Workflow
BeiGene(BGNE)
icon
Search documents
积极推进国际化进程
浦银国际证券· 2024-02-25 16:00
Investment Rating - The report maintains a "Buy" rating for the company with a target price of $275, HKD 165, and RMB 175 [1][3]. Core Insights - The company is actively advancing its internationalization process, with expectations of total revenue of approximately $660 million in Q4 2023. The second overseas product, Tislelizumab (PD-1), is anticipated to receive approval in the U.S. in the first half of the year [1]. - The report highlights that the impact of anti-corruption measures on hospital sales is gradually diminishing, which is expected to lead to a sequential increase in product sales revenue in Q4 2023 [1]. - The company forecasts revenues of $2.486 billion, $3.014 billion, and $3.671 billion for 2023, 2024, and 2025, respectively, representing a CAGR of 37% from 2023 to 2025 [1][4]. Financial Projections - Revenue for 2023 is projected at $2.486 billion, with a year-on-year growth of 75.6%. The net loss for the same year is expected to be $771 million [2][4]. - The report provides detailed financial metrics, including a gross profit margin of 84.2% for 2023 and a projected operating loss of $1.089 billion [4][26]. - The company’s cash and cash equivalents are expected to decrease from $3.557 billion in 2023 to $2.836 billion in 2024 [27]. Market Performance - The current stock price is $153.8, with a potential upside of 79% to the target price of $275 [3]. - The report notes a market capitalization of approximately $16.6 billion [3]. Upcoming Catalysts - Key upcoming catalysts include the expected approval of Tislelizumab for esophageal squamous cell carcinoma (ESCC) in the U.S. and the expansion of indications for other products [1]. - Other anticipated developments include the launch of Zebrutinib in the U.S. and data readouts for various clinical trials [1].
BeiGene(BGNE) - 2023 Q4 - Annual Results
2024-02-25 16:00
Exhibit 99.1 BeiGene Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates • Continued rapid global growth with record total revenues of $634 million in fourth quarter and $2.5 billion in full-year 2023, increases of 67% and 74% from the prior-year periods • Strengthened leadership in hematology with global BRUKINSA® (zanubrutinib) sales of $413 million and $1.3 billion for the quarter and full year, increases of 135% and 129% • Progressed innovative hematology pipeline with initi ...
BeiGene(BGNE) - 2023 Q4 - Annual Report
2024-02-25 16:00
Regulatory Approvals - BRUKINSA received FDA approval for CLL and SLL in January 2023, with a label update in December 2023 showing superior progression-free survival results from the Phase 3 ALPINE trial[27]. - BRUKINSA is approved in over 65 markets as of February 2024, including multiple indications in the EU and China, with all five approved indications included in the updated National Reimbursement Drug List[29]. - TEVIMBRA is approved in China for twelve indications, including first-line treatments for various cancers, with ongoing reviews for additional indications[32][34]. - PARTRUVIX received conditional approval in China for gBRCA mutation-associated recurrent advanced ovarian cancer, with full approval contingent on ongoing trials[39]. - XGEVA is approved in over 70 countries, with inclusion in the National Reimbursement Drug List in China for GCTB and SRE indications[41]. - BLINCYTO has been approved in 60 countries for acute lymphoblastic leukemia, with commercialization in China starting in August 2021[42]. - KYPROLIS was approved in China for R/R multiple myeloma in July 2021, with inclusion on the National Reimbursement Drug List beginning in March 2023[44]. - REVLIMID and VIDAZA have been included in the National Reimbursement Drug List in China, with various approved indications for treating multiple myeloma and myelodysplastic syndromes[46][47]. - SYLVANT was approved in China in December 2021 for treating adult patients with idiopathic multicentric Castleman disease and will be included in the NRDL starting January 2024[49]. - QARZIBA received conditional approval from the NMPA for treating high-risk neuroblastoma in patients aged 12 months and above, with commercialization beginning in December 2021[50]. - BAITUOWEI was approved in June 2023 for prostate cancer requiring androgen deprivation therapy and included in the NRDL in 2023[55]. - The NRDL now includes Tislelizumab for eleven indications effective January 1, 2024, expanding access to various cancer treatments[60]. - BRUKINSA was included in the NRDL for all five of its approved indications, enhancing its market presence in China[61]. - The 2023 NRDL introduced new rules for contract renewals, allowing for price renegotiation and potential price cuts for long-listed drugs[58]. Market Trends and Projections - Global revenues for BTK inhibitors were approximately $8.5 billion in 2022, projected to exceed $15 billion by 2028[31]. - The global market for PD-1/PD-L1 antibody medicines reached approximately $36 billion in 2022, with projections exceeding $50 billion by 2025[38]. Clinical Trials and Research - The company is conducting 11 