Net revenues of
GAAP net income of
Adjusted non-GAAP net income of
Company to hold a conference call today at
"In the first quarter of 2026, we continued to strengthen our commercial foundation and core business, highlighted by the approval and subsequent launch of Ipratropium Bromide HFA, while also making meaningful advancements across our pipeline that will support our long‑term strategy," said Dr.
| Three Months Ended |
| ||||||
|
|
| ||||||
|
| 2026 |
|
| 2025 |
| ||
|
| (in thousands, except per share data) |
| |||||
Net revenues |
| $ | 171,171 |
|
| $ | 170,528 |
|
GAAP net income |
| $ | 6,420 |
|
| $ | 25,285 |
|
Adjusted non-GAAP net income* |
| $ | 19,478 |
|
| $ | 36,871 |
|
GAAP diluted EPS |
| $ | 0.14 |
|
| $ | 0.51 |
|
Adjusted non-GAAP diluted EPS* |
| $ | 0.42 |
|
| $ | 0.74 |
|
________________________________
* 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.
First Quarter Results
|
| Three Months Ended |
|
|
|
|
|
|
| |||||||
|
|
|
| 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 | % |
Changes in net revenues as compared to the first quarter of the prior year were primarily driven by:
BAQSIMI® sales decreased 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
Primatene MIST® sales increased due to an increase in unit volumes
Epinephrine sales increased primarily due to an increase in demand for our epinephrine pre-filled syringe, as a result of other supplier shortages, contributing
Glucagon sales decreased primarily due to a decrease in unit volumes, impacting sales by
Other pharmaceutical product sales increased primarily due to recently launched products including an increase in albuterol sales of
|
| Three Months Ended |
|
|
|
|
|
|
| |||||||
|
|
|
| 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 |
|
| 41.1 | % |
|
| 50.0 | % |
|
|
|
|
|
|
|
|
Changes in the cost of revenues and gross margin were primarily driven by:
Lower average selling price for our higher margin products, such as BAQSIMI®, glucagon, phytonadione, and our epinephrine multi-dose vial product
Increased manufacturing expenses due to the expansion of our manufacturing facility in
|
| Three Months Ended |
|
|
|
|
|
|
| |||||||
|
|
|
| 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 | % |
Research and development |
|
| 26,737 |
|
|
| 20,096 |
|
|
| 6,641 |
|
|
| 33 | % |
General and administrative expenses increased primarily due to an increase in legal expenses, expenses associated with implementing a new ERP system and salary and personnel-related expenses
Research and development expenses increased primarily due to spending for our insulin, inhalation, and proprietary pipeline products. Additionally, we had a
| Three Months Ended |
|
|
|
|
|
|
| ||||||||
|
|
|
| Change |
| |||||||||||
|
| 2026 |
|
| 2025 |
|
| Dollars |
|
| % |
| ||||
|
| (in thousands) |
|
|
|
| ||||||||||
Non-operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Interest income |
| $ | 2,400 |
|
| $ | 2,089 |
|
| $ | 311 |
|
|
| 15 | % |
Interest expense |
|
| (6,553 | ) |
|
| (6,286 | ) |
|
| (267 | ) |
|
| 4 | % |
Other income (expenses), net |
|
| 575 |
|
|
| (2,234 | ) |
|
| 2,809 |
|
|
| (126 | )% |
Total non-operating expenses, net |
| $ | (3,578 | ) |
| $ | (6,431 | ) |
| $ | 2,853 |
|
|
| (44 | )% |
The change in non-operating expenses, net, is primarily 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
Cash flow provided by operating activities for the three months ended
Pipeline Information
The Company currently has one abbreviated new drug application ("ANDA") and one biosimilar insulin candidate filed with the FDA targeting products with a combined market size exceeding
The Company's proprietary pipeline also includes four recently in-licensed products including three proprietary peptides targeting oncology and ophthalmology indications, and a fully synthetic corticotropin compound designed to address inflammatory and autoimmune conditions.
Conference Call Information
The Company will hold a conference call to discuss its financial results today,
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, www.amphastar.com.
