Core Insights - OneSource Specialty Pharma has received approval for its generic version of Ozempic in Saudi Arabia, allowing it to enter a significant market for type-2 diabetes and weight-loss drugs [1][2] - The partnership with Hikma Pharmaceuticals PLC aims to meet the rising demand for affordable generic drug alternatives in the Middle East and North Africa (MENA) region [3][4] Company Strategy - OneSource will manufacture semaglutide at its Bengaluru facility, while Hikma will leverage its commercial reach to enhance the drug's availability [3] - The collaboration with Hikma, the largest pharmaceutical company in the MENA region by sales, is expected to provide a strong platform for scaling access to this therapy [4] Market Dynamics - OneSource is preparing for a significant increase in demand for generic semaglutide as Novo Nordisk is set to lose patent exclusivity in over 80 countries this year [5] - The company is fast-tracking a $100 million capacity expansion to capitalize on the global boom in weight-loss drugs [5] Financial Performance - In Q3, OneSource's revenue fell 26% year-over-year to ₹290.3 crore ($33.1 million) due to delays in semaglutide approvals in Canada [6] - The company's EBITDA dropped 88%, with the EBITDA margin contracting to 6% from 36% a year earlier [6] - OneSource aims to achieve $500 million in revenue by FY28 [6]

Financial Performance - The company reported a consolidated revenue of INR 8,727 crores ($971 million), reflecting a year-over-year growth of 4.4% and a sequential decline of 0.9% [7] - The EBITDA margin was reported at 23.5%, which included a one-time provision related to new labor codes; adjusting for this, the underlying EBITDA margin was 24.8% [10][15] - Profit after tax attributable to equity holders was INR 1,210 crores ($135 million), a decline of 14% year-over-year and 16% sequentially [11] Business Line Performance - The North America generic business generated revenues of $338 million, a decline of 16% year-over-year and 9% sequentially, primarily due to lower lenalidomide sales [21] - The European generic business reported revenue of $140 million, showing a growth of 4% year-over-year and sequentially [21] - The emerging market business delivered revenue of INR 1,896 crores, reflecting robust growth of 32% year-over-year and 15% sequentially [22] - The India business reported revenue of INR 1,603 crores, achieving a healthy double-digit growth of 19% year-over-year and 2% sequentially [23] - The PSA business reported revenue of $92 million, resulting in a decline of 5% year-over-year and 15% sequentially [24] Market Performance - The company’s emerging market growth was driven by new product launches and favorable forex, with Russia showing a growth of 21% year-over-year [22] - In India, the company outperformed the Indian pharmaceutical market with a quarterly growth of 12.3% compared to the market's 11.8% [23] Strategic Direction - The company entered a strategic collaboration with Immutep for the commercialization of a novel immunotherapy oncology drug, Eftilagimod Alpha, with potential milestones of up to $350 million [16] - The integration of the acquired nicotine replacement therapy business is progressing well, with 85% of the business now under operational controls [16] - The company is focused on advancing its key pipeline products, including Semaglutide and Abatacept, and aims to enhance its innovation portfolio through strategic collaborations [24] Management Commentary - Management expressed confidence in the sustainability of the strong growth in the India business, attributing it to the performance of innovative products and effective brand strategies [32][45] - The management acknowledged challenges in the U.S. market due to lenalidomide sales decline but noted that the base business is growing [56] - The company is preparing for potential competition in the Semaglutide market but remains optimistic about maintaining a competitive edge [49][51] Other Important Information - The company announced a science-based net-zero climate target, making it the only Indian pharmaceutical company to commit to such a target by FY24 [20] - The company has a net cash surplus of INR 3,069 crores ($342 million) as of December 31, 2025 [12] Q&A Session Question: What is the organic growth for the India business considering the Stugeron acquisition? - Management indicated that organic growth without acquisitions is more than 17% [29][30] Question: What is driving the strong growth in the India business? - The growth is primarily driven by innovative products that are gaining market recognition [32] Question: What are the expectations for Semaglutide approval in Canada? - Approval is expected between February and May, with preparations for a launch in Q4 or Q1 [40][41] Question: How much has lenalidomide contributed to EBITDA margins this quarter? - Management could not disclose specific figures due to confidentiality but noted that the decline in the U.S. is primarily due to lenalidomide [56] Question: What are the timelines for Denosumab and Rituximab in the U.S.? - Denosumab is expected to face delays of at least six months, while Rituximab's re-inspection is anticipated soon [60][66] Question: What is the addressable market for Abatacept in Europe? - The addressable market is estimated to be around $2 billion, with plans to launch in multiple countries [94]

