ANI Pharmaceuticals Reports Record Fourth Quarter and Full-Year 2024 Financial Results and Raises 2025 Guidance
ANI Pharmaceuticals (ANIP) reported record Q4 2024 results with net revenues of $190.6 million, up 44.8% year-over-year. The company's Rare Disease segment generated $87.0 million, including $59.4 million from Cortrophin Gel (up 42.3%) and $27.6 million from ILUVIEN and YUTIQ.
Key financial metrics include adjusted non-GAAP EBITDA of $50.0 million (up 65.7%) and adjusted non-GAAP diluted EPS of $1.63. The company raised its 2025 guidance, projecting net revenues of $756.0-776.0 million and adjusted non-GAAP EBITDA of $190.0-200.0 million.
The Generics segment showed 9.4% growth to $78.6 million, with five new product launches in Q4. The company ended 2024 with $144.9 million in cash and $639.2 million in outstanding debt.
ANI Pharmaceuticals (ANIP) ha riportato risultati record per il quarto trimestre del 2024 con ricavi netti di 190,6 milioni di dollari, in aumento del 44,8% rispetto all'anno precedente. Il segmento Malattie Rare dell'azienda ha generato 87,0 milioni di dollari, di cui 59,4 milioni di dollari provenienti da Cortrophin Gel (in aumento del 42,3%) e 27,6 milioni di dollari da ILUVIEN e YUTIQ.
I principali indicatori finanziari includono un EBITDA rettificato non-GAAP di 50,0 milioni di dollari (in aumento del 65,7%) e un utile per azione diluito rettificato non-GAAP di 1,63 dollari. L'azienda ha alzato le previsioni per il 2025, prevedendo ricavi netti tra 756,0 e 776,0 milioni di dollari e un EBITDA rettificato non-GAAP tra 190,0 e 200,0 milioni di dollari.
Il segmento Generici ha mostrato una crescita del 9,4% a 78,6 milioni di dollari, con cinque nuovi lanci di prodotti nel quarto trimestre. L'azienda ha chiuso il 2024 con 144,9 milioni di dollari in cassa e 639,2 milioni di dollari di debito in essere.
ANI Pharmaceuticals (ANIP) reportó resultados récord en el cuarto trimestre de 2024 con ingresos netos de 190,6 millones de dólares, un aumento del 44,8% en comparación con el año anterior. El segmento de Enfermedades Raras de la compañía generó 87,0 millones de dólares, incluidos 59,4 millones de dólares de Cortrophin Gel (un aumento del 42,3%) y 27,6 millones de dólares de ILUVIEN y YUTIQ.
Los principales indicadores financieros incluyen un EBITDA ajustado no-GAAP de 50,0 millones de dólares (un aumento del 65,7%) y un EPS diluido ajustado no-GAAP de 1,63 dólares. La compañía elevó su guía para 2025, proyectando ingresos netos de 756,0 a 776,0 millones de dólares y un EBITDA ajustado no-GAAP de 190,0 a 200,0 millones de dólares.
El segmento de Genéricos mostró un crecimiento del 9,4% hasta 78,6 millones de dólares, con cinco nuevos lanzamientos de productos en el cuarto trimestre. La compañía terminó 2024 con 144,9 millones de dólares en efectivo y 639,2 millones de dólares en deuda pendiente.
ANI Pharmaceuticals (ANIP)는 2024년 4분기 기록적인 실적을 보고하며 순수익 1억 9060만 달러를 기록했으며, 이는 전년 대비 44.8% 증가한 수치입니다. 회사의 희귀질환 부문은 8700만 달러를 창출했으며, 이 중 5940만 달러는 Cortrophin Gel에서 발생했으며(42.3% 증가) 2760만 달러는 ILUVIEN 및 YUTIQ에서 발생했습니다.
주요 재무 지표로는 조정된 비-GAAP EBITDA가 5000만 달러 (65.7% 증가)이며, 조정된 비-GAAP 희석 EPS는 1.63 달러입니다. 회사는 2025년 가이던스를 상향 조정하여 순수익을 7억 5600만에서 7억 7600만 달러로, 조정된 비-GAAP EBITDA를 1억 9000만에서 2억 달러로 예상하고 있습니다.
제네릭 부문은 7860만 달러로 9.4% 성장했으며, 4분기 동안 5개의 신제품이 출시되었습니다. 회사는 2024년을 1억 4490만 달러의 현금과 6억 3920만 달러의 미지급 부채로 마감했습니다.
ANI Pharmaceuticals (ANIP) a annoncé des résultats records pour le quatrième trimestre de 2024 avec des revenus nets de 190,6 millions de dollars, en hausse de 44,8 % par rapport à l'année précédente. Le segment des Maladies Rares de l'entreprise a généré 87,0 millions de dollars, dont 59,4 millions de dollars provenant de Cortrophin Gel (en hausse de 42,3 %) et 27,6 millions de dollars de ILUVIEN et YUTIQ.
