Amphastar Pharmaceuticals Reports Financial Results for the Three Months and Full Year Ended December 31, 2024
Amphastar Pharmaceuticals (NASDAQ:AMPH) reported strong financial results for Q4 and full year 2024. Q4 revenues reached $186.5 million with GAAP net income of $38.0 million ($0.74 per share) and adjusted non-GAAP net income of $47.2 million ($0.92 per share).
For the full year 2024, the company achieved net revenues of $732.0 million, GAAP net income of $159.5 million ($3.06 per share), and adjusted non-GAAP net income of $200.8 million ($3.86 per share). Notable achievements include exceeding $100 million in annual sales for Primatene MIST and BAQSIMI showing 12% factory sales growth compared to Q4 2023.
The company's pipeline includes four ANDAs targeting products with >$2 billion market size, four biosimilar products targeting >$7 billion market size, and two generic products targeting >$1.3 billion market size. Operating cash flow for 2024 was $213.4 million.
Amphastar Pharmaceuticals (NASDAQ:AMPH) ha riportato risultati finanziari solidi per il quarto trimestre e l'intero anno 2024. I ricavi del Q4 hanno raggiunto 186,5 milioni di dollari, con un utile netto GAAP di 38,0 milioni di dollari (0,74 dollari per azione) e un utile netto non-GAAP rettificato di 47,2 milioni di dollari (0,92 dollari per azione).
Per l'anno intero 2024, l'azienda ha ottenuto ricavi netti di 732,0 milioni di dollari, un utile netto GAAP di 159,5 milioni di dollari (3,06 dollari per azione) e un utile netto non-GAAP rettificato di 200,8 milioni di dollari (3,86 dollari per azione). Tra i risultati notevoli c'è il superamento dei 100 milioni di dollari in vendite annuali per Primatene MIST e BAQSIMI, che ha mostrato una crescita delle vendite in fabbrica del 12% rispetto al Q4 2023.
Il pipeline dell'azienda include quattro ANDA che mirano a prodotti con una dimensione di mercato superiore ai 2 miliardi di dollari, quattro prodotti biosimilari che mirano a una dimensione di mercato superiore ai 7 miliardi di dollari e due prodotti generici che mirano a una dimensione di mercato superiore a 1,3 miliardi di dollari. Il flusso di cassa operativo per il 2024 è stato di 213,4 milioni di dollari.
Amphastar Pharmaceuticals (NASDAQ:AMPH) reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024. Los ingresos del Q4 alcanzaron 186,5 millones de dólares, con una ganancia neta GAAP de 38,0 millones de dólares (0,74 dólares por acción) y una ganancia neta ajustada no GAAP de 47,2 millones de dólares (0,92 dólares por acción).
Para el año completo 2024, la compañía logró ingresos netos de 732,0 millones de dólares, una ganancia neta GAAP de 159,5 millones de dólares (3,06 dólares por acción) y una ganancia neta ajustada no GAAP de 200,8 millones de dólares (3,86 dólares por acción). Entre los logros notables se incluye superar los 100 millones de dólares en ventas anuales para Primatene MIST y BAQSIMI, mostrando un crecimiento del 12% en las ventas de fábrica en comparación con el Q4 2023.
El pipeline de la compañía incluye cuatro ANDA que apuntan a productos con un tamaño de mercado superior a 2 mil millones de dólares, cuatro productos biosimilares que apuntan a un tamaño de mercado superior a 7 mil millones de dólares y dos productos genéricos que apuntan a un tamaño de mercado superior a 1,3 mil millones de dólares. El flujo de caja operativo para 2024 fue de 213,4 millones de dólares.
Amphastar Pharmaceuticals (NASDAQ:AMPH)는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했습니다. 4분기 수익은 1억 8650만 달러에 달하며, GAAP 기준 순이익은 3800만 달러(주당 0.74달러), 조정된 비GAAP 기준 순이익은 4720만 달러(주당 0.92달러)입니다.
2024년 전체 연도 동안 회사는 순수익 7억 3200만 달러, GAAP 기준 순이익 1억 5950만 달러(주당 3.06달러), 조정된 비GAAP 기준 순이익 2억 800만 달러(주당 3.86달러)를 달성했습니다. 주요 성과로는 Primatene MIST의 연간 매출이 1억 달러를 초과하고, BAQSIMI가 2023년 4분기 대비 12%의 공장 매출 성장을 보였습니다.
회사의 파이프라인에는 네 개의 ANDA가 포함되어 있으며, 이들은 20억 달러 이상의 시장 규모를 목표로 하고, 네 개의 바이오시밀러 제품은 70억 달러 이상의 시장 규모를 목표로 하며, 두 개의 일반 의약품은 13억 달러 이상의 시장 규모를 목표로 하고 있습니다. 2024년 운영 현금 흐름은 2억 1340만 달러였습니다.
