Company Overview - Tianchen Biopharmaceutical (Suzhou) Co., Ltd. is a clinical-stage biopharmaceutical company focused on the discovery and development of biologics for allergic and autoimmune diseases [3] - The company has two main products: LP-003, an anti-IgE antibody for treating allergic diseases, and LP-005, a dual-function antibody targeting complement proteins C5 and C3b [3][4] - LP-003 has shown significant efficacy in clinical trials for chronic spontaneous urticaria (CSU) and moderate to severe seasonal allergic rhinitis (AR) [3][4][12] - LP-005 has received IND approvals for multiple indications, including paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated kidney diseases, and is currently undergoing clinical trials in China [4] Financial Information - The company reported revenues of RMB 2.33 million, RMB 3.07 million, RMB 2.17 million, and RMB 2.397 million for the fiscal years 2023, 2024, and the nine months ending September 30 for 2024 and 2025, respectively [5][6] - The total loss for the fiscal years 2023, 2024, and the nine months ending September 30 for 2024 and 2025 was RMB 95.778 million, approximately RMB 137.321 million, RMB 92.334 million, and approximately RMB 137.575 million, respectively [5][6] Industry Overview - The global market for allergic disease medications has grown from USD 42.8 billion in 2018 to an expected USD 68.8 billion by 2024, with a CAGR of 8.2%, projected to reach USD 111.4 billion by 2030 [6][7] - In China, the market for allergic disease medications is expected to grow from USD 3.8 billion in 2018 to USD 8.1 billion by 2024, with a CAGR of 13.3%, and projected to reach USD 22.9 billion by 2030 [7] - The market share of biologics in the global allergic disease medication market is expected to increase from 40.4% in 2024 to 61.3% by 2030 [6] - The market for anti-IgE antibody medications in China is projected to grow from RMB 1 billion in 2018 to RMB 2 billion by 2024, and further to RMB 12.1 billion by 2030, with a CAGR of 32.5% [7][10]

Core Viewpoint - The approval of the clinical trial for the innovative drug GB19 injection by the National Medical Products Administration (NMPA) marks a significant milestone for the company in the field of autoimmune disease treatment, specifically targeting systemic lupus erythematosus (SLE) [1][2][4]. Group 1: Clinical Trial Approval - The NMPA has granted approval for the clinical trial of GB19 injection, which is designed to treat systemic lupus erythematosus (SLE) [2]. - The product name is GB19 injection, with the acceptance number CXSL2501080 [2]. - The approval indicates that the clinical trial application meets the requirements for drug registration under Chinese law [2]. Group 2: Drug Mechanism and Potential - GB19 injection targets BDCA2, a specific antigen expressed on plasmacytoid dendritic cells (pDC), and operates through a mechanism that differs significantly from existing B-cell targeted therapies [3]. - The drug has shown promising in vitro activity, high bioavailability, and a safety profile that suggests it could provide new treatment options for patients with autoimmune diseases related to interferon pathway abnormalities [3]. Group 3: Impact on the Company - The approval of the clinical trial for GB19 injection is not expected to have a significant immediate impact on the company's financial status or operating performance [4]. - This development represents a key achievement based on the company's proprietary technology platform in monoclonal antibody research and is an important step in the company's strategy for innovation in autoimmune disease treatments [4]. - Successful commercialization of GB19 injection could enhance the company's product portfolio and improve its market competitiveness [4].

Core Viewpoint - The company has received a notice of acceptance for its new drug application (NDA) for SSGJ-611, a humanized monoclonal antibody targeting IL-4Rα, from the National Medical Products Administration of China, but the approval process remains uncertain [1][4]. Drug Basic Information - SSGJ-611 is a self-developed humanized monoclonal antibody with a novel amino acid sequence that specifically binds to IL-4Rα, blocking IL-4 and IL-13 signaling pathways to alleviate atopic dermatitis (AD) [2]. - Atopic dermatitis is a chronic, recurrent inflammatory skin disease with limited treatment options, significantly affecting patients' quality of life. The prevalence of AD has been increasing globally over the past 30 years, with an adult prevalence rate of 6.1% in China [2]. Clinical Research Results - The Phase III clinical study of SSGJ-611 in adult patients with moderate to severe atopic dermatitis achieved its primary endpoints, showing significant efficacy compared to the placebo group (P values < 0.0001) [3]. - SSGJ-611 demonstrated a 45.4% response rate in reducing itch severity by ≥4 points from baseline at week 16, compared to 15.6% in the placebo group (P value < 0.0001) [3]. - The maintenance phase of the study showed high retention rates for EASI-75 and IGA 0/1 at week 52, with percentages of 96.9% and 89.6% for the 300 mg Q2W dosing regimen, respectively [3]. - SSGJ-611 exhibited good safety and tolerability throughout the core treatment period and the 52-week treatment duration [3].

