PRINCETON, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that its Chief Executive Officer, Nikhil Lalwani, has been named an Ernst & Young LLP (EY US) Entrepreneur Of The Year® 2024 New Jersey Award winner. Entrepreneur Of The Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. Mr. Lalwani was selected by an independent judging panel made up of previous award winners, leading CEOs, a ...

PRINCETON, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that its Chief Executive Officer, Nikhil Lalwani, has been named an Ernst & Young LLP (EY US) Entrepreneur Of The Year® 2024 New Jersey Award winner. Entrepreneur Of The Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. Mr. Lalwani was selected by an independent judging panel made up of previous award winners, leading CEOs, ...

Conference call scheduled for today at 8:30 a.m. ET Strengthens Rare Disease segment as largest driver of future growth, expected to add approximately $105 million in highly durable branded revenueAdds two commercial assets ILUVIEN® and YUTIQ® with significant growth potential, expanding ANI’s foothold in key strategic therapeutic area of ophthalmology Anticipated to drive high single digit to low double digit accretion in adjusted non-GAAP EPS in 2025 and to be substantially accretive thereafterExpected to ...

JHVEPhoto/iStock Editorial via Getty Images Since Ani Pharmaceuticals (NASDAQ:ANIP) merged with Biosante Pharmaceuticals in 2013, ANIP's growth has largely been fueled by M&A, the most important of which are the acquisition Purified Cortrophin Gel from Merck & Co., Inc. (MRK) in 2016 and the merger with Novitium Pharma in 2021. The market sees these as drivers of ANIP's growth, and analyst estimates currently reflect this. However, ANIP's royalty revenue potential is largely unnoticed. This article looks at ...

