健友股份 20250320 由于 2023 年肝素原料药行业不景气，无论是销售额还是价格均有所下滑。健友 股份因此计提了 12.4 亿元存货跌价准备，导致 2023 年归母净利润为负。到 2024 年肝素钠行业温和复苏，公司原材料采购价明显降低，因此转回存货跌价 准备 1.6 至 2.4 亿元，提高了归母净利润。2024 年公司发布业绩预告显示归母 净利润约为 8.0 至 10.5 亿元，实现扭亏为盈。 摘要 Q&A 健友股份近年来的转型和业务发展情况如何？ 健友股份近年来成功从肝素原料药企业转型为高端制剂企业。公司制剂业务的 营收占比已超过七成，成为主营业务，并且覆盖国内外市场，尤其在海外市场 拥有成熟的自营团队和丰富的 ANDA 批件数。在包括美国等海外市场，公司有超 过 50 个产品正在运行，同时在超过二十多个国家推进注册和销售拓展工作。公 司还与国内优秀企业合作拓展海外市场，如与双城药业合作白蛋白紫杉醇、与 通化东宝合作多个胰岛素类似物，这些产品在美国及其他海外市场上市工作正 在推进中。 健友股份在国内外市场的发展情况如何？ 在国内，健友股份近几年受到集采影响，其主要制剂进入国采范围后，通过集 采实现 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5]. Core Views - The company is transitioning from heparin raw materials to high-end injectable formulations, with a significant increase in the proportion of its formulation business, which accounted for over 70% of revenue in 2023 [1][17]. - The company has established a strong presence in the U.S. market, with over 50 products running and a sales revenue of 1.63 billion yuan in 2023, marking it as one of the largest Chinese pharmaceutical companies in the U.S. high-end formulation market [2][19]. - The heparin raw material business is stabilizing after a period of decline, with a projected mild recovery in 2024, which is expected to positively impact net profit [3][19]. Company Overview - The company is one of the largest global suppliers of heparin raw materials and formulations, with over 80 formulation varieties operating in more than 60 countries [1][10]. - The company has a mature R&D, quality, registration, and sales team in the U.S., leading the domestic industry in ANDA approvals [1][10]. Formulation Business - The formulation business is the main source of revenue and profit for the company, with sales increasing from 762 million yuan in 2019 to 2.77 billion yuan in 2023, representing 70.50% of total revenue [22]. - The company has been actively expanding its domestic market presence through successful bids in national procurement, although sales have faced pressure due to price reductions [24][40]. - The company is also expanding its global footprint, with overseas revenue exceeding 70% of total revenue in 2023, driven by a robust product pipeline and strategic market entry [19][41]. Heparin Raw Material Business - The heparin raw material business has shown a stable production trend, with a slight recovery expected in 2024, which will help mitigate previous losses from inventory write-downs [3][19]. - The company recorded a write-down of 1.24 billion yuan in 2023 due to declining heparin prices, impacting net profit [3][19]. Financial Forecast and Investment Recommendations - The company is expected to achieve revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively, with corresponding net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan [4][19]. - The report anticipates continued growth in the formulation business, which will drive overall performance improvements [4][19].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5]. Core Views - The company is transitioning towards high-end formulations, with a significant increase in the proportion of its formulation business, which accounted for over 70% of total revenue in 2023. This shift reflects a successful transformation from a traditional raw material supplier to an international sterile injection enterprise [1][17]. - The company has established a strong presence in the U.S. market, with over 50 products operational and a leading position in ANDA approvals among domestic peers. The U.S. subsidiary generated sales of 1.63 billion yuan in 2023, marking it as one of the largest Chinese pharmaceutical companies engaged in high-end formulation sales in the U.S. [2][19]. - The report forecasts revenue growth for the company, projecting revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively, with corresponding net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan [4][19]. Summary by Sections Company Overview - The company is one of the largest global suppliers of heparin raw materials and formulations, with over 80 formulation varieties marketed in more than 60 countries. It has been increasing R&D investments to support its transition to high-end formulations [1][10]. Formulation Business - The formulation business is the main source of revenue and profit for the company, with sales increasing from 762 million yuan in 2019 to 2.77 billion yuan in 2023, representing 70.50% of total revenue. The gross profit from this segment also rose significantly during the same period [22][23]. - The company has been actively expanding its domestic market presence through successful bids in national procurement, although sales have faced pressure due to price reductions [24][40]. Heparin Raw Materials - The heparin raw material business has shown a mild recovery, with stable production levels. However, the company faced a significant inventory impairment in 2023, leading to a net profit decrease of 1.05 billion yuan. A recovery in the global heparin market is expected in 2024, with potential reversals of inventory impairments [3][19]. Financial Forecast and Investment Recommendations - The report anticipates substantial growth in the company's overseas formulation business, which is expected to drive overall performance. The projected earnings per share (EPS) for 2024, 2025, and 2026 are 0.59 yuan, 0.72 yuan, and 1.00 yuan, respectively [4][19].

