证券代码：688331 证券简称：荣昌生物 荣昌生物制药（烟台）股份有限公司 RemeGen Co., Ltd. （中国（山东）自由贸易试验区烟台片区烟台开发区北京中路 58 号） 2024 年度向特定对象发行 A 股股票 募集资金使用的可行性分析报告 （修订稿） 二〇二四年七月 荣昌生物制药（烟台）股份有限公司 2024年度向特定对象发行A股股票 募集资金使用的可行性分析报告（修订稿） 一、本次募集资金使用计划 荣昌生物制药（烟台）股份有限公司（以下简称"荣昌生物"或"公司") 为 进一步增强公司综合竞争力，根据公司业务发展需要，拟向特定对象发行股票募 集资金总额不超过195,292.12万元（含本数），募集资金总额扣除相关发行费用后 的净额将用于投资以下项目： 单位：万元 1、项目基本情况 公司是一家具有全球化视野的创新型生物制药企业，为满足市场不断增长的 需求，推动公司创新药物的研发进程，巩固并进一步提高公司的核心竞争力，公 司及其全资子公司上海荣昌生物科技有限公司作为该项目的实施主体，拟使用募 集资金195,292.12万元用于创新药物的研究与开发，包括RC18、RC48、RC28、 RC88、RC1 ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 56.00, representing a potential upside of 86.7% from the current price of HKD 30.00 [9][10]. Core Insights - The company reported strong product sales in Q1 2024, with revenue reaching RMB 330 million, a year-on-year increase of 96.4% and a quarter-on-quarter growth of 5.4%. The net loss narrowed to RMB 350 million, down from RMB 480 million in Q4 2023, aided by a reduction in sales and R&D expenses [1][2]. - The management has guided for over 50% revenue growth for the full year 2024, with expectations of further declines in R&D and sales expense ratios. The company anticipates a funding requirement of approximately RMB 1.5 to 2 billion for the year [1][2]. - The upcoming ASCO conference will showcase 16 clinical study results, including the first human data for the mesothelin ADC RC88, which is being compared with other treatments [2]. - The company is progressing with its international expansion, with significant milestones expected in 2024, including the initiation of Phase III trials for its products [2][3]. Financial Summary - Revenue projections for the company are as follows: RMB 1.663 billion in 2024, RMB 2.503 billion in 2025, and RMB 3.728 billion in 2026, with net losses expected to gradually narrow [3][10]. - The company reported a cash balance of RMB 620 million as of Q1 2024, with an additional bank credit line of RMB 4 billion, ensuring operational sustainability until breakeven [1][2]. - The financial outlook includes a projected EBIT of RMB 821 million by 2027, indicating a path towards profitability [6][10].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 37.02, indicating a potential upside of 24.2% from the current price of HKD 29.80 [2][3]. Core Insights - The company is expected to achieve a revenue of CNY 1.08 billion in 2023, representing a year-on-year growth of 40.2%. However, it is projected to incur a net loss of CNY 1.51 billion, which is an increase of 51.3% compared to the previous year [1]. - The company has seen a recovery in Q1 2024, with revenues reaching CNY 330 million, a quarter-on-quarter increase of over 13%, and a reduction in net loss by 27.4% to CNY 349 million [1]. - The company plans to initiate an A-share private placement to raise CNY 2.55 billion, aimed at supporting innovative drug research and development [1]. Summary by Sections Financial Performance - The company reported a total revenue of CNY 1.08 billion for 2023, with a year-on-year growth of 40.2%. The net loss for the year is projected at CNY 1.51 billion, which is a 51.3% increase from the previous year [1]. - In Q1 2024, the company achieved revenues of CNY 330 million, with a quarter-on-quarter growth of over 13% and a net loss reduction of 27.4% to CNY 349 million [1]. Funding and Financial Strategy - As of the end of Q1 2024, the company had CNY 620 million in cash and equivalents. It is actively seeking various financing tools to increase cash reserves, in addition to a CNY 4.4 billion loan obtained in Q1 [1]. - The company announced plans for a private placement to raise CNY 2.55 billion, which will be fully allocated to support innovative drug development [1]. Product Pipeline and Market Potential - The company is advancing its product pipeline, with multiple candidates entering Phase III clinical trials, including indications for SLE, MG, pSS, and IgAN [2]. - The company is facing a strategic decision regarding the timing of data release for its product, which could impact potential overseas licensing agreements and FDA approval [2]. - The oncology pipeline is set to present up to 16 research data points at the upcoming ASCO conference, which could provide significant insights into the company's future growth [2].

