Takeda Reinforces Long-term Growth Through Pipeline Advancement and Two Targeted Acquisitions; Delivers Another Strong Quarter in FY2022 Q3

Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the third quarter of fiscal year 2022 (period ended December 31, 2022).

Takeda chief financial officer, Costa Saroukos, commented:
"Our third-quarter performance demonstrates sustained momentum as our Growth and Launch Products and solid commercial execution again drove strong revenue and core profit growth. We continue to advance our organic pipeline, including notable approvals in the EU and China, and in December announced a significant acquisition that will add a potentially best-in-class TYK2 inhibitor to our late-stage pipeline and enhance our long-term growth strategy. Our robust cash flow and strong financial position enabled us to make substantive progress in deleveraging even as we continued to invest for growth."

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS
Growth in our key business areas in FY2022 Q3 YTD was driven largely by Growth & Launch Products¹, which delivered reported revenue of 1,199.6 billion yen, marking a +20% increase on a CER basis.

• Gastroenterology (GI), with 857.5 billion yen in reported revenue, grew +11% on a CER basis, driven by ENTYVIO^® (for ulcerative colitis and Crohn's disease; +17% on a CER basis) and by TAKECAB^®/VOCINTI (for acid-related diseases), whose strong uptake in China was also a key contributor to growth.

• Rare Diseases, with 553.6 billion yen in reported revenue, grew +5% on a CER basis. Sales of TAKHZYRO^® (for hereditary angioedema) grew +25% on a CER basis due to expansion of the prophylactic market, continued geographic expansion and strong patient uptake. LIVTENCITYtm (for post-transplant cytomegalovirus) continues to generate high interest and strong uptake since its launch in the U.S. in December 2021, with 87% of U.S. transplant centers having initiated therapy with at least one patient.
• Plasma-Derived Therapies (PDT) Immunology, with 502.4 billion yen in reported revenue, delivered outstanding growth of +18% on a CER basis. Growth was driven by higher sales of immunoglobulin products (for primary immunodeficiency and multifocal motor neuropathy), with +19% growth on a CER basis, particularly in the U.S. amid easing of pandemic pressures coupled with increasing supply. Robust growth for albumin products (primarily used for hypovolemia and hypoalbuminemia), at +20% on a CER basis, was driven by strong demand in the U.S. and in China. We added 5 donation centers as planned in the U.S. in FY2022 Q3, bringing us to 21 new centers YTD, and our global donation network to 225 centers.
• Oncology, with 345.0 billion yen in reported revenue, declined -13% on a CER basis as a result of the expected entry of VELCADE^® generics (for multiple myeloma) that began in the U.S. in May 2022. Besides VELCADE, all other revenue totaled 320.2 billion yen, a year-over-year increase of +7% on a CER basis, driven by strong demand for ALUNBRIG^® (for non-small cell lung cancer; +39% growth on a CER basis) in Europe and Growth & Emerging Markets, and China. ADCETRIS^® (for malignant lymphomas) grew +18% on a CER basis, driven by increased access and uptake in frontline indications, while increased awareness of positive OPTIC trial results and label update contributed to +13% growth of ICLUSIG^® (for Leukemia) on a CER basis. Sales of EXKIVITY^® (for non-small cell lung cancer), which was first launched in the U.S. in September 2021 followed by several other countries, also contributed.
• Neuroscience, with 477.1 billion yen in reported revenue, grew +10% on a CER basis, driven by an expanding ADHD adult market in the U.S., Europe and Canada for VYVANSE^®/ELVANSE. Sales of TRINTELLIX were 79.7 billion yen (+5% growth on a CER basis), due to continued recovery of the Major Depressive Disorder market in the U.S. and strong market share gains in Japan.

PIPELINE UPDATE
Takeda has continued to deliver on its ability to bring new therapies to patients and capitalize on momentum within its innovative pipeline. Updates since the FY2022 H1 announcement include:

• Takeda announced that it has entered into an exclusive licensing agreement with HUTCHMED for the further development and commercialization of fruquintinib worldwide (ex-China, Hong Kong, and Macau). Fruquintinib is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. It is orally administered and offers a potential new treatment option for patients with refractory metastatic colorectal cancer, regardless of biomarker status.
  Additional information related to this announcement is available here.
  