Investment Rating - The report gives a "Buy" rating for the company [5]. Core Views - The company is transitioning towards high-end formulations, with a significant increase in the proportion of formulation business, which accounted for over 70% of total revenue in 2023. This shift reflects a successful transformation from a traditional raw material supplier to an international sterile injection enterprise [1][17]. - The company has established a strong presence in the U.S. market, with over 50 products operational and a leading position in ANDA approvals among domestic peers. The U.S. subsidiary generated sales of 1.63 billion yuan in 2023, marking it as one of the largest Chinese pharmaceutical companies engaged in high-end formulation sales in the U.S. [2][19]. - The report forecasts revenue growth driven by overseas formulation business, with projected revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively [4][19]. Summary by Sections Company Overview - The company is one of the largest global suppliers of heparin raw materials and formulations, with over 80 formulation varieties in more than 60 countries. It has been increasing R&D investments to support its transition to high-end formulations [1][10]. Formulation Business - The formulation business is the main source of revenue and profit for the company, with sales increasing from 762 million yuan in 2019 to 2.77 billion yuan in 2023, representing 70.50% of total revenue. The gross profit from this segment also rose significantly during the same period [22][23]. - The company has been actively participating in national procurement, which has helped maintain growth in domestic formulation sales despite some price pressures [24][40]. Heparin Raw Materials - The heparin raw material business has seen a mild recovery, with stable production levels. However, the company faced a significant inventory impairment charge of 1.24 billion yuan in 2023 due to declining prices, which impacted net profit [3][19]. - The report anticipates a recovery in the global heparin market in 2024, with a potential reversal of inventory impairment provisions, which could positively affect net profit [3][19]. Financial Forecast and Investment Recommendations - The company is expected to achieve a turnaround in profitability, with projected net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan for 2024, 2025, and 2026, respectively. The earnings per share (EPS) are forecasted to be 0.59 yuan, 0.72 yuan, and 1.00 yuan for the same years [4][19]. - The report emphasizes the company's commitment to high-margin formulation business and its ongoing expansion into international markets, which are expected to drive future growth [17][19].