Amphastar Pharmaceuticals (NASDAQ:AMPH) a annoncé de solides résultats financiers pour le quatrième trimestre et l'année entière 2024. Les revenus du Q4 ont atteint 186,5 millions de dollars, avec un bénéfice net GAAP de 38,0 millions de dollars (0,74 dollar par action) et un bénéfice net ajusté non-GAAP de 47,2 millions de dollars (0,92 dollar par action).
Pour l'année entière 2024, la société a réalisé des revenus nets de 732,0 millions de dollars, un bénéfice net GAAP de 159,5 millions de dollars (3,06 dollars par action) et un bénéfice net ajusté non-GAAP de 200,8 millions de dollars (3,86 dollars par action). Parmi les réalisations notables, on trouve le dépassement de 100 millions de dollars en ventes annuelles pour Primatene MIST et BAQSIMI, qui a montré une croissance des ventes en usine de 12 % par rapport au Q4 2023.
Le pipeline de l'entreprise comprend quatre ANDA visant des produits avec une taille de marché supérieure à 2 milliards de dollars, quatre produits biosimilaires visant une taille de marché supérieure à 7 milliards de dollars et deux produits génériques visant une taille de marché supérieure à 1,3 milliard de dollars. Le flux de trésorerie d'exploitation pour 2024 était de 213,4 millions de dollars.
Amphastar Pharmaceuticals (NASDAQ:AMPH) hat starke finanzielle Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 gemeldet. Die Umsätze im Q4 beliefen sich auf 186,5 Millionen Dollar, mit einem GAAP-Nettoeinkommen von 38,0 Millionen Dollar (0,74 Dollar pro Aktie) und einem bereinigten Non-GAAP-Nettoeinkommen von 47,2 Millionen Dollar (0,92 Dollar pro Aktie).
Für das gesamte Jahr 2024 erzielte das Unternehmen Nettoumsätze von 732,0 Millionen Dollar, ein GAAP-Nettoeinkommen von 159,5 Millionen Dollar (3,06 Dollar pro Aktie) und ein bereinigtes Non-GAAP-Nettoeinkommen von 200,8 Millionen Dollar (3,86 Dollar pro Aktie). Zu den bemerkenswerten Erfolgen gehört, dass die jährlichen Verkäufe von Primatene MIST 100 Millionen Dollar überstiegen und BAQSIMI ein Wachstum der Werkverkäufe von 12 % im Vergleich zum Q4 2023 zeigte.
Die Pipeline des Unternehmens umfasst vier ANDAs, die Produkte mit einem Marktvolumen von über 2 Milliarden Dollar anvisieren, vier biosimilar Produkte, die ein Marktvolumen von über 7 Milliarden Dollar anvisieren, und zwei Generika, die ein Marktvolumen von über 1,3 Milliarden Dollar anvisieren. Der operative Cashflow für 2024 betrug 213,4 Millionen Dollar.
- Primatene MIST exceeded $100M in annual sales
- BAQSIMI showed 12% factory sales growth vs Q4 2023
- Strong operating cash flow of $213.4M in 2024
- Robust pipeline targeting >$10B total market opportunity
- Q4 revenue growth to $186.5M
- Decreased sales in glucagon due to competition
- Declining epinephrine sales from new competition
- Lower sales of phytonadione and naloxone due to volume decrease
- Decreased enoxaparin sales from lower volumes
- Increased selling and marketing expenses from BAQSIMI expansion
Insights
Amphastar Pharmaceuticals delivered robust Q4 2024 results with
The company's product mix is evolving favorably, with two key growth drivers emerging: Primatene MIST exceeded the long-term goal of
The operational cash flow generation of
While several legacy products faced competitive pressures (glucagon, enoxaparin, naloxone), the company's strategic shift toward higher-margin proprietary products is improving the overall financial profile. The pipeline remains robust with four ANDAs filed targeting
The company's ability to successfully commercialize Primatene MIST and integrate BAQSIMI demonstrates execution capabilities that should support continued growth as they advance their proprietary pipeline in 2025.
Amphastar's Q4 and full-year 2024 results highlight a successful strategic pivot toward higher-margin proprietary respiratory products while leveraging vertical integration capabilities. The standout achievement was Primatene MIST exceeding
The BAQSIMI integration represents another strategic win, with the product now fully transitioned from Lilly's distribution to Amphastar's direct control. The
The company's diversified manufacturing capabilities across injectable, inhalation, and intranasal delivery systems provide technological barriers to entry that support their specialized product portfolio. This is complemented by vertical integration through their ANP subsidiary in China, which develops DMFs and supplies APIs, helping insulate against supply chain disruptions that have created opportunities in products like dextrose and sodium bicarbonate.
While legacy injectable products face competitive pressures, Amphastar's pipeline strategy balances near-term opportunities (four filed ANDAs targeting
The robust
Reports Net Revenues of
RANCHO CUCAMONGA, CA / ACCESS Newswire / February 27, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months and full year ended December 31, 2024.