Investment Rating - The report assigns an "Buy" rating for Rongchang Biopharma (9995.HK) [3][6] Core Insights - Rongchang Biopharma is positioned as a pioneer in the domestic autoimmune and oncology sectors, with a comprehensive capability from R&D to commercialization, and is advancing multiple clinical studies overseas [7][14] - The company has successfully launched two products: VidiXimab, the first domestic ADC, and Taitasip, the first domestic biological agent for systemic lupus erythematosus (SLE) [14][24] - The report anticipates significant revenue growth, projecting revenues of 16.1 billion, 21.7 billion, and 28.9 billion CNY for 2024, 2025, and 2026 respectively [6][8] Summary by Sections Company Overview - Rongchang Biopharma was established in 2008 and focuses on discovering, developing, and commercializing innovative biopharmaceuticals targeting major diseases such as autoimmune disorders and cancer [14][18] - The company has a strong executive team with extensive experience in the pharmaceutical industry, enhancing its strategic planning and operational capabilities [18][20] Product Pipeline - The company has eight products in clinical trials, with VidiXimab and Taitasip already approved for commercialization [14][15] - Taitasip is positioned as a potential global best-in-class (BIC) and first-in-class (FIC) product for SLE, with multiple ongoing clinical studies [35][40] - VidiXimab has been recognized as the first domestic ADC and has established a partnership with Seagen for global development [24][30] Financial Projections - The report estimates revenues for VidiXimab to be 7.6 billion, 8.5 billion, and 11.7 billion CNY for 2024, 2025, and 2026 respectively [8][6] - Taitasip is projected to generate revenues of 7.6 billion, 12.4 billion, and 15.9 billion CNY over the same period [8][6] Market Potential - The report highlights the significant market potential for VidiXimab in gastric cancer and urothelial carcinoma, with a large patient base and promising early clinical data [25][30] - The global market for ADCs is expected to grow, with VidiXimab leading the way in the domestic market [24][30] Conclusion - The report concludes with a total valuation of Rongchang Biopharma at 241 billion CNY, equivalent to 265 billion HKD, supporting the "Buy" rating [6][8]

Investment Rating - The report maintains a "Hold" rating for Rongchang Biologics (9995.HK) with a target price of HKD 33 [2][4]. Core Views - The net loss for Q1 2024 was in line with expectations, with revenue reaching RMB 330 million, representing a year-on-year increase of 96.41% and a quarter-on-quarter increase of 6.6%. The net loss was RMB 349 million, up 7.8% year-on-year but down 27.4% quarter-on-quarter, primarily due to better-than-expected gross margin and lower operating expenses [2]. - The company maintains its revenue guidance for 2024, projecting a 50% year-on-year increase, driven by sales from two listed products, RC18 and RC48, both expected to grow by over 50% [2]. - The A-share private placement of RMB 2.55 billion is still pending regulatory approval, with no clear timeline for issuance. The funds will support innovative drug development [2]. - Key catalysts for 2024 include potential overseas licensing for RC18, approval for RA indications in China, and data readouts for RC48 and RC88 at the 2024 ASCO conference [2]. Financial Summary - Q1 2024 revenue was RMB 330 million, with a gross margin of 77.5%, slightly down from 4Q23 [2]. - The company expects total revenue of RMB 1.6 billion in 2024, with a projected net loss of RMB 1.39 billion [6][8]. - The financial outlook includes a significant increase in revenue from RMB 1.08 billion in 2023 to RMB 1.61 billion in 2024, with continued losses expected to decrease over the following years [6][8].

