noodls browser compatibility check

The security settings of your browser are blocking the execution of scripts.

To use noodls, javascript support must be enabled. Please change your browser's security settings to enable javascript.

If you have changed your browser's security settings, you can click here.

related announcements

News

CytomX Therapeutics Inc.

Notice of Proposed Sale of Securities (Form 144)
City of Victorville, CA

Low-Cost Pet Vaccination Clinic & Adoption Event Nov. 8
University of California

‘Every time I relapsed, there would be a new course of therapy’

Amphastar Pharmaceuticals Inc.

11/06/2025 | Press release | Distributed by Public on 11/06/2025 15:38

Quarterly Report for Quarter Ending 2025-09-30 (Form 10-Q)

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, 2024, particularly in Item 1A. "Risk Factors".

Overview

We are a biopharmaceutical 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, and lidocaine.

We are currently developing a portfolio of generic abbreviated new drug applications, or ANDAs, biologics license applications, or BLAs, including biosimilar insulin product candidates, and proprietary product candidates, which are in various stages of development and target a variety of indications. Three of the ANDAs and one biosimilar insulin candidate 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 worldwide events and macroeconomic factors, such as international trade relations, tariffs, new legislation and regulations, changes in administration, taxation or monetary policy changes, public sector budgetary cycles and funding authorization in the United States, political and civil unrest, global conflicts, supply chain disruptions, heightened inflationary pressures, and fluctuating interest rates, as well as rising healthcare costs among other factors, also increase volatility in the global economy and continue to pose challenges to our business. For example, there is significant uncertainty relating to tariffs. While all of our finished products and four of our APIs are manufactured in the United States, we import APIs, starting materials for APIs, and components from various countries.

See the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, 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

In August 2025, the FDA approved our Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, which we launched in the third quarter of 2025.

In August 2025, we entered into a License Agreement with Nanjing Anji Biotechnology Co., Ltd., or Anji, pursuant to which Anji has granted an exclusive license to certain intellectual property controlled by Anji to develop, make, use and commercialize products incorporating or comprising certain compounds, including three identified products, or Licensed Products, in the United States and Canada. During the nine months ended September 30, 2025, we made an earnest payment and upfront payment totaling $6.0 million to Anji upon the signing of the License agreement. The agreement is

-30-

also subject to potential development milestone payments, as well as sales milestone and royalty payments. For more information regarding the Anji license agreement, see "Part I - Item 1. Financial Statements - Notes to Condensed Consolidated Financial Statements - Note 17. Commitments and Contingencies."

Business Segments

Our performance is assessed and resources are allocated based on one reportable segment, pharmaceutical products.

For more information regarding our segments, see "Part I - Item 1. Financial Statements - Notes to Condensed Consolidated Financial Statements - Note 5. Segment Reporting."

Results of Operations

Three Months Ended September 30, 2025 Compared to Three Months Ended September 30, 2024

Net revenues


	Three Months Ended
	September 30,						Change
	2025			2024			Dollars		%

	(in thousands)
Net revenues
Product revenues, net	$	191,840		$	188,819		$	3,021	2	%
Other revenues		-			2,395			(2,395)	(100)	%
Total net revenues	$	191,840		$	191,214		$	626	0	%

Cost of revenues	$	93,194		$	89,273		$	3,921	4	%
Gross profit	$	98,646		$	101,941		$	(3,295)	(3)	%
as % of net revenues		51	%		53	%

The increase in product revenues, net, was primarily due to the following changes:


	Three Months Ended
	September 30,				Change
	2025		2024		Dollars		%

	(in thousands)
Product revenues, net:
BAQSIMI^®	$	53,608	$	40,409	$	13,199	33	%
Primatene MIST^®		28,808		26,055		2,753	11	%
Epinephrine		18,789		21,341		(2,552)	(12)	%
Glucagon		13,558		26,792		(13,234)	(49)	%
Lidocaine		12,932		15,884		(2,952)	(19)	%
Other products		64,145		58,338		5,807	10	%
Total product revenues, net	$	191,840	$	188,819	$	3,021	2	%