registration or registration-enabling clinical trials for zanubrutinib, with six in Phase 3 and three designed as registration-enabling Phase 2 trials[79]. - Tislelizumab (TEVIMBRA) is being evaluated in over 17 potentially registration-enabling clinical trials globally, including 13 Phase 3 randomized trials[85]. - A Phase 3 trial of zanubrutinib in combination with sonrotoclax is ongoing for front-line CLL/SLL treatment[83]. - Tislelizumab is being tested in multiple Phase 3 trials for NSCLC, including a global trial comparing it to docetaxel in advanced or metastatic cases[85]. - The company has initiated broad global pivotal programs for zanubrutinib across various B-cell malignancies, indicating a strong pipeline for future growth[78]. - The company is exploring combination studies for zanubrutinib with both sonrotoclax and tislelizumab, enhancing its therapeutic potential[83]. - As of December 2023, over 13,000 subjects have been enrolled in clinical trials of tislelizumab across more than 30 countries, with 3,500+ subjects outside of China[89]. - Sonrotoclax has shown safety and tolerability in combination with BRUKINSA, with deep and durable responses observed in over 700 patients enrolled by December 2023[92]. - A Phase 3 study of sonrotoclax combined with BRUKINSA versus venetoclax plus obinutuzumab has started enrollment to support sonrotoclax's development in the first-line CLL indication[93]. - Ociperlimab has enrolled more than 2,000 subjects across eight global trials in patients with various cancers, including lung cancers and esophageal squamous cell carcinoma[97]. - Zanidatamab is in late-stage clinical development, with positive topline results announced in 2022 for a Phase 2b study in advanced or metastatic HER2-amplified biliary tract cancers[99]. - Lifirafenib is being developed for cancers with aberrations in the MAPK pathway, including BRAF and KRAS/NRAS mutations, showing antitumor activities in preclinical models[106]. Manufacturing and Supply Chain - The manufacturing facility in Suzhou has an annual production capacity of approximately 100 million tablets and capsules, with a new facility capable of producing up to 1 billion solid oral dosages annually[114]. - The Guangzhou manufacturing facility has a total committed capacity of 64,000 liters, with an additional expansion of 10,000 liters expected to be qualified by the end of 2024[115]. - The U.S. flagship manufacturing and clinical R&D facility in New Jersey is expected to be operational in summer 2024, with 8,000 liters of large molecule biologics manufacturing capacity[116]. - The company has commercial supply agreements with Catalent and Boehringer Ingelheim for the production of BRUKINSA and tislelizumab, respectively[119]. - The Guangzhou facility is approved for the end-to-end commercial production of tislelizumab for the China market[115]. - The company is in the process of building a new campus for clinical R&D and biologics manufacturing in New Jersey to support future demand[113]. Collaborations and Agreements - The company entered into a collaboration agreement with Amgen, committing up to $1.25 billion for global development costs and sharing profits and losses for oncology products in China[125]. - Under the Novartis collaboration agreement, the company received an upfront cash payment of $650 million and is eligible for up to $1.3 billion in regulatory milestone payments[135]. - The Novartis Collaboration and License Agreement for tislelizumab was mutually terminated in September 2023, allowing the company to regain full global rights for development and commercialization without royalty payments[137]. - The termination of the Novartis Option, Collaboration and License Agreement for ociperlimab occurred in July 2023, also resulting in the company regaining full global rights and recognizing all remaining deferred revenue balances[142]. - Under the Novartis Option, Collaboration and License Agreement, the company received an upfront cash payment of $300 million and could receive up to $2.045 billion in additional payments upon the exercise of options and achievement of milestones[140]. - The company entered into a settlement agreement with BMS in August 2023, terminating the License and Supply Agreement for ABRAXANE, effective December 31, 2023, while retaining rights to sell REVLIMID and VIDAZA until inventory is depleted or December 31, 2024[144]. Intellectual Property and Patent Strategy - The company has filed for and obtained 63 issued U.S. patents and 46 issued China patents as of February 14, 2024, with ongoing efforts to secure additional patent protections[146]. - The company has a right to commercialize three medicines in China under its collaboration with Amgen, with key patents expiring between 2025 and 2029[148]. - The company relies on trade secrets and unpatented know-how to protect its proprietary technology, alongside its patent strategy[153]. Competitive Landscape - The company faces competition from established BTK inhibitors like IMBRUVICA and CALQUENCE in the lymphoma treatment market, which may impact its product positioning[154]. - The