Les principaux indicateurs financiers incluent un EBITDA ajusté non-GAAP de 50,0 millions de dollars (en hausse de 65,7 %) et un BPA dilué ajusté non-GAAP de 1,63 dollars. L'entreprise a relevé ses prévisions pour 2025, projetant des revenus nets entre 756,0 et 776,0 millions de dollars et un EBITDA ajusté non-GAAP entre 190,0 et 200,0 millions de dollars.
Le segment Génériques a montré une croissance de 9,4 % à 78,6 millions de dollars, avec cinq nouveaux lancements de produits au quatrième trimestre. L'entreprise a terminé 2024 avec 144,9 millions de dollars en liquidités et 639,2 millions de dollars de dettes en cours.
ANI Pharmaceuticals (ANIP) hat im vierten Quartal 2024 Rekordergebnisse mit Nettoumsätzen von 190,6 Millionen Dollar gemeldet, was einem Anstieg von 44,8% im Vergleich zum Vorjahr entspricht. Das Segment Seltene Krankheiten des Unternehmens erzielte 87,0 Millionen Dollar, darunter 59,4 Millionen Dollar aus Cortrophin Gel (Anstieg um 42,3%) und 27,6 Millionen Dollar aus ILUVIEN und YUTIQ.
Wichtige Finanzkennzahlen umfassen ein angepasstes non-GAAP EBITDA von 50,0 Millionen Dollar (Anstieg um 65,7%) und einen angepassten non-GAAP verwässerten EPS von 1,63 Dollar. Das Unternehmen hat die Prognose für 2025 angehoben und erwartet Nettoumsätze zwischen 756,0 und 776,0 Millionen Dollar sowie ein angepasstes non-GAAP EBITDA zwischen 190,0 und 200,0 Millionen Dollar.
Das Generika-Segment zeigte ein Wachstum von 9,4% auf 78,6 Millionen Dollar, mit fünf neuen Produkteinführungen im vierten Quartal. Das Unternehmen schloss das Jahr 2024 mit 144,9 Millionen Dollar in bar und 639,2 Millionen Dollar an ausstehenden Schulden ab.
- Record Q4 revenue of $190.6M (+44.8% YoY)
- Cortrophin Gel revenue up 42.3% to $59.4M
- Record adjusted EBITDA of $50.0M (+65.7%)
- Generics revenue grew 9.4% to $78.6M
- Raised 2025 guidance
- Strong cash flow from operations of $64.0M
- GAAP net loss of $10.7M in Q4
- GAAP gross margin decreased from 59.4% to 57.9%
- R&D expenses increased 68.7%
- SG&A expenses increased 56.8%
- High debt level of $639.2M
Insights
ANI Pharmaceuticals' Q4 results significantly exceeded expectations with
Cortrophin Gel continues its remarkable growth trajectory, generating
The recently acquired ophthalmic assets (ILUVIEN/YUTIQ) contributed
With
ANI's impressive results reveal the remarkable market adoption of Cortrophin Gel, which is now capturing significant ACTH market share by expanding the total addressable market rather than merely cannibalizing existing therapy. The revelation that
The ophthalmology portfolio acquisition appears strategically sound, with ANI making significant moves to secure supply chain integrity through the Siegfried manufacturing partnership extension through 2029. The FDA's decision on adding the non-infectious uveitis affecting the posterior segment (NIU-PS) indication to ILUVIEN in Q2 2025 represents a meaningful near-term catalyst that could expand the product's addressable market substantially in the US, mirroring its broader label in Europe.
ANI's
The decision to not renew the YUTIQ supply agreement with EyePoint (effective May 31, 2025) while expanding manufacturing with Siegfried introduces some near-term supply transition risk, though the significant investment in manufacturing capacity expansion demonstrates commitment to the ophthalmology franchise's long-term growth. The strong execution across multiple therapeutic areas suggests ANI has evolved beyond its generics roots into a sophisticated specialty pharmaceutical company with diversified growth drivers.
