on operational decisions about the most effective use of existing resources. This inventory is referred to as pre-launch inventory. It is the Company’s accounting policy that the pre-launch inventory is capitalized if it has a probable future economic benefit at the time it is purchased or manufactured. If regulatory approval is received and previously expensed pre-launch inventory is sold, such sales may contribute up to a 100% margin to the Company’s operating results. Pre-launch inventory costs include cost of work in process, materials, and finished drug products. As of December 31, 2022, 2021, and 2020, the Company did not have material capitalized pre-launch inventory.
Financial Instruments
The carrying amounts of cash and cash equivalents, short-term investments, restricted cash and short-term investments, accounts receivable, accounts payable, accrued expenses, and short-term borrowings approximate fair value due to the short maturity of these items. The majority of the Company’s long-term obligations consist of variable rate debt, and their carrying value approximates fair value as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities. The Company at times enters into interest rate swap contracts to manage its exposure to interest rate changes and its overall cost of long-term debt. The Company’s interest rate swap contracts exchange the variable interest rates for fixed interest rates.
The Company from time to time may enter into forward currency contracts to lock in currency exchange rates to manage its foreign currency exchange rate exposure. The Company’s interest rate swaps and forward currency contracts have not been designated as hedging instruments and, therefore are recorded at their fair values at the end of each reporting period with changes in fair value recorded in other income (expenses) on the consolidated statements of operations. As of December 31, 2022, the Company had an unsettled forward currency contract to purchase foreign currency with a fair value of approximately $ 0.2 million based on Level 2 inputs, which was recorded as a liability in the accounts payable and accrued liabilities line in the accompanying consolidated balance sheets.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash, money market accounts, certificates of deposit and highly liquid investments with original maturities of three months or less.
Investments
Investments as of December 31, 2022 and 2021 consisted of certificates of deposit and investment grade corporate and municipal bonds with original maturity dates between three and fifteen months.
Restricted Cash
Restricted cash is collateral required for the Company to guarantee certain vendor payments in France. As of December 31, 2022 and 2021, the restricted cash balance was $ 0.2 million.
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Restricted Short-Term Investments
Restricted short-term investments consist of certificates of deposit that are collateral for standby letters of credit to qualify for workers’ compensation self-insurance. The certificates of deposit have original maturities greater than three months, but less than one year. As of December 31, 2022 and 2021, the balance of restricted short-term investments was $ 2.2 million.
Allowance for Credit Losses
The Company evaluates the collectability of accounts receivable based on a combination of factors. When the Company is aware of circumstances that may impair a customer’s ability to pay subsequent to the original sale, the Company records a specific allowance to reduce the amounts receivable to the amount that the Company reasonably believes to be collectable. For all other customers, the Company recognizes an allowance for credit losses based on factors that include the length of time the receivables are past due, industry and geographic concentrations, the current economic conditions and historical collection experience. As of December 31, 2022 and 2021, the Company's allowance for credit losses was $ 2.7 million and $ 2.3 million, respectively.
Inventories
Inventories consist of currently marketed products and products manufactured under contract. Inventories are stated using the first-in, first-out method, on a consistent basis. The Company states inventory at the lower of cost or net realizable value. Provisions are made for slow moving, unsellable, or obsolete items. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose.
Property, Plant and Equipment
Property, plant and equipment are stated at cost or, in the case of assets acquired in a business combination, at fair value on the purchase date. Depreciation and amortization expense is computed using the straight line method over the estimated useful lives of the related assets as follows:
Buildings
20 - 31 years
Machinery and equipment
3 - 12 years
Furniture and fixtures
3 - 7 years
Automobiles
4 - 5 years
Leasehold improvements
Lesser of remaining lease term or useful life
Intangible Assets
Intangible assets with finite lives are amortized using the straight-line method over the period the asset is expected to contribute directly or indirectly to the future cash flows of the Company as follows:
Product rights
10 - 15 years
Patents
10 - 20 years
Land-use rights
37 - 50 years
Impairment of Long-Lived Assets, including Identifiable Definite-Lived Intangible Assets
The Company assesses long-term and identifiable definite-lived intangible assets or asset groups for impairment when events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset or an asset group, further impairment analysis is performed. An impairment loss is measured as the amount by which the carrying amount
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of the asset or asset groups exceeds the fair value (assets to be held and used) or fair value less cost to sell (assets to be disposed of). The Company also assesses the useful lives of its assets periodically to determine whether events and circumstances warrant a revision to the remaining useful life. Changes in the useful life are adjusted prospectively by revising the remaining period over which the asset is amortized.
Deferred Income Taxes
The Company utilizes the liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized.
Impairment of Indefinite-Lived Intangible Asset and Goodwill
The Company assesses indefinite lived intangible asset and goodwill for impairment in the fourth quarter of each year or more frequently if indicators of impairment are present. When the Company chooses to perform a qualitative assessment, it evaluates economic, industry and company-specific factors as an initial step. If the Company determines it is more likely than not that the indefinite-lived intangible asset is impaired or the fair value of a reporting unit is less than its carrying amount, further quantitative impairment testing is then performed; otherwise, no further testing is required. An impairment loss is recorded if the asset’s fair value is less than its carrying value. The Company also periodically assesses its indefinite-lived intangible asset to determine if events and circumstances continue to support an indefinite useful life. If the life is no longer indefinite, the asset is tested for impairment. The carrying value, after recognition of any impairment loss, is amortized over its remaining useful life.
Self-Insured Claims
The Company is primarily self-insured, up to certain limits, for workers’ compensation claims. The Company has purchased stop-loss insurance, which will reimburse the Company for individual claims in excess of $ 350,000 or aggregate minimum attachment of $ 4.4 million annually. The cost of claims reported and an estimate of claims incurred but not reported are charged to operating expenses. A liability for unpaid claims and the associated claim expenses, including incurred but not reported losses, is actuarially determined and reflected in accrued liabilities in the accompanying consolidated balance sheets. Total expense under the program was approximately $ 0.3 million, $ 0.5 million, and $ 0.5 million, for the years ended December 31, 2022, 2021 and 2020, respectively. The self-insured claims liability was $ 3.7 million and $ 4.1 million at December 31, 2022 and 2021, respectively. The determination of such claims and expenses and the appropriateness of the related liability is reviewed periodically and updated, as necessary. Changes in estimates are recorded in the period identified.
Litigation, Commitments and Contingencies
Litigation, commitments and contingencies are accrued when management, after considering the facts and circumstances of each matter as then known to management, has determined it is probable a liability will be found to have been incurred and the amount of the loss can be reasonably estimated. When only a range of amounts is reasonably estimable and no amount within the range is more likely than another, the low end of the range is recorded. Legal fees are expensed as incurred. Due to the inherent uncertainties surrounding gain contingencies, the Company generally does not recognize potential gains until they are realized.
In the fourth quarter of 2021, the Company settled a legal dispute with an unaffiliated third party and subsequently received a settlement payment, net of contingent legal fees, in the amount of $ 2.7 million. The net amount of $ 2.7 million was recorded as other income in the other income (expense), net line in the consolidated statements of operations for the year ended December 31, 2021.
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Recent Accounting Pronouncements
The Company does not believe that any recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements.
Note 3. ANP Restructuring
As a result of the ANP restructuring that was completed during the third quarter of 2021, and subsequent investments by other equity holders of Hanxin, the Company has a 14 % noncontrolling investment in Hanxin as of December 31, 2022 that is accounted for as an equity method investment.
In addition to the retained noncontrolling investment in Hanxin, the Company maintains a seat on Hanxin’s board of directors, and Henry Zhang, a relative of Dr. Jack Zhang and Dr. Mary Luo, is an equity holder, general manager, and chairman of the board of directors of Hanxin. As a result, it was determined that the Company has significant influence over Hanxin and as such the retained noncontrolling investment in Hanxin is accounted for as an equity method investment.
Hanxin continues to be a related party after the deconsolidation.
Note 4. Revenue Recognition
In accordance with Accounting Standard Codification, or ASC, 606 Revenue from Contracts with Customers , revenue is recognized at the time that the Company’s customers obtain control of the promised goods.
Generally, revenue is recognized at the time of product delivery to the Company’s customers. In some cases, revenue is recognized at the time of shipment when stipulated by the terms of the sale agreements.
