Q4 '25 Earnings Call February 3, 2026 Safe Harbor Statement This presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the performance o ...

Kyowa Kirin 坚定致力于将罗卡替尼单抗开发为具有显著市场潜力、能够改变患者生活的差异化创新药物。罗卡替尼单抗作为一种试验性 T 细胞再平衡疗法，其创新之处在于直接作用于致病性 T 细胞上表达的 OX40 受体，有望为中重度特应性皮炎 (msAD) 患者提供长期疾病控制。公司计划于 2026 年上半年递交监管申请。 东京、新泽西普林斯顿, Jan. 31, 2026 (GLOBE NEWSWIRE) -- 总部位于日本的全球专业制药公司 Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) 今日宣布终止与 Amgen 公司目前有关罗卡替尼单抗的研发及商业化合作。 Kyowa Kirin 将重新掌控全球罗卡替尼单抗项目，包括监管申报及未来商业化进程。 此项商业决策源于 Amgen 对其战略投资组合进行优先排序和优化的考量。 双方正推动该项目的平稳有序交接，重点确保当前临床试验受试者的连续性和权益不受影响。 与 Kyowa Kirin 合作开发多款试验性疗法已超过 41 年的 Amgen，将继续负责罗卡替尼单抗的生产。 Kyowa Kirin 总裁兼首席运营官 Abd ...

Core Insights - Kyowa Kirin Co., Ltd. and Amgen Inc. have terminated their collaboration on the development and commercialization of rocatinlimab, with Kyowa Kirin regaining control over the global program [1][2] Group 1: Collaboration Details - The collaboration was initiated in June 2021, focusing on KHK4083, a Phase 3-ready anti-OX40 monoclonal antibody for atopic dermatitis and other autoimmune diseases [2] - Amgen made an upfront payment of $400 million and Kyowa Kirin was eligible for milestone payments up to $850 million [3] Group 2: Clinical Trial Insights - Preliminary topline results from the ASCEND study, evaluating rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis, were released in September 2025 [3] - The incidence of gastrointestinal ulceration events with rocatinlimab is reported to be less than 1 per 100 patient-years across the Phase 3 ROCKET program [4] Group 3: Analyst Commentary - The decision to terminate the agreement was unexpected, occurring after a broad Phase 3 program and just before a planned regulatory submission [5] - Recent updates in the OX40 development landscape have diminished enthusiasm for the target, with Phase 3 efficacy falling short of Phase II benchmarks [5] - Concerns regarding rocatinlimab's toxicity profile, including high rates of pyrexia and chills, may pose commercial challenges [6] Group 4: Investor Sentiment - The discontinuation of rocatinlimab is not expected to impact the investment thesis for Amgen, given low investor expectations for therapies targeting the OX40 pathway [7] - Amgen's CEO shared findings from part 2 of the Phase 2 study of MariTide, an investigational obesity treatment, at a J.P. Morgan Healthcare Conference [7] - Amgen acquired Dark Blue Therapeutics for up to $840 million, focusing on precision oncology medicines [7] Group 5: Stock Performance - As of the publication date, Amgen's stock was down 0.81% at $340.17 [8]

Kyowa Kirin affirms commitment to developing rocatinlimab as a life-changing differentiated asset with significant market potential.Rocatinlimab’s novel approach as an investigational T-cell rebalancing therapy directly targeting the OX40 receptor expressed on pathogenic T-cells shows potential to deliver long-term disease control in patients with moderate-to-severe atopic dermatitis (msAD).Regulatory submission is planned in the first half of 2026. TOKYO and PRINCETON, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) ...

