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Takeda Announces FY2024 Full Year Results and FY2025 Outlook Reflecting Growth & Launch Products Momentum, Strong Cash Flow Generation and Late-Stage Pipeline Progress

On May 8, 2025 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for fiscal year 2024 (period ended March 31, 2025) with continued strong momentum in Growth & Launch Products offsetting loss of exclusivity impact to drive revenue and Core Operating Profit growth, supported by robust cost management (Press release, Takeda, MAY 8, 2025, View Source [SID1234652790]).

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Takeda has built a high-value late-stage pipeline with potentially life-transforming new treatment options for patients. Following a positive Phase 3 readout for rusfertide in Oncology in March 2025, the company anticipates a further two Phase 3 readouts in core therapeutic areas this fiscal year.

FY2025 Management Guidance at CER reflects residual carry-over of VYVANSE generic impact, continued efficiency savings and investment in R&D and launch preparation for Takeda’s late-stage pipeline.

Takeda chief executive officer, Christophe Weber, commented:
"Takeda delivered excellent results in FY2024. Our return to Core Operating Profit margin growth underscores the strength of our Growth & Launch Products portfolio and the ability of our multi-year efficiency program to deliver meaningful cost savings.

"FY2025 will be a pivotal year as we invest in launch readiness for the late-stage pipeline, which will contribute to our broadly flat Core Operating Profit outlook for FY2025 but will be key to achieving Takeda’s long-term growth potential."

Takeda chief financial officer, Milano Furuta, commented:
"Takeda’s success in delivering revenue and Core Operating Profit growth in FY2024 and our outlook for broadly flat revenue and profit in FY2025, demonstrates our ability to manage through one of the largest generic impacts on our business in Takeda’s history while progressing a highly promising late-stage pipeline. Our performance and outlook speak to the strength of our Growth & Launch Products, our innovative pipeline and the resilience of our organization as a whole.

"Takeda is now at an inflection point, with multiple anticipated Phase 3 data readouts this fiscal year, and I’m excited about our growth trajectory."

FINANCIAL HIGHLIGHTS for FY2024 Ended March 31, 2025

(Billion yen, except percentages and per share amounts)

FY2024

FY2023

vs. PRIOR YEAR

(Actual % change)

Revenue

4,581.6

4,263.8

+7.5%

Operating Profit

342.6

214.1

+60.0%

Net Profit

107.9

144.1

-25.1%

EPS (Yen)

-25.8%

Operating Cash Flow

1,057.2

716.3

+47.6%

Adjusted Free Cash Flow (Non-IFRS)

769.0

283.4

+171.3%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

FY2024

FY2023

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change)

Revenue

4,579.8

4,263.8

+7.4%

+2.8%

Operating Profit

1,162.6

1,054.9

+10.2%

+4.9%

Margin

25.4%

24.7%

+0.6pp

―

Net Profit

775.6

756.8

+2.5%

-3.4%

EPS (Yen)

491

484

+1.5%

-4.3%

FY2025 Outlook

(Billion yen, except percentages and per share amounts)

Item

FY2025 FORECAST

FY2025

MANAGEMENT

GUIDANCE

Core Change at CER

(Non-IFRS)

Revenue

4,530.0

—

Core Revenue (Non-IFRS)

4,530.0

Broadly flat

Operating Profit

475.0

—

Core Operating Profit (Non-IFRS)

1,140.0

Broadly flat

Net Profit

228.0

—

EPS (Yen)

145

—

Core EPS (Yen) (Non-IFRS)

485

Broadly flat

Adjusted Free Cash Flow (Non-IFRS)

750.0-850.0

—

Annual Dividend per Share (Yen)

200

—

Additional Information About Takeda’s FY2024 Results
For more details about Takeda’s FY2024 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2024 Q4 investor presentation (available at View Source)

Vergent Bioscience to Present Data on Abenacianine for Injection (VGT-309) at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 8, 2025 Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, reported that an abstract on abenacianine for injection (VGT-309) will be featured at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30-June 3 in Chicago (Press release, Vergent Bioscience, MAY 8, 2025, View Source [SID1234652789]). The poster will highlight data from the Phase 2B, multicenter VISUALIZE study (NCT06145048) evaluating the safety and efficacy of abenacianine in patients undergoing surgery for proven or suspected cancer in the lung. Abenacianine is an investigational tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization with minimally invasive and robotic-assisted surgical procedures.

