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Headquarters: Osaka, Japan
twitter.com/TakedaPharma
www.takeda.com
Headcount: 47,347
Year Established: 1781
Revenues: $30,368 (+13%)
Net Income: $2,390 (+38%)
R&D: $4,775 (+20%)
Maintaining its position at number 11, Takeda delivered strong growth in its fiscal year ended March 31, 2023, with reported revenue of $30.4 billion, up 13% and a 38% increase in earnings to $2.4 billion. Key pipeline milestones included the first approvals for dengue vaccine Qdenga, positive late-stage readouts for TAK-755 and fazirsiran, and the acquisition of Nimbus Therapeutics’ NDI-034858 for immune-mediated diseases.
Takeda reported strong double-digit growth across four of its five business units, gastrointestinal and inflammation, rare diseases, plasma-derived therapies, and neuroscience, largely driven by top sellers Entyvio, Immunoglobulin, Vyvanse, Takhzyro, and albumin products. The company’s largest revenue generator, gastroenterology, brought in $8.2 billion, up 25% for the fiscal year driven by Entyvio. Meanwhile, rare diseases came in second with $5.45 billion in revenue, up 18%. Revenue for Takhzyro, for hereditary angioedema, grew 47% driven by continued strong demand in the U.S. and geographic expansion. Notably, Plasma-Derived Therapies (PDTs) delivered outstanding growth with $5.1 billion in revenue, up 34%.
Neuroscience, with $4.8 billion in sales, grew 32% driven by increased demand for Vyvanse for ADHD in the adult market. Meanwhile, Oncology sales declined 6% to $3.3 billion impacted by the rapid generic erosion of Velcade sales in the U.S.
Acquired assets
For $4 billion upfront, and as much as $2 billion in commercial milestone payments, Takeda entered an agreement to acquire Nimbus Therapeutics’ NDI-034858, a potential best-in-class profile among new therapeutic class of selective allosteric TYK2 inhibitors for immune-mediated diseases, including psoriasis.
Also, under an exclusive license agreement with Innate Pharma, Takeda was granted exclusive worldwide rights to research and develop antibody drug conjugates (ADC) using a panel of selected Innate antibodies against an undisclosed target, with a primary focus in Celiac disease. For $5 million upfront, and as much as $410 million in potential development, regulatory and commercial milestones, plus royalties on potential sales, Takeda takes on future development, manufacture and commercialization of any potential products developed using the licensed antibodies.
Additionally, Takeda entered an exclusive licensing agreement with Hutchmed (China) Ltd. for the further development and commercialization of fruquintinib. For $400 million upfront, and as much as $730 million in additional potential payments, Takeda receives an exclusive worldwide license to develop and commercialize fruquintinib in all indications and territories outside of mainland China, Hong Kong and Macau.
Approved in China in 2018, fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. Fruquintinib is orally administered and has the potential to be used across subtypes of refractory metastatic colorectal cancer (CRC), regardless of biomarker status. A Phase 3 trial of fruquintinib in refractory metastatic CRC, FRESCO-2, met its primary endpoint of improving overall survival and was generally well tolerated.
Facility expansions
Expanding its presence in Kendall Square, MA, Takeda signed a 15-year lease with BioMed Realty for approximately 600,000 sq.-ft. of research and development and office space to be built at 585 Third Street. The state-of-the-art facility allows Takeda to create a purpose-built R&D facility with labs of the future featuring modern design elements and upgraded technology to support the company in its efforts to advance innovation. The company will also expand its existing space in 650 East Kendall to include two additional floors.
Furthermore, in line with Takeda’s capital allocation policy of “Investing in Growth Drivers” the company is investing approximately $764.6 million to build a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan. The investment enables Takeda to establish an end-to-end manufacturing facility for PDTs, which is expected to be operational by around 2030. The new site increases the capacity of Takeda’s current plasma manufacturing site in Narita, Japan almost five-fold.
Alliances
To aid in advancing its pipeline, Takeda is partnering with Adaptive Biotechnologies to leverage its clonoSEQ assay, and Arzeda to access its digital biology tool. The recent collaboration with Adaptive aims to measure Minimal Residual Disease (MRD) with clonoSEQ Assay to facilitate the development and commercialization of Takeda’s pipeline of treatments for lymphoid malignancies. MRD can be used to assess depth of response and to detect early signs of relapse prior to clinical symptoms. The clonoSEQ Assay is the first and only next-generation sequencing-based MRD test authorized by the U.S. FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.
Additionally, an alliance with Arzeda will deploy AI-based protein design to optimize the properties of protein biologics. Takeda will leverage Arzeda's Intelligent Protein Design Technology, which has the potential to accelerate the optimization of proteins that can be incorporated into therapeutic products. Applying the latest advances in digital biology, using computational design and machine learning algorithms, the collaboration aims to help improve therapeutic proteins in Takeda's research pipeline.
Lastly, Takeda, Zedira and Dr. Falk Pharma GmbH entered a collaboration and licensing agreement to develop ZED1227/TAK-227, a Phase 2b investigational therapy for the treatment of celiac disease. TAK-227 is a potential first-in-class therapy designed to prevent the immune response to gluten in celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage to the small intestine.
Pipeline highlights
Over the course of the year, Takeda gained several expanded indications for its therapies for pediatric use, including Takhzyro. The FDA approved the expanded use of TAKHZYRO to prevent attacks of Hereditary angioedema (HAE) in pediatric patients, making it the first prophylaxis treatment option for this age group.
Also, Qdenga, Takeda’s dengue vaccine, which has received several approvals to date, was recently approved by Brazil’s National Health Surveillance Agency (ANVISA) to protect against all four serotypes. Qdenga is the only dengue vaccine that is approved for use regardless of previous exposure and without need of pre-vaccination testing. Importantly, Takeda received Orphan Drug Designation from the Japanese Ministry of Health, Labour and Welfare for TAK-755 for the expected indication of thrombotic thrombocytopenic purpura (TTP).
TAK-755 is being developed globally for congenital and acquired TTP.