# Amphastar Pharmaceuticals, Inc. (AMPH)

Informational only - not investment advice.

CIK: 0001297184
SIC: 2834 Pharmaceutical Preparations
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2834 Pharmaceutical Preparations](/industry/2834/)
Latest 10-K filed: 2026-02-26
SEC page: https://www.sec.gov/edgar/browse/?CIK=1297184
Filing source: https://www.sec.gov/Archives/edgar/data/1297184/000129718426000009/amph-20251231x10k.htm

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Revenue | 719887000 | USD | 2025 | 2026-02-26 |
| Net income | 98094000 | USD | 2025 | 2026-02-26 |
| Assets | 1629299000 | USD | 2025 | 2026-02-26 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-02-26. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001297184.json. Derived margins are computed from the extracted annual SEC facts.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Revenue | 255,165,000 | 240,175,000 | 294,666,000 | 322,357,000 | 349,846,000 | 437,768,000 | 498,987,000 | 644,395,000 | 731,967,000 | 719,887,000 |
| Net income | 9,820,000 | 3,647,000 | -5,738,000 | 48,939,000 | 1,403,000 | 62,116,000 | 91,386,000 | 137,545,000 | 159,519,000 | 98,094,000 |
| Operating income | 15,376,000 | -1,269,000 | -8,623,000 | -39,000 | 10,954,000 | 69,887,000 | 107,497,000 | 196,987,000 | 205,419,000 | 140,403,000 |
| Gross profit | 104,196,000 | 90,509,000 | 106,985,000 | 131,923,000 | 143,340,000 | 199,739,000 | 248,860,000 | 351,121,000 | 373,855,000 | 356,057,000 |
| Diluted EPS | 0.21 | 0.08 | -0.12 | 0.98 | 0.03 | 1.25 | 1.74 | 2.60 | 3.06 | 2.03 |
| Assets | 427,738,000 | 451,072,000 | 513,563,000 | 586,971,000 | 631,236,000 | 671,529,000 | 741,987,000 | 1,512,912,000 | 1,577,470,000 | 1,629,299,000 |
| Liabilities | 98,483,000 | 117,336,000 | 149,204,000 | 159,443,000 | 182,513,000 | 226,007,000 | 213,329,000 | 873,491,000 | 845,172,000 | 840,494,000 |
| Stockholders' equity | 326,523,000 | 333,736,000 | 364,359,000 | 427,528,000 | 448,723,000 | 445,522,000 | 528,658,000 | 639,421,000 | 732,298,000 | 788,805,000 |
| Cash and cash equivalents | 72,354,000 | 65,594,000 | 86,337,000 | 73,685,000 | 92,642,000 | 126,353,000 | 156,098,000 | 144,296,000 | 151,609,000 | 170,177,000 |
| Net margin | 3.85% | 1.52% | -1.95% | 15.18% | 0.40% | 14.19% | 18.31% | 21.34% | 21.79% | 13.63% |
| Operating margin | 6.03% | -0.53% | -2.93% | -0.01% | 3.13% | 15.96% | 21.54% | 30.57% | 28.06% | 19.50% |

## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-07. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001297184.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2022-Q2 | 2022-06-30 |  |  | 0.33 | reported discrete quarter |
| 2022-Q3 | 2022-09-30 |  |  | 0.30 | reported discrete quarter |
| 2023-Q2 | 2023-03-31 |  | 26,032,000 |  | reported discrete quarter |
| 2023-Q1 | 2023-03-31 |  |  | 0.50 | reported discrete quarter |
| 2023-Q2 | 2023-06-30 | 145,712,000 |  | 0.49 | reported discrete quarter |
| 2023-Q3 | 2023-06-30 |  | 26,124,000 |  | reported discrete quarter |
| 2023-Q3 | 2023-09-30 | 180,556,000 |  | 0.91 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 | 178,105,000 | 36,167,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 | 171,836,000 | 43,177,000 | 0.81 | reported discrete quarter |
| 2024-Q2 | 2024-03-31 |  | 43,177,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-06-30 |  | 37,949,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 | 182,394,000 |  | 0.73 | reported discrete quarter |
| 2024-Q3 | 2024-09-30 | 191,214,000 |  | 0.78 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 | 186,523,000 | 37,964,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 | 170,528,000 | 25,285,000 | 0.51 | reported discrete quarter |
| 2025-Q2 | 2025-03-31 |  | 25,285,000 |  | reported discrete quarter |
| 2025-Q3 | 2025-06-30 |  | 31,030,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-06-30 | 174,414,000 |  | 0.64 | reported discrete quarter |
| 2025-Q3 | 2025-09-30 | 191,840,000 |  | 0.37 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 | 183,105,000 | 24,429,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 | 171,171,000 | 6,420,000 | 0.14 | reported discrete quarter |