company is competing with multiple PD-1 and PD-L1 antibody medicines, with nine approved PD-1 antibodies and five approved PD-L1 antibodies in China as of December 25, 2023[156]. - The company acknowledges the presence of several pharmaceutical companies developing TIGIT antibodies, with no approved anti-TIGIT antibodies currently available[157]. - The company is aware of the competitive landscape, including the development of BCL2 inhibitors by various pharmaceutical companies, with venetoclax being a notable approved product[157]. Regulatory Environment and Compliance - The company is subject to extensive government regulations in the U.S., China, Europe, and other jurisdictions regarding drug development, testing, and marketing[160]. - The FDA's drug approval process involves multiple stages, including preclinical tests, human clinical trials, and submission of an NDA or BLA for review[163]. - Human clinical trials are conducted in three phases, with Phase 3 trials evaluating overall risk/benefit relationships for the product[169]. - Post-approval trials (Phase 4) may be mandated by the FDA to gather additional safety data after initial marketing approval[170]. - The approval process can be lengthy, with the FDA potentially issuing a complete response letter detailing deficiencies that must be addressed before approval[176]. - The FDA may grant a seven-year exclusive marketing period for orphan drugs after approval[201]. - The FDA provides a five-year period of non-patent data exclusivity for the first applicant to gain approval of an NDA for a new chemical entity[195]. - The FDA may approve a drug under accelerated approval regulations if it provides meaningful therapeutic benefit over available treatments[183]. - The FDA may withdraw product approval if compliance with regulatory requirements is not maintained[192]. - The FDA requires that post-approval studies be conducted to confirm clinical benefits for drugs approved under accelerated regulations[183]. Economic and Pricing Considerations - The U.S. government is implementing cost containment programs that may reduce drug profitability, including increased Medicaid rebates and mandatory discounts for Medicare beneficiaries[210]. - The Inflation Reduction Act of 2022 reduces out-of-pocket spending for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025[212]. - The Bipartisan Budget Act of 2018 increased the point-of-sale discount owed by pharmaceutical manufacturers in Medicare Part D from 50% to 70%[211]. - The ACA includes provisions that may reduce drug product profitability, such as increased rebates and annual fees based on sales to federal healthcare programs[210]. - The company may need to conduct pharmacoeconomic studies to demonstrate cost-effectiveness for third-party payor coverage[207]. - Legislative changes at the state level are increasingly controlling pharmaceutical pricing and reimbursement[218]. - The federal transparency requirements under the ACA mandate manufacturers to report annual payments or transfers of value to physicians and teaching hospitals[224]. - Manufacturers must disclose ownership and investment interests held by physicians and their immediate family members[224]. - Federal price reporting laws require manufacturers to accurately calculate and report complex pricing metrics to government programs[224]. - Federal consumer protection laws regulate marketplace activities that may harm consumers[225]. - The Foreign Corrupt Practices Act prohibits improper payments to non-U.S. officials to obtain or retain business[225].
百济神州:港股公告:审计委员会会议日期
2024-02-18 07:36
BeiGene, Ltd. 百濟神州有限公司 (於開曼群島註冊成立的有限公司) (股份代號:06160) 香港,2024年2月9日 審計委員會會議日期 於本公告日期,本公司董事會包括主席兼執行董事歐雷強先生、非執行董事 王曉東博士,以及獨立非執行董事Olivier Brandicourt博士、Margaret Han Dugan 博士、Donald W. Glazer先生、Michael Goller先生、Anthony C. Hooper先生、 Ranjeev Krishana先生、Alessandro Riva博士、Corazon (Corsee) D. Sanders博士及 易清清先生。 百濟神州有限公司(「本公司」)謹此公佈,本公司董事會(「董事會」)審計委員會 會議將於2024年2月26日舉行,以(其中包括)審議及批准本公司及其附屬公司根 據美國公認會計原則及美國證券交易委員會適用規則編製的截至2023年12月31日 止年度的經審核財務業績及其發佈。本公司另將於2024年3月28日或之前公佈其 根據香港聯合交易所有限公司證券上市規則(「香港上市規則」)編製的截至2023年 12月31日止年度的經審核 ...
百济神州:港股公告:证券变动月报表
2024-02-07 09:14
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2024年1月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 百濟神州有限公司(於開曼群島註冊成立的有限公司) 呈交日期: 2024年2月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 | 06160 | 說明 | | | | | | | | | 法定/註冊股份數目 | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | 9,500,000,000 | USD | | 0.0001 USD | | 950,000 | | 增加 / 減少 (-) | | | 0 | | USD | | 0 | | 本月底結存 | | 9,500,000,000 | USD | | 0.0001 USD | | 950,000 | | 2. 股份分類 | 其他分類 (請註明) | 股份類別 ...
百济神州:港股公告:翌日披露报表
2024-02-01 09:32
FF304 翌日披露報表 (股份發行人 ── 已發行股本變動及/或股份購回) 呈交日期: 2024年2月1日 | 第一章節 | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 普通股 | 1. 股份分類 | | 股份類別 | 不適用 | | | | 於香港聯交所上市(註11) | 是 | | | | | 證券代號 (如於香港聯交所上市) 06160 | | | 說明 | | | | | | | | | | | 發行股份 (註6及7) | | | 股份數目 | | 已發行股份佔 有關股份發行前的 現有已發行股份數目 百分比 (註4、6及7) | | 每股發行價 (註1及7) | | 上一個營業日 的每股收市價 (註5) | | 發行價較市值的折讓/ 溢價幅度(百分比) (註7) | | | 於下列日期開始時的結存(註2) 2024年1月29日 | | | | 1,239,751,891 | | | | | | | | | | 1). 於股份獎勵計劃下 ...