Non-GAAP Financial Measures
To supplement its consolidated financial statements, which are prepared and presented in accordance with
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 is a biopharmaceutical company that focuses on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells active pharmaceutical ingredient, or API products. Most of the Company's finished products are contracted and distributed through group purchasing organizations, drug wholesalers, and drug retailers. 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 and our ability to continue to scale, 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 long-term strategic vision, our ability to leverage our existing expertise and technology, the impacts of any licensing agreements and ability to commercialize additional therapies, our in-house manufacturing expertise, our ability to deliver high-quality, affordable therapies to patients, 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
Contact Information:
Chief Financial Officer
(909) 476-3416
Table I
Condensed Consolidated Statement of Operations
(Unaudited; in thousands, except per share data)
| Three Months Ended |
| ||||||
|
|
| ||||||
|
| 2026 |
|
| 2025 |
| ||
Net revenues |
| $ | 171,171 |
|
| $ | 170,528 |
|
Cost of revenues |
|
| 100,849 |
|
|
| 85,277 |
|
Gross profit |
|
| 70,322 |
|
|
| 85,251 |
|
|
|
|
|
|
|
|
| |
Operating expenses: |
|
|
|
|
|
|
|
|
Selling, distribution, and marketing |
|
| 11,927 |
|
|
| 11,866 |
|
General and administrative |
|
| 18,028 |
|
|
| 15,996 |
|
Research and development |
|
| 26,737 |
|
|
| 20,096 |
|
Total operating expenses |
|
| 56,692 |
|
|
| 47,958 |
|
|
|
|
|
|
|
|
| |
Income from operations |
|
| 13,630 |
|
|
| 37,293 |
|
|
|
|
|
|
|
|
| |
Non-operating expenses: |
|
|
|
|
|
|
|
|
Interest income |
|
| 2,400 |
|
|
| 2,089 |
|
Interest expense |
|
| (6,553 | ) |
|
| (6,286 | ) |
Other income (expenses), net |
|
| 575 |
|
|
| (2,234 | ) |
Total non-operating expenses, net |
|
| (3,578 | ) |
|
| (6,431 | ) |
|
|
|
|
|
|
|
| |
Income before income taxes |
|
| 10,052 |
|
|
| 30,862 |
|
Income tax provision |
|
| 3,632 |
|
|
| 5,577 |
|
|
|
|
|
|
|
|
| |
Net income |
| $ | 6,420 |
|
| $ | 25,285 |
|
|
|
|
|
|
|
|
| |
Net income per share: |
|
|
|
|
|
|
|
|
Basic |
| $ | 0.14 |
|
| $ | 0.53 |
|
Diluted |
| $ | 0.14 |
|
| $ | 0.51 |
|
|
|
|
|
|
|
|
| |
Weighted-average shares used to compute net income per share: |
|
|
|
|
|
|
|
|
Basic |
|
| 45,322 |
|
|
| 47,641 |
|
Diluted |
|
| 46,458 |
|
|
| 49,890 |
|
Table II
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
|
|
|
| |||||
|
| 2026 |
|
| 2025 |
| ||
|
| (unaudited) |
|
|
|
| ||
ASSETS |
|
|
|
|
|
| ||
Current assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 170,939 |
|
| $ | 170,177 |
|
Restricted cash |
|
| 235 |
|
|
| 235 |
|
Short-term investments |
|
| 121,012 |
|
|
| 112,635 |
|
Restricted short-term investments |
|
| 2,200 |
|
|
| 2,200 |
|
Accounts receivable, net |
|
| 147,848 |
|
|
| 143,560 |
|
Inventories |
|
| 170,194 |
|
|
| 176,890 |
|
Income tax refunds and deposits |
|
| 9,605 |
|
|
| 17,167 |
|
Prepaid expenses and other assets |
|
| 11,650 |
|
|
| 13,152 |
|
Total current assets |
|
| 633,683 |
|
|
| 636,016 |
|
|
|
|
|
|
|
|
| |
Property, plant, and equipment, net |
|
| 307,231 |
|
|
| 310,567 |
|
Finance lease right-of-use assets |
|
| 185 |
|
|
| 221 |
|
Operating lease right-of-use assets |
|
| 71,496 |
|
|
| 42,931 |
|
|
| 559,623 |
|
|
| 565,965 |
| |
Other assets |
|
| 33,480 |
|
|
| 31,135 |
|
Deferred tax assets |
|
| 42,464 |
|
|
| 42,464 |
|
Total assets |
| $ | 1,648,162 |
|
| $ | 1,629,299 |
|
|
|
|
|
|
|
|
| |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
| $ | 152,688 |
|
| $ | 148,348 |
|
