UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
⌧ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024
or
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 001-36509
(Exact name of Registrant as specified in its charter)
Delaware |
| 33-0702205 |
(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer |
11570 6th Street |
| |
Rancho Cucamonga, CA |
| 91730 |
(Address of principal executive offices) | (zip code) |
(909) 980-9484
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ⌧ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☐ | Smaller reporting company | ☐ | |||
Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ⌧
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||
Common Stock, par value $0.0001 per share | AMPH | The NASDAQ Stock Market LLC | ||||
The number of shares outstanding of the registrant’s only class of common stock as of May 3, 2024 was 48,901,965.
AMPHASTAR PHARMACEUTICALS, INC.
TABLE OF CONTENTS
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024
Special Note About Forward-Looking Statements
SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or Quarterly Report, contains “forward-looking statements” that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements relate to future events or future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by the forward-looking statements. These forward-looking statements include, but are not limited to, statements about:
● | our expectations regarding the sales and marketing of our products; |
● | our expectations regarding our newly acquired product, BAQSIMI®, including with respect to our ability to increase our revenues and derive certain benefits as a result of our acquisition of BAQSIMI®; |
● | our ability to successfully acquire and integrate assets, including our ability to integrate BAQSIMI®; |
● | our expectations regarding our manufacturing and production and the integrity of our supply chain for our products, including the risks associated with our single source suppliers; |
● | our business and operations in general, including: adverse impacts of the Russia-Ukraine and Middle East conflicts and challenging macroeconomic conditions on our business, financial condition, operations, cash flows and liquidity; |
● | our ability to attract, hire, and retain highly skilled personnel; |
● | interruptions to our manufacturing and production as a result of natural catastrophic events or other causes beyond our control such as power disruptions or widespread disease outbreaks, the Russia-Ukraine and Middle East conflicts; |
● | global, national and local economic and market conditions, specifically with respect to geopolitical uncertainty, including the Russia-Ukraine and Middle East conflicts, inflation and rising interest rates; |
● | the timing and likelihood of U.S. Food and Drug Administration, or FDA, approvals and regulatory actions on our product candidates, manufacturing activities and product marketing activities; |
● | our ability to advance product candidates in our platforms into successful and completed clinical trials and our subsequent ability to successfully commercialize our product candidates; |
● | cost and delays resulting from the extensive pharmaceutical regulations to which we are subject; |
● | our ability to compete in the development and marketing of our products and product candidates; |
● | our expectations regarding the business of our Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Ltd., or ANP; |
● | the potential for adverse application of environmental, health and safety and other laws and regulations on our operations; |
● | our expectations for market acceptance of our new products and proprietary drug delivery technologies, as well as those of our active pharmaceutical ingredient, or API, customers; |
● | the effects of reforms in healthcare regulations and reductions in pharmaceutical pricing, reimbursement and coverage; |
● | our expectations in obtaining insurance coverage and adequate reimbursement for our products from third-party payers; |
● | the amount of price concessions or exclusion of suppliers adversely affecting our business; |
● | variations in intellectual property laws, our ability to establish and maintain intellectual property protection for our products and our ability to successfully defend our intellectual property in cases of alleged infringement; |
● | the implementation of our business strategies, product development strategies and technology utilization; |
● | the potential for exposure to product liability claims; |
● | our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions, divestitures or investments, including the anticipated benefits of such acquisitions, divestitures or investments; |
● | our ability to expand internationally; |
● | economic and industry trends and trend analysis; |
● | our ability to remain in compliance with laws and regulations that currently apply or become applicable to our business both in the United States and internationally; |
● | the impact of trade tariffs, export or import restrictions, or other trade barriers; |
● | the impact of Patient Protection and Affordable Care Act (as amended) and other legislative and regulatory healthcare reforms in the countries in which we operate including the potential for drug price controls; |
● | the impact of global and domestic tax reforms; |
● | the timing for completion and the validation of the new construction at our ANP and Amphastar facilities; |
● | the timing and extent of share buybacks; and |
● | our financial performance expectations, including our expectations regarding our backlog, revenue, cost of revenue, gross profit or gross margin, operating expenses, including changes in research and development, sales and marketing and general and administrative expenses, and our ability to achieve and maintain future profitability. |
You should read this Quarterly Report and the documents that we reference elsewhere in this Quarterly Report completely and with the understanding that our actual results may differ materially from what we expect as expressed or implied by our forward-looking statements. In light of the significant risks and uncertainties to which our forward-looking statements are subject, you should not place undue reliance on or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. We discuss many of these risks and uncertainties in greater detail in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2023, particularly in Item 1A. “Risk Factors.” These forward-looking statements represent our estimates and assumptions only as of the date of this Quarterly Report regardless of the time of delivery of this Quarterly Report, and such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this Quarterly Report.
Unless expressly indicated or the context requires otherwise, references in this Quarterly Report to “Amphastar,” “the Company,” “we,” “our,” and “us” refer to Amphastar Pharmaceuticals, Inc. and our subsidiaries.
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
| March 31, |
| December 31, | |||
2024 | 2023 | |||||
(unaudited) | ||||||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 201,148 | $ | 144,296 | ||
Restricted cash | 235 | 235 | ||||
Short-term investments | 88,407 | 112,510 | ||||
Restricted short-term investments |
| 2,200 |
| 2,200 | ||
Accounts receivable, net |
| 138,114 |
| 114,943 | ||
Inventories |
| 115,494 |
| 105,833 | ||
Income tax refunds and deposits |
| 784 |
| 526 | ||
Prepaid expenses and other assets |
| 8,696 |
| 9,057 | ||
Total current assets |
| 555,078 |
| 489,600 | ||
Property, plant, and equipment, net |
| 288,523 |
| 282,746 | ||
Finance lease right-of-use assets | 516 | 564 | ||||
Operating lease right-of-use assets | 31,352 | 32,333 | ||||
Investment in unconsolidated affiliate | — | 527 | ||||
Goodwill and intangible assets, net |
| 607,064 |
| 613,295 | ||
Long-term investments | 15,163 | 14,685 | ||||
Other assets |
| 23,369 |
| 25,910 | ||
Deferred tax assets |
| 53,252 |
| 53,252 | ||
Total assets | $ | 1,574,317 | $ | 1,512,912 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable and accrued liabilities | $ | 116,697 | $ | 93,366 | ||
Accrued payments for BAQSIMI® (see Note 3) | 128,245 | 126,090 | ||||
Income taxes payable |
| 5,857 |
| 1,609 | ||
Current portion of long-term debt |
| 428 |
| 436 | ||
Current portion of operating lease liabilities | 3,942 | 3,906 | ||||
Total current liabilities |
| 255,169 |
| 225,407 | ||
Long-term reserve for income tax liabilities |
| 6,066 |
| 6,066 | ||
Long-term debt, net of current portion and unamortized debt issuance costs |
| 594,006 |
| 589,579 | ||
Long-term operating lease liabilities, net of current portion | 28,739 | 29,721 | ||||
Other long-term liabilities |
| 17,981 |
| 22,718 | ||
Total liabilities |
| 901,961 |
| 873,491 | ||
Commitments and contingencies | ||||||
Stockholders’ equity: | ||||||
Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding |
|
| ||||
Common stock: par value $0.0001; 300,000,000 shares authorized; 60,160,459 and 48,841,343 shares issued and outstanding as of March 31, 2024 and 59,390,194 and 48,068,881 shares issued and outstanding as of December 31, 2023, respectively |
| 6 |
| 6 | ||
Additional paid-in capital |
| 476,072 |
| 486,056 | ||
Retained earnings |
| 452,445 |
| 409,268 | ||
Accumulated other comprehensive loss |
| (8,769) |
| (8,478) | ||
Treasury stock |
| (247,398) |
| (247,431) | ||
Total equity | 672,356 | 639,421 | ||||
Total liabilities and stockholders’ equity | $ | 1,574,317 | $ | 1,512,912 |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-1-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in thousands, except per share data)
Three Months Ended |
| ||||||
March 31, | |||||||
| 2024 |
| 2023 |
| |||
Net revenues: | |||||||
Product revenues, net | $ | 157,629 | $ | 140,022 | |||
Other revenues | 14,207 | — | |||||
Total net revenues | 171,836 | 140,022 | |||||
Cost of revenues |
| 81,736 |
| 66,182 | |||
Gross profit |
| 90,100 |
| 73,840 | |||
Operating expenses: | |||||||
Selling, distribution, and marketing |
| 9,371 |
| 7,109 | |||
General and administrative |
| 15,676 |
| 13,483 | |||
Research and development |
| 17,043 |
| 19,815 | |||
Total operating expenses |
| 42,090 |
| 40,407 | |||
Income from operations |
| 48,010 |
| 33,433 | |||
Non-operating income (expenses): | |||||||
Interest income |
| 2,556 |
| 924 | |||
Interest expense |
| (8,611) |
| (398) | |||
Other income (expenses), net |
| 5,921 |
| (390) | |||
Total non-operating income (expenses), net |
| (134) |
| 136 | |||
Income before income taxes |
| 47,876 |
| 33,569 | |||
Income tax provision |
| 4,126 |
| 6,752 | |||
Income before equity in losses of unconsolidated affiliate | 43,750 | 26,817 | |||||
Equity in losses of unconsolidated affiliate | (573) | (785) | |||||
Net income | $ | 43,177 | $ | 26,032 | |||
Net income per share: | |||||||
Basic | $ | 0.90 | $ | 0.54 | |||
Diluted | $ | 0.81 | $ | 0.50 | |||
Weighted-average shares used to compute net income per share: | |||||||
Basic |
| 48,212 |
| 48,000 | |||
Diluted |
| 53,013 |
| 51,970 |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-2-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited; in thousands)
Three Months Ended | |||||||
March 31, | |||||||
| 2024 |
| 2023 |
| |||
Net income | $ | 43,177 | $ | 26,032 | |||
Other comprehensive income (loss), net of income taxes | |||||||
Foreign currency translation adjustment |
| (291) | 356 | ||||
Total other comprehensive income (loss) |
| (291) |
| 356 | |||
Total comprehensive income | $ | 42,886 | $ | 26,388 |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-3-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited; in thousands, except share data)
Common Stock | Accumulated | Treasury Stock | ||||||||||||||||||||
Additional | Other | |||||||||||||||||||||
Paid-in | Retained | Comprehensive | ||||||||||||||||||||
Shares | Amount | Capital | Earnings | Income (loss) | Shares | Amount | Total | |||||||||||||||
Balance as of December 31, 2023 |
| 59,390,194 | $ | 6 | $ | 486,056 | $ | 409,268 | $ | (8,478) |
| (11,321,313) | $ | (247,431) | $ | 639,421 | ||||||
Net income |
| — |
| — |
| — |
| 43,177 |
| — |
| — |
| — |
| 43,177 | ||||||
Other comprehensive loss |
| — |
| — |
| — |
| — |
| (291) |
| — |
| — |
| (291) | ||||||
Issuance of treasury stock in connection with the Company's equity plans | — | — | (33) | — | — | 2,197 | 33 | — | ||||||||||||||
Issuance of common stock in connection with the Company's equity plans |
| 770,265 |
| — |
| (17,311) |
| — |
| — |
| — |
| — |
| (17,311) | ||||||
Share-based compensation expense |
| — |
| — |
| 7,360 |
| — |
| — |
| — |
| — |
| 7,360 | ||||||
Balance as of March 31, 2024 |
| 60,160,459 | $ | 6 | $ | 476,072 | $ | 452,445 | $ | (8,769) |
| (11,319,116) | $ | (247,398) | $ | 672,356 |
Common Stock | Accumulated | Treasury Stock | ||||||||||||||||||||
Additional | Other | |||||||||||||||||||||
Paid-in | Retained | Comprehensive | ||||||||||||||||||||
Shares | Amount | Capital | Earnings | Income (loss) | Shares | Amount | Total | |||||||||||||||
Balance as of December 31, 2022 |
| 58,110,231 | $ | 6 | $ | 455,077 | $ | 271,723 | $ | (8,624) |
| (9,998,162) | $ | (189,524) | $ | 528,658 | ||||||
Net income |
| — |
| — |
| — |
| 26,032 |
| — |
| — |
| — |
| 26,032 | ||||||
Other comprehensive income |
| — |
| — |
| — |
| — |
| 356 |
| — |
| — |
| 356 | ||||||
Purchase of treasury stock |
| — |
| — |
| — |
| — |
| — |
| (263,131) | (8,015) |
| (8,015) | |||||||
Issuance of common stock in connection with the Company's equity plans |
| 330,300 |
| — |
| (4,565) |
| — |
| — |
| — |
| — |
| (4,565) | ||||||
Share-based compensation expense |
| — |
| — |
| 6,111 |
| — |
| — |
| — |
| — |
| 6,111 | ||||||
Balance as of March 31, 2023 |
| 58,440,531 | $ | 6 | $ | 456,623 | $ | 297,755 | $ | (8,268) |
| (10,261,293) | $ | (197,539) | $ | 548,577 |
See Accompanying Notes to Condensed Consolidated Financial Statements
-4-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in thousands)
Three Months Ended | ||||||
March 31, | ||||||
| 2024 |
| 2023 | |||
Cash Flows From Operating Activities: | ||||||
Net income | $ | 43,177 | $ | 26,032 | ||
Reconciliation to net cash provided by operating activities: | ||||||
Loss on disposal of assets |
| — |
| 2 | ||
Loss (gain) on interest rate swaps and foreign currency transactions, net | (4,645) | 195 | ||||
Depreciation of property, plant, and equipment |
| 6,816 |
| 6,252 | ||
Amortization of product rights, trademarks, and patents |
| 6,167 |
| 241 | ||
Operating lease right-of-use asset amortization | 980 | 903 | ||||
Amortization of discounts, premiums, and debt issuance costs | 2,128 | 59 | ||||
Equity in losses of unconsolidated affiliate | 573 | 785 | ||||
Share-based compensation expense |
| 7,360 |
| 6,111 | ||
Changes in operating assets and liabilities: | ||||||
Accounts receivable, net |
| (23,201) |
| (11,796) | ||
Inventories |
| (9,995) |
| 268 | ||
Prepaid expenses and other assets |
| (192) |
| 219 | ||
Income tax refunds, deposits, and payable, net |
| 3,992 |
| 6,459 | ||
Operating lease liabilities | (947) | (862) | ||||
Accounts payable and accrued liabilities |
| 23,078 |
| 5,514 | ||
Net cash provided by operating activities |
| 55,291 |
| 40,382 | ||
Cash Flows From Investing Activities: | ||||||
Purchases and construction of property, plant, and equipment |
| (8,793) |
| (9,477) | ||
Purchase of investments | (22,507) | (10,574) | ||||
Maturity of investments | 47,497 | 14,064 | ||||
Deposits and other assets |
| (960) |
| (346) | ||
Net cash provided by (used in) investing activities |
| 15,237 |
| (6,333) | ||
Cash Flows From Financing Activities: | ||||||
Proceeds from equity plans, net of withholding tax payments |
| (17,311) |
| (4,565) | ||
Purchase of treasury stock |
| — |
| (8,015) | ||
Debt issuance costs | (252) | — | ||||
Proceeds from borrowing under lines of credit |
| 4,082 |
| — | ||
Principal payments on long-term debt |
| (98) |
| (968) | ||
Net cash used in financing activities |
| (13,579) |
| (13,548) | ||
Effect of exchange rate changes on cash |
| (97) | 16 | |||
Net increase in cash, cash equivalents, and restricted cash |
| 56,852 |
| 20,517 | ||
Cash, cash equivalents, and restricted cash at beginning of period |
| 144,531 | 156,333 | |||
Cash, cash equivalents, and restricted cash at end of period | $ | 201,383 | $ | 176,850 | ||
Noncash Investing and Financing Activities: | ||||||
Capital expenditures included in accounts payable | $ | 5,943 | $ | 4,802 | ||
Operating lease right-of-use assets in exchange for operating lease liabilities | $ | — | $ | 1,150 | ||
Supplemental Disclosures of Cash Flow Information: | ||||||
Interest paid, net of capitalized interest | $ | 8,632 | $ | 1,245 | ||
Income taxes paid | $ | 349 | $ | 336 |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-5-
Note 1. General
Amphastar Pharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, hereinafter referred to as the “Company”) is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, including products with high technical barriers to market entry. Additionally, the Company sells insulin active pharmaceutical ingredient, or API, products. Most of the Company’s products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company’s insulin API products are sold to other pharmaceutical companies for use in their own products and are being used by the Company in the development of injectable finished pharmaceutical products. The Company’s inhalation product, Primatene MIST®, is primarily distributed through drug retailers.
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2023 and the notes thereto as filed with the Securities and Exchange Commission, or SEC, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, have been condensed or omitted from the accompanying condensed consolidated financial statements. The accompanying year-end condensed consolidated balance sheet was derived from the audited financial statements. The accompanying interim financial statements are unaudited, but reflect all adjustments which are, in the opinion of management, necessary for a fair presentation of the Company’s consolidated financial position, results of operations, comprehensive income (loss), stockholders’ equity, and cash flows for the periods presented. Unless otherwise noted, all such adjustments are of a normal, recurring nature. The Company’s results of operations, comprehensive income (loss) and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries, and are prepared in accordance with GAAP. All intercompany activity has been eliminated in the preparation of the condensed consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, which are of a normal recurring nature, necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company.