Financial Performance - The company reported a consolidated revenue of 8,727 crores (approximately $971 million), reflecting a year-over-year growth of 4.4% but a sequential decline of 0.9% [5][9] - The EBITDA margin was reported at 23.5%, which included a one-time provision related to new labor codes in India; adjusting for this, the underlying EBITDA margin was 24.8% [4][8] - Profit after tax attributable to equity holders was 1,210 crores (approximately $135 million), a decline of 14% year-over-year and 16% sequentially [9] Business Line Performance - The North America generic business generated revenues of $338 million, a decline of 16% year-over-year and 9% sequentially, primarily due to lower lenalidomide sales and pricing pressures [18] - The European generic business reported revenue of $140 million, showing a growth of 4% year-over-year and sequentially [18] - The emerging market business delivered revenue of 1,896 crores, reflecting robust growth of 32% year-over-year and 15% sequentially, driven by new product launches and favorable forex [19] - The India business reported revenue of 1,603 crores, achieving a healthy double-digit growth of 19% year-over-year and 2% sequentially, attributed to innovation and new brand launches [20] Market Performance - The company’s emerging market segment, particularly Russia, showed a growth of 21% year-over-year and 16% sequentially in constant currency terms, despite adverse macroeconomic conditions [19] - The company continues to outperform the Indian pharmaceutical market, with a moving quarterly total months growth of 12.3% compared to the market growth of 11.8% [20] Strategic Direction - The company entered a strategic collaboration with Immutep for the commercialization of a novel immunotherapy oncology drug, Eftilagimod Alpha, with potential milestones of up to $350 million [13] - The integration of the acquired nicotine replacement therapy business is progressing well, with 85% of the business now under operational controls [14] - The company is focused on advancing its key pipeline products, including Semaglutide and Abatacept, and aims to launch these products in various markets [15][16] Management Commentary - Management expressed confidence in the sustainability of growth in the India business, attributing it to the performance of innovative products and effective pricing strategies [25][30] - The company anticipates a competitive landscape for Semaglutide in Canada but remains optimistic about maintaining healthy pricing [31] - Management indicated that the new labor law provisions would have a limited impact on future employee expenses, estimating a potential increase of less than 50 basis points [42] Other Important Information - The company announced a science-based net-zero climate target, making it the only Indian pharmaceutical company to commit to such a target by FY24 [18] - The company has a net cash surplus of 3,069 crores (approximately $342 million) as of December 31, 2025 [9] Q&A Session Summary Question: How should organic growth for the India business be viewed, considering the Stugeron acquisition? - Management indicated that organic growth without acquisitions would still be above 17% [25] Question: What is driving the strong growth in the India business? - The growth is primarily driven by innovative products that are gaining market recognition [26] Question: What are the expectations for Semaglutide approval in Canada? - Approval is expected between the end of February and May, with preparations for a launch in Q4 [28] Question: What is the outlook for SG&A spend in FY27? - SG&A spend is expected to grow at a slower rate, with a focus on cost containment [55]

Core Insights - ANI Pharmaceuticals (ANIP) and Teva Pharmaceuticals (TEVA) are both key players in the pharmaceutical sector, focusing on generic and specialty medications [1][2] - ANIP's growth is primarily driven by its rare disease therapies, particularly Cortrophin Gel, while TEVA operates as a global leader in both branded and generic drugs [1][10] Summary of ANI Pharmaceuticals (ANIP) - ANIP has shown strong financial performance, particularly in its rare disease and generics segments [3] - The rare disease franchise, led by Cortrophin Gel, is the main growth driver, with projected sales of approximately $348 million for 2025, reflecting a 76% year-over-year increase [4] - For 2026, ANIP anticipates Cortrophin Gel sales to reach between $540 million and $575 million, indicating a 55-65% increase over 2025 [5] - The company also expects its recently acquired ophthalmology assets to contribute around $75 million in 2025, with growth anticipated in 2026 [6] - Total projected revenues for ANIP in 2026 are estimated to be between $1.055 billion and $1.115 billion, with about 60% from rare disease products [7] - The generics segment is expected to contribute 40% of revenues, with plans to launch 10-15 new generic products annually [8] - Competitive pressure is increasing in the rare disease market, particularly from Keenova Therapeutics' Acthar Gel, which has raised its sales growth outlook [9] Summary of Teva Pharmaceuticals (TEVA) - TEVA is the largest generic drug company globally, holding a 7% market share in the U.S. generics market [12] - The company has been expanding its biosimilars portfolio, with several successful launches and a goal to double biosimilars sales by 2027 [15] - TEVA maintains a diversified portfolio of branded products, with growing market shares for newer drugs like Austedo, Ajovy, and Uzedy [16] - However, the generics business has faced challenges, including competitive pressure and a decline in certain markets [17] - TEVA's revenue estimates for 2026 are expected to remain flat, with EPS growth projected at 6% [21] Financial Performance and Valuation - Over the past year, ANIP shares have increased by 48%, while TEVA shares have risen by 49%, outperforming the industry average of 39% [22] - ANIP trades at a price/earnings (P/E) ratio of 12.74, slightly higher than TEVA's 12.39, indicating a premium valuation for ANIP [23] Investment Outlook - ANIP's sales momentum and earnings growth provide a competitive edge over TEVA, which is experiencing margin pressures [27] - ANIP holds a Zacks Rank of 2 (Buy), while TEVA has a Zacks Rank of 3 (Hold), further supporting ANIP's favorable investment position [28]