Core Viewpoint - The company, Hualan Biological Engineering Inc., announced that part of its fundraising special account funds were frozen due to a procurement contract dispute, but the funds have since been released, and the company’s operations remain unaffected [1][2]. Group 1: Account Information - The special account that was frozen involved an amount of approximately 1.4 million yuan [1]. - The freezing of the funds was due to a procurement contract dispute [1]. Group 2: Impact on the Company - The frozen amount of 1,409,065.28 yuan represents 0.02% of the company's most recent audited net assets [2]. - The freezing period was short, and it did not adversely affect the company's fundraising, operational activities, or the implementation of investment projects [2].

Group 1 - Tianchen Biopharma (Suzhou) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with Guotai Junan Securities (Hong Kong) as the sole sponsor [1] - The company focuses on the discovery and development of biopharmaceuticals targeting allergic and autoimmune diseases, currently in the clinical stage [1] - The core product, LP-003, is an anti-IgE antibody designed to block free IgE in blood and tissues, aiming to treat allergic diseases such as allergic rhinitis, chronic spontaneous urticaria, and allergic asthma [1]

Group 1 - Tianchen Biopharma (Suzhou) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with Guotai Junan Securities (Hong Kong) as the sole sponsor [1] - The company focuses on the discovery and development of biopharmaceuticals targeting allergic and autoimmune diseases, with a core product LP-003, an anti-IgE antibody [1] - LP-003 aims to block free IgE in blood and tissues to inhibit IgE-mediated allergic reactions, targeting conditions such as allergic rhinitis, chronic spontaneous urticaria, and allergic asthma [1]

Financial Data and Key Metrics Changes - In Q4 2025, net product revenues reached $127.5 million, reflecting an 84% year-over-year growth and a 29% sequential growth from Q3 2025 [51] - For the full year 2025, net product revenues were $372.1 million, a 123% increase compared to 2024, driven by increasing demand for ZORYVE products [55] - The company achieved positive cash flow in Q4 2025, with cash and marketable securities totaling $221.3 million as of December 31, 2025 [54] Business Line Data and Key Metrics Changes - ZORYVE's net product revenues grew to $372 million in 2025, representing a 123% year-on-year increase, driven by a doubling in total prescription volume [7] - In Q4 2025, ZORYVE generated $127.5 million in net product revenues, with a 19% increase in prescription volume [17] - The company holds approximately 45% market share in the branded non-steroidal topical segment across approved indications [7] Market Data and Key Metrics Changes - The branded non-steroidal topical segment is growing, gaining share from topical corticosteroids, which are seeing flat or declining usage [23] - ZORYVE is positioned to benefit from the shift away from topical corticosteroids, with each 1 point share shift translating to approximately $150 million in incremental revenue [24] - Over 80% of patients insured by commercial insurance have access to ZORYVE, with high-quality access through a single step edit [66] Company Strategy and Development Direction - The company has a three-pillar corporate strategy focusing on growth, expansion, and building its pipeline, which includes expanding ZORYVE's indications and enhancing its commercial presence [12][14] - Plans include expanding the dermatology specialty sales force by 20% and building a targeted sales force for primary care physicians and pediatricians [25][30] - The company aims to pursue label expansions for ZORYVE to treat younger populations, including infants with atopic dermatitis [42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in ZORYVE's continued growth and momentum in 2026, raising the full-year net product revenue guidance to $480-495 million [15] - The company anticipates maintaining positive cash flow throughout 2026 while investing in ZORYVE's growth and pipeline [16] - Management highlighted the importance of ZORYVE as a safe alternative to topical steroids, addressing significant unmet needs in chronic inflammatory skin conditions [5][40] Other Important Information - The company reported a net income of $17.4 million in Q4 2025, compared to a net loss of $10.8 million in the same period last year [53] - R&D expenses for Q4 2025 were $20.5 million, reflecting an increase due to ongoing clinical development activities [52] - The company is preparing to submit an sNDA for ZORYVE Cream 0.05% for infants in Q2 2026, with a PDUFA date for ZORYVE Cream 0.3% in children ages 2 to 5 set for June 29, 2026 [42][43] Q&A Session Summary Question: Can you comment on the competitive dynamics in the market, particularly regarding access and pricing? - Management indicated that they do not anticipate material erosion of gross net due to improved access strategies, with over 80% of patients having access to ZORYVE [66] Question: What are the implications of recent federal court decisions on rebate dynamics? - Management noted ongoing discussions in Washington about reimbursement reforms but expressed confidence in ZORYVE's market position regardless of potential changes [72] Question: Can you provide insights on sales growth trends for different SKUs? - Management did not break out sales for each SKU but acknowledged the importance of growth trends as they move into 2026 [75]

Financial Data and Key Metrics Changes - Total revenue for the full year 2025 was $510 million, representing a 20% year-over-year growth [5][14] - Adjusted EBITDA reached $231 million, increasing 40% year-over-year, while adjusted net income was $161 million, up 35% year-over-year [5][14] - Gross margin expanded to 57.4% from 51.5% in 2024, driven by Asceniv's growing contribution and yield-enhanced production [14] Business Line Data and Key Metrics Changes - Asceniv achieved $363 million in net revenue for 2025, reflecting a 51% year-over-year growth [7] - The company expects Asceniv to continue to grow, with a projected 70-30 revenue split between Asceniv and Bivigam in 2025 [30] - Fourth quarter 2025 adjusted EBITDA grew by 52% to $73.6 million, and adjusted net income increased by 57% to $52.6 million [15] Market Data and Key Metrics Changes - The company anticipates total revenue to exceed $635 million in 2026, with adjusted net income expected to exceed $255 million [16] - For 2027, total revenue is projected to exceed $775 million, and adjusted EBITDA is expected to exceed $455 million [16] Company Strategy and Development Direction - The company is focused on driving commercial execution, investing in a capital-efficient pipeline, and maintaining balance sheet discipline [11][12] - Strategic repositioning of the plasma collection network aims to enhance capital efficiency and secure long-term supply visibility [9][23] - The lead pipeline asset, SG-001, is viewed as a potential $300 million-$500 million peak annual revenue opportunity [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position entering 2026, highlighting strong demand in the U.S. IG market and improved earnings profile [17][22] - The integration of yield-enhanced production is expected to support meaningful gross margin growth and increasing earnings power [9][18] - Management noted that the company is well-positioned for sustained revenue growth and cash generation in the coming years [23] Other Important Information - The company announced a leadership transition with Terry Kohler appointed as the new CFO, succeeding Brad Tade [11][19] - The company ended 2025 with $88 million in cash, excluding proceeds from the plasma center divestiture [15] Q&A Session Summary Question: Update on Asceniv's role in product mix and revenue guidance - Management indicated a 70-30 split between Asceniv and Bivigam in 2025, expecting Asceniv's growth to continue [30] Question: Update on third-party supply contracts for RSV plasma - Management confirmed ongoing performance of third-party supply agreements and plans for expansion [34][36] Question: Expectations for receivables normalization and McKesson's impact - Management anticipates seeing McKesson's impact in the first half of the year, with normalization expected by mid to late 2026 [46][48]

Financial Data and Key Metrics Changes - Total revenue for 2025 was $510 million, representing a 20% year-over-year growth [5][14] - Adjusted EBITDA reached $231 million, increasing 40% year-over-year [5][14] - Adjusted net income totaled $161 million, reflecting a 35% year-over-year increase [5][14] - Gross margin expanded to 57.4% from 51.5% in 2024, driven by Asceniv's growing contribution [14] Business Line Data and Key Metrics Changes - Asceniv achieved $363 million in net revenue for 2025, representing a 51% year-over-year growth [7] - The company expects Asceniv to continue driving growth, with a projected 70-30 revenue split between Asceniv and Bivigam in 2025 [30] Market Data and Key Metrics Changes - The company anticipates total revenue to exceed $635 million in 2026 and $775 million in 2027, with significant contributions from Asceniv [16][17] - The U.S. immunoglobulin market is expected to grow, providing a favorable environment for Asceniv's continued penetration [22] Company Strategy and Development Direction - The company is focused on driving commercial execution, investing in a capital-efficient pipeline, and maintaining balance sheet discipline [11][12] - Strategic repositioning of the plasma collection network aims to enhance capital efficiency and secure long-term supply visibility [9][23] - The lead pipeline asset, SG-001, is expected to represent a significant long-term revenue opportunity, with a pre-IND package submission anticipated in 2026 [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position entering 2026, highlighting strong demand and improved margins [22][18] - The integration of yield-enhanced production is expected to support gross margin growth and increased cash generation [9][18] Other Important Information - The company announced a leadership transition with Terry-Ann Kohler appointed as the new CFO, succeeding Brad Tade [11][19] - The company maintains a healthy balance sheet with $88 million in cash at the end of 2025 [15] Q&A Session Summary Question: Update on Asceniv's role in product mix and revenue guidance - Management indicated a 70-30 split between Asceniv and Bivigam in 2025, with expectations for continued growth in Asceniv's contribution [30][32] Question: Update on third-party supply contracts for RSV plasma - Management confirmed ongoing performance of third-party supply agreements and plans for expansion, adding about 30 centers today with projections for 50 additional centers [34][36] Question: Expectations for new immunology centers and prescriber base growth in 2026 - Management actively calls on about 300 immunologists and expects to grow both reach and depth in existing institutions, contributing to revenue growth [41][43] Question: Timeline for McKesson's impact on receivables - Management anticipates seeing McKesson's impact in the first half of the year, with normalization of accounts receivable expected by mid to late 2026 [46][48]

Financial Data and Key Metrics Changes - The company reported GAAP revenue of $33 million for Q4 2025, an increase from $26 million in Q3 2025, primarily driven by collaboration with Gilead [35] - R&D expenses decreased to $121 million in Q4 2025 from $141 million in Q3 2025, while G&A expenses slightly decreased from $27 million to $26 million [35] - The cash position improved to $1 billion at the end of Q4 2025, up from $841 million at the end of Q3 2025, bolstered by a $288 million financing in November [35] Business Line Data and Key Metrics Changes - The confirmed overall response rate (ORR) for the 100 mg cohort of casdatifan increased from 35% to 45%, indicating significant efficacy improvement [16] - The median progression-free survival (PFS) for the 100 mg cohort was reported at 15.1 months, with a follow-up of 17.8 months, showcasing a strong performance compared to belzutifan [16][18] - The pooled analysis of casdatifan showed an ORR increase from 31% to 35%, further establishing its efficacy over belzutifan [16] Market Data and Key Metrics Changes - The renal cell carcinoma (RCC) market is projected to grow from over $10 billion annually today to $13 billion by 2030, with casdatifan targeting both late-line and early-line settings [24] - The company estimates a peak sales opportunity of $2.5 billion in the IO-experienced setting and potentially $3 billion or more in the first-line setting, indicating a substantial market opportunity [26] Company Strategy and Development Direction - The company aims to establish casdatifan as the best-in-class HIF-2 inhibitor and the new standard of care for clear cell RCC, focusing on a TKI-free regimen [4][8] - The first phase 3 study, PEAK-1, is actively enrolling and designed to establish casdatifan plus cabozantinib as the new standard of care in IO-experienced RCC [19] - The company is also exploring its immunology portfolio, with plans to advance two lead programs into the clinic by early next year [30] Management's Comments on Operating Environment and Future Outlook - Management emphasized that 2026 will be transformative for the company, with multiple data presentations and advancements in clinical programs expected [4] - The management expressed confidence in the differentiation of casdatifan compared to belzutifan, particularly in terms of safety and efficacy [7][8] - The company anticipates that the results from the upcoming ASCO GU presentations will validate their ongoing studies and drive enrollment in PEAK-1 [66] Other Important Information - The company plans to initiate a phase 3 study for casdatifan in the frontline setting by the end of 2026, contingent on safety and efficacy data [22] - The company owns nearly all rights to casdatifan, with revenues expected to accrue primarily to them, enhancing their financial outlook [27] Q&A Session Summary Question: What are the benchmarks for IO therapies as the company moves away from TKI-based regimens? - Management highlighted ipilimumab-nivolumab (ipi-nivo) as a key benchmark, noting its primary progression rate of 20%-25% and PFS of around 12 months [44] Question: What is the status of the volrustomig plus casdatifan study? - The study was paused but continues to provide valuable data, with no primary progression observed since dose adjustments [50] Question: How does the company view the upcoming LITESPARK-011 data from Merck? - Management expects positive data from LITESPARK-011 to validate the field and drive enrollment in their own studies, believing they can outperform Merck's combination [66]