Exelixis (EXEL) Q1 2025 Earnings Call May 13, 2025 05:00 PM ET Company Participants Susan Hubbard - EVP, Public Affairs and IRMichael Morrissey - CEO, President & DirectorChristopher Senner - Executive VP & CFOP.J. Haley - EVP, CommercialAmy Peterson - Executive VP, Product Development & Medical Affairs and Chief Medical OfficerDana Aftab - Executive VP of Discovery and Translational Research & Chief Scientific OfficerMichael Schmidt - Senior Managing Director, Equity ResearchSilvan Türkcan - Managing Direc ...

Financial Data and Key Metrics Changes - The company reported total revenues of approximately $555 million for Q1 2025, which included cabozantinib franchise net product revenues of $513.3 million, a 36% year-over-year increase from $378 million in Q1 2024 [7][13] - Non-GAAP net income for Q1 2025 was approximately $179.6 million, or $0.64 per share basic, compared to $159.6 million GAAP net income [16] - The company increased its full-year 2025 net product revenue guidance to $2.05 billion to $2.15 billion, reflecting a $100 million increase from previous guidance [18] Business Line Data and Key Metrics Changes - The U.S. cabozantinib franchise net product revenues grew 36% year-over-year to $513 million [7] - Global cabozantinib franchise net product revenues were approximately $680 million in Q1 2025, compared to $559 million in Q1 2024 [7] - The gross-to-net for the cabozantinib franchise in Q1 2025 was 28.9%, higher than the previous quarter, primarily due to increased PHS and 340B volumes [13] Market Data and Key Metrics Changes - CABOMETYX grew its market share from 40% to 44% in the TKI market basket, with TRx volume growing 18% year-over-year [20][21] - New prescription share for CABOMETYX increased from 38% to 43%, with NRx volume growing 27% year-over-year [22] - The oral market opportunity for neuroendocrine tumors in 2025 is forecasted to be approximately $1 billion in the U.S. [24] Company Strategy and Development Direction - The company aims to build a multi-compound, multi-franchise oncology enterprise, focusing on improving the standard of care for cancer patients [4][5] - The launch of CABOMETYX in neuroendocrine tumors is seen as a significant commercial opportunity, with expectations of rapid establishment as a market leader [20][25] - The company is advancing ZANZA as its next oncology franchise opportunity, with several pivotal trials expected to report data in the second half of 2025 [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance of CABOMETYX and the potential for new indications to drive further growth [6][9] - The company is focused on advancing new molecules from its pipeline and expects to file up to three new INDs in 2025 [11][34] - Management highlighted the importance of capital allocation, balancing investments in R&D, business development, and share repurchases [12][86] Other Important Information - The company repurchased approximately $289 million of its shares during Q1 2025, with a remaining authorization of $5.5 million under the previous buyback plan [17] - The company is focused on late-stage assets in GU and GI oncology for business development opportunities [72] Q&A Session Summary Question: What has been driving CABOMETYX growth? - The company noted significant growth in market share and volume, particularly in frontline RCC, driven by positive physician feedback and updated data from CheckMate 9ER [42][46] Question: What are the expectations for the NET launch? - Management indicated that it is early days for the NET launch, with positive prescriber excitement and new prescriptions being tracked closely [49][54] Question: What is the impact of Medicare Part D redesign? - The company reported minimal impact from the redesign, with a roughly equal split between commercial and Medicare business [74][78] Question: What is the company's approach to business development? - The company remains open to business development opportunities, focusing on high-conviction assets that align with its oncology franchise [68][70]