Income taxes payable |
|
| 414 |
|
|
| 239 |
|
Current portion of long-term debt |
|
| 1,671 |
|
|
| 1,641 |
|
Current portion of operating lease liabilities |
|
| 9,705 |
|
|
| 7,928 |
|
Total current liabilities |
|
| 164,478 |
|
|
| 158,156 |
|
|
|
|
|
|
|
|
| |
Long-term reserve for income tax liabilities |
|
| 5,926 |
|
|
| 5,926 |
|
Long-term debt, net of current portion and unamortized debt issuance costs |
|
| 609,801 |
|
|
| 608,749 |
|
Long-term operating lease liabilities, net of current portion |
|
| 65,201 |
|
|
| 37,684 |
|
Other long-term liabilities |
|
| 29,365 |
|
|
| 29,979 |
|
Total liabilities |
|
| 874,771 |
|
|
| 840,494 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock: par value |
|
| - |
|
|
| - |
|
Common stock: par value |
|
| 6 |
|
|
| 6 |
|
Additional paid-in capital |
|
| 543,816 |
|
|
| 535,380 |
|
Retained earnings |
|
| 673,301 |
|
|
| 666,881 |
|
Accumulated other comprehensive loss |
|
| (5,736 | ) |
|
| (5,314 | ) |
|
| (437,996 | ) |
|
| (408,148 | ) | |
Total stockholders' equity |
|
| 773,391 |
|
|
| 788,805 |
|
Total liabilities and stockholders' equity |
| $ | 1,648,162 |
|
| $ | 1,629,299 |
|
Table III
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
| Three Months Ended |
| ||||||
|
|
| ||||||
|
| 2026 |
|
| 2025 |
| ||
|
|
|
|
|
|
| ||
GAAP net income |
| $ | 6,420 |
|
| $ | 25,285 |
|
Adjusted for: |
|
|
|
|
|
|
|
|
Intangible asset amortization |
|
| 6,270 |
|
|
| 6,240 |
|
Share-based compensation |
|
| 9,274 |
|
|
| 8,393 |
|
Litigation provision |
|
| 1,000 |
|
|
| - |
|
Income tax provision on pre-tax adjustments |
|
| (3,486 | ) |
|
| (3,047 | ) |
Adjusted non-GAAP net income |
| $ | 19,478 |
|
| $ | 36,871 |
|
|
|
|
|
|
|
|
| |
Adjusted non-GAAP net income per share: |
|
|
|
|
|
|
|
|
Basic |
| $ | 0.43 |
|
| $ | 0.77 |
|
Diluted |
| $ | 0.42 |
|
| $ | 0.74 |
|
|
|
|
|
|
|
|
| |
Weighted-average shares used to compute adjusted non-GAAP net income per share: |
|
|
|
|
|
|
|
|
Basic |
|
| 45,322 |
|
|
| 47,641 |
|
Diluted |
|
| 46,458 |
|
|
| 49,890 |
|
| Three Months Ended |
| ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
| Selling, |
|
| General |
|
| Research |
|
|
|
| |||||
|
| Cost of |
|
| distribution |
|
| and |
|
| and |
|
| Income |
| |||||
|
| revenue |
|
| and marketing |
|
| administrative |
|
| development |
|
| tax provision |
| |||||
GAAP |
| $ | 100,849 |
|
| $ | 11,927 |
|
| $ | 18,028 |
|
| $ | 26,737 |
|
| $ | 3,632 |
|
Intangible asset amortization |
|
| (6,250 | ) |
|
| - |
|
|
| (1 | ) |
|
| (19 | ) |
|
| - |
|
Share-based compensation |
|
| (2,456 | ) |
|
| (360 | ) |
|
| (5,137 | ) |
|
| (1,321 | ) |
|
| - |
|
Litigation provision |
|
| - |
|
|
| - |
|
|
| (1,000 | ) |
|
| - |
|
|
| - |
|
Income tax provision on pre-tax adjustments |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 3,486 |
|
Non-GAAP |
| $ | 92,143 |
|
| $ | 11,567 |
|
| $ | 11,890 |
|
| $ | 25,397 |
|
| $ | 7,118 |
|
|
| Three Months Ended |
| |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
| Selling, |
|
| General |
|
| Research |
|
|
|
| |||||
|
| Cost of |
|
| distribution |
|
| and |
|
| and |
|
| Income |
| |||||
| revenue |
|
| and marketing |
|
| administrative |
|
| development |
|
| tax provision |
| ||||||
GAAP |
| $ | 85,277 |
|
| $ | 11,866 |
|
| $ | 15,996 |
|
| $ | 20,096 |
|
| $ | 5,577 |
|
Intangible asset amortization |
|
| (6,220 | ) |
|
| - |
|
|
| (1 | ) |
|
| (19 | ) |
|
| - |
|
Share-based compensation |
|
| (2,338 | ) |
|
| (313 | ) |
|
| (4,569 | ) |
|
| (1,173 | ) |
|
| - |
|
Income tax provision on pre-tax adjustments |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 3,047 |
|
Non-GAAP |
| $ | 76,719 |
|
| $ | 11,553 |
|
| $ | 11,426 |
|
| $ | 18,904 |
|
| $ | 8,624 |
|
SOURCE: