Supplementary Documents [IFRS] Financial results for the the fiscal year 2019 (FY2019) Astellas Pharma Inc. - FY2019 Financial Results For the year ended March 31, 2020 Three months ended March 31, 2020 - Pipeline list Cautionary Notes In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this material is not intended to constitute an advertisement or medical advice. S-1
24
Embed
Supplementary Documents [IFRS]...Financial results for the the fiscal year 2019 (FY2019) Astellas Pharma Inc. - FY2019 Financial Results For the year ended March 31, 2020 Three months
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Supplementary Documents [IFRS] Financial results for the the fiscal year 2019 (FY2019)
Astellas Pharma Inc.- FY2019 Financial Results
For the year ended March 31, 2020
Three months ended March 31, 2020
- Pipeline list
- Cautionary Notes In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are nothistorical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and newproducts effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highlycompetitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this material is not intendedto constitute an advertisement or medical advice.
S-1
[For the year ended March 31, 2020]1. Consolidated Results (Full Basis)
Unit: B¥ Revised Forecasts ForecastsChange from
FY19
FY18 FY19 Change Change FY19 FY20 ChangeFull Year Full Year (%) Full Year Full Year (%)
Ratio to Revenue 22.4% 21.3%Gross profit 1,014.3 1,024.1 9.8 1.0%SG&A expenses 490.3 499.3 9.0 1.8%
Ratio to Revenue 37.5% 38.4% Advertising and Sales Promotion 158.1 172.4 14.3 9.1% Personnel expenses 182.2 179.8 -2.3 -1.3% Other 150.0 147.0 -3.0 -2.0%R&D expenses 208.7 224.2 15.5 7.4% 216.0 239.0 6.6%
Ratio to Revenue 16.0% 17.2% 17.2% 18.6%Amortisation of intangible assets 35.2 21.2 -14.0 -39.9%Share of profit (loss) of investments accounted for using equity method -1.6 -1.7 -0.0 -Operating profit 278.5 277.8 -0.8 -0.3% 264.0 257.0 -7.5%
Ratio to Revenue 21.3% 21.4% 21.0% 20.0%Finance income 6.3 4.4 -2.0 -31.2%Finance expense 1.3 3.0 1.7 130.7%Profit before tax 283.6 279.1 -4.4 -1.6%
Ratio to Revenue 21.7% 21.5%Income tax expense 34.2 55.9 21.7 63.5%Profit 249.3 223.2 -26.2 -10.5% 214.0 206.0 -7.7%
Ratio to Revenue 19.1% 17.2% 17.0% 16.1%
3. Exchange Rate Unit: yen Revised Forecasts Forecasts
FY18 FY19 FY18 FY19 FY19 FY20Ave. Ave. End End Full Year Full Year
USD/Yen 111 109 111 109 108 110 EUR/Yen 128 121 125 120 120 120 * Fx impacts:Net sales -36.7 billion yen and Core operating profit -12.6 billion yen * Fx impact on elimination of unrealized gain: COGs ratio -0.3ppt
Share of profit (loss) of investments accounted for using equitymethod
* "Other income" and "Other expense" are excluded from Full basis results. "Other income" and "Other expense" include gain/loss on sale and disposal of property, plant and equipment, impairment losses, restructuring costs, litigation costs and foreignexchange gains/losses, etc.
FY19Full year Full year
FY18
S-4
5. Revenue by Region Unit: B¥ Revised Forecasts ForecastsChange from
FY19
FY18 FY19 Change Change FY19 FY20 ChangeFull Year Full Year (%) Full Year Full Year (%)
Ratio to Revenue 28.3% 26.6% 26.7% 22.6%United States 421.6 443.5 21.9 5.2% 427.8 490.9 10.7%
Ratio to Revenue 32.3% 34.1% 34.1% 38.3%Established Market 300.0 296.1 -3.9 -1.3% 283.8 299.0 1.0%
Ratio to Revenue 23.0% 22.8% 22.6% 23.3%Greater China 62.4 60.4 -2.1 -3.3% 62.5 67.6 12.0%
Ratio to Revenue 4.8% 4.6% 5.0% 5.3%International 122.7 134.8 12.1 9.9% 129.1 120.1 -10.9%
Ratio to Revenue 9.4% 10.4% 10.3% 9.4%Others 30.2 20.7 -9.5 -31.4% 18.0 15.3 -26.4%
Ratio to Revenue 2.3% 1.6% 1.4% 1.2%- Established Market: Europe, Canada, Australia- Greater China: China, Hong Kong, Taiwan- International: Russia, Latin America, Middle East, Africa, South East Asia, South Asia, Korea, Export sales, etc.