The Company’s subsidiaries include: (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Amphastar Nanjing Pharmaceuticals Inc., or ANP, (4) Amphastar France Pharmaceuticals, S.A.S., or AFP, (5) Amphastar UK Ltd., or AUK, (6) International Medication Systems (UK) Limited, or IMS UK, and (7) Amphastar Medication Co., LLC, or Amphastar Medication.
Investment in Unconsolidated Affiliate
The Company applies the equity method of accounting for investments when it has significant influence, but not controlling interest in the investee. The Company’s proportionate share of the earnings or losses resulting from these investments is reported as “Equity in losses of unconsolidated affiliate” in the accompanying consolidated statements of operations. Investments accounted for using the equity method may be reported on a lag of up to three months if financial statements of the investee are not available in sufficient time for the investor to apply the equity method as of the current reporting date.
-6-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The carrying value of equity method investments is reported as “Investment in unconsolidated affiliate” in the accompanying 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.
During the three months ended March 31, 2024, the book value of the Company’s investment in Hanxin was reduced to zero, as a result of recording of the Company’s share of the losses of Hanxin
Use of Estimates
The preparation of condensed consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: fair value of acquired assets, determination of allowances for credit losses, fair value of financial instruments, allowance for discounts, provision for chargebacks and rebates, provision for product returns, adjustment of inventory to its net realizable value, impairment of investments, long-lived and intangible assets and goodwill, accrual for workers’ compensation liabilities, litigation reserves, stock price volatility for share-based compensation expense, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions.
Foreign Currency
The functional currency of the Company, its domestic subsidiaries, its Chinese subsidiary ANP, and its U.K. subsidiary, AUK, is the U.S. Dollar, or USD. ANP maintains its books of record in Chinese yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s condensed consolidated statements of operations.
The Company’s French subsidiary, AFP, maintains its book of record in euros. AUK’s subsidiary, IMS UK, maintains its book of record in British pounds. These local currencies have been determined to be the subsidiaries’ respective functional currencies. Activities in the statements of operations are translated to USD using average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other comprehensive income (loss). The unrealized gains or losses of intercompany foreign currency transactions that are of a long-term investment nature are reported in other accumulated comprehensive income (loss).
The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature for the three months ended March 31, 2024 and 2023 were $0.7 million loss and $0.6 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.
Acquisitions
The Company evaluates acquisitions and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and substantive processes that
-7-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
have the ability to create outputs, which would meet the definition of a business.
Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.
For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis, with the exception of non-qualifying assets. Goodwill is not recognized in an asset acquisition. When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration, including assumed contingent considerations, is not recognized until all contingencies are resolved and the consideration is paid or becomes payable (unless contingent considerations meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired), at which point the consideration is allocated to the assets acquired based on their relative fair values at the acquisition date, with the exception of non-qualifying assets.
Judgments are used in determining estimates of useful lives of long-lived assets. Useful life estimates are based on, among other factors, estimates of expected future net cash flows, the assessment of each asset’s life cycle, and the impact of competitive trends on each asset’s life cycle and other factors. These judgments can materially impact the estimates used to allocate purchase consideration to assets acquired and liabilities assumed, and the resulting timing and amounts charged to or recognized in current and future operating results. For these and other reasons, actual results may vary significantly from estimated results.
Advertising Expense
Advertising expenses, primarily associated with Primatene MIST®, are recorded as they are incurred, except for expenses related to the development of a major commercial or media campaign, which are expensed in the period in which the commercial or campaign is first presented, and are reflected as a component of selling, distribution and marketing in the Company’s condensed consolidated statements of operations. For the three months ended March 31, 2024 and 2023, advertising expenses were $2.7 million and $3.3 million, respectively.
Financial Instruments
The Company’s accompanying condensed consolidated balance sheets include the following financial instruments: cash and cash equivalents, restricted cash, accounts receivable, accounts payable, accrued expenses, short-term borrowings, and long-term obligations. The Company considers the carrying amounts of current assets and liabilities on the condensed consolidated balance sheets to approximate the fair value of these financial instruments due to the short maturity of these items. The carrying value of the Company’s long-term obligations, with the exception of the convertible debt (See Note 14) approximates their fair value, as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities. Investments and short-term investments are recorded at fair value based on quoted prices from recognized security exchanges and other methods (See Note 9). 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.
-8-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
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 March 31, 2024 and December 31, 2023 consisted of certificates of deposit and investment grade corporate, agency 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 each of March 31, 2024 and December 31, 2023, the restricted cash balance was $0.2 million.
Restricted Short-Term Investments
Restricted short-term investments consist of certificates of deposit that are collateral for standby letters of credit to qualify for workers’ compensation self-insurance. The certificates of deposit have original maturities greater than three months, but less than one year. As of March 31, 2024 and December 31, 2023, the balance of restricted short-term investments was $2.2 million.
Deferred Income Taxes
The Company utilizes the liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized.
Debt Issuance Costs
Debt issuance costs related to non-revolving debt are recognized as a reduction to the related debt balance in the accompanying condensed consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Debt issuance costs associated with revolving debt are capitalized within other long-term assets on the condensed consolidated balance sheets and are amortized to interest expense over the term of the related revolving debt.
Convertible Debt
The Company accounts for its convertible debt instruments as a single unit of accounting, a liability, because the Company concluded that the conversion features do not require bifurcation as a derivative under Accounting Standards Codification, or ASC, 815-15, Derivatives and Hedging and the Company did not issue its convertible debt instruments at a substantial premium. The Company records debt issuance costs as contra-liabilities in our condensed consolidated balance sheets at issuance and amortizes them over the contractual term of the convertible debt instrument using the effective interest rate.
In accordance with Accounting Standards Update, or ASU, 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, the Company evaluates convertible debt instruments to determine if the conversion feature is freestanding or embedded. If the conversion feature is embedded, the conversion
-9-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
feature is not bifurcated from the host instrument. If the conversion feature does not require derivative treatment under ASC 815, the instrument is evaluated under ASC 470-20, Debt with Conversion and Other Options for consideration of any beneficial conversion features. If no beneficial conversion features exist that require separate recognition, convertible debt instruments are accounted for as a single liability measured at its amortized cost as long as no other features require separation and recognition as derivatives.
Litigation, Commitments and Contingencies
Litigation, commitments and contingencies are accrued when management, after considering the facts and circumstances of each matter as then known to management, has determined it is probable a liability will be found to have been incurred and the amount of the loss can be reasonably estimated. When only a range of amounts is reasonably estimable and no amount within the range is more likely than another, the low end of the range is recorded. Legal fees are expensed as incurred. Due to the inherent uncertainties surrounding gain contingencies, the Company generally does not recognize potential gains until they are realized.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board, or FASB, issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures which is intended to improve reportable segment disclosure requirements, primarily through additional disclosures about significant segment expenses. The standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the disclosure requirements related to the new standard.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures which requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the disclosure requirements related to the new standard.
Note 3. BAQSIMI® Asset Acquisition
On June 30, 2023, the Company completed its acquisition of BAQSIMI® glucagon nasal powder, or BAQSIMI® pursuant to an asset purchase agreement, or the Purchase Agreement, with Eli Lilly & Company, or Lilly, dated April 21, 2023.
The Company accounted for the BAQSIMI® acquisition as an asset acquisition in accordance with ASC 805, Business Combinations, as substantially all the fair value of the assets acquired was concentrated in a single identifiable asset, BAQSIMI® product rights. The BAQSIMI® product rights include the license for the BAQSIMI® intellectual property, regulatory documentation, marketing authorizations, and domain names, which are considered a single asset as they are inextricably linked.
-10-
The total purchase price was allocated to the acquired assets based on their relative fair values, as follow:
Fair Value | |||
(in thousands) | |||
Property, plant, and equipment |
| $ | 34,426 |
BAQSIMI® product rights |
| 591,338 | |
Deferred tax assets | 2,341 | ||
Total assets acquired | $ | 628,105 |
The Company amortizes the acquired intangible asset on a straight line basis over its estimated useful life of 24 years (See Note 10 for additional information).
A portion of the consideration for the asset acquisition was a deferred cash payment. The fair value of the deferred cash payment is being accreted to its full $129.0 million amount over a one-year period from the date of acquisition through interest expense. During the three months ended March 31, 2024, $1.8 million of interest expense was recognized related to accretion of the deferred cash payments.
Manufacturing Services Agreement
In connection with the Closing, the Company entered into a Manufacturing Services Agreement, or the MSA, with Lilly, pursuant to which Lilly has agreed, for a period of time not to exceed 18 months, to provide certain manufacturing, packaging, labeling and supply services for BAQSIMI® directly or through third-party contractors to the Company in connection with its operation of the development, manufacture, and commercialization of BAQSIMI®. Upon termination of the MSA, the Company will be obligated to purchase all API, components, and finished goods on hand at prices agreed upon in the MSA.
Transition Services Agreement
In connection with the Closing, the Company entered into a Transition Services Agreement, or the TSA, with Lilly pursuant to which Lilly has agreed, for a period of time not to exceed 18 months, to provide certain services to the Company to support the transition of BAQSIMI® operations to the Company, including with respect to the conduct of certain clinical, regulatory, medical affairs, and commercial sales channel activities.
During the first quarter of 2024, the Company assumed distribution responsibilities, from Lilly, to its customers in the United States, and certain countries in Europe. As a result, the Company has recorded the sales and related cost of BAQSIMI® in these countries as product revenue, net and cost of revenues, respectively. The Company will continue to assume distribution of BAQSIMI® for the remaining territories on a country by country basis throughout 2024.
Note 4. Revenue Recognition
Product revenues, net
In accordance with ASC 606 Revenue from Contracts with Customers, revenue is recognized at the time that the Company’s customers obtain control of the promised goods.
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 to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration including provision for chargebacks and rebates, accrual for product returns, prompt pay discounts,
-11-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
distributor fees, patient co-pay assistance, and other related deductions. These deductions to product sales are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product sales occur. Payment terms offered to customers generally range from 30 to 75 days; however, payment terms differ by jurisdiction, by customer and, in some instances, by type of product. Revenues from product sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable of occurring when the uncertainty associated with gross-to-net deductions is subsequently resolved. Taxes assessed by governmental authorities and collected from customers are excluded from product sales. If the Company expects, at contract inception, that the period between the transfer of control and corresponding payment from the customer will be one year or less, the amount of consideration is not adjusted for the effects of a financing component. Shipping and handling activities are considered to be fulfillment activities rather than a separate performance obligation and are recorded within selling, distribution and marketing expenses in the accompanying condensed consolidated statements of operations.
Provision for Chargebacks and Rebates
The provision for chargebacks and rebates is a significant estimate used in the recognition of revenue. Wholesaler chargebacks relate to sales terms under which the Company agrees to reimburse wholesalers for differences between the gross sales prices at which the Company sells its products to wholesalers and the actual prices of such products that wholesalers resell under the Company’s various contractual arrangements with third parties such as hospitals 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, historical chargeback and rebate rates, and current contract pricing.
The provision for chargebacks and rebates is reflected as a component of product revenues, net. The following table is an analysis of the chargeback and rebate provision:
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 retailers’ and other indirect customers’ purchases. The approach that the Company uses to estimate chargebacks and rebates has been consistently applied for all periods presented. Variations in estimates have been historically small. The Company continually monitors the provision for chargebacks and rebates and makes adjustments when it believes that the actual chargebacks and rebates may differ from the estimates. 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.
-12-
The provision for chargebacks and rebates is included in the following balance sheet accounts:
March 31, | December 31, | ||||
2024 | 2023 | ||||
(in thousands) | |||||
Reduction to accounts receivable, net | $ | 19,782 |
| $ | 21,861 |
Accounts payable and accrued liabilities |
| 14,436 |
| 6,059 | |
Total | $ | 34,218 | $ | 27,920 |
Accrual for Product Returns: The Company offers certain 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.
Prompt Pay Discounts: The Company provides its customers with a percentage discount on their invoice if the customers pay within the agreed upon timeframe. The Company expects that its customers will earn prompt pay discounts. The Company estimates the probability of customers paying promptly based on the percentage of discount outlined in the purchase agreement between the two parties, and deducts the full amount of these discounts from gross product sales and accounts receivable at the time revenue is recognized.
Distributor Fees: The Company engages with wholesalers to distribute its products to end customers. The Company pays the wholesalers a fee for services such as: inventory management, chargeback administration, and service level commitments. The Company estimates the amount of distribution services fees to be paid and adjusts the transaction price with the amount of such estimate at the time of sale to the customer. An accrued liability is recorded for unpaid distribution service fees.
Patient Co-Pay Assistance: Co-pay assistance represents financial assistance to qualified patients, assisting them with prescription drug co-payments required by insurance. The accrual for co-pay is based on an estimate of claims and the cost per claim that the Company expects to receive associated with inventory that exists in the distribution channel at period end.
Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers. The Company’s accounting policy is to review each agreement involving contract development and manufacturing services to determine if there are multiple revenue-generating activities that constitute more than one unit of accounting. Revenues are recognized for each unit of accounting based on revenue recognition criteria relevant to that unit.
Service revenues derived from research and development contracts are recognized over time based on progress toward satisfaction of the performance obligation. For each performance obligation satisfied over time, the Company assesses the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction of services or an output method of determining the progress of completion of performance obligation. For the three months ended March 31, 2024 and 2023, revenues from research and development services at ANP were $0.4 million and $0.1 million, respectively.
Other revenues
Revenues related to sales of BAQSIMI®, which was supplied and sold by Lilly under the TSA during the three months
-13-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
ended March 31, 2024, or BAQSIMI® NEB, were recorded on a net basis, similar to a royalty arrangement. This includes revenues in the United States and certain countries in Europe for a portion of the period.
Disaggregation of Revenues
The following table summarizes total net revenues by product and by geographic area, based on customers’ locations:
Three Months Ended March 31, | |||||||||||||||||||
2024 | 2023 | ||||||||||||||||||
U.S. | International | Total | U.S. | International | Total | ||||||||||||||
(in thousands) | |||||||||||||||||||
Product revenues, net |
|
|
|
|
| ||||||||||||||
Glucagon | $ | 25,276 | $ | 3,259 | $ | 28,535 | $ | 25,696 | $ | — | $ | 25,696 | |||||||
Epinephrine | 26,110 | — | 26,110 | 20,091 | — | 20,091 | |||||||||||||
Primatene MIST® | 24,166 | — | 24,166 | 23,453 | 30 | 23,483 | |||||||||||||
BAQSIMI® | 13,089 | 754 | 13,843 | — | — | — | |||||||||||||
Lidocaine | 12,773 | — | 12,773 | 13,646 | — | 13,646 | |||||||||||||
Phytonadione | 9,973 | — | 9,973 | 7,713 | — | 7,713 | |||||||||||||
Enoxaparin |
| 7,096 | — | 7,096 |
| 9,867 | — | 9,867 | |||||||||||
Naloxone | 4,287 | — | 4,287 | 4,957 | — | 4,957 | |||||||||||||
API | 669 | 1,023 | 1,692 | 2,075 | 1,937 | 4,012 | |||||||||||||
Other product revenues, net |
| 28,354 | 800 | 29,154 |
| 30,227 | 330 | 30,557 | |||||||||||
$ | 151,793 | $ | 5,836 | 157,629 | $ | 137,725 | $ | 2,297 | 140,022 | ||||||||||
Other revenues | |||||||||||||||||||
BAQSIMI® NEB | 14,207 | — | |||||||||||||||||
Total net revenues | $ | 171,836 | $ | 140,022 |
Note 5. Net Income per Share
Basic net income per share is calculated based upon the weighted-average number of shares outstanding during the period. Diluted net income per share gives effect to all potentially dilutive shares outstanding during the period, such as stock options, non-vested restricted stock units and shares issuable under the Company’s Employee Stock Purchase Plan, or ESPP, and potential common shares issued upon conversion of Convertible Notes of the Company, due March 2029, or the 2029 Convertible Notes.
For the three months ended March 31, 2024, the Company did
have any options that were excluded from the computation of diluted net income per share because their effect would be anti-dilutive. The 2029 Convertible Notes had no impact on the computation of diluted net income per share, as the average stock price during the period was less than the conversion price.For the three months ended March 31, 2023, options to purchase 1,403,859 shares of stock with a weighted-average exercise price of $34.96 per share were excluded from the computation of diluted net income per share because their effect would be anti-dilutive.
-14-
The following table provides the calculation of basic and diluted net income per share for each of the periods presented:
Three Months Ended | |||||||
March 31, | |||||||
2024 | 2023 | ||||||
(in thousands, except per share data) | |||||||
Basic and dilutive numerator: |
|
|
|
|
| ||
Net income | $ | 43,177 | $ | 26,032 | |||
Denominator: | |||||||
Weighted-average shares outstanding — basic |
| 48,212 | 48,000 | ||||
Net effect of dilutive securities: | |||||||
Incremental shares from equity awards |
| 4,801 | 3,970 | ||||
Weighted-average shares outstanding — diluted |
| 53,013 |
| 51,970 | |||
Net income per share — basic | $ | 0.90 | $ | 0.54 | |||
Net income per share — diluted | $ | 0.81 | $ | 0.50 |
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 BAQSIMI®, 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.
