News Detail
Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2025
May 7, 2025
Reports Net Revenues of
First Quarter Highlights
Net revenues of
$170.5 million for the first quarterGAAP net income of
$25.3 million , or$0.51 per share, for the first quarterAdjusted non-GAAP net income of
$36.9 million , or$0.74 per share, for the first quarter
Dr.
| Three Months Ended |
| ||||||
|
| |||||||
| 2025 |
|
| 2024 |
| |||
| (in thousands, except per share data) |
| ||||||
Net revenues |
| $ | 170,528 |
|
| $ | 171,836 |
|
GAAP net income |
| $ | 25,285 |
|
| $ | 43,177 |
|
Adjusted non-GAAP net income* |
| $ | 36,871 |
|
| $ | 55,296 |
|
GAAP diluted EPS |
| $ | 0.51 |
|
| $ | 0.81 |
|
Adjusted non-GAAP diluted EPS* |
| $ | 0.74 |
|
| $ | 1.04 |
|
______________________________________
* 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 |
| ||||||||||||
| 2025 |
|
| 2024 |
|
| Dollars |
|
| % |
| |||||
| (in thousands) |
|
|
|
| |||||||||||
Product revenues, net: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
BAQSIMI® |
| $ | 38,355 |
|
| $ | 13,843 |
|
| $ | 24,512 |
|
|
| 177 | % |
Primatene MIST® |
|
| 29,051 |
|
|
| 24,166 |
|
|
| 4,885 |
|
|
| 20 | % |
Glucagon |
|
| 20,843 |
|
|
| 28,535 |
|
|
| (7,692 | ) |
|
| (27 | )% |
Epinephrine |
|
| 18,587 |
|
|
| 26,110 |
|
|
| (7,523 | ) |
|
| (29 | )% |
Lidocaine |
|
| 13,644 |
|
|
| 12,773 |
|
|
| 871 |
|
|
| 7 | % |
Other products |
|
| 50,048 |
|
|
| 52,202 |
|
|
| (2,154 | ) |
|
| (4 | )% |
Total product revenues, net |
| $ | 170,528 |
|
| $ | 157,629 |
|
| $ | 12,899 |
|
|
| 8 | % |
Other revenues |
|
| - |
|
|
| 14,207 |
|
|
| (14,207 | ) |
|
| (100 | )% |
Total net revenues |
| $ | 170,528 |
|
| $ | 171,836 |
|
| $ | (1,308 | ) |
|
| (1 | )% |
Changes in net revenues as compared to the first quarter of the prior year were primarily driven by:
BAQSIMI® sales increased primarily due to an increase in unit volume, as we assumed full distribution responsibilities globally at the beginning of 2025
Primatene MIST® sales increased primarily due to an increase in unit volumes
Glucagon sales decreased primarily due to a decrease in unit volumes, as a result of competition
Epinephrine sales decreased due to both a decrease in unit volumes, as well as a lower average selling price for our multi-dose vial product, as a result of increased competition
Other pharmaceutical product sales changes were primarily due to:
Decrease in sales of enoxaparin, dextrose and naloxone, due to increased competition
This decrease was partially offset by an increase in unit volumes of albuterol, which we launched in
August 2024 , and higher unit sales of phytonadione
Other revenues decreased as we completed the assumption of distribution responsibilities globally for BAQSIMI® by 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
$14.2 million in BAQSIMI® sales made by Lilly on our behalf under the Transition Service Agreement, orTSA . The other revenues balance was net of$10.4 million in cost of sales and other expenses
| Three Months Ended |
|
|
|
| |||||||||||
|
|
| Change |
| ||||||||||||
