Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2025

Reports Net Revenues of $191.8 million for the Three Months Ended September 30, 2025

GAAP net income of $17.4 million, or $0.37 per share, for the third quarter

Adjusted non-GAAP net income of $44.7 million, or $0.93 per share, for the third quarter

Company to hold a conference call today at 2:00 p.m. Pacific Time

RANCHO CUCAMONGA, CA / ACCESS Newswire / November 6, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company"), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today reported results for the three months ended September 30, 2025.

"Amphastar delivered another strong quarter, led by double-digit growth from BAQSIMI ®, which achieved a 14% increase in revenue compared to the same period last year. Additionally, we received FDA approval and launched iron sucrose injection, a key generic alternative which expands patient access to affordable therapies while contributing to our revenue growth. This achievement underscores our commitment to advancing complex generics and leveraging our domestic in-house manufacturing expertise to deliver high-quality therapies to patients. In addition, we bolstered our proprietary pipeline through an exclusive licensing agreement with Nanjing Anji Biotechnology to develop and commercialize three novel peptides targeting high-growth markets across oncology and ophthalmology," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "Together, our sustained commercial momentum, strategic pipeline expansion, and recent FDA approval, position Amphastar to accelerate growth and drive long-term value across its portfolio."

Three Months Ended

Nine Months Ended

September 30,

2025

2024

2025

2024

(in thousands, except per share data)

191,840

191,214

536,782

545,444

17,350

40,429

73,665

121,555

44,696

49,585

122,460

153,569

0.37

0.78

1.52

2.32

0.93

0.96

2.52

2.94

________________________________________

* Adjusted non-GAAP net income and adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled "Non-GAAP Financial Measures" and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release.

Third Quarter Results

Three Months Ended

September 30,

Change

2025

2024

Dollars

(in thousands)

53,608

40,409

13,199

28,808

26,055

2,753

18,789

21,341

(2,552

)

(12

13,558

26,792

(13,234

)

(49

12,932

15,884

(2,952

)

(19

64,145

58,338

5,807

191,840

188,819

3,021

2,395

(2,395

)

(100

191,840

191,214

626

Changes in product revenues, net as compared to the third quarter of the prior year were primarily driven by:

BAQSIMI ® sales increased primarily due to an increase in unit volumes, as a result of an expanded marketing effort in the United States; total sales of BAQSIMI ® grew 14% from the prior year's quarter including prior quarter sales by Eli Lilly and Company, or Lilly, which was accounted for in Other revenues

Primatene MIST ® sales increased due to an increase in unit volumes driven by our continued marketing efforts

Epinephrine sales decreased 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

Glucagon sales decreased primarily due to a lower average selling price, impacting sales by $7.0 million, as well as a decrease in unit volumes, impacting sales by $6.2 million, as a result of competition and the continued shift to ready to use glucagon products such as BAQSIMI ®

Lidocaine sales decreased primarily due to a decrease in unit volumes, as a result of other suppliers returning to their historical distribution levels

Other pharmaceutical product sales changes were primarily due to an increase in sales of albuterol totaling $4.7 million as well as sales of iron sucrose injection, which we launched in August 2025 totaling $2.4 million. This increase was partially offset by a decrease in unit volumes of enoxaparin and dextrose, primarily due to increased competition

Other revenues were zero in the third quarter of 2025 as we completed the assumption of distribution responsibilities globally for BAQSIMI ® at the beginning of 2025, with all of BAQSIMI ® related revenues in the current period being recognized in Product revenues, net. Other revenues in the previous period consisted of $2.4 million in BAQSIMI ® sales made by Lilly on our behalf under the Transition Service Agreement, or TSA, and was net of $4.0 million in cost of sales and other expenses

Three Months Ended

September 30,

Change

2025

2024

Dollars

(in thousands)

191,840

191,214

626

93,194

89,273

3,921

98,646

101,941

(3,295

)

51.4

53.3

Changes in the cost of revenues and gross margin were primarily driven by:

Decrease in other revenues related to Lilly's sales of BAQSIMI ® under the TSA, which were recorded net of cost of sales and other expenses; as we assumed distribution of BAQSIMI ® to all of our customers by the beginning of 2025, we recorded those sales in product revenues and cost of sales separately

Decrease in unit sales and pricing of glucagon, and lower pricing for our epinephrine multi-dose vial product, both of which are higher-margin products

Cost control efforts across the business partially offset the impact of pricing declines

Three Months Ended

September 30,

Change

2025

2024

Dollars

(in thousands)

11,505

8,995

2,510

39,467

14,821

24,646

166

22,354

21,077

1,277

Selling, distribution, and marketing expenses increased primarily due 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 ®

General and administrative expenses increased primarily due to a litigation provision, which increased expenses by $23.1 million

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

Three Months Ended

September 30,

Change

2025

2024

Dollars

(in thousands)

2,246

2,427

(181

)

(6,284

)

(6,698

)

414

231

(5,094

)

5,325

105

(3,807

)

(9,365

)

5,558

(59

The change in non-operating expenses, net is primarily due to a change in Other income (expenses), net, as a result of foreign currency fluctuation, as well as mark-to-market adjustments relating to our interest rate swap contracts during the three months ended September 30, 2025.

Cash flow provided by operating activities for the nine months ended September 30, 2025, was $123.3 million.

Pipeline Information

The Company currently has three abbreviated new drug applications ("ANDAs") and one biosimilar insulin candidate filed with the FDA targeting products with a combined market size exceeding $2 billion, along with three biosimilar products in development targeting products with a market size exceeding $6 billion, and two generic products in development targeting products with a market size of over $1 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2025. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.

The Company entered into an exclusive license agreement with Anji for the development, manufacturing, use, and commercialization of three proprietary peptides. The first product is based on the discovery by Anji of an endogenous peptide that demonstrates a novel mechanism of action that potentially suppresses the growth and metastasis of multiple poorly treated cancers. The second product is a novel peptide-docetaxel conjugate that targets a specific receptor, designed to improve the selectivity and bioavailability of docetaxel. It is designed to reduce docetaxel-induced toxicity, which will improve the efficacy and safety of current taxane therapies. The third product is an anti-vascular endothelial growth factor receptor (VEGFR) peptide of novel design, developed as a topical eye drop for the treatment of wet age-related macular degeneration (wAMD). It is intended to be an alternative to the routine eye injections used for current treatment.

Conference Call Information

The Company will hold a conference call to discuss its financial results today, November 6, 2025, at 2:00 p.m. Pacific Time.

To access the conference call, dial toll-free (877) 407-0989 or (201) 389-0921 for international callers, ten minutes before the conference.

The call can also be accessed on the Investors page on the Company's website at www.amphastar.com.

Non-GAAP Financial Measures

To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, which generally excludes amortization expense, share-based compensation, impairment charges, expenses related to our acquisition of BAQSIMI ® , certain debt issuance costs, legal settlements, and other one-time events in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because the Company's management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP.

Market Data

This press release contains market data that we obtained from industry sources. These sources do not guarantee the accuracy or completeness of the information. Although we believe that our industry sources are reliable, we do not independently verify the information. The market data may include projections that are based on a number of other projections. While we believe these assumptions to be reasonable and sound as of the date of this press release, actual results may differ from the projections.

About Amphastar Pharmaceuticals, Inc.

Amphastar is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information and resources are available at www.amphastar.com.

Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar ®, BAQSIMI ®, Primatene MIST ®, REXTOVY ®, Amphadase ®, and Cortrosyn ®, are the property of Amphastar.

Forward-Looking Statements

All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the impact of our products, including their potential for continued revenue growth, the strategic trajectory of and market for our product pipeline, our ability to leverage our existing expertise and technology, the impacts of any licensing agreements and ability to commercialize additional therapies, our manufacturing in-house expertise, our commercial momentum and position in the market. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission ("SEC"), including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, and our other filings or reports that we may file with the SEC. In particular, there can be no guarantee that our sales strategies will be successful, or that we will continue to experience significant sales of BAQSIMI ®. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.

Contact Information:

Amphastar Pharmaceuticals, Inc.

Bill Peters

Chief Financial Officer

(909) 476-3416

Table I

Amphastar Pharmaceuticals, Inc.

