ANI Pharmaceuticals Reports Second Quarter 2024 Financial Results and Raises 2024 Guidance
ANI Pharmaceuticals reported Q2 2024 net revenues of $138 million, a YoY growth of 18.4%. Rare Disease revenues hit a record $49.2 million, up 102.4% YoY. Adjusted non-GAAP EBITDA was $33.2 million, and adjusted non-GAAP EPS was $1.02. However, they posted a net loss of $(2.7) million and a GAAP loss per share of $(0.14). The company plans to close the acquisition of Alimera Sciences in Q3 2024.
ANI raised its 2024 guidance, projecting net revenues between $540 million and $560 million, adjusted non-GAAP EBITDA of $140 million to $150 million, and adjusted non-GAAP EPS of $4.38 to $4.82. This guidance includes revenue from Cortrophin Gel, expected to be $185 million to $195 million, a YoY growth of 65% to 74%.
ANI Pharmaceuticals ha riportato entrate nette nel secondo trimestre del 2024 di 138 milioni di dollari, con una crescita del 18,4% rispetto all'anno precedente. Le entrate da Malattie Rare hanno raggiunto un record di 49,2 milioni di dollari, aumentando del 102,4% anno su anno. L'EBITDA rettificato non-GAAP è stato di 33,2 milioni di dollari, e l'EPS rettificato non-GAAP è stato di 1,02 dollari. Tuttavia, hanno registrato una perdita netta di 2,7 milioni di dollari e una perdita per azione secondo i GAAP di 0,14 dollari. L'azienda pianifica di concludere l'acquisizione di Alimera Sciences nel terzo trimestre del 2024.
ANI ha alzato le sue previsioni per il 2024, prevedendo entrate nette tra 540 milioni di dollari e 560 milioni di dollari, un EBITDA rettificato non-GAAP di 140 milioni di dollari a 150 milioni di dollari, e un EPS rettificato non-GAAP tra 4,38 dollari e 4,82 dollari. Queste previsioni includono ricavi da Cortrophin Gel, che si prevede siano tra 185 milioni di dollari e 195 milioni di dollari, con una crescita anno su anno del 65% a 74%.
ANI Pharmaceuticals reportó ingresos netos en el segundo trimestre de 2024 de 138 millones de dólares, con un crecimiento interanual del 18,4%. Los ingresos por Enfermedades Raras alcanzaron un récord de 49,2 millones de dólares, aumentando un 102,4% en comparación con el año anterior. El EBITDA ajustado no GAAP fue de 33,2 millones de dólares, y el EPS ajustado no GAAP fue de 1,02 dólares. Sin embargo, registraron una pérdida neta de 2,7 millones de dólares y una pérdida por acción bajo GAAP de 0,14 dólares. La empresa planea cerrar la adquisición de Alimera Sciences en el tercer trimestre de 2024.
ANI elevó su guía para 2024, proyectando ingresos netos entre 540 millones de dólares y 560 millones de dólares, un EBITDA ajustado no GAAP de 140 millones de dólares a 150 millones de dólares, y un EPS ajustado no GAAP de 4,38 dólares a 4,82 dólares. Esta guía incluye ingresos de Cortrophin Gel, que se espera sean entre 185 millones de dólares y 195 millones de dólares, con un crecimiento interanual del 65% a 74%.
ANI Pharmaceuticals는 2024년 2분기 순매출이 1억 3,800만 달러에 달하며, 전년 대비 18.4% 성장했다고 보고했습니다. 희귀질환에서의 매출은 기록적인 4,920만 달러에 도달하며, 전년 대비 102.4% 증가했습니다. 조정된 비 GAAP EBITDA는 3,320만 달러였고, 조정된 비 GAAP EPS는 1.02 달러였습니다. 그러나 순손실은 270만 달러, GAAP 기준 주당 손실은 0.14 달러로 집계되었습니다. 회사는 2024년 3분기에 Alimera Sciences 인수를 종료할 계획입니다.
ANI는 2024년 예상치를 상향 조정하여, 순매출을 5억 4천만 달러에서 5억 6천만 달러 사이로, 조정된 비 GAAP EBITDA를 1억 4천만 달러에서 1억 5천만 달러 사이로, 조정된 비 GAAP EPS를 4.38 달러에서 4.82 달러 사이로 전망했습니다. 이번 전망에는 Cortrophin Gel에서의 수익이 포함되어 있으며, 이는 1억 8천 500만 달러에서 1억 9천 500만 달러로 예상되며, 전년 대비 65%에서 74% 성장을 기록할 것으로 보입니다.