5月7日，百济神州发布2025年一季报。披露公司Q1营收增长50.2%至80.48亿元，净亏损9450.3万元。 2025年第一季度，百泽安®的销售额总计12.45亿元，同比增长19.3%。百泽安®销售额的增长，主要得益于在中国获批 新适应症纳入医保所带来的新增患者需求以及药品进院数量的增加。百泽安®已在中国PD-1市场取得领先的市场份 额。目前，百泽安®在中国获批14项适应症，其中符合纳入条件的13项适应症已纳入国家医保目录。 公司自主研发的BTK抑制剂百悦泽®是全球获批适应症最广泛的BTK抑制剂。它同时也是唯一一款给药灵活，可每日 一次或每日两次的BTK抑制剂。 百悦泽®临床开发项目迄今已在全球超过30个国家和地区开展超过35项试验，入组约7,100例患者。百悦泽®目前已在 全球75个市场获批，本季度在11个市场新增纳入或扩大报销范围，包括日本、欧洲和巴西。 百悦泽®"头对头"对比亿珂®（伊布替尼）用于治疗复发或难治性（R/R）CLL/小淋巴细胞淋巴瘤（SLL）成人患者的 全球临床三期ALPINE试验展示出持续的无进展生存期（PFS）获益，且心血管事件发生率较低。 百悦泽®说明书更新已在美国、欧盟和英国获 ...

Day One Biopharmaceuticals (DAWN) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Speaker0 Hello, ladies and gentlemen, and welcome to the DayOne Biopharmaceuticals First Quarter twenty twenty five Financial and Operating Results Conference Call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Please be advised that this conference call is being recorded. I would now like to turn the call over to Joy Peroni, Senior Vice President of Finance and ...

Financial Data and Key Metrics Changes - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024, indicating an improvement in loss per share [12] - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, primarily due to lower employee-related costs [12] - General and administrative expenses also decreased to $4 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related costs and professional fees [12] - Cash and cash equivalents totaled $20.3 million as of March 31, 2025, with the company expecting this to support operations into Q4 2025 [13] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is progressing, evaluating emavucertib in combination with ibrutinib in patients with relapsed/refractory primary CNS lymphoma [7] - As of January 2, 2025, 27 patients have been treated with the emavucertib and ibrutinib combination, showing promising results in tumor burden reduction [8] - In AML, a 38% composite complete response rate was observed in a study of 21 patients with FLT3 mutations treated with emavucertib, which is significantly higher than the 21% rate for gilteritinib [10] Market Data and Key Metrics Changes - The company is focusing on expanding the use of emavucertib beyond primary CNS lymphoma into additional indications such as NHL, AML, and solid tumors [5] - The enrollment for the lymphoma study is ongoing, with 37 sites currently open across the U.S., Europe, and Israel [20] Company Strategy and Development Direction - Curis is prioritizing the PCNSL study while also advancing its AML studies, with a focus on safety and tolerability in the frontline setting [18] - The company aims to enroll 30 to 40 additional patients for NDA submission in the lymphoma study, targeting six to eight responses in that dataset [9] - The addition of Dr. Ahmad Hamdi to the executive team is expected to enhance the company's strategic direction in expanding treatment options [4] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the collaboration with the FDA, indicating no concerns about changes affecting their agreement [28] - The company is optimistic about the potential of emavucertib in combination therapies and is focused on maximizing its utility across various indications [36] Other Important Information - Curis completed a registered direct financing and private placement in March 2025, raising approximately $8.8 million [13] - The company plans to provide additional updates on the Take Aim Lymphoma study at the ASH conference later this year [9] Q&A Session Summary Question: Positioning of lymphoma versus AML - Management is advancing both lymphoma and AML studies simultaneously, with more resources allocated to the PCNSL study due to its advanced stage [18] Question: Enrollment in lymphoma study and FDA conversations - Enrollment is on track with 37 sites open, and management is confident in their collaboration with the FDA [25][28] Question: Mutations affecting responses and AML development steps - It is too early to discuss specific mutations affecting responses; the focus is on the mechanism of action [33] - Future plans for AML development will be discussed after completing the ongoing triplet study [35]

2025 年 04 月 30 日 公司点评 买入/ 维持 君实生物(688180) 目标价: 48.10 昨收盘:30.45 拓益收入同比增长 46%，关注 DKK1 胃肠道肿瘤早期数据 ◼ 走势比较 (30%) (18%) (6%) 6% 18% 30% 24/4/30 24/7/11 24/9/21 24/12/2 25/2/12 25/4/25 ◼ 股票数据 总股本/流通(亿股) 9.86/7.65 总市值/流通(亿元) 300.14/232.81 12 个月内最高/最低价 (元) 38.36/23.08 相关研究报告 观点： 拓益销售收入保持高增速，公司运营效率显著提升，在手现金 30 亿 元。2025 年第一季度公司实现收入 5 亿元（同比+31.46%），其中，核心 产品特瑞普利单抗于国内市场实现销售收入 4.47 亿元（同比+45.72%）。 同时，公司积极落实"提质增效重回报"行动方案，提升销售效率，并将资 源聚焦于更具潜力的研发项目，与上年同期相比亏损减少。2025Q1 销售 费用 2.26 亿元（同比+17.79%），占总收入比重为 45%，较 2024Q1 下降 了 5pcts。研发费用 ...

