Question-and-Answer SessionWith that, we can begin. We are pleased to host Nikhil Lalwani, CEO of ANI Pharmaceuticals with us today. Nikhil, why don't we start out by -- maybe if you can just give us a high-level overview of each of your businesses. You have multiple businesses under the ANI Pharmaceuticals umbrella. Talk about the different drivers in each segment and how investors should think about growth in those segments.Nikhil LalwaniPresident, CEO & Director Thank you, Daniel, and good afternoon, eve ...

Question-and-Answer SessionWith that, we can begin. We are pleased to host Nikhil Lalwani, CEO of ANI Pharmaceuticals with us today. Nikhil, why don't we start out by -- maybe if you can just give us a high-level overview of each of your businesses. You have multiple businesses under the ANI Pharmaceuticals umbrella. Talk about the different drivers in each segment and how investors should think about growth in those segments.Nikhil LalwaniPresident, CEO & Director Thank you, Daniel, and good afternoon, eve ...

ANI Pharmaceuticals (NasdaqGM:ANIP) FY Conference September 09, 2025 01:50 PM ET Company ParticipantsDaniel Cohen - Managing DirectorNikhil Lalwani - President and CEONikhil LalwaniOh, you're supposed to read that?Daniel CohenOkay, good afternoon, everybody. My name is Daniel Cohen. I'm a Managing Director in Morgan Stanley. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Mo ...

Summary of ANI Pharmaceuticals FY Conference Call Company Overview - ANI Pharmaceuticals is a publicly traded company listed on Nasdaq under the ticker ANIP [1] Key Points and Arguments - The conference call took place on September 8, 2025, at 09:00 AM ET, indicating a focus on the company's financial performance for the fiscal year [1] - Specific financial metrics and performance indicators were discussed, although detailed figures were not provided in the excerpt [1] - The company likely addressed its strategic initiatives and future outlook, which are critical for investors [1] Important but Possibly Overlooked Content - The call may have included insights into market trends affecting the pharmaceutical industry, which could impact ANI Pharmaceuticals' operations and growth [1] - Potential risks and challenges faced by the company in the current economic environment were likely discussed, although specifics are not available in the excerpt [1] This summary captures the essential elements of the conference call, focusing on the company and industry context without delving into specific financial data or detailed discussions that were not included in the provided content.

ANI Pharmaceuticals FY Conference Summary Company Overview - ANI Pharmaceuticals operates in the biopharmaceutical sector, focusing on rare disease therapeutics, generics, and branded products [2][3] - The company aims to build a high-growth, profitable business while serving patients and improving lives [2] Key Business Segments 1. **Rare Disease** - Primary growth driver with two main products: Purified Cortrophin Gel and ILUVIEN [2][3] - Plans to expand through mergers and acquisitions [2] - Expected to account for 57% of H2 2025 revenues [8] 2. **Generics** - Growth driven by R&D capabilities and U.S.-based manufacturing [3][24] - Achieved record revenues in Q2 2025, with a 22% year-over-year increase [24] 3. **Brands** - Generates high margins and strong cash flows, supporting investments in rare disease [3] Financial Performance - **2025 Guidance**: - Net revenues projected between $818 million to $843 million, representing a 33% to 37% year-over-year growth [3][7] - Adjusted non-GAAP EBITDA expected to be between $213 million to $223 million, indicating a 37% to 43% year-over-year growth [7] - Adjusted non-GAAP EPS forecasted at $6.98 to $7.35, reflecting a 34% to 45% year-over-year growth [7] - **Historical Growth**: - Revenues grew from $316 million in 2022 to a projected $818 million to $843 million in 2025, representing a 38% CAGR [4] - Adjusted non-GAAP EBITDA increased from $56 million in 2022 to a projected $213 million to $223 million in 2025, reflecting a 57% CAGR [4] Product Highlights 1. **Purified Cortrophin Gel** - Key growth asset with expected sales of $326 million in its fourth year [4] - Significant growth driven by new patient starts and demand for new presentations [5][6] - Addressable patient populations are significantly underpenetrated, indicating strong multi-year growth potential [12][18] 2. **ILUVIEN and YUTIQ** - Durable ocular therapies with significant growth potential in underserved patient populations [19][21] - Recent label expansion for chronic non-infectious uveitis and diabetic macular edema [19][20] - Expected revenues between $87 million to $93 million for 2025 [21] Market Dynamics - The overall ACTH market was approximately $600 million in 2022 and is projected to grow to $933 million by 2025 [10][12] - The company maintains a strong commitment to U.S. manufacturing, with over 90% of revenues derived from domestically produced products [6] Strategic Initiatives - Continued investment in R&D to support the use of Cortrophin Gel, including a phase IV clinical trial for acute gouty arthritis [15] - Expansion of sales teams in targeted therapeutic areas to capture revenue synergies [14] - Focus on enhancing patient convenience through new product presentations, such as the prefilled syringe [15] Conclusion - ANI Pharmaceuticals is positioned for strong growth in the rare disease sector, with a strategic focus on expanding its product offerings and addressing underpenetrated markets [25] - The generics business is also expected to contribute significantly to overall revenue growth, supported by operational excellence and cost management strategies [25]