## Macro Cross-References
- [CPIAUCSL](/indicator/CPIAUCSL/): Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
- [UNRATE](/indicator/UNRATE/): Unemployment Rate
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [DFEDTARU](/indicator/DFEDTARU/): Federal Funds Target Range - Upper Limit
- [DFEDTARL](/indicator/DFEDTARL/): Federal Funds Target Range - Lower Limit
- [DGS3MO](/indicator/DGS3MO/): Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
- [DGS2](/indicator/DGS2/): Market Yield on U.S. Treasury Securities at 2-Year Constant Maturity
- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- [DGS30](/indicator/DGS30/): Market Yield on U.S. Treasury Securities at 30-Year Constant Maturity
- [T10Y2Y](/indicator/T10Y2Y/): 10-Year Treasury Constant Maturity Minus 2-Year Treasury Constant Maturity
- [CPILFESL](/indicator/CPILFESL/): Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
- [CPIUFDSL](/indicator/CPIUFDSL/): Consumer Price Index for All Urban Consumers: Food
- [CPIENGSL](/indicator/CPIENGSL/): Consumer Price Index for All Urban Consumers: Energy
- [CUSR0000SAH1](/indicator/CUSR0000SAH1/): Consumer Price Index for All Urban Consumers: Shelter
- [PCEPI](/indicator/PCEPI/): Personal Consumption Expenditures: Chain-type Price Index
- [PCEPILFE](/indicator/PCEPILFE/): Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
- [T10YIE](/indicator/T10YIE/): 10-Year Breakeven Inflation Rate
- [U6RATE](/indicator/U6RATE/): Total Unemployed, Plus All Marginally Attached Workers Plus Total Employed Part Time for Economic Reasons
- [PAYEMS](/indicator/PAYEMS/): All Employees, Total Nonfarm
- [CIVPART](/indicator/CIVPART/): Labor Force Participation Rate
- [EMRATIO](/indicator/EMRATIO/): Employment-Population Ratio
- [UNEMPLOY](/indicator/UNEMPLOY/): Unemployed
- [CE16OV](/indicator/CE16OV/): Employment Level
- [ICSA](/indicator/ICSA/): Initial Claims
- [JTSJOL](/indicator/JTSJOL/): Job Openings: Total Nonfarm
- [JTSQUR](/indicator/JTSQUR/): Quits: Total Nonfarm
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [A191RL1Q225SBEA](/indicator/A191RL1Q225SBEA/): Real Gross Domestic Product: Percent Change from Preceding Period
- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [HOUST](/indicator/HOUST/): New Privately-Owned Housing Units Started: Total Units
- [PERMIT](/indicator/PERMIT/): New Privately-Owned Housing Units Authorized in Permit-Issuing Places: Total Units
- [RSAFS](/indicator/RSAFS/): Advance Retail Sales: Retail Trade
- [PCE](/indicator/PCE/): Personal Consumption Expenditures
- [DSPIC96](/indicator/DSPIC96/): Real Disposable Personal Income
- [PSAVERT](/indicator/PSAVERT/): Personal Saving Rate
- [M2SL](/indicator/M2SL/): M2
- [BOPGSTB](/indicator/BOPGSTB/): U.S. International Trade in Goods and Services: Balance
- [MSPUS](/indicator/MSPUS/): Median Sales Price of Houses Sold for the United States
- [HSN1F](/indicator/HSN1F/): New One Family Houses Sold: United States
- [RHORUSQ156N](/indicator/RHORUSQ156N/): Homeownership Rate in the United States
- [TTLCONS](/indicator/TTLCONS/): Total Construction Spending: Total Construction in the United States
- [RRVRUSQ156N](/indicator/RRVRUSQ156N/): Rental Vacancy Rate in the United States
- [TOTALSL](/indicator/TOTALSL/): Total Consumer Credit Owned and Securitized
- [REVOLSL](/indicator/REVOLSL/): Revolving Consumer Credit Owned and Securitized
- [DRCCLACBS](/indicator/DRCCLACBS/): Delinquency Rate on Credit Card Loans, All Commercial Banks
- [GDP](/indicator/GDP/): Gross Domestic Product
- [GPDI](/indicator/GPDI/): Gross Private Domestic Investment
- [GCE](/indicator/GCE/): Government Consumption Expenditures and Gross Investment
- [PCEC](/indicator/PCEC/): Personal Consumption Expenditures
- [NETEXP](/indicator/NETEXP/): Net Exports of Goods and Services
- [GFDEBTN](/indicator/GFDEBTN/): Federal Debt: Total Public Debt
- [GFDEGDQ188S](/indicator/GFDEGDQ188S/): Federal Debt: Total Public Debt as Percent of Gross Domestic Product
- [FYFSD](/indicator/FYFSD/): Federal Surplus or Deficit
- [FGRECPT](/indicator/FGRECPT/): Federal Government Current Receipts
- [FGEXPND](/indicator/FGEXPND/): Federal Government: Current Expenditures
- [MANEMP](/indicator/MANEMP/): All Employees, Manufacturing
- [USCONS](/indicator/USCONS/): All Employees, Construction
- [USTRADE](/indicator/USTRADE/): All Employees, Retail Trade
- [USFIRE](/indicator/USFIRE/): All Employees, Financial Activities
- [USGOVT](/indicator/USGOVT/): All Employees, Government
- [AWHAETP](/indicator/AWHAETP/): Average Weekly Hours of All Employees, Total Private
- [DGORDER](/indicator/DGORDER/): Manufacturers' New Orders: Durable Goods
- [NEWORDER](/indicator/NEWORDER/): Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
- [BUSINV](/indicator/BUSINV/): Total Business Inventories
- [EXPGS](/indicator/EXPGS/): Exports of Goods and Services
- [IMPGS](/indicator/IMPGS/): Imports of Goods and Services
- [IR](/indicator/IR/): Import Price Index (End Use): All Commodities
- [PPIFIS](/indicator/PPIFIS/): Producer Price Index by Commodity: Final Demand