Fourth quarter Highlights
Net revenues of
$186.5 million for the fourth quarterGAAP net income of
$38.0 million , or$0.74 per share, for the fourth quarterAdjusted non-GAAP net income of
$47.2 million , or$0.92 per share, for the fourth quarter
Full Year Highlights
Net revenues of
$732.0 million for the fiscal yearGAAP net income of
$159.5 million , or$3.06 per share, for the fiscal yearAdjusted non-GAAP net income of
$200.8 million , or$3.86 per share, for the fiscal year
Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We are incredibly proud that in 2024, we exceeded our long-term goal of achieving
| Three Months Ended |
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| Year Ended |
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| December 31, |
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| December 31, |
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| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| |||||
| (in thousands, except per share data) |
| ||||||||||||||
Net revenues |
| $ | 186,523 |
|
| $ | 178,105 |
|
| $ | 731,967 |
|
| $ | 644,395 |
|
GAAP net income |
| $ | 37,964 |
|
| $ | 36,167 |
|
| $ | 159,519 |
|
| $ | 137,545 |
|
Adjusted non-GAAP net income* |
| $ | 47,237 |
|
| $ | 46,875 |
|
| $ | 200,806 |
|
| $ | 175,699 |
|
GAAP diluted EPS |
| $ | 0.74 |
|
| $ | 0.68 |
|
| $ | 3.06 |
|
| $ | 2.60 |
|
Adjusted non-GAAP diluted EPS* |
| $ | 0.92 |
|
| $ | 0.88 |
|
| $ | 3.86 |
|
| $ | 3.32 |
|
____________________________________
* 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.
Fourth quarter Results
| Three Months Ended |
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| December 31, |
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| Change |
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| 2024 |
|
| 2023 |
|
| Dollars |
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| % |
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| (in thousands) |
|
|
|
| |||||||||||
Product revenues, net: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
BAQSIMI ® |
| $ | 41,792 |
|
| $ | - |
|
| $ | 41,792 |
|
|
| N/A |
|
Primatene MIST ® |
|
| 28,935 |
|
|
| 24,484 |
|
|
| 4,451 |
|
|
| 18 | % |
Glucagon |
|
| 25,619 |
|
|
| 31,198 |
|
|
| (5,579 | ) |
|
| (18 | )% |
Epinephrine |
|
| 18,698 |
|
|
| 24,646 |
|
|
| (5,948 | ) |
|
| (24 | )% |
Lidocaine |
|
| 14,397 |
|
|
| 14,988 |
|
|
| (591 | ) |
|
| (4 | )% |
Phytonadione |
|
| 11,171 |
|
|
| 11,922 |
|
|
| (751 | ) |
|
| (6 | )% |
Enoxaparin |
|
| 3,731 |
|
|
| 6,092 |
|
|
| (2,361 | ) |
|
| (39 | )% |
Naloxone |
|
| 3,604 |
|
|
| 4,230 |
|
|
| (626 | ) |
|
| (15 | )% |
Other products |
|
| 39,031 |
|
|
| 38,089 |
|
|
| 942 |
|
|
| 2 | % |
Total product revenues, net |
| $ | 186,978 |
|
| $ | 155,649 |
|
| $ | 31,329 |
|
|
| 20 | % |
Other revenues |
|
| (455 | ) |
|
| 22,456 |
|
|
| (22,911 | ) |
|
| (102 | )% |
Total net revenues |
| $ | 186,523 |
|
| $ | 178,105 |
|
| $ | 8,418 |
|
|
| 5 | % |
Changes in product revenues, net as compared to the fourth quarter of the prior year were primarily driven by:
BAQSIMI® revenues consisting of
$41.8 million in sales made by the Company directly to its customers, which are recorded as part of product revenues, netPrimatene MIST® sales increased primarily due to an increase in unit volumes
Glucagon sales decreased due to a decrease in unit volumes as a result of competition and a market shift towards ready-to-use glucagon products such as BAQSIMI®
Epinephrine sales decreased due to a decrease in unit volumes, as well as a decrease in average selling price, primarily as a result of new competition for our epinephrine vial product
The decrease in sales of phytonadione and naloxone was due to a decrease in unit volume, as well as a decrease in average selling price
Enoxaparin sales decreased primarily due to a decrease in unit volumes
Other pharmaceutical product sales changes were primarily due to:
Higher unit volumes of dextrose and sodium bicarbonate due to increased demand caused by supplier shortages during the fourth quarter
This increase was partially offset by:
Lower sales of ganirelix and medroxyprogesterone due to a decrease in average selling price, as well as lower unit volumes
Other revenues decreased as the Transition Service Agreement, or TSA, with Lilly expired in the fourth quarter of 2024, and since we have assumed all distribution responsibilities, we record BAQSIMI® sales in product revenues, net and costs of sales. The other revenues included in the fourth quarter of 2024 represents BAQSIMI® sales of
$0.3 million , less associated costs of sales, and a true-up of the Net Economic Benefit payments due at the expiration of the TSA.