The consideration the Company receives in exchange for its goods or services is only recognized when it is probable that a significant reversal will not occur. The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration. The Company makes significant estimates for related variable consideration at the point of sale, including chargebacks, rebates, product returns, other discounts and allowances.
The Company’s payment terms vary by types and locations of customers and the products or services offered. Payment terms differ by jurisdiction and customers, but payment is generally required in a term ranging from 30 to 75 days from date of shipment or satisfaction of the performance obligation. For certain products or services and certain customer types, the Company may require payment before products are delivered or services are rendered to customers.
Provisions for estimated chargebacks, rebates, discounts, product returns and credit losses are made at the time of sale and are analyzed and adjusted, if necessary, at each balance sheet date.
Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers.
The Company’s accounting policy is to review each agreement involving contract development and manufacturing services to determine if there are multiple revenue-generating activities that constitute more than one unit of accounting. Revenues are recognized for each unit of accounting based on revenue recognition criteria relevant to that unit. The Company does not have any revenue arrangements with multiple performance obligations.
Service revenues derived from research and development contracts is recognized over time based on progress toward completion of the performance obligation. For each performance obligation satisfied over time, the Company assesses the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction
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of services or an output method of determining the progress of completion of performance obligation. Revenue from research and development services at ANP was $ 4.3 million and $ 5.1 million for the years ended December 31, 2022 and 2021, respectively.
Provision for Chargebacks and Rebates
The provision for chargebacks and rebates is a significant estimate used in the recognition of revenue. Wholesaler chargebacks relate to sales terms under which the Company agrees to reimburse wholesalers for differences between the gross sales prices at which the Company sells its products to wholesalers and the actual prices of such products that wholesalers resell under the Company’s various contractual arrangements with third parties such as hospitals and group purchasing organizations in the United States. Rebates include primarily amounts paid to retailers, payers, and providers in the United States, including those paid to state Medicaid programs, and are based on contractual arrangements or statutory requirements. The Company estimates chargebacks and rebates using the expected value method at the time of sale to wholesalers based on wholesaler inventory stocking levels, historic chargeback and rebate rates, and current contract pricing.
The provision for chargebacks and rebates is reflected as a component of net revenues. The following table is an analysis of the chargeback and rebate provision:
Year Ended December 31,
2022
2021
(in thousands)
Beginning balance
$
20,167
$
20,380
Provision for chargebacks and rebates
208,081
201,133
Credits and payments issued to third parties
( 201,642 )
( 201,346 )
Ending balance
$
26,606
$
20,167
Changes in the chargeback provision from period to period are primarily dependent on the Company’s sales to its wholesalers, the level of inventory held by wholesalers, and the wholesalers’ customer mix. Changes in the rebate provision from period to period are primarily dependent on retailer’s and other indirect customers’ purchases. The approach that the Company uses to estimate chargebacks has been consistently applied for all periods presented. Variations in estimates have been historically small. The Company continually monitors the provision for chargebacks and rebates and makes adjustments when it believes that the actual chargebacks and rebates may differ from the estimates. The settlement of chargebacks and rebates generally occurs within 20 days to 60 days after the sale to wholesalers. Accounts receivable and/or accounts payable and accrued liabilities are reduced and/or increased by the chargebacks and rebate amounts depending on whether the Company has the right to offset with the customer. Of the provision for chargebacks and rebates as of December 31, 2022 and 2021, $ 20.5 million and $ 15.6 million were included as a reduction to accounts receivable, net, on the consolidated balance sheets, respectively. The remaining provision as of December 31, 2022 and 2021 was $ 6.1 million and $ 4.6 million, respectively, which were included in accounts payable and accrued liabilities in the accompanying consolidated balance sheets.
Accrual for Product Returns
The Company offers most customers the right to return qualified excess or expired inventory for partial credit; however, API product sales are generally non-returnable. The Company’s product returns primarily consist of the returns of expired products from sales made in prior periods. Returned products cannot be resold. At the time product revenue is recognized, the Company records an accrual for product returns estimated using the expected value method. The accrual is based, in part, upon the historical relationship of product returns to sales and customer contract terms. The Company also assesses other factors that could affect product returns including market conditions, product obsolescence, and new competition. Although these factors do not normally give the Company’s customers the right to return products outside of the regular return policy, the Company realizes that such factors could ultimately lead to increased returns. The
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Company analyzes these situations on a case-by-case basis and makes adjustments to the product return reserve as appropriate.
The provision for product returns is reflected as a component of net revenues. The following table is an analysis of the product return liability:
Year Ended December 31,
2022
2021
(in thousands)
Beginning balance
$
21,677
$
14,204
Provision for product returns
4,405
15,005
Credits issued to third parties
( 6,631 )
( 7,532 )
Ending balance
$
19,451
$
21,677
Of the provision for product returns as of December 31, 2022 and 2021, $ 14.9 million and $ 16.0 million were included in accounts payable and accrued liabilities on the accompanying consolidated balance sheets, respectively. The remaining provision as of December 31, 2022 and 2021, of $ 4.6 million and $ 5.7 million were included in other long-term liabilities, respectively. For the years ended December 31, 2022 and 2021, the Company’s aggregate product return rate was 1.4 % and 1.7 % of qualified sales, respectively.
Note 5. Income per Share Attributable to Amphastar Pharmaceuticals, Inc. Stockholders
Basic net income per share attributable to Amphastar Pharmaceuticals Inc. stockholders is calculated based upon the weighted-average number of shares outstanding during the period. Diluted net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders gives effect to all potential dilutive shares outstanding during the period, such as stock options, non-vested restricted stock units, and shares issuable under the Company’s Employee Stock Purchase Plan, or ESPP.
For the year ended December 31, 2022, options to purchase 704,483 shares of stock with a weighted-average exercise price of $ 34.79 per share were excluded from the computation of diluted net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders because their effect would be anti-dilutive.
For the year ended December 31, 2021, options to purchase 1,906,029 shares of stock with a weighted-average exercise price of $ 20.82 per share and the reallocation of net income attributable to non-controlling interest were excluded from the computation of diluted net income per common share attributable to Amphastar Pharmaceuticals, Inc. stockholders because their effect would be anti-dilutive.
For the year ended December 31, 2020, options to purchase 1,917,437 shares of stock with a weighted-average exercise price of $ 20.85 per share and the reallocation of net income attributable to non-controlling interest were excluded from the computation of diluted net income per common share attributable to Amphastar Pharmaceuticals, Inc. stockholders because their effect would be anti-dilutive.
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The following table provides the calculation of basic and diluted net income per share attributable to Amphastar Pharmaceuticals, Inc. shareholders for each of the periods presented:
Year Ended December 31,
2022
2021
2020
(in thousands, except per share data)
Basic and dilutive numerator:
Net income attributable to Amphastar Pharmaceuticals, Inc.
$
91,386
$
62,116
$
1,403
Denominator:
Weighted-average shares outstanding — basic
48,551
47,777
47,038
Net effect of dilutive securities:
Incremental shares from equity awards
3,876
2,007
2,086
Weighted-average shares outstanding — diluted
52,427
49,784
49,124
Net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders — basic
$
1.88
$
1.30
$
0.03
Net income per share attributable to Amphastar Pharmaceuticals, Inc. stockholders — diluted
$
1.74
$
1.25
$
0.03
Note 6. Segment Reporting
The Company’s business is the development, manufacture, and marketing of pharmaceutical products. The Company has identified two reporting segments that each report to the Chief Operating Decision Maker, or CODM, as defined in ASC 280, Segment Reporting. The Company’s performance is assessed and resources are allocated by the CODM based on the following two reportable segments:
● Finished pharmaceutical products
● APIs
The finished pharmaceutical products segment manufactures, markets and distributes Primatene MIST ® , glucagon, enoxaparin, naloxone, phytonadione, lidocaine, epinephrine, various critical and non-critical care drugs, as well as certain contract manufacturing and contract research revenues. The API segment manufactures and distributes recombinant human insulin API and porcine insulin API for external customers and internal product development.