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1297184/000129718426000033/amph-20260331x10q.htm

Extracted between Part I Item 2 and the next Item 3/4 or Part II heading after HTML sanitization.
Confidence: high
Filing date: 2026-05-07
Report date: 2026-03-31

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, 2025, particularly in Item 1A. “Risk Factors”.

​

Overview

​

We are a biopharmaceutical company focusing on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as active pharmaceutical ingredient, or API products. We currently manufacture and sell over 25 prescription pharmaceutical products, and one over-the-counter product, Primatene MIST®.

​

Our largest products by net revenues currently include BAQSIMI®, Primatene MIST®, epinephrine, glucagon, 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. One ANDA and one biosimilar insulin candidate are currently on file with the FDA.

​

To complement our internal growth and expertise, we have in-licensed several early-stage proprietary products and 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, APIs, 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, 2025, 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 January 2026, we entered into a License Agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd., or Hanxin, pursuant to which Hanxin has granted an exclusive license to a fully synthetic corticotropin (ACTH) analog, now designated AMP-110, in the United States and Canada. AMP-110 is designed to address inflammatory and autoimmune conditions with a potentially improved safety profile compared to porcine-derived ACTH products. In January 2026, we made an upfront payment of $2.0 million to Hanxin upon signing the License Agreement. The agreement is also subject to potential development milestone payments, as well as sales milestone and royalty payments.

-32-

Table of Contents

For more information regarding the Hanxin license agreement, see “Part I – Item 1. Financial Statements (unaudited) – Notes to Condensed Consolidated Financial Statements – Note 17. Commitments and Contingencies.”

​

In February 2026, the FDA approved our Ipratropium Bromide HFA inhalation aerosol, 17 mcg/actuation, which we launched in April 2026.

​

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 (unaudited) – Notes to Condensed Consolidated Financial Statements – Note 5. Segment Reporting.”

​

Results of Operations

​

Three Months Ended March 31, 2026 compared to Three Months Ended March 31, 2025

​

Net revenues

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended

​

​

​

​

​

March 31, 

​

Change

​

​

​

  ​ ​ ​

2026

  ​ ​ ​

2025

  ​ ​ ​

Dollars

  ​ ​ ​

%

​

​

​

(in thousands)

​

​

​

Net revenues

​

$

171,171

​

$

170,528

​

$

643

0

%

​

Cost of revenues

​

$

100,849

​

$

85,277

​

$

15,572

18

%

​

Gross profit

​

$

70,322

​

$

85,251

​

$

(14,929)

​

(18)

%

​

as % of net revenues

​

41

%  

50

%  

​

​

​

​

​

​

​

The following table summarizes our revenue by product for the three months ended March 31, 2026 and 2025:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended

​

​

​

​

​

March 31, 

​

Change

​

​

​

  ​ ​ ​

2026

  ​ ​ ​

2025

  ​ ​ ​

Dollars

  ​ ​ ​

%

​

​

​

(in thousands)

​

​

​

Net revenues:

​

​

​

​

​

​

​

​

​

​

​

​

​

BAQSIMI®

​

$

32,434

​

$

38,355

​

$

(5,921)

​

(15)

%

​

Primatene MIST®

​

​

29,763

​

​

29,051

​

​

712

​

2

%

​

Epinephrine

​

​

19,213

​

​

18,587

​

​

626

​

3

%

​

Lidocaine

​

​

13,460

​

​

13,644

​

​

(184)

​

(1)

%

​

Glucagon

​

​

9,170

​

​

20,843

​

​

(11,673)

​

(56)

%

​

Other products

​

67,131

​

50,048

​

17,083

34

%

​

Total net revenues

​

$

171,171

​

$

170,528

​

$

643

0

%

​

​

The decrease in sales of BAQSIMI® was primarily due to a lower average selling price, as a result of a change in gross-to-net discounts due to changes in chargebacks and rebates and changes to the customer mix, impacting sales of approximately $8.0 million. This decrease was partially offset by an increase in unit volumes, contributing $2.0 million in sales driven by our continued marketing efforts. Primatene MIST® sales increased primarily due to an increase in unit volumes. The increase in sales of epinephrine was due to an increase in demand for our epinephrine pre-filled syringe, as a result of other supplier shortages, contributing $4.1 million in sales. This increase was partially offset by a decrease in our epinephrine multi-dose vial product, as a result increased competition, impacting sales by $3.5 million. The decrease in sales of glucagon was due to a decrease in unit volumes, impacting sales by $6.1 million, as well as a lower average selling price, which impacted sales by $5.6 million, as a result of increased competition and the continued shift to ready to use glucagon products such as BAQSIMI®. The increase in other products was primarily due to recently launched products including an increase in albuterol sales of $2.8 million, iron sucrose sales of $1.4 million and teriparatide sales of $2.2 million, which were launched in August 2024, August 2025, and December 2025, respectively. An increase in API sales and an increase in dextrose sales as a result of an increase in demand caused by other supplier shortages, also