Core Insights - The combination of ziftomenib with venetoclax and azacitidine shows promising clinical activity in treating acute myeloid leukemia (AML) with NPM1 mutations, achieving an 86% composite complete remission (CRc) rate in newly diagnosed patients and a 65% overall response rate (ORR) in relapsed/refractory cases [1][2][5] - Ziftomenib has a favorable safety profile, with low rates of myelosuppression and manageable side effects, supporting its potential integration into treatment regimens for AML [4][7][8] - Ongoing registrational trials for ziftomenib are expected to further establish its role in both front-line and relapsed/refractory settings for AML [2][8][13] Summary by Category Clinical Efficacy - In newly diagnosed NPM1-m AML, 86% of patients achieved CRc, with 68% of responders attaining molecular minimal residual disease (MRD) negativity [1][3] - In relapsed/refractory NPM1-m AML, the ORR was 65%, and in venetoclax-naïve patients, it increased to 83% [2][11] - For KMT2A-r AML, the ORR was 41%, with 70% in venetoclax-naïve patients [1][11] Safety Profile - The triplet combination of ziftomenib, venetoclax, and azacitidine was well tolerated, with low rates of ziftomenib-related myelosuppression [4][7] - Adverse events included one case of grade 2 differentiation syndrome and one case of grade 3 QTc prolongation, both managed without treatment discontinuation [4][7] Ongoing Development - Kura Oncology is conducting registrational trials for ziftomenib in both intensive chemotherapy-eligible and -ineligible patients [1][2] - The company is also activating sites for pivotal trials, indicating confidence in the drug's potential as a foundational treatment for AML [8][13]

Core Insights - The combination of ziftomenib with venetoclax and azacitidine shows promising clinical activity in treating acute myeloid leukemia (AML) with NPM1 mutations and KMT2A rearrangements, with high rates of complete remission and molecular negativity [2][3][8] Group 1: Clinical Efficacy - In newly diagnosed NPM1-m AML, 86% achieved composite complete remission (CRc) and 73% achieved complete remission (CR), with 68% of CRc responders attaining molecular minimal residual disease (MRD) negativity [1][2] - In relapsed/refractory (R/R) NPM1-m AML, the overall response rate (ORR) was 65%, and in venetoclax-naïve patients, the ORR was 83% [1][2] - For R/R KMT2A-r AML, the ORR was 41%, with 70% in venetoclax-naïve patients [1][2] Group 2: Safety Profile - The triplet combination of ziftomenib, venetoclax, and azacitidine was well tolerated, with low rates of ziftomenib-related myelosuppression and no increase in toxicity beyond venetoclax/azacitidine alone [1][4][7] - Adverse reactions included differentiation syndrome and QTc prolongation, but these were managed without treatment discontinuation [4][7] Group 3: Ongoing Development - Kura Oncology is conducting registrational trials for ziftomenib in both intensive chemotherapy-eligible and -ineligible patients [1][2][8] - The ongoing KOMET-007 Phase 1a/1b trial is evaluating ziftomenib's efficacy across multiple AML subtypes, reinforcing its potential as a foundational treatment option [1][8][12] Group 4: Company Information - Kura Oncology is focused on precision medicines for cancer treatment, with KOMZIFTI (ziftomenib) being the first oral menin inhibitor approved for adult patients with R/R AML harboring NPM1 mutations [12][28] - Kyowa Kirin collaborates with Kura Oncology, emphasizing their commitment to innovative treatments for high unmet medical needs [29]

Core Insights - KOMZIFTI (ziftomenib) is the first and only once-daily oral menin inhibitor approved by the FDA for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, now commercially available in the U.S. [1][2] - The drug has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines as a Category 2A recommended treatment option for this patient population [1][3] Company Overview - Kura Oncology, Inc. is a biopharmaceutical company focused on precision medicines for cancer treatment, with KOMZIFTI being a key product in its pipeline [19] - Kyowa Kirin Co., Ltd. is a global specialty pharmaceutical company with a long history in drug discovery and biotechnology innovation, collaborating with Kura on the commercialization of KOMZIFTI [20] Clinical Data - KOMZIFTI received full FDA approval on November 13, 2025, based on the KOMET-001 clinical trial, which demonstrated a 21.4% complete response (CR) or complete response with partial hematologic recovery (CRh) rate and a median duration of response of 5 months [2] - The clinical trial involved 112 patients with R/R AML and NPM1 mutation, with differentiation syndrome (DS) occurring in 26% of patients [8][14] Treatment Guidelines - The inclusion of KOMZIFTI in the NCCN Guidelines highlights its potential impact on patients with R/R NPM1-mutated AML and reflects the commitment to patient access [3] - KOMZIFTI is also being developed for front-line treatment of AML with various mutations, indicating its potential to benefit a broader patient population [5] Safety Information - KOMZIFTI has a boxed warning for differentiation syndrome, which can be fatal, and requires monitoring and management protocols [6][7] - Adverse reactions reported in clinical trials include serious reactions in 79% of patients, with the most common being infections and differentiation syndrome [14][16]