| Three Months Ended |
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| December 31, |
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| Change |
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| 2024 |
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| 2023 |
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| Dollars |
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| % |
| |||||
| (in thousands) |
|
|
|
| |||||||||||
Net revenues |
| $ | 186,523 |
|
| $ | 178,105 |
|
| $ | 8,418 |
|
|
| 5 | % |
Cost of revenues |
|
| 99,875 |
|
|
| 81,965 |
|
|
| 17,910 |
|
|
| 22 | % |
Gross profit |
| $ | 86,648 |
|
| $ | 96,140 |
|
| $ | (9,492 | ) |
|
| (10 | )% |
as % of net revenues |
|
| 46.5 | % |
|
| 54.0 | % |
|
|
|
|
|
|
|
|
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 our customers and now record those sales in product revenues and cost of sales separately
Increased labor costs and certain component costs
This was partially offset by an increase in sales of Primatene MIST®, which is a higher-margin product
| Three Months Ended |
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| December 31, |
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| Change |
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| 2024 |
|
| 2023 |
|
| Dollars |
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| % |
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| (in thousands) |
|
|
|
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Selling, distribution, and marketing |
| $ | 10,424 |
|
| $ | 8,619 |
|
| $ | 1,805 |
|
|
| 21 | % |
General and administrative |
|
| 12,938 |
|
|
| 13,122 |
|
|
| (184 | ) |
|
| (1 | )% |
Research and development |
|
| 18,142 |
|
|
| 20,419 |
|
|
| (2,277 | ) |
|
| (11 | )% |
Selling, distribution, and marketing expenses increased primarily due to the expansion of our sales and marketing efforts related to BAQSIMI®
Research and development expenses decreased primarily due to a decrease in clinical trial expense, as well as a decrease in materials and supply expense, as a result of expenses in 2023 for our insulin and inhalation pipeline products that were higher than those incurred in 2024
| Three Months Ended |
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| December 31, |
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| Change |
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| 2024 |
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| 2023 |
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| Dollars |
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| % |
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| (in thousands) |
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Non-operating income (expenses) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Interest income |
| $ | 2,292 |
|
| $ | 2,303 |
|
| $ | (11 | ) |
|
| (0 | )% |
Interest expense |
|
| (6,425 | ) |
|
| (9,456 | ) |
|
| 3,031 |
|
|
| (32 | )% |
Other income (expenses), net |
|
| 2,951 |
|
|
| (5,482 | ) |
|
| 8,433 |
|
|
| 154 | % |
Total non-operating income (expenses), net |
| $ | (1,182 | ) |
| $ | (12,635 | ) |
| $ | 11,453 |
|
|
| (91 | )% |
The change in non-operating income (expenses), net is primarily a result of:
A decrease in interest expense, primarily related to the accretion of the
$129.0 million deferred cash payment to Lilly, which was made in June 2024, as well as a lower principal balance on the Wells Fargo Term Loan, along with the write-off of unamortized debt issuance costs related to such Term Loan in 2023A 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
Year-End Results
| Year Ended December 31, |
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| Change |
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| 2024 |
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| 2023 |
|
| Dollars |
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| % |
| |||||
| (in thousands) |
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|
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Product revenues, net: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
BAQSIMI ® |
| $ | 126,898 |
|
| $ | - |
|
| $ | 126,898 |
|
|
| N/A |
|
Glucagon |
|
| 108,319 |
|
|
| 113,684 |
|
|
| (5,365 | ) |
|
| (5 | )% |
Primatene MIST ® |
|
| 102,012 |
|
|
| 89,321 |
|
|
| 12,691 |
|
|
| 14 | % |
Epinephrine |
|
| 94,090 |
|
|
| 81,650 |
|
|
| 12,440 |
|
|
| 15 | % |
Lidocaine |
|
| 55,854 |
|
|
| 58,162 |
|
|
| (2,308 | ) |
|
| (4 | )% |
Phytonadione |
|
| 43,169 |
|
|
| 44,939 |
|
|
| (1,770 | ) |
|
| (4 | )% |
Enoxaparin |
|
| 21,715 |
|
|
| 31,533 |
|
|
| (9,818 | ) |
|
| (31 | )% |
Naloxone |
|
| 15,728 |
|
|
| 19,004 |
|
|
| (3,276 | ) |
|
| (17 | )% |
Other products |
|
| 145,029 |
|
|
| 154,945 |
|
|
| (9,916 | ) |
|
| (6 | )% |
Total product revenues, net |
| $ | 712,814 |
|
| $ | 593,238 |
|
| $ | 119,576 |
|
|
| 20 | % |
Other revenues |
|
| 19,153 |
|
|
