Astellas Pharma Inc

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Astellas Pharma, Inc. engages in the research, development, manufacture, import, and export of pharmaceutical products. Its products focus on therapeutic fields that include transplantation, immunology, infectious diseases, urology, oncology, neuroscience, diabetic complications, and metabolic diseases. The firm's global brands include Prograf, Vesicare, Protopic, Harnal, and Funguard. The company was founded by Kenji Yamanouchi in April 1923 and is headquartered in Tokyo, Japan.

Poseida Therapeutics

- Leverages Poseida's proprietary allogeneic CAR-T platform to develop innovative convertibleCAR® programs targeting solid tumors - TOKYO and SAN DIEGO , May 1, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Poseida Therapeutics, Inc. (NASDAQ: PSTX, President and CEO: Kristin Yarema, "Poseida") today announced that Xyphos Biosciences, Inc., (a wholly owned subsidiary of Astellas, "Xyphos") and Poseida have entered into a research collaboration and license agreement to develop novel convertibleCAR® programs by combining the innovative cell therapy platforms from each of the companies. Poseida is advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases.

Astellas and Poseida Therapeutics Enter Into Research Collaboration and License Agreement to Develop Novel Allogeneic Cell Therapies in Oncology

Astellas Pharma Inc. (OTCPK:ALPMF) Q4 2023 Results Conference Call April 25, 2024 4:00 AM ET Company Participants Hiromitsu Ikeda - Chief Communications and Investor Relations Officer Naoki Okamura - President and Chief Executive Office Yoshitsugu Shitaka - Chief Scientific Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Atsushi Kitamura - Chief Financial Officer Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Shinichiro Muraoka - Morgan Stanley MUFJ Securities Akinori Ueda - Goldman Sachs Securities Kasumi Haruta - UBS Securities Kazuaki Hashiguchi - Daiwa Securities Seiji Wakao - JPMorgan Securities Miki Sogi - AllianceBernstein Japan Ltd Shinya Tsuzuki - Mizuho Securities Hiromitsu Ikeda Thank you very much for joining our FY 2023 earnings call, despite your busy schedule. I'm Chief Communications and IR Officer, Ikeda.

Astellas Pharma Inc. (ALPMF) Q4 2023 Earnings Call Transcript

XTANDI is now the first and only novel hormone therapy available for the treatment of high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in the European Union (EU) XTANDI can be given alone or in combination with androgen deprivation therapy Approval is based on results from the positive Phase 3 EMBARK study which showed XTANDI alone or in combination with leuprolide reduced the risk of metastasis or death TOKYO , April 23, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy. The extended approval for XTANDI is based on results from the Phase 3 EMBARK trial in 1,068 men with high-risk BCR nmHSPC, in whom levels of prostate-specific antigen (PSA), the biomarker which can be indicative of prostate cancer activity, doubled in nine months or less.

Astellas' XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting

- Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing chemotherapy- - If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer- TOKYO , March 28, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for enfortumab vedotin with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved, enfortumab vedotin with KEYTRUDA has the potential to change the treatment paradigm, becoming the first combination treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

China's National Medical Products Administration Accepts Astellas and Pfizer's Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Permanent J-code J2782 effective April 1, 2024 NORTHBROOK, Ill. , March 26, 2024 /PRNewswire/ -- Iveric Bio, An Astellas Company (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the U.S. Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPS) J-code for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Astellas Receives Permanent J-code for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

VYLOY approved in combination with chemotherapy for patients with human epidermal growth factor receptor 2 (HER2)-negative, CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer MHLW approval makes VYLOY the first and only CLDN18.2-targeted therapy approved in the world TOKYO , March 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that on March 26, 2024, Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. VYLOY is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world.

Astellas' VYLOY™ (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer

- If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk biochemical recurrent non-metastatic hormone sensitive prostate cancer patient populations in the European Union (EU) - A decision on the EU marketing authorisation is expected by June 2024- TOKYO , March 22, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.1 Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas "Men with nmHSPC with high-risk biochemical recurrence are very likely to experience disease progression. With approximately 9 out of 10 of these men developing metastatic disease, the need for new and effective treatment options is critical.

Astellas Receives Positive CHMP Opinion for XTANDI™ in Additional Recurrent Early Prostate Cancer Treatment Setting

DUNDEE, Scotland--(BUSINESS WIRE)--Ubiquigent Limited (Ubiquigent), a drug discovery and development company harnessing novel deubiquitinase (DUB) modulators as new therapeutics for areas of high unmet medical need, today announced an agreement with Nanna Therapeutics (Nanna). Under the terms of the agreement, Ubiquigent will provide Nanna with access to its deubiquitylase (DUB) focused drug discovery platform to support the development of novel therapeutics for human disease targets selected b.

Ubiquigent Enters Agreement With Astellas Subsidiary, Nanna Therapeutics

TOKYO , March 3, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms (VMS) associated with menopause in Japanese women. In Japan, two Phase 3 clinical studies are underway.

Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan

- Innovative universal, off-the-shelf in vivo CAR-T Cell therapy - TOKYO and BOSTON , Feb. 15, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Kelonia Therapeutics (CEO, Founder: Kevin Friedman, Ph.D., "Kelonia") today announced that Xyphos Biosciences, Inc., (a wholly owned subsidiary of Astellas, "Xyphos") and Kelonia have entered into a research collaboration and license agreement to develop novel Immuno-Oncology therapeutics.