Company Overview - ANI Pharmaceuticals (ANIP) currently holds a Momentum Style Score of A, indicating strong momentum characteristics [2] - The company has a Zacks Rank of 1 (Strong Buy), suggesting a favorable outlook compared to the market [3] Price Performance - Over the past week, ANIP shares have increased by 4.05%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 0.67% [5] - In a longer time frame, ANIP's shares have surged by 43.49% over the past month, while the industry only saw a 0.85% increase [5] - Over the last quarter, ANIP shares have risen by 50.94%, and over the past year, they have gained 46.49%, significantly outperforming the S&P 500's increases of 9.72% and 16.49%, respectively [6] Trading Volume - The average 20-day trading volume for ANIP is 737,319 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the past two months, 6 earnings estimates for ANIP have been revised upwards, with no downward revisions, leading to an increase in the consensus estimate from $6.51 to $7.25 [9] - For the next fiscal year, 6 estimates have also moved higher without any downward revisions [9] Conclusion - Given the strong momentum indicators and positive earnings outlook, ANIP is positioned as a solid momentum pick and is recommended for consideration in the near term [11]

Core Viewpoint - ANI Pharmaceuticals, Inc. is actively engaging with investors through presentations at two upcoming conferences, highlighting its commitment to transparency and investor relations [1]. Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [2]. - The company aims to deliver sustainable growth through its Rare Disease business, Generics business, and Brands business, targeting areas such as ophthalmology, rheumatology, nephrology, neurology, and pulmonology [2]. Upcoming Events - ANI Pharmaceuticals will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 9:00 am ET [1]. - The company will also participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 1:50 pm ET [1]. - Live and archived webcasts of these presentations will be available on the company's website for 90 days [1].

Core Viewpoint - ANI Pharmaceuticals has experienced significant stock performance, with a 36.5% increase over the past month and a 64.9% rise since the beginning of the year, outperforming the Zacks Medical sector and the Zacks Medical - Biomedical and Genetics industry [1][2]. Financial Performance - ANI has consistently exceeded earnings expectations, reporting an EPS of $1.8 against a consensus estimate of $1.38 in its last earnings report [2]. - For the current fiscal year, ANI is projected to achieve earnings of $7.25 per share on revenues of $840.7 million, reflecting a 39.42% increase in EPS and a 36.84% increase in revenues [3]. - The next fiscal year forecasts earnings of $7.74 per share on revenues of $904.39 million, indicating year-over-year changes of 6.64% and 7.58%, respectively [3]. Valuation Metrics - ANI's current valuation metrics show a Value Score of B, with Growth and Momentum Scores of A, resulting in a combined VGM Score of A [6]. - The stock trades at 12.6 times the current fiscal year EPS estimates, below the peer industry average of 20.1 times, and at 12 times trailing cash flow compared to the peer group's average of 16.1 times [6]. Zacks Rank - ANI holds a Zacks Rank of 1 (Strong Buy), driven by rising earnings estimates, which aligns with the recommendation for investors to select stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B [7].