6. Per Share Information Revised Forecasts ForecastsFY18 FY19 FY19 FY20
Full Year Full Year Full Year Full YearThe number of shares issued (thousand) 1,979,823 1,861,787 Treasury Shares (thousand) 93,986 4,276 The number of shares issued after deducting Treasury Shares (thousand) 1,885,837 1,857,511 Earnings per share (yen) 115.05 104.15 111.37 108.75 Earnings per share (yen) core base 129.07 118.95 113.49 110.90 Dividend per share (yen) 38 40 40 42
Return on Equity (%) 17.6% 15.3%Dividend on Earnings (%) 5.8% 5.9%
7. Addition to Property, Plant and Equipment Depreciation/Amortisation
Unit: B¥ Revised Forecasts ForecastsChange from
FY19
FY18 FY19 Change Change FY19 FY20 ChangeFull Year Full Year (%) Full Year Full Year (%)
Addition to Property, Plant and EquipmentConsolidated 27.7 41.8 14.0 50.5% 44.0 29.0 -30.6%
- International: Russia, Latin America, Middle East, Africa, South East Asia, South Asia, Korea, Export sales, etc.
S-9
9. Consolidated statements of financial positionUnit: B¥
End EndAssets 1,897.6 2,318.2 420.5
Non-current assets 1,040.5 1,450.6 410.2 Property, plant and equipment 173.5 268.6 95.1 Goodwill 225.9 267.5 41.6 Intangible assets 429.7 738.5 308.8 Trade and other receivables 25.2 34.0 8.8 Investments accounted for using equity method 3.7 4.7 1.0 Deferred tax assets 93.0 52.9 -40.1 Other financial assets 81.5 74.3 -7.2 Other non-current assets 8.1 10.2 2.1
Current assets 857.2 867.5 10.4 Inventories 151.5 151.0 -0.5 Trade and other receivables 342.6 347.0 4.4 Income tax receivable 20.1 23.6 3.4 Other financial assets 2.6 9.5 6.9 Other current assets 25.1 18.0 -7.0 Cash and cash equivalents 311.1 318.4 7.3 Assets held for sale 4.1 - -4.1
Unit: B¥
End EndEquity and Liabilities 1,897.6 2,318.2 420.5
Equity 1,258.4 1,289.2 30.8 Equity attributable to owners of the parent 1,258.4 1,289.2 30.8
Share capital 103.0 103.0 - Capital surplus 177.3 177.5 0.2 Treasury shares -164.6 -7.2 157.5 Retained earnings 992.0 905.9 -86.1 Other components of equity 150.8 110.0 -40.8
Trade and other payables 1.6 3.1 1.6 Deferred tax liabilities 5.2 27.7 22.5 Retirement benefit liabilities 40.2 38.1 -2.1 Provisions 5.4 6.1 0.7 Other financial liabilities 52.9 129.3 76.4 Other non-current liabilities 36.4 26.0 -10.4
Current liabilities 497.7 798.7 301.0 Trade and other payables 185.3 172.0 -13.3 Income tax payable 17.6 4.0 -13.6 Provisions 22.8 14.2 -8.6 Other financial liabilities 14.1 345.7 331.6 Other current liabilities 255.9 262.8 6.9 Liabilities directly associated with assets held for sale 1.9 - -1.9
FY19 Change
FY18 FY19 Change
FY18
S-10
10. Employees Number of employees
FY18 FY19End End
Total 16,243 15,883
11. ShareholdersFY18 FY19End End
Banks 32.4% 35.6%Securities 4.3% 2.8%Other companies 3.0% 3.2%Foreign companies 47.0% 49.8%Individuals and others 8.6% 8.6%Treasury Stock* 4.7% 0.1%* Treasury Stock does not include shares owned by the executive compensation BIP (Board Incentive Plan) trust.
S-11
[For the year ended March 31, 2020]1. Consolidated Results (Full Basis) Unit: B¥
Ratio to Revenue 29.5% 26.8% 27.5% 22.2%United States 105.3 2.5% 111.4 5.9% 115.1 1.7% 111.6 11.1%
Ratio to Revenue 31.5% 35.2% 34.1% 35.7%Established Market 75.8 -1.4% 71.0 -2.4% 71.2 -10.2% 78.1 10.0%
Ratio to Revenue 22.7% 22.4% 21.1% 25.0%Greater China 14.7 7.4% 14.7 -5.9% 14.9 -5.1% 16.0 -7.8%
Ratio to Revenue 4.4% 4.6% 4.4% 5.1%International 34.2 6.6% 29.1 -6.2% 39.5 25.6% 32.0 13.8%
Ratio to Revenue 10.2% 9.2% 11.7% 10.2%Others 5.6 -41.0% 5.3 -23.2% 4.4 -37.4% 5.4 -20.3%
Ratio to Revenue 1.7% 1.7% 1.3% 1.7%- Established Market: Europe, Canada, Australia- Greater China: China, Hong Kong, Taiwan- International: Russia, Latin America, Middle East, Africa, South East Asia, South Asia, Korea, Export sales, etc.
