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一品红20251215
2025-12-16 03:26
摘要 一品红出售安硕环球资产,获得总计 15 亿美元收益,包括 9.5 亿美元 首付款和 5.5 亿美元里程碑付款,同时保留 AR882 在大中华区的全部 权益和全球供应权,预计 Sobi 对 AR882 的销售峰值预估为 30 亿美元。 AR882 海外定价预计为每年 7 万美元,国内市场定价预期在 2 至 3 万元 之间,一品红拥有原料药和制剂生产的优先供应权,预计通过直接供应 而非按股份比例分成将带来更高收益。 一品红因 ODI 政策限制未能参与安硕公司最后一轮增资,并非针对中小 股东的不公平行为,而是受客观条件所限,安硕公司资金需求紧迫,每 月支出超过 1,000 万美元。 国内 AR882 三期临床已完成入组,预计 2026 年上半年完成全部试验, 中国市场痛风石患者约 2000 万人,高尿酸血症患者 1.8 亿人,市场潜 力巨大,不亚于美国市场。 AR882 在美国主要针对痛风石患者,定位二线用药,定价约 7 万美元, 美国痛风石患者约 180 万人,美国专利到期时间为 2039 年,中国专利 到期时间为 2042 年。 Q&A 请介绍一下此次一品红与 Sobi 的交易情况及其条款细节。 此次交易 ...
一品红参股美国生物技术公司获15亿美元收购要约,痛风创新药成核心资产
Jin Rong Jie· 2025-12-15 05:13
交易完成需满足多项条件。根据Arthrosi公司章程,并购需获得过半数有表决权股东同意。同时需要E轮 优先股股东中超过75%表决权支持。一品红及关联方未参与E轮融资,不持有相关股份。交易还需通过 美国反垄断审查等监管程序。 一品红参股的美国生物技术公司Arthrosi Therapeutics收到瑞典药企Sobi旗下子公司发出的并购协议。该 交易总额最高可达15亿美元,包括9.5亿美元首付款和最高5.5亿美元的里程碑付款。 此次并购的核心资产为Arthrosi开发的痛风创新药AR882。该药物为新一代口服URAT1抑制剂,目前正 处于关键性Ⅲ期临床试验阶段。临床数据表明,AR882在全球多中心Ⅱ期试验中表现出色。针对难治性 痛风石患者,75mg单药治疗组在12个月时靶痛风石完全消退率达43%。联合别嘌醇治疗组的完全消退 率提升至57%。 Sobi作为专注罕见病领域的国际生物制药公司,其业务涵盖血液学、免疫学和专科护理等领域。此次采 用"首付款+里程碑"的并购模式收购Arthrosi全部股权。9.5亿美元首付款将为后续临床试验和商业化提供 资金保障。里程碑付款则与临床进展、注册审批及销售业绩相关联。 交易对价和 ...
一品红:美国参股公司Arthrosi将被Sobi并购 总金额15亿美元
Zheng Quan Shi Bao Wang· 2025-12-14 11:36
12月14日晚间,一品红(300723)发布公告,公司参股公司美国Arthrosi Therapeutics,Inc.(简 称"Arthrosi")收到Sobi美国发出的相关协议条款,Sobi美国拟以9.5亿美元首付款(折合人民币约67.13亿 元),以及最高达5.5亿美元(折合人民币约38.87亿元)的临床、注册和销售里程碑付款收购Arthrosi100% 股权。 公告显示,此次交易的收购方Sobi美国系瑞典上市医药公司Sobi(斯德哥尔摩证券交易所股票代码: SOBI.ST)的全资子公司。Sobi是一家专注于罕见病领域的国际生物制药公司,主要治疗领域包括血液 学、免疫学和专科护理。 今年8月,据一品红公告,AR882全球关键Ⅲ期临床试验均已完成全部入组,预计将于2026年第二季度 披露Ⅲ期REDUCE2试验数据,2026年第四季度披露Ⅲ期REDUCE1试验数据。 而AR882是一种口服药物,拟用于降低尿酸和溶解皮下痛风石。临床结论显示,对初治及难治性痛风石 患者,AR882单药治疗或与别嘌醇联合治疗可以有效降低sUA、降低尿酸盐晶体负荷且靶痛风石完全溶 解率高。AR882单药或联合治疗,可为现有治疗方案疗 ...