- Generated record quarterly net revenues of
$190.6 million , representing year-over-year growth of44.8% - Total Rare Disease quarterly net revenue of
$87.0 million , which includes:- Record quarterly net revenue for Purified Cortrophin® Gel of
$59.4 million , an increase of42.3% year-over-year, and - ILUVIEN® and YUTIQ® net revenues of
$27.6 million in the first full quarter of ownership following the acquisition of Alimera Sciences
- Record quarterly net revenue for Purified Cortrophin® Gel of
- Delivered record quarterly adjusted non-GAAP EBITDA of
$50.0 million , an increase of65.7% year-over-year - Diluted GAAP loss per share of
$(0.55) and adjusted non-GAAP diluted earnings per share of$1.63 - Increased 2025 guidance with expected net revenues of
$756.0 million to$776.0 million and adjusted non-GAAP EBITDA of$190.0 million to$200.0 million ; announced adjusted non-GAAP diluted earnings per share guidance of$6.12 t o$6.49 - Rare Disease net revenues expected to represent
48% to49% of total Company net revenues in 2025, including:- Purified Cortrophin Gel net revenues of
$265.0 million to$274.0 million , representing year-over-year growth of33.8% to38.3% , and - ILUVIEN and YUTIQ net revenues of
$97.0 million to$103.0 million
- Purified Cortrophin Gel net revenues of
BAUDETTE, Minn., Feb. 28, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the fourth quarter and full year ended December 31, 2024.
Nikhil Lalwani, President and CEO of ANI stated, “We’re thrilled to report another year of strong execution for ANI, capped by our record fourth quarter results, with total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS all finishing above our previously announced guidance for the full year. Cortrophin Gel generated nearly
“With our business off to a strong start in 2025, particularly Cortrophin Gel, Generics, and Brands, we are raising our 2025 guidance for total net revenues and adjusted non-GAAP EBITDA. On the heels of what was a transformative year for our company, I’d like to thank the ANI team as well as our customers, suppliers, partners, and investors for helping us deliver on our purpose of ‘Serving Patients, Improving Lives,’” concluded Mr. Lalwani.
Change in Segment Reporting
Following the acquisition of Alimera and in accordance with FASB ASC 280, Segment Reporting, the Company has reorganized the segment information that is regularly provided to the chief operating decision maker. Starting in the fourth quarter, the Company is now organized into two reportable segments as follows:
- Rare Disease and Brands: Consists of Rare Disease products Cortrophin Gel, ILUVIEN, and YUTIQ, and a portfolio of approximately 16 branded products that were previously included in Established Brands.
- Generics and Other: Consists of generic pharmaceutical products including those sold through traditional wholesale and retail sales channels, sales of contract manufactured products, royalties on contract manufactured products, and revenue from product development services.
Fourth Quarter and Recent Business Highlights:
Rare Disease and Brands
Revenues for ANI’s lead Rare Disease asset Cortrophin Gel totaled
Cortrophin Gel remains on a strong multi-year growth trajectory with the overall ACTH category returning to growth in 2024 and the number of patients on ACTH therapy today still substantially lower than it was several years ago. Notably, approximately
Revenues for ILUVIEN and YUTIQ were
ANI has made substantial progress toward increasing supply security for the ILUVIEN and YUTIQ franchise. The Company has submitted a prior approval supplement (PAS) to the FDA seeking to add YUTIQ’s indication of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) to the ILUVIEN label. The Company expects FDA approval of the PAS in the second quarter of 2025 and plans to market ILUVIEN for chronic NIU-PS in addition to its current indication of diabetic macular edema (DME) in the U.S. For reference, ILUVIEN is already approved and marketed for DME and NIU-PS outside the U.S., including in 17 European countries and the Middle East. In order to support the transition to ILUVIEN, in July 2024, ANI extended its partnership with Siegfried, its long-term supplier for ILUVIEN, through 2029, and contracted with Siegfried to upgrade equipment on the existing manufacturing line and significantly expand capacity through the addition of a second manufacturing line. In conjunction with these initiatives, ANI and EyePoint have agreed to non-renewal of the current supply agreement for supply of YUTIQ by EyePoint to ANI effective May 31, 2025.
Revenues for Brands increased
Generics and Other
ANI’s Generics revenues increased
| Fourth Quarter 2024 Financial Results | |||||||||
| Three Months Ended December 31, | |||||||||
| (in thousands) | 2024 | 2023 | Change | % Change | |||||
| Rare Disease and Brands | |||||||||
| Cortrophin Gel | $ | 59,400 | $ | 41,749 | $ | 17,651 | 42.3 | % | |
| ILUVIEN and YUTIQ | 27,643 | - | 27,643 | 100.0 | % | ||||
| Rare Disease total net revenues | $ | 87,043 | $ | 41,749 | $ | 45,294 | 108.5 | % | |
| Brands | 19,842 | 12,488 | 7,354 | 58.9 | % | ||||
| Rare Disease and Brands total net revenues | $ | 106,885 | $ | 54,237 | $ | 52,648 | 97.1 | % | |
| Generics and Other | |||||||||
| Generic pharmaceutical products | $ | 78,600 | $ | 71,826 | $ | 6,774 | 9.4 | % | |
| Royalties and other pharmaceutical services | 5,089 | 5,591 | (502 | ) | (9.0 | )% | |||
| Generics and Other total net revenues | $ | 83,689 | $ | 77,417 | $ | 6,272 | 8.1 | % | |
| Total net revenues | $ | 190,574 | $ | 131,654 | $ | 58,920 | 44.8 | % | |
All comparisons are made versus the same period in 2023 unless otherwise stated.