ANI Pharmaceuticals a rapporté pour le deuxième trimestre 2024 un chiffre d'affaires net de 138 millions de dollars, en hausse de 18,4% par rapport à l'année précédente. Les revenus provenant des Maladies Rares ont atteint un record de 49,2 millions de dollars, soit une augmentation de 102,4% d'une année sur l'autre. L'EBITDA ajusté non-GAAP s'élevait à 33,2 millions de dollars, tandis que le BPA ajusté non-GAAP était de 1,02 dollar. Cependant, l'entreprise a déclaré une perte nette de 2,7 millions de dollars et une perte par action selon les GAAP de 0,14 dollar. La société prévoit de conclure l'acquisition d'Alimera Sciences au troisième trimestre 2024.
ANI a relevé ses prévisions pour 2024, prévoyant un chiffre d'affaires net compris entre 540 millions de dollars et 560 millions de dollars, un EBITDA ajusté non-GAAP de 140 millions de dollars à 150 millions de dollars, et un BPA ajusté non-GAAP de 4,38 dollars à 4,82 dollars. Ces prévisions incluent des revenus de Cortrophin Gel, qui devraient être compris entre 185 millions de dollars et 195 millions de dollars, avec une croissance d'une année sur l'autre de 65% à 74%.
ANI Pharmaceuticals berichtete für das zweite Quartal 2024 über Nettoumsätze von 138 Millionen Dollar, was einem Jahr-zu-Jahr-Wachstum von 18,4% entspricht. Die Umsätze aus Seltenen Krankheiten erreichten einen Rekord von 49,2 Millionen Dollar, was einem Anstieg von 102,4% im Vergleich zum Vorjahr entspricht. Bereinigtes EBITDA nach non-GAAP betrug 33,2 Millionen Dollar, und bereinigter non-GAAP EPS lag bei 1,02 Dollar. Dennoch verzeichnete das Unternehmen einen Nettverlust von 2,7 Millionen Dollar und einen GAAP-Verlust pro Aktie von 0,14 Dollar. Das Unternehmen plant, die Übernahme von Alimera Sciences im dritten Quartal 2024 abzuschließen.
ANI hat seine Prognose für 2024 angehoben und erwartet Nettoumsätze zwischen 540 Millionen Dollar und 560 Millionen Dollar, ein bereinigtes non-GAAP EBITDA von 140 Millionen Dollar bis 150 Millionen Dollar, und einen bereinigten non-GAAP EPS von 4,38 Dollar bis 4,82 Dollar. Diese Prognose beinhaltet Einnahmen aus Cortrophin Gel, die voraussichtlich zwischen 185 Millionen Dollar und 195 Millionen Dollar liegen werden, mit einem Jahr-zu-Jahr-Wachstum von 65% bis 74%.
- Record quarterly net revenues of $138 million, an 18.4% increase YoY.
- Rare Disease net revenues reached $49.2 million, up 102.4% YoY.
- Raised 2024 guidance with expected net revenues of $540 million to $560 million.
- Adjusted non-GAAP EBITDA projected at $140 million to $150 million for 2024.
- Adjusted non-GAAP EPS guidance increased to $4.38 to $4.82.
- Net loss of $(2.7) million for Q2 2024.
- GAAP loss per share of $(0.14).
- Operating expenses increased 27.6% YoY.
- Adjusted non-GAAP EBITDA decreased by 2.6% YoY.
- Generated record quarterly net revenues of
$138.0 million, representing year-over-year growth of18.4% , and record Rare Disease net revenues of$49.2 million, an increase of102.4% year-over-year - Delivered adjusted non-GAAP EBITDA of
$33.2 million, and adjusted non-GAAP diluted earnings per share of$1.02 - Net loss available to common shareholders of
$(2.7) million and diluted GAAP loss per share of$(0.14) - On track to close acquisition of Alimera Sciences, Inc. in the third quarter of 2024, adding two durable commercial assets ILUVIEN® and YUTIQ® with significant growth potential to its Rare Disease portfolio
- Increased 2024 guidance with expected net revenues of
$540 million to$560 million , adjusted non-GAAP EBITDA of$140 million to$150 million and adjusted non-GAAP earnings per share of$4.38 to$4.82 - Guidance includes Purified Cortrophin® Gel (Repository Corticotrophin Injection USP) 80 U/ml (Cortrophin Gel) net revenues of
$185 million to$195 million , representing year-over-year growth of65% to74%
BAUDETTE, Minn., Aug. 06, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the three months ended June 30, 2024.
