Hong Kong Exchanges and Clearing Limited, The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. ProteLight Pharmaceuticals (Jiangsu) Co., Ltd. 普萊醫藥(江 蘇)股份有限公司 (A joint stock company incorporated in th ...

Hong Kong Exchanges and Clearing Limited, The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. ProteLight Pharmaceuticals (Jiangsu) Co., Ltd. 普萊醫藥(江 蘇)股份有限公司 (A joint stock company incorporated in th ...

Core Insights - Regeneron Pharmaceuticals (REGN) reported a solid performance for Q4 2025 and full-year 2025, with overall revenues increasing despite a significant decline in sales of its flagship product, Eylea [1] Eylea Performance - Eylea sales in the U.S. fell by 42% to $2.7 billion in 2025, driven by competitive pressures, market share loss to compounded bevacizumab, and patient transitions to Eylea HD [2] - Eylea remains Regeneron's largest revenue contributor, but declining sales are impacting overall revenues [3] - Eylea HD, a higher-dose formulation, saw sales increase by 36% to $1.6 billion in the U.S. in 2025, as Regeneron aims to defend its market share [5][10] Competitive Landscape - Roche's Vabysmo has intensified competition, achieving sales growth of 12% to CHF 4.1 billion in 2025 [4] - Regeneron introduced Eylea HD to improve durability and extend dosing intervals in response to competitive pressures [4] Future Projections - Eylea sales are expected to decline further in 2026, particularly in the second half of the year as multiple biosimilars enter the U.S. market [5][10] - Eylea HD is gaining traction due to steady label expansions, with recent FDA approvals enhancing its market position [6][7] Other Revenue Streams - Regeneron's revenue is bolstered by its share of profits from global Dupixent sales, which continue to grow due to strong demand across various indications [8] - Libtayo, Regeneron's PD-1 inhibitor, generated $1.4 billion in sales in 2025, reflecting a 19% year-over-year increase [11] Oncology Developments - The oncology portfolio received a boost with the FDA's accelerated approval of linvoseltamab-gcpt for relapsed or refractory multiple myeloma [12] - The European Commission approved Ordspono for relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, further strengthening Regeneron's oncology franchise [13] Pipeline and Future Approvals - Regeneron has a robust pipeline, with additional drug approvals expected to support revenue growth [13] - The company submitted a biologics license application for DB-OTO, a gene therapy for profound genetic hearing loss, with a decision expected in H1 2026 [14] - Regeneron is also pursuing approval for garetosmab for fibrodysplasia ossificans progressiva and expanding its obesity-focused pipeline [15]

Core Viewpoint - The approval of tirzepatide for monotherapy in adult type 2 diabetes in China marks a significant shift in treatment protocols, allowing for earlier intervention and potentially better patient outcomes [4][5]. Group 1: Approval and Clinical Impact - Tirzepatide has received approval for use as a monotherapy for adult type 2 diabetes, simplifying treatment pathways for both physicians and patients [4]. - The SURPASS-CN-MONO study demonstrated significant reductions in HbA1c levels, with the 5 mg group showing a decrease of 2.19% compared to a 0.77% decrease in the placebo group, indicating strong efficacy in blood sugar control [5]. - Approximately 90.38% of patients in the 5 mg group achieved HbA1c levels below 7.0%, highlighting the drug's effectiveness in early-stage treatment [5]. Group 2: Market and Treatment Paradigm Shift - The approval of tirzepatide as a monotherapy disrupts traditional treatment pathways, which typically start with metformin, potentially leading to faster blood sugar control and earlier management of complications [6]. - The market may see a bifurcation based on patient access and adherence, with economic factors influencing the uptake of this new treatment option [6]. - The expansion of tirzepatide's indications is part of a broader strategy to position the drug as a long-term platform medication for metabolic diseases, enhancing its lifecycle value [8]. Group 3: Competitive Landscape - The competition in the diabetes medication market is intensifying, shifting from mere efficacy comparisons to a comprehensive evaluation of clinical evidence, long-term safety, and patient management strategies [8]. - The focus is now on creating smoother, earlier, and more sustainable treatment pathways rather than just achieving lower HbA1c levels [8].