Sobi to acquire Arthrosi Therapeutics, strengthening pipeline for the potential treatment of gout
Prnewswire· 2025-12-13 20:57
Core Viewpoint - Sobi has entered into a definitive agreement to acquire Arthrosi Therapeutics, enhancing its gout treatment pipeline with pozdeutinurad, a next-generation oral URAT1 inhibitor currently in Phase 3 trials [1][2][3] Company Overview - Sobi is a global biopharma company focused on rare diseases, employing approximately 1,900 people and generating SEK 26 billion in revenue in 2024 [10] - Arthrosi Therapeutics is a private late-stage biotechnology company based in San Diego, CA, specializing in pozdeutinurad for gout treatment [6] Acquisition Details - The acquisition involves an upfront payment of USD 950 million (approximately SEK 9.1 billion) and potential additional payments of up to USD 550 million (approximately SEK 5.3 billion) based on clinical, regulatory, and sales milestones [3][4] - The transaction is expected to close in the first half of 2026, subject to customary closing conditions [3] Product Information - Pozdeutinurad (AR882) is an investigational URAT1 inhibitor aimed at treating progressive and tophaceous gout, having shown compelling efficacy in Phase 2 studies [5] - It is currently being evaluated in two fully enrolled Phase 3 studies, with pivotal data expected in 2026 [5] Strategic Implications - The acquisition is anticipated to significantly enhance Sobi's growth trajectory and margin potential, with pozdeutinurad positioned as a therapy of choice for patients inadequately treated by first-line therapies [2][4]
Apellis Stock Down Despite Q3 Earnings and Revenues Beat Estimates
ZACKS· 2025-10-31 19:21
Core Insights - Apellis Pharmaceuticals reported Q3 2025 earnings of $1.67 per share, exceeding the Zacks Consensus Estimate of $1.03 per share, compared to a loss of 46 cents in the same quarter last year [1][7] - Total revenues for the quarter reached $458.6 million, surpassing the Zacks Consensus Estimate of $366 million and more than doubling from $196.8 million in the prior year, largely due to a $275 million upfront payment from Sobi related to a royalty purchase agreement [2][7] Financial Performance - The revenue growth was primarily driven by the one-time payment from Sobi, raising concerns about the sustainability of core performance, as Syfovre sales declined year-over-year [3][6] - Syfovre sales were reported at $150.9 million, down 1% year-over-year, missing both the Zacks Consensus Estimate of $156.6 million and the internal estimate of $160.4 million [5][7] - Empaveli generated sales of $26.8 million, reflecting a 9% increase from the previous year, and exceeded the Zacks Consensus Estimate of $22.1 million [8] Expenses and Cash Position - Research and development expenses decreased by 23% year-over-year to $68.2 million, attributed to lower external costs and personnel expenses [9] - Selling, general, and administrative expenses rose 17% year-over-year to $142.7 million due to increased commercial activities and personnel costs [9] - As of September 30, 2025, Apellis had cash and marketable securities totaling $479.2 million, up from $370 million as of June 30, 2025, indicating sufficient liquidity to fund operations towards profitability [10] Product Pipeline and Market Position - Syfovre is the market leader in geographic atrophy with over 60% market share, and new patient starts increased by over 52% in Q3 [6] - Empaveli is approved for treating paroxysmal nocturnal hemoglobinuria in the U.S. and Europe, with ongoing regulatory filings for expanded indications [11][12] - Apellis plans to initiate two pivotal phase III studies for Empaveli in rare kidney diseases by the end of 2025 [14] Strategic Developments - A capped royalty purchase agreement with Sobi allows Apellis to receive up to $300 million, with $275 million paid upfront for 90% of ex-U.S. Aspaveli royalties [16]
Apellis Pharmaceuticals Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-10-30 11:05
Core Insights - Apellis Pharmaceuticals reported strong third quarter 2025 results, highlighting significant progress in its commercial and development portfolio, including a new regulatory approval for EMPAVELI, a first-in-class C3 therapy for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) [2][5][12] Financial Performance - Total revenue for Q3 2025 was $458.6 million, a substantial increase from $196.8 million in Q3 2024, driven by product sales and a $275 million upfront payment from Sobi [8][12] - U.S. net product revenue for SYFOVRE was $150.9 million, while EMPAVELI generated $26.8 million in net product revenue [5][8] - Cash and cash equivalents stood at $479 million as of September 30, 2025, indicating a strong financial position to support future growth [14] Product Developments - EMPAVELI received FDA approval on July 28, 2025, as the first treatment for C3G and primary IC-MPGN, showing a 68% reduction in proteinuria in clinical trials [6][12] - The launch of EMPAVELI has seen 152 new patient start forms in the first two months, indicating strong early adoption [5][6] - SYFOVRE continues to lead the geographic atrophy market with a market share exceeding 60% and a 4% increase in total injection demand quarter-over-quarter [12][16] Research and Development - R&D expenses decreased to $68.2 million in Q3 2025 from $88.6 million in Q3 2024, reflecting cost management efforts [10] - The company plans to initiate pivotal studies for focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) by the end of 2025 [6][12] Strategic Collaborations - Apellis and Sobi have a collaboration agreement for the global co-development of pegcetacoplan, with Sobi holding exclusive ex-U.S. commercialization rights [18][12] - The recent royalty purchase agreement with Sobi allows Apellis to receive up to $300 million in exchange for 90% of future ex-U.S. royalties for Aspaveli [12][8]
