- Generated record quarterly net revenues of
$137.4 million, representing year-over-year growth of 28.7%, net income to common shareholders of$17.8 million, and GAAP diluted earnings per share of$0.82 - Delivered record adjusted non-GAAP EBITDA of
$37.6 million, and adjusted non-GAAP diluted earnings per share of$1.21 - Rare Disease business delivered Q1 net revenues of
$36.9 million, representing year-over-year growth of 126.2% - Reiterated 2024 guidance of net revenues of
$520 million to$542 million , adjusted non-GAAP EBITDA of$135 million to$145 million and adjusted non-GAAP earnings per share of$4.26 to$4.67 - Guidance includes Purified Cortrophin® Gel (Repository Corticotrophin Injection USP) 80 U/ml (Cortrophin Gel) net revenues of
$170 million to$180 million , representing year-over-year growth of 52% to 61%
“Our Generics, Established Brands and Other segment also delivered strong performance in the first quarter. We are proud to report another quarter of double-digit increase in Generics revenue supported by strong new launch execution and operational excellence. We are energized by our first quarter results and look forward to building momentum throughout 2024 as we remain committed to our purpose of ‘Serving Patients, Improving Lives’,” concluded
First Quarter and Recent Business Highlights:
Rare Disease Segment
Revenues for the Company’s lead asset, Cortrophin Gel, totaled
Generics, Established Brands and Other Segment
Revenues for generic pharmaceuticals products, established brands and other grew 11.1% year-over-year in the first quarter of 2024. ANI’s Generics business launched six new products during the quarter, including a Competitive Generic Therapy (CGT) product with 180-day exclusivity. The Company retained its number two ranking for CGT approvals and top 15 ranking for overall generic approvals.
First Quarter 2024 Financial Results
Three Months Ended | |||||||||||||||
(in thousands) | 2024 | 2023 | Change | % Change | |||||||||||
Generics, Established Brands, and Other Segment | |||||||||||||||
Generic pharmaceutical products | $ | 70,217 | $ | 63,713 | $ | 6,504 | 10.2 | % | |||||||
Established brand pharmaceutical products, royalties, and other pharmaceutical services | 30,276 | 26,743 | 3,533 | 13.2 | % | ||||||||||
Generics, established brands, and other segment total net revenues | $ | 100,493 | $ | 90,456 | $ | 10,037 | 11.1 | % | |||||||
Rare Disease Segment | |||||||||||||||
Rare disease pharmaceutical products | 36,937 | 16,330 | 20,607 | 126.2 | % | ||||||||||
Total net revenues | $ | 137,430 | $ | 106,786 | $ | 30,644 | 28.7 | % | |||||||
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 30.4% year-over-year to
$49.2 million , primarily due to significant growth in sales volumes of pharmaceutical products across all segments.
- Research and development expenses increased 77.4% year-over-year to
$10.5 million , primarily due to a higher level of activity associated with ongoing and new projects.
- Selling, general, and administrative expenses increased 31.7% year-over-year to
$48.0 million , primarily due to increased employment-related costs, investment in our Rare Disease sales and marketing infrastructure and activities, legal expenses, as well as an overall increase in activities to support revenue growth.
During the first quarter of 2024, ANI completed the sale of its
Net income available to common shareholders for the first quarter of 2024 was
Adjusted non-GAAP EBITDA for the first 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
Full Year 2024 Guidance:
2024 Guidance | 2023 Actual | Growth | ||||
Net Revenue ( | 7% - 11% | |||||
Cortrophin Gel Net Revenue | 52% - 61% | |||||
Adjusted Non-GAAP EBITDA | 1% - 8% | |||||
Adjusted Non-GAAP Diluted EPS | (10)% - (1)% | |||||
ANI continues to expect total company adjusted non-GAAP gross margin between 62% and 63% and the Company will continue to tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share at a tax rate of 26.0%.
The Company now anticipates between 19.4 million and 19.7 million shares outstanding (reflective of a full year of shares outstanding resulting from the
Conference Call
The Company’s management will host a conference call today to discuss its first quarter 2024 results.
Date | |
Time | |
Toll free ( | 800-274-8461 |
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 800-938-2239 and entering access code 4555224.
