ANI Pharmaceuticals Reports Fourth Quarter and Record Full-Year 2023 Financial Results and Provides 2024 Guidance
ANI Pharmaceuticals, Inc. (ANIP) reported strong financial results for Q4 and full year 2023, with quarterly net revenues of $131.7 million, a 39.7% YoY growth, and adjusted non-GAAP EBITDA of $30.2 million. The Rare Disease business saw significant growth, with Q4 net revenues of $41.7 million, a 40.4% QoQ increase. ANIP ended the year with $221.1 million in cash and issued a 2024 guidance with net revenues of $520 million to $542 million.
Positive
Strong financial performance with quarterly net revenues of $131.7 million, a 39.7% YoY growth.
Adjusted non-GAAP EBITDA of $30.2 million and adjusted non-GAAP diluted earnings per share of $1.00.
Rare Disease business showed impressive growth with Q4 net revenues of $41.7 million, a 40.4% QoQ increase.
Generated $119.0 million in cash from operating activities during the year, ending Q4 with $221.1 million in cash.
2024 guidance issued with net revenues of $520 million to $542 million and adjusted non-GAAP EBITDA of $135 million to $145 million.
Guidance includes expected net revenues of $170 million to $180 million for Purified Cortrophin Gel, showing significant growth.
ANI Pharmaceuticals CEO highlighted the record growth in annual net revenue and adjusted non-GAAP EBITDA.
Expectations for continued growth in Rare Disease business with a focus on Cortrophin Gel franchise.
Plans to launch new products, address patient needs, and drive market share in core therapeutic areas.
Strong balance sheet provides flexibility for further expansion in Rare Disease business.
The reported financial results by ANI Pharmaceuticals, Inc. reflect a robust fiscal performance, with a significant year-over-year growth of 39.7% in net revenues , which is a strong indicator of the company's expanding market presence and operational efficiency. The net income to common shareholders and the GAAP diluted earnings per share provide a snapshot of profitability that is essential for shareholders assessing the company's earnings quality. Moreover, the adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share are critical metrics for investors as they exclude non-recurring items, providing a clearer picture of the company's ongoing financial health.
The Rare Disease business segment's remarkable growth, with a quarter-over-quarter increase of 40.4% and a year-over-year surge of 137.3%, signals strong market demand and successful commercialization efforts for their products, notably the Cortrophin Gel. The provided 2024 guidance with projected net revenues and EBITDA suggests confidence in sustained growth and operational performance. The anticipated growth in Cortrophin Gel revenues indicates the company's strategic focus on this product, potentially leading to increased market share and revenue diversification.
Investors would be prudent to consider the company's operational cash flow, which at $119.0 million, alongside a solid ending cash position of $221.1 million, signifies a robust liquidity position that could support future investments and buffer against market volatility. The financial guidance for the upcoming year, especially the expected revenue growth from Cortrophin Gel, is an optimistic sign but also warrants scrutiny to ensure these targets are realistic and achievable.
The performance of ANI Pharmaceuticals, particularly in the Rare Disease sector, reflects a well-executed strategy in a niche but rapidly growing market. The Rare Disease market is known for high barriers to entry due to the complexity of the diseases and the treatments involved, which can lead to less competition and potentially higher profit margins for companies that succeed. The significant growth in the Rare Disease business, especially with Cortrophin Gel, suggests that ANI has effectively capitalized on this opportunity.
ANI's focus on R&D, operational excellence and U.S.-based manufacturing provides a competitive advantage in terms of speed to market and compliance with regulatory standards. The company's strategic direction to expand the overall ACTH market and enter new therapeutic areas could further strengthen its market position. However, it is essential to monitor the competitive landscape and the entry of new players or alternative therapies that could impact ANI's market share and growth trajectory.
