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Interested in Ascentage Pharma Group International - Unsponsored ADR? Here are five stocks we like better. First-half revenue rose 29.3% year over year to $44.5 million, including $41.6 million in product sales. Ascentage ended June with $279.4 million in cash and reiterated that its runway extends through the end of 2027. Research and development spending increased to $102.8 million as the company advanced nine global registrational studies, while management said operating expenses may have peaked. Enrollment for key lisaftoclax and olverembatinib trials is expected to conclude by late 2026 or early 2027, supporting potentially multiple NDA filings in 2027. Ascentage is expanding commercial capabilities outside China and advancing its pipeline, including lisaftoclax, olverembatinib, APG-5918 and APG-3288. Takeda’s olverembatinib agreement could generate up to $1.2 billion in milestone payments plus tiered royalties. Ascentage Pharma Group International (NASDAQ:AAPG) reported first-half 2026 revenue growth as it continued investing in global registrational studies for its hematology-oncology pipeline and began building commercial capabilities outside China. Total revenue for the six months ended June 30 was $44.5 million, up 29.3% on a constant-currency basis from $32.6 million a year earlier, according to Chief Financial Officer Veet Misra. Product sales accounted for $41.6 million of total revenue. The company ended the period with $279.4 million in cash and reaffirmed that its cash runway extends through the end of 2027. → Datavault AI Locks Down CyberCatch in $94M Security Rollup Chairman and Chief Executive Officer Dajun Yang said the company is focused on becoming a “leading global, fully integrated hematology oncology company,” supported by two products approved in China and a portfolio of global clinical programs. Ascentage said it is advancing nine registrational trials, including four cleared by both the U.S. Food and Drug Administration and the European Medicines Agency. Research and development expense rose to $102.8 million in the first half, from $73.8 million in the prior-year period, reflecting enrollment activity across multiple global registrational programs. Selling and distribution expense increased to $33.4 million from $19.2 million, driven by marketing and commercial investment behind the company’s products. Administrative expense was $17.5 million, compared with $13.9 million a year earlier, primarily due to restricted stock unit expense. → Michael Burry Is Betting Against Palantir Again—Should Investors Care? Misra said operating expenses have reached their peak as the company moves through the later stages of trial enrollment. He said the company expects its existing cash to support enrollment completion, clinical data generation and multiple anticipated new drug application filings. During the call, management also addressed potential future financing and partnership opportunities. Misra said the company has sought flexibility through its dual listing and is not under pressure to pursue a single financing path. He added that partnerships may be considered where appropriate. → Home Depot Analysts See a Path to $375 and Beyond Ascentage highlighted lisaftoclax, a selective BCL-2 inhibitor approved in China for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma previously treated with a BTK inhibitor. Yang said the company is conducting four global registrational studies of the drug. Chief Medical Officer Yifan Zhai said enrollment has been completed in the GLORA-2 study in frontline CLL/SLL and is nearing completion in GLORA-3, a study of lisaftoclax in combination with azacitidine in acute myeloid leukemia. The company expects enrollment in its remaining global registrational trials, including GLORA-4 in frontline high-risk myelodysplastic syndromes, to finish by the end of 2026 or early 2027. GLORA-4 is evaluating lisaftoclax plus azacitidine against azacitidine alone in high-risk MDS and has been cleared in multiple jurisdictions, including the U.S., Europe, China and Japan. Yang said the company expects to potentially file as many as three NDAs in the second half of 2027, including filings related to its lead programs. Management emphasized lisaftoclax’s daily dose ramp-up schedule and stated that its observed safety profile and drug-drug interaction characteristics could differentiate it from other BCL-2 inhibitors. Yang noted that comparisons discussed on the call were not head-to-head studies. In China, Yang said lisaftoclax has passed an initial review for inclusion in the National Reimbursement Drug List and is on the final product list for expert review. He said the company expects a final reimbursement decision later in the process, while noting that price remains a consideration. National reimbursement could improve hospital access and reduce patient out-of-pocket costs, management said. The company’s other approved product in China, olverembatinib, is a third-generation BCR-ABL inhibitor for chronic-phase chronic myeloid leukemia. Yang said tens of thousands of patients have been treated with the drug in China and that some patients have remained on therapy for nearly a decade. Ascentage is advancing POLARIS-2, a global study in chronic-phase CML patients who have received at least two prior tyrosine kinase inhibitors. The study includes a randomized comparison of olverembatinib against bosutinib, as well as a single-arm cohort for patients with the T315I mutation. The company expects enrollment to conclude by the end of 2026 or early 2027. Zhai said the POLARIS-2 primary endpoint is the major molecular response rate at 24 weeks and that patients who fail the control arm may cross over to olverembatinib. Yang said the company expects an NDA filing based on the six-month major molecular response rate after the final patient is enrolled. POLARIS-1 is a global Phase III study in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. Yang said the planned NDA filing endpoint is the three-month minimal residual disease-negative complete response rate. The company also cited earlier study data for olverembatinib in heavily pretreated CML patients, including patients previously treated with ponatinib or asciminib. Takeda holds an exclusive option to license olverembatinib outside Greater China and certain other territories. Yang said Takeda paid $100 million upfront and made a $75 million equity investment under the 2024 agreement. The potential deal includes up to $1.2 billion in aggregate payments and tiered royalties ranging from 12% to 19%, management said. Ascentage appointed Faiçal Miyara as chief business officer and Jim Ziegler as chief commercial officer. Miyara previously held oncology business-development roles at companies including Lilly, Pfizer, Sanofi, Ipsen, Kadmon and IO Biotech. Ziegler said his immediate priorities include establishing commercial strategy, market access and related capabilities for potential launches in the U.S. and other markets. Beyond its two approved products, the company discussed clinical-stage assets including MDM2 inhibitor APG-115, EED inhibitor APG-5918 and BTK degrader APG-3288. Yang said Ascentage plans to present data from the Phase I APG-5918 program at the American Society of Hematology meeting this year. The company does not expect to present Phase I data for APG-3288 at ASH, but said it may have data to share at the European Hematology Association meeting in 2027. Management said APG-3288 is being studied in the U.S. and China in patients previously exposed to BTK inhibitors, and that the company plans to file investigational new drug applications for autoimmune indications, including multiple sclerosis. Ascentage Pharma Group International is a clinical‐stage biopharmaceutical company focused on developing small‐molecule therapeutics that modulate programmed cell death pathways, including the Bcl‐2 family and the MDM2–p53 axis. Its pipeline features orally bioavailable inhibitors such as APG-2575, a selective Bcl-2 inhibitor, and APG-115, a potent MDM2 antagonist, both aimed at reactivating apoptosis in cancer cells across hematologic malignancies and solid tumors. Founded in 2008 by biotechnology entrepreneur Dr. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Ascentage Pharma Group International H1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Image source: The Motley Fool. Thursday, July 30, 2026 at 6 a.m. ET Head of Investor Relations - Christopher David O'Reilly President and Chief Executive Officer - Julie Kim Chief Financial Officer - Milano Furuta President, R&D - Andy Plump Christopher David O'Reilly: [Interpreted] Thank you very much for joining us today despite a very busy schedule for the FY '26 Q1 earnings announcement by Takeda. My name is O'Reilly, and I'm the Head of IR. I'll be facilitating the discussion today. Thank you for this opportunity. And first of all, allow me to explain about the language setting. [Operator Instructions] Before starting, I'd like to remind everyone that we will be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in our other SEC filings. Please also refer to the important notice on Page 2 of the presentation regarding forward-looking statements and our non-IFRS financial measures, which will be also discussed during this call. Definitions of our non-IFRS measures and reconciliations with comparable IFRS financial statements are introduced in the appendix of the presentation. Now we would like to start the presentation. We have President and CEO, Julie Kim; Chief Financial Officer, Milano Furuta; and President, R&D, Andy Plump. They will do the presentation, which will be followed by the Q&A session. We will get started. Julie, please go ahead. Julie Kim: Thank you, Chris. Thank you for joining us for today's earnings call focused on the first quarter of fiscal year 2026. We delivered a solid start to the fiscal year, and our performance this quarter demonstrates steady progress against our strategic priorities, keeping us firmly on track to achieve our full year guidance. These achievements reflect our continued execution against the 2-Horizon strategic road map we shared last quarter, which will position us for accelerated growth in the years ahead to expand impact for patients and set the stage for sustained value creation. Today, I will outline this quarter's progress against our priorities. Financially, we delivered a solid quarter and made steady progress against our fiscal year '26 priorities. In the first quarter, core revenue declined slightly at 0.5% at constant exchange rate, or CER, in line with our expectations as momentum across our core in-line brands and existing new launch brands largely offset anticipated headwinds in our mature portfolio. Core operating profit declined 0.5% year-over-year at CER, reflecting the continued investment behind our upcoming launches and exciting late-stage pipeline, which we are partially offsetting by savings generated through our transformation program. And core EPS was JPY 154, a decrease of 11.8% at CER, mainly due to a favorable tax position in the prior year. Milano will walk you through the financial dynamics in more detail shortly, but the key takeaway is that we are well on track towards our full year guidance. This quarter, we had strong execution across all Horizon One priorities. We are ensuring the resilience of our existing portfolio with our core in-line brands growing by 2.3% at CER. We also continue to execute against our transformation program. As an example, we have largely completed the implementation of our international business unit, which is bringing leadership and teams closer to patients and customers and supports more simplicity, speed and efficiency. We'll do all of this without sacrificing quality to help us move at pace to bring life-transforming medicines to patients. Takeda's consistent and effective execution of our enterprise transformation is enabling us to fund our launches and advance our pipeline. It also represents a fundamental change in how we work today and how we will grow as a company in the future. We also made excellent progress across the pipeline this quarter. We are pleased to have received our first approval for oveporexton in narcolepsy type 1 under the brand name ORZEYFUL in China, and approvals in U.S. and Japan are key milestones expected in Q2. I will speak more about the important milestones and progress towards launch for ORZEYFUL, rusfertide and zasocitinib on the next slide. In oncology, we presented TAK-928 data at ASCO in first- and second-line non-small cell lung cancer. And we initiated a Phase III study of elritercept in first-line anemia-associated MDS. Taken together, our 3 priorities for FY '26 remain firmly on track, continue advancing preparations for the successful launch of ORZEYFUL, rusfertide and zasocitinib, progress the next wave of our pipeline and continued execution of our transformation program to unlock new capabilities and efficiencies. We continue to build the foundation for our future growth by preparing to bring new medicines to patients. With the first ORZEYFUL approval obtained in China. We eagerly look forward to bringing our first-in-class orexin agonist for narcolepsy type 1 to patients in the U.S. and Japan as well, with launches expected in the second half of 2026. ORZEYFUL has delivered transformative efficacy across a broad range of NT1 symptoms. At the SLEEP 2026 meeting, we presented additional ORZEYFUL Phase III data, reinforcing the potential of this medicine to establish a new standard of care by improving measures of daily function, cognition and nighttime sleep in patients with narcolepsy type 1. Rusfertide, our potential first-in-class hepcidin mimetic for polycythemia vera has demonstrated rapid, stable and durable hematocrit control while reducing patients' reliance on phlebotomy. Rusfertide has obtained U.S. FDA priority review, and we expect a U.S. launch also in the second half of 2026. Following Protagonist's opt-out from U.S. co-commercialization, we are excited to have sole responsibility for commercializing rusfertide globally, and we are committed to maximizing its growth potential and impact on patients. Turning to the third of these transformative medicines, zasocitinib is our potential best-in-class oral treatment for psoriasis, delivering rapid and durable skin clearance in a convenient once-daily pill with no fasting restrictions. We are on track towards launching in the U.S. in the first half of 2027. Our confidence in its profile is stronger than ever. In our recent head-to-head Phase III psoriasis study versus deucravacitinib, zasocitinib demonstrated statistical superiority for all primary and key secondary endpoints with more than 35% of patients achieving PASI 100 or complete skin clearance at week 16. We also shared new data this month from the pivotal Phase III psoriasis studies, demonstrating that zasocitinib achieved consistent high rates of skin clearance across the body, including hard-to-treat and high-impact sites. Andy will talk more about this in a few minutes. Importantly, we are not just generating compelling data. We are continuing to lay the groundwork for successful launches. For ORZEYFUL, we have had Medical Science Liaisons in the field for more than a year. We've engaged payers and KOLs, and we've set up specialty pharmacy and patient support programs to facilitate an exceptional patient experience. For rusfertide, we are building HCP awareness of the importance of sustained hematocrit control and leveraging our established hematology commercial infrastructure to ensure we're ready for a successful launch. For zasocitinib, payer discussions and broader prelaunch preparations are already underway, supporting our ambition not only to gain market share, but also to expand the oral treatment segment. Our efforts are planful. We believe they will enable us to ensure these transformative medicines will reach patients as quickly as possible, delivering on our commitments in Horizon One and positioning Takeda for accelerated long-term growth. These milestones reinforce the depth of our late-stage pipeline and reflect the sustained disciplined commitment we have to faster AI-enabled discovery and development, strong market access and best-in-class scientific, medical, manufacturing, technology and commercial capabilities. Today, we are in Horizon One and fundamentally transforming Takeda from within. This includes optimizing our operations, strengthening our competitiveness and successfully launching new medicines that will become our future growth drivers. As I just shared, this phase is progressing well through our launch preparation, pipeline progress, core in-line brand resilience and execution of our transformation. To provide an additional example, we recently announced a landmark collaboration with the Indonesian government to build plasma operations in the country, starting with establishing plasma donation centers and assessing the feasibility of potential future manufacturing capabilities. Partnerships like this support the growth of our PDT business and the competitive resilience of our core in-line brands while reinforcing our commitment to a sustainable global plasma ecosystem. Throughout this period, we are committed to a clear set of performance measures, returning to top line growth, protecting our core operating profit margins while making substantial growth investments and improving our return on equity to above 5%. The entire Takeda team is working diligently to execute on our priorities and establish a strong foundation in Horizon One. Every milestone we accomplish reinforces our path of progress towards Horizon Two growth acceleration. Our employees' relentless dedication and discipline will continue to set the stage for sustained value creation for patients and shareholders. With that, I will hand the call over to Milano to walk through our first quarter financial results in more detail. Milano Furuta: Thank you, Julie, and hello, everyone. Let me walk through our financial highlights for Q1 of fiscal year 2026. Overall, our Q1 results are on track towards full year guidance. Revenue was JPY 1.22 trillion, an increase of 10.2% on an actual FX basis or a decline of 0.5% at constant exchange rates or CER. Core operating profit was JPY 358.9 billion, up 11.5% at actual FX or minus 0.5% at CER, while reported operating profit was JPY 201.4 billion. Core EPS was JPY 154 with an 11.8% decline at CER as expected, mainly reflecting tax favorability in the prior year. Reported EPS was JPY 72. Operating cash flow was lower than prior year, reflecting changes in working capital related to our trade receivables factoring program. Adjusted free cash flow also reflects a payment of USD 200 million to Protagonist following the decision in April to opt-out of our co-promotion agreement for rusfertide. As Julie highlighted, this means that Takeda now holds exclusive development and commercialization rights for rusfertide globally. Overall, we are on track to deliver JPY 650 billion to JPY 750 billion free cash flow for the full year. Slide 10 shows a revenue bridge versus prior year. At CER, core revenue declined 0.5% as growth from core in-line brands and new launches largely offset the decline from LOE and mature products, which includes the continued generic erosion of VYVANSE in the U.S. Core in-line brands represented 58% of total revenue and grew 2.3% at CER, which is on track with our expectations for Q1. Our largest product, ENTYVIO, remains resilient with 4% growth at CER, while immunoglobulin and albumin were both impacted by phasing in the U.S., which was within our expectation. Our new launches category is still small today, only 4% of total revenue, but it is growing strongly at 22.6% at CER, supported by FRUZAQLA, LIVTENCITY, ADZYNMA, QDENGA. We're excited at the prospect of introducing new products to this category with the potential launches of ORZEYFUL and rusfertide later this year. Finally, FX was a big positive to our top line, adding JPY 118.2 billion to deliver 10.2% growth at actual exchange rates. Slide 11 shows a bridge for core operating profit. Consistent with our priorities in Horizon One, we have positioned fiscal year 2026 as a year of growth investments funded by savings from our transformation program. The transformation program is firmly on track, as Julie commented earlier. However, many of the initiatives were implemented at the end of the quarter, meaning the savings amount captured in Q1 results is still relatively limited. All the high priority growth investments are on track, including launch readiness for ORZEYFUL, rusfertide and zasocitinib as well as progress of late-stage development programs such as TAK-928 and TAK-921. We continue to demonstrate cost discipline alongside targeted investments. And finally, you can see in the chart that gross profit was positive in Q1, primarily driven by favorable FX variance in cost of goods as well as a one-time divestiture-related milestone. Next, reported operating profit on Slide 12. As you can see in this chart, the 2 main factors impacting year-on-year performance were lower amortization of intangible assets, mainly due to the completion of VYVANSE amortization in January 2026 and higher restructuring expenses related to the transformation program. FX also provided a tailwind, resulting in 9.1% growth versus prior year at actual exchange rates. Slide 13 shows our full year fiscal 2026 outlook, which is unchanged from May. And our Q1 performance was fully on track towards our targets for this year. I will close my section of the presentation by reemphasizing our commitment to strict financial discipline through our 2 growth horizons. In particular, during this Horizon One, our focus is on returning to revenue growth, protecting operating profit, improving reported profit and ROE and maintaining strong adjusted free cash flow. I look forward to sharing our ongoing progress towards these goals. Thank you. And I'll now pass to Andy for updates on the pipeline. Andrew Plump: Thank you, Milano, and hello to everyone on today's call. I want to frame this quarter simply. Takeda R&D is ready to convert pipeline progress into commercial performance that supports our 2-Horizon growth strategy. Over the coming months, we are poised to launch 3 transformative medicines: ORZEYFUL, rusfertide and zasocitinib, each with the potential to redefine the standard of care in its field and together setting Takeda on a new growth trajectory. Let me begin with ORZEYFUL, which I believe is one of the most exciting stories in neuroscience today. Narcolepsy type 1 is a lifelong disorder caused by the loss of orexin signaling, leading to disabling daytime and nighttime symptoms. At the 2025 World Sleep Congress, we presented groundbreaking results from 2 Phase III studies that met all 14 primary and secondary endpoints, demonstrating statistically significant and clinically meaningful improvements. ORZEYFUL delivered transformative efficacy across the broad disease spectrum, including daytime symptoms like excessive daytime sleepiness and cataplexy as well as nighttime symptoms, cognitive symptoms, functional improvements and quality of life. ORZEYFUL doesn't just manage symptoms, it addresses the underlying orexin deficiency in NT1, offering patients a single, well-tolerated oral therapy that could restore how a majority of NT1 patients feel and function. We are on track to bring the first and only orexin agonist to patients living with NT1. As Julie mentioned, we have received our first approval in China, and we eagerly await decisions in the U.S. and Japan this quarter. At SLEEP 2026, we presented additional Phase III data that I would describe as remarkable with improvements spanning daily function, cognition and nighttime sleep. Let me share a few of the highlights. Using the functional impacts of narcolepsy instrument, or FINI for short, we saw significant improvement across all functional domains with p-values below 0.0001, including benefits to cognitive functioning, social activities, everyday activities and daily responsibilities. These important benefits led to significant gains in work productivity, activity impairment and quality of life. On cognition, we saw improvement versus placebo in attention, memory and executive function, each with a very significant p-value. On nighttime sleep, I want to dwell for a moment on the striking REM latency finding. REM latency is the time it takes to enter the first REM sleep stage after falling asleep. REM sleep disturbances can manifest as sleep paralysis, sleep-related hallucinations and sleep disruptions. At baseline, our NT1 patients had a mean REM latency of about 50 minutes against a healthy control value of roughly 130 minutes. ORZEYFUL shifted mean REM latency into the normative range across all treatment groups in both the First Light or 3001 study and the Radiant Light or 3002 study. This objective shift in sleep is unprecedented. To keep it simple, we are showing data from the Radiant Light study. Both trials produced similar results. As you can see, the objective REM shift is corroborated by the subjective assessments. We measured the subjective effects on REM [ linked ] sleep using the NSS-CT or Narcolepsy Severity Scale for clinical trials, a validated instrument used in narcolepsy. ORZEYFUL significantly reduced hallucinations and sleep paralysis in all treatment groups. And it did so with no clinically meaningful disruption to sleep