Product Revenues, net

The increase in sales of BAQSIMI^® was primarily due to growth in unit volumes as a result of an expanded marketing effort in the United States. Total BAQSIMI^® sales growth, including units sold by Eli Lilly and Company, or Lilly, in 2024 which were accounted for in Other revenues, was 14%. Primatene MIST^® sales increased due an increase in unit volumes driven by our continued marketing efforts. The decrease in sales of epinephrine was primarily due to a lower average selling price of the multi-dose vial product, causing a revenue reduction of $3.1 million, as a result of increased competition. This trend was partially offset by an increase in unit volumes for our epinephrine pre-filled syringe, as a result of an increase in demand caused by shortages from other suppliers during the quarter. The decrease in sales of glucagon was due to a lower average selling price, impacting sales of $7.0 million, as well as a decrease in unit volumes, impacting sales of $6.2 million, as a result of competition and the continued shift to ready-to-use glucagon products such

-31-

as BAQSIMI^®. The decrease in sales of lidocaine was primarily due to a decrease in unit volumes as a result of other suppliers returning to their historical distribution level. The increase in other products was primarily due to a $4.7 million increase in sales of albuterol and $2.4 million sales of iron sucrose injection, which we launched in August 2025. This increase was partially offset by a decrease in unit volumes of enoxaparin and dextrose, due to increased competition.

We anticipate that sales of glucagon will continue to decline in the future due to competitive dynamics. We also anticipate that sales of epinephrine and other products will continue to fluctuate depending on the ability of our competitors to supply market demands.

Other Revenues

Other revenues in the previous period include the portion of BAQSIMI^® sales made by Lilly on our behalf under the Transition Service Agreement, or TSA, which amounted to $2.4 million during the three months ended September 30, 2024, based on total BAQSIMI^® sales of $6.4 million as reported to us by Lilly which was recognized on a net basis, similar to a royalty arrangement. As we completed the assumption of distribution responsibilities globally for BAQSIMI^® at the beginning of 2025, all BAQSIMI^® related revenues in the current period are recognized in Product revenues, net.

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. We had no significant backlog as of September 30, 2025. 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

In 2024, under the TSA, the portion of revenues relating to BAQSIMI^® sales made by Lilly on our behalf were reported on a net basis, similar to a royalty arrangement with no amount reported as cost of revenues resulting in increased gross margins for that period. Gross margins were also impacted by decrease in unit sales and pricing of glucagon, and lower pricing for our epinephrine multi-dose vial product, both of which are higher-margin products. Additionally, cost control efforts across the business partially offset the impact of pricing declines.

Selling, distribution and marketing, and general and administrative


	Three Months Ended
	September 30,				Change
	2025		2024		Dollars		%

	(in thousands)
Selling, distribution, and marketing	$	11,505	$	8,995	$	2,510	28	%
General and administrative	$	39,467	$	14,821	$	24,646	166	%

The increase in selling, distribution and marketing expenses was primarily related to the expansion of our sales and marketing efforts related to BAQSIMI^®, including expenses related to our co-promotion contract with MannKind, and sales efforts related to Primatene MIST^®. The increase in general and administrative expense was primarily related to a litigation provision, which increased expenses by $23.1 million.

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.

-32-

Research and development


	Three Months Ended
	September 30,				Change
	2025		2024		Dollars		%

	(in thousands)
Salaries and personnel-related expenses	$	8,291	$	7,768	$	523	7	%
Clinical trials		352		9		343	NM
FDA fees		45		34		11	32	%
Materials and supplies		1,035		5,852		(4,817)	(82)	%
Depreciation		3,627		3,278		349	11	%
Other expenses⁽¹⁾		9,004		4,136		4,868	118	%
Total research and development expenses	$	22,354	$	21,077	$	1,277	6	%

(1)

Includes the upfront payment of $5.3 million relating to the licensing agreement with Anji.

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.

Research and development expenses increased primarily due to the $5.3 million upfront payment for the licensing agreement that we entered into with Anji during the quarter, as well as an increase in clinical trial expense. This was partially offset by a decrease in material and supply expenses.

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.

Non-operating expenses, net


	Three Months Ended
	September 30,				Change
	2025		2024		Dollars		%

	(in thousands)
Non-operating expenses:
Interest income	$	2,246	$	2,427	$	(181)	(7)	%
Interest expense		(6,284)		(6,698)		414	(6)	%
Other income (expenses), net		231		(5,094)		5,325	105	%
Total non-operating expenses, net	$	(3,807)	$	(9,365)	$	5,558	(59)	%

The change in non-operating expenses, net, is primarily due to a change to Other income (expenses), net, 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 September 30, 2025.