The reference to new patient starts and the increase in new unique and repeat prescribers is a positive indicator of the product's acceptance in the market and the effectiveness of the company's sales and marketing strategies. The company's strong balance sheet and the intention to leverage it for expanding the Rare Disease business suggest potential future acquisitions or investments that could enhance the company's portfolio and drive long-term growth.
The impressive growth of ANI's Rare Disease business, particularly the Cortrophin Gel, highlights the product's increasing acceptance in the healthcare market. Cortrophin Gel is a therapeutic for certain chronic autoimmune disorders and its success is indicative of effective clinical application and market penetration. The acceleration in new patient starts in the fourth quarter suggests that the drug is gaining traction among healthcare providers and patients, which is often a result of positive clinical outcomes and effective marketing.
ANI's intention to expand into new therapeutic areas and indications for Cortrophin Gel could potentially increase the addressable market for the product. However, this expansion requires continuous investment in clinical research to support the safety and efficacy of the product in new indications. The company's R&D capabilities will be crucial in driving these efforts and maintaining the momentum in revenue growth.
It is important to assess the sustainability of growth within the Rare Disease market, as it often involves high-cost treatments and a limited patient population. The long-term success of ANI's Rare Disease portfolio will depend on ongoing investment in R&D, maintaining a strong regulatory compliance record and navigating the complexities of market access and reimbursement within the healthcare system.
02/29/2024 - 06:50 AM
Generated quarterly net revenues of $131.7 million, representing year-over-year growth of 39.7% , net income to common shareholders of $0.7 million , GAAP diluted earnings per share of $0.04 Delivered adjusted non-GAAP EBITDA of $30.2 million, and adjusted non-GAAP diluted earnings per share of $1.00 Rare Disease business delivered Q4 net revenues of $41.7 million, representing quarter-over-quarter growth of 40.4% and year-over-year growth of 137.3% Generated $119.0 million in cash from operating activities during the year, ending Q4 with $221.1 million in cash 2024 guidance issued w ith 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 t o $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% BAUDETTE, Minn., Feb. 29, 2024 (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, 2023.
Nikhil Lalwani, President and CEO of ANI stated, “The fourth quarter capped off a record year for ANI, as we delivered record growth in annual net revenue and adjusted non-GAAP EBITDA. For our lead Rare Disease asset, Cortrophin Gel, new patient starts accelerated in Q4, and we posted the strongest sequential growth in net revenue to date. The momentum continued for new cases initiated, new unique and repeat prescribers, and we made steady gains across all core indications while also tapping into new therapeutic areas.”
“In 2024, we will continue to use our highly capable R&D engine, operational excellence and U.S.-based manufacturing footprint to launch new products and address patient needs. We expect our Rare Disease business to remain the primary driver of growth, with our Cortrophin Gel franchise estimated to deliver more than a 50% year-on-year increase in revenues in 2024. We are still early in the trajectory for this franchise and believe we have plenty of headroom to drive market share in our core therapeutic areas while also addressing new indications and expanding the overall ACTH market. We believe our strong balance sheet gives us the flexibility to further increase the scope and scale of our Rare Disease business by adding an asset that will leverage our well-established platform. With a record 2023, we are excited about the path ahead, and the opportunity to continue ‘Serving Patients, Improving Lives’,” concluded Mr. Lalwani.
Fourth Quarter and Recent Business Highlights:
Rare Disease Business
Revenues for the Company’s lead asset, Cortrophin Gel, totaled $41.7 million for the fourth quarter of 2023, an increase of 137.3% over the same period in 2022, driven by increased volume. During the quarter, the Company achieved a record number of new cases initiated and new patient starts, and saw continued growth in the number of new unique and repeat prescribers. The overall ACTH category again experienced growth led by increased demand for Cortrophin Gel across the initially targeted specialties of neurology, rheumatology, and nephrology, while gaining momentum in the newer area of pulmonology.
The Company continues to believe that its Rare Disease business remains ANI’s largest future growth driver, and is actively exploring opportunities to acquire assets and/or establish partnerships to increase its scope and scale.
