07.16.21
Headquarters: Osaka, Japan
twitter.com/TakedaPharma
www.takeda.com
Headcount: 47,495
Year Established: 1781
Revenues: $28,911 (-3%)
Net Income: $3,401 (>100%)
R&D: $4,121 (-10%)
TOP SELLING DRUGS
Maintaining its position in the top 10 despite a 3% slip in revenues, Takeda’s top selling drugs Entyvio, a monoclonal antibody used in gastroenterology, and Photodynamic therapy Immunoglobulin used in immunology, along with strategic divestitures, supported underlying growth in 2020.
Takeda’s five key business areas of Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience with $23.8 billion in revenue represent approximately 82% of the company’s total FY2020 revenues, and delivered 5% growth. Sales of Takeda’s 14 global brands were up 16% to $11.0 billion, and include top seller Entyvio, up 24%, Takhzyro, up 30% and Immunoglobulin, up 16%, which helped offset declines in neuroscience (-5%), and rare diseases (-7%), particularly Advate, which was down 19%. In Oncology, Velcade sales were down 15% and Leuprorelin sales were down 13%. Reported earnings growth of approximately 750% reflects gains on non-core asset sales and lower acquisition-related expenses (the Shire deal was finalized in January 2019).
According to the company, the overall impact of COVID-19 on financial results for the fiscal year ended March 31, 2021, was not material, with several offsetting factors, including benefits from prescribing trends during the pandemic, such as an expansion of certain products with a more convenient administration profile.
To date, Takeda’s non-core asset divestiture total reached ~$12.9 billion, exceeding its $10 billion goal, with 12 deals since January 2019. Most recently, Takeda sold a portfolio of approximately 130 select over the counter and prescription products, and two manufacturing sites to Orifarm for $670 million, a portfolio of four type 2 diabetes products to Teijin Pharma for JPY 133.0 billion, and sold Takeda Consumer Healthcare Company to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates, for JPY 227.7 billion.
Takeda also gained key approvals and advanced several assets this past year, and invested in rare disease and oncology assets, as well as cell therapy manufacturing capabilities.
Acquisitions and investments
In March 2021, Takeda entered an agreement to acquire Maverick Therapeutics to advance T-cell engager therapies for solid tumors and expand its novel immuno-oncology portfolio, for up to $525 million upfront and potential milestones. Takeda gains Maverick’s T-cell engager COBRA platform and a broad development portfolio, including lead development candidate TAK-186 currently in a Phase 1/2 study for the treatment of EGFR-expressing solid tumors, and TAK-280, which is anticipated to enter the clinic in the second half of Takeda’s FY2021 for the treatment of patients with B7H3-expressing solid tumors.
Takeda also secured global rights from Ovid Therapeutics to develop and commercialize Soticlestat for the treatment of Dravet Syndrome and Lennox-Gastaut Syndrome for up to $856 million in payments, including a $196 million upfront. The potential first-in-class therapy has been shown to reduce seizure frequency in children with Dravet Syndrome and Lennox-Gastaut Syndrome in a Phase 2 trial. Takeda Plans to Initiate Phase 3 studies in 2Q21.
Additionally, to help accelerate efforts to develop next-generation cell therapies, Takeda is expanding its cell therapy manufacturing capabilities with the opening of a new 24,000 sq.-ft. R&D cell therapy manufacturing facility at its headquarters in Boston, MA. The facility will provide end-to-end research and development capabilities and will initially focus on oncology with potential to expand into other therapeutic areas. Takeda currently has five collaborative oncology cell therapy programs expected to be in clinical development by the end of FY2021. The cGMP facility builds on cell therapy capabilities and increases capacity to supply cell therapies for global clinical trials.
R&D highlights
Takeda’s R&D model is focused on more targeted patient populations where there is potential for greater therapeutic benefit, smaller and less costly development programs, and faster tracks to registration with enhanced patent protection and marketing rights. The company plans to increase R&D investment to 522 billion JPY to advance 40+ prioritized NMEs and new partnerships, as well additional capabilities in oncology and data and digital sciences. In FY2020, Takeda gained 12 global and regional approvals in the U.S., EU, China and Japan.
The main driver for new product launches in the near term are 11 NMEs that include several potential best-in-class / first-in-class therapies, and two regional COVID-19 vaccines. Takeda anticipates five to six “Wave 1” new molecular entities (NMEs) to be submitted to FDA in FY2021, with the potential for four more approvals. The following highlights some of these therapies.
Recently, Takeda’s Dengue vaccine candidate TAK-003, was shown to prevent 83.6% of hospitalizations and 62% of Dengue illness overall, in an ongoing Phase 3 trial, with no identified safety risks through three years following vaccination. Regulatory filings are progressing in the EU and many Dengue-Endemic Countries; filing in in the U.S. is planned for later this year. According to the company, Dengue is the fastest-spreading mosquito-borne viral disease with an estimated 390 million cases and 500,000 hospitalizations each year globally, with limited prevention options.