Apellis Pharmaceuticals Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-07-31 11:05
Core Insights - Apellis Pharmaceuticals reported strong second quarter 2025 financial results, highlighting the FDA approval of EMPAVELI for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) as a significant milestone in their product portfolio [2][5][6] Financial Performance - Total revenue for Q2 2025 was $178.5 million, a decrease from $199.7 million in Q2 2024, driven by lower EMPAVELI sales [10] - U.S. net product sales included $151 million from SYFOVRE and $20.8 million from EMPAVELI, with licensing and other revenue contributing $7.1 million [10] - Cost of sales decreased to $13.6 million from $23.1 million year-over-year, attributed to lower product volumes supplied to Sobi and reduced expenses related to obsolete inventory [11] - R&D expenses were $67 million, down from $78 million in the same period last year, reflecting lower external costs and personnel expenses [14] - SG&A expenses increased to $131.1 million from $128.1 million, primarily due to higher office and travel expenses [15] - The net loss for Q2 2025 was $42.2 million, compared to a net loss of $37.7 million in Q2 2024 [16] Product Developments - EMPAVELI is the first FDA-approved treatment for C3G and primary IC-MPGN, showing a 68% reduction in proteinuria and stabilization of kidney function in clinical trials [6][20] - SYFOVRE continues to lead the market in geographic atrophy (GA) with a 55% share of new patient starts and total market share exceeding 60% [5][10] - The company is on track to initiate pivotal studies for delayed graft function (DGF) and focal segmental glomerulosclerosis (FSGS) in the second half of 2025 [6] Strategic Partnerships - Apellis entered a capped royalty purchase agreement with Sobi, allowing the company to receive up to $300 million for 90% of future ex-U.S. royalties for Aspaveli [5][13] - Sobi anticipates an opinion from the European Medicines Agency regarding Aspaveli's indication extension application by the end of 2025 [6] Cash Position - As of June 30, 2025, Apellis had $370 million in cash and cash equivalents, down from $411.3 million at the end of 2024, with expectations that current cash and future revenues will support operations until profitability [17]
看好小分子偶联药物及相关标的
CAITONG SECURITIES· 2025-07-28 08:00
Core Insights - The report maintains a positive outlook on small molecule drug conjugates (SMDCs) and related companies, highlighting their potential in cancer treatment due to their ability to enhance efficacy while reducing toxicity [1][5][17] - The report emphasizes the clinical advantages of SMDCs, including better tumor penetration, reduced toxicity to normal cells, and easier control over synthesis and costs compared to antibody-drug conjugates (ADCs) [5][11][12] - The report identifies domestic biopharmaceutical companies, particularly Affinivax, as leaders in the SMDC space, showcasing significant advancements in innovative cancer drug development [5][12][17] Industry Overview - The pharmaceutical and biotechnology sector has shown a relative price-to-earnings (P/E) ratio of 51.14 as of July 25, 2025, which is significantly higher than its historical low of 24.38, indicating a premium valuation compared to the broader market [19] - The report notes that the healthcare sector's valuation is 279% higher than the Shanghai Composite Index, reflecting strong investor interest and confidence in the industry [19] - Recent market performance indicates a 1.90% increase in the pharmaceutical and biotechnology sector from July 21 to July 25, 2025, ranking it 16th among 27 sub-industries [26][29] Company Focus - The report suggests monitoring companies involved in the SMDC space, including Affinivax, and those collaborating with them, such as Innovent Biologics and others, which are expected to benefit from the growing interest in innovative cancer therapies [5][17][18] - Specific companies highlighted for their innovative drug development capabilities include Innovent Biologics, Shunyi Pharmaceutical, and others, which are positioned to capitalize on the advancements in SMDC technology [5][18]
X @Bloomberg
Bloomberg· 2025-07-16 10:12
Drugmaker Sobi’s CEO Oelkers said he doesn’t think tariff threats on the pharmaceutical industry are likely to materialize imminently https://t.co/ebuXL5Augo ...
大摩上调Apellis Pharmaceuticals(APLS.US)目标价至26美元 维持“持有”评级
智通财经网· 2025-07-07 04:04
Group 1 - Morgan Stanley analyst Judah Frommer raised the target price for Apellis Pharmaceuticals (APLS.US) from $25 to $26 while maintaining a "Hold" rating, based on the company's market position and recent financial strategy [1] - The significant licensing agreement between Apellis and Sobi is strategically important, ensuring Apellis can receive up to $300 million in revenue, including a $275 million upfront payment, while reducing Sobi's royalty obligations on Aspaveli sales by 90% [1] - This agreement provides immediate financial benefits to Apellis and may alleviate investor concerns regarding its profitability [1] Group 2 - Apellis is a commercial-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative therapies for unmet medical needs [2] - The company's core product lines include EMPAVELI, used for treating paroxysmal nocturnal hemoglobinuria (PNH), and SYFOVRE, which treats geographic atrophy (GA) secondary to age-related macular degeneration [2]