| 2024 |
|
| 2023 |
|
| Dollars |
|
| % |
| |||||
| (in thousands) |
|
|
|
| |||||||||||
Net revenues |
| $ | 170,528 |
|
| $ | 171,836 |
|
| $ | (1,308 | ) |
|
| (1 | )% |
Cost of revenues |
|
| 85,277 |
|
|
| 81,736 |
|
|
| 3,541 |
|
|
| 4 | % |
Gross profit |
| $ | 85,251 |
|
| $ | 90,100 |
|
| $ | (4,849 | ) |
|
| (5 | )% |
as % of net revenues |
|
| 50.0 | % |
|
| 52.4 | % |
|
|
|
|
|
|
|
|
Changes in the cost of revenues and the resulting gross margins were primarily driven by:
Decrease in other revenues are 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 separatelyLower average selling price for epinephrine multi-dose vials, which is a higher-margin product
Increase in labor costs
This was partially offset by an increase in sales of Primatene MIST® and phytonadione, which are higher-margin products
| Three Months Ended |
|
|
|
|
|
|
| ||||||||
|
|
| Change |
| ||||||||||||
| 2025 |
|
| 2024 |
|
| Dollars |
|
| % |
| |||||
| (in thousands) |
|
|
|
| |||||||||||
Selling, distribution, and marketing |
| $ | 11,866 |
|
| $ | 9,371 |
|
| $ | 2,495 |
|
|
| 27 | % |
General and administrative |
|
| 15,996 |
|
|
| 15,676 |
|
|
| 320 |
|
|
| 2 | % |
Research and development |
|
| 20,096 |
|
|
| 17,043 |
|
|
| 3,053 |
|
|
| 18 | % |
Selling, distribution, and marketing expenses increased 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®
Research and development expenses increased primarily due to an increase in salary and personnel-related expenses, as well as an increase in clinical trial expenses, and an increase in
U.S. Food and Drug Administration (the "FDA") filing fees.
| Three Months Ended |
|
|
|
|
|
|
| ||||||||
|
|
| Change |
| ||||||||||||
| 2025 |
|
| 2024 |
|
| Dollars |
|
| % |
| |||||
| (in thousands) |
|
|
|
| |||||||||||
Non-operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Interest income |
| $ | 2,089 |
|
| $ | 2,556 |
|
| $ | (467 | ) |
|
| (18 | )% |
Interest expense |
|
| (6,286 | ) |
|
| (8,611 | ) |
|
| 2,325 |
|
|
| (27 | )% |
Other income (expenses), net |
|
| (2,234 | ) |
|
| 5,921 |
|
|
| (8,155 | ) |
|
| 138 | % |
Total non-operating expenses, net |
| $ | (6,431 | ) |
| $ | (134 | ) |
| $ | (6,297 | ) |
|
| NM |
|
The change in non-operating income (expenses), net is primarily a result of:
A decrease in interest income resulting from a decrease in cash and investments
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 inJune 2024 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 three months ended
March 31, 2025
Cash flow provided by operating activities for the three months ended
Pipeline Information
The Company currently has four abbreviated new drug applications ("ANDAs") and one biosimilar insulin candidate filed with the FDA targeting products with a combined market size exceeding
Company Information
Amphastar is a bio-pharmaceutical 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®, REXTOVYTM, Amphadase®, and Cortrosyn®, are the property of Amphastar.
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.
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.