Total net revenues for the fourth quarter of 2024 were
Net revenues for Rare Disease, which includes Cortrophin Gel, ILUVIEN and YUTIQ, increased
Net revenues for Brands increased
Net revenues for Generic pharmaceutical products increased
On a GAAP basis, gross margin decreased from
On a GAAP basis, research and development expenses increased
On a GAAP basis, selling, general, and administrative expenses increased
On a GAAP basis, the Company reported a net loss attributable to common shareholders of
Adjusted non-GAAP EBITDA for the fourth quarter of 2024 was
For reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4 below, respectively.
Liquidity
As of December 31, 2024, the Company had
| Revised Full Year 2025 Guidance: | ||||||
| Full Year 2025 Guidance | Previous Full Year 2025 Guidance | 2024 Actual | Growth | |||
| Net Revenue (Total Company) | ||||||
| Cortrophin Gel Net Revenue | n/p | |||||
| ILUVIEN and YUTIQ Net Revenue | n/p | n/m | ||||
| Adjusted Non-GAAP EBITDA | ||||||
| Adjusted Non-GAAP Diluted EPS | n/p | |||||
n/p - not provided in January 13, 2025 preliminary guidance.
n/m - not meaningful percentage due to comparison of only a partial year of ILUVIEN and YUTIQ Net Revenue in 2024.
ANI expects total company adjusted non-GAAP gross margin between
The Company anticipates approximately 20.1 million and 20.4 million shares outstanding for the purpose of calculating adjusted non-GAAP diluted EPS and expects its annual U.S. GAAP effective tax rate to be approximately
Upcoming Events
ANI plans to participate in the following investor events:
Raymond James Annual Institutional Investors Conference
March 4, 2025
Orlando, FL
Leerink Partners Global Healthcare Conference
March 11, 2025
Miami Beach, FL
Conference Call
The Company’s management will host a conference call today to discuss its fourth quarter and full-year 2024 results.
| Date Time Toll free (U.S.) Conference ID | Friday, February 28, 2025 8:00 a.m. ET 800-579-2543 4860276 |
This conference call will also be webcast and can be accessed from the “Investors” section of ANI’s website at www.anipharmaceuticals.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.
A replay of the conference call will also be available within two hours of the call’s completion and will remain accessible for two weeks by dialing 800-756-0554 and entering access code 4860276.
Non-GAAP Financial Measures
Adjusted non-GAAP EBITDA
ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as net (loss) income, excluding tax provision or benefit, interest expense, net, other expense, net, loss on extinguishment of debt, depreciation and amortization expense, non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, amortization of certain purchase price adjustments, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below.
ANI is not providing a reconciliation for the forward-looking full year 2025 adjusted EBITDA guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.
Adjusted non-GAAP Net Income
ANI’s management considers adjusted non-GAAP net income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, loss on extinguishment of debt, amortization of certain purchase price adjustments, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income when analyzing Company performance.
Adjusted non-GAAP net income is defined as net (loss) income, plus the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, loss on extinguishment of debt, amortization of certain purchase price adjustments, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided below.
Adjusted non-GAAP Diluted Earnings per Share
ANI’s management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, loss on extinguishment of debt, amortization of certain purchase price adjustments, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance.
Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings (loss) per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided below.
ANI is not providing a reconciliation for the forward-looking full year 2025 adjusted diluted earnings per share guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.
Other non-GAAP metrics
ANI’s management considers non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses to be financial indicators of ANI’s operating performance, providing investors and analysts with useful measures of operating results unaffected by non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, amortization of certain purchase price adjustments, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.
Management uses adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses when analyzing Company performance.
Non-GAAP research and development expenses is defined as research and development expenses, excluding non-cash stock-based compensation expense, M&A transaction and integration expenses, and certain other items that vary in frequency and impact on ANI’s results of operations.
Non-GAAP selling, general, and administrative expenses is defined as selling, general, and administrative expenses, excluding impact of Canada operations, non-cash stock-based compensation expense, M&A transaction and integration expenses, litigation expenses related to certain matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.
Each of adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses should be considered in addition to, but not in lieu of, research and development expenses, and selling, general, and administrative expenses reported under GAAP, respectively.
A reconciliation of each of non-GAAP research and development expenses and non-GAAP selling, general and administrative expenses to the most directly comparable GAAP financial measure is provided below.