Other revenues includes the portion of BAQSIMI® sales by Lilly on the Company’s behalf under the TSA and is accounted for as a component of the finished pharmaceutical product segment.
-15-
Selected financial information by reporting segment is presented below:
Three Months Ended | |||||||
March 31, | |||||||
2024 | 2023 | ||||||
(in thousands) | |||||||
Net revenues: |
|
|
|
|
| ||
Finished pharmaceutical products | $ | 170,144 | $ | 136,010 | |||
API |
| 1,692 | 4,012 | ||||
Total net revenues |
| 171,836 |
| 140,022 | |||
Gross profit (loss): | |||||||
Finished pharmaceutical products |
| 96,142 |
| 76,176 | |||
API |
| (6,042) | (2,336) | ||||
Total gross profit |
| 90,100 |
| 73,840 | |||
Operating expenses |
| 42,090 |
| 40,407 | |||
Income from operations |
| 48,010 |
| 33,433 | |||
Non-operating (expenses) income |
| (134) |
| 136 | |||
Income before income taxes | $ | 47,876 | $ | 33,569 |
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:
-16-
The amount of depreciation and amortization expense included in cost of revenues by reporting segment is presented below:
Three Months Ended | |||||||
March 31, | |||||||
2024 | 2023 | ||||||
(in thousands) | |||||||
Depreciation and amortization expense |
|
|
|
|
| ||
Finished pharmaceutical products | $ | 8,658 | $ | 2,446 | |||
API |
| 1,004 |
| 953 | |||
Total depreciation and amortization expense | $ | 9,662 | $ | 3,399 |
Net revenues and carrying values of long-lived assets by geographic regions, based on where the Company conducts its operations, are as follows:
(1) | Includes Other revenues from the sales of BAQSIMI® |
Note 7. Customer and Supplier Concentration
Customer Concentrations
Three large wholesale drug distributors, Cencora Inc., formally AmerisourceBergen, or Cencora, 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. Lilly currently manufactures and sells BAQSIMI® on the Company’s behalf pursuant to the terms of the TSA in certain jurisdictions (See Note 3 for additional information). The Company considers these four customers to be its major customers, as each individually, and these customers collectively, represented a significant percentage of the Company’s net revenue for the three months ended March 31, 2024 and 2023 and accounts receivable as of March 31, 2024 and December 31, 2023, respectively. The following table provides accounts receivable and net revenue information for these major customers:
Supplier Concentrations
The Company depends on suppliers for raw materials, APIs, and other components that are subject to stringent FDA
-17-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
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; |
● | 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 March 31, 2024 and December 31, 2023, cash equivalents include money market accounts and corporate and municipal bonds with original maturities of less than three months. Investments consist of certificates of deposit as well as investment-grade corporate, agency and municipal bonds with original maturity dates between three and fifteen months. The certificates of deposit are carried at amortized cost in the Company’s condensed consolidated balance sheets, which approximates their fair value determined based on Level 2 inputs. The corporate, agency and municipal bonds are classified as held-to-maturity and are carried at amortized cost net of allowance for credit losses. The fair value of such bonds is disclosed in Note 9 and was determined based on Level 2 inputs. The restrictions on restricted cash and investments have an immaterial effect on the fair value of these financial assets.
The fair values of the Company’s financial assets and liabilities measured on a recurring basis as of March 31, 2024 and December 31, 2023, are as follows:
-18-
| Total |
| (Level 1) |
| (Level 2) |
| (Level 3) | |||||
(in thousands) | ||||||||||||
Cash equivalents | $ | 116,441 | $ | 116,441 | $ | — | $ | — | ||||
Restricted cash | 235 | 235 | — | — | ||||||||
Short-term investments | 37,142 | — | 37,142 | — | ||||||||
Restricted short-term investments |
| 2,200 |
| — |
| 2,200 |
| — | ||||
Interest rate swaps related to variable rate loans | (5,243) | — | (5,243) | — | ||||||||
Total assets and liabilities measured at fair value as of December 31, 2023 | $ | 150,775 | $ | 116,676 | $ | 34,099 | $ | — |
The Company does not hold any Level 3 instruments that are measured at fair value on a recurring basis.
Nonfinancial assets and liabilities are not measured at fair value on a recurring basis but are subject to fair value adjustments in certain circumstances. These items primarily include investments in unconsolidated affiliates, long-lived assets, goodwill, and intangible assets for which the fair value is determined as part of an impairment test. As of March 31, 2024 and December 31, 2023, there were no significant adjustments to fair value for nonfinancial assets or liabilities.
The Company’s deferred compensation plan assets are valued using the cash surrender value of the life insurance policies and are not included in the table above.
Note 9. Investments
The following is a summary of the Company’s investments that are classified as held-to-maturity:
Gross | Gross | |||||||||||
Amortized | Unrealized | Unrealized | Fair | |||||||||
| Cost |
| Gains |
| Losses |
| Value | |||||
(in thousands) | ||||||||||||
Corporate and agency bonds (due within 1 year) | $ | 69,573 | $ | 1 | $ | (65) | $ | 69,509 | ||||
Corporate bonds (due within 1 to 3 years) | 15,088 | 8 | (60) | 15,036 | ||||||||
Total investments as of March 31, 2024 | $ | 84,661 | $ | 9 | $ | (125) | $ | 84,545 | ||||
Corporate and agency bonds (due within 1 year) | $ | 73,815 | $ | 7 | $ | (21) | $ | 73,801 | ||||
Corporate bonds (due within 1 to 3 years) | 14,621 | 56 | (1) | 14,676 | ||||||||
Municipal bonds (due within 1 year) | 1,081 | 1 | — | 1,082 | ||||||||
Total investments as of December 31, 2023 | $ | 89,517 | $ | 64 | $ | (22) | $ | 89,559 |
At each reporting period, the Company evaluates securities for impairment when the fair value of the investment is less than its amortized cost. The Company evaluated the underlying credit quality and credit ratings of the issuers, identifying neither a significant deterioration since purchase nor any other factors that would indicate a material credit loss.
The Company measures expected credit losses on held-to-maturity investments on a collective basis. All the Company’s held-to-maturity investments were considered to be one pool. The estimate for credit losses considers historical loss information that is adjusted for current conditions and reasonable and supportable forecasts. Expected credit losses on held-to-maturity investments were not material to the condensed consolidated financial statements.
-19-
Note 10. Goodwill and Intangible Assets
The table below shows the weighted-average life, original cost, accumulated amortization, and net book value by major intangible asset classification:
Weighted-Average | Accumulated |
| ||||||||||
| Life (Years) |
| Original Cost |
| Amortization |
| Net Book Value |
| ||||
(in thousands) |
| |||||||||||
Definite-lived intangible assets | ||||||||||||
BAQSIMI® product rights(1) | 24 | $ | 591,338 | $ | 18,479 | $ | 572,859 | |||||
Patents |
| 12 |
| 486 | 377 |
| 109 | |||||
Land-use rights |
| 39 |
| 2,540 | 821 |
| 1,719 | |||||
Subtotal |
| 24 |
| 594,364 |
| 19,677 |
| 574,687 | ||||
Indefinite-lived intangible assets | ||||||||||||
Trademark |
| * |
| 29,225 |
| — |
| 29,225 | ||||
Goodwill - Finished pharmaceutical products |
| * |
| 3,152 |
| — |
| 3,152 | ||||
Subtotal |
| * |
| 32,377 |
| — |
| 32,377 | ||||
As of March 31, 2024 |
| * | $ | 626,741 | $ | 19,677 | $ | 607,064 |
Weighted-Average | Accumulated |
| ||||||||||
| Life (Years) |
| Original Cost |
| Amortization |
| Net Book Value |
| ||||
(in thousands) |
| |||||||||||
Definite-lived intangible assets | ||||||||||||
BAQSIMI® product rights(1) | 24 | $ | 591,338 | $ | 12,319 | $ | 579,019 | |||||
IMS (UK) international product rights(2) | 10 | $ | 8,462 | 8,462 | — | |||||||
Patents |
| 12 |
| 486 | 376 |
| 110 | |||||
Land-use rights |
| 39 |
| 2,540 | 815 |
| 1,725 | |||||
Subtotal |
| 11 |
| 602,826 |
| 21,972 |
| 580,854 | ||||
Indefinite-lived intangible assets | ||||||||||||
Trademark |
| * |
| 29,225 |
| — |
| 29,225 | ||||
Goodwill - Finished pharmaceutical products |
| * |
| 3,216 |
| — |
| 3,216 | ||||
Subtotal |
| * |
| 32,441 |
| — |
| 32,441 | ||||
As of December 31, 2023 |
| * | $ | 635,267 | $ | 21,972 | $ | 613,295 |
* | Intangible assets with indefinite lives have an indeterminable average life. |
(1) | See Note 3 |
(2) | In June 2023, the Company recorded an impairment related to its IMS (UK) international product rights in the amount of $2.7 million. The Company recorded the impairment in the cost of revenue in its consolidated statement of operations for the year ended December 31, 2023 |
Goodwill
The changes in the carrying amounts of goodwill are as follows:
March 31, | December 31, |
| |||||
2024 | 2023 |
| |||||
(in thousands) |
| ||||||
Beginning balance |
| $ | 3,216 |
| $ | 3,126 | |
Currency translation |
| (64) |
| 90 | |||
Ending balance | $ | 3,152 | $ | 3,216 |
-20-
Note 11. Inventories
Inventories consist of the following:
March 31, | December 31, |
| |||||
2024 | 2023 |
| |||||
(in thousands) |
| ||||||
Raw materials and supplies |
| $ | 51,411 |
| $ | 50,082 | |
Work in process |
| 33,331 |
| 30,822 | |||
Finished goods |
| 30,752 |
| 24,929 | |||
Total inventories | $ | 115,494 | $ | 105,833 |
Charges of $5.7 million and $1.9 million were included in the cost of revenues in the Company’s condensed consolidated statements of operations for the three months ended March 31, 2024 and 2023, respectively, to adjust the Company’s inventory and related firm purchase commitments to its net realizable value.
Losses on firm purchase commitments related to raw materials on order as of March 31, 2024 and December 31, 2023 were $3.6 million and $1.0 million, respectively, which are recorded in cost of revenues in the Company’s condensed consolidated statement of operations.
Note 12. Property, Plant, and Equipment
Property, plant, and equipment consist of the following:
March 31, | December 31, |
| |||||
2024 | 2023 |
| |||||
(in thousands) |
| ||||||
Buildings |
| $ | 168,647 |
| $ | 168,771 | |
Leasehold improvements |
| 42,012 |
| 41,686 | |||
Land |
| 7,460 |
| 7,484 | |||
Machinery and equipment |
| 259,845 |
| 259,484 | |||
Furniture, fixtures, and automobiles |
| 33,251 |
| 31,943 | |||
Construction in progress |
| 28,916 |
| 18,676 | |||
Total property, plant, and equipment |
| 540,131 |
| 528,044 | |||
Less accumulated depreciation |
| (251,608) |
| (245,298) | |||
Total property, plant, and equipment, net | $ | 288,523 | $ | 282,746 |
-21-
Note 13. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consisted of the following:
March 31, | December 31, | ||||
2024 | 2023 | ||||
(in thousands) | |||||
Accrued customer fees and rebates | $ | 29,002 | $ | 16,702 | |
Accrued payroll and related benefits | 25,392 | 25,203 | |||
Accrued product returns, current portion | 12,704 | 12,263 | |||
Accrued loss on firm purchase commitments | 3,632 | 918 | |||
Other accrued liabilities | 9,433 | 12,842 | |||
Total accrued liabilities |
| 80,163 |
| 67,928 | |
Accounts payable |
| 36,534 |
| 25,438 | |
Total accounts payable and accrued liabilities | $ | 116,697 | $ | 93,366 |
Note 14. Debt
Debt consists of the following:
March 31, | December 31, | |||||
2024 | 2023 | |||||
(in thousands) | ||||||
Convertible Debt | ||||||
2029 Convertible Notes | $ | 345,000 | $ | 345,000 | ||
Term Loan | ||||||
Wells Fargo Term Loan due June 2028 | 250,000 | 250,000 | ||||
Mortgage Loans | ||||||
Mortgage payable with East West Bank due June 2027 | 7,972 | 8,016 | ||||
Other Loans and Payment Obligations | ||||||
French government loans due December 2026 | 157 | 158 | ||||
Line of Credit Facilities |
|
|
|
| ||
Line of credit facility with China Merchant Bank due October 2026 |
| — |
| — | ||
Wells Fargo Revolving line of credit facility due June 2028 | — | — | ||||
Line of credit facility with ICBC Bank due November 2033 | 4,082 | — | ||||
| 562 |
| 616 | |||
Total debt |
| 607,773 |
| 603,790 | ||
Less current portion of long-term debt |
| 428 |
| 436 | ||
Less: Loan issuance costs | 13,339 | 13,775 | ||||
Long-term debt, net of current portion and unamortized debt issuance costs | $ | 594,006 | $ | 589,579 |
-22-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Credit Agreement
2029 Convertible Notes
In September 2023, the Company issued the 2029 Convertible Notes, in the aggregate principal amount of $345.0 million in a private offering pursuant to Section 4(a)(2) and Rule 144A under the Securities Act of 1933, as amended. The Company used portions of the net proceeds from the 2029 Convertible Notes to (i) repay approximately $200.0 million of the Company’s borrowings under the Wells Fargo Term Loan and (ii) repurchase $50.0 million of the Company’s common stock.
In connection with the issuance of the 2029 Convertible Notes, the Company incurred approximately $10.8 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. Unamortized debt issuance costs related to the 2029 Convertible Notes were $9.8 million as of March 31, 2024. The fair value of the 2029 Convertible Notes was approximately $348.1 million as of March 31, 2024 based on level 2 inputs.
The 2029 Convertible Notes are general senior, unsecured obligations and bear an interest rate of 2.0% per year. The 2029 Convertible Notes were issued pursuant to an indenture, dated September 15, 2023, or the Indenture, between the Company and U.S. Bank Trust Company, National Association, as trustee.
The 2029 Convertible Notes will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the 2029 Convertible Notes; equal in right of payment to all of the Company’s unsecured indebtedness that is not so subordinated; effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness, including any amount outstanding under the Company’s credit facilities; and structurally junior to all indebtedness and other liabilities of the Company’s current or future subsidiaries, including trade payables.
Interest is payable semi-annually in arrears on March 15 and September 15 of each year. The 2029 Convertible Notes may bear additional interest under specified circumstances relating to the Company’s failure to comply with its reporting obligations under the Indenture or if the 2029 Convertible Notes are not freely tradeable as required by the Indenture.
The 2029 Convertible Notes will mature on March 15, 2029, unless earlier converted, repurchased or redeemed.
Conversions of the 2029 Convertible Notes will be settled in cash up to the aggregate principal amount of the 2029 Convertible Notes to be converted, and cash, shares of common stock or a combination of cash and shares of common stock, at the Company’s election, with respect to the remainder, if any, of the Company’s conversion obligation in excess of the aggregate principal amount.
Holders may convert their 2029 Convertible Notes at their option prior to the close of business on the business day immediately preceding December 15, 2028, in multiples of $1,000 principal amount, only under the following circumstances; (i) during any calendar quarter commencing after the calendar quarter ending on December 31, 2023 (and only during such calendar quarter), if the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the 2029 Convertible Notes on each applicable trading day, (ii) during the five business day period after any five consecutive trading day period in which the trading price, as defined in the Indenture, per $1,000 principal amount of the 2029 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day, (iii) if the Company calls the 2029 Convertible Notes for redemption, at any time prior to the close of business on the second scheduled trading day immediately preceding the redemption date, and (iv) upon the occurrence of specified corporate events defined in the
-23-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Indenture.
On or after December 15, 2028, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their 2029 Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances.
The Company may redeem the 2029 Convertible Notes, at its option, in whole or in part (subject to certain limitations), on or after September 20, 2026 and prior to the 41st scheduled trading day preceding the maturity date, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on and including the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the 2029 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.
The initial conversion rate is 15.8821 shares of the Company’s common stock per $1,000 principal amount of the 2029 Convertible Notes, which represents an initial conversion price of approximately $62.96 per share of common stock. The initial conversion price of $62.96 represents a premium of approximately 35.0% over the last reported sale price of the Company’s common stock on Nasdaq Global Select Market on September 12, 2023. The conversion rate is subject to adjustment under certain circumstances in accordance with the terms of the Indenture.
If a fundamental change, as defined in the Indenture, occurs at any time prior to the maturity date, then, subject to certain conditions, holders of the 2029 Convertible Notes may require the Company to repurchase for cash all or any portion of their 2029 Convertible Notes at a repurchase price equal to 100% of the principal amount of the 2029 Convertible Notes to be repurchased, plus any accrued and unpaid interest. In addition, following certain specified corporate events or if the Company issues a notice of redemption, the Company will, under certain circumstances, increase the conversion rate for holders who convert their 2029 Convertible Notes in connection with such corporate event or during a redemption period.