Financial Performance - The company's revenue for Q1 2024 was CNY 330,434,802.62, representing a 96.41% increase compared to the same period last year[5]. - Total operating revenue for Q1 2024 was CNY 330,434,802.62, a significant increase from CNY 168,238,991.99 in Q1 2023, representing a growth of approximately 96.5%[18]. - Total operating costs for Q1 2024 reached CNY 682,453,542.19, compared to CNY 506,546,573.98 in Q1 2023, indicating an increase of about 34.7%[18]. - Net loss for Q1 2024 was CNY 348,921,696.49, compared to a net loss of CNY 323,774,631.80 in Q1 2023, showing an increase in loss of about 7.8%[19]. - The total comprehensive loss for Q1 2024 was CNY -372,204,285.59, compared to CNY -326,630,103.58 in Q1 2023, reflecting an increase in comprehensive loss of about 13.9%[19]. Cash Flow - The net cash flow from operating activities was a negative CNY 426,289,929.83[5]. - Cash flow from operating activities resulted in a net outflow of CNY -426,289,929.83 in Q1 2024, worsening from CNY -349,845,397.38 in Q1 2023[20]. - Cash flow from investing activities showed a net outflow of CNY -81,362,490.71 in Q1 2024, compared to CNY -584,089,411.54 in Q1 2023, indicating a reduction in outflow[21]. - Cash flow from financing activities generated a net inflow of CNY 401,987,661.35 in Q1 2024, contrasting with an outflow of CNY -47,838,016.27 in Q1 2023[21]. - The ending cash and cash equivalents balance as of Q1 2024 was CNY 619,732,575.42, down from CNY 1,086,332,437.19 at the end of Q1 2023[21]. Shareholder Information - The company reported a total of 5,422 common shareholders at the end of the reporting period[10]. - The top shareholder, HKSCC NOMINEES LIMITED, held 189,566,728 shares, accounting for 34.83% of total shares[10]. - The company had a total of 5,422 shareholders as of the reporting date, with 5,397 being A-share holders and 25 being H-share holders[12]. - The top 10 shareholders held a total of 189,566,728 shares, representing a significant portion of the company's equity[12]. Assets and Liabilities - Total assets at the end of the reporting period were CNY 5,478,656,892.82, a decrease of 0.90% from the previous year[6]. - The total liabilities as of March 31, 2024, were RMB 2,400,104,697.08, compared to RMB 2,090,972,550.70 at the end of 2023, indicating an increase in liabilities[16]. - The total equity attributable to shareholders decreased to RMB 3,078,552,195.74 from RMB 3,437,268,153.89[17]. - The company reported a net loss of RMB 3,202,432,084.51 in retained earnings as of March 31, 2024, compared to a loss of RMB 2,853,510,388.02 at the end of 2023[17]. - The inventory increased to RMB 751,473,242.66 from RMB 741,559,576.19, reflecting a rise in stock levels[16]. - The company’s short-term borrowings rose significantly to RMB 574,000,648.97 from RMB 284,276,638.87, indicating increased leverage[16]. Research and Development - Research and development expenses totaled CNY 331,178,800.01, an increase of 32.62% year-on-year[6]. - The ratio of R&D expenses to revenue was 100.23%, a decrease of 48.20 percentage points due to the significant increase in revenue[6][9]. - Research and development expenses amounted to CNY 331,178,800.01 in Q1 2024, up from CNY 249,722,218.25 in Q1 2023, reflecting a rise of approximately 32.5%[18]. Earnings Per Share - Basic and diluted earnings per share were both -CNY 0.65[6]. - The company reported a basic and diluted earnings per share of CNY -0.65 for Q1 2024, compared to CNY -0.60 in Q1 2023[19].