Condensed Consolidated Statement of Operations

(Unaudited; in thousands, except per share data)

Three Months Ended

Nine Months Ended

September 30,

2025

2024

2025

2024

191,840

188,819

536,782

525,836

2,395

19,608

191,840

191,214

536,782

545,444

93,194

89,273

266,395

258,237

98,646

101,941

270,387

287,207

11,505

8,995

33,606

27,378

39,467

14,821

69,454

43,782

22,354

21,077

62,530

55,772

73,326

44,893

165,590

126,932

25,320

57,048

104,797

160,275

2,246

2,427

6,256

8,320

(6,284

)

(6,698

)

(18,851

)

(23,918

)

231

(5,094

)

(492

)

1,125

(3,807

)

(9,365

)

(13,087

)

(14,473

)

21,513

47,683

91,710

145,802

4,163

7,254

18,045

23,674

17,350

40,429

73,665

122,128

(573

)

17,350

40,429

73,665

121,555

0.38

0.83

1.57

2.50

0.37

0.78

1.52

2.32

46,474

48,621

47,021

48,580

47,677

51,862

48,565

52,307

Table II

Amphastar Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(Unaudited; in thousands, except share data)

September 30,

December 31,

2025

2024

(unaudited)

216,265

151,609

235

59,944

70,036

2,200

146,808

136,289

185,932

153,741

2,065

1,747

26,021

18,214

639,470

534,071

308,689

297,345

259

383

44,577

46,899

572,237

590,660

10,996

29,866

25,992

71,124

1,666,222

1,577,470

190,844

157,057

5,633

9,664

923

234

7,827

6,804

205,227

173,759

6,957

608,582

601,630

39,441

41,881

29,269

20,945

889,476

845,172

527,215

505,400

642,451

568,787

(5,273

)

(9,181

)

(387,653

)

(332,714

)

776,746

732,298

1,666,222

1,577,470

Table III

Amphastar Pharmaceuticals, Inc.

Reconciliation of Non-GAAP Measures

(Unaudited; in thousands, except per share data)

Three Months Ended

Nine Months Ended

September 30,

2025

2024

2025

2024

GAAP net income

17,350

40,429

73,665

121,555

Adjusted for:

Intangible asset amortization

6,269

6,179

18,778

18,539

Share-based compensation

6,297

5,596

21,072

18,736

Expenses related to BAQSIMI ® acquisition

3,651

Litigation provision

23,147

Income tax provision on pre-tax adjustments

(8,367)

(2,619)

(14,202)

(8,912)

Adjusted non-GAAP net income

44,696

49,585

122,460

153,569

Adjusted non-GAAP net income per share:

Basic

0.96

1.02

2.60

3.16

Diluted

0.93

0.96

2.52

2.94

Weighted-average shares used to compute adjusted non-GAAP net income per share:

Basic

46,474

48,621

47,021

48,580

Diluted

47,677

51,862

48,565

52,307

Three Months Ended September 30, 2025

Selling,

General

Research

Non-operating

Cost of

distribution

and

(expenses)

Income

revenue

and marketing

administrative

development

income, net

tax provision

93,194

11,505

39,467

22,354

(3,807

)

4,163

(6,248

)

(20

)

(1,274

)

(301

)

(4,140

)

(582

)

(23,147

)

8,367

85,672

11,204

12,179

21,752

(3,807

)

12,530

Three Months Ended September 30, 2024

Selling,

General

Research

Non-operating

Cost of

distribution

and

(expenses)

Income

revenue

and marketing

administrative

development

income, net

tax provision

89,273

8,995

14,821

21,077

(9,365

)

7,254

(6,159

)

(19

)

(1,133

)

(249

)

(3,710

)

(504

)

2,619

81,981

8,746

11,110

20,554

(9,365

)

9,873

Nine Months Ended September 30, 2025

Selling,

General

Research

Non-operating

Cost of

distribution

and

(expenses)

Income

revenue

and marketing

administrative

development

income, net

tax provision

266,395

33,606

69,454

62,530

(13,087

)

18,045

(18,718

)

(58

)

(5,012

)

(925

)

(12,777

)

(2,358

)

(23,147

)

14,202

242,665

32,681

33,528

60,114

(13,087

)

32,247

Nine Months Ended September 30, 2024

Selling,

General

Research

Non-operating

Cost of

distribution

and

(expenses)

Income

revenue

and marketing

administrative

development

income, net

tax provision

258,237

27,378

43,782

55,772

(14,473

)

23,674

(18,479

)

(56

)

(4,583

)

(777

)

(11,239

)

(2,137

)

3,651

8,912

235,175

26,601

32,539

53,579

(10,822

)

32,586

SOURCE: Amphastar Pharmaceuticals, Inc.