Syndicated Line of Credit Facility with ICBC Bank – Due November 2033
In January 2024, the Company entered into a credit agreement with Industrial and Commercial Bank of China Limited, or ICBC Bank, acting as a lender and as agent for other lenders. The credit agreement allows the Company to borrow up to $40.0 million secured by equipment and buildings at ANP. The interest rate and other terms will be determined at the time of the borrowing, depending on the type of loan requested. The credit agreement expires in November 2033.
In the first quarter of 2024, the Company borrowed approximately $4.1 million under the credit agreement. The loan bears interest at the prime rate as published by The People’s Bank of China minus 0.2%. Interest payments are due quarterly and repayment of the principal amount are biannual and begins May 2026. As of March 31, 2024, the Company had $4.1 million outstanding under this loan.
Interest Rate Swap Contracts
As of March 31, 2024, the fair value of the loans listed above approximated their carrying amount based on Level 2 inputs. For the mortgage loan with East West Bank, as well as the Wells Fargo Term Loan, the Company has entered into fixed interest rate swap contracts to exchange the variable interest rates for fixed interest rates. The interest rate swap contracts are recorded at fair value in the other assets line in the condensed consolidated balance sheets. Changes in the fair values of interest rate swaps were $5.2 million gain and $1.0 million loss for the three months ended March 31, 2024 and 2023, respectively.
-24-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Covenants
At March 31, 2024 and December 31, 2023, the Company was in compliance with all of its debt covenants.
Note 15. Income Taxes
The following table sets forth the Company’s income tax provision for the periods indicated:
Three Months Ended | |||||||
March 31, | |||||||
| 2024 |
| 2023 |
| |||
(in thousands) | |||||||
Income before taxes | $ | 47,876 | $ | 33,569 | |||
Income tax provision | 4,126 |
| 6,752 | ||||
Income before equity in losses of unconsolidated affiliate | $ | 43,750 | $ | 26,817 | |||
Income tax provision as a percentage of income before income taxes | 8.6 | % |
| 20.1 | % |
Valuation Allowance
In assessing the need for a valuation allowance, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will be realized. Ultimately, realization depends on the existence of future taxable income. Management considers sources of taxable income such as income in prior carryback periods, future reversal of existing deferred taxable temporary differences, tax-planning strategies, and projected future taxable income.
The Company continues to record a full valuation allowance on the net deferred income tax assets of its France subsidiary, AFP, and its U.K. subsidiaries, AUK and IMS UK. The Company will continue to do so until the subsidiaries generate sufficient taxable income to realize their respective deferred income tax assets.
The Company records a valuation allowance on net deferred income tax assets in states where it files separately and will continue to do so until sufficient taxable income is generated to realize these state deferred income tax assets.
Note 16. Stockholders' Equity
Share Buyback Program
Pursuant to the Company’s existing share buyback program, the Company did
purchase any shares of its common stock during the three months ended March 31, 2024. For the three months ended March 31, 2023, the Company purchased 263,131 shares of its common stock, totaling $8.0 million.In August 2023, the Company’s Board of Directors authorized a $50.0 million increase to the Company’s share buyback program, which is expected to continue for an indefinite period of time. Since the inception of the program, the Company’s Board of Directors have authorized a total of $285.0 million in the share buyback program. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs.
Purchases are made through open market and private block transactions pursuant to Rule 10b5-1 plans, privately negotiated transactions or other means as determined by the Company’s management and in accordance with the requirements of the SEC and applicable laws. The timing and actual number of treasury share purchases will depend on a variety of factors including price, corporate and regulatory requirements, and other conditions. These treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s condensed consolidated balance sheets.
-25-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Amended and Restated 2015 Equity Incentive Plan
As of March 31, 2024, the Company reserved an aggregate of 7,874,154 shares of common stock for future issuance under the Amended and Restated 2015 Equity Incentive Plan, or the 2015 Plan, including 1,201,722 shares, which were reserved in January 2024 pursuant to the evergreen provision in the 2015 Plan.
2014 Employee Stock Purchase Plan
As of March 31, 2024, the Company has issued 1,192,134 shares of common stock under the ESPP and 807,866 shares of its common stock remain available for issuance under the ESPP.
For the three months ended March 31, 2024 and 2023, the Company recorded ESPP expense of $0.3 million and $0.3 million, respectively.
Share-Based Award Activity and Balances
The Company accounts for share-based compensation payments in accordance with ASC 718, which requires measurement and recognition of compensation expense at fair value for all share-based payment awards made to employees and directors. Under these standards, the fair value of option awards and the option components of the ESPP awards are estimated at the grant date using the Black-Scholes option-pricing model. The fair value of RSUs is estimated at the grant date using the Company’s common share price. Compensation cost for all share-based payments granted with service-based graded vesting schedules is recognized using the straight-line method over the requisite service period.
The weighted-averages for key assumptions used in determining the fair value of options granted are as follows:
Three Months Ended | ||||||
March 31, | ||||||
| 2024 |
| 2023 |
| ||
Average volatility |
| 41.3 | % | 41.5 | % | |
Average risk-free interest rate |
| 4.2 | % | 4.2 | % | |
Weighted-average expected life in years |
| 6.3 | 6.3 | |||
Dividend yield rate |
| — | % | — | % |
A summary of option activity under all plans for the three months ended March 31, 2024, is presented below:
-26-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(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 March 31, 2024. |
For the three months ended March 31, 2024 and 2023, the Company recorded expense of $3.7 million and $3.0 million, respectively, related to stock options granted under all plans.
Information relating to option grants and exercises is as follows:
A summary of the status of the Company’s non-vested options as of March 31, 2024, and changes during the three months ended March 31, 2024, are presented below:
As of March 31, 2024, there was $24.6 million of total unrecognized compensation cost, net of forfeitures, related to non-vested stock option-based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 3.0 years and will be adjusted for future changes in estimated forfeitures.
Restricted Stock Units
The Company grants restricted stock units, or RSUs, to certain employees and members of the Board of Directors with a vesting period of up to four years. The grantee receives one share of common stock at a specified future date for each RSU awarded. The RSUs may not be sold or otherwise transferred until vested. The RSUs do not have any voting or dividend rights prior to the issuance of the underlying common stock. The share-based expense associated with these grants was based on the Company’s common stock fair value at the time of grant and is amortized over the requisite service period, which generally is the vesting period using the straight-line method. For the three months ended March 31, 2024 and 2023, the Company recorded expenses of $3.4 million and $2.9 million, respectively, related to RSU awards granted under all plans.
As of March 31, 2024, there was $26.1 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 3.0 years and will be adjusted for future changes in estimated forfeitures.
-27-
Information relating to RSU grants and deliveries is as follows:
Total Fair Market |
| |||||
Total RSUs | Value of RSUs |
| ||||
| Issued |
| Issued(1) |
| ||
(in thousands) |
| |||||
RSUs outstanding at December 31, 2023 |
| 920,376 | ||||
RSUs granted |
| 274,862 | $ | 12,831 | ||
RSUs forfeited |
| (1,752) | ||||
RSUs vested(2) |
| (355,387) | ||||
RSUs outstanding at March 31, 2024 |
| 838,099 |
(1) | The total fair market value is derived from the number of RSUs granted times the current stock price on the date of grant. |
(2) | Of the vested RSUs, 143,277 shares of common stock were surrendered to fulfil tax withholding obligations. |
Share-based Compensation Expense
The Company recorded share-based compensation expense, which is included in the Company’s condensed consolidated statement of operations as follows:
Three Months Ended | ||||||
March 31, | ||||||
2024 | 2023 | |||||
(in thousands) | ||||||
Cost of revenues |
| $ | 2,125 |
| $ | 1,706 |
Operating expenses: | ||||||
Selling, distribution, and marketing |
| 260 |
| 209 | ||
General and administrative |
| 3,876 |
| 3,357 | ||
Research and development |
| 1,099 |
| 839 | ||
Total share-based compensation | $ | 7,360 | $ | 6,111 |
Note 17. Employee Benefits
401(k) Plan
The Company has a defined contribution 401(k) plan, or the Plan, whereby eligible employees voluntarily contribute up to a defined percentage of their annual compensation. The Company matches contributions at a rate of 50% on the first 6% of employee contributions, and pays the administrative costs of the Plan. Total employer contributions for the three months ended March 31, 2024 and 2023, were approximately $0.8 million and $0.6 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 3.25% as of March 31, 2024 and December 31, 2023. The liability is included in other long-term liabilities in the accompanying condensed consolidated balance sheets. The plan is currently unfunded, and the benefit obligation under the plan was $2.6 million at March 31, 2024 and December 31, 2023. The Company recorded an immaterial amount of expense under the plan for each of the three months ended March 31, 2024 and 2023.
-28-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
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 $7.8 million and $6.8 million as of March 31, 2024 and December 31, 2023, respectively. The plan liabilities were valued at approximately $8.1 million and $7.1 million as of March 31, 2024 and December 31, 2023, respectively. The plan assets and liabilities are included in other long-term assets and other long-term liabilities, respectively, on the Company’s condensed consolidated balance sheets.
Note 18. Commitments and Contingencies
Purchase Commitments
As of March 31, 2024, the Company has entered into commitments to purchase equipment and raw materials for an aggregate amount of approximately $68.5 million.
Note 19. Related Party Transactions
Investment in Hanxin
The Company has an 11.5% ownership in Hanxin that is accounted for as an equity method investment. The Company maintains a seat on Hanxin’s board of directors, and Henry Zhang, the son of Dr. Jack Zhang is an equity holder, the general manager, and the chairman of the board of directors of Hanxin. Additionally, Dr. Mary Luo and Dr. Jack Zhang, have an ownership interest in Hanxin through an affiliated entity. As a result, Hanxin is a related party.
Contract manufacturing agreement with Hanxin
In April 2022, ANP, entered into a contract manufacturing agreement with Hanxin, whereby Hanxin will develop several active pharmaceutical ingredients and finished products for the Chinese market and will engage ANP to manufacture the products on a cost-plus basis. Hanxin will commit to purchase certain quantities from ANP subject to the terms and conditions set forth in the agreement, including Hanxin filing for and obtaining any required marketing authorizations.
During the three months ended March 31, 2024, the Company recognized $0.3 million of revenue from manufacturing services provided to Hanxin. During the three months ended March 31, 2023, the Company recognized an
amount of revenue from manufacturing services provided to Hanxin. As of March 31, 2024, the Company had $0.3 million of 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
-29-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
development will belong to the Company. The Company will also own any confidential and proprietary information, technology regarding development and manufacturing of the RCBs. This will include engineering, scientific and practical information and formula, research data, design, and procedures and others to develop and manufacture the RCBs, in use or developed by Hanxin. The total cost of the agreement to the Company shall not exceed approximately $2.2 million, with payments adjusted based on the then current exchange rates. Any additional work or changes to the scope of work requested by the Company will be charged by Hanxin to the Company on a cost-plus basis, plus any applicable taxes.
In March 2023, the Company amended the agreement with Hanxin, whereby Hanxin will perform scale-up manufacturing process development using the RCBs for the Company. Per the terms of the amended agreement the Company will own any confidential and proprietary information and technology produced during the scale-up manufacturing. This will include engineering, scientific and practical information and formula, research data design and procedures and others to develop and manufacture the RCBs. The amendment agreement will remain in full force and effect until July 5, 2025. The total cost of the amended agreement to the Company shall not exceed approximately $0.5 million in additional payments beyond the $2.2 million in payments under the contract research agreement, with payments adjusted based on actual currency exchange rates. Any additional work or changes to the scope of work requested by the Company will be charged by Hanxin to the Company on a cost-plus basis, plus any applicable taxes.
During the three months ended March 31, 2024 and 2023, the Company paid $0.2 million and $0.6 million, respectively, under this amended agreement and has accrued an immaterial amount payable to Hanxin as of March 31, 2024 and December 31, 2023.
Supply Agreement with Letop
In November 2022, ANP, entered into a supply agreement with Nanjing Letop Biotechnology Co., Ltd., or Letop, which is considered a related-party due to an ownership stake by Henry Zhang. Under the terms of the supply agreement Letop will manufacture and deliver chemical intermediates to ANP on a cost-plus basis. The agreement is effective for three years and the total cost of the agreement shall not exceed approximately $1.5 million, with payments adjusted based on the then current exchange rates.
During the three months ended March 31, 2024, ANP did
make any payments under this agreement. During the three months ended March 31, 2023, ANP paid $0.7 million under this agreement. As of March 31, 2024 and December 31, 2023, the Company did not have any amounts payable to Letop.Note 20. Litigation
The Company is subject to various 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 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following is a discussion and analysis of the consolidated operating results, financial condition, liquidity and cash flows of our company as of and for the periods presented below. The following discussion and analysis should be read in conjunction with the “Condensed Consolidated Financial Statements” and the related notes thereto included in this Quarterly Report on Form 10-Q, or Quarterly Report. This discussion contains forward-looking statements that are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those discussed in or implied by forward-looking statements. These risks, uncertainties, and other factors include, among others, those identified under the “Special Note About Forward-Looking Statements,” above and described in greater detail elsewhere in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2023, particularly in Item 1A. “Risk Factors”.
Overview
We are a bio-pharmaceutical company focusing primarily on developing, manufacturing, marketing and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin API products. We currently manufacture and sell over 25 products.
Our largest products by net revenues currently include BAQSIMI®, Primatene MIST®, glucagon, epinephrine, lidocaine, enoxaparin sodium, and phytonadione. In March 2023, the FDA approved our naloxone hydrochloride nasal spray 4mg, REXTOVYTM, which we recently launched.
We are currently developing a portfolio of generic abbreviated new drug applications, or ANDAs, biosimilar insulin product candidates and proprietary product candidates, which are in various stages of development and target a variety of indications. Four of the ANDAs are currently on file with the FDA.
To complement our internal growth and expertise, we have made several strategic acquisitions of companies, products and technologies. These acquisitions collectively have strengthened our core injectable and inhalation product technology infrastructure by providing additional manufacturing, marketing, and research and development capabilities, including the ability to manufacture raw materials, API, and other components for our products.
Macroeconomic Trends and Uncertainties
Recent uncertain macroeconomic conditions and worldwide events, including extended periods of heightened inflation, rising interest rates and instability in the financial systems, ongoing geopolitical conflicts such as the Russia-Ukraine and Middle East conflicts, as well as rising healthcare costs continue to pose challenges to our business.
See the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, for further discussion of the potential adverse impact of unfavorable global and geopolitical economic conditions on our business, results of operations and financial conditions.
Recent Developments
BAQSIMI® Acquisition
In connection with the acquisition of BAQSIMI® in June 2023, we entered into a Transition Service Agreement, or the TSA with Lilly pursuant to which Lilly agreed, for a period of time not to exceed 18 months to provide certain services to us to support the transition of the BAQSIMI® operations, including with respect to the conduct of certain clinical, regulatory, medical affairs, and commercial sales channel activities. Revenues from the sales of BAQSIMI® under the TSA with Lilly during the three months ended March 31, 2024, were recognized on a net basis similar to a royalty arrangement. The impact of this revenue recognition method resulted in lower reported revenues relative to the revenue that would have been reported had we recognized gross revenues from sales of BAQSIMI®.
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During the first quarter of 2024, we assumed distribution responsibilities from Lilly to our customers in the United States, which comprises approximately 80% of BAQSIMI® worldwide revenues, as well as certain countries in Europe. As a result, for a portion of the quarter ended March 31, 2024, we started recognizing gross revenues and cost of revenues from the sales of BAQSIMI® in these countries, which is classified as product revenue, net and cost of revenue, respectively on the condensed consolidated statement of operations. The assumption of distribution in countries outside the United States will occur on a country-by-country basis once the marketing authorizations for each territory have been transferred to us, we have set up distribution agreements, and we have obtained sufficient inventory.
For more information regarding our acquisition of BAQSIMI®, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 3. BAQSIMI® Acquisition.”
Business Segments
As of March 31, 2024, our performance is assessed and resources are allocated based on the following two reportable segments: (1) finished pharmaceutical products and (2) Active Pharmaceutical Ingredient, or API, products. The finished pharmaceutical products segment manufactures, markets and distributes BAQSIMI®, Primatene MIST®, epinephrine, glucagon, phytonadione, lidocaine, enoxaparin, naloxone, as well as various other critical and non-critical care drugs. The API segment manufactures and distributes Recombinant Human Insulin, or RHI API, and porcine insulin API for external customers and internal product development. Information reported herein is consistent with how it is reviewed and evaluated by our chief operating decision maker. Factors used to identify our segments include markets, customers and products.
For more information regarding our segments, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 6. Segment Reporting.”