Generics Business, Established Brands and Other
Revenues for generic pharmaceuticals products, established brands and other grew 17.3% year-over-year in the fourth quarter of 2023. ANI’s Generics business concluded a successful year with 11 new products launched, 20 new products filed and the number two ranking retained in Competitive Generic Therapy approvals.
Throughout 2023, ANI supplied patients with over 1.5 billion doses of therapeutics to patients in need and leveraged its operational excellence and U.S.-based manufacturing to further market share gains by providing customers a stable supply of products.
Fourth Quarter 2023 Financial Results
Three Months Ended December 31, (in thousands) 2023 2022 Change % Change Generics, Established Brands, and Other Segment Generic pharmaceutical products $ 71,826 $ 58,014 $ 13,812 23.8 % Established brand pharmaceutical products, royalties, and other pharmaceutical services 18,079 18,628 (549 ) (2.9 )% Generics, established brands, and other segment total net revenues $ 89,905 $ 76,642 $ 13,263 17.3 % Rare Disease Segment Rare disease pharmaceutical products 41,749 17,590 24,159 137.3 % Total net revenues $ 131,654 $ 94,232 $ 37,422 39.7 %
Net revenues for generic pharmaceutical products were $71.8 million , an increase of 23.8% year-over-year, driven by increased volumes in the base business and contribution from new products launched in 2022 and 2023.
Net revenues for established brand pharmaceutical products, royalties, and other pharmaceutical services were $18.1 million , a decrease of 2.9% year-over-year, driven by lower volume.
Net revenues for Rare Disease pharmaceutical products, which consist entirely of sales of Cortrophin Gel, were $41.7 million , an increase of 137.3% year-over-year driven by increased volume.
Operating expenses were $124.9 million , an increase of 35.2% year-over-year, as a result of the following factors:
Cost of sales increased 47.1% year-over-year to $53.4 million , primarily due to significant growth in sales volumes of generic and Rare Disease pharmaceutical products. Research and development expenses increased 89.0% year-over-year to $9.9 million , primarily due to a higher level of activity associated with ongoing and new projects. Selling, general, and administrative expenses increased 34.0% year-over-year to $44.5 million , primarily due to increased employment related costs, Rare Disease sales and marketing costs, legal expenses, and patient assistance program costs, as well as an overall increase in activities required to support growth. Net income available to common shareholders for the fourth quarter of 2023 was $0.7 million as compared to net loss of $(4.7) million in the prior year period. Diluted earnings per share for the fourth quarter of 2023 was $0.04 compared to diluted GAAP loss per share of $(0.28) in the prior year period.
Adjusted non-GAAP diluted earnings per share was $1.00 in the fourth quarter of 2023 compared to $0.76 in the fourth quarter of 2022.
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, 2023, the Company had $221.1 million in unrestricted cash and cash equivalents, $162.1 million in net accounts receivable and $294.0 million (face value) in outstanding debt. The Company generated year-to-date cash flow from operations of $119.0 million .
Full Year 2024 Guidance:
(in millions, except for percentages and EPS) 2024 Guidance 2023 Actual Growth Net Revenue (Total Company) $520 million - $542 million $ 486.8 7% - 11% Cortrophin Gel Net Revenue $170 million - $180 million $ 112.1 52% - 61% Adjusted Non-GAAP EBITDA $135 million - $145 million $ 133.8 1% - 8% Adjusted Non-GAAP Diluted EPS $4.26 - $4.67 $ 4.71 (10)% - (8)%
ANI expects total company adjusted non-GAAP gross margin between 62% and 63% . In addition, the Company anticipates between 19.3 million and 19.7 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 a U.S. GAAP effective tax rate of between approximately 20.0% to 22.0% . The Company will tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share at a tax rate of 26.0% .
Conference Call
The Company’s management will host a conference call today to discuss its fourth quarter and full-year 2023 results.
Date Thursday, February 29, 2024
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 800-839-8531 and entering access code 4470257.
