Summary of Kelun Biotech Conference Call Company Overview - **Company**: Kelun Biotech (6990.HK) - **Industry**: Biotechnology, specifically focusing on antibody-drug conjugates (ADCs) Key Points 1. Strong Sales Growth - Significant sales ramp-up for sac-TMT (TROP2 ADC) observed in Q2, primarily driven by 3L EGFRmut NSCLC following NMPA approval in March - First commercial interim results reported at Rmb302 million for sac-TMT, on track to meet FY25 guidance of Rmb800 million to Rmb1 billion - Achieved commercial profitability in H1 2025, with drug sales surpassing SG&A expenses, and expects firmwide profitability in the near term due to licensing income from MSD partnership, estimated at US$100 million to US$150 million per year [3][4][8] 2. Upcoming Data Presentation at ESMO 2025 - ESMO 2025 (October 17-21) is anticipated to be a data-rich event for Kelun Biotech - Management highlighted three LBA presentations, including: - Clinical readouts from Phase 3 studies of sac-TMT in 2L EGFRmut NSCLC and HR+/HER2- breast cancer - Phase 3 head-to-head study of A166 (HER2 ADC) versus T-DM1 - POC-stage data for various tumor types, including ph2 ORR data of sac-TMT combined with Keytruda in 1L PD-L1+ NSCLC [4][7] 3. Early Pipeline Developments - Kelun Biotech is progressing its early-stage ADC pipeline, including: - SKB410 (Nectin-4 ADC, Phase 2 global study led by MSD) - SKB518 (PTK7 ADC, Phase 1b/2) showing early anti-tumor signals in NSCLC and SCLC - SKB571 (EGFR/c-Met ADC, Phase 1) undergoing dose-escalation trials - Management prefers to release data with certain maturity to provide a comprehensive drug profile [7][8] 4. Investment Rating and Price Target - Goldman Sachs maintains a Buy rating on Kelun Biotech with a 12-month price target of HK$454.04 - Current price is HK$491.40, indicating a downside potential of 7.6% - Key risks include R&D challenges, competition in the ADC field, limited commercial track record, talent competition, and partnership risks [8][9] 5. Financial Projections - Market cap: HK$114.6 billion (approximately US$14.7 billion) - Revenue projections for the next few years: - 2024: Rmb1,933 million - 2025E: Rmb1,950.6 million - 2026E: Rmb3,579.7 million - 2027E: Rmb5,432.9 million - EBITDA projections show a turnaround from negative to positive by 2026 [9] Additional Insights - The company is focusing on achieving greater visibility into the differentiated profiles and treatment potential of its next-generation assets through upcoming data releases [7] - The management's emphasis on commercial profitability and the strategic partnership with MSD indicates a strong outlook for future growth in the ADC market [3][4][8]

Core Viewpoint - The company reported a significant decline in revenue and net profit for the first half of 2025, with a focus on the challenges faced in its infusion, generic drugs, and raw materials segments, while highlighting growth opportunities from innovative product launches [1][2]. Revenue and Profit Summary - The company’s total revenue for the first half of 2025 was 9.083 billion yuan, a decrease of 23.2% year-on-year, with a net profit attributable to the parent company of 1.001 billion yuan, down 44.41% [1]. - In Q2 alone, revenue was 4.693 billion yuan, reflecting a year-on-year decline of 16.3%, and net profit was 416 million yuan, down 46.2% [1]. Business Segment Performance - **Infusion Segment**: Revenue was 3.750 billion yuan, a decline of 19.65% year-on-year. The company is transitioning to fully closed infusion systems, with the market share of closed infusion products increasing by 0.39 percentage points [2]. - **Non-Infusion Formulations**: Revenue reached 1.955 billion yuan, down 3.18% year-on-year. The sales of plastic water injections decreased by 11.96% due to reduced demand for glucose injections and the failure to win bids in national procurement [2]. - **Intermediate and Raw Materials**: Revenue from antibiotic intermediates and raw materials was 2.282 billion yuan, down 30.29% year-on-year, primarily due to market demand fluctuations [2]. International Business - The company achieved overseas revenue of 1.130 billion yuan, a decline of 39.69% year-on-year, mainly due to a decrease in overseas licensing income [3]. R&D and Innovation - The company is advancing its R&D pipeline with a dual focus on core business and innovative exploration. The innovative product Jiatailai has been launched, and further exploration for its use in treating various solid tumors is ongoing [3]. - Collaborations with Merck are progressing on 14 clinical studies for sac-TMT as a monotherapy or in combination with other drugs for multiple cancer types [3]. Investment Outlook - The company’s infusion and raw material intermediate businesses are expected to reach a bottom, with ongoing progress in the pipeline and accelerated sales of innovative products. Projected net profits for 2025-2027 are 1.675 billion, 2.248 billion, and 2.716 billion yuan, with year-on-year growth rates of -43%, 34%, and 21% respectively [4].