Mobocertinib (TAK-788), a potential new oral standard of care for epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC), has completed its NDA submission with a potential approval in FY2021. Mobocertinib was granted priority review by the FDA and is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.
Meanwhile, primary analysis from a Phase 3 trial evaluating Maribavir (TAK-620) showed significantly more patients achieved cytomegalovirus (CMV) clearance versus conventional therapies in transplant recipients with CMV infection. The trial met key secondary endpoints, maintaining superior CMV clearance and is on track for NDA submission. The FDA granted the drug priority review and breakthrough therapy designation. If approved, Maribavir will be the first treatment indicated for post-transplant CMV infection in patients that are refractory, with or without resistance. Maribavir is Takeda’s fourth NME accepted for regulatory review within a six month period.
Also, Orexin (TAK-994), is a potential first therapy to treat orexin deficiency, which is associated with narcolepsy type 1, a rare, underdiagnosed and undertreated condition that disrupts the sleep awake cycles, and with narcolepsy type 2 and idiopathic hypersomnia to follow as potential additional indications.
These are in addition to Soticlestat acquired from Ovid Therapeutics and TAK-186 acquired from Maverick Therapeutics, as mentioned above.
COVID efforts
Takeda has partnered with the Government of Japan, Novavax and Moderna, to help accelerate the availability of COVID-19 vaccines leveraging its extensive global manufacturing and supply capabilities and building on its existing influenza pandemic preparedness efforts in Japan. Takeda also has a mutual agreement with IDT Biologika GmbH to use capacity at IDT for three months, previously reserved for Takeda’s dengue vaccine candidate, to manufacture Johnson & Johnson’s single-shot COVID-19 vaccine.
This past February the first subject was dosed in its Phase 1/2 immunogenicity and safety study of Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan, and Takeda completed enrollment in its Phase 1/2 immunogenicity and safety study of Moderna’s COVID-19 vaccine candidate (TAK-919) in Japan. Results from the TAK-919 study are expected in 1H21 and results from the TAK-019 study in 2H21. Once available, results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) as part of the NDA filing process. Pending regulatory approval, Takeda intends to start distributing TAK-919 in the 1H21 and aims to start distributing TAK-019 in late 2021.
twitter.com/TakedaPharma
www.takeda.com
Headcount: 47,495
Year Established: 1781
Revenues: $28,911 (-3%)
Net Income: $3,401 (>100%)
R&D: $4,121 (-10%)
TOP SELLING DRUGS
Drug | Indication | 2020 Sales | (+/-%) |
Entyvio | ulcerative colitis, Crohn’s disease | $3,895 | 24% |
Immunoglobulin | immunoglobulin deficiency | $3,039 | 12% |
Vyvanse | attention deficit disorder/hyperactivity | $2,464 | -1% |
Advate | haemophilia A | $1,166 | -19% |
Velcade | multiple myeloma | $917 | -15% |
Lupron Depot | hormone associated therapy | $865 | -13% |
Ninlaro | multiple myeloma | $793 | 13% |
Takhzyro | hereditary angioedema | $787 | 27% |
Maintaining its position in the top 10 despite a 3% slip in revenues, Takeda’s top selling drugs Entyvio, a monoclonal antibody used in gastroenterology, and Photodynamic therapy Immunoglobulin used in immunology, along with strategic divestitures, supported underlying growth in 2020.
Takeda’s five key business areas of Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience with $23.8 billion in revenue represent approximately 82% of the company’s total FY2020 revenues, and delivered 5% growth. Sales of Takeda’s 14 global brands were up 16% to $11.0 billion, and include top seller Entyvio, up 24%, Takhzyro, up 30% and Immunoglobulin, up 16%, which helped offset declines in neuroscience (-5%), and rare diseases (-7%), particularly Advate, which was down 19%. In Oncology, Velcade sales were down 15% and Leuprorelin sales were down 13%. Reported earnings growth of approximately 750% reflects gains on non-core asset sales and lower acquisition-related expenses (the Shire deal was finalized in January 2019).
According to the company, the overall impact of COVID-19 on financial results for the fiscal year ended March 31, 2021, was not material, with several offsetting factors, including benefits from prescribing trends during the pandemic, such as an expansion of certain products with a more convenient administration profile.
To date, Takeda’s non-core asset divestiture total reached ~$12.9 billion, exceeding its $10 billion goal, with 12 deals since January 2019. Most recently, Takeda sold a portfolio of approximately 130 select over the counter and prescription products, and two manufacturing sites to Orifarm for $670 million, a portfolio of four type 2 diabetes products to Teijin Pharma for JPY 133.0 billion, and sold Takeda Consumer Healthcare Company to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates, for JPY 227.7 billion.
Takeda also gained key approvals and advanced several assets this past year, and invested in rare disease and oncology assets, as well as cell therapy manufacturing capabilities.