公 华福证券 生物类似药出海天地广阔，自研+BD 模式进一步打开成长天花板 随着全球多个重磅生物药专利陆续到期，全球生物类似药市场规 模有望快速增长。自研方面，截至 23 年公司多肽类制剂有 4 个产品 美国审批中、1 个产品注册批生产完成、6 个产品前期研发中。BD 方 面，公司 2024 年购买阿达木单抗类似药取得美国生物类似药市场入场 券， 近年来公司积极寻求外部合作，先后与海南双成、通化东宝达成 战略合作，取得白蛋白紫杉醇、甘精、门冬、赖脯三种胰岛素在美国 市场的独家商业化权益，未来随着生物类似药在美国市场获批，有望 助力海外制剂业务快速放量。 华福证券 投资要点： 肝素原料药市场边际改善，公司 API 业务有望稳健增长 公 司 首 次 覆 盖 2023 受到下游企业去库存影响，肝素原料药需求端减弱，价格进 入下跌周期，公司于 23 年对 API 存货计提 12.4 亿元跌价准备，当前 随着供给端格局稳定+需求端去库存周期或接近尾声，肝素价格有望恢 复。公司作为肝素原料药龙头，相关业务收入体量及毛利率未来有望 回升。2024 年公司拟转回存货跌价准备 1.6-2.4 亿元，我们认为若未来 肝素行业景气 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5][7]. Core Views - The heparin raw material market is showing marginal improvement, and the company's API business is expected to grow steadily [3][29]. - The company is focusing on sterile injection formulations, with rapid growth in overseas formulation business [4][41]. - The global biosimilar drug market is anticipated to grow significantly, with the company leveraging both self-research and business development (BD) models to expand its growth potential [5][67]. Summary by Sections 1. Company Overview - The company is a leading supplier of heparin raw materials and has been transitioning towards high-end injection formulations and biosimilars, aiming to reduce its reliance on traditional raw material labels [13][16]. 2. Heparin Raw Material Market - The heparin raw material market is expected to recover as supply-side stability and the end of inventory destocking on the demand side are anticipated [3][31]. - The company has established stable supply relationships with major global heparin formulation manufacturers, providing a solid cash flow for its injection business [36][37]. 3. Focus on Sterile Injection Formulations - The company's injection business has shown robust growth, with a revenue increase of 12.8% in 2023 and a compound annual growth rate (CAGR) of 47.4% from 2018 to 2023 [41][46]. - The company has a diverse product matrix in sterile injections, including low molecular weight heparin and anti-tumor agents, with a significant portion of revenue coming from overseas markets [47][55]. 4. Biosimilar Drug Development - The global biosimilar market is projected to grow rapidly, with the company actively pursuing opportunities in this space, including acquiring rights to a biosimilar of adalimumab [5][72]. - The company has multiple biosimilar products in various stages of development, enhancing its growth prospects in international markets [67][72]. 5. Financial Projections - The company is expected to achieve net profits of 0.9 billion, 1.2 billion, and 1.5 billion yuan for the years 2024, 2025, and 2026, respectively, with significant growth rates projected [5][6].

Investment Rating - The investment rating for the company is maintained as "Buy" with a target price of RMB 20.34 [6][7]. Core Insights - The company is expected to turn a profit in 2024, projecting a net profit attributable to shareholders of RMB 8.0-10.5 billion, with a non-recurring net profit of RMB 7.5-10.0 billion. The reversal of inventory impairment provisions is expected to increase net profit by RMB 1.36-2.04 billion [1]. - The company's formulation business remains the main growth driver, with strong performance in the U.S. market, where approximately 90 products have been approved, and 7 new products are expected to be approved in 2024. The domestic market is also stabilizing with 8 new product approvals expected in 2024 [2]. - The biosimilar drug segment is anticipated to become a significant growth engine, with the launch of adalimumab biosimilar and other products like liraglutide and paclitaxel expected to be approved in 1H25 [3]. Summary by Sections Financial Performance - The company forecasts net profits of RMB 9.92 billion, RMB 12.31 billion, and RMB 16.14 billion for 2024-2026, with a 16.8% upward adjustment for 2024 due to inventory impairment reversal. The EPS for 2024-2026 is projected at RMB 0.61, RMB 0.76, and RMB 1.00 respectively [4][10]. Valuation - The company is assigned a PE ratio of 26.70x for 2025, reflecting a 20% premium over comparable companies, leading to a reasonable valuation of RMB 328.60 billion [4][11]. Market Data - As of January 24, the closing price was RMB 13.48, with a market capitalization of RMB 21.779 billion. The 52-week price range was RMB 10.70-15.61 [7][10].

Financial Performance Forecast - The company expects a net profit attributable to shareholders of between 800 million and 1.05 billion yuan for the year 2024, indicating a turnaround from a loss in the previous year[4]. - The estimated net profit after deducting non-recurring gains and losses for 2024 is projected to be between 750 million and 1 billion yuan[4]. - The company plans to reverse inventory impairment provisions between 160 million and 240 million yuan in 2024, which is expected to increase net profit by approximately 136 million to 204 million yuan[8]. - The performance forecast is based on preliminary calculations and has not yet been audited by a registered accounting firm[9]. - The company emphasizes that the forecast data is subject to change and the final figures will be disclosed in the official 2024 annual report[10]. - There are currently no major uncertainties affecting the accuracy of the performance forecast[9]. Previous Financial Performance - In 2023, the company reported a net loss attributable to shareholders of approximately 189.45 million yuan[7]. - The company faced a significant inventory impairment of 1.24 billion yuan in 2023 due to downstream customer destocking in the heparin industry[8]. Raw Material Costs - The average procurement price of raw materials in 2024 is expected to decrease significantly compared to the previous year, leading to lower inventory costs[8]. Communication and Discrepancies - The company has communicated with its accounting firm regarding the performance forecast, and there are no significant discrepancies[4].

Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook for its stock performance [2][114]. Core Insights - The company is positioned as an international injection platform, focusing on biosimilars, which are expected to yield significant performance improvements as approvals are granted [7][114]. - The company has a strong presence in the heparin raw material and formulation markets, with a stable growth trajectory anticipated for its domestic formulation business [8][30]. - The company has significantly increased its R&D investment, with a notable rise in the number of ANDA approvals in the U.S. market, indicating a robust pipeline for future growth [9][71]. Summary by Sections Company Overview - The company has evolved from a traditional raw material supplier to a leading international sterile injection provider, with operations in over 60 countries [18][21]. - It has established three major R&D centers globally, enhancing its innovation capabilities [80]. Heparin API Market - The heparin API market is expected to grow steadily, with price stabilization anticipated following a period of inventory destocking [46][49]. - The company ranks among the top three domestic suppliers of heparin raw materials, benefiting from a stable competitive landscape [49]. R&D and Product Pipeline - R&D expenditures have surged, with a 89.42% year-on-year increase in 2023, reflecting the company's commitment to innovation [71][73]. - The company has a diverse pipeline with 59 projects underway, covering various therapeutic areas, and has successfully obtained approvals for 13 new formulations in 2023 [81][87]. Financial Projections - The company forecasts significant growth in net profit from 8.59 billion to 16.79 billion yuan from 2024 to 2026, with corresponding PE ratios decreasing from 26.6 to 13.6 [7][114]. - Revenue from the formulation segment is expected to grow at a compound annual growth rate (CAGR) of 24% to 30% over the same period, driven by new product launches and market expansion [108][114]. Market Position and Competitive Advantage - The company has successfully integrated its operations through strategic acquisitions, such as Meitheal, enhancing its market access in the U.S. [89]. - It has a strong market share in key heparin products, with the company’s formulations contributing significantly to its revenue [62][64].

Investment Rating - The report assigns an "Accumulate" rating for the company [4]. Core Views - The company reported a revenue of 3.088 billion yuan for the first three quarters of 2024, a year-on-year decrease of 1.72%, with a net profit attributable to shareholders of 606 million yuan, down 27.82% year-on-year [4]. - The company is transitioning from a focus on raw materials to high-end formulations, successfully establishing a presence in the international sterile formulations market [4]. - The company has built a complete sales channel and operational experience in the North American market, positioning itself to capitalize on opportunities in the biosimilar drug market [4]. - Earnings per share (EPS) forecasts for 2024-2026 are 0.51, 0.69, and 0.91 yuan, with corresponding price-to-earnings (PE) ratios of 28.62, 21.23, and 16.16 [4]. Financial Performance Summary - For the first three quarters of 2024, the gross margin was 41.41%, down 7.99 percentage points year-on-year, and the net profit margin was 19.62%, down 7.10 percentage points year-on-year [4]. - The company’s revenue for the third quarter alone was 945 million yuan, reflecting a year-on-year increase of 12.79% [4]. - The company’s revenue projections for 2024-2026 are 4.218 billion, 5.230 billion, and 6.602 billion yuan, with year-on-year growth rates of 7.3%, 24.0%, and 26.2% respectively [5]. Market Position and Strategy - The company has successfully reduced the proportion of revenue from heparin raw materials from over 60% in 2019 to 20% in the first half of 2024, indicating a strategic shift towards high-end formulations [4]. - The company has acquired the rights to the FDA approval and related patents for a biosimilar drug, making it the first Chinese company to gain entry into the U.S. market for this specific biosimilar [4].