每经记者 甄素静 每经编辑 张益铭 丨2025年4月29日 星期二丨 NO.1 药明康德一季度净利润同比增长89.06% 4月28日，药明康德公告称，2025年第一季度实现营业收入96.55亿元，同比增长20.96%；归属于上市公 司股东的净利润36.72亿元，同比增长89.06%。 点评：药明康德2025年一季度营收、净利双增，展现强劲增长势头，凸显其在医药研发服务领域强大竞 争力与行业领先地位。 NO.2 派格生物通过港交所聆讯即将上市，8轮融资估值40亿 派格生物近日通过聆讯，拟在香港主板上市，独家保荐人为中金。公司是自主研究及开发慢性疾病创新 疗法的生物技术公司。2024年收入0.07亿元，净亏损2.83亿元。 点评：派格生物通过港交所聆讯，即将登陆港股。其专注慢性疾病创新疗法，虽目前亏损，但核心产品 潜力大，8轮融资获40亿估值，上市后有望借资本加速发展。 NO.3 德国默克将以39亿美元收购SpringWorks 4月28日，德国默克宣布，将收购SpringWorks，交易代价约为39亿美元的股权价值，或根据 SpringWorks截至2024年12月31日的现金余额计算的34亿美元企业价值。 点 ...

2025年4月25日，中国北京——生物医药高科技公司诺诚健华(上交所代码：688428；香港联交所代码： 09969)今天宣布，公司自主研发的新型BTK(布鲁顿酪氨酸激酶)抑制剂奥布替尼(商品名：宜诺凯)获得 中国国家药品监督管理局(NMPA)批准，用于一线治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤 (CLL/SLL)。此次一线CLL/SLL的获批将惠及更多淋巴瘤患者。 此前，奥布替尼已在中国获批用于治疗既往至少接受过一次治疗的CLL/SLL、套细胞淋巴瘤(R/R MCL) 和边缘区淋巴瘤(R/R MZL)，三项适应症均已纳入国家医保。 临床试验的主要研究者、江苏省人民医院李建勇教授表示："作为我国自主研发的I类创新药，奥布替尼 自2020年上市以来，已经在复发/难治性CLL/SLL等B细胞恶性肿瘤的治疗中展现了卓越的疗效和安全 性，显示出更高的完全缓解率。此次获批一线治疗CLL/SLL，意味着更多淋巴瘤患者能获益这种高效、 精准的治疗方案，一线治疗研究显示完全缓解率高达12.1%，将为我国血液肿瘤的治疗带来新的希望和 突破。" 临床试验的主要研究者、中国医学科学院血液病医院邱录贵教授表示："此项研究开展整个过 ...

NovoCure posted stronger-than-expected Q1 2025 results, driven by revenue and GAAP earnings surpassing estimates. NovoCure (NVCR 7.34%), a leader in oncology treatments using Tumor Treating Fields (TTFields) therapy, released its first-quarter results on April 24, 2025. The company reported notable gains with revenue rising to $155 million (GAAP) in Q1 2025, surpassing Wall Street's estimate of $146 million. The first quarter was marked by considerable revenue growth for NovoCure. GAAP revenue reached $155 ...

NovoCure (NVCR) Q1 2025 Earnings Call April 24, 2025 08:00 AM ET Company Participants Ingrid Goldberg - Vice President of Finance and Investor RelationsWilliam Doyle - Executive ChairmanAshley Cordova - CEOChristoph Brackmann - CFOFrank Leonard - Executive VP & President of Novocure OncologyYiwen Zhang - Equity Research AssociateVijay Kumar - Senior Managing DirectorEmily Bodnar - Vice President of Equity Research Conference Call Participants Lawrence Biegelsen - AnalystJason Bednar - Senior Research Analys ...