Following are details about the poster presentation at ASCO (Free ASCO Whitepaper) 2025:

Title:

"Phase 2 Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Abenacianine for Injection (VGT-309), a Tumor-Targeted, Intraoperative Molecular Imaging Agent, for Patients Undergoing Surgery for Cancer in the Lung"

Authors:

Luis J Herrera; Gavin M Wright, MBBS, FRACS, Ph.D.; Jae Y Kim, M.D.; Janani S Reisenauer, M.D.; David C Rice, M.D.; Sunil Singhal, M.D.

Presenter:

Sunil Singhal, M.D., director of the Center for Precision Surgery at the Abramson Cancer Center, vice chair of translational research in the Department of Surgery, chief of thoracic surgery and William Maul Measey Professor in Surgical Research at University of Pennsylvania Perelman School of Medicine

Abstract ID:

3069

Poster Board #:

384

Date and Time:

June 2, 2025, at 1:30-4:30 p.m. CT

About the VISUALIZE Clinical Trial
The Phase 2B, multicenter, open-label VISUALIZE study (NCT06145048) was designed to evaluate the efficacy and safety of abenacianine for injection in patients undergoing surgery for proven or suspected cancer in the lung. Each of the 89 patients in the study received 0.32mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor using standard surgical techniques, investigators used a commercially available near-infrared (NIR) endoscope to assess the presence of tumor tissue, which was then confirmed by pathology. The primary efficacy endpoint included localization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively.

About Abenacianine for Injection (VGT-309)
Abenacianine for injection is a tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization with open, minimally invasive and robotic-assisted surgical procedures. Abenacianine for injection is delivered to patients via a short intravenous infusion several hours to several days before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are overexpressed across a broad range of solid tumors. This approach, if successful, would provide distinct clinical advantages and position abenacianine for injection as an ideal tumor imaging agent. Abenacianine for injection’s imaging component is the near-infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is a preferred dye to minimize confounding background autofluorescence.

OmRx Oncology Initiates Phase 2 Trial of Oral PD-L1 Inhibitor OX-4224 in NSCLC

On May 8, 2025 OmRx Oncology, or "OmRx," a clinical-stage biopharmaceutical venture dedicated to expanding access to cancer immunotherapy worldwide, reported the initiation of a Phase 2 clinical trial of its investigational oral PD-L1 inhibitor, OX-4224, in patients with non-small cell lung cancer (NSCLC) (Press release, OmRx Oncology, MAY 8, 2025, View Source [SID1234652788]).

OX-4224 is an investigational oral small molecule that targets the PD-1/PD-L1 immune checkpoint pathway and offers a potentially more accessible and cost-effective option compared to existing antibody-based therapies.

The open-label, randomized, Phase 2 study will enroll approximately 50 patients with metastatic NSCLC whose tumors express PD-L1 and who have not previously received immune checkpoint inhibitors, with a focus on India. The trial will assess OX-4224 as a second line monotherapy, evaluating overall response rate in addition to safety and other secondary efficacy endpoints.

"Launching this clinical trial is a key step toward fulfilling OmRx’s mission of addressing global health disparities in cancer treatment," said Isy Goldwasser, CEO, OmRx. "Checkpoint inhibitor antibodies have revolutionized cancer care in high-income countries, but remain largely inaccessible to many patients globally. With OX-4224, we have the opportunity to bring the benefits of immunotherapy to many more people."