4. Addition to Property,Plant and EquipmentDepreciation/Amortisation
Harnal/Omnic 10.9 -4.7% 11.3 -6.2% 11.1 -11.0% 9.4 -18.1%Funguard/MYCAMINE 9.0 3.2% 8.7 -7.6% 9.5 11.3% 7.9 1.9%Eligard 3.6 -11.7% 3.2 -6.2% 3.8 -3.2% 3.5 7.1%- Sales of products in Japan are shown in a gross sales basis- Established Market: Europe, Canada, Australia- Greater China: China, Hong Kong, Taiwan- International: Russia, Latin America, Middle East, Africa, South East Asia, South Asia, Korea, Export sales, etc.
- International: Russia, Latin America, Middle East, Africa, South East Asia, South Asia, Korea, Export sales, etc.
S-18
R&D Pipeline The list shows the development status in the target diseases for which we aim to obtain approval in Japan, the United States, Europe and/or China. As of May 13, 2020
Underlined items indicate changes from the previous announcement on Jan 31, 2020.
Key post-POC projects and projects to maximize their VALUE (1/2)
Astellas hasrights in Japan,Europe, theCommonwealthof IndependentStates, theMiddle East, andSouth Africa.
Updates from the previous announcement (Jan 2020):enzalutamide (MDV3100): Removed the description of the approval in China for metastatic castration-resistant prostate cancer in Nov 2019 and in US for metastatic castration-sensitive prostate cancer in Dec2019.enfortumab vedotin (ASG-22ME): Removed the description of the approval in US for locally advanced or metastatic urothelial cancer in patients who have received prior treatment with a PD-1/PD-L1 inhibitorand platinum-containing chemotherapy in Dec 2019.gilteritinib (ASP2215): Filed in China for relapsed or refractory acute myeloid leukemia with a FLT3 mutation in Mar 2020. Entered into Phase 1 for acute myeloid leukemia in pediatric patients.
FibroGenHIF-PH inhibitor
* Compounds are developed globally unless noted. The list shows the most advanced stage if the stages are different depending on the region. The list specifies the area if the compound is developed in limited areas.** Compounds with "In-house" in this column include ones discovered by collaborative research.
Others ASP3772 Next generationvaccine (MAPStechnology)
Infectiousdisease
Pneumococcal vaccinebased on a multiple antigen-presenting system (MAPS)platform
Prevention of pneumococcal disease P-II Affinivax
Updates from the previous announcement (Jan 2020):AT845: Entered into Phase 1 for Pompe disease.reldesemtiv (CK-2127107): Discontinued the development for spinal muscular atrophy and amyotrophic lateral sclerosis in Phase 2 due to strategic prioritization.
Phase *
* Compounds are developed globally unless noted. The list shows the most advanced stage if the stages are different depending on the region. The list specifies the area if the compound is developed in limited areas.** Compounds with "In-house" in this column include ones discovered by collaborative research.
Update from the previous announcement (Jan 2020):micafungin: Removed the description of the approval in US for invasive candidiasis in neonates and young infants less than 120 days of life in Dec 2019.fidaxomicin: Approved in EU for clostridium difficile infection in pediatric patients in Feb 2020.ASP0819: Discontinued the development for fibromyalgia in Phase 2 due to strategic prioritization.ASP4345: Discontinued the development for cognitive impairment associated with schizophrenia because Phase 2 study did not meet its primary endpoint.
* Compounds are developed globally unless noted. The list shows the most advanced stage if the stages are different depending on the region. The list specifies the area if the compound is developed in limited areas.** Compounds with "In-house" in this column include ones discovered by collaborative research.
Antibody
Antibody-drug conjugate (ADC)
Small molecule
Small molecule
Small molecule
Antibody
Small molecule
Small molecule
Small molecule
Small molecule
Small molecule
Phase *Modality / Technology
S-23
Rx+TM ProgramAs of May 13, 2020
Underlined item indicates changes from the previous announcement on Jan. 31 2020
Sphere(Business area ) Project Remarks
Chronicdiseaseprogressionprevention
Smartphoneapplication
BlueStar
Patientoutcomemaximization
ASP5354
Status
Update from the previous announcement (Jan 2020):Smartphone application: Enter into agreement with BANDAI NAMCO Entertainment to co-develop and co-commercialize smartphone exercise support application
P-Ⅱ
Preparing for productdevelopment
Implementing medical andhealth research
Partner
Welldoc
BANDAI NAMCOEntertainment
Concept
Precision surgery-guide enabling identification of ureter in hysterectomy and colorectal surgery, etc.
Digital therapeutics for adults with diabetes
Offer smartphone application to support exercise using wearable device to people who needs regularexercise