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Results of Operations
Three Months Ended March 31, 2024 Compared to Three Months Ended March 31, 2023
Net revenues
Three Months Ended |
| ||||||||||||
March 31, | Change | ||||||||||||
| 2024 |
| 2023 |
| Dollars |
| % |
| |||||
(in thousands) |
| ||||||||||||
Net revenues | |||||||||||||
Finished pharmaceutical products | $ | 155,937 | $ | 136,010 | $ | 19,927 | 15 | % | |||||
API |
| 1,692 |
| 4,012 |
| (2,320) |
| (58) | % | ||||
Total product revenues, net | 157,629 | 140,022 | 17,607 |
| 13 | % | |||||||
Other revenues | 14,207 | — | 14,207 | N/A | |||||||||
Total net revenues | $ | 171,836 | $ | 140,022 | $ | 31,814 |
| 23 | % | ||||
Cost of revenues | |||||||||||||
Finished pharmaceutical products | $ | 74,002 | $ | 59,834 | $ | 14,168 |
| 24 | % | ||||
API |
| 7,734 |
| 6,348 |
| 1,386 |
| 22 | % | ||||
Total cost of revenues | $ | 81,736 | $ | 66,182 | $ | 15,554 |
| 24 | % | ||||
Gross profit | $ | 90,100 | $ | 73,840 | $ | 16,260 | 22 | % | |||||
as % of net revenues |
| 52 | % |
| 53 | % |
The increase in net revenues of the finished pharmaceutical products for the three months ended March 31, 2024, was due to the following changes:
Product Revenues, net
In the first quarter of 2024, we assumed distribution responsibilities for BAQSIMI® from Lilly to our customers in the United States, and certain countries in Europe. As a result, a portion of our first quarter BAQSIMI® revenues of $13.8 million are recognized similar to other products.
For more information, see “Part I – Item 1. Financial Statements – Notes to the Condensed Consolidated Financial Statements – Note 4. Revenue Recognition.”
The increase in sales of glucagon was due to a growth in unit volumes, impacting sales by $1.8 million, as well as a higher average selling price impacting sales by $1.1 million, as we launched glucagon in Canada. The increase in sales of epinephrine and phytonadione was primarily due to an increase in unit volumes, as a result of an increase in demand
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caused by other supplier shortages. Primatene MIST® sales increased primarily due to an increase in unit volumes and a higher average selling price. The decrease in the sales of lidocaine is primarily due to lower unit volumes, as a result of other suppliers returning to their historical distribution levels. The decrease in sales of enoxaparin and naloxone was primarily due to a decrease in unit volumes. The decrease in other finished pharmaceutical products was primarily due to lower unit sales of MPA as our API supplier discontinued making the active ingredient. This decrease was partially offset by higher unit volumes of dextrose and sodium bicarbonate due to an increase in demand caused by other supplier shortages during the quarter, as well as the launch of regadenoson in April 2023.
We anticipate that sales of naloxone and enoxaparin will continue to fluctuate in the future due to competitive dynamics. We also anticipate that sales of epinephrine and other finished pharmaceutical products will continue to fluctuate depending on the ability of our competitors to supply market demands. Sales of medroxyprogesterone were essentially halted as of August 2023, as our API supplier discontinued manufacturing this product. During the fourth quarter of 2023, we qualified our subsidiary, ANP, to manufacture this API. Sales of medroxyprogesterone totaled $0.2 million in the three months ended March 31, 2024, compared to $5.4 million in the three months ended March 31, 2023. We plan to relaunch the product during the second half of 2024.
Sales of API primarily depend on the timing of customer purchases, and will be lower because MannKind, our largest RHI customer, is in the process of qualifying our upgraded Recombinant Human Insulin, or RHI, which uses our internally produced inclusion bodies made at AFP. Until they complete this process, we anticipate sales will be at levels lower than historical ones.
Other Revenues
Other revenues include the portion of BAQSIMI® sales made by Lilly on our behalf under the TSA which amounted to $14.2 million during the three months ended March 31, 2024, based on total BAQSIMI® sales of $24.6 million as reported to us by Lilly, which was recognized on a net basis similar to a royalty arrangement.
Backlog
A significant portion of our customer shipments in any period relate to orders received and shipped in the same period, generally resulting in low product backlog relative to total shipments at any time. However, as of March 31, 2024, we experienced a backlog of approximately $6.8 million for various products, primarily as a result of competitor shortages and supplier constraints. Historically, our backlog has not been a meaningful indicator in any given period of our ability to achieve any particular level of overall revenue or financial performance.
Gross Margins
The decrease in gross margins during the three months ended March 31, 2024, is primarily due to an increase in depreciation and amortization expenses related to the acquired BAQSIMI® assets, an increase in labor costs and certain component costs, as well as charges included in cost of revenues to adjust our inventory and related purchase commitments to their net realizable value. This was partially offset by the increase in sales of glucagon, Primatene MIST®, and epinephrine, which are higher-margin products, the sales of regadenoson, which we launched in April 2023, as well as the sales of BAQSIMI® into the United States and certain countries in Europe as we assumed distribution responsibilities from Lilly in the first quarter of 2024. Additionally, as a result of the TSA with Lilly, revenues relating to BAQSIMI® sold by Lilly are reported on a net basis similar to a royalty arrangement with no amount reported as cost of revenues.
We are experiencing increased costs for labor and certain APIs and purchased components. However, we believe that this trend will be offset by increased sales of our higher-margin products, including BAQSIMI®, glucagon, vasopressin, ganirelix, regadenoson and new products we anticipate launching in 2024.
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Selling, distribution and marketing, and general and administrative
Three Months Ended |
| ||||||||||||
March 31, | Change | ||||||||||||
2024 | 2023 | Dollars | % |
| |||||||||
(in thousands) |
| ||||||||||||
Selling, distribution, and marketing |
| $ | 9,371 |
| $ | 7,109 |
| $ | 2,262 |
| 32 | % | |
General and administrative | $ | 15,676 | $ | 13,483 | $ | 2,193 |
| 16 | % |
The increase in selling, distribution and marketing expenses was primarily due to expenses related to the expansion of our sales and marketing efforts related to BAQSIMI®. The increase in general and administrative expense was primarily due to an increase in salary and personnel-related expenses and expenses related to BAQSIMI®.
We expect that selling, distribution and marketing expenses will continue to increase due to the increase in marketing expenditures for BAQSIMI® and Primatene MIST®. Legal fees may fluctuate from period to period due to the timing of patent challenges and other litigation matters.
Research and development
The decrease in research and development expenses is primarily due to a decrease in clinical trial expense, as well as a decrease in materials and supply expense, as a result of a ramp-up of expenses in 2023 for our insulin and inhalation pipeline products.
Research and development expenses consist primarily of costs associated with the research and development of our product candidates including the cost of developing APIs. We expense research and development costs as incurred.
We have made, and expect to continue to make, substantial investments in research and development to expand our product portfolio and grow our business. We expect that research and development expenses will increase on an annual basis due to increased clinical trials costs related to our insulin and inhalation product candidates. These expenditures will include costs of APIs developed internally as well as APIs purchased externally, the cost of purchasing reference listed drugs and the costs of performing the clinical trials. As we undertake new and challenging research and development projects, we anticipate that the associated costs will increase significantly over the next several quarters and years.
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Non-operating income (expenses), net
Three Months Ended |
| ||||||||||||
March 31, | Change | ||||||||||||
2024 | 2023 | Dollars | % |
| |||||||||
(in thousands) |
| ||||||||||||
Non-operating income (expenses) | |||||||||||||
Interest income | $ | 2,556 | $ | 924 | $ | 1,632 | NM | ||||||
Interest expense | (8,611) | (398) | (8,213) | NM | |||||||||
Other income (expenses), net |
| 5,921 |
| (390) |
| 6,311 |
| NM | |||||
Total non-operating income (expenses), net | $ | (134) | $ | 136 | $ | (270) | NM |
The change in non-operating income (expenses), net is primarily a result of:
● | An increase in interest income resulting from an increase in cash and investments. |
● | An increase in interest expense resulting from the Term Loan used to finance the acquisition of BAQSIMI®, as well as the 2029 Convertible Notes. For more information regarding our debt, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 14. Debt.” |
● | A change to Other income (expenses), net primarily as a result of foreign currency fluctuation, as well as mark-to-market adjustments relating to our interest rate swap contracts during the three months ended March 31, 2024. |
Income tax provision
Three Months Ended |
| ||||||||||||
March 31, | Change | ||||||||||||
| 2024 |
| 2023 |
| Dollars |
| % |
| |||||
(in thousands) |
| ||||||||||||
Income tax provision | $ | 4,126 | $ | 6,752 | $ | (2,626) | (39) | % | |||||
Effective tax rate | 9 | % |
| 20 | % |
Our effective tax rate for the three months ended March 31, 2024 decreased in comparison to the three months ended March 31, 2023, primarily due to timing of discrete tax items. For more information regarding our income taxes, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 15. Income Taxes.”
Beginning in 2024, many countries are implementing some or all of the Organisation for Economic Co-operation and Development’s Inclusive Framework on Base Erosion and Profit Shifting Two-Pillar in response to tax challenges arising from the digitalization of the global economy. While we continue to evaluate those countries’ implementations, we do not expect those implementations to have a material impact on our consolidated financial statements in 2024.
Liquidity and Capital Resources
Cash Requirements and Sources
We need capital resources to maintain and expand our business. We expect our cash requirements to increase significantly in the foreseeable future as we sponsor clinical trials for, seek regulatory approvals of, and develop, manufacture and market our current development stage product candidates and pursue strategic acquisitions of businesses or assets. Our future capital expenditures include projects to upgrade, expand, and improve our manufacturing facilities in the United States and China, including a significant increase in capital expenditures over the next few years. We plan to fund this facility expansion primarily with cash flows from operations. Our cash obligations include the
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principal and interest payments due on our existing loans and lease payments, as described below and throughout this Quarterly Report.
As of March 31, 2024, our foreign subsidiaries collectively held $11.2 million in cash and cash equivalents. Cash or cash equivalents held at foreign subsidiaries are not available to fund the parent company’s operations in the United States. We believe that our cash reserves, operating cash flows, and borrowing availability under our credit facilities will be sufficient to fund our operations for at least the next 12 months from the date of filing of this Quarterly Report on Form 10-Q. We expect additional cash flows to be generated in the longer term from future product introductions, although there can be no assurance as to the receipt of regulatory approval for any product candidates that we are developing or the timing of any product introductions, which could be lengthy or ultimately unsuccessful.
We maintain a shelf registration statement on Form S-3 pursuant to which we may, from time to time, sell up to an aggregate of $250 million of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units. If we require or elect to seek additional capital through debt or equity financing in the future, we may not be able to raise capital on terms acceptable to us or at all. To the extent we raise additional capital through the sale of equity or convertible debt securities, the issuance of such securities will result in dilution to our stockholders. If we are required and unable to raise additional capital when desired, our business, operating results and financial condition may be adversely affected.
Working capital increased $35.7 million to $299.9 million at March 31, 2024, compared to $264.2 million at December 31, 2023.
Cash Flows from Operations
The following table summarizes our cash flows used in operating, investing, and financing activities for the three months ended March 31, 2024 and 2023:
Three Months Ended March 31, |
| |||||||
| 2024 | 2023 |
| |||||
(in thousands) |
| |||||||
Statement of Cash Flow Data: | ||||||||
Net cash provided by (used in) | ||||||||
Operating activities | $ | 55,291 | $ | 40,382 | ||||
Investing activities |
| 15,237 |
| (6,333) | ||||
Financing activities |
| (13,579) |
| (13,548) | ||||
Effect of exchange rate changes on cash |
| (97) |
| 16 | ||||
Net increase in cash, cash equivalents, and restricted cash | $ | 56,852 | $ | 20,517 |
Sources and Use of Cash
Operating Activities
Net cash provided by operating activities was $55.3 million for the three months ended March 31, 2024, which included net income of $43.2 million. Non-cash items comprised primarily of $16.1 million of depreciation and amortization, which includes $6.8 million related to deprecation of property, plant and equipment, $6.2 million related to amortization of product rights, trademarks and patents, $2.1 million related to amortization of discounts, premiums, and debt issuance costs. Additionally, non-cash items included share-based compensation expense of $7.4 million.
Additionally, for the three months ended March 31, 2024, there was a net cash outflow from changes in operating assets and liabilities of $7.3 million, which resulted from an increase in accounts receivables and an increase in inventories, which was partially offset by an increase in accounts payable and accrued liabilities. Accounts payable and accrued liabilities increased primarily due to the increase in accrued customer fees and rebates associated with BAQSIMI® sales. The increase in accounts receivables was primarily due to the increase in sales, as well as the timing of payment from Lilly for BAQSIMI® revenues during the quarter, which was received subsequent to the quarter end.
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Net cash provided by operating activities was $40.4 million for the three months ended March 31, 2023, which included net income of $26.0 million. Non-cash items comprised primarily of $7.4 million of depreciation and amortization and $6.1 million of share-based compensation expense. Additionally, for the three months ended March 31, 2023, there was a net cash outflow from changes in operating assets and liabilities of $0.1 million, which resulted from an increase in accounts receivables, which was partially offset by an increase in accounts payable and accrued liabilities. Accounts payable and accrued liabilities increased primarily due to the timing of payments. The increase in accounts receivables was due to both increases in sales and timing of sales.
Investing Activities
Net cash provided by investing activities was $15.2 million for the three months ended March 31, 2024, primarily as a result of a net cash inflow of $25.0 million from sales and purchases of investments during the quarter. This was partially offset by $8.8 million in purchases of property, plant, and equipment, which included $3.7 million incurred in the United States, $0.4 million in France, and $4.7 million in China.
Net cash used in investing activities was $6.3 million for the three months ended March 31, 2023, primarily as a result of $9.5 million in purchases of property, plant, and equipment, which included $6.6 million incurred in the United States, $0.1 million in France, and $2.8 million in China. This was partially offset by a net cash inflows from purchases and sales of short-term investments during the period of $3.5 million.
Financing Activities
Net cash used in financing activities was $13.6 million for the three months ended March 31, 2024, primarily as a result of $17.3 million used to settle share-based compensation awards under our equity plan and for tax payments related to the net share settlement of options exercised. This was partially offset by $4.1 million of net proceeds from borrowings on our line of credit.
Net cash used in financing activities was $13.5 million for the three months ended March 31, 2023, primarily as a result of purchases of $8.0 million of treasury stock and $4.5 million used to settle share-based compensation awards under our equity plan. Additionally, we also made $1.0 million in principal payments on our long-term debt.
Indebtedness
For more information regarding our outstanding indebtedness, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 14. Debt”.
Critical Accounting Policies
The preparation of our condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and notes to the financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Part II, Item 7, of our Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to our critical accounting policies as compared to the critical accounting policies as described in our Annual Report on Form 10-K for the year ended December 31, 2023.
Recent Accounting Pronouncements
For information regarding recent accounting pronouncements, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 2. Summary of Significant Accounting Policies”.
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Government Regulation
Our products and facilities are subject to regulation by a number of federal and state governmental agencies. The FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of our products. The Drug Enforcement Administration, or DEA, maintains oversight over our products that are considered controlled substances.
From February 6 through February 16, 2023, our IMS facility in South El Monte, California was subject to pre-approval inspection by the FDA. The inspection included a review of compliance with FDA regulations to support one of our pending applications. The inspection resulted in two observations on Form 483. We responded to those observations. We believe that our response to the observations will satisfy the requirements of the FDA and that no significant further actions will be necessary.
From February 20 through March 1, 2024, our Amphastar facility in Rancho Cucamonga, California was subject to pre-approval and cGMP inspection by the FDA. The inspection included a review of compliance with FDA regulations to support one of our pending applications as well as to compliance with Good Manufacturing Practices. The inspection resulted in several observations on Form 483. We responded to those observations. We believe that our response to the observations will satisfy the requirements of the FDA and that no significant further actions will be necessary.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Except for the broad, ongoing macroeconomic challenges facing the global economy and financial markets, there have been no material changes in market risk from the information provided in our Annual Report on Form 10-K for the year ended December 31, 2023. We are exposed to market risk in the ordinary course of business. Market risk represents the potential loss arising from adverse changes in the value of financial instruments. The risk of loss is assessed based on the likelihood of adverse changes in fair values, cash flows or future earnings. We are exposed to market risk for changes in the market values of our investments (Investment Risk), the impact of interest rate changes (Interest Rate Risk), and the impact of foreign currency exchange changes (Foreign Currency Exchange Risk).
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, our principal executive and principal financial officers, respectively, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective (a) to ensure that information that we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms and (b) to include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in reports filed or submitted under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act).
Inherent Limitations of Internal Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management overriding of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
For information regarding legal proceedings, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 20. Litigation.”
ITEM 1A. RISK FACTORS
There were no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 29, 2024.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(c)Issuer Purchases of Equity Securities
The table below provides information with respect to repurchases of our common stock.
(1) | On August 28, 2023, we announced that our Board of Directors authorized an increase of $50.0 million to our share buyback program. As of March 31, 2024, $35.5 million remained available for repurchase under such program. The share buyback program does not have an expiration date. |
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Securities Trading Plans of Directors and Executive Officers
During our last fiscal quarter, the following officer, as defined in Rule 16a-1(f), adopted a Rule 10b5-1 trading arrangement, as defined in Regulation S-K Item 408, as follows:
On March 14, 2024, William J. Peters, our Chief Financial Officer, Executive Vice President of Finance, and Treasurer, President of International Medication Systems, Limited, and Director, adopted a
trading arrangement providing for the sale from time to time of an aggregate of up to 95,738 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until May 31, 2025, or earlier if all transactions under the trading arrangement are completed.other directors or officers, as defined in Rule 16a-1(f), adopted or a trading arrangement, or a non-Rule 10b5-1 trading arrangement, each as defined in Regulation S-K Item 408.