ANI’s management also considers non-GAAP gross margin to be a financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by unaffected by non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, amortization of certain purchase price adjustments, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses non-GAAP gross margin when analyzing Company performance.
Non-GAAP gross margin is defined as adjusted non-GAAP net revenues less non-GAAP cost of sales (excluding depreciation and amortization) divided by non-GAAP net revenues. Non-GAAP gross margin should be considered in addition to, but not in lieu of, gross margin reported under GAAP.
About ANI
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, 2025 guidance, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.
Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of our cash flow as a result of the indebtedness and liabilities incurred from the recent acquisition of Alimera; the risks that our acquisitions and investments, including the recent acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays and disruptions in production of our approved products, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel, ILUVIEN and YUTIQ; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; our obligations in agreements under which we license, develop or commercialize rights to products or technology from third parties and our ability to maintain such licenses; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission.
More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contact Lisa M. Wilson, In-Site Communications, Inc.
212-452-2793
lwilson@insitecony.com
SOURCE: ANI Pharmaceuticals, Inc.
FINANCIAL TABLES FOLLOW
| ANI Pharmaceuticals, Inc. and Subsidiaries | ||||||||||||||
| Table 1: US GAAP Statements of Operations | ||||||||||||||
| (unaudited, in thousands, except per share amounts) | ||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||
| Net Revenues | $ | 190,574 | $ | 131,654 | $ | 614,376 | $ | 486,816 | ||||||
| Operating Expenses | ||||||||||||||
| Cost of sales (excluding depreciation and amortization) | 80,280 | 53,420 | 250,210 | 181,513 | ||||||||||
| Research and development | 16,646 | 9,867 | 44,581 | 34,286 | ||||||||||
| Selling, general, and administrative | 69,719 | 44,462 | 249,636 | 161,697 | ||||||||||
| Depreciation and amortization | 22,600 | 15,194 | 67,731 | 59,791 | ||||||||||
| Contingent consideration fair value adjustment | (1,893 | ) | 1,985 | (619 | ) | 1,426 | ||||||||
| Gain on sale of building | - | - | (5,347 | ) | - | |||||||||
| Restructuring activities | - | - | - | 1,132 | ||||||||||
| Intangible asset impairment charge | 7,600 | - | 7,600 | - | ||||||||||
| Total Operating Expenses, net | 194,952 | 124,928 | 613,792 | 439,845 | ||||||||||
| Operating (Loss) Income | (4,378 | ) | 6,726 | 584 | 46,971 | |||||||||
| Other Expense, net | ||||||||||||||
| Unrealized (loss) gain on investment in equity securities | (1,991 | ) | - | 6,307 | - | |||||||||
| Interest expense, net | (6,015 | ) | (5,746 | ) | (17,602 | ) | (26,940 | ) | ||||||
| Other expense, net | (1,378 | ) | (33 | ) | (4,033 | ) | (159 | ) | ||||||
| Loss on extinguishment of debt | - | - | (7,468 | ) | - | |||||||||
| Income (Loss) Before (Benefit) Expense for Income Taxes | (13,762 | ) | 947 | (22,212 | ) | 19,872 | ||||||||
| Income tax (benefit) expense | (3,486 | ) | (208 | ) | (3,690 | ) | 1,093 | |||||||
| Net (Loss) Income | $ | (10,276 | ) | $ | 1,155 | $ | (18,522 | ) | $ | 18,779 | ||||
| Dividends on Series A Convertible Preferred Stock | (406 | ) | (406 | ) | (1,625 | ) | (1,625 | ) | ||||||
| Net (Loss) Income Available to Common Shareholders | $ | (10,682 | ) | $ | 749 | $ | (20,147 | ) | $ | 17,154 | ||||
| Basic and Diluted (Loss) Income Per Share: | ||||||||||||||
| Basic (Loss) Income Per Share | $ | (0.55 | ) | $ | 0.04 | $ | (1.04 | ) | $ | 0.86 | ||||
| Diluted (Loss) Income Per Share | $ | (0.55 | ) | $ | 0.04 | $ | (1.04 | ) | $ | 0.85 | ||||
| Basic Weighted-Average Shares Outstanding | 19,445 | 19,003 | 19,318 | 18,001 | ||||||||||
| Diluted Weighted-Average Shares Outstanding | 19,445 | 19,219 | 19,318 | 18,194 | ||||||||||
| ANI Pharmaceuticals, Inc. and Subsidiaries | ||||||||
| Table 2: US GAAP Balance Sheets | ||||||||
| (unaudited, in thousands) | ||||||||