[Legal & Financial Disclosures](index=2&type=section&id=1-legal-financial-disclosures) [Disclaimer](index=2&type=section&id=1-1-disclaimer) This section outlines forward-looking statements, emphasizing that actual results may differ materially due to various risks and uncertainties, and states the company undertakes no obligation to update these statements - Forward-looking statements are subject to risks and uncertainties, including commercialization success, regulatory approvals, supply chain disruptions, and economic conditions, which may cause actual results to differ materially[3](index=3&type=chunk) - The company does not undertake any obligation to update or revise forward-looking statements[3](index=3&type=chunk) [Non-GAAP Financial Measures](index=2&type=section&id=1-2-non-gaap-financial-measures) This section defines non-GAAP financial measures like Adjusted EBITDA and Adjusted EPS, explaining their use by management for evaluation and strategic decisions, while clarifying their limitations - Non-GAAP financial measures, including Adjusted EBITDA and Adjusted EPS, are used by management to evaluate performance and make strategic decisions, providing useful information to investors[4](index=4&type=chunk) - These non-GAAP measures are not substitutes for GAAP measures and have limitations due to subjective calculations and potential differences in calculation methods compared to other companies[4](index=4&type=chunk) - The company does not provide a reconciliation for forward-looking non-GAAP measures due to the inability to accurately estimate all variables and adjustments without unreasonable effort[4](index=4&type=chunk) [Company Profile & Strategic Overview](index=3&type=section&id=2-company-profile-strategic-overview) [Business Model and Growth Pillars](index=3&type=section&id=2-1-business-model-growth-pillars) ANI Pharmaceuticals operates with a business model driven by Rare Disease, Generics, and Established Brands, with Purified Cortrophin® Gel as a key growth driver - ANI's business model is driven by three pillars: Rare Disease (lead asset Purified Cortrophin® Gel), Generics (enhanced R&D and operational excellence), and Established Brands (unique commercial capability, high margins, strong cash flow)[7](index=7&type=chunk) 2023 Financial Snapshot | Metric | Value | | :---------------------------- | :------ | | 2023 Revenue | $487 million | | Adjusted non-GAAP EBITDA Growth | 140% | [Historical Performance and Growth Drivers](index=4&type=section&id=2-2-historical-performance-growth-drivers) ANI has consistently achieved high revenue growth since 2021, with the Rare Disease segment, particularly Cortrophin Gel, projected as the primary future growth driver - ANI has consistently delivered high revenue growth since 2021[8](index=8&type=chunk) - Rare Disease is expected to be the largest driver of growth going forward[8](index=8&type=chunk) - Rare Disease contributed to profitability in 2023, in its second year of launch, following 2022 investment in infrastructure[14](index=14&type=chunk) [Q1 2024 Business Highlights](index=6&type=section&id=2-3-q1-2024-business-highlights) In Q1 2024, ANI saw steady gains for Cortrophin Gel across core therapeutic areas and strong traction in new areas, alongside six new generic product launches - Cortrophin Gel achieved steady gains in Q1 2024 across core therapeutic areas (rheumatology, neurology, nephrology) and strong traction in new areas (pulmonology, ophthalmology)[17](index=17&type=chunk) - Cortrophin Gel momentum continued into Q2 2024 with record new patient starts in April and May[17](index=17&type=chunk) - **Six new generic products** were launched in Q1 2024, leveraging operational excellence and U.S.-based manufacturing[17](index=17&type=chunk) [Financial Outlook: 2024 Guidance](index=7&type=section&id=3-financial-outlook-2024-guidance) [2024 Guidance Overview](index=7&type=section&id=3-1-2024-guidance-overview) ANI Pharmaceuticals has reiterated its 2024 guidance, projecting total net revenue between $520 million and $542 million, with strong contributions from Cortrophin Gel 2024 Full Year Guidance vs. 2023 Actuals | Metric | Full Year 2024 Guidance | 2023 Actuals | | :--------------------------- | :---------------------- | :----------- | | Net Revenue (Total Company) | $520 million - $542 million | $487 million | | Cortrophin Gel Net Revenue | $170 million - $180 million | $112 million | | Adjusted Non-GAAP EBITDA | $135 million - $145 million | $134 million | | Adjusted Non-GAAP Diluted EPS | $4.26 - $4.67 | $4.71 | - 2024 guidance for Adjusted Non-GAAP Diluted EPS reflects a full year of shares outstanding from the May 2023 secondary equity raise[23](index=23&type=chunk) [Rare Disease Segment: Cortrophin Gel](index=8&type=section&id=4-rare-disease-segment-cortrophin-gel) [Cortrophin Gel Product & Market Overview](index=8&type=section&id=4-1-cortrophin-gel-product-market-overview) Cortrophin Gel, a purified corticotropin (ACTH), is a treatment for chronic autoimmune disorders in a market with limited competition and significant growth potential - Cortrophin Gel is purified corticotropin (ACTH) for chronic autoimmune disorders, facing limited competition with high barriers to entry[25](index=25&type=chunk)[28](index=28&type=chunk) - The ACTH market was estimated at **$600 million** at Cortrophin Gel's 2022 launch, with a category potential of **~$1.2 billion** for significant future growth[28](index=28&type=chunk) - Cortrophin Gel is approved for multiple indications, initially launched in nephrology and rheumatology, and recently expanded into pulmonology and ophthalmology[28](index=28&type=chunk) [Cortrophin Gel Performance & Market Expansion](index=9&type=section&id=4-2-cortrophin-gel-performance-market-expansion) Cortrophin Gel is ANI's primary growth engine, demonstrating continued prescription growth and active expansion into new therapeutic areas with new product formulations - Cortrophin Gel shows continued prescription growth in original therapeutic areas (neurology, nephrology, rheumatology) and strong prescribing momentum[30](index=30&type=chunk) - The company is gaining traction in new therapeutic areas, adding a second geographical region to the pulmonology sales force in Q1 2024 and deploying a targeted ophthalmology sales force[30](index=30&type=chunk) - A **1-mL vial** size of Cortrophin Gel was launched in Q4 2023, indicated for acute gouty arthritis flares, expanding treatment options[30](index=30&type=chunk) [ACTH Market Dynamics](index=10&type=section&id=4-3-acth-market-dynamics) The overall ACTH market is projected to return to growth in 2024, with Cortrophin Gel expected to maintain a strong multi-year growth trajectory due to significant room for market expansion - The ACTH market is expected to return to growth in 2024, projected to grow **~8-10%+**[32](index=32&type=chunk) - Cortrophin Gel is believed to remain on a strong multi-year growth trajectory[31](index=31&type=chunk) - The number of patients on ACTH therapy today is substantially lower than a few years ago, indicating significant room for growth[32](index=32&type=chunk) ACTH Market Sales ($ millions) | Year | ACTH Market Sales ($ millions) | | :--- | :----------------------------- | | 2019 | $953 million | | 2020 | $768 million | | 2021 | $594 million | | 2022 | $558 million | | 2023 | $537 million | | 2024E | $580 million - $590 million | [Strategic Expansion Initiatives](index=11&type=section&id=4-4-strategic-expansion-initiatives) ANI is actively pursuing M&A and in-licensing opportunities to expand its Rare Disease business, prioritizing existing therapeutic areas and other rare disease segments - ANI is focused on M&A and in-licensing to expand its Rare Disease business[33](index=33&type=chunk)[34](index=34&type=chunk) - Priority 1 opportunities are in existing therapeutic areas: nephrology, neurology, rheumatology, pulmonology, and ophthalmology[34](index=34&type=chunk) - Priority 2 includes rare disease opportunities outside current priority areas where ANI can leverage its Rare Disease platform[34](index=34&type=chunk) [Generics & Established Brands Segment](index=13&type=section&id=5-generics-established-brands-segment) [R&D, New Product Launches & Operational Excellence](index=13&type=section&id=5-1-rd-new-product-launches-operational-excellence) ANI demonstrates superior R&D capabilities and operational excellence, evidenced by new product launches, high CGT approval rankings, and a strong U.S.