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 income, excluding tax provision or benefit, interest expense, (net), other expense, (net), depreciation and amortization expense, non-cash stock-based compensation expense, Novitium transaction expenses, contingent consideration fair value adjustment, unrealized gain on our investment in equity securities, gain on sale of the former
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, Novitium transaction expenses, contingent consideration fair value adjustment, unrealized gain on our investment in equity securities, gain on sale of the former
Adjusted non-GAAP net income is defined as net income, plus the non-cash stock-based compensation expense, Novitium 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
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, Novitium transaction expenses, contingent consideration fair value adjustment, unrealized gain on our investment in equity securities, gain on sale of the former
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
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: Cortrophin Gel is our first rare disease pharmaceutical product; to the extent we are not able to continue to achieve commercial success with this product, including expanding the market and gaining market share, our business, financial condition, and results of operations will be negatively impacted; our approved products, including Cortrophin Gel, may not achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; acquisitions and other investments could disrupt our business and harm our financial position and operating results; the limited number of suppliers for our active pharmaceutical ingredients could result in lengthy delays in production if we need to change suppliers; delays or failure in obtaining or maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA and other regulatory agencies, including drug recalls; acceptance of our products at levels that will allow us to achieve profitability; 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; our dependence on single source suppliers of ingredients due to the time and cost to validate a second source of supply; 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
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
Investor Contact
212-452-2793
lwilson@insitecony.com
SOURCE:
FINANCIAL TABLES FOLLOW
Table 1: US GAAP Statement of Operations (unaudited, in thousands, except per share amounts) | |||||||
Three Months Ended | |||||||
2024 | 2023 | ||||||
Net Revenues | $ | 137,430 | $ | 106,786 | |||
Operating Expenses | |||||||
Cost of sales (excluding depreciation and amortization) | 49,157 | 37,708 | |||||
Research and development | 10,511 | 5,924 | |||||
Selling, general, and administrative | 48,021 | 36,468 | |||||
Depreciation and amortization | 14,686 | 14,700 | |||||
Contingent consideration fair value adjustment | 90 | 961 | |||||
Restructuring activities | — | 1,130 | |||||
Gain on sale of building | (5,347 | ) | — | ||||
Total Operating Expenses, net | 117,118 | 96,891 | |||||
Operating Income | 20,312 | 9,895 | |||||
Other Income (Expense), net | |||||||
Unrealized gain on investment in equity securities | 9,655 | — | |||||
Interest expense, net | (4,600 | ) | (7,696 | ) | |||
Other expense, net | (32 | ) | (34 | ) | |||
Income Before Income Tax Expense | 25,335 | 2,165 | |||||
Income tax expense | 7,128 | 726 | |||||
Net Income | $ | 18,207 | $ | 1,439 | |||
Dividends on Series A Convertible Preferred Stock | (406 | ) | (406 | ) | |||
Net Income Available to Common Shareholders | $ | 17,801 | $ | 1,033 | |||
Basic and Diluted Income Per Share: | |||||||
Basic Income Per Share | $ | 0.84 | $ | 0.06 | |||
Diluted Income Per Share | $ | 0.82 | $ | 0.06 | |||
Basic Weighted-Average Shares Outstanding | 19,099 | 16,392 | |||||
Diluted Weighted-Average Shares Outstanding | 19,422 | 16,531 | |||||
Table 2: US GAAP Balance Sheets (unaudited, in thousands) | |||||||
2024 | 2023 | ||||||
Current Assets | |||||||
Cash and cash equivalents | $ | 228,597 | $ | 221,121 | |||
Accounts receivable, net | 172,418 | 162,079 | |||||
Inventories | 113,837 | 111,196 | |||||
Assets held for sale | — | 8,020 | |||||
Prepaid expenses and other current assets | 16,050 | 17,400 | |||||
Investment in equity securities | 9,655 | — | |||||
Total Current Assets | 540,557 | 519,816 | |||||
Non-current Assets | |||||||
Property and equipment, net | 48,526 | 44,593 | |||||
Deferred tax assets, net of deferred tax liabilities and valuation allowance | 87,607 | 90,711 | |||||
Intangible assets, net | 196,044 | 209,009 | |||||
28,221 | 28,221 | ||||||
Derivatives and other non-current assets | 13,569 | 12,072 | |||||
Total Assets | $ | 914,524 | $ | 904,422 | |||
Current Liabilities | |||||||