| December 31, 2024 | December 31, 2023 | |||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 144,861 | $ | 221,121 | ||||
| Restricted cash | 33 | - | ||||||
| Accounts receivable, net | 221,726 | 162,079 | ||||||
| Inventories | 136,782 | 111,196 | ||||||
| Assets held for sale | - | 8,020 | ||||||
| Prepaid expenses and other current assets | 17,975 | 17,400 | ||||||
| Investment in equity securities | 6,307 | - | ||||||
| Total Current Assets | 527,684 | 519,816 | ||||||
| Non-current Assets | ||||||||
| Property and equipment, net | 56,863 | 44,593 | ||||||
| Deferred tax assets, net of deferred tax liabilities and valuation allowance | 85,106 | 90,711 | ||||||
| Intangible assets, net | 541,834 | 209,009 | ||||||
| Goodwill | 59,990 | 28,221 | ||||||
| Derivatives and other non-current assets | 12,220 | 12,072 | ||||||
| Total Assets | $ | 1,283,697 | $ | 904,422 | ||||
| Current Liabilities | ||||||||
| Current debt, net of deferred financing costs | 9,172 | 850 | ||||||
| Accounts payable | 45,656 | 36,683 | ||||||
| Accrued royalties | 22,626 | 16,276 | ||||||
| Accrued compensation and related expenses | 37,725 | 23,786 | ||||||
| Accrued government rebates | 18,714 | 12,168 | ||||||
| Income taxes payable | 6,749 | 8,164 | ||||||
| Returned goods reserve | 39,274 | 29,678 | ||||||
| Current contingent consideration | 29 | 12,266 | ||||||
| Accrued expenses and other | 13,735 | 5,606 | ||||||
| Total Current Liabilities | 193,680 | 145,477 | ||||||
| Non-current Liabilities | ||||||||
| Non-current debt, net of deferred financing costs and current component | 309,108 | 284,819 | ||||||
| Non-current convertible notes, net of deferred financing costs | 305,812 | - | ||||||
| Non-current contingent consideration, net of current | 19,825 | 11,718 | ||||||
| Accrued licensor payments due | 20,961 | - | ||||||
| Other non-current liabilities | 5,781 | 4,809 | ||||||
| Total Liabilities | $ | 855,167 | $ | 446,823 | ||||
| Mezzanine Equity | ||||||||
| Convertible Preferred Stock, Series A | 24,850 | 24,850 | ||||||
| Stockholders’ Equity | ||||||||
| Common Stock | 2 | 2 | ||||||
| Class C Special Stock | - | - | ||||||
| Preferred Stock | - | - | ||||||
| Treasury stock | (21,040 | ) | (10,081 | ) | ||||
| Additional paid-in capital | 519,653 | 514,103 | ||||||
| Accumulated deficit | (100,279 | ) | (80,132 | ) | ||||
| Accumulated other comprehensive income, net of tax | 5,344 | 8,857 | ||||||
| Total Stockholders’ Equity | 403,680 | 432,749 | ||||||
| Total Liabilities, Mezzanine Equity, and Stockholders’ Equity | $ | 1,283,697 | $ | 904,422 | ||||
| ANI Pharmaceuticals, Inc. and Subsidiaries | ||||||||||||||||||||||||||||||||
| Table 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation | ||||||||||||||||||||||||||||||||
| (unaudited, in thousands) | ||||||||||||||||||||||||||||||||
| Reconciliation of certain adjusted non-GAAP accounts: | ||||||||||||||||||||||||||||||||
| Net Revenues | Cost of sales (excluding depreciation and amortization) | Selling, general, and administrative | Research and development | |||||||||||||||||||||||||||||
| Three Months Ended December 31, | Three Months Ended December 31, | Three Months Ended December 31, | Three Months Ended December 31, | Three Months Ended December 31, | ||||||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
| Net (Loss) Income | $ | (10,276 | ) | $ | 1,155 | As reported: | $ | 190,574 | $ | 131,654 | $ | 80,280 | $ | 53,420 | $ | 69,719 | $ | 44,462 | $ | 16,646 | $ | 9,867 | ||||||||||
| Add/(Subtract): | ||||||||||||||||||||||||||||||||
| Interest expense, net | 6,015 | 5,746 | ||||||||||||||||||||||||||||||
| Other expense, net | 1,378 | 33 | ||||||||||||||||||||||||||||||
| (Benefit) provision for income taxes | (3,486 | ) | (208 | ) | ||||||||||||||||||||||||||||
| Depreciation and amortization | 22,600 | 15,194 | ||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment | (1,893 | ) | 1,985 | |||||||||||||||||||||||||||||
| Unrealized loss on investment in equity securities | 1,991 | — | ||||||||||||||||||||||||||||||
| Intangible asset impairment charge | 7,600 | — | ||||||||||||||||||||||||||||||
| Impact of Canada operations (1) | — | 283 | Impact of Canada operations (1) | — | — | — | (51 | ) | — | (232 | ) | — | — | |||||||||||||||||||
