TX45 Phase 1b (Part B) PH-HFrEF Data Release Single Dose Hemodynamic Trial O c t o b e r 2025 DISCLAIMER Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Ea ...

Financial Data and Key Metrics Changes - Total sales increased by 8% for the quarter, with core operating profit up 11% and core earnings per share up 14% to 55p [3][4] - Cash generation for the year so far is £6.3 billion, supporting growth investments and shareholder returns, including a dividend of 16p for the quarter [4][36] - Operating margin improved by 90 basis points in the quarter, driven by SG&A margin improvement [38] Business Line Data and Key Metrics Changes - Specialty medicines sales grew by 16%, with significant contributions from oncology (up 39%) and respiratory immunology (up 15%) [10][12] - HIV portfolio delivered 12% growth, primarily driven by long-acting injectables [21] - Vaccine sales increased by 2%, with strong demand for Shingrix, particularly in Europe [29] Market Data and Key Metrics Changes - In the U.S., Shingrix penetration is now at 43% of the eligible older adult population, with international sales accounting for around 70% of global Shingrix sales [30] - The oncology portfolio is expected to be a material growth driver, with Glenrep approved in eight markets [16][18] Company Strategy and Development Direction - The company is focused on investing for growth, with a pipeline of 15 scale opportunities expected to launch before 2031 [5][7] - Continued emphasis on business development to expand the pipeline, particularly in oncology and respiratory [6][84] - The company is committed to optimizing supply capacity and investing $30 billion in R&D and advanced manufacturing in the U.S. over the next five years [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver on long-term commitments for growth, with an upgraded guidance for the year [8][42] - The company remains cautious about the near-term outlook for vaccines in the U.S. but is optimistic about long-term prospects [33] Other Important Information - The company has secured four FDA approvals this year and expects a fifth before year-end [4] - The company is upgrading its full-year sales expectations from 3-5% to 6-7% [42] Q&A Session Summary Question: Revenue gap between market expectations and GSK's target for 2031 - Management acknowledged the gap and highlighted underappreciated assets in oncology and respiratory as key areas for growth [51][54] Question: Future strategy updates - Management indicated that more details on the strategy would be provided at the full-year results, with confidence in achieving the £40 billion target by 2031 [52][58] Question: Shingrix growth expectations - Management confirmed that growth in Europe is expected to continue, with a focus on expanding immunization rates [60][66] Question: Investment in R&D and operational expenses - Management confirmed that R&D investment will continue to grow ahead of sales, with significant investments in new product launches [68] Question: Updates on Glenrep and Depamokimab - Management shared insights on the early experiences with Glenrep in Europe and the competitive landscape for Depamokimab, emphasizing the potential for both products [72][76]

Investment Rating - The report maintains a "Buy" rating for the company [3][6]. Core Insights - The company is experiencing pressure on profitability, but progress on research and development (R&D) products is on track [2]. - Revenue for the first three quarters of 2025 was 526 million yuan, a year-on-year decrease of 8.1%, with a net profit attributable to the parent company of 31 million yuan, down 73.0% year-on-year [12]. - The company is expected to see a gradual recovery in revenue growth, with projections of 754 million yuan in 2025, 964 million yuan in 2026, and 1.308 billion yuan in 2027, reflecting growth rates of 4.6%, 27.8%, and 35.8% respectively [5][12]. Financial Forecasts - The earnings per share (EPS) for 2025, 2026, and 2027 are projected to be 0.22 yuan, 0.48 yuan, and 0.85 yuan respectively, revised down from previous estimates [3]. - The company’s gross margin is expected to improve from 57.0% in 2025 to 70.8% in 2027, while the net profit margin is projected to increase from 12.3% to 27.6% over the same period [5][12]. - The target price for the company is set at 32.64 yuan based on a price-to-earnings (P/E) ratio of 68 times for 2026 [3][6]. Clinical Development Progress - The company is set to initiate Phase III clinical trials for CKBA for vitiligo and Phase II/III trials for rosacea by the end of 2025 [12]. - Several high-potential products are progressing through the review process, with expectations for approvals either by the end of this year or next year [12].

Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.8 billion for Q3 2025, reflecting a 1% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of Dupixent and LIBTAYO, partially offset by lower EYLEA sales [39][40] - Diluted net income per share was $11.83, with net income reaching $1.3 billion [39] - Gross margin on net product sales was 86%, lower than the previous year due to a changing product mix and increased investments in manufacturing operations [41] Business Line Data and Key Metrics Changes - Dupixent achieved worldwide net sales of $4.9 billion in Q3 2025, a 26% increase year-over-year at constant currency, with U.S. sales growing 28% [7][35] - LIBTAYO's global net sales were $365 million, up 24% on a constant currency basis, with U.S. sales growing 12% [9][36] - EYLEA HD reached U.S. net sales of $431 million, an all-time high, while EYLEA sales decreased 10% to $681 million due to competitive dynamics and patient affordability issues [10][33] Market Data and Key Metrics Changes - Dupixent is positioned to address over 4 million patients in the U.S., with more than 1.3 million patients currently treated globally [8] - LIBTAYO is the market leader in advanced non-melanoma skin cancers and has recently been approved for high-risk adjuvant cutaneous squamous cell carcinoma, with an estimated 10,000 eligible patients in the U.S. [9][37] - EYLEA HD now represents approximately 40% of Regeneron's U.S. retina franchise, with expectations for moderate to high single-digit demand growth in the upcoming quarter [34] Company Strategy and Development Direction - Regeneron is focused on maximizing growth from existing brands while launching new products and indications, with significant investments in R&D to support its pipeline [16][39] - The company is engaged in discussions with the U.S. government to lower drug costs while preserving innovation and has committed over $7 billion to infrastructure and manufacturing in the U.S. [15][39] - The pipeline includes advancements in immunology, oncology, and rare diseases, with positive Phase III data for several programs [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing discussions with the U.S. government regarding drug pricing and the importance of U.S. manufacturing for national security [15] - The company anticipates continued growth across its commercial portfolio, with a focus on addressing unmet patient needs and expanding treatment options [16][39] - Regeneron expects to advance multiple registrational programs in 2026, with a mid-teens percentage increase in R&D expenses planned [43] Other Important Information - The FDA issued a complete response letter for the prefilled syringe supplemental BLA for EYLEA HD due to unresolved inspection findings at a third-party facility [11] - Regeneron is advancing its siRNA portfolio and has made significant progress in clinical trials for various conditions, including ultra-rare diseases [29][30] Q&A Session Summary Question: Changes in EYLEA commercial strategy and pricing - Management acknowledged competitive issues and emphasized the importance of EYLEA HD's clinical efficacy and safety in driving its performance [45][48] Question: Future balance sheet utilization for large deals - Management indicated openness to using the balance sheet for strategic opportunities and highlighted ongoing investments in domestic manufacturing [54][56] Question: Importance of label enhancements for EYLEA HD - Management noted that label enhancements are crucial for providing dosing flexibility and improving market share [59][60] Question: Insights from IL-33 COPD trials - Management refrained from commenting on specific insights but indicated plans for further discussions with the FDA [63][64] Question: Probability of approval for RVO and dosing filing - Management discussed the complexities of the approval process and the timeline for the new filler, expressing cautious optimism [66][68] Question: Internal changes to prevent CRLs - Management clarified that issues were not due to internal regulatory problems but rather manufacturing challenges, emphasizing ongoing efforts to rectify the situation [72][75] Question: Factor XI antibody program and future opportunities - Management highlighted the focus on understanding the benefit-risk ratio and the potential for broader applications of the Factor XI antibodies [78][80]

Financial Data and Key Metrics Changes - The company reported total revenues of $1.37 billion and product sales of $1.15 billion, representing a 20% and 19% increase year-over-year, respectively [3][29] - GAAP R&D expenses were $507 million, with a 7% year-over-year increase when excluding one-time expenses from the prior year [29] - GAAP SG&A expenses were $329 million, reflecting a 6% increase year-over-year, primarily due to international marketing activities [29] - The company raised its full-year net product revenue guidance to a range of $4.23 billion to $4.32 billion [29] Business Line Data and Key Metrics Changes - Jakafi sales reached $791 million, a 7% increase, with strong demand growth of 10% year-over-year [4] - Opzelura sales were $188 million, a 35% increase year-over-year, with $144 million from the U.S., representing a 21% increase [5] - Niktimvo sales totaled $46 million, a 27% increase from the second quarter, with 90% of U.S. bone marrow transplant centers adopting the product [6][7] Market Data and Key Metrics Changes - International sales for Opzelura and vitiligo reached $44 million, a 117% increase from last year [6] - The branded non-steroidal topical market is expanding at a 20% rate, with Opzelura positioned to benefit from this trend [5] Company Strategy and Development Direction - The company is focusing on optimizing promotional strategies and investments for key products to drive future growth [3] - Upcoming product launches include Ruxolitinib XR, Opzelura AD in Europe, and povorcitinib in HS, which are expected to contribute significantly to future growth [9][10] - The company is conducting a thorough review of its pipeline to prioritize high-value programs and streamline operations [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of key products and emphasized the importance of demonstrating single-agent activity for new therapies [3][35] - The company is focused on maintaining financial discipline while investing in strategic growth drivers [14][70] - Management highlighted the potential of povorcitinib and other pipeline products to address significant medical needs and drive future growth [18][20] Other Important Information - The company is actively studying Niktimvo in combination with ruxolitinib and steroids, which could shift the standard of care in GVHD [8] - The company plans to submit an application for ruxolitinib cream in moderate AD in the EU by year-end, with potential approval in the second half of 2026 [6] Q&A Session Summary Question: Importance of mCALR data for efficacy - Management emphasized the need to demonstrate single-agent activity for the mCALR antibody program, with a focus on clinical and translational endpoints [33][35] Question: Termination of povorcitinib program at CSU - The decision was based on prioritizing projects with better return profiles, and data from the terminated program may still be presented at a future conference [39][40] Question: Sustainability of Naktinvo's growth trajectory - Management expressed confidence in Naktinvo's growth, noting broad adoption among transplant centers and a healthy margin profile [71][74] Question: Current pipeline maturity and growth post-Jakafi LOE - The company is focused on several key projects, including povorcitinib and mCALR, to drive growth and build a robust oncology portfolio [79][80]

Core Viewpoint - The company has received a notice from the National Medical Products Administration regarding the acceptance of the clinical trial application for HSK44459 tablets, aimed at treating inflammatory bowel disease [1] Group 1: Product Development - HSK44459 tablets are independently developed by the company for the treatment of inflammatory bowel disease [1] - Preclinical research results indicate that HSK44459 has independent intellectual property rights, confirmed efficacy, and good safety [1] Group 2: Clinical Trials - HSK44459 tablets have already received clinical trial approval notices for other indications, including interstitial lung disease, Behçet's disease, psoriasis, and atopic dermatitis, all of which are currently undergoing Phase II clinical studies [1]

Group 1 - The VTX3232 results press release is now available on the company's website, indicating a focus on transparency and accessibility of information [2] - Slides presented during the call will be available on the webcast and subsequently posted on the company's website, emphasizing the company's commitment to providing detailed information to stakeholders [2] Group 2 - The call includes forward-looking statements under the Safe Harbor Act, highlighting the company's proactive approach to communicate potential future developments while acknowledging associated risks and uncertainties [3]

Core Insights - JieTai Technology announced that its AI-driven small molecule formulation optimization platform AiTEM has successfully reached the primary endpoint of Phase III clinical trials for the candidate drug MTS-004, making it the first AI-enabled formulation new drug to complete Phase III trials in China [1][2] - MTS-004 is the first and currently the only drug in China to complete Phase III clinical trials for PBA (Pseudobulbar Affect), addressing a significant gap in the domestic treatment landscape for this condition [1][3] Summary by Sections Drug Development and Clinical Trials - MTS-004 is an innovative oral treatment candidate for PBA, designed as an orally disintegrating tablet (ODT) that dissolves quickly in the mouth without water, improving patient experience and adherence [1][3] - The AiTEM platform, powered by JieTai's proprietary AI nano-delivery platform NanoForge, significantly reduced the preclinical formulation optimization cycle from the industry average of 1-2 years to just 3 months [2] - The Phase III clinical trial involved 264 participants over 9.5 months, led by Professor Fan Dongsheng from Peking University Third Hospital, and included multiple centers across China [2] Clinical Efficacy and Safety - MTS-004 demonstrated good overall safety and clear efficacy in treating PBA secondary to neurological diseases, with statistically significant reductions in average attack frequency after 12 weeks of treatment [3] - The drug showed improvements in various assessments, including CNS-LS scores, CGI-C, PGI-C evaluations, and SF-36 mental health index, indicating enhanced emotional control and quality of life for patients [3] Future Prospects - JieTai plans to submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for MTS-004 in 2026, with potential expansion into indications for swallowing disorders post-approval [3] - The CEO of JieTai emphasized the role of AI in accelerating clinical treatment and addressing unmet patient needs, highlighting the successful completion of the drug's development cycle as a foundation for future projects [4]

Summary of the Conference Call for 诺诚健华 Company Overview - **Company**: 诺诚健华 (Nuo Cheng Jian Hua) - **Key Product**: 奥布替尼 (Aubutinib) Industry Insights - **Sales Growth**: Aubutinib's domestic sales are projected to reach 1 billion yuan in 2024, representing a year-on-year growth of 49%. In the first half of 2025, sales are expected to be 637 million yuan, with a growth rate exceeding 50%. The annual growth rate is anticipated to exceed 30% due to new indications and inclusion in medical insurance [2][4]. Core Developments - **New Indications**: The company is actively advancing Aubutinib's development in autoimmune indications, with the first IDP indication expected to be approved by 2027. The RB phase study for systemic lupus erythematosus (SLE) is expected to report RB7 data by the end of this year [2][5]. - **Clinical Trials**: A phase III clinical trial for BCL-2 inhibitors combined with Aubutinib for CLL/SLL has been approved. A registration trial for single-agent BTK inhibitors in previously treated MCL is ongoing, and FDA approval has been granted for BCL-2 inhibitors combined with azacitidine for AML and MDS [2][7]. Product Pipeline - **Solid Tumors**: The second-generation TRK inhibitor ICP723 for NTRK fusion gene advanced solid tumors has had its application accepted by CDE, with approval expected next year. The company is also expanding its ADC platform, focusing on B7H3 ADC products [2][8]. - **New Product Launch**: CT19 monoclonal antibody (Ming Nuo Kai) has been approved for use in combination with lenalidomide for relapsed refractory DLBCL, although its commercial contribution may be limited due to high pricing and being an imported drug [3][7]. Future Catalysts - **Upcoming Events**: Significant catalysts expected in the next six months to a year include the release of SLE RB7 data, BCL-2 data for AML treatment, and initial human data for ADC. In the first half of next year, data from multiple phase II and III trials for Tec Two JAK 1 (ICP 332) are anticipated, along with a planned submission for Aubutinib for ITP [2][9]. Additional Considerations - **Market Position**: Aubutinib is the second domestically produced and the fourth globally approved BTK inhibitor, which has seen rapid sales growth since its inclusion in medical insurance in 2021 [4]. - **Collaborations**: The company is collaborating with Zena for the development of multiple sclerosis treatments, which is significant for international cooperation and risk management [6]. This summary encapsulates the key points from the conference call, highlighting the company's growth trajectory, product pipeline, and future prospects in the pharmaceutical industry.

轩竹生物此次全球发售所得款项净额约为7.01亿元。公司拟将其中约45%用于核心产品(即KBP-3571、 XZP-3287及XZP-3621)的研发与商业化；约14%将用于关键产品(即KM602、KM501、XZP-7797及XZP- 6924)的研发；约11%将用于为其他候选药物(包括XZB-0004、XZP-5610、XZP-6019及XZP-6877)的研发 拨资；约20%用于增强商业化及市场营销能力，尤其是通过扩张销售及市场营销团队；约10%作于营运 资金及其他一般公司用途。 公开资料显示，轩竹生物是一家以创新为驱动的中国生物制药公司。截至最后实际可行日期，公司有超 过十种药物资产在积极开发中，涵盖消化系统疾病、肿瘤和非酒精性脂肪性肝炎(NASH)，包括三项 NDA批准资产，一个药物项目处于NDA注册阶段，一个药物项目处于III期临床试验阶段，四个药物项 目处于I期临床试验阶段，五个已获IND批准。 轩竹生物(02575)尾盘涨超8%，较招股价11.6港元涨近150%，截至发稿，涨8.21%，报28.46港元，成交 额5632.89万港元。 ...