Core Insights - The FDA has granted full approval for KOMZIFTI (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, marking it as the first once-daily oral menin inhibitor approved for this indication [1][11] - The approval is based on the KOMET-001 trial, which demonstrated a complete remission rate of 21.4% and a median duration of response of 5.0 months in patients with R/R NPM1-m AML [5][6] - KOMZIFTI is positioned to address a significant unmet need in a patient population with historically poor outcomes and limited treatment options [1][4] Company Overview - Kura Oncology, in collaboration with Kyowa Kirin, is committed to advancing the development of KOMZIFTI across the treatment continuum for AML, aiming to improve patient outcomes [2][8] - The companies have established a global strategic collaboration for the development and commercialization of KOMZIFTI, with Kura leading efforts in the U.S. [8] Clinical Data - In the pivotal KOMET-001 trial, 112 patients were evaluated, with 88% of those achieving complete remission or complete remission with partial hematologic recovery within 6 months of treatment initiation [5][6] - The trial also reported a median time to first response of 2.7 months, indicating a rapid onset of efficacy [5] Safety Profile - KOMZIFTI has a favorable safety profile, with no Boxed Warning related to QTc prolongation or Torsades de Pointes, which is significant for patients on multiple concurrent medications [6][7] - The most common adverse reactions included increased liver enzymes and infections, with serious adverse reactions reported in 79% of patients [21][23] Market Potential - The approval of KOMZIFTI represents a major advancement in targeted therapies for AML, particularly for patients who are older and unable to tolerate intensive chemotherapy [6][8] - The drug's once-daily oral administration and compatibility with other medications enhance its potential to become the preferred treatment option in its approved indication [2][6] Access and Support - Kura has established a support program, Kura RxKonnect, to facilitate access and reimbursement for patients prescribed KOMZIFTI [9]

Core Insights - Ardelyx, Inc. presented data on XPHOZAH at the American Society of Nephrology's Kidney Week, highlighting its effectiveness in real-world settings for patients with chronic kidney disease on dialysis [1][3] Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines to address significant unmet medical needs [1][15] - The company has two commercial products approved in the United States: IBSRELA and XPHOZAH, with ongoing development of next-generation therapies [15][16] Product Information - XPHOZAH is the first phosphate absorption inhibitor approved by the FDA for reducing serum phosphorus in adults with chronic kidney disease on dialysis [2][14] - It is administered as a single tablet taken twice daily and works by blocking phosphate absorption in the gut [2][10] Clinical Study Results - The first real-world study of XPHOZAH showed that patients experienced an average reduction in serum phosphate of nearly 1 mg/dL, with 45.3% of participants achieving a reduction of ≥1 mg/dL [3][4] - A separate survey indicated that 63% of patients reported improved phosphate levels since starting tenapanor, with 69% feeling better about their phosphate control [4] Patient Experience - Positive patient experiences were reported, including improved bowel movements and lower pill burden, with 44% attributing improvements to better phosphate control [4] - Tenapanor also demonstrated effectiveness in improving bowel movements in patients with end-stage kidney disease and constipation [6][7] Economic Analysis - A cost-effectiveness analysis in Japan concluded that tenapanor is cost-effective for hemodialysis patients, meeting the threshold of five million Japanese Yen for willingness to pay [8]

Core Insights - Kura Oncology and Kyowa Kirin announced that results from the KOMET-007 trial of ziftomenib will be presented at the ASH 2025 Annual Meeting on December 8, 2025 [1][2] Group 1: Trial Details - KOMET-007 is a Phase 1a/b study assessing ziftomenib in combination with standard chemotherapies for adults with NPM1-mutated or KMT2A-rearranged acute myeloid leukemia (AML) [2] - The upcoming presentations will include data on newly diagnosed adults with NPM1-m AML and updated results for relapsed or refractory cases treated with ziftomenib combined with venetoclax and azacitidine [2][3] Group 2: Presentation Information - Two oral presentations will take place on December 8, 2025, focusing on the safety and clinical activity results from the KOMET-007 trial [5] - The presentations will provide more mature data, including additional response-evaluable patients and expanded safety summaries [3] Group 3: Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors [6] - Ziftomenib is a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemias, with ongoing efforts to advance menin inhibition in various cancer types [6]