Amphastar Pharmaceuticals, Inc.

Previous wording

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. Four of the ANDAs and one biosimilar insulin candidate are currently on file with the FDA.

Current wording

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.

Previous wording

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, tariffs 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.

Current wording

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.

Previous wording

The increase in sales of BAQSIMI® was primarily due to growth in unit volumes, as we assumed full distribution responsibilities globally at the beginning of 2025. The decrease in sales of epinephrine was primarily due to a decrease in unit volumes, as a result of other suppliers returning to their historical distribution levels for the epinephrine pre-filled syringe, as well as increased competition for our multi-dose epinephrine vial product. The decrease in sales of glucagon was due to a lower average selling price, impacting sales by $4.7 million, as well as a decrease in unit volumes, impacting sales by $2.1 million, as a result of competition and a move to ready-to-use glucagon products such as BAQSIMI®. The increase in sales of lidocaine was primarily due to an increase in unit volumes due to an increase in demand caused by shortages from other suppliers during the quarter. The decrease in other products was primarily due to a decrease in sales of enoxaparin, dextrose and sodium bicarbonate, due to increased competition. This decrease was partially offset by sales of albuterol, which we launched in August 2024.

Current wording

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

Previous wording

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 Transition Service

Current wording

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.

Previous wording

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 due to an increase in salary and personnel-related expenses, which was partially offset by a decrease in accounting and consulting service fees.

Current wording

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.

Previous wording

Our effective tax rate for the three months ended June 30, 2025 decreased in comparison to the three months ended June 30, 2024, primarily due to differences in pre-tax income positions, partially offset by 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.”

Current wording

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.”

Previous wording

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

Current wording

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

Previous wording

BAQSIMI® sales increased primarily due to an increase in unit volume, as we assumed full distribution responsibilities globally at the beginning of 2025. Primatene MIST® sales increased primarily due to an increase in unit volumes. Lidocaine sales increased due to both an increase in unit volumes contributing sales of $1.9 million, as well as an increase in average selling price, which contributed sales of $1.2 million. The decrease in sales of epinephrine was primarily due to a decrease in unit volume, as a result of other suppliers returning to their historical distribution level for the epinephrine pre-filled syringe, as well as increased competition for our multi-dose epinephrine vial product. The decrease in sales of glucagon was due to a decrease in unit volumes, impacting sales of $7.6 million, as well as a decrease in average selling price, which impact sales of $6.9 million, as a result of competition and a move to ready to use glucagon products such as BAQSIMI®. 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 partially offset by sales of albuterol, which we launched in August 2024.

Current wording

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

Previous wording

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

Current wording

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.

Previous wording

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. Additionally, cost control efforts across the business partially offset the impact of pricing declines.

Current wording

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.

Previous wording

The decrease in gross margins was partially offset by the increase in sales of Primatene MIST®, which is a higher-margin product.

Current wording

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.

Previous wording

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 due to an increase in salary and personnel-related expenses, which was partially offset by a decrease in accounting and consulting service fees.

Current wording

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.

Previous wording

Research and development expenses increased primarily due to an increase in material and supply expenses for our inhalation pipeline products. Additionally, we had an increase in depreciation expense, as well as an increase in clinical trial expense.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

Our effective tax rate for the six months ended June 30, 2025 increased in comparison to the six months ended June 30, 2024, primarily due to timing of discrete tax items, partially offset by differences in pre-tax income positions. For more information regarding our income taxes, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 14. Income Taxes.”

Current wording

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.”

Previous wording

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.

Current wording

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.

Previous wording

As of June 30, 2025, our foreign subsidiaries collectively held $9.7 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.

Current wording

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.

Previous wording

Working capital increased $44.1 million to $404.4 million at June 30, 2025, compared to $360.3 million at December 31, 2024.

Current wording

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

Previous wording

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

Current wording

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:

Previous wording

Net cash provided by operating activities was $70.7 million for the six months ended June 30, 2025, which included net income of $56.3 million. Non-cash items comprised primarily of $33.0 million of depreciation and amortization, which includes $15.7 million related to depreciation of property, plant and equipment; $12.5 million related to amortization of intangible assets; $3.2 million related to amortization of operating lease right-of-use assets; $1.6 million related to amortization of discounts, premiums, and debt issuance costs; and share-based compensation expense of $14.8 million.

Current wording

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.

Previous wording

Additionally, for the six months ended June 30, 2024, there was a net cash inflow from changes in operating assets and liabilities of $1.4 million, which resulted primarily from an increase in accounts payable and accrued liabilities, which was partially offset by an increase in accounts receivables and inventories. 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. The increase in inventories was primarily due to the increased purchases of certain raw materials and components.

Current wording

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

Previous wording

Additionally, for the six months ended June 30, 2025, there was a net cash outflow from changes in operating assets and liabilities of $35.2 million, which resulted primarily from an increase in inventories. This was partially offset by an increase in accounts payable and accrued liabilities and a decrease in accounts receivable. The increase in inventories was primarily due to the increased purchases of finished product, raw materials and components for BAQSIMI®, as we assumed full responsibility for the supply chain from Lilly. Accounts payable and accrued liabilities increased primarily due to the increase in accrued customer fees and rebates, mainly associated with BAQSIMI® sales. The decrease in accounts receivables was primarily due to the timing of sales.

Current wording

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.

Previous wording

Net cash provided by investing activities was $9.9 million for the six months ended June 30, 2025, primarily as a result of $35.7 million from sales and purchases of investments during the period. This was partially offset by $21.3 million in purchases of property, plant, and equipment, which included $13.5 million incurred in the United States, $1.4 million in France, and $6.3 million in China.

Current wording

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.

Previous wording

Net cash used in investing activities was $54.7 million for the six months ended June 30, 2024, primarily due to the payment of $129.0 million relating to the BAQSIMI® acquisition, $14.8 million in purchases of property, plant, and equipment, which included $6.9 million incurred in the United States, $1.6 million in France, and $6.3 million in China. This was partially offset by a net cash inflow of $90.8 million from sales and purchases of investments during the period.

Current wording

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.

Previous wording

Net cash used in financing activities was $44.7 million for the six months ended June 30, 2025, primarily as a result of $50.2 million used to purchase treasury stock. This was partially offset by $5.8 million of net proceeds from borrowings on our line of credit in China.

Current wording

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.

Previous wording

Net cash used in financing activities was $24.3 million for the six months ended June 30, 2024, primarily as a result of $11.5 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 and $8.5 million used to purchase treasury stock. 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 $4.1 million of net proceeds from borrowings on our line of credit in China.

Current wording

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.

Previous wording

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, 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.

Current wording

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.

Previous wording

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

Current wording

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.

Previous wording

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 June 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 six months ended June 30, 2025, we had inspections conducted by various regulatory agencies at some of our manufacturing facilities, which resulted in no major observations.

Current wording

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.