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Selected financial information by reporting segment is presented below:
Year Ended December 31,
2022
2021
2020
(in thousands)
Net revenues:
Finished pharmaceutical products
$
486,505
$
419,570
$
331,368
API
12,482
18,198
18,478
Total net revenues
498,987
437,768
349,846
Gross profit (loss):
Finished pharmaceutical products
256,710
209,715
151,645
API
( 7,850 )
( 9,976 )
( 8,305 )
Total gross profit
248,860
199,739
143,340
Operating expenses
141,363
129,852
132,386
Income from operations
107,497
69,887
10,954
Non-operating income (expenses)
8,543
14,252
( 6,317 )
Income before income taxes
$
116,040
$
84,139
$
4,637
The Company manages its business segments to the gross profit level and manages its operating and other costs on a company-wide basis. The Company does not identify total assets by segment for internal purposes, as the Company’s CODM does not assess performance, make strategic decisions, or allocate resources based on assets.
The amount of net revenues in the finished pharmaceutical product segment is presented below:
Year Ended December 31,
2022
2021
2020
(in thousands)
Finished pharmaceutical products net revenues:
Primatene MIST ®
$
84,309
$
73,113
$
51,725
Epinephrine
74,204
57,530
23,799
Glucagon
55,322
47,639
—
Lidocaine
52,539
44,413
41,113
Phytonadione
49,500
45,498
42,646
Enoxaparin
34,950
35,962
48,681
Naloxone
26,269
27,540
33,416
Other finished pharmaceutical products
109,412
87,875
89,988
Total finished pharmaceutical products net revenues
$
486,505
$
419,570
$
331,368
The amount of depreciation and amortization expense included in cost of revenues, by reporting segment is presented below:
Year Ended December 31,
2022
2021
2020
(in thousands)
Depreciation and amortization expense
Finished pharmaceutical products
$
8,884
$
6,003
$
5,766
API
3,713
4,222
3,264
Total depreciation and amortization expense
$
12,597
$
10,225
$
9,030
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Net revenues and carrying values of long-lived assets by geographic regions are as follows:
Net Revenue
Long-Lived Assets
Year Ended December 31,
December 31,
2022
2021
2020
2022
2021
(in thousands)
United States
$
486,833
$
419,869
$
333,093
$
136,328
$
134,731
China
4,697
6,020
3,161
88,647
91,876
France
7,457
11,879
13,592
39,598
44,884
Total
$
498,987
$
437,768
$
349,846
$
264,573
$
271,491
Note 7. Customer and Supplier Concentration
Customer Concentrations
Three large wholesale drug distributors, AmerisourceBergen Corporation, or AmerisourceBergen, Cardinal Health, Inc., or Cardinal, and McKesson Corporation, or McKesson, are all distributors of the Company’s products, as well as suppliers of a broad range of health care products. The Company considers these three customers to be its major customers, as each individually and these customers collectively, represented a significant percentage of the Company’s net revenue for the years ended December 31, 2022, 2021, and 2020, and accounts receivable as of December 31, 2022 and 2021, respectively. The following table provides accounts receivable and net revenue information for these major customers:
% of Total Accounts
% of Net
Receivable
Revenue
December 31,
December 31,
Year Ended December 31,
2022
2021
2022
2021
2020
AmerisourceBergen
16
%
13
%
23
%
24
%
23
%
McKesson
32
%
30
%
22
%
21
%
22
%
Cardinal Health
19
%
20
%
17
%
16
%
17
%
Supplier Concentrations
The Company depends on suppliers for raw materials, APIs, and other components that are subject to stringent FDA requirements. Some of these materials may only be available from one or a limited number of sources. Establishing additional or replacement suppliers for these materials may take a substantial period of time, as suppliers must be approved by the FDA. Furthermore, a significant portion of raw materials may only be available from foreign sources. If the Company is unable to secure, on a timely basis, sufficient quantities of the materials it depends on to manufacture and market its products, it could have a materially adverse effect on the Company’s business, financial condition, and results of operations.
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, 2022, cash equivalents include money market accounts and corporate and municipal bonds with original maturities of less than three months. Investments consist of certificates of deposit as well as investment-grade corporate and municipal bonds with original maturity dates between three and twelve months. The certificates of deposit are carried at amortized cost in the Company’s consolidated balance sheets, which approximates their fair value determined based on Level 2 inputs. The corporate and municipal bonds are classified as held-to-maturity and are carried at amortized cost net of allowance for credit losses, which approximates their fair value determined based on Level 2 inputs. The restrictions on restricted cash and investments have an immaterial effect on the fair value of these financial assets.
The fair value of the Company’s financial assets and liabilities measured on a recurring basis as of December 31, 2022 and 2021, are as follows:
Total
(Level 1)
(Level 2)
(Level 3)
(in thousands)
Cash equivalents
$
130,249
$
130,249
$
—
$
—
Restricted cash
235
235
—
—
Short-term investments
4,600
—
4,600
—
Restricted short-term investments
2,200
—
2,200
—
Corporate, agency and municipal bonds
23,453
—
23,453
—
Interest rate swaps related to variable rate loans
6,048
—
6,048
—
Fair value measurement as of December 31, 2022
$
166,785
$
130,484
$
36,301
$
—
Cash equivalents
$
102,863
$
102,863
$
—
$
—
Restricted cash
235
235
—
—
Short-term investments
5,103
—
5,103
—
Restricted short-term investments
2,200
—
2,200
—
Corporate and municipal bonds
6,984
—
6,984
—
Interest rate swaps related to variable rate loans
596
—
596
—
Fair value measurement as of December 31, 2021
$
117,981
$
103,098
$
14,883
$
—
The Company does not hold any Level 3 instruments that are measured at fair value on a recurring basis.
Nonfinancial assets and liabilities are not measured at fair value on a recurring basis but are subject to fair value adjustments in certain circumstances. These items primarily include investments in unconsolidated affiliates, long-lived assets, goodwill, and intangible assets for which the fair value is determined as part of the related impairment test. As of December 31, 2022 and 2021, there were no significant adjustments to fair value for nonfinancial assets or liabilities.
The deferred compensation plan assets are valued using the cash surrender value of the life insurance policies and are not included in the table above.
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Note 9. Investments
A summary of the Company’s investments that are classified as held-to-maturity are as follows:
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
(in thousands)
Corporate and agency bonds (due within 1 year)
$
21,612
$
—
$
( 60 )
$
21,552
Municipal bonds (due within 1 year)
1,903
—
( 2 )
1,901
Total investments as of December 31, 2022
$
23,515
$
—
$
( 62 )
$
23,453
Corporate bonds (due within 1 year)
$
2,481
$
—
$
( 3 )
$
2,478
Corporate bonds (due within 1 to 3 years)
1,248
—
( 3 )
1,245
Municipal bonds (due within 1 year)
3,263
—
( 2 )
3,261
Total investments as of December 31, 2021
$
6,992
$
—
$
( 8 )
$
6,984
At each reporting period, the Company evaluates securities for impairment when the fair value of the investment is less than its amortized cost. The Company evaluated the underlying credit quality and credit ratings of the issuers, noting neither a significant deterioration since purchase nor any other factors that would indicate a material credit loss.
The Company measures expected credit losses on held-to-maturity investments on a collective basis. All the Company’s held-to-maturity investments were considered to be one pool. The estimate for credit losses considers historical loss information that is adjusted for current conditions and reasonable and supportable forecasts. Expected credit losses on held-to-maturity investments were not material to the consolidated financial statements.
Investment in unconsolidated affiliate
The Company accounts for its share of the earnings or losses of its unconsolidated affiliate (Hanxin) with a reporting lag of three months, as the financial statements of Hanxin are not completed on a basis that is sufficient for the Company to apply the equity method on a current basis. The Company’s share of Hanxin’s losses for the years ended December 31, 2022 and 2021 was $ 1.2 million and $ 0.2 million, respectively, which was recorded in the “Equity in losses of unconsolidated affiliate” line on the accompanying consolidated statement of operations.