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 BAQSIMI® and Primatene MIST®, 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, and other future events. 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
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 |
| ||||||
|
| |||||||
| 2025 |
|
| 2024 |
| |||
Net revenues: |
|
|
|
|
|
| ||
Product revenues, net |
| $ | 170,528 |
|
| $ | 157,629 |
|
Other revenues |
|
| - |
|
|
| 14,207 |
|
Total net revenues |
|
| 170,528 |
|
|
| 171,836 |
|
|
|
|
|
|
|
|
| |
Cost of revenues |
|
| 85,277 |
|
|
| 81,736 |
|
Gross profit |
|
| 85,251 |
|
|
| 90,100 |
|
|
|
|
|
|
|
|
| |
Operating expenses: |
|
|
|
|
|
|
|
|
Selling, distribution, and marketing |
|
| 11,866 |
|
|
| 9,371 |
|
General and administrative |
|
| 15,996 |
|
|
| 15,676 |
|
Research and development |
|
| 20,096 |
|
|
| 17,043 |
|
Total operating expenses |
|
| 47,958 |
|
|
| 42,090 |
|
|
|
|
|
|
|
|
| |
Income from operations |
|
| 37,293 |
|
|
| 48,010 |
|
|
|
|
|
|
|
|
| |
Non-operating expenses: |
|
|
|
|
|
|
|
|
Interest income |
|
| 2,089 |
|
|
| 2,556 |
|
Interest expense |
|
| (6,286 | ) |
|
| (8,611 | ) |
Other income (expenses), net |
|
| (2,234 | ) |
|
| 5,921 |
|
Total non-operating expenses, net |
|
| (6,431 | ) |
|
| (134 | ) |
|
|
|
|
|
|
|
| |
Income before income taxes |
|
| 30,862 |
|
|
| 47,876 |
|
Income tax provision |
|
| 5,577 |
|
|
| 4,126 |
|
Income before equity in losses of unconsolidated affiliate |
|
| 25,285 |
|
|
| 43,750 |
|
|
|
|
|
|
|
|
| |
Equity in losses of unconsolidated affiliate |
|
| - |
|
|
| (573 | ) |
|
|
|
|
|
|
|
| |
Net income |
| $ | 25,285 |
|
| $ | 43,177 |
|
|
|
|
|
|
|
|
| |
Net income per share: |
|
|
|
|
|
|
|
|
Basic |
| $ | 0.53 |
|
| $ | 0.90 |
|
Diluted |
| $ | 0.51 |
|
| $ | 0.81 |
|
|
|
|
|
|
|
|
| |
Weighted-average shares used to compute net income per share: |
|
|
|
|
|
|
|
|
Basic |
|
| 47,641 |
|
|
| 48,212 |
|
Diluted |
|
| 49,890 |
|
|
| 53,013 |
|
Table II
Condensed Consolidated Balance Sheet
(in thousands, except per share data)
|
|
|
| |||||
| 2025 |
|
| 2024 |
| |||
| (unaudited) |
|
|
|
| |||
ASSETS |
|
|
|
|
|
| ||
Current assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 182,782 |
|
| $ | 151,609 |
|
Restricted cash |
|
| 235 |
|
|
| 235 |
|
Short-term investments |
|
| 54,101 |
|
|
| 70,036 |
|
Restricted short-term investments |
|
| 2,200 |
|
|
| 2,200 |
|
Accounts receivable, net |
|
| 144,636 |
|
|
| 136,289 |
|
Inventories, net |
|
| 185,476 |
|
|
| 153,741 |
|
Income tax refunds and deposits |
|
| 758 |
|
|
| 1,747 |
|
Prepaid expenses and other assets |
|
| 17,773 |
|
|
| 18,214 |
|
Total current assets |
|
| 587,961 |
|
|
| 534,071 |
|
|
|
|
|
|
|
|
| |
Property, plant, and equipment, net |
|
| 307,602 |
|
|
| 297,345 |
|
Finance lease right-of-use assets |
|
| 335 |
|
|
| 383 |
|
Operating lease right-of-use assets |
|
| 45,822 |
|
|
| 46,899 |
|
|
| 584,528 |
|
|
| 590,660 |
| |
Long-term investments |
|
| 5,913 |
|
|
| 10,996 |
|
Other assets |
|
| 22,991 |
|
|
| 25,992 |
|
Deferred tax assets |
|
| 71,124 |
|
|
| 71,124 |
|
Total assets |
| $ | 1,626,276 |
|
| $ | 1,577,470 |
|
|
|
|
|
|
|
|
| |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
| $ | 175,940 |
|
| $ | 157,057 |
|
Income taxes payable |
|
| 15,142 |
|
|
| 9,664 |
|
Current portion of long-term debt |
|
| 224 |
|
|
| 234 |
|
Current portion of operating lease liabilities |
|