-33-

Table of Contents

positively impacted sales.

​

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.

​

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 March 31, 2026. 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 was impacted by lower average selling prices for our higher margin products, such as BAQSIMI®, glucagon, phytonadione, and epinephrine multi-dose vials. Additionally, our manufacturing expenses increased due to the expansion of our manufacturing facilities in Rancho Cucamonga, CA.

​

Selling, distribution, and marketing, and general and administrative

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended

​

​

​

​

​

March 31, 

​

Change

​

​

​

​

2026

​

2025

​

Dollars

​

%

​

​

​

(in thousands)

​

​

​

Selling, distribution, and marketing

  ​ ​ ​

$

11,927

  ​ ​ ​

$

11,866

  ​ ​ ​

$

61

  ​ ​ ​

1

%

​

General and administrative

​

$

18,028

​

$

15,996

​

$

2,032

13

%

​

​

The increase in general and administrative expenses was primarily due to an increase in legal expense, expenses associated with implementing a new ERP system and salary and personnel-related expenses.

​

Legal fees may fluctuate from period to period due to the timing of patent challenges and other litigation matters.

​

Research and development

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended

​

​

​

​

​

March 31, 

​

Change

​

​

​

  ​ ​ ​

2026

  ​ ​ ​

2025

  ​ ​ ​

Dollars

  ​ ​ ​

%

​

​

​

(in thousands)

​

​

​

Salaries and personnel-related expenses

​

$

10,372

​

$

9,061

​

$

1,311

14

%

​

Clinical trials

​

1,552

​

948

​

604

64

%

​

FDA fees

​

15

​

1,485

​

(1,470)

(99)

%

​

Materials and supplies

​

5,445

​

2,828

​

2,617

93

%

​

Depreciation

​

3,834

​

3,175

​

659

21

%

​

Other expenses(1)

​

5,519

​

2,599

​

2,920

112

%

​

Total research and development expenses

​

$

26,737

​

$

20,096

​

$

6,641

​

33

%

​

(1)

Includes the upfront payment of $2.0 million relating to the licensing agreement with Hanxin.

​

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 spending for our insulin, inhalation, and proprietary pipeline products. Additionally, we made a $2.0 million upfront payment for the licensing agreement that we entered into with Hanxin during the quarter.

​

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

-34-

Table of Contents

basis due to increased clinical trials costs related to our proprietary, insulin and inhalation product candidates. These expenditures will include costs of APIs developed internally as well as APIs purchased externally for use in research and development, 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

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A

Extracted between Item 7 and the next Item 7A/8 heading after HTML sanitization.
Confidence: high

Item 7. 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 audited consolidated financial statements and the related notes thereto included in Item 8 under the heading “Financial Statements and Supplementary Data.” 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 Annual Report on Form 10-K, particularly in Item 1A, under the heading “Risk Factors.”

In this section, we generally discuss the results of our operations for the year ended December 31, 2025, compared to the year ended December 31, 2024. For a discussion of the year ended December 31, 2024, to the year ended December 31, 2023, please refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, which discussion is hereby incorporated herein by reference.

​

Overview

We are a biopharmaceutical company focusing on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as active pharmaceutical ingredient, or API products. We currently manufacture and sell over 25 prescription pharmaceutical products, and an over-the-counter product, Primatene MIST®.

Our largest products by net revenues currently include BAQSIMI®, Primatene MIST®, epinephrine, glucagon, 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. One ANDA and one biosimilar insulin candidate are currently on file with the FDA.

To complement our internal growth and expertise, we have in-licensed several early-stage proprietary products and 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, APIs, 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 “Part I – Item 1A, Risk Factors” for further discussion of the potential adverse impact of unfavorable global and geopolitical economic conditions on our business, results of operations and financial conditions.

​

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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 year ended December 31, 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 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 II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 17. Commitments and Contingencies.”

​

In December 2025, the FDA approved our Teriparatide Injection, USP 560mcg/2.24mL in single-patient-use prefilled pen, which we launched in December 2025.

​

In January 2026, we entered into a License Agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd., or Hanxin, pursuant to which Hanxin has granted an exclusive license to a fully synthetic corticotropin (ACTH) analog, now designated AMP-110, in the United States and Canada. AMP-110 is designed to address inflammatory and autoimmune conditions with a potentially improved safety profile compared to porcine-derived ACTH products. In January 2026, we made an upfront payment of $2.0 million to Hanxin upon signing the License Agreement. The agreement is also subject to potential development milestone payments, as well as sales milestone and royalty payments. For more information regarding the Hanxin license agreement, see “Part II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 20. Subsequent Events.”