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ITEM 6. EXHIBITS
# | The information in Exhibits 32.1 and 32.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act (including this Report), unless the Registrant specifically incorporates the foregoing information into those documents by reference. |
* | Certain confidential information contained in this Exhibit was omitted by means of marking such portions with brackets because the identified confidential information (i) is not material and (ii) would be competitively harmful if publicly disclosed. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AMPHASTAR PHARMACEUTICALS, INC. | |
By: | /s/ JACK Y. ZHANG |
Jack Y. Zhang | |
Chief Executive Officer |
Date: May 10, 2024
AMPHASTAR PHARMACEUTICALS, INC. | |
By: | /s/ WILLIAM J. PETERS |
William J. Peters | |
Chief Financial Officer |
Date: May 10, 2024
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Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED BECAUSE
THE INFORMATION (I) IS NOT MATERIAL AND
(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Syndicated Loan Contract
[Amphastar Nanjing Pharmaceuticals Inc.]
(As the Borrower)
[Nanjing Branch of Industrial and Commercial Bank of China Limited]
(As the Lead Bank)
[Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited]
[East West Bank (China) Limited]
(As the Lenders)
And
[Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited]
(As the Agent Bank)
RMB [280,000,000.00] Yuan Fixed Assets Syndicated Loan Contract (2017 Version) |
Contract No.: [***]
————————————————————————————————————————————————
Syndicated Loan Contract
[Amphastar Nanjing Pharmaceuticals Inc.]
(As the Borrower)
[Nanjing Branch of Industrial and Commercial Bank of China Limited]
(As the Lead Bank)
[Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited]
[East West Bank (China) Limited]
(As the Lenders)
And
[Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited]
(As the Agent Bank)
RMB [280,000,000.00] Yuan Fixed Assets Syndicated Loan Contract (2017 Version) |
Contract No.: [***]
————————————————————————————————————————————————
Table of Contents
Header Page Number
I.Definitions and interpretation 7
1.1Definitions 7
1.2Interpretation rules 13
II.Loan amount 14
III.Intended use of loan 14
IV.Withdrawal 15
4.1Withdrawal 15
4.2Prerequisites for first withdrawal 15
4.3Prerequisites for each withdrawal 18
V.Interest 18
5.1Loan interest rate 18
5.2Penalty interest rate 18
5.3Interest period 19
5.4Interest accrual 20
5.5Interest payment 20
VI.Repayment 20
6.1Loan term 20
6.2Repayment 21
6.3Repayment reserve account 21
VII.Early repayment and cancellation 21
7.1Voluntary early repayment 21
7.2Voluntary cancellation 22
7.3Automatic cancellation 23
7.4Forced cancellation 23
VIII.Provisions as to payment 24
8.1Disbursement of loan funds 24
8.2Payment of loan funds 24
8.3Payment by borrower 25
8.4Payment by agent bank 26
8.5Order of payment 26
8.6Advance 27
8.7Currency of payment 27
8.8Set-off 27
8.9Non-business day 28
8.10Apportionment 28
IX.Taxes and fees 29
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9.1Taxes and fees 29
9.2Stamp tax 29
X.Cost increase 29
10.1Notice of cost increase 29
10.2Compensation 30
XI.Change of law 30
11.1Notice of change of law 30
11.2Cancellation and early repayment 31
XII.Mitigation of losses 31
12.1Mitigation of losses 31
12.2Limitation of obligations 32
XIII.Statement of facts 32
XIV.Agreed matters 35
14.1Positive obligations 35
14.2Restrictions 39
XV.Event of default 40
15.1Event of default 40
15.2Remedies of syndicate member banks 42
XVI.Relationships of syndicate member banks 44
16.1Appointment of the agent bank 44
16.2Agency relationship 45
16.3Responsibilities of the agent bank 45
16.4Rights of the agent bank 46
16.5Independent credit assessment 47
16.6Agent bank and lead bank as the lenders 48
16.7Syndicate meeting 48
16.8Lenders’ compensation 51
16.9Resignation of the agent bank 51
16.10Deductions by the agent bank 52
16.11Other business 52
16.12Dealings with the lenders 52
XVII.Fees and compensation 52
17.1Syndication fees 52
17.2Syndication costs 53
17.3Compensation for losses 53
17.4Currency compensation 54
17.5Basis of calculation 54
17.6Exemption from compensation 54
XVIII.Transfer 54
18.1Transfer by borrower 55
18.2Transfer by lenders 55
18.3Effectiveness of transfer 55
18.4Binding force of transfer 55
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18.5Consequences of transfer 56
18.6Exemption of the transferring bank 56
18.7Further exemption of the transferring bank 56
18.8Bookkeeping and archiving 56
18.9Change of handling bank 57
XIX.Relationship of rights and obligations among syndicate member banks 57
19.1Independence of obligations 57
19.2Independence of rights 57
XX.Obligation of confidentiality 57
20.1Scope of confidentiality 57
20.2Scope of other disclosure 58
20.3Replacement 59
20.4Information collection 59
XXI.Modification and exemption 59
21.1Application and consent for modification or exemption 59
21.2Written modification 60
21.3Agent bank’s consent 60
XXII.Notification 61
22.1Through the agent bank 61
22.2Method of notification 61
22.3Service of notice 61
22.4Change of address 62
22.5Notification language 62
XXIII.Debt certificate 62
XXIV.Other agreements 62
XXV.Accumulation of rights and independence of provisions 63
25.1Accumulation of rights 63
25.2Independence of provisions 63
XXVI.Text of the contract 64
26.1Language 64
26.2Original copy 64
XXVII.Governing law and dispute resolution 64
XXVIII.Effectiveness 65
Appendix ILenders’ Original Loan Amount 66
Appendix IIForm of Document Confirmation Letter 67
Appendix IIIForm of Transfer Certificate 69
AnnexShares of Transfer 70
Appendix IVAccounts of Various Parties 71
Signature Page 73
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This Contract was entered into by the following parties on [January] [17], [2024] in [Nanjing City]:
Registered address: Legal representative: | No. 5 Xinghe Road, Nanjing Economic and Technological Development Zone [***] |
Registered address: Responsible person: Handling bank: Registered address of the handling bank: Responsible person of the handling bank: | No. 379, Jiangdong Middle Road, Jianye District, Nanjing [***] Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited Building B, Financial Building, Xingang Industrial Zone, Nanjing [***] |
Registered address: Responsible person: Handling bank: Registered address of the handling bank: Responsible person of the handling bank: | Building B, Financial Building, Xingang Industrial Zone, Nanjing [***] Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited Building B, Financial Building, Xingang Industrial Zone, Nanjing [***] |
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Registered address: Responsible person: Handling bank: Registered address of the handling bank: Responsible person of the handling bank: | Units 01-08, 33/F, Jinmao Building, No. 88 Century Avenue, China (Shanghai) Pilot Free Trade Zone [***] East West Bank (China) Limited Units 01-08, 33/F, Jinmao Building, No. 88 Century Avenue, China (Shanghai) Pilot Free Trade Zone [***] |
| |
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Whereas:
In witness whereof, both parties, through friendly and equal negotiations, based on genuine intentions, hereby enter into this Contract as follows for mutual compliance.
In this Contract:
Contract of guarantee | Refers to a [/] contract of guarantee entered into by the warrantor and the agent bank on [/] [/], [/]. |
Warrantor | Refers to [/]. |
Financial year | Refers to the period from January 1 (inclusive) to December 31 (inclusive) of each Gregorian calendar year. |
Loan amount ratio | Refers to, for each lender, the ratio between the loan amount of a particular lender and the total loan amount at a specific time. |
Loan amount | Refers to: 1. For each original lender, the original loan amount minus its share of the total loan funds already withdrawn, minus its share of the amount canceled or transferred in accordance with the provisions of this Agreement: |
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| 2. For each transferee bank, the loan amount transferred to it in accordance with Article 18 of this Contract (Transfer), minus its share of the total loan funds already withdrawn, minus its share of the amount canceled or transferred in accordance with the provisions of this Agreement |
Original loan amount | Refers to each original lender’s original loan amount as specified in Article 2 of this Contract (Loan amount) and Appendix I to this Contract (Lenders’ Original Loan Amount). |
Pledgor | Refers to [/]. |
Lender | Refers to the original lender and/or the transferee bank. |
Loan interest rate | Refers to the annual loan interest rate agreed upon in Article 5.1 of this Contract (Loan interest rate) for each loan fund. |
Loan balance | Refers to the total amount of loan funds that the borrower has already withdrawn but not yet paid off. |
Loan fund | Refers to any loan principal under this Contract that has already been withdrawn or will be withdrawn. |
Loan fund account | Refers to such accounts listed in Appendix IV to this Contract (Accounts of Various Parties). |
Agent bank | Refers to [Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited] or its successor agent bank. |
Agent bank’s payment account | Refers to such accounts listed in Appendix IV to this Contract (Accounts of Various Parties). |
Guaranty contract | Refers to contract of guarantee, mortgage contract and/or pledge contract. |
Guarantor | Refers to warrantor, mortgagor and/or pledgor. |
Security interest | Refers to any mortgage, pledge, lien, deposit or any agreement or arrangement with the effect or purpose of security (regardless |
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| [√] The twentieth (20th) day of the last month of each quarter, which shall be postponed to the first business day after it if that day falls on a non-business day, as the interest settlement date when interest is settled quarterly; [x] The maturity date of the loan as the interest settlement date when interest is collected in a lump sum when the loan matures, with the interest being cleared along with the principal; [x] Other date: refers to [/]. |
Borrower’s counterparty account | Refers to those account notified by the borrower to the agent bank. |
Handling bank | Refers to the handing agency for the performance of this Contract by any of the syndicate member banks listed under this Contract, including the handling bank after change according to Article 18.9 of this Contract (Change of handling bank). |
Accounting standards | Refer to the accounting standards that comply with Chinese laws and regulations, and are generally accepted in China. |
Interest rate determination date | Refers to, for each loan fund, (i) the effective date of contract, and (ii) from the effective date of contract (Check √ one of the following options according to the situation, and mark the unselected one with a x; mark all options with a x if it’s a fixed interest rate): [x] The [/] day of each month starting from the date of adjustment of the loan prime rate; [x] The [/] day of the last month of each quarter starting from the date of adjustment of the loan prime rate; [x] The [/] [/] of each year starting from the date of adjustment of the loan prime rate; [x] The day immediately following each interest settlement date; [x] The date of adjustment of the loan prime rate; [√] Other date, refers to [every 12th month anniversary]. |
Interest period | Refers to the period determined according to Article 5.3 of this Contract (Interest period). |
Potential event of default | Refers to any event or circumstance that will constitute an event of default (following the expiration of the cure period, the issuance of notice, the making of any decision and/or similar events). |
People’s bank | Refers to the People’s Bank of China. |
RMB | Refers to the fiat currency of China. |
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Financing documents | Include this Contract, any fee letter, guaranty contract and transfer certificate (if any) and other documents designated as the financing documents by the agent bank and the borrower. |
Effective date | Refers to the definition stipulated in Article XXVIII of this Contract (Effectiveness). |
Taxes and fees | Refer to taxes, fees, duties, withholding duties or other taxes and charges of a similar nature imposed by the tax, fiscal or other administrative authorities of any jurisdiction, as well as penalties and interest payable for late payment of the above. |
Tax bureau | Refers to the State Taxation Administration and/or its branches. |
Withdrawal period | Refers to the period from the effective date of this Contract/first withdrawal date to [December] [31], [2026] (inclusive). |
Withdrawal date | Refers to each date for withdrawal of loan funds as specified in Article 4.1 of this Contract (Withdrawal). Should the actual withdrawal date be different from the date for withdrawal of the loan fund specified in the withdrawal notice, it should refer to the date the loan fund is transferred to the loan fund account. |
Event of default | Refers to any event or circumstance listed in Article 15.1 of this Contract (Event of default). |
Document confirmation letter | Refers to the document confirmation letter signed and submitted by the borrower substantially in accordance with the form and content required in Appendix II to this Contract (Form of Document Confirmation Letter). |
Project | Refers to the [***]. |
Information memo | Refers to the information memo on the [RMB 280,000,000.00 Yuan Syndicated Loan for Amphastar Nanjing Pharmaceuticals Inc.’s “Insulin and Injection Solution Phase I Project”] prepared by the lead bank in [May] [2023], as entrusted by the borrower. |
Permitted liability | Refers to any of the following liabilities of the borrower: |
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| 1. Any liability under the financing documents; 2. [/]; and/or 3. Any liability as agreed by the agent bank (according to the decision of the majority lender). |
Permitted investment | Refers to any of the following investments of the borrower: 1. [/]; 2. [/]; and/or 3. Any investment as agreed by the agent bank (according to the decision of the majority lender). |
Business day | Refers to the day on which the syndicate member banks open for business and engage in general corporate business (except Saturdays and Sundays (excluding Saturdays and Sundays required to work due to compensatory time-off plan according to national regulations) and other statutory holidays). |
Syndicate member bank | Refers to the lead bank, various lenders and/or the agent bank. |
Syndicate member bank account | Refers to the account of various syndicate member banks as listed in Appendix IV to this Contract (Accounts of Various Parties). |
Pledge contract | Refers to the pledge contract signed by the pledgor and the agent bank when the pledgor meets the conditions later. |
Material adverse effect | Refers to a material change in the legal position, asset position, financial condition or business condition of the borrower or any guarantor that, in the reasonable judgment of the majority lender, has or will have a material adverse effect on the ability of the borrower or such guarantor to fully meet its obligations under any financing document. |
China | Refers to the People’s Republic of China, and for the purpose of this Contract only, excluding the Hong Kong Special Administrative Region, the Macao Special Administrative Region and the Taiwan Region. |
Certified public accountant | Refers to a certified public accountant with good credit standing and qualifications to practice within the territory of China. |
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Transfer certificate | Refers to the transfer document signed and submitted by the transferring bank, the transferee bank and the agent bank substantially in accordance with the form and content required in Appendix III to this Contract (Form of Transfer Certificate). |
Total loan amount | Refers to the sum of the loan amount of each lender. |
Total amount | Refers to the sum of the total loan amount and the loan balance. |
1.2 Interpretation rules
In this Contract:
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All lenders agree to provide the borrower with a medium- and long-term loan amount with the total principal amount of no more than RMB [280,000,000.00] Yuan (in words: RMB [Two Hundred and Eighty Million] Yuan Only) in accordance with the provisions of this contract.
Wherein, the original loan amount of each original lender is listed in Appendix I to this Contract (Lenders’ Original Loan Amount).
3.1 | The borrower shall use each loan fund withdrawn to [purchase production equipment, decorate and renovate workshops, and construct new factory buildings and supporting facilities for the “Insulin and Injection Solution Phase I Project”], provided that the use of the loan funds shall comply with relevant national laws, regulations, policies and the relevant systems of the lender. |
3.2 | The borrower shall actually use each loan fund according to the intended use of the loan funds specified under this Contract, and without the prior written consent of the agent bank (according to the decision of the majority lender), the borrower shall not change the intended use of the loan. |
3.3 | Notwithstanding the provisions of paragraph (5) of Article 4.3 and paragraph (12) of Article 14.1 (Positive obligations) of this Contract, each syndicate member bank shall not be liable to the borrower for the actual use of each loan fund by the borrower. |
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4.1 Withdrawal
Before [December] [31], [2026], withdraw RMB [280,000,000.00] Yuan in installments.
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After the following conditions are met, each lender shall notify its agent bank to disburse each loan fund in accordance with its loan amount ratio and in accordance with the provisions of Article 8.1 of this Contract (Disbursement of loan funds).
5.1 Loan interest rate
The interest rate (simple interest) for each loan fund under this Contract is the loan prime rate on each interest rate determination date minus 20BP.
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5.3 Interest period
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5.4 Interest accrual
5.5 Interest payment
6.1 Loan term
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6.2 Repayment
The borrower shall repay the loan on each repayment date according to the following repayment plan.
Repayment date | Amount of repayment |
May 20, 2026 | 5 million yuan |
November 20, 2026 | 5 million yuan |
May 20, 2027 | 20 million yuan |
November 20, 2027 | 20 million yuan |
May 20, 2028 | 20 million yuan |
November 20, 2028 | 20 million yuan |
May 20, 2029 | 30 million yuan |
November 20, 2029 | 30 million yuan |
May 20, 2030 | 25 million yuan |
November 20, 2030 | 25 million yuan |
May 20, 2031 | 20 million yuan |
November 20, 2031 | 20 million yuan |
May 20, 2032 | 10 million yuan |
November 20, 2032 | 10 million yuan |
May 20, 2033 | 10 million yuan |
November 20, 2033 | 10 million yuan |
If the loan is not fully withdrawn in the end, the above repayment plan can be adjusted in proportion to the withdrawal amount.
6.3 Repayment reserve account
The borrower shall open a repayment reserve account at the agent bank within [one day after the signing of the syndicated loan]. All proceeds under the project shall first be deposited into this account and then used by the borrower. The fund balance in this account shall not be less than [the sum of principal and interest payable in the current period] [15] days before the first repayment date.
In the event that the borrower fails to repay any amount due and payable on time and in full in accordance with the provisions of this Contract, the agent bank shall have the right to deduct the relevant amount directly from the repayment reserve account for repayment.