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. Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin Gel pre-launch charges and sales and marketing expenses from its non-GAAP results. Historically, the Company excluded these charges. These changes have been made to align with views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes.
Adjusted non-GAAP EBITDA is defined as net income (loss), excluding tax expense or benefit, interest expense, (net), other expense, (net), depreciation, amortization, the excess of fair value over cost of acquired inventory, non-cash stock-based compensation expense, Novitium transaction expenses, contingent consideration fair value adjustment, 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 (Loss)
ANI’s management considers adjusted non-GAAP net income (loss) 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 excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Novitium transaction expenses, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income (loss) when analyzing Company performance. Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin Gel pre-launch charges and sales and marketing expenses from its non-GAAP results. Historically, the Company excluded these charges. These changes have been made to align with views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes.
Adjusted non-GAAP net income (loss) is defined as net income (loss), plus the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation expense, Novitium transaction expenses, non-cash interest expense, depreciation and amortization expense, contingent consideration fair value adjustment, 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 (loss) should be considered in addition to, but not in lieu of, net income (loss) reported under GAAP. A reconciliation of adjusted non-GAAP net income (loss) to the most directly comparable GAAP financial measure is provided below.
Adjusted non-GAAP Diluted Earnings (Loss) per Share
ANI’s management considers adjusted non-GAAP diluted earnings (loss) 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 excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Novitium transaction expenses, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted earnings (loss) per share when analyzing Company performance.
Adjusted non-GAAP diluted earnings (loss) per share is defined as adjusted non-GAAP net income (loss), 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 (loss) per share should be considered in addition to, but not in lieu of, diluted earnings or loss per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings (loss) 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: 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; whether we experience difficulties closing a sale transaction with a buyer for the plant and property resulting from the closure of our Oakville, Ontario manufacturing plant; 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, or conflicts relating to attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, such as COVID-19, 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. lwilson@insitecony.com
SOURCE: ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, Inc. and Subsidiaries Table 1: US GAAP Statement of Operations (unaudited, in thousands, except per share amounts) Three Months Ended December 31, Twelve Months Ended December 31, 2023 2022 2023 2022 Net Revenues $ 131,654 $ 94,232 $ 486,816 $ 316,385 Operating Expenses Cost of sales (excluding depreciation and amortization) 53,420 36,326 181,513 138,785 Research and development 9,867 5,222 34,286 22,318 Selling, general, and administrative 44,462 33,188 161,697 124,044 Depreciation and amortization 15,194 14,484 59,791 56,972 Contingent consideration fair value adjustment 1,985 1,624 1,426 3,758 Restructuring activities - 1,568 1,132 5,679 Intangible asset impairment charge - - - 112 Total Operating