​

In February 2026, the FDA approved our Ipratropium Bromide HFA inhalation aerosol, 17 mcg/actuation, which we plan to launch early in the second quarter of 2026.

​

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 II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 5. – Segment Reporting.”

Results of Operations

Year ended December 31, 2025 compared to year ended December 31, 2024

Net revenues

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Year Ended December 31, 

​

Change

​

  ​ ​ ​

​

2025

  ​ ​ ​

2024

  ​ ​ ​

Dollars

  ​ ​ ​

%

​

​

​

(in thousands)

​

​

Net revenues

​

​

​

​

​

​

​

​

​

​

​

​

​

Product revenues, net

​

​

$

719,887

​

$

712,814

​

$

7,073

1

%

Other revenues

​

​

​

—

​

​

19,153

​

​

(19,153)

​

(100)

%

Total net revenues

​

​

$

719,887

​

$

731,967

​

$

(12,080)

(2)

%

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Cost of revenues

​

​

$

363,830

​

$

358,112

​

$

5,718

2

%

Gross profit

​

​

$

356,057

​

$

373,855

​

$

(17,798)

​

(5)

%

as % of net revenues

​

​

49

%  

51

%  

​

​

​

​

​

​

​

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The increase in product revenues, net, for 2025 was primarily due to the following changes:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Year Ended December 31, 

​

Change

​

  ​ ​ ​

​

2025

  ​ ​ ​

2024

  ​ ​ ​

Dollars

  ​ ​ ​

%

​

​

​

(in thousands)

​

​

Product revenues, net:

​

​

​

​

​

​

​

​

​

​

​

​

​

BAQSIMI®

​

​

$

185,358

​

$

126,898

​

$

58,460

​

46

%

Primatene MIST®

​

​

​

108,669

​

​

102,012

​

​

6,657

​

7

%

Epinephrine

​

​

​

70,643

​

​

94,090

​

​

(23,447)

​

(25)

%

Glucagon

​

​

​

69,084

​

​

108,319

​

​

(39,235)

​

(36)

%

Lidocaine

​

​

​

56,479

​

​

55,854

​

​

625

​

1

%

Other products

​

​

229,654

​

225,641

​

4,013

2

%

Total product revenues, net

​

​

$

719,887

​

$

712,814

​

$

7,073

1

%

​

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 epinephrine was due to a decrease in unit volume, impacting sales by $13.4 million, as well as a lower average selling price, which impacted sales by $10.0 million, primarily as a result of increased competition for our multi-dose epinephrine vial product. The decrease in sales of glucagon was due to a lower average selling price, which impacted sales by $24.3 million, as well as a decrease in unit volumes, impacting sales by $14.9 million, as a result of competition and the continued shift to ready to use glucagon products such as BAQSIMI®. The increase in other products was primarily due to an increase in albuterol sales of $14.7 million and iron sucrose sales of $4.4 million, which were launched in August 2024 and August 2025, respectively, as well as an increase in sales for several other products including sodium bicarbonate and atropine due to an increase in demand caused by other supplier shortages. This increase was partially offset by a decrease in sales of enoxaparin of $9.9 million and dextrose of $9.6 million 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

​

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 $19.2 million during the year ended December 31, 2024, based on total BAQSIMI® sales of $37.6 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. We had no significant backlog as of December 31, 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 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

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

​

Selling, distribution, and marketing, and general and administrative

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Year Ended December 31, 

​

Change

​

​

​

2025

​

2024

​

Dollars

​

%

​

​

​

(in thousands)

​

​

Selling, distribution, and marketing

  ​ ​ ​

​

$

43,885

  ​ ​ ​

$

37,802

  ​ ​ ​

$

6,083

  ​ ​ ​

16

%

General and administrative

​

​

85,925

​

56,720

​

29,205

51

%

​

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 legal settlement, 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.

​

Research and development

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Year Ended December 31, 

​

Change

​

​

2025

  ​ ​ ​

2024

  ​ ​ ​

Dollars

  ​ ​ ​

%

​

​

(in thousands)

​

​

Salaries and personnel-related expenses

​

$

34,027

​

$

31,634

​

$

2,393

8

%

Pre-launch inventory

​

960

​

483

​

477

99

%

Clinical trials

​

3,038

​

594

​

2,444

411

%

FDA fees

​

1,568

​

1,715

​

(147)

(9)

%

Materials and supplies

​

15,157

​

16,813

​

(1,656)

(10)

%

Depreciation

​

14,603

​

12,486

​

2,117

17

%

Other expenses(1)

​

16,491

​

10,189

​

6,302

62

%

Total research and development expenses

​

$

85,844

​

$

73,914

​

$

11,930

​

16

%

(1)