architecture. In practical terms, we are significantly improving, often normalizing a patient's day and night. Now let me turn to zasocitinib, our next-generation, highly selective and potent oral TYK2 inhibitor. Here, too, the data speak for themselves. In our Phase III head-to-head psoriasis study, zasocitinib significantly outperformed deucravacitinib. At week 16, more than 35% of zasocitinib-treated patients achieved complete skin clearance as measured by PASI 100. We have 2 key takeaway messages from these top line results. One, this was a well-run trial with deucravacitinib having data consistent with past Phase III trials. Two, this is the best 16-week efficacy in psoriasis that we have seen from a pill. Zasocitinib is poised to be a leading oral option with a fantastic efficacy and safety profile. Full details will be shared at a medical meeting this fall. What gives us additional confidence is the performance in the hard-to-treat high-impact areas like psoriasis of the scalp, palms and soles as demonstrated here by the high rates of skin clearance in the Phase III LATITUDE programs as well as statistically significant benefits to nails. These are the places where psoriasis can have greatest day-to-day impact for patients who are among the hardest to treat. The new psoriasis data continues to add to our library of outstanding Phase III results. I'd like to take a moment to remind you that zasocitinib is far more than just a psoriasis story. As you can see here at the top, zasocitinib has studies underway across a broad range of immune-mediated diseases like Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis, Vitiligo, and Hidradenitis Suppurativa. Zasocitinib is a molecule we believe could redefine what is possible with a convenient once-daily oral therapy. We anticipate a Phase II data readout for Crohn's disease and ulcerative colitis at the end of our fiscal year 2026. Our orexin franchise continues to advance. ORZEYFUL has initiated the important 3003 Phase III study, which will support filing in Europe. This potentially label-enabling trial will, for the first time, generate clinical data on direct switches from polypharmacy to ORZEYFUL. In addition, for the small number of patients who may benefit from dose escalation, the trial will include a higher dose option. Beyond ORZEYFUL, we are advancing TAK-360 in narcolepsy type 2 and Idiopathic Hypersomnia and anticipate Phase II data later this calendar year. The third of our imminent launches is rusfertide, a first-in-class hepcidin mimetic for polycythemia vera. Rusfertide delivers rapid, stable and durable hematic control, addressing a major unmet medical need in PV. It is filed in the U.S. with an EU filing targeted later this fiscal year. We have an August PDUFA date and anticipate launch immediately thereafter. Now I want to be clear that our story does not end with these 3 assets. They are the starting acts of the most robust late-stage pipeline in Takeda's history. And as we continue through Horizon One, we will advance the next wave of pipeline progress with key readouts and milestones. As Julie shared earlier, in oncology, elritercept has started 2 Phase III trials in first- and second-line myelodysplastic syndrome and will soon start a pivotal trial in myelofibrosis. We presented important updates at ASCO in June for TAK-928, our PD-1/IL-2 alpha-biased bispecific fusion protein. First, in patients with second-line plus IO-resistant non-squamous non-small cell lung cancer, an area of great unmet need, we showed a 42% overall survival rate at 2 years. We are planning for a pivotal Phase III in this refractory population later this fiscal year. In first-line non-small cell lung cancer patients with less than 50% PD-L1 expression, we were excited to see outstanding early data for TAK-928 in combination with chemotherapy with favorable safety data. We are looking forward to additional data cuts in the coming months as the trial matures. TAK-921, also known as arcotatug tavatecan, is an oncology program that has received less attention but remains highly promising. Strong progression-free survival data was announced from our partners at Innovent in June from a regional Phase III trial in third-line gastric cancer. We plan on filing in Japan in fiscal year 2027 using mature overall survival data from this trial. In PDT, TAK-881, our 20% next-generation facilitated [ subcu Ig ] is advancing towards a U.S. filing in primary immunodeficiency and filings in multiple indications in Europe and Japan. Let me close where I began. What you're seeing from Takeda R&D is the result of our sustained focus on pursuing science where we have the depth to lead. and commitment to disciplined choices that allow us to advance programs with the most meaningful patient potential. ORZEYFUL, rusfertide and zasocitinib are the leading edge of that strategy. And behind them is a pipeline with the depth to sustain this momentum well into the future. If we take a step back, we anticipate U.S. launch of ORZEYFUL in the second half of 2026, rusfertide launch in the second half of 2026 and zasocitinib launch in the first half of 2027, 3 potential new standards of care launching in close succession, 2 of which carry breakthrough and Fast Track Designations. This is the launch cadence that underpins our confidence in Takeda's growth trajectory. I have never been more confident in the science, and the team behind it and in our ability to improve patients' lives and build a healthier world for generations. I look forward to sharing our continued progress with you. Thank you. And with that, I'll turn it back to Julie to wrap up the presentation. Julie? Julie Kim: Thank you, Andy. As you have heard, the momentum across our R&D organization is translating directly into tangible milestones with the goal of bridging us from transformation to growth acceleration. We are also dedicated to operational discipline, and our enterprise transformation is already starting to unlock capital to reinvest in our pipeline and launches. In summary, we are delivering on our priorities in Horizon One towards a clear set of operational and financial goals. These milestones will enable us to secure a strong foundation that will advance us to Horizon Two, an era that will be defined by accelerated revenue growth, structural margin expansion and sustained value creation. We know our shareholders are eager to discuss more details of this path forward, and I am pleased to announce that we will host a Capital Markets Day in Tokyo on December 11, 2026. At that event, the executive team and I will provide a deep dive into our pipeline progress and mid- to long-term financial ambitions in-line with our 2-Horizon strategic road map that will guide our growth through the end of the decade and beyond. We have the right strategy, a highly competitive portfolio and a united, deeply committed global team. I am proud of the progress we made this quarter, and I am incredibly energized by the trajectory we are on. With that, I'll now turn the call over to Chris for Q&A. Christopher David O'Reilly: [Interpreted] I would like to take questions from the participants.[Operator Instructions]. The first question is Yamaguchi-san from Citigroup. Please unmute and ask your question. Hidemaru Yamaguchi: Yamaguchi from Citi. I have 2 questions. The first question is the overall earnings. And Milano-san mentioned gross margin on the Q1 seems to be relatively high compared to full year guidance. And you talked about some mix -- product mix, but also you talked about some divestiture related things. So how much is contributing this divestiture thing? And is this just a one-off or not? So can you give me a comment on those gross margin prospects, Q1 and full year? The second question is that you may not have answered yet, but ORZEYFUL has been -- is now launched approved in China and also will be launched -- will be approved in the U.S. and Japan. Can you give me the overall strategy, how you're going to position this drug compared to the current therapy? Are you going to add on or are you going to replace? Are you going to take the new patients? Or are you going to take the share from the existing patients? How about the pricing strategy? So if you have any kind of general strategy on a global basis on ORZEYFUL, please let me know. Those are 2 questions. Christopher David O'Reilly: Thank you, Yamaguchi-san. So the first question on breakdown of gross margin performance. So Milano can take that. And then the second question on ORZEYFUL as we prepare for global launch, any additional commentary on positioning, where we'll get the patients pricing, et cetera? Julie, you can comment on that one. Milano? Milano Furuta: [Interpreted] Thank you very much, Yamaguchi-san, for your questions. I think according to the several points Yamaguchi-san mentioned, I'd like to give you a response. As you mentioned, the gross margin in this quarter compared to the same quarter last year by about 1.4 points, visibly, there was an improvement observed. And actually, the impact from the product mix was more or less neutral. And you also mentioned one-time factor. That contribution was relatively small. It is divestiture-related technology transfer, which was completed. And as a result, we had a one-time milestone gain or income that impacted us the reduction of cost of sales. And however, it is a small portion of Q1, and it is much smaller in the full year. Therefore, in the full year basis, it is almost negligible. And actually, in the Q1 for the gross margin enhancement, PDT contributed most greatly. There was a transactional FX. In this quarter, it worked in a positive direction. And it is because of past year's FX levels. The euro against the U.S. dollar was appreciated. As a result, PDT cost of goods improved. And regarding your question about the full year outlook, we have just finished Q1. And in May, we mentioned the 65%. And based upon the FX movement moving forward, we'll be giving an update as it's necessary. But at the moment, we are maintaining the 65%. Julie Kim: Thank you, Yamaguchi-san, for the question about ORZEYFUL positioning. So let me share a few thoughts with everyone on this. First, just a quick reminder why we're so excited about ORZEYFUL. It is the first-in-class and potentially best-in-class orexin agonist designed to treat the underlying orexin deficiency that causes NT1. And as you saw from the information that we've shared previously and Andy shared on the call today, the efficacy across broad disease spectrum is really impressive. And so we do anticipate that ORZEYFUL will redefine the standard of care in NT1. So in terms of how we expect ORZEYFUL to be used, we studied it as a monotherapy. So that is our anticipation that ORZEYFUL is an effective monotherapy treatment. In terms of where the patients will come from, I would say there's 2 sources. First and foremost, we will be addressing the patient need for individuals who are already diagnosed with NT1 and already on therapy. That will be the initial source of growth for ORZEYFUL. The second source of growth will come from improved diagnosis. This will take a bit longer time in order to drive better diagnosis, but that would be the second source of growth. And then I think your third question was on pricing for ORZEYFUL. So obviously, we don't share pricing at this point ahead of launch. But our -- in general, our approach to pricing is to ensure appropriate value recognition for the transformative nature of the medicine, but at the same time, support fast access as this is a significant breakthrough in treatment option for individuals with NT1. Thank you. Christopher David O'Reilly: [Interpreted] Next question from Morgan Stanley, Muraoka-san. Please ask your question. Shinichiro Muraoka: [Interpreted] This is Muraoka, Morgan Stanley. First question is about 360. 