Expansion Plans - Hims and Hers is expanding its telehealth platform globally, moving from the US and UK to Germany, Spain, France, Ireland, and Canada by the end of 2025 [1] - The company has completed an all-cash acquisition of Live Well, a Canadian digital health provider focused on weight loss care, which positions Hims and Hers in a market where two-thirds of adults are living with obesity [2] Product Rollout - The acquisition sets the stage for a full rollout of weight loss products in the upcoming year, coinciding with the expected availability of the first generic semaglutide, a drug similar to Novo's blockbuster offerings [3] - The introduction of lower-cost generics is anticipated to significantly impact affordability and demand for obesity therapies [4] Market Dynamics - Hims and Hers' CEO highlighted that unbranded GLP-1s represent a unique opportunity to assess the effects of a different price point on public health, potentially pressuring major pharmaceutical companies like Novo and Eli Lilly to reduce their prices [4] - Although no supplier has been secured in Canada for the generic drugs yet, an unbranded version is expected to be approved by June 2026 at approximately half the price of branded alternatives [5]

Financial Performance - The company achieved consolidated revenue of ₹8,805 crores (approximately $992 million), reflecting a year-over-year growth of 9.8% and a sequential growth of 3% [8][19] - EBITDA margin for the quarter was reported at 26.7%, a decrease of 174 basis points year-over-year, but flat sequentially [13][20] - Profit after tax attributable to equity holders was ₹14.37 crores (approximately $162 million), representing a 14% year-over-year growth [16] Business Line Performance - The North America generic business generated revenues of $373 million, a decline of 16% year-over-year, primarily due to price erosion in key products [27] - The European business reported revenues of €135 million, a growth of 150% year-over-year, driven by contributions from the acquired nicotine replacement therapy portfolio [28] - The emerging market business delivered revenue of ₹16.55 crores, reflecting a growth of 14% year-over-year [30] Market Performance - The India business reported revenues of ₹15.78 crores, achieving a year-over-year growth of 137% [31] - The company's market position in India improved, moving up to the ninth position in the pharmaceutical market as of September [31] - The PSAI business reported revenue of $108 million, registering growth of 8% year-over-year [32] Strategic Direction and Industry Competition - The company is focused on growing its base business, scaling its presence in consumer healthcare, and advancing innovative therapies and biosimilars [19][33] - The integration of the acquired nicotine replacement therapy business is progressing well, with successful integration in key markets [23] - The company aims to enhance cost efficiencies while pursuing business development activities to support sustainable growth [19] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in maintaining double-digit growth in markets outside the U.S. over the next one to two years [10][96] - The company is actively pursuing strategic collaborations and partnerships to enhance its innovation ecosystem and accelerate development timelines [32] - Management acknowledged challenges in the U.S. generics market but remains optimistic about future product launches and pipeline developments [39][86] Other Important Information - The company retained its MSCI ESG rating of A for the second consecutive year, indicating strong sustainability performance [26] - The company has a net cash surplus of approximately $310 million, reinforcing its balance sheet strength [21] Q&A Session Summary Question: What should be expected for the U.S. business in Q3? - Management indicated that some revenue from settlements would still be expected in Q3, but less than in the current quarter [38] Question: How is the product pipeline in the U.S. evolving? - Management confirmed that the focus is on biosimilars and complex generics, with around 100 products in the pipeline [40] Question: What is the status of semaglutide litigation in India? - The company is currently challenging the patents in the Delhi High Court and awaiting the judge's decision [53] Question: What are the growth drivers for the India business? - Management highlighted successful execution of strategy and acquisitions as key factors driving growth in India [65] Question: What is the outlook for EBITDA margins? - Management remains committed to returning to 25% EBITDA margins in the next two years, despite current pressures from product discontinuations [78]