| 51,157 |
|
|
| (32,004 | ) |
|
| (63 | )% |
Total net revenues |
| $ | 731,967 |
|
| $ | 644,395 |
|
| $ | 87,572 |
|
|
| 14 | % |
Changes in product revenues, net were primarily driven by:
BAQSIMI® revenues consisting of
$126.9 million in sales made by the Company directly to its customers, which are recorded as part of product revenues, netPrimatene MIST® sales increased primarily due to an increase in unit volumes
Epinephrine sales increased primarily due to an increase in unit volumes, as we began selling our epinephrine pre-filled syringes in Canada starting in the third quarter of 2024
Glucagon sales decreased primarily due to a decrease in unit volumes, as a result competition and a move to ready-to-use glucagon products such as BAQSIMI®
Enoxaparin and naloxone sales decreased primarily due to a decrease in unit volumes
Other pharmaceutical products sales decreased primarily due to:
Lower unit sales of atropine and calcium chloride, as a result of other suppliers returning to their historical distribution levels
Lower unit sales of medroxyprogesterone, as our API supplier discontinued making the active ingredient
These decreases were partially offset by:
Higher unit volumes of dextrose and sodium bicarbonate due to an increase in demand caused by other supplier shortages
The launch of albuterol in August 2024
Other revenues which consisted of
$38.9 million in BAQSIMI® sales made by Lilly, on behalf of the Company under the TSA, which resulted in a net payment to the Company of$19.2 million after deducting the cost of sales and other expenses
| Year Ended December 31, |
|
| Change |
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| 2024 |
|
| 2023 |
|
| Dollars |
|
| % |
| |||||
| (in thousands) |
|
|
|
| |||||||||||
Net revenues |
| $ | 731,967 |
|
| $ | 644,395 |
|
| $ | 87,572 |
|
|
| 14 | % |
Cost of revenues |
|
| 358,112 |
|
|
| 293,274 |
|
|
| 64,838 |
|
|
| 22 | % |
Gross profit |
| $ | 373,855 |
|
| $ | 351,121 |
|
| $ | 22,734 |
|
|
| 6 | % |
as % of net revenues |
|
| 51.1 | % |
|
| 54.5 | % |
|
|
|
|
|
|
|
|
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 are recorded net of cost of sales and other expenses, as we assumed distribution of BAQSIMI® to our customers and now record those sales in product revenues and cost of sales separately
Increase in depreciation and amortization expenses related to the acquired BAQSIMI® assets
Increased labor and certain component costs
This was partially offset by increased sales of Primatene MIST® and epinephrine, which are higher-margin products
| Year Ended December 31, |
|
| Change |
| |||||||||||
| 2024 |
|
| 2023 |
|
| Dollars |
|
| % |
| |||||
| (in thousands) |
|
|
|
| |||||||||||
Selling, distribution, and marketing |
| $ | 37,802 |
|
| $ | 28,853 |
|
| $ | 8,949 |
|
|
| 31 | % |
General and administrative |
|
| 56,720 |
|
|
| 51,540 |
|
|
| 5,180 |
|
|
| 10 | % |
Research and development |
|
| 73,914 |
|
|
| 73,741 |
|
|
| 173 |
|
|
| 0 | % |
Selling, distribution, and marketing expenses increased primarily due to expenses related to the expansion of our sales and marketing efforts related to BAQSIMI®
General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses and expenses related to BAQSIMI®
Research and development expenses remained flat during the year. Salary and personnel-related expenses and FDA filing fees increased, while clinical trial expense, as well as materials and supply expense decreased
| Year Ended December 31, |
|
| Change |
| |||||||||||
| 2024 |
|
| 2023 |
|
| Dollars |
|
| % |
| |||||
| (in thousands) |
|
|
|
| |||||||||||
Non-operating income (expenses) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Interest income |
| $ | 10,612 |
|
| $ | 5,459 |
|
| $ | 5,153 |
|
|
| 94 | % |
Interest expense |
|
| (30,343 | ) |
|
| (27,158 | ) |
|
| (3,185 | ) |
|
| 12 | % |
Other income (expenses), net |
|
| 4,076 |
|
|
| (3,929 | ) |
|
| 8,005 |
|
|
| 204 | % |
Total non-operating income (expenses), net |
| $ | (15,655 | ) |
| $ | (25,628 | ) |
| $ | 9,973 |
|
|
| (39 | )% |
The change in non-operating income (expenses), net is primarily a result of:
An increase in interest income resulting from an increase in cash and investments.
An increase in interest expense resulting from the Term Loan used to finance the acquisition of BAQSIMI®, as well as the 2029 Convertible Notes, which we entered into in the second half of 2023.
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, 2024.
Cash flow provided by operating activities for the year ended December 31, 2024, was
Pipeline Information
The Company currently has four abbreviated new drug applications ("ANDAs") filed with the U.S. Food and Drug Administration (the "FDA") targeting products with a market size exceeding
Amphastar's Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Co., Ltd. ("ANP"), currently has multiple Drug Master Files ("DMFs") on file with the FDA and is developing several additional DMFs.