-based manufacturing footprint - Launched **six new products** in Q1 2024, including a Competitive Generic Therapy (CGT) product with 180-day exclusivity[38](index=38&type=chunk) - Ranks number two in CGT approvals and among the top 15 manufacturers in product approvals[38](index=38&type=chunk) - Increased 2024 R&D spend to fuel new launches and drive high single-digit/low double-digit growth[38](index=38&type=chunk) - Supplied over **1.5 billion doses** of therapeutics in 2023 and maintains excellent compliance with successful FDA audits across all sites, including a Q1 2024 capacity expansion at the New Jersey site[38](index=38&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk) - Focuses on cost excellence through systematic reduction of raw materials and finished goods costs, and a lean approach to corporate spending[38](index=38&type=chunk) - U.S.-based manufacturing and operational nimbleness enable quick response to drug shortages and patient needs, establishing ANI as a partner of choice[40](index=40&type=chunk) [Financial Strength](index=12&type=section&id=6-financial-strength) [Balance Sheet and Cash Flow](index=12&type=section&id=6-1-balance-sheet-cash-flow) ANI maintains a strong balance sheet to support its Rare Disease business development, reporting $221 million in cash and a significantly improved net debt to EBITDA ratio of 0.5x as of March 31, 2024 Balance Sheet Metrics | Metric | 2022 | 2023 | | :-------------------------- | :--- | :--- | | Cash & Cash Equivalents | $48 million | $221 million | | Net Debt/EBITDA | 4.4x | 0.5x | | Gross Debt | $297 million | $294 million | | Net Debt | $249 million | $73 million | | Adjusted Non-GAAP EBITDA (1) | $56 million | $134 million | - Strong balance sheet supports Rare Disease business development[37](index=37&type=chunk) [Leadership Team](index=15&type=section&id=7-leadership-team) [Executive Management](index=15&type=section&id=7-1-executive-management) ANI Pharmaceuticals is led by an experienced and purpose-driven management team with extensive expertise in pharmaceuticals and healthcare, including key executives across various functions - Nikhil Lalwani, President & CEO, has over **20 years** of leadership experience in pharmaceuticals and a proven track record of strategic growth[89](index=89&type=chunk) - Chris Mutz, Head of Rare Diseases, brings over **25 years** of commercialization experience, including building and leading the launch of Soliris[89](index=89&type=chunk) - Samy Shanmugam, COO & Head of Global R&D, has extensive R&D and operations experience, having developed over **100 specialty dosage forms** and ANDAs[89](index=89&type=chunk) - The leadership team includes experienced professionals in finance (Stephen Carey), HR (Krista Davis), legal (Meredith Cook), generics (Ori Gutwerg), corporate development (Chad Gassert), and operations (James Marken)[89](index=89&type=chunk)[90](index=90&type=chunk) [Key Investment Highlights](index=16&type=section&id=8-key-investment-highlights) [Investment Summary](index=16&type=section&id=8-1-investment-summary) ANI Pharmaceuticals presents a compelling investment case driven by its strong and growing Rare Disease business, robust Generics segment, solid financial strength, and an experienced management team - Strong and growing Rare Disease business, with Cortrophin Gel forecasted at **$170 million - $180 million** revenues in 2024 (**+52% - 61%**) and significant multi-year future growth opportunity[91](index=91&type=chunk) - Robust and nimble Generics segment with targeted growth in the high single-digit to low double-digit range, driven by R&D excellence and reliable supply from U.S. manufacturing[91](index=91&type=chunk) Financial Strength Highlights | Metric | Value (as of March 31, 2024) | | :-------------------------------- | :--------------------------- | | Unrestricted Cash | $229 million | | 2023 Cash Flow from Operations | $119 million | | Estimated 2024 Revenue | $520 million - $542 million (7% - 11% YoY growth) | | Estimated 2024 Adjusted non-GAAP EBITDA | $135 million - $145 million | | Estimated 2024 Adjusted non-GAAP EPS | $4.26 - $4.67 | - Experienced, purpose-driven management team with deep expertise across Rare Disease, Generics, and Established Brands, focused on serving patients[91](index=91&type=chunk) [Appendix: Non-GAAP Reconciliations](index=18&type=section&id=9-appendix-non-gaap-reconciliations) [Adjusted non-GAAP EBITDA Reconciliation](index=18&type=section&id=9-1-adjusted-non-gaap-ebitda-reconciliation) This section provides a detailed reconciliation of Net Income to Adjusted non-GAAP EBITDA for the three months ended March 31, 2024, and 2023, including various non-recurring and non-cash adjustments Adjusted non-GAAP EBITDA Reconciliation (Three Months Ended March 31) | Metric | 2024 ($) | 2023 ($) | | :------------------------------------------ | :--------- | :--------- | | Net Income | 18,207 | 1,439 | | Interest expense, net | 4,600 | 7,696 | | Provision for income taxes | 7,128 | 726 | | Depreciation and amortization | 14,686 | 14,700 | | Contingent consideration fair value adjustment | 90 | 961 | | Restructuring activities | - | 1,130 | | Gain on sale of building | (5,347) | - | | Unrealized gain on investment in equity securities | (9,655) | - | | Impact of Canada operations | - | 1,647 | | Stock-based compensation | 6,934 | 4,338 | | Novitium transaction expenses | 713 | 342 | | Litigation expenses | 245 | - | | **Adjusted non-GAAP EBITDA** | **37,633** | **33,013** | [Adjusted non-GAAP EPS Reconciliation](index=19&type=section&id=9-2-adjusted-non-gaap-eps-reconciliation) This section details the reconciliation of Net Income Available to Common Shareholders to Adjusted non-GAAP Diluted EPS for the three months ended March 31, 2024, and 2023, with adjustments for non-cash and non-recurring items Adjusted non-GAAP EPS Reconciliation (Three Months Ended March 31) | Metric | 2024 ($) | 2023 ($) | | :-------------------------------------------------- | :--------- | :--------- | | Net Income Available to Common Shareholders | 17,801 | 1,033 | | 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 Canada operations | - | 1,647 | | Stock-based compensation | 6,934 | 4,338 | | Novitium transaction expenses | 713 | 342 | | Litigation expenses | 245 | - | | Less: Estimated tax impact of adjustments | (1,991) | (5,785) | | **Adjusted non-GAAP Net Income Available to Common Shareholders** | **23,466** | **19,353** | | Diluted Weighted-Average Shares Outstanding | 19,422 | 16,531 | | **Adjusted non-GAAP Diluted Earnings per Share** | **1.21** | **1.17** |