Core Insights - Esperion has entered into a settlement agreement with Dr. Reddy's Laboratories, resolving patent litigation related to generic versions of NEXLETOL and NEXLIZET, preventing Dr. Reddy's from marketing these generics in the U.S. before April 19, 2040 [1] - The settlement with Dr. Reddy's follows previous agreements with other companies regarding their generic versions of NEXLETOL, ensuring no remaining challenges to the validity of U.S. Patent No. 7,335,799, which expires in December 2030 [2] - Ongoing patent litigation against other defendants remains, with uncertainty regarding the potential for generic versions of NEXLETOL and/or NEXLIZET to be marketed before the 2040 date [3] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing oral, once-daily, non-statin medications for patients at risk for cardiovascular disease, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [4] - The company is advancing its pre-clinical pipeline and aims to evolve into a leading global biopharmaceutical entity through commercial execution and international partnerships [5]

Core Insights - Hims & Hers Health is set to offer generic semaglutide in Canada as Novo Nordisk's patent on Ozempic and Wegovy is expiring in January [1][2] - The company aims to provide affordable and high-quality weight loss care, emphasizing accessibility and personalized care [2] - The Canadian semaglutide market generated $1.18 billion in 2024 and is projected to grow to $4.03 billion by 2035 [4] Company Strategy - Hims & Hers is entering the Canadian market for the first time, joining other drugmakers capitalizing on the expired patent of GLP-1 drugs [2] - The company is collaborating with an approved partner to ensure compliance with local laws and regulations regarding the generic semaglutide [5] Market Context - Generic semaglutide is a copy of the brand-name drugs Ozempic and Wegovy, offering the same efficacy and safety standards once the patent expires [3] - The approval process for generic semaglutide is underway in Canada, although no generic version has been approved yet [4][5]

Financial Data and Key Metrics Changes - The company reported record fourth quarter and full year 2024 results, with total revenues of $190.6 million, representing a year-over-year increase of 45% on an as-reported basis and 24% on an organic basis [10][38] - Adjusted non-GAAP EBITDA for the fourth quarter was $50 million, compared to $30.2 million in the prior year period, reflecting strong operational performance [43] - The company raised its 2025 revenue guidance to between $756 million and $776 million, representing growth of 23% to 26% over 2024 [8][44] Business Line Data and Key Metrics Changes - Rare disease was the primary driver of growth, with Cortrophin Gel generating close to $200 million in sales in its third year since launch [9] - Revenues from rare disease more than doubled to $87 million in the fourth quarter, with Cortrophin Gel revenues at $59.4 million, up 42% from the prior year [39] - The generics business delivered $78.6 million in revenues, an increase of 9% over the fourth quarter of 2023, driven by operational excellence and new product launches [20][40] Market Data and Key Metrics Changes - The overall ACTH market is expected to have grown about 25% to approximately $660 million in 2024, with Cortrophin Gel's growth contributing significantly [27] - The company estimates that the addressable patient population for ILUVIEN and YUTIQ is approximately six to ten times higher than the current number of patients on therapy [19][64] - The generics segment is expected to see low double-digit growth in 2025, supported by new product launches and a strong base business [22][46] Company Strategy and Development Direction - The company aims to broaden its presence in the rare disease space, as evidenced by the acquisition of Alimera Sciences [9] - The focus will remain on rare disease as the primary growth driver, with continued investment in R&D and commercial initiatives to support this segment [55] - The company is also expanding its ophthalmology sales team and investing in marketing to increase awareness of its products [13][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth prospects for Cortrophin Gel and the overall rare disease market, despite near-term challenges related to market access for ILUVIEN and YUTIQ [19][64] - The company anticipates a typical Q4 to Q1 drop in sales for Cortrophin Gel due to prescription reauthorizations, followed by strong sequential growth in subsequent quarters [44][66] - Management highlighted the importance of addressing unmet needs in autoimmune disorders and inflammatory diseases, which could significantly expand the addressable market for Cortrophin Gel [28] Other Important Information - The company has taken steps to enhance supply security for ILUVIEN and YUTIQ, including extending its partnership with its contract manufacturer [15] - A prefilled syringe for Cortrophin Gel is under FDA review, expected to launch in the second quarter of 2025, aimed at improving patient convenience [30][31] - The company has redefined its reporting segments to better reflect its business structure post-acquisition [38] Q&A Session Summary Question: Business development and M&A capacity - Management indicated a thoughtful approach to leverage ratios, historically keeping it under three, and expressed intent to pursue additional business development and M&A without straining the balance sheet [53][54] Question: Gout's contribution to Cortrophin sales - Currently, 15% of Cortrophin's volume comes from gout, which is seen as a gateway indication for new prescribers [56][57] Question: Access issues for ILUVIEN and YUTIQ - Management acknowledged access issues due to funding shortfalls for patient assistance programs but remains confident in the long-term growth prospects for these products [64][65] Question: Seasonality impact on Cortrophin - Typical Q4 to Q1 dynamics are expected, with a drop in sales followed by sequential growth, supported by strong early trends [66] Question: Transitioning supply from EyePoint to Siegfried - Management is confident in the transition and has built up inventory to ensure supply security during the change [70][73]