7.1 Voluntary early repayment
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submit an early repayment notice (“early repayment notice”) to the agent bank and obtain the written consent of the agent bank (according to the decision of the majority lender) [5] business days before the proposed early repayment date.
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integral multiple of RMB [10,000,000.00] Yuan (in words: RMB [Ten Million] Yuan Only).
7.3 Automatic cancellation
Unless otherwise agreed by the parties to this Contract, after the end of the withdrawal period, all the total loan amount that has not been withdrawn at that time will be automatically canceled, and the loan amount of each lender will be canceled at the same time, and any such canceled total loan amount and loan mount cannot be reinstated.
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The change in control mentioned above refers to [a change in the actual controller of the borrower].
8.1 Disbursement of loan funds
When participating in the disbursement of each loan fund in accordance with the provisions of this Contract, each lender shall pay its share of the loan fund to the payment account of the agent bank before [17:00] (Beijing time) on the scheduled withdrawal date of the loan fund.
Should any lender fail to disburse its share of the loan funds to be withdrawn, the borrower shall still withdraw the loan funds disbursed by other lenders according to the withdrawal notice.
Each lender shall disburse its share of the loan fund to be withdrawn in accordance with the loan amount ratio. For the purpose of facilitating the performance of this Contract, the lenders under this Contract may make other flexible arrangements for the allocation of the ratio of the loan fund through consensus of all the lenders, but such arrangements shall not affect the total amount of loan fund to be disbursed by each lender to the borrower under this Contract.
8.2 Payment of loan funds
If the lender’s entrusted payment method is adopted, the borrower shall submit documentation proving the use of the loan funds to the agent bank before the relevant loan funds are disbursed, and the agent bank (at its sole discretion) will disburse the loan funds after review and approval. No syndicate member bank shall be responsible for the
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authenticity and legality of the transactions corresponding to the entrusted payment.
8.3 Payment by borrower
The borrower shall pay the amount due and payable under this Contract to the payment account of the agent bank before [16:00] (Beijing time) on the due date of any amount payable under this Contract.
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8.5 Order of payment
Unless otherwise required by laws and regulations, the agent bank shall distribute the various amounts received under Article 8.3 of this Contract (Payment by borrower) in the following order:
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8.6 Advance
8.7 Currency of payment
Unless otherwise agreed by the parties, any payment under this Contract shall be made in RMB.
8.8 Set-off
The borrower shall not exercise any right of set-off in making any payment under this Contract.
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8.9 Non-business day
If the date an amount becomes due and payable does not fall on a business day, the payment date of such amount shall be postponed to the nearest business day after it within the same Gregorian calendar month (if any) or advanced to the nearest business day before it (if there is no business day after it within the same Gregorian calendar month)/advanced to the nearest business day before that non-business day.
8.10 Apportionment
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9.1 Taxes and fees
Unless otherwise expressly required by laws and regulations, any amount paid or payable by the borrower to any syndicate member bank (whether as the actual payee or transferor) in accordance with the provisions of this Contract shall be the net amount that the syndicate member bank shall receive, and shall not include any taxes and fees.
9.2 Stamp tax
The borrower and each syndicate member bank shall separately bear the stamp duty related to the financing documents in accordance with the provisions of laws and regulations.
10.1 Notice of cost increase
After the effective date, if any of the following costs is caused or will occur to any lender (“cost affected lender”) due to the promulgation, implementation or change of any applicable laws, regulations or their interpretation, and/or in order to comply with the requirements of the central bank, the fiscal, tax, financial supervisory or other administrative authorities having jurisdiction over it (“increased costs”):
Then, after the cost affected lender becomes aware of the situation, it shall notify the agent bank (“notice of cost increase”) in a timely manner and explain in detail the reasons for the
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increased costs and the basis for calculation; after receiving the notice of cost increase, the agent bank shall notify the borrower in a timely manner.
10.2 Compensation
Within [10] business days after the borrower receives the notice of cost increase, the borrower shall pay an amount equal to the increased costs to the cost affected lender through the agent bank. However, the borrower is not required to compensate for the following increased costs:
11.1 Notice of change of law
After the effective date, if, due to the promulgation, implementation or change of any applicable laws, regulations or their interpretation, and/or in order to comply with the requirements of the central bank, the fiscal, financial supervisory or other administrative authorities having jurisdiction over it, it is or it would be unlawful or in violation of regulatory provisions for any lender (“lender affected by change of law”) to continue to perform the financing documents, participate in the disbursement of any loan funds, maintain or raise its loan amount or maintain its share of any loan balance, such lender affected by change of law
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shall, after becoming aware of such situations, promptly notify (“notice of change of law”) the agent bank, and explain in detail the reasons and basis for such illegality or violation of regulatory provisions. The agent bank shall promptly notify the borrower after receiving any notice of change of law.
11.2 Cancellation and early repayment
12.1 Mitigation of losses
In any of the following circumstances, the affected syndicate member bank shall negotiate in good faith with the borrower and other syndicate member banks, and shall make reasonable efforts to mitigate the impact of such circumstances. However, the borrower’s obligations under the financing documents shall not be exempted or reduced due to the provisions hereof;
The measures that any syndicate member bank shall take under this article include but are not limited to:
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12.2 Limitation of obligations
The borrower shall make the following statements to each syndicate member bank on each effective date, each withdrawal date and each interest payment date, based on the facts and circumstances at that time:
The borrower and each guarantor are corporate legal persons legally established and validly existing in accordance with the laws and regulations of their place of registration.
The borrower and each guarantor have the necessary civil capacity of conduct and civil rights to own its assets, operate its business, and sign and perform the financing documents to which it is a party.
All internal authorizations from the company required for the borrower and each guarantor to sign and perform the financing documents to which they are a party have been obtained and are in full force and effect, and such financing documents have been validly signed by their legal representatives or authorized signatories.
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The borrower and each guarantor have obtained all necessary approvals, permits, consents, registrations and filings in full force and effect in order to lawfully own the assets, operate the business, and sign and perform the financing documents to which they are a party.
The borrower and each guarantor have submitted annual reports in accordance with the requirements of relevant laws, and neither the borrower nor any guarantor has been included in the list of enterprises with abnormal operations or the list of enterprises with serious violations of law.
The obligations of the borrower and each guarantor under the financing documents to which they are a party are legal, valid and binding on them.
The borrower and each guarantor’s execution and performance of the financing documents to which they are a party does not, and will not, violate or conflict with any of the following:
No court action, arbitration, administrative proceeding, enforcement proceeding by a judicial or administrative authority or other proceeding of a similar nature has occurred or is pending against the borrower or any guarantor that has or is likely to have any material adverse effect on the performance by the borrower or any guarantor of the financing documents to which it is a party.
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The borrower and each guarantor have not initiated or been initiated any cessation of operations, dissolution, liquidation, bankruptcy, reorganization, reconciliation, rectification or similar procedures.
No event of default has occurred or subsisted.
The borrower and each guarantor comply in all respects with all laws and regulations applicable to them and have not violated any laws and regulations relating to their business and operations.
The creditor’s rights of each syndicate member bank against the borrower (or, as the case may be, each guarantor) under the financing documents are in at least the same priority of payment as the unsecured or non-statutory priority rights of other creditors of the borrower (or, as the case may be, each guarantor) against the borrower (or, as the case may be, each guarantor).
The borrower, each guarantor and their respective assets shall not enjoy any immunities or privileges with respect to prosecution, judgment, enforcement, property preservation or other proceedings in any judicial proceeding.
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condition, financial condition or asset condition of the borrower (guarantor, if any).
No events or circumstances of material adverse effect has occurred.
The borrower undertakes that from the effective date until the date on which all obligations of the borrower under this Contract are fully performed:
14.1 Positive obligations
The creditor’s rights of each syndicate member bank against the borrower (or, as the case may be, each guarantor) under the financing documents are in at least the same priority of payment as the existing and future unsecured or non-statutory priority rights of other creditors of the borrower (or, as the case may be, each guarantor) against the borrower (or, as the case may be, each guarantor).
The borrower shall (and cause each guarantor to) maintain the legal, continuous and effective existence of its corporate legal person status, and ensure that it has the necessary civil capacity of conduct and civil rights to perform the financing documents to which it is a party.
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The borrower shall (and cause each guarantor to) ensure compliance in all material aspects with any laws and regulations related to its business and operations, including but not limited to laws and regulations on environmental protection and taxation, as well as laws and regulations on energy conservation and emission reduction, and government regulations and industry regulatory measures.
The borrower shall (and cause each guarantor to) obtain in a timely manner all necessary approvals, permits, consents, registrations and filings in order to perform the financing documents to which it is a party, and comply with such matters, and maintain such matters in full force and effect continuously.
The borrower shall (and cause each guarantor to) submit an annual report to the Administration for Market Regulation in a timely manner, and ensure that the borrower and each guarantor are not included in the list of enterprises with abnormal operations or the list of enterprises with serious violations of law.
The borrower shall insure its business and assets with a reputable insurance company, and the type of insurance purchased shall be the type of insurance commonly taken out by enterprises engaged in the same or similar business; the borrower shall continuously keep such insurance in full force and effect and renew it in a timely manner.
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In case of any of the following circumstances, the borrower shall notify the agent bank immediately after becoming aware of it:
The borrower shall comply with the following financial indicators:
[/].
The borrower shall ensure that the capital fund of the project is in place before the loan fund or in the same proportion as the loan fund, and that the capital fund of the project is utilized in conjunction with the loan fund.
The borrower shall ensure that the actual progress of the project matches the investment amount.
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The agent bank may inspect and supervise the borrower’s use of each loan fund at any time, and the borrower shall cooperate with the agent bank in loan payment management, post-loan management and related inspections. The agent bank’s methods of inspection and supervision include but are not limited to: (i) requiring the borrower to provide valid proof of its use of loan funds: (ii) conducting account analysis, voucher inspection or on-site investigation on the use of loan funds; and (iii) other methods permitted by laws and regulations.
The borrower and each guarantor agree to provide each lender with the following support or guarantee:
14.2 Restrictions
The borrower shall ensure that no security interest is created or exists in any of its assets, other than the security interest created pursuant to the guaranty contract, except with the consent of the majority lender.
The borrower shall ensure that it will not sell, lease, assign, transfer or otherwise dispose of any of its material assets in a single or multiple transactions or a series of transactions, unless with the consent of the majority lender.
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The borrower shall ensure that no merger, spin-off, contracted operation or similar arrangement will take place, unless with the consent of the majority lender.
The borrower shall ensure that it will not reduce its registered capital, unless with the consent of the majority lender.
In case of any of the following circumstances, the borrower shall not distribute profits:
The borrower shall not incur any liabilities other than the permitted liabilities.
The borrower shall not make any external investments other than the permitted investments.
15.1 Event of default
Any of the following circumstances constitutes an event of default:
The borrower fails to pay any amount due and payable in the amount, currency, payment method and timeline as agreed under this Contract, unless such failure is due to an
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administrative or technical error and such payment is made within (5 business days) after the due date.
The borrower has not used any of the loan funds for the purposes agreed under this Contract.
Any statement of fact made by the borrower under Article XIII of this Contract (Statement of facts) is untrue, inaccurate, incomplete or misleading in any material respect.
The borrower fails to comply with the obligations under Article 14 (Agreed matters) or fails to perform or comply with any other obligations in accordance with this Contract.
The borrower has not paid off any liabilities due and payable, and the total amount reaches or exceeds RMB [10,000,000.00] Yuan.
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The borrower or any guarantor has initiated or been initiated any cessation of operations, dissolution, liquidation, bankruptcy, reorganization, reconciliation, rectification or similar procedures.
The borrower’s assets, whose total market value or book value (whichever is lower) reaches or exceeds RMB [10,000,000.00] Yuan, are sealed, frozen, seized, executed, expropriated, confiscated or imposed by other similar measures, and such measures are not lifted within [30] business days after commencement.
The borrower fails to comply with any of the financial indicators stipulated in paragraph 9 (Compliance with financial indicators) of Article 14.1 (Positive obligations) of this Contract.
Any event or circumstance with a material adverse effect occurs.
The financing documents become invalid or unenforceable.
15.2 Remedies of syndicate member banks
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During the duration of any event of default, the agent bank (according to the decision of the majority lender) may exercise one or more of the following rights:
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During the continuance of an event of default, each syndicate member bank shall have the right to withhold the balance of any account opened by the borrower at such syndicate member bank (including any of its branches) and forward it to the agent bank in accordance with Article 8.10 of this Contract (Apportionment) for apportionment.
16.1 Appointment of the agent bank
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16.2 Agency relationship
16.3 Responsibilities of the agent bank
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16.4 Rights of the agent bank
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However, if the agent bank is aware of, or any other party to this Contract is aware of, the contrary and notifies the agent bank, the agent bank shall not only have the right but also the obligation to notify each lender in accordance with the relevant provisions of this Contract.
16.5 Independent credit assessment
Each lender confirms that it has and will continue to independently investigate, review and assess the borrower’s financial status, creditworthiness, business status, legal status and other conditions which include but are not limited to the following, and make independent judgments and decisions based on this and bear risks:
Accordingly, the agent bank shall not be liable to any lender for any of the foregoing issues and possible risks.
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16.6 Agent bank and lead bank as the lenders
Where the agent bank or the lead bank is also a lender, it shall enjoy the rights of the lender and assume the obligations of the lender in accordance with the provisions of this Contract.
16.7 Syndicate meeting
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Unless otherwise agreed in this Contract, modifications to the terms of this Contract concerning any of the following matters must be approved by all syndicate member banks:
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16.8 Lenders’ compensation
16.9 Resignation of the agent bank
5. | The resigning agent bank shall, within [10] business days after receiving the succession notice from the successor agent bank, provide the successor agent bank with the documents, records and necessary assistance that it reasonably requires in order to exercise its rights and perform its obligations in accordance with this Contract. |
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16.10 Deductions by the agent bank
In the event that any syndicate member bank owes any money to the agent bank under this Contract, the agent bank may, upon notice to such syndicate member bank, deduct no more than the amount that the agent bank should have paid to the syndicate member bank in accordance with this Contract to settle such arrears, and such deducted amounts shall be deemed to have been received by the syndicate member bank.
16.11 Other business
Each syndicate member bank (including its branches) may accept deposits from the borrower, provide other loans to the borrower or conduct any other type of banking business.
16.12 Dealings with the lenders
Unless notified by the relevant lender in accordance with the provisions of this Contract to the contrary, the agent bank may consider that the lender is entitled to receive payment in accordance with this Contract and is acting through its handling bank.
XVII Fees and compensation
[Each party may separately sign a syndication fee letter with the relevant party for the transactions under this Contract, and if the following provisions of this Contract are inconsistent with the provisions in the syndication fee letter, the provisions in the syndication fee letter shall prevail.]
17.1 Syndication fees
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bank on the withdrawal date of the first loan fund, and subsequent annual agency fees shall be paid to the account designated by the agent bank on [ / ] each year.
17.2 Syndication costs
17.3 Compensation for losses
The borrower shall, within [10] business days after receiving the request from any syndicate member bank, compensate the syndicate member bank for any loss other than the penalty interest suffered and incurred by the syndicate member bank as a result of the borrower’s violation of its obligations under this Contract (including but not limited to any of the following circumstances):
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17.4 Currency compensation
If any payment made by the borrower under this Contract is not made in the currency payable as expressly agreed in this Contract (“contract currency”), but in any currency other than the contract currency (“payment currency”), and after the syndicate member bank converts the payment currency into the contract currency according to the market exchange rate, the amount is less than the amount that the syndicate member bank should receive, the borrower shall compensate for the shortfall and the related expenses incurred by the syndicate member bank in the conversion of currency.
17.5 Basis of calculation
Any syndicate member bank that intends to make a request in accordance with Article 17.2 (Syndication costs), Article 17.3 (Compensation for losses) and/or Article 17.4 (Currency compensation) of this Contract shall notify the agent bank and provide detailed calculation basis of such request, and the agent bank shall promptly notify the borrower after receiving such a request.
17.6 Exemption from compensation
The borrower shall not be liable to any syndicate member bank in accordance with Article 17.2 (Syndication costs), Article 17.3 (Compensation for losses) and/or Article 17.4 (Currency compensation) of this Contract in the following circumstances:
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18.1 Transfer by borrower
The borrower shall not transfer all or any of its rights or obligations under this Contract.
18.2 Transfer by lenders
18.3 Effectiveness of transfer
The transfer made by the lender in accordance with Article 18.2 (Transfer by lenders) of this Contract shall become effective on the date of transfer specified in the transfer certificate which is prepared in the form and content of Appendix III of this Contract (Form of Transfer Certificate) and signed by the transferring bank, the transferee bank and the agent bank. The agent bank shall not refuse or delay its signing of the transfer certificate.
18.4 Binding force of transfer
Any transfer carried out and completed in accordance with the provisions of Article XVIII of this Contract (Transfer) shall be binding on all parties to this Contract.
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18.5 Consequences of transfer
From the effective date of the transfer, the transferee bank shall officially become a lender, and within the scope of the subject matter of the transfer listed in the transfer certificate:
18.6 Exemption of the transferring bank
The transferring bank shall not be liable to the transferee bank for any of the following:
18.7 Further exemption of the transferring bank
The transferring bank is not obliged to:
The agent bank shall keep a list of all parties to this Contract, be responsible for transfer registration, record all transfers of syndicated loans, and notify other parties to this Contract in a timely manner after the transfer occurs.