“We are very proud of our accomplishments in the second quarter. We delivered both record revenues and a major milestone in our ongoing efforts to expand the scope and scale of our Rare Disease business with the proposed acquisition of Alimera,” said Nikhil Lalwani, President & CEO of ANI. “Rare Disease continues to be ANI's primary growth driver, and the strategic investments we’ve made in our Cortrophin Gel franchise have been yielding positive results. During the second quarter, we achieved the highest number of both new patient starts and unique prescribers since our January 2022 launch and continued to have momentum across all targeted specialties.”
“Our Generics business also delivered a strong quarter, with high-teens growth stemming from the strength of our base business, our operational excellence and our ability to consistently and effectively launch new products. Based on our solid second quarter results and the continued momentum we’re seeing across the business, we are raising our full year 2024 guidance.”
“Following the acquisition of Alimera, ANI will have three growing and durable commercial Rare Disease assets, an expanded commercial team covering five specialties, and a global infrastructure covering over 20 countries. We’re pleased with our progress thus far in 2024 and are excited about the opportunities that lie ahead, as we make further strides in our mission of ‘Serving Patients, Improving Lives’,” concluded Mr. Lalwani.
Second Quarter and Recent Business Highlights:
Rare Disease Segment
Revenues for the Company’s lead asset, Cortrophin Gel, totaled
On June 24, 2024, the Company announced that it had entered into a definitive agreement to acquire Alimera Sciences for
The Company anticipates completing the acquisition during the third quarter of 2024.
Generics, Established Brands and Other Segment
Revenues for generic pharmaceuticals products, established brands and other decreased
Second Quarter 2024 Financial Results
| Three Months Ended June 30, | |||||||||||||||
| (in thousands) | 2024 | 2023 | Change | % Change | |||||||||||
| Generics, Established Brands, and Other Segment | |||||||||||||||
| Generic pharmaceutical products | $ | 73,964 | $ | 63,317 | $ | 10,647 | 16.8 | % | |||||||
| Established brand pharmaceutical products, royalties, and other pharmaceutical services | 14,883 | 28,926 | (14,043 | ) | (48.5 | )% | |||||||||
| Generics, established brands, and other segment total net revenues | $ | 88,847 | $ | 92,243 | $ | (3,396 | ) | (3.7 | )% | ||||||
| Rare Disease Segment | |||||||||||||||
| Rare disease pharmaceutical products | 49,193 | 24,304 | 24,889 | 102.4 | % | ||||||||||
| Total net revenues | $ | 138,040 | $ | 116,547 | $ | 21,493 | 18.4 | % | |||||||
Net revenues for generic pharmaceutical products were
Net revenues for established brand pharmaceutical products, royalties, and other pharmaceutical services were
Net revenues for Rare Disease pharmaceutical products, which consist entirely of sales of Cortrophin Gel, were
Operating expenses were
- Cost of sales increased
36.5% year-over-year to$57.7 million , primarily due to significant net growth in sales volumes of pharmaceutical products and significant growth of royalty bearing products, including Cortrophin Gel.
- Research and development expenses decreased
1.1% year-over-year to$7.3 million .
- Selling, general, and administrative expenses increased
36.3% year-over-year to$52.8 million , primarily due to increased employment-related costs, investment in our Rare Disease sales and marketing infrastructure and activities, legal expenses, expenses related to the pending acquisition of Alimera, and an overall increase in activities to support revenue growth.
Net loss available to common shareholders for the second quarter of 2024 was
Adjusted non-GAAP EBITDA for the second quarter of 2024 was
Adjusted non-GAAP diluted earnings per share 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 June 30, 2024, the Company had
Revised Full Year 2024 Guidance:
The following guidance for 2024 does not include contribution from the pending acquisition of Alimera.
| Revised Full Year 2024 Guidance | Prior Full Year 2024 Guidance | 2023 Actual | Growth | ||||||
| Net Revenue (Total Company) | |||||||||
| Cortrophin Gel Net Revenue | |||||||||
| Adjusted Non-GAAP EBITDA | |||||||||
| Adjusted Non-GAAP Diluted EPS | (7)% - | ||||||||
ANI now expects total company adjusted non-GAAP gross margin between
The Company now anticipates between 19.4 million and 19.8 million shares outstanding (reflective of a full year of shares outstanding resulting from the May 2023 equity raise) for the purpose of calculating diluted EPS and continues to expect its U.S. GAAP effective tax rate to be between
Conference Call
The Company’s management will host a conference call today to discuss its second quarter 2024 results.
| Date | Tuesday, August 6, 2024 |
| Time | 8:30 a.m. ET |
| Toll free (U.S.) | 800-245-3047 |
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 800-753-5212 and entering access code 4619279.