| 7,746 |
|
|
| 6,804 |
|
Total current liabilities |
|
| 199,052 |
|
|
| 173,759 |
|
|
|
|
|
|
|
|
| |
Long-term reserve for income tax liabilities |
|
| 6,957 |
|
|
| 6,957 |
|
Long-term debt, net of current portion and unamortized debt issuance costs |
|
| 603,858 |
|
|
| 601,630 |
|
Long-term operating lease liabilities, net of current portion |
|
| 40,705 |
|
|
| 41,881 |
|
Other long-term liabilities |
|
| 24,421 |
|
|
| 20,945 |
|
Total liabilities |
|
| 874,993 |
|
|
| 845,172 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock: par value |
|
| - |
|
|
| - |
|
Common stock: par value |
|
| 6 |
|
|
| 6 |
|
Additional paid-in capital |
|
| 509,108 |
|
|
| 505,400 |
|
Retained earnings |
|
| 594,071 |
|
|
| 568,787 |
|
Accumulated other comprehensive loss |
|
| (7,969 | ) |
|
| (9,181 | ) |
|
| (343,933 | ) |
|
| (332,714 | ) | |
Total equity |
|
| 751,283 |
|
|
| 732,298 |
|
Total liabilities and stockholders' equity |
| $ | 1,626,276 |
|
| $ | 1,577,470 |
|
Table III
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
| Three Months Ended |
| ||||||
|
| |||||||
| 2025 |
|
| 2024 |
| |||
|
|
|
|
|
| |||
GAAP net income |
| $ | 25,285 |
|
| $ | 43,177 |
|
Adjusted for: |
|
|
|
|
|
|
|
|
Intangible asset amortization |
|
| 6,240 |
|
|
| 6,167 |
|
Share-based compensation |
|
| 8,393 |
|
|
| 7,360 |
|
Expenses related to BAQSIMI® acquisition |
|
| - |
|
|
| 1,826 |
|
Income tax provision on pre-tax adjustments |
|
| (3,047 | ) |
|
| (3,234 | ) |
Adjusted non-GAAP net income |
| $ | 36,871 |
|
| $ | 55,296 |
|
|
|
|
|
|
|
|
| |
Adjusted non-GAAP net income per share: |
|
|
|
|
|
|
|
|
Basic |
| $ | 0.77 |
|
| $ | 1.15 |
|
Diluted |
| $ | 0.74 |
|
| $ | 1.04 |
|
|
|
|
|
|
|
|
| |
Weighted-average shares used to compute adjusted non-GAAP net income per share: |
|
|
|
|
|
|
|
|
Basic |
|
| 47,641 |
|
|
| 48,212 |
|
Diluted |
|
| 49,890 |
|
|
| 53,013 |
|
| Three Months Ended |
| ||||||||||||||||||||||
|
|
|
|
|
|
|
|
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| |||||||
|
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| |||||||
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|
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|
|
|
|
|
|
| |||||||
|
|
|
| Selling, |
|
| General |
|
|
|
|
| Non-operating |
|
| Income |
| |||||||
GAAP |
| $ | 85,277 |
|
| $ | 11,866 |
|
| $ | 15,996 |
|
| $ | 20,096 |
|
| $ | (6,431 | ) |
| $ | 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 |
|
| $ | (6,431 | ) |
| $ | 8,624 |
|
| Three Months Ended |
| ||||||||||||||||||||||
|
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| |||||||
| Cost of |
|
| Selling, |
|
| General |
|
| Research |
|
| Non-operating |
|
| Income |
| |||||||
GAAP |
| $ | 81,736 |
|
| $ | 9,371 |
|
| $ | 15,676 |
|
| $ | 17,043 |
|
| $ | (134 | ) |
| $ | 4,126 |
|
Intangible asset amortization |
|
| (6,147 | ) |
|
| - |
|
|
| (3 | ) |
|
| (17 | ) |
|
| - |
|
|
| - |
|
Share-based compensation |
|
| (2,125 | ) |
|
| (260 | ) |
|
| (3,876 | ) |
|
| (1,099 | ) |
|
| - |
|
|
| - |
|
Expenses related to BAQSIMI® acquisition |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 1,826 |
|
|
| - |
|
Income tax provision on pre-tax adjustments |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 3,234 |
|
Non-GAAP |
| $ | 73,464 |
|
| $ | 9,111 |
|
| $ | 11,797 |
|
| $ | 15,927 |
|
| $ | 1,692 |
|
| $ | 7,360 |
|
SOURCE:
View the original press release on ACCESS Newswire