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NOTES TO 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
IMS (UK) international product rights
10
$
8,462
$
5,430
$
3,032
Patents
12
486
362
124
Land-use rights
39
2,540
749
1,791
Subtotal
11
11,488
6,541
4,947
Indefinite-lived intangible assets
Trademark
*
29,225
—
29,225
Goodwill - Finished pharmaceutical products
*
3,126
—
3,126
Subtotal
*
32,351
—
32,351
As of December 31, 2022
*
$
43,839
$
6,541
$
37,298
Weighted-Average
Accumulated
Life (Years)
Original Cost
Amortization
Net Book Value
(in thousands)
Definite-lived intangible assets
IMS (UK) international product rights
10
$
9,445
$
5,116
$
4,329
Patents
12
486
340
146
Land-use rights
39
2,540
683
1,857
Subtotal
12
12,471
6,139
6,332
Indefinite-lived intangible assets
Trademark
*
29,225
—
29,225
Goodwill - Finished pharmaceutical products
*
3,313
—
3,313
Subtotal
*
32,538
—
32,538
As of December 31, 2021
*
$
45,009
$
6,139
$
38,870
*
Intangible assets with indefinite lives have an indeterminable average life.
Goodwill
The changes in the carrying amounts of goodwill are as follows:
December 31,
2022
2021
(in thousands)
Beginning balance
$
3,313
$
3,940
ANP restructuring
—
( 374 )
Currency translation
( 187 )
( 253 )
Ending balance
$
3,126
$
3,313
Primatene ® Trademark
In January 2009, the Company acquired the exclusive rights to the trademark, domain name, website and domestic marketing, distribution and selling rights related to Primatene MIST ® , 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, 2022.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The trademark was determined to have an indefinite life. In determining its indefinite life, the Company considered the following: the expected use of the intangible; the longevity of the brand; the legal, regulatory and contractual provisions that affect their maximum useful life; the Company’s ability to renew or extend the asset’s legal or contractual life without substantial costs; effects of the regulatory environment; expected changes in distribution channels; maintenance expenditures required to obtain the expected future cash flows from the asset; and considerations for obsolescence, demand, competition and other economic factors.
Amortization
Included in cost of revenues for the years ended December 31, 2022, 2021 and 2020 is product rights amortization expense of $ 0.9 million, $ 1.0 million, and $ 1.2 million, respectively.
As of December 31, 2022, the expected amortization expense for all amortizable intangible assets during the next five fiscal years ended December 31 and thereafter is as follows:
(in thousands)
2023
$
1,035
2024
1,035
2025
1,035
2026
243
2027
79
Thereafter
1,520
Total amortizable intangible assets
4,947
Indefinite-lived intangibles
32,351
Total intangibles (net of accumulated amortization)
$
37,298
Note 11. Inventories
Inventories consist of the following:
December 31,
2022
2021
(in thousands)
Raw materials and supplies
$
47,607
$
41,853
Work in process
37,090
33,298
Finished goods
18,887
17,656
Total inventories
$
103,584
$
92,807
Charges of $ 17.2 million, $ 24.6 million, and $ 13.9 million were included in the cost of revenues in the Company’s consolidated statements of operations for the years ended December 31, 2022, 2021, and 2020, respectively, to adjust the Company’s inventory and related firm purchase commitments to their net realizable value. For the year ended December 31, 2022, the charge included $ 14.9 million in the cost of revenues to adjust the Company’s enoxaparin inventory and related firm purchase commitments to their net realizable value. For the year ended December 31, 2021, the charge included $ 20.7 million as a result of an increase in the price of heparin as well as a decrease in the forecasted average selling price of enoxaparin. For the year ended December 31, 2020, the charge included $ 9.4 million as a result of an increase in the price of heparin as well as a decrease in the forecasted average selling price of enoxaparin.
Losses on firm purchase commitments related to raw materials on order as of December 31, 2022 and 2021 were $ 2.7 million and $ 7.1 million, respectively, which are recorded in cost of revenues in the Company’s consolidated statement of operations.
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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,
2022
2021
(in thousands)
Buildings
$
130,726
$
130,582
Leasehold improvements
31,535
29,221
Land
7,451
7,615
Machinery and equipment
208,068
207,883
Furniture, fixtures, and automobiles
29,674
27,376
Construction in progress
50,842
41,186
Total property, plant, and equipment
458,296
443,863
Less accumulated depreciation
( 220,030 )
( 199,619 )
Total property, plant, and equipment, net
$
238,266
$
244,244
The Company incurred depreciation expense of $ 23.8 million, $ 22.2 million, and $ 20.5 million for the years ended December 31, 2022, 2021, and 2020, respectively.
Interest expense capitalized was approximately $ 1.4 million, $ 1.4 million, and $ 1.8 million, for the years ended December 31, 2022, 2021, and 2020, respectively.
Note 13. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consisted of the following:
December 31,
2022
2021
(in thousands)
Accrued customer fees and rebates
$
14,198
$
12,121
Accrued payroll and related benefits
22,847
23,256
Accrued product returns, current portion
14,867
16,028
Accrued loss on firm purchase commitments
2,686
7,133
Other accrued liabilities
9,143
8,793
Total accrued liabilities
63,741
67,331
Accounts payable
20,501
22,214
Total accounts payable and accrued liabilities
$
84,242
$
89,545
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 14. Debt
Debt consists of the following:
December 31,
2022
2021
(in thousands)
Term Loan
Term loan with Capital One N.A. due August 2026
$
68,250
$
69,563
Mortgage Loans
Mortgage payable with East West Bank due June 2027
8,188
8,353
Other Loans and Payment Obligations
French government loans due December 2026
204
269
Line of Credit Facilities
Line of credit facility with China Merchant Bank
—
—
Revolving line of credit facility with Capital One N.A. due August 2026
—
—
Equipment under Finance Leases
790
398
Total debt
77,432
78,583
Less current portion of long-term debt
3,046
2,202
Less: Loan issuance costs
1,547
1,605
Long-term debt, net of current portion and unamortized debt issuance costs
$
72,839
$
74,776
Credit Agreement
Credit Agreement with Capital One N.A. - Due August 2026
In August 2021, the Company entered into a $ 140.0 million credit agreement with Capital One N.A. acting as a lender and as agent for other lenders. Under the terms of the credit agreement, the Company borrowed $ 70.0 million in the form of a term loan. Proceeds from the loan were used to pay down certain of the Company’s outstanding loans and revolving lines of credit with Cathay Bank and East West Bank. The interest rate on the term loan is based on a variable interest rate, plus an applicable margin rate ranging between 0.5 % and 2.5 %, determined based on the Company’s net leverage ratio as defined by the terms of the agreement. The loan matures in August 2026.
The loan requires principal payments of $ 1.8 million per year for the first two years, which increases to $ 3.5 million during the third and fourth year and to $ 3.9 million in the fifth year, with the remaining balance due at maturity. The loan is secured by substantially all of the Company’s assets, excluding the assets of ANP.
The credit agreement provides for a $ 70.0 million revolving credit facility, which bears a variable interest rate, plus a fixed margin.
In conjunction with the new credit agreement, the Company entered into an interest rate swap agreement with Capital One N.A., with a notional amount of $ 55.0 million to exchange the variable interest rate on the new term loan for a fixed rate of 0.93 %.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
As of December 31, 2022, the Company has incurred approximately $ 2.1 million in issuance costs in connection with this credit agreement, which are being amortized over the term of the loan.
Mortgage Loans
Mortgage Payable with East West Bank — Due June 2027
In May 2017, the Company entered into a mortgage term loan with East West Bank in the principal amount of $ 9.0 million, which matures in June 2027. The loan is payable in monthly installments with a final balloon payment of $ 7.4 million plus interest. The loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex and two buildings at the Company’s Chino, California, facility. The loan bears a variable interest rate at the one-month LIBOR rate plus 2.5 %. As of December 31, 2022, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. The Company entered into a fixed interest rate swap contract on this loan to exchange the variable interest rate for a fixed interest rate of 4.79 % until June 2024.
Line of Credit Facilities
Line of Credit Facility with China Merchant Bank – Due March 2023
In March 2020, the Company entered into a credit agreement with China Merchant Bank. The credit agreement allows the Company to borrow up to $ 14.6 million secured by buildings and land use rights held by ANP. The interest rate and other terms will be determined at the time of the borrowing, depending on the type of loan requested. The credit period is for 36 months and expires in March 2023.
Other Loans and Payment Obligations
Loans with Seine-Normandie Water Agency
In December 2018, the Company entered into two additional French government loans with the Seine-Normandie water agency in the aggregate amount $ 0.5 million. The loans have 8 year maturities, and include annual equal payments and bear no interest.
As of December 31, 2022, the payment obligation had an aggregate book value of $ 0.2 million, which approximates fair value.
Interest Rate Swap Contracts
As of December 31, 2022, the fair value of the loans listed above approximated their carrying amount. The interest rate used in the fair value estimation was determined to be a Level 2 input. For the mortgage loan with East West Bank, as well as the term loan with Capital One N.A., the Company has entered into fixed interest rate swap contracts to exchange the variable interest rates for fixed interest rates. The interest rate swap contracts are recorded at fair value in the other assets line in the condensed consolidated balance sheets. Gains from changes in the fair values of interest rate swaps were $ 5.5 million and $ 1.5 million for the years ended December 31, 2022 and 2021, respectively.
Covenants
At December 31, 2022 and 2021, the Company was in compliance with all of its debt covenants.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Long-Term Debt Maturities
As of December 31, 2022, the principal amounts of long-term debt maturities during each of the next five fiscal years ending December 31 are as follows:
Long-term
Debt
(in thousands)
2023
$
2,848
2024
3,733
2025
4,181
2026
58,440
2027
7,440
Thereafter
—
$
76,642
Note 15. Income Taxes
The Company’s income (loss) before income taxes generated from its operations were:
Year Ended December 31,
2022
2021
2020
(in thousands)
Income (loss) before income taxes:
United States
$
127,204
$
86,236
$
15,634
Foreign
( 11,164 )
( 2,097 )
( 10,997 )
Total income (loss) before taxes
$
116,040
$
84,139
$
4,637
The Company’s provision for income taxes consisted of the following:
Year Ended December 31,
2022
2021
2020
(in thousands)
Current provision:
Federal
$
37,626
$
14,088
$
1,803
State
732
1,182
541
Foreign
998
1,676
279
Total current provision
39,356
16,946
2,623
Deferred provision (benefit):
Federal
( 16,119 )
2,657
1,770
State
816
110
( 1,489 )
Foreign
( 576 )
917
636
Total deferred provision
( 15,879 )
3,684
917
Total provision for income taxes
$
23,477
$
20,630
$
3,540
For tax years beginning after December 31, 2021, certain research and development costs are required to be capitalized and amortized over a five or fifteen-year period under the Tax Cuts and Jobs Act of 2017. The Company has reviewed and incorporated this change, which increases the current U.S. federal and state tax expense and cash taxes to be paid for the tax year ending December 31, 2022.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
A reconciliation of the statutory federal income tax rate to the Company’s effective tax rate is as follows:
Year Ended December 31,
2022
2021
2020
Statutory federal income tax
21.0
%
21.0
%
21.0
%
State tax expense, net of federal tax benefit
1.1
1.2
( 16.2 )
Foreign tax rate differences
( 0.3 )
( 2.0 )
( 20.1 )
Foreign valuation allowance
2.6
5.5
89.5
Research and development credits
( 3.1 )
( 3.2 )
( 65.1 )
Share-based compensation
( 3.5 )
( 0.2 )
18.7
Executive compensation
2.3
2.3
48.1
Employee-related expenses
0.2
0.1
1.7
Other
( 0.1 )
( 0.2 )
( 1.3 )
Effective tax rate
20.2
%
24.5
%
76.3
%
The Company’s effective tax rate for 2022 decreased in comparison to 2021 primarily due to differences in pre-tax income positions and excess tax benefit from share-based compensation.
Deferred Tax Assets and Liabilities
Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, tax credit carryforwards, and the tax effects of net operating loss carryforwards.
The significant components of the Company’s deferred tax assets and liabilities are as follows:
December 31,
2022
2021
(in thousands)
Deferred tax assets:
Research and development credits
$
15,418
$
17,019
Net operating loss carryforward
20,019
17,568
Inventory capitalization and reserve
9,598
8,489
Share-based compensation
5,208
4,892
Operating leases
6,684
6,555
Accrued expenses
4,956
5,188
Accrued chargebacks
5,125
3,694
Product return allowance
5,464
5,611
Intangibles
2,124
2,124
Research and development capitalization
17,988
—
Total deferred tax assets
92,584
71,140
Deferred tax liabilities:
Depreciation/amortization
13,272
13,525
Intangibles
8,564
7,893
Operating leases
6,398
6,368
Federal impact of state deferred taxes
3,800
3,966
Other
2,467
642
Total deferred tax liabilities
34,501
32,394
Valuation allowance
( 19,700 )
( 16,881 )
Net deferred tax assets
$
38,383
$
21,865
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Net Operating Loss Carryforwards and Tax Credits
At December 31, 2022, the Company had no material U.S. federal or state net operating loss carryforwards, or NOL carryforwards. The Company had France and United Kingdom foreign NOL carryforwards of approximately $ 75.3 million and $ 2.5 million, respectively. The France and United Kingdom NOL carryforwards can be used annually with certain limitations and have an indefinite carryforward.
At December 31, 2022, the Company had California research and development tax credit carryforwards of approximately $ 21.9 million. The California research and development tax credit has an indefinite carryforward period.
The utilization of NOL and credit carryforwards and other tax attributes could be subject to an annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, or the Code, whereby they could be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period as defined in the Code.
Valuation Allowance
In assessing the need for a valuation allowance, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will be realized. Ultimately, realization depends on the existence of future taxable income. Management considers sources of taxable income such as future reversal of existing deferred taxable temporary differences, tax-planning strategies, and projected future taxable income.
The Company continues to record a full valuation allowance on AFP’s net deferred income tax assets and will continue to do so until AFP generates sufficient taxable income to realize its deferred income tax assets. As of December 31, 2022 and 2021, the Company had a full valuation allowance against the net deferred tax assets of AFP, which totaled $ 18.9 million and $ 16.9 million, respectively.
The Company records a valuation allowance on net deferred income tax assets in states where it files separately and will continue to do so until sufficient taxable income is generated to realize these state deferred income tax assets.
Undistributed Earnings from Foreign Operations
As of December 31, 2022 and 2021, deferred income taxes have not been provided for any undistributed earnings from foreign operations. The foreign subsidiaries have significant accumulated losses, and as such there are no earnings in which to provide taxes. It is the Company’s plan not to repatriate future foreign earnings to the U.S. and indefinitely reinvest such earnings in the foreign jurisdiction.
Uncertain Income Tax Positions
A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows:
December 31,
2022
2021
2020
(in thousands)
Balance at the beginning of the year
$
11,796
$
10,053
$
8,331
Deductions based on tax positions related to prior year
( 41 )
—
—
Additions based on tax positions related to the current year
1,643
1,754
1,815
Deductions based on statute of limitations
( 503 )
( 11 )
( 93 )
Balance at the end of the year
$
12,895
$
11,796
$
10,053
Included in the balance of unrecognized tax benefits as of December 31, 2022 and 2021, was $ 12.2 million and $ 11.4 million, respectively that represents the portion that would impact the effective income tax rate if recognized.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company recognizes interest and penalties related to unrecognized tax benefits in its income tax provision. For the years ended December 31, 2022, 2021 and 2020, the Company accrued interest of approximately $ 0.8 million, $ 0.5 million and $ 0.2 million, respectively, related to its uncertain tax positions.
The Company and/or one or more of its subsidiaries files income tax returns in the U.S. federal jurisdiction and various U.S. states and foreign jurisdictions. As of December 31, 2022, the Company does not have a tax examination in progress for federal, state, or foreign jurisdictions. The Company is subject to income tax audit by tax authorities for tax years 2019 to 2021 for federal, 2018 to 2021 for states, and 2012 to 2021 for foreign.
Note 16. Stockholders' Equity
Equity Plans
As of December 31, 2022, the Company has two equity plans: the Amended and Restated 2015 Equity Incentive Plan, or 2015 Plan, and the 2014 Employee Stock Purchase Plan or ESPP. Prior to the adoption of these plans, the Company granted options pursuant to the Amended and Restated 2005 Equity Incentive Award Plan. Upon termination of the predecessor plans, the shares available for grant at the time of termination, and shares subsequently returned to the plans upon forfeiture or option termination, were transferred to the successor plan in effect at the time of share return. The Company issues new shares of common stock upon exercise of stock options, vesting of restricted stock units, or RSU, and settlement of ESPP, with the exception of the awards granted to employees at AFP, which are settled through re-issuance of the Company’s treasury shares.