Current debt, net of deferred financing costs | $ | 850 | $ | 850 | |||
Accounts payable | 49,430 | 36,683 | |||||
Accrued royalties | 15,475 | 16,276 | |||||
Accrued compensation and related expenses | 9,526 | 23,786 | |||||
Accrued government rebates | 9,509 | 12,168 | |||||
Income taxes payable | 11,402 | 8,164 | |||||
Returned goods reserve | 32,853 | 29,678 | |||||
Current contingent consideration | 414 | 12,266 | |||||
Accrued expenses and other | 7,430 | 5,606 | |||||
Total Current Liabilities | 136,889 | 145,477 | |||||
Non-current Liabilities | |||||||
Non-current debt, net of deferred financing costs and current component | 284,607 | 284,819 | |||||
Non-current contingent consideration | 11,160 | 11,718 | |||||
Other non-current liabilities | 5,055 | 4,809 | |||||
Total Liabilities | $ | 437,711 | $ | 446,823 | |||
Mezzanine Equity | |||||||
Convertible Preferred Stock, Series A | 24,850 | 24,850 | |||||
Stockholders’ Equity | |||||||
Common Stock | 2 | 2 | |||||
Class | — | — | |||||
Preferred Stock | — | — | |||||
(18,742 | ) | (10,081 | ) | ||||
Additional paid-in capital | 523,628 | 514,103 | |||||
Accumulated deficit | (62,331 | ) | (80,132 | ) | |||
Accumulated other comprehensive income, net of tax | 9,406 | 8,857 | |||||
Total Stockholders’ Equity | 451,963 | 432,749 | |||||
Total Liabilities, Mezzanine Equity, and Stockholders’ Equity | $ | 914,524 | $ | 904,422 |
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 expenses | Research and development expenses | |||||||||||||||||||||||||||||||||||||
Three Months Ended | Three Months Ended | Three Months Ended | Three Months Ended | Three Months Ended | ||||||||||||||||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||||||||||
Net Income | $ | 18,207 | $ | 1,439 | As reported: | $ | 137,430 | $ | 106,786 | $ | 49,157 | $ | 37,708 | $ | 48,021 | $ | 36,468 | $ | 10,511 | $ | 5,924 | |||||||||||||||||||
Add/(Subtract): | ||||||||||||||||||||||||||||||||||||||||
Interest expense, net | 4,600 | 7,696 | ||||||||||||||||||||||||||||||||||||||
Other expense, net | 32 | 34 | ||||||||||||||||||||||||||||||||||||||
Provision for income taxes | 7,128 | 726 | ||||||||||||||||||||||||||||||||||||||
Depreciation and amortization | 14,686 | 14,700 | ||||||||||||||||||||||||||||||||||||||
Contingent consideration fair value adjustment | 90 | 961 | ||||||||||||||||||||||||||||||||||||||
Restructuring activities | — | 1,130 | ||||||||||||||||||||||||||||||||||||||
Gain on sale of building | (5,347 | ) | — | |||||||||||||||||||||||||||||||||||||
Unrealized gain on investment in equity securities | (9,655 | ) | — | |||||||||||||||||||||||||||||||||||||
Impact of | — | 1,647 | Impact of | — | (565 | ) | — | (1,416 | ) | — | (732 | ) | (2 | ) | — | (64 | ) | |||||||||||||||||||||||
Stock-based compensation | 6,934 | 4,338 | Stock-based compensation | — | — | (280 | ) | (151 | ) | (6,371 | ) | (3,980 | ) | (283 | ) | (207 | ) | |||||||||||||||||||||||
Novitium transaction expenses | 713 | 342 | Novitium transaction expenses | — | — | — | — | (713 | ) | (342 | ) | — | — | |||||||||||||||||||||||||||
Litigation expenses | 245 | — | Litigation expenses | — | — | — | — | (245 | ) | — | — | — | ||||||||||||||||||||||||||||
Adjusted non-GAAP EBITDA | $ | 37,633 | $ | 33,013 | As adjusted: | $ | 137,430 | $ | 106,221 | $ | 48,877 | $ | 36,141 | $ | 40,692 | $ | 31,414 | (2) | $ | 10,228 | $ | 5,653 |
(1) Impact of
(2) The Company corrected the Impact of Canada Operations in the Selling, general, and administrative expenses column for the three months ended
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 | |||||||
2024 | 2023 | ||||||
Net Income Available to Common Shareholders | $ | 17,801 | $ | 1,033 | |||
Add/(Subtract): | |||||||
Non-cash interest (income) expense | (10 | ) | 987 | ||||
Depreciation and amortization | 14,686 | 14,700 | |||||
Contingent consideration fair value adjustment | 90 | 961 | |||||
Restructuring activities | — | 1,130 | |||||
Gain on sale of building | (5,347 | ) | — | ||||
Unrealized gain on investment in equity securities | (9,655 | ) | — | ||||
Impact of | — | 1,647 | |||||
Stock-based compensation | 6,934 | 4,338 | |||||
Novitium transaction expenses | 713 | 342 | |||||
Litigation expenses | 245 | — | |||||
Less: | |||||||
Estimated tax impact of adjustments (calc. at 26% and 24% for the three months ended | (1,991 | ) | (5,785 | ) | |||
Adjusted non-GAAP Net Income Available to Common Shareholders (2) | $ | 23,466 | $ | 19,353 | |||
Diluted Weighted-Average | |||||||
Shares Outstanding | 19,422 | 16,531 | |||||
Adjusted Diluted Weighted-Average | |||||||
Shares Outstanding | 19,422 | 16,531 | |||||
Adjusted non-GAAP | |||||||
Diluted Earnings per Share | $ | 1.21 | $ | 1.17 |
(1) Impact of
(2) Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities.
Source:
2024 GlobeNewswire, Inc., source