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), depreciation and amortization expense, non-cash stock-based compensation expense, M&A transaction 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, 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 2024 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 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, 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 expense, M&A transaction expenses, non-cash interest expense, depreciation and amortization expense, 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, 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 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, 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 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 2024 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.
About ANI
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced research and development capability, innovation in established brands and leveraging our U.S. based manufacturing capabilities. For more information, please visit our website 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, 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: our ability to continue to achieve commercial success with Cortrophin Gel, our first rare disease pharmaceutical product, including expanding the market and gaining market share, our business, financial condition, and results of operations will be negatively impacted; the ability of our approved products, including Cortrophin Gel, 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 pending acquisition of Alimera, in a timely manner or at all; the risks that our acquisitions and investments, including the pending acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays in production, 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, excipients and other materials; our reliance on single source third-party contract manufacturing supply for certain of our key products, including Cortrophin Gel, and post-consummation of the proposed acquisition of Alimera, for Alimera’s products; 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, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; our ability to develop, license or acquire, and commercialize new products; 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 between Israel and Gaza, 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 June 30, | Six Months Ended June 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Net Revenues | $ | 138,040 | $ | 116,547 | $ | 275,470 | $ | 223,333 | ||||
| Operating Expenses | ||||||||||||
| Cost of sales (excluding depreciation and amortization) | 57,698 | 42,284 | 106,855 | 79,992 | ||||||||
| Research and development | 7,296 | 7,374 | 17,807 | 13,298 | ||||||||
| Selling, general, and administrative | 52,821 | 38,760 | 100,842 | 75,228 | ||||||||
| Depreciation and amortization | 14,697 | 14,690 | 29,383 | 29,390 | ||||||||
| Contingent consideration fair value adjustment | 359 | 1,035 | 449 | 1,996 | ||||||||
| Restructuring activities | - | 2 | - | 1,132 | ||||||||
| Gain on sale of building | - | - | (5,347 | ) | - | |||||||
| Total Operating Expenses, net | 132,871 | 104,145 | 249,989 | 201,036 | ||||||||
| Operating Income | 5,169 | 12,402 | 25,481 | 22,297 | ||||||||
| Other Income (Expense), net | ||||||||||||
| Unrealized (loss) gain on investment in equity securities | (2,712 | ) | - | 6,943 | - | |||||||
| Interest expense, net | (4,656 | ) | (7,100 | ) | (9,256 | ) | (14,796 | ) | ||||
| Other expense, net | (88 | ) | (53 | ) | (120 | ) | (87 | ) | ||||
| (Loss) Income Before Income Tax Expense (Benefit) | (2,287 | ) | 5,249 | 23,048 | 7,414 | |||||||
| Income tax expense (benefit) | - | (996 | ) | 7,128 | (270 | ) | ||||||
| Net (Loss) Income | $ | (2,287 | ) | $ | 6,245 | $ | 15,920 | $ | 7,684 | |||
| Dividends on Series A Convertible Preferred Stock | (407 | ) | (407 | ) | (813 | ) | (813 | ) | ||||
| Net (Loss) Income Available to Common Shareholders | $ | (2,694 | ) | $ | 5,838 | $ | 15,107 | $ | 6,871 | |||