Financial Performance - The company's operating revenue for Q1 2024 was RMB 330,434,802.62, representing a year-on-year increase of 96.41%[4] - The net profit attributable to shareholders was a loss of RMB 348,921,696.49, with a net profit excluding non-recurring items also showing a loss of RMB 345,576,207.04[4] - Total operating revenue for Q1 2024 reached RMB 330,434,802.62, a significant increase from RMB 168,238,991.99 in Q1 2023, representing a growth of 96.5%[18] - The net profit for Q1 2024 was a loss of RMB 348,921,696.49, compared to a loss of RMB 323,774,631.80 in Q1 2023, showing a decline of 7.8%[19] - Total comprehensive loss for Q1 2024 was RMB -372,204,285.59, compared to RMB -326,630,103.58 in Q1 2023, reflecting an increase in losses of 13.9%[19] Cash Flow and Liquidity - The net cash flow from operating activities was negative at RMB 426,289,929.83[4] - Cash flow from operating activities in Q1 2024 was negative at RMB -426,289,929.83, compared to RMB -349,845,397.38 in Q1 2023, indicating a worsening cash flow situation[21] - Cash and cash equivalents at the end of Q1 2024 stood at RMB 619,732,575.42, down from RMB 1,086,332,437.19 at the end of Q1 2023, a decrease of 42.9%[21] - The company reported cash and cash equivalents of CNY 622.79 million, down from CNY 743.39 million[16] - The company received cash inflows from operating activities totaling RMB 289,128,725.27 in Q1 2024, compared to RMB 224,413,979.30 in Q1 2023, an increase of 28.8%[21] - Investment activities resulted in a net cash outflow of RMB -81,362,490.71 in Q1 2024, compared to RMB -584,089,411.54 in Q1 2023, indicating an improvement in investment cash flow[21] Assets and Liabilities - Total assets at the end of the reporting period were RMB 5,478,656,892.82, a decrease of 0.90% from the end of the previous year[5] - As of March 31, 2024, total assets amounted to approximately CNY 5.48 billion, a decrease from CNY 5.53 billion as of December 31, 2023[16] - Current assets totaled CNY 2.20 billion, slightly down from CNY 2.23 billion in the previous period[16] - Total liabilities increased to CNY 2.40 billion from CNY 2.09 billion, indicating a rise in financial obligations[17] - The company's equity attributable to shareholders decreased to CNY 3.08 billion from CNY 3.44 billion[17] Shareholder Information - The total number of common shareholders at the end of the reporting period was 5,422[9] - The number of A-share shareholders totaled 5,397, while H-share shareholders numbered 25, totaling 5,422 shareholders[12] - The company has engaged in securities lending, with 1,425,000 shares lent out, representing 0.26% of total shares[13] Research and Development - R&D investment totaled RMB 331,178,800.01, which accounted for 100.23% of operating revenue, a decrease of 48.20 percentage points compared to the previous year[5][8] - Research and development expenses rose to RMB 331,178,800.01 in Q1 2024, compared to RMB 249,722,218.25 in Q1 2023, reflecting a growth of 32.5%[18] Inventory and Receivables - Inventory levels rose to CNY 751.47 million, compared to CNY 741.56 million previously[16] - Accounts receivable stood at CNY 296.38 million, showing a slight decrease from CNY 297.68 million[16] - The company has a short-term loan of CNY 574.00 million, significantly higher than CNY 284.28 million reported earlier[17]

Sales Performance - The sales of Taitasip for the treatment of systemic lupus erythematosus (SLE) saw significant growth in 2023, attributed to its inclusion in the national medical insurance drug list and a commercial team of over 700 professionals covering more than 2,300 hospitals in China[5]. - The sales of Vidiqi monoclonal antibody for the treatment of locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) also experienced notable growth, supported by its inclusion in the national medical insurance drug list and a commercial team of over 600 professionals covering more than 2,000 hospitals in China[5]. - The company reported a significant increase in sales volume for both of its marketed products in 2023, reflecting strong market demand[5]. - The company's revenue increased from RMB 767.8 million in 2022 to RMB 1,076.1 million in 2023, driven by strong sales of its autoimmune product TaiTasi and oncology product VidiCim[30]. Clinical Development - The company initiated three Phase III clinical studies in 2023 for Taitasip, targeting IgA nephropathy, Sjögren's syndrome, and myasthenia gravis, with significant progress reported[5]. - The Phase III clinical trial for systemic lupus erythematosus (SLE) in China was completed in Q3 2022 with positive results, leading to NMPA approval in November 2023[11]. - The Phase III clinical trial for IgA nephropathy has been initiated in China in H1 2023, following positive