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 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 and (ii) Adjusted non-GAAP diluted EPS, which exclude amortization expense, share-based compensation, impairment charges, expenses related to our acquisition of BAQSIMI®, certain debt issuance costs, income tax provisions on pre-tax adjustments, 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.
Conference Call Information
The Company will hold a conference call to discuss its financial results today, February 27, 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.
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, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the benefits BAQSIMI®, including its 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 Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 29, 2024, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 10, 2024, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 9, 2024, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 7, 2024, 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 |
|
| Year Ended |
| |||||||||||
| December 31, |
|
| December 31, |
| |||||||||||
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| |||||
Net revenues: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Product revenues, net |
| $ | 186,978 |
|
| $ | 155,649 |
|
| $ | 712,814 |
|
| $ | 593,238 |
|
Other revenues |
|
| (455 | ) |
|
| 22,456 |
|
|
| 19,153 |
|
|
| 51,157 |
|
Total net revenues |
|
| 186,523 |
|
|
| 178,105 |
|
|
| 731,967 |
|
|
| 644,395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Cost of revenues |
|
| 99,875 |
|
|
| 81,965 |
|
|
| 358,112 |
|
|
| 293,274 |
|
Gross profit |
|
| 86,648 |
|
|
| 96,140 |
|
|
| 373,855 |
|
|
| 351,121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, distribution, and marketing |
|
| 10,424 |
|
|
| 8,619 |
|
|
| 37,802 |
|
|
| 28,853 |
|
General and administrative |
|
| 12,938 |
|
|
| 13,122 |
|
|
| 56,720 |
|
|
| 51,540 |
|
Research and development |
|
| 18,142 |
|
|
| 20,419 |
|
|
| 73,914 |
|
|
| 73,741 |
|
Total operating expenses |
|
| 41,504 |
|
|
| 42,160 |
|
|
| 168,436 |
|
|
| 154,134 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Income from operations |
|
| 45,144 |
|
|
| 53,980 |
|
|
| 205,419 |
|
|
| 196,987 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Non-operating income (expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
| 2,292 |
|
|
| 2,303 |
|
|
| 10,612 |
|
|
| 5,459 |
|
Interest expense |
|
| (6,425 | ) |
|
| (9,456 | ) |
|
| (30,343 | ) |
|
| (27,158 | ) |
Other income (expenses), net |
|
| 2,951 |
|
|
| (5,482 | ) |
|
| 4,076 |
|
|
| (3,929 | ) |
Total non-operating income (expenses), net |
|
| (1,182 | ) |
|
| (12,635 | ) |
|
| (15,655 | ) |
|
| (25,628 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Income before income taxes |
|
| 43,962 |
|
|
| 41,345 |
|
|
| 189,764 |
|
|
| 171,359 |
|
Income tax provision |
|
| 5,998 |
|
|
| 4,673 |
|
|
| 29,672 |
|
|
| 31,833 |
|
Net income before equity in losses of unconsolidated affiliate |
|
| 37,964 |
|
|
| 36,672 |
|
|
| 160,092 |
|
|
| 139,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Equity in losses of unconsolidated affiliate |
|
| - |
|
|
| (505 | ) |
|
| (573 | ) |
|
| (1,981 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net income |
| $ | 37,964 |
|
| $ | 36,167 |
|
| $ | 159,519 |
|
| $ | 137,545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
| $ | 0.79 |
|
| $ | 0.75 |
|
| $ | 3.29 |
|
| $ | 2.85 |
|
Diluted |
| $ | 0.74 |
|
| $ | 0.68 |
|
| $ | 3.06 |
|
| $ | 2.60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Weighted-average shares used to compute net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
| 47,975 |
|
|
| 47,957 |
|
|
| 48,429 |
|
|
| 48,265 |
|
Diluted |
|
| 51,310 |
|
|
| 53,014 |
|
|
| 52,058 |
|
|
| 53,001 |
|
Table II
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited; in thousands, except share data)
| December 31, |
|
| December 31, |
| |||
| 2024 |
|
| 2023 |
| |||