Includes the earnest payment and upfront payment totaling $6.0 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 $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, primarily for our insulin and inhalation pipeline products, as well as an increase in depreciation 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 for use in research and development, 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 expenses, net

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Year Ended December 31, 

​

Change

​

​

​

2025

​

2024

​

Dollars

​

%

​

​

​

(in thousands)

​

​

Non-operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

​

Interest income

​

​

$

8,679

​

$

10,612

​

$

(1,933)

​

(18)

%

Interest expense

​

​

​

(25,481)

​

​

(30,343)

​

​

4,862

​

(16)

%

Other income (expenses), net

  ​ ​ ​

​

​

23

  ​ ​ ​

​

4,076

  ​ ​ ​

​

(4,053)

  ​ ​ ​

(99)

%

Total non-operating expenses, net

​

​

$

(16,779)

​

$

(15,655)

​

$

(1,124)

​

7

%

​

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 II – Item 8. Financial Statements and Supplementary Data – Notes to 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 year ended December 31, 2025.

​

Income tax provision

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Year Ended December 31, 

​

Change

​

​

2025

  ​ ​ ​

2024

  ​ ​ ​

Dollars

  ​ ​ ​

%

​

​

(in thousands)

​

​

Income tax provision

​

$

25,530

​

$

29,672

​

$

(4,142)

​

(14)

%

Effective tax rate

​

​

21

%

16

%

​

​

​

​

​

​

Our effective tax rate for the year ended December 31, 2025 increased in comparison to the year ended December 31, 2024, primarily due to lower excess tax benefit from share-based compensation. For more information regarding our income taxes, see “Part II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 14. – Income Taxes.”

​

On July 4, 2025, the One Big Beautiful Bill Act, or OBBB Act, was enacted into law. The OBBB Act 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. The OBBB Act did not result in any material adjustments to our total income tax provision for the year ended December 31, 2025.

​

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 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 with cash flows from operations.

​

Our cash obligations include the principal and interest payments due on our existing loans, and finance and operating lease payments. In addition, upon the achievement of various development, regulatory and commercial milestones for agreements, we have entered into with third parties, we are contractually obligated to pay additional amounts that, in the aggregate, are significant. These payments are contingent upon the occurrence of various future events, substantially all

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of which have a high degree of uncertainty of occurring, and any resulting cash requirements are managed through our operating budgeting processes. These obligations are not recorded on our consolidated balance sheets. As of December 31, 2025, the maximum amount that may be payable in the future for agreements we have entered into with third parties is approximately $1.0 billion. These obligations are further described below and throughout this Annual Report on Form 10-K. 

​

As of December 31, 2025, our foreign subsidiaries collectively held $15.7 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 Annual Report on Form 10-K. 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 $117.6 million to $477.9 million at December 31, 2025, compared to $360.3 million at December 31, 2024.

Debt and Borrowing Capacity

Our outstanding debt obligations are summarized as follows:

​

​

​

​

​

​

​

​

​

​

​

​

December 31, 

​

​

​

​

2025

  ​ ​ ​

2024

  ​ ​ ​

Change

​

(in thousands)

Short-term debt and current portion of long-term debt

​

$

1,641

​

$

234

​

$

1,407

​

Long-term debt

​

608,749

​

601,630

​

7,119

​

Total debt

​

$

610,390

​

$

601,864

​

$

8,526

​

​

As of December 31, 2025, we had $219.5 million in unused borrowing capacity under revolving lines of credit with Wells Fargo Bank, China Merchant Bank, and Industrial and Commercial Bank of China Limited.

​

The weighted average interest rates on lines of credit as of December 31, 2025 and 2024 were 3.4% and 4.0%, respectively. For our loans with Wells Fargo Bank, we have entered into fixed interest rate swap contracts to exchange the variable interest rates for fixed interest rates.

​

For more information regarding our outstanding indebtedness, see “Part II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 13. – Debt.”

Contractual Obligations and Commitments

Operating Lease Obligations

​

As of December 31, 2025 we had a total of $55.2 million of minimum rental payments due under operating leases. Of that amount, $10.6 million is due within 12 months as of December 31, 2025. For more information regarding our operating lease obligations see “Part II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements –Note. 17 – Commitments and Contingencies.”

​

Milestone Obligations

​

BAQSIMI®

​

The terms of our Purchase Agreement with Lilly require us to make future sales-based milestone payments aggregating up to $575.0 million based on achievement of specified net sales amounts. As of December 31, 2025, we have not triggered any milestones and therefore no amounts have been recognized or paid. The amount and timing of such future obligations are unknown and uncertain.

​

​

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Licensing Agreement with Anji

​

The terms of the license agreement with Anji require us to make cash payments to Anji of up to $42.0 million in development-based milestone payments and up to $225.0 million in sales-based milestone payments, subject to the achievement of the applicable development and sales milestone events respectively. Additionally, we are obligated to make royalty payments of 5% on net sales, not to exceed a maximum annual amount of $22.5 million each calendar year for each Licensed Product and a maximum accumulated amount of $60.0 million for each of the three Licensed Products. We are also required to pay Anji a certain percentage of sublicense income received from the sublicense transactions. As of December 31, 2025, we have not triggered any milestones and therefore no amounts have been recognized or paid. The amount and timing of such future obligations are unknown and uncertain.

