General Announcement::The 145th Interim Business Report (April 1, 2021 - September 30, 2021)
11/30/2021 | 06:31am EST
The 145th (interim period)
April 1, 2021 ― September 30, 2021
Takeda Pharmaceutical Company Limited
TSE Code: 4502
I am pleased to share Takeda's Business Report for the 145th interim period (April 1, 2021 to September 30, 2021).
Takeda's fi rst-half results, announced on October 28, 2021, demonstrated strong progress and conviction in our strategy and our consistent efforts to deliver on our fundamentals. As a result, we confi rmed full-year FY2021 guidance and we continue to track toward topline growth and strong core operating profi t margins. Our strategic vision to discover and deliver life-transforming treatments is supported by the strength of our leading products and our innovative pipeline. Our growth is driven by our 14 Global Brands, and we expect that our brands will remain our primary growth driver for the coming years. Our ambitious pipeline is starting to deliver results, including the recent U.S. FDA approval of EXKIVITY. We have a highly innovative pipeline of approximately 40 clinical stage assets diversifi ed across four core therapeutic areas, and while there have been setbacks with TAK-994 and pevonedistat, we have confi dence in the potential of the pipeline to transform patients' lives and our business over the long-term.
We believe that the combination of these growth drivers will continue to propel our business forward and help to ensure our future growth is resilient, for not just the next quarter, but the next decade.
The announcement on October 28 of our new share buyback program further demonstrates our confi dence in our business strategy and our commitment to delivering shareholder value.
We appreciate your continued trust and support as we build long-term value for our shareholders and move closer toward realizing our vision to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
Representative Director, President & CEO
About EXKIVITY (mobocertinib)
EXKIVITY is a fi rst-in-class, oral tyrosine kinase inhibitor (TKI) specifi cally designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.
EXKIVITY is approved in the U.S. for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion
mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Results from the Phase 1/2 trial of mobocertinib have
also been accepted for review by the Center for Drug Evaluation (CDE) in China for locally advanced or metastatic NSCLC patients with EGFR Exon20 insertion mutations who
have been previously treated with at least one prior systemic chemotherapy. For more information about EXKIVITY, visit www.EXKIVITY.com. For Prescribing Information, including
Consolidated Financial Results (April 1 to September 30, 2021)
Billion JPY or percentage
Change versus the same period
of the previous fiscal year
Cost of sales
Selling, general and administrative expenses
Research and development expenses
Amortization and impairment losses on
intangible assets associated with products
Other operating income
Other operating expenses
Operating profi t
Finance income and (expenses), net
Share of loss of investments accounted for
using the equity method
Profi t before tax
Income tax expenses
Net profi t for the period
FeatureCondensed Interim Consolidated Financial Highlights Message from CEO
Revenue for the six-month period ended September 30, 2021 was 1,794.4 billion JPY, an increase of
203.6 billion JPY, or 12.8%, compared to the same period of the previous fiscal year. Excluding the impact from fluctuations in foreign exchange rates, which was calculated by translating revenue of the six-month period ended September 30, 2021 using corresponding exchange rates in the same period of the previous fiscal year, the increase in revenue was 8.7%. In April 2021, Takeda completed the sale of a portfolio of diabetes products in Japan to Teijin Pharma Limited for 133.0 billion JPY, which was recorded as revenue and accounted for 8.4 percentage points ("pp") of the increase in revenue. Excluding this selling price from revenue for the six-month period ended September 30, 2021, the increase was 4.4%.
Each of our core therapeutic areas (i.e. Gastroenterology ("GI"), Rare Diseases, Plasma-Derived Therapies ("PDT") Immunology, Oncology, and Neuroscience) contributed to positive revenue growth; however, Rare Diseases would have declined if not for the positive impact of the depreciation of the yen. Intensified competition impacted some products in this area, especially treatments for Rare Hematology. Overall, the global spread of COVID-19 did not have a material effect on our revenue for the six-month period ended September 30, 2021.
Revenue outside of our core therapeutic areas increased by 68.0 billion JPY, or 23.3%, compared to the same period of the previous fiscal year to 359.8 billion JPY, largely due to the 133.0 billion JPY selling price of the diabetes portfolio in Japan, offsetting the impact from divestitures.