Core Viewpoints - The company's revenue for the first half of 2025 was 950 million yuan, a year-on-year decrease of 31.3%, primarily due to reduced milestone payments from licensing and collaboration agreements compared to the same period in 2024 [1][4] - The core product SKB264 generated revenue of 302 million yuan, with commercialization performance meeting market expectations [1][2] - Merck is actively advancing SKB264 with 14 global multi-center Phase III clinical studies [1][3] Financial Performance - The company reported a loss of 145 million yuan for the first half of 2025, a year-on-year decrease of 146.8%, while the adjusted loss was 69 million yuan, down 118.0% [1][5] - Drug sales revenue reached 310 million yuan, with a gross margin of 69.4% [1][5] - Cash and financial assets amounted to 4.528 billion yuan, a year-on-year increase of 47.2%, providing a solid foundation for long-term development [2][5] Product Development and Pipeline - SKB264 has achieved significant breakthroughs in breast cancer and lung cancer, becoming the first TROP2 ADC drug approved for EGFR mutation non-small cell lung cancer in the third-line treatment [2][3] - The company is pursuing multiple clinical studies covering high-incidence cancers, focusing on combination therapies and frontline treatments [2][3] - Early pipeline products are progressing well, with SKB315's Phase 1b clinical study ongoing and dual-specific ADC product SKB571's Phase II clinical trial set to launch in China [3][4] Future Catalysts - Key catalysts for the second half of 2025 include the expected approval of SKB264 for the 2L EGFR TKI-resistant NSCLC indication and the release of clinical data at academic conferences [4] - Other early ADC pipelines are anticipated to show preliminary clinical results [4] - The company has a robust pipeline with multiple products, including A166 and SKB315, expected to receive regulatory approvals in the near future [4][5]

Financial Data and Key Metrics Changes - The company reported a revenue of RMB950 million for the first half of 2025, with over RMB300 million coming from commercialized drugs, marking a significant achievement in its first year of commercialization [50][51] - Gross profit was RMB660 million, comparable to the previous year, while the net loss for the first half was RMB145 million, with an adjusted loss of RMB69 million after one-off budget adjustments [52][53] Business Line Data and Key Metrics Changes - The company has three main products ready for the market, with significant progress in approvals and commercialization efforts [12][21] - The commercialization team has expanded to nearly 400 personnel to support the increasing number of products [12] Market Data and Key Metrics Changes - The company has covered over 30 provinces, 300 cities, and over 1,000 hospitals across China, with partnerships established with over 400 pharmacies [28][32] - The company is actively working towards gaining medical insurance coverage for its products, which is expected to enhance market access [33][34] Company Strategy and Development Direction - The company aims to advance differentiated pipelines targeting significant medical needs, optimizing payload linker strategies, and exploring applications in non-oncology areas [26] - The focus is on expanding global partnerships and strengthening strategic collaborations to maximize the value of its pipelines [26] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the future income from sales revenue, anticipating continued cash flow generation from both R&D partnerships and commercialized drugs [51] - The company is preparing for the implementation of new medical insurance policies, which could significantly impact product sales strategies [97][100] Other Important Information - The company completed a follow-on financing of US$250 million and is included in several global equity indexes, enhancing its financial stability [25] - The company is involved in ongoing litigation regarding IP disputes with several founders, which has been accepted for review by the Sichuan Provincial High Court [101] Q&A Session Summary Question: What is the breakdown of sales revenue for breast cancer and lung cancer? - Lung cancer is the biggest contributor to sales revenue, consistent with patient numbers and indications. The sales expenses are expected to decrease once products are included in medical insurance coverage [62][63] Question: What is the focus for R&D going into