Astellas and Kelonia Therapeutics Enter into Research and License Agreement to Develop Novel Immuno-Oncology Therapeutics

TOKYO , Feb. 6, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the following changes to its management structure effective April 1, 2024. Top Management Addition of Chief Digital & Transformation Officer ( C DTO)  to the Top Management Digital initiatives and investments are critical in every part of Astellas business for transformation and to create VALUE creation for patients.

Astellas Makes Announcement about Management Structure

Astellas is returning to the Super Bowl to help educate game viewers about VEOZAH and vasomotor symptoms (VMS), the most commonly reported menopause symptoms 1 The "Fewer Hot Flashes, More Not Flashes" ad features women experiencing common moderate to severe hot flash and night sweat moments that impact their daily lives NORTHBROOK, Ill. , Feb. 1, 2024 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that it will air a new version of its commercial for VEOZAH® (fezolinetant) just before Super Bowl kickoff on Sunday, February 11, 2024.

Astellas to Air New VEOZAH® (fezolinetant) TV Spot During the Super Bowl

– Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing chemotherapy –  – If approved, PADCEV with KEYTRUDA would be the first combination in Japan to offer an alternative to chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer –  TOKYO , Jan. 31, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a Supplemental New Drug Application (sNDA) on January 31 to Japan's Ministry of Health, Labour and Welfare (MHLW) for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved, PADCEV with KEYTRUDA has the potential to change the treatment paradigm, becoming the first combination treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

Astellas Submits Supplemental New Drug Application in Japan for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer

- Five-year collaboration to advance translational medicine and accelerate early development of novel therapies -- Focus on oncology, rare disease, and cell and gene therapies - TOKYO , Jan. 30, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that it has entered into a strategic collaboration with Mass General Brigham (President and CEO: Anne Klibanski, MD) that is focused on translational medicine and early development to establish an integrated approach to scientific advancement and clinical expertise. Initial projects of mutual interest will be focused in key areas of R&D investment for Astellas, including oncology, rare disease, and cell and gene therapy.

Astellas Announces Strategic Collaboration with Mass General Brigham

Japan's Astellas Pharma said on Monday the U.S. Food and Drug Administration (FDA) has declined to approve its experimental drug to treat a type of gastric cancer, citing issues related to a third-party manufacturer.

US FDA declines to approve Astellas' gastric cancer drug

TOKYO , Jan. 8, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. The FDA stated that the agency cannot approve the BLA by the Prescription Drug User Fee Act (PDUFA) action date of January 12, 2024, due to unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab.

Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.

BOSTON--(BUSINESS WIRE)--Propella has been acquired by Astellas Pharma; Outcome Capital serves as strategic advisor to Peterson Companies, majority shareholder of Propella.

Outcome Capital Announces Acquisition of Propella Therapeutics, Portfolio Company of Peterson Companies, by Astellas Pharma

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SHANGHAI and SUZHOU, China and TOKYO , Dec. 28, 2023 /PRNewswire/ -- Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D.

Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager

TOKYO , Dec. 21, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that it has completed the acquisition of Propella Therapeutics, Inc. (President and CEO: William Moore, "Propella"), and has become a wholly owned subsidiary of Astellas as of U.S. Eastern Time December 21, 2023. Through the acquisition of Propella, Astellas has acquired PRL-02 (abiraterone decanoate), a next-generation androgen biosynthesis inhibitor being developed by Propella to treat prostate cancer.

Astellas Completes Acquisition of Propella Therapeutics

The European Commission has approved Astellas Pharma's fezolinetant, a non-hormonal treatment for managing moderate-to-severe vasomotor symptoms (VMS) like hot flashes and night sweats in menopausal women. This approval addresses a large unmet need, as up to 97% of women aged 40 to 64 in Europe experience these symptoms.

Astellas gets green light from European Commission for menopause drug

- Astellas contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium - TOKYO , Dec. 17, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium (Consortium). The Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel to treat one of the neglected tropical diseases, schistosomiasis, in preschool-aged children (3 months to 6 years of age) on December 15.

EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children

The U.S. Food and Drug Administration on Friday approved Astellas Pharma's Padcev in combination with Merck's Keytruda for a type of bladder cancer.

US FDA approves Astellas' combination therapy for bladder cancer

Both companies have earned a year-long opportunity for access to a distinguished life-science incubator in San Francisco, CA, along with the invaluable expertise provided by Astellas to advance their research endeavors Award helps biotech start-ups accelerate early research efforts TOKYO and SAN FRANCISCO , Dec. 12, 2023 /PRNewswire/ -- Astellas Venture Management LLC (President: William Watt, Ph.D., "AVM"), a wholly-owned venture capital subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Mission BioCapital BioLabs ("MBC BioLabs"), a life-science incubator, today announced TippingPoint Biosciences and Altay Therapeutics as the winners of the Astellas-sponsored "Future Innovator Prize" at MBC BioLabs.

Astellas and MBC BioLabs Announce 2023 Future Innovator Prize Awarded to TippingPoint Biosciences and Altay Therapeutics

First-in-class treatment option reduces number and intensity of hot flashes and night sweats  TOKYO , Dec. 10, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.  VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS, with rates in Europe ranging from 56% to 97%.3,4,5 The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.6 VMS can have a disruptive impact on women's daily activities and overall quality of life.2 Prof.

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