| Basic and Diluted (Loss) Income Per Share: | ||||||||||||
| Basic (Loss) Income Per Share | $ | (0.14 | ) | $ | 0.30 | $ | 0.71 | $ | 0.36 | |||
| Diluted (Loss) Income Per Share | $ | (0.14 | ) | $ | 0.29 | $ | 0.70 | $ | 0.36 | |||
| Basic Weighted-Average Shares Outstanding | 19,321 | 17,688 | 19,210 | 17,044 | ||||||||
| Diluted Weighted-Average Shares Outstanding | 19,321 | 17,855 | 19,561 | 17,177 | ||||||||
| ANI Pharmaceuticals, Inc. and Subsidiaries | ||||||
| Table 2: US GAAP Balance Sheets | ||||||
| (unaudited, in thousands) | ||||||
| June 30, 2024 | December 31, 2023 | |||||
| Current Assets | ||||||
| Cash and cash equivalents | $ | 240,110 | $ | 221,121 | ||
| Accounts receivable, net | 166,091 | 162,079 | ||||
| Inventories | 125,448 | 111,196 | ||||
| Prepaid income taxes | 2,867 | - | ||||
| Assets held for sale | - | 8,020 | ||||
| Prepaid expenses and other current assets | 14,001 | 17,400 | ||||
| Investment in equity securities | 6,943 | - | ||||
| Total Current Assets | 555,460 | 519,816 | ||||
| Non-current Assets | ||||||
| Property and equipment, net | 51,640 | 44,593 | ||||
| Deferred tax assets, net of deferred tax liabilities and valuation allowance | 89,506 | 90,711 | ||||
| Intangible assets, net | 183,078 | 209,009 | ||||
| Goodwill | 28,221 | 28,221 | ||||
| Derivatives and other non-current assets | 12,848 | 12,072 | ||||
| Total Assets | $ | 920,753 | $ | 904,422 | ||
| Current Liabilities | ||||||
| Current debt, net of deferred financing costs | $ | 850 | $ | 850 | ||
| Accounts payable | 48,681 | 36,683 | ||||
| Accrued royalties | 20,357 | 16,276 | ||||
| Accrued compensation and related expenses | 16,111 | 23,786 | ||||
| Accrued government rebates | 12,324 | 12,168 | ||||
| Income taxes payable | - | 8,164 | ||||
| Returned goods reserve | 33,897 | 29,678 | ||||
| Current contingent consideration | 841 | 12,266 | ||||
| Accrued expenses and other | 6,917 | 5,606 | ||||
| Total Current Liabilities | 139,978 | 145,477 | ||||
| Non-current Liabilities | ||||||
| Non-current debt, net of deferred financing costs and current component | 284,394 | 284,819 | ||||
| Non-current contingent consideration | 11,092 | 11,718 | ||||
| Other non-current liabilities | 4,679 | 4,809 | ||||
| Total Liabilities | $ | 440,143 | $ | 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 | (20,042 | ) | (10,081 | ) | ||
| Additional paid-in capital | 532,497 | 514,103 | ||||
| Accumulated deficit | (65,025 | ) | (80,132 | ) | ||
| Accumulated other comprehensive income, net of tax | 8,328 | 8,857 | ||||
| Total Stockholders’ Equity | 455,760 | 432,749 | ||||
| Total Liabilities, Mezzanine Equity, and Stockholders’ Equity | $ | 920,753 | $ | 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 June 30, | Three Months Ended June 30, | Three Months Ended June 30, | Three Months Ended June 30, | Three Months Ended June 30, | |||||||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||||||
| Net (Loss) Income | $ | (2,287 | ) | $ | 6,245 | As reported: | $ | 138,040 | $ | 116,547 | $ | 57,698 | $ | 42,284 | $ | 52,821 | $ | 38,760 | $ | 7,296 | $ | 7,374 | |||||||||||
| Add/(Subtract): | |||||||||||||||||||||||||||||||||
| Interest expense, net | 4,656 | 7,100 | |||||||||||||||||||||||||||||||
| Other expense, net | 88 | 53 | |||||||||||||||||||||||||||||||
| Provision (benefit) for income taxes | — | (996 | ) | ||||||||||||||||||||||||||||||
| Depreciation and amortization | 14,697 | 14,690 | |||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment | 359 | 1,035 | |||||||||||||||||||||||||||||||
| Restructuring activities | — | 2 | |||||||||||||||||||||||||||||||
| Unrealized loss on investment in equity securities | 2,712 | — | |||||||||||||||||||||||||||||||
| Impact of Canada operations (1) | — | 492 | Impact of Canada operations (1) | — | — | — | (289 | ) | — | (194 | ) | — | (9 | ) | |||||||||||||||||||
| Stock-based compensation | 7,864 | 5,249 | Stock-based compensation | — | — | (312 | ) | (188 | ) | (7,206 | ) | (4,836 | ) | (346 | ) | (225 | ) | ||||||||||||||||