results from a Phase II trial[13]. - The FDA approved the global Phase III IND for the treatment of adult primary Sjögren's syndrome (pSS) in December 2023[14]. - The company is currently conducting a Phase III clinical trial for HER2-expressing urothelial carcinoma patients and a Phase II trial for HER2-expressing invasive bladder cancer patients in China[6]. Research and Development - The company has established a comprehensive end-to-end drug development capability since its founding in 2008, focusing on unmet medical needs in China and globally[5]. - The company is focused on expanding its market presence both domestically and internationally, maintaining strong momentum in 2024[6]. - The company is developing multiple candidates, including RC88 (Mesothelin ADC), which has the potential to be the next first-in-class product[6]. - The company has a robust pipeline with over ten candidate drugs in various stages of clinical development targeting a wide range of indications[7]. - The company aims to develop more first-in-class and best-in-class products to meet unmet medical needs and provide substantial returns to shareholders[6]. Financial Performance - The company reported a net loss of RMB 1,511,229,000 for the year 2023, compared to a loss of RMB 998,830,000 in 2022[191]. - The net loss for the year was RMB 1,511,229 thousand, an increase from RMB 998,830 thousand in the previous year, indicating a worsening financial position[186]. - Basic loss per share for the year was RMB 2.80, compared to RMB 1.88 in 2022, showing a decline in shareholder value[186]. - Total revenue for 2023 reached RMB 1,076,130 thousand, a 40.1% increase from RMB 767,775 thousand in 2022[186]. - The company’s cash and cash equivalents decreased to RMB 726,552,000 in 2023 from RMB 2,069,180,000 in 2022, a decline of 64.9%[188]. Corporate Governance - The board consists of four executive directors, two non-executive directors, and three independent non-executive directors, ensuring compliance with listing rules regarding independence[59]. - The company has maintained compliance with corporate governance codes throughout the fiscal year ending December 31, 2023[58]. - The board is committed to high standards of corporate governance to protect shareholder interests[58]. - The company has implemented a robust internal control and risk management system, overseen by the board of directors[61]. - The company has purchased liability insurance for directors and senior management to cover potential legal responsibilities[61]. Risk Management - The company faces risks related to delays in clinical development and regulatory approvals, which could severely impact its business[102]. - The company has implemented a risk management framework to identify, assess, and monitor key risks related to its strategic objectives[87]. - The audit committee has conducted an annual review and is confident in the implementation and effectiveness of the group's risk management and internal control procedures[88]. - The company has established a mechanism for the board to obtain independent opinions and advice, ensuring effective governance practices[72]. - The company warns that it cannot ensure the successful development and commercialization of its drug candidates, urging shareholders and potential investors to act cautiously[20][24][27]. Shareholder Engagement - The company emphasizes the importance of maintaining effective communication with investors to enhance transparency and mutual understanding[96]. - The company encourages shareholder participation in meetings to express concerns and provide feedback to the board[95]. - The company has made amendments to its articles of association to improve governance in accordance with regulatory requirements[97]. - The company has not disclosed any significant interests held by the controlling shareholder in contracts important to the group's business during the reporting period[115]. - The company has established employee incentive platforms holding a total of 102,381,891 A-shares as of December 31, 2023[145]. Future Outlook - The company aims to commercialize TaiTasi and VidiCim in China and expand their market presence in 2024[30]. - The company plans to enhance market penetration for Vidiqi monoclonal antibody in 2024 through continued efforts in the oncology sector[5]. - The company plans to utilize all remaining unutilized A-share issuance funds by December 31, 2024, based on current market conditions[44]. - The company aims to enhance its long-term incentive mechanism to attract and retain talent, aligning the interests of shareholders, the company, and core team members[136]. - The company plans to expand its market presence with new product launches and technology developments in the upcoming quarters[124].