Expenses 124,928 92,412 439,845 351,668 Operating Income (Loss) 6,726 1,820 46,971 (35,283 ) Other Expense, net Interest expense, net (5,746 ) (7,506 ) (26,940 ) (28,052 ) Other (expense) income, net (33 ) (42 ) (159 ) 670 Income (Loss) Before (Benefit) Expense for Income Taxes 947 (5,728 ) 19,872 (62,665 ) Income tax (benefit) expense (208 ) (1,485 ) 1,093 (14,769 ) Net Income (Loss) $ 1,155 $ (4,243 ) $ 18,779 $ (47,896 ) Dividends on Series A Convertible Preferred Stock (406 ) (407 ) $ (1,625 ) (1,625 ) Net Income (Loss) Available to Common Shareholders $ 749 $ (4,650 ) $ 17,154 $ (49,521 ) Basic and Diluted Income (Loss) Per Share: Basic Income (Loss) Per Share $ 0.04 $ (0.28 ) $ 0.86 $ (3.05 ) Diluted Income (Loss) Per Share $ 0.04 $ (0.28 ) $ 0.85 $ (3.05 ) Basic Weighted-Average Shares Outstanding 19,003 16,325 18,001 16,260 Diluted Weighted-Average Shares Outstanding 19,219 16,325 18,194 16,260
ANI Pharmaceuticals, Inc. and Subsidiaries Table 2: US GAAP Balance Sheets (unaudited, in thousands) December 31, 2023 December 31, Current Assets Cash and cash equivalents $ 221,121 $ 48,228 Current restricted cash - 5,006 Accounts receivable, net 162,079 165,438 Inventories 111,196 105,355 Prepaid income taxes - 3,827 Assets held for sale 8,020 8,020 Prepaid expenses and other current assets 17,400 8,387 Total Current Assets 519,816 344,261 Non-current Assets Property and equipment, net 44,593 43,246 Deferred tax assets, net of deferred tax liabilities and valuation allowance 90,711 81,363 Intangible assets, net 209,009 251,635 Goodwill 28,221 28,221 Derivatives and other non-current assets 12,072 11,361 Total Assets $ 904,422 $ 760,087 Current Liabilities Current debt, net of deferred financing costs $ 850 $ 850 Accounts payable 36,683 29,305 Accrued royalties 16,276 9,307 Accrued compensation and related expenses 23,786 10,312 Accrued government rebates 12,168 10,872 Income taxes payable 8,164 - Returned goods reserve 29,678 33,399 Current contingent consideration 12,266 - Accrued expenses and other 5,606 5,394 Total Current Liabilities 145,477 99,439 Non-current Liabilities Non-current debt, net of deferred financing costs and current component 284,819 285,669 Non-current contingent consideration, net of current 11,718 35,058 Other non-current liabilities 4,809 1,381 Total Liabilities $ 446,823 $ 421,547 Mezzanine Equity Convertible Preferred Stock, Series A 24,850 24,850 Stockholders’ Equity Common Stock 2 1 Class C Special Stock - - Preferred Stock - - Treasury stock (10,081 ) (5,094 ) Additional paid-in capital 514,103 403,901 Accumulated deficit (80,132 ) (97,286 ) Accumulated other comprehensive income, net of tax 8,857 12,168 Total Stockholders’ Equity 432,749 313,690 Total Liabilities, Mezzanine Equity, and Stockholders’ Equity $ 904,422 $ 760,087
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 Three Months Three Months Three Months Three Months 2023 2022 2023 2022 2023 2022 2023 2022 2023 2022 Net Income (Loss) $ 1,155 $ (4,243) As reported: $ 131,654 $ 94,232 $ 53,420 $ 36,326 $ 44,462 $ 33,188 $ 9,867 $ 5,222 Add/(Subtract): Interest expense, net 5,746 7,506 Other expense, net 33 42 Benefit for income taxes (208) (1,485) Depreciation and amortization 15,194 14,484 Contingent consideration fair value adjustment 1,985 1,624 Restructuring activities — 1,568 Impact of Canada operations (1) 283 79 Impact of Canada operations (1) — (1,227) (51) (474) (232) (776) — (56) Stock-based compensation 5,621 3,737 Stock-based compensation — — (185) (104) (5,196) (3,444) (240) (189) Excess of fair value over cost of acquired inventory — 48 Excess of fair value over cost of acquired inventory — — — (48) — — — — Novitium transaction expenses 391 (31) Novitium transaction expenses — — — — (391) 31 — — Adjusted non-GAAP EBITDA $ 30,200 $ 23,329 As adjusted: $ 131,654 $ 93,005 $ 53,184 $ 35,700 $ 38,643 $ 28,999 $ 9,627 $ 4,977 (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 (on-going as of December 31, 2023). 