• Takeda announced that it will acquire NDI-034858, an oral selective allosteric TYK2 inhibitor being evaluated for the potential treatment of multiple autoimmune diseases, from Nimbus Therapeutics. With Phase 3 studies in psoriasis expected to begin this year, NDI-034858 has the potential to demonstrate best-in-class efficacy and safety and convenience in psoriasis as well as other immune-mediated diseases including psoriatic arthritis, inflammatory bowel disease and systemic lupus erythematosus. The acquisition is expected to strengthen Takeda's growing late-stage pipeline in alignment with the company's therapeutic area strategy and expertise in immune-mediated diseases. Takeda will pay Nimbus USD 4 billion upfront in addition to two milestone payments of USD 1 billion each upon achieving annual net sales of USD 4 billion and USD 5 billion for products developed from the NDI-034858 program. The upfront payment will be primarily funded by cash on hand. The transaction is expected to be finalized before the end of FY2022.
  Additional information related to this announcement is available here.
  

• QDENGA, Takeda's dengue vaccine, was approved by the European Commission (EC) in December 2022 for use in individuals four years of age and older. With the EC approval, QDENGA becomes the only dengue vaccine approved in the EU for use in individuals regardless of previous dengue exposure. In November, the U.S. FDA granted priority review of the Biologics License Application.
  Additional information related to the EC and U.S. FDA announcements is available here and here.

• China's National Medical Products Administration (NMPA) approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY is now the first and only treatment available for this patient population in China and was reviewed as part of the NMPA's Breakthrough Therapy program.
  Additional information related to this announcement is available here.

• LIVTENCITY^tm (maribavir) was approved by the European Commission (EC) for the treatment of adults with post-transplant cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies. This approval makes LIVTENCITY the first and only treatment approved for this indication by the EC. CMV is one of the most common and serious post-transplant infections and can lead to loss of transplanted organ and failure of graft.
  Additional information related to this announcement is available here.

• Takeda announced favorable safety and efficacy results of TAK-755 from the first and only Phase 3 trial in congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare disease with limited treatment options. Based on this data, Takeda aims to seek marketing authorization for TAK-755 as the first recombinant ADAMTS13 replacement therapy for cTTP, a disorder with considerable unmet patient need.
  Additional information related to this announcement is available here.

• Takeda and Arrowhead Pharmaceuticals Inc. announced topline results from the SEQUOIA Phase 2 study of investigational fazirsiran (TAK-999/ARO-AAT) in patients with liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD). Takeda has initiated a Phase 3 study to evaluate the safety and efficacy of fazirsiran in the treatment of patients with AATD-LD with METAVIR stage F2 to F4 fibrosis.
  Additional information related to this announcement is available here.

• Results from Takeda's Phase 3 AURORA trial provided evidence of maribavir's clinically meaningful and durable effect in cytomegalovirus infection in hematopoietic stem cell transplant patients despite missing the primary endpoint. Full data results will be submitted for publication in a peer-reviewed journal and are being shared with relevant regulatory agencies.
  Additional information related to this announcement is available here.

• Takeda's Phase 3 PhALLCON trial met its primary endpoint, demonstrating that adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) treated with ICLUSIG^® (ponatinib) plus reduced-intensity chemotherapy achieved higher rates of minimal residual disease-negative complete remission compared to imatinib. There are currently no targeted treatments approved for Ph+ ALL in the U.S.
  Additional information related to this announcement is available here.

• TAK-861, Takeda's oral orexin agonist for narcolepsy, met pre-specified criteria set to advance the program into two Phase 2b studies in narcolepsy type 1 and narcolepsy type 2. Both Phase 2b trials are currently enrolling patients.
  Additional information related to this update is available here.

About Takeda
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI), with expertise in immune and inflammatory diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.

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¹Please refer to slide 18 of Takeda's FY2022 Q3 investor presentation (available at takeda.com/investors/financial-results) for the definition of Growth & Launch Products.