Income tax provision


	Three Months Ended
	September 30,						Change
	2025			2024			Dollars		%

	(in thousands)
Income tax provision	$	4,163		$	7,254		$	(3,091)	(43)	%
Effective tax rate		19	%		15	%

-33-

Our effective tax rate for the three months ended September 30, 2025 increased in comparison to the three months ended September 30, 2024, primarily due to differences in pre-tax income positions, and 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 14. Income Taxes."

On July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was enacted into law. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. As of September 30, 2025, we do not expect the provisions of the OBBBA will have a material impact on income tax expense, but we do expect certain provisions will change the timing of cash tax payments in the current year and future periods.

Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024

Net revenues


	Nine Months Ended
	September 30,						Change
	2025			2024			Dollars		%

	(in thousands)
Net revenues
Product revenues, net	$	536,782		$	525,836		$	10,946	2	%
Other revenues		-			19,608			(19,608)	(100)	%
Total net revenues	$	536,782		$	545,444		$	(8,662)	(2)	%

Cost of revenues	$	266,395		$	258,237		$	8,158	3	%
Gross profit	$	270,387		$	287,207		$	(16,820)	(6)	%
as % of net revenues		50	%		53	%

The increase in product revenues, net, was primarily due to the following changes:


	Nine Months Ended
	September 30,				Change
	2025		2024		Dollars		%

	(in thousands)
Product revenues, net:
BAQSIMI^®	$	138,650	$	85,106	$	53,544	63	%
Primatene MIST^®		80,739		73,077		7,662	10	%
Glucagon		55,003		82,700		(27,697)	(33)	%
Epinephrine		53,556		75,392		(21,836)	(29)	%
Lidocaine		41,575		41,457		118	0	%
Other products		167,259		168,104		(845)	(1)	%
Total product revenues, net	$	536,782	$	525,836	$	10,946	2	%

Product Revenues, net

BAQSIMI^® sales increased primarily due to an increase in unit volume, as we assumed full distribution responsibilities globally at the beginning of 2025. Total BAQSIMI^® sales growth, including units sold by Lilly in 2024 which were accounted for in Other revenues, was 12%. Primatene MIST^® sales increased primarily due to an increase in unit volumes driven by our continued marketing efforts. The decrease in sales of glucagon was due to a decrease in unit volumes, impacting sales of $14.3 million, as well as a decrease in average selling price, which impact sales of $13.4 million, as a result of competition and the continued shift to ready to use glucagon products such as BAQSIMI^®. The decrease in sales of epinephrine was due to a decrease in unit volume, impacting sales of $13.4 million, as well as a decrease in average selling price, which impact sales of $8.4 million, primarily as a result of increased competition for our multi-dose epinephrine vial product. The decrease in other products was primarily due to a decrease in sales of enoxaparin, dextrose and naloxone, due to increased competition. This decrease was primarily offset by an increase of

-34-

$10.5 million in albuterol sales, which was launched in August 2024, and $2.4 million in sales of iron sucrose injection, which we launched in August 2025.

Other Revenues

As we completed the assumption of distribution responsibilities globally for BAQSIMI^® at the beginning of 2025, all BAQSIMI^® related revenues in the current period are recognized in Product revenues, net. Other revenues in the previous period include the portion of BAQSIMI^® sales made by Lilly on our behalf under the TSA, which amounted to $19.6 million during the nine months ended September 30, 2024, based on total BAQSIMI^® sales of $38.6 million as reported to us by Lilly, which was recognized on a net basis, similar to a royalty arrangement.

Gross Margins

In 2024, under the TSA, the portion of revenues relating to BAQSIMI^® sales made by Lilly on our behalf were reported on a net basis, similar to a royalty arrangement with no amount reported as cost of revenues resulting in increased gross margins for that period. Gross margins were also impacted by lower pricing for glucagon and epinephrine multi-dose vials, both of which are higher-margin products, as well as an increase in labor costs.

The decrease in gross margins was partially offset by the increase in sales of Primatene MIST^®, which is a higher-margin product. Additionally, cost control efforts across the business partially offset the impact of pricing declines.