Core Insights - ANI Pharmaceuticals reported $211.37 million in revenue for Q2 2025, a 53.1% year-over-year increase, with an EPS of $1.80 compared to $1.02 a year ago, exceeding Zacks Consensus Estimates [1] - The company achieved a revenue surprise of +12.22% and an EPS surprise of +30.43% compared to analyst expectations [1] Revenue Breakdown - Net Revenues from Rare Disease and Brands - Cortrophin Gel: $81.65 million, surpassing the estimated $65.23 million [4] - Net Revenues from Rare Disease and Brands - ILUVIEN and YUTIQ: $22.32 million, slightly above the $21.74 million estimate [4] - Net Revenues from Generic pharmaceutical products: $90.3 million, exceeding the $85.32 million estimate [4] - Total Net Revenues from Rare Disease: $103.96 million, compared to the estimated $86.96 million [4] - Total Net Revenues from Generics and Other: $94.21 million, slightly below the $96.49 million estimate [4] - Net Revenues from Royalties and other pharmaceutical services: $3.92 million, significantly below the estimated $10.46 million [4] - Total Net Revenues from Rare Disease and Brands: $117.16 million, far exceeding the estimated $94.3 million, representing a year-over-year change of +138.2% [4] Stock Performance - ANI's shares have returned +25.4% over the past month, outperforming the Zacks S&P 500 composite's +2.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market [3]

Financial Data and Key Metrics Changes - The company reported total net revenues of $211.4 million for Q2 2025, representing a year-over-year growth of 53% on an as-reported basis and 37% on an organic basis [9][31] - Adjusted non-GAAP EBITDA was $54.1 million, compared to $33.2 million in the prior year period, reflecting strong operational performance [35] - Adjusted non-GAAP EPS was $1.80 for the second quarter, up from $1.02 in the prior year period [34] Business Line Data and Key Metrics Changes - Revenues from the rare disease segment were $104 million, up 111% from the prior year, driven by strong demand for Cortrophin Gel [31][32] - Cortrophin Gel revenues reached $81.6 million, a 66% increase year-over-year, with new patient starts and cases initiated at record highs [9][32] - The retina portfolio, including ILUVIEN and YUTIQ, generated revenues of $22.3 million, consistent with expectations despite ongoing market access challenges [13][32] - The generics business reported revenues of $90.3 million, a 22% increase over the prior year, supported by new product launches [17][32] Market Data and Key Metrics Changes - The ACTH market grew 27% to $684 million in 2024 and is expected to grow 36% to $933 million in 2025, indicating a robust market opportunity [11] - The current number of patients on ACTH therapy is significantly below historical levels, suggesting substantial room for expansion [11][12] Company Strategy and Development Direction - The company is raising its 2025 guidance for total net revenues to between $818 million and $843 million, reflecting strong momentum across both rare disease and generics business units [8][36] - The focus remains on expanding the Cortrophin Gel franchise and addressing market access challenges in the retina segment [12][17] - The company is committed to maintaining a strong presence in the U.S. pharmaceutical industry, with over 90% of revenues coming from domestically manufactured products [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining robust multiyear growth for Cortrophin Gel, driven by increased demand and a growing prescriber base [12][60] - The company anticipates continued challenges in the retina market due to Medicare access issues but remains optimistic about future revenue synergies [17][29] - Management highlighted the importance of ongoing investments in evidence generation and new product presentations to support long-term growth [43][60] Other Important Information - The company ended Q2 with $217.8 million in unrestricted cash, up from $149.8 million at the end of Q1 [35] - The gross margin for Q2 was 64.9%, an increase of over six points from the prior year, driven by a favorable mix towards rare disease products [34][35] Q&A Session Summary Question: Was there anything unusual in Cortrophin's performance? - Management confirmed that the performance was driven by underlying demand, with new patient starts more than doubling in Q2 2025 compared to Q2 2024 [42] Question: What are the priorities for capital use? - The company aims to build cash reserves for reinvestment into the business and potential M&A, with debt paydowns considered in the future [51] Question: How is the payer landscape expected to evolve? - Management indicated that they will continue to engage with payers as they bring Cortrophin therapy to appropriate patients, but specifics were not disclosed [75] Question: What is driving the growth in the ACTH class? - Multiple factors contribute to growth, including increased prescriber adoption, new indications, and the launch of easier-to-use dosage forms [60] Question: How is the prefilled syringe performing? - Seventy percent of new patient starts were with the prefilled syringe, indicating strong adoption across various indications [62] Question: What impact did the New Day trial results have on ILUVIEN? - While the feedback on the New Day study was positive, the expected benefits will be more long-term rather than immediately reflected in guidance [71]