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, 2023 2022 2023 2022 2023 2022 2023 2022 2023 2022 Net Income (Loss) $ 18,779 $(47,896) As reported: $ 486,816 $ 316,385 $ 181,513 $ 138,785 $ 161,697 $ 124,044 $ 34,286 $ 22,318 Add/(Subtract): Interest expense, net 26,940 28,052 Other expense, net (1) 159 80 Expense (benefit) for income taxes 1,093 (14,769) Depreciation and amortization 59,791 56,972 Contingent consideration fair value adjustment 1,426 3,758 Intangible asset impairment charge — 112 Restructuring activities 1,132 5,679 Impact of Canada operations(2) 2,697 2,740 Impact of Canada operations(2) (565) (3,241) (1,884) (2,404) (1,304) (3,374) (73) (203) Stock-based compensation 20,652 14,599 Stock-based compensation — — (706) (546) (19,036) (13,302) (910) (751) Excess of fair value over cost of acquired inventory — 5,294 Excess of fair value over cost of acquired inventory — — — (5,294) — — — — Novitium transaction expenses 1,148 1,244 Novitium transaction expenses — — — — (1,148) (1,244) — — Adjusted non-GAAP EBITDA $ 133,817 $ 55,865 As adjusted: $ 486,251 $ 313,144 $ 178,923 $ 130,541 $ 140,209 $ 106,124 $ 33,303 $ 21,364 (1) Adjustment to Other expense, net excludes $750 thousand of income related to the sale of an ANDA during the twelve months ended December 31, 2022.(2) 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 (on-going as of December 31, 2023). 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, 2023 2022 2023 2022 Net Income (Loss) Available to Common Shareholders $ 749 $ (4,650 ) $ 17,154 $ (49,521 ) Add/(Subtract): Non-cash interest expense 804 982 3,335 3,865 Depreciation and amortization 15,194 14,484 59,791 56,972 Contingent consideration fair value adjustment 1,985 1,624 1,426 3,758 Restructuring activities — 1,568 1,132 5,679 Intangible asset impairment charge — — — 112 Impact of Canada operations (1) 283 79 2,697 2,740 Stock-based compensation 5,621 3,737 20,652 14,599 Excess of fair value over cost of acquired inventory — 48 — 5,294 Novitium transaction expenses 391 (31 ) 1,148 1,244 Less: Estimated tax impact of adjustments (calc. at 24% ) (5,827 ) (5,398 ) (21,643 ) (22,623 ) Adjusted non-GAAP Net Income Available to Common Shareholders (2) $ 19,200 $ 12,443 $ 85,692 $ 22,119 Diluted Weighted-Average Shares Outstanding 19,219 16,325 18,194 16,260 Adjusted Diluted Weighted-Average Shares Outstanding 19,219 16,357 18,194 16,282 Adjusted non-GAAP Diluted Earnings per Share $ 1.00 $ 0.76 $ 4.71 $ 1.36 (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 (on-going as of December 31, 2023). 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 (Loss) Available to Common Shareholders excludes undistributed earnings to participating securities.
ANI Pharmaceuticals reported quarterly net revenues of $131.7 million for Q4 2023, a 39.7% year-over-year growth.
ANI Pharmaceuticals delivered adjusted non-GAAP EBITDA of $30.2 million in Q4 2023.
ANI Pharmaceuticals generated $119.0 million in cash from operating activities during 2023.
ANI Pharmaceuticals issued a 2024 guidance with net revenues expected to be between $520 million to $542 million.
The 2024 guidance includes Purified Cortrophin Gel (Cortrophin Gel) net revenues of $170 million to $180 million.
The CEO highlighted the record growth in annual net revenue and adjusted non-GAAP EBITDA for ANI Pharmaceuticals in 2023.
ANI Pharmaceuticals plans to focus on the growth of the Rare Disease business, particularly the Cortrophin Gel franchise, in 2024.
ANI Pharmaceuticals aims to launch new products, address patient needs, and expand market share in core therapeutic areas.
The strong balance sheet of ANI Pharmaceuticals provides flexibility for further expansion in the Rare Disease business.
The 2024 guidance includes a year-over-year growth of 52% to 61% for Purified Cortrophin Gel net revenues.