ASSETS |
|
|
|
|
|
| ||
Current assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 151,609 |
|
| $ | 144,296 |
|
Restricted cash |
|
| 235 |
|
|
| 235 |
|
Short-term investments |
|
| 70,036 |
|
|
| 112,510 |
|
Restricted short-term investments |
|
| 2,200 |
|
|
| 2,200 |
|
Accounts receivable, net |
|
| 136,289 |
|
|
| 114,943 |
|
Inventories |
|
| 153,741 |
|
|
| 105,833 |
|
Income tax refunds and deposits |
|
| 1,747 |
|
|
| 526 |
|
Prepaid expenses and other assets |
|
| 18,214 |
|
|
| 9,057 |
|
Total current assets |
|
| 534,071 |
|
|
| 489,600 |
|
|
|
|
|
|
|
|
| |
Property, plant, and equipment, net |
|
| 297,345 |
|
|
| 282,746 |
|
Finance lease right-of-use assets |
|
| 383 |
|
|
| 564 |
|
Operating lease right-of-use assets |
|
| 46,899 |
|
|
| 32,333 |
|
Investment in unconsolidated affiliate |
|
| - |
|
|
| 527 |
|
Goodwill and intangible assets, net |
|
| 590,660 |
|
|
| 613,295 |
|
Long-term investments |
|
| 10,996 |
|
|
| 14,685 |
|
Other assets |
|
| 25,992 |
|
|
| 25,910 |
|
Deferred tax assets |
|
| 71,124 |
|
|
| 53,252 |
|
Total assets |
| $ | 1,577,470 |
|
| $ | 1,512,912 |
|
|
|
|
|
|
|
|
| |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
| $ | 157,057 |
|
| $ | 93,366 |
|
Accrued payments for BAQSIMI ® |
|
| - |
|
|
| 126,090 |
|
Income taxes payable |
|
| 9,664 |
|
|
| 1,609 |
|
Current portion of long-term debt |
|
| 234 |
|
|
| 436 |
|
Current portion of operating lease liabilities |
|
| 6,804 |
|
|
| 3,906 |
|
Total current liabilities |
|
| 173,759 |
|
|
| 225,407 |
|
|
|
|
|
|
|
|
| |
Long-term reserve for income tax liabilities |
|
| 6,957 |
|
|
| 6,066 |
|
Long-term debt, net of current portion and unamortized debt issuance costs |
|
| 601,630 |
|
|
| 589,579 |
|
Long-term operating lease liabilities, net of current portion |
|
| 41,881 |
|
|
| 29,721 |
|
Other long-term liabilities |
|
| 20,945 |
|
|
| 22,718 |
|
Total liabilities |
|
| 845,172 |
|
|
| 873,491 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock: par value |
|
| - |
|
|
| - |
|
Common stock: par value |
|
| 6 |
|
|
| 6 |
|
Additional paid-in capital |
|
| 505,400 |
|
|
| 486,056 |
|
Retained earnings |
|
| 568,787 |
|
|
| 409,268 |
|
Accumulated other comprehensive loss |
|
| (9,181 | ) |
|
| (8,478 | ) |
Treasury stock |
|
| (332,714 | ) |
|
| (247,431 | ) |
Total equity |
|
| 732,298 |
|
|
| 639,421 |
|
Total liabilities and stockholders' equity |
| $ | 1,577,470 |
|
| $ | 1,512,912 |
|
Table III
Amphastar Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
| Three Months Ended |
|
| Year Ended |
| |||||||||||
| December 31, |
|
| December 31, |
| |||||||||||
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| |||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
GAAP net income |
| $ | 37,964 |
|
| $ | 36,167 |
|
| $ | 159,519 |
|
| $ | 137,545 |
|
Adjusted for: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset amortization |
|
| 6,179 |
|
|
| 6,178 |
|
|
| 24,718 |
|
|
| 12,830 |
|
Share-based compensation |
|
| 5,632 |
|
|
| 4,622 |
|
|
| 24,368 |
|
|
| 20,242 |
|
Impairment of long-lived assets |
|
| - |
|
|
| 1 |
|
|
| - |
|
|
| 3,175 |
|
Expenses related to BAQSIMI ® acquisition |
|
| - |
|
|
| 2,148 |
|
|
| 3,651 |
|
|
| 5,830 |
|
Debt issuance costs |
|
| - |
|
|
| 742 |
|
|
| - |
|
|
| 6,785 |
|
Income tax provision on pre-tax adjustments |
|
| (2,538 | ) |
|
| (2,983 | ) |
|
| (11,450 | ) |
|
| (10,708 | ) |
Adjusted non-GAAP net income |
| $ | 47,237 |
|
| $ | 46,875 |
|
| $ | 200,806 |
|
| $ | 175,699 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Adjusted non-GAAP net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
| $ | 0.99 |
|
| $ | 0.98 |
|
| $ | 4.15 |
|
| $ | 3.64 |
|
Diluted |
| $ | 0.92 |
|
| $ | 0.88 |
|
| $ | 3.86 |
|
| $ | 3.32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Weighted-average shares used to compute adjusted non-GAAP net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
| 47,975 |
|
|
| 47,957 |
|
|
| 48,429 |
|
|
| 48,265 |
|
Diluted |
|
| 51,310 |
|
|
| 53,014 |
|
|