NEW YORK, May 20, 2024 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) on behalf of the company's shareholders. The investigation seeks to determine whether ANI Pharmaceuticals's directors breached their fiduciary duties in connection with recent corporate actions.If you are a shareholder of ANI Pharmaceuticals, Inc. and are interested in obtaining additional information about your rights and options, please visit us at: https://pjlfirm.com ...

ANI Pharmaceuticals (ANIP) has been on a downward spiral lately with significant selling pressure. After declining 6.2% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a ...

BAUDETTE, Minn., May 20, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the launch of Kionex® (Sodium Polystyrene Sulfonate Suspension USP) for Oral or Rectal use. Kionex® Suspension is the only commercially available therapeutically equivalent to the reference listed drug (RLD) SPS® Suspension for Oral or Rectal use. "The launch of Kionex® Suspension for Oral or Rectal use exemplifies our capability to bring complex generics with limited market competi ...

BAUDETTE, Minn., May 20, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Kionex® (Sodium Polystyrene Sulfonate Suspension USP) for Oral or Rectal use. Kionex® Suspension is the only commercially available therapeutically equivalent to the reference listed drug (RLD) SPS® Suspension for Oral or Rectal use. "The launch of Kionex® Suspension for Oral or Rectal use exemplifies our capability to bring complex generics with limited market compet ...

ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) Q1 2024 Earnings Conference Call May 10, 2024 8:30 AM ET Company Participants Lisa Wilson - In-Site Communications, Investor Relations Nikhil Lalwani - President and Chief Executive Officer Stephen Carey - Senior Vice President, Finance and Chief Financial Officer Conference Call Participants Gary Nachman - Raymond James Leszek Sulewski - Truist Securities Vamil Divan - Guggenheim Securities Oren Livnat - H.C. Wainwright Timothy Chiang - Capital One Operator Good day, ...