Core Viewpoint - Novo Nordisk is facing a challenging outlook for 2026, with anticipated sales slowdown for its key drugs, Ozempic and Wegovy, despite a recent stock upgrade from Jefferies [2][5] Group 1: Company Overview - Novo Nordisk specializes in diabetes care and hormone replacement therapies, known for its innovative GLP-1 drugs, Ozempic and Wegovy [1] - The company reported strong results for 2025, with semaglutide-based GLP-1 drugs generating 206.2 billion Danish kroner, including 53.7 billion from the fourth quarter [3][5] Group 2: Financial Outlook - Jefferies upgraded Novo Nordisk's stock from "Underperform" to "Hold," with the stock priced at $48.74 [2][5] - The company expects adjusted sales and operating profits to drop by 5-13% at constant exchange rates for 2026, excluding a $4.2 billion rebate reversal [2][5] Group 3: Market Challenges - The anticipated decline in sales is attributed to pricing pressure in the U.S., increased competition, foreign exchange headwinds, and higher research and development spending [3][5] - Sales momentum for Ozempic and Wegovy has slowed over the past year due to increasing competition [4][5]

Core Viewpoint - Sanofi's stock experienced a significant decline following the unexpected ousting of CEO Paul Hudson by the board, who has been replaced by Belen Garijo from Merck KGaA [1] Group 1: Company Performance - Sanofi recently reported fourth-quarter earnings that exceeded Wall Street expectations, but the sales figures were lighter than anticipated [1] - The company is widely recognized for its blockbuster drug Dupixent, developed in collaboration with Regeneron Pharmaceuticals, which treats allergic conditions [1] Group 2: Leadership Changes - The abrupt removal of Paul Hudson as CEO has raised concerns among investors, leading to a drop in Sanofi's stock price [1] - Belen Garijo's appointment as the new CEO marks a significant leadership change within the company [1]

Financial Data and Key Metrics Changes - In Q4 2025, global sales from continuing operations totaled $3 billion, representing an 8% increase on a reported basis and a 3% increase on an operational basis [8][18] - Adjusted earnings from continuing operations were $0.44 per diluted share, which fell short of expectations despite exceeding top-line forecasts [8][18] - Adjusted gross margins from continuing operations were 35.5%, a decrease of 900 basis points compared to the prior year [26] - Adjusted operating margin was 11.8%, a decrease of 340 basis points compared to the prior year [27] Business Line Data and Key Metrics Changes - Medical Products and Therapies (MPT) segment sales were $1.4 billion, increasing 4% in the quarter, driven by growth in Infusion Therapies and Technologies [18][19] - Advanced Surgery sales totaled $328 million, growing 11% due to strong demand for hemostats and sealants [20] - Healthcare Systems and Technologies (HST) sales were $827 million, increasing 4%, with Care and Connectivity Solutions growing 4% globally [21] - Pharmaceuticals segment sales totaled $668 million, increasing 2%, but the Injectables and Anesthesia division saw a decline of 9% [23][24] Market Data and Key Metrics Changes - Total U.S. capital orders for Care and Connectivity Solutions increased nearly 30% compared to the prior year, indicating strong demand [22] - The company has not observed a slowdown in U.S. hospital capital spending, although macroeconomic uncertainty is being monitored closely [22] Company Strategy and Development Direction - The company is focused on three main priorities: stabilizing business areas, strengthening the balance sheet, and driving a culture of continuous improvement [11][12] - A new operating model has been announced to simplify the organization, accelerate innovation, and improve performance by delayering leadership and embedding critical functional roles [12][62] - Continuous investment in R&D is expected to remain at or above historical levels to drive innovation [10][11] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges faced in Q4 2025 and emphasized the need for improvement in performance and execution [9][10] - The outlook for 2026 anticipates total sales growth to be flat to 1% on a reported basis, with organic sales growth expected to be approximately flat [30][32] - The first quarter of 2026 is expected to be the most challenging, with improvements anticipated in the second half of the year [35][36] Other Important Information - Free cash flow generation exceeded $450 million in Q4 2025, with full-year free cash flow reaching $438 million [29] - The company plans to deploy cash towards reducing leverage in line with its capital allocation framework [29] Q&A Session Summary Question: Strategic review and sustainability of the business - Management emphasized the importance of accountability at lower levels and the need for continuous improvement to enhance customer support and performance [41][42] Question: Progress on reducing G&A and support costs - Management confirmed that they are on track with cost takeout and streamlining operations, with a commitment to eliminate stranded costs by the end of 2027 [46][48] Question: Earnings growth as TSAs roll off - Management indicated that while they anticipate growth in 2027, specific guidance is not being provided at this time [51][52] Question: Q4 gross margin decline factors - Management identified unfavorable sales mix, higher manufacturing costs, and non-recurring items as key contributors to the gross margin decline [70][71] Question: Improving margins in the Pharmaceuticals business - Management expressed confidence in the fundamentals of the Pharmaceuticals business and outlined ongoing efforts to improve operational execution and address supplier challenges [76][78]