the next stage? - The focus is on developing differentiated products targeting clinical demands, with an emphasis on bispecific targets and new payload strategies [68][70] Question: Can you provide guidelines on the sales trend for Q3? - The company expects quarter-over-quarter growth, with significant contributions anticipated from lung cancer indications [72] Question: What is the rationale behind the clinical trial design for PD L1 positive and negative patients? - The company is focusing on first-line treatment for wild-type non-small cell lung cancer, with ongoing projects in development [88] Question: How is the company planning to navigate the new medical insurance policy? - The company is prioritizing entry into the medical insurance catalog and is actively preparing to comply with the new policy [97][98]

Financial Data and Key Metrics Changes - The company reported a revenue of RMB 950 million for the first half of 2025, with over RMB 300 million coming from commercialized drugs, marking a significant achievement in its first year of commercialization [52][53]. - The gross profit was RMB 660 million, comparable to the previous year, while the net loss for the first half was RMB 145 million, with an adjusted loss of RMB 69 million after one-off budget adjustments [54][55]. - Cash and financial assets totaled RMB 4.5 billion, indicating a healthy financial status to support upcoming R&D and innovation [58]. Business Line Data and Key Metrics Changes - The company has three main products ready for the market, with significant progress in commercialization, covering over 30 provinces and 300 cities, and engaging over 10,000 doctors [32][34]. - The commercialization team has expanded to nearly 400 personnel to support the increasing number of products ready for market [14][15]. Market Data and Key Metrics Changes - The company has successfully partnered with over 400 pharmacies across China, enhancing its market access and professional services [32][34]. - The company is actively pursuing medical insurance coverage for its products, with seven provinces already covered under specific affordable care programs [36][37]. Company Strategy and Development Direction - The company aims to advance differentiated pipelines targeting significant medical needs, optimizing payload linker strategies, and exploring applications in non-oncology areas [30]. - The focus is on developing ADCs and small molecules, with an emphasis on bi-specific targets and innovative payloads to replace traditional chemotherapy [70][72]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future income from sales revenue, anticipating continued cash flow generation from both R&D partnerships and commercialized drugs [53]. - The company is preparing for the implementation of new medical insurance policies, which are expected to enhance market access and sales volume [100][101]. Other Important Information - The company has completed a follow-on financing of USD 250 million and is included in major global equity indexes, enhancing its market presence [29]. - The company has made significant advancements in clinical trials, with multiple pivotal trials initiated both domestically and globally [25][26]. Q&A Session Summary Question: What is the breakdown of sales revenue for breast cancer and lung cancer? - Lung cancer is the biggest contributor to sales revenue, consistent with patient numbers and indications. The sales expenses are expected to decrease once products are included in the national medical insurance catalog [60][64]. Question: What is the focus for R&D going into the next stage? - The focus is on developing differentiated products targeting clinical demands, with an emphasis on bi-specific targets and innovative payloads [70][72]. Question: Can you provide guidelines on the sales trend for Q3? - The company has recorded quarter-over-quarter growth of several dozen percentage points, indicating a positive sales trend [76]. Question: What is the rationale behind the clinical trial design for PD L1 positive and negative patients? - The company is focusing on developing effective treatments for both PD L1 positive and negative patients, with ongoing trials to assess efficacy [91]. Question: How does the company plan to navigate the new medical insurance policies? - The company is prioritizing entry into the medical insurance catalog and is actively preparing to comply with new policies to enhance market access [100][101].