OmRx is developing OX-4224 initially for low and middle-income countries (LMICs), where biologics are often inaccessible due to high cost and distribution challenges. OX-4224’s oral formulation removes the need for infusion centers, allows flexible dosing schedules, and offers a more scalable manufacturing model.

"This trial brings us closer to realizing a long-held vision—to offer effective, affordable, and easier-to-administer immunotherapies to the patients who need them most," said Dr. William Lee, Chairman of OmRx and former EVP of Research at Gilead Sciences. "If OX-4224 demonstrates safety and efficacy in the upcoming NSCLC study, it would provide development opportunity to meaningfully change the standard of care for patients in resource-limited settings."

In-licensed from Gilead Sciences, OX-4224 is initially being advanced to improve access to immunotherapy in low-resource settings. Positive results from this trial could also pave the way for broader global development, including in high-income countries, where OmRx aims to explore innovative, all-oral immuno-oncology combination regimens.

OX-4224 is an investigational product and statements regarding its potential benefits are forward-looking and subject to risks and uncertainties.

Signatera Data From I-SPY 2 Trial to Be Presented at ESMO Breast Annual Congress

On May 8, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that it will present multiple datasets in breast cancer together with its collaborators at the 2025 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in Munich, Germany, taking place from May 14-17, 2025 (Press release, Natera, MAY 8, 2025, View Source [SID1234652787]).

Results from the I-SPY 2 clinical trial, sponsored and operated by Quantum Leap Healthcare Collaborative, will be shared in a mini-oral presentation on May 16, 2025. The report includes data from 712 patients with early-stage, high-risk breast cancer, and it evaluates the association of distant recurrence free survival (DRFS) with ctDNA concentration at diagnosis, before receiving neoadjuvant systemic therapy and curative-intent surgery. Key highlights include:

Signatera positive patients at diagnosis had 3x higher risk of recurrence than Signatera negative patients (HR 3.1, p< 0.001%), though the risk can be significantly reduced based on response to subsequent therapy.
Patients who were Signatera negative at diagnosis had extremely good outcomes.
Among patients who were Signatera positive at diagnosis, higher ctDNA quantities at the time of diagnosis were significantly correlated with a higher risk of recurrence. However, effective treatment can affect ctDNA levels as well as pathologic response status, both of which further refine risk of recurrence. This is the first time that pre-treatment absolute ctDNA quantity has been shown to correlate with clinical outcomes in breast cancer.
Among all clinicopathologic risk factors available at diagnosis, a multivariate analysis identified Signatera status as the most significant factor in predicting DRFS, regardless of disease subtype (p<0.001). DRFS prediction can be further refined by integrating additional variables before, during, and after treatment, including ctDNA dynamics.
"The I-SPY 2 trial is uncovering insights that may allow us to tailor treatment plans for breast cancer patients based on their individual genomic profiles and better identify patients who may be more likely to experience adverse outcomes," said Laura Esserman, M.D., MBA, and Laura van ‘t Veer, Ph.D., professors at the University of California, San Francisco, and principal investigators of the I-SPY 2 study. "Our hope is that these findings will encourage future interventional trials in breast cancer, specifically in the neoadjuvant setting."

"Signatera was able to predict excellent clinical outcomes in a high risk population at the time of diagnosis," said Angel Rodriguez, M.D., medical director, oncology at Natera. "This may give rise to new protocols, evaluating whether some patients can avoid chemotherapy or other intensive treatments, if they test Signatera-negative at diagnosis."

Natera will present an additional three abstracts at the ESMO (Free ESMO Whitepaper) Breast conference, highlighting real-world evidence and genomic landscaping from its multi-modal database of de-identified clinical and genomic data in over 200,000 early- and late-stage cancer patients.