360 data presentation, will that happen before the Capital Markets Day or will happen at the same time as the Capital Market Day? So 360 NT1 Phase II has actually started. Can you please talk about the background? Do you want to have flexibility in terms of pricing strategy? Or do you feel that once daily is going to be necessary? What is the background or the reasoning? That's my first question. And the second question is Zaso UC/CD , how the information will be shared? I heard information will be shared at the end of the year. And is this announcement going to be for both UC and CD together? And is it going to be in the form of press release? And can we expect this information maybe during the earnings announcement for the third quarter? How do you intend to share this information? That's the second question. Christopher David O'Reilly: Thank you for the questions. So the first on TAK-360 data disclosure timing, would that be ahead of the Capital Markets Day in December? And then what is the positioning or the background behind studying TAK-360 in narcolepsy type 1? And then the second question on timing of zasocitinib UC and CD data and also how that data would be presented? Will you announce the results of both studies simultaneously? So both of these questions, I'd like to call on Andy to comment on those, please. Andrew Plump: Great. Thanks, Chris, and thank you very much, Muraoka-san. This is Andy Plump. So firstly, with respect to TAK-360, -- so as I'll just remind everybody, the TAK-360 is in the midst of 3 ongoing Phase II studies, one in idiopathic hypersomnia, one in type 2 narcolepsy and then recently started one in type 1 narcolepsy. In terms of timing for the former 2, IH and NT2, the study design is such that is built around an adaptive design that allows us to rapidly pivot and explore both dose and dose regimen. We're testing both once a day and twice a day doses. So in such a design, we don't have a clear end date. We will see data from that trial this year. The exact timing and whether it's available for the Capital Markets Day in December remains to be determined. In terms of the rationale for starting TAK-360 in type 1 narcolepsy, first, I'll say that we are extremely confident and you've seen the data for ORZEYFUL. We believe that ORZEYFUL is not just a first-in-class, but a best-in-class agent for type 1 narcolepsy. With that said, we're at the very front end of understanding what orexin agonist can do across a broad range of diseases. And so our interest is to continue to learn more and to continue to explore. With respect to zasocitinib and IBD, both the UC and Crohn's disease trials are going well. We expect to have data by the end of this fiscal year. In terms of how and where we present those data, that's still something that we're sorting through. Thank you. Christopher David O'Reilly: [Interpreted] Next is Matsubara-san from Nomura Securities, please. Matsubara: [Interpreted] This is Matsubara from Nomura Securities. I have 2 questions. First is about ENTYVIO. In the first quarter, CER 3.8% increase was observed, and I believe [ SC ] contributed a lot. And compared to the last year, I think the customer base have been expanding. But what is the immediate situation right now? And what is the outlook? And next is the rusfertide, PDUFA is approaching in August. And regarding your pricing strategy, as you have discussions with the physicians, -- so how do you think about your pricing strategy? And how about your view of the [ patient ] burden in terms of pricing? Christopher David O'Reilly: In the first quarter. So any comments on sort of prescription trends, how the performance is going for ENTYVIO? And then the second question on rusfertide, in particular, how you go positioning versus phlebotomy in terms of pricing strategy. So I think both of those questions, Julie, I'd like to ask you to comment on those, please. Julie Kim: Thanks for the questions, Matsubara-san. Let me tackle ENTYVIO first. So when we look at ENTYVIO, as you know, it's been on the market for over a decade now, and we're pleased that we continue to be able to grow ENTYVIO. It's still the #1 prescribed brand in IBD overall, particularly with the first-line leadership in UC. And when you look at the performance in the U.S., I would say a couple of things. Although sales were down in Q1 year-over-year at constant exchange rate, we do see overall demand growth. The decline is due to pricing mix and lower days on hand. When we look at the growth of pen, we continue to see very strong growth of ENTYVIO PEN in the U.S. And so we're pleased with that continued progression. For our markets outside of the U.S., here, we continue to see strong growth with 6.7% growth in Europe, 10% in Japan and the rest of our intercontinental markets at just about 36% growth. So again, very strong performance for ENTYVIO, driven by ENTYVIO subcu or the pen across all of our markets. So for the full year, we do expect to be able to hit our guidance. Your second question in terms of rusfertide pricing. So again, we won't share details of pricing at this point. And I'll just reiterate that our approach to pricing is to make sure that we can receive appropriate value recognition for rusfertide, but also allowing rapid access for patients. So we will balance that as we look to finalize pricing. Christopher David O'Reilly: For the next question, I'd like to call on Mike Nedelcovych from TD Cowen. Michael Nedelcovych: I have 2. My first is actually on mezagitamab. Back in December 2024, you laid out a peak sales ambition in ITP and IgAN of USD 1 billion to USD 3 billion. Have there been any developments in either mezagitamab's development or in the competitive landscape that make you more confident in one or the other end of that range? And are there any indications being explored that could be added to this target in the near future? So that's my first question. And then my second question is on the risk of ENTYVIO biosimilars in the U.S. What's the road map from here to your estimated 2032 time line? What is the next step that we should be monitoring? And is there any ENTYVIO PEN IP that could be -- that could extend exclusivity further than 2032? Christopher David O'Reilly: Great. Thank you, Mike. So the first question on how we're progressing with mezagitamab and thoughts on recent developments in these markets. I think Andy can take that question. And then the second on biosimilars for ENTYVIO and sort of route from here to 2032 in terms of biosimilar entry and whether the pen gives us any extended IP. Julie can answer that question, please. Andrew Plump: Mike, thank you very much. This is Andy. So as you know, we have 2 ongoing Phase III studies for mezagitamab. One is in third-line ITP and the other is in IgAN. We just recently started a Phase II program in antibody-mediated rejection. So we have 3 indications that are going rapidly with mezagitamab. We do continue to look at additional indications. So stay tuned. I think the -- to your question, the biggest development for us recently has been the recognition from our long-term extension data from our Phase Ib/II proof-of-concept study that with short-term dosing, we're seeing a very durable effect. And we presented data, and I think I've shared it in previous earnings calls that with up to 6 months of therapy, we see sustained activity on clinical endpoints up to 2 years. So this is really exciting. The confidence we have that this is a real effect and can be -- and relates back to the underlying pharmacology of the drug and the biology of this disease, we think is real. So we actually made an adaptation to the Phase III design. Initially, the administration schedule was going to be 6 months off (sic) [ on ], 6 months off. We've now decided to administer mezagitamab for 6 months and then track patients thereafter to the primary endpoint at 1 year and at 2 years. So we believe we have a product that not only is going to be differentiated in terms of its safety and efficacy, but also in terms of its administration schedule. Julie Kim: Thanks, Mike, for your questions. And let me just add a quick comment because I think you did also inquire about peak sales estimates for Meza. So we're not changing any peak sales at this point. But when we get to the Capital Markets Day in December, we will provide peak sales based on current assumptions and current landscape. So hold until then for that information. In terms of your second question regarding ENTYVIO and timing in relation to biosimilar entry. So our time frames here have not changed. So when you look at the U.S., because I think your question was specific to the U.S., we expect it to still be roughly 3 to 5 years in litigation. We will defend our IP positions. We feel very good about our IP position. And so this is something that we will continue to provide updates on, but no change in overall time line. Christopher David O'Reilly: Thank you Mike. And so for the next question, I'd like to call on Miki Sogi from Bernstein. Miki Sogi: I have 2 questions. The first one is to Andy about IBI-363. So on the Page 23, I see that you have achieved the proof of concept of this product for second-line non-squamous non-small cell lung cancer and first-line non-small cell lung cancer. So are these the data that we have not seen? And then we are also -- we should be expecting to see the data at ESMO this year? That's the first question. Second question is about the new product launches of oveporexton and rusfertide. I was -- to be honest with you, I'm a little bit surprised that you didn't really mention any commercial launch preparation during this -- the presentation despite the fact that launch or approval is imminent. And I'd like to see what are the key operational KPI that you are currently thinking of for these product launches. And hopefully, we will get the update on that later on. Christopher David O'Reilly: Thank you, Miki. So the first question on TAK-928 POC achievements as we've marked on this slide. So Andy can provide some color on that. And then the second question, ORZEYFUL, rusfertide launch preparation, what the operational KPIs will be, et cetera. Julie can comment on that one, please. Andrew Plump: Great. Thank you, Miki. So just to remind everybody, IBI-363 or what we now call TAK-928 is our PD-1/IL-2 alpha-biased bispecific protein that we've partnered with Innovent on. We're pursuing multiple indications in parallel. We've already started a Phase III global program in IO refractory second-line squamous non-small cell lung cancer. And to your question, Miki, we now have very encouraging Phase I/II data out of our partners work at Innovent in both first-line non-small cell lung cancer and also second-line adeno or non-squamous non-small cell lung cancer. So those data were actually presented by Innovent at ASCO, and I can just provide some high-level summary information. So firstly, in the refractory setting for patients with non-squamous or adeno non-small cell, we've seen really striking overall survival data. So 42% overall survival data at 2 years. And of course, it's difficult to compare study to study, but this is a population that at 2 years has an overall survival rate of approximately 20%. So we're very excited to get that Phase III study going. And then, of course, the largest population is going to be in frontline we had data that was presented -- we have maturing data that was presented at ASCO by our partners at Innovent that suggests response rates of upwards of 80%. So we'll continue to track maturing data, but we're preparing to start that Phase III study later in this fiscal year. Miki Sogi: Andy, I have a follow-up question on the first-line. I believe that the data that was presented at ASCO was dose escalation or dose selection phase and you are running or Innovent is running the dose expansion phase, which is actually hit -- the head-to-head against that KEYTRUDA plus chemotherapy, I believe. And I just wanted to see that if that dose expansion phase that with [ comparator ] data will be presented at ESMO. And -- so your part you're referring to doesn't really include that data. Andrew Plump: Yes. So thank you very much. So of course, the Phase III study will be done depending on the mutation burden, it will be done either against a PD-1 pembro with chemo or versus a PD-1 alone. In terms of the maturing data, Miki, we don't have specific plans to share today as to when those data will be available, but we assure you that as those data mature, we would present them in a rapid fashion. Julie Kim: So thank you for the question, Sogi-san. Maybe I wasn't excited enough in my voice. We did -- I did talk about the launch preparation during the presentation, but let me share in more detail so that you get a sense of what we've been doing. So first, I will tackle ORZEYFUL when you look at the -- and I'm assuming you're asking specifically about the U.S., although both China and Japan are also fully prepared in China, we now have the approval, as you heard. One thing I do want to say about China is that the submission for NRDL approval only -- the window is only once per year. And so the approval came after that window. So we won't be able to submit for NRDL until next year, meaning NRDL listing wouldn't be available until January of '28. So between now and then, we will focus on private market and then the full launch will be after we receive -- hopefully, we receive NRDL listing. So in the U.S., as I mentioned during the presentation, we've had our MSLs in the field now for over a year. Focused on awareness and education around orexin and the mechanism of action. We've had our sales in the field mapping accounts, getting introduced to the