Year-on-year change in revenue for this six-month period in each of our main therapeutic areas was primarily attributable to the following products:
In Gastroenterology, revenue was 429.1 billion JPY, a year-on-year increase of 49.3 billion JPY, or 13.0%. Growth was driven by Takeda's top-selling product ENTYVIO (for ulcerative colitis ("UC") and Crohn's disease ("CD")), with sales of 255.9 billion JPY, a year-on-year increase of 48.9 billion JPY, or 23.6%. Sales in the U.S. increased by 28.2 billion JPY, or 19.7%, to 171.3 billion JPY and sales in Europe and Canada increased by
15.1 billion JPY, or 29.3%, to 66.6 billion JPY, due to an increase in demand. In the Growth and Emerging Markets, the increase in sales was primarily driven by Brazil and China. Sales of TAKECAB (for acid-related diseases) were 49.1 billion JPY, an increase of 9.2 billion JPY, or 22.9%, versus the same period of the previous fiscal year. This increase was mainly driven by the expansion of new prescriptions in the Japanese market due to TAKECAB's efficacy in reflux esophagitis and the prevention of recurrence of gastric and duodenal ulcers during low-dose aspirin administration. Sales of GATTEX/REVESTIVE (for short bowel syndrome) were 36.8 billion JPY, an increase of 3.6 billion JPY, or 10.9%. In August 2021, REVESTIVE was launched as the first therapy to treat this disease in Japan. Sales of AMITIZA (for chronic constipation) decreased by 8.5 billion JPY, or 68.6%, to 3.9 billion JPY, due to generic entrants in the U.S. in January 2021.
In Rare Diseases, revenue was 300.1 billion JPY, a year-on-year increase of 4.7 billion JPY, or 1.6%. Revenue in Rare Metabolic increased by 4.6 billion JPY, or 5.8%, compared to the same period of the
previous fiscal year to 84.2 billion JPY. Sales of enzyme replacement therapies VPRIV (for Gaucher disease), REPLAGAL (for Fabry disease) and ELAPRASE (for Hunter syndrome) increased primarily in Europe and Growth and Emerging Markets.
Revenue in Rare Hematology decreased by 1.2 billion JPY, or 0.9%, to 141.6 billion JPY. Sales of ADVATE decreased by 2.1 billion JPY, or 3.3%, to 61.3 billion JPY. Sales of ADYNOVATE increased by 0.5 billion JPY, or 1.6%, to 30.0 billion JPY, helped by the positive impact of the depreciation of the yen. Both products were impacted by the competitive landscape in the hemophilia A non-inhibitors market in the U.S. FEIBA sales decreased by 0.4 billion JPY, or 1.9%, to 20.2 billion JPY.
Revenue in Hereditary Angioedema ("HAE") was 74.3 billion JPY, a year-on-year increase of 1.3 billion JPY, or 1.8%. Sales of TAKHZYRO were 47.5 billion JPY, an increase of 3.8 billion JPY, or 8.7%, versus the same period of the previous fiscal year primarily due to new launches including prefilled syringe administration in Europe. Sales of FIRAZYR decreased by 0.8 billion JPY, or 5.3%, to 14.3 billion JPY, primarily due to the continued impact of generic entrants in the U.S.
Plasma-Derived Therapies (PDT) Immunology
In Plasma-Derived Therapies Immunology, revenue increased by 32.1 billion JPY, or 15.6%, compared to the same period of the previous fiscal year to 238.0 billion JPY. Aggregate sales of immunoglobulin products were 181.3 billion JPY, an increase of 18.7 billion JPY, or 11.5%, compared to the same period of the previous fiscal year. In particular, sales of GAMMAGARD LIQUID (for the treatment of primary immunodeficiency ("PID") and multifocal motor neuropathy ("MMN")) increased due to higher demand versus the same period of the previous fiscal year. In addition, CUVITRU, a SCIG (subcutaneous immunoglobulin) therapy continued to mark double digit growth. Aggregate sales of albumin products including HUMAN ALBUMIN and FLEXBUMIN (primarily used for hypovolemia and hypoalbuminemia) were 41.7 billion JPY, an increase of 13.2 billion JPY, or 46.1%, versus the same period of the previous fiscal year driven by higher China sales following the resolution of the supply interruption which impacted HUMAN ALBUMIN for release in China in the second half of the previous fiscal year.
In Oncology, revenue was 233.7 billion JPY, a year-on-year increase of 23.7 billion JPY, or 11.3%. Sales of VELCADE (for multiple myeloma) increased by 5.1 billion JPY, or 10.2% versus the same period of the previous fiscal year to 55.1 billion JPY. While royalty income outside the U.S. decreased due to continued generic erosion, sales in the U.S. increased by 5.9 billion JPY, or 12.3%, versus the same period of the previous fiscal year. This reflects a rebound in demand after lower sales in the previous fiscal year, particularly in the first quarter, when prescribers favored orally administered products over infusions or injections early in the COVID-19 pandemic. In addition, increased use of VELCADE as part of initial treatment for new patients contributed to the growth this year in the U.S. Sales of NINLARO (for multiple myeloma) were 45.8 billion JPY, an increase of 1.4 billion JPY, or 3.3%, versus the same period of the previous fiscal year. In the U.S., NINLARO's profile as an effective oral treatment led to a temporary increase in demand early in the COVID-19 pandemic in 2020 because its oral administration facilitated treatment in the at-home setting. This benefit has been less impactful in the U.S. this year; however, there have been strong demand increases in other
Feature Condensed Interim Consolidated Financial HighlightsMessage from CEO
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