​

Purchase Obligations

​

We have certain purchase obligations under which we are required to make minimum payments for items including, but not limited to inventory and raw materials. As of December 31, 2025, we had an aggregate amount of approximately $37.5 million of purchase obligations.

​

Cash Flows

​

The following table summarizes our cash flow activities for the years ended December 31, 2025 and 2024.

​

​

​

​

​

​

​

​

​

​

Year Ended December 31, 

​

  ​ ​ ​

2025

  ​ ​ ​

2024

​

​

(in thousands) 

Statement of Cash Flow Data:

​

​

​

​

​

​

Net cash provided by (used in)

​

​

​

​

​

​

Operating activities

​

$

156,115

​

$

213,386

Investing activities

​

(70,332)

​

(124,930)

Financing activities

​

(67,425)

​

(80,953)

Effect of exchange rate changes on cash

​

210

​

(190)

Net increase in cash, cash equivalents, and restricted cash

​

$

18,568

​

$

7,313

​

Sources and Use of Cash

​

Operating Activities

Net cash provided by operating activities was $156.1 million for the year ended December 31, 2025, which included net income of $98.1 million. Non-cash items comprised primarily of $66.6 million of depreciation and amortization, which includes $31.6 million related to depreciation of property, plant and equipment; $25.1 million related to amortization of intangible assets; $6.5 million related to amortization of operating lease right-of-use assets; $3.4 million related to amortization of discounts, premiums, and debt issuance costs; and share-based compensation expense of $27.3 million.

​

Additionally, for the year ended December 31, 2025, there was a net cash outflow from changes in operating assets and liabilities of $66.0 million, which resulted primarily from increases in inventories and accounts receivable, and the net change in income tax. 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. The increase in accounts receivables was primarily due to the timing of sales.

​

Net cash provided by operating activities was $213.4 million for the year ended December 31, 2024, which included net income of $159.5 million. Non-cash items comprised primarily of $63.2 million of depreciation and amortization, which includes $28.2 million related to depreciation of property, plant and equipment; $24.7 million related to amortization of intangible assets; $4.2 million related to amortization of operating lease right-of-use assets; $6.0 million related to amortization of discounts, premiums, and debt issuance costs; and share-based compensation expense of $24.4 million. Additionally, for the year ended December 31, 2024, there was a net cash outflow from changes in operating assets and liabilities of $14.5 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

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inventories was primarily due to the increased purchases of finished product, raw materials and components for BAQSIMI®. Accounts payable and accrued liabilities increased primarily due to the increase in accrued customer fees and rebates associated with BAQSIMI® sales, as we continued to assume distribution responsibilities for BAQSIMI® from Lilly to our customers in the United States and certain other countries throughout 2024.

​

Investing Activities

​

Net cash used in investing activities was $70.3 million for the year ended December 31, 2025, primarily as a result of $34.9 million in purchases of property, plant, and equipment, which included $22.3 million incurred in the United States, $3.0 million in France, and $9.6 million in China, as well as a net cash outflow of $28.8 million from sales and purchases of investments during the period.

​

Net cash used in investing activities was $124.9 million for the year ended December 31, 2024, primarily due to the payment of $129.0 million relating to the BAQSIMI® acquisition, $41.0 million in purchases of property, plant, and equipment, which included $16.6 million incurred in the United States, $2.9 million in France, and $21.5 million in China. This was partially offset by a net cash inflow of $49.2 million from sales and purchases of investments during the period.

​

Financing Activities

Net cash used in financing activities was $67.4 million for the year ended December 31, 2025, primarily as a result of $75.6 million used to purchase treasury stock. This was partially offset by $2.9 million in net proceeds from the settlement of share-based compensation awards under our equity plan, as well as $6.2 million of net proceeds from borrowings on our line of credit in China.

​

Net cash used in financing activities was $81.0 million for the year ended December 31, 2024, primarily as a result of $85.5 million used to purchase treasury stock and $4.9 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 $8.3 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 $18.4 million of net proceeds from borrowings on our line of credit in China.

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Critical Accounting Policies

We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. In some cases, changes in the accounting estimates are reasonably likely to occur from period to period. Accordingly, actual results could differ materially from our estimates. To the extent that there are material differences between these estimates and actual results, our financial condition and results of operations will be affected. We base our estimates on past experience and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an ongoing basis. We refer to accounting estimates of this type as critical accounting policies, which we discuss further below. While our significant accounting policies are more fully described in Part II – Item 8. Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 2. – Summary of Significant Accounting Policies”, we believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our audited consolidated financial statements.

Revenue Recognition

Product revenues, net

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Our net revenues consist principally of revenues generated from the sale of our pharmaceutical products. Generally, we recognize revenues at the time of product delivery to our customers in accordance with ASC, 606 Revenue from Contracts with Customers. In some cases, revenues are recognized at the time of shipment when stipulated by the terms of the sale agreements. Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers, after the customer has accepted test samples of the products to be shipped.