Amended and Restated 2015 Equity Incentive Plan
In March 2015, the Board of Directors adopted the Company’s 2015 Equity Incentive Plan, or the 2015 Plan, which was approved by the Company’s stockholders in May 2015 and is set to expire in March 2025. The 2015 Plan is designed to meet the needs of a publicly traded company, including the requirements for granting “performance based compensation” under Section 162(m) of the Internal Revenue Code. The 2015 Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units, performance shares, and other stock or cash awards to employees of the Company and its subsidiaries, members of the Board of Directors and consultants.
In November 2020, the Board of Directors approved the Amendment and Restated 2015 Equity Incentive Plan to provide that at least 95 % of the shares awarded under the plan will be subject to a minimum vesting requirement of at least one year .
The Company initially reserved 5,000,000 shares of common stock for issuance under the 2015 Plan. This number will be increased by the number of shares available for issuance under the Company’s prior equity incentive plans or arrangements that are not subject to options or other awards, plus the number of shares of common stock related to options or other awards granted under the Company’s prior equity incentive plans or arrangements that are repurchased, forfeited, expired, or cancelled on or after the effective date of the 2015 Plan. The 2015 Plan also contains an “evergreen provision” that allows for an annual increase in the number of shares available for issuance on January 1 of each year during the 10 year term of the 2015 Plan, beginning January 1, 2016. The annual increase in the number of shares shall be the lesser of (i) 3,000,000 shares, (ii) two and one-half percent ( 2.5 % ) of the outstanding shares on the last day of the immediately preceding fiscal year, or (iii) such number of shares as determined by the Board of Directors. As of the effective date of the 2015 Plan, there were 5,300,296 shares available for grant under the 2015 Plan.
As of December 31, 2022, the Company reserved an aggregate of 6,499,954 shares of common stock for future issuance under the Amended and Restated 2015 Equity Incentive Plan, or the 2015 Plan, including 1,202,802 shares, which were reserved in January 2023 pursuant to the evergreen provision in the 2015 Plan.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Amended and Restated 2005 Equity Incentive Award Plan
The Amended and Restated 2005 Equity Incentive Award Plan, or 2005 Plan, provided for the grant of incentive stock options, or ISOs, nonqualified stock options, or NQSOs, restricted stock awards, restricted stock unit awards, stock appreciation rights, or SARs, dividend equivalents and stock payments to the Company’s employees, members of the Board of Directors and consultants. Stock options under the 2005 Plan were granted with a term of up to ten years and at prices no less than the fair market value of the Company’s common stock on the date of grant. To date, stock options granted to existing employees generally vest over three to five years and stock options granted to new employees vest over four years . Stock options granted to Board of Directors and consultants generally vested over one year .
As of March 2015, consequent to the 2015 Plan becoming effective, awards were no longer granted under the 2005 Plan.
2014 Employee Stock Purchase Plan
In June 2014, the Company adopted the ESPP in connection with its initial public offering. A total of 2,000,000 shares of common stock are reserved for issuance under this plan. The Company’s ESPP permits eligible employees to purchase common stock at a discount through payroll deductions during defined offering periods. Under the ESPP, the Company may specify offerings with durations of not more than 27 months, and may specify shorter purchase periods within each offering. Each offering will have one or more purchase dates on which shares of its common stock will be purchased for employees participating in the offering. An offering may be terminated under certain circumstances. The price at which the stock is purchased is equal to 85 % of the lower of the fair market value of the common stock at the beginning of an offering period or on the date of purchase.
As of December 31, 2022, the Company has issued 1,089,545 shares of common stock under the ESPP and 910,455 shares of its common stock remains available for issuance under the ESPP.
For the years ended December 31, 2022, 2021, and 2020, the Company recorded ESPP expense of $ 0.9 million, $ 0.7 million, and $ 0.8 million, respectively.
Share Buyback Program
As of December 31, 2022, the Company’s Board of Directors have authorized a total of $ 235.0 million in the share buyback program. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs. The Company’s share buyback program is expected to continue for an indefinite period of time.
Purchases are made through open market and private block transactions pursuant to Rule 10b5-1 plans, privately negotiated transactions or other means as determined by the Company’s management and in accordance with the requirements of the SEC and applicable laws. The timing and actual number of treasury share purchases will depend on a variety of factors including price, corporate and regulatory requirements, and other conditions. These treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s consolidated balance sheets.
Pursuant to the Company’s existing share buyback program, the Company purchased 1,335,528 shares, 1,477,305 shares, and 1,366,384 , shares of its common stock during the years ended December 31, 2022, 2021 and 2020, for total consideration of $ 39.9 million, $ 28.9 million, and $ 24.4 million, respectively.
Share-Based Award Activity and Balances (excluding the ANP Equity Plan)
The Company accounts for share-based compensation payments in accordance with ASC 718, which requires measurement and recognition of compensation expense at fair value for all share-based payment awards made to employees and directors. Under these standards, the fair value of option awards and the option components of the ESPP
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
awards are estimated at the grant date using the Black-Scholes option-pricing model. The fair value of RSUs is estimated at the grant date using the Company’s common share price. Compensation cost for all share-based payments granted with service-based graded vesting schedules is recognized using the straight-line method over the requisite service period.
Options issued under the Company’s 2015 Plan and 2005 Plan are granted at exercise prices equal to or greater than the fair value of the underlying common shares on the date of grant and vest based on continuous service. There have been no awards with performance conditions and no awards with market conditions. The options have a contractual term of five 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 since IPO.
● Expected Term. The expected term represents the period of time in which the options granted are expected to be outstanding. The Company estimates the expected term of options with consideration of vesting date, contractual term, and historical experience for exercise and post-vesting employment or contractual termination behavior after its common stock has been publicly traded. The expected term of “plain vanilla” options is estimated (using the simplified method as outlined in SAB Topic 14 due to a lack of sufficient historical exercise data) based on the midpoint between the vesting date and the end of the contractual term under the simplified method permitted by the SEC implementation guidance.
● Risk- Free Rate. The risk-free interest rate is selected based upon the implied yields in effect at the time of the option grant on U.S. Treasury zero-coupon issues with a term approximately equal to the expected life of the option being valued.
● Dividends. The Company does not anticipate paying cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield rate of zero.
The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual experience differs from those estimates. For the years ended December 31, 2022, 2021 and 2020, the Company estimated an average overall forfeiture rate of approximately 7 %, 6 %, and 5 %, respectively, based on historical experience. Forfeiture rates are separately estimated for its (1) directors and officers, (2) management personnel and (3) other employees. Share-based compensation is recorded net of expected forfeitures. The Company periodically assesses the forfeiture rate and the amount of expense recognized based on estimated historical forfeitures as compared to actual forfeitures. Changes in estimates are recorded in the period they are identified.
Tax benefits resulting from tax deductions in excess of the share-based compensation cost recognized (excess tax benefits) are recorded in the statements of cash flows as financing activities.
The weighted-averages for key assumptions used in determining the fair value of options granted during the years ended
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AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2022, 2021, and 2020 are as follows:
Year Ended December 31,
2022
2021
2020
Average volatility
41.0
%
42.1
%
43.1
%
Average risk-free interest rate
2.3
%
1.2
%
0.8
%
Weighted-average expected life in years
6.1
6.1
5.7
Dividend yield rate
—
%
—
%
—
%
Stock Options
A summary of option activity under all plans for the year ended December 31, 2022, is presented below:
Weighted-Average
Weighted-Average
Remaining
Aggregate
Exercise
Contractual
Intrinsic
Options
Price
Term (Years)
Value (1)
(in thousands)
Outstanding as of December 31, 2021
8,455,721
$
15.67
Options granted
792,441
34.35
Options exercised
( 1,222,147 )
14.56
Options cancelled
( 91,251 )
19.56
Options expired
( 5,614 )
13.79
Outstanding as of December 31, 2022
7,929,150
$
17.66
4.94
87,025
Exercisable as of December 31, 2022
5,550,697
$
15.69
3.64
68,413
Vested and expected to vest as of December 31, 2022
7,757,291
$
17.51
4.87
85,920
(1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the estimated fair value of the Company’s stock for those awards that have an exercise price below the estimated fair value at December 31, 2022.
During the years ended December 31, 2022, 2021, and 2020, the Company recorded expense of $ 8.5 million, $ 8.0 million, and $ 9.1 million, respectively, related to stock options granted under all plans.