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Any lender may change its handling bank by notifying the borrower and the agent bank at least [10] business days in advance.
19.1 Independence of obligations
The obligations of each syndicate member bank under this Contract are independent of each other. Any syndicate member bank’s failure to perform its obligations under this Contract will not affect or exempt any other syndicate member bank from performing its obligations under this Contract. No syndicate member bank shall bear any responsibility for the obligations of any other syndicate member bank under this Contract.
19.2 Independence of rights
The rights of each syndicate member bank under this Contract are independent of each other. Any debts incurred by any party to this Contract to any syndicate member bank from time to time under this Contract shall be separate debts. Unless otherwise agreed in this Contract, each syndicate member bank shall have the right to independently exercise its rights under this Contract. No syndicate member bank shall fail to perform any obligation under this Contract on the excuse of independence of rights.
20.1 Scope of confidentiality
Each party to this Contract shall be obliged to keep confidential any information provided to it by other parties in accordance with this Contract that is marked as confidential. However, such party shall have the right to disclose such information under the following circumstances:
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20.2 Scope of other disclosure
Any syndicate member bank may disclose to any person who may or has already entered into any transfer or indirect sub-lending agreement as stipulated in Article XVIII of this Contract (Transfer) with the syndicate member bank:
However, the disclosed party must, before receiving any such information, undertake to the syndicate member bank to comply with the confidentiality obligations stipulated in Article XX of this Contract (Obligation of confidentiality).
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20.3 Replacement
The agreements in Article 20.1 (Scope of confidentiality) and Article 20.2 (Scope of other disclosure) of this Contract shall supersede any confidentiality commitment made by any syndicate member bank before becoming a party to this Contract in relation to the borrower, this Contract and the transactions under this Contract.
20.4 Information collection
The borrower agrees and irrevocably authorizes that, the syndicate member banks, on the premise of not violating the prohibitions of the Regulation on the Administration of Credit Investigation Industry and the relevant laws and regulations, and in accordance with the collection requirements of the Financial Credit Information Basic Database set up by the State; shall have the right to provide to the Financial Credit Information Basic Database established by the State, the information relating to all the contracts/agreements/undertakings signed between the borrower and the syndicate member banks, including information relating to the performance of all the aforesaid contracts/agreements/undertakings and the basic corporate information and other information provided by the borrower to the Financial Credit Information Basic Database set up by the State for query and use by units with the qualification to query; at the same time, the syndicate member banks also have the right to query and use the credit information of the borrower that has been entered into the Financial Credit Information Basic Database set up by the State. Such authorization covers all aspects of the necessary management of the business under this Contract by the syndicate member banks before and after the signing of this Contract, and shall expire with the actual termination of this Contract.
21.1 Application and consent for modification or exemption
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21.2 Written modification
Any modification to any provision of this Contract shall be made in writing and shall become effective with the signatures of all parties to this Contract.
21.3 Agent bank’s consent
Modifications to the provisions concerning any of the following matters must be approved by the agent bank:
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22.1 Through the agent bank
All communications between the borrower and any syndicate member bank regarding this Contract shall be made through the agent bank.
22.2 Method of notification
Any notice, request or other document sent by any party to this Contract to any other party shall be made in writing and sent to the contact address or telex number or fax number or e-mail specified in writing by the recipient at any time and indicating the contact person (if any). The initial contact address, telex number, fax number, e-mail and contact person (if any) designated by each party are listed on the signature page of this Contract.
Each party to this Contract confirms that the contact information originally designated by the parties on the signature page of this Contract or the contact information subsequently changed according to this Contract is the address for service of documents of litigation or arbitration in respect of the dispute under this Contract, and each party to this Contract shall bear the legal consequences arising therefrom.
22.3 Service of notice
Any communication between the parties to this Contract is deemed to have been received by the recipient when the following conditions are met:
Notwithstanding the foregoing in this article, any communication or document made or delivered in accordance with this article shall be deemed to be effective on the next business day if received after [10 days] on the date of receipt at the place of receipt.
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22.4 Change of address
When any party to this Contract changes its contact address, telex number, fax number or e-mail, it shall notify the agent bank of such changes as soon as possible. Upon receipt of such notice of change, the agent bank shall immediately notify the other parties to this Contract.
22.5 Notification language
Notices given under this Contract shall be in Chinese.
Any syndicate member bank shall record relevant accounting information and records related to this Contract on its accounting books in accordance with its ordinary business practice. In the absence of manifest errors, the information recorded in the accounting documents of the syndicate member banks prepared in accordance with its ordinary business practice constitutes conclusive evidence of the debt owed by the borrower to the syndicate member banks under this Contract.
24.1 | The borrower shall open a special account for loan payment and a special account for fund withdrawal with the syndicate agent bank, and sign the Account Supervision Agreement and the Entrusted Payment Agreement. During the construction period, the project construction funds must be transferred to the special account, earmarked for the special purpose, and the external payments shall be made according to relevant requirements of entrusted payment management, and the syndicate shall have the right to supervise the use of funds in the special accounts; |
24.2 | The borrower’s comprehensive operating income must be fully deposited into a special account for collection. Apart from reasonable operating expenses, it should be primarily used for repaying the principal and interest of the loan, and the syndicate is authorized to deduct the principal and interest of the loan from the special account; |
24.3 | Complete the mortgage formalities for the land and factory buildings under the borrower’s name, make the syndicate the first mortgagee, and explicitly state that the syndicate is the first claimant for insurance proceeds; |
24.4 | The project assets and their proceeds shall not be refinanced externally, the project assets shall not be mortgaged again except to the syndicate, the borrower’s equity and project income rights shall not be pledged to parties other than the syndicate. In the event of significant changes in the borrower’s equity, capital operations, external investments, external guarantees, or other matters affecting the repayment of loans to the syndicate, the borrower must obtain prior written consent from the syndicate; |
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24.5 | The project funds shall not be misappropriated in any form until the full repayment of the loan principal and interest, and no profit distribution shall be made before repaying the loan principal and interest for the current year. If the project construction exceeds the budget, the excess amount shall be self-financed by the borrower, and it shall be ensured that the proportion of project capital fund is not lower than the proportion required by the relevant national regulations; |
24.6 | If the borrower has suffered losses for two consecutive years, the syndicate shall have the right to declare the loan due in advance or request the borrower to provide additional risk mitigation measures approved by the syndicate; |
Should the borrower violate the conditions above, the syndicate shall have the right to increase the interest rate of the loan by 50% or declare the loan due in advance and recall the loan.
25.1 Accumulation of rights
The failure or delay of any syndicate member bank in exercising any of its rights under this Contract shall not be deemed to be a waiver of such rights, and any exercise by any syndicate member bank of any such rights, alone or in part, shall not preclude the subsequent exercise of such right or any other rights in any other manner or to any further extent by that syndicate member bank. The rights and remedies stipulated in this Contract are cumulative and do not exclude any other rights or remedies granted to any syndicate member bank by laws and regulations.
25.2 Independence of provisions
If, at any time, any provision of this Contract becomes illegal, invalid or unenforceable, the legality, validity or enforceability of the remaining provisions in this Contract will not in any way be affected or impaired.
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26.1 Language
This Contract is drafted and signed in Chinese.
26.2 Original copy
This Contract is made in [ten] original copies, which are of equal force and effect.
27.1 Governing law
This Contract shall be governed by and construed in accordance with the laws of China.
27.2 Dispute resolution
Any dispute arising out of or in connection with this Contract shall be resolved by amicable negotiation among all parties within [10] days of receipt of written notice from any other party. In the event of failure to negotiate within that period, any party shall have the right to choose the [second] dispute resolution method below:
27.3 Waiver of immunity
The borrower hereby irrevocably waives any immunity it or its assets may have or hereafter acquire in any jurisdiction from any legal proceedings or judicial process.
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This Contract shall become effective on the date on which the legal representative/responsible person or the authorized signatory of each party signs and affixes its official seal or the special seal for contract (“effective date”).
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Appendix I Lenders’ Original Loan Amount
Original lender | Original loan amount |
Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited | RMB 210,000,000.00 |
East West Bank (China) Limited | RMB 70,000,000.00 |
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Appendix II Form of Document Confirmation Letter
To: [Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited]
As the agent bank
Date: [ ] [ ], [ ]
Subject: [Syndicated] Loan Contract signed on [ ] [ ], [ ]
Our company hereby references the [Syndicated Loan] Contract (hereinafter referred to as the “Loan Contract”) signed on [ ] [ ], [ ] by [Amphastar Nanjing Pharmaceuticals Inc.] as the borrower, with (1) [Nanjing Branch of Industrial and Commercial Bank of China Limited] as the lead bank, (2) [Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited] and [East West Bank (China) Limited] as the original lenders, and (3) [Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited] as the agent bank. The terms defined in the Loan Contract shall have the same meanings when used in this Confirmation Letter.
Our company hereby confirms:
1.Among the various documents listed in paragraph 1 of Article 4.2 of the Loan Contract (Prerequisites for first withdrawal), the originals are true and complete, and the photocopies (including but not limited to the documents attached to this Confirmation Letter) are true, accurate and complete copies of their originals, and such documents are completely effective on the date of this Confirmation Letter.
2.The resolutions passed at the meeting of our company’s [board of shareholders]/[board of directors] and stated in the meeting minutes are completely effective and have not been revoked, amended or replaced as of the date of this Confirmation Letter.
3.Our company is currently solvent.
4.The following is a list of all current directors of our company as of the date of this Confirmation Letter and the list of directors as of the date of the board meeting:
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[Zhang Yongfeng, Mary Luo, Rong Zhou, Yakob Liawatidewi, Qiu Yinhua].
5.Unless our company notifies you in writing to the contrary, your bank may believe that the content contained in this Confirmation Letter is always true and accurate on and before the withdrawal date.
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Legal Representative/Responsible Person (or Authorized Signatory) [•] Official seal | |
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Appendix III Form of Transfer Certificate
To: [/]
Address: [/]
Contact person: [/]
[/]
Address: [/]
Contact person: [/]
From: [Transferring bank] and [Transferee bank]
[•] Contract dated [•] (“Loan Contract”)
We hereby reference the Article XVIII of the Loan Contract (Transfer). The terms defined in the Loan Contract shall have the same meanings when used in this Certificate.
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Annex Shares of Transfer
Under the total loan amount:
Transferring bank’s loan amount | Transferred loan amount |
[/] | [/] |
Transferring bank’s share of loan balance | Transferred part |
[/] | [/] |
Transferee bank’s information: [/]
Name of the transferee bank: [/]
Handling agency: [/]
Address for delivery of notices: [/]
Phone: [/]
Telex: [/]
Fax: [/]
Contact person: [/]
Email: [/]
[Transferring bank] [/][Transferee bank] [/]
Signatory: [/]Signatory: [/]
___________________ (Official Seal)___________________ (Official Seal)
[Agent bank][/]
Signatory:[/]
___________________ (Official Seal)
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Appendix IV Accounts of Various Parties
Borrower
Loan fund account
Account name: [Amphastar Nanjing Pharmaceuticals Inc.]
Opening bank: [Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited]
Account No.: [ *** ]
Remarks: [Disbursement of syndicated loan]
Syndicate member banks
Agent bank’s payment account
Account name: [/]
Opening bank: [/]
Account No.: [/]
Bank No.: [/]
Remarks: [/]
[Name of the lead bank]
Account name: [/]
Opening bank: [/]
Account No.: [/]
Bank No.: [/]
Remarks: [/]
[Name of the agent bank]
Account name: [/]
Opening bank: [/]
Account No.: [/]
Bank No.: [/]
Remarks: [/]
[Name of the lender]
Account name: [/]
Opening bank: [/]
Account No.: [/]
Bank No.: [/]
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Remarks: [/]
[Name of the lender]
Account name: [/]
Opening bank: [/]
Account No.: [/]
Bank No.: [/]
Remarks: [/]
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This page is the stamp page of the Syndicated Loan Contract signed by Nanjing Branch of Industrial and Commercial Bank of China Limited, Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited, East West Bank (China) Limited and Amphastar Nanjing Pharmaceuticals Inc., and there is no text on this page.
Borrower
[Amphastar Nanjing Pharmaceuticals Inc.]
Address:[No. 5, Xinghe Road, Nanjing Economic and Technological Development Zone]
Zip code:[210000]
Phone:[***]
Fax:[ / ]
Contact person:[***]
Email:[***]
Legal Representative/Responsible Person (or Authorized Signatory)
[seal:] [illegible] _______ Name: Title: | Amphastar Nanjing Pharmaceuticals Inc. [seal] _________________ Official Seal/Special Seal for Contract |
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This page is the stamp page of the Syndicated Loan Contract signed by Nanjing Branch of Industrial and Commercial Bank of China Limited, Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited, East West Bank (China) Limited and Amphastar Nanjing Pharmaceuticals Inc., and there is no text on this page.
Lead bank
[Nanjing Branch of Industrial and Commercial Bank of China Limited]
Address:[No. 379, Jiangdong Middle Road, Jianye District, Nanjing]
Zip code:[210000]
Phone:[***]
Fax:[***]Contact person:[***]
Email:[***]
Legal Representative/Responsible Person (or Authorized Signatory):
Seal of Yang Qingsheng [seal] _______ Name: Title: | Nanjing Branch of Industrial and Commercial Bank of China Limited [seal] _________________ Official Seal/Special Seal for Contract |
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This page is the stamp page of the Syndicated Loan Contract signed by Nanjing Branch of Industrial and Commercial Bank of China Limited, Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited, East West Bank (China) Limited and Amphastar Nanjing Pharmaceuticals Inc., and there is no text on this page.
Agent bank
[Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited]
Mailing address:Building B, Financial Building, Xingang Industrial Zone, Nanjing
Zip code:[210038]
Phone:[***]
Fax:[***]
Contact person:[***]
Email:[***]
Legal Representative/Responsible Person (or Authorized Signatory):
Li Lei [seal] _______ Name: Title: | Special Seal for Business Contract of Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited 50BFF37A1036 [seal] _________________ Official Seal/Special Seal for Contract |
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This page is the stamp page of the Syndicated Loan Contract signed by Nanjing Branch of Industrial and Commercial Bank of China Limited, Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited, East West Bank (China) Limited and Amphastar Nanjing Pharmaceuticals Inc., and there is no text on this page.
Lender
[Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited]
Mailing address:Building B, Financial Building, Xingang Industrial Zone, Nanjing
Zip code:[210038]
Phone:[***]
Fax:[***]
Contact person:[***]
Email:[***]
Legal Representative/Responsible Person (or Authorized Signatory):
Li Lei [seal] _______ Name: Title: | Special Seal for Business Contract of Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited 50BFF37A1036 [seal] _________________ Official Seal/Special Seal for Contract |
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This page is the stamp page of the Syndicated Loan Contract signed by Nanjing Branch of Industrial and Commercial Bank of China Limited, Nanjing Zidong Sub-branch of Industrial and Commercial Bank of China Limited, East West Bank (China) Limited and Amphastar Nanjing Pharmaceuticals Inc., and there is no text on this page.
Lender
[East West Bank (China) Limited]
Mailing address: | [Units 01-08, 33/F, Jinmao Building, No. 88 Century Avenue, China (Shanghai) Pilot Free Trade Zone] |
Zip code:[200000]
Phone:[***]
Fax:[***]
Contact person:[***]
Email:[***]
Legal Representative/Responsible Person (or Authorized Signatory):
/s/Julia Zhu Name: Title: | East West Bank (China) Limited [seal] _________________ Official Seal/Special Seal for Contract |
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14a OF
THE SECURITIES EXCHANGE ACT OF 1934
AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES OXLEY ACT OF 2002
I, Jack Y. Zhang, Ph.D., certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q of Amphastar Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: May 10, 2024 | By: | /s/ JACK Y. ZHANG | |
| | Jack Y. Zhang | |
| | Chief Executive Officer | |
| | (Principal Executive Officer) | |
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14a OF
THE SECURITIES EXCHANGE ACT OF 1934
AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES OXLEY ACT OF 2002
I, William J. Peters, certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q of Amphastar Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: May 10, 2024 | By: | /s/ WILLIAM J. PETERS | |
| | William J. Peters | |
| | Chief Financial Officer | |
| | (Principal Financial and Accounting Officer) | |
CERTIFICATIONS OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
The undersigned officer of Amphastar Pharmaceuticals, Inc. (the “Company”), hereby certifies, to the best of such officer’s knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2024 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the dates and for the periods indicated.
Date: May 10, 2024 | By: | /s/ JACK Y. ZHANG | |
| | Jack Y. Zhang | |
| | Chief Executive Officer | |
| | (Principal Executive Officer) | |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. §1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Exhibit 32.2
CERTIFICATIONS OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
The undersigned officer of Amphastar Pharmaceuticals, Inc. (the “Company”), hereby certifies, to the best of such officer’s knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2024 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the dates and for the periods indicated.
Date: May 10, 2024 | By: | /s/ WILLIAM J. PETERS | |
| | William J. Peters | |
| | Chief Financial Officer | |
| | (Principal Financial and Accounting Officer) | |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. §1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.