| Stock-based compensation | 7,061 | 5,621 | Stock-based compensation | — | — | (367 | ) | (185 | ) | (6,233 | ) | (5,196 | ) | (461 | ) | (240 | ) | |||||||||||||||
| M&A transaction and integration expenses | 5,965 | 391 | M&A transaction and integration expenses | — | — | — | — | (5,965 | ) | (391 | ) | — | — | |||||||||||||||||||
| Litigation expenses | 1,657 | — | Litigation expenses | — | — | — | — | (1,657 | ) | — | — | — | ||||||||||||||||||||
| Inventory step-up amortization | 10,375 | — | Inventory step-up amortization | — | — | (10,375 | ) | — | — | — | — | — | ||||||||||||||||||||
| Severance | 1,057 | — | Severance | — | — | — | — | (1,057 | ) | — | — | — | ||||||||||||||||||||
| Adjusted non-GAAP EBITDA | $ | 50,044 | $ | 30,200 | As adjusted: | $ | 190,574 | $ | 131,654 | $ | 69,538 | $ | 53,184 | $ | 54,807 | $ | 38,643 | $ | 16,185 | $ | 9,627 | |||||||||||
| (1) Impact of Canada operations includes CDMO revenues, cost of sales relating to CDMO revenues, all selling, general, and administrative expenses, and all research and development expenses recorded in Canada in the period presented, exclusive of restructuring activities, stock-based compensation, and depreciation and amortization, which are included within their respective line items above. The adjustment of Canada operations represents revenues, cost of sales and expense that will not recur after the completion of the closure of our Canada operations (complete as of March 31, 2023) and the sale of the facility (complete as of March 31, 2024). The adjustment of Canada operations does not adjust for revenues, cost of sales, and expense that will recur at our other manufacturing facilities after the transfer of certain manufacturing activities is complete. | ||||||||||||||||||||||||||||||||
| Reconciliation of certain adjusted non-GAAP accounts: | ||||||||||||||||||||||||||||||||
| Net Revenues | Cost of sales (excluding depreciation and amortization) | Selling, general, and administrative | Research and development | |||||||||||||||||||||||||||||
| Twelve Months Ended December 31, | Twelve Months Ended December 31, | Twelve Months Ended December 31, | Twelve Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
| Net (Loss) Income | $ | (18,522 | ) | $ | 18,779 | As reported: | $ | 614,376 | $ | 486,816 | $ | 250,210 | $ | 181,513 | $ | 249,636 | $ | 161,697 | $ | 44,581 | $ | 34,286 | ||||||||||
| Add/(Subtract): | ||||||||||||||||||||||||||||||||
| Interest expense, net | 17,602 | 26,940 | ||||||||||||||||||||||||||||||
| Other expense, net | 4,033 | 159 | ||||||||||||||||||||||||||||||
| Loss on extinguishment of debt | 7,468 | — | ||||||||||||||||||||||||||||||
| (Benefit) provision for income taxes | (3,690 | ) | 1,093 | |||||||||||||||||||||||||||||
| Depreciation and amortization | 67,731 | 59,791 | ||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment | (619 | ) | 1,426 | |||||||||||||||||||||||||||||
| Unrealized gain on investment in equity securities | (6,307 | ) | — | |||||||||||||||||||||||||||||
| Intangible asset impairment charge | 7,600 | — | ||||||||||||||||||||||||||||||
| Gain on sale of building | (5,347 | ) | — | |||||||||||||||||||||||||||||
| Restructuring activities | — | 1,132 | ||||||||||||||||||||||||||||||
| Impact of Canada operations(1) | — | 2,697 | Impact of Canada operations(1) | — | (565 | ) | — | (1,884 | ) | — | (1,304 | ) | — | (73 | ) | |||||||||||||||||
| Stock-based compensation | 29,344 | 20,652 | Stock-based compensation | — | — | (1,277 | ) | (706 | ) | (26,533 | ) | (19,036 | ) | (1,534 | ) | (910 | ) | |||||||||||||||
| M&A transaction and integration expenses | 20,163 | 1,148 | M&A transaction and integration expenses | — | — | — | — | (20,163 | ) | (1,148 | ) | — | — | |||||||||||||||||||
| Litigation expenses | 6,395 | — | Litigation expenses | — | — | — | — | (6,395 | ) | — | — | — | ||||||||||||||||||||
| Inventory step-up amortization | 13,599 | — | Inventory step-up amortization | — | — | (13,599 | ) | — | — | — | — | — | ||||||||||||||||||||
| Severance | 6,365 | — | Severance | — | — | — | — | (6,365 | ) | — | — | — | ||||||||||||||||||||
| Equity Payout | 10,190 | — | Equity Payout | — | — | — | — | (9,171 | ) | — | (1,019 | ) | — | |||||||||||||||||||