Information relating to option grants and exercises is as follows:
Year Ended December 31,
2022
2021
2020
(in thousands, except per share data)
Weighted-average grant date fair value per option share
$
14.75
$
7.62
$
5.51
Intrinsic value of options exercised
21,279
7,906
9,169
Cash received from options exercised
19,202
16,757
24,357
Total fair value of the options vested during the period
8,174
8,177
9,978
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AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
A summary of the status of the Company’s non-vested options as of December 31, 2022, and changes during the year ended December 31, 2022, are presented below:
Weighted-Average
Grant Date
Options
Fair Value
Non-vested as of December 31, 2021
2,848,934
$
6.95
Options granted
792,441
14.75
Options vested
( 1,171,671 )
6.98
Options forfeited
( 91,251 )
8.41
Non-vested as of December 31, 2022
2,378,453
9.48
As of December 31, 2022, there was $ 14.5 million of total unrecognized compensation cost, net of forfeitures, related to non-vested stock option based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.5 years and will be adjusted for future changes in estimated forfeitures.
In April 2020, Jason Shandell resigned from his position as the Company’s President and General Counsel and as a member of the Company’s board of directors. In connection with his resignation, the Company and Mr. Shandell entered into a separation agreement. As part of the separation agreement, the Company agreed to accelerate 80 % of his unvested stock options and extended the expiration date of certain vested stock option awards. As a result of this modification, the Company incurred share-based compensation expense of $ 0.7 million, which is included within general and administration expenses in the consolidated statement of operations for the year ended December 31, 2020.
Restricted Stock Units
The Company grants restricted stock units, or RSUs, to certain employees and members of the Board of Directors with a vesting period of up to five years . The grantee receives one share of common stock at a specified future date for each RSU awarded. The RSUs may not be sold or otherwise transferred until vested. The RSUs do not have any voting or dividend rights prior to the issuance of certificates of the underlying common stock. The share-based expense associated with these grants was based on the Company’s common stock fair value at the time of grant and is amortized over the requisite service period, which generally is the vesting period, using the straight-line method. During the years ended December 31, 2022, 2021, and 2020, the Company recorded expenses of $ 8.4 million, $ 8.1 million, and $ 10.0 million, respectively, related to RSU awards granted under all plans.
As part of the separation agreement with Mr. Shandell, the Company agreed to accelerate the vesting of 80 % of his RSU awards. As a result of this modification, the Company incurred share-based compensation expense of $ 1.6 million, which is included within general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2020.
As of December 31, 2022, there was $ 15.3 million of total unrecognized compensation cost, net of forfeitures, related to non-vested RSU-based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.5 years and will be adjusted for future changes in estimated forfeitures.
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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, 2021
1,184,842
RSUs granted
339,397
$
11,675
RSUs forfeited
( 39,119 )
RSUs vested (2)
( 478,068 )
RSUs outstanding at December 31, 2022
1,007,052
(1) The total FMV is derived from the number of RSUs granted times the current stock price on the date of grant.
(2) Of the vested RSUs, 181,547 shares of common stock were surrendered to fulfil tax withholding obligations.
The 2018 ANP Equity Incentive Plan
In December 2018, ANP’s board of directors approved the 2018 Plan, which was set to expire in December 2023. The 2018 Plan permitted the grant of stock options and other equity awards in ANP shares to ANP employees.
During the second quarter of 2021, in connection with the ANP restructuring, the 2018 Plan was terminated.
At the time the 2018 Plan was terminated, the number of stock options outstanding under the 2018 Plan was 5,018,880 . As part of the termination, ANP cash settled 4,091,080 stock options, of which 1,944,771 stock options were vested and 2,146,309 stock options were unvested, for $ 0.8 million which approximated the fair value of these awards at the time of the settlement. The cash settlement of these awards was recorded as a reduction in equity.
For the remaining 927,800 stock option awards that were outstanding under the 2018 Plan at the time the 2018 Plan was terminated, of which 56,925 stock options were vested and 870,875 were unvested, the Company cancelled these awards and issued replacement awards under the 2015 Plan. The modified awards vest over periods ranging from 1 to 2 years and have a 10-year contractual term. The cancellation and replacement of the awards was accounted for as a modification in accordance with ASC 718.
As a result of the modification, the cost to the Company was $ 2.3 million, of which $ 1.8 million was recorded as share-based compensation within general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2021, and the remaining $ 0.5 million which will be recognized over the vesting period of the modified awards.
Prior to the termination of the 2018 Plan, for the years ended December 31, 2021 and 2020, the Company recorded expense of $ 0.5 million and $ 0.7 million related to stock options issued by ANP under the 2018 Plan, respectively.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Share-based Compensation Expense
The Company recorded share-based compensation expense, which is included in the Company’s consolidated statement of operations as follows:
Year Ended December 31,
2022
2021
2020
(in thousands)
Cost of revenues
$
4,179
$
3,778
$
4,248
Operating expenses:
Selling, distribution, and marketing
726
596
456
General and administrative
11,180
12,622
14,089
Research and development
1,775
1,691
1,705
Total share-based compensation
$
17,860
$
18,687
$
20,498
Note 17. Employee Benefits
401(k) Plan
The Company has a defined contribution 401(k) plan, or the Plan, whereby eligible employees voluntarily contribute up to a defined percentage of their annual compensation. The Company matches contributions at a rate of 50 % on the first 6 % of employee contributions, and pays the administrative costs of the Plan. Total employer contributions for the years ended December 31, 2022, 2021, and 2020 were approximately $ 2.2 million, $ 2.0 million, and $ 1.9 million, respectively.
Defined Benefit Pension Plan
The Company’s subsidiary, AFP, has an obligation associated with a defined-benefit plan for its eligible employees. This plan provides benefits to the employees from the date of retirement and is based on the employee’s length of time employed by the Company. The calculation is based on a statistical calculation combining a number of factors that include the employee’s age, length of service, and AFP employee turnover rate.
The liability under the plan is based on a discount rate of 3.75 % and 1.00 % as of December 31, 2022 and 2021, respectively. The liability is included in other long-term liabilities in the accompanying consolidated balance sheets. The plan is currently unfunded, and the benefit obligation under the plan was $ 2.2 million and $ 2.7 million at December 31, 2022 and 2021, respectively. The Company recorded an immaterial amount of expense under the plan for each of the years ended December 31, 2022, 2021 and 2020. Gain or loss due to change in actuarial valuation of the Company’s defined benefit pension plan is recorded in other comprehensive income (loss).
Non-qualified Deferred Compensation Plan
In December 2019, the Company established a non-qualified deferred compensation plan. The plan allows certain eligible participants to defer a portion of their cash compensation and provides a matching contribution at the discretion of the Company. The plan obligations are payable upon retirement, termination of employment and/or certain other times in a lump-sum distribution or in installments, as elected by the participant in accordance with the plan. Participants can allocate their deferred compensation amongst various investment options with earnings accruing to the participant. The Company has established a Rabbi Trust to fund the plan obligations and to hold the plan assets. Eligible participants began contributing to the plan in January 2020. The plan assets were valued at approximately $ 4.5 million and $ 3.4 million as of December 31, 2022 and December 31, 2021, respectively. The plan liabilities were valued at approximately $ 4.6 million and $ 3.5 million as of December 31, 2022 and December 31, 2021, respectively. The plan assets and liabilities are included in other long-term assets and other long-term liabilities, respectively, on the Company’s
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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 .