Selling, distribution and marketing, and general and administrative


	Nine Months Ended
	September 30,				Change
	2025		2024		Dollars		%

	(in thousands)
Selling, distribution, and marketing	$	33,606	$	27,378	$	6,228	23	%
General and administrative	$	69,454	$	43,782	$	25,672	59	%

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^®, including expenses related to our co-promotion contract with MannKind, and sales efforts related to Primatene MIST^®. The increase in general and administrative expense was primarily related to a litigation provision, which increased expenses by $23.1 million.

Research and development


	Nine Months Ended
	September 30,				Change
	2025		2024		Dollars		%

	(in thousands)
Salaries and personnel-related expenses	$	25,437	$	23,898	$	1,539	6	%
Clinical trials		1,489		292		1,197	NM
FDA fees		1,554		1,333		221	17	%
Materials and supplies		8,735		12,334		(3,599)	(29)	%
Depreciation		10,788		9,206		1,582	17	%
Other expenses⁽¹⁾		14,527		8,709		5,818	67	%
Total research and development expenses	$	62,530	$	55,772	$	6,758	12	%

(1)

Includes the earnest payment and upfront payment totaling $6.0 million relating to the licensing agreement with Anji.

-35-

Research and development expenses increased primarily due to the $6.0 million payment for the licensing agreement that we entered into with Anji in the third quarter of 2025. Additionally, we had an increase in clinical trial expense, as well as an increase in depreciation expense. This was partially offset by a decrease in material and supply expenses.

Non-operating expenses, net


	Nine Months Ended
	September 30,				Change
	2025		2024		Dollars		%

	(in thousands)
Non-operating expenses:
Interest income	$	6,256	$	8,320	$	(2,064)	(25)	%
Interest expense		(18,851)		(23,918)		5,067	(21)	%
Other income (expenses), net		(492)		1,125		(1,617)	(144)	%
Total non-operating expenses, net	$	(13,087)	$	(14,473)	$	1,386	(10)	%

The change in non-operating expenses, net is primarily a result of:

●

A decrease in interest income resulting from a decrease in interest rates on our cash and investments accounts.

●

A decrease in interest expense as a result of the repayment of the mortgage loan with East West Bank, as well as the accretion of the interest on the deferred payment for BAQSIMI^®, both of which were paid in full in June 2024. For more information regarding our debt, see "Part I - Item 1. Financial Statements - Notes to Condensed Consolidated Financial Statements - Note 13. 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 nine months ended September 30, 2025.

Income tax provision


	Nine Months Ended
	September 30,						Change
	2025			2024			Dollars		%

	(in thousands)
Income tax provision	$	18,045		$	23,674		$	(5,629)	(24)	%
Effective tax rate		20	%		16	%

Our effective tax rate for the nine months ended September 30, 2025 increased in comparison to the nine months ended September 30, 2024, primarily due to differences in pre-tax income positions and 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 14. Income Taxes."

-36-

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 may trigger milestone payments for our BAQSIMI^® acquisition of up to an aggregate of $575 million contingent upon certain net sales milestones, 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 with cash flows from operations. Our cash obligations include the principal and interest payments due on our existing loans and lease payments, as described below and throughout this Quarterly Report.

As of September 30, 2025, our foreign subsidiaries collectively held $15.3 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 filing of this Quarterly Report on Form 10-Q. We expect additional cash flows to be generated in the longer term from future product launches, 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 launches, which could be lengthy or ultimately unsuccessful.

Working capital increased $73.9 million to $434.2 million at September 30, 2025, compared to $360.3 million at December 31, 2024.

Cash Flows from Operations

The following table summarizes our cash flows provided by and used in operating, investing, and financing activities for the nine months ended September 30, 2025 and 2024:


	Nine Months Ended September 30,
	2025		2024

	(in thousands)
Statement of Cash Flow Data:
Net cash provided by (used in)
Operating activities	$	123,252	$	184,362
Investing activities		(9,763)		(89,252)
Financing activities		(49,052)		(47,111)
Effect of exchange rate changes on cash		219		(179)
Net increase in cash, cash equivalents, and restricted cash	$	64,656	$	47,820

Sources and Use of Cash

Operating Activities

Net cash provided by operating activities was $123.3 million for the nine months ended September 30, 2025, which included net income of $73.7 million. Non-cash items comprised primarily of $49.7 million of depreciation and amortization, which includes $23.5 million related to depreciation of property, plant and equipment; $18.8 million related to amortization of intangible assets; $4.9 million related to amortization of operating lease right-of-use assets; $2.5 million related to amortization of discounts, premiums, and debt issuance costs; and share-based compensation expense of $21.1 million.