Investment Rating - The report downgrades the investment rating of Rongchang Biopharmaceutical (9995.HK) to "Hold" from a previous rating, maintaining a target price of HKD 33.0, indicating a potential upside of 12% from the current price of HKD 30.0 [1][2]. Core Views - The company is expected to achieve a revenue growth of over 50% year-on-year in 2024, driven by its innovative drugs RC18 and RC48. However, the lack of clear guidance on the international launch timeline for its product Tai Tasi Pu has led to the downgrade in rating [1][2]. - The company reported a revenue of RMB 1.08 billion in 2023, reflecting a year-on-year increase of 40.2%, with product sales contributing RMB 1.05 billion, up 42.1% year-on-year. The net loss attributable to shareholders was RMB 1.51 billion, a 51.3% increase year-on-year [1][2]. - The report highlights that the company has sufficient cash flow to sustain operations for approximately three years, with a cash balance of RMB 727 million at the end of 2023 and a net cash burn of RMB 1.5 billion for the year [1][2]. Financial Performance - The report provides a financial forecast indicating that revenue is expected to grow to RMB 1.61 billion in 2024, representing a 49.9% year-on-year increase, and further to RMB 2.52 billion in 2025 [6][7]. - The gross profit margin for product sales improved to 75.9% in 2023, an increase of 12.4 percentage points year-on-year, primarily driven by the sales growth of innovative drugs [1][2]. - The report anticipates that research and development expenses will rise to RMB 1.5 billion in 2024, reflecting the ongoing clinical trials for core products [1][2]. Key Catalysts - Major catalysts for 2024 include potential international licensing for RC18, approval for RA indications in China, and data readouts for RC48 and RC88 in clinical trials [1][2]. - The management expressed confidence in achieving the revenue guidance for 2024, citing strong sales performance in the first quarter [1][2].

Investment Rating - The report maintains a "BUY" rating for RemeGen, with a revised target price of HK$41.72, down from HK$57.65, indicating a potential upside of 53.7% from the current price of HK$27.15 [5][3]. Core Insights - RemeGen recorded revenue of RMB1.08 billion in FY23, with product sales contributing RMB1.05 billion, reflecting a 42% year-over-year increase. The gross profit margin improved to 76.9% from 63.4% in FY22. However, the company reported a wider attributable net loss of RMB1.51 billion in FY23 compared to RMB999 million in FY22 [3][11]. - The company anticipates a significant ramp-up in sales for FY24, targeting at least a 50% year-over-year increase in product sales, driven by strong performance of RC18 and RC48, an expanded salesforce, and inclusion in numerous top-grade hospitals [3][9]. - RemeGen is progressing with the global development of RC18, with the first stage of its Phase 3 trial completed. The company is considering whether to unblind the study results, which could serve as a catalyst for further development and potential out-licensing deals [3][10]. - The report highlights the potential for overseas business development collaborations, particularly for RC18 and RC88, which has received fast track designation from the FDA. These collaborations are expected to be crucial for RemeGen's growth trajectory [3][10]. Financial Summary - In FY23, RemeGen's revenue was RMB1,076 million, with a gross profit of RMB823 million, resulting in a gross margin of 76.5%. The company incurred operating expenses of RMB2,334 million, leading to an operating loss of RMB1,488 million [11][13]. - For FY24, the revenue is projected to reach RMB1,601 million, with a gross profit of RMB1,225 million, maintaining a gross margin of 76.5% [11][10]. - The net profit for FY24 is expected to be a loss of RMB1,451 million, improving to a loss of RMB1,070 million in FY25, and further narrowing to a loss of RMB362 million in FY26 [11][10].