| 52,058 |
|
|
| 53,001 |
|
| Three Months Ended December 31, 2024 |
| ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
| Cost of |
|
| Selling, |
|
| General |
|
| Research |
|
| Non-operating |
|
| Income |
| |||||||
|
|
|
|
|
|
|
|
|
|
|
| |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
| |||||||||||||
GAAP |
| $ | 99,875 |
|
| $ | 10,424 |
|
| $ | 12,938 |
|
| $ | 18,142 |
|
| $ | (1,182 | ) |
| $ | 5,998 |
|
Intangible asset amortization |
|
| (6,160 | ) |
|
| - |
|
|
| - |
|
|
| (19 | ) |
|
| - |
|
|
| - |
|
Share-based compensation |
|
| (1,159 | ) |
|
| (286 | ) |
|
| (3,682 | ) |
|
| (505 | ) |
|
| - |
|
|
| - |
|
Income tax provision on pre-tax adjustments |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 2,538 |
|
Non-GAAP |
| $ | 92,556 |
|
| $ | 10,138 |
|
| $ | 9,256 |
|
| $ | 17,618 |
|
| $ | (1,182 | ) |
| $ | 8,536 |
|
| Three Months Ended December 31, 2023 |
| ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
| Cost of |
|
| Selling, |
|
| General |
|
| Research |
|
| Non-operating |
|
| Income |
| |||||||
GAAP |
| $ | 81,965 |
|
| $ | 8,619 |
|
| $ | 13,122 |
|
| $ | 20,419 |
|
| $ | (12,635 | ) |
| $ | 4,673 |
|
Intangible asset amortization |
|
| (6,158 | ) |
|
| - |
|
|
| (3 | ) |
|
| (17 | ) |
|
| - |
|
|
| - |
|
Share-based compensation |
|
| (1,023 | ) |
|
| (221 | ) |
|
| (2,946 | ) |
|
| (432 | ) |
|
| - |
|
|
| - |
|
Impairment of long-lived assets |
|
| - |
|
|
| - |
|
|
| (1 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
Expenses related to BAQSIMI ® acquisition |
|
| - |
|
|
| - |
|
|
| (322 | ) |
|
| - |
|
|
| 1,826 |
|
|
| - |
|
Debt issuance costs |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 742 |
|
|
| - |
|
Income tax provision on pre-tax adjustments |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 2,983 |
|
Non-GAAP |
| $ | 74,784 |
|
| $ | 8,398 |
|
| $ | 9,850 |
|
| $ | 19,970 |
|
| $ | (10,067 | ) |
| $ | 7,656 |
|
| Year Ended December 31, 2024 |
| ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
| Cost of |
|
| Selling, |
|
| General |
|
| Research |
|
| Non-operating |
|
| Income |
| |||||||
GAAP |
| $ | 358,112 |
|
| $ | 37,802 |
|
| $ | 56,720 |
|
| $ | 73,914 |
|
| $ | (15,655 | ) |
| $ | 29,672 |
|
Intangible asset amortization |
|
| (24,639 | ) |
|
| - |
|
|
| (4 | ) |
|
| (75 | ) |
|
| - |
|
|
| - |
|
Share-based compensation |
|
| (5,742 | ) |
|
| (1,063 | ) |
|
| (14,921 | ) |
|
| (2,642 | ) |
|
| - |
|
|
| - |
|
Expenses related to BAQSIMI ® acquisition |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 3,651 |
|
|
| - |
|
Income tax provision on pre-tax adjustments |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 11,450 |
|
Non-GAAP |
| $ | 327,731 |
|
| $ | 36,739 |
|
| $ | 41,795 |
|
| $ | 71,197 |
|
| $ | (12,004 | ) |
| $ | 41,122 |
|
| Year Ended December 31, 2023 |
| ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
| Cost of |
|
| Selling, |
|
| General |
|
| Research |
|
| Non-operating |
|
| Income |
| |||||||
GAAP |
| $ | 293,274 |
|
| $ | 28,853 |
|
| $ | 51,540 |
|
| $ | 73,741 |
|
| $ | (25,628 | ) |
| $ | 31,833 |
|
Intangible asset amortization |
|
| (12,741 | ) |
|
| - |
|
|
| (19 | ) |
|
| (70 | ) |
|
| - |
|
|
| - |
|
Share-based compensation |
|
| (4,891 | ) |
|
| (870 | ) |
|
| (12,269 | ) |
|
| (2,212 | ) |
|
| - |
|
|
| - |
|
Impairment of long-lived assets |
|
| (3,170 | ) |
|
| - |
|
|
| (5 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
Expenses related to BAQSIMI ® acquisition |
|
| - |
|
|
| - |
|
|
| (2,179 | ) |
|
| - |
|
|
| 3,651 |
|
|
| - |
|
Debt issuance costs |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 6,785 |
|
|
| - |
|
Income tax provision on pre-tax adjustments |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 10,708 |
|
Non-GAAP |
| $ | 272,472 |
|
| $ | 27,983 |
|
| $ | 37,068 |
|
| $ | 71,459 |
|
| $ | (15,192 | ) |
| $ | 42,541 |
|
SOURCE: Amphastar Pharmaceuticals, Inc.
View the original press release on ACCESS Newswire
FAQ
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