sleep centers in particular. We've been running disease state education campaigns. We've been having payer meetings. Our specialty pharmacy network and patient support programs are ready to go. So at this point, we are waiting for the FDA approval and then the subsequent DEA scheduling, and we'll be ready to go. For rusfertide, some very similar activities, again, in the field doing education and awareness. As I mentioned in previous calls, there is a sense of inertia in terms of the current level of treatment for polycythemia vera patients. They're viewed as a "good cancer patients". And so it's a lot of education we need to do to help shine a light on the burden that PV patients have. We're also doing end-to-end patient experience programs that are, again, ready to go and of course, the payer engagements. So all of that is in play. In terms of the things that we -- metrics that we'll be looking at, it will be things like patient numbers, payer coverage and source of patients. So hopefully, that addresses your question. Miki Sogi: Sure. Julie, I have one additional question. What is your -- the target of payer coverage after 12 months of launch? Commercial coverage. Julie Kim: Yes. So we are trying to secure commercial coverage as quickly as possible. So at this point, I'm not going to share a target with you, but we want to make sure we have broad coverage. Christopher David O'Reilly: Thank you, Miki. I think we'll take one final question. So we'll end with Stephen Barker from Jefferies. Stephen Barker: Steve Barker from Jefferies. So congratulations on the China approval of ORZEYFUL. Could you clarify whether the approved label includes both the 1-milligram and 2-milligram tablet strengths? That is do the physicians in China have the flexibility to prescribe either dose? Or is the label focused on the 2-milligram BID regimen that was tested in Radiant Light? And a follow-up question, is the same strength profile reflected in the U.S. and Japan applications, please? Christopher David O'Reilly: Thank you, Steve. So Andy, would you like to answer those questions, please? Andrew Plump: Sure. So Steve, the label hasn't been released yet in China. And of course, we're still in the process of discussing the label in the U.S. and Japan. So we can't comment specifically what's on the label, but we can say that the expectation in China and the U.S., at least, we've not gotten to this point of discussions with Japan is that physicians will have access to multiple doses for patients. Stephen Barker: Okay. Great. And if I can just follow up with a question about TAK-360. There's 2 aspects of what you presented today that caught my attention. So you are testing an NT1, which suggests that it has the potential to expand the market opportunity beyond ORZEYFUL. I was wondering if you could explain that. And then also the fact that you're evaluating both once daily and twice daily dosing, if you could explain that development choice as well, please? Andrew Plump: So just quickly in the interest of time, Steve. So again, we're fully confident in ORZEYFUL and the profile that we've seen for ORZEYFUL. We think it's going to be a best-in-class agent for type 1 narcolepsy. We also recognize that we're really at the front end of understanding what orexin biology can do across a range of diseases, understanding dose, dose exposure and clinical response. And so with TAK-360, given that it's relatively early in development, our goal is to be as thoughtful as possible within a disease, testing as broader range of doses and dose regimens as well as across diseases to understand what the potential of that molecule is. And once we have all those data, then we'll make decisions as to what doses we bring forward and what indications. Christopher David O'Reilly: Thank you, Steve, for your questions. That brings our Q&A session to a close. And I'd like to now hand over to Julie for some closing remarks. Julie Kim: So thank you, everyone, for joining us today and for your very thoughtful questions. I hope you are equally excited about our expected launches as we are. And I hope that many of you will join us later this year for our Capital Markets Day on December 11 here in Tokyo. I look forward to sharing our longer-term ambition with you and spending a bit more time on our strategic road map that will guide our growth through the end of the decade and beyond. So thank you again for your time, and have a wonderful rest of your day or evening. [Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.] Before you buy stock in Takeda Pharmaceutical, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Takeda Pharmaceutical wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Takeda (TAK) Q1 2026 Earnings Call Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Total Revenues: Approximately $629 million for Q2 2026. Cabozantinib Franchise Net Product Revenues (US): $573 million, up approximately 10% year-over-year. Global Cabozantinib Franchise Net Product Revenues (Exelixis and partners): $806 million, up approximately 13% year-over-year. CABOMETYX Net Product Revenues: $571 million, including approximately $2.7 million in clinical trial sales. Royalty Revenues: Approximately $53 million from partners Ipsen and Takeda. Gross to Net: 29.5% for Q2 2026; full-year 2026 guidance updated to between 30% and 31%. Total Operating Expenses: Approximately $380 million in Q2 2026, up from $359 million in Q1 2026. GAAP Net Income: Approximately $212 million, or $0.85 per share basic and $0.82 per share diluted. Non-GAAP Net Income: Approximately $237 million, or $0.95 per share basic and $0.91 per share diluted, excluding approximately $25 million of stock-based compensation. Cash and Marketable Securities: Approximately $1.4 billion as of June 30, 2026. Share Repurchases: Approximately $312 million of common stock repurchased in Q2 2026, retiring approximately 6.5 million shares at an average price of $47.85 per share. Full-Year 2026 Guidance: Total revenues and net product revenue guidance lowered, with the midpoint reduced by $50 million; R&D expense guidance midpoint also reduced by $50 million. Warning! GuruFocus has detected 6 Warning Signs with OSUR. Is EXEL fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Exelixis Inc (NASDAQ:EXEL) reported strong Q2 2026 financial results with total revenues of approximately $629 million and GAAP net income of $212 million, reflecting solid operational performance. The cabozantinib franchise continues to grow, with US net product revenues up 10% year-over-year to $573 million and global revenues up 13% to $806 million, driven by strong RCC and NET market share gains. Zanzalintinib is advancing well, with the STELLAR-303 NDA under FDA review (PDUFA in December 2026) and six additional pivotal trials progressing, including STELLAR-304 expected to read out in H2 2026. The company is executing on its strategic expansion, with new trials like STELLAR-316 (adjuvant CRC) and STELLAR-202 (squamous NSCLC) set to initiate, and expansion cohorts in bladder and prostate cancer showing early promise. Exelixis Inc (NASDAQ:EXEL) maintains strong financial discipline, reducing R&D expense guidance by $50 million while keeping free cash flow essentially unchanged, and continues to return capital to shareholders via a $750 million buyback program. The NET franchise is gaining traction, with CABOMETYX achieving over 45% new patient market share in the second-line plus setting, positioning it as the leading oral therapy and a key growth driver. Exelixis Inc (NASDAQ:EXEL) lowered its full-year 2026 revenue guidance by $50 million at the midpoint, reflecting a more gradual ramp in the NET indication due to slower patient kinetics and indolent disease characteristics. The STELLAR-303 trial's non-liver metastasis subgroup failed to achieve statistical significance on overall survival, raising potential concerns about the robustness of the overall data despite the ITT population being positive. The NET market ramp is slower than expected, with patients often taking treatment breaks or delaying subsequent therapy, which could limit near-term revenue growth from this indication. The company faces potential competitive and regulatory risks, including the tentative approval of ANDAs for generic versions of cabozantinib, which could impact future market exclusivity despite existing agreements. Enrollment in the STELLAR-304 trial took longer than originally projected, and the company remains cautious about data timing, with results still expected in H2 2026 but subject to event rate variability. The launch of zanzalintinib in CRC is pending FDA approval, and any label restrictions or subgroup limitations could constrain commercial uptake, especially in the third-line plus setting. Q: Regarding the STELLAR-304 trial in non-clear cell renal cell carcinoma, can you provide an update on the timing of the data readout and whether it could be presented at a major medical meeting this year?A: Dana Aftab, EVP of R&D, stated that the trial is expected to achieve the planned number of events in the second half of 2026, but declined to speculate on the exact timing of the data release or presentation at a medical meeting, noting the company will communicate at the appropriate time. Q: Given the recent LITESPARK-022 data showing improved disease-free survival with a pembro plus HIF-2 alpha combination in the adjuvant setting, do you anticipate this will reduce the patient population for your first-line post-adjuvant study (LITESPARK-033)?A: P.J. Haley, EVP of Commercial, responded that it is too early to speculate on the utilization of the new adjuvant combination. He noted that the adjuvant setting is historically sensitive to toxicity, and given the high overall survival bar set by pembro monotherapy, physicians will be cautious about adding another agent with potential toxicity. He does not expect a significant impact on the first-line patient population. Q: Is the ongoing STELLAR-311 trial in neuroendocrine tumors potentially cannibalizing cabo sales, contributing to the more gradual ramp and lowered guidance?A: P.J. Haley acknowledged that any recruiting study can draw patients from the commercial pool, which may have a small impact in a smaller tumor type like NET. However, he emphasized that the primary driver of the slower ramp is the indolent nature of NET, where patients often take more time to initiate subsequent therapy. He remains confident in the long-term opportunity, citing the achievement of over 45% new patient market share in the second-line plus setting. Q: With the upcoming PDUFA date for zanzalintinib in colorectal cancer, what label language would be most commercially meaningful, and what limitations could constrain uptake?A: P.J. Haley stated that the review is ongoing and the company cannot comment on label discussions with the agency. He reiterated the excitement about the potential approval, which would be the first immunotherapy-containing regimen for the vast majority of third-line plus CRC patients and the first launch of the company's next franchise molecule. Q: Can you highlight the progress made towards the aspirational goal of $5 billion in revenue for zanza by 2033, and how has the makeup of that projection evolved?A: Mike Morrissey, President and CEO, noted that the company is executing on its strategy with seven pivotal trials either ongoing or imminent, and a next wave of trials in development. He expressed excitement about the depth and breadth of the opportunity, emphasizing the company's commitment to making zanza a valuable second franchise for patients and shareholders. Q: If the ANDA filers receive full approval, could that accelerate the timing of generic entry before the 2031 timelines in your agreements?A: Andrew Peters, SVP of Strategy and IR, declined to discuss specifics of the agreements but noted that the scenario described is not common in such agreements and should not be expected. Q: Regarding STELLAR-201 in meningioma, how quickly could data be generated, and can a new salt (505(b)(2)) get NCCN guideline placement without clinical data?A: Dana Aftab noted that STELLAR-201 is a single-arm Phase II study with high unmet need and no standard of care, and the company is designing a confirmatory Phase III trial. Andrew Peters added that 505(b)(2) products differ significantly from standard ANDAs in labeling and interchangeability, and successful examples like ABRAXANE were based on large Phase III trials. He emphasized the company's focus on patient safety and IP rights. Q: STELLAR-304 enrollment ran longer than originally projected. Does the extra follow-up time mean the overall survival data will be more mature at the top-line readout?A: Dana Aftab explained that trial timelines are based on projections and actual