Financial Data and Key Metrics Changes - In 2025, Organon reported $6.2 billion in revenue and $1.9 billion of adjusted EBITDA, representing a 3% decline on both a reported and ex-FX basis [6][9] - Adjusted gross margin for Q4 2025 was 56.7%, down from 60.6% in Q4 2024, primarily due to pricing pressure and unfavorable product mix [22] - Net loss for Q4 2025 was $205 million, or $0.79 per diluted share, compared to net income of $109 million, or $0.42 per diluted share in Q4 2024 [23][24] Business Line Data and Key Metrics Changes - Women's health revenue decreased 16% ex-FX in Q4 and 2% for the year, with Nexplanon sales down 20% ex-FX in Q4 and 4% for the full year [11][12] - The fertility business declined 6% ex-FX in Q4 2025 but grew 8% for the full year, driven by performance in the U.S. [14] - Biosimilars revenue was driven by Hadlima, which grew 61% ex-FX globally for the full year, reflecting strong clinical performance and pricing strategy [16] Market Data and Key Metrics Changes - Nexplanon faced challenges due to government policy-related access restrictions impacting its market share in the U.S. [12] - The JADA System generated $74 million in revenue in 2025, with its divestiture expected to impact consolidated revenue in 2026 [15] - The company anticipates strong growth in Latin America for Nexplanon, offsetting U.S. declines [14] Company Strategy and Development Direction - Organon plans to lower its dividend payout ratio to focus on debt reduction and improve its balance sheet capacity for future growth opportunities [7][8] - The company is committed to managing operating expenses and capital deployment in a disciplined manner to achieve progress on deleveraging efforts [32] - Future launches include a Pertuzumab biosimilar in the U.K. in 2027 and in the U.S. in 2028, indicating a strategic focus on expanding its biosimilars portfolio [16] Management's Comments on Operating Environment and Future Outlook - Management expects revenue and adjusted EBITDA in 2026 to be in line with 2025, projecting approximately $6.2 billion in revenue and $1.9 billion in adjusted EBITDA [9][10] - The company anticipates a modest FX tailwind to offset the loss of revenue from the JADA System divestiture [29] - Management expressed confidence in maintaining performance that aligns with the previous year while managing operating expenses effectively [32] Other Important Information - The company achieved over $200 million in cost savings in 2025, which helped offset investments in growth drivers like VTAMA [8] - Non-GAAP adjusted net income for full year 2025 was $954 million, or $3.66 per share, down from $1,065 million, or $4.11 per share in 2024 [24] Q&A Session Summary Question: Concerns about channel behavior issues and audit committee investigation scope - Management stated they cannot provide additional details at this time [36] Question: Status of FDA draft guidance on biosimilars and its impact - Management views the guidance as incremental and believes their strategy for biosimilars is appropriate [40] Question: Nexplanon contribution to 2026 sales guidance - Nexplanon is expected to be roughly flat year-on-year, with growth anticipated in ex-U.S. markets [41][42] Question: Operating expense savings and underlying EBITDA performance - Management confirmed that some savings will be redirected to revenue growth opportunities while continuing to manage operating expenses aggressively [46] Question: Update on CEO search - No public update was provided regarding the search for a permanent CEO [62] Question: Strategy for Denosumab biosimilar in the osteoporosis market - Management indicated that the market will be competitive, and peak revenues for the Denosumab product are estimated at around $100 million over five years [63]

Financial Data and Key Metrics Changes - In 2025, Organon reported $6.2 billion in revenue and $1.9 billion of adjusted EBITDA, representing a 3% decline on both a reported and ex-FX basis [6] - Adjusted gross margin for Q4 2025 was 56.7%, down from 60.6% in Q4 2024, primarily due to pricing pressure and unfavorable product mix [22] - Net loss for Q4 2025 was $205 million, or $0.79 per diluted share, compared to net income of $109 million, or $0.42 per diluted share in Q4 2024 [23] Business Line Data and Key Metrics Changes - Women's health revenue decreased 16% ex-FX in Q4 and 2% for the year, with Nexplanon sales down 20% ex-FX in Q4 and 4% for the full year [11] - The fertility business declined 6% ex-FX in Q4 2025 but grew 8% ex-FX for the full year, driven by performance in the U.S. [14] - Biosimilars revenue was driven by HADLIMA, which grew 61% ex-FX globally for the full year [16] Market Data and Key Metrics Changes - Nexplanon faced challenges due to government policy-related access restrictions impacting its market share in the U.S. [12] - The JADA System generated $74 million in revenue in 2025 before its divestiture, which will impact consolidated revenue in 2026 [15] - The company expects strong growth in Latin America for Nexplanon, offsetting U.S. declines [14] Company Strategy and Development Direction - Organon decided to lower its dividend payout ratio to focus on debt reduction and improve its balance sheet capacity for future growth opportunities [7] - The company is scrutinizing spending and has discontinued early-stage clinical programs to focus on products already in the market [9] - For 2026, Organon expects to maintain revenue and adjusted EBITDA in line with 2025, targeting approximately $6.2 billion in revenue and $1.9 billion in adjusted EBITDA [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2026 targets despite anticipated gross margin deterioration and ongoing operational challenges [10] - The company is committed to managing operating expenses and capital deployment to support deleveraging efforts [32] - Management highlighted the importance of maintaining performance aligned with the previous year while navigating a competitive landscape [32] Other Important Information - The company divested the JADA System, resulting in approximately $390 million in net proceeds to reduce net debt in 2026 [8] - Organon expects to achieve net leverage below 4x by the end of 2026, supported by debt repayments and revenue from the JADA divestiture [27] Q&A Session Summary Question: Concerns about channel behavior issues and audit committee investigation scope - Management could not provide additional details regarding the audit committee's findings beyond what was previously disclosed [36] Question: Status of FDA draft guidance on biosimilars and its impact - Management views the FDA guidance as incremental and believes their current biosimilar strategy is appropriate for future growth [40] Question: Nexplanon contribution to 2026 sales guidance - Nexplanon is expected to be roughly flat year-on-year, with growth anticipated outside the U.S. but a dip in the U.S. due to the transition to a five-year label [41] Question: Operating costs and margins outlook - Management emphasized the need to streamline operations while ensuring that cost reductions do not hinder revenue growth opportunities [51] Question: Pressure on established brands and competitive dynamics for Vtama - Management expects established brands to stabilize but acknowledges potential challenges, particularly in the respiratory segment [58]