| Adjusted non-GAAP EBITDA | $ | 156,005 | $ | 133,817 | As adjusted: | $ | 614,376 | $ | 486,251 | $ | 235,334 | $ | 178,923 | $ | 181,009 | $ | 140,209 | $ | 42,028 | $ | 33,303 | |||||||||||
| (1) Impact of Canada operations includes CDMO revenues, cost of sales relating to CDMO revenues, all selling, general, and administrative expenses, and all research and development expenses recorded in Canada in the period presented, exclusive of restructuring activities, stock-based compensation, and depreciation and amortization, which are included within their respective line items above. The adjustment of Canada operations represents revenues, cost of sales and expense that will not recur after the completion of the closure of our Canada operations (complete as of March 31, 2023) and the sale of the facility (complete as of March 31, 2024). The adjustment of Canada operations does not adjust for revenues, cost of sales, and expense that will recur at our other manufacturing facilities after the transfer of certain manufacturing activities is complete. | ||||||||||||||||||||||||||||||||
| ANI Pharmaceuticals, Inc. and Subsidiaries | |||||||||||||
| Table 4: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation | |||||||||||||
| (unaudited, in thousands, except per share amounts) | |||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| Net (Loss) Income Available to Common Shareholders | $ | (10,682 | ) | $ | 749 | $ | (20,147 | ) | $ | 17,154 | |||
| Add/(Subtract): | |||||||||||||
| Non-cash interest expense | 232 | 804 | 149 | 3,335 | |||||||||
| Depreciation and amortization | 22,600 | 15,194 | 67,731 | 59,791 | |||||||||
| Contingent consideration fair value adjustment | (1,893 | ) | 1,985 | (619 | ) | 1,426 | |||||||
| Restructuring activities | — | — | — | 1,132 | |||||||||
| Gain on sale of building | — | — | (5,347 | ) | — | ||||||||
| Unrealized loss (gain) on investment in equity securities | 1,991 | — | (6,307 | ) | — | ||||||||
| Intangible asset impairment charge | 7,600 | — | 7,600 | — | |||||||||
| Impact of Canada operations (1) | — | 283 | — | 2,697 | |||||||||
| Stock-based compensation | 7,061 | 5,621 | 29,344 | 20,652 | |||||||||
| M&A transaction and integration expenses | 5,965 | 391 | 20,163 | 1,148 | |||||||||
| Litigation expenses | 1,657 | — | 6,395 | — | |||||||||
| Inventory step-up amortization | 10,375 | — | 13,599 | — | |||||||||
| Severance | 1,057 | — | 6,365 | — | |||||||||
| Equity payout | — | — | 10,190 | — | |||||||||
| Loss on extinguishment of debt | — | — | 7,468 | — | |||||||||
| Other expense | 1,335 | — | 3,869 | — | |||||||||
| Less: | |||||||||||||
| Estimated tax impact of adjustments | (15,021 | ) | (5,827 | ) | (38,154 | ) | (21,643 | ) | |||||
| Adjusted non-GAAP Net Income Available to Common Shareholders (2) | $ | 32,277 | $ | 19,200 | $ | 102,299 | $ | 85,692 | |||||
| Diluted Weighted-Average | |||||||||||||
| Shares Outstanding | 19,445 | 19,219 | 19,318 | 18,194 | |||||||||
| Adjusted Diluted Weighted-Average | |||||||||||||
| Shares Outstanding | 19,785 | 19,219 | 19,668 | 18,194 | |||||||||
| Adjusted non-GAAP | |||||||||||||
| Diluted Earnings per Share | $ | 1.63 | $ | 1.00 | $ | 5.20 | $ | 4.71 | |||||
| (1) Impact of Canada operations includes CDMO revenues, cost of sales relating to CDMO revenues, all selling, general, and administrative expenses, and all research and development expenses recorded in Canada in the period presented, exclusive of restructuring activities, stock-based compensation, and depreciation and amortization, which are included within their respective line items above. The adjustment of Canada operations represents revenues, cost of sales and expense that will not recur after the completion of the closure of our Canada operations (complete as of March 31, 2023) and the sale of the facility (complete as of March 31, 2024). The adjustment of Canada operations does not adjust for revenues, cost of sales, and expense that will recur at our other manufacturing facilities after the transfer of certain manufacturing activities is complete. | |||||||||||||
| (2) Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities. | |||||||||||||
FAQ
What were ANI Pharmaceuticals' (ANIP) Q4 2024 revenue and growth figures?
How much revenue did ANIP's Cortrophin Gel generate in Q4 2024?
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