enrollment can shift. She confirmed the company still expects the readout in the second half of 2026, based on current event rates, but did not comment on the maturity of the OS data. Q: How might zanza play alongside novel agents in NETs, such as ADCs or radiopharmaceuticals?A: P.J. Haley stated that STELLAR-311 is designed to position zanza as potentially the first oral agent in NET. He noted that other modalities like SSAs and radioligand therapies exist, but a positive Phase III readout against an approved oral agent would position zanza very well in the marketplace. Q: Given the observed patient kinetics for cabo in NET, do you expect a similar dynamic for zanza, and can you provide the contribution of NET to cabo sales this quarter?A: P.J. Haley responded that zanza's positioning as a potential first or second-line agent, if approved, could change the patient flow kinetics compared to cabo. He did not provide specific NET sales figures but reiterated excitement about the STELLAR-311 study and the potential for a different trajectory. Q: Are you still looking to partner zanza ex-US, similar to the cabo model, or will you keep it internal globally?A: Mike Morrissey confirmed that the company is still evaluating all options for ex-US partnering, taking into account various factors. He noted there is significant interest and expects it to grow as more pivotal trial data read out positively. Q: What might have driven the lack of statistical significance in the non-liver mets subgroup of STELLAR-303, and has this been discussed with the FDA?A: Dana Aftab explained that the non-liver mets subgroup was a small subpopulation and the treatment effect was similar to the interim results. She emphasized that the ITT population, which includes both liver and non-liver mets patients, is the basis of the NDA submission and remains the most important dataset. Q: How will you ensure patient persistency with oral TKIs in the maintenance setting for STELLAR-316 and STELLAR-202, given historical challenges?A: Mike Morrissey highlighted the importance of dose selection and balancing short-term activity with long-term For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Takeda Pharmaceutical Co.? Here are five stocks we like better. Takeda’s first-quarter fiscal 2026 results were broadly on track: Revenue reached JPY 1.22 trillion, while core operating profit was JPY 358.9 billion. The company maintained its full-year guidance, including JPY 650 billion to JPY 750 billion in free cash flow. Growth in core brands and new launches offset pressure from mature products and generic erosion. New products grew 22.6% at constant exchange rates, led by FRUZAQLA, LIVTENCITY, ADZYNMA and QDENGA, while ENTYVIO sales increased 4%. Three potential launches are central to Takeda’s growth strategy: ORZEYFUL could launch in the U.S. and Japan in the second half of 2026, rusfertide could launch after an expected FDA decision in August, and zasocitinib remains on track for a U.S. launch in the first half of 2027. Analysts Predict 85% Upside for Wave Life Sciences After Rate Cut Takeda Pharmaceutical (NYSE:TAK) said its first-quarter fiscal 2026 results were in line with its full-year outlook as growth from core brands and newer products largely offset expected declines in its mature portfolio. Revenue totaled JPY 1.22 trillion, up 10.2% on an actual foreign-exchange basis but down 0.5% at constant exchange rates, according to Chief Financial Officer Milano Furuta. Core operating profit was JPY 358.9 billion, rising 11.5% on an actual FX basis and declining 0.5% at constant exchange rates. Reported operating profit was JPY 201.4 billion. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now Time to buy these 3 healthcare companies that raised revenue guidance? Core earnings per share were JPY 154, down 11.8% at constant exchange rates, primarily reflecting a favorable tax position in the prior year. Reported EPS was JPY 72. The company left its fiscal 2026 guidance unchanged and said it remains on track to generate JPY 650 billion to JPY 750 billion in free cash flow for the year. Core inline brands, which represented 58% of total revenue, grew 2.3% at constant exchange rates. Takeda said ENTYVIO, its largest product, grew 4% at constant exchange rates, while immunoglobulin and albumin sales were affected by U.S. shipment timing that was within the company’s expectations. → 3 Value ETFs to Consider as Growth Stocks Lag Behind Price Growth & Yield: For That Magical Combo, Leave the U.S. Furuta said new launches represented 4% of revenue but grew 22.6% at constant exchange rates, supported by FRUZAQLA, LIVTENCITY, ADZYNMA and QDENGA. Those gains helped counter continued generic erosion for Vyvanse in the U.S. and other loss-of-exclusivity and mature-product headwinds. Takeda said first-quarter gross-profit performance benefited principally from favorable FX effects on plasma-derived therapies costs, particularly as the euro strengthened against the U.S. dollar. Furuta said a one-time milestone related to a divestiture and technology transfer made a comparatively small contribution. The company continues to expect a full-year gross margin of 65%. → 5 AI Stocks Are Pulling Back—Which Growth Catalysts Still Look Strongest? Operating cash flow was below the prior-year level due to working-capital changes related to its trade receivables factoring program. Adjusted free cash flow also reflected a $200 million payment to Protagonist after the partner opted out of a co-promotion arrangement for rusfertide. Takeda said it now has exclusive global development and commercialization rights for rusfertide. The company highlighted preparations for three potential product launches: ORZEYFUL for narcolepsy type 1, rusfertide for polycythemia vera, and zasocitinib for psoriasis. Takeda received its first approval for ORZEYFUL, its orexin agonist oveporexton, in China. The company expects regulatory decisions in the U.S. and Japan during the second quarter and anticipates launches in the second half of 2026. Research and Development President Andy Plump said ORZEYFUL is designed to address the underlying orexin deficiency associated with narcolepsy type 1. At the SLEEP 2026 meeting, Takeda presented additional Phase III data that it said showed improvements in daily function, cognition and nighttime sleep. Plump said the treatment shifted mean REM latency into the normative range across treatment groups in two studies and reduced hallucinations and sleep paralysis without clinically meaningful disruption to sleep architecture. Management expects ORZEYFUL initially to serve patients already diagnosed with narcolepsy type 1 and receiving therapy, with improved diagnosis representing a longer-term source of growth. Takeda said it has medical-science liaisons, specialty-pharmacy arrangements and patient-support programs in place ahead of a U.S. launch. Rusfertide has received FDA priority review, with an August PDUFA date and an anticipated U.S. launch immediately afterward if approved. Takeda said the hepcidin mimetic demonstrated rapid, stable and durable hematocrit control while reducing reliance on phlebotomy in polycythemia vera. The company also plans an EU filing later in fiscal 2026. Zasocitinib, an oral TYK2 inhibitor, remains on track for a U.S. launch in the first half of 2027. Takeda said its Phase III head-to-head psoriasis study found statistical superiority over deucravacitinib across primary and key secondary endpoints, with more than 35% of treated patients achieving complete skin clearance, or PASI 100, at week 16. The company expects Phase II data in Crohn’s disease and ulcerative colitis by the end of fiscal 2026. Takeda said its enterprise transformation program is intended to fund launch investments and pipeline development while improving efficiency. Furuta said many initiatives were implemented near the end of the quarter, limiting the amount of savings recognized in first-quarter results. The company has largely completed implementation of its international business unit. In oncology, the company initiated Phase III studies of elritercept in first- and second-line myelodysplastic syndrome and expects to begin a pivotal study in myelofibrosis. Takeda also plans to begin a pivotal Phase III study of TAK-928 in refractory non-squamous non-small cell lung cancer later in fiscal 2026 after reporting a 42% overall survival rate at two years in the cited patient population. Takeda said it will host a capital markets day in Tokyo on Dec. 11, 2026, where management plans to provide further details on pipeline progress and its medium- and long-term financial ambitions. Takeda Pharmaceutical Company Limited (NYSE: TAK) is a Tokyo-based, multinational biopharmaceutical company with roots dating back to 1781. The company researches, develops, manufactures and commercializes pharmaceutical and biopharmaceutical products for patients worldwide. Takeda is publicly listed and operates as a fully integrated R&D-driven healthcare company focused on delivering specialty medicines and therapies across a range of therapeutic areas. Takeda's main business activities encompass discovery and development of prescription medicines, clinical development and regulatory affairs, manufacturing of small molecules and biologics, and global commercial operations. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Takeda Pharmaceutical Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

Solid first quarter performance broadly in line with guidance, underpinned by resilient demand across core in-line brands Commercial execution and late-stage pipeline investments on schedule, including first approval for ORZEYFULTM (oveporexton) in China, setting the foundation for next wave of medicines No change to FY2026 full-year forecast and management guidance OSAKA, Japan, July 30, 2026--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) announced financial results for the first quarter of fiscal year 2026 (April 1, 2026 to June 30, 2026), marking a period of disciplined execution and operational momentum. Takeda leveraged the resilient performance of its core in-line portfolio to support its long-term strategy, advancing commercial launch preparations and driving critical R&D pipeline milestones. With a clear operational trajectory established in the first quarter and under a new operating model, Takeda remains on track to deliver its strategic and financial commitments for the fiscal year. FY2026 First Quarter Highlights Revenue increased by +10.2% versus the prior-year period on an actual exchange rate (AER) basis and decreased by -0.5% on a Constant Exchange Rate (CER) basis as the negative impact of the loss of exclusivity of VYVANSE® was largely offset by growth from core in-line brands. Core Operating Profit increased by +11.5% on an AER basis and decreased by -0.5% on a CER basis, reflecting continued growth investments supported by the transformation program. Reported Operating Profit increased by +9.1% on an AER basis. Core EPS increased by +1.5% at AER and decreased by -11.8% at CER, while Reported EPS decreased by -9.8% YoY. Adjusted Free Cash Flow amounted to JPY 68.6 billion. Launch preparations for key late-stage pipeline assets (ORZEYFUL, rusfertide and zasocitinib) are progressing on schedule, with the first approval for ORZEYFUL achieved in China. FY2026 full-year outlook remains unchanged. A Capital Markets Day will be held on December 11, 2026, in Tokyo, Japan. Takeda President and Chief Executive Officer, Julie Kim, commented:"Our solid performance this quarter marks a good start to the fiscal year and keeps us on track to achieve our full-year targets. "This quarter’s results reflect our unwavering commitment to financial discipline and the progressing execution of our enterprise transformation. The efficiencies unlocked by this ongoing program are directly fueling our highest priorities in Horizon One in our two-horizon growth strategy: the successful launch of three medicines that have the potential to be blockbuster brands, the advancement of our late-stage pipeline, the enduring resilience of our core in-line portfolio and new capabilities and efficiencies gained through transformation. We look forward to sharing the detailed strategic roadmap for these two growth horizons at our Capital Markets Day in December." Takeda Chief Financial Officer, Milano Furuta, commented:"Our first-quarter performance is tracking consistently with management guidance, with the resilience of our core in-line brands largely offsetting our mature portfolio decline, and OPEX savings through the transformation program being strategically reinvested to fund future growth opportunities. Our full-year forecast and guidance remain unchanged." FINANCIAL HIGHLIGHTS for First Quarter Results