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The consideration we receive in exchange for our goods or services is only recognized when it is probable that a significant reversal will not occur. The consideration to which we expect to be entitled includes a stated list price, less various forms of variable consideration. We make significant estimates for related variable consideration at the point of sale, including chargebacks, rebates, product returns, other discounts and allowances.

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We establish allowances for estimated chargebacks, rebates and product returns based on a number of qualitative and quantitative factors, including:

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●

contract pricing and return terms of our agreements with customers;

●

wholesaler inventory levels and turnover;

●

historical chargeback and product return rates;

●

shelf lives of our products, which is generally two years;

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direct communication with customers;

●

anticipated introduction of competitive products or authorized generics; and

●

anticipated pricing strategy changes by us and/or our competitors.

Although we believe that our estimates and assumptions are reasonable as of the date when made, actual results may differ significantly from these estimates. Our financial position, results of operations and cash flows may be materially and negatively impacted if actual returns exceed our estimated allowances for returns.

The following table summarizes activity in each of our product revenue allowance categories for the years ended December 31, 2025 and 2024:

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​

​

​

​

​

​

​

​

​

​

​

Chargebacks and

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​

​

Management fees

​

​

Rebates(1)

​

Product Returns(2)

and Incentives(3)

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​

(in thousands)

Balance as of December 31, 2023

  ​ ​ ​

$

27,920

  ​ ​ ​

$

17,179

​

$

14,483

Provisions

​

298,230

​

​

9,597

​

62,939

Credits and payments issued to third parties

​

(260,361)

​

​

(6,917)

​

(60,166)

Balance as of December 31, 2024

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$

65,789

​

$

19,859

​

$

17,256

Provisions

​

452,070

​

​

19,963

​

72,581

Credits and payments issued to third parties

​

(433,828)

​

​

(15,746)

​

(71,612)

Balance as of December 31, 2025

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$

84,031

​

$

24,076

​

$

18,225

(1)

Chargeback and Rebates include chargebacks, managed care rebates, GPO rebates, government rebates, and co-pay program incentives. Chargeback and rebates were deducted from gross revenue at the time revenues were recognized and were recorded as a reduction to accounts receivables, net and accounts payable and accrued liabilities on our consolidated balance sheets.

(2)

Estimated provisions for product returns were deducted from gross revenues at the time revenues were recognized and are included in accounts payable and accrued liabilities and other long-term liabilities on our consolidated balance sheets.

(3)

Management fees and incentives include management and GPO fees and sales incentives and allowances, which were deducted from gross revenues at the time revenues were recognized and were recorded as accounts payable and accrued liabilities on our consolidated balance sheets.

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Recent Accounting Pronouncements

In December 2023, the Financial Accounting Standard Board, or FASB, issued Accounting Standard Update, or ASU, 2023-09, Income taxes (Topic 740): Improvements to Income Tax Disclosures, which requires entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation table, as well as disclosure of income taxes paid disaggregated by jurisdiction. The disclosure requirements will be applied prospectively. We adopted this guidance on December 31, 2025 and updated our disclosures to conform to this tax disclosure requirements. The adoption of this guidance did not have a material impact on our consolidated financial statements and related disclosures.

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In November 2024, the FASB issued ASU 2024-03, Income Statement Reporting-Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income Statement Expenses. The standard update improves the disclosures about a public business entity’s expenses by requiring more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation and amortization) included within income statement expense captions. The guidance will be effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The standard updates are to be applied prospectively with the option for retrospective application. We are currently evaluating the impact of disclosure requirements related to the new standard on our consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-04, Debt– Debt with Conversion and Other Options, (subtopic 470-20). The update is intended to improve the relevance and consistency in application of the induced conversion guidance in Subtopic 470-20 for (a) convertible debt instruments with cash conversion features and (b) debt instruments that are not currently convertible. ASU 2024-04 is effective for annual reporting periods beginning after December 15, 2025. We are currently evaluating the impact of the new standard on our consolidated financial statements and related disclosures.

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In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other-Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. The ASU amends the existing standard to remove all references to prescriptive and sequential software development project stages. Under this guidance, eligible software development costs will begin to be capitalized when management has authorized and committed to funding the software project, and it is probable that the project will be completed and the software will be used to perform the function intended. In evaluating whether it is probable the project will be completed; management is required to consider whether there is significant uncertainty associated with the development activities of the software. This guidance is effective for all annual periods beginning after December 15, 2027, and for interim periods within those annual reporting periods, with early adoption permitted. The guidance may be applied on a prospective basis, a modified basis for in-process projects, or a retrospective basis. We are currently evaluating the impact of the new standard on our consolidated financial statements and related disclosures.

Government Regulation

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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.

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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 December 31, 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. Throughout 2025, we had inspections conducted by various regulatory agencies at some of our manufacturing facilities, which resulted in no critical observations.

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