Acquisitions and investments
In March 2021, Takeda entered an agreement to acquire Maverick Therapeutics to advance T-cell engager therapies for solid tumors and expand its novel immuno-oncology portfolio, for up to $525 million upfront and potential milestones. Takeda gains Maverick’s T-cell engager COBRA platform and a broad development portfolio, including lead development candidate TAK-186 currently in a Phase 1/2 study for the treatment of EGFR-expressing solid tumors, and TAK-280, which is anticipated to enter the clinic in the second half of Takeda’s FY2021 for the treatment of patients with B7H3-expressing solid tumors.
Takeda also secured global rights from Ovid Therapeutics to develop and commercialize Soticlestat for the treatment of Dravet Syndrome and Lennox-Gastaut Syndrome for up to $856 million in payments, including a $196 million upfront. The potential first-in-class therapy has been shown to reduce seizure frequency in children with Dravet Syndrome and Lennox-Gastaut Syndrome in a Phase 2 trial. Takeda Plans to Initiate Phase 3 studies in 2Q21.
Additionally, to help accelerate efforts to develop next-generation cell therapies, Takeda is expanding its cell therapy manufacturing capabilities with the opening of a new 24,000 sq.-ft. R&D cell therapy manufacturing facility at its headquarters in Boston, MA. The facility will provide end-to-end research and development capabilities and will initially focus on oncology with potential to expand into other therapeutic areas. Takeda currently has five collaborative oncology cell therapy programs expected to be in clinical development by the end of FY2021. The cGMP facility builds on cell therapy capabilities and increases capacity to supply cell therapies for global clinical trials.
R&D highlights
Takeda’s R&D model is focused on more targeted patient populations where there is potential for greater therapeutic benefit, smaller and less costly development programs, and faster tracks to registration with enhanced patent protection and marketing rights. The company plans to increase R&D investment to 522 billion JPY to advance 40+ prioritized NMEs and new partnerships, as well additional capabilities in oncology and data and digital sciences. In FY2020, Takeda gained 12 global and regional approvals in the U.S., EU, China and Japan.
The main driver for new product launches in the near term are 11 NMEs that include several potential best-in-class / first-in-class therapies, and two regional COVID-19 vaccines. Takeda anticipates five to six “Wave 1” new molecular entities (NMEs) to be submitted to FDA in FY2021, with the potential for four more approvals. The following highlights some of these therapies.
Recently, Takeda’s Dengue vaccine candidate TAK-003, was shown to prevent 83.6% of hospitalizations and 62% of Dengue illness overall, in an ongoing Phase 3 trial, with no identified safety risks through three years following vaccination. Regulatory filings are progressing in the EU and many Dengue-Endemic Countries; filing in in the U.S. is planned for later this year. According to the company, Dengue is the fastest-spreading mosquito-borne viral disease with an estimated 390 million cases and 500,000 hospitalizations each year globally, with limited prevention options.
Mobocertinib (TAK-788), a potential new oral standard of care for epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC), has completed its NDA submission with a potential approval in FY2021. Mobocertinib was granted priority review by the FDA and is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.
Meanwhile, primary analysis from a Phase 3 trial evaluating Maribavir (TAK-620) showed significantly more patients achieved cytomegalovirus (CMV) clearance versus conventional therapies in transplant recipients with CMV infection. The trial met key secondary endpoints, maintaining superior CMV clearance and is on track for NDA submission. The FDA granted the drug priority review and breakthrough therapy designation. If approved, Maribavir will be the first treatment indicated for post-transplant CMV infection in patients that are refractory, with or without resistance. Maribavir is Takeda’s fourth NME accepted for regulatory review within a six month period.
Also, Orexin (TAK-994), is a potential first therapy to treat orexin deficiency, which is associated with narcolepsy type 1, a rare, underdiagnosed and undertreated condition that disrupts the sleep awake cycles, and with narcolepsy type 2 and idiopathic hypersomnia to follow as potential additional indications.
These are in addition to Soticlestat acquired from Ovid Therapeutics and TAK-186 acquired from Maverick Therapeutics, as mentioned above.
COVID efforts
Takeda has partnered with the Government of Japan, Novavax and Moderna, to help accelerate the availability of COVID-19 vaccines leveraging its extensive global manufacturing and supply capabilities and building on its existing influenza pandemic preparedness efforts in Japan. Takeda also has a mutual agreement with IDT Biologika GmbH to use capacity at IDT for three months, previously reserved for Takeda’s dengue vaccine candidate, to manufacture Johnson & Johnson’s single-shot COVID-19 vaccine.
This past February the first subject was dosed in its Phase 1/2 immunogenicity and safety study of Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan, and Takeda completed enrollment in its Phase 1/2 immunogenicity and safety study of Moderna’s COVID-19 vaccine candidate (TAK-919) in Japan. Results from the TAK-919 study are expected in 1H21 and results from the TAK-019 study in 2H21. Once available, results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) as part of the NDA filing process. Pending regulatory approval, Takeda intends to start distributing TAK-919 in the 1H21 and aims to start distributing TAK-019 in late 2021.