| M&A transaction expenses | 3,540 | 249 | M&A transaction expenses | — | — | — | — | (3,540 | ) | (249 | ) | — | — | ||||||||||||||||||||
| Litigation expenses | 1,594 | — | Litigation expenses | — | — | — | — | (1,594 | ) | — | — | — | |||||||||||||||||||||
| Adjusted non-GAAP EBITDA | $ | 33,223 | $ | 34,119 | As adjusted: | $ | 138,040 | $ | 116,547 | $ | 57,386 | $ | 41,807 | $ | 40,481 | $ | 33,481 | $ | 6,950 | $ | 7,140 | ||||||||||||
(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 | ||||||||||||||||||||||||||||||
| Six Months Ended June 30, | Six Months Ended June 30, | Six Months Ended June 30, | Six Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||||||
| Net Income | $ | 15,920 | $ | 7,684 | As reported: | $ | 275,470 | $ | 223,333 | $ | 106,855 | $ | 79,992 | $ | 100,842 | $ | 75,228 | $ | 17,807 | $ | 13,298 | ||||||||||||
| Add/(Subtract): | |||||||||||||||||||||||||||||||||
| Interest expense, net | 9,256 | 14,796 | |||||||||||||||||||||||||||||||
| Other expense, net | 120 | 87 | |||||||||||||||||||||||||||||||
| Provision (benefit) for income taxes | 7,128 | (270 | ) | ||||||||||||||||||||||||||||||
| Depreciation and amortization | 29,383 | 29,390 | |||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment | 449 | 1,996 | |||||||||||||||||||||||||||||||
| Restructuring activities | — | 1,132 | |||||||||||||||||||||||||||||||
| Gain on sale of building | (5,347 | ) | — | ||||||||||||||||||||||||||||||
| Unrealized gain on investment in equity securities | (6,943 | ) | — | ||||||||||||||||||||||||||||||
| Impact of Canada operations (1) | — | 2,138 | Impact of Canada operations (1) | — | (565 | ) | — | (1,705 | ) | — | (925 | ) | — | (73 | ) | ||||||||||||||||||
| Stock-based compensation | 14,798 | 9,587 | Stock-based compensation | — | — | (592 | ) | (339 | ) | (13,577 | ) | (8,816 | ) | (629 | ) | (432 | ) | ||||||||||||||||
| M&A transaction expenses | 4,253 | 591 | M&A transaction expenses | — | — | — | — | (4,253 | ) | (591 | ) | — | — | ||||||||||||||||||||
| Litigation expenses | 1,839 | — | Litigation expenses | — | — | — | — | (1,839 | ) | — | — | — | |||||||||||||||||||||
| Adjusted non-GAAP EBITDA | $ | 70,856 | $ | 67,131 | As adjusted: | $ | 275,470 | $ | 222,768 | $ | 106,263 | $ | 77,948 | $ | 81,173 | $ | 64,896 | $ | 17,178 | $ | 12,793 | ||||||||||||
(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 June 30, | Six Months Ended June 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Net (Loss) Income Available to Common Shareholders | $ | (2,694 | ) | $ | 5,838 | $ | 15,107 | $ | 6,871 | |||
| Add/(Subtract): | ||||||||||||
| Non-cash interest (income) expense | (55 | ) | 710 | (65 | ) | 1,675 | ||||||
| Depreciation and amortization | 14,697 | 14,690 | 29,383 | 29,390 | ||||||||
| Contingent consideration fair value adjustment | 359 | 1,035 | 449 | 1,996 | ||||||||
| Restructuring activities | — | 2 | — | 1,132 | ||||||||
| Gain on sale of building | — | — | (5,347 | ) | — | |||||||
| Unrealized loss (gain) on investment in equity securities | 2,712 | — | (6,943 | ) | — | |||||||
| Impact of Canada operations (1) | — | 492 | — | 2,138 | ||||||||
| Stock-based compensation | 7,864 | 5,249 | 14,798 | 9,587 | ||||||||
| M&A transaction expenses | 3,540 | 249 | 4,253 | 591 | ||||||||
| Litigation expenses | 1,594 | — | 1,839 | — | ||||||||
| Less: | ||||||||||||
| Estimated tax impact of adjustments (calc. at | (7,985 | ) | (5,382 | ) | (9,975 | ) | (11,162 | ) | ||||
| Adjusted non-GAAP Net Income Available to Common Shareholders (2) | $ | 20,032 | $ | 22,883 | $ | 43,499 | $ | 42,218 | ||||
| Diluted Weighted-Average | ||||||||||||
| Shares Outstanding | 19,321 | 17,855 | 19,561 | 17,177 | ||||||||
| Adjusted Diluted Weighted-Average | ||||||||||||
| Shares Outstanding | 19,686 | 17,855 | 19,561 | 17,177 | ||||||||
| Adjusted non-GAAP | ||||||||||||
| Diluted Earnings per Share | $ | 1.02 | $ | 1.28 | $ | 2.22 | $ | 2.46 | ||||
(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.
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