Additionally, for the nine months ended September 30, 2025, there was a net cash outflow from changes in operating assets and liabilities of $23.2 million, which resulted primarily from an increase in inventories and an increase in accounts receivable. This was partially offset by an increase in accounts payable and accrued liabilities. The increase in inventories was primarily due to the increased purchases of finished product, raw materials and components for

-37-

BAQSIMI^®, as we assumed full responsibility for the supply chain from Lilly. The increase in accounts receivables was primarily due to the timing of sales. Accounts payable and accrued liabilities increased primarily due to the increase in accrued customer fees and rebates, mainly associated with BAQSIMI^® sales, as well as a legal accrual related to the personal injury lawsuit.

Net cash provided by operating activities was $184.4 million for the nine months ended September 30, 2024, which included net income of $121.6 million. Non-cash items comprised primarily of $47.8 million of depreciation and amortization, which includes $21.0 million related to depreciation of property, plant and equipment; $18.5 million related to amortization of product rights, trademarks and patents; $3.0 million related to amortization of operating lease right-of-use assets; $5.3 million related to amortization of discounts, premiums, and debt issuance costs; and share-based compensation expense of $18.7 million. Additionally, for the nine months ended September 30, 2024, there was a net cash outflow from changes in operating assets and liabilities of $6.0 million, which resulted primarily from an increase in accounts receivables, an increase in inventories, as well as an increase in prepaid expenses and other assets, which was partially offset by an increase in accounts payable and accrued liabilities. The increase in accounts receivables was primarily due to the increase in sales. The increase in inventories was primarily due to the increased purchases of certain raw materials and components. Accounts payable and accrued liabilities increased primarily due to the increase in accrued customer fees and rebates associated with BAQSIMI^® sales, as we continue to assume distribution responsibilities for BAQSIMI^® from Lilly to our customers in the United States and certain other countries.

Investing Activities

Net cash used in investing activities was $9.8 million for the nine months ended September 30, 2025, primarily as a result of $26.6 million in purchases of property, plant, and equipment, which included $16.9 million incurred in the United States, $2.0 million in France, and $7.7 million in China. This was partially offset by a net cash inflow of $23.0 million from sales and purchases of investments during the period.

Net cash used in investing activities was $89.3 million for the nine months ended September 30, 2024, primarily due to the payment of $129.0 million relating to the BAQSIMI^® acquisition, $28.6 million in purchases of property, plant, and equipment, which included $10.2 million incurred in the United States, $2.4 million in France, and $15.9 million in China. This was partially offset by a net cash inflow of $71.0 million from sales and purchases of investments during the period.

Financing Activities

Net cash used in financing activities was $49.1 million for the nine months ended September 30, 2025, primarily as a result of $55.1 million used to purchase treasury stock. This was partially offset by $5.9 million of net proceeds from borrowings on our line of credit in China.

Net cash used in financing activities was $47.1 million for the nine months ended September 30, 2024, primarily as a result of $43.5 million used to purchase treasury stock and $8.2 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. Additionally, we made $8.1 million in principal payments on our long-term debt, primarily as a result of paying off the mortgage loan with East West Bank. This was partially offset by $13.6 million of net proceeds from borrowings on our line of credit in China.

Indebtedness

For more information regarding our outstanding indebtedness, see "Part I - Item 1. Financial Statements - Notes to Condensed Consolidated Financial Statements - Note 13. 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

-38-

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, 2024. 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, 2024.

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".

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.

Our manufacturing facilities as well as our CMOs are subject to periodic inspection by the FDA to ensure that they are operating in compliance with cGMP requirements. We believe that as of September 30, 2025, all of our manufacturing facilities and our CMOs are in compliance with all applicable regulations of federal and state governmental agencies, including all those of the FDA and DEA. During the nine months ended September 30, 2025, we had inspections conducted by various regulatory agencies at some of our manufacturing facilities, which resulted in no critical observations.

-39-

Amphastar Pharmaceuticals Inc. published this content on November 06, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 06, 2025 at 21:39 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]

related announcements

News

Healthcare

Amphastar Pharmaceuticals Inc.

Quarterly Report for Quarter Ending 2025-09-30 (Form 10-Q)