百济神州:港股公告:翌日披露报表
2024-01-30 09:34
FF304 翌日披露報表 (股份發行人 ── 已發行股本變動及/或股份購回) 表格類別: 股票 狀態: 新提交 公司名稱: 百濟神州有限公司 (於開曼群島註冊成立的有限公司) 呈交日期: 2024年1月30日 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市(註11) | 是 | | | 證券代號 (如於香港聯交所上市) | 06160 | 說明 | | | | | | | 發行股份 | (註6及7) | 股份數目 | 已發行股份佔 有關股份發行前的 現有已發行股份數目 百分比 (註4、6及7) | | 每股發行價 (註1及7) | 上一個營業日 的每股收市價 (註5) | 發行價較市值的折讓/ 溢價幅度(百分比) (註7) | | 於下列日期開始時的結存(註2) | 2023年12月31日 | 1,239,663,933 | | | | | | | 1). 於股份獎勵計劃下發行股份 | | 87,958 | 0.006 | % U ...
百济神州:港股公告:授出购股权及受限制股份单位
2024-01-29 10:10
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeiGene, Ltd. 百濟神州有限公司 (於開曼群島註冊成立的有限公司) (股份代號:06160) 授出購股權及受限制股份單位 本公告乃根據上市規則第17.06A、17.06B以及17.06C條作出。於2024年1月24 日,董事會薪酬委員會根據2016期權及激勵計劃的條款向四名承授人授出可認購 合共3,821股美國存託股份的購股權並向兩百四十五名承授人授出涉及合共86,131 股美國存託股份的受限制股份單位。 2016期權及激勵計劃項下的購股權 於2024年1月24日,董事會薪酬委員會根據2016期權及激勵計劃的條款授予四名 承授人可認購合共3,821股美國存託股份的購股權。 授出購股權詳情 購股權詳情如下: 授出日期: 2024年1月24日 承授人數目: 四名 已授出購股權涉及的相關股份數目: 49,673 購股權總數(美國存託股份): 3,821 因已授出購股權獲行使而可予 認購的新美國存託股 ...
百济神州:港股公告:董事名单及其角色与职能
2024-01-24 10:10
百濟神州有限公司(「本公司」)董事會(「董事會」)成員載於下文。 執行董事 歐雷強先生 (主席兼首席執行官) 非執行董事 BeiGene, Ltd. 百濟神州有限公司 (於開曼群島註冊成立的有限公司) (股份代號:06160) 董事名單及其角色與職能 王曉東博士 獨立非執行董事 Olivier Brandicourt博士 Margaret Han Dugan博士 Donald W. Glazer先生 Michael Goller先生 Anthony C. Hooper先生 Ranjeev Krishana先生 Alessandro Riva博士 Corazon (Corsee) D. Sanders博士 易清清先生 1 M 相關董事會委員會成員 2024年1月23日 2 董事會有五個董事會委員會。下表提供本公司每位董事所任職於這些委員會的成 員資料。 | | | | | | 商業及 | | --- | --- | --- | --- | --- | --- | | | | | 提名及企業 | 科學 | 醫學事務 | | | 審計委員會 | 薪酬委員會 | 管治委員會 | 諮詢委員會 | 諮詢委員會 | | 歐 ...
百济神州:百济神州有限公司关于独立非执行董事辞任、委任独立非执行董事及董事会专门委员会成员变动的公告
2024-01-23 11:08
A 股代码:688235 A 股简称:百济神州 公告编号:2024-001 港股代码:06160 港股简称:百济神州 美股代码:BGNE 百济神州有限公司 关于独立非执行董事辞任、委任独立非执行董事及 董事会专门委员会成员变动的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 Thomas Malley 先生("Malley 先生")于 2024 年 1 月 22 日因计划将更多 时间用于其他事务而辞任百济神州有限公司(以下简称"公司")独立非执行 董事职务及董事会专门委员会相应职务。经公司董事会("董事会")审议, Olivier Brandicourt 博士("Brandicourt 博士")被任命为董事会独立非执行董 事,自 2024 年 1 月 23 日起生效。现将有关情况公告如下: 一、辞任独立非执行董事及专门委员会相应职务的情况 2024 年 1 月 22 日,Malley 先生因计划将更多时间用于其他事务而辞任公司 董事会独立非执行董事职务。由于辞任董事职务,Malley 先生同时辞任董事会 审计委员会( ...