The components of lease costs for the years ended December 31, 2022, 2021 and 2020 were as follows:
Year Ended December 31,
2022
2021
2020
(in thousands)
Operating lease costs
$
4,709
$
4,328
$
4,462
Short-term lease costs
300
518
649
Finance lease costs
Amortization of right-of-use assets
237
384
351
Interest on lease liabilities
26
26
33
Total finance lease costs
$
263
$
410
$
384
Total lease costs
$
5,272
$
5,256
$
5,495
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Other information pertaining to leases is as follows:
Year Ended December 31,
2022
2021
2020
(in thousands, except lease term and discount rate)
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$
4,329
$
4,446
$
4,491
Operating cash flows from finance leases
18
25
33
Financing cash flows from finance leases
233
310
369
Right-of use assets obtained in exchange for lease liabilities
Operating leases
2,166
11,041
4,819
Finance leases
642
110
61
Weighted-average remaining lease term (years)
Operating leases
8.7
9.5
8.7
Finance leases
4.3
2.4
2.3
Weighted-average discount rate
Operating leases
4.4
%
4.5
%
5.2
%
Finance leases
6.7
%
5.2
%
5.0
%
Future minimum rental payments under leases that have initial or remaining non-cancelable lease terms in excess of 12 months as of December 31, 2022, are as follows:
Operating
Finance
Leases
Leases
Total
(in thousands)
2023
$
4,078
$
243
$
4,321
2024
3,742
212
3,954
2025
3,635
189
3,824
2026
3,534
159
3,693
2027
3,364
104
3,468
Thereafter
14,080
—
14,080
Total lease payments
$
32,433
$
907
$
33,340
Less: interest
5,736
117
5,853
Total
$
26,697
$
790
$
27,487
Purchase Commitments
As of December 31, 2022, the Company has entered into commitments to purchase equipment and raw materials for an aggregate amount of approximately $ 58.2 million.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 19. Related-Party Transactions
ANP Restructuring
Subsequent to the ANP restructuring discussed in Note 3, which involved various related parties, Hanxin is no longer a wholly-owned subsidiary of the Company and was deconsolidated in the third quarter of 2021.
The Company determined that it has significant influence over Hanxin as a result of its 14 % ownership interest, its seat on Hanxin’s board of directors, and Henry Zhang’s position as an equity holder, general manager, and chairman of the board of directors of Hanxin, given he is the son of Dr. Jack Zhang. Additionally, Dr. Mary Luo and Dr. Jack Zhang, through an affiliated entity, have an ownership interest in Hanxin and as such Hanxin continues to be a related party after the restructuring.
Contract manufacturing agreement with Hanxin
In April 2022, the Company’s Chinese subsidiary, ANP, entered into a contract manufacturing agreement with Hanxin, a related party, whereby Hanxin will develop several active pharmaceutical ingredients and finished products for the Chinese market and will engage ANP to manufacture the products on a cost-plus basis. Hanxin will commit to purchase certain quantities from ANP subject to the terms and conditions set forth in the agreement, including Hanxin filing for and obtaining any required marketing authorizations.
During the year ended December 31, 2022, the Company recognized $ 0.4 million of revenue from manufacturing services provided to Hanxin. As of December 31, 2022, the Company did not have any Receivables from Hanxin.
Contract Research Agreement with Hanxin
In July 2022, the Company entered into a three-year contract research agreement with Hanxin, a related party, whereby Hanxin will develop Recombinant Human Insulin Research Cell Banks, or RCBs, for the Company and license the RCBs to the Company subject to a fully paid, exclusive, perpetual, transferable, sub-licensable worldwide license. The RCBs will be used by the Company to make Master Cell Banks for one of its product candidates. Per the terms of the agreement with Hanxin, all title to the RCBs developed, prepared and produced by Hanxin in conducting research and development will belong to the Company. The Company will also own any confidential and proprietary information, technology regarding development and manufacturing of the RCBs, which shall include engineering, scientific and practical information and formula, research data, design, and procedures and others to develop and manufacture the RCBs, in use or developed by Hanxin. The total cost of the agreement to the Company shall not exceed approximately $ 2.2 million, with payments adjusted based on the then current exchange rates. Any additional work or changes to the scope of work requested by the Company will be charged by Hanxin to the Company on a cost-plus basis, plus any applicable taxes.
During the year ended December 31, 2022, the Company paid $ 0.6 million under this agreement and has accrued an additional $ 0.4 million payable to Hanxin as of December 31, 2022.
Supply Agreement with Letop
In November 2022, the Company’s Chinese subsidiary, ANP, entered in to a supply agreement with Nanjing Letop Biotechnology Co., Ltd., or Letop, a related party, whereby Letop would manufacture and deliver chemical intermediates for ANP on a cost-plus basis. The agreement is effective for three years and the total cost of the agreement shall not exceed approximately $ 1.5 million, with payments adjusted based on the then current exchange rates.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
During the year ended December 31, 2022, ANP paid $ 0.2 million under this agreement. As of December 31, 2022, the Company did not have any additional accruals payable to Letop.
Retirement of James Luo
In December 2020, James Luo retired from his position as the Company’s Senior Vice President of Engineering and President of AFP. Mr. Luo is a relative of the Company’s Chief Operating Officer, Dr. Mary Luo. In connection with his retirement, the Company and Mr. Luo entered into a retirement agreement where the Company agreed to pay Mr. Luo approximately $ 1.0 million in cash compensation over a period of three years as well as provide health insurance coverage for a six year period beginning in 2021. As a result, the Company recorded a total of $ 1.1 million in general and administrative expense in the fourth quarter of 2020 related to this agreement.
Note 20. Litigation
Amphastar Pharmaceuticals, Inc. v Aventis Pharma, SA
In January 2009, the Company filed a qui tam complaint in the U.S. District Court for the Central District of California, alleging that Aventis Pharma S.A., or Aventis, through its acquisition of a patent through false and misleading statements to the U.S. Patent and Trademark Office, as well as through false and misleading statements to the FDA, overcharged the federal and state governments for its Lovenox ® product (the “Aventis FCA Action”).
On November 13, 2020, the Court issued an Order (“November Order”) awarding Aventis $ 12.1 million in attorneys’ fees and $ 0.7 million in costs and expenses. The Company recorded $ 12.8 million in other income (expenses) in the consolidated statement of operations for the year ended December 31, 2020.
On May 3, 2021, the Court issued a further Order based upon supplemental application to the Court seeking fees, expenses, and interest for the period after, and not covered by, the November Order. The Court awarded Aventis an additional $ 4.4 million bringing the total amount awarded to Aventis to $ 17.2 million.
On June 30, 2021, the Company and Aventis entered into a settlement agreement to settle the attorney fees’ and expenses claim for $ 14.5 million. The additional $ 1.7 million was recorded in other income (expenses), in the consolidated statement of operations. The settlement was paid in full in the third quarter of 2021.
Hatch-Waxman Litigation
Regadenoson (0.4 mg/5 mL, 0.08 mg/mL) Patent Litigation
On February 25, 2020, Astellas US LLC, Astellas Pharma US, Inc., and Gilead Sciences, Inc. (collectively, “Astellas-Gilead”) filed a Complaint in the United States District Court for the District of Delaware against IMS for infringement of U.S. Patent Nos. 8,106,183 (the “‘183 patent”), RE47,301 (the “‘301 patent”), and 8,524,883 (the “‘883 patent”) (collectively, “Astellas-Gilead Patents”) with regard to IMS’s ANDA No. 214,252 for approval to manufacture and sell 0.4 mg/5 mL (0.08 mg/mL) intravenous solution of Regadenoson. On March 4, 2020, IMS filed its Answer and Counterclaims. On March 30, 2020, the Court issued an Order allowing the Company to join pending consolidated litigation with five other generic Regadenoson ANDA filers involving similar claims. The Company’s 30-month FDA stay expired August 10, 2022. On January 26, 2022, the Company and Astellas-Gilead reached an agreement to resolve the lawsuit. The parties submitted, and the Court granted on January 27, 2022, a Motion to Dismiss Without Prejudice for Astellas-Gilead’s complaint of infringement against IMS. Under the terms of the agreement, the Company received $ 5.4 million from Astellas constituting saved litigation expenses. The Company recorded the settlement amount in the other income (expenses) line in its consolidated statement of operations for the year ended December 31, 2022.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Employee Litigations
In 2021 and 2020, the Company settled employee litigations relating to alleged violations of various California labor laws pertaining to wage and hour against the Company. For each of the years ended December 31, 2021 and 2020, the Company recorded $ 1.0 million, related to the settlement of employment litigation, in general and administrative expense in the Company’s consolidated statements of operations.
Other Litigation
The Company is also subject to various other claims, arbitrations, investigations, and lawsuits from time to time arising in the ordinary course of business. In addition, third parties may, from time to time, assert claims against the Company in the forms of letters and other communications.
The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a material adverse effect on its financial position, results of operations, or cash flows; however, the results of litigation and claims are inherently unpredictable and the Company’s view of these matters may change in the future. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.