ended June 30, 2026 Pipeline Progress Building the Foundation for Future GrowthTakeda’s next-generation growth engine is anchored by three, high-potential, late-stage pipeline assets expected to obtain regulatory approvals in the U.S. and other key regions in the coming year. While this represents a pivotal period of strategic investment and commercial launch execution, Takeda is positioned to deliver tangible milestones over the next 12 to 24 months. By establishing a track record of launch excellence today, Takeda is securing the foundation that will underpin the Company’s sustained, long-term growth and meaningful impact for patients globally. ORZEYFUL An orexin receptor agonist with a first-in-class mechanism of action, designed to address the orexin deficiency that causes narcolepsy type 1 (NT1). The first approval of oveporexton was recently granted in China under the brand name ORZEYFUL. New drug applications are currently under review in the United States and Japan. Preparations for the expected launches in the U.S., Japan and China in the second half of the year are well underway. At SLEEP 2026, Takeda presented Phase 3 clinical trial results for ORZEYFUL demonstrating improvements in daily functioning, cognition and nighttime sleep in patients with narcolepsy type 1. Rusfertide A potential first-in-class hepcidin mimetic for the treatment of adults with the blood cancer polycythemia vera (PV). Demonstrated significant improvements in hematocrit control and phlebotomy reduction for patients with PV in a Phase 3 clinical trial. Granted Priority Review by the U.S. FDA, Takeda is prepared for a commercial U.S. launch expected in the second half of 2026. Zasocitinib A next generation, highly selective and potent TYK2 inhibitor that has demonstrated rapid, durable skin clearance in a convenient once-daily oral pill with no fasting restrictions. Achieved positive topline results across the primary endpoint and all key secondary endpoints in a head-to-head Phase 3 clinical trial against deucravacitinib. Achieved consistent, high rates of skin clearance across the body, including hard-to-treat and high-impact sites in Phase 3 psoriasis studies. Takeda is making the necessary investments with a view toward regulatory submissions in 2026 and a commercial launch anticipated in the first half of 2027. Capital Allocation and Shareholder ReturnsTakeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation with the goal of driving growth and enabling the company to deliver returns to shareholders under its progressive dividend policy. The annual dividend forecast for FY2026 is JPY 204 per share. Additional Information Regarding FY2026 First Quarter ResultsTakeda will host a conference call for investors and analysts on Thursday, July 30, 2026, at 19:00 Japan Time / 6:00 U.S. Eastern Time to discuss its FY2026 first quarter results. A live webcast of the conference call and the presentation materials will be available in the Investor Relations section of Takeda’s website (www.takeda.com/investors). The presentation materials include details on Takeda’s FY2026 first quarter results, business progress and pipeline updates, as well as definitions of non-IFRS measures. About TakedaTakeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit https://www.takeda.com. Important NoticeFor the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could", "anticipates", "estimates", "projects", "forecasts", "outlook" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Financial information and Non-IFRS Measures Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards ("IFRS"). This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate ("CER") change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as "reported" measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2026 Q1 investor presentation (available at www.takeda.com/investors). Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. View source version on businesswire.com: https://www.businesswire.com/news/home/20260727883646/en/ Contacts Investor Relations Christopher O’[email protected] Media Relations Shoko [email protected] (Tokyo)[email protected] (Boston)

After long-term follow-up, IBI363 monotherapy demonstrated strong overall survival (OS) with a long tail effect in IO-resistant squamous NSCLC and adenoNSCLC IBI363 has entered a global Phase 3 clinical study (MarsLight-11) for IO-resistant squamous NSCLC; pending regulatory communications, initiation of a global Phase 3 clinical study of IBI363 for IO-resistant non-squamous NSCLC is also planned. Innovent and Takeda are co-developing IBI363 (Takeda R&D code: TAK-928) globally. SAN FRANCISCO and SUZHOU, China, May 31, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announces updated data from the Phase 1 PoC clinical study of its first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the treatment of advanced immunotherapy(IO)-resistant non-small cell lung cancer (NSCLC) The detailed data was presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The updated data is from a PoC clinical study conducted in China to evaluate the safety and efficacy of IBI363 monotherapy in subjects with advanced NSCLC (ClinicalTrials.gov, NCT05460767). As of the follow-up cutoff date of November 20, 2025, a total of 136 subjects with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg once every 3 weeks, Q3W). IBI363 Showed Robust Survival Benefits with a Long Tail Effect in IO-Resistant Squamous NSCLC All 67 squamous NSCLC patients had no known EGFR mutations. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg Q3W dose group, the median PFS reached 10.1 (95%CI 6.0, 14.0) months, and the median OS achieved 18.2 (95%CI 10.7, NE; maturity 48.4%) months, with a 24-month OS rate of 47.8% (95%CI 28.7, 64.7). IBI363 Showed Potential for Long-Term Survival Benefits with a Long Tail Effect in IO-Resistant Wild-type AdenoNSCLC, Especially in Patients with a Smoking History Among the 58 patients with EGFR wild-type adenoNSCLC, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 25 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg dose group, the median PFS reached 4.2 (95%CI 3.0, 7.0) months, and the median OS achieved 15.2 months (95%CI 9.6, NE; maturity 56.0%), with a 24-month OS rate of 42.7% (95%CI 23.1, 61.0). Smoking history may be an important influencing factor for efficacy in immuno-resistant adenoNSCLC. In adenoNSCLC subjects with a smoking history, better survival benefits were observed. The median OS for smokers across all dose groups (N=31) reached 23.4 (95%CI 11.3, NE, maturity 48.4%) months. IBI363 Showed a Favorable Safety Profile in Long-Term Follow-up In the long-term follow-up of the overall population (n = 136), IBI363 demonstrated a favorable safety profile: treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 30.6% of patients treated with 1/1.5 mg/kg and 64.9% of patients treated with 3mg/kg. The most common adverse events among all patients were arthralgia (52.2%, 3.7% ≥grade 3), anemia (46.3%, 4.4% ≥grade 3), and rash (39.0%, 8.8% ≥grade 3), which were mostly controllable and manageable with mild-to-moderate AEs. No new safety signals were observed. Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, commented: "Lung cancer remains the most commonly diagnosed and deadliest malignancy worldwide, representing a major public health challenge. Despite the transformative impact of immunotherapy on the treatment landscape of NSCLC, patients with wild-type NSCLC who experience disease progression following immunotherapy continue to face limited treatment options, with docetaxel-based standard-of-care therapy offering only modest efficacy. In recent years, emerging approaches such as immunotherapy-based combinations and ADCs have brought new hope. However, multiple large-scale Phase III clinical trials in NSCLC patients who had failed both platinum-based chemotherapy and immunotherapy have not yet delivered satisfactory outcomes. Therefore, there remains a substantial and urgent unmet medical need in the post-immunotherapy setting for NSCLC. As a PD-1/IL-2α-bias bispecific molecule, IBI363 has demonstrated encouraging clinical benefit in immunotherapy-resistant NSCLC, with both objective response rate (ORR) and progression-free survival (PFS) showing meaningful improvement. Notably, in the 3 mg/kg Q3W cohort, more than 40% of patients with either squamous or adenocarcinoma histology survived beyond 24 months. These findings highlight the potential of IBI363 to generate a durable immunotherapy tail effect and deliver long-term survival benefits for patients." Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "While immunotherapy has significantly improved survival outcomes for certain patients, treatment options remain extremely limited for patients with NSCLC who do not respond to immunotherapy and lack actionable driver gene mutations, making long-term survival difficult to achieve.The proof-of-concept (PoC) data presented at this year's ASCO meeting are highly encouraging. IBI363 has demonstrated not only meaningful short-term disease control, but also, through extended follow-up, validated the unique long-term survival benefits of its dual mechanism of action, combining immune checkpoint blockade with cytokine agonism. We are excited about the potential of IBI363 to provide a novel treatment option for a broad population of patients and ultimately help deliver durable, long-term survival benefits." About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor through binding to IL-2 receptor alpha. IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far. In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. View original content to download multimedia:https://www.prnewswire.com/news-releases/2026-asco--innovent-presents-long-term-follow-up-results-from-the-poc-study-of-ibi363-tak-928-pd-1il-2-bias-bispecific-fusion-protein-showing-robust-survival-benefits-in-advanced-immunotherapy-resistant-non-small-cell-lung-302786450.html

Interested in Takeda Pharmaceutical Co.? Here are five stocks we like better. Fiscal 2025 results were mixed: Takeda’s core revenue fell 2.6% at constant exchange rates and VYVANSE generic erosion cut about JPY 150 billion from revenue, but cost controls helped keep core operating profit nearly flat and lifted reported operating profit. The company also generated JPY 684.5 billion in adjusted free cash flow. Three near-term launches are central to Takeda’s growth plan: oveporexton for narcolepsy type 1, rusfertide for polycythemia vera, and zasocitinib for psoriasis. Management said the first two could launch in the U.S. in the second half of 2026, while zasocitinib is targeted for commercialization in the first half of 2027. Fiscal 2026 guidance calls for revenue to be down low single digits at constant currency and core operating profit to fall 5% to 8% as Takeda invests in launches and R&D. The company also announced a new transformation program affecting about 4,500 roles, with more than JPY 200 billion in annualized gross savings expected by fiscal 2028. Analysts Predict 85% Upside for Wave Life Sciences After Rate Cut Takeda Pharmaceutical (NYSE:TAK) reported fiscal 2025 results that management described as solid despite pressure from generic competition to VYVANSE, while outlining a transition plan built around three expected product launches and a broader cost transformation program. The earnings call also marked Christophe Weber’s final call as president and chief executive officer. Weber, who has led Takeda for 12 years, said the company has become “a focused global R&D-driven biopharmaceutical leader” with global scale, a stronger portfolio and a late-stage pipeline with significant potential. CEO-elect Julie Kim is scheduled to formally become president and CEO in June. → Micron Investors Face a High-Stakes Moment After the Latest Rally Time to buy these 3 healthcare companies that raised revenue guidance? Kim said Takeda is entering its next chapter “from a position of strength,” citing fiscal 2025 financial performance and positive late-stage data. She said the company’s near-term priorities are the launches of oveporexton, rusfertide and zasocitinib, which Takeda expects to launch over the next 12 months if approved. Chief Financial Officer Milano Furuta said Takeda generated core revenue of just over JPY 4.5 trillion in fiscal 2025, down 2.6% at constant exchange rates. Core operating profit was JPY 1.17 trillion, down 0.9% at constant exchange rates, as operating expense discipline helped offset the impact of VYVANSE generic erosion. → How Bad Could Tesla’s Cybertruck Recall Be for Shares? Price Growth & Yield: For That Magical Combo, Leave the U.S. Reported operating profit rose 19.3% to JPY 408.8 billion, which Furuta attributed primarily to lower amortization and restructuring costs. Core earnings per share were JPY 517, up 3.1% at constant exchange rates, while reported EPS was JPY 122. Adjusted free cash flow was JPY 684.5 billion, after a $1.2 billion upfront payment to Innovent Biologics tied to Takeda’s oncology partnership. Furuta said Takeda lost approximately JPY 150 billion in VYVANSE revenue during the year, but added that this headwind should be “much smaller” in fiscal 2026. He also said the company delivered more than JPY 150 billion in fiscal 2025 cost savings and about JPY 300 billion in gross annualized savings over the past two years through an enterprise-wide efficiency program. → Reading the Stripes: Is The Industrial Recession Over? Takeda said its growth and launch products represented more than half of total revenue and grew 4.5% at constant exchange rates. ENTYVIO grew 4.2%, slightly below the company’s forecast, as the brand faced pricing pressure and increased competition, especially in later-line treatment settings. Furuta said Takeda expects ENTYVIO to grow around 4% at constant exchange rates again in fiscal 2026. TAKHZYRO was roughly flat compared with the prior year, with international uptake offset by new competition in the U.S. Takeda’s plasma-derived therapies business grew 1.9% at constant exchange rates. Immunoglobulin products grew 4.1%, while albumin declined 2.1% due to lower demand in China tied to government cost containment measures, partially offset by tenders in other markets. Other products included FRUZAQLA, which grew 14.6% at constant exchange rates, and dengue vaccine QDENGA, which grew 10.7%. Furuta said QDENGA’s growth was below forecast because of a delayed contract signing in Brazil and lower dengue outbreak incidence in certain regions compared with the prior year. For fiscal 2026, Takeda guided for a low single-digit percentage decline in revenue at constant exchange rates. On an actual basis, using assumptions of JPY 156 to the U.S. dollar and JPY 182 to the euro, the company expects revenue to rise 3% to JPY 4.64 trillion. Takeda expects core operating profit to decline 5% to 8% at constant exchange rates, reflecting investment in launches, research and development, and technology. On an actual foreign exchange basis, core operating profit is expected to decline 1.1% to JPY 1.16 trillion. Reported operating profit is forecast to rise 2.7% to JPY 420 billion. Furuta said adjusted free cash flow is expected to be between JPY 650 billion and JPY 750 billion, and Takeda plans to raise its annual dividend to JPY 204 per share. The company also expects to repay about JPY 500 billion of debt maturing in fiscal 2026 mainly through cash on hand and free cash flow, without refinancing through long-term debt. Kim said Takeda’s three near-term assets could become future blockbuster brands if approved. Oveporexton, an orexin agonist for narcolepsy type 1, has received FDA priority review, and Takeda is preparing for a U.S. launch in the second half of 2026. Kim said the drug could address the underlying orexin deficiency in narcolepsy type 1 and has “multi-billion dollar potential” in that market. Rusfertide, a potential first-in-class hepcidin mimetic for polycythemia vera, also has FDA priority review. Kim said Takeda is preparing for launch in the second half of 2026 and will focus on disease awareness, patient access and leveraging its hematology expertise. Zasocitinib is being positioned as an oral treatment for psoriasis, with commercialization planned for the first half of 2027. R&D President Andrew Plump said data presented at the American Academy of Dermatology showed rapid and durable skin clearance, improvements in quality of life and no new safety signals. He said Takeda expects to file a new drug application for psoriasis during fiscal 2026 and anticipates a fiscal 2027 filing for psoriatic arthritis. Plump also highlighted TAK-881, a 20% facilitated subcutaneous immunoglobulin formulation for primary immunodeficiency disease. He said the product has the potential to deliver the required immunoglobulin dose in half the infusion volume compared with HYQVIA, with regulatory submissions planned this year. Takeda is launching a new transformation program tied to its updated operating model. Furuta said about 4,500 roles are expected to be affected in fiscal 2026, with restructuring costs of JPY 170 billion expected this year. The company expects more than JPY 200 billion in annualized gross savings by fiscal 2028, including JPY 100 billion in fiscal 2026, with savings reinvested into launches and pipeline programs. Kim described Takeda’s strategy in two phases: a two- to three-year “Horizon One” focused on transforming for growth, launching the three new products, advancing late-stage assets and maintaining resilience in core brands; and “Horizon Two,” focused on growth acceleration as new products scale. During the question-and-answer session, Kim said Takeda is not yet providing growth projections beyond fiscal 2026, but expects to share more at a Capital Markets Day later this fiscal year. Management also addressed board changes, with Kim saying Takeda is proposing Bruce Broussard, Koichiro Kimura and Paul Stoffels as new board members, subject to approval at the annual general meeting in June. She said the changes are intended to align board expertise with Takeda’s next phase of growth. In response to analyst questions, Furuta said Takeda aims to return core operating profit to growth after fiscal 2026, depending on the uptake of new products. He also said the main driver of the company’s longer-term goal to expand core operating profit margin to the low-to-mid 30% range would be a series of successful launches from Takeda’s late-stage pipeline. Takeda Pharmaceutical Company Limited (NYSE: TAK) is a Tokyo-based, multinational biopharmaceutical company with roots dating back to 1781. The company researches, develops, manufactures and commercializes pharmaceutical and biopharmaceutical products for patients worldwide. Takeda is publicly listed and operates as a fully integrated R&D-driven healthcare company focused on delivering specialty medicines and therapies across a range of therapeutic areas. Takeda's main business activities encompass discovery and development of prescription medicines, clinical development and regulatory affairs, manufacturing of small molecules and biologics, and global commercial operations. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Takeda Pharmaceutical Q4 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

FY2025 Pipeline Successes Set the Stage for Pivotal Product Launches Achieved Latest FY2025 Management Guidance Takeda is Entering a New Era & Transforming for Growth Acceleration   OSAKA, Japan, May 13, 2026--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the fiscal year 2025 (period ended March 31, 2026). The Company delivered solid results in line with its latest FY2025 Management Guidance, reflecting strong OPEX savings, mitigating revenue headwinds while continuing to invest in future growth. Key Highlights for FY2025 Revenue decreased by 1.7% YoY at actual exchange rates (AER), resulting from the loss of exclusivity for VYVANSE® which was partially mitigated by Growth and Launch Products. On a Core basis, Revenue decreased by 2.6% at Constant Exchange Rate (CER). Core Operating Profit increased by 0.8% YoY at AER and declined by 0.9% at CER, protected by OPEX savings, while still investing for growth. Reported Operating Profit increased by 19.3% YoY at AER, also reflecting a step-down in amortization expenses for VYVANSE and lower restructuring expenses. Core EPS increased by 5.2% YoY at AER and by 3.1% at CER, while reported EPS increased by 78.1% YoY. Adjusted Free Cash Flow amounted to JPY 684.5 billion, in line with forecast, and the Company ended fiscal year with strong cash balance. Delivered key milestones for oveporexton, rusfertide, and zasocitinib, with positive Phase 3 readouts; completed regulatory submissions for oveporexton and rusfertide, and launch preparations underway. Takeda Chief Executive Officer (CEO)-elect, Julie Kim, commented:"FY2025 was a pivotal year, validating the strength of our execution against demanding development and regulatory milestones, the resilience of our commercial portfolio and our strong position with three major launches planned in the next 12 months and the most robust late-stage pipeline in our history. Our growth roadmap is built around two strategic horizons: transforming for growth through near-term launches and strengthening competitiveness and accelerating growth by transitioning to a new cohort of blockbuster brands, together positioning us for long-term profitable growth and patient impact." Takeda Chief Financial Officer, Milano Furuta, commented:"In FY2025, despite topline headwinds, we delivered solid profit and cash flow through disciplined cost control, while directing growth investment toward new product launches and the pipeline. In FY2026, we will continue to focus on transforming operations and protecting profitability while delivering successful launches and advancing our pipeline. Strong cash flow generation and deleveraging will support long-term investment for growth acceleration and ensure competitive returns for our shareholders." Full-year FY2026 Forecast and GuidanceBased on the current business outlook and planned investment profile, Takeda issued the following FY2026 forecast and management guidance. Pipeline Achievements Set the Stage for Future GrowthOur three leading late-stage assets are positioned for regulatory approvals in the U.S. and other geographies in FY2026-2027. We expect this will be a pivotal period for launches and investment with clear near-term wins and proof points over the next 12–24 months. oveporexton: Oveporexton is potentially a first-of-its-kind orexin agonist designed to address the underlying orexin deficiency that causes narcolepsy type 1. Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for oveporexton in the second half of 2026 and has also completed regulatory filings in Japan and China. rusfertide: Rusfertide is a potential first‑in‑class hepcidin mimetic that has demonstrated rapid, stable, and durable hematocrit control in patients with polycythemia vera, or PV, and has the potential to shift the standard of care in this blood cancer. Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for rusfertide in the second half of 2026. zasocitinib: Zasocitinib is poised to be a leading oral treatment option for psoriasis patients with the potential to significantly expand the oral segment in a growing psoriasis market. Takeda is making decisive investments to support a planned regulatory filing in 2026 and a commercial launch in the first half of 2027. Capital Allocation and Shareholder ReturnsTakeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation to drive growth and enables the company to deliver returns to shareholders under its progressive dividend policy. In FY2025, the proposed annual dividend was JPY 200 per share, and year-end adjusted net debt/adjusted EBITDA was 2.6x. Additional Information About Takeda’s FY2025 ResultsTakeda will host a conference call for investors and analysts on Wednesday, May 13, 2026, at 7:00 PM JST / 6:00 AM EDT to discuss its full-year 2025 financial results. A live webcast of the conference call, along with presentation materials, will be available on the investor relations section of Takeda’s website at www.takeda.com/investors. The presentation will contain further details on Takeda’s FY2025 results, commercial progress, pipeline updates, and other financial information, including key assumptions for the FY2026 forecast and definitions of non-IFRS measures. About TakedaTakeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit https://www.takeda.com. Important NoticeFor the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could", "anticipates", "estimates", "projects", "forecasts", "outlook" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Financial information and Non-IFRS Measures Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards ("IFRS"). This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate ("CER") change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as "reported" measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2025 Q4 investor presentation (available at www.takeda.com/investors). Medical information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Please refer to slide 14 of Takeda’s FY2025 Q4 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products. View source version on businesswire.com: https://www.businesswire.com/news/home/20260510786927/en/ Contacts Investor Relations Christopher O’Reilly [email protected] +81 (0) 90-6481-3412Media Relations [email protected]