Full list of Natera’s ESMO (Free ESMO Whitepaper) Breast presentations:

May 16, 9:40 AM CT | FPN 5MO
Presenter: Mark Magbanua, Ph.D., UCSF Helen Diller Family Comprehensive Cancer Center
Pretreatment Circulating Tumor (ct)DNA Predicts Metastatic Recurrence in Patients (pts) With High-Risk Early Breast Cancer (eBC) Enrolled in the I-SPY 2 Trial

May 15, 12:00 PM CT | FPN 115P
Presenter: Chu-Ling Yu, Merck
Real-World Testing Patterns of Circulating Tumor DNA (ctDNA) in Early-Stage Triple-Negative Breast Cancer (TNBC): a U.S. Nationwide Database Study

May 15, 12:00 PM CT | FPN 12P
Presenter: Melinda Telli, M.D., Stanford University School of Medicine
Real-world experience of longitudinal circulating tumor (ct)DNA monitoring in patients (pts) with early-stage triple-negative breast cancer (TNBC)

May 15, 12:00 PM CT | FPN 412TiP
Presenter: Thibault De La Motte Rouge, M.D., Ph.D., Comprehensive Cancer Centre Eugène Marquis (Rennes, France)
HEROES: De-escalation of medical therapies in HER2-positive metastatic breast cancer in long-term persistent response and minimal residual disease undetectable in circulating tumor DNA

May 15, 12:00 PM CT | FPN 37P
Presenter: Marla Lipsyc-Sharf, M.D., UCLA Health
Genetic Ancestry and Tumor Mutations Influence Circulating Tumor DNA (ctDNA) Detection Rates in Breast Cancer: A Large Real-World Study

May 15, 12:00 PM CT | FPN 93P
Presenter: Yara Abdou, M.D., UNC School of Medicine
Assessment of antibody-drug conjugate utilization in patients with breast cancer undergoing circulating tumor DNA testing

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

Cellipont Bioservices and Optieum Biotechnologies Partner to Advance cGMP Manufacturing of Groundbreaking CAR-T Therapy for Glioblastoma

On May 8, 2025 Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies (Optieum), a preclinical stage company dedicated to the discovery and development of innovative Chimeric Antigen Receptor (CAR) T cell therapies, reported a partnership for cGMP manufacturing of OPTF01, Optieum’s novel CAR-T therapy for glioblastoma treatment, a product derived from their proprietary Eumbody System (Press release, Optieum Biotechnologies, MAY 8, 2025, View Source [SID1234652786]).

OPTF01 specifically targets Fibroblast activation protein-alpha (FAPα) a protein expressed on both tumor cells and the surrounding pericytes and Cancer-associated Fibroblasts (CAFs). Hence, OPTF01 can potentially disrupt the immunosuppressive microenvironment around the tumor while simultaneously attacking the malignant cells within the tumor. Successful development of this therapeutic approach would address a critical unmet medical need for patients with refractory glioblastoma who currently face limited treatment options with poor prognoses, as well as various other solid tumor indications.

Under this collaboration, Cellipont Bioservices will provide the technology transfer, process development, and cGMP manufacturing of Optieum’s novel OPTF01 CAR-T product. "Glioblastoma remains one of the most aggressive and difficult-to-treat cancers, demanding urgent innovation beyond traditional approaches," said Darren Head, CEO of Cellipont Bioservices. "Our collaboration with Optieum presents an exciting opportunity to leverage advanced CAR-T technologies and bring meaningful solutions to patients in need. We are honored to be part of this critical mission."

Shun Nishioka, CEO of Optieum added, "At Optieum, we are committed to redefining the future of CAR-T therapy through relentless innovation and scientific rigor. Partnering with Cellipont’s team of experts ensures that our groundbreaking therapies are manufactured to the highest standards, accelerating our progress toward delivering next-generation therapies for glioblastoma and other solid tumors."

OPTF01 is derived from the Eumbody System, a proprietary platform representing a significant advancement in CAR-T cell therapy development. This platform leverages rapid and expansive functional screening to identify and optimize CAR constructs in unprecedented fashion. By dynamically harmonizing single-chain variable fragment (scFv) sequences to enhance the functional capabilities of T cells, the Eumbody System sets a new standard in CAR-T innovation.