Financial Data and Key Metrics Changes - In Q4 2025, global sales from continuing operations totaled $3 billion, representing an 8% increase on a reported basis and a 3% increase on an operational basis [8][17] - Adjusted earnings from continuing operations were $0.44 per diluted share, which fell short of expectations despite exceeding top-line forecasts [8][17] - Adjusted gross margins from continuing operations were 35.5%, a decrease of 900 basis points compared to the prior year [25] - Adjusted operating margin from continuing operations was 11.8%, a decrease of 340 basis points compared to the prior year [26] Business Line Data and Key Metrics Changes - Medical Products and Therapies (MPT) segment sales were $1.4 billion, increasing 4% in the quarter, driven by growth in Infusion Therapies and Technologies [17][18] - Advanced Surgery products grew 11%, totaling $328 million, reflecting strong demand and commercial execution [10][19] - Healthcare Systems and Technologies (HST) sales totaled $827 million, increasing 4%, with Care and Connectivity Solutions growing 4% globally [20] - Pharmaceuticals segment sales were $668 million, increasing 2%, but the injectables and anesthesia division saw a decline of 9% [21][22] Market Data and Key Metrics Changes - U.S. capital orders for Care and Connectivity Solutions increased nearly 30% compared to the prior year, indicating strong demand in the market [20] - The company has not observed a slowdown in U.S. hospital capital spending, although broader macroeconomic uncertainty is being monitored [20] Company Strategy and Development Direction - The company is focused on three main priorities: stabilizing the business, strengthening the balance sheet, and driving a culture of continuous improvement [11][12] - A new operating model has been announced to simplify the organization, accelerate innovation, and improve performance by delayering leadership and embedding critical functional roles [12][60] - Innovation is emphasized as a critical element for success, with continued investment in R&D at or above historical levels [10] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges faced and emphasizes the need for improvement in performance and execution [9] - The outlook for 2026 anticipates total sales growth to be flat to 1% on a reported basis, with organic sales growth expected to be approximately flat [29][31] - The first quarter of 2026 is expected to be the most challenging, with improvements anticipated in the second half of the year [34] Other Important Information - Free cash flow generation exceeded $450 million in Q4 2025, with full-year free cash flow at $438 million [28] - The company plans to deploy cash towards reducing leverage in line with its capital allocation framework [28] Q&A Session Summary Question: Strategic review and sustainability of the business - Management emphasized the importance of accountability at lower levels and the need for continuous improvement to enhance performance [38][39] Question: Progress on reducing G&A and support costs - Management confirmed that they are on track with cost takeout and streamlining operations to meet demand, with a commitment to eliminate stranded costs by the end of 2027 [44][45] Question: Earnings growth as TSAs roll off - Management anticipates growth but has not provided specific guidance for 2027, as TSAs will tail off in early 2027 [48][49] Question: Q4 gross margin decline - Management attributed the decline to unfavorable sales mix, higher manufacturing costs, and non-recurring items, with expectations for improvement in the second half of 2026 [68][72] Question: Improving margins in the pharmaceuticals business - Management expressed confidence in the fundamentals of